,,ii ,cal5d> ,no4 #ddd #aag? ,,congress #b;d ,session ,s4 #dcdh ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,may #bf1 #bjbb,mrs4 ,murray 7= h]self & ,mr4 ,burr7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,july #ac1 #bjbb,report$ by ,mrs4 ,murray1 ) an amendment,strike out all aft] ! enact+ clause & ins]t ! "p pr9t$ 9 italic ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to revise & ext5d ! us]-fee programs = prescription drugs1 m$ical devices1 g5]ic drugs1 & biosimil> biological products1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,food & ,drug ,adm9i/ration ,safety & ,l&m>k ,advancem5ts ,act ( #bjbb or ! ,,fdasla ,act ( #bjbb4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4,,title ,i--,fees relat+ to drugs,sec4 #aja4 ,%ort title2 f9d+4,sec4 #ajb4 ,def9itions4,sec4 #ajc4 ,au?ority to assess & use drug fees4,sec4 #ajd4 ,reau?orization2 report+ requirem5t4,sec4 #aje4 ,sunset dates4,sec4 #ajf4 ,effective date4,sec4 #ajg4 ,sav+s clause4,,title ,,ii--,fees relat+ to devices,sec4 #bja4 ,%ort title2 f9d+4,sec4 #bjb4 ,def9itions4,sec4 #bjc4 ,au?ority to assess & use device fees4,sec4 #bjd4 ,accr$itation programs4,sec4 #bje4 ,sunset dates4,sec4 #bjf4 ,effective date4,sec4 #bjg4 ,sav+s clause4,,title ,,iii--,fees relat+ to g5]ic drugs,sec4 #cja4 ,%ort title2 f9d+4,sec4 #cjb4 ,au?ority to assess & use human g5]ic drug fees4,sec4 #cjc4 ,reau?orization2 report+ requirem5ts4,sec4 #cjd4 ,sunset dates4,sec4 #cje4 ,effective date4,sec4 #cjf4 ,sav+s clause4,,title ,,iv--,fees relat+ to biosimil> biological products,sec4 #dja4 ,%ort title2 f9d+4,sec4 #djb4 ,def9itions4,sec4 #djc4 ,au?ority to assess & use biosimil> biological product fees4,sec4 #djd4 ,reau?orization2 report+ requirem5ts4,sec4 #dje4 ,sunset dates4,sec4 #djf4 ,effective date4,sec4 #djg4 ,sav+s clause4,,title ,v--,improv+ regulation ( drugs & biological products,sec4 #eja4 ,alt]natives to animal te/+4,sec4 #ejb4 ,saf] disposal ( opioids4,sec4 #ejc4 ,cl>ifications to exclusivity provisions = fir/ int]*angeable biosimil> biological products4,sec4 #ejd4 ,improvem5ts to ! ,purple ,book4,sec4 #eje4 ,!rapeutic equival5ce evaluations4,sec4 #ejf4 ,mod]niz+ accel]at$ approval4,,title ,,vi--,o!r reauthorizations,sec4 #fja4 ,reau?orization ( ! critical pa? public-private p>tn]%ip4,sec4 #fjb4 ,reau?orization ( ! be/ ph>maceuticals = *ildr5 program4,sec4 #fjc4 ,reau?orization ( ! humanit>ian device exemption inc5tive4,sec4 #fjd4 ,reau?orization ( ! p$iatric device consortia program4,sec4 #fje4 ,reau?orization ( provision p]ta9+ to drugs conta9+ s+le enantiom]s4,sec4 #fjf4 ,reau?orization ( orphan drug grants4,sec4 #fjg4 ,reau?orization ( c]ta9 device inspections4,,title ,,vii--,enhanc+ ,,fda hir+ authorities,sec4 #gja4 ,enhanc+ ,,fda hir+ au?ority = sci5tific1 te*nical1 & pr(essional p]sonnel4,sec4 #gjb4 ,/rategic work=ce plan & report4,,title ,,viii--,advanc+ regulation ( cosmetics1 diet>y supplem5ts1 & laboratory develop$ tests,subtitle ,a--,cosmetics,sec4 #hja4 ,%ort title4,sec4 #hjb4 ,am5dm5ts to cosmetic requirem5ts4,sec4 #hjc4 ,en=cem5t & con=m+ am5dm5ts4,sec4 #hjd4 ,records inspection4,sec4 #hje4 ,talc-conta9+ cosmetics4,sec4 #hjf4 ,,pfas 9 cosmetics4,sec4 #hjg4 ,fund+4,subtitle ,b--,diet>y supplements,sec4 #haa4 ,regulation ( diet>y supplem5ts4,subtitle ,c--,9 vitro cl9ical tests,sec4 #hba4 ,%ort title2 table ( cont5ts4,sec4 #hbb4 ,def9itions4,sec4 #hbc4 ,regulation ( 9 vitro cl9ical te/s4,sec4 #hbd4 ,en=cem5t & o!r provisions4,sec4 #hbe4 ,transition4,sec4 #hbf4 ,em]g5cy use au?orization4,sec4 #hbg4 ,antimicrobial susceptibility te/s4,sec4 #hbh4 ,comb9ation products4,sec4 #hbi4 ,res\rces4,sec4 #hcj4 ,au?orization ( appropriations4,,title ,,ix--,o!r provisions,sec4 #ija4 ,facilities managem5t4,sec4 #ijb4 ,annual report on inspections4,sec4 #ijc4 ,us] fee program transp>5cy & acc\ntability4,sec4 #ijd4 ,,otc he>+ aids f9al rule4,sec4 #ije4 ,enhance intra-ag5cy coord9ation & public heal? assessm5t ) reg>d to compliance activities4 ,i ,fees relat+ to drugs #aja4 ,%ort title2 f9d+ 7a7 ,%ort title ,?is title may be cit$ z ! ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjbb4 7b7 ,f9d+ ,congress f9ds t ! fees au?oriz$ by ! am5dm5ts made 9 ?is title w be d$icat$ t[>d exp$it+ ! drug developm5t process & ! process = ! review ( human drug applications1 includ+ po/m>ket drug safety activities1 z set =? 9 ! goals id5tifi$ = purposes ( "p #b ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g et seq471 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #ajb4 ,def9itions ,section #gce ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g7 is am5d$-- 7#a7 9 p>agraph 7#a71 9 ! matt] foll[+ subp>agraph 7,b71 by /rik+ an all]g5ic extract product1 or & ins]t+ does n include an application ) respect to an all]g5ic extract product lic5s$ be=e ,octob] #a1 #bjbb1 does n include an application ) respect to a /&>diz$ all]g5ic extract product submitt$ pursuant to a notification to ! applicant f ! ,secret>y reg>d+ ! exi/5ce ( a pot5cy te/ t measures ! all]g5ic activity ( an all]g5ic extract product lic5s$ by ! applicant be=e ,octob] #a1 #bjbb1 does n include an application ) respect to2 7#b7 9 p>agraph 7#c71 9 ! matt] foll[+ subp>agraph 7,c7-- 7,a7 by ins]t+ lic5s$ be=e ,octob] #a1 #bjbb1 a /&>diz$ all]g5ic extract product submitt$ pursuant to a notification to ! applicant f ! ,secret>y reg>d+ ! exi/5ce ( a pot5cy te/ t measures ! all]g5ic activity ( an all]g5ic extract product lic5s$ by ! applicant be=e ,octob] #a1 #bjbb1 aft] an all]g5ic extract product2 7,b7 by add+ at ! end ! foll[+3 ,if a writt5 reque/ to place a product 9 ! discont9u$ section ( ei!r ( ! li/s describ$ 9 subp>agraph 7,c7 is submitt$ to ! ,secret>y on behalf ( an applicant1 & ! reque/ id5tifies ! date ! product is1 or w be1 )drawn f sale1 !n1 = purposes ( assess+ ! prescription drug program fee "u section #gcf7;a77#b71 ! ,secret>y %all consid] su* product to h be5 includ$ 9 ! discont9u$ section on ! lat] ( 7i7 ! date su* reque/ 0 receiv$1 or 7ii7 if ! product w be )drawn f sale on a future date1 su* future date :5 ! product is )drawn f sale4 ,= purposes ( subp>agraph 7,c71 a product %all be consid]$ )drawn f sale once ! applicant has ceas$ its own di/ribution ( ! product1 :e!r or n ! applicant has ord]$ recall ( all previ\sly di/ribut$ lots ( ! product1 except t a r\t9e1 tempor>y int]ruption 9 supply %all n r5d] a product )drawn f sale42 & 7,c7 by add+ at ! end ! foll[+3 7#ab7 ,! t]m sk9-te/ diagno/ic product-- 7,a7 means a product-- 7i7 = prick1 scrat*1 intrad]mal1 or subcutane\s adm9i/ration2 7ii7 expect$ to produce a limit$1 local reaction at ! site ( adm9i/ration 7if positive71 r ?an a sy/emic effect2 7iii7 n int5d$ to be a prev5tive or !rapeutic int]v5tion2 & 7iv7 int5d$ to detect an imm$iate or delay$-type sk9 hyp]s5sitivity reaction to aid 9 ! diagnosis (-- 7,i7 an all]gy to an antimicrobial ag5t2 7,,ii7 an all]gy t is n to an antimicrobial ag5t1 if ! diagno/ic product 0 au?oriz$ = m>ket+ prior to ,octob] #a1 #bjbb2 or 7,,iii7 infection ) fungal or mycobact]ial pa?og5s2 & 7,b7 includes positive & negative controls requir$ to int]pret ! results ( a product describ$ 9 subp>agraph 7,a74 4 #ajc4 ,au?ority to assess & use drug fees 7a7 ,types ( fees ,section #gcf7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7a77 is am5d$-- 7#a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ #bjah & ins]t+ #bjbc2 7#b7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a71 by /rik+ subsection 7c77#e7 ea* place x appe>s & ins]t+ subsection 7c77#f72 7,b7 9 subp>agraph 7,c71 by ins]t+ prior to approval aft] or 0 )drawn2 & 7,c7 by add+ at ! end ! foll[+3 7,h7 ,exception = sk9-te/ diagno/ic products ,a human drug application = a sk9-te/ diagno/ic product %all n be subject to a fee "u subp>agraph 7,a74 2 & 7#c7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a7-- 7i7 by /rik+ subsection 7c77#e7 & ins]t+ subsection 7c77#f72 7ii7 by /rik+ ,except z provid$ & ins]t+ ! foll[+3 7i7 ,paym5t ( fees ,except z provid$ 2 & 7iii7 by add+ at ! end ! foll[+3 7ii7 ,previ\sly discont9u$ drug products ,if a drug product t is id5tifi$ 9 a human drug application approv$ z ( ,octob] #a ( a fiscal ye> is n a prescription drug product z ( t date because ! drug product is 9 ! discont9u$ section ( a li/ id5tifi$ 9 section #gce7c71 & on any subsequ5t day dur+ su* fiscal ye> ! drug product is a prescription drug product1 !n except z provid$ 9 subp>agraphs 7,b7 & 7,c71 ea* p]son :o is nam$ z ! applicant 9 a human drug application ) respect to su* product1 & :o1 aft] ,septemb] #a1 #aiib1 _h p5d+ be=e ! ,secret>y a human drug application or supplem5t1 %all pay ! annual prescription drug program fee e/abli%$ = a fiscal ye> "u subsection 7c77#f7 = su* prescription drug product4 ,su* fee %all be due on ! la/ bus9ess day ( su* fiscal ye> & %all be paid only once = ea* product = a fiscal ye> 9 :i* ! fee is payable4 2 & 7,b7 by am5d+ subp>agraph 7,b7 to read z foll[s3 7,b7 ,exception = c]ta9 prescription drug products ,a prescription drug program fee %all n be assess$ = a prescription drug product "u subp>agraph 7,a7 if su* product is-- 7i7 a l>ge volume p>5t]al product 7a /]ile aque\s drug product packag$ 9 a s+le-dose conta9] ) a volume great] ?an or equal to #ajj m,l1 n includ+ p[d]s = recon/itution or ph>macy bulk packages7 id5tifi$ on ! li/ compil$ "u section #eje7;j77#g72 7ii7 ph>maceutically equival5t 7z def9$ 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations771 to ano!r product on ! li/ ( products compil$ "u section #eje7;j77#g7 7n includ+ ! discont9u$ section ( su* li/72 or 7iii7 a sk9-te/ diagno/ic product4 4 7b7 ,fee rev5ue am\nts ,section #gcf7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7b77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 7,b7 by r$esignat+ subp>agraphs 7,c7 ?r\gh 7,f7 z subp>agraphs 7,d7 ?r\gh 7,g71 respectively2 7,c7 by ins]t+ aft] subp>agraph 7,b7 ! foll[+3 7,c7 ,! doll> am\nt equal to ! /rategic hir+ & ret5tion adju/m5t = ! fiscal ye> 7z det]m9$ "u subsection 7c77#b772 2 7,d7 9 subp>agraph 7,d71 z s r$esignat$1 by /rik+ 7c77#b7 & ins]t+ 7c77#c72 7,e7 9 subp>agraph 7,e71 z s r$esignat$1 by /rik+ 7c77#c7 & ins]t+ 7c77#d72 7,f7 9 subp>agraph 7,f71 z s r$esignat$1 by /rik+ 7c77#d7 & ins]t+ 7c77#e72 & 7,g7 9 subp>agraph 7,g71 z s r$esignat$1 by /rik+ clauses 7i7 ?r\gh 7v7 & ins]t+ ! foll[+3 7i7 #fe1ggc1fic = fiscal ye> #bjbc4 7ii7 #be1jig1fga = fiscal ye> #bjbd4 7iii7 #ad1aed1afi = fiscal ye> #bjbe4 7iv7 #d1hfd1hfj = fiscal ye> #bjbf4 7v7 #a1cad1fbj = fiscal ye> #bjbg4 2 & 7#b7 9 p>agraph 7#c7-- 7,a7 9 subp>agraph 7,a71 by /rik+ #bjah1 #hgh1eij1jjj & ins]t+ #bjbc1 #a1aea1ebb1ieh2 & 7,b7 9 subp>agraph 7,b7-- 7i7 by /rik+ #bjai ?r\gh #bjbb & ins]t+ #bjbd ?r\gh #bjbg2 & 7ii7 by /rik+ subsection 7c77#c7 or 7c77#d7 & ins]t+ subsection 7c77#d7 or 7c77#e74 7c7 ,adju/m5ts2 annual fee sett+ ,section #gcf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is am5d$-- 7#a7 9 p>agraph 7#a77;,b77ii71 by /rik+ ,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv & ins]t+ ,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 7#b7 by r$esignat+ p>agraphs 7#b7 ?r\gh 7#f7 z p>agraphs 7#c7 ?r\gh 7#g71 respectively2 7#c7 by ins]t+ aft] p>agraph 7#a7 ! foll[+3 7#b7 ,/rategic hir+ & ret5tion adju/m5t ,= ea* fiscal ye>1 aft] ! annual base rev5ue e/abli%$ 9 subsection 7b77#a77;,a7 is adju/$ = inflation 9 accordance ) p>agraph 7#a71 ! ,secret>y %all fur!r increase ! fee rev5ue & fees-- 7,a7 = fiscal ye> #bjbc1 by #i1jjj1jjj2 & 7,b7 = fiscal ye> #bjbd & ea* subsequ5t fiscal ye>1 by #d1jjj1jjj4 2 7#d7 9 p>agraph 7#c71 z s r$esignat$-- 7,a7 9 subp>agraph 7,a7-- 7i7 by /rik+ = inflation2 & 7ii7 by /rik+ p>agraph 7#a7 & ins]t+ p>agraphs 7#a7 & 7#b72 7,b7 by am5d+ subp>agraph 7,b7 to read z foll[s3 7,b7 ,me?odology ,= purposes ( ?is p>agraph1 ! ,secret>y %all employ ! capacity plann+ me?odology utiliz$ by ! ,secret>y 9 sett+ fees = fiscal ye> #bjba1 z describ$ 9 ! notice titl$ ,prescription ,drug ,us] ,fee ,rates = ,fiscal ,ye> #bjba 7#he ,f$4 ,reg4 #dffea2 ,augu/ #c1 #bjbj74 ,! workload categories us$ 9 =eca/+ %all include only ! activities describ$ 9 su* notice &1 z feasible1 additional activities t are directly relat$ to ! direct review ( applications & supplem5ts1 includ+ additional =mal meet+ types1 ! direct review ( po/m>ket+ commitm5ts & requirem5ts1 ! direct review ( risk evaluation & mitigation /rategies1 & ! direct review ( annual reports = approv$ prescription drug products4 ,subject to ! exceptions 9 ! prec$+ s5t5ce1 ! ,secret>y %all n include z workload categories 9 =eca/+ any non-core review activities1 includ+ any activities t ! ,secret>y ref]5c$ = pot5tial future use 9 su* notice b did n utilize 9 ! sett+ fees = fiscal ye> #bjba4 2 7,c7 by /rik+ subp>agraph 7,c72 7,d7 by r$esignat+ subp>agraphs 7,d7 & 7,e7 z subp>agraphs 7,c7 & 7,d71 respectively2 7,e7 9 subp>agraph 7,c71 z s r$esignat$-- 7i7 by /rik+ ye>7 & & ins]t+ ye>712 & 7ii7 by ins]t+ 1 & subsection 7b77#a77;,c7 7! doll> am\nt ( ! /rategic hir+ & ret5tion adju/m5t742 & 7,f7 9 subp>agraph 7,d71 z s r$esignat$1 by /rik+ p>agraph 7#e7 & ins]t+ p>agraph 7#f72 7#e7 9 p>agraph 7#d71 z s r$esignat$-- 7,a7 by am5d+ subp>agraph 7,a7 to read z foll[s3 7,a7 ,increase ,= fiscal ye> #bjbc & subsequ5t fiscal ye>s1 ! ,secret>y %all1 9 addition to adju/m5ts "u p>agraphs 7#a71 7#b71 & 7#c71 fur!r increase ! fee rev5ue & fees if su* an adju/m5t is necess>y to provide = at lea/ ! foll[+ am\nts ( op]at+ res]ves ( c>ryov] us] fees = ! process = ! review ( human drug applications = ea* fiscal ye>1 z foll[s3 7i7 ,= fiscal ye> #bjbc1 at lea/ #h weeks ( op]at+ res]ves4 7ii7 ,= fiscal ye> #bjbd1 at lea/ #i weeks ( op]at+ res]ves4 7iii7 ,= fiscal ye> #bjbe & subsequ5t fiscal ye>s1 at lea/ #aj weeks ( op]at+ res]ves4 2 & 7,b7 9 subp>agraph 7,c71 by /rik+ p>agraph 7#e7 & ins]t+ p>agraph 7#f72 7#f7 by am5d+ p>agraph 7#e71 z s r$esignat$1 to read z foll[s3 7#e7 ,additional direct co/ adju/m5t ,! ,secret>y %all1 9 addition to adju/m5ts "u p>agraphs 7#a71 7#b71 7#c71 & 7#d71 fur!r increase ! fee rev5ue & fees-- 7,a7 = fiscal ye> #bjbc1 by #dd1chf1aej2 & 7,b7 = fiscal ye>s #bjbd ?r\gh #bjbg1 by ! am\nt set =? 9 clauses 7i7 ?r\gh 7iv71 z applicable1 multipli$ by ! ,consum] ,price ,index = urban consum]s 7,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 ,n ,seasonally ,adju/$2 ,all ,items2 ,annual ,index7 = ! mo/ rec5t ye> ( available data1 divid$ by su* ,index = #bjba-- 7i7 = fiscal ye> #bjbd1 #fj1ifg1iic2 7ii7 = fiscal ye> #bjbe1 #ce1gii1cad2 7iii7 = fiscal ye> #bjbf1 #ce1gii1cad2 & 7iv7 = fiscal ye> #bjbg1 #ce1gii1cad4 2 & 7#g7 9 p>agraph 7#f71 z s r$esignat$1 by /rik+ #bjag & ins]t+ #bjbb4 7d7 ,cr$it+ & availability ( fees ,section #gcf7;g77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7g77#c77 is am5d$ by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 7e7 ,writt5 reque/s = waiv]s1 r$uctions1 & refunds ,section #gcf7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7i77 is am5d$ to read z foll[s3 7i7 ,writt5 reque/s = waiv]s1 r$uctions1 exemptions1 & returns2 disputes conc]n+ fees ,to qualify = consid]ation = a waiv] or r$uction "u subsection 7d71 an exemption "u subsection 7k71 or ! return ( any fee paid "u ?is section1 includ+ if ! fee is claim$ to h be5 paid 9 error1 a p]son %all submit to ! ,secret>y a writt5 reque/ ju/ify+ su* waiv]1 r$uction1 exemption1 or return n lat] ?an #ahj days aft] su* fee is due4 ,a reque/ submitt$ "u ?is p>agraph %all include any legal au?orities "u :i* ! reque/ is made4 4 7f7 ,orphan drugs ,section #gcf7k7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7k77 is am5d$-- 7#a7 9 p>agraph 7#a77;,b71 by /rik+ dur+ ! previ\s ye> & ins]t+ 1 z det]m9$ "u p>agraph 7#b72 & 7#b7 9 p>agraph 7#b71 by /rik+ t its gross annual rev5ues & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ support$ by tax returns submitt$ to ! ,int]nal ,rev5ue ,s]vice1 or1 z necess>y1 by o!r appropriate f9ancial in=mation1 t its gross annual rev5ues did n exce$ #ej1jjj1jjj = ! la/ cal5d> ye> end+ prior to ! fiscal ye> = :i* ! exemption is reque/$44 #ajd4 ,reau?orization2 report+ requirem5t ,section #gcf;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7 is am5d$-- 7#a7 by /rik+ #bjah ea* place x appe>s & ins]t+ #bjbc2 7#b7 by /rik+ ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjag ea* place x appe>s & ins]t+ ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjbb2 7#c7 9 subsection 7a77#d71 by /rik+ #bjbj & ins]t+ #bjbc2 & 7#d7 9 subsection 7f71 by /rik+ #bjbb ea* place x appe>s & ins]t+ #bjbg4 #aje4 ,sunset dates 7a7 ,au?orization ,sections #gce & #gcf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g2 #cgi;h7 %all cease to be effective ,octob] #a1 #bjbg4 7b7 ,report+ requirem5ts ,section #gcf;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7 %all cease to be effective ,janu>y #ca1 #bjbh4 7c7 ,previ\s sunset provision ,effective ,octob] #a1 #bjbb1 subsections 7a7 & 7b7 ( section #ajd ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 are repeal$4 #ajf4 ,effective date ,! am5dm5ts made by ?is title %all take effect on ,octob] #a1 #bjbb1 or ! date ( ! enactm5t ( ?is ,act1 :i*ev] is lat]1 except t fees "u "p #b ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g et seq47 %all be assess$ = all human drug applications receiv$ on or aft] ,octob] #a1 #bjbb1 reg>dless ( ! date ( ! enactm5t ( ?is ,act4 #ajg4 ,sav+s clause ,not)/&+ ! am5dm5ts made by ?is title1 "p #b ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g et seq471 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is title1 %all cont9ue to be 9 effect ) respect to human drug applications & supplem5ts 7z def9$ 9 su* "p z ( su* day7 t 7 accept$ by ! ,food & ,drug ,adm9i/ration = fil+ on or aft] ,octob] #a1 #bjag1 b be=e ,octob] #a1 #bjbb1 ) respect to assess+ & collect+ any fee requir$ by su* "p = a fiscal ye> prior to fiscal ye> #bjbc4 ,,ii ,fees relat+ to devices #bja4 ,%ort title2 f9d+ 7a7 ,%ort title ,?is title may be cit$ z ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb4 7b7 ,f9d+ ,congress f9ds t ! fees au?oriz$ "u ! am5dm5ts made by ?is title w be d$icat$ t[>d exp$it+ ! process = ! review ( device applications & = assur+ ! safety & effectiv5ess ( devices1 z set =? 9 ! goals id5tifi$ = purposes ( "p #c ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #bjb4 ,def9itions ,section #gcg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i7 is am5d$-- 7#a7 9 p>agraph 7#i7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ & prem>ket notification submissions & ins]t+ prem>ket notification submissions1 & de novo classification reque/s2 7,b7 9 subp>agraph 7,d71 by /rik+ & submissions & ins]t+ submissions1 & de novo classification reque/s2 7,c7 9 subp>agraph 7,f71 by /rik+ & prem>ket notification submissions & ins]t+ prem>ket notification submissions1 & de novo classification reque/s2 7,d7 9 subp>agraphs 7,g7 & 7,h71 by /rik+ or submissions ea* place x appe>s & ins]t+ submissions1 or reque/s2 & 7,e7 9 subp>agraph 7,k71 by /rik+ or prem>ket notification submissions & ins]t+ prem>ket notification submissions1 or de novo classification reque/s2 & 7#b7 9 p>agraph 7#aa71 by /rik+ #bjaf & ins]t+ #bjba4 #bjc4 ,au?ority to assess & use device fees 7a7 ,types ( fees ,section #gch7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7a77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ #bjah & ins]t+ #bjbc2 & 7#b7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! matt] prec$+ clause 7i71 by /rik+ #bjag & ins]t+ #bjbb2 7ii7 9 clause 7iii71 by /rik+ #ge p]c5t & ins]t+ #hj p]c5t2 & 7iii7 9 clause 7viii71 by /rik+ #c4d p]c5t & ins]t+ #d4e p]c5t2 7,b7 9 subp>agraph 7,b77iii71 by /rik+ or prem>ket notification submission & ins]t+ prem>ket notification submission1 or de novo classification reque/2 & 7,c7 9 subp>agraph 7,c71 by /rik+ or p]iodic report+ conc]n+ a class ,,iii device & ins]t+ p]iodic report+ conc]n+ a class ,,iii device1 or de novo classification reque/4 7b7 ,fee am\nts ,section #gch7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7b77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 7#b7 by am5d+ ! table 9 p>agraph 7#b7 to read z foll[s3 ,fee ,type,fiscal ,ye> #bjbc;,fiscal ,ye> #bjbd;,fiscal ,ye> #bjbe;,fiscal ,ye> #bjbf;,fiscal ,ye> #bjbg,prem>ket ,application#dbe1jjjdce1jjjdde1jjjdee1jj jdgj1jjj;,e/abli%m5t ,regi/ration#f1bejf1hgeg1ajjg1egeh1dfe 2 & 7#c7 9 p>agraph 7#c71 by am5d+ subp>agraphs 7,a7 ?r\gh 7,e7 to read z foll[s3 7,a7 #cab1fjf1jjj = fiscal ye> #bjbc4 7,b7 #cce1gej1jjj = fiscal ye> #bjbd4 7,c7 #cej1gdf1djj = fiscal ye> #bjbe4 7,d7 #cff1dhf1cjj = fiscal ye> #bjbf4 7,e7 #dah1cdc1jjj = fiscal ye> #bjbg4 4 7c7 ,annual fee sett+2 adju/m5ts ,section #gch7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7c77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ #bjag & ins]t+ #bjbb2 7#b7 9 p>agraph 7#b7-- 7,a7 by /rik+ #bjah ea* place x appe>s & ins]t+ #bjbc2 7,b7 9 subp>agraph 7,b77ii71 by /rik+ #bjaf & ins]t+ #bjbb2 7,c7 9 subp>agraph 7,c77i77,,ii71 by /rik+ ,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv & ins]t+ ,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 & 7,d7 9 subp>agraph 7,d71 by /rik+ #bjbb & ins]t+ #bjbg2 7#c7 9 p>agraph 7#c71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 7#d7 by r$esignat+ p>agraphs 7#d7 & 7#e7 z p>agraphs 7#g7 & 7#h71 respectively2 & 7#e7 by ins]t+ aft] p>agraph 7#c7 ! foll[+3 7#d7 ,p]=mance improvem5t adju/m5t 7,a7 ,9 g5]al ,= ea* ( fiscal ye>s #bjbe ?r\gh #bjbg1 aft] ! adju/m5t "u p>agraph 7#c71 ! base e/abli%m5t regi/ration fee am\nts = su* fiscal ye> %all be increas$ to reflect *anges 9 ! res\rce ne$s ( ! ,secret>y due to improv$ review p]=mance goals = ! process = ! review ( device applications id5tifi$ 9 ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb1 z ! ,secret>y det]m9es necess>y to a*ieve an increase 9 total fee collections = su* fiscal ye>1 equal to ! foll[+ am\nts1 z applicable3 7i7 ,= fiscal ye> #bjbe1 ! product (-- 7,i7 ! am\nt det]m9$ "u subp>agraph 7,b77i77,i72 & 7,,ii7 ! applicable inflation adju/m5t "u p>agraph 7#b77;,b7 = su* fiscal ye>4 7ii7 ,= fiscal ye> #bjbf1 ! product (-- 7,i7 ! sum ( ! am\nts det]m9$ "u subp>agraphs 7,b77i77,,ii71 7,b77ii77,i71 & 7,b77iii77,i72 & 7,,ii7 ! applicable inflation adju/m5t "u p>agraph 7#b77;,b7 = su* fiscal ye>4 7iii7 ,= fiscal ye> #bjbg1 ! product (-- 7,i7 ! sum ( ! am\nts det]m9$ "u subp>agraphs 7,b77i77,,iii71 7,b77ii77,,ii71 & 7,b77iii77,,ii72 & 7,,ii7 ! applicable inflation adju/m5t "u p>agraph 7#b77;,b7 = su* fiscal ye>4 7,b7 ,am\nts 7i7 ,presubmission am\nt ,= purposes ( subp>agraph 7,a71 ) respect to ! presubmission writt5 fe$back goal1 ! am\nts det]m9$ "u ?is subp>agraph are z foll[s3 7,i7 ,= fiscal ye> #bjbe1 #ae1cif1fjj if ! goal = fiscal ye> #bjbc is met4 7,,ii7 ,= fiscal ye> #bjbf-- 7aa7 #ae1cif1fjj if ! goal = fiscal ye> #bjbc is met & ! goal = fiscal ye> #bjbd is miss$2 or 7bb7 #cf1gib1bjj if ! goal = fiscal ye> #bjbd is met4 7,,iii7 ,= fiscal ye> #bjbg-- 7aa7 #ae1cif1fjj if ! goal = fiscal ye> #bjbc is met & ! goal = ea* ( fiscal ye>s #bjbd & #bjbe is miss$2 7bb7 #cf1gib1bjj if ! goal = fiscal ye> #bjbd is met & ! goal = fiscal ye> #bjbe is miss$2 or 7cc7 #dj1egb1fjj if ! goal = fiscal ye> #bjbe is met4 7ii7 ,de novo classification reque/ am\nt ,= purposes ( subp>agraph 7,a71 ) respect to ! de novo decision goal1 ! am\nts det]m9$ "u ?is subp>agraph are z foll[s3 7,i7 ,= fiscal ye> #bjbf1 #f1cbc1ejj if ! goal = fiscal ye> #bjbc is met4 7,,ii7 ,= fiscal ye> #bjbg-- 7aa7 #f1cbc1ejj if ! goal = fiscal ye> #bjbc is met & ! goal = fiscal ye> #bjbd is miss$2 or 7bb7 #aa1gfe1djj if ! goal = fiscal ye> #bjbd is met4 7iii7 ,prem>ket notification & prem>ket approval am\nt ,= purposes ( subp>agraph 7,a71 ) respect to ! #eaj7k7 decision goal1 #eaj7k7 %>$ outcome total "t to decision goal1 ,,pma decision goal1 & ,,pma %>$ outcome total "t to decision goal1 ! am\nts det]m9$ "u ?is subp>agraph are z foll[s3 7,i7 ,= fiscal ye> #bjbf1 #a1jbj1jjj if ! #d goals = fiscal ye> #bjbc are met4 7,,ii7 ,= fiscal ye> #bjbg-- 7aa7 #a1jbj1jjj if ! #d goals = fiscal ye> #bjbc are met & "o or m ( ! #d goals = fiscal ye> #bjbd is miss$2 or 7bb7 #c1ijf1jjj if ! #d goals = fiscal ye> #bjbd are met4 7,c7 ,p]=mance calculation ,= purposes ( ?is p>agraph1 p]=mance ( ! foll[+ goals %all be det]m9$ z specifi$ 9 ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb & bas$ on data available z ( ! applicable dates z foll[s3 7i7 ,! p]=mance ( ! presubmission writt5 fe$back goal-- 7,i7 = fiscal ye> #bjbc1 %all be bas$ on data available z ( ,m>* #ca1 #bjbd2 7,,ii7 = fiscal ye> #bjbd1 %all be bas$ on data available z ( ,m>* #ca1 #bjbe2 & 7,,iii7 = fiscal ye> #bjbe1 %all be bas$ on data available z ( ,m>* #ca1 #bjbf4 7ii7 ,! p]=mance ( ! de novo decision goal1 #eaj7k7 decision goal1 #eaj7k7 %>$ outcome total "t to decision goal1 ,,pma decision goal1 & ,,pma %>$ outcome total "t to decision goal-- 7,i7 = fiscal ye> #bjbc1 %all be bas$ on data available z ( ,m>* #ca1 #bjbe2 & 7,,ii7 = fiscal ye> #bjbd1 %all be bas$ on data available z ( ,m>* #ca1 #bjbf4 7,d7 ,def9itions ,= purposes ( ?is p>agraph1 ! t]ms presubmission writt5 fe$back goal1 de novo decision goal1 #eaj7k7 decision goal1 #eaj7k7 %>$ outcome total "t to decision goal1 ,,pma decision goal1 & ,,pma %>$ outcome total "t to decision goal h ! mean+s giv5 su* t]ms 9 ! goals id5tifi$ 9 ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb4 7#e7 ,hir+ adju/m5t 7,a7 ,9 g5]al ,= ea* ( fiscal ye>s #bjbe ?r\gh #bjbg1 aft] ! adju/m5ts "u p>agraphs 7#c7 & 7#d71 if applicable1 ! base e/abli%m5t regi/ration fee am\nts %all be decreas$ z ! ,secret>y det]m9es necess>y to a*ieve a r$uction 9 total fee collections equal to ! hir+ adju/m5t am\nt "u subp>agraph 7,b71 if ! numb] ( hires to support ! process = ! review ( device applications falls bel[ ! foll[+ ?re%olds = ! applicable fiscal ye>s3 7i7 ,= fiscal ye> #bjbe1 #he p]c5t ( ! hir+ goal specifi$ 9 subp>agraph 7,c7 = fiscal ye> #bjbc4 7ii7 ,= fiscal ye> #bjbf1 #ij p]c5t ( ! hir+ goal specifi$ 9 subp>agraph 7,c7 = fiscal ye> #bjbd4 7iii7 ,= fiscal ye> #bjbg1 #ij p]c5t ( ! hir+ goal specifi$ 9 subp>agraph 7,c7 = fiscal ye> #bjbe4 7,b7 ,hir+ adju/m5t am\nt ,! hir+ adju/m5t am\nt = fiscal ye> #bjbe & ea* subsequ5t fiscal ye> is ! product (-- 7i7 ! numb] ( hires by :i* ! hir+ goal specifi$ 9 subp>agraph 7,c7 = ! fiscal ye> be=e ! prior fiscal ye> 0 miss$2 7ii7 #gb1hgg2 & 7iii7 ! applicable inflation adju/m5t "u p>agraph 7#b77;,b7 = ! fiscal ye> = :i* ! hir+ goal 0 miss$4 7,c7 ,hir+ goals 7i7 ,9 g5]al ,= purposes ( subp>agraph 7,b71 ! hir+ goals = ea* ( fiscal ye>s #bjbc ?r\gh #bjbe are z foll[s3 7,i7 ,= fiscal ye> #bjbc1 #add hires4 7,,ii7 ,= fiscal ye> #bjbd1 #db hires4 7,,iii7 ,= fiscal ye> #bjbe-- 7aa7 #bd hires if ! base e/abli%m5t regi/ration fees are n increas$ by ! am\nt det]m9$ "u p>agraph 7#d77;,a77i72 or 7bb7 #hc hires if ! base e/abli%m5t regi/ration fees are increas$ by ! am\nt det]m9$ "u p>agraph 7#d77;,a77i74 7ii7 ,numb] ( hires ,= purposes ( ?is p>agraph1 ! numb] ( hires = a fiscal ye> %all be det]m9$ by ! ,secret>y1 z set =? 9 ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb4 7#f7 ,op]at+ res]ve adju/m5t 7,a7 ,9 g5]al ,= ea* ( fiscal ye>s #bjbc ?r\gh #bjbg1 aft] ! adju/m5ts "u p>agraphs 7#c71 7#d71 & 7#e71 if applicable1 if ! ,secret>y has op]at+ res]ves ( c>ryov] us] fees = ! process = ! review ( device applications 9 excess ( ! designat$ am\nt 9 subp>agraph 7,b71 ! ,secret>y %all decrease ! base e/abli%m5t regi/ration fee am\nts to provide = n m ?an su* designat$ am\nt ( op]at+ res]ves4 7,b7 ,designat$ am\nt ,subject to subp>agraph 7,c71 = ea* fiscal ye>1 ! designat$ am\nt 9 ?is subp>agraph is equal to ! sum (-- 7i7 #ac weeks ( op]at+ res]ves ( c>ryov] us] fees2 & 7ii7 ! #a mon? ( op]at+ res]ves describ$ 9 p>agraph 7#h74 7,c7 ,exclud$ am\nt ,= ! p]iod ( fiscal ye>s #bjbc ?r\gh #bjbf1 a total am\nt equal to #aah1jjj1jjj %all n be consid]$ "p ( ! designat$ am\nt "u subp>agraph 7,b7 & %all n be subject to ! decrease "u subp>agraph 7,a74 4 7d7 ,small bus9esses ,section #gch ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is am5d$-- 7#a7 9 subsection 7d77#b77;,b77iii71 by ins]t+ 1 if extant1 aft] national tax+ au?ority2 & 7#b7 9 subsection 7e77#b77;,b77iii71 by ins]t+ 1 if extant1 aft] national tax+ au?ority4 7e7 ,conditions ,section #gch7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7g77 is am5d$-- 7#a7 9 p>agraph 7#a77;,a71 by /rik+ #cbj1hbe1jjj & ins]t+ #cih1eff1jjj2 & 7#b7 9 p>agraph 7#b71 by ins]t+ de novo classification reque/s1 aft] class ,,iii device14 7f7 ,au?orization ( appropriations ,section #gch7;h77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7h77#c77 is am5d$ to read z foll[s3 7#c7 ,au?orization ( appropriations 7,a7 ,9 g5]al ,= ea* ( ! fiscal ye>s #bjbc ?r\gh #bjbg1 !re is au?oriz$ to be appropriat$ = fees "u ?is section an am\nt equal to ! rev5ue am\nt det]m9$ 9 subp>agraph 7,b71 less ! am\nt ( r$uctions det]m9$ 9 subp>agraph 7,c74 7,b7 ,rev5ue am\nt ,= purposes ( ?is p>agraph1 ! rev5ue am\nt = ea* fiscal ye> is ! sum (-- 7i7 ! total rev5ue am\nt "u subsection 7b77#c7 = ! fiscal ye>1 z adju/$ "u subsection 7c77#b72 & 7ii7 ! p]=mance improvem5t adju/m5t am\nt = ! fiscal ye> "u subsection 7c77#d77;,a71 if applicable4 7,c7 ,am\nt ( r$uctions ,= purposes ( ?is p>agraph1 ! am\nt ( r$uctions = ea* fiscal ye> is ! sum (-- 7i7 ! hir+ adju/m5t am\nt = ! fiscal ye> "u subsection 7c77#e71 if applicable2 & 7ii7 ! op]at+ res]ve adju/m5t am\nt = ! fiscal ye> "u subsection 7c77#f71 if applicable4 4 #bjd4 ,accr$itation programs 7a7 ,accr$itation s*eme = con=mity assessm5t ,section #ead7;d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7d77 is am5d$-- 7#a7 9 ! subsection head+1 by /rik+ ,pilot2 7#b7 9 p>agraph 7#a7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ pilot2 7,b7 9 subp>agraph 7,a7-- 7i7 by ins]t+ meet+ crit]ia specifi$ by ! ,secret>y 9 guidance aft] te/+ laboratories2 7ii7 by ins]t+ 9 guidance aft] by ! ,secret>y2 & 7iii7 by /rik+ assess ! con=mance ( a device ) & ins]t+ conduct te/+ to support ! assessm5t ( ! con=mance ( a device to2 & 7,c7 9 subp>agraph 7,b7-- 7i7 by /rik+ det]m9ations & ins]t+ results2 7ii7 by ins]t+ to support aft] s accr$it$2 & 7iii7 by /rik+ a p>ticul> su* det]m9ation & ins]t+ p>ticul> su* results2 7#c7 9 p>agraph 7#b7-- 7,a7 9 ! p>agraph head+1 by /rik+ det]m9ations & ins]t+ results2 7,b7 9 subp>agraph 7,a7-- 7i7 by /rik+ det]m9ations by te/+ laboratories & all t foll[s ?r\gh su* det]m9ations or & ins]t+ results by te/+ laboratories accr$it$ pursuant to ?is subsection1 includ+ by conduct+ p]iodic audits ( su* results or ( !2 7ii7 by ins]t+ a comma aft] or te/+ laboratories2 7iii7 by ins]t+ or recognition ( an accr$itation body aft] accr$itation ( su* te/+ laboratory2 & 7iv7 by /rik+ su* device & ins]t+ a device2 & 7,c7 9 subp>agraph 7,b7-- 7i7 by /rik+ by a te/+ laboratory s accr$it$ & ins]t+ "u ?is subsection2 & 7ii7 by ins]t+ or recognition ( an accr$itation body be=e "u p>agraph 7#a77;,a72 7#d7 9 p>agraph 7#c77;,c7-- 7,a7 9 ! subp>agraph head+1 by ins]t+ & transition aft] initiation2 & 7,b7 by add+ at ! end ! foll[+3 ,aft] ,septemb] #cj1 #bjbc1 su* pilot program w be consid]$ to be complet$1 & ! ,secret>y %all h ! au?ority to cont9ue op]at+ a program consi/5t ) ?is subsection42 & 7#e7 by /rik+ p>agraph 7#d74 7b7 ,accr$it$ p]sons ,section #ebc7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjm7c77 is am5d$ by /rik+ #bjbb & ins]t+ #bjbg4 #bje4 ,sunset dates 7a7 ,au?orization ,sections #gcg & #gch ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i2 #cgi;fj7 %all cease to be effective ,octob] #a1 #bjbg4 7b7 ,report+ requirem5ts ,section #gch;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7 %all cease to be effective ,janu>y #ca1 #bjbh4 7c7 ,previ\s sunset provision ,effective ,octob] #a1 #bjbb1 subsections 7a7 & 7b7 ( section #baj ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 are repeal$4 #bjf4 ,effective date ,! am5dm5ts made by ?is title %all take effect on ,octob] #a1 #bjbb1 or ! date ( ! enactm5t ( ?is ,act1 :i*ev] is lat]1 except t fees "u "p #c ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i et seq47 %all be assess$ = all submissions li/$ 9 section #gch7;a77#b77;,a7 ( su* ,act receiv$ on or aft] ,octob] #a1 #bjbb1 reg>dless ( ! date ( ! enactm5t ( ?is ,act4 #bjg4 ,sav+s clause ,not)/&+ ! am5dm5ts made by ?is title1 "p #c ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i et seq471 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is title1 %all cont9ue to be 9 effect ) respect to ! submissions li/$ 9 section #gch7;a77#b77;,a7 ( su* ,act 7z def9$ 9 su* "p z ( su* day7 t on or aft] ,octob] #a1 #bjag1 b be=e ,octob] #a1 #bjbb1 7 receiv$ by ! ,food & ,drug ,adm9i/ration ) respect to assess+ & collect+ any fee requir$ by su* "p = a fiscal ye> prior to fiscal ye> #bjbc4 ,,iii ,fees relat+ to g5]ic drugs #cja4 ,%ort title2 f9d+ 7a7 ,%ort title ,?is title may be cit$ z ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbb4 7b7 ,f9d+ ,! ,congress f9ds t ! fees au?oriz$ by ! am5dm5ts made 9 ?is title w be d$icat$ to human g5]ic drug activities1 z set =? 9 ! goals id5tifi$ = purposes ( "p #g ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #cjb4 ,au?ority to assess & use human g5]ic drug fees 7a7 ,types ( fees ,section #gdd;,b7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;a77 is am5d$-- 7#a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ #bjah & ins]t+ #bjbc2 7#b7 9 p>agraph 7#b77;,c71 by /rik+ fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ fiscal ye>s #bjbc ?r\gh #bjbg2 7#c7 9 p>agraph 7#c77;,b71 by /rik+ fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ fiscal ye>s #bjbc ?r\gh #bjbg2 7#d7 9 p>agraph 7#d77;,d71 by /rik+ fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ fiscal ye>s #bjbc ?r\gh #bjbg2 & 7#e7 9 p>agraph 7#e77;,d71 by /rik+ fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ fiscal ye>s #bjbc ?r\gh #bjbg4 7b7 ,fee rev5ue am\nts ,section #gdd;,b7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;b77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! head+1 by /rik+ #bjah & ins]t+ #bjbc2 7ii7 by /rik+ #bjah & ins]t+ #bjbc2 & 7iii7 by /rik+ #dic1fjj1jjj & ins]t+ #ehb1ejj1jjj2 & 7,b7 9 subp>agraph 7,b7-- 7i7 9 ! head+1 by /rik+ #bjai ?r\gh #bjbb & ins]t+ #bjbd ?r\gh #bjbg2 7ii7 by /rik+ ,= ea* & ins]t+ ! foll[+3 7i7 ,9 g5]al ,= ea* 2 7iii7 by /rik+ #bjai ?r\gh #bjbb & ins]t+ #bjbd ?r\gh #bjbg2 7iv7 by /rik+ #dic1fjj1jjj & ins]t+ ! base rev5ue am\nt "u clause 7ii72 & 7v7 by add+ at ! end ! foll[+3 7ii7 ,base rev5ue am\nt ,! base rev5ue am\nt = a fiscal ye> is ! total rev5ue am\nt e/abli%$ "u ?is p>agraph = ! previ\s fiscal ye>1 n includ+ any adju/m5ts made = su* previ\s fiscal ye> "u subsection 7c77#c74 2 & 7#b7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,c71 by /rik+ "o-?ird ! am\nt & ins]t+ #bd p]c5t2 7,b7 9 subp>agraph 7,d71 by /rik+ ,sev5 & ins]t+ ,six2 & 7,c7 9 subp>agraph 7,e77i71 by /rik+ ,?irty-five & ins]t+ ,?irty-six4 7c7 ,adju/m5ts ,section #gdd;,b7c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;c77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a7-- 7i7 by /rik+ #bjai & ins]t+ #bjbd2 & 7ii7 by /rik+ ! product ( ! total rev5ues e/abli%$ 9 su* notice = ! prior fiscal ye> & ins]t+ ! base rev5ue am\nt = ! fiscal ye> det]m9$ "u subsection 7b77#a77;,b77ii72 & 7,b7 9 subp>agraph 7,c71 by /rik+ ,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv & ins]t+ ,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 & 7#b7 by /rik+ p>agraph 7#b7 & ins]t+ ! foll[+3 7#b7 ,capacity plann+ adju/m5t 7,a7 ,9 g5]al ,beg9n+ ) fiscal ye> #bjbd1 ! ,secret>y %all1 9 addition to ! adju/m5t "u p>agraph 7#a71 fur!r increase ! fee rev5ue & fees "u ?is section = a fiscal ye>1 9 accordance ) ?is p>agraph1 to reflect *anges 9 ! res\rce capacity ne$s ( ! ,secret>y = human g5]ic drug activities4 7,b7 ,capacity plann+ me?odology ,! ,secret>y %all e/abli% a capacity plann+ me?odology = purposes ( ?is p>agraph1 :i* %all-- 7i7 be d]iv$ f ! me?odology & recomm5dations made 9 ! report titl$ ,indep5d5t ,evaluation ( ! ,,gdufa ,res\rce ,capacity ,plann+ ,adju/m5t ,me?odology3 ,evaluation & ,recomm5dations z ann\nc$ 9 ! ,f$]al ,regi/] on ,augu/ #c1 #bjbj 7#he ,f$4 ,reg4 #dffeh72 & 7ii7 incorporate approa*es & attributes det]m9$ appropriate by ! ,secret>y1 includ+ ^? made 9 su* report recomm5dations1 except ! workload categories us$ 9 =eca/+ res\rces %all only be ^? specifi$ 9 section ,,viii4,b4#b4;e4 ( ! lett]s describ$ 9 section #cja7;b7 ( ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbb4 7,c7 ,limitations 7i7 ,9 g5]al ,"u no circum/ances %all an adju/m5t "u ?is p>agraph result 9 fee rev5ue = a fiscal ye> t is less ?an ! sum ( ! am\nts "u subsection 7b77#a77;,b77ii7 7! base rev5ue am\nt = ! fiscal ye>7 & p>agraph 7#a7 7! doll> am\nt ( ! inflation adju/m5t = ! fiscal ye>74 7ii7 ,additional limitation ,an adju/m5t "u ?is p>agraph %all n exce$ #c p]c5t ( ! sum describ$ 9 clause 7i7 = ! fiscal ye>1 except t su* limitation %all be #d p]c5t if-- 7,i7 = purposes ( an adju/m5t = fiscal ye> #bjbd1 ! ,secret>y det]m9es t1 dur+ ! p]iod f ,april #a1 #bjba1 ?r\gh ,m>* #ca1 #bjbc-- 7aa7 ! total numb] ( abbreviat$ new drug applications submitt$ 0 great] ?an or equal to #b1jjj2 or 7bb7 ?irty-five p]c5t or m ( abbreviat$ new drug applications submitt$ relat$ to complex products 7z t t]m is def9$ 9 section ,,xi ( ! lett]s describ$ 9 section #cja7;b7 ( ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbb72 7,,ii7 = purposes ( an adju/m5t = fiscal ye> #bjbe1 ! ,secret>y det]m9es t1 dur+ ! p]iod f ,april #a1 #bjbb1 ?r\gh ,m>* #ca1 #bjbd-- 7aa7 ! total numb] ( abbreviat$ new drug applications submitt$ 0 great] ?an or equal to #b1cjj2 or 7bb7 ?irty-five p]c5t or m ( abbreviat$ new drug applications submitt$ relat$ to complex products 7z s def9$72 7,,iii7 = purposes ( an adju/m5t = fiscal ye> #bjbf1 ! ,secret>y det]m9es t1 dur+ ! p]iod f ,april #a1 #bjbc1 ?r\gh ,m>* #ca1 #bjbe-- 7aa7 ! total numb] ( abbreviat$ new drug applications submitt$ 0 great] ?an or equal to #b1cjj2 or 7bb7 ?irty-five p]c5t or m ( abbreviat$ new drug applications submitt$ relat$ to complex products 7z s def9$72 & 7,,iv7 = purposes ( an adju/m5t = fiscal ye> #bjbg1 ! ,secret>y det]m9es t1 dur+ ! p]iod f ,april #a1 #bjbd1 ?r\gh ,m>* #ca1 #bjbf-- 7aa7 ! total numb] ( abbreviat$ new drug applications submitt$ 0 great] ?an or equal to #b1cjj2 or 7bb7 ?irty-five p]c5t or m ( abbreviat$ new drug applications submitt$ relat$ to complex products 7z s def9$74 7,d7 ,publication 9 f$]al regi/] ,! ,secret>y %all publi% 9 ! ,f$]al ,regi/] notice "u subsection 7a71 ! fee rev5ue & fees result+ f ! adju/m5t & ! me?odology "u ?is p>agraph4 7#c7 ,op]at+ res]ve adju/m5t 7,a7 ,9 g5]al ,= fiscal ye> #bjbd & subsequ5t fiscal ye>s1 ! ,secret>y may1 9 addition to adju/m5ts "u p>agraphs 7#a7 & 7#b71 fur!r increase ! fee rev5ue & fees "u ?is section if su* an adju/m5t is necess>y to provide op]at+ res]ves ( c>ryov] us] fees = human g5]ic drug activities = n m ?an ! numb] ( weeks specifi$ 9 subp>agraph 7,b74 7,b7 ,numb] ( weeks ,! numb] ( weeks specifi$ 9 ?is subp>agraph is-- 7i7 #h weeks = fiscal ye> #bjbd2 7ii7 #i weeks = fiscal ye> #bjbe2 & 7iii7 #aj weeks = ea* ( fiscal ye> #bjbf & #bjbg4 7,c7 ,decrease ,if ! ,secret>y has c>ryov] balances = human g5]ic drug activities 9 excess ( #ab weeks ( ! op]at+ res]ves ref]r$ to 9 subp>agraph 7,a71 ! ,secret>y %all decrease ! fee rev5ue & fees ref]r$ to 9 su* subp>agraph to provide = n m ?an #ab weeks ( su* op]at+ res]ves4 7,d7 ,rationale = adju/m5t ,if an adju/m5t "u ?is p>agraph is made1 ! rationale = ! am\nt ( ! increase or decrease 7z applicable7 9 fee rev5ue & fees %all be conta9$ 9 ! annual ,f$]al ,regi/] notice "u subsection 7a7 publi%+ ! fee rev5ue & fees = ! fiscal ye> involv$4 4 7d7 ,annual fee sett+ ,section #gdd;,b7d77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;d77#a77 is am5d$-- 7#a7 9 ! head+1 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 7#b7 by /rik+ m & ins]t+ lat]2 & 7#c7 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 7e7 ,effect ( failure ,to pay fees ,! head+ ( p>agraph 7#c7 ( section #gdd;,b7g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;g77 is am5d$ by /rik+ & prior approval supplem5t fee4 7f7 ,cr$it+ & availability ( fees ,section #gdd;,b7i77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;i77#c77 is am5d$ by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 #cjc4 ,reau?orization2 report+ requirem5ts ,section #gdd;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 by /rik+ #bjah ea* place x appe>s & ins]t+ #bjbc2 & 7,b7 by /rik+ ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjag ea* place x appe>s & ins]t+ ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbb2 7#b7 9 subsection 7b71 by /rik+ #bjah & ins]t+ #bjbc2 7#c7 9 subsection 7c7-- 7,a7 by /rik+ #bjah & ins]t+ #bjbc2 & 7,b7 by /rik+ ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjag ea* place x appe>s & ins]t+ ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbb2 & 7#d7 9 subsection 7f7-- 7,a7 9 p>agraph 7#a71 by /rik+ #bjbb & ins]t+ #bjbg2 & 7,b7 9 p>agraph 7#e71 by /rik+ ,janu>y #ae1 #bjbb & ins]t+ ,janu>y #ae1 #bjbg4 #cjd4 ,sunset dates 7a7 ,au?orization ,sections #gdd;,a & #gdd;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da2 #cgi;j-#db7 %all cease to be effective ,octob] #a1 #bjbg4 7b7 ,report+ requirem5ts ,section #gdd;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7 %all cease to be effective ,janu>y #ca1 #bjbh4 7c7 ,previ\s sunset provision ,effective ,octob] #a1 #bjbb1 subsections 7a7 & 7b7 ( section #cje ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 are repeal$4 #cje4 ,effective date ,! am5dm5ts made by ?is title %all take effect on ,octob] #a1 #bjbb1 or ! date ( ! enactm5t ( ?is ,act1 :i*ev] is lat]1 except t fees "u "p #g ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act %all be assess$ = all abbreviat$ new drug applications receiv$ on or aft] ,octob] #a1 #bjbb1 reg>dless ( ! date ( ! enactm5t ( ?is ,act4 #cjf4 ,sav+s clause ,not)/&+ ! am5dm5ts made by ?is title1 "p #g ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is title1 %all cont9ue to be 9 effect ) respect to abbreviat$ new drug applications 7z def9$ 9 su* "p z ( su* day7 t 7 receiv$ by ! ,food & ,drug ,adm9i/ration )9 ! mean+ ( section #eje7;j77#e77;,a7 ( su* ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,a771 prior approval supplem5ts t 7 submitt$1 & drug ma/] files = ,type ,,ii active ph>maceutical +r$i5ts t 7 fir/ ref]5c$ on or aft] ,octob] #a1 #bjag1 b be=e ,octob] #a1 #bjbb1 ) respect to assess+ & collect+ any fee requir$ by su* "p = a fiscal ye> prior to fiscal ye> #bjbc4 ,,iv ,fees relat+ to biosimil> biological products #dja4 ,%ort title2 f9d+ 7a7 ,%ort title ,?is title may be cit$ z ! ,biosimil> ,us] ,fee ,am5dm5ts ( #bjbb4 7b7 ,f9d+ ,congress f9ds t ! fees au?oriz$ by ! am5dm5ts made 9 ?is title w be d$icat$ to exp$it+ ! process = ! review ( biosimil> biological product applications1 includ+ po/m>ket safety activities1 z set =? 9 ! goals id5tifi$ = purposes ( "p #h ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea et seq471 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #djb4 ,def9itions ,section #gdd;,g ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea7 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 by /rik+ ,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv & ins]t+ ,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 7,b7 by /rik+ ,octob] ( & ins]t+ ,septemb] (2 & 7,c7 by /rik+ ,octob] #bjaa & ins]t+ ,septemb] #bjaa2 & 7#b7 9 p>agraph 7#d77;,b77iii7-- 7,a7 by /rik+ subclause 7,,ii72 & 7,b7 by r$esignat+ subclauses 7,,iii7 & 7,,iv7 z subclauses 7,,ii7 & 7,,iii71 respectively4 #djc4 ,au?ority to assess & use biosimil> biological product fees 7a7 ,types ( fees ,section #gdd;,h7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77 is am5d$-- 7#a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ #bjah & ins]t+ #bjbc2 7#b7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 clause 7iv77,i71 by /rik+ #e days & ins]t+ #g days2 & 7ii7 9 clause 7v77,,ii71 by /rik+ #e days & ins]t+ #g days2 7,b7 9 subp>agraph 7,b7-- 7i7 9 clause 7i71 by ins]t+ except t1 9 ! case t su* product 7includ+1 :]e applicable1 own]%ip ( ! relevant inve/igational new drug application7 is transf]r$ to a lic5see1 assignee1 or successor ( su* p]son1 & writt5 notice ( su* transf] is provid$ to ! ,secret>y1 su* lic5see1 assignee or successor %all pay ! annual biosimil> biological product developm5t fee be=e ! p]iod2 7ii7 9 clause 7iii7-- 7,i7 9 subclause 7,i71 by /rik+ 2 or & ins]t+ a semicolon2 7,,ii7 9 subclause 7,,ii71 by /rik+ ! p]iod & ins]t+ 2 or2 & 7,,iii7 by add+ at ! end ! foll[+3 7,,iii7 be5 adm9i/ratively remov$ f ! biosimil> biological product developm5t program = ! product "u subp>agraph 7,e77v74 2 & 7iii7 9 clause 7iv71 by /rik+ accept$ = fil+ on or aft] ,octob] #a ( su* fiscal ye> & ins]t+ subsequ5tly accept$ = fil+2 7,c7 9 subp>agraph 7,d7-- 7i7 9 clause 7i7-- 7,i7 9 ! matt] prec$+ subclause 7,i71 by /rik+ %all1 if ! p]son seeks to resume p>ticipation 9 su* program1 pay & ins]t+ or :o has be5 adm9i/ratively remov$ f su* program = a product "u subp>agraph 7,e77v7 %all1 if ! p]son seeks to resume p>ticipation 9 su* program1 pay all annual biosimil> biological product developm5t fees previ\sly assess$ = su* product & /ill ow$ &2 7,,ii7 9 subclause 7,i7-- 7aa7 by /rik+ #e days & ins]t+ #g days2 & 7bb7 by ins]t+ or ! date ( adm9i/rative removal1 z applicable aft] discont9u$2 & 7,,iii7 9 subclause 7,,ii71 by ins]t+ or ! date ( adm9i/rative removal1 z applicable aft] discont9u$2 & 7ii7 9 clause 7ii71 by ins]t+ except t1 9 ! case t su* product 7includ+1 :]e applicable1 own]%ip ( ! relevant inve/igational new drug application7 is transf]r$ to a lic5see1 assignee1 or successor ( su* p]son1 & writt5 notice ( su* transf] is provid$ to ! ,secret>y1 su* lic5see1 assignee or successor %all pay ! annual biosimil> biological product developm5t fee be=e ! p]iod at ! end2 & 7,d7 9 subp>agraph 7,e71 by add+ at ! end ! foll[+3 7v7 ,adm9i/rative removal f ! biosimil> biological product developm5t program ,if a p]son has fail$ to pay an annual biosimil> biological product developm5t fee = a product z requir$ "u subp>agraph 7,b7 = a p]iod ( #b consecutive fiscal ye>s1 ! ,secret>y may adm9i/ratively remove su* p]son f ! biosimil> biological product developm5t program = ! product4 ,at lea/ #cj days prior to adm9i/ratively remov+ a p]son f ! biosimil> biological product developm5t program = a product "u ?is clause1 ! ,secret>y %all provide writt5 notice to su* p]son ( ! int5d$ adm9i/rative removal4 2 7#c7 9 p>agraph 7#b77;,d71 by ins]t+ prior to approval aft] )drawn2 7#d7 9 p>agraph 7#c7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 clause 7i71 by /rik+ 2 & & ins]t+ a semicolon2 7ii7 by r$esignat+ clause 7ii7 z clause 7iii72 & 7iii7 by ins]t+ ! foll[+ aft] clause 7i73 7ii7 may be disp5s$ only "u prescription pursuant to section #ejc7;b72 & 2 & 7,b7 by add+ at ! end ! foll[+3 7,e7 ,movem5t to discont9u$ li/ 7i7 ,writt5 reque/ to place on discont9u$ li/ 7,i7 ,9 g5]al ,if a writt5 reque/ to place a product on ! li/ ( discont9u$ biosimil> biological products ref]r$ to 9 subp>agraph 7,a77iii7 is submitt$ to ! ,secret>y on behalf ( an applicant1 & ! reque/ id5tifies ! date ! product is1 or w be1 )drawn f sale1 !n = purposes ( assess+ ! biosimil> biological product program fee1 ! ,secret>y %all consid] su* product to h be5 includ$ on su* li/ on ! lat] (-- 7aa7 ! date su* reque/ 0 receiv$2 or 7bb7 if ! product w be )drawn f sale on a future date1 su* future date :5 ! product is )drawn f sale4 7,,ii7 ,)drawn f sale def9$ ,= purposes ( ?is clause1 a product %all be consid]$ )drawn f sale once ! applicant has ceas$ its own di/ribution ( ! product1 :e!r or n ! applicant has ord]$ recall ( all previ\sly di/ribut$ lots ( ! product1 except t a r\t9e1 tempor>y int]ruption 9 supply %all n r5d] a product )drawn f sale4 7ii7 ,products remov$ f discont9u$ li/ ,if a biosimil> biological product t is id5tifi$ 9 a biosimil> biological product application approv$ z ( ,octob] #a ( a fiscal ye> appe>s1 z ( ,octob] #a ( su* fiscal ye>1 on ! li/ ( discont9u$ biosimil> biological products ref]r$ to 9 subp>agraph 7,a77iii71 & on any subsequ5t day dur+ su* fiscal ye> ! biosimil> biological product does n appe> on su* li/1 except z provid$ 9 subp>agraph 7,d71 ea* p]son :o is nam$ z ! applicant 9 ! biosimil> biological product application %all pay ! annual biosimil> biological product program fee e/abli%$ = a fiscal ye> "u subsection 7c77#e7 = su* biosimil> biological product4 ,not)/&+ subp>agraph 7,b71 su* fee %all be due on ! la/ bus9ess day ( su* fiscal ye> & %all be paid only once = ea* product = ea* fiscal ye>4 2 & 7#e7 by /rik+ p>agraph 7#d74 7b7 ,fee rev5ue am\nts ,section #gdd;,h7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 77#ba ,u4,s4,c4 #cgi;j-#eb7;b77 is am5d$-- 7#a7 by /rik+ p>agraph 7#a72 7#b7 by r$esignat+ p>agraphs 7#b7 ?r\gh 7#d7 z p>agraphs 7#a7 ?r\gh 7#c71 respectively2 7#c7 9 p>agraph 7#a71 z s r$esignat$-- 7,a7 9 ! p>agraph head+1 by /rik+ ,subsequ5t fiscal ye>s & ins]t+ ,9 g5]al2 7,b7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ #bjai ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 7,c7 9 subp>agraph 7,a71 by /rik+ p>agraph 7#d7 & ins]t+ p>agraph 7#c72 7,d7 by r$esignat+ subp>agraphs 7,c7 & 7,d7 z subp>agraphs 7,d7 & 7,e71 respectively2 7,e7 by ins]t+ aft] subp>agraph 7,b7 ! foll[+3 7,c7 ! doll> am\nt equal to ! /rategic hir+ & ret5tion adju/m5t 7z det]m9$ "u subsection 7c77#b772 2 7,f7 9 subp>agraph 7,d71 z s r$esignat$1 by /rik+ subsection 7c77#b772 & & ins]t+ subsection 7c77#c7722 7,g7 9 subp>agraph 7,e71 z s r$esignat$1 by /rik+ subsection 7c77#c774 & ins]t+ subsection 7c77#d772 &2 & 7,h7 by add+ at ! end ! foll[+3 7,f7 = fiscal ye>s #bjbc & #bjbd1 additional doll> am\nts equal to-- 7i7 #d1dbh1 #hhf = fiscal ye> #bjbc2 & 7ii7 #cbj1efi = fiscal ye> #bjbd4 2 7#d7 9 p>agraph 7#b71 z s r$esignat$-- 7,a7 9 ! p>agraph head+1 by /rik+ 2 limitations on fee am\nts2 7,b7 by /rik+ subp>agraph 7,b72 & 7,c7 by r$esignat+ subap>agraphs 7,c7 & 7,d7 z subp>agraphs 7,b7 & 7,c71 respectively2 & 7#e7 by am5d+ p>agraph 7#c71 z s r$esignat$1 to read z foll[s3 7#c7 ,annual base rev5ue ,= purposes ( p>agraph 7#a71 ! doll> am\nt ( ! annual base rev5ue = a fiscal ye> %all be-- 7,a7 = fiscal ye> #bjbc1 #dc1cgf1ibb2 & 7,b7 = fiscal ye>s #bjbd ?r\gh #bjbg1 ! doll> am\nt ( ! total rev5ue am\nt e/abli%$ "u p>agraph 7#a7 = ! previ\s fiscal ye>1 exclud+ any adju/m5ts to su* rev5ue am\nt "u subsection 7c77#d74 4 7c7 ,adju/m5ts2 annual fee sett+ ,section #gdd;,h7c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 77#ba ,u4,s4,c4 #cgi;j-#eb7;c77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! matt] prec$+ clause 7i71 by /rik+ subsection 7b77#b77;,b7 & ins]t+ subsection 7b77#a77;,b72 & 7ii7 9 clause 7i71 by /rik+ subsection 7b7 & ins]t+ subsection 7b77#a77;,a72 & 7,b7 9 subp>agraph 7,b77ii71 by /rik+ ,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv & ins]t+ ,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 7#b7 by /rik+ p>agraph 7#d72 7#c7 by r$esignat+ p>agraphs 7#b7 & 7#c7 z p>agraphs 7#c7 & 7#d71 respectively2 7#d7 by ins]t+ aft] p>agraph 7#a7 ! foll[+3 7#b7 ,/rategic hir+ & ret5tion adju/m5t ,= ea* fiscal ye> beg9n+ 9 fiscal ye> #bjbc1 aft] ! annual base rev5ue "u subsection 7b77#a77;,a7 is adju/$ = inflation 9 accordance ) p>agraph 7#a71 ! ,secret>y %all fur!r increase ! fee rev5ue & fees by #aej1jjj4 2 7#e7 9 p>agraph 7#c71 z s r$esignat$-- 7,a7 9 subp>agraph 7,a7-- 7i7 by /rik+ ,beg9n+ ) ! fiscal ye> describ$ 9 subp>agraph 7,b77ii77,,ii7 & ins]t+ ,= ea* fiscal ye>2 & 7ii7 by /rik+ adju/m5t "u p>agraph 7#a71 fur!r increase & ins]t+ adju/m5ts "u p>agraphs 7#a7 & 7#b71 fur!r adju/2 & 7,b7 by am5d+ subp>agraph 7,b7 to read z foll[s3 7,b7 ,me?odology ,= purposes ( ?is p>agraph1 ! ,secret>y %all employ ! capacity plann+ me?odology utiliz$ by ! ,secret>y 9 sett+ fees = fiscal ye> #bjba1 z describ$ 9 ! notice titl$ ,biosimil> ,us] ,fee ,rates = ,fiscal ,ye> #bjba 7#he ,f$4 ,reg4 #dgbbj2 ,augu/ #d1 #bjbj74 ,! workload categories us$ 9 =eca/+ %all include only ! activities describ$ 9 su* notice &1 z feasible1 additional activities t are also directly relat$ to ! direct review ( biosimil> biological product applications & supplem5ts1 includ+ additional =mal meet+ types & ! direct review ( po/m>ket+ commitm5ts & requirem5ts1 ! direct review ( risk evaluation & mitigation /rategies1 & ! direct review ( annual reports = approv$ biosimil> biological products4 ,subject to ! exceptions 9 ! prec$+ s5t5ce1 ! ,secret>y %all n include z workload categories 9 =eca/+ any non-core review activities1 includ+ any activities t ! ,secret>y ref]5c$ = pot5tial future use 9 su* notice b did n utilize 9 sett+ fees = fiscal ye> #bjba4 2 & 7,c7 9 subp>agraph 7,c7-- 7i7 by /rik+ subsections 7b77#b77;,a7 & ins]t+ subsections 7b77#a77;,a72 7ii7 by /rik+ & 7b77#b77;,b7 & ins]t+ 1 7b77#a77;,b72 & 7iii7 by ins]t+ 1 & 7b77#a77;,c7 7! doll> am\nt ( ! /rategic hir+ & ret5tion adju/m5t7 be=e ! p]iod at ! end2 7#f7 by am5d+ p>agraph 7#d71 z s r$esignat$1 to read z foll[s3 7#d7 ,op]at+ res]ve adju/m5t 7,a7 ,increase ,= fiscal ye> #bjbc & subsequ5t fiscal ye>s1 ! ,secret>y %all1 9 addition to adju/m5ts "u p>agraphs 7#a71 7#b71 & 7#c71 fur!r increase ! fee rev5ue & fees if su* an adju/m5t is necess>y to provide = at lea/ #aj weeks ( op]at+ res]ves ( c>ryov] us] fees = ! process = ! review ( biosimil> biological product applications4 7,b7 ,decrease 7i7 ,fiscal ye> #bjbc ,= fiscal ye> #bjbc1 if ! ,secret>y has c>ryov] balances = ! process = ! review ( biosimil> biological product applications 9 excess ( #cc weeks ( su* op]at+ res]ves1 ! ,secret>y %all decrease su* fee rev5ue & fees to provide = n m ?an #cc weeks ( su* op]at+ res]ves4 7ii7 ,fiscal ye> #bjbd ,= fiscal ye> #bjbd1 if ! ,secret>y has c>ryov] balances = ! process = ! review ( biosimil> biological product applications 9 excess ( #bg weeks ( su* op]at+ res]ves1 ! ,secret>y %all decrease su* fee rev5ue & fees to provide = n m ?an #bg weeks ( su* op]at+ res]ves4 7iii7 ,fiscal ye> #bjbe & subsequ5t fiscal ye>s ,= fiscal ye> #bjbe & subsequ5t fiscal ye>s1 if ! ,secret>y has c>ryov] balances = ! process = ! review ( biosimil> biological product applications 9 excess ( #ba weeks ( su* op]at+ res]ves1 ! ,secret>y %all decrease su* fee rev5ue & fees to provide = n m ?an #ba weeks ( su* op]at+ res]ves4 7,c7 ,f$]al regi/] notice ,if an adju/m5t "u subp>agraph 7,a7 or 7,b7 is made1 ! rationale = ! am\nt ( ! increase or decrease 7z applicable7 9 fee rev5ue & fees %all be conta9$ 9 ! annual ,f$]al ,regi/] notice "u p>agraph 7#e77;,b7 e/abli%+ fee rev5ue & fees = ! fiscal ye> involv$4 2 & 7#g7 9 p>agraph 7#e71 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ #bjah & ins]t+ #bjbc4 7d7 ,cr$it+ & availability ( fees ,section #gdd;,h7f77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 77#ba ,u4,s4,c4 #cgi;j-#eb7;f77#c77 is am5d$ by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 7e7 ,writt5 reque/s = waiv]s & refunds ,subsection 7h7 ( section #gdd;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7 is am5d$ to read z foll[s3 7h7 ,writt5 reque/s = waiv]s & returns2 disputes conc]n+ fees ,to qualify = consid]ation = a waiv] "u subsection 7d71 or ! return ( any fee paid "u ?is section1 includ+ if ! fee is claim$ to h be5 paid 9 error1 a p]son %all submit to ! ,secret>y a writt5 reque/ ju/ify+ su* waiv] or return &1 except z o!rwise specifi$ 9 ?is section1 su* writt5 reque/ %all be submitt$ to ! ,secret>y n lat] ?an #ahj days aft] su* fee is due4 ,a reque/ submitt$ "u ?is p>agraph %all include any legal au?orities "u :i* ! reque/ is made4 4 #djd4 ,reau?orization2 report+ requirem5ts ,section #gdd;,i ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7 is am5d$-- 7#a7 by /rik+ #bjah ea* place x appe>s & ins]t+ #bjbc2 7#b7 by /rik+ ,biosimil> ,us] ,fee ,am5dm5ts ( #bjag ea* place x appe>s & ins]t+ ,biosimil> ,us] ,fee ,am5dm5ts ( #bjbb2 7#c7 9 subsection 7a77#d71 by /rik+ #bjbj & ins]t+ #bjbc2 & 7#d7 9 subsection 7f71 by /rik+ #bjbb ea* place x appe>s & ins]t+ #bjbg4 #dje4 ,sunset dates 7a7 ,au?orization ,sections #gdd;,g & #gdd;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea1 #cgi;j-#eb 7 %all cease to be effective ,octob] #a1 #bjbg4 7b7 ,report+ requirem5ts ,section #gdd;,i ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7 %all cease to be effective ,janu>y #ca1 #bjbh4 7c7 ,previ\s sunset provision ,effective ,octob] #a1 #bjbb1 subsections 7a7 & 7b7 ( section #dje ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 are repeal$4 #djf4 ,effective date ,! am5dm5ts made by ?is title %all take effect on ,octob] #a1 #bjbb1 or ! date ( ! enactm5t ( ?is ,act1 :i*ev] is lat]1 except t fees "u "p #h ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea et seq47 %all be assess$ = all biosimil> biological product applications receiv$ on or aft] ,octob] #a1 #bjbb1 reg>dless ( ! date ( ! enactm5t ( ?is ,act4 #djg4 ,sav+s clause ,not)/&+ ! am5dm5ts made by ?is title1 "p #h ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea et seq471 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is title1 %all cont9ue to be 9 effect ) respect to biosimil> biological product applications & supplem5ts 7z def9$ 9 su* "p z ( su* day7 t 7 accept$ by ! ,food & ,drug ,adm9i/ration = fil+ on or aft] ,octob] #a1 #bjag1 b be=e ,octob] #a1 #bjbb1 ) respect to assess+ & collect+ any fee requir$ by su* "p = a fiscal ye> prior to fiscal ye> #bjbc4 ,v ,improv+ regulation ( drugs & biological products #eja4 ,alt]natives to animal te/+ 7a7 ,9 g5]al ,section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is am5d$-- 7#a7 9 subsection 7i7-- 7,a7 9 p>agraph 7#a77;,a71 by /rik+ precl9ical te/s 7includ+ te/s on animals7 & ins]t+ noncl9ical te/s2 & 7,b7 9 p>agraph 7#b77;,b71 by /rik+ animal & ins]t+ noncl9ical te/s2 & 7#b7 aft] subsection 7y71 by ins]t+ ! foll[+3 7z7 ,noncl9ical te/ def9$ ,= purposes ( ?is section1 ! t]m noncl9ical te/ means a te/ conduct$ 9 vitro1 9 silico1 or 9 *emico1 or a non-human 9 vivo te/ t occurs be=e or dur+ ! cl9ical trial phase ( ! inve/igation ( ! safety & effectiv5ess ( a drug1 & may include animal te/s1 or non-animal or human biology-bas$ te/ me?ods1 su* z cell-bas$ assays1 microphysiological sy/ems1 or comput] models4 4 7b7 ,biosimil> biological product applications ,item 7bb7 ( section #cea7k77#b77;,a77i77,i7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77#b77;,a77i77,i77 is am5d$ to read z foll[s3 7bb7 an assessm5t ( toxicity 7:i* may rely on1 or consi/ (1 a /udy or /udies describ$ 9 item 7aa7 or 7cc772 & 4 #ejb4 ,saf] disposal ( opioids ,section #eje-a7;e77#d77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;e77#d77;,b77 is am5d$ by /rik+ = purposes ( r5d]+ drugs nonretrievable 7z def9$ 9 section #acjj4je ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulation774 #ejc4 ,cl>ifications to exclusivity provisions = fir/ int]*angeable biosimil> biological products ,section #cea7k77#f7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77#f77 is am5d$-- 7#a7 9 ! matt] prec$+ subp>agraph 7,a7-- 7,a7 by /rik+ ,^u review ( & ins]t+ ,! ,secret>y %all n make lic5sure z an int]*angeable biological product effective ) respect to2 7,b7 by /rik+ rely+ on & ins]t+ t relies on2 & 7,c7 by /rik+ ! ,secret>y %all n make a det]m9ation "u p>agraph 7#d7 t ! second or subsequ5t biological product is int]*angeable = any condition ( use2 & 7#b7 9 ! flu% text t foll[s subp>agraph 7,c71 by /rik+ ! p]iod & ins]t+ 1 & ! t]m fir/ int]*angeable biosimil> biological product means any int]*angeable biosimil> biological product t is approv$ on ! fir/ day on :i* su* a product is approv$ z int]*angeable ) ! ref]5ce product44 #ejd4 ,improvem5ts to ! ,purple ,book 7a7 ,9 g5]al ,section #ejf;,i ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;i7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 by /rik+ ,! hold] ( an application approv$ "u subsection 7c7 or 7j7 ( section #eje & ins]t+ ,! hold] ( an application approv$ "u subsection 7c7 or 7j7 ( section #eje ( ?is ,act or subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act2 7,b7 9 p>agraph 7#b71 by ins]t+ 79 ! case ( a biological product1 ! prop] "n7 aft] e/abli%$ "n2 & 7,c7 9 p>agraph 7#c71 by /rik+ or abbreviat$ application numb] & ins]t+ 1 abbreviat$ application numb]1 or biologics lic5se application numb]2 & 7#b7 9 subsection 7b7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ ,! hold] ( an application approv$ "u subsection 7c7 or 7j7 & ins]t+ ,! hold] ( an application approv$ "u subsection 7c7 or 7j7 ( section #eje ( ?is ,act or subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act2 7,b7 9 p>agraph 7#a71 by ins]t+ 79 ! case ( a biological product1 ! prop] "n7 aft] e/abli%$ "n2 & 7,c7 9 p>agraph 7#b71 by /rik+ or abbreviat$ application numb] & ins]t+ 1 abbreviat$ application numb]1 or biologics lic5se application numb]4 7b7 ,additional "o-,"t report ,subsection 7c7 ( section #ejf;,i ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;i7 is am5d$ to read z foll[s3 7c7 ,additional "o-,"t report ,)9 #ahj days ( ! date ( enactm5t ( ! ,food & ,drug ,adm9i/ration ,safety & ,l&m>k ,advancem5ts ,act ( #bjbb1 all hold]s ( applications approv$ "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act %all review ! in=mation 9 ! li/ publi%$ "u section #cea7k77#i77;,a7 & %all submit a writt5 notice to ! ,secret>y-- 7#a7 /at+ t all ( ! application hold]'s biological products 9 ! li/ publi%$ "u section #cea7k77#i77;,a7 t are n li/$ z discont9u$ are available = sale2 or 7#b7 includ+ ! in=mation requir$ pursuant to subsection 7a7 or 7b71 z applicable1 = ea* ( ! application hold]'s biological products t are 9 ! li/ publi%$ "u section #cea7k77#i77;,a7 & n li/$ z discont9u$1 b h be5 discont9u$ f sale or nev] h be5 available = sale4 4 7c7 ,purple book ,section #ejf;,i ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;i7 is am5d$-- 7#a7 9 subsection 7d7-- 7,a7 by /rik+ or 7c71 ! ,secret>y & ins]t+ 8or 7c7-- 7#a7 ! ,secret>y 2 7,b7 by /rik+ ! p]iod at ! end1 & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+3 7#b7 ! ,secret>y may id5tify ! application hold]'s biological products z discont9u$ 9 ! li/ publi%$ "u section #cea7k77#i77;,a7 ( ! ,public ,heal? ,s]vice ,act1 except t ! ,secret>y %all remove f ! li/ 9 accordance ) section #cea7k77#i77;,b7 ( su* ,act any biological product = :i* a lic5se has be5 revok$ or susp5d$ = reasons ( safety1 purity1 or pot5cy4 2 & 7#b7 9 subsection 7e7-- 7,a7 by ins]t+ aft] ! fir/ s5t5ce ! foll[+3 ,! ,secret>y %all update ! li/ publi%$ "u section #cea7k77#i77;,a7 ( ! ,public ,heal? ,s]vice ,act bas$ on in=mation provid$ "u subsections 7a71 7b71 & 7c7 by id5tify+ z discont9u$ biological products t are n available = sale1 except t any biological product = :i* ! lic5se has be5 revok$ or susp5d$ = reasons ( safety1 purity1 or pot5cy %all be remov$ f ! li/ 9 accordance ) section #cea7k77#i77;,b7 ( ! ,public ,heal? ,s]vice ,act42 & 7,b7 9 ! la/ s5t5ce-- 7i7 by /rik+ updates to ! li/ & ins]t+ updates to ! li/s publi%$ "u section #eje7;j77#g77;,a7 ( ?is ,act & section #cea7k77#i77;,a7 ( ! ,public ,heal? ,s]vice ,act2 & 7ii7 by /rik+ update ! li/ & ins]t+ update su* li/s4 #eje4 ,!rapeutic equival5ce evaluations ,section #eje7;j77#g77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77;,a77 is am5d$ by add+ at ! end ! foll[+3 7v7 7,i7 ,) respect to an application submitt$ pursuant to subsection 7b77#b7 = a drug t is subject to section #ejc7;b7 = :i* ! sole diff]5ce f a li/$ drug reli$ ^u 9 ! application is a diff]5ce 9 inactive +r$i5ts n p]mitt$ "u clause 7iii7 or 7iv7 ( section #cad4id7;a77#i7 ( title #ba1 ,code ( ,f$]al ,regulations 7or successor regulations71 ! ,secret>y %all make an evaluation ) respect to :e!r su* drug is a !rapeutic equival5t 7z def9$ 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations77 to ano!r approv$ drug product 9 ! prescription drug product section ( ! li/ "u ?is p>agraph z foll[s3 7aa7 ,) respect to su* an application submitt$ aft] ! date ( enactm5t ( ! ,food & ,drug ,adm9i/ration ,safety & ,l&m>k ,advancem5ts ,act ( #bjbb1 ! evaluation %all be made ) respect to a li/$ drug reli$ ^u 9 ! application "u subsection 7b77#b7 t is a ph>maceutical equival5t 7z def9$ 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations77 to ! drug 9 ! application "u subsection 7b77#b7 at ! "t ( approval ( su* application or n lat] ?an #ahj days aft] ! date ( su* approval1 provid$ t ! reque/ = su* a det]m9ation is made 9 ! orig9al application 7or 9 a resubmission to a complete response lett]71 & all necess>y data & in=mation are submitt$ 9 ! orig9al application 7or 9 a resubmission 9 response to a complete response lett]7 = ! !rapeutic equival5ce evaluation1 includ+ in=mation to demon/rate bioequival5ce1 9 a =m & mann] prescrib$ by ! ,secret>y4 7bb7 ,) respect to su* an application submitt$ prior to ! date ( enactm5t ( ! ,food & ,drug ,adm9i/ration ,safety & ,l&m>k ,advancem5ts ,act ( #bjbb1 ) respect to an application approv$ on or aft] ! date ( enactm5t ( su* ,act1 ! evaluation %all be made n lat] ?an #ahj days aft] receipt ( a reque/ = a !rapeutic equival5ce evaluation submitt$ z "p ( a supplem5t to su* application2 or ) respect to an application t 0 n approv$ z ( ! date ( enactm5t ( su* ,act1 ! evaluation %all be made n lat] ?an #ahj days aft] ! date ( approval ( su* application if a reque/ = su* evaluation is submitt$ to ! application1 provid$ t-- 7,,aa7 su* reque/ = a !rapeutic equival5t evaluation is be+ s\ght ) respect to a li/$ drug reli$ ^u 9 ! application1 & ! reli$ ^u li/$ drug is 9 ! prescription drug product section ( ! li/ "u ?is p>agraph & is a ph>maceutical equival5t 7z def9$ 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations77 to ! drug = :i* a !rapeutic equival5ce evaluation is s\ght2 & 7,,bb7 ! initial submission conta9+ su* reque/1 or ! relevant application1 includes all necess>y data & in=mation = ! !rapeutic equival5ce evaluation1 includ+ in=mation to demon/rate bioequival5ce1 9 a =m & mann] prescrib$ by ! ,secret>y4 7,,ii7 ,:5 ! ,secret>y makes an evaluation "u subclause 7,i71 ! ,secret>y %all1 9 revisions made to ! li/ pursuant to clause 7ii71 include su* in=mation = su* drug4 4 #ejf4 ,mod]niz+ accel]at$ approval 7a7 ,9 g5]al ,section #ejf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;c77 is am5d$-- 7#a7 9 p>agraph 7#b7-- 7,a7 by r$esignat+ subp>agraphs 7,a7 & 7,b7 z clauses 7i7 & 7ii71 respectively1 & adju/+ ! m>g9s accord+ly2 7,b7 by /rik+ ,approval ( a product & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,approval ( a product 2 7,c7 9 clause 7i7 ( su* subp>agraph 7,a71 z s r$esignat$1 by /rik+ appropriate po/approval /udies & ins]t+ an appropriate po/approval /udy or /udies 7:i* may be augm5t$ or support$ by real _w evid5ce72 & 7,d7 by add+ at ! end ! foll[+3 7,b7 ,/udies n requir$ ,if ! ,secret>y does n require t ! sponsor ( a product approv$ "u accel]at$ approval conduct a po/approval /udy "u ?is p>agraph1 ! ,secret>y %all publi% on ! website ( ! ,food & ,drug ,adm9i/ration ! rationale = :y su* /udy is n appropriate or necess>y4 7,c7 ,po/approval /udy conditions ,n lat] ?an ! "t ( approval ( a product "u accel]at$ approval1 ! ,secret>y %all specify ! conditions = a po/approval /udy or /udies requir$ to be conduct$ "u ?is p>agraph ) respect to su* product1 :i* may include enrollm5t t>gets1 ! /udy protocol1 & mile/ones1 includ+ ! t>get date ( /udy completion4 7,d7 ,/udies ,begun ,be=e ,approval ,! ,secret>y may require su* /udy or /udies to be und]way prior to approval4 2 & 7#b7 9 p>agraph 7#c7-- 7,a7 by r$esignat+ subp>agraphs 7,a7 ?r\gh 7,d7 z clauses 7i7 ?r\gh 7iv71 respectively & adju/+ ! m>g9s accord+ly2 7,b7 by /rik+ ,! ,secret>y may & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,! ,secret>y may 2 7,c7 9 clause 7i7 ( su* subp>agraph 7,a71 z s r$esignat$1 by /rik+ drug ) due dilig5ce & ins]t+ product ) due dilig5ce1 includ+ ) respect to conditions specifi$ by ! ,secret>y "u p>agraph 7#b77;,c72 7,d7 9 clause 7iii7 ( su* subp>agraph 7,a71 z s r$esignat$1 by ins]t+ %[n to be aft] product is n2 & 7,e7 by add+ at ! end ! foll[+3 7,b7 ,exp$it$ proc$ures describ$ ,exp$it$ proc$ures describ$ 9 ?is subp>agraph %all consi/ (1 prior to ! )drawal ( accel]at$ approval-- 7i7 provid+ ! sponsor )-- 7,i7 due notice2 7,,ii7 an explanation = ! propos$ )drawal2 7,,iii7 an opportunity = a meet+ ) ! ,commission] or ! ,commission]'s designee2 & 7,,iv7 an opportunity = writt5 appeal to-- 7aa7 ! ,commission]2 or 7bb7 a designee ( ! ,commission] :o has n p>ticipat$ 9 ! proposal )drawal ( approval 7o!r ?an a meet+ pursuant to subclause 7,,iii77 & is n subord9ate ( an individual 7o!r ?an ! ,commission]7 :o p>ticipat$ 9 su* propos$ )drawal2 7ii7 provid+ an opportunity = public comm5t on ! propos+ to )drawal approval2 7iii7 ! publication ( a summ>y ( ! public comm5ts receiv$1 & ! ,secret>y's response to su* comm5ts1 on ! website ( ! ,food & ,drug ,adm9i/ration2 & 7iv7 conv5+ & consult+ an advisory committee on issues relat$ to ! propos$ )drawal1 if reque/$ by ! sponsor & if no su* advisory committee has previ\sly advis$ ! ,secret>y on su* issues ) respect to ! )drawal ( ! product prior to ! sponsor's reque/4 4 7b7 ,reports ( po/m>ket+ /udies ,section #ejf;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;b7a77 is am5d$-- 7#a7 by r$esignat+ p>agraph 7#b7 z p>agraph 7#c72 & 7#b7 by ins]t+ aft] p>agraph 7#a7 ! foll[+3 7#b7 ,accel]at$ approval ,not)/&+ p>agraph 7#a71 a sponsor ( a drug approv$ "u accel]at$ approval %all submit to ! ,secret>y a report ( ! progress ( any /udy requir$ "u section #ejf7;c71 includ+ progress t[>d enrollm5t t>gets1 mile/ones1 & o!r in=mation z requir$ by ! ,secret>y1 n lat] ?an #ahj days aft] ! approval ( su* drug & n less frequ5tly ?an e #ahj days !reaft]1 until ! /udy is complet$ or t]m9at$4 4 7c7 ,en=cem5t ,section #cja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca71 z am5d$ by section #hbd1 is fur!r am5d$ by add+ at ! end ! foll[+3 7ll7 ,! failure ( a sponsor ( a product approv$ "u accel]at$ approval pursuant to section #ejf7;c7-- 7#a7 to conduct ) due dilig5ce any po/approval /udy requir$ "u section #ejf7;c7 ) respect to su* product2 or 7#b7 to submit timely reports ) respect to su* product 9 accordance ) section #ejf;,b7a77#b74 4 7d7 ,guidance 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all issue guidance describ+-- 7,a7 h[ sponsor que/ions relat$ to ! id5tification ( novel surrogate or int]m$iate cl9ical endpo9ts may be address$ 9 e>ly-/age developm5t meet+s ) ! ,food & ,drug ,adm9i/ration2 7,b7 ! use ( novel cl9ical trial designs t may be us$ to conduct appropriate po/-approval /udies z may be requir$ "u section #ejf7;c77#b77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z am5d$ by subsection 7a72 7,c7 ! exp$it$ proc$ures describ$ 9 section #ejf7;c77#c77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 & 7,d7 consid]ations relat$ to ! use ( surrogate or int]m$iate cl9ical endpo9ts t may support ! accel]at$ approval ( an application "u #ejf7;c77#a77;,a71 includ+ consid]ations 9 evaluat+ ! evid5ce relat$ to any su* endpo9ts4 7#b7 ,f9al guidance ,! ,secret>y %all issue-- 7,a7 a draft guidance "u p>agraph 7#a7 n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act2 & 7,b7 f9al guidance n lat] ?an #a ye> aft] ! close ( ! public comm5t p]iod on su* draft guidance4 7e7 ,r>e disease endpo9t advancem5t pilot 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all e/abli% a pilot program "u :i* ! ,secret>y w e/abli% proc$ures to provide increas$ int]action ) sponsors ( r>e disease drug developm5t programs = purposes ( advanc+ ! developm5t ( efficacy endpo9ts1 includ+ surrogate & int]m$iate endpo9ts1 = drugs int5d$ to treat r>e diseases1 includ+ ?r\gh-- 7,a7 det]m9+ eligibility ( p>ticipants = su* program2 & 7,b7 develop+ & implem5t+ a process = apply+ to1 & p>ticipat+ 91 su* a program4 7#b7 ,public work%ops ,! ,secret>y %all conduct up to #c public work%ops1 :i* %all be complet$ n lat] ?an ,septemb] #cj1 #bjbf1 to discuss topics relevant to ! developm5t ( endpo9ts = r>e diseases1 :i* may include discussions ab\t-- 7,a7 novel endpo9ts develop$ ?r\gh ! pilot program e/abli%$ "u ?is subsection2 & 7,b7 z appropriate1 ! use ( real _w evid5ce & real "w data to support ! validation ( efficacy endpo9ts1 includ+ surrogate & int]m$iate endpo9ts1 = r>e diseases4 7#c7 ,report ,n lat] ?an ,septemb] #cj1 #bjbg1 ! ,secret>y %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report describ+ ! outcomes ( ! pilot program e/abli%$ "u ?is subsection4 7#d7 ,guidance ,n lat] ?an ,septemb] #cj1 #bjbg1 ! ,secret>y %all issue guidance describ+ be/ practices & /rategies = developm5t ( efficacy endpo9ts1 includ+ surrogate & int]m$iate endpo9ts1 = r>e diseases4 7#e7 ,sunset ,! ,secret>y may n accept any new application or reque/ to p>ticipate 9 ! program e/abli%$ by ?is subsection on or aft] ,octob] #a1 #bjbg4 7f7 ,accel]at$ approval c\ncil 7#a7 ,g5]al ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all e/abli% an intra-ag5cy coord9at+ c\ncil )9 ! ,food & ,drug ,adm9i/ration to ensure ! consi/5t & appropriate use ( accel]at$ approval across ! ,food & ,drug ,adm9i/ration1 pursuant to section #ejf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;c774 7#b7 ,memb]%ip ,! memb]s ( ! ,c\ncil %all consi/ ( ! foll[+ s5ior (ficials1 or a designee ( su* (ficial1 f ! ,food & ,drug ,adm9i/ration & relevant ,c5t]s3 7,a7 ,! ,director ( ! ,c5t] = ,drug ,evaluation & ,rese>*4 7,b7 ,! ,director ( ! ,c5t] = ,biologics ,evaluation & ,rese>*4 7,c7 ,! ,director ( ! ,oncology ,c5t] ( ,excell5ce4 7,d7 ,! ,director ( ! ,(fice ( ,new ,drugs4 7,e7 ,! ,director ( ! ,(fice ( ,orphan ,products ,developm5t4 7,f7 ,! ,director ( ! ,(fice ( ,tissues & ,advanc$ ,!rapies4 7,g7 ,! ,director ( ! ,(fice ( ,m$ical ,policy4 7,h7 ,at lea/ #c directors ( review division ov]see+ products approv$ "u accel]at$ approval1 includ+ at lea/ "o director ( a review division )9 ! ,(fice ( ,neurosci5ce4 7#c7 ,duties ( ! c\ncil 7,a7 ,meet+s ,! ,c\ncil %all conv5e n few] ?an #c times p] cal5d> ye> to discuss issues relat$ to accel]at$ approval1 includ+ any relevant cross-discipl9>y approa*es relat$ to product review ) respect to accel]at$ approval4 7,b7 ,policy developm5t ,! ,c\ncil %all directly engage ) product review teams to support ! consi/5t & appropriate use ( accel]at$ approval across ! ,food & ,drug ,adm9i/ration4 ,su* activities may include-- 7i7 develop+ guidance = ,food & ,drug ,adm9i/ration /aff & be/ practices =1 & across1 product review teams1 includ+ ) respect to communication betwe5 sponsors & ! ,food & ,drug ,adm9i/ration & ! review ( products "u accel]at$ approval2 7ii7 provid+ tra9+ = product review teams2 & 7iii7 advis+ review divisions on product-specific developm5t1 review1 & )drawal ( products "u accel]at$ approval4 7#d7 ,publication ( a report ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 & annually !reaft]1 ! c\ncil %all publi% on ! public website ( ! ,food & ,drug ,adm9i/ration a report on ! activities ( ! c\ncil4 7g7 ,rule ( con/ruction ,no?+ 9 ?is section 7includ+ ! am5dm5ts made by ?is section7 %all be con/ru$ to affect products approv$ "u #ejf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;c77 prior to ! date ( enactm5t ( ?is ,act4 ,,vi ,o!r reau?orizations #fja4 ,reau?orization ( ! critical pa? public-private p>tn]%ip ,section #eff7;f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#e7;f77 is am5d$ by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 #fjb4 ,reau?orization ( ! be/ ph>maceuticals = *ildr5 program ,section #dji;,i7d77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhdm7d77#a77 is am5d$ by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 #fjc4 ,reau?orization ( ! humanit>ian device exemption inc5tive ,section #ebj7m77#f77;,a77iv7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7m77#f77;,a77iv77 is am5d$ by /rik+ #bjbb & ins]t+ #bjbg4 #fjd4 ,reau?orization ( ! p$iatric device consortia program ,section #cje7;e7 ( ! ,food & ,drug ,adm9i/ration ,am5dm5ts ,act ( #bjjg 7,public ,law #aaj-he2 #db ,u4,s4,c4 #bhb note7 is am5d$ by /rik+ #e1bej1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ #g1jjj1jjj = ea* ( fiscal ye>s #bjbc ?r\gh #bjbg4 #fje4 ,reau?orization ( provision p]ta9+ to drugs conta9+ s+le enantiom]s ,section #eje7u7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7u77 is am5d$ by-- 7#a7 9 p>agraph 7#a77;,a77ii77,,ii71 by add+ 7o!r ?an bioavailability /udies7 aft] any cl9ical inve/igations2 & 7#b7 9 p>agraph 7#d71 by /rik+ ,octob] #a1 #bjbb & ins]t+ ,octob] #a1 #bjbg4 #fjf4 ,reau?orization ( orphan drug grants ,section #e7;c7 ( ! ,orphan ,drug ,act 7#ba ,u4,s4,c4 #cfj;ee7c77 is am5d$ by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 #fjg4 ,reau?orization ( c]ta9 device inspections ,section #gjd7;g77#aa7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;g77#aa77 is am5d$ by /rik+ #bjbb & ins]t+ #bjbg4 ,,vii ,enhanc+ ,,fda hir+ au?orities #gja4 ,enhanc+ ,,fda hir+ au?ority = sci5tific1 te*nical1 & pr(essional p]sonnel ,section #gad;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;d-#c;a7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 by ins]t+ 1 includ+ cross-cutt+ op]ational positions1 aft] pr(essional positions2 & 7,b7 by ins]t+ & ! regulation ( food aft] m$ical products2 & 7#b7 9 subsection 7d77#a7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a7-- 7i7 by /rik+ ! #ba/ ,c5tury ,cures ,act & ins]t+ ! ,food & ,drug ,adm9i/ration ,safety & ,l&m>k ,advancem5ts ,act ( #bjbb2 & 7ii7 by /rik+ t exam9es ! ext5t & all t foll[s ?r\gh 1 includ+ & ins]t+ t addresses2 7,b7 9 subp>agraph 7,a7-- 7i7 by ins]t+ updat$ be=e analysis2 & 7ii7 by /rik+ 2 & & ins]t+ a semicolon2 7,c7 by r$esignat+ subp>agraph 7,b7 z subp>agraph 7,c72 7,d7 by ins]t+ aft] subp>agraph 7,a7 ! foll[+3 7,b7 an analysis ( h[ ! ,secret>y has us$ ! au?orities provid$ "u ?is section1 & a plan = h[ ! ,secret>y w use ! au?ority "u ?is section1 & o!r applicable hir+ au?orities1 = employees ( ! ,food & ,drug ,adm9i/ration2 & 2 & 7,e7 9 subp>agraph 7,c71 z s r$esignat$1 by /rik+ a recruitm5t & ins]t+ an updat$ recruitm5t4 #gjb4 ,/rategic work=ce plan & report ,*apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cga et seq47 is am5d$ by ins]t+ aft] section #gad;,a ! foll[+3 #gad;,b4 ,/rategic work=ce plan & report 7a7 ,9 g5]al ,n lat] ?an ,septemb] #cj1 #bjbc1 & at lea/ e #d ye>s !reaft]1 ! ,secret>y %all develop & submit to ! appropriate committees ( ,congress & po/ on ! website ( ! ,food & ,drug ,adm9i/ration1 a coord9at$ /rategy & report to provide direction = ! activities & programs ( ! ,secret>y to recruit1 hire1 tra91 develop1 & reta9 ! work=ce ne$$ to fulfill ! public heal? mission ( ! ,food & ,drug ,adm9i/ration1 includ+ to facilitate collaboration across c5t]s1 to keep pace ) new biom$ical1 te*nological1 & sci5tific advancem5ts1 & support ! developm5t1 review1 & regulation ( m$ical products4 ,ea* su* report %all be kn[n z ! ,food & ,drug ,adm9i/ration ,/rategic ,work=ce ,plan4 7b7 ,use ( ! food & drug adm9i/ration /rategic work=ce plan ,ea* c5t] )9 ! ,food & ,drug ,adm9i/ration %all develop & update1 z appropriate1 a /rategic plan t w be in=m$ by ! ,food & ,drug ,adm9i/ration ,/rategic ,work=ce ,plan develop$ & updat$ "u ?is subsection4 7c7 ,cont5ts ( ! food & drug adm9i/ration /rategic work=ce plan ,ea* ,food & ,drug ,adm9i/ration ,/rategic ,work=ce ,plan "u subsection 7a7 %all-- 7#a7 include ag5cy-wide /rategic goals & priorities = recruit+1 hir+1 tra9+1 develop+1 & reta9+ a qualifi$ work=ce = ! ,food & ,drug ,adm9i/ration2 7#b7 e/abli% specific activities ! ,secret>y w take to a*ieve its /rategic goals & priorities & address ! work=ce ne$s ( ! ,food & ,drug ,adm9i/ration 9 ! =?com+ fiscal ye>s2 7#c7 id5tify *all5ges & risks ! ,secret>y w face 9 meet+ its /rategic goals & priorities1 & ! activities ! ,secret>y w und]take to ov]come ^? *all5ges & mitigate ^? risks2 7#d7 e/abli% metrics & mile/ones t ! ,secret>y w use to measure progress 9 a*iev+ its /rategic goals & priorities2 & 7#e7 def9e functions1 capabilities1 & gaps 9 su* work=ce & id5tify /rategies to recruit1 hire1 tra91 develop1 & reta9 su* work=ce4 7d7 ,consid]ations ,9 develop+ ea* ,food & ,drug ,adm9i/ration ,/rategic ,work=ce ,plan "u subsection 7a71 ! ,secret>y %all consid]-- 7#a7 ! numb] ( employees1 employee exp]tise1 & employ+ c5t] ( employees1 includ+ s5ior lead]%ip & non-s5ior lead]%ip employees1 eligible = retirem5t2 7#b7 ! vacancy & turnov] rates = employees ) diff]5t types ( exp]tise & f diff]5t c5t]s1 includ+ any *anges or tr5ds relat$ to su* rates2 7#c7 ! results ( ! ,f$]al ,employee ,viewpo9t ,survey = employees ( ! ,food & ,drug ,adm9i/ration1 includ+ any *anges or tr5ds relat$ to su* results2 7#d7 rates ( pay = diff]5t types ( positions1 includ+ rates = diff]5t types ( exp]tise )9 ! same field 7su* z diff]5ces 9 pay betwe5 diff]5t m$ical speciali/s71 & h[ su* rates ( pay impact ! ability ( ! ,secret>y to a*ieve /rategic goals & priorities2 & 7#e7 ! /atutory hir+ au?orities us$ to hire ,food & ,drug ,adm9i/ration employees1 & ! "t to hire across diff]5t hir+ au?orities4 7e7 ,evaluation ( progress ,ea* ,food & ,drug ,adm9i/ration ,/rategic ,work=ce ,plan issu$ pursuant to subsection 7a71 ) ! exception ( ! fir/ su* ,food & ,drug ,adm9i/ration ,/rategic ,work=ce ,plan1 %all include an evaluation ( ! progress ! ,secret>y has made1 bas$ on ! metrics1 b5*m>ks1 & o!r mile/ones t measure successful recruitm5t1 hir+1 tra9+1 developm5t1 & ret5tion activities2 & :e!r su* actions improv$ ! capacity ( ! ,food & ,drug ,adm9i/ration to a*ieve ! /rategic goals & priorities set =? 9 ! previ\s ,food & ,drug ,adm9i/ration ,/rategic ,work=ce ,plan4 7f7 ,additional consid]ations ,! ,food & ,drug ,adm9i/ration ,/rategic ,work=ce ,plan issu$ 9 fiscal ye> #bjbc %all address ! effect ( ! ,,covid-#ai p&emic on hir+1 ret5tion1 & o!r work=ce *all5ges = ! ,food & ,drug ,adm9i/ration1 includ+ protect+ su* work=ce dur+ public heal? em]g5cies4 4 ,,viii ,advanc+ regulation ( cosmetics1 diet>y supplem5ts1 & laboratory develop$ te/s ,a ,cosmetics #hja4 ,%ort title ,?is subtitle may be cit$ z ! ,mod]nization ( ,cosmetics ,regulation ,act ( #bjbb4 #hjb4 ,am5dm5ts to cosmetic requirem5ts ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq47 is am5d$ by add+ at ! end ! foll[+3 #fjd4 ,def9itions ,9 ?is *apt]3 7#a7 ,adv]se ev5t ,! t]m adv]se ev5t means any heal?-relat$ ev5t associat$ ) ! use ( a cosmetic product t is adv]se4 7#b7 ,cosmetic product ,! t]m cosmetic product means a prep>ation ( cosmetic +r$i5ts ) a qualitatively & quantitatively set composition = use 9 a f9i%$ product4 7#c7 ,facility 7,a7 ,9 g5]al ,! t]m facility includes any e/abli%m5t 7includ+ an e/abli%m5t ( an import]7 t manufactures or processes cosmetic products di/ribut$ 9 ! ,unit$ ,/ates4 7,b7 ,su* t]m does n include any ( ! foll[+3 7i7 ,beauty %ops & salons1 unless su* e/abli%m5t manufactures or processes cosmetic products at t location4 7ii7 ,cosmetic product retail]s1 includ+ individual sales repres5tatives1 direct sell]s1 retail di/ribution facilities1 & ph>macies1 unless su* e/abli%m5t manufactures or processes cosmetic products t are n sold directly to consum]s at t location4 7iii7 ,hospitals1 physicians' (fices1 & heal? c>e cl9ics4 7iv7 ,public heal? ag5cies & o!r nonpr(it entities t provide cosmetic products directly to ! consum]4 7v7 ,entities 7su* z hotels & airl9es7 t provide complim5t>y cosmetic products to cu/om]s incid5tal to o!r s]vices4 7vi7 ,trade %[s & o!r v5ues :]e cosmetic product samples are provid$ free ( *>ge4 7vii7 ,an e/abli%m5t t manufactures or processes cosmetic products t are solely = use 9 rese>* or evaluation1 includ+ = production te/+ & n (f]$ = retail sale4 7viii7 ,an e/abli%m5t t solely p]=ms "o or m ( ! foll[+ ) respect to cosmetic products3 7,i7 ,label+4 7,,ii7 ,relabel+4 7,,iii7 ,packag+4 7,,iv7 ,repackag+4 7,v7 ,hold+4 7,,vi7 ,di/ribut+4 7,c7 ,cl>ification ,= ! purposes ( subp>agraph 7,b77viii71 ! t]ms packag+ & repackag+ d n include fill+ a product conta9] ) a cosmetic product4 7#d7 ,responsible p]son ,! t]m responsible p]son means ! manufactur]1 pack]1 or di/ributor ( a cosmetic product ^: "n appe>s on ! label ( su* cosmetic product 9 accordance ) section #fji7;a7 ( ?is ,act or section #d7;a7 ( ! ,fair ,packag+ & ,label+ ,act4 7#e7 ,s]i\s adv]se ev5t ,! t]m s]i\s adv]se ev5t means an adv]se ev5t t-- 7,a7 results 9-- 7i7 dea?2 7ii7 a life-?reat5+ exp]i5ce2 7iii7 inpati5t hospitalization2 7iv7 a p]si/5t or significant disability or incapacity2 7v7 a cong5ital anomaly or bir? defect2 or 7vi7 significant disfigurem5t 7includ+ s]i\s & p]si/5t ra%es or infections1 second- or ?ird-degree burns1 significant hair loss1 or p]man5t or significant alt]ation ( appe>ance71 o!r ?an z int5d$1 "u conditions ( use t are cu/om>y or usual2 or 7,b7 requires1 bas$ on reasonable m$ical judgm5t1 a m$ical or surgical int]v5tion to prev5t an outcome describ$ 9 subp>agraph 7,a74 #fje4 ,adv]se ev5ts 7a7 ,s]i\s adv]se ev5t report+ requirem5ts ,! responsible p]son %all submit to ! ,secret>y any report receiv$ ( a s]i\s adv]se ev5t associat$ ) ! use1 9 ! ,unit$ ,/ates1 ( a cosmetic product manufactur$1 pack$1 or di/ribut$ by su* p]son4 7b7 ,submission ( reports 7#a7 ,s]i\s adv]se ev5t report ,! responsible p]son %all submit to ! ,secret>y a s]i\s adv]se ev5t report accompani$ by a copy ( ! label on or )9 ! retail packag+ ( su* cosmetic product no lat] ?an #ae bus9ess days aft] ! report is receiv$ by ! responsible p]son4 7#b7 ,new m$ical in=mation ,! responsible p]son %all submit to ! ,secret>y any new & mat]ial m$ical in=mation1 relat$ to a s]i\s adv]se ev5t report submitt$ to ! ,secret>y 9 accordance ) p>agraph 7#a71 t is receiv$ by ! responsible p]son )9 #a ye> ( ! initial report to ! ,secret>y1 no lat] ?an #ae bus9ess days aft] su* in=mation is receiv$ by su* responsible p]son4 7#c7 ,consolidation ( reports ,! ,secret>y %all develop sy/ems to enable responsible p]sons to submit a s+le report t includes duplicate reports (1 or new m$ical in=mation relat$ to1 a s]i\s adv]se ev5t4 7c7 ,exemptions ,! ,secret>y may e/abli% by regulation an exemption to any ( ! requirem5ts ( ?is section if ! ,secret>y det]m9es t su* exemption w\ld h no significant adv]se effect on public heal?4 7d7 ,contact in=mation ,! responsible p]son %all receive reports ( adv]se ev5ts ?r\gh ! dome/ic address1 dome/ic telephone numb]1 or electronic contact in=mation includ$ on ! label 9 accordance ) section #fji7;a74 7e7 ,ma9t5ance & inspection ( adv]se ev5t records 7#a7 ,ma9t5ance ,! responsible p]son %all ma9ta9 records relat$ to ea* report ( an adv]se ev5t associat$ ) ! use1 9 ! ,unit$ ,/ates1 ( a cosmetic product manufactur$ or di/ribut$ by su* p]son receiv$ by su* p]son1 = a p]iod ( #f ye>s4 7#b7 ,inspection 7,a7 ,9 g5]al ,! responsible p]son %all p]mit an au?oriz$ p]son to h access to records requir$ to be ma9ta9$ "u ?is section dur+ an inspection pursuant to section #gjd4 7,b7 ,au?oriz$ p]son ,= purposes ( ?is p>agraph1 ! t]m au?oriz$ p]son means an (fic] or employee ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices :o has-- 7i7 appropriate cr$5tials1 z det]m9$ by ! ,secret>y2 & 7ii7 be5 duly designat$ by ! ,secret>y to h access to ! records requir$ "u ?is section4 7f7 ,fragrance & flavor +r$i5ts ,if ! ,secret>y has reasonable gr\nds to believe t an +r$i5t or comb9ation ( +r$i5ts 9 a fragrance or flavor has caus$ or contribut$ to a s]i\s adv]se ev5t requir$ to be report$ "u ?is section1 ! ,secret>y may reque/ 9 writ+ a complete li/ ( +r$i5ts 9 ! specific fragrances or flavors 9 ! cosmetic product1 f ! responsible p]son4 ,! responsible p]son %all ensure t ! reque/$ in=mation is submitt$ to ! ,secret>y )9 #cj days ( su* reque/4 ,in=mation submitt$ to ! ,secret>y "u ?is subsection t is confid5tial comm]cial or trade secret in=mation %all be exempt f disclosure "u section #eeb ( title #e1 ,unit$ ,/ates ,code4 7g7 ,protect$ in=mation ,a s]i\s adv]se ev5t report submitt$ to ! ,secret>y "u ?is section1 includ+ any new m$ical in=mation submitt$ "u subsection 7a77#b71 or an adv]se ev5t report1 or any new in=mation1 volunt>ily submitt$ to ! ,secret>y %all be consid]$ to be-- 7#a7 a safety report "u section #gef & may be accompani$ by a /atem5t1 :i* %all be a "p ( any report t is releas$ = public disclosure1 t d5ies t ! report or ! records con/itute an admission t ! product involv$ caus$ or contribut$ to ! adv]se ev5t2 & 7#b7 a record ab\t an individual "u section #eeb;a ( title #e1 ,unit$ ,/ates ,code 7commonly ref]r$ to z ! ,privacy ,act ( #aigd7 & a m$ical or simil> file ! disclosure ( :i* w\ld con/itute a violation ( section #eeb ( su* title #e 7commonly ref]r$ to z ! ,fre$om ( ,in=mation ,act71 & %all n be publicly disclos$ unless all p]sonally id5tifiable in=mation is r$act$4 7h7 ,effect ( section 7#a7 ,9 g5]al ,no?+ 9 ?is section %all affect ! au?ority ( ! ,secret>y to provide adv]se ev5t reports & in=mation to any heal?1 food1 or drug (fic] or employee ( any ,/ate1 t]ritory1 or political subdivision ( a ,/ate or t]ritory1 "u a memor&um ( und]/&+ betwe5 ! ,secret>y & su* ,/ate1 t]ritory1 or political subdivision4 7#b7 ,p]sonally id5tifiable in=mation ,not)/&+ any o!r provision ( law1 p]sonally id5tifiable in=mation 9 adv]se ev5t reports provid$ by ! ,secret>y to any heal?1 food1 or drug (fic] or employee ( any ,/ate1 t]ritory1 or political subdivision ( a ,/ate or t]ritory1 %all n-- 7,a7 be made publicly available pursuant to any ,/ate or o!r law requir+ disclosure ( in=mation or records2 or 7,b7 o!rwise be disclos$ or di/ribut$ to any p>ty )\t ! writt5 cons5t ( ! ,secret>y & ! p]son submitt+ su* in=mation to ! ,secret>y4 7#c7 ,use ( reports ,no?+ 9 ?is section %all p]mit a ,/ate1 t]ritory1 or political subdivision ( a ,/ate or t]ritory1 to use any safety report receiv$ f ! ,secret>y 9 a mann] inconsi/5t ) ?is section4 7#d7 ,rule ( con/ruction ,! submission ( any report 9 compliance ) ?is section %all n be con/ru$ z an admission t ! cosmetic product involv$ caus$ or contribut$ to ! relevant adv]se ev5t4 #fjf4 ,good manufactur+ practice 7a7 ,9 g5]al ,! ,secret>y %all by regulation e/abli% good manufactur+ practices = facilities t are consi/5t1 to ! ext5t practicable1 & appropriate1 ) national & int]national /&>ds1 9 accordance ) section #fja4 ,any su* regulations %all be int5d$ to protect ! public heal? & ensure t cosmetic products are n adult]at$4 ,su* regulations may all[ = ! ,secret>y to inspect records necess>y to demon/rate compliance ) good manufactur+ practices prescrib$ by ! ,secret>y "u ?is p>agraph dur+ an inspection conduct$ "u section #gjd4 7b7 ,consid]ations ,9 e/abli%+ regulations = good manufactur+ practices "u ?is section1 ! ,secret>y %all take into acc\nt ! size & scope ( ! bus9esses engag$ 9 ! manufacture ( cosmetics1 & ! risks to public heal? pos$ by su* cosmetics1 & provide suffici5t flexibility to be practicable = all sizes & types ( facilities to :i* su* regulations w apply4 ,su* regulations %all include simplifi$ good manufactur+ practice requirem5ts = small] bus9esses1 z appropriate1 to ensure t su* regulations d n impose undue economic h>d%ip = small] bus9esses1 & may include long] compliance times = small] bus9esses4 ,be=e issu+ regulations to implem5t subsection 7a71 ! ,secret>y %all consult ) cosmetics manufactur]s1 includ+ small] bus9esses1 consum] organizations1 & o!r exp]ts select$ by ! ,secret>y4 7c7 ,timeframe ,! ,secret>y %all publi% a notice ( propos$ rulemak+ n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,mod]nization ( ,cosmetics ,regulation ,act ( #bjbb & %all publi% a f9al su* rule n lat] ?an #c ye>s aft] su* date ( enactm5t4 #fjg4 ,regi/ration & product li/+ 7a7 ,submission ( regi/ration 7#a7 ,initial regi/ration 7,a7 ,exi/+ facilities ,e p]son t1 on ! date ( enactm5t ( ! ,mod]nization ( ,cosmetics ,regulation ,act ( #bjbb1 owns or op]ates a facility t engages 9 ! manufactur+ or process+ ( a cosmetic product = di/ribution 9 ! ,unit$ ,/ates %all regi/] ea* facility ) ! ,secret>y n lat] ?an #a ye> aft] date ( enactm5t ( su* ,act4 7,b7 ,new facilities ,e p]son t owns or op]ates a facility t fir/ engages1 aft] ! date ( enactm5t ( ! ,mod]nization ( ,cosmetics ,regulation ,act ( #bjbb1 9 manufactur+ or process+ ( a cosmetic product = di/ribution 9 ! ,unit$ ,/ates1 %all regi/] ) ! ,secret>y su* facility )9 #fj days ( fir/ engag+ 9 su* activity or #fj days aft] ! deadl9e = regi/ration "u subp>agraph 7,a71 :i*ev] is lat]4 7#b7 ,bi5nial r5ewal ( regi/ration ,a p]son requir$ to regi/] a facility "u p>agraph 7#a7 %all r5ew su* regi/rations ) ! ,secret>y bi5nially4 7#c7 ,contract manufactur]s ,if a facility manufactures or processes cosmetic products on behalf ( a responsible p]son1 ! ,secret>y %all require only a s+le regi/ration = su* facility ev5 if su* facility is manufactur+ or process+ its own cosmetic products or cosmetic products on behalf ( m ?an "o responsible p]son4 ,su* s+le regi/ration may be submitt$ to ! ,secret>y by su* facility or any responsible p]son ^: products are manufactur$ or process$ at su* facility4 7#d7 ,updates to cont5t ,a p]son t is requir$ to regi/] "u subsection 7a77#a7 %all notify ! ,secret>y )9 #fj days ( any *anges to in=mation requir$ "u subsection 7b77#b74 7#e7 ,abbreviat$ r5ewal regi/rations ,! ,secret>y %all provide = an abbreviat$ regi/ration r5ewal process = any p]son t owns or op]ates a facility t has n be5 requir$ to submit updates "u p>agraph 7#d7 = a regi/]$ facility s9ce submission ( ! mo/ rec5t regi/ration ( su* facility "u p>agraph 7#a7 or 7#b74 7b7 ,=mat2 cont5ts ( regi/ration 7#a7 ,9 g5]al ,regi/ration in=mation "u ?is section may be submitt$ at su* "t & 9 su* mann] z ! ,secret>y may prescribe4 7#b7 ,cont5ts ,! regi/ration "u subsection 7a7 %all conta9-- 7,a7 ! facility's "n1 physical address1 email address1 & telephone numb]2 7,b7 ) respect to any =eign facility1 ! contact = ! ,unit$ ,/ates ag5t ( ! facility1 &1 if available1 ! electronic contact in=mation2 7,c7 ! facility regi/ration numb]1 if any1 previ\sly assign$ by ! ,secret>y "u subsection 7d72 7,d7 all br& names "u :i* cosmetic products manufactur$ or process$ 9 ! facility are sold2 & 7,e7 ! product category or categories & responsible p]son = ea* cosmetic product manufactur$ or process$ at ! facility4 7c7 ,cosmetic product li/+ 7#a7 ,9 g5]al ,= ea* cosmetic product1 ! responsible p]son %all submit1 or ensure is submitt$1 to ! ,secret>y a cosmetic product li/+1 at su* "t & 9 su* mann] z ! ,secret>y may prescribe4 7#b7 ,cosmetic product li/+ ,! responsible p]son ( a cosmetic product t is m>ket$ on ! date ( enactm5t ( ! ,mod]nization ( ,cosmetics ,regulation ,act ( #bjbb %all submit to ! ,secret>y a cosmetic product li/+ n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,mod]nization ( ,cosmetics ,regulation ,act ( #bjbb1 or = a cosmetic product t is fir/ m>ket$ aft] ! date ( enactm5t ( su* ,act1 )9 #abj days ( m>ket+ su* product 9 int]/ate comm]ce4 ,!reaft]1 any updates to su* li/+ %all be made annually1 consi/5t ) p>agraphs 7#d7 & 7#e74 7#c7 ,abbreviat$ r5ewal ,! ,secret>y %all provide = an abbreviat$ process = ! r5ewal ( any cosmetic product li/+ "u ?is subsection ) respect to :i* !re has be5 no *ange s9ce ! responsible p]son submitt$ ! previ\s li/+4 7#d7 ,cont5ts ( li/+ 7,a7 ,9 g5]al ,ea* su* cosmetic product li/+ %all include-- 7i7 ! facility regi/ration numb] ( ea* facility :]e ! cosmetic product is manufactur$ or process$2 7ii7 ! "n & contact numb] ( ! responsible p]son & ! "n = ! cosmetic product1 z su* "n appe>s on ! label2 7iii7 ! applicable cosmetic category or categories = ! cosmetic product2 7iv7 a li/ ( +r$i5ts 9 ! cosmetic product1 includ+ any fragrances1 flavors1 or colors1 ) ea* +r$i5t id5tifi$ by ! "n adopt$ 9 regulations promulgat$ by ! ,secret>y1 if any1 or by ! common or usual "n ( ! +r$i5t2 & 7v7 ! product li/+ numb]1 if any previ\sly assign$ by ! ,secret>y "u subsection 7d74 7,b7 ,flexible li/+s ,a s+le li/+ submission = a cosmetic product may include multiple cosmetic products ) id5tical =mulations1 or =mulations t diff] only ) respect to colors1 fragrances or flavors1 or quantity ( cont5ts4 7#e7 ,updates to cont5t ,a responsible p]son t is requir$ to submit a cosmetic product li/+ %all submit any updates to su* cosmetic product li/+ annually4 7#f7 ,submission ,a responsible p]son may submit product li/+ in=mation z "p ( a facility regi/ration or sep>ately4 7d7 ,facility regi/ration & product li/+ numb]s ,at ! "t ( ! initial regi/ration ( any facility "u subsection 7a77#a7 or initial li/+ ( any cosmetic product "u 7c77#a71 ! ,secret>y %all assign a facility regi/ration numb] to ! facility & a product li/+ numb] to ea* cosmetic product4 ,! ,secret>y %all n make su* product li/+ numb] publicly available4 7e7 ,confid5tiality ,in=mation submitt$ to ! ,secret>y "u ?is section t is confid5tial comm]cial or trade secret in=mation %all be exempt f disclosure "u section #eeb ( title #e1 ,unit$ ,/ates ,code1 includ+ all in=mation submitt$ "u subsection 7b77#b77;,d7 or 7c77#d77;,a77i74 7f7 ,susp5sions 7#a7 ,susp5sion ( regi/ration ( a facility ,! ,secret>y may susp5d ! regi/ration ( a facility if ! ,secret>y det]m9es t a cosmetic product manufactur$ or process$ by a regi/]$ facility & di/ribut$ 9 ! ,unit$ ,/ates has a reasonable probability ( caus+ s]i\s adv]se heal? consequ5ces or dea? to humans & ! ,secret>y has a reasonable belief t o!r products manufactur$ or process$ by ! facility may be simil>ly affect$ because ( a failure t _c be isolat$ to a product or products1 or is suffici5tly p]vasive to raise conc]ns ab\t o!r products manufactur$ 9 ! facility4 7#b7 ,notice ( susp5sion ,be=e susp5d+ a facility regi/ration "u ?is section1 ! ,secret>y %all provide-- 7,a7 notice to ! facility regi/rant ( ! cosmetic product or o!r responsible p]son1 z appropriate1 ( ! int5t to susp5d ! facility regi/ration1 :i* %all specify ! basis ( ! det]m9ation by ! ,secret>y t ! facility %\ld be susp5d$2 & 7,b7 an opportunity1 )9 #e bus9ess days ( ! notice provid$ "u subp>agraph 7,a71 = ! responsible p]son to provide a plan = address+ ! reasons = possible susp5sion ( ! facility regi/ration4 7#c7 ,he>+ on susp5sion ,! ,secret>y %all provide ! regi/rant subject to an ord] "u p>agraph 7#a7 or 7#b7 ) an opportunity = an in=mal he>+1 to be held z soon z possible b n lat] ?an #e bus9ess days aft] ! issuance ( ! ord]1 or su* o!r "t p]iod agre$ ^u by ! ,secret>y & ! regi/rant1 on ! actions requir$ = re9/atem5t ( regi/ration & :y ! regi/ration t is subject to ! susp5sion %\ld be re9/at$4 ,! ,secret>y %all re9/ate a regi/ration if ! ,secret>y det]m9es1 bas$ on evid5ce pres5t$1 t adequate gr\nds d n exi/ to cont9ue ! susp5sion ( ! regi/ration4 7#d7 ,po/-he>+ corrective action plan ,if1 aft] provid+ opportunity = an in=mal he>+ "u p>agraph 7#c71 ! ,secret>y det]m9es t ! susp5sion ( regi/ration rema9s necess>y1 ! ,secret>y %all require ! regi/rant to submit a corrective action plan to demon/rate h[ ! regi/rant plans to correct ! conditions f\nd by ! ,secret>y4 ,! ,secret>y %all review su* plan n lat] ?an #ad bus9ess days aft] ! submission ( ! corrective action plan or su* o!r "t p]iod z det]m9$ by ! ,secret>y1 9 consultation ) ! regi/rant4 7#e7 ,vacat+ ( ord]2 re9/atem5t ,^u a det]m9ation by ! ,secret>y t adequate gr\nds d n exi/ to cont9ue ! susp5sion actions1 ! ,secret>y %all promptly vacate ! susp5sion & re9/ate ! regi/ration ( ! facility4 7#f7 ,effect ( susp5sion ,if ! regi/ration ( ! facility is susp5d$ "u ?is section1 no p]son %all introduce or deliv] = introduction into comm]ce 9 ! ,unit$ ,/ates cosmetic products f su* facility4 7#g7 ,no delegation ,! au?ority conf]r$ by ?is section to issue an ord] to susp5d a regi/ration or vacate an ord] ( susp5sion %all n be delegat$ to any (fic] or employee o!r ?an ! ,commission]4 #fjh4 ,safety sub/antiation 7a7 ,sub/antiation ( safety ,a responsible p]son = a cosmetic product %all ensure1 & ma9ta9 records support+1 t !re is adequate sub/antiation ( safety ( su* cosmetic product4 7b7 ,coal-,t> hair dye ,subsection 7a7 %all n apply to coal-t> hair dye t o!rwise complies ) ! requirem5ts ( section #fja7;a74 ,a responsible p]son = a coal-t> hair dye %all ma9ta9 records relat$ to ! safety ( su* product4 7c7 ,def9itions ,= purposes ( ?is section3 7#a7 ,adequate sub/antiation ( safety ,! t]m adequate sub/antiation ( safety means te/s or /udies1 rese>*1 analyses1 or o!r evid5ce or in=mation t is consid]$1 among exp]ts qualifi$ by sci5tific tra9+ & exp]i5ce to evaluate ! safety ( cosmetic products & _! +r$i5ts1 suffici5t to support a reasonable c]ta9ty t a cosmetic product is safe4 7#b7 ,safe ,! t]m safe means t ! cosmetic product1 includ+ any +r$i5t !re(1 is n injuri\s to us]s "u ! conditions ( use prescrib$ 9 ! label+ !re(1 or "u su* conditions ( use z are cu/om>y or usual4 ,! ,secret>y %all n consid] a cosmetic +r$i5t or cosmetic product injuri\s to us]s solely because x c cause m9or & transi5t reactions or m9or & transi5t sk9 irritations 9 "s us]s4 ,9 det]m9+ = purposes ( ?is section :e!r a cosmetic product is safe1 ! ,secret>y may consid]1 z appropriate & available1 ! cumulative or o!r relevant exposure to ! cosmetic product1 includ+ any +r$i5t !re(4 #fji4 ,label+ 7a7 ,g5]al requirem5t ,ea* cosmetic product %all be> a label t includes a dome/ic address1 dome/ic phone numb]1 or electronic contact in=mation1 :i* may include a website1 ?r\gh :i* ! responsible p]son c receive adv]se ev5t reports ) respect to su* cosmetic product4 7b7 ,fragrance all]g5s ,! responsible p]son %all id5tify on ! label ( a cosmetic product ea* fragrance all]g5 includ$ 9 su* cosmetic product4 ,sub/ances t are fragrance all]g5s = purposes ( ?is subsection %all be det]m9$ by ! ,secret>y by regulation4 ,! ,secret>y %all issue a notice ( propos$ rulemak+ promulgat+ ! regulation implem5t+ ?is requirem5t n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ! ,mod]nization ( ,cosmetics ,regulation ,act ( #bjbb1 & n lat] ?an #ahj days aft] ! date on :i* ! public comm5t p]iod on ! propos$ rulemak+ closes1 %all issue a f9al rulemak+4 ,9 promulgat+ regulations implem5t+ ?is subsection1 ! ,secret>y %all consid] int]national1 ,/ate1 & local requirem5ts = all]g5 disclosure1 includ+ ! sub/ance & =mat ( requirem5ts 9 ! ,european ,union1 & may e/abli% ?re%old levels ( am\nts ( sub/ances subject to disclosure pursuant to su* regulations4 7c7 ,cosmetic products = pr(essional use 7#a7 ,def9ition ( pr(essional ,= purposes ( ?is subsection1 ! t]m pr(essional means an individual :o is lic5s$ by an (ficial ,/ate au?ority to practice 9 ! field ( cosmetology1 nail c>e1 b>b]+1 or e/hetics4 7#b7 ,pr(essional use label+ ,a cosmetic product introduc$ into int]/ate comm]ce & int5d$ to be us$ only by a pr(essional %all be> a label t-- 7,a7 conta9s a cle> & prom95t /atem5t t ! product %all be adm9i/]$ or us$ only by lic5s$ pr(essionals2 & 7,b7 is 9 con=mity ) ! requirem5ts ( ! ,secret>y = cosmetics label+ "u ?is ,act & section #d7;a7 ( ! ,fair ,packag+ & ,label+ ,act4 #faj4 ,records 7a7 ,9 g5]al ,if ! ,secret>y has a reasonable belief t a cosmetic product1 includ+ an +r$i5t 9 su* cosmetic product1 & any o!r cosmetic product t ! ,secret>y reasonably believes is likely to be affect$ 9 a simil> mann]1 is likely to be adult]at$ su* t ! use or exposure to su* product pres5ts a ?reat ( s]i\s adv]se heal? consequ5ces or dea? to humans1 ea* responsible p]son & facility %all1 at ! reque/ ( an (fic] or employee duly designat$ by ! ,secret>y1 p]mit su* (fic] or employee1 ^u pres5tation ( appropriate cr$5tials & a writt5 notice to su* p]son1 at reasonable times & )9 reasonable limits & 9 a reasonable mann]1 to h access to & copy all records relat+ to su* cosmetic product1 & to any o!r cosmetic product t ! ,secret>y reasonably believes is likely to be affect$ 9 a simil> mann]1 t are ne$$ to assi/ ! ,secret>y 9 det]m9+ :e!r ! cosmetic product is adult]at$ & pres5ts a ?reat ( s]i\s adv]se heal? consequ5ces or dea? to humans4 ,?is subsection %all n be con/ru$ to ext5d to recipes or =mulas = cosmetics1 f9ancial data1 pric+ data1 p]sonnel data 7o!r ?an data z to qualification ( te*nical & pr(essional p]sonnel p]=m+ functions subject to ?is ,act71 rese>* data 7o!r ?an safety sub/antiation data = cosmetic products & _! +r$i5ts71 or sales data 7o!r ?an %ipm5t data reg>d+ sales74 7b7 ,protection ( s5sitive in=mation ,! ,secret>y %all take appropriate measures to ensure t !re are 9 effect effective proc$ures to prev5t ! unau?oriz$ disclosure ( any trade secret or confid5tial in=mation t is obta9$ by ! ,secret>y pursuant to ?is section4 7c7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to limit ! au?ority ( ! ,secret>y to inspect records or require e/abli%m5t & ma9t5ance ( records "u any o!r provision ( ?is ,act1 includ+ section #fje or #fjf4 #faa4 ,m&atory recall au?ority 7a7 ,9 g5]al ,if ! ,secret>y det]m9es t !re is a reasonable probability t a cosmetic is adult]at$ "u section #fja or misbr&$ "u section #fjb & ! use ( or exposure to su* cosmetic w cause s]i\s adv]se heal? consequ5ces or dea?1 ! ,secret>y %all provide ! responsible p]son ) an opportunity to volunt>ily cease di/ribution & recall su* article4 ,if ! responsible p]son refuses to or does n volunt>ily cease di/ribution or recall su* cosmetic )9 ! "t & mann] prescrib$ by ! ,secret>y 7if s prescrib$71 ! ,secret>y may1 by ord]1 require1 z ! ,secret>y deems necess>y1 su* p]son to imm$iately cease di/ribution ( su* article4 7b7 ,he>+ ,! ,secret>y %all provide ! responsible p]son :o is subject to an ord] "u subsection 7a7 ) an opportunity = an in=mal he>+1 to be held n lat] ?an #aj days aft] ! date ( issuance ( ! ord]1 on :e!r adequate evid5ce exi/s to ju/ify ! ord]4 7c7 ,ord] resolution ,aft] an ord] is issu$ accord+ to ! process "u subsections 7a7 & 7b71 ! ,secret>y %all1 except z provid$ 9 subsection 7d7-- 7#a7 vacate ! ord]1 if ! ,secret>y det]m9es t inadequate gr\nds exi/ to support ! actions requir$ by ! ord]2 7#b7 cont9ue ! ord] ceas+ di/ribution ( ! cosmetic until a date specifi$ 9 su* ord]2 or 7#c7 am5d ! ord] to require a recall ( ! cosmetic1 includ+ any requirem5ts to notify appropriate p]sons1 a timetable = ! recall to occur1 & a s*$ule = updates to be provid$ to ! ,secret>y reg>d+ su* recall4 7d7 ,action foll[+ ord] ,any p]son :o is subject to an ord] pursuant to p>agraph 7#b7 or 7#c7 ( subsection 7c7 %all imm$iately cease di/ribution ( or recall1 z applicable1 ! cosmetic & provide notification z requir$ by su* ord]4 7e7 ,notice to p]sons affect$ ,if ! ,secret>y det]m9es necess>y1 ! ,secret>y may require ! p]son subject to an ord] pursuant to subsection 7a7 or an am5d$ ord] pursuant to p>agraph 7#b7 or 7#c7 ( subsection 7c7 to provide ei!r a notice ( a recall ord] =1 or an ord] to cease di/ribution (1 su* cosmetic1 z applicable1 "u ?is section to appropriate p]sons1 includ+ p]sons :o manufacture1 di/ribute1 import1 or (f] = sale su* product t is ! subject ( an ord] & to ! public4 7f7 ,public notification ,9 conduct+ a recall "u ?is section1 ! ,secret>y %all-- 7#a7 ensure t a press release is publi%$ reg>d+ ! recall1 & t al]ts & public notices are issu$1 z appropriate1 9 ord] to provide notification-- 7,a7 ( ! recall to consum]s & retail]s to :om su* cosmetic 01 or may h be51 di/ribut$2 & 7,b7 t includes1 at a m9imum-- 7i7 ! "n ( ! cosmetic subject to ! recall2 7ii7 a description ( ! risk associat$ ) su* article2 & 7iii7 to ! ext5t practicable1 in=mation = consum]s ab\t simil> cosmetics t are n affect$ by ! recall2 & 7#b7 ensure publication1 z appropriate1 on ! website ( ! ,food & ,drug ,adm9i/ration ( an image ( ! cosmetic t is ! subject ( ! press release describ$ 9 p>agraph 7#a71 if available4 7g7 ,no delegation ,! au?ority conf]r$ by ?is section to ord] a recall or vacate a recall ord] %all n be delegat$ to any (fic] or employee o!r ?an ! ,commission]4 7h7 ,effect ,no?+ 9 ?is section %all affect ! au?ority ( ! ,secret>y to reque/ or p>ticipate 9 a volunt>y recall1 or to issue an ord] to cease di/ribution or to recall "u any o!r provision ( ?is *apt]4 #fab4 ,small bus9esses 7a7 ,9 g5]al ,responsible p]sons1 & own]s & op]ators ( facilities1 ^: av]age gross annual sales 9 ! ,unit$ ,/ates ( cosmetic products = ! previ\s #c-ye> p]iod is less ?an #a1jjj1jjj1 adju/$ = inflation1 & :o d n engage 9 ! manufactur+ or process+ ( ! cosmetic products describ$ 9 subsection 7b71 %all be consid]$ small bus9esses & n subject to ! requirem5ts ( section #fjf or #fjg4 7b7 ,requirem5ts applicable to all manufactur]s & processors ( cosmetics ,! exemptions "u subsection 7a7 %all n apply to any responsible p]son or facility engag$ 9 ! manufactur+ or process+ ( any ( ! foll[+ products3 7#a7 ,cosmetic products t regul>ly come into contact ) mucus membrane ( ! eye "u conditions ( use t are cu/om>y or usual4 7#b7 ,cosmetic products t are inject$4 7#c7 ,cosmetic products t are int5d$ = int]nal use4 7#d7 ,cosmetic products t are int5d$ to alt] appe>ance = m ?an #bd h\rs "u conditions ( use t are cu/om>y or usual & removal by ! consum] is n "p ( su* conditions ( use t are cu/om>y or usual4 #fac4 ,exemption = c]ta9 products & facilities 7a7 ,9 g5]al ,not)/&+ any o!r provision ( law1 except z provid$ 9 subsection 7b71 a cosmetic product or facility t is also subject to ! requirem5ts ( *apt] ,v %all be exempt f ! requirem5ts ( sections #fje1 #fjf1 #fjg1 #fjh1 #fji7;a71 #faj1 & #faa4 7b7 ,exception ,a facility describ$ 9 subsection 7a7 t also manufactures or processes cosmetic products t are n subject to ! requirem5ts ( *apt] ,v %all n be exempt f ! requirem5ts ( sections #fje1 #fjf1 #fjg1 #fjh1 #fji7;a71 #faj1 & #faa1 ) respect to su* cosmetic products4 #fad4 ,preemption 7a7 ,9 g5]al ,no ,/ate or political subdivision ( a ,/ate may e/abli% or cont9ue 9 effect any law1 regulation1 ord]1 or o!r requirem5t = cosmetics t is diff]5t f or 9 addition to1 or o!rwise n id5tical )1 any requirem5t applicable "u ?is *apt] ) respect to regi/ration & product li/+1 good manufactur+ practice1 recordkeep+1 recalls1 adv]se ev5t report+1 or safety sub/antiation4 7b7 ,limitation ,no?+ 9 ! am5dm5ts to ?is ,act made by ! ,mod]nization ( ,cosmetics ,regulation ,act ( #bjbb %all be con/ru$ to preempt any ,/ate /atute1 public initiative1 ref]5dum1 regulation1 or o!r ,/ate action1 except z expressly provid$ 9 subsection 7a74 ,not)/&+ subsection 7a71 no?+ 9 ?is section %all be con/ru$ to prev5t any ,/ate f prohibit+ ! use or limit+ ! am\nt ( an +r$i5t 9 a cosmetic product1 or f cont9u+ 9 effect a requirem5t ( any ,/ate t is 9 effect at ! "t ( enactm5t ( ! ,mod]nization ( ,cosmetics ,regulation ,act ( #bjbb = ! report+ to ! ,/ate ( an +r$i5t 9 an cosmetic product4 7c7 ,sav+s ,no?+ 9 ! am5dm5ts to ?is ,act made by ! ,mod]nization ( ,cosmetics ,regulation ,act ( #bjbb1 nor any /&>d1 rule1 requirem5t1 regulation1 or adv]se ev5t report %all be con/ru$ to modify1 preempt1 or displace any action = damages or ! liability ( any p]son "u ! law ( any ,/ate1 :e!r /atutory or bas$ 9 common law4 7d7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to am5d1 exp&1 or limit ! provisions "u section #geb4 4 #hjc4 ,en=cem5t & con=m+ am5dm5ts 7a7 ,9 g5]al 7#a7 ,prohibit$ acts ,section #cja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is am5d$-- 7,a7 by add+ at ! end ! foll[+3 7fff7 ,! failure to regi/] or submit li/+ in=mation 9 accordance ) section #fjg4 7ggg7 ,! refusal or failure to foll[ an ord] "u section #faa4 2 & 7,b7 9 p>agraph 7d71 by /rik+ or #efd & ins]t+ 1 #efd1 or #fjg4 7#b7 ,adult]at$ products ,section #fja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa7 is am5d$ by add+ at ! end ! foll[+3 7f7 ,if x has be5 manufactur$ or process$ "u conditions t d n meet good manufactur+ practice regulations1 z prescrib$ by ! ,food & ,drug ,adm9i/ration 9 accordance ) section #fjf4 7g7 ,if x is a cosmetic product1 & ! cosmetic product1 includ+ ea* +r$i5t 9 ! cosmetic product1 does n h adequate sub/antiation = safety1 z def9$ 9 section #fjh7;c74 4 7#c7 ,misbr&$ cosmetics ,section #fjb7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfb7;b77 is am5d$-- 7,a7 by /rik+ & 7#b7 & ins]t+ 7#b72 & 7,b7 by ins]t+ aft] num]ical c\nt ! foll[+3 2 & 7#c7 ! in=mation requir$ "u section #fji4 7#d7 ,adv]se ev5t report+ ,! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 is am5d$-- 7,a7 9 section #cja7;e7 7#ba ,u4,s4,c4 #cca7;e77-- 7i7 by /rik+ #efd1 #gjc & ins]t+ #efd1 #fje1 #gjc2 & 7ii7 by /rik+ #efd1 #gfj & ins]t+ #efd1 #fje1 #faa1 #gfj2 7,b7 9 section #cja7;ii7 7#ba ,u4,s4,c4 #cca7;ii77-- 7i7 by /rik+ #gfj or #gfa7 or & ins]t+ #fjd1 #gfj1 or #gfa7 or2 & 7ii7 by ins]t+ or requir$ "u section #fje7;a7 aft] report 7z def9$ "u section #gfj or #gfa2 7,c7 9 section #hja7;a7 7#ba ,u4,s4,c4 #cha7;a77-- 7i7 by /rik+ "u section #gfj or #gfa & ins]t+ "u section #fje1 #gfj1 or #gfa2 7ii7 by /rik+ def9$ 9 su* section #gfj or #gfa & ins]t+ def9$ 9 section #fjd1 #gfj1 or #gfa2 7iii7 by /rik+ ( su* section #gfj or #gfa & ins]t+ ( su* section #fje1 #gfj1 or #gfa2 & 7iv7 by /rik+ describ$ 9 su* section #gfj or #gfa & ins]t+ describ$ 9 su* section #fje1 #gfj1 or #gfa2 & 7,d7 9 section #hja7;b7 7#ba ,u4,s4,c4 #cha7;b77-- 7i7 by /rik+ requirem5ts ( sections #gfj or #gfa1 & ins]t+ requirem5ts ( section #fje1 #gfj1 or #gfa2 7ii7 by /rik+ z def9$ 9 section #gfj or #gfa & ins]t+ z def9$ 9 section #fjd1 #gfj1 or #gfa2 & 7iii7 by /rik+ ) section #gfj or #gfa & ins]t+ ) section #fje1 #gfj1 or #gfa4 7b7 ,effective date ,! am5dm5ts made by subsection 7a7 %all take effect on ! date t is #a ye> aft] ! date ( enactm5t ( ?is ,act4 #hjd4 ,records inspection ,section #gjd7;a77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77#a77 is am5d$ by ins]t+ aft] ! second s5t5ce ! foll[+3 ,9 ! case ( a facility 7z def9$ 9 section #fjd7 t manufactures or processes cosmetic products1 ! inspection %all ext5d to all records & o!r in=mation describ$ 9 sections #fje1 #fjf1 & #faj1 :5 ! /&>d = records inspection "u su* section applies44 #hje4 ,talc-conta9+ cosmetics ,! ,secret>y ( ,heal? & ,human ,s]vices-- 7#a7 n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is ,act1 %all promulgate propos$ regulations to e/abli% & require /&>diz$ te/+ me?ods = detect+ & id5tify+ asbe/os 9 talc-conta9+ cosmetic products2 & 7#b7 n lat] ?an #ahj days aft] ! date on :i* ! public comm5t p]iod on ! propos$ regulations closes1 %all issue su* f9al regulations4 #hjf4 ,,pfas 9 cosmetics 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all assess ! use ( p]fluoroalkyl & polyfluoroalkyl sub/ances 9 cosmetic products & ! sci5tific evid5ce reg>d+ ! safety ( su* use 9 cosmetic products1 includ+ any risks associat$ ) su* use4 ,9 conduct+ su* assessm5t1 ! ,secret>y may1 z appropriate1 consult ) ! ,national ,c5t] = ,toxicological ,rese>*4 7b7 ,report ,n lat] ?an #b ye>s aft] enactm5t ( ?is ,act1 ! ,secret>y %all publi% on ! website ( ! ,food & ,drug ,adm9i/ration a report summ>iz+ ! results ( ! assessm5t conduct$ "u subsection 7a74 #hjg4 ,fund+ ,!re is au?oriz$ to be appropriat$ #ad1bjj1jjj = fiscal ye> #bjbc1 #be1ifj1jjj = fiscal ye> #bjbd1 & #da1hij1jjj = ea* ( ! fiscal ye>s #bjbe ?r\gh #bjbg1 = purposes ( conduct+ ! activities "u ?is subtitle 7includ+ ! am5dm5ts made by ?is subtitle7 & hir+ p]sonnel requir$ to c>ry out ?is subtitle 7includ+ ! am5dm5ts made by ?is subtitle74 ,b ,diet>y supplem5ts #haa4 ,regulation ( diet>y supplem5ts 7a7 ,9 g5]al ,*apt] ,,iv ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cda et seq47 is am5d$ by add+ aft] section #djc;,c ( su* ,act 7#ba ,u4,s4,c4 #cdc-c7 ! foll[+3 #djc;,d4 ,diet>y supplem5t li/+ requirem5t 7a7 ,9 g5]al ,beg9n+ on ! date specifi$ 9 subsection 7b77#d71 ea* diet>y supplem5t %all be li/$ ) ! ,secret>y 9 accordance ) ?is section4 ,ea* su* li/+ %all include1 ) respect to ! diet>y supplem5t1 ! in=mation specifi$ 9 subsection 7b77#a74 7b7 ,requirem5ts 7#a7 ,9 g5]al ,! manufactur]1 pack]1 or di/ributor ( a diet>y supplem5t ^: "n 7pursuant to section #djc7;e77#a77 appe>s on ! label ( a diet>y supplem5t m>ket$ 9 ! ,unit$ ,/ates 7ref]r$ to 9 ?is section z ! responsible p]son71 or if ! responsible p]son is a =eign entity1 ! ,unit$ ,/ates ag5t ( su* p]son1 %all submit to ! ,secret>y 9 accordance ) ?is section ! foll[+ in=mation = a diet>y supplem5t t is m>ket$3 7,a7 ,any "n ( ! diet>y supplem5t & ! /atem5t ( id5tity1 includ+ br& "n & specifi$ flavors1 if applicable4 7,b7 ,! "n & address ( ! responsible p]son & ! "n & email address ( ! own]1 op]ator1 or ag5t 9 *>ge ( ! responsible p]son4 7,c7 ,! "n1 dome/ic address1 & email address = ! ,unit$ ,/ates ag5t1 if ! responsible p]son is a =eign entity4 7,d7 ,! bus9ess "n & mail+ address ( all locations at :i* ! responsible p]son manufactures1 packages1 labels1 or holds ! diet>y supplem5t4 7,e7 ,a li/ ( all +r$i5ts 9 ea* su* diet>y supplem5t requir$ "u sections #aja4d & #aja4cf1 title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations7 to appe> on ! label ( a diet>y supplem5t1 includ+-- 7i7 :]e applicable1 +r$i5ts 9 a propriet>y bl5d z describ$ 9 section #aja4cf7;c7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations72 7ii7 ! am\nt p] s]v+ ( ea* li/$ diet>y +r$i5t2 7iii7 if requir$ by section #aja4cf ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations71 ! p]c5t ( ! daily value ( ea* li/$ diet>y +r$i5t2 & 7iv7 ! am\nt p] s]v+ ( diet>y +r$i5ts )9 a propriet>y bl5d4 7,f7 ,! numb] ( s]v+s p] conta9] = ea* conta9] size ( ! id5tical =mulation4 7,g7 ,! directions = use4 7,h7 ,w>n+s1 notice1 & safe h&l+ /atem5ts1 z requir$ by section #aja4ag ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7,i7 ,all]g5 /atem5ts = major food all]g5s 7pursuant to sections #djc7w7 & #djc7x774 7,j7 ,! =m ( ! diet>y supplem5t 7su* z tablets1 capsules74 7,k7 ,any heal? claims or /ructure or function claims4 7,l7 ,! diet>y supplem5t product li/+ numb] = ! product provid$ by ! ,secret>y 9 accordance ) subsection 7c7 = t product4 7#b7 ,=mat ,! ,secret>y may require t a li/+ submitt$ "u p>agraph 7#a7 be submitt$ 9 an electronic =mat4 ,^u receipt ( a complete li/+ "u p>agraph 7#a71 ! ,secret>y %all promptly notify ! responsible p]son ( ! receipt ( su* li/+4 7#c7 ,li/+ cont5t ,a s+le li/+ submission = a diet>y supplem5t "u p>agraph 7#a7 may include multiple diet>y supplem5ts ) id5tical =mulations1 or =mulations t diff] only ) respect to color1 additives1 or flavor+s1 :e!r (f]$ 9 a s+le package size or 9 multiple package sizes4 7#d7 ,tim+ 7,a7 ,9 g5]al 7i7 ,diet>y supplem5ts on ! m>ket ,9 ! case ( a diet>y supplem5t t is be+ (f]$ 9 int]/ate comm]ce on or be=e ,janu>y #a1 #bjbd1 a li/+ = ea* su* diet>y supplem5t introduc$ or deliv]$ = introduction into int]/ate comm]ce %all be submitt$ by ! responsible p]son to ! ,secret>y "u ?is subsection n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ! ,food & ,drug ,adm9i/ration ,safety & ,l&m>k ,advancem5ts ,act ( #bjbb4 7ii7 ,new diet>y supplem5ts ,9 ! case ( a diet>y supplem5t t is n be+ (f]$ 9 int]/ate comm]ce on or be=e ,janu>y #a1 #bjbd1 a li/+ = ea* su* diet>y supplem5t introduc$ or deliv]$ = introduction into int]/ate comm]ce t has n be5 includ$ 9 any li/+ previ\sly submitt$ by ! responsible p]son to ! ,secret>y "u ?is subsection %all be submitt$ to ! ,secret>y at ! "t ( introduction into int]/ate comm]ce4 7,b7 ,discont9u$ diet>y supplem5ts ,! responsible p]son %all notify ! ,secret>y )9 "o ye> ( ! date ( discont9uance ( a diet>y supplem5t requir$ to be li/$ ) ! ,secret>y "u p>agraph 7#a7 = :i* ! responsible p]son has discont9u$ comm]cial m>ket+4 7,c7 ,*anges to exi/+ li/+s ,! responsible p]son %all submit to ! ,secret>y a *ange or modification to li/+ in=mation submitt$ "u p>agraph 7#a7 includ$ on ! label = a diet>y supplem5t at ! "t ! diet>y supplem5t ) ! *ange or modification is introduc$ into int]/ate comm]ce4 7#e7 ,additional in=mation ,! responsible p]son %all provide ^u reque/ f ! ,secret>y1 )9 #aj cal5d> days ( su* reque/1 ! full bus9ess "n & physical & mail+ address f :i* ! responsible p]son receives a diet>y +r$i5t or comb9ation ( diet>y +r$i5ts t ! responsible p]son uses 9 ! manufacture ( ! diet>y supplem5t or1 if applicable1 f :i* ! responsible p]son receives ! diet>y supplem5t4 7c7 ,product li/+ numb] & diet>y supplem5t electronic database 7#a7 ,diet>y supplem5t product li/+ numb] ,! ,secret>y %all provide ea* diet>y supplem5t li/$ 9 accordance ) subsection 7b77#a7 a diet>y supplem5t product li/+ numb]1 :i* may apply to multiple diet>y supplem5ts ) id5tical =mulations1 or =mulations t diff] only ) respect to color1 additives1 or flavor+s1 includ+ diet>y supplem5ts (f]$ 9 a s+le package size or 9 multiple package sizes4 ,! ,secret>y %all provide a process = a responsible p]son to res]ve diet>y supplem5t li/+ numb]s 9 advance ( li/+ "u subsection 7b77#a74 7#b7 ,electronic database ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,food & ,drug ,adm9i/ration ,safety & ,l&m>k ,advancem5ts ,act ( #bjbb1 ! ,secret>y %all e/abli% & ma9ta9 an electronic database t is publicly available & conta9s in=mation submitt$ "u subsection 7b77#a7 7except = ! in=mation submitt$ "u subp>agraphs 7,d7 & 7,e77iv7 ( su* subsection74 ,! ,secret>y %all make su* in=mation ma9ta9$ 9 ! electronic database publicly se>*able1 includ+ by diet>y supplem5t product li/+ numb]1 & by any field ( in=mation or comb9ation ( fields ( in=mation provid$ "u subsection 7b77#a74 7d7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$-- 7#a7 to limit ! au?ority ( ! ,secret>y to inspect or copy records or to require ! e/abli%m5t & ma9t5ance ( records "u any o!r provision ( ?is ,act2 or 7#b7 to au?orize ! disclosure ( trade secret or confid5tial comm]cial in=mation subject to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 z prohibit$ "u section #cja7;j7 ( ?is ,act or section #aije ( title #ah1 ,unit$ ,/ates ,code1 includ+ in=mation provid$ to ! ,secret>y "u subsection 7b77#a77;,d7 or 7b77#a77;,e77iv74 7e7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ #g1dih1jhj = fiscal ye> #bjbc1 & #f1cjj1jjj = ea* ( fiscal ye>s #bjbd ?r\gh #bjbg1 = purposes ( conduct+ ! activities "u ?is section & hir+ p]sonnel requir$ to c>ry out ?is section4 4 7b7 ,guidance ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all publi% f9al guidance relat$ to ! draft guidance titl$1 ,diet>y ,supplem5ts3 ,new ,diet>y ,+r$i5t ,notifications & ,relat$ ,issues2 ,revis$ ,draft ,guidance = ,indu/ry2 ,availability 7#ha ,f$4 ,reg4 #ecdhf2 ,augu/ #ab1 #bjaf71 consi/5t ) section #djc;,d ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a74 7c7 ,inspections = c]ta9 diet>y supplem5ts ,! ,secret>y ( ,heal? & ,human ,s]vices %all direct res\rces to inspections ( facilities1 suppli]s1 & diet>y supplem5t types t pres5t a high risk to public heal? 7z id5tifi$ by ! ,secret>y74 7d7 ,misbr&+ ,section #djc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7 is am5d$ by add+ at ! end ! foll[+3 7z7 ,if x is a diet>y supplem5t = :i* a responsible p]son is requir$ "u section #djc;,d to file a li/+1 file a *ange to an exi/+ li/+1 or provide additional in=mation to ! ,secret>y1 & su* p]son has fail$ to comply ) any su* requirem5ts "u section #djc;,d ) respect to su* diet>y supplem5t4 4 7e7 ,new prohibit$ act ,section #cja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca71 z am5d$ by section #hjc7;a71 is fur!r am5d$ by add+ at ! end ! foll[+3 7hhh7 ,! introduction or deliv]y = introduction into int]/ate comm]ce ( any product m>ket$ z a diet>y supplem5t t does n meet ! def9ition ( a diet>y supplem5t "u section #bja7;ff74 7iii7 ,! introduction or deliv]y = introduction into int]/ate comm]ce ( a diet>y supplem5t t has be5 prep>$1 pack$1 or held us+ ! assi/ance (1 or at ! direction (1 a p]son deb>r$ "u section #cjf4 4 ,c ,9 vitro cl9ical te/s #hba4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is subtitle may be cit$ z ! ,food & ,drug ,adm9i/ration ,safety & ,l&m>k ,advancem5ts ,act ( #bjbb or ! ,,valid ,act ( #bjbb4 7b7 ,table ( cont5ts ,! table ( cont5ts ( ?is subtitle is z foll[s3 ,,sub*apt] ,c--,9 ,vitro ,cl9ical ,tests,sec4 #hba4 ,%ort title2 table ( cont5ts4,sec4 #hbb4 ,def9itions4,sec4 #hbc4 ,regulation ( 9 vitro cl9ical te/s4,,sub*apt] ,j--,9 ,vitro ,cl9ical ,tests,s,u,b,c,h,a,p,t,e,r ,j4 ,9 ,vitro ,cl9ical ,tests,sec4 #ehg4 ,def9itions4,sec4 #ehg;,a4 ,regulation ( 9 vitro cl9ical te/s4,sec4 #ehg;,b4 ,prem>ket review4,sec4 #ehg;,c4 ,exemptions4,sec4 #ehg;,d4 ,te*nology c]tification4,sec4 #ehg;,e4 ,mitigat+ measures4,sec4 #ehg;,f4 ,regulatory pa?way designation4,sec4 #ehg;,g4 ,gr&fa!r$ 9 vitro cl9ical te/s4,sec4 #ehg;,h4 ,advisory committees4,sec4 #ehg;,i4 ,break?r\gh 9 vitro cl9ical te/s4,sec4 #ehg;,j4 ,regi/ration & li/+4,sec4 #ehg,k4 ,te/ design & quality requirem5ts4,sec4 #ehg,l4 ,label+ requirem5ts4,sec4 #ehg,m4 ,adv]se ev5t report+4,sec4 #ehg,n4 ,corrections & removals4,sec4 #ehg,o4 ,re/rict$ 9 vitro cl9ical te/s4,sec4 #ehg,p4 ,appeals4,sec4 #ehg,q4 ,accr$it$ p]sons4,sec4 #ehg,r4 ,recogniz$ /&>ds4,sec4 #ehg,s4 ,inve/igational use4,sec4 #ehg,t4 ,collaborative communities = 9 vitro cl9ical te/s4,sec4 #ehg,u4 ,compreh5sive te/ in=mation sy/em4,sec4 #ehg,v4 ,preemption4,sec4 #ehg,w4 ,adult]ation4,sec4 #ehg,x4 ,misbr&+4,sec4 #ehg,y4 ,po/m>ket surveillance4,sec4 #ehg,z4 ,electronic =mat = submissions4,sec4 #ehg;,,aa4 ,po/m>ket rem$ies4,sec4 #ehg;,,bb4 ,applicability4,sec4 #ehg;,,cc4 ,judicial review4,sec4 #hbd4 ,en=cem5t & o!r provisions4,sec4 #hbe4 ,transition4,sec4 #hbf4 ,em]g5cy use au?orization4,sec4 #hbg4 ,antimicrobial susceptibility te/s4,sec4 #hbh4 ,comb9ation products4,sec4 #hbi4 ,res\rces4 #hbb4 ,def9itions 7a7 ,9 g5]al ,section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is am5d$-- 7#a7 by add+ at ! end ! foll[+3 7ss7 7#a7 ,! t]m 9 vitro cl9ical te/ means an article specifi$ 9 subp>agraph 7#b7 t is int5d$ by its develop] 7z def9$ 9 section #ehg7 to be us$ 9 ! collection1 prep>ation1 analysis1 or 9 vitro cl9ical exam9ation ( specim5s tak5 or d]iv$ f ! human body = ! purpose (-- 7,a7 id5tify+ or diagnos+ a disease or condition2 7,b7 provid+ in=mation = diagnos+1 scre5+1 measur+1 detect+1 pr$ict+1 prognos+1 analyz+1 or monitor+ a disease or condition1 includ+ by mak+ a det]m9ation ( an individual's /ate ( heal?2 or 7,c7 select+1 monitor+1 or in=m+ !rapy or treatm5t = a disease or condition4 7#b7 ,an article specifi$ 9 ?is subp>agraph is-- 7,a7 a te/ kit2 7,b7 a te/ sy/em2 7,c7 a te/ protocol or laboratory te/ protocol2 7,d7 an in/rum5t 7z def9$ 9 section #ehg7aa772 7,e7 a specim5 receptacle 7z def9$ 9 section #ehg7ag772 7,f7 s(tw>e1 exclud+ s(tw>e t is exclud$ by section #ebj7o7 f ! def9ition ( a device "u section #bja7;h71 t-- 7i7 is a compon5t or "p ( ano!r 9 vitro cl9ical te/ or analyzes1 processes1 or int]prets a signal or patt]n f ano!r 9 vitro cl9ical te/2 & 7ii7 does n analyze1 process1 or int]pret a signal1 patt]n1 or m$ical image f a device2 & 7,g7 subject to subp>agraph 7#c71 a compon5t or "p ( a te/1 a te/ protocol1 an in/rum5t1 an article1 or s(tw>e describ$ 9 any ( clauses 7,a7 ?r\gh 7,d7 ( su* subp>agraph1 :e!r alone or 9 comb9ation1 includ+ reag5ts1 calibrators1 & controls4 7#c7 ,not)/&+ subp>agraph 7#b77;,g71 an article int5d$ to be us$ z a compon5t or "p ( an 9 vitro cl9ical te/ describ$ 9 subp>agraph 7#a7 is exclud$ f ! def9ition 9 subp>agraph 7#a7 if ! article consi/s ( any ( ! foll[+3 7,a7 ,blood1 blood compon5ts1 or human cells or tissues1 f ! "t ( acquisition1 donation1 or recov]y ( su* article1 includ+ det]m9ation ( donor eligibility1 z applicable1 until su* "t z ! article is releas$ z a compon5t or "p ( an 9 vitro cl9ical te/ by ! e/abli%m5t t collect$ su* article4 7,b7 ,an article us$ = invasive sampl+1 a ne$le1 or a lancet1 except to ! ext5t su* article1 ne$le1 or lancet is an integral compon5t ( an article = hold+1 /or+1 or transport+ a specim54 7,c7 ,g5]al purpose laboratory equipm5t1 includ+ c]ta9 pre-analytical equipm5t1 z det]m9$ by ! ,secret>y4 7,d7 ,an article us$ solely = p]sonal protection dur+ ! adm9i/]+1 conduct+1 or o!rwise p]=m+ ( te/ activities4 2 7#b7 by add+ at ! end ( section #bja7;g7 ! foll[+3 7#c7 ,! t]m drug does n include an 9 vitro cl9ical te/4 2 & 7#c7 9 section #bja7;h77#a71 9 ! matt] foll[+ clause 7,c71 by /rik+ section #ebj7o7 & ins]t+ section #ebj7o7 or an 9 vitro cl9ical te/4 7b7 ,exclusion f def9ition ( biological product ,section #cea7;i77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;i77#a77 is am5d$-- 7#a7 by /rik+ 7#a7 ,! t]m biological product means & ins]t+ 7#a77;,a7 ,! t]m biological product means2 & 7#b7 by add+ at ! end ! foll[+3 7,b7 ,! t]m biological product does n include an 9 vitro cl9ical te/ z def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 4 7c7 ,9 vitro cl9ical te/ def9ition ,9 ?is ,act1 ! t]m 9 vitro cl9ical te/ has ! mean+ giv5 su* t]m 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a74 #hbc4 ,regulation ( 9 vitro cl9ical te/s ,! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 is am5d$-- 7#a7 by am5d+ ! head+ ( *apt] ,v to read z foll[s3 ,drugs1 ,devices1 & ,9 ,vitro ,cl9ical ,te/s2 & 7#b7 by add+ at ! end ( *apt] ,v ! foll[+3 ,j ,9 ,vitro ,cl9ical ,te/s #ehg4 ,def9itions ,9 ?is sub*apt]3 7#a7 ,analytical validity ,! t]m analytical validity means1 ) respect to an 9 vitro cl9ical te/1 ! ability ( ! 9 vitro cl9ical te/1 to id5tify1 measure1 detect1 calculate1 or analyze 7or assi/ 9 su* id5tification1 measurem5t1 detection1 calculation1 or analysis (7 "o or m analytes1 biom>k]s1 sub/ances1 or o!r t>gets int5d$ to be id5tifi$1 measur$1 detect$1 calculat$1 or analyz$ by ! te/4 7#b7 ,applicable /&>d ,! t]m applicable /&>d1 ) respect to an 9 vitro cl9ical te/1 means a reasonable assurance ( analytical & cl9ical validity = its indications = use1 & a reasonable assurance ( safety = individuals :o come into contact ) su* 9 vitro cl9ical te/1 except t su* t]m1 ) respect to specim5 receptacles & te/ in/rum5ts1 means a reasonable assurance ( analytical validity = its indications = use & safety = individuals :o come into contact ) su* specim5 receptacle or te/ in/rum5t4 7#c7 ,cl9ical use ,! t]m cl9ical use means ! op]ation1 application1 or function+ ( an 9 vitro cl9ical te/ = ! purpose = :i* x is int5d$ z describ$ 9 section #bja7ss77#a74 7#d7 ,cl9ical validity ,! t]m cl9ical validity means ! ability ( an 9 vitro cl9ical te/ to a*ieve ! purpose = :i* x is int5d$ z describ$ 9 section #bja7ss77#a74 7#e7 ,compon5t or "p ,! t]m compon5t or "p means a sub/ance1 piece1 "p1 raw mat]ial1 s(tw>e1 firmw>e1 label+1 or assembly1 includ+ reag5ts1 t is int5d$ by ! develop] to be includ$ z an aspect ( an 9 vitro cl9ical te/ describ$ 9 section #bja7ss77#a74 7#f7 ,develop ,! t]m develop1 ) respect to an 9 vitro cl9ical te/1 means-- 7,a7 design+1 validat+1 produc+1 manufactur+1 remanufactur+1 label+1 adv]tis+1 propagat+1 or assembl+ an 9 vitro cl9ical te/2 7,b7 modify+ an 9 vitro cl9ical te/1 includ+ modify+ ! indications = use ( ! 9 vitro cl9ical te/1 or modify+ an article to be 9 an 9 vitro cl9ical te/2 or 7,c7 e/abli%+ a te/ sy/em z describ$ or includ$ 9 a te/ protocol develop$ by ano!r entity unless su* te/ protocol is li/$ z an 9 vitro cl9ical te/ 9 ! compreh5sive te/ in=mation sy/em e/abli%$ "u section #ehg,t by t o!r entity4 7#g7 ,develop] ,! t]m develop] means a p]son :o engages 9 developm5t z describ$ 9 p>agraph 7#f71 except ! t]m does n include a laboratory t-- 7,a7 is c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act2 & 7,b7 assembles = use solely )9 t laboratory1 )\t o!rwise develop+1 an 9 vitro cl9ical te/ appropriately li/$ 9 ! compreh5sive te/ in=mation sy/em e/abli%$ "u section #ehg,t by a diff]5t p]son4 7#h7 ,fir/-(-a-k9d ,! t]m fir/-(-a-k9d1 ) respect to an 9 vitro cl9ical te/1 means t su* te/ has any novel comb9ation ( ! elem5ts specifi$ 9 p>agraph 7#aj7 t diff]s f 9 vitro cl9ical te/s t already are legally available 9 ! ,unit$ ,/ates1 except = su* te/s (f]$ "u section #ehg;,c7a77#c71 #ehg;,c7a77#d71 or #ehg;,g4 7#i7 ,high-risk ,! t]m high-risk1 ) respect to an 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s1 means t an undetect$ inaccurate result f su* te/1 or su* category ( te/s1 :5 us$ z int5d$-- 7,a7 7i7 has ! sub/antial likelihood to result 9 s]i\s or irrev]sible h>m or dea? to a pati5t or pati5ts1 or w\ld o!rwise cause s]i\s h>m to ! public heal?2 or 7ii7 is reasonably likely to result 9 ! abs5ce1 significant delay1 or discont9uation ( life-support+ or life-su/a9+ m$ical treatm5t2 & 7,b7 suffici5t mitigat+ measures are n able to be e/abli%$ & appli$ to prev5t1 mitigate1 or detect ! inaccurate result1 or o!rwise mitigate ! risk result+ f an undetect$ inaccurate result describ$ 9 subp>agraph 7,a71 su* t ! te/ w\ld be mod]ate-risk or l[-risk4 7#aj7 ,indications = use ,! t]m indications = use1 ) respect to an 9 vitro cl9ical te/1 means ! foll[+ elem5ts3 7,a7 ,sub/ance or sub/ances measur$ by ! 9 vitro cl9ical te/1 su* z an analyte1 prote91 or pa?og54 7,b7 ,te/ me?od4 7,c7 ,te/ purpose or purposes1 z describ$ 9 section #bja7ss77#a74 7,d7 ,diseases or conditions = :i* ! 9 vitro cl9ical te/ is int5d$ = use1 includ+ int5d$ pati5t populations4 7,e7 ,context ( use1 su* z 9 a cl9ical laboratory1 9 a heal? c>e facility1 prescription home use1 ov]-!-c\nt] use1 or direct-to-consum] te/+4 7#aa7 ,in/rum5t 7,a7 ,9 g5]al ,! t]m in/rum5t means an analytical or pre-analytical in/rum5t4 7,b7 ,analytic in/rum5t ,! t]m analytic in/rum5t means an 9 vitro cl9ical te/ t is h>dw>e int5d$ by ! h>dw>e develop] to be us$ ) "o or m o!r 9 vitro cl9ical te/s to g5]ate a cl9ical te/ result1 includ+ s(tw>e us$ to effectuate ! functionality ( ! h>dw>e4 7,c7 ,pre-analytical in/rum5t ,! t]m pre-analytical in/rum5t means an 9 vitro cl9ical te/ t is h>dw>e int5d$ by ! h>dw>e's develop] solely to g5]ate an output = use exclusively ) "o or m analytical in/rum5ts z def9$ 9 subp>agraph 7,b7 & :i* does n itself g5]ate a cl9ical te/ result4 ,su* t]m may include s(tw>e us$ to effectuate ! h>dw>e's functionality4 7#ab7 ,in/rum5t family ,! t]m in/rum5t family means m ?an "o in/rum5t develop$ by ! same develop] = :i* ! develop] demon/rates & docum5ts1 ) respect to all su* in/rum5ts1 t all-- 7,a7 h ! same basic ar*itecture1 design1 & p]=mance *>act]i/ics2 7,b7 h ! same indications = use & capabilities2 7,c7 %>e ! same measurem5t pr9ciples1 detection me?ods1 & reaction conditions1 z applicable2 & 7,d7 produce ! same or simil> analytical results f samples ( ! same specim5 type or types4 7#ac7 ,l[-risk ,! t]m l[-risk1 ) respect to an 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s1 means t an undetect$ inaccurate result f su* 9 vitro cl9ical te/1 or su* category ( 9 vitro cl9ical te/s1 :5 us$ z int5d$-- 7,a7 w\ld cause only m9imal or imm$iately rev]sible h>m1 & w\ld lead to only a remote risk ( adv]se pati5t impact or adv]se public heal? impact2 or 7,b7 suffici5t mitigat+ measures are able to be e/abli%$ & appli$ su* t ! 9 vitro cl9ical te/ meets ! /&>d describ$ 9 subp>agraph 7,a74 7#ad7 ,mitigat+ measures ,! t]m mitigat+ measures-- 7,a7 means controls1 /&>ds1 & o!r requirem5ts t ! ,secret>y det]m9es1 bas$ on evid5ce1 are necess>y-- 7i7 = an 9 vitro cl9ical te/1 or a category ( 9 vitro cl9ical te/s1 to meet ! applicable /&>d2 or 7ii7 to mitigate ! risk ( h>m ensu+ f an undetect$ inaccurate result or mis9t]pretation ( a result2 & 7,b7 may include1 z requir$ by ! ,secret>y1 z appropriate1 applicable requirem5ts reg>d+ label+1 con=mance to p]=mance /&>ds & cons5sus /&>ds1 p]=mance te/+1 submission ( cl9ical data1 adv]tis+1 website po/+ ( in=mation1 cl9ical /udies1 po/m>ket surveillance1 us] compreh5sion /udies1 tra9+1 & confirmatory laboratory1 cl9ical f9d+s1 or te/+4 7#ae7 ,mod]ate-risk ,! t]m mod]ate-risk1 ) respect to an 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s1 means t1 :5 us$ z int5d$1 su* te/ or category ( te/s-- 7,a7 meets ! crit]ia specifi$ 9 p>agraph 7#i7 = classification z high-risk1 b "o or m mitigat+ measures are able to be e/abli%$ & appli$ to prev5t or detect an inaccurate result or o!rwise suffici5tly mitigate su* risk1 b are n suffici5t su* t ! te/ is l[-risk2 or 7,b7 7i7 an undetect$ inaccurate result = ! int5d$ use ( ! te/ w\ld cause only non-life-?reat5+ h>m1 h>m t is m$ically rev]sible1 or ! abs5ce1 significant delay1 or discont9uation ( necess>y treatm5t t is n life-support+ or life-su/a9+2 & 7ii7 mitigat+ measures are n able to be e/abli%$ & appli$ to prev5t or detect su* inaccurate result or o!rwise suffici5tly mitigate ! risk ( su* inaccurate result su* t ! te/ w\ld be l[-risk4 7#af7 ,specim5 receptacle ,! t]m specim5 receptacle means an 9 vitro cl9ical te/ int5d$ = tak+1 collect+1 hold+1 /or+1 or transport+ ( specim5s d]iv$ f ! human body or = 9 vitro exam9ation = purposes describ$ 9 subp>agraph 7,a7 or 7,b7 ( section #bja7ss77#a74 7#ag7 ,te*nology ,! t]m te*nology-- 7,a7 means a set ( control me*anisms1 en]gy s\rces1 or op]at+ pr9ciples-- 7i7 t d n diff] significantly among multiple 9 vitro cl9ical te/s2 & 7ii7 = :i* design & developm5t 7includ+ analytical & cl9ical validation1 z applicable7 ( ! te/s w\ld be address$ 9 a simil> mann] or ?r\gh simil> proc$ures2 & 7,b7 may include clot detection1 colorimetric 7non-immunoassay71 electro*emical 7non-immunoassay71 enzymatic 7non-immunoassay71 fl[ cytometry1 fluorometry 7non-immunoassay71 immunoassay1 mass spectrometry or *romatography1 microbial culture1 next g5]ation sequ5c+1 nephlometric or turbidimetric 7non-immunoassay71 s+leplex or multiplex non-,,ngs nucleic acid analysis1 slide-bas$ te*nology1 spectroscopy1 & any o!r te*nology1 z ! ,secret>y det]m9es appropriate4 7#ah7 ,te/ ,! t]m te/1 unless o!rwise provid$1 means an 9 vitro cl9ical te/4 7#ai7 ,valid sci5tific evid5ce ,! t]m valid sci5tific evid5ce-- 7,a7 means1 ) respect to an 9 vitro cl9ical te/1 evid5ce t-- 7i7 has be5 g5]at$ & evaluat$ by p]sons qualifi$ by tra9+ or exp]i5ce to d s1 us+ proc$ures g5]ally accept$ by o!r p]sons s qualifi$2 & 7ii7 =ms an appropriate basis = conclud+ by qualifi$ exp]ts :e!r ! applicable /&>d has be5 met by ! 9 vitro cl9ical te/2 & 7,b7 may include evid5ce describ$ 9 subp>agraph 7,a7 consi/+ (-- 7i7 pe]-review$ lit]ature2 7ii7 cl9ical guidel9es2 7iii7 reports ( significant human exp]i5ce ) an 9 vitro cl9ical te/2 7iv7 b5* /udies2 7v7 case /udies or hi/ories2 7vi7 cl9ical data2 7vii7 cons5sus /&>ds2 7viii7 ref]5ce /&>ds2 7ix7 data regi/ries2 7x7 po/m>ket data2 7xi7 real _w data2 7xii7 cl9ical trials2 & 7xiii7 data collect$ 9 c\ntries o!r ?an ! ,unit$ ,/ates if su* data are demon/rat$ to be appropriate = ! purpose ( mak+ a regulatory det]m9ation "u ?is sub*apt]4 #ehg;,a4 ,regulation ( 9 vitro cl9ical te/s 7a7 ,9 g5]al ,no p]son %all introduce or deliv] = introduction into int]/ate comm]ce any 9 vitro cl9ical te/1 unless-- 7#a7 an approval ( an application fil$ pursuant to subsection 7a7 or 7b7 ( section #ehg;,b is effective ) respect to su* 9 vitro cl9ical te/2 7#b7 a te*nology c]tification ord] is 9 effect "u section #ehg;,d2 or 7#c7 ! te/ is exempt "u sections #ehg;,c or #ehg;,g f ! requirem5ts ( section #ehg;,b4 7b7 ,transf] or sale ( ,9 vitro cl9ical te/s 7#a7 ,transf] & assumption ( regulatory obligations ,if own]%ip ( an 9 vitro cl9ical te/ is sold or transf]r$ 9 su* mann] t ! develop] transf]s ! regulatory submissions & obligations applicable "u ?is sub*apt] ) respect to ! te/1 ! transf]ee or pur*as] becomes ! develop] ( ! te/ & %all h all regulatory obligations applicable to su* a te/ "u ?is sub*apt]4 ,! transf]ee or pur*as] %all update ! regi/ration & li/+ in=mation "u section #ehg;,j = ! 9 vitro cl9ical te/4 7#b7 ,transf] or sale ( prem>ket approval 7,a7 ,notice requir$ ,if a develop] ( an 9 vitro cl9ical te/ transf]s or sells ! approval ( ! 9 vitro cl9ical te/1 ! transf]or or sell] %all-- 7i7 submit a notice ( ! transf] or sale to ! ,secret>y & update ! regi/ration & li/+ in=mation "u section #ehg;,j = ! 9 vitro cl9ical te/2 & 7ii7 submit a supplem5t to an application if requir$ "u section #ehg;,b7h74 7,b7 ,effective date ( approval transf] ,a transf] or sale describ$ 9 subp>agraph 7,a7 %all become effective ^u completion ( a transf] or sale describ$ 9 p>agraph 7#a7 or ! approval ( a supplem5t to an application "u section #ehg;,b7h7 if requir$1 :i*ev] is lat]4 ,! transf]ee or pur*as] %all update ! regi/ration & li/+ in=mation "u section #ehg;,j = ! 9 vitro cl9ical te/ )9 #ae cal5d> days ( ! effective date ( ! transf] or sale4 7#c7 ,transf] or sale ( te*nology c]tification 7,a7 ,requirem5ts = transf] or sale ( te*nology c]tification ,an unexpir$ te*nology c]tification c be transf]r$ or sold if ! transf]ee or pur*as]-- 7i7 is an eligible p]son "u section #ehg;,d7a77#b72 & 7ii7 ma9ta9s1 ^u su* transf] or sale1 te/ design & quality requirem5ts1 processes & proc$ures "u ! scope ( te*nology c]tification1 & scope ( ! te*nology c]tification id5tifi$ 9 ! applicable te*nology c]tification ord]4 7,b7 ,notice requir$ ,if a develop] ( an 9 vitro cl9ical te/ transf]s or sells a te*nology c]tification ord] t has n expir$1 ! transf]or or sell] %all submit a notice ( ! transf] or sale to ! ,secret>y & %all update ! regi/ration & li/+ in=mation "u section #ehg;,j = all 9 vitro cl9ical te/s cov]$ by ! te*nology c]tification4 7,c7 ,effective date ( te*nology c]tification transf] ,! transf] ( a te*nology c]tification %all become effective ^u completion ( a transf] or sale describ$ 9 subp>agraph 7,a74 ,! transf]ee or pur*as] %all update ! regi/ration & li/+ in=mation "u section #ehg;,j = ! 9 vitro cl9ical te/ )9 #cj cal5d> days ( ! effective date ( ! te*nology c]tification transf]4 7,d7 ,new te*nology c]tification requir$ ,if ! requirem5ts ( subp>agraph 7,a77ii7 are n met1 ! te*nology c]tification ord] may n be transf]r$ & ! transf]ee or pur*as] ( an 9 vitro cl9ical te/ is requir$ to submit an application = te*nology c]tification & obta9 a te*nology c]tification ord] prior to (f]+ ! te/ = cl9ical use4 7c7 ,regulations ,! ,secret>y may issue regulations to implem5t ?is sub*apt]4 #ehg;,b4 ,prem>ket review 7a7 ,application 7#a7 ,fil+ ,any develop] may file ) ! ,secret>y an application = prem>ket approval ( an 9 vitro cl9ical te/ "u ?is subsection4 7#b7 ,transp>5cy & pr$ictability ,if a develop] files a prem>ket application "u ?is section & provides any additional docum5tation requir$ "u section #ehg;,d1 ! 9 vitro cl9ical te/ t is ! subject ( ! prem>ket application may be utiliz$ z ! repres5tative 9 vitro cl9ical te/ review$ by ! ,secret>y to support a te*nology c]tification ord] "u section #ehg;,d4 7#c7 ,application cont5t ,an application submitt$ "u p>agraph 7#a7 %all include ! foll[+1 9 su* =mat z ! ,secret>y specifies3 7,a7 ,g5]al in=mation reg>d+ ! 9 vitro cl9ical te/1 includ+-- 7i7 ! "n & address ( ! applicant2 7ii7 ! table ( cont5ts = ! application & ! id5tification ( ! in=mation ! applicant claims z trade secret or confid5tial comm]cial or f9ancial in=mation2 7iii7 a description ( ! te/'s design & int5d$ use1 includ+ ! indications = use2 & 7iv7 a description reg>d+ te/ function & p]=mance *>act]i/ics4 7,b7 ,a summ>y ( ! data & in=mation 9 ! application = ! 9 vitro cl9ical te/1 includ+-- 7i7 a brief description ( ! =eign & dome/ic m>ket+ hi/ory ( ! te/1 if any1 includ+ a li/ ( all c\ntries 9 :i* ! te/ has be5 m>ket$ & a li/ ( all c\ntries 9 :i* ! te/ has be5 )drawn f m>ket+ = any reason relat$ to ! ability ( ! 9 vitro cl9ical te/ to meet ! applicable /&>d1 if kn[n by ! applicant2 7ii7 a description ( b5efit & risk consid]ations relat$ to ! 9 vitro cl9ical te/1 includ+ a description ( any applicable adv]se effects ( ! te/ on heal? & h[ su* adv]se effects h be51 or w be1 mitigat$2 7iii7 a risk assessm5t ( ! te/2 & 7iv7 a description ( h[ ! data & in=mation 9 ! application con/itute valid sci5tific evid5ce & support a %[+ t ! te/ meets ! applicable /&>d "u section #ehg7b74 7,c7 ,! signature ( ! develop] fil+ ! prem>ket application or an au?oriz$ repres5tative4 7,d7 ,a bibliography ( applicable publi%$ reports reli$ ^u by ! applicant & a description ( any /udies conduct$1 includ+ any unpubli%$ /udies relat$ to su* te/1 t are kn[n or t %\ld reasonably be kn[n to ! applicant1 & a description ( data & in=mation relevant to ! evaluation ( :e!r ! te/ meets ! applicable /&>d4 7,e7 ,applicable in=mation reg>d+ ! me?ods us$ 91 & ! facilities or controls us$ =1 ! developm5t ( ! te/ to demon/rate compliance ) ! applicable quality requirem5ts "u section #ehg,k4 7,f7 ,in=mation demon/rat+ compliance ) any relevant & applicable-- 7i7 mitigat+ measures "u section #ehg;,e2 & 7ii7 /&>ds e/abli%$ or recogniz$ "u section #ead prior to ! date ( enactm5t ( ! ,,valid ,act ( #bjbb1 or1 aft] applicable /&>ds are e/abli%$ or recogniz$ "u section #ehg,q1 ) su* /&>ds4 7,g7 ,valid sci5tific evid5ce to support t ! te/ meets ! applicable /&>d1 :i* %all include-- 7i7 summ>y in=mation = all support+ validation /udies p]=m$1 includ+ a description ( ! objective ( ! /udy1 a description ( ! exp]im5tal design ( ! /udy1 a description ( any limitations ( ! /udy1 a brief description ( h[ ! data 7 collect$ & analyz$1 a brief description ( ! results ( ea* /udy1 & conclusions drawn f ea* /udy2 7ii7 new raw data = ea* /udy1 :i* may include1 z applicable1 tabulations ( data & results z requir$ "u section #had4bj7;b77#f77;ii7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations72 & 7iii7 = noncl9ical laboratory /udies involv+ ! te/1 if applicable1 a /atem5t t /udies 7 conduct$ 9 compliance ) applicable good laboratory practices4 7,h7 ,to ! ext5t ! application seeks au?orization to make modifications to ! te/ )9 ! scope ( ! approval t are n o!rwise p]mitt$ )\t prem>ket review "u ?is sub*apt]1 a propos$ *ange protocol t includes validation proc$ures & acceptance crit]ia = anticipat$ modifications t c\ld be made to ! te/ )9 ! scope ( ! approval4 7,i7 ,propos$ label+1 9 accordance ) ! requirem5ts ( section #ehg,l4 7,j7 ,su* o!r data or in=mation z ! ,secret>y may require 9 accordance ) ! lea/ burd5some requirem5ts "u section #ehg;,,aa7c74 7#d7 ,guidance = prem>ket & abbreviat$ prem>ket applications ,9 accordance ) section #hbe ( ! ,,valid ,act ( #bjbb1 ! ,secret>y %all issue draft guidance detail+ ! in=mation to be provid$ 9 a prem>ket application & abbreviat$ prem>ket application "u ?is section4 ,! ,secret>y %all issue f9al guidance detail+ ! in=mation to be provid$ 9 a prem>ket application & abbreviat$ prem>ket application "u ?is section n lat] ?an #a ye> prior to ! effective date ( su* ,act4 7#e7 ,refuse to file a prem>ket or abbreviat$ prem>ket application ,! ,secret>y may refuse to file an application "u ?is section only = lack ( complet5ess or legibility ( ! application4 ,if1 aft] receipt ( an application "u ?is section1 ! ,secret>y refuses to file su* an application1 ! ,secret>y %all provide to ! develop]1 )9 #fj cal5d> days ( receipt ( su* application1 a description ( ! reason = su* refusal1 & id5tify ! in=mation requir$1 if any1 to all[ = ! fil+ ( ! application4 7#f7 ,sub/antive review = defici5t application ,if1 aft] receipt ( an application "u ?is section1 ! ,secret>y det]m9es t any portion ( su* application is mat]ially defici5t1 ! ,secret>y %all provide to ! applicant a description ( su* mat]ial defici5cies & ! in=mation requir$ to resolve su* defici5cies4 7#g7 ,inspections ,) respect to an application "u p>agraph 7#a71 preapproval inspections au?oriz$ by an employee ( ! ,food & ,drug ,adm9i/ration or a p]son accr$it$ "u section #ehg,q ne$ n occur unless reque/$ by ! ,secret>y4 7b7 ,abbreviat$ prem>ket review 7#a7 ,9 g5]al ,any develop] may file ) ! ,secret>y an application = abbreviat$ prem>ket approval =-- 7,a7 an in/rum5t2 7,b7 a specim5 receptacle2 7,c7 an 9 vitro cl9ical te/ t is mod]ate-risk2 or 7,d7 an 9 vitro cl9ical te/ t is det]m9$ by ! ,secret>y to be eligible = abbreviat$ prem>ket review "u section #ehg;,f7a77#a77;,b74 7#b7 ,application cont5t ,an application "u p>agraph 7#a7 %all include-- 7,a7 ! in=mation requir$ = applications submitt$ "u subsection 7a77#b71 except t applications "u p>agraph 7#a7 ne$ n include-- 7i7 quality requirem5t in=mation2 or 7ii7 raw data1 unless explicitly reque/$ by ! ,secret>y2 & 7,b7 data1 z applicable1 to support s(tw>e validation1 electromagnetic compatibility1 & electrical safety1 & in=mation demon/rat+ compliance ) ma9ta9+ quality sy/ems docum5tation4 7#c7 ,safety in=mation ,! develop] ( an 9 vitro cl9ical te/ specim5 receptacle review$ "u ?is subsection %all ma9ta9 safety in=mation = su* specim5 receptacle4 7#d7 ,inspections ,) respect to an application "u p>agraph 7#a71 preapproval inspections au?oriz$ by an employee ( ! ,food & ,drug ,adm9i/ration or a p]son accr$it$ "u section #ehg,q ne$ n occur unless reque/$ by ! ,secret>y4 7c7 ,in/rum5ts & in/rum5t families 7#a7 ,9 g5]al ,a develop] ( an in/rum5t family %all file ) ! ,secret>y an application = prem>ket approval ( "o v]sion ( an in/rum5t "u ?is subsection4 ,any modifi$ v]sions ( ! in/rum5t t g5]ate a new in/rum5t )9 ! same in/rum5t family %all be exempt f prem>ket review requirem5ts ( ?is section1 provid$ t ! develop] ( su* in/rum5t or in/rum5t family-- 7,a7 ma9ta9s docum5tation t ! new in/rum5t is "p ( ! in/rum5t family1 z def9$ 9 section #ehg2 7,b7 p]=ms1 docum5ts1 & ma9ta9s a risk assessm5t 7z describ$ 9 subsection 7a77#b77;,b77iv77 ( ! new in/rum5t comp>$ to ! in/rum5t approv$ "u subsection 7b7 & no new risks are id5tifi$2 7,c7 p]=ms1 docum5ts1 & ma9ta9s validation & v]ification activities = ! new in/rum5t2 7,d7 makes su* docum5tation available to ! ,secret>y ^u reque/2 & 7,e7 regi/]s & li/s ! new in/rum5t 9 accordance ) section #ehg;,j4 7#b7 ,te/ kits & te/ protocols ,a te/ kit or te/ protocol t is approv$ "u ?is section = use on an approv$ in/rum5t or an in/rum5t exempt f prem>ket review1 includ+ an in/rum5t )9 an in/rum5t family "u ?is section1 a submission "u ?is section %all n be requir$ = su* te/ kit or te/ protocol 9 ord] = x to be us$ on a new in/rum5t )9 its in/rum5t family1 provid$ t-- 7,a7 use ( ! te/ kit or te/ protocol ) ! new in/rum5t does n-- 7i7 *ange ! claims = ! te/ kit or te/ protocol1 except z applicable1 claims reg>d+ an in/rum5t or in/rum5ts t c be us$ ) su* te/ kit or te/ protocol2 7ii7 adv]sely affect p]=mance ( ! te/ kit or te/ protocol2 or 7iii7 cause ! te/ kit or te/ protocol to no long] con=m ) p]=mance /&>ds requir$ "u section #ehg,r or comply ) any applicable mitigat+ measures "u section #ehg;,e1 conditions ( approval "u subsection 7e77#b77;,b71 or re/rictions "u section #ehg,o2 7,b7 ! te/ develop] does n id5tify any new risks = ! te/ kit or te/ protocol :5 us+ ! new in/rum5t2 7,c7 ! te/ develop] validates ! use ( ! new in/rum5t ) ! te/ kit or te/ protocol & ma9ta9s validation docum5tation2 7,d7 ! te/ kit or te/ protocol is n int5d$ = use-- 7i7 at ! po9t ( c>e sett+ or 9 sett+s = :i* a c]tificate ( waiv] is 9 effect "u section #cec ( ! ,public ,heal? ,s]vice ,act2 7ii7 )\t a prescription2 7iii7 at home2 or 7iv7 9 te/+ donors1 donations1 & recipi5ts ( blood1 blood compon5ts1 human cells1 tissues1 cellul>-bas$ products1 or tissue-bas$ products2 7,e7 ! te/ develop] makes ! docum5tation describ$ "u subp>agraph 7,c7 available to ! ,secret>y ^u reque/2 & 7,f7 ! te/ develop] updates ! li/+ in=mation = ! te/ kit or te/ protocol1 z applicable4 7d7 ,am5dm5ts to an application ,an applicant %all am5d an application submitt$ "u subsection 7a71 7b71 or 7f7 if ! applicant becomes aw>e ( in=mation t c\ld reasonably affect an evaluation "u subsection 7e7 ( :e!r ! approval /&>d has be5 met4 7e7 ,action on an application = prem>ket approval 7#a7 ,review 7,a7 ,disposition ,z promptly z possible1 b n lat] ?an #ij cal5d> days aft] an application "u subsection 7a7 is accept$ = submission 7unless ! ,secret>y det]m9es t an ext5sion is necess>y to review "o or m major am5dm5ts to ! application71 or n lat] ?an #fj cal5d> days aft] an application "u subsection 7b7 is accept$ = submission or a supplem5tal application "u subsection 7f7 is accept$ = submission1 ! ,secret>y1 aft] consid]+ any applicable report & recomm5dations pursuant to advisory committees "u section #ehg;,h1 %all issue an ord] approv+ ! application1 unless ! ,secret>y f9ds t ! gr\nds = approval 9 p>agraph 7#b7 are n met4 7,b7 ,reliance on propos$ label+ ,9 det]m9+ :e!r to approve or d5y an application "u p>agraph 7#a71 ! ,secret>y %all rely on ! indications = use includ$ 9 ! propos$ label+1 provid$ t su* label+ is n false or mislead+ bas$ on a fair evaluation ( all mat]ial facts4 7#b7 ,approval ( an application 7,a7 ,9 g5]al ,! ,secret>y %all approve an application submitt$ "u subsection 7a7 or 7b7 ) respect to an 9 vitro cl9ical te/ if ! ,secret>y f9ds t ! applicable /&>d is met1 &-- 7i7 ! applicant is 9 compliance ) applicable quality requirem5ts 9 section #ehg,k2 7ii7 ! application does n conta9 a false /atem5t or misrepres5tation ( mat]ial fact2 7iii7 bas$ on a fair evaluation ( all mat]ial facts1 ! propos$ label+ is tru?ful & non-mislead+ & complies ) ! requirem5ts ( section #ehg,l2 7iv7 ! applicant p]mits1 if reque/$1 au?oriz$ employees ( ! ,food & ,drug ,adm9i/ration & p]sons accr$it$ "u section #ehg,q an opportunity to inspect pursuant to section #gjd2 7v7 ! te/ con=ms ) any applicable p]=mance /&>ds requir$ "u section #ehg,r & any applicable mitigat+ measures "u section #ehg;,e2 7vi7 all noncl9ical laboratory /udies & cl9ical inve/igations involv+ human subjects t are describ$ 9 ! application 7 conduct$ 9 a mann] t meets ! applicable requirem5ts ( ?is sub*apt]2 & 7vii7 o!r data & in=mation ! ,secret>y may require "u subsection 7a77#b77,k7 support approval4 7,b7 ,conditions ( approval ,an ord] approv+ an application pursuant to ?is section may require reasonable conditions ( approval = ! 9 vitro cl9ical te/1 :i* may include con=mance ) applicable mitigat+ measures "u section #ehg;,e1 re/rictions "u section #ehg,o1 & p]=mance /&>ds "u section #ehg,r4 7,c7 ,publication ,! ,secret>y %all publi% an ord] = ea* application approv$ pursuant to ?is p>agraph on ! public website ( ! ,food & ,drug ,adm9i/ration & make publicly available a summ>y ( ! data us$ to approve su* application1 except to ! ext5t ! ,secret>y det]m9es t su* ord]-- 7i7 conta9s comm]cially confid5tial or trade secret in=mation2 or 7ii7 if publi%$1 w\ld pres5t a risk to national security4 7#c7 ,review ( d5ials ,an applicant ^: application submitt$ "u ?is section has be5 d5i$ approval "u ?is subsection may1 by petition fil$ n m ?an #fj cal5d> days aft] ! date on :i* ! applicant receives notice ( su* d5ial1 obta9 review ( ! d5ial 9 accordance ) section #ehg,p4 7f7 ,supplem5ts to an approv$ application 7#a7 ,risk analysis ,prior to implem5t+ any modification to an 9 vitro cl9ical te/1 ! hold] ( ! application approv$ "u subsection 7a7 or 7b7 = su* te/ %all p]=m risk analyses 9 accordance ) ?is subsection1 unless su* modification is includ$ 9 ! *ange protocol submitt$ by ! applicant & approv$ "u ?is section or exempt "u section #ehg;,c4 7#b7 ,supplem5t requirem5t 7,a7 ,9 g5]al ,if ! hold] ( an application ( an approv$ 9 vitro cl9ical te/ makes a modification to su* 9 vitro cl9ical te/1 except z provid$ 9 subp>agraph 7,c71 or o!rwise specifi$ by ! ,secret>y1 ! hold] ( ! application approv$ "u subsection 7e7 = an 9 vitro cl9ical te/ %all submit a supplem5tal application to ! ,secret>y4 ,! hold] ( ! application may n implem5t su* modification to ! 9 vitro cl9ical te/ until su* supplem5tal application is approv$4 ,! in=mation requir$ 9 a supplem5tal application is limit$ to :at is ne$$ to support ! *ange4 7,b7 ,adju/m5ts to *ange protocol ,! hold] ( an approv$ application may submit "u ?is p>agraph a supplem5tal application to modify ! *ange protocol ( ! te/ at any "t aft] ! application is submitt$ "u subsection 7a7 or 7b74 7,c7 ,exceptions ,not)/&+ subp>agraphs 7,a7 & 7,b71 & s long z ! hold] ( an approv$ application submitt$ "u subsection 7a7 or 7b7 = an 9 vitro cl9ical te/ does n add a manufactur+ site1 or *ange activities at an exi/+ manufactur+ site1 ) respect to ! te/1 ! hold] ( an approv$ application may1 )\t submission ( a supplem5tal application1 implem5t ! foll[+ modifications to ! te/3 7i7 ,modifications 9 accordance ) an approv$ *ange protocol "u subsection 7a77#c77;,h74 7ii7 ,modifications t are exempt "u section #ehg;,c7b74 7iii7 ,label+ *anges t are appropriate to address a safety conc]n1 except su* label+ *anges t include any ( ! foll[+1 rema9 subject to subp>agraph 7,a73 7,i7 ,a *ange to ! indications = use ( ! te/4 7,,ii7 ,a *ange to ! p]=mance claims made ) respect to ! te/4 7,,iii7 ,a *ange t adv]sely affects p]=mance ( ! te/4 7,d7 ,report+ = c]ta9 modifications made pursuant to a *ange protocol ,! hold] ( an application approv$ "u subsection 7e71 ) an approv$ *ange protocol "u subsection 7a77#b77;,h7 = su* 9 vitro cl9ical te/ %all-- 7i7 report any modification to su* te/ made pursuant to su* *ange protocol approv$ "u subsection 7a77#b77;,h7 9 a submission "u section #ehg;,j7c77#b77;,b72 & 7ii7 include 9 su* report-- 7,i7 a description ( ! modification2 7,,ii7 ! rationale = implem5t+ su* modification2 & 7,,iii7 z applicable1 a summ>y ( ! evid5ce support+ t ! te/1 z modifi$1 meets ! applicable /&>d1 complies ) p]=mance /&>ds requir$ "u section #ehg,q1 & complies ) any mitigat+ measures e/abli%$ "u section #ehg;,e & any re/rictions "u section #ehg,o4 7,e7 ,report+ = c]ta9 safety relat$ label+ *anges ,! hold] ( ! application = an 9 vitro cl9ical te/ approv$ "u subsection 7a7 or 7b7 pursuant to subsection 7e7 %all-- 7i7 report to ! ,secret>y any modification to ! te/ describ$ 9 subp>agraph 7,c77iii7 n m ?an #cj days aft] ! date on :i* ! te/1 ) ! modifications1 is introduc$ into int]/ate comm]ce2 & 7ii7 include 9 ! report-- 7,i7 a description ( ! *ange or *anges2 7,,ii7 ! rationale = implem5t+ su* *ange or *anges2 & 7,,iii7 a description ( h[ ! *ange or *anges 7 evaluat$4 7#c7 ,cont5ts ( supplem5t ,unless o!rwise specifi$ by ! ,secret>y1 a supplem5t "u ?is subsection %all include-- 7,a7 = modifications o!r ?an manufactur+ site *anges requir+ a supplem5t-- 7i7 a description ( ! modification2 7ii7 data relevant to ! modification to demon/rate t ! applicable /&>d is met1 n to exce$ data requirem5ts = ! orig9al submission2 7iii7 acceptance crit]ia2 & 7iv7 any revis$ label+2 & 7,b7 = manufactur+ site *anges-- 7i7 ! in=mation li/$ 9 subp>agraph 7,a72 & 7ii7 in=mation reg>d+ ! me?ods us$ 91 or ! facilities or controls us$ =1 ! developm5t ( ! te/ to demon/rate compliance ) ! applicable quality requirem5ts "u section #ehg,k4 7#d7 ,additional data ,! ,secret>y may require1 :5 necess>y1 data to evaluate a modification to an 9 vitro cl9ical te/ t is 9 addition to ! data o!rwise requir$ "u ! prec$+ p>agraphs if ! data reque/ is 9 accordance ) ! lea/ burd5some requirem5ts "u section #ehg;,,aa7c74 7#e7 ,conditions ( approval ,9 an ord] approv+ a supplem5t "u ?is subsection1 ! ,secret>y may require conditions ( approval = ! 9 vitro cl9ical te/1 includ+ compliance ) re/rictions "u section #ehg,o & con=mance to p]=mance /&>ds "u section #ehg,r4 7#f7 ,approval ,! ,secret>y %all approve a supplem5t "u ?is subsection if-- 7,a7 ! data demon/rate t ! modifi$ 9 vitro cl9ical te/ meets ! applicable /&>d2 & 7,b7 ! hold] ( ! application approv$ "u subsection 7e7 = ! te/ has demon/rat$ compliance ) applicable quality & inspection requirem5ts1 z applicable & appropriate4 7#g7 ,publication ,! ,secret>y %all publi% on ! public website ( ! ,food & ,drug ,adm9i/ration notice ( any ord] approv+ a supplem5t "u ?is subsection1 except t su* publication %all exclude-- 7,a7 comm]cial confid5tial or trade secret in=mation2 & 7,b7 any o!r in=mation t ! ,secret>y det]m9es to relate to national security or c\nt]measures or to be re/rict$ f disclosure pursuant to ano!r provision ( law4 7#h7 ,review ( d5ial ,an applicant ^: supplem5t "u ?is subsection has be5 d5i$ approval may1 by petition fil$ on or be=e ! #fj? cal5d> day aft] ! date ^u :i* ! applicant receives notice ( su* d5ial1 obta9 review ( ! d5ial 9 accordance ) section #ehg,p4 7g7 ,)drawal & tempor>y susp5sion ( approval 7#a7 ,ord] )draw+ approval 7,a7 ,9 g5]al ,! ,secret>y may1 aft] provid+ due notice & an opportunity = an in=mal he>+ to ! hold] ( an approv$ application = an 9 vitro cl9ical te/ "u ?is section1 issue an ord] )draw+ approval ( ! application if ! ,secret>y f9ds t-- 7i7 ! gr\nds = approval "u subsection 7e7 are no long] met2 7ii7 !re is a reasonable likelihood t ! te/ w\ld cause dea? or s]i\s adv]se heal? consequ5ces1 includ+ by caus+ ! abs5ce1 significant delay1 or discont9uation ( life-sav+ or life su/a9+ m$ical treatm5t2 7iii7 ! hold] ( ! approv$ application-- 7,i7 has fail$ to1 or repeat$ly or delib]ately fail$ to1 ma9ta9 records to make reports1 z requir$ "u section #ehg,m2 7,,ii7 has refus$ to p]mit access to1 or copy+ or v]ification ( su* records1 z requir$ "u section #gjd2 7,,iii7 has n compli$ ) ! requirem5ts ( section #ehg,k2 or 7,,iv7 has n compli$ ) any mitigat+ measure requir$ "u section #ehg;,e or re/riction "u section #ehg,o2 or 7iv7 ! label+ ( su* 9 vitro cl9ical te/1 bas$ on a fair evaluation ( all mat]ial facts1 is false or mislead+ 9 any p>ticul> & 0 n correct$ )9 a reasonable "t aft] receipt ( writt5 notice f ! ,secret>y ( su* fact4 7,b7 ,cont5t ,an ord] "u subp>agraph 7,a7 )draw+ approval ( an application %all /ate ea* gr\nd = )drawal & %all notify ! hold] ( su* application #fj cal5d> days prior to issu+ su* ord]4 7,c7 ,publication ,! ,secret>y %all publi% any ord] "u subp>agraph 7,a7 on ! public website ( ! ,food & ,drug ,adm9i/ration1 except t su* publication %all exclude-- 7i7 comm]cial confid5tial or trade secret in=mation2 & 7ii7 any o!r in=mation t ! ,secret>y det]m9es1 if publi%$1 w\ld pres5t a risk to national security4 7#b7 ,ord] ( tempor>y susp5sion ,if1 aft] provid+ due notice & an opportunity = an in=mal he>+ to ! hold] ( an approv$ application = an 9 vitro cl9ical te/ "u ?is section1 ! ,secret>y det]m9es1 bas$ on sci5tific evid5ce1 t !re is a reasonable likelihood t ! 9 vitro cl9ical te/ w\ld cause dea? or s]i\s adv]se heal? consequ5ces1 su* z by caus+ ! abs5ce1 significant delay1 or discont9uation ( life-sav+ or life-su/a9+ m$ical treatm5t1 ! ,secret>y %all1 by ord]1 tempor>ily susp5d ! approval ( ! application4 ,if ! ,secret>y issues su* an ord]1 ! ,secret>y %all proce$ exp$iti\sly "u p>agraph 7#a7 to )draw approval ( su* application4 7#c7 ,appeal )draw+ approval & ord]s ( tempor>y susp5sions ,an ord] ( )drawal or an ord] ( tempor>y susp5sion may be appeal$ "u #ehg,p4 #ehg;,c4 ,exemptions 7a7 ,9 g5]al ,! foll[+ 9 vitro cl9ical te/s are exempt f prem>ket review "u section #ehg;,b1 & may be lawfully m>ket$ subject to o!r applicable requirem5ts ( ?is ,act3 7#a7 ,te/s exempt f section #eaj7k7 7,a7 ,exemption ,an 9 vitro cl9ical te/ is exempt f prem>ket review "u section #ehg;,b & may be lawfully m>ket$ subject to ! o!r applicable requirem5ts ( ?is ,act1 if ! develop] ( ! 9 vitro cl9ical te/-- 7i7 ma9ta9s docum5tation demon/rat+ t ! te/ meets & cont9ues to meet ! crit]ia set =? 9 subp>agraph 7,b72 & 7ii7 makes su* docum5tation available to ! ,secret>y ^u reque/4 7,b7 ,crit]ia = exemption ,an 9 vitro cl9ical te/ is exempt z specifi$ 9 subp>agraph 7,a7 if su* te/-- 7i7 7,i7 0 (f]$ = cl9ical use prior to ! date ( enactm5t ( ! ,,valid ,act ( #bjbb2 7,,ii7 imm$iately prior to su* date ( enactm5t 0 exempt pursuant to subsection 7l7 or 7m77#b7 ( section #eaj f ! requirem5ts = submission ( a report "u section #eaj7k72 or 7,,iii7 7aa7 0 n (f]$ = cl9ical use prior to su* date ( enactm5t2 7bb7 is n an in/rum5t2 & 7cc7 falls )9 a category ( te/s t 0 exempt f ! requirem5ts = submission ( a report "u section #eaj7k7 z ( su* date ( enactm5t 7includ+ class ,,ii devices & exclud+ class ,i devices describ$ 9 section #eaj7l772 7ii7 meets ! applicable /&>d z describ$ 9 section #ehg7b72 7iii7 is n (f]$ ) label+ & adv]tis+ t is false or mislead+2 & 7iv7 is n likely to cause or contribute to s]i\s adv]se heal? consequ5ces4 7,c7 ,effect on special controls ,= any 9 vitro cl9ical te/1 or category ( 9 vitro cl9ical te/s1 t is exempt f prem>ket review bas$ on ! crit]ia 9 subp>agraph 7,b71 any special control t appli$ to a device )9 a pr$ecessor category imm$iately prior to ! date ( enactm5t ( ! ,,valid ,act ( #bjbb %all be deem$ a mitigat+ measure applicable "u section #ehg;,e to an 9 vitro cl9ical te/ )9 ! successor category1 except to ! ext5t su* mitigat+ measure is )drawn or *ang$ 9 accordance ) section #ehg;,e4 7,d7 ,ne>-pati5t te/+ ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbb1 ! ,secret>y %all issue draft guidance indicat+ categories ( te/s t %all be exempt f prem>ket review "u section #ehg;,b :5 (f]$ = ne>-pati5t te/+ 7po9t ( c>e71 :i* 7 n exempt f submission ( a report "u section #eaj7k7 pursuant to subsection 7l7 or 7m77#b7 ( section #eaj & regulations impos+ limitations on exemption = 9 vitro devices int5d$ = ne>-pati5t te/+ 7po9t ( c>e74 7#b7 ,l[-risk te/s 7,a7 ,exemption ,an 9 vitro cl9ical te/ is exempt f prem>ket review "u section #ehg;,b & may be lawfully m>ket$ subject to ! o!r applicable requirem5ts ( ?is ,act1 includ+ section #ehg;,j7b77#f71 if su* te/ meets ! def9ition ( l[-risk "u section #ehg & if ! develop] ( ! te/-- 7i7 ma9ta9s docum5tation demon/rat+ t ! 9 vitro cl9ical te/ meets & cont9ues to meet ! crit]ia set =? 9 p>agraph 7#b72 & 7ii7 makes su* docum5tation available to ! ,secret>y ^u reque/4 7,b7 ,crit]ia = exemption ,an 9 vitro cl9ical te/ is exempt z specifi$ 9 subp>agraph 7,a7 if-- 7i7 ! 9 vitro cl9ical te/ meets ! applicable /&>d z describ$ 9 #ehg7b72 7ii7 ! label+ & adv]tis+ are n false or mislead+2 7iii7 ! 9 vitro cl9ical te/ is n likely to cause or contribute to s]i\s adv]se heal? consequ5ces2 & 7iv7 ! 9 vitro cl9ical te/ is li/$ pursuant to section #ehg;,j or falls )9 a category ( te/s li/$ z describ$ 9 subp>agraph 7,c74 7,c7 ,li/ ( l[-risk te/s 7i7 ,9 g5]al ,! ,secret>y %all ma9ta91 & make publicly available on ! website ( ! ,food & ,drug ,adm9i/ration1 a li/ ( 9 vitro cl9ical te/s1 & categories ( 9 vitro cl9ical te/s1 t are l[-risk 9 vitro cl9ical te/s = purposes ( ! exemption "u ?is p>agraph4 7ii7 ,inclusion ,! li/ "u clause 7i7 %all consi/ (-- 7,i7 all 9 vitro cl9ical te/s & categories ( 9 vitro cl9ical te/s t are exempt f prem>ket review pursuant to subsection 7d77#a7 or 7d77#c72 & 7,,ii7 all 9 vitro cl9ical te/s & categories ( 9 vitro cl9ical te/s t are designat$ by ! ,secret>y pursuant to subp>agraph 7,c7 z l[-risk = purposes ( ?is p>agraph4 7,d7 ,designation ( te/s & categories ,)\t reg>d to sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code1 ! ,secret>y may designate1 9 addition to ! te/s & categories describ$ 9 subp>agraph 7,c77i71 additional 9 vitro cl9ical te/s1 & categories ( 9 vitro cl9ical te/s1 z l[-risk 9 vitro cl9ical te/s = purposes ( ! exemption "u ?is p>agraph4 ,! ,secret>y may make su* a designation on ! ,secret>y's own initiative or 9 response to a reque/ by a develop] pursuant to subsection 7a7 or 7b7 ( section #ehg;,f4 ,9 mak+ su* a designation = a te/ or category ( te/s1 ! ,secret>y %all consid]-- 7i7 :e!r ! te/1 or category ( te/s1 is l[-risk2 7ii7 ! exi/5ce ( & ability to develop mitigat+ measures suffici5t = su* te/ category to meet ! l[-risk /&>d2 & 7iii7 su* o!r factors z ! ,secret>y det]m9es to be appropriate = ! protection ( ! public heal?4 7#c7 ,humanit>ian te/ exemption 7,a7 ,9 g5]al ,an 9 vitro cl9ical te/ t meets ! crit]ia "u subp>agraph 7,b7 is exempt f prem>ket review "u section #ehg;,b & may be lawfully (f]$ subject to ! o!r applicable requirem5ts ( ?is sub*apt]1 if ! develop] ( ! te/-- 7i7 ma9ta9s docum5tation 7:i* may include lit]ature citations 9 specializ$ m$ical j\rnals1 textbooks1 specializ$ m$ical society proce$+s1 & gov]nm5tal /ati/ics publications1 or1 if no su* /udies or lit]ature citations exi/1 cr$ible conclusions f appropriate rese>* or surveys7 demon/rat+ t su* te/ meets & cont9ues to meet ! crit]ia describ$ 9 ?is subsection2 & 7ii7 makes su* docum5tation available to ! ,secret>y ^u reque/4 7,b7 ,crit]ia = exemption ,an 9 vitro cl9ical te/ is exempt z describ$ 9 subp>agraph 7,a7 if-- 7i7 ! 9 vitro cl9ical te/ is int5d$ by ! develop] = use = a diagno/ic purpose = a disease or condition t affects n m ?an #aj1jjj 7or su* o!r high] numb] det]m9$ by ! ,secret>y7 individuals 9 ! ,unit$ ,/ates p] ye>2 & 7ii7 ! 9 vitro cl9ical te/ meets ! applicable /&>d describ$ 9 section #ehg7b72 7iii7 ! label+ & adv]tis+ = ! 9 vitro cl9ical te/ are n false or mislead+2 7iv7 ! 9 vitro cl9ical te/ is n likely to cause or contribute to s]i\s heal? consequ5ces2 & 7v7 ! 9 vitro cl9ical te/ is n int5d$ = scre5+4 7,c7 ,exception = c]ta9 te/s ,an 9 vitro cl9ical te/ int5d$ to in=m ! use ( a specific individual or specific type ( biological product1 drug1 or device %all be eligible = an exemption f prem>ket review "u ?is subsection only if1 ! develop] submits a reque/ "u subsection 7m7 = in=mal fe$back & ! ,secret>y det]m9es t su* 9 vitro cl9ical te/ is eligible = an exemption f prem>ket review "u ?is subsection4 7#d7 ,cu/om te/s & l[-,volume te/s ,an 9 vitro cl9ical te/ is exempt f prem>ket review "u section #ehg;,b1 quality requirem5ts "u section #ehg,k1 & li/+ requirem5ts "u section #ehg;,j1 & may be lawfully m>ket$ subject to ! o!r applicable requirem5ts ( ?is ,act1 if-- 7,a7 su* 9 vitro cl9ical te/-- 7i7 is a te/ protocol p]=m$ = n m ?an #e pati5ts p] ye> 7or su* o!r high] numb] det]m9$ by ! ,secret>y71 9 a laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act t-- 7,i7 meets ! requirem5ts to p]=m te/s ( high-complexity 9 :i* ! te/ protocol 0 develop$2 or 7,,ii7 meets ! requirem5ts to p]=m te/s ( high-complexity )9 ! same corporate organization & hav+ common own]%ip by ! same p>5t corporation z ! laboratory 9 :i* su* te/ protocol 0 develop$2 or 7ii7 is an 9 vitro cl9ical te/ develop$ or modifi$ to diagnose a unique pa?ology or physical condition ( a specific pati5t or pati5ts1 ^u ord] ( a heal? pr(essional or o!r specially qualifi$ p]son designat$ "u regulations1 = :i* no o!r 9 vitro cl9ical te/ is comm]cially available 9 ! ,unit$ ,/ates1 & is-- 7,i7 n int5d$ = use ) respect to m ?an #e 7or su* o!r high] numb] det]m9$ by ! ,secret>y7 o!r pati5ts2 & 7,,ii7 aft] ! developm5t ( su* te/1 n includ$ 9 any te/ m5u or template te/ report or o!r promotional mat]ials1 & is n o!rwise adv]tis$2 & 7,b7 ! develop] ( ! 9 vitro cl9ical te/-- 7i7 ma9ta9s docum5tation demon/rat+ t su* te/ meets ! applicable crit]ia describ$ 9 subp>agraph 7,a72 7ii7 makes su* docum5tation1 su* z a prescription ord] reque/+ ! cu/om te/ = an individual pati5t1 available to ! ,secret>y ^u reque/2 & 7iii7 in=ms ! ,secret>y1 on an annual basis1 9 a mann] prescrib$ by ! ,secret>y by guidance1 t su* te/ 0 (f]$4 7#e7 ,9 vitro cl9ical te/s "u a te*nology c]tification ord] ,an 9 vitro cl9ical te/ t is )9 ! scope ( a te*nology c]tification ord]1 z describ$ 9 section #ehg;,d7a71 is exempt f prem>ket review "u section #ehg;,b4 4 7#f7 ,modifi$ te/s 7,a7 ,9 g5]al ,an 9 vitro cl9ical te/ t is modifi$ is exempt f prem>ket review "u section #ehg;,b if-- 7i7 7,i7 ! modification is made by-- 7aa7 ! develop] t obta9$ prem>ket approval = ! unmodifi$ v]sion ( ! te/ "u section #ehg;,b2 or 7bb7 a cl9ical laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act t meets ! requirem5ts = p]=m+ high complexity te/+1 to a lawfully (f]$ 9 vitro cl9ical te/1 includ+ ano!r develop]'s lawfully (f]$ 9 vitro cl9ical te/1 exclud+ inve/igational 9 vitro cl9ical te/s (f]$ "u section #ehg,s1 & ! modifi$ te/ is p]=m$-- 7,,aa7 9 ! same cl9ical laboratory 9 :i* x 0 develop$ = :i* a c]tification is /ill 9 effect "u section #cec t meets ! requirem5ts to p]=m te/s ( high complexity2 7,,bb7 by ano!r cl9ical laboratory = :i* a c]tificate is 9 effect "u section #cec t meets ! requirem5ts to p]=m te/s ( high complexity1 is )9 ! same corporate organization1 & has common own]%ip by ! same p>5t corporation z ! laboratory 9 :i* ! te/ 0 develop$2 or 7,,cc7 by a cl9ical laboratory = :i* a c]tificate is 9 effect "u section #cec t meets ! requirem5ts to p]=m te/s ( high complexity & is )9 a public heal? laboratory network coord9at$ or manag$ by ! ,c5t]s = ,disease ,control & ,prev5tion1 if ! te/ 0 develop$ by ! ,c5t]s = ,disease ,control & ,prev5tion or ano!r laboratory )9 su* public heal? laboratory network2 or 7,,ii7 ! modification does n-- 7aa7 con/itute a significant *ange to ! indications = use2 7bb7 cause ! te/ to no long] comply ) applicable mitigat+ measures "u section #ehg;,e or re/rictions "u section #ehg,o2 7cc7 significantly *ange p]=mance claims or significantly & adv]sely *ange p]=mance1 unless provid$ = "u an approv$ *ange protocol "u section #ehg7;a77#b77;,h72 or 7dd7 con/itute an adv]se *ange 9 ! safety ( ! 9 vitro cl9ical te/ = individuals :o come 9 contact ) ! 9 vitro cl9ical te/2 7ii7 ! te/ meets ! applicable /&>d z describ$ 9 section #ehg7b72 7iii7 ! label+ & adv]tis+ are n false or mislead+2 & 7iv7 ! te/ is n likely to cause or contribute to s]i\s adv]se heal? consequ5ces4 7,b7 ,c]ta9 modifications ,a modification to ext5d specim5 /ability is exempt f prem>ket review "u section #ehg;,b if ! modifi$ te/ meets ! requirem5ts 9 clauses 7iii7 ?r\gh 7v7 ( subp>agraph 7,a74 7,c7 ,modifications "u a *ange protocol ,not)/&+ subp>agraph 7,a71 a modification made "u a *ange protocol pursuant to subsection 7a77#b77;,h7 ( section #ehg;,b is exempt f review "u su* section4 7,d7 ,docum5tation ,a p]son :o modifies an 9 vitro cl9ical te/ 9 a mann] t is a modification describ$ 9 subp>agraph 7,a7 %all-- 7i7 docum5t ! modification t 0 made & ! basis = det]m9+ t ! modification1 consid]+ ! *anges individually & collectively1 is a type ( modification describ$ 9 subp>agraph 7,a71 7,b71 or 7,c72 & 7ii7 provide su* docum5tation to ! ,secret>y ^u reque/ or inspection4 7,e7 ,guidance ,n lat] ?an #cj mon?s aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbb1 ! ,secret>y %all issue guidance reg>d+ ! 9 vitro cl9ical te/s t are modifi$ & exempt f prem>ket review "u section #ehg;,b pursuant to ?is p>agraph4 7b7 ,manual te/s 7#a7 ,exemption ,an 9 vitro cl9ical te/ is exempt f all requirem5ts ( ?is sub*apt] if ! output ( su* 9 vitro cl9ical te/ is ! result ( direct1 manual obs]vation1 )\t ! use ( automat$ in/rum5tation or s(tw>e = int]m$iate or f9al int]pretation1 by a qualifi$ laboratory pr(essional1 & su* 9 vitro cl9ical te/-- 7,a7 is design$1 develop$1 & us$ )9 a s+le cl9ical laboratory = :i* a c]tificate is 9 effect "u section #cec ( ! ,public ,heal? ,s]vice ,act t meets ! requirem5ts "u section #cec = p]=m+ high-complexity te/+2 7,b7 is n a specim5 receptacle1 in/rum5t1 or an 9 vitro cl9ical te/ t includes an in/rum5t or specim5 receptacle t is n approv$ "u or exempt f section #ehg;,b2 7,c7 is n a high-risk te/1 or is a high-risk te/ t ! ,secret>y has det]m9$ meets at lea/ "o condition 9 p>agraph 7#b7 & is o!rwise appropriate = ?is exemption2 & 7,d7 is n int5d$ = te/+ donors1 donations1 or recipi5ts ( blood1 blood compon5ts1 human cells1 tissues1 cellul>-bas$ products1 or tissue-bas$ products4 7#b7 ,high-risk te/ limitation or condition ,a high-risk te/ may be exempt "u p>agraph 7#a7 f ! requirem5ts ( ?is sub*apt] only if-- 7,a7 no compon5t or "p ( su* te/1 includ+ any reag5t1 is introduc$ into int]/ate comm]ce "u ! exemption "u p>agraph 7#e71 & any article = tak+ or d]iv+ specim5s f ! human body us$ 9 conjunction ) ! te/ rema9s subject to ! requirem5ts ( ?is sub*apt]2 or 7,b7 ! te/ has be5 develop$ 9 accordance ) ! applicable te/ design & quality requirem5ts "u section #ehg;,j4 7c7 ,public heal? surveillance activities 7#a7 ,9 g5]al ,! provisions ( ?is sub*apt] %all n apply to a te/ int5d$ by ! develop] to be us$ solely = public heal? surveillance activities4 7#b7 ,exclusion ,an 9 vitro cl9ical te/ us$ = public heal? surveillance activities is n exclud$ f ! provisions ( ?is sub*apt] pursuant to ?is subsection if su* te/ is int5d$ = use 9 mak+ cl9ical decisions = individual pati5ts4 7d7 ,g5]al laboratory equipm5t ,any in/rum5t t does n produce an analytical result1 & t functions z a compon5t ( pre-analytical proc$ures relat$ to 9 vitro cl9ical te/s1 is n subject to ! requirem5ts ( ?is sub*apt]1 provid$ t ! in/rum5t is op]at+ 9 a cl9ical laboratory t is c]tifi$ "u section #cec ( ! ,public ,heal? ,s]vice ,act4 7e7 ,compon5ts & ,p>ts 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 a compon5t or "p describ$ 9 section #bja7ss77#b77;,e7 is-- 7,a7 exempt f ! requirem5ts ( ?is sub*apt] if x is int5d$ = fur!r developm5t z describ$ 9 p>agraph 7#c72 or 7,b7 subject to ! requirem5ts ( ?is sub*apt] & regulat$ bas$ on its risk :5 us$ z int5d$ by ! develop]1 not)/&+ its subsequ5t use by a develop] z a compon5t1 "p1 or raw mat]ial ( ano!r 9 vitro cl9ical te/4 7#b7 ,inapplicability to o!r te/s ,not)/&+ p>agraph 7#a71 an 9 vitro cl9ical te/ t is describ$ 9 section #bja7ss77#a77;,b7 & t uses a compon5t or "p describ$ 9 su* subp>agraph %all be subject to ! requirem5ts ( ?is sub*apt]1 unless ! te/ is o!rwise exempt "u ?is section4 7#c7 ,fur!r developm5t ,a compon5t1 "p1 or raw mat]ial 7z describ$ 9 p>agraph 7#a77 is int5d$ = fur!r developm5t 7= purposes ( su* p>agraph7 if-- 7,a7 x is int5d$ solely = use 9 ! developm5t ( ano!r 9 vitro cl9ical te/2 & 7,b7 9 ! case ( su* a te/ t is introduc$ or deliv]$ = introduction into int]/ate comm]ce aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbb1 ! label+ ( su* te/ be>s ! foll[+ /atem5t3 ,?is product is int5d$ solely = fur!r developm5t ( an 9 vitro cl9ical te/ & is exempt f ,,fda regulation4 ,?is product mu/ be evaluat$ by ! 9 vitro cl9ical te/ develop] if x is us$ ) or 9 ! developm5t ( an 9 vitro cl9ical te/44 7f7 ,g5]al exemption au?ority ,! ,secret>y may1 by ord] publi%$ 9 ! ,f$]al ,regi/] foll[+ notice & an opportunity = comm5t1 exempt a class ( p]sons f any section "u ?is sub*apt] ^u a f9d+ t su* exemption is appropriate = ! protection ( ! public heal? & o!r relevant consid]ations4 7g7 ,exemption ,an 9 vitro cl9ical te/ t is int5d$ solely = use 9 =5sic analysis or law en=cem5t activity is exempt f ! requirem5ts ( ?is sub*apt]4 ,an 9 vitro cl9ical te/ t is int5d$ = use 9 mak+ cl9ical decisions = individual pati5ts1 or ^: individually id5tifiable results may be report$ back to an individual pati5t or ! pati5t's heal? c>e provid]1 ev5 if also int5d$ = =5sic analysis or law en=cem5t purposes1 is n int5d$ solely = =5sic analysis or law en=cem5t = purposes ( ?is subsection4 7h7 ,revocation 7#a7 ,9 g5]al ,! ,secret>y may revoke any exemption ) respect to 9 vitro cl9ical te/s ) ! same indications = use if new cl9ical in=mation indicates t ! exemption ( an 9 vitro cl9ical te/ or te/s f prem>ket review "u section #ehg;,b has a reasonable probability ( sev]e adv]se heal? consequ5ces1 includ+ ! abs5ce1 delay1 or discont9uation ( appropriate m$ical treatm5t4 7#b7 ,process ,any action "u p>agraph 7#a7 %all be made by publication ( a notice ( su* propos$ action on ! website ( ! ,food & ,drug ,adm9i/ration1 ! consid]ation ( comm5ts to a public docket on su* proposal1 & publication ( a f9al action on su* website )9 #fj cal5d> days ( ! close ( ! comm5t p]iod po/$ to su* public docket1 not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code4 7i7 ,pre-,analytical in/rum5t ,a pre-analytical in/rum5t is exempt f prem>ket review "u section #ehg;,b & may be lawfully (f]$ subject to ! o!r applicable requirem5ts ( ?is ,act1 if ei!r ( ! foll[+ applies3 7#a7 ,su* in/rum5t provides additional in=mation reg>d+ ! sample or p]=ms an action on ! sample b is n prep>+ or process+ ! sample & does n p]=m any function ( an analytical in/rum5t4 ,su* types ( pre-analytical in/rum5ts include b>code read]s1 sample mov]s1 & sample id5tifi]s4 7#b7 ,su* in/rum5t processes or prep>es ! sample prior to use on an analytical in/rum5t1 does n p]=m any function ( an analytical in/rum5t1 & does n select1 isolate1 or prep>e a "p ( a sample bas$ on specific prop]ties4 ,su* types ( pre-analytical in/rum5ts may include sample mix]s1 ,,dna extractors & ^? us$ to dilute samples4 #ehg;,d4 ,te*nology c]tification 7a7 ,def9itions ,9 ?is section3 7#a7 ,eligible 9 vitro cl9ical te/ ,! t]m eligible 9 vitro cl9ical te/ means an 9 vitro cl9ical te/ t is n-- 7,a7 a compon5t or "p ( an 9 vitro cl9ical te/ z describ$ 9 section #bja7ss77#b77;,e72 7,b7 an in/rum5t "u section #bja7ss77#b77;,b7 or an 9 vitro cl9ical te/ t includes an in/rum5t t is n approv$ "u1 or exempt f1 section #ehg;,b2 7,c7 a specim5 receptacle "u section #bja7ss77#b77;,c7 or an 9 vitro cl9ical te/ t includes a specim5 receptacle t is n approv$ "u1 or exempt f1 section #ehg;,b2 7,d7 an 9 vitro cl9ical te/1 includ+ reag5ts us$ 9 su* te/s1 int5d$ = use = te/+ donors1 donations1 & recipi5ts ( blood1 blood compon5ts1 human cells1 tissues1 cellul>-bas$ products1 or tissue-bas$ products2 7,e7 high-risk2 7,f7 a comb9ation product unless su* te/ has be5 det]m9$ to be eligible to be introduc$ into int]/ate comm]ce "u a te*nology c]tification ord] pursuant to ! regulatory pa?way designation process describ$ 9 section #ehg;,f1 or z describ$ 9 subsection 7k72 or 7,g7 a fir/-(-a-k9d 9 vitro cl9ical te/1 unless su* te/ has be5 det]m9$ to be eligible to be introduc$ into int]/ate comm]ce "u a te*nology c]tification ord] pursuant to ! regulatory pa?way designation process describ$ 9 section #ehg;,f1 or z describ$ 9 subsection 7k74 7#b7 ,eligible p]son ,! t]m eligible p]son means an 9 vitro cl9ical te/ develop] unless su* develop]-- 7,a7 is a laboratory subject to section #cec ( ! ,public ,heal? ,s]vice ,act & does n h 9 effect a c]tificate applicable to ! category ( laboratory exam9ation or o!r proc$ure2 7,b7 0 a laboratory1 or an own] or op]ator or any employee ( a laboratory1 f\nd to h committ$ a significant violation ( section #cec ( ! ,public ,heal? ,s]vice ,act t result$ 9 a susp5d$1 revok$1 or limit$ c]tificate )9 ! #b-ye> p]iod prec$+ ! date ( ! submission ( ! application = a te*nology c]tificate "u subsection 7c7 & su* violation has n be5 resolv$2 or 7,c7 has be5 f\nd to h submitt$ in=mation to ! ,secret>y1 or o!rwise dissem9at$ in=mation1 t-- 7i7 made false or mislead+ /atem5ts relevant to ! requirem5ts ( ?is sub*apt]2 or 7ii7 violat$ any requirem5t ( ?is ,act1 :]e su* violation expos$ individuals to s]i\s risk ( illness1 injury1 or dea?1 unless-- 7,i7 su* violation has be5 resolv$2 or 7,,ii7 su* violation is n p]t95t to any 9 vitro cl9ical te/ )9 ! scope ( ! te*nology c]tification t su* develop] seeks4 7b7 ,applicability 7#a7 ,9 g5]al ,an 9 vitro cl9ical te/ is n subject to section #ehg;,b & may be introduc$ into int]/ate comm]ce if ! 9 vitro cl9ical te/-- 7,a7 is an eligible 9 vitro cl9ical te/2 7,b7 is develop$ by an eligible p]son2 7,c7 falls )9 ! scope ( a te*nology c]tification ord] issu$ "u ?is section & t is 9 effect2 7,d7 complies ) ! conditions ( ! te*nology c]tification ord]1 includ+ ) applicable mitigat+ measures "u section #ehg;,e1 re/rictions "u section #ehg,o1 & p]=mance /&>ds "u section #ehg,r2 & 7,e7 meets ! applicable /&>d describ$ 9 section #ehg7b74 7#b7 ,scope 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 ! scope ( a te*nology c]tification ord] issu$ "u ?is section %all apply to multiple 9 vitro cl9ical te/s utiliz+ ! te*nology d n significantly diff] 9 control me*anisms1 en]gy s\rces1 or op]at+ pr9ciples & = :i* developm5t1 includ+ design1 & analytical & cl9ical validation1 ( ! 9 vitro cl9ical te/s w\ld be address$ ?r\gh simil> proc$ures1 & be no broad] ?an-- 7i7 a s+le te*nology type2 or 7ii7 a fix$ comb9ation ( te*nologies4 7,b7 ,te*nology type ,a te*nology type describ$ 9 ?is p>agraph may include clot detection1 colorimetric 7non-immunoassay71 electro*emical 7non-immunoassay71 enzymatic 7non-immunoassay71 fl[ cytometry1 fluorometry 7non-immunoassay71 immunoassay1 mass spectrometry or *romatography1 microbial culture1 next g5]ation sequ5c+1 nephlometric or turbidimetric 7non-immunoassay71 s+leplex or multiplex non-,,ngs nucleic acid analysis1 slide-bas$ te*nology1 spectroscopy1 & any o!r te*nology1 z ! ,secret>y det]m9es appropriate4 7c7 ,application = te*nology c]tification 7#a7 ,9 g5]al ,a develop] seek+ a te*nology c]tification ord] %all submit an application "u ?is subsection1 :i* %all conta9 ! in=mation specifi$ "u p>agraph 7#b74 7#b7 ,cont5t ( application ,a develop] t submits an application = a te*nology c]tification %all include all necess>y in=mation to make a %[+ t all eligible 9 vitro cl9ical te/s develop$ )9 ! scope ( ! te*nology c]tification ord] w meet ! applicable /&>d1 includ+-- 7,a7 ! "n & address ( ! develop]2 7,b7 a table ( cont5ts = ! application & ! id5tification ( ! in=mation ! develop] claims z trade secret or confid5tial comm]cial or f9ancial in=mation2 7,c7 ! signature ( ! individual fil+ ! application or an au?oriz$ repres5tative2 7,d7 a /atem5t id5tify+ ! scope ( ! propos$ te*nology c]tification int5d$ to be introduc$ into int]/ate comm]ce "u ! application2 7,e7 in=mation e/abli%+ t ! develop] submitt+ ! application is an eligible p]son2 7,f7 quality proc$ures %[+ t eligible 9 vitro cl9ical te/s cov]$ "u ! te*nology c]tification w con=m to ! applicable quality requirem5ts ( section #ehg,k ) respect to-- 7i7 design controls1 includ+ relat$ pur*as+ controls & acceptance activities2 7ii7 compla9t inve/igation1 adv]se ev5t report+1 & corrections & removals2 & 7iii7 process validation1 z applicable2 7,g7 proc$ures = analytical & cl9ical validation1 includ+ all proc$ures = validation1 v]ification1 & acceptance crit]ia1 & an explanation z to h[ su* proc$ures1 :5 us$1 provide a %[+ ( analytical validity ( eligible 9 vitro cl9ical te/s )9 ! propos$ scope ( ! te*nology c]tification ord] t is analytically & cl9ically valid2 7,h7 proc$ures t provide a %[+ t 9 vitro cl9ical te/s cov]$ by ! propos$ scope ( ! te*nology c]tification ord] w be safe = individuals :o come into contact ) 9 vitro cl9ical te/s cov]$ by su* ord]2 7,i7 a propos$ li/+ submission "u section #ehg;,j7b7 = 9 vitro cl9ical te/s t ! develop] int5ds to introduce into int]/ate comm]ce ^u receiv+ a te*nology c]tification ord]1 :i* %all n be con/ru$ to limit ! develop] f introduc+ additional te/s n includ$ 9 su* submission "u ! same te*nology c]tification ord]2 7,j7 in=mation conc]n+ "o or m repres5tative 9 vitro cl9ical te/s1 includ+-- 7i7 a te/ )9 ! scope ( ! te*nology c]tification application ) ! appropriate analytical complexity at ! "t ( ! submission ( ! application "u ?is section to s]ve z ! repres5tative te/ & validate & run )9 ! develop]'s /at$ scope2 7ii7 ! in=mation specifi$ 9 subsection 7a7 or 7b7 ( section #ehg;,b1 z applicable1 = ! repres5tative 9 vitro cl9ical te/ or te/s1 includ+ in=mation & data requir$ pursuant to subsection 7a77#b77;,g7 ( section #ehg;,b1 unless ! ,secret>y det]m9es t su* in=mation is n necess>y2 7iii7 a summ>y ( a risk assessm5t ( ! 9 vitro cl9ical te/2 7iv7 an explanation ( ! *oice ( ! repres5tative 9 vitro cl9ical te/ or te/s = ! te*nology c]tification application & h[ su* te/ adequately demon/rates ! range ( proc$ures t ! develop] includes 9 ! application "u subp>agraphs 7,f71 7,g71 7,h71 & 7,i72 & 7v7 a brief explanation ( ! ways 9 :i* ! proc$ures includ$ 9 ! application "u subp>agraphs 7,f71 7,g71 7,h71 & 7,i7 h be5 appli$ to ! repres5tative 9 vitro cl9ical te/ or te/s2 & 7,k7 su* o!r in=mation necess>y to make a det]m9ation on a te*nology c]tification application z ! ,secret>y may det]m9e necess>y4 7#c7 ,ref]5ce to exi/+ applications ,) respect to ! cont5t requirem5ts 9 ! te*nology c]tification application describ$ 9 p>agraph 7#b71 a develop] may incorporate by ref]5ce any cont5t ( an application previ\sly submitt$ by ! develop]4 7d7 ,action on an application = te*nology c]tification 7#a7 ,secret>y response 7,a7 ,9 g5]al ,z promptly z practicable1 & n lat] ?an #ij days aft] receipt ( an application "u subsection 7c71 ! ,secret>y %all-- 7i7 issue a te*nology c]tification ord] grant+ ! application1 :i* %all specify ! scope ( ! te*nology c]tification1 if ! ,secret>y f9ds t all ( ! gr\nds 9 p>agraph 7#c7 are met2 or 7ii7 d5y ! application if ! ,secret>y f9ds 7& sets =? ! basis ( su* f9d+ z "p ( or accompany+ su* d5ial7 t "o or m gr\nds = grant+ ! application specifi$ 9 p>agraph 7#c7 are n met4 7,b7 ,ext5sion ,! timel9e describ$ 9 subp>agraph 7,a7 may be ext5d$ by mutual agreem5t betwe5 ! ,secret>y & ! applicant4 7#b7 ,defici5t applications 7,a7 ,9 g5]al ,if1 aft] receipt ( an application "u ?is section1 ! ,secret>y det]m9es t any portion ( su* application is defici5t1 ! ,secret>y1 n lat] ?an #fj days aft] receipt ( su* application1 %all provide to ! applicant a description ( su* defici5cies & id5tify ! in=mation requir$ to resolve su* defici5cies4 7,b7 ,conv]t+ to prem>ket applications ,:5 respond+ to ! defici5cy lett]1 ! develop] may conv]t ! application = te*nology c]tification "u subsection 7c7 into a prem>ket application "u section #ehg;,b4 7#c7 ,te*nology c]tification ord] ,! ,secret>y %all issue an ord] grant+ a te*nology c]tification "u ?is section if1 on ! basis ( ! in=mation submitt$ to ! ,secret>y z "p ( ! application & any o!r in=mation ) respect to su* applicant1 ! ,secret>y f9ds t-- 7,a7 !re is a %[+ t 9 vitro cl9ical te/s )9 ! scope ( ! te*nology c]tification ord] w meet ! applicable /&>d2 7,b7 ! me?ods us$ 91 & ! facilities or controls us$ =1 ! developm5t ( eligible 9 vitro cl9ical te/s cov]$ by ! propos$ scope ( ! te*nology c]tification con=m to ! applicable requirem5ts ( section #ehg,k ) respect to-- 7i7 design controls1 includ+ relat$ pur*as+ controls & acceptance activities2 7ii7 compla9t inve/igation1 adv]se ev5t report+1 & corrections & removals2 & 7iii7 process validation1 z applicable2 7,c7 bas$ on a fair evaluation ( all mat]ial facts1 ! applicant's propos$ label+ & adv]tis+ are n false or mislead+ 9 any p>ticul>2 7,d7 ! application does n conta9 a false /atem5t ( mat]ial fact2 7,e7 !re is a %[+ t ! repres5tative 9 vitro cl9ical te/ or te/s-- 7i7 meet ! applicable /&>d2 & 7ii7 reasonably repres5t ! range ( proc$ures requir$ to be submitt$ 9 ! application2 7,f7 ! applicant has agre$ to p]mit1 ^u reque/1 au?oriz$ employees ( ! ,food & ,drug ,adm9i/ration or p]sons accr$it$1 or recogniz$ "u ?is ,act1 an opportunity to inspect at a reasonable "t & 9 a reasonable mann] ! facilities & all p]t95t equipm5t1 f9i%$ & unf9i%$ mat]ials1 conta9]s1 & label+ !re91 includ+ all ?+s 7includ+ records1 files1 pap]s1 & controls7 be>+ on :e!r an 9 vitro cl9ical te/ is adult]at$1 misbr&$1 or o!rwise 9 violation ( ?is ,act1 & p]mits su* au?oriz$ employees or p]sons accr$it$ "u ?is ,act to view & to copy & v]ify all records p]t95t to ! application & ! 9 vitro cl9ical te/2 & 7,g7 bas$ on o!r data & in=mation ! ,secret>y may require "u subsection 7c77#b77,k71 ! ,secret>y f9ds t su* data & in=mation support grant+ a te*nology c]tification ord]4 7#d7 ,review ( d5ials ,an applicant ^: application has be5 d5i$ "u ?is subsection may obta9 review ( su* d5ial "u section #ehg,p4 7e7 ,supplem5ts 7#a7 ,supplem5tal applications 7,a7 ,9 g5]al ,) respect to any ( ! foll[+ *anges relat$ to an 9 vitro cl9ical te/ "u a te*nology c]tification ord]1 a supplem5tal application to a te*nology c]tification ord] %all be submitt$ by ! hold] ( ! te*nology c]tification ord] describ+ su* propos$ *anges1 prior to introduc+ ! 9 vitro cl9ical te/ t is ! subject ( ! te*nology c]tification ord] into int]/ate comm]ce-- 7i7 any significant *ange to ! proc$ures provid$ 9 support ( ! application = te*nology c]tification submitt$ "u subp>agraph 7,g7 or 7,h7 ( subsection 7c77#b72 or 7ii7 any significant *ange to ! proc$ures provid$ 9 support ( ! application = te*nology c]tification submitt$ "u subp>agraph 7,f7 ( subsection 7c77#b74 7,b7 ,secret>y action on supplem5tal applications ,any action by ! ,secret>y on a supplem5tal application %all be 9 accordance ) subsection 7d71 & any ord] result+ f su* supplem5t %all be treat$ z an am5dm5t to a te*nology c]tification ord]4 7#b7 ,cont5t ( application 7,a7 ,9 g5]al ,a supplem5tal application = a *ange to an 9 vitro cl9ical te/ "u a te*nology c]tification ord] %all-- 7i7 conta9 all necess>y in=mation to make a %[+ t any 9 vitro cl9ical te/ affect$ by su* *ange t is )9 ! scope ( ! te*nology c]tification ord] w meet ! applicable /&>d2 & 7ii7 be limit$ to su* in=mation t is ne$$ to support ! *ange4 7,b7 ,cont5t ,unless o!rwise specifi$ by ! ,secret>y1 a supplem5tal application "u ?is subsection %all include-- 7i7 a description ( ! *ange1 includ+ a rationale = implem5t+ su* *ange2 7ii7 a description ( h[ ! *ange 0 evaluat$2 7iii7 data f a repres5tative 9 vitro cl9ical te/ or te/s t supports a %[+ t1 9 us+ ! modifi$ proc$ure or proc$ures1 all eligible 9 vitro cl9ical te/s )9 ! scope ( ! te*nology c]tification w meet ! applicable /&>d2 7iv7 z applicable1 in=mation to demon/rate t ! modifi$ proc$ure or proc$ures submitt$ "u subsection 7c77#b77;,f7 cont9ue to con=m to applicable requirem5ts "u section #ehg,k2 & 7v7 any o!r in=mation reque/$ by ! ,secret>y4 7#c7 ,*anges 9 response to a public heal? risk 7,a7 ,9 g5]al ,if ! hold] ( a te*nology c]tification makes a *ange to an 9 vitro cl9ical te/ or te/s to address a pot5tial risk to public heal? by add+ a new specification or te/ me?od1 su* hold] may imm$iately implem5t su* *ange & %all submit a notification = su* *ange to ! ,secret>y )9 #cj days4 7,b7 ,cont5t ,any notification to ! ,secret>y "u ?is p>agraph %all include-- 7i7 a summ>y ( ! relevant *ange2 7ii7 ! rationale = implem5t+ su* *ange2 7iii7 7,i7 if su* a *ange necessitates a *ange to ! proc$ures review$ z "p ( ! grant$ te*nology c]tification ord]1 ! modifi$ proc$ures2 or 7,,ii7 if ! proc$ures 7 n *ang$1 an explanation z to :y !y 7 n *ang$2 & 7iv7 if su* a *ange necessitates a *ange to ! proc$ures review$ z "p ( ! grant$ te*nology c]tification ord]1 data f a repres5tative 9 vitro cl9ical te/ or te/s t support a %[+ t1 9 us+ ! modifi$ proc$ures1 all eligible 9 vitro cl9ical te/s )9 ! scope ( ! te*nology c]tification w meet ! applicable /&>d4 7f7 ,tempor>y hold 7#a7 ,9 g5]al ,subject to ! process specifi$ 9 p>agraph 7#b71 & bas$ on "o or m f9d+s "u p>agraph 7#d71 ! ,secret>y may issue a tempor>y hold prohibit+ any hold] ( a te*nology c]tification ord] issu$ "u ?is section f introduc+ into int]/ate comm]ce an 9 vitro cl9ical te/ t 0 n previ\sly ! subject ( a li/+ "u section #ehg;,j4 ,! tempor>y hold %all id5tify ! gr\nds = ! tempor>y hold "u p>agraph 7#d7 & ! rationale = su* f9d+4 7#b7 ,process = issu+ a tempor>y hold ,if ! ,secret>y makes a f9d+ t a tempor>y hold may be w>rant$ bas$ on "o or m gr\nds specifi$ 9 p>agraph 7#d71 ! ,secret>y %all promptly notify ! hold] ( ! te*nology c]tification ord] ( su* f9d+ & provide #cj cal5d> days = ! develop] to come into compliance ) or o!rwise resolve ! f9d+4 7#c7 ,writt5 reque/s ,any writt5 reque/ to ! ,secret>y f ! hold] ( a te*nology c]tification ord] t a tempor>y hold "u p>agraph 7#a7 be remov$ %all receive a decision1 9 writ+ & specify+ ! reasons !re=e1 )9 #ij days aft] receipt ( su* reque/4 ,any su* reque/ %all include in=mation to support ! removal ( ! tempor>y hold4 7#d7 ,gr\nds = tempor>y hold ,! ,secret>y may initiate a tempor>y hold "u ?is subsection ^u a f9d+ t ! hold] ( a te*nology c]tification ord]-- 7,a7 is n 9 compliance ) ! conditions ( ! te*nology c]tification ord] pursuant to subsection 7b77#a77;,d72 7,b7 (f]s "o or m 9 vitro cl9ical te/s ) adv]tis+ or label+ t is false or mislead+2 7,c7 has report$ a correction or removal ( an 9 vitro cl9ical te/ t is (f]$ "u a te*nology c]tification ord] "u ?is section & has fail$ to demon/rate t ! issue or issues caus+ ! correction or removal does n adv]sely impact ! ability ( o!r 9 vitro cl9ical te/s (f]$ "u ! same te*nology c]tification ord] to meet ! applicable /&>d2 or 7,d7 has introduc$ into int]/ate comm]ce an 9 vitro cl9ical te/ "u a te*nology c]tification ord] & su* te/ is adult]at$ or misbr&$1 bas$ on a det]m9ation by ! ,secret>y1 & has fail$ to demon/rate t ! issue or issues caus+ ! adult]ation or misbr&+ does n adv]sely impact ! ability ( o!r 9 vitro cl9ical te/s (f]$ "u ! same te*nology c]tification grant$ "u ?is section to meet ! applicable /&>d4 7g7 ,)drawal ,! ,secret>y may1 aft] due notice & opportunity = an in=mal he>+1 issue an ord] )draw+ a te*nology c]tification ord] includ+ all te/s introduc$ into int]/ate comm]ce "u ! te*nology c]tification ord] if ! ,secret>y f9ds t-- 7#a7 ! application1 supplem5t1 or report "u subsection 7h7 conta9s false or mislead+ in=mation or fails to reveal a mat]ial fact2 7#b7 su* hold] fails to correct false or mislead+ label+ or adv]tis+ ^u ! reque/ ( ! ,secret>y2 7#c7 9 connection ) a te*nology c]tification1 ! hold] provides false or mislead+ in=mation to ! ,secret>y2 or 7#d7 ! hold] ( su* te*nology c]tification ord] fails to correct ! gr\nds = a tempor>y hold )9 a timeframe specifi$ 9 ! tempor>y hold ord]4 7h7 ,reports to ,congress 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! effective date ( ! ,,valid ,act ( #bjbb1 & annually !reaft] = ! next #d ye>s1 ! ,secret>y %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 & make publicly available1 includ+ ?r\gh po/+ on ! website ( ! ,food & ,drug ,adm9i/ration1 a report conta9+ ! in=mation describ$ 9 p>agraph 7#b74 7#b7 ,cont5t 7,a7 ,9 g5]al ,ea* report "u p>agraph 7#a7 %all address1 at a m9imum-- 7i7 ! total numb] ( applications = te*nology c]tifications fil$1 grant$1 )drawn & d5i$2 7ii7 ! total numb] ( te*nology c]tification ord]s ! ,secret>y put on tempor>y hold "u subsection 7h7 & ! numb] ( te*nology c]tification ord]s )drawn "u subsection 7i72 7iii7 ! types ( te*nologies = :i* ! ,secret>y grant$ te*nology c]tification ord]s2 7iv7 ! total numb] ( hold]s ( te*nology c]tification ord]s t are 9 effect2 & 7v7 ! total numb] ( 9 vitro cl9ical te/ categories t requir$ prem>ket review "u section #ehg;,b t 7 r$esignat$ z eligible 9 vitro cl9ical te/s "u ?is section4 7,b7 ,f9al report ,! fif? report submitt$ "u p>agraph 7#a7 %all include a summ>y (1 & responses to1 comm5ts rais$ 9 ! docket4 7,c7 ,p]=mance reports ,! reports requir$ "u ?is section may be issu$ ) p]=mance reports z requir$ "u section #hbi ( ! ,,valid ,act ( #bjbb4 7i7 ,public meet+ & input 7#a7 ,public docket ,n lat] ?an #cj days aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbb1 ! ,secret>y %all e/abli% a public docket to receive comm5ts conc]n+ recomm5dations = implem5tation ( ?is section1 includ+ crit]ia & proc$ures = subsections 7c7 ?r\gh 7h74 ,! public docket %all rema9 op5 = at lea/ #a ye> aft] ! e/abli%m5t ( ! public docket4 7#b7 ,public meet+ ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbb1 ! ,secret>y %all conv5e a public meet+ to :i* /akehold]s f organizations repres5t+ pati5ts & consum]s1 academia1 & ! 9 vitro cl9ical te/ indu/ry are invit$ to discuss ! te*nology c]tification process includ+ application requirem5ts1 inspections1 alignm5t ) ?ird-p>ty accr$itors1 & ! def9ition ( ! t]m te*nology "u section #ehg4 7j7 ,regulations ,! ,secret>y %all issue regulations reg>d+ ! te*nology c]tification process1 includ+ describ+ crit]ia or proc$ures relat+ to te*nology c]tification "u ?is section1 :i* %all be subject to public comm5t = a m9imum ( #fj days f issuance prior to f9aliz+ su* regulations aft] consid]+ ! comm5ts receiv$4 ,! regulation %all include an outl9e ( ! application process1 opportunities to meet ) (ficials ( ! ,food & ,drug ,adm9i/ration1 & plans to /reaml9e inspections4 7k7 ,notification 7#a7 ,9 g5]al ,not)/&+ subsection 7a77#a71 a fir/-(-a-k9d 9 vitro cl9ical te/ or a comb9ation product t meets ! def9ition ( a mod]ate-risk te/ "u section #ehg;,a may be introduc$ into int]/ate comm]ce "u a te*nology c]tification ord] t has be5 issu$ by ! ,secret>y1 subject to o!r applicable requirem5ts if-- 7,a7 ! develop] provides notification to ! ,secret>y #fj days prior to introduc+ su* te/s into int]/ate comm]ce t includes in=mation demon/rat+ t ! te/ is mod]ate-risk & )9 ! scope ( ! applicable te*nology c]tification ord]2 & 7,b7 ! ,secret>y has n issu$ a notification to ! develop] "u p>agraph 7#b7 be=e su* "t has elaps$4 7#b7 ,notification f ,secret>y ,! ,secret>y %all issue a notification to ! develop] t su* te/ may n be introduc$ into int]/ate comm]ce "u su* ord] if ! ,secret>y det]m9es t-- 7,a7 su* te/-- 7i7 does n meet ! def9ition ( a mod]ate-risk te/ "u section #ehg;,a2 7ii7 is n eligible to be introduc$ into int]/ate comm]ce "u ! ref]5c$ te*nology c]tification ord] issu$ by ! ,secret>y2 or 7iii7 is n eligible = te*nology c]tification "u subsection 7b77#b72 or 7,b7 bas$ on ! in=mation includ$ 9 ! notification submitt$ by ! develop] pursuant to ?is subsection1 !re is insuffici5t in=mation = ! ,secret>y to make ! det]m9ations describ$ 9 clauses 7i71 7ii71 & 7iii7 ( subp>agraph 7,a74 #ehg;,e4 ,mitigat+ measures 7a7 ,e/abli%m5t ( mitigat+ measures 7#a7 ,e/abli%+1 *ang+1 or )draw+ 7,a7 ,e/abli%m5t ,! ,secret>y may e/abli% & require1 on ! basis ( evid5ce1 mitigat+ measures = any 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s ) ! same indications = use t is introduc$ or deliv]$ = introduction into int]/ate comm]ce aft] ! e/abli%m5t ( su* mitigat+ measures4 7,b7 ,me?ods ( e/abli%m5t ,! ,secret>y may e/abli% mitigat+ measures-- 7i7 "u ! process set =? 9 subp>agraph 7,d72 7ii7 z provid$ "u section #ehg;,f2 or 7iii7 ?r\gh a prem>ket approval or te*nology c]tification ord]1 :i* may e/abli% mitigat+ measures = an individual 9 vitro cl9ical te/ or a category ( 9 vitro cl9ical te/s4 7,c7 ,me?ods ( *ange or )drawal ,! ,secret>y may *ange or )draw mitigat+ measures-- 7i7 "u ! process set =? 9 subp>agraph 7,d72 or 7ii7 z provid$ "u section #ehg;,f4 7,d7 ,process = e/abli%m5t1 *ange1 or )drawal ,not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code1 ! ,secret>y may1 ^u ! initiative ( ! ,secret>y or ^u petition ( an int]e/$ p]son-- 7i7 e/abli%1 *ange1 or )draw mitigat+ measures = an 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s by-- 7,i7 publi%+ a propos$ ord] 9 ! ,f$]al ,regi/]2 7,,ii7 provid+ an opportunity = public comm5t = a p]iod ( n less ?an #cj #fj cal5d> days2 & 7,,iii7 aft] consid]ation ( any comm5ts submitt$1 publi%+ a f9al ord] 9 ! ,f$]al ,regi/] t responds to ! comm5ts submitt$1 & :i* %all include a reasonable transition p]iod4 7,e7 ,effect ( mitigat+ measures on gr&fa!r$ te/s ,a mitigat+ measure %all n be requir$ by ! ,secret>y = an 9 vitro cl9ical te/ subject to section #ehg;,g7a71 unless o!rwise provid$ "u section #ehg;,f4 7#b7 ,9 vitro cl9ical te/s previ\sly cle>$ or exempt z devices ) special controls 7,a7 ,9 g5]al ,any special controls applicable to an 9 vitro cl9ical te/ previ\sly cle>$ or exempt "u section #eaj7k71 or classifi$ "u section #eac7;f77#b7 prior to date ( enactm5t ( ! ,,valid ,act ( #bjbb1 includ+ any su* special controls e/abli%$ dur+ ! p]iod beg9n+ on ! date ( enactm5t ( ! ,,valid ,act ( #bjbb & end+ on ! effective date ( su* ,act 7z describ$ 9 section #e7;b7 ( su* ,act7-- 7i7 %all cont9ue to apply to su* 9 vitro cl9ical te/ aft] su* effective date2 & 7ii7 are deem$ to be mitigat+ measures z ( ! effective date specifi$ 9 section #hbe7;a77#a77;,a7 ( ! ,,valid ,act ( #bjbb4 7,b7 ,*anges ,not)/&+ subp>agraph 7,a71 ! ,secret>y may e/abli%1 *ange1 or )draw mitigat+ measures = su* te/s or category ( te/s us+ ! proc$ures "u p>agraph 7#a74 7b7 ,docum5tation 7#a7 ,9 vitro cl9ical te/s subject to prem>ket review ,! develop] ( an 9 vitro cl9ical te/ subject to prem>ket review "u section #ehg;,b & to :i* mitigat+ measures apply %all-- 7,a7 9 accordance ) section #ehg;,b7c77#b77;,g77i71 submit docum5tation to ! ,secret>y z "p ( ! application = ! te/ "u subsection 7c7 or 7d7 ( section #ehg;,b demon/rat+ t su* mitigat+ measures h be5 met2 7,b7 if su* application is approv$1 ma9ta9 docum5tation demon/rat+ t su* mitigat+ measures cont9ue to be met foll[+ a te/ modification by ! develop]2 & 7,c7 make su* docum5tation available to ! ,secret>y ^u reque/ or inspection4 7#b7 ,o!r te/s ,! develop] ( an 9 vitro cl9ical te/ t is (f]$ "u a te*nology c]tification ord] or o!r exemption f prem>ket review "u section #ehg;,b & to :i* mitigat+ measures apply %all-- 7,a7 ma9ta9 docum5tation 9 accordance ) ! applicable quality requirem5ts "u section #ehg;,j demon/rat+ t su* mitigat+ measures cont9ue to be met foll[+ a te/ modification by ! develop]2 7,b7 make su* docum5tation available to ! ,secret>y ^u reque/ or inspection2 & 7,c7 include 9 ! p]=mance summ>y = su* te/ a brief description ( h[ su* mitigat+ measures are met1 if applicable4 #ehg;,f4 ,regulatory pa?way designation 7a7 ,pa?way det]m9ations 7#a7 ,9 g5]al ,aft] consid]+ available evid5ce ) respect to an 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s ) ! same int5d$ use1 includ+ ! id5tification1 e/abli%m5t1 & implem5tation ( mitigat+ measures "u section #ehg;,e1 z appropriate1 ! ,secret>y may1 ^u ! initiative ( ! ,secret>y or ^u reque/ ( a develop]1 det]m9e t-- 7,a7 su* 9 vitro cl9ical te/ is high-risk & subject to prem>ket review "u section #ehg;,b2 7,b7 su* 9 vitro cl9ical te/s1 includ+ a fir/ ( a k9d te/1 is mod]ate-risk & subject to abbreviat$ prem>ket review "u section #ehg;,b7d7 or te*nology c]tification "u section #ehg;,d7b77#b72 or 7,c7 su* 9 vitro cl9ical te/1 includ+ a fir/ ( a k9d te/ is l[-risk or o!rwise exempt f prem>ket review "u section #ehg;,b4 7#b7 ,reque/s 7,a7 ,submissions by develop]s 7i7 ,special prem>ket review2 te*nology c]tification ,a develop] submitt+ a reque/ t ! ,secret>y make a det]m9ation z describ$ 9 p>agraph 7#a77;,b7 %all submit in=mation to support t ! 9 vitro cl9ical te/ is mod]ate-risk or propose mitigat+ measures1 if applicable1 t w\ld support su* a det]m9ation4 7ii7 ,l[-risk2 exempt f prem>ket review ,a develop] submitt+ a reque/ t ! ,secret>y make a det]m9ation z describ$ 9 p>agraph 7#a77;,c7 %all submit in=mation t ! 9 vitro cl9ical te/ is l[-risk1 or o!rwise appropriate = exemption f prem>ket review "u section #ehg;,b & propose mitigat+ measures1 if applicable1 t w\ld support su* a det]m9ation4 7,b7 ,response by ! ,secret>y ,aft] receiv+ a reque/ "u clause 7i7 or 7ii7 ( subp>agraph 7,a71 ! ,secret>y %all provide a timely response describ+ :e!r or n ! ,secret>y w initiate ! process = mak+ a det]m9ation "u p>agraph 7#a77;,b7 or 7#a77;,c7 z describ$ 9 p>agraph 7#d74 7#c7 ,suffici5cy ( mitigat+ measures ,:5 det]m9+ :e!r mitigat+ measures = an 9 vitro cl9ical te/1 or category ( 9 vitro cl9ical te/s1 are suffici5t to make su* te/ mod]ate-risk or l[-risk1 ! ,secret>y %all take into acc\nt ! foll[+3 7,a7 ,! degree to :i* ! te*nology = ! int5d$ use ( ! 9 vitro cl9ical te/ is well-*>act]iz$1 tak+ into consid]ation factors t include "o or m ( ! foll[+3 7i7 ,pe]-review$ lit]ature4 7ii7 ,practice guidel9es4 7iii7 ,cons5sus /&>ds4 7iv7 ,recogniz$ /&>ds ( c>e4 7v7 ,use ( su* te*nology1 includ+ hi/orical use4 7vi7 ,multiple sci5tific publications by diff]5t au?ors4 7vii7 ,adoption by ! sci5tific or cl9ical community4 7viii7 ,real _w evid5ce4 7,b7 ,:e!r ! crit]ia = p]=mance ( ! te/ are well-e/abli%$ to be suffici5t = ! int5d$ use4 7,c7 ,! cl9ical circum/ances "u :i* ! 9 vitro cl9ical te/ is us$1 includ+ :e!r ! 9 vitro cl9ical te/ is ! sole det]m9ate = ! diagnosis or treatm5t ( ! t>get$ disease1 & ! availability ( o!r te/s 7su* z confirmatory or adjunctive te/s7 or relevant mat]ial /&>ds4 7,d7 ,:e!r su* mitigat+ measures suffici5tly mitigate ! risk ( h>m su* t ! te/ or category ( te/s is mod]ate-risk or l[-risk4 7#d7 ,process 7,a7 ,9 g5]al ,= a te/ t is n fir/-(-a-k9d1 any action "u p>agraph 7#a7 %all be made by publication ( a notice ( su* propos$ action on ! website ( ! ,food & ,drug ,adm9i/ration1 ! consid]ation ( comm5ts to a public docket on su* proposal1 & publication ( a f9al action on su* website )9 #fj cal5d> days ( ! close ( ! comm5t p]iod po/$ to su* public docket1 not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code4 7,b7 ,process = fir/-(-a-k9d te/ ,9 ! case ( an 9 vitro cl9ical te/ t is fir/-(-a-k9d1 ! process is z foll[s3 7i7 ,any det]m9ation t ! te/ is subject to prem>ket approval or abbreviat$ prem>ket review "u subp>agraph 7,a7 or 7,b7 ( p>agraph 7#a7 %all be publi%$ on ! website ( ! ,food & ,drug ,adm9i/ration1 not)/&+ subclause ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code1 only aft] ! 9 vitro cl9ical te/ is approv$ "u section #ehg;,b4 ,until t "t1 ! det]m9ation %all n be b9d+ on o!r 9 vitro cl9ical te/s4 7ii7 ,any det]m9ation o!r ?an ^? made "u clause 7i7 %all be made by publication ( a notice ( f9al action on ! website ( ! ,food & ,drug ,adm9i/ration1 not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code4 7b7 ,transition p]iod ,^u a decision by ! ,secret>y to *ange a regulatory pa?way designation1 or reclassifies an 9 vitro cl9ical te/1 or category ( 9 vitro cl9ical te/s1 ! ,secret>y %all provide an appropriate transition p]iod ) respect to any new requirem5ts4 7c7 ,appeals ,a decision by ! ,secret>y "u ?is section %all be deem$ a significant decision subject to appeal "u section #ehg,p4 7d7 ,advisory committee ,! ,secret>y may reque/ recomm5dations f an advisory committee "u section #ehg;,h pursuant to c>ry+ out ?is section4 7e7 ,reque/ = in=mal fe$back ,be=e submitt+ a prem>ket application or te*nology c]tification application = an 9 vitro cl9ical te/-- 7#a7 ! develop] ( ! te/ may submit to ! ,secret>y a writt5 reque/ = a meet+1 conf]5ce1 or writt5 fe$back to discuss & provide in=mation relat+ to ! regulation ( su* 9 vitro cl9ical te/ :i* may include-- 7,a7 ! submission process & ! type & am\nt ( evid5ce expect$ to demon/rate ! applicable /&>d2 7,b7 :i* regulatory pa?way is appropriate = an 9 vitro cl9ical te/2 & 7,c7 an inve/igation plan = an 9 vitro cl9ical te/1 includ+ a cl9ical protocol2 & 7#b7 ^u receipt ( su* a reque/1 ! ,secret>y %all-- 7,a7 if a meet+ is reque/$-- 7i7 )9 #fj cal5d> days aft] su* receipt1 or )9 su* "t p]iod z may be agre$ to by ! develop]1 meet or conf] ) ! develop] submitt+ ! reque/2 & 7ii7 )9 #ae cal5d> days aft] su* meet+ or conf]5ce1 provide to ! develop] a writt5 record or response describ+ ! issues discuss$ & conclusions rea*$ 9 ! meet+ or conf]5ce2 & 7,b7 if writt5 fe$back is reque/$1 provide fe$back to ! reque/or )9 #ge days aft] su* receipt4 #ehg;,g4 ,gr&fa!r$ 9 vitro cl9ical te/s 7a7 ,9 g5]al ,subject to subsection 7d71 an 9 vitro cl9ical te/ is exempt f ! requirem5ts ( ?is sub*apt] specifi$ 9 subsection 7b7 if-- 7#a7 ! te/ 0 fir/ (f]$ = cl9ical use be=e ! date ( enactm5t ( ! ,,valid ,act ( #bjbb2 7#b7 ! 0 develop$ by a cl9ical laboratory = :i* a c]tificate 0 9 effect "u section #cec ( ! ,public ,heal? ,s]vice ,act t meets ! requirem5ts = p]=m+ te/s ( high complexity2 7#c7 ! te/ is p]=m$-- 7,a7 9 ! same cl9ical laboratory 9 :i* ! te/ 0 develop$ = :i* a c]tification is /ill 9 effect "u section #cec ( ! ,public ,heal? ,s]vice ,act t meets ! requirem5ts to p]=m te/s ( high complexity2 7,b7 by ano!r cl9ical laboratory = :i* a c]tificate is 9 effect "u section #cec ( su* ,act t meets ! requirem5ts to p]=m te/s ( high complexity1 & t is )9 ! same corporate organization & hav+ common own]%ip by ! same p>5t corporation z ! laboratory 9 :i* ! te/ 0 develop$2 or 7,c7 9 ! case ( a te/ t 0 develop$ by ! ,c5t]s = ,disease ,control & ,prev5tion or ano!r laboratory a public heal? laboratory network coord9at$ or manag$ by ! ,c5t]s = ,disease ,control & ,prev5tion1 by a cl9ical laboratory = :i* a c]tificate is 9 effect "u section #cec ( su* ,act t meets ! requirem5ts to p]=m te/s ( high complexity1 & t is )9 a public heal? laboratory network coord9at$ or manag$ by ! ,c5t]s = ,disease ,control & ,prev5tion2 7#d7 ! te/ does n h 9 effect an approval "u section #eae1 a cle>ance "u section #eaj7k71 an au?orization "u section #eac7;f77#b71 or an exemption "u section #ebj7m71 or lic5sure "u section #cea ( ! ,public ,heal? ,s]vice ,act2 7#e7 any modification to ! te/ on or aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbb made by ! initial develop] & con=m ) section #ehg;,c7a77#f77;,a77ii7 & does n meet ! crit]ial 9 subsection 7d77#a72 7#f7 ! te/ is n = inve/igational use2 7#g7 ! te/ is (f]$ ) an ord] f an au?oriz$ p]son z requir$ "u section #cec ( ! ,public ,heal? ,s]vice ,act1 & 0 (f]$ ) a prescription requir$ "u section #hji4cj7;f7 ( title #ba1 ,code ( ,f$]al ,regulations prior to ! effective date ( ?is sub*apt]2 7#h7 ! te/ is n = use ) home specim5 collection1 unless ! specim5 is collect$ ) a collection conta9]1 receptacle1 or kit t-- 7,a7 has be5 approv$1 cle>$1 or au?oriz$ by ! ,secret>y = home specim5 collection & ! collection is p]=m$ pursuant to ! approv$1 cle>$1 or au?oriz$ label+1 includ+ any indication = use z prescription use or ov]-!-c\nt] use1 or 7,b7 is exempt f prem>ket review & its use is consi/5t ) applicable limitations on ! exemption2 7#i7 is n a specim5 receptacle or in/rum5t 7#aj7 ea* te/ report template = ! te/ be>s a /atem5t t reads z foll[s3 ,?is 9 vitro cl9ical te/ has n be5 review$ by ! ,food & ,drug ,adm9i/ration42 & 7#aa7 ! develop] ( ! te/-- 7,a7 ma9ta9s docum5tation demon/rat+ t ! te/ meets & cont9ues to meet ! crit]ia set =? 9 ?is subsection2 & 7,b7 makes su* docum5tation available to ! ,secret>y ^u reque/4 7b7 ,exemptions applicable to gr&fa!r$ te/s ,an 9 vitro cl9ical te/ t meets ! crit]ia specifi$ 9 subsection 7a7 is exempt f prem>ket review "u #ehg;,b1 label+ requirem5ts "u #ehg,l1 & te/ design requirem5ts & quality requirem5ts "u #ehg,k1 & may be lawfully (f]$ subject to ! o!r applicable requirem5ts ( ?is ,act4 7c7 ,modifications ,9 ! case ( an 9 vitro cl9ical te/ t meets ! crit]ia specifi$ 9 subsection 7a71 su* te/ cont9ues to qualify = ! exemptions describ$ 9 subsection 7b7 if ! te/ is modifi$ & ! modification is n ( a type describ$ 9 subsection 7a77#e71 & ! p]son modify+ su* 9 vitro cl9ical te/-- 7#a7 docum5ts ea* su* modification & ma9ta9s docum5tation ( ! basis = su* det]m9ation2 7#b7 provides su* docum5tation relat+ to ! *ange to ! ,secret>y ^u reque/ or inspection2 & 7#c7 does n modify ! 9 vitro cl9ical te/ su* t x no long] meets ! crit]ia "u subsection 7a74 7d7 ,reque/ = in=mation 7#a7 ,crit]ia ,! crit]ia describ$ 9 ?is p>agraph are any ( ! foll[+3 7,a7 ,!re is insuffici5t valid sci5tific evid5ce to support t ! te/ is analytically valid or cl9ically valid4 7,b7 ,su* 9 vitro cl9ical te/ is be+ (f]$ by its develop] ) any false or mislead+ analytical or cl9ical claims4 7,c7 ,x is probable t su* 9 vitro cl9ical te/ w cause s]i\s adv]se heal? consequ5ces4 7#b7 ,process 7,a7 ,writt5 reque/ = in=mation ,! ,secret>y may issue a writt5 reque/ to a develop] id5tify+ specific sci5tific conc]ns1 bas$ on cr$ible in=mation1 ) an 9 vitro cl9ical te/1 :i* indicate t "o or m ( ! crit]ia describ$ 9 p>agraph 7#a7 apply to su* 9 vitro cl9ical te/s4 ,su* writt5 reque/ %all include specific in=mation reque/s p]ta9+ to su* crit]ia4 7,b7 ,deadl9e = submitt+ in=mation ,n lat] ?an #de days aft] receiv+ a reque/ = in=mation "u subp>agraph 7,a7-- 7i7 ! develop] ( an 9 vitro cl9ical te/-- 7,i7 may seek a teleconf]5ce prior to ! submission ( in=mation "u clause 7ii7 to discuss ! ,secret>y's reque/2 & 7,,ii7 %all submit ! in=mation reque/$ pursuant to subp>agraph 7,a7 )9 #cj days ( receipt ( su* reque/2 & 7ii7 ! ,secret>y %all-- 7,i7 s*$ule a teleconf]5ce reque/$ "u clause 7i77,i72 & 7,,ii7 hold a teleconf]5ce s reque/$ )9 #aj days ( ! ,secret>y's receipt ( ! in=mation reque/$ "u clause 7i77,,ii74 7,c7 ,review deadl9e ,^u receiv+ a submission "u subp>agraph 7,b71 ! ,secret>y %all-- 7i7 review ! submitt$ in=mation )9 #de cal5d> days ( su* receipt1 :i* may include communication ) ! develop]2 & 7ii7 det]m9e :e!r ! crit]ia li/$ 9 p>agraph 7#a7 apply to ! 9 vitro cl9ical te/ & communicate su* det]m9ation to ! develop] z describ$ 9 subp>agraph 7,d74 7,d7 ,communication & results ( det]m9ation ,! ,secret>y %all notify ! develop]1 9 writ+1 ( ! ,secret>y's det]m9ation "u subp>agraph 7,c71 z foll[s3 7i7 ,if ! ,secret>y det]m9es t none ( ! crit]ia li/$ 9 p>agraph 7#a7 apply to ! 9 vitro cl9ical te/1 su* te/ %all be exempt f relevant requirem5ts ( ?is sub*apt]1 z set =? 9 subsection 7b71 subject to applicable limitation4 7ii7 ,if ! ,secret>y det]m9es t "o or m ( ! crit]ia li/$ 9 subp>agraph 7#a7 apply to ! te/ b su* a det]m9ation may be resolv$ )9 a reasonable "t1 & ! te/ has n be5 previ\sly subject to ?is subsection on ! basis ( ! same or sub/antially simil> sci5tific conc]ns id5tifi$ 9 ! writt5 reque/ issu$ "u p>agraph 7d77#b77;,a7-- 7,i7 ! ,secret>y %all notify ! develop] ( su* a det]m9ation & all[ ! develop] to seek a teleconf]5ce to discuss ! f9d+2 7,,ii7 ! develop] %all submit in=mation demon/rat+ resolution ( ! det]m9ation )9 #ae days ( receiv+ ! notification2 & 7,,iii7 ! ,secret>y %all make a det]m9ation )9 #cj days ( ! submission ( in=mation z to :e!r ! crit]ia "u p>agraph 7#a7 apply to ! te/4 7iii7 ,if ! ,secret>y det]m9es t none ( ! crit]ia li/$ 9 p>agraph 7#a7 apply to ! te/1 su* te/ %all be exempt f relevant requirem5ts ( ! sub*apt] z set =? 9 subsection 7b71 subject to applicable limitations4 7iv7 ,if ! ,secret>y det]m9es t "o or m ( ! crit]ia li/$ 9 p>agraph 7#a7 apply to ! 9 vitro cl9ical te/1 su* te/ is n exempt z set =? 9 ?is section & %all n be (f]$ unless approv$ "u section #ehg;,b1 (f]$ "u a te*nology c]tification ord] "u section #ehg;,d1 or (f]$ z a l[-risk te/4 ^u a det]m9ation by ! ,secret>y pursuant to section #ehg;,f4 7v7 ,if ! ,secret>y det]m9es t "o or m ( ! crit]ia li/$ 9 p>agraph 7#a7 apply to ! 9 vitro cl9ical te/ & clause 7ii7 does n apply1 ! 9 vitro cl9ical te/ is n exempt z set =? 9 section & %all n be (f]$ unless approv$ "u section #ehg;,b1 (f]$ "u a te*nology c]tification ord] "u section #ehg;,d1 or (f]$ z a l[-risk te/ ^u a det]m9ation by ! ,secret>y pursuant to section #ehg;,f4 #ehg;,h4 ,advisory committees 7a7 ,9 g5]al ,! ,secret>y may e/abli% advisory committees or use advisory committee panels ( exp]ts e/abli%$ be=e ! date ( enactm5t ( ! ,,valid ,act ( #bjbb 7includ+ a device classification panel "u section #eac7 = ! purposes ( provid+ exp]t sci5tific advice & mak+ recomm5dations relat$ to-- 7#a7 ! approval ( an application = an 9 vitro cl9ical te/ submitt$ "u ?is sub*apt]1 includ+ = evaluat+1 z applicable1 ! analytical validity1 cl9ical validity1 & safety ( 9 vitro cl9ical te/s2 7#b7 ! pot5tial effectiv5ess ( mitigat+ measures = a det]m9ation ( ! applicable regulatory pa?way "u section #ehg;,f7b7 or risk evaluation = an 9 vitro cl9ical te/ or te/s2 7#c7 quality requirem5ts "u section #ehg,k or apply+ su* requirem5ts to 9 vitro cl9ical te/s develop$ or import$ by develop]s2 7#d7 appeals "u section #ehg,p2 or 7#e7 su* o!r purposes z ! ,secret>y det]m9es appropriate4 7b7 ,appo9tm5ts 7#a7 ,vot+ memb]s ,! ,secret>y %all appo9t to ea* committee e/abli%$ "u subsection 7a71 z vot+ memb]s1 individuals :o are qualifi$ by tra9+ & exp]i5ce to evaluate 9 vitro cl9ical te/s ref]r$ to ! committee = ! purposes specifi$ 9 subsection 7a71 includ+ individuals )1 to ! ext5t feasible1 sci5tific exp]tise 9 ! developm5t ( su* 9 vitro cl9ical te/s1 laboratory op]ations1 & ! use ( 9 vitro cl9ical te/s4 ,! ,secret>y %all designate "o memb] ( ea* committee to s]ve z *air4 7#b7 ,nonvot+ memb]s ,9 addition to ! individuals appo9t$ pursuant to p>agraph 7#a71 ! ,secret>y %all appo9t to ea* committee e/abli%$ "u subsection 7a71 z nonvot+ memb]s-- 7,a7 a repres5tative ( consum] int]e/s2 & 7,b7 a repres5tative ( int]e/s ( 9 vitro cl9ical te/ develop]s n directly affect$ by ! matt] to be br\ght be=e ! committee4 7#c7 ,limitation ,no individual :o is a regul> full-"t employee ( ! ,unit$ ,/ates & engag$ 9 ! adm9i/ration ( ?is ,act may be a memb] ( any advisory committee e/abli%$ "u subsection 7a74 7#d7 ,education & tra9+ ,! ,secret>y %all1 z appropriate1 provide education & tra9+ to ea* new committee memb] be=e su* memb] p>ticipates 9 a committee's activities1 includ+ education reg>d+ requirem5ts "u ?is ,act & relat$ regulations ( ! ,secret>y1 & ! adm9i/rative processes & proc$ures relat$ to committee meet+s4 7#e7 ,meet+s ,! ,secret>y %all ensure t sci5tific advisory committees meet regul>ly & at appropriate int]vals s t any matt] to be review$ by su* a committee c be pres5t$ to ! committee n m ?an #fj cal5d> days aft] ! matt] is ready = su* review4 ,meet+s ( ! committee may be held us+ electronic or telephonic communication to conv5e ! meet+s4 7#f7 ,comp5sation ,memb]s ( an advisory committee e/abli%$ "u subsection 7a71 :ile att5d+ meet+s or conf]5ces or o!rwise engag$ 9 ! bus9ess ( ! advisory committee-- 7,a7 %all be entitl$ to receive comp5sation at rates to be fix$ by ! ,secret>y1 b n to exce$ ! daily equival5t ( ! rate 9 effect = positions classifi$ above level ,,gs-#ae ( ! ,g5]al ,s*$ule2 & 7,b7 may be all[$ travel exp5ses z au?oriz$ by section #egjc ( title #e1 ,unit$ ,/ates ,code1 = employees s]v+ int]mitt5tly 9 ! ,gov]nm5t s]vice4 7c7 ,guidance ,! ,secret>y may issue guidance on ! policies & proc$ures gov]n+ advisory committees e/abli%$ "u subsection 7a74 #ehg;,i4 ,break?r\gh 9 vitro cl9ical te/s 7a7 ,9 g5]al ,! purpose ( ?is section is to enc\rage ! ,secret>y1 & provide ! ,secret>y ) suffici5t au?ority1 to apply effici5t & flexible approa*es to exp$ite ! developm5t (1 & prioritize ! review (1 9 vitro cl9ical te/s t repres5t break?r\gh te*nologies4 7b7 ,e/abli%m5t ( program ,! ,secret>y %all e/abli% a program to exp$ite ! developm5t (1 & provide = ! priority review (1 9 vitro cl9ical te/s4 7c7 ,eligibility ,! program develop$ "u subsection 7b7 %all be available = any 9 vitro cl9ical te/ t-- 7#a7 provides or enables m effective treatm5t or diagnosis ( life-?reat5+ or irrev]sibly debilitat+ human disease or conditions comp>$ to exi/+ approv$ or cle>$ alt]natives1 includ+ an 9 vitro cl9ical te/ (f]$ "u a te*nology c]tification ord]2 & 7#b7 is a te/-- 7,a7 t repres5ts a break?r\gh te*nology2 7,b7 = :i* no approv$ or cle>$ alt]native 9 vitro cl9ical te/ exi/s1 includ+ no 9 vitro cl9ical te/ (f]$ "u a te*nology c]tification ord]2 7,c7 t (f]s a cl9ically mean+ful advantage ov] any exi/+ alt]native 9 vitro cl9ical te/ t is approv$ or cle>$ 7includ+ any 9 vitro cl9ical te/ (f]$ "u a te*nology c]tification ord]71 includ+ ! pot5tial to r$uce or elim9ate ! ne$ = hospitalization1 improve pati5t quality ( life1 facilitate pati5ts' ability to manage _! own c>e 7su* z ?r\gh self-direct$ p]sonal assi/ance71 or e/abli% long-t]m cl9ical effici5cies2 or 7,d7 ! availability ( :i* is 9 ! be/ int]e/ ( pati5ts or public heal?4 7d7 ,designation 7#a7 ,reque/ ,to receive break?r\gh designation "u ?is section1 an applicant may reque/ t ! ,secret>y designate ! 9 vitro cl9ical te/ = exp$it$ developm5t & priority review4 ,any su* reque/ = designation may be made at any "t prior to1 or at ! "t (1 ! submission ( an application "u section #ehg;,b or #ehg;,d1 & %all include in=mation demon/rat+ t ! te/ meets ! crit]ia describ$ 9 subsection 7c74 7#b7 ,det]m9ation ,n lat] ?an #fj cal5d> days aft] ! receipt ( a reque/ "u p>agraph 7#a71 ! ,secret>y %all det]m9e :e!r ! 9 vitro cl9ical te/ t is ! subject ( ! reque/ meets ! crit]ia describ$ 9 subsection 7c74 ,if ! ,secret>y det]m9es t ! te/ meets ! crit]ia1 ! ,secret>y %all designate ! te/ = exp$it$ developm5t & priority review4 7#c7 ,review ,review ( a reque/ "u p>agraph 7#a7 %all be und]tak5 by a team t is compos$ ( exp]i5c$ /aff & s5ior manag]s ( ! ,food & ,drug ,adm9i/ration4 7#d7 ,)drawal 7,a7 ,9 g5]al ,! designation ( an 9 vitro cl9ical te/ "u ?is subsection is deem$ to be )drawn1 & su* 9 vitro cl9ical te/ %all no long] be eligible = designation "u ?is section1 if an application = approval = su* te/ "u section #ehg;,b or #ehg;,d is d5i$4 ,su* te/ %all be eligible = break?r\gh designation ^u a new reque/ = su* designation4 7,b7 ,exception ,! ,secret>y may n )draw a designation grant$ "u ?is subsection bas$ on ! subsequ5t approval or te*nology c]tification ( ano!r 9 vitro cl9ical te/ t-- 7i7 is designat$ "u ?is section2 or 7ii7 0 giv5 priority review "u section #eae;,b4 7e7 ,actions ,= purposes ( exp$it+ ! developm5t & review ( 9 vitro cl9ical te/s "u ?is section1 ! ,secret>y may take ! actions & additional actions set =? 9 p>agraphs 7#a7 & 7#b71 respectively1 ( section #eae;,b7e7 :5 review+ su* te/s4 ,any ref]5ce or au?orization 9 section #eae;,b7e7 ) respect to a device %all be deem$ a ref]5ce or au?orization ) respect to an 9 vitro cl9ical te/ = purposes ( ?is section4 7f7 ,guidance ,n lat] ?an ! date specifi$ = f9al guidance "u section #hbe ( ! ,,valid ,act ( #bjbb1 ! ,secret>y %all issue f9al guidance on ! implem5tation ( ?is section4 ,su* guidance %all-- 7#a7 set =? ! process by :i* a p]son may seek a designation "u subsection 7d72 7#b7 provide a template = reque/ "u subsection 7d72 7#c7 id5tify ! crit]ia ! ,secret>y w use 9 evaluat+ a reque/ = designation2 & 7#d7 id5tify ! crit]ia & processes ! ,secret>y w use to assign a team ( /aff1 includ+ team lead]s1 to review 9 vitro cl9ical te/s designat$ = exp$it$ developm5t & priority review1 includ+ any tra9+ requir$ = su* p]sonnel to ensure effective & effici5t review4 7g7 ,rules ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to affect-- 7#a7 ! crit]ia & /&>ds = evaluat+ an application pursuant to section #ehg;,b or #ehg;,d1 includ+ ! recognition ( valid sci5tific evid5ce z describ$ 9 section #ehg7ag7 & consid]ation & application ( ! lea/ burd5some means describ$ "u section #ehg;,,aa7c72 7#b7 ! au?ority ( ! ,secret>y ) respect to cl9ical holds "u section #ehg,r2 7#c7 ! au?ority ( ! ,secret>y to act on an application pursuant to section #ehg;,b be=e completion ( an e/abli%m5t inspection1 z ! ,secret>y det]m9es appropriate2 or 7#d7 ! au?ority ( ! ,secret>y ) respect to po/m>ket surveillance "u sections #ehg,l7d7 & #ehg,y4 #ehg;,j4 ,regi/ration & li/+ 7a7 ,regi/ration requirem5t 7#a7 ,9 g5]al ,ea* p]son describ$ 9 subsection 7b77#a7 %all-- 7,a7 dur+ ! p]iod beg9n+ on ,octob] #a & end+ on ,decemb] #ca ( ea* ye>1 regi/] ) ! ,secret>y ! "n ( su* p]son1 places ( bus9ess ( su* p]son1 all e/abli%m5ts engag$ 9 ! activities specifi$ "u ?is p>agraph1 ! e/abli%m5t regi/ration numb] ( ea* su* e/abli%m5t1 & a po9t ( contact = ea* su* e/abli%m5t1 includ+ an electronic po9t ( contact2 & 7,b7 submit an initial regi/ration conta9+ ! in=mation requir$ "u subp>agraph 7,a7 n lat] ?an-- 7i7 ! effective date ( ?is section if su* e/abli%m5t is engag$ 9 any activity describ$ 9 subsection 7b77#a7 on su* effective date1 unless ! ,secret>y e/abli%es by guidance a date lat] ?an su* implem5tation date = all or a category ( su* e/abli%m5ts2 or 7ii7 #cj days prior to engag+ 9 any activity describ$ 9 subsection 7b77#a71 if su* e/abli%m5t is n engag$ 9 any activity describ$ 9 ?is p>agraph on su* effective date4 7#b7 ,regi/ration numb]s ,! ,secret>y may assign a regi/ration numb] to any p]son or an e/abli%m5t regi/ration numb] to any e/abli%m5t regi/]$ 9 accordance ) ?is section4 ,regi/ration in=mation %all be made publicly available by publication on ! website ma9ta9$ by ! ,food & ,drug ,adm9i/ration1 9 accordance ) subsection 7d74 7#c7 ,inspection ,ea* p]son or e/abli%m5t t is requir$ to be regi/]$ ) ! ,secret>y "u ?is section %all be subject to inspection pursuant to section #gjd4 7b7 ,li/+ ,in=mation = ,9 ,vitro ,cl9ical ,te/s 7#a7 ,9 g5]al ,ea* p]son :o-- 7,a7 is a develop]2 & 7,b7 introduces or proposes to beg9 ! introduction or deliv]y = introduction into int]/ate comm]ce ?r\gh an exemption "u subsection 7a77#a71 7a77#b71 7a77#c71 or 7g7 ( section #ehg;,c or section #ehg;,g or ?r\gh ! fil+ ( an application "u section #ehg;,b or section #ehg;,d1 %all submit a li/+ to ! ,secret>y conta9+ ! in=mation describ$ 9 p>agraph 7#b71 7#d71 or 7#e71 z applicable1 9 accordance ) ! applicable s*$ule describ$ "u subsection 7c74 ,su* li/+ %all be prep>$ 9 su* =m & mann] z ! ,secret>y may specify 9 guidance4 ,li/+ in=mation %all be submitt$ ?r\gh ! compreh5sive te/ in=mation sy/em 9 accordance ) section #ehg,t1 z appropriate4 7#b7 ,submissions ,ea* develop] submitt+ a li/+ "u p>agraph 7#a7 %all electronically submit to ! compreh5sive te/ in=mation sy/em describ$ 9 section #ehg,t ! foll[+ in=mation1 z applicable1 = ea* 9 vitro cl9ical te/ = :i* su* p]son is a develop] 9 ! =m & mann] prescrib$ by ! ,secret>y1 tak+ into acc\nt lea/ burd5some pr9ciples3 7,a7 ,"n ( ! e/abli%m5t & its e/abli%m5t regi/ration numb]4 7,b7 ,contact in=mation = ! (ficial correspond5t = ! li/+4 7,c7 ,"n 7common "n & trade "n1 if applicable7 ( ! 9 vitro cl9ical te/ & its te/ li/+ numb] 7:5 available74 7,d7 ,! c]tificate numb] = any laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act t meets ! requirem5ts to p]=m high-complexity te/+ & t is ! develop] ( ! 9 vitro cl9ical te/1 & ! c]tificate numb] "u su* section = any laboratory t is p]=m+ ! te/1 is )9 ! same corporate organization1 & has common own]%ip by ! same p>5t corporation4 7,e7 ,:e!r ! 9 vitro cl9ical te/ is1 z applicable1 (f]$ z a te/ approv$ "u section #ehg;,b1 cle>$ to be (f]$ "u a grant$ te*nology c]tification ord]1 or (f]$ z an exempt 9 vitro cl9ical te/ "u section #ehg;,a4 7,f7 ,indications = use in=mation "u section #ehg7aj74 7,g7 ,a brief summ>y ( ! analytical & cl9ical p]=mance ( ! 9 vitro cl9ical te/1 & z applicable1 ! lot release crit]ia4 7,h7 ,a brief description ( con=mance ) any applicable mitigat+ measures1 re/rictions1 & /&>ds4 7,i7 ,repres5tative label+ = ! 9 vitro cl9ical te/1 z appropriate4 7#c7 ,te/ li/+ numb] ,! ,secret>y may assign a te/ li/+ numb] to ea* 9 vitro cl9ical te/ t is ! subject ( a li/+ "u ?is section4 ,! process = assign+ te/ li/+ numb]s may be e/abli%$ ?r\gh guidance1 & may include ! recognition ( /&>ds1 =mats1 or conv5tions develop$ by a ?ird-p>ty organization4 7#d7 ,abbreviat$ li/+ ,a p]son :o is n a develop] b is o!rwise requir$ to regi/] pursuant to subsection 7a7 %all submit an abbreviat$ li/+ to ! ,secret>y conta9+ ! in=mation describ$ 9 subp>agraphs 7,a7 ?r\gh 7,c7 ( p>agraph 7#b71 & ! "n ( ! develop]4 ,! in=mation %all be submitt$ 9 accordance ) ! applicable s*$ule describ$ "u subsection 7c74 ,su* abbreviat$ li/+ %all be prep>$ 9 su* =m & mann] z ! ,secret>y may specify ?r\gh guidance4 ,li/+ in=mation %all be submitt$ to ! compreh5sive te/ in=mation sy/em 9 accordance ) section #ehg,t1 z appropriate4 7#e7 ,gr&fa!r$ te/s ,a develop] (f]+ a te/ t is a gr&fa!r$ 9 vitro cl9ical te/ "u section #ehg;,g7a7 %all submit li/+ in=mation requir$ "u subp>agraphs 7,a7 ?r\gh 7,f7 ( p>agraph 7#b71 & may submit a /atem5t ( ! p]=mance specifications = su* 9 vitro cl9ical te/s4 7#f7 ,exempt te/s ,a develop] ( an 9 vitro cl9ical te/ :o introduces or proposes to beg9 ! introduction or deliv]y = introduction into int]/ate comm]ce t is o!rwise exempt f ! requirem5t to submit li/+ in=mation pursuant to an exemption "u section #ehg;,c may submit li/+ in=mation "u ?is subsection4 7c7 ,timel9es = submission ( li/+ in=mation 7#a7 ,9 g5]al ,! timel9es = submission ( regi/ration & li/+ "u subsections 7a7 & 7b7 are z foll[s3 7,a7 ,= an 9 vitro cl9ical te/ t 0 li/$ z a device "u section #eaj7;j7 prior to ! effective date ( ?is section1 a p]son %all ma9ta9 a device li/+ "u section #eaj until su* "t z ! sy/em = submitt+ ! li/+ in=mation requir$ "u subsection 7b7 becomes available & !reaft] %all submit ! li/+ in=mation n lat] ?an ! lat] ( #a ye> aft] ! sy/em = submitt+ ! li/+ "u ?is section becomes available or ! effective date ( ?is section4 7,b7 ,= an 9 vitro cl9ical te/ t is subject to gr&fa!r+ "u section #ehg;,g7a7 a p]son %all submit ! li/+ in=mation requir$ "u subsection 7b77#e7 n lat] t ! lat] ( #a ye> aft] ! sy/em = submitt+ ! li/+ "u ?is section becomes available or ! effective date ( ?is section4 7,c7 ,= an 9 vitro cl9ical te/ t is n describ$ 9 subp>agraph 7,a7 or 7,b71 a p]son %all submit ! requir$ li/+ in=mation z foll[s3 7i7 ,= an 9 vitro cl9ical te/ t is n exempt f prem>ket approval "u section #ehg;,b1 a p]son %all submit ! requir$ li/+ in=mation1 prior to (f]+ ! 9 vitro cl9ical te/ & n lat] ?an #cj bus9ess days aft] ! date ( approval ( ! prem>ket approval application4 7ii7 ,= an 9 vitro cl9ical te/ t is exempt f prem>ket review "u section #ehg;,c1 ! requir$ li/+ in=mation %all be submitt$ prior to (f]+ ! 9 vitro cl9ical te/4 7#b7 ,updates 7,a7 ,updates aft] *anges ,ea* develop] requir$ to submit li/+ in=mation "u ?is section %all update su* in=mation )9 #aj bus9ess days ( any *ange t causes any previ\sly li/$ in=mation to be inaccurate or incomplete4 7,b7 ,annual updates ,ea* develop] requir$ to submit li/+ in=mation "u ?is section %all update its in=mation annually dur+ ! p]iod beg9n+ on ,octob] #a & end+ on ,decemb] #ca ( ea* ye>4 7d7 ,public availability ( li/+ in=mation 7#a7 ,9 g5]al ,li/+ in=mation submitt$ pursuant to ?is section %all be made publicly available on ! website ( ! ,food & ,drug ,adm9i/ration 9 accordance ) p>agraph 7#c74 7#b7 ,confid5tiality ,li/+ in=mation = an 9 vitro cl9ical te/ t is subject to prem>ket approval or te*nology c]tification %all rema9 confid5tial until su* date z ! 9 vitro cl9ical te/ receives ! applicable prem>ket approval or ! develop] receives a te*nology c]tification ord] & = subsequ5t te/s introduc$ "u a te*nology c]tification ord] until _! introduction4 7#c7 ,exceptions f public availability requirem5ts ,! public li/+ requirem5ts ( ?is subsection %all n apply to any regi/ration & li/+ in=mation submitt$ "u subsection 7a7 or 7b71 if ! ,secret>y det]m9es t su* in=mation-- 7,a7 is a trade secret or confid5tial comm]cial in=mation2 or 7,b7 if po/$1 w\ld pres5t a risk to national security4 7e7 ,submission ( in=mation by accr$it$ p]sons ,if agre$ ^u by ! develop]1 ! in=mation requir$ "u ?is section may be submitt$ by a p]son accr$it$ "u section #ehg,q4 #ehg,k4 ,te/ design & quality requirem5ts 7a7 ,applicability 7#a7 ,9 g5]al ,ea* develop] & ea* o!r p]son requir$ to regi/] "u section #ehg;,i7b77#a7 %all e/abli% & ma9ta9 quality requirem5ts 9 accordance ) ! applicable requirem5ts set =? 9 subsection 7b74 7#b7 ,c]tifi$ laboratory requirem5ts ,a develop] %all e/abli% & ma9ta9 quality requirem5t "u subsection 7b77#b7 or 7b77#c71 z applicable1 if su* develop] is a cl9ical laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act t-- 7,a7 is c]tifi$ to p]=m high-complexity te/+2 7,b7 develops an 9 vitro cl9ical te/ t is = use only-- 7i7 )9 ! laboratory c]tifi$ by ! ,secret>y "u su* section #cec 9 :i* su* te/ 0 develop$2 or 7ii7 )9 ano!r laboratory c]tifi$ by ! ,secret>y "u su* section #cec if su* laboratory is-- 7,i7 )9 ! same corporate organization & has common own]%ip by ! same p>5t corporation z ! laboratory 9 :i* ! te/ 0 develop$2 or 7,,ii7 )9 a public heal? laboratory network coord9at$ or manag$ by ! ,c5t]s = ,disease ,control & ,prev5tion1 if ! te/ is develop$ by a public heal? laboratory or ! ,c5t]s = ,disease ,control & ,prev5tion2 & 7,c7 does n manufacture1 produce1 or di/ribute 9 vitro cl9ical te/s o!r ?an laboratory te/ protocols4 7#c7 ,regulations ,! ,secret>y %all promulgate quality sy/em regulations implem5t+ ?is section4 ,9 promulgat+ su* regulations "u ?is section1 ! ,secret>y %all consid] :e!r1 & to :at ext5t1 int]national h>monization is appropriate4 7#d7 ,quality sy/ems = hybrid develop]s ( bo? laboratory te/ protocols & o!r 9 vitro cl9ical te/s ,an entity t develops bo? f9i%$ products & laboratory te/ protocols & o!r 9 vitro cl9ical te/s %all comply ) subsection 7b77#a7 = activities relat$ to ! developm5t ( any 9 vitro cl9ical te/ t is n a laboratory te/ protocol product & ) subsection 7b77#b7 or 7b77#c71 z applicable1 = activities relat$ to ! developm5t ( any laboratory te/ protocol4 7b7 ,quality requirem5ts 7#a7 ,9 g5]al ,! quality requirem5ts applicable "u ?is section %all-- 7,a7 avoid duplication ( regulations "u section #cec ( ! ,public ,heal? ,s]vice ,act2 & 7,b7 %all include ! foll[+1 z applicable1 subject to subp>agraph 7,a7 & p>agraphs 7#b7 & 7#c7-- 7i7 managem5t responsibilities2 7ii7 quality audits2 7iii7 p]sonnel2 7iv7 design controls2 7v7 docum5t controls2 7vi7 pur*as+ controls2 7vii7 id5tification & traceability2 7viii7 production & process controls2 7ix7 acceptance activities2 7x7 noncon=m+ 9 vitro cl9ical te/s2 7xi7 corrective & prev5tive action2 7xii7 label+ & packag+ controls2 7xiii7 h&l+1 /orage1 di/ribution1 & in/allation2 7xiv7 compla9ts & records2 7xv7 s]vic+2 & 7xvi7 /ati/ical te*niques4 7#b7 ,exception = laboratory te/ protocols ,develop]s t are develop+ te/ protocols = use z describ$ 9 subsection 7a77#b77;,b77i7 are exempt f ! requirem5ts "u p>agraph 7#a77;,b7 except = ! requirem5ts describ$ 9 clauses 7iv71 7vi71 7ix71 7xi71 & 7xiv7 ( su* p>agraph4 7#c7 ,quality requirem5ts = c]ta9 laboratories di/ribut+ laboratory te/ protocols )9 organizations or public heal? networks ,quality requirem5ts applicable to ! develop] :o is di/ribut+ a laboratory te/ protocol z describ$ 9 subsection 7a77#b77;,b77ii7 %all consi/ ( ! foll[+3 7,a7 ,clauses 7iv71 7vi71 7ix71 7xi71 7xiv71 7xii7 ( p>agraph 7#a77;,b74 7,b7 ,! requirem5t to ma9ta9 records ( ! laboratories to :i* ! laboratory te/ protocol is di/ribut$4 7c7 ,regulations ,9 implem5t+ quality requirem5ts = te/ develop]s t p>ticipate 9 int]national audit programs "u ?is section1 ! ,secret>y %all-- 7#a7 = purposes ( facilitat+ int]national h>monization1 consid] :e!r ! develop] p>ticipates 9 an int]national audit program 9 :i* ! ,unit$ ,/ates p>ticipates & recognizes compliance )1 or con=mance to1 su* /&>ds recogniz$ by ! ,secret>y2 & 7#b7 ensure a lea/ burd5some approa* describ$ 9 section #ehg;,,aa7c7 by lev]ag+1 to ! ext5t applicable1 ! quality assurance requirem5ts applicable to develop]s c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act4 #ehg,l4 ,label+ requirem5ts 7a7 ,9 g5]al ,an 9 vitro cl9ical te/ %all be> or be accompani$ by label+1 z applicable1 t meets ! requirem5ts set =? 9 subsections 7b7 & 7c71 unless su* te/ is exempt "u subsection 7d7 or 7e74 7b7 ,labels 7#a7 ,9 g5]al ,! label ( an 9 vitro cl9ical te/1 %all meet ! requirem5ts set =? 9 p>agraph 7#b7 if !re is an imm$iate conta9] to :i* ! label is appli$4 7#b7 ,regulations ,! label ( an 9 vitro cl9ical te/ %all /ate ! "n & place ( bus9ess ( its develop] & meet ! requirem5ts set =? 9 regulations promulgat$ 9 accordance ) ?is section4 7c7 ,label+ 7#a7 ,9 g5]al ,label+ ( an 9 vitro cl9ical te/1 includ+ label+ 9 ! =m ( a package ins]t1 website1 /&alone laboratory ref]5ce docum5t1 or o!r simil> docum5t %all include-- 7,a7 adequate directions = use & %all meet ! requirem5ts set =? 9 regulations promulgat$ "u ?is section1 except z provid$ 9 subsection 7d7 or 7e72 & 7,b7 ! in=mation describ$ 9 p>agraph 7#b71 z applicable4 7#b7 ,cont5t ,label+ ( an 9 vitro cl9ical te/ %all include-- 7,a7 ! te/ li/+ numb] t 0 provid$ to ! develop] at ! "t ( li/+2 7,b7 in=mation to facilitate report+ an adv]se ev5t2 7,c7 in=mation reg>d+ access+ ! p]=mance summ>y data display$ 9 ! li/+ database = ! te/2 7,d7 ! indications ( use ( ! 9 vitro cl9ical te/2 & 7,e7 any w>n+s1 contra9dications1 or limitations4 7#c7 ,public availability ( in=mation ,! ,secret>y %all make all ( ! in=mation describ$ 9 p>agraph 7#b7 ) respect to ea* 9 vitro cl9ical te/ available to ! public1 z applicable1 9 accordance ) section #ehg,t1 except to ! ext5t t ! ,secret>y det]m9es t su* in=mation-- 7,a7 is trade secret or confid5tial comm]cial in=mation2 or 7,b7 if po/$1 w\ld pres5t a risk to national security4 7#d7 ,additional requirem5ts ,label+ = an 9 vitro cl9ical te/ us$ = immunohematology te/+ %all meet ! applicable requirem5ts set =? 9 "p #ffj ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations71 relat$ to ! label+ ( blood gr\p+ reag5ts1 reag5t r$ blood cells1 & anti-human globul94 7d7 ,exemptions & alt]native requirem5ts 7#a7 ,9 g5]al 7,a7 ,9 g5]al ,) respect to an 9 vitro cl9ical te/ t meets ! crit]ia ( subp>agraph 7,b71 ! /ate 9 "o place regulations "u section #hji4aj7;b7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations7 may be satisfi$ by ! laboratory po/+ su* in=mation on its website or 9 multiple docum5ts1 if su* docum5ts are ma9ta9$ & accessible 9 "o place4 7,b7 ,applicable te/s ,an 9 vitro cl9ical te/ meets ! crit]ia ( ?is subp>agraph if su* te/ is-- 7i7 develop$ by a laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act t meets ! requirem5ts to p]=m te/s ( high-complexity2 & 7ii7 p]=m$ 9-- 7,i7 ! same laboratory 9 :i* su* te/ 0 develop$2 or 7,,ii7 by ano!r laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act t-- 7aa7 meets ! requirem5ts to p]=m te/s ( high complexity2 & 7bb7 is "u common own]%ip & control z ! laboratory t develop$ ! te/4 7#b7 ,te/ in/rum5t label+ ,unless ! in/rum5t is ! entire te/ sy/em1 ! label+ = an in/rum5t is n requir$ to be> ! in=mation indicat$ 9 p>agraphs 7#c71 7#d71 7#e71 7#g71 7#h71 7#i71 7#aj71 7#aa71 7#ab71 & 7#ac7 ( section #hji4aj7;b7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7#c7 ,reag5t label+ ,= purposes ( compliance ) subsection 7c77#a71 ! label+ = a reag5t int5d$ = use z a replacem5t 9 an 9 vitro cl9ical te/ may be limit$ to t in=mation necess>y to id5tify ! reag5t adequately & to describe its prop] use 9 ! te/4 7#d7 ,inve/igational use ,a %ipm5t or o!r deliv]y ( an 9 vitro cl9ical te/ = inve/igational use pursuant to section #ehg,s %all be exempt f ! label+ requirem5ts ( subsections 7b7 & 7c77#a7 & f any /&>d promulgat$ ?r\gh regulations1 except z requir$ "u section #cec ( ! ,public ,heal? ,s]vice ,act or section #ehg,r ( ?is ,act4 7#e7 ,g5]al purpose laboratory reag5ts ,! label+ ( g5]al purpose laboratory reag5ts 7su* z hydro*loric acid7 ^: uses are g5]ally kn[n by p]sons tra9$ 9 _! use ne$ n be> ! directions = use requir$ by subsection 7c77#a77;,a74 7#f7 ,ov]-!-c\nt] te/ specim5 receptacle label+ ,! label+ = ov]-!-c\nt] te/ specim5 receptacles = drugs ( abuse te/+ %all be> ! "n & place ( bus9ess ( ! develop] includ$ 9 ! regi/ration "u section #ehg;,j & any in=mation specifi$ 9 applicable regulations promulgat$ "u ?is section1 9 language appropriate = ! int5d$ us]s4 7e7 ,te/s 9 ! /rategic national /ockpile 7#a7 ,9 g5]al ,! ,secret>y may grant an exception or alt]native to any provision li/$ 9 ?is section1 unless explicitly requir$ by a /atutory provision outside ?is sub*apt]1 = specifi$ lots1 bat*es1 or o!r units ( an 9 vitro cl9ical te/1 if ! ,secret>y det]m9es t compliance ) su* label+ requirem5t c\ld adv]sely affect ! availability ( su* products t are1 or w be1 includ$ 9 ! ,/rategic ,national ,/ockpile "u section #cai;,f-#b ( ! ,public ,heal? ,s]vice ,act4 7#b7 ,regulations ,! ,secret>y may issue regulations am5d+ section #hji4aa ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulation7 to apply 9 full or 9 "p to 9 vitro cl9ical te/s & 9 vitro cl9ical te/ develop]s4 7f7 ,regulations ,! ,secret>y %all issue or revise regulations relat$ to /&>diz$1 g5]al cont5t & =mat = 9 vitro cl9ical te/ label+ pursuant to ?is subsection4 #ehg,m4 ,adv]se ev5t report+ 7a7 ,9 g5]al ,ea* 9 vitro cl9ical te/ develop] %all e/abli% & ma9ta9 a sy/em = e/abli%+ & ma9ta9+ records ( adv]se ev5ts & report+ adv]se ev5ts 9 accordance ) ?is section4 7b7 ,submission ( individual reports ,a develop] %all submit an individual adv]se ev5t n lat] ?an #e cal5d> days aft] ! develop] receives or becomes aw>e ( an adv]se ev5t t reasonably sugge/s t an 9 vitro cl9ical te/ may-- 7#a7 h caus$ or contribut$ to a pati5t or us] dea?2 or 7#b7 pres5t an imm95t ?reat to public heal?4 7c7 ,submission ( qu>t]ly reports ,z applicable1 a develop] %all submit qu>t]ly reports t include any 9 vitro cl9ical te/ errors & s]i\s injuries t occurr$ dur+ ! applicable qu>t]4 ,su* qu>t]ly reports %all be submitt$ n lat] ?an ! end ( ! qu>t] foll[+ ! qu>t] 9 :i* ! develop] receives or becomes aw>e ( su* adv]se ev5ts4 7d7 ,def9itions ,= ! purposes ( ?is section-- 7#a7 ! t]m 9 vitro cl9ical te/ error means a failure ( an 9 vitro cl9ical te/ to meet its p]=mance specifications1 or to o!rwise p]=m z int5d$ by ! develop]1 includ+ an inaccurate result result+ f su* failure2 & 7#b7 ! t]m s]i\s injury means-- 7,a7 a significant delay 9 a diagnosis t results 9 ! abs5ce1 delay1 or discont9uation ( critical m$ical treatm5t or t irrev]sibly or s]i\sly & negatively alt]s ! c\rse ( a disease or condition2 or 7,b7 an injury t-- 7i7 is life ?reat5+2 7ii7 results 9 p]man5t impairm5t ( a body function or p]man5t damage to a body /ructure2 or 7iii7 necessitates m$ical or surgical int]v5tion to preclude p]man5t impairm5t ( a body function or p]man5t damage to a body /ructure4 7e7 ,regulations ,! ,secret>y %all promulgate regulations to implem5t ?is section4 #ehg,n4 ,corrections & removals 7a7 ,regulations ,! ,secret>y %all promulgate regulations1 or am5d exi/+ regulations1 z appropriate1 to implem5t ?is section4 7b7 ,reports ( corrections & removals 7#a7 ,9 g5]al ,ea* 9 vitro cl9ical te/ develop] %all report to ! ,secret>y any correction or removal ( an 9 vitro cl9ical te/ und]tak5 by su* develop] if ! correction or removal 0 und]tak5-- 7,a7 to r$uce ! risk to heal? pos$ by ! 9 vitro cl9ical te/2 or 7,b7 to rem$y a violation ( ?is ,act caus$ by ! 9 vitro cl9ical te/ :i* may pres5t a risk to heal?4 7#b7 ,exception = 9 vitro cl9ical te/s (f]$ "u a te*nology c]tification ord] ,= any eligible te/ (f]$ "u a te*nology c]tification ord] "u section #ehg;,d1 a correction & removal report = any correction or removal ( an 9 vitro cl9ical te/ %\ld demon/rate t ! issue or issues caus+ ! correction or removal d n adv]sely impact ! ability ( o!r 9 vitro cl9ical te/s (f]$ "u ! same te*nology c]tification ord] to meet ! applicable /&>d4 7c7 ,tim+ ,a develop] %all submit any report requir$ "u ?is subsection to ! ,secret>y )9 #ae bus9ess days ( initiat+ su* correction or removal4 7d7 ,recordkeep+ ,a develop] ( an 9 vitro cl9ical te/ t und]takes a correction or removal ( an 9 vitro cl9ical te/ :i* is n requir$ to be report$ "u ?is subsection %all keep a record ( su* correction or removal4 7e7 ,recall communications ,^u ! volunt>y report+ ( a correction or removal by ! develop]-- 7#a7 ! ,secret>y %all classify su* correction or removal "u ?is section )9 #ae cal5d> days2 & 7#b7 n lat] ?an #de cal5d> days aft] ! develop] or o!r responsible p>ty notifies ! ,secret>y t x has complet$ a recall action1 ! ,secret>y %all provide ! develop] or o!r responsible p>ty ) a writt5 /atem5t clos+ ! recall action or /at+ ! reasons ! ,secret>y _c close ! recall at t "t4 #ehg,o4 ,re/rict$ 9 vitro cl9ical te/s 7a7 ,applicability 7#a7 ,9 g5]al ,= ! types ( 9 vitro cl9ical te/s describ$ 9 p>agraph 7#c7 ! ,secret>y may require1 9 issu+ an approval ( an 9 vitro cl9ical te/ "u section #ehg;,b1 grant+ a te*nology c]tification ord] "u section #ehg;,d1 or 9 issu+ a det]m9ation "u section #ehg;,f7a71 or by issu+ a regulation1 t su* te/1 or category ( te/s1 be re/rict$ to sale1 di/ribution1 or use ^u su* conditions z ! ,secret>y may prescribe "u p>agraph 7#b74 7#b7 ,conditions ,! ,secret>y may prescribe conditions "u ?is section1 bas$ on available evid5ce1 ) respect to an 9 vitro cl9ical te/ describ$ 9 p>agraph 7#c71 t are det]m9$ to be ne$$ due to ! pot5tial = h>mful effect ( su* te/ 7includ+ any result+ abs5ce1 significant delay1 or discont9uation ( appropriate m$ical treatm5t71 & are necess>y to ensure t ! te/ meets ! applicable /&>d4 7#c7 ,9 vitro cl9ical te/s subject to re/rictions ,! re/rictions or conditions au?oriz$ "u ?is section may be appli$ by ! ,secret>y to any high-risk or mod]ate-risk 9 vitro cl9ical te/1 prescription home-use 9 vitro cl9ical te/1 direct-to-consum] 9 vitro cl9ical te/1 or ov]-!-c\nt] 9 vitro cl9ical te/4 7b7 ,label+ & adv]tis+ ( a re/rict$ 9 vitro cl9ical te/ ,! label+ & adv]tis+ ( an 9 vitro cl9ical te/ to :i* re/rictions apply "u subsection 7a7 %all be> su* appropriate /atem5ts ( ! re/rictions z ! ,secret>y may prescribe 9 an approval "u section #ehg;,b1 an ord] "u section #ehg;,d1 a det]m9ation "u section #ehg;,f7a71 or 9 regulation1 z applicable4 7c7 ,device re/rictions ,an 9 vitro cl9ical te/ t 0 (f]$ z a re/rict$ device prior to ! date ( enactm5t ( ?is sub*apt]-- 7#a7 %all cont9ue to comply ) ! applicable re/rictions "u section #eae or section #ebj7;e7 until ! ?is sub*apt] takes effect2 & 7#b7 except = 9 vitro cl9ical te/s requir$ to meet section #hji4cj ( title #ba1 ,code ( ,f$]al ,regulations prior to ! effective date ( ?is sub*apt] specifi$ 9 section #hbe7;a77#a77;,a7 ( ! ,,valid ,act ( #bjbb1 su* re/rictions %all be deem$ to be re/rictions "u ?is ,act z ( su* effective date4 #ehg,p4 ,appeals 7a7 ,significant decision 7#a7 ,9 g5]al ,! ,secret>y %all ma9ta9 a sub/antive summ>y ( ! sci5tific & regulatory rationale = any significant decision ( ! ,food & ,drug ,adm9i/ration pursuant to section #ehg;,f1 reg>d+-- 7,a7 ! submission ( an application =1 or a review (1 an 9 vitro cl9ical te/ "u section #ehg;,b or section #ehg;,d2 7,b7 an exemption "u section #ehg;,c2 or 7,c7 any requirem5ts = mitigation measures to an 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s4 ,su* summ>ies %all include docum5tation ( significant controv]sies or diff]5ces ( op9ion & ! resolution ( su* controv]sies or diff]5ces ( op9ion4 7#b7 ,provision ( docum5tation ,^u reque/1 ! ,secret>y %all furni% a sub/antive summ>y describ$ 9 p>agraph 7#a7 to ! p]son :o has made1 or is seek+ to make1 a submission describ$ 9 su* p>agraph4 7#c7 ,application ( lea/ burd5some requirem5ts ,! sub/antive summ>y requir$ "u ?is subsection %all include a brief /atem5t reg>d+ h[ ! lea/ burd5some requirem5ts 7 consid]$ & appli$ consi/5t ) section #ehg;,,aa7c71 z applicable4 7b7 ,review ( significant decisions 7#a7 ,reque/ = sup]visory review ( significant decision ,a develop] may reque/ a sup]visory review ( ! significant decision describ$ 9 subsection 7a77#a74 ,su* review may be conduct$ at ! next sup]visory level or high] above ! ag5cy (ficial :o made ! significant decision4 7#b7 ,submission ( reque/ ,a develop] reque/+ a sup]visory review "u p>agraph 7#a7 %all submit su* reque/ to ! ,secret>y n lat] ?an #cj days aft] ! decision = :i* ! review is reque/$ & %all indicate 9 ! reque/ :e!r su* develop] seeks an 9-p]son meet+ or a teleconf]5ce review4 7#c7 ,timeframe ,! ,secret>y %all s*$ule an 9-p]son or teleconf]5ce review1 if s reque/$1 n lat] ?an #cj days aft] su* reque/ is made4 ,! ,secret>y %all issue a decision to ! develop] reque/+ a review "u ?is subsection n lat] ?an #de days aft] ! reque/ is made "u p>agraph 7#a71 or1 9 ! case ( a develop] :o reque/s an 9-p]son meet+ or teleconf]5ce1 #cj days aft] su* meet+ or teleconf]5ce4 7c7 ,advisory panels ,! process e/abli%$ "u subsection 7a7 %all p]mit ! appellant to reque/ review by an advisory committee e/abli%$ "u section #ehg;,g :5 !re is a dispute involv+ sub/antial sci5tific fact4 ,if an advisory panel meet+ is held1 ! ,secret>y %all make a det]m9ation "u ?is subsection n lat] ?an #de days aft] ! reque/$ advisory committee meet+ has conclud$4 7d7 ,lea/ burd5some review ,any develop] :o has submitt$ an application "u section #ehg;,b or #ehg;,d may reque/ a sup]visory review ( a reque/ = additional in=mation dur+ an evaluation ( su* submission )9 #fj cal5d> days ( receipt ( ! additional in=mation reque/ f ! ,secret>y4 7e7 ,availability ( all rem$ies ,! proc$ures set =? 9 ?is section %all be 9 addition to1 & n 9 lieu (1 o!r rem$ies available to ! develop]4 #ehg,q4 ,accr$it$ p]sons 7a7 ,9 g5]al 7#a7 ,au?orization ,beg9n+ on ! date ( enactm5t ( ! ,,valid ,act ( #bjbb1 ! ,secret>y %all accr$it p]sons = any ( ! foll[+ purposes3 7,a7 ,review+ applications = prem>ket approval "u section #ehg;,b & mak+ f9d+s ) respect to su* applications4 7,b7 ,review+ applications = te*nology c]tification "u section #ehg;,d & mak+ recomm5dations to ! ,secret>y ) respect to su* applications4 7,c7 ,conduct+ inspections z specifi$ 9 subsection 7c7 ( 9 vitro cl9ical te/ develop]s & o!r p]sons requir$ to regi/] pursuant to section #ehg;,i4 7#b7 ,p]sons submitt+ applications ,a p]son submitt+ an application = prem>ket approval "u section #ehg;,b or an application = te*nology c]tification "u section #ehg;,d may submit su* application to ! ,secret>y or to a p]son accr$it$ pursuant to subp>agraph 7,a7 or 7,b7 ( p>agraph 7#a74 7b7 ,accr$it$ p]sons application reviews1 f9d+s & recomm5dations 7#a7 ,requirem5ts = prem>ket application 7,a7 ,review & f9d+ requirem5ts ,an accr$it$ p]son receiv+ an application = prem>ket approval "u section #ehg;,b %all ei!r-- 7i7 provide to ! ,secret>y1 toge!r ) ! application = prem>ket approval submitt$ by ! applicant1 a f9d+ t ! crit]ia = approval ( ! application "u section #ehg;,b7g77#b77;,a7 are met & issue a copy ( su* f9d+ to ! applicant1 :i* f9d+ %all pla9ly /ate-- 7,i7 ! basis = ! accr$it$ p]son's f9d+ t ! crit]ia "u section #ehg;,b7g77#b77;,a7 are met2 & 7,,ii7 any propos$ re/rictions1 mitigat+ measures1 or conditions ( approval "u section #ehg;,b7g77#b77;,b71 z applicable2 or 7ii7 provide a notification to ! applicant t ! accr$it$ p]son _c f9d t ! crit]ia = approval ( ! application "u section #ehg;,b7g77#b77;,a7 are met & ! reasons = su* decision4 7,b7 ,reque/+ miss+ or cl>ify+ in=mation ,aft] receipt ( an application "u ?is section1 ! ,secret>y may reque/ miss+ or cl>ify+ in=mation f ! applicant conc]n+ ! application1 :i* ! applicant %all promptly provide4 7,c7 ,secret>y action on f9d+ t approval crit]ia are met ,if ! accr$it$ p]son transmits a f9d+ to ! ,secret>y "u clause 7i7 ( subp>agraph 7,a71 !n prior to ! date t is #de cal5d> days aft] ! transmittal date ! ,secret>y %all-- 7i7 approve ! application = prem>ket approval "u section #ehg;,b7g77#b7 ) appropriate re/rictions1 mitigat+ measures1 or conditions ( approval1 z applicable2 or 7ii7 d5y approval ( ! application by issu+ a writt5 notice t reflects appropriate managem5t input & concurr5ce to ! accr$it$ p]son & ! applicant detail+ ! sci5tific basis = ! ,secret>y's det]m9ation t ! crit]ia = issuance ( an approval "u section #ehg;,b7g77#b77;,a7 h n be5 met4 7,d7 ,effect ( inaction on f9d+ ,if ! ,secret>y fails to take an action "u subp>agraph 7,c7 ! ,secret>y %all-- 7i7 )9 #de cal5d> days aft] ! transmittal date1 provide writt5 fe$back to ! applicant t-- 7,i7 includes all out/&+ issues ) ! application prev5t+ ! ,secret>y f tak+ an action "u subp>agraph 7,b72 7,,ii7 reflects appropriate managem5t input & concurr5ce2 & 7,,iii7 includes action items = ! ,secret>y1 ! applicant1 or bo?1 z appropriate1 ) an e/imat$ date ( completion = ! ,secret>y & ! applicant to complete _! respective tasks1 z applicable2 & 7ii7 promptly s*$ule a meet+ or teleconf]5ce to discuss ! fe$back provid$ "u clause 7i71 unless ! ,secret>y & applicant agree t ! out/&+ issues are adequately pres5t$ ?r\gh writt5 correspond5ce & a meet+ or teleconf]5ce is n necess>y4 7#b7 ,requirem5ts = te*nology c]tification 7,a7 ,review & recomm5dation requirem5ts ,an accr$it$ p]son receiv+ an application = te*nology c]tification "u section #ehg;,d %all ei!r-- 7i7 provide to ! ,secret>y1 toge!r ) ! application = te*nology c]tification submitt$ by ! applicant1 a recomm5dation t ! crit]ia = issuance ( a te*nology c]tification ord] "u section #ehg;,d7f77#c7 are met & issue a copy ( su* recomm5dation to ! applicant1 :i* recomm5dation %all pla9ly /ate ! basis = ! accr$it$ p]son's recomm5dation t ! crit]ia "u section #ehg;,d7f77#c7 are met2 or 7ii7 provide a notification to ! applicant t ! accr$it$ p]son _c recomm5d t ! crit]ia = issuance ( a te*nology c]tification ord] "u section #ehg;,d7f77#c7 are met & ! reasons = su* decision4 7,b7 ,reque/+ miss+ or cl>ify+ in=mation ,aft] receipt ( an application "u ?is section1 ! ,secret>y may reque/ miss+ or cl>ify+ in=mation f ! applicant conc]n+ ! application1 :i* ! applicant %all promptly provide4 7,c7 ,secret>y action on recomm5dation = issuance ( a te*nology c]tification ord] ,if ! accr$it$ p]son transmits a recomm5dation to ! ,secret>y "u clause 7i7 ( subp>agraph 7,a71 !n prior to ! date t is #fj cal5d> days aft] ! transmittal date ! ,secret>y %all-- 7i7 issue ! te*nology c]tification ord] "u section #ehg;,d7f77#c71 consi/5t ) su* recomm5dation f ! accr$it$ p]son2 or 7ii7 d5y approval ( ! application by issu+ a writt5 notice to ! accr$it$ p]son & ! applicant detail+ ! sci5tific basis = a det]m9ation by ! ,secret>y t ! crit]ia = issuance ( a te*nology c]tification ord] "u section #ehg;,d7f77#c7 h n be5 met4 7c7 ,requirem5ts = inspections 7#a7 ,9 g5]al ,:5 conduct+ inspection1 p]sons accr$it$ "u subp>agraph 7a77#a77;,b7 %all record 9 writ+ _! specific obs]vations & %all pres5t _! obs]vations to ! designat$ repres5tative ( ! inspect$ e/abli%m5t4 7#b7 ,inspection report requirem5ts ,ea* p]son accr$it$ "u ?is subp>agraph 7a77#a77;,c7 %all prep>e & submit to ! ,secret>y an inspection report 9 a =m & mann] designat$ by ! ,secret>y = conduct+ inspections4 ,any /atem5t or repres5tation made by an employee or ag5t ( an e/abli%m5t to a p]son accr$it$ to conduct inspections "u subp>agraph 7a77#a77;,c7 %all be subject to section #ajja ( title #ah1 ,unit$ ,/ates ,code4 7#c7 ,sav+s clause ,no?+ 9 ?is section affects ! au?ority ( ! ,secret>y to inspect any 9 vitro cl9ical te/ develop] or o!r p]son regi/]$ "u section #ehg;,i or recognize inspections conduct$ by audit+ organizations z describ$ "u section #gjd7;g77#ae74 7#d7 ,inspection limitations ,! ,secret>y %all ensure t inspections c>ri$ out "u ?is section are n duplicative ( inspections c>ri$ out "u section #cec ( ! ,public ,heal? ,s]vice ,act4 ,inspections "u ?is section %all be limit$ to ! data & in=mation necess>y-- 7,a7 = r\t9e surveillance activities ( facilities associat$ ) an approv$ application "u section #ehg;,b or issuance ( a te*nology c]tification ord] "u section #ehg;,d2 or 7,b7 to meet ! requirem5ts = prem>ket approval "u section #ehg;,b or issuance ( a te*nology c]tification ord] "u section #ehg;,d1 z applicable4 7d7 ,accr$itation 7#a7 ,accr$itation program ,! ,secret>y may provide = accr$itation "u ?is section ?r\gh programs adm9i/]$ by ! ,food & ,drug ,adm9i/ration1 by o!r non-,f$]al gov]nm5t ag5cies1 or by qualifi$ nongov]nm5tal organizations4 ,a p]son may be accr$it$ = ! review ( applications submitt$ "u sections #ehg;,b z describ$ 9 subsection 7a77#a77;,a71 = ! review ( applications submitt$ "u section #ehg;,d z describ$ 9 subsection 7a77#a77;,b7 & to conduct inspection activities "u subsection 7a77#a77;,c71 or = a subset ( su* reviews or activities4 7#b7 ,eligible p]sons 7,a7 ,m9imum qualifications ,an accr$it$ p]son1 at a m9imum1 %all-- 7i7 n be an employee ( ! ,f$]al ,gov]nm5t2 7ii7 n engage 9 ! activities ( a develop]1 z def9$ 9 section #ehg7g72 7iii7 n be a p]son requir$ to regi/] "u section #ehg;,i1 unless su* p]son has e/abli%$ suffici5t processes & protocols to sep>ate activities to develop 9 vitro cl9ical te/s & ! activities = :i* su* p]son w\ld be accr$it$ "u subsection 7a7 & discloses applicable in=mation "u ?is section2 7iv7 n be own$ or controll$ by1 & %all h no organizational1 mat]ial1 or f9ancial affiliation )1 an 9 vitro cl9ical te/ develop] or o!r p]son requir$ to regi/] "u section #ehg;,i2 7v7 be a legally con/itut$ entity p]mitt$ to conduct ! activities = :i* x seeks accr$itation2 7vi7 ensure t ! op]ations ( su* p]son are 9 accordance ) g5]ally accept$ pr(essional & e?ical bus9ess practices2 & 7vii7 include 9 its reque/ = accr$itation a commitm5t to1 at ! "t ( accr$itation & at any "t x is p]=m+ activities pursuant to ?is section-- 7,i7 c]tify t ! in=mation report$ to ! ,secret>y accurately reflects ! data or protocol review$1 & ! docum5t$ inspection f9d+s1 z applicable2 7,,ii7 limit "w to t = :i* compet5ce & capacity are available2 7,,iii7 treat in=mation receiv$ or le>n$1 records1 reports1 & recomm5dations z propriet>y in=mation ( ! p]son submitt+ su* in=mation2 & 7,,iv7 9 conduct+ ! activities = :i* ! p]son is accr$it$ 9 respect to a p>ticul> 9 vitro cl9ical te/1 protect aga9/ ! use ( any employee or consultant :o has a f9ancial conflict ( int]e/ reg>d+ t 9 vitro cl9ical te/4 7,b7 ,waiv] ,! ,secret>y may waive any requirem5ts 9 clauses 7i71 7ii71 7iii71 or 7iv7 ( subp>agraph 7,a7 ^u mak+ a det]m9ation t su* p]son has implem5t$ o!r appropriate controls suffici5t to ensure a compet5t & imp>tial review4 7#c7 ,accr$itation process 7,a7 ,accr$itation process guidance & regulations ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbb1 ! ,secret>y %all issue draft guidance specify+ ! process = submitt+ a reque/ = accr$itation & reaccr$itation "u ?is section1 includ+ ! =m & cont5t ( in=mation to be submitt$1 includ+ ! crit]ia t ! ,secret>y w consid] to accr$it or d5y accr$itation &1 n lat] ?an #a ye> aft] ! close ( ! comm5t p]iod = ! draft guidance1 issue f9al guidance4 7,b7 ,response to reque/ ,! ,secret>y %all respond to a reque/ = accr$itation or reaccr$itation )9 #fj cal5d> days ( ! receipt ( ! reque/4 ,! ,secret>y's response may be to accr$it or reaccr$it ! p]son1 to d5y accr$itation1 or to reque/ additional in=mation 9 support ( ! reque/4 ,if ! ,secret>y reque/s additional in=mation1 ! ,secret>y %all respond )9 #fj cal5d> days ( receipt ( su* additional in=mation to accr$it or d5y ! accr$itation4 7,c7 ,type ( accr$itation ,! accr$itation or reaccr$itation ( a p]son %all specify ! p>ticul> activity or activities "u subsection 7a7 = :i* su* p]son is accr$it$1 & %all include any limitation to c]ta9 eligible 9 vitro cl9ical te/s4 7,d7 ,public li/ ,! ,secret>y %all publi% on ! website ( ! ,food & ,drug ,adm9i/ration a li/ ( p]sons :o are accr$it$ "u ?is section4 ,su* li/ %all be updat$ on at lea/ a mon?ly basis4 ,! li/ %all specify ! p>ticul> activity or activities "u ?is section = :i* ! p]son is accr$it$4 7,e7 ,audit ,! ,secret>y may audit ! p]=mance ( p]sons accr$it$ "u ?is section = purposes ( ensur+ t su* p]sons cont9ue to meet ! publi%$ crit]ia = accr$itation1 & may modify ! scope or p>ticul> activities = :i* a p]son is accr$it$ if ! ,secret>y det]m9es t su* p]son fails to meet "o or m crit]ia = accr$itation4 7,f7 ,susp5sion or )drawal ,! ,secret>y may susp5d or )draw accr$itation ( any p]son accr$it$ "u ?is section1 aft] provid+ notice & an opportunity = an in=mal he>+1 :5 su* p]son is sub/antially n 9 compliance ) ! requirem5ts ( ?is section or ! publi%$ crit]ia = accr$itation1 or poses a ?reat to public heal?1 or fails to act 9 a mann] t is consi/5t ) ! purposes ( ?is section4 7,g7 ,reaccr$itation ,accr$it$ p]sons may be initially accr$it$ = up to #c ye>s4 ,aft] expiration ( su* initial p]iod1 p]sons may be reaccr$it$ = unlimit$ additional #ce-ye> p]iods1 z det]m9$ by ! ,secret>y4 7e7 ,comp5sation ( accr$it$ p]sons ,comp5sation ( an accr$it$ p]son %all be det]m9$ by agreem5t betwe5 ! accr$it$ p]son & ! p]son :o engages ! s]vices ( ! accr$it$ p]son1 & %all be paid by ! p]son :o engages su* s]vices4 7f7 ,int]national h>monization ,not)/&+ any o!r provision ( ?is section1 to facilitate int]national h>monization ! ,secret>y may recognize p]sons accr$it$ or recogniz$ by gov]nm5ts1 :o h also ent]$ into in=mation %>+ agreem5ts1 includ+ confid5tiality commitm5ts1 ) ! ,commission] ( ,food & ,drugs4 7g7 ,in=mation %>+ agreem5ts ,an accr$it$ p]son may ent] into an agreem5t ) a te/ develop] to provide in=mation to ! compreh5sive te/ in=mation sy/em "u section #ehg,t1 includ+ any requirem5ts "u section #ehg;,i4 7h7 ,reports ,n lat] ?an #b ye>s aft] ! effective date ( ! ,,valid ,act ( #bjbb1 & annually !reaft] = ! next #d ye>s1 ! ,secret>y %all po/ on ! website ( ! ,food & ,drug ,adm9i/ration1 a report describ+ ! ,secret>y's p]=mance 9 implem5t+ ?is section1 includ+ ! ,secret>y's progress 9 m9imiz+ duplicative reviews ( applications = :i* an accr$it$ p]son f9ds ! crit]ia = approval are met4 ,su* reports %all include1 = ea* p]iod-- 7#a7 ) reg>d to prem>ket approval applications-- 7,a7 ! total numb] ( f9d+s transmitt$ to ! ,secret>y "u subsection 7b77#a77;,a77i72 7,b7 ! total numb] ( det]m9ations made by ! ,secret>y "u subsection 7b77#a77;,b77i7 )9 #cj cal5d> days ( ! transmittal date to approve an application2 7,c7 ! total numb] ( det]m9ations made by ! ,secret>y "u subsection 7b77#a77;,b77ii7 )9 #cj cal5d> days ( ! transmittal date to d5y approval ( an application2 & 7,d7 ! total numb] ( applications t 7 approv$ & ! total numb] ( applications t 7 d5i$ approval1 aft] ! ,secret>y fail$ to make a det]m9ation )9 #cj cal5d> days ( ! transmittal date "u subsection 7b77#a77;,b72 & 7#b7 ) reg>d to applications = te*nology c]tification-- 7,a7 ! total numb] ( recomm5dations transmitt$ to ! ,secret>y "u subsection 7b77#b77;,a77i72 7,b7 ! total numb] ( det]m9ations made by ! ,secret>y "u subsection 7b77#b77;,b77i7 to issue a te*nology c]tification ord]1 includ+ det]m9ations made )9 #cj days ( ! transmittal date2 7,c7 ! total numb] ( det]m9ations made by ! ,secret>y "u subsection 7b77#b77;,b77ii7 to d5y ! application = te*nology c]tification1 includ+ det]m9ations made )9 #cj cal5d> days ( ! transmittal date2 & 7,d7 ! total numb] ( te*nology c]tification ord]s issu$1 & ! total numb] ( applications = te*nology c]tification t 7 d5i$1 includ+ applications d5i$ aft] ! ,secret>y fail$ to make a det]m9ation )9 #cj cal5d> days ( ! transmittal date "u subsection 7b77#b77;,b74 #ehg,r4 ,recogniz$ /&>ds 7a7 ,9 g5]al ,! ,secret>y may recognize all or "p ( appropriate /&>ds e/abli%$ by nationally or int]nationally recogniz$ /&>ds developm5t organizations = :i* a p]son may submit a decl>ation ( con=mity 9 ord] to meet a requirem5t "u ?is sub*apt] to :i* t /&>d is applicable4 ,/&>ds = 9 vitro diagno/ic devices previ\sly recogniz$ "u section #ead7;c7 %all be consid]$ recogniz$ /&>ds "u ?is section4 ,recogniz$ & propos$ /&>ds %all be accessible to ! public at no *>ge4 ,! application ( any su* cons5sus /&>d %all only apply prospectively4 ,! ,secret>y %all issue regulations e/abli%+ ! crit]ia & process1 = su* recognition & adoption4 7b7 ,am5dm5t process ,! proc$ures e/abli%$ 9 ?is section or 9 regulation or guidance issu$ "u ?is section %all apply to am5dm5t ( an exi/+ /&>d4 #ehg,s4 ,inve/igational use 7a7 ,9 g5]al ,subject to ! conditions prescrib$ 9 subsections 7c71 7d71 7e71 7f71 & 7g7 ( ?is section1 an 9 vitro cl9ical te/ = inve/igational use %all be exempt f ! requirem5ts ( ?is sub*apt] o!r ?an sections #ehg;,a1 #ehg,p1 #ehg,t1 & #ehg,v4 ,! ,secret>y may am5d p>ts #ej1 #ed1 & #ef ( title #ba ( ! ,code ( ,f$]al ,regulations1 or any successor regulations1 to apply to 9 vitro cl9ical te/s to p]mit ! inve/igational use ( su* te/s by exp]ts qualifi$ by sci5tific tra9+ & exp]i5ce4 7b7 ,regulations 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbb1 ! ,secret>y %all promulgate regulations1 or am5d exi/+ regulations1 to implem5t ?is section4 7#b7 ,v>iation ,! requirem5ts 9 ! regulations promulgat$ "u ?is section %all take into acc\nt v>iations bas$ on-- 7,a7 ! scope & duration ( cl9ical te/+ to be conduct$ "u inve/igation t is ! subject ( su* application2 7,b7 ! numb] ( human subjects t are to be involv$ 9 su* te/+2 7,c7 ! ne$ to p]mit *anges to be made to ! 9 vitro cl9ical te/ involv$ dur+ te/+ conduct$ 9 accordance ) a plan requir$ "u subsection 7c77#e72 or 7,d7 :e!r ! cl9ical te/+ ( su* 9 vitro cl9ical te/ is = ! purpose ( develop+ data to obta9 approval to (f] su* te/4 7c7 ,application = inve/igational use ,! foll[+ %all apply ) respect to 9 vitro cl9ical te/s = inve/igational use3 7#a7 ,significant risk & o!r /udies ,9 ! case ( an 9 vitro cl9ical te/ ! inve/igational use ( :i* poses a significant risk to ! human subject1 a sponsor ( an inve/igation ( su* a te/ seek+ an inve/igational use exemption %all submit to ! ,secret>y an inve/igational use application ) respect to ! 9 vitro cl9ical te/ 9 accordance ) p>agraphs 7#c7 & 7#d74 ,= purposes ( ?is subp>agraph1 ! t]m significant risk means1 ) respect to an 9 vitro cl9ical te/ & t ! use ( su* 9 vitro cl9ical te/-- 7,a7 is ( sub/antial importance 9 p]=m+ an activity or activities describ$ 9 section #bja7ss77#a7 =1 a s]i\s or life-?reat5+ disease or condition )\t confirmation ( ! diagnosis by a m$ically e/abli%$ diagno/ic product or proc$ure2 7,b7 requires an invasive sampl+ proc$ure t pres5ts a significant risk to ! human subject1 provid$ t r\t9e v5ipuncture %all n be consid]$ an invasive sampl+ proc$ure2 or 7,c7 o!rwise pres5ts a pot5tial = s]i\s risk to ! heal? ( a human subject4 7#b7 ,non-significant risk /udies ,9 ! case ( an 9 vitro cl9ical te/1 ! inve/igational use ( :i* is n describ$ 9 p>agraph 7#a7-- 7,a7 ! sponsor ( su* inve/igation %all-- 7i7 ensure su* inve/igation is conduct$ 9 compliance ) an inve/igational plan approv$ by an in/itutional review committee & ! label+ ( ! 9 vitro cl9ical te/ involv$ cle>ly & conspicu\sly /ates1 ,= inve/igational use only1 z specifi$ 9 p>agraph 7#d77;,a77ii72 7ii7 ensure ea* inve/igator obta9s in=m$ cons5t z requir$ "u "p #ej1 #ed1 & #ef ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations71 subject to ! exceptions set =? 9 p>agraph 7#f77;,c72 7iii7 e/abli% & ma9ta9 records ) respect to all requirem5ts 9 ?is subp>agraph2 7iv7 ma9ta9 records & make reports z e/abli%$ by ! ,secret>y 9 regulations issu$ "u subsection 7b72 & 7v7 ensure t inve/igators monitor inve/igations1 ma9ta9 records & make reports z e/abli%$ by ! ,secret>y 9 regulations issu$ "u subsection 7b72 & 7,b7 ! sponsor may rely on any exception or exemption describ$ 9 p>agraph 7#e77;,b7 or z e/abli%$ by ! ,secret>y 9 regulations issu$ "u subsection 7b74 7#c7 ,application ,an inve/igational use application %all be submitt$ 9 su* "t & mann] & conta9 su* in=mation z ! ,secret>y may require 9 regulation1 & %all include an inve/igational plan = propos$ cl9ical te/+ & assurances t ! sponsor submitt+ ! application w-- 7,a7 e/abli% & ma9ta9 records relevant to ! inve/igation ( su* 9 vitro cl9ical te/2 & 7,b7 submit to ! ,secret>y annual reports ( data obta9$ z a result ( ! inve/igational use ( ! 9 vitro cl9ical te/ dur+ ! p]iod cov]$ by ! exemption t ! ,secret>y reasonably det]m9es w enable ! ,secret>y-- 7i7 to ensure compliance ) ! conditions = ! exemption specifi$ 9 p>agraph 7#d72 7ii7 to review ! progress ( ! inve/igation involv$2 & 7iii7 to evaluate ! ability to meet ! applicable /&>d4 7#d7 ,conditions = exemption 7,a7 ,9 g5]al ,an application = an inve/igational use exemption ) respect to a significant risk /udy %all be grant$ if ea* ( ! foll[+ conditions is met3 7i7 ,! risks to ! subjects ( ! 9 vitro cl9ical te/ are outweigh$ by ! anticipat$ b5efits ( ! te/ to ! subjects & ! importance ( ! k to be ga9$1 & adequate assurance ( in=m$ cons5t is provid$ 9 accordance ) p>agraphs 7#f77;,a77iii7 & 7#f77;,b74 7ii7 ,! propos$ label+ = ! 9 vitro cl9ical te/ involv$ cle>ly & conspicu\sly /ates ,= inve/igational use only4 7iii7 ,su* o!r requirem5ts ! ,secret>y det]m9es-- 7,i7 are necess>y = ! protection ( ! public heal? & safety2 & 7,,ii7 d n unduly delay inve/igation4 7,b7 ,c]ta9 significant risk /udies ( 9 vitro cl9ical te/s = an unmet ne$ ,! ,secret>y %all n impose a limit on ! sample size = a significant risk /udy ( an 9 vitro cl9ical te/ t has receiv$ break?r\gh designation "u section #ehg;,i4 7#e7 ,coord9ation ) inve/igational new drug applications ,any requirem5t = ! submission ( a report to ! ,secret>y pursuant to an application = an inve/igational new drug exemption involv+ an 9 vitro cl9ical te/ %all sup]s$e ! report+ requirem5t 9 p>agraph 7#c77;,b71 b only to ! ext5t ! requirem5t ) respect to ! application = exemption ) respect to ! drug is duplicative ( ! report+ requirem5t "u su* p>agraph4 7#f7 ,inve/igational plan1 proc$ures1 & conditions ,) respect to an inve/igational plan submitt$ "u p>agraph 7#c71 ! sponsor submitt+ su* plan %all-- 7,a7 promptly notify ! ,secret>y ( ! approval or ! susp5sion or t]m9ation ( ! approval ( su* plan by an in/itutional review committee2 7,b7 9 ! case ( an 9 vitro cl9ical te/ made available to inve/igators = cl9ical te/+1 obta9 agreem5ts f ea* inve/igator t any te/+ ( ! 9 vitro cl9ical te/ involv+ human subjects w be "u su* inve/igator's sup]vision & 9 accordance ) p>agraph 7,c7 & submit su* agreem5ts to ! ,secret>y t ensure-- 7i7 all inve/igators w comply ) ?is section1 regulations promulgat$ or revis$ "u ?is section1 & applicable human subjects regulations2 & 7ii7 ! inve/igator w ensure t-- 7,i7 in=m$ cons5t is obta9$ z requir$ "u "p #ej ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations71 am5d$ to apply to 9 vitro cl9ical te/s2 & 7,,ii7 ! requirem5ts = in/itutional review bo>d "u "p #ef ( title #ba ( ! ,code ( ,f$]al ,regulations 7or successor regulations71 am5d$ to apply to 9 vitro cl9ical te/s1 are met2 & 7,c7 assure t in=m$ cons5t w be obta9$ f ea* human subject 7or ! repres5tative ( su* subject7 ( propos$ cl9ical te/+ involv+ su* 9 vitro cl9ical te/1 except :]e1 subject to su* o!r conditions z ! ,secret>y may prescribe-- 7i7 ! propos$ cl9ical te/+ poses no m ?an m9imal risk to ! human subject & includes appropriate safegu>ds to protect ! rights1 safety1 & welf>e ( ! human subject2 or 7ii7 ! inve/igator conduct+ or sup]vis+ ! cl9ical te/+ det]m9es 9 writ+ t !re exi/s a life-?reat5+ situation involv+ ! human subject ( su* te/+ :i* necessitates ! use ( su* 9 vitro cl9ical te/ & x is n feasible to obta9 in=m$ cons5t f ! subject & !re is n suffici5t "t to obta9 su* cons5t f a repres5tative ( su* subject4 7#g7 ,concurr$ by lic5s$ physician ,! det]m9ation requir$ by p>agraph 7#f77;,c77ii7 %all be concurr$ 9 writ+ by a lic5s$ physician :o is n involv$ 9 ! te/+ ( ! human subject ) respect to :i* su* det]m9ation is made unless imm$iate use ( ! device is requir$ to save ! life ( ! human subject ( su* te/+ & !re is n suffici5t "t to obta9 su* concurr5ce4 7d7 ,review ( applications 7#a7 ,9 g5]al ,! ,secret>y may issue an ord] approv+ an inve/igation z propos$1 approv+ x ) conditions or modifications1 or disapprov+ x4 7#b7 ,failure to act ,unless ! ,secret>y1 n lat] ?an ! date t is #cj cal5d> days aft] ! date ( ! submission ( an application = an inve/igational use exemption t meets ! requirem5ts ( subsection 7c71 issues an ord] "u p>agraph 7#a7 & notifies ! sponsor submitt+ ! application1 ! application %all be treat$ z approv$ z ( su* date )\t fur!r action by ! ,secret>y4 7#c7 ,d5ial ,! ,secret>y may d5y an inve/igational use application submitt$ "u ?is subsection if ! ,secret>y det]m9es t ! inve/igation ) respect to :i* ! application is submitt$ does n con=m to ! requirem5ts ( subsection 7c74 ,a notification ( su* d5ial submitt$ to ! sponsor ) respect to su* a reque/ %all conta9 ! ord] ( disapproval & a complete /atem5t ( ! reasons = ! ,secret>y's d5ial ( ! application4 7e7 ,)drawal ( exemption 7#a7 ,9 g5]al ,! ,secret>y may1 by adm9i/rative ord]1 )draw an exemption approv$ "u ?is section ) respect to an 9 vitro cl9ical te/1 includ+ an exemption treat$ z approv$ bas$ on ! ,secret>y's failure to act pursuant to subsection 7d77#b71 if ! ,secret>y det]m9es t an inve/igation conduct$ "u su* an exemption does n meet ! applicable conditions "u subsection 7c77#c7 = su* exemption4 7#b7 ,opportunity to be he>d 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 an ord] )draw+ an inve/igational use exemption grant$ "u ?is section may be issu$ only aft] ! ,secret>y provides ! sponsor ( ! 9 vitro cl9ical te/ ) an opportunity = an in=mal he>+4 7,b7 ,exception ,an ord] ref]r$ to 9 subp>agraph 7,a7 ) respect to an inve/igational use exemption grant$ "u ?is section may be issu$ on a prelim9>y basis be=e ! provision ( an opportunity = an in=mal he>+ if ! ,secret>y det]m9es t ! cont9uation ( te/+ "u ! exemption w result 9 an unreasonable risk to ! public heal?4 ,! ,secret>y w provide an opportunity = an in=mal he>+ promptly foll[+ any prelim9>y action "u ?is subp>agraph4 7f7 ,*anges 7#a7 ,9 g5]al ,! regulations promulgat$ "u subsection 7b7 %all provide1 ) respect to an 9 vitro cl9ical te/ = :i* an exemption "u ?is subsection is 9 effect1 proc$ures & conditions "u :i* *anges are all[$ )\t ! additional approval ( an application = an exemption or submission ( a supplem5t to su* an application4 ,su* regulations %all provide t su* a *ange may be made if-- 7,a7 ! sponsor det]m9es1 on ! basis ( cr$ible in=mation 7z def9$ 9 regulations7 t ! *ange meets ! conditions specifi$ 9 p>agraph 7#b72 & 7,b7 ! sponsor submits to ! ,secret>y1 n lat] ?an #e cal5d> days aft] mak+ ! *ange1 a notice ( ! *ange4 7#b7 ,conditions ,! conditions specifi$ 9 ?is p>agraph are t-- 7,a7 9 ! case ( developm5tal *anges to an 9 vitro cl9ical te/1 includ+ manufactur+ *anges1 ! *anges-- 7i7 d n con/itute a significant *ange 9 design or 9 basic pr9ciples ( op]ation2 7ii7 d n affect ! rights1 safety1 or welf>e ( ! human subjects involv$ 9 ! inve/igation2 & 7iii7 are made 9 response to in=mation ga!r$ dur+ ! c\rse ( an inve/igation2 & 7,b7 9 ! case ( *anges to cl9ical protocols applicable to ! te/1 ! *anges d n affect-- 7i7 ! validity ( data or in=mation result+ f ! completion ( an approv$ cl9ical protocol1 or ! relation%ip ( likely pati5t risk to b5efit reli$ ^u to approve a product2 7ii7 ! sci5tific s\ndness ( a plan submitt$ "u subsection 7c77#c72 or 7iii7 ! rights1 safety1 or welf>e ( ! human subjects involv$ 9 ! inve/igation4 7g7 ,cl9ical hold 7#a7 ,9 g5]al ,at any "t1 ! ,secret>y may impose a cl9ical hold ) respect to an inve/igation ( an 9 vitro cl9ical te/ if ! ,secret>y makes a writt5 det]m9ation describ$ 9 p>agraph 7#b74 ,! ,secret>y %all1 9 impos+ su* cl9ical hold1 specify ! basis = ! cl9ical hold1 includ+ ! specific in=mation available to ! ,secret>y :i* s]v$ z ! basis = su* cl9ical hold1 & confirm su* det]m9ation 9 writ+4 ,! applicant may imm$iately appeal any su* det]m9ation pursuant to section #ehg,p4 7#b7 ,det]m9ation 7,a7 ,9 g5]al ,= purposes ( p>agraph 7#a71 a det]m9ation describ$ 9 ?is subp>agraph ) respect to a cl9ical hold is a det]m9ation t1 bas$ on cr$ible evid5ce1 ! 9 vitro cl9ical te/ involv$ repres5ts an unreasonable risk to ! safety ( ! p]sons :o are ! subjects ( ! cl9ical inve/igation1 tak+ into acc\nt ! qualifications ( ! cl9ical inve/igators1 in=mation ab\t ! 9 vitro cl9ical te/1 ! design ( ! cl9ical inve/igation1 ! condition = :i* ! 9 vitro cl9ical te/ is to be inve/igat$1 & ! heal? /atus ( ! subjects involv$4 7,b7 ,removal ( cl9ical hold ,any writt5 reque/ to ! ,secret>y f ! sponsor ( an inve/igation t a cl9ical hold be remov$ %all receive a decision1 9 writ+ & specify+ ! reasons !re=1 )9 #cj days aft] receipt ( su* reque/4 ,any su* reque/ %all include suffici5t in=mation to support ! removal ( su* cl9ical hold4 #ehg,t4 ,compreh5sive te/ in=mation sy/em 7a7 ,e/abli%m5t ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbb1 ! ,secret>y %all make available a compreh5sive te/ in=mation sy/em = 9 vitro cl9ical te/s t is design$ to-- 7#a7 provide a transp>5t int]face on ! website ( ! ,food & ,drug ,adm9i/ration = /akehold]s1 to ! ext5t p]mitt$ by applicable law1 :i* may include access to !-- 7,a7 regulatory pa?way designation in=mation = ea* 9 vitro cl9ical te/ or te/s ) ! same indications = use2 7,b7 regi/ration & li/+ in=mation provid$ by develop]s "u section #ehg;,j1 includ+ ! use ( a l9k = labels2 7,c7 adv]se ev5t reports submitt$ "u section #ehg,m1 z appropriate2 7,d7 reports ( corrections & removals submitt$ "u section #ehg,n2 & 7,e7 o!r in=mation p]ta9+ to an 9 vitro cl9ical te/ or te/s ) ! same indications = use1 z ! ,secret>y det]m9es appropriate2 & 7#b7 provide a secure portal = electronic submission1 includ+ applications & o!r 9 vitro cl9ical te/ submissions1 regi/ration & li/+ in=mation1 & adv]se ev5t reports1 :i* provides protections f unau?oriz$ disclosure ( in=mation1 includ+ (-- 7,a7 trade secret or comm]cial confid5tial in=mation2 & 7,b7 national security1 c\nt]measure1 or o!r in=mation re/rict$ f disclosure pursuant to any provision ( law4 7b7 ,submission function ,! compreh5sive te/ in=mation sy/em %all s]ve z ! electronic submission s]vice = te/ develop]s submitt+ in=mation = applications "u sections #ehg;,b & #ehg;,d4 #ehg,u4 ,preemption 7a7 ,9 g5]al ,except z provid$ 9 subsection 7b71 no ,/ate1 ,tribal1 or local gov]nm5t 7or political subdivision !re(7 may e/abli% or cont9ue 9 effect any requirem5t t-- 7#a7 is diff]5t f1 or 9 addition to1 any requirem5t applicable to an 9 vitro cl9ical te/ "u ?is ,act2 or 7#b7 ) respect to ! analytical validity1 cl9ical validity1 or safety = individuals :o come into contact ) su* an 9 vitro cl9ical te/ "u ?is ,act4 7b7 ,exceptions ,subsection 7a7 %all n be con/ru$ to affect ! au?ority ( a ,/ate1 ,tribal1 or local gov]nm5t to d any ( ! foll[+3 7#a7 ,to lic5se laboratory p]sonnel1 heal? c>e practition]s1 or heal? c>e facilities or to regulate any aspect ( a heal? c>e practition]-pati5t relation%ip4 7#b7 ,to en=ce laws ( g5]al applicability1 su* z zon+ laws1 environm5tal laws1 labor laws1 & g5]al bus9ess laws4 7#c7 ,to au?orize laboratories to develop & p]=m an 9 vitro cl9ical te/1 pursuant to a law enact$ by a ,/ate prior to ,janu>y #a1 #bjbb1 z long z su* law does n impose requirem5ts t are diff]5t f any requirem5t applicable to an 9 vitro cl9ical te/ "u ?is ,act4 ,if a ,/ate has enact$ su* a law1 ! ,secret>y may exempt su* laboratories 9 t ,/ate f compliance ) ?is sub*apt]4 7c7 ,cl>ification ,no?+ 9 ?is section %all be con/ru$ to-- 7#a7 modify any action = damages or ! liability ( any p]son "u ! law ( any ,/ate2 or 7#b7 %ift liability to heal? c>e practition]s or o!r us]s4 #ehg,v4 ,adult]ation ,an 9 vitro cl9ical te/ %all be deem$ to be adult]at$3 7#a7 ,if x consi/s 9 :ole or 9 "p ( any fil?y1 putrid1 or decompos$ sub/ance4 7#b7 ,if x has be5 develop$1 prep>$1 pack$1 or held "u insanit>y conditions :]eby x may h be5 contam9at$ ) fil?1 or :]eby x may h be5 r5d]$ injuri\s to heal?4 7#c7 ,if its conta9] or package is compos$1 9 :ole or 9 "p1 ( any poison\s or delet]i\s sub/ance :i* may r5d] ! cont5ts injuri\s to heal?4 7#d7 ,if x be>s or conta9s1 = purposes ( color+ only1 a color additive :i* is unsafe )9 ! mean+ ( section #gba7;a74 7#e7 ,if its analytical or cl9ical validity1 z applicable1 or ) respect to a specim5 receptacle1 its safety1 falls bel[ t :i* x purports or is repres5t$ to possess4 7#f7 ,if x is requir$ to be1 decl>$ to be1 purports to be1 or is repres5t$ z be+1 9 con=mity ) any p]=mance /&>d e/abli%$ or recogniz$ "u section #ehg,r & is n 9 con=mity ) su* /&>d4 7#g7 ,if x is requir$ to be 9 compliance ) mitigat+ measures e/abli%$ "u section #ehg;,e & is n 9 con=mity ) su* mitigat+ measures4 7#h7 ,if x fails to h 9 effect an approv$ prem>ket application "u section #ehg;,b unless su* 9 vitro cl9ical te/ is 9 compliance ) ! requirem5ts =-- 7,a7 (f]+ )\t an approv$ prem>ket application "u section #ehg;,d2 7,b7 an exemption f prem>ket approval "u section #ehg;,c or #ehg;,g2 or 7,c7 inve/igational use pursuant to section #ehg,s4 7#i7 ,if x is n 9 con=mity ) any condition e/abli%$ "u section #ehg;,b or #ehg;,d4 7#aj7 ,if x purports to be an 9 vitro cl9ical te/ subject to an exemption "u section #ehg;,c & x fails to meet or ma9ta9 any crit]ia1 condition1 or requirem5t ( su* exemption4 7#aa7 ,if x has be5 grant$ an exemption "u section #ehg,s = inve/igational use1 & ! p]son grant$ su* exemption or any inve/igator :o uses su* 9 vitro cl9ical te/ "u su* exemption fails to comply ) a requirem5t prescrib$ by or "u su* section4 7#ab7 ,if x fails to meet ! quality requirem5ts prescrib$ 9 or e/abli%$ "u section #ehg,k 7z applicable71 or ! me?ods us$ 91 or facilities or controls us$ =1 its developm5t1 packag+1 /orage1 or in/allation are n 9 con=mity ) applicable requirem5ts e/abli%$ "u su* section4 7#ac7 ,if x has be5 develop$1 process$1 packag$1 or held 9 any e/abli%m5t1 factory1 or w>eh\se & ! own]1 op]ator or ag5t ( su* e/abli%m5t1 factory1 or w>eh\se delays1 d5ies1 or limits an inspection1 or refuses to p]mit entry or inspection4 7#ad7 ,if x is n 9 compliance ) any re/riction requir$ "u section #ehg,o4 #ehg,w4 ,misbr&+ ,an 9 vitro cl9ical te/ %all be deem$ to be misbr&$3 7#a7 ,if its label+ is false or mislead+ 9 any p>ticul>4 7#b7 ,if 9 a package =m unless x be>s a label conta9+-- 7,a7 ! "n & place ( bus9ess ( ! te/ develop]1 packag]1 or di/ributor2 & 7,b7 an accurate /atem5t ( ! quantity ( cont5ts 9 t]ms ( weight1 measure1 or num]ical c\nt ) respect to small packages1 unless an exemption is grant$ by ! ,secret>y by ! issuance ( guidance4 7#c7 ,if any ^w1 /atem5t1 or o!r in=mation requir$ by or "u au?ority ( ?is ,act to appe> on ! label or label+1 includ+ a te/ report1 is n prom95tly plac$ !reon ) su* conspicu\sness 7z comp>$ ) o!r words1 /atem5ts1 designs1 or devices1 9 ! label+7 & 9 su* t]ms z to r5d] x likely to be read & und]/ood by ! ord9>y individual "u cu/om>y conditions ( pur*ase & use4 7#d7 ,unless its label+ be>s adequate directions = use & su* adequate w>n+s z are necess>y = ! protection ( us]s ( ! 9 vitro cl9ical te/ & recipi5ts ( ! results ( su* 9 vitro cl9ical te/1 includ+ pati5ts1 consum]s1 donors1 & relat$ heal? c>e pr(essionals4 ,requir$ label+ = 9 vitro cl9ical te/s int5d$ = use 9 heal? c>e facilities1 blood e/abli%m5ts1 or by a heal? c>e pr(essional may be made available solely by electronic means1 provid$ t ! label+ complies ) all applicable requirem5ts ( law1 & t ! te/ develop]1 or di/ributor af=ds su* us]s ! opportunity to reque/ ! label+ 9 pap] =m1 & aft] su* reque/1 promptly provides ! reque/$ in=mation )\t additional co/4 7#e7 ,if !re is a reasonable probability t x c\ld cause s]i\s or adv]se heal? consequ5ces or dea?1 includ+ ?r\gh abs5ce1 delay1 or discont9uation 9 diagnosis or treatm5t1 :5 us$ 9 ! mann] prescrib$1 recomm5d$1 or sugge/$ 9 ! label+ !re(4 7#f7 ,if x 0 develop$1 /]iliz$1 packag$1 repackag$1 relabel$1 in/all$1 or import$ 9 an e/abli%m5t n duly regi/]$ "u section #ehg;,j or x 0 n includ$ 9 a li/+ "u section #ehg;,j1 9 accordance ) timely report+ requirem5ts "u ?is sub*apt]4 7#g7 ,9 ! case ( any 9 vitro cl9ical te/ subject to re/rictions "u section #ehg,o1 7#a7 if its adv]tis+ is false or mislead+ 9 any p>ticul>1 7#b7 if x is (f]$ = cl9ical use1 sold1 di/ribut$1 or us$ 9 violation ( su* re/rictions1 or 7#c7 unless ! te/ develop] or di/ributor includes 9 all adv]tisem5ts & o!r descriptive pr9t$ matt] t su* p]son issues or causes to be issu$1 a brief /atem5t ( ! indications = use ( ! 9 vitro cl9ical te/ & relevant w>n+s1 precautions1 side effects1 & contra9dications4 ,?is subsection %all n be applicable to any pr9t$ matt] t ! ,secret>y det]m9es to be label+ z def9$ 9 section #bja7m74 7#h7 ,if x is subject to a mitigat+ measure e/abli%$ "u section #ehg;,e & does n be> su* label+ z may be prescrib$ 9 su* mitigat+ measure4 7#i7 ,if x is subject to a /&>d e/abli%$ "u section #ehg,r & x does n be> su* label+ z may be prescrib$ 9 su* /&>d4 7#aj7 ,unless x be>s su* label+ z may be requir$ by or e/abli%$ "u an applicable label+ requirem5t "u ?is ,act4 7#aa7 ,if !re 0 a failure to comply ) any requirem5t prescrib$ 9 or "u section #ehg;,d1 #ehg;,j1 #ehg,k1 #ehg,l1 #ehg,m1 #ehg,n1 #ehg,x1 #ehg,y1 #ehg,z1 or to provide any report1 mat]ial1 or o!r in=mation requir$ ) respect to 9 vitro cl9ical te/s "u ?is sub*apt]4 #ehg,x4 ,po/m>ket surveillance 7a7 ,9 g5]al 7#a7 ,9 g5]al ,9 addition to o!r applicable requirem5ts "u ?is ,act1 ! ,secret>y may issue an ord] requir+ a develop] ( a high-risk or mod]ate-risk 9 vitro cl9ical te/ to conduct po/m>ket surveillance ( su* 9 vitro cl9ical te/1 if ! failure ( ! 9 vitro cl9ical te/ is reasonably likely to result 9 s]i\s adv]se heal? consequ5ces or dea? f use ( su* 9 vitro cl9ical te/4 7#b7 ,consid]ation ,9 det]m9+ :e!r to require a develop] to conduct po/m>ket surveillance ( an 9 vitro cl9ical te/1 ! ,secret>y %all take into consid]ation ! b5efits & risks = ! pati5t & ! lea/ burd5some pr9ciples "u section #ehg;,b7j74 7b7 ,surveillance approval 7#a7 ,9 g5]al ,ea* develop] requir$ to conduct surveillance ( an 9 vitro cl9ical te/ %all submit1 )9 #cj days ( receiv+ an ord] f ! ,secret>y1 a plan = ! requir$ surveillance4 ,! ,secret>y1 )9 #fj days ( ! receipt ( su* plan1 %all det]m9e if ! p]son designat$ to conduct ! surveillance has ! appropriate qualifications & exp]i5ce to und]take su* surveillance & if ! plan w result 9 useful data t c reveal un=ese5 adv]se ev5ts or o!r in=mation necess>y to protect ! heal? ( pati5ts or ! public4 7#b7 ,timel9e ,! develop] %all comm5ce surveillance "u ?is section n lat] ?an #ae mon?s aft] ! day on :i* ! ,secret>y ord]s su* po/m>ket surveillance1 unless ! ,secret>y det]m9es m "t is ne$$ to comm5ce surveillance4 7#c7 ,prospective surveillance ,! ,secret>y may ord] a prospective surveillance p]iod ( up to #c ye>s4 ,any det]m9ation by ! ,secret>y t a long] p]iod is necess>y %all be made by mutual agreem5t betwe5 ! ,secret>y & ! develop] or1 if no agreem5t c be rea*$1 ^u ! completion ( a dispute resolution process pursuant to section #efb4 #ehg,y4 ,electronic =mat = submissions 7a7 ,9 g5]al ,all submissions to ! ,food & ,drug ,adm9i/ration ) respect to an 9 vitro cl9ical te/1 unless o!rwise agre$ to by ! ,secret>y1 %all-- 7#a7 be made electronically2 & 7#b7 ) respect to ! in=mation requir$ "u sections #ehg;,b & #ehg;,d1 utilize ! sy/em describ$ 9 section #ehg,u4 7b7 ,electronic =mat ,beg9n+ on su* date z ! ,secret>y specifies 9 f9al guidance issu$ "u subsection 7c71 submissions = 9 vitro cl9ical te/s1 includ+ recomm5dations submitt$ by accr$it$ & recogniz$ p]sons "u section #ehg,q1 & any appeals ( action tak5 by ! ,secret>y ) respect to su* submissions1 %all be submitt$ 9 su* electronic =mat z specifi$ by ! ,secret>y 9 su* guidance4 7c7 ,guidance ,! ,secret>y %all issue guidance implem5t+ ?is section4 ,su* guidance may-- 7#a7 provide /&>ds = ! electronic submission requir$ "u subsection 7a7 or ! submission 9 electronic =mat requir$ "u subsection 7b72 7#b7 set =? crit]ia = waiv]s (1 or exemptions f1 ! requirem5ts ( subsection 7a7 or 7b72 & 7#c7 provide any o!r in=mation = ! effici5t implem5tation & en=cem5t ( ?is section4 #ehg,z4 ,po/m>ket rem$ies 7a7 ,safety ,notice 7#a7 ,9 g5]al ,if ! ,secret>y det]m9es t an 9 vitro cl9ical te/ pres5ts an unreasonable risk ( sub/antial h>m to ! public heal?1 & notification "u ?is subsection is necess>y to elim9ate ! unreasonable risk ( su* h>m & no m practicable means is available "u ! provisions ( ?is ,act 7o!r ?an ?is section7 to elim9ate ! risk1 ! ,secret>y may issue su* ord] z may be necess>y to ensure t adequate safety notice is provid$ 9 an appropriate =m1 by ! p]sons & means be/ suit$ "u ! circum/ances1 to all heal? c>e pr(essionals :o prescribe1 ord]1 or use ! 9 vitro cl9ical te/ & to any o!r p]son 7includ+ develop]s1 import]s1 di/ributors1 retail]s1 & us]s7 :o %\ld prop]ly receive su* notice4 7#b7 ,notice to individuals ,an ord] "u ?is subsection %all require t ! individuals subject to ! risk ) respect to :i* ! ord] is to be issu$ be includ$ 9 ! p]sons to be notifi$ ( ! risk unless ! ,secret>y det]m9es t notice to su* individuals w\ld pres5t a great] dang] to ! heal? ( su* individuals ?an no su* notice4 ,if ! ,secret>y makes su* a det]m9ation ) respect to su* individuals1 ! ord] %all require ! heal? c>e pr(essionals :o prescrib$1 ord]$1 or us$ ! 9 vitro cl9ical te/ provide notification to ! individuals = :om ! heal? pr(essionals prescrib$1 ord]$1 or us$ su* te/1 ( ! risk pres5t$ by su* 9 vitro cl9ical te/ & ( any action :i* may be tak5 by or on behalf ( su* individuals to elim9ate or r$uce su* risk4 ,be=e issu+ an ord] "u ?is subsection1 ! ,secret>y %all consult ) ! p]sons requir$ to give notice "u ! ord]4 7b7 ,repair1 ,replacem5t1 or ,refund 7#a7 ,det]m9ation aft] an in=mal he>+ 7,a7 ,9 g5]al ,if1 aft] af=d+ opportunity = an in=mal he>+1 ! ,secret>y det]m9es t-- 7i7 an 9 vitro cl9ical te/ pres5ts an unreasonable risk ( sub/antial h>m to ! public heal?2 7ii7 !re are reasonable gr\nds to believe t ! 9 vitro cl9ical te/ 0 n prop]ly develop$ or manufactur$ consid]+ ! /ate ( ! art z x exi/$ at ! "t ( its developm5t2 7iii7 !re are reasonable gr\nds to believe t ! unreasonable risk 0 n caus$ by failure ( a p]son o!r ?an a develop]1 import]1 di/ributor1 or retail] ( ! 9 vitro cl9ical te/ to ex]cise due c>e 9 ! in/allation1 ma9t5ance1 repair1 or use ( ! 9 vitro cl9ical te/2 & 7iv7 ! notice au?oriz$ by subsection 7a7 w\ld n by itself be suffici5t to elim9ate ! unreasonable risk & action describ$ 9 p>agraph 7#b7 ( ?is subsection is necess>y to elim9ate su* risk1 ! ,secret>y may ord] ! develop]1 import]1 or any di/ributor ( su* 9 vitro cl9ical te/1 or any comb9ation ( su* p]sons1 to submit to him )9 a reasonable "t a plan = tak+ "o or m ( ! actions describ$ 9 p>agraph 7#b74 ,an ord] issu$ "u ! prec$+ s5t5ce :i* is direct$ to m ?an "o p]son %all specify :i* p]son may decide :i* action %all be tak5 "u su* plan & ! p]son specifi$ %all be ! p]son :o ! ,secret>y det]m9es be>s ! pr9cipal1 ultimate f9ancial responsibility = action tak5 "u ! plan unless ! ,secret>y _c det]m9e :o be>s su* responsibility or ! ,secret>y det]m9es t ! protection ( ! public heal? requires t su* decision be made by a p]son 7includ+ a heal? pr(essional or us] ( ! 9 vitro cl9ical te/7 o!r ?an ! p]son ! ,secret>y det]m9es be>s su* responsibility4 7,b7 ,secret>y approval ( plan ,! ,secret>y %all approve a plan submitt$ pursuant to an ord] issu$ "u subp>agraph 7,a7 unless ! ,secret>y det]m9es 7aft] af=d+ opportunity = an in=mal he>+7 t ! action or actions to be tak5 "u ! plan or ! mann] 9 :i* su* action or actions are to be tak5 "u ! plan w n assure t ! unreasonable risk ) respect to :i* su* ord] 0 issu$ w be elim9at$4 ,if ! ,secret>y disapproves a plan1 ! ,secret>y %all ord] a revis$ plan to be submitt$ )9 a reasonable "t4 ,if ! ,secret>y det]m9es 7aft] af=d+ opportunity = an in=mal he>+7 t ! revis$ plan is unsatisfactory or if no revis$ plan or no initial plan has be5 submitt$ to ! ,secret>y )9 ! prescrib$ "t1 ! ,secret>y %all 7i7 prescribe a plan to be c>ri$ out by ! p]son or p]sons to :om ! ord] issu$ "u subp>agraph 7,a7 0 direct$1 or 7ii7 aft] af=d+ an opportunity = an in=mal he>+1 by ord] prescribe a plan to be c>ri$ out by a p]son :o is a develop]1 import]1 di/ributor1 or retail] ( ! 9 vitro cl9ical te/ ) respect to :i* ! ord] 0 issu$ b to :om ! ord] "u subp>agraph 7,a7 0 n direct$4 7#b7 ,actions on a plan ,! actions :i* may be tak5 "u a plan submitt$ "u an ord] issu$ "u p>agraph 7#a77;,a7 are z foll[s3 7,a7 ,to repair ! 9 vitro cl9ical te/ s t x does n pres5t ! unreasonable risk ( sub/antial h>m ) respect to :i* ! ord] "u p>agraph 7#a77;,a7 0 issu$4 7,b7 ,to replace ! 9 vitro cl9ical te/ ) a l or equival5t te/ :i* is 9 con=mity ) all applicable requirem5ts ( ?is ,act4 7,c7 ,to refund ! pur*ase price ( ! 9 vitro cl9ical te/ 7less a reasonable all[ance = use if su* 9 vitro cl9ical te/ has be5 9 ! possession ( ! us] = "o ye> or m at ! "t ( notice ord]$ "u subsection 7a71 or at ! "t ! us] receives actual notice ( ! unreasonable risk ) respect to :i* ! ord] 0 issu$ "u p>agraph 7#a77;,a71 :i*ev] occurs fir/74 7#c7 ,no *>ge ,no *>ge %all be made to any p]son 7o!r ?an a develop]1 import]1 di/ributor or retail]7 = us+ a rem$y describ$ 9 p>agraph 7#b7 & provid$ "u an ord] issu$ "u p>agraph 7#a71 & ! p]son subject to ! ord] %all reimburse ea* p]son 7o!r ?an a develop]1 manufactur]1 import]1 di/ributor1 or retail]7 :o is entitl$ to su* a rem$y = any reasonable & =eseeable exp5ses actually incurr$ by su* p]son 9 us+ su* rem$y4 7c7 ,reimbursem5t ,an ord] issu$ "u subsection 7b77#a77;,a7 ) respect to an 9 vitro cl9ical te/ may require any p]son :o is a develop]1 import]1 di/ributor1 or retail] ( ! 9 vitro cl9ical te/ to reimburse any o!r p]son :o is a develop]1 import]1 di/ributor1 or retail] ( su* 9 vitro cl9ical te/ = su* o!r p]son's exp5ses actually incurr$ 9 connection ) c>ry+ out ! ord] if ! ,secret>y det]m9es su* reimbursem5t is requir$ = ! protection ( ! public heal?4 ,any su* requirem5t %all n affect any rights or obligations "u any contract to :i* ! p]son receiv+ reimbursem5t or ! p]son mak+ su* reimbursem5t is a p>ty4 7d7 ,recall ,au?ority 7#a7 ,9 g5]al ,if ! ,secret>y f9ds t !re is a reasonable probability t an 9 vitro cl9ical te/ approv$ "u section #ehg;,b or (f]$ "u a te*nology c]tification ord] "u section #ehg;,d w\ld cause s]i\s1 adv]se heal? consequ5ces or dea?1 includ+ by ! abs5ce1 significant delay1 or discont9uation ( appropriate m$ical treatm5t1 ! ,secret>y %all issue an ord] requir+ ! appropriate p]son 7includ+ ! develop]s1 import]s1 di/ributors1 or retail]s ( ! 9 vitro cl9ical te/7-- 7,a7 to imm$iately cease di/ribution ( su* 9 vitro cl9ical te/2 & 7,b7 to imm$iately notify heal? pr(essionals & applicable 9 vitro cl9ical te/ us] facilities ( ! ord] & to in/ruct su* pr(essionals & facilities to cease use ( su* 9 vitro cl9ical te/4 7#b7 ,in=mal he>+ ,! ord] issu$ "u p>agraph 7#a77;,a71 %all provide ! p]son subject to ! ord] ) an opportunity = an in=mal he>+1 to be held n lat] ?an #aj cal5d> days aft] ! date ( ! issuance ( ! ord]1 on ! actions requir$ by ! ord] & on :e!r ! ord] %\ld be am5d$ to require a recall ( su* 9 vitro cl9ical te/4 ,if1 aft] provid+ an opportunity = su* a he>+1 ! ,secret>y det]m9es t inadequate gr\nds exi/ to support ! actions requir$ by ! ord]1 ! ,secret>y %all vacate ! ord]4 7#c7 ,am5d$ ord] 7,a7 ,9 g5]al ,if1 aft] provid+ an opportunity = an in=mal he>+ "u p>agraph 7#b71 ! ,secret>y det]m9es t ! ord] %\ld be am5d$ to include a recall ( ! 9 vitro cl9ical te/ ) respect to :i* ! ord] 0 issu$1 ! ,secret>y %all1 except z provid$ 9 subp>agraph 7,b71 am5d ! ord] to require a recall4 ,! ,secret>y %all specify a timetable 9 :i* ! recall w occur & %all require p]iodic reports describ+ ! progress ( ! recall4 7,b7 ,requirem5ts ,an am5d$ ord] "u subp>agraph 7,a7-- 7i7 %all n include recall ( ! 9 vitro cl9ical te/ f individuals2 7ii7 %all n include recall ( an 9 vitro cl9ical te/ f te/ us] facilities if ! ,secret>y det]m9es t ! risk ( recall+ su* 9 vitro cl9ical te/ f ! facilities pres5ts a great] heal? risk ?an ! heal? risk ( n recall+ ! 9 vitro cl9ical te/ f use2 & 7iii7 %all provide = notice to individuals subject to ! risks associat$ ) ! use ( su* 9 vitro cl9ical te/4 ,9 provid+ ! notice requir$ by ?is clause1 ! ,secret>y may use ! assi/ance ( heal? pr(essionals :o prescrib$1 ord]$1 or us$ su* an 9 vitro cl9ical te/ = individuals4 7#d7 ,cl>ification ,! rem$y provid$ by ?is subsection %all be 9 addition to rem$ies provid$ by subsections 7a71 7b71 & 7c74 #ehg;,,aa4 ,applicability 7a7 ,9 g5]al ,an 9 vitro cl9ical te/ %all be subject to ! requirem5ts ( ?is sub*apt]1 except z o!rwise provid$ 9 ?is sub*apt]4 7b7 ,int]/ate comm]ce ,any 9 vitro cl9ical te/ t is (f]$1 includ+ by mak+ available = cl9ical use 9 ! ,unit$ ,/ates is deem$ to be an act t con/itutes introduction into int]/ate comm]ce = purposes ( en=c+ ! requirem5ts ( ?is ,act4 7c7 ,lea/ burd5some requirem5ts 7#a7 ,9 g5]al ,9 c>ry+ out ?is sub*apt]1 ! ,secret>y %all consid] ! lea/ burd5some means necess>y to meet ! applicable /&>d1 & o!r regulatory requirem5ts1 z det]m9$ by ! ,secret>y4 7#b7 ,necess>y def9$ ,= purposes ( p>agraph 7#a7 & p>agraph 7#c71 ! t]m necess>y means ! m9imum requir$ in=mation t w\ld support a det]m9ation by ! ,secret>y t ! application meet ! applicable /&>d or regulatory requirem5t1 z det]m9$ by ! ,secret>y4 7d7 ,s]vice ( ord]s ,ord]s ( ! ,secret>y "u ?is section ) respect to applications "u subsection 7a7 or 7b7 ( section #ehg;,b or supplem5ts "u subsection 7f7 ( su* section %all be s]v$-- 7#a7 9 p]son by any (fic] or employee ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices designat$ by ! ,secret>y2 or 7#b7 by mail+ ! ord] by regi/]$ mail or c]tifi$ mail or electronic equival5t address$ to ! applicant at ! la/ kn[n address 9 ! records ( ! ,secret>y4 7e7 ,laboratories & blood & tissue e/abli%m5ts 7#a7 ,relation to laboratory c]tification pursuant to section #cec ( ! ,public ,heal? ,s]vice ,act ,no?+ 9 ?is sub*apt] %all be con/ru$ to modify ! au?ority ( ! ,secret>y ) respect to laboratories or cl9ical laboratories "u section #cec ( ! ,public ,heal? ,s]vice ,act4 7#b7 ,avoid+ duplication ,9 implem5t+ ?is sub*apt]1 ! ,secret>y %all avoid issu+ or en=c+ regulations or guidance t are duplicative ( regulations or guidance "u section #cec ( ! ,public ,heal? ,s]vice ,act4 7#c7 ,blood & tissue ,no?+ 9 ?is sub*apt] %all be con/ru$ to modify ! au?ority ( ! ,secret>y ) respect to laboratories1 e/abli%m5ts1 or o!r facilities to ! ext5t !y are engag$ 9 ! propagation1 manufacture1 or prep>ation1 includ+ fill+1 label+1 packag+1 & /orage1 ( blood1 blood compon5ts1 human cells1 tissues1 or tissue products pursuant to any requirem5ts "u ?is ,act or section #cea or #cfa ( ! ,public ,heal? ,s]vice ,act4 7f7 ,n comb9ation product ,a product con/itut$ ( a device & an 9 vitro cl9ical te/ is n a comb9ation product & %all be regulat$ z a device4 7g7 ,practice ( m$ic9e ,no?+ 9 ?is sub*apt] %all be con/ru$ to limit or int]f]e ) ! au?ority ( a heal? c>e practition] to prescribe or adm9i/] any lawfully (f]$ 9 vitro cl9ical te/ = any condition or disease )9 a legitimate heal? c>e practition]-pati5t relation%ip pursuant to applicable ,f$]al or ,/ate law4 7h7 ,rules ( con/ruction 7#a7 ,sale1 di/ribution1 label+ ,no?+ 9 ?is p>agraph %all be con/ru$ to limit ! au?ority ( ! ,secret>y to e/abli% or en=ce re/rictions on ! sale1 di/ribution1 or label+ ( an 9 vitro cl9ical te/ "u ?is ,act4 7#b7 ,promotion ( unapprov$ uses ,no?+ 9 ?is p>agraph %all be con/ru$ to alt] any prohibition on ! promotion ( unapprov$ uses ( legally m>ket$ 9 vitro cl9ical te/s4 #ehg;,,bb4 ,judicial review 7a7 ,9 g5]al ,n lat] ?an #cj days aft] an ord] issu$ pursuant to sections #ehg;,b or #ehg;,d1 any p]son adv]sely affect$ by su* ord] may file a petition ) ! ,unit$ ,/ates ,c\rt ( ,appeals = ! ,di/rict ( ,columbia or = ! circuit :]e9 su* p]son resides or has a pr9cipal place ( bus9ess = judicial review ( su* ord]1 9 accordance ) ! proc$ure set =? 9 section #eag7;a74 7b7 ,application ( provisions ,subsections 7a7 ?r\gh 7e7 ( section #eag %all apply ) respect to a petition "u subsection 7a7 ( ?is section 9 ! same mann] su* subsections apply to a petition "u section #eag4 ,subsection 7f7 ( section #eag %all apply to an ord] issu$ "u section #ehg;,b or #ehg;,d4 4 #hbd4 ,en=cem5t & o!r provisions 7a7 ,prohibit$ acts ,section #cja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca71 z am5d$ by section #haa1 is fur!r am5d$-- 7#a7 9 p>agraphs 7a71 7b71 7c71 7g71 7h71 7k71 7q71 7r71 & 7y71 by ins]t+ 9 vitro cl9ical te/1 aft] device1 ea* place x appe>s2 7#b7 9 p>agraph 7g71 by ins]t+ aft] misbr&$1 1 & ! developm5t )9 any ,t]ritory ( any 9 vitro cl9ical te/ t is adult]at$ or misbr&$2 7#c7 9 p>agraph 7y71 by ins]t+ or #ehg,q aft] section #ebc ea* place x appe>s2 7#d7 9 p>agraph 7ff71 by /rik+ or device & ins]t+ 1 device1 or 9 vitro cl9ical te/2 & 7#e7 by add+ at ! end1 ! foll[+3 7jjj7 7#a7 ,=g+1 c\nt]feit+1 simulat+1 or falsely repres5t+1 or )\t prop] au?ority us+ any m>k1 /amp1 tag1 label1 or o!r id5tification ^u any 9 vitro cl9ical te/ or conta9]1 packag+1 or label+ !re( s z to r5d] su* 9 vitro cl9ical te/ a c\nt]feit 9 vitro cl9ical te/4 7#b7 ,mak+1 sell+1 dispos+ (1 or keep+ 9 possession1 control1 or cu/ody1 or conceal+ any pun*1 die1 plate1 /one1 or o!r ?+ design$ to pr9t1 impr9t1 or reproduce ! tradem>k1 trade "n1 or o!r id5tify+ m>k or impr9t ( ano!r or any lik5ess ( any ( ! =ego+ ^u any 9 vitro cl9ical te/ or conta9]1 packag+1 or label+ !re( s z to r5d] su* 9 vitro cl9ical te/ a c\nt]feit 9 vitro cl9ical te/4 7#c7 ,! do+ ( any act :i* causes an 9 vitro cl9ical te/ to be a c\nt]feit 9 vitro cl9ical te/1 or ! sale or disp5s+1 or ! hold+ = sale or disp5s+1 ( a c\nt]feit 9 vitro cl9ical te/4 7kkk7 7#a7 ,! introduction or deliv]y = introduction into int]/ate comm]ce ( an 9 vitro cl9ical te/ 9 violation ( section #ehg;,b7a74 7#b7 ,! mak+ ( a false1 fraudul5t1 or deceptive /atem5t ab\t an 9 vitro cl9ical te/ t is exempt f prem>ket review "u section #ehg;,c4 7#c7 ,! failure to ma9ta9 complete & accurate docum5tation = an exemption z requir$ "u section #ehg;,c or ! failure to provide label+ requir$ "u section #ehg,l4 7#d7 ,) respect to an 9 vitro cl9ical te/1 ! submission ( any report or li/+ "u ?is ,act t is false or mislead+ 9 any mat]ial respect4 7#e7 ,! failure to comply ) a condition ( approval1 or re/riction requir$ "u an approv$ application "u section #ehg;,b2 ! failure to p]=m a risk analysis requir$ by section #ehg;,b2 ! failure to submit an annual update requir$ "u section #ehg;,j7c77#b77;,b72 or ! failure to complete po/m>ket surveillance z requir$ "u section #ehg,x4 7#f7 ,! failure to comply ) applicable requirem5ts to submit an application or report "u section #ehg;,d7e74 7#g7 ,! failure to comply ) applicable mitigat+ measures e/abli%$ "u section #ehg;,e or to submit1 ma9ta91 or make available ! docum5tation requir$ "u section #ehg;,e7b72 or ! failure to comply ) applicable p]=mance /&>ds e/abli%$ "u section #ehg,r4 7#h7 ,! failure to regi/] 9 accordance ) section #ehg;,j1 ! failure to provide in=mation requir$ "u section #ehg;,j7b71 or ! failure to ma9ta9 or submit in=mation requir$ "u section #ehg;,j7c74 7#i7 ,! failure to comply ) requirem5ts "u section #ehg,m or #ehg,n1 ! failure to comply ) a re/riction requir$ "u section #ehg,o1 or ! failure to comply ) label+ & adv]tis+ requirem5ts "u section #ehg,o7b74 7#aj7 ,! failure to comply ) ! requirem5ts ( section #ehg,q4 7#aa7 ,! failure to comply ) any requirem5t ( section #ehg,s2 ! failure to furni% any notification1 in=mation1 mat]ial1 or report requir$ "u section #ehg,s2 or ! failure to comply ) an ord] issu$ "u section #ehg,s4 7#ab7 ,! failure to furni% in=mation reque/$ by ! ,secret>y "u #ehg;,g7d77#b74 4 7b7 ,p5alties ,section #cjc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 is am5d$-- 7#a7 9 subsection 7b77#h71 by ins]t+ or c\nt]feit 9 vitro cl9ical te/ aft] c\nt]feit drug2 7#b7 9 subsection 7c7-- 7,a7 by /rik+ 2 or 7#e7 & ins]t+ 2 7#e72 & 7,b7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 2 or 7#f7 = hav+ violat$ section #cja7;fff77#b7 if su* p]son act$ 9 good fai? & _h no reason to believe t use ( ! pun*1 die1 plate1 /one1 or o!r ?+ involv$ w\ld result 9 an 9 vitro cl9ical te/ be+ a c\nt]feit 9 vitro cl9ical te/1 or = hav+ violat$ section #cja7;fff77#c7 if ! p]son do+ ! act or caus+ x to be done act$ 9 good fai? & _h no reason to believe t ! 9 vitro cl9ical te/ 0 a c\nt]feit 9 vitro cl9ical te/2 & 7#c7 9 subsection 7f77#a7-- 7,a7 9 subp>agraph 7,a7-- 7i7 by ins]t+ or 9 vitro cl9ical te/s aft] :i* relates to devices2 7ii7 by ins]t+ or section #ehg,q7a77#b7 aft] section #gjd7;g72 & 7iii7 by ins]t+ or 9 vitro cl9ical te/s1 z applicable be=e ! p]iod at ! end ( ! second s5t5ce2 & 7,b7 9 subp>agraph 7,b77i71 by /rik+ or #ebj7;f7 & ins]t+ 1 #ebj7;f71 #ehg,k1 or #ehg,m14 7c7 ,seizure ,section #cjd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccd7 is am5d$-- 7#a7 9 subsection 7a77#b7-- 7,a7 by /rik+ 1 & 7,e7 & ins]t+ 1 7,e72 & 7,b7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 & 7,f7 ,any 9 vitro cl9ical te/ t is a c\nt]feit 9 vitro cl9ical te/1 7,g7 ,any conta9]1 packag+1 or label+ ( a c\nt]feit 9 vitro cl9ical te/1 & 7,h7 ,any pun*1 die1 plate1 /one1 label+1 conta9]1 or o!r ?+ us$ or design$ = use 9 mak+ a c\nt]feit 9 vitro cl9ical te/2 7#b7 9 subsection 7d77#a71 by ins]t+ 9 vitro cl9ical te/1 aft] device12 & 7#c7 9 subsection 7g7-- 7,a7 9 p>agraph 7#a71 by ins]t+ 1 9 vitro cl9ical te/1 aft] device ea* place x appe>s2 & 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,a71 by ins]t+ 1 9 vitro cl9ical te/1 aft] device2 & 7ii7 9 subp>agraph 7,b71 by ins]t+ or 9 vitro cl9ical te/ aft] device ea* place x appe>s4 7d7 ,deb>m5t1 tempor>y d5ial ( approval1 & susp5sion ,section #cjf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cce;a7 is am5d$ by add+ at ! end ! foll[+3 7n7 ,9 vitro cl9ical te/s2 m&atory deb>m5t reg>d+ ?ird-,p>ty inspections & reviews 7#a7 ,9 g5]al ,if ! ,secret>y f9ds t a p]son has be5 convict$ ( a felony = a violation ( section #cja7;gg7 or #cja7;jjj77#a71 ! ,secret>y %all deb> su* p]son f be+ accr$it$ "u section #ehg,q & f c>ry+ out activities "u an agreem5t describ$ 9 section #hjc7;b74 7#b7 ,deb>m5t p]iod ,! ,secret>y %all deb> a p]son "u p>agraph 7#a7 = ! foll[+ p]iods3 7,a7 ,! p]iod ( deb>m5t ( a p]son 7o!r ?an an individual7 %all n be less ?an #a ye> or m ?an #aj ye>s1 b if an act lead+ to a subsequ5t deb>m5t "u su* p>agraph occurs )9 #aj ye>s aft] su* p]son has be5 deb>r$ "u su* p>agraph1 ! p]iod ( deb>m5t %all be p]man5t4 7,b7 ,! deb>m5t ( an individual %all be p]man5t4 7#c7 ,t]m9ation ( deb>m5t2 judicial review2 o!r matt]s ,subsections 7c77#c71 7d71 7e71 7i71 7j71 & 7l77#a7 apply ) respect to a p]son 7o!r ?an an individual7 or an individual :o is deb>r$ "u p>agraph 7#a7 to ! same ext5t & 9 ! same mann] z su* subsections apply ) respect to a p]son :o is deb>r$ "u subsection 7a77#a71 or an individual :o is deb>r$ "u subsection 7a77#b71 respectively4 4 7e7 ,exp&$ access to unapprov$ !rapies & diagno/ics ,section #efa ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7 is am5d$-- 7#a7 9 subsections 7a7 ?r\gh 7d7-- 7,a7 by /rik+ or inve/igational devices ea* place x appe>s & ins]t+ 1 inve/igational devices1 or inve/igational 9 vitro cl9ical te/s2 & 7,b7 by /rik+ or inve/igational device ea* place x appe>s 7o!r ?an ! second su* place 9 p>agraph 7#c77;,a77 ( subsection 7c77 & ins]t+ 1 inve/igational device1 or inve/igational 9 vitro cl9ical te/2 7#b7 9 subsection 7b77#d7 by /rik+ or #ebj7;g7 & ins]t+ 1 #ebj7;g71 or #ehg,s ea* place x appe>s2 7#c7 9 subsection 7c7-- 7,a7 by am5d+ ! subsection head+ to read3 ,treatm5t ,inve/igational ,new ,drug ,applications1 ,treatm5t ,inve/igational ,device ,exemptions1 & ,treatm5t ,inve/igational 9 ,vitro ,cl9ical ,te/ ,exemptions4--2 7,b7 9 p>agraph 7#c77;,a71 by /rik+ or inve/igational device exemption 9 effect "u section #ebj7;g7 & ins]t+ 1 inve/igational device exemption 9 effect "u section #ebj7;g71 or inve/igational 9 vitro cl9ical te/ exemption "u section #ehg,s2 7,c7 by /rik+ or treatm5t inve/igational device exemption ea* place x appe>s & ins]t+ 1 treatm5t inve/igational device exemption1 or treatm5t inve/igational 9 vitro cl9ical te/ exemption2 7,d7 9 p>agraph 7#e71 by /rik+ or #ebj7;g7 & ins]t+ 1 #ebj7;g71 or #ehg,s2 & 7,e7 9 ! matt] foll[+ p>agraph 7#g7 by /rik+ or #ebj7;g7 ea* place x appe>s & ins]t+ 1 #ebj7;g7 or #ehg,s2 & 7#d7 by am5d+ subsection 7e7 to read z foll[s3 7e7 ,def9itions ,9 ?is section1 ! t]ms inve/igational drug1 inve/igational device1 inve/igational 9 vitro cl9ical te/1 treatm5t inve/igational new drug application1 treatm5t inve/igational device exemption1 & treatm5t inve/igational 9 vitro cl9ical te/ exemption %all h ! mean+s giv5 ! t]ms 9 regulations prescrib$ by ! ,secret>y4 4 7f7 ,optimiz+ global cl9ical trials ,section #efi;,a7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;a7b77 is am5d$ by ins]t+ an 9 vitro cl9ical te/1 z def9$ 9 subsection 7ss7 ( su* section1 be=e or a biological product4 7g7 ,pati5t p>ticipation 9 m$ical product discussion ,! head+ ( subsection 7a7 ( section #efi;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c7 is am5d$ by /rik+ ,drugs & ,devices & ins]t+ ,drugs1 ,devices1 & ,9 ,vitro ,cl9ical ,te/s4 7h7 ,regulations & he>+s ,section #gja7;h77#a77;,c77ii7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cga7;h77#a77;,c77ii77 is am5d$ by ins]t+ & 9 vitro cl9ical te/s aft] devices4 7i7 ,records ,section #gjc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgc7 is am5d$-- 7#a7 by ins]t+ 9 vitro cl9ical te/s aft] devices ea* place su* t]m appe>s2 & 7#b7 by ins]t+ 9 vitro cl9ical te/ aft] device ea* place su* t]m appe>s4 7j7 ,factory inspection ,section #gjd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7 7o!r ?an subsection 7g77 is am5d$-- 7#a7 by /rik+ drugs or devices ea* place x appe>s & ins]t+ drugs1 devices1 or 9 vitro cl9ical te/s2 7#b7 9 subsection 7a77#a71 9 ! f\r? s5t5ce1 by /rik+ or *apt] ,,ix & ins]t+ section #ehg,s1 section #ehg,m1 section #ehg,n1 or *apt] ,,ix2 7#c7 aft] mak+ ! am5dm5ts 9 p>agraphs 7#a7 & 7#b71 by ins]t+ 9 vitro cl9ical te/s1 aft] devices1 ea* place x appe>s2 7#d7 9 subsection 7a77#b77;,b7-- 7,a7 by ins]t+ or 9 vitro cl9ical te/s aft] prescribe or use devices2 & 7,b7 by ins]t+ or 9 vitro cl9ical te/s aft] process devices2 7#e7 by ins]t+ 9 vitro cl9ical te/1 aft] device1 ea* place x appe>s2 7#f7 9 subsection 7e71 by ins]t+ 1 or section #ehg,m1 #ehg,n1 or #ehg,s1 aft] section #eai or #ebj7;g72 7#g7 9 subsection 7f77#c7-- 7,a7 9 subp>agraph 7,a71 by /rik+ or at ! end2 7,b7 9 subp>agraph 7,b71 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7,c7 aft] subp>agraph 7,b71 by ins]t+ ! foll[+3 7,c7 is accr$it$ "u section #ehg,q4 2 & 7#h7 by add+ at ! end ! foll[+3 7i7 ,= purposes ( ?is section1 ! t]m e/abli%m5t includes a laboratory p]=m+ an 9 vitro cl9ical te/4 4 7k7 ,publicity ,section #gje7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cge7;b77 is am5d$ by ins]t+ 9 vitro cl9ical te/s1 aft] devices14 7l7 ,presumption ,section #gji ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;a7 is am5d$ by ins]t+ 9 vitro cl9ical te/1 aft] device14 7m7 ,li/+ & c]tification ( color additives = foods1 drugs1 & cosmetics ,section #gba7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;e7a77 is am5d$-- 7#a7 9 ! matt] prec$+ p>agraph 7#a71 by ins]t+ or 9 vitro cl9ical te/s aft] or devices2 & 7#b7 9 ! flu% text foll[+ p>agraph 7#b7-- 7,a7 by ins]t+ or an 9 vitro cl9ical te/ aft] a device2 & 7,b7 by ins]t+ or 9 vitro cl9ical te/s aft] devices4 7n7 ,imports & exports ,section #hja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 by ins]t+ 9 vitro cl9ical te/s1 aft] devices1 ea* place x appe>s2 & 7,b7 by ins]t+ 9 ! case ( an 9 vitro cl9ical te/1 ! te/ does n con=m to ! applicable requirem5ts ( section #ehg,k1 or aft] requirem5ts ( section #ebj7;f71 or2 7#b7 9 subsection 7d77#c7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! matt] prec$+ clause 7i71 by ins]t+ & no compon5t ( an 9 vitro cl9ical te/ or o!r article ( 9 vitro cl9ical te/ t requires fur!r process+1 aft] heal?-relat$ purposes2 7ii7 9 clause 7i71 by /rik+ drug or device & ins]t+ drug1 device1 or 9 vitro cl9ical te/2 & 7iii7 9 clause 7i77,i71 by ins]t+ 9 vitro cl9ical te/1 aft] device12 & 7,b7 9 subp>agraph 7,b71 by ins]t+ 9 vitro cl9ical te/1 aft] device12 7#c7 9 subsection 7e77#a71 by ins]t+ 9 vitro cl9ical te/1 aft] device12 & 7#d7 9 subsection 7o7-- 7,a7 by ins]t+ or 9 vitro cl9ical te/ aft] device2 & 7,b7 by ins]t+ section #ehg;,j ( ea* =eign e/abli%m5t aft] section #eaj7;i7 ( ea* e/abli%m5t4 7o7 ,(fice ( int]national relations ,section #hjc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #chc7 is am5d$-- 7#a7 9 subsection 7b7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by ins]t+ & 9 vitro cl9ical te/s aft] devices2 & 7,b7 9 p>agraph 7#a71 by ins]t+ quality requirem5ts e/abli%$ "u section #ehg,k2 & at ! end2 & 7#b7 9 subsection 7c7-- 7,a7 9 p>agraph 7#b71 by ins]t+ 9 vitro cl9ical te/s1 aft] devices12 & 7,b7 9 p>agraph 7#d71 by ins]t+ or 9 vitro cl9ical te/s aft] devices4 7p7 ,recognition ( =eign gov]nm5t inspections ,section #hji7;a77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #chd;e7a77#a77 is am5d$ by ins]t+ 1 or ( =eign e/abli%m5ts regi/]$ "u section #ehg;,j aft] #eaj7;h74 7q7 ,food & drug adm9i/ration ,section #ajjc7;b77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cic7;b77#b77 is am5d$-- 7#a7 9 subp>agraph 7,d71 by /rik+ & at ! end2 7#b7 9 subp>agraph 7,e71 by /rik+ ! semicolon at ! end & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7,f7 9 vitro cl9ical te/s are analytically & cl9ically valid2 4 7r7 ,(fice ( wom5's heal? ,section #ajaa7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cii;b7b77 is am5d$-- 7#a7 9 p>agraph 7#a71 by ins]t+ 9 vitro cl9ical te/s1 aft] devices12 & 7#b7 9 p>agraph 7#d71 by /rik+ & device manufactur]s & ins]t+ device manufactur]s1 & 9 vitro cl9ical te/ develop]s14 7s7 ,c\nt]measure provisions ( ! public heal? s]vice act ,title ,,iii ( ! ,public ,heal? ,s]vice ,act is am5d$-- 7#a7 9 section #cai;,f-#a7;a77#b77;,a7 7#db ,u4,s4,c4 #bdg;d-#f;a7a77#b77;,a77-- 7,a7 9 ! matt] prec$+ clause 7i7-- 7i7 by /rik+ or device & ins]t+ device2 & 7ii7 by ins]t+ or an 9 vitro cl9ical te/s 7z t t]m is def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7ss7771 aft] ,act 7#ba ,u4,s4,c4 #cba7;h77712 & 7,b7 9 ea* ( clauses 7ii7 & 7iii71 by /rik+ or device & ins]t+ device1 or 9 vitro cl9ical te/2 7#b7 9 section #cai;,f-#b7;c77#a77;,b7 7#db ,u4,s4,c4 #bdg;d-#f;b7c77#a77;,b77-- 7,a7 by /rik+ or device & ins]t+ device2 & 7,b7 by ins]t+ 1 or an 9 vitro cl9ical te/ 7z t t]m is def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7ss777 aft] ,act 7#ba ,u4,s4,c4 #cba7;h77712 & 7#c7 9 section #cai;,f-#c7;i77#g7 7#db ,u4,s4,c4 #bdg;d-#f;d7i77#g77-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a7-- 7i7 by /rik+ or device & ins]t+ device2 & 7ii7 by ins]t+ or an 9 vitro cl9ical te/s 7z t t]m is def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7ss7771 aft] ,act 7#ba ,u4,s4,c4 #cba7;h772 7,b7 9 subp>agraph 7,a7-- 7i7 by mov+ ! m>g9 ( clause 7iii7 #b ems to ! left2 & 7ii7 9 clause 7iii71 by /rik+ or device & ins]t+ device1 or 9 vitro cl9ical te/2 & 7,c7 9 subp>agraph 7,b7-- 7i7 9 clause 7i71 by ins]t+ or ! subject ( a te*nology c]tification ord] aft] approv$ or cle>$2 & 7ii7 9 clause 7ii71 by /rik+ or #ebj7;g7 & ins]t+ 1 #ebj7;g71 or #ehg,s4 #hbe4 ,transition 7a7 ,implem5tation 7#a7 ,effective date 7,a7 ,9 g5]al ,except z o!rwise provid$ 9 ?is section1 ! am5dm5ts made by ?is ,act %all take effect on ,octob] #a1 #bjbg 79 ?is section & 9 sub*apt] ,j ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act1 ref]r$ to 9 ?is section z ! effective date ( ?is ,act74 7,b7 ,exceptions 7i7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 may take ! actions describ$ 9 p>agraph 7#c71 & may exp5d su* funds z ! ,secret>y det]m9es necess>y to ensure an ord]ly transition1 includ+ prior to ! effect date ( ?is ,act4 7ii7 ,implem5tation ( c]ta9 provisions ,! ,secret>y may implem5t sections #ehg;,j & #ehg,u ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by section #c7 beg9n+ on ,octob] #a1 #bjbd1 & su* sections may take effect n e>li] ?an ,octob] #a1 #bjbg1 to ! ext5t & = ! purposes indicat$ 9 su* sections4 ,9 ! case ( a develop] :o1 betwe5 ,octob] #a1 #bjbd1 & ! effective date ( ?is ,act specifi$ 9 subp>agraph 7,a71 regi/]s "u su* section #ehg,k ) respect to an article t is an 9 vitro cl9ical te/1 su* develop] %all n be requir$ to regi/] ) respect to su* article "u section #eaj ( su* ,act 7#ba ,u4,s4,c4 #cfj74 7#b7 ,actions ,! ,secret>y-- 7,a7 %all-- 7i7 )9 #a ye> ( ! date ( enactm5t ( ?is ,act1 hold ! public meet+s describ$ 9 section #ehg;,d7c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by section #c72 7ii7 )9 #c ye>s ( ! date ( enactm5t ( ?is ,act1 promulgate f9al regulations requir$ "u ! am5dm5ts made by ?is ,act2 & 7iii7 )9 #cj mon?s ( ! date ( enactm5t ( ?is ,act1 issue f9al guidance on applicability requirem5ts "u am5dm5ts made by ?is ,act2 & 7,b7 may take additional actions aft] ! date ( enactm5t t ! ,secret>y det]m9es necess>y to ensure an ord]ly transition1 :i* may n take effect until aft] ! effective date1 includ+-- 7i7 e/abli%m5t ( mitigat+ measures = an 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s2 & 7ii7 e/abli%m5t ( ! compreh5sive te/ in=mation sy/em "u section #ehg,t4 7#c7 ,applicability ( guidance & regulations ,not)/&+ ! date on :i* guidance or regulations are issu$ "u p>agraph 7#c7 & section #ehg,k1 no guidance or regulations issu$ pursuant to ! am5dm5ts made by ?is ,act %all be implem5t$ or take effect until ! effective date ( ?is ,act1 z describ$ 9 p>agraph 7#a71 except z o!rwise specifi$ 9 ?is ,act 7includ+ ! am5dm5ts made by ?is ,act74 7b7 ,application ( au?orities to 9 vitro cl9ical te/s "u review on ! effective date ( ?is act ,= any 9 vitro cl9ical te/1 z def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #hbb1 = :i* a submission = approval "u section #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e71 cle>ance "u section #eaj7k7 ( su* ,act 7#ba ,u4,s4,c4 #cfj7k771 au?orization "u section #eac7;f77#b7 ( su* ,act 7#ba ,u4,s4,c4 #cfj;c7f77#b771 or lic5sure "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 is p5d+ on ! effective date ( ?is ,act1 includ+ transitional 9 vitro cl9ical te/s z describ$ 9 subsection 7c71 ! ,secret>y may review & take action on su* submission aft] ! effective date ( ?is ,act accord+ to ! /atutory provision "u :i* su* submission 0 submitt$4 7c7 ,application ( au?orities to transitional ,9 vitro cl9ical te/s 7#a7 ,def9ition ,= purposes ( ?is section1 ! t]m transitional 9 vitro cl9ical te/ means an 9 vitro cl9ical te/1 z def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act1 t-- 7,a7 is fir/ (f]$ = cl9ical use dur+ ! p]iod beg9n+ on ! date ( enactm5t ( ?is ,act & end+ on ! effective date ( ?is ,act2 7,b7 is develop$ by a cl9ical laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfc;a7 t meets ! requirem5ts = p]=m+ high-complexity te/+ & p]=m$-- 7i7 9 ! same cl9ical laboratory 9 :i* ! te/ 0 develop$ & = :i* a c]tification is /ill 9 effect "u su* section #cec t meets ! requirem5ts to p]=m te/s ( high complexity2 7ii7 by ano!r laboratory = :i* a c]tificate is 9 effect "u su* section #cec t meets ! requirem5ts to p]=m te/s ( high complexity1 is )9 ! same corporate organization1 & has common own]%ip by ! same p>5t corporation z ! laboratory 9 :i* ! te/ 0 develop$2 or 7iii7 9 ! case ( a te/ t 0 develop$ by ! ,c5t]s = ,disease ,control & ,prev5tion or ano!r laboratory a public heal? laboratory network coord9at$ or manag$ by ! ,c5t]s = ,disease ,control & ,prev5tion1 by a cl9ical laboratory = :i* a c]tificate is 9 effect "u section #cec ( su* ,act t meets ! requirem5ts to p]=m te/s ( high complexity1 & t is )9 a public heal? laboratory network coord9at$ or manag$ by ! ,c5t]s = ,disease ,control & ,prev5tion2 & 7,c7 :5 fir/ (f]$1 is n approv$ "u section #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 cle>$ "u section #eaj7k7 ( su* ,act1 au?oriz$ "u section #eac7;f77#b7 ( su* ,act1 subject to a humanit>ian device exemption "u section #ebj7m7 ( su* ,act 7#ba ,u4,s4,c4 #cfj;j7m771 subject to an exemption = inve/igation use "u section #ebj7;g7 ( su* ,act 7#ba ,u4,s4,c4 #cfj;j7g771 au?oriz$ "u section #efd ( su* ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c71 or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 7#b7 ,prem>ket review or te*nology c]tification ,a transitional 9 vitro cl9ical te/ t is ! subject ( an application = prem>ket review "u section #ehg;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or te*nology c]tification application "u section #ehg;,d ( su* ,act1 z add$ by ?is ,act1 may cont9ue to be (f]$1 sold1 or di/ribut$ until completion ( ! ,secret>y's review ( ! prem>ket application or te*nology c]tification application1 if su* application is submitt$ no lat] ?an #ij days aft] ! effective date ( ?is ,act4 7#c7 ,te/s approv$ by new york /ate ,not)/&+ p>agraph 7#b71 a transitional 9 vitro cl9ical te/ t has be5 approv$ by ! ,new ,york ,/ate ,dep>tm5t ( ,heal? may cont9ue to be (f]$1 sold1 or di/ribut$ aft] ! effective date if-- 7,a7 />t+ on ! effective date ( ?is ,act1 ! 9 vitro cl9ical te/ complies ) ! requirem5ts ( sub*apt] ,j ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act1 except = sections #ehg;,b & design control provisions ( section #ehg,k2 7,b7 ea* te/ report template = ! te/ be>s a /atem5t ( adequate prom95ce t reads z foll[s3 ,?is 9 vitro cl9ical te/ 0 develop$ & fir/ introduc$ prior to ! effective date ( ! ,,valid ,act ( #bjbb4 ,?is te/ 0 approv$ by ! ,new ,york ,/ate ,dep>tm5t ( ,heal?1 b ! te/ has n be5 review$ by ! ,food & ,drug ,adm9i/ration42 7,c7 a prem>ket application "u section #ehg;,b or te*nology c]tification application "u section #ehg;,d is submitt$ no lat] ?an-- 7i7 #e ye>s aft] ! effective date ( ?is ,act1 if ! 9 vitro cl9ical te/ is approv$ by ! ,new ,york ,/ate ,dep>tm5t ( ,heal? z a g5etic te/+ molecul> te/1 a microbiology molecul> te/1 an oncology molecul> te/1 or any o!r type ( molecul> te/2 or 7ii7 #b ye>s aft] ! effective date ( ?is ,act1 if ! 9 vitro cl9ical te/ is approv$ by ! ,new ,york ,/ate ,dep>tm5t ( ,heal? z a type ( te/ n describ$ 9 clause 7i72 & 7,d7 a te/ 9 compliance ) ?is p>agraph 7#c7 may cont9ue to be (f]$1 sold1 or di/ribut$ until ! completion ( ! ,secret>y's review ( ! prem>ket application or te*nology c]tification application ref]5c$ 9 subp>agraph 7,c74 7d7 ,conv]sion 7#a7 ,deem$ prem>ket approval ,beg9n+ on ! effective date ( ?is ,act-- 7,a7 any 9 vitro cl9ical te/ 7z def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #hbb7 ) a prem>ket approval "u section #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7 or a lic5sure "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 is deem$ to be approv$ pursuant to an application "u section #ehg;,b7c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act2 & 7,b7 any 9 vitro cl9ical te/ 7z s def9$7 t 0 cle>$ "u section #eaj7k7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7k77 or au?oriz$ "u section #eac7;f77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7f77#b77 is deem$ to be approv$ pursuant to an application "u section #ehg;,b7d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act4 7#b7 ,deem$ inve/igational use exemption ,any 9 vitro cl9ical te/ 7z def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #hbb7 t has an inve/igational device exemption 9 effect "u section #ebj7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7g77 is deem$ to h an inve/igational use exemption 9 effect "u section #ehg,s ( su* ,act1 z add$ by ?is ,act1 beg9n+ on ! effective date ( ?is ,act4 7#c7 ,deem$ humanit>ian device exemption ,any 9 vitro cl9ical te/ 7z def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #hbb7 t has an approv$ humanit>ian device exemption "u section #ebj7m7 ( su* ,act is deem$ to h a humanit>ian te/ exemption "u section #ehg;,a7g7 ( su* ,act1 z add$ by ?is ,act1 beg9n+ on ! effective date ( ?is ,act4 7#d7 ,deem$ designat$ break?r\gh ,any 9 vitro cl9ical te/ 7z def9$ 9 section #bja7;gg7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #hbb7 t has receiv$ a break?r\gh device designation "u section #eae;,b7e77#a77;,d7 ( su* ,act 7#ba ,u4,s4,c4 #cfj;e-#c7;e77#a77;,d77 is deem$ to h a break?r\gh 9 vitro cl9ical te/ designation "u section #ehg;,c ( su* ,act1 z add$ by ?is ,act1 beg9n+ on ! effective date ( ?is ,act4 7#e7 ,deem$ reque/ = in=mal fe$back ,) reg>d to any 9 vitro cl9ical te/ t is ! subject ( a pre-submission reque/ describ$ 9 ! guidance1 ,reque/s = ,fe$back & ,meet+s = ,m$ical ,device ,submissions3 ,! ,q-,submission ,program1 issu$ by ! ,food & ,drug ,adm9i/ration on ,janu>y #f1 #bjba1 su* reque/ is deem$ to con/itute a reque/ = in=mal fe$back "u section #ehg;,f ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #hbc1 beg9n+ on ! effective date ( ?is ,act4 7e7 ,previ\sly classifi$ devices ,not)/&+ section #ehg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #hbc1 = purposes ( sub*apt] ,j ( *apt] ,v ( su* ,act1 z add$ by section #hbc1 ! foll[+ apply3 7#a7 ,9 ! case ( an 9 vitro cl9ical te/ type t has be5 classifi$ by ! ,secret>y z a class ,i device pursuant to section #eac ( su* ,act 7#ba ,u4,s4,c4 #cfj;c71 su* 9 vitro cl9ical te/ %all be l[-risk1 unless ! 9 vitro cl9ical te/ is a te/ describ$ 9 section #eaj7l7 or ! te/ is r$esignat$ by ! ,secret>y pursuant to section #ehg;,f ( su* ,act4 7#b7 ,9 ! case ( an 9 vitro cl9ical te/ type t has be5 classifi$ by ! ,secret>y z a class ,,ii device pursuant to section #eac ( su* ,act 7#ba ,u4,s4,c4 #cfj;c71 su* 9 vitro cl9ical te/ %all be mod]ate-risk1 unless inaccurate results f ! te/ w\ld be imm$iately life ?reat5+ or ! te/ is r$esignat$ by ! ,secret>y pursuant to section #ehg;,f ( su* ,act4 7#c7 ,9 ! case ( an 9 vitro cl9ical te/ type t is a class ,,iii device pursuant to section #eac ( su* ,act 7#ba ,u4,s4,c4 #cfj;c71 su* 9 vitro cl9ical te/ %all be high-risk1 unless r$esignat$ by ! ,secret>y pursuant to section #ehg;,f ( su* ,act4 #hbf4 ,em]g5cy use au?orization 7a7 ,9 g5]al ,section #efd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraphs 7#a7 & 7#d77;,c71 by ins]t+ 9 vitro cl9ical te/1 be=e or biological product ea* place su* t]m appe>s2 & 7,b7 9 p>agraph 7#b77;,a71 by /rik+ or #eae & ins]t+ #eae1 or #ehg;,b2 7#b7 9 subsection 7e7-- 7,a7 9 p>agraph 7#c7-- 7i7 9 subp>agraph 7,b71 by /rik+ & at ! end2 7ii7 9 subp>agraph 7,c71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+3 7,d7 quality requirem5ts 7) respect to 9 vitro cl9ical te/s7 "u section #ehg,k4 2 & 7,b7 9 p>agraph 7#d7-- 7i7 9 subp>agraph 7,a71 by /rik+ 2 or & ins]t+ a semicolon2 7ii7 9 subp>agraph 7,b71 by /rik+ ! p]iod & ins]t+ 2 or2 & 7iii7 by add+ at ! end ! foll[+3 7,c7 ) respect to 9 vitro cl9ical te/s1 requirem5ts applicable to re/rict$ 9 vitro cl9ical te/s pursuant to section #ehg,o4 2 7#c7 9 subsection 7m7-- 7,a7 9 ! subsection head+1 by /rik+ ,laboratory te/s associat$ ) devices ins]t+ 9 vitro cl9ical te/s aft] devices2 & 7,b7 9 p>agraph 7#a7-- 7i7 by /rik+ to a device & ins]t+ to an 9 vitro cl9ical te/2 & 7ii7 by /rik+ su* device & ins]t+ su* 9 vitro cl9ical te/4 7b7 ,em]g5cy use ( m$ical products ,section #efd;,a7a77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c;a7a77#b77 is am5d$ by ins]t+ 9 vitro cl9ical te/1 aft] device14 7c7 ,products held = em]g5cy use ,section #efd;,b7#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c;b7#b77 is am5d$-- 7#a7 9 subp>agraph 7,a71 by /rik+ or #eae & ins]t+ #eae1 or #ehg;,b2 & 7#b7 9 subp>agraph 7,b71 by /rik+ or #ebj & ins]t+ #ebj1 or #ehg,s4 #hbg4 ,antimicrobial susceptibility te/s ,section #eaa;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;a-#b7 is am5d$-- 7#a7 9 subsection 7a77#a77;,c7-- 7,a7 by /rik+ cle> "u section #eaj7k71 classify "u section #eac7;f77#b71 or approve "u section #eae & ins]t+ approve "u section #ehg;,b1 exempt f prem>ket review "u section #ehg;,c1 or grant a te*nology c]tification ord] "u section #ehg;,d2 & 7,b7 by /rik+ te/+ devices & ins]t+ 9 vitro cl9ical te/s2 7#b7 9 subsection 7c77#e71 by /rik+ drug or device ea* place x appe>s & ins]t+ drug1 device1 or 9 vitro cl9ical te/2 7#c7 9 subsection 7e7-- 7,a7 9 ! head+1 by /rik+ te/+ devices & ins]t+ ,9 vitro cl9ical te/s2 7,b7 9 p>agraph 7#a7-- 7i7 by /rik+ #eaj1 #eac1 & #eae1 & ins]t+ #ehg;,b1 & #ehg;,d2 7ii7 by /rik+ antimicrobial susceptibility te/+ device & ins]t+ antimicrobial susceptibility 9 vitro cl9ical te/2 & 7iii7 by /rik+ su* device & ins]t+ su* 9 vitro cl9ical te/2 & 7,c7 9 p>agraph 7#b7-- 7i7 9 ! head+1 by /rik+ te/+ devices & ins]t+ 9 vitro cl9ical te/s2 7ii7 9 subp>agraphs 7,a7 & 7,b7 7o!r ?an clause 7iii7 ( su* subp>agraph 7,b771 by /rik+ device ea* place x appe>s & ins]t+ 9 vitro cl9ical te/2 7iii7 9 subp>agraph 7,b77iii71 by /rik+ a device & ins]t+ an 9 vitro cl9ical te/2 & 7iv7 by am5d+ subp>agraph 7,c7 to read z foll[s3 7,c7 ,! antimicrobial susceptibility 9 vitro cl9ical te/ meets all o!r requirem5ts to be approv$ "u section #ehg;,b1 exempt$ f prem>ket review "u section #ehg;,c1 or (f]$ "u a te*nology c]tification ord] "u section #ehg;,d4 2 7#d7 9 subsection 7f71 by am5d+ p>agraph 7#a7 to read z foll[s3 7#a7 ,! t]m antimicrobial susceptibility 9 vitro cl9ical te/ means an 9 vitro cl9ical te/ t utilizes susceptibility te/ int]pretive crit]ia to det]m9e & report ! 9 vitro susceptibility ( c]ta9 microorganisms to a drug 7or drugs74 2 & 7#e7 9 subsection 7g77#b7-- 7,a7 by am5d+ ! matt] prec$+ subp>agraph 7,a7 to read z foll[s3 7#b7 ) respect to approv+ an application "u section #ehg;,b or grant+ a te*nology c]tification ord] "u section #ehg;,d-- 2 & 7,b7 9 subp>agraph 7,a7-- 7i7 by /rik+ device & ins]t+ 9 vitro cl9ical te/2 & 7ii7 by /rik+ antimicrobial susceptibility te/+ device & ins]t+ antimicrobial susceptibility 9 vitro cl9ical te/4 #hbh4 ,comb9ation products 7a7 ,9 g5]al ,section #ejc7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;g77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a71 by /rik+ or biological product & ins]t+ 9 vitro cl9ical te/1 or biological product 7except = a product con/itut$ ( a device & an 9 vitro cl9ical te/72 7,b7 9 subp>agraph 7,b71 by add+ at ! end ! foll[+3 ,= purposes ( ?is ,act1 a product t con/itutes a comb9ation ( a drug & an 9 vitro cl9ical te/ is n a comb9ation product )9 ! mean+ ( ?is subsection42 & 7,c7 9 subp>agraph 7,d77ii7-- 7i7 by ins]t+ or 9 vitro cl9ical te/ aft] device2 & 7ii7 by ins]t+ & 9 vitro cl9ical te/s be=e %all2 7#b7 9 p>agraph 7#c71 by /rik+ safety & effectiv5ess or sub/antial equival5ce & ins]t+ safety & effectiv5ess1 sub/antial equival5ce1 or analytical validity & cl9ical validity be=e = ! approv$ con/itu5t "p2 7#c7 9 p>agraph 7#d7-- 7,a7 9 subp>agraph 7,a71 by /rik+ or #eac7;f77#b7 7submitt$ 9 accordance ) p>agraph 7#e77 & ins]t+ #eac7;f77#b7 7submitt$ 9 accordance ) p>agraph 7#e771 #ehg;,b1 or #ehg;,d1 or an exempt te/ "u section #ehg;,c1 z applicable2 & 7,b7 9 subp>agraph 7,b71 by ins]t+ 1 #ehg;,b1 or #ehg;,d aft] section #eae2 7#d7 9 p>agraph 7#e77;,a71 by /rik+ or #eaj7k7 & ins]t+ 1 #eaj7k71 #ehg;,b1 or #ehg;,d2 7#e7 9 p>agraph 7#g71 by /rik+ or sub/antial equival5ce & ins]t+ 1 sub/antial equival5ce1 or analytical validity & cl9ical validity2 7#f7 9 p>agraph 7#h71 by add+ at ! end ! foll[+3 7,i7 ,?is p>agraph %all n apply to a product con/itut$ ( a device & an 9 vitro cl9ical te/4 2 & 7#g7 9 p>agraph 7#i7-- 7,a7 9 subp>agraph 7,c77i71 by /rik+ or #ebj7;g7 & ins]t+ #ebj7;g71 #ehg;,b1 or #ehg;,d2 & 7,b7 9 subp>agraph 7,d71 by /rik+ or #ebj & ins]t+ #ebj1 #ehg;,b1 or #ehg;,d4 7b7 ,classification ( products ,section #efc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#b7 is am5d$ by add+ at ! end ! foll[+3 7d7 ,exemption ,?is section %all n apply to a product con/itut$ ( a device & an 9 vitro cl9ical te/4 4 #hbi4 ,res\rces 7a7 ,f9d+s ,congress f9ds t ! fees au?oriz$ by ?is section w be d$icat$ to meet+ ! goals id5tifi$ 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 7b7 ,au?orization ( appropriations ,= purposes ( fund+ implem5tation ( sub*apt] ,j ( title ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act1 includ+ und]tak+ activities = ! developm5t ( regulations & guidances1 hir+ ( necess>y /aff1 & ! developm5t ( te*nology sy/ems to implem5t ?is sub*apt] 9 a timely1 effective1 & effici5t mann] !re is au?oriz$ to be appropriat$ #dhj1jjj1jjj4 7c7 ,e/abli%m5t ( us] fee program 7#a7 ,developm5t ( us] fees = 9 vitro cl9ical te/s 7,a7 ,9 g5]al ,beg9n+ n lat] ?an ,octob] #a1 #bjba1 ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all develop recomm5dations to pres5t to ,congress ) respect to ! goals1 & plans = meet+ ! goals1 = ! process = ! review ( 9 vitro cl9ical te/ submissions & applications "u sub*apt] ,j ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act1 = ! fir/ #e fiscal ye>s aft] fiscal ye> #bjbb4 ,9 develop+ su* recomm5dations1 ! ,secret>y %all consult )-- 7i7 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate2 7ii7 ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 7iii7 sci5tific & academic exp]ts2 7iv7 heal? c>e pr(essionals2 7v7 repres5tatives ( pati5t & consum] advocacy gr\ps2 & 7vi7 ! regulat$ indu/ry4 7,b7 ,prior public input ,prior to beg9n+ negotiations ) ! regulat$ indu/ry on ! au?orization ( su* sub*apt] ,j1 ! ,secret>y %all-- 7i7 publi% a notice 9 ! ,f$]al ,regi/] reque/+ public input on ! au?orization ( us] fees2 7ii7 hold a public meet+ at :i* ! public may pres5t its views on ! au?orization1 includ+ specific sugge/ions = ! recomm5dations submitt$ "u subp>agraph 7,e72 7iii7 provide a p]iod ( #cj days aft] ! public meet+ to obta9 writt5 comm5ts f ! public sugge/+ *anges to su* sub*apt] ,j2 & 7iv7 publi% any comm5ts receiv$ "u clause 7iii7 on ! website ( ! ,food & ,drug ,adm9i/ration4 7,c7 ,p]iodic consultation ,n less frequ5tly ?an once e mon? dur+ negotiations ) ! regulat$ indu/ry1 ! ,secret>y %all hold discussions ) repres5tatives ( pati5t & consum] advocacy gr\ps to cont9ue discussions ( ! au?orization "u su* sub*apt] ,j & to solicit sugge/ions to be includ$ 9 ! recomm5dations transmitt$ to ,congress "u subp>agraph 7,e74 7,d7 ,public review ( recomm5dations ,aft] negotiations ) ! regulat$ indu/ry1 ! ,secret>y %all-- 7i7 pres5t ! recomm5dations develop$ "u subp>agraph 7,a7 to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 7ii7 publi% su* recomm5dations 9 ! ,f$]al ,regi/]2 7iii7 provide = a p]iod ( #cj days = ! public to provide writt5 comm5ts on su* recomm5dations2 7iv7 hold a meet+ at :i* ! public may pres5t its views on su* recomm5dations2 & 7v7 aft] consid]ation ( su* public views & comm5ts1 revise su* recomm5dations z necess>y4 7,e7 ,transmittal ( recomm5dations 7i7 ,9 g5]al ,n lat] ?an ,janu>y #ae1 #bjbg1 ! ,secret>y %all transmit to ,congress ! revis$ recomm5dations "u subp>agraph 7,a71 a summ>y ( ! views & comm5ts receiv$ "u su* subp>agraph1 & any *anges made to ! recomm5dations 9 response to su* views & comm5ts4 7ii7 ,recomm5dation requirem5ts ,! recomm5dations transmitt$ "u ?is subp>agraph %all-- 7,i7 include ! numb] ( full-"t equival5t employees p] fiscal ye> t are agre$ to be hir$ to c>ry out ! goals includ$ 9 su* recomm5dations = ea* ye> ( ! #e-ye> p]iod2 7,,ii7 provide t ! am\nt ( op]at+ res]ve balance 9 ! us] fee program e/abli%$ "u ?is section is n m ?an ! equival5t ( #aj weeks ( op]at+ res]ve2 7,,iii7 require ! developm5t ( a /rategic plan = any surplus )9 ! op]at+ res]ve acc\nt above ! #aj-week op]at+ res]ve )9 #b ye>s ( ! e/abli%m5t ( ! program2 7,,iv7 include an op]at+ res]ve adju/m5t su* t1 if ! ,secret>y has an op]at+ res]ve balance 9 excess ( #aj weeks ( su* op]at+ res]ves1 ! ,secret>y %all decrease su* fee rev5ue & fees to provide = n m ?an #aj weeks ( su* op]at+ res]ves2 7,v7 if an adju/m5t is made z describ$ 9 subclause 7,,iv71 provide ! rationale = ! am\nt ( ! decrease 9 fee rev5ue & fees %all be conta9$ 9 ! ,f$]al ,regi/]2 & 7,,vi7 provide t ! fees assess$ & collect$ = ! full-"t equival5t employees at ! ,c5t] = ,devices & ,radiological ,heal?1 ) respect to :i* ! majority ( "t report+ data indicates are d$icat$ to ! process = ! review ( 9 vitro cl9ical te/ submissions & applications "u p>agraph 7#e71 are n support$ by ! funds au?oriz$ to be collect$ & assess$ "u section #gch ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j74 7,f7 ,publication ( recomm5dations ,! ,secret>y %all publi% on ! website ( ! ,food & ,drug ,adm9i/ration ! revis$ recomm5dations "u subp>agraph 7,a71 a summ>y ( ! views & comm5ts receiv$ "u subp>agraphs 7,b7 ?r\gh 7,d71 & any *anges made to ! recomm5dations orig9ally propos$ by ! ,secret>y 9 response to su* views & comm5ts4 7,g7 ,m9utes ( negotiation meet+s 7i7 ,public availability ,! ,secret>y %all make publicly available1 on ! website ( ! ,food & ,drug ,adm9i/ration1 m9utes ( all negotiation meet+s conduct$ "u ?is subsection betwe5 ! ,food & ,drug ,adm9i/ration & ! regulat$ indu/ry n lat] ?an #cj days aft] su* meet+4 7ii7 ,cont5t ,! m9utes describ$ "u clause 7i7 %all summ>ize any sub/antive proposal made by any p>ty to ! negotiations1 any significant controv]sies or diff]5ces ( op9ion dur+ ! negotiations1 & ! resolution ( any su* controv]sy or diff]5ce ( op9ion4 7#b7 ,e/abli%m5t ( us] fee program ,effective on ,octob] #a1 #bjbg1 provid$ t ! ,secret>y transmits ! recomm5dations "u p>agraph 7#a77;,e71 ! ,secret>y is au?oriz$ to collect us] fees relat+ to ! review ( 9 vitro cl9ical te/ submissions & applications "u sub*apt] ,j ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act4 ,fees "u su* program %all be assess$ & collect$ only if ! requirem5ts "u p>agraph 7#d7 are met4 7#c7 ,audit 7,a7 ,9 g5]al ,on ! date t is #b ye>s aft] fir/ receiv+ a us] fee applicable to submission ( an 9 vitro cl9ical te/ application submitt$ "u sub*apt] ,j ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act1 & on a bi5nial basis !reaft]1 ! ,secret>y %all p]=m an audit ( ! co/s ( review+ su* applications "u su* sub*apt] ,j4 ,su* an audit %all comp>e ! co/s ( review+ su* applications "u su* sub*apt] ,j to ! am\nt ( ! us] fee applicable to su* applications4 7,b7 ,alt]ation ( us] fee ,if ! audit p]=m$ "u subp>agraph 7,a7 indicates t ! us] fees applicable to applications submitt$ "u su* sub*apt] ,j exce$ #di p]c5t ( ! co/s ( review+ su* applications1 ! ,secret>y %all alt] ! us] fees applicable to applications submitt$ "u su* sub*apt] ,j su* t ! us] fees d n exce$ su* p]c5tage4 7,c7 ,acc\nt+ /&>ds ,! ,secret>y %all p]=m an audit "u subp>agraph 7,a7 9 con=mance ) ! acc\nt+ pr9ciples1 /&>ds1 & requirem5ts prescrib$ by ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates "u section #ceaa ( title #ca1 ,unit$ ,/ates ,code1 to ensure ! validity ( any pot5tial v>iability4 7#d7 ,conditions ,! us] fee program describ$ 9 ?is subsection %all take effect only if ! ,food & ,drug ,adm9i/ration issues draft guidance relat$ to ! review requirem5ts = 9 vitro diagno/ic te/s t w\ld be subject to prem>ket review "u section #ehg;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #hbc1 ! review requirem5ts = te/ categories eligible = te*nology c]tification "u section #ehg;,d ( su* ,act1 z add$ by section #hbc1 & ! p>amet]s = ! te/ categories t w\ld be exempt f any review "u sub*apt] ,j ( *apt] ,v ( su* ,act4 7#e7 ,us] fee program def9itions & res\rce requirem5ts 7,a7 ,9 g5]al ,! t]m process = ! review ( 9 vitro cl9ical te/ submissions & applications means ! foll[+ activities ( ! ,secret>y ) respect to ! review ( 9 vitro cl9ical te/ prem>ket & te*nology c]tification applications includ+ supplem5ts = su* applications3 7i7 ,! activities necess>y = ! review ( prem>ket applications1 prem>ket reports1 te*nology c]tification applications1 & supplem5ts to su* applications4 7ii7 ,actions relat$ to submissions 9 connection ) 9 vitro cl9ical te/ developm5t1 ! issuance ( action lett]s t all[ ! m>ket+ ( 9 vitro cl9ical te/s or :i* set =? 9 detail ! specific defici5cies 9 su* applications1 reports1 supplem5ts1 or submissions &1 :]e appropriate1 ! actions necess>y to support ! developm5t ( 9 vitro cl9ical te/s4 7iii7 ,! inspection ( manufactur+ e/abli%m5ts & o!r facilities und]tak5 z "p ( ! ,secret>y's review ( p5d+ prem>ket applications1 te*nology c]tifications1 & supplem5ts4 7iv7 ,monitor+ ( rese>* conduct$ 9 connection ) ! review ( su* applications1 supplem5ts1 & submissions4 7v7 ,review ( 9 vitro cl9ical te/ applications subject to section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 & activities conduct$ 9 anticipation ( ! submission ( su* applications = inve/igational use "u section #ehg,s ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by section #hbc74 7vi7 ,! developm5t ( guidance1 policy docum5ts1 or regulations to improve ! process = ! review ( prem>ket applications1 te*nology c]tification applications1 & supplem5ts4 7vii7 ,! developm5t ( volunt>y te/ me?ods1 cons5sus /&>ds1 or m&atory p]=mance /&>ds 9 connection ) ! review ( su* applications1 supplem5ts1 or submissions & relat$ activities4 7viii7 ,! provision ( te*nical assi/ance to 9 vitro cl9ical te/ develop]s 9 connection ) ! submission ( su* applications1 reports1 supplem5ts1 or submissions4 7ix7 ,any activity und]tak5 9 connection ) ! initial classification or reclassification ( an 9 vitro cl9ical te/ 9 connection ) any requirem5t = approval or eligibility = an exemption f prem>ket review ( an 9 vitro cl9ical te/4 7x7 ,any activity und]tak5 9 connection ) mak+ a pa?way det]m9ation ( an 9 vitro cl9ical te/1 includ+ ! id5tification1 e/abli%m5t1 & implem5tation ( mitigation measures4 7xi7 ,evaluation ( po/m>ket /udies requir$ z a condition ( an approval ( a prem>ket application ( an 9 vitro cl9ical te/ & ensur+ su* /udies are conduct$ z requir$4 7xii7 ,any activity und]tak5 9 connection ) ensur+ 9 vitro cl9ical te/s m>ket$ "u an exemption f prem>ket review pursuant to section #ehg;,c or #ehg;,g meet ! crit]ia = su* exemption & ! applicable /&>d4 7xiii7 ,compil+1 develop+1 & review+ in=mation on 9 vitro cl9ical te/s necess>y to id5tify issues ) ! ability ( 9 vitro cl9ical te/s to meet ! applicable /&>d1 z applicable4 7,b7 ,res\rce requirem5ts ,fees collect$ & assess$ "u ?is section %all be us$ = ! process = ! review ( 9 vitro cl9ical te/ applications1 z describ$ 9 subp>agraph 7,a71 & %all-- 7i7 be subject to ! limitation "u section #gch7;g77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7g77#c771 9 ! same mann] t fees collect$ & assess$ "u section #gcg7i77;,c7 ( su* ,act 7#ba ,u4,s4,c4 #cgi;i7#i77;,c77 are subject to su* limitation2 7ii7 include travel exp5ses = (fic]s & employees ( ! ,food & ,drug ,adm9i/ration only if ! ,secret>y det]m9es t su* travel is directly relat$ to an activity describ$ 9 subp>agraph 7,a72 & 7iii7 n be allocat$ to purposes describ$ "u section #gbb7;a7 ( ! ,consolidat$ ,appropriations ,act1 #bjah 7,public ,law #aae-ada74 7d7 ,reports 7#a7 ,p]=mance report 7,a7 ,9 g5]al 7i7 ,g5]al requirem5ts ,beg9n+ ) fiscal ye> #bjbg1 = ea* fiscal ye> = :i* fees are collect$ "u ?is section1 ! ,secret>y %all prep>e & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives annual reports conc]n+ ! progress ( ! ,food & ,drug ,adm9i/ration 9 a*iev+ ! goals id5tifi$ 9 ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,e7 dur+ su* fiscal ye> & ! future plans ( ! ,food & ,drug ,adm9i/ration = meet+ ! goals4 7ii7 ,additional in=mation ,beg9n+ ) fiscal ye> #bjba1 ! annual report "u ?is subp>agraph %all include ! progress ( ! ,food & ,drug ,adm9i/ration 9 a*iev+ ! goals1 & future plans = meet+ ! goals1 includ+-- 7,i7 ! numb] ( prem>ket applications fil$ "u section #ehg;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act dur+ ! applicable fiscal ye>2 7,,ii7 ! numb] ( te*nology c]tification applications submitt$ "u section #ehg;,d ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act dur+ ! applicable fiscal ye> = ea* review division2 7,,iii7 ! numb] ( break?r\gh designations "u section #ehg;,i ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act dur+ ! applicable fiscal ye>2 & 7,,iv7 ! numb] ( in=mation reque/s reque/$ by ! ,secret>y pursuant to section #ehg;,g7d7 ( su* ,act4 7iii7 ,real-"t report+ 7,i7 ,9 g5]al ,n lat] ?an #cj cal5d> days aft] ! end ( ! second qu>t] ( fiscal ye> #bjbg1 & n lat] ?an #cj cal5d> days aft] ! end ( ea* qu>t] ( ea* fiscal ye> !reaft]1 ! ,secret>y %all po/ ! data describ$ 9 subclause 7,,ii7 on ! website ( ! ,food & ,drug ,adm9i/ration = su* qu>t] & on a cumulative basis = su* fiscal ye>1 & may remove duplicative data f ! annual report "u ?is subp>agraph4 7,,ii7 ,data ,! ,secret>y %all po/ ! foll[+ data 9 accordance ) subclause 7,i73 7aa7 ,! numb] & titles ( draft & f9al regulations on topics relat$ to ! process = ! review ( 9 vitro cl9ical te/ submissions & applications1 & :e!r su* guidances 7 requir$ by /atute or pursuant to ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,e74 7bb7 ,! numb] & titles ( draft & f9al guidance on topics relat$ to ! process = ! review ( 9 vitro cl9ical te/ submissions & applications1 & :e!r su* guidances 7 issu$ z requir$ by /atute or pursuant to ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7c77#a77;,e74 7cc7 ,! numb] & titles ( public meet+s held on topics relat$ to ! process = ! review ( 9 vitro cl9ical te/s1 & if su* meet+s 7 requir$ by /atute or pursuant to ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7c77#a77;,e74 7iv7 ,rationale = ,,ivct us] fee program *anges ,beg9n+ ) fiscal ye> #bjbg1 ! ,secret>y %all include 9 ! annual p]=mance report "u p>agraph 7#a7-- 7,i7 data1 analysis1 & discussion ( ! *anges 9 ! numb] ( full-"t equival5ts hir$ z agre$ ^u 9 ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,e7 & ! numb] ( full-"t equival5ts fund$ by budget au?ority at ! ,food & ,drug ,adm9i/ration by ea* division )9 ! ,c5t] = ,devices & ,radiological ,heal?1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 ! ,(fice ( ,regulatory ,affairs1 & ! ,(fice ( ! ,commission]2 7,,ii7 data1 analysis1 & discussion ( ! *anges 9 ! fee rev5ue am\nts & co/s = ! process = ! review ( 9 vitro cl9ical te/ submissions & applications1 includ+ id5tify+ driv]s ( su* *anges2 & 7,,iii7 = ea* ( ! ,c5t] = ,devices & ,radiological ,heal?1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 ! ,(fice ( ,regulatory ,affairs1 & ! ,(fice ( ! ,commission]1 ! numb] ( employees = :om "t report+ is requir$ & ! numb] ( employees = :om "t report+ is n requir$4 7v7 ,analysis ,= ea* fiscal ye>1 ! ,secret>y %all include 9 ! report "u clause 7i7 an analysis ( ! foll[+3 7,i7 ,! diff]5ce betwe5 ! aggregate numb] ( prem>ket applications fil$ "u section #ehg;,b or section #ehg;,d ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act & ! aggregate numb] ( major defici5cy lett]s1 n approvable lett]s1 & d5ials = su* applications issu$ by ! ag5cy1 acc\nt+ =-- 7aa7 ! numb] ( applications fil$ "u ea* ( sections #ehg;,b & #ehg;,d ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act dur+ "o fiscal ye> = :i* a decision is n s*$ul$ to be made until ! foll[+ fiscal ye>2 & 7bb7 ! aggregate numb] ( applications "u ea* ( sections #ehg;,b & #ehg;,d ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act = ea* fiscal ye> t did n meet ! goals z id5tifi$ by ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,e74 7,,ii7 ,relevant data to det]m9e :e!r ! ,c5t] = ,devices & ,radiological ,heal? has met p]=mance enhancem5t goals id5tifi$ by ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,e74 7,,iii7 ,! mo/ common causes & tr5ds = ext]nal or o!r circum/ances affect+ ! ability ( ! ,food & ,drug ,adm9i/ration to meet review "t & p]=mance enhancem5t goals id5tifi$ by ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,e74 7,b7 ,publication ,) reg>d to in=mation to be report$ by ! ,food & ,drug ,adm9i/ration to indu/ry on a qu>t]ly & annual basis pursuant to recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,e71 ! ,secret>y %all make su* in=mation publicly available on ! website ( ! ,food & ,drug ,adm9i/ration n lat] ?an #fj days aft] ! end ( ea* qu>t] or #abj days aft] ! end ( ea* fiscal ye>1 respectively1 to :i* su* in=mation applies4 7,c7 ,updates ,! ,secret>y %all include 9 ea* report "u subp>agraph 7,a7 in=mation on all previ\s cohorts = :i* ! ,secret>y has n giv5 a complete response on all 9 vitro cl9ical te/ prem>ket applications & te*nology c]tification ord]s & supplem5ts1 prem>ket1 & te*nology c]tification notifications 9 ! cohort4 7#b7 ,corrective action report ,beg9n+ ) fiscal ye> #bjbb1 = ea* fiscal ye> = :i* fees are collect$ "u ?is section1 ! ,secret>y %all prep>e & submit a corrective action report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives4 ,! report %all include ! foll[+ in=mation1 z applicable3 7,a7 ,goals met ,= ea* fiscal ye>1 if ! ,secret>y det]m9es1 bas$ on ! analysis "u p>agraph 7#a77;,a77v71 t ea* ( ! goals id5tifi$ by ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,e7 = ! applicable fiscal ye> h be5 met1 ! corrective action report %all include recomm5dations on ways 9 :i* ! ,secret>y c improve & /reaml9e ! 9 vitro cl9ical te/ prem>ket application & te*nology c]tification review process4 7,b7 ,goals miss$ ,= ea* ( ! goals id5tifi$ by ! lett]s describ$ 9 recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,e7 = ! applicable fiscal ye> t ! ,secret>y det]m9es to n h be5 met1 ! corrective action report %all include-- 7i7 a ju/ification = su* det]m9ation2 7ii7 a description ( ! types ( circum/ances1 9 ! aggregate1 "u :i* applications or reports submitt$ "u sections #ehg;,b & #ehg;,d ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act miss$ ! review goal times b 7 approv$ dur+ ! fir/ cycle review1 z applicable2 7iii7 a summ>y & any tr5ds ) reg>d to ! circum/ances = :i* a review goal 0 miss$2 & 7iv7 ! p]=mance enhancem5t goals t 7 n a*iev$ dur+ ! previ\s fiscal ye> & a description ( ef=ts ! ,food & ,drug ,adm9i/ration has put 9 place = ! fiscal ye> 9 :i* ! report is submitt$ to improve ! ability ( su* ag5cy to meet ea* su* goal = ! su* fiscal ye>4 7#c7 ,fiscal report ,= fiscal ye>s #bjbg & annually !reaft]1 n lat] ?an #abj days aft] ! end ( ea* fiscal ye> dur+ :i* fees are collect$ "u ?is subp>t1 ! ,secret>y %all prep>e & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 a report on ! implem5tation ( ! au?ority = su* fees dur+ su* fiscal ye> & ! use1 by ! ,food & ,drug ,adm9i/ration1 ( ! fees collect$ dur+ su* fiscal ye> = :i* ! report is made4 7,a7 ,cont5ts ,su* report %all include exp5ditures del9eat$ by budget au?ority & us] fee doll>s relat$ to adm9i/rative exp5ses & in=mation te*nology infra/ructure contracts & exp5ditures4 7,b7 ,op]at+ res]ve ,su* report %all provide ! am\nt ( op]at+ res]ve balance available ea* ye>1 & any plann$ allocations or obligations ( su* balance t is above #aj weeks ( op]at+ res]ve = ! program4 7#d7 ,public availability ,! ,secret>y %all make ! reports requir$ "u p>agraphs 7#a7 ?r\gh 7#c7 available to ! public on ! website ( ! ,food & ,drug ,adm9i/ration4 7#e7 ,enhanc$ communication 7,a7 ,communications ) ,congress ,ea* fiscal ye>1 z applicable & reque/$1 repres5tatives f ! ,c5t]s ) exp]tise 9 ! review ( 9 vitro cl9ical te/s %all meet ) repres5tatives f ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives to report on ! cont5ts describ$ 9 ! reports "u ?is section4 7,b7 ,p>ticipation 9 congressional he>+ ,ea* fiscal ye>1 z applicable & reque/$1 repres5tatives f ! ,food & ,drug ,adm9i/ration %all p>ticipate 9 a public he>+ be=e ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 to report on ! cont5ts describ$ 9 ! reports "u ?is section4 ,su* he>+ %all occur n lat] ?an #abj days aft] ! end ( ea* fiscal ye> = :i* fees are collect$ "u ?is section4 #hcj4 ,au?orization ( appropriations ,= purposes ( fund+ implem5tation ( ?is subtitle 7includ+ ! am5dm5ts made by ?is subtitle71 includ+ und]tak+ activities = ! developm5t ( regulations & guidances1 hir+ ( necess>y /aff1 & ! developm5t ( te*nology sy/ems to implem5t ?is subtitle 7includ+ ! am5dm5ts made by ?is subtitle7 9 a timely1 effective1 & effici5t mann]1 !re is au?oriz$ to be appropriat$ n m ?an #dhj1jjj1jjj1 to rema9 available ?r\gh ! end ( fiscal ye> #bjbg4 ,,ix ,o!r provisions #ija4 ,facilities managem5t 7a7 ,,pdufa au?ority ,section #gcf7;g77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7g77#b77-- 7#a7 9 subp>agraph 7,a77ii7-- 7,a7 by /rik+ %all be available to defray & ins]t+ ! foll[+3 8%all be available-- 7,i7 = fiscal ye> #bjbc1 to defray 2 7,b7 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+3 7,,ii7 = fiscal ye> #bjbd & ea* subsequ5t fiscal ye>1 to defray ! co/s ( ! res\rces allocat$ = ! process = ! review ( human drug applications 7includ+ su* co/s = an additional numb] ( full-"t equival5t positions 9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices to be engag$ 9 su* process71 only if ! sum ( ! am\nts allocat$ by ! ,secret>y = su* co/s1 exclud+ co/s paid f fees collect$ "u ?is section1 plus o!r co/s = ! ma9t5ance1 r5ovation1 & repair ( facilities & acquisition1 ma9t5ance1 & repair ( fixtures1 furniture1 & o!r necess>y mat]ials & supplies 9 connection ) ! process = ! review ( human drug applications1 is no less ?an ! am\nt allocat$ = su* co/s1 exclud+ any su* co/s paid f fees collect$ "u ?is section1 = fiscal ye> #aiig1 multipli$ by ! adju/m5t factor4 2 & 7#b7 9 subp>agraph 7,b71 by /rik+ = ! process = ! review ( human drug applications & ins]t+ z describ$ 9 subclause 7,i7 or 7,,ii7 ( su* subp>agraph1 z applicable4 7b7 ,bs,u,f,a au?ority ,section #gdd;,h7f77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;f77#b77 is am5d$-- 7#a7 9 subp>agraph 7,b77i7-- 7,a7 by /rik+ available = a fiscal ye> beg9n+ aft] fiscal ye> #bjab & ins]t+ ! foll[+3 8available-- 7,i7 = fiscal ye> #bjbc 2 7,b7 by /rik+ ! fiscal ye> involv$4 & ins]t+ su* fiscal ye>2 &2 & 7,c7 by add+ at ! end ! foll[+3 7,,ii7 = fiscal ye> #bjbd & ea* subsequ5t fiscal ye>1 to defray ! co/s ( ! process = ! review ( biosimil> biological product applications 7includ+ su* co/s = an additional numb] ( full-"t equival5t positions 9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices to be engag$ 9 su* process71 only if ! sum ( ! am\nts allocat$ by ! ,secret>y = su* co/s1 exclud+ co/s paid f fees collect$ "u ?is section1 plus o!r co/s = ! ma9t5ance1 r5ovation1 & repair ( facilities & acquisition1 ma9t5ance1 & repair ( fixtures1 furniture1 & o!r necess>y mat]ials & supplies 9 connection ) ! process = ! review ( biosimil> biological product applications1 is no less ?an #bj1jjj1jjj1 multipli$ by ! adju/m5t factor applicable to ! fiscal ye> involv$4 2 & 7#b7 9 subp>agraph 7,c71 by /rik+ subp>agraph 7,b7 9 any fiscal ye> if ! co/s describ$ 9 su* subp>agraph & ins]t+ subp>agraph 7,b77i7 9 any fiscal ye> if ! co/s allocat$ z describ$ 9 subclause 7,i7 or 7,,ii7 ( su* subp>agraph1 z applicable14 7c7 ,,gdufa au?ority ,section #gdd;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7 is am5d$-- 7#a7 9 subsection 7e77#b71 by /rik+ #gdd;,a7#aa77;,c7 & ins]t+ #gdd;,a7#ab77;,c72 & 7#b7 9 subsection 7i77#b7-- 7,a7 9 subp>agraph 7,a77ii7-- 7i7 by /rik+ available = a fiscal ye> beg9n+ aft] fiscal ye> #bjab & ins]t+ ! foll[+3 8available-- 7,i7 = fiscal ye> #bjbc2 & 2 7ii7 by /rik+ ! fiscal ye> involv$4 & ins]t+ su* fiscal ye>2 &2 & 7iii7 by add+ at ! end ! foll[+3 7,,ii7 = fiscal ye> #bjbd & ea* subsequ5t fiscal ye>1 to defray ! co/s ( human g5]ic drug activities 7includ+ su* co/s = an additional numb] ( full-"t equival5t positions 9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices to be engag$ 9 su* activities71 only if ! sum ( ! am\nts allocat$ by ! ,secret>y = su* co/s1 exclud+ co/s paid f fees collect$ "u ?is section1 plus o!r co/s = ! ma9t5ance1 r5ovation1 & repair ( facilities & acquisition1 ma9t5ance1 & repair ( fixtures1 furniture1 & o!r necess>y mat]ials & supplies 9 connection ) human g5]ic drug activities1 is no less ?an #ig1jjj1jjj multipli$ by ! adju/m5t factor def9$ 9 section #gdd;,a7#c7 applicable to ! fiscal ye> involv$4 2 & 7,b7 9 subp>agraph 7,b71 by /rik+ = human g5]ic activities & ins]t+ z describ$ 9 subclause 7,i7 or 7,,ii7 ( su* subp>agraph1 z applicable4 7d7 ,,mdufa au?ority ,section #gch ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is am5d$-- 7#a7 9 subsection 7h77#b7-- 7,a7 9 subp>agraph 7,a77ii7-- 7i7 by /rik+ %all be available to defray & ins]t+ ! foll[+3 8%all be available-- 7,i7 = fiscal ye> #bjbc1 to defray 2 7ii7 by /rik+ ! p]iod & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+3 7,,ii7 = fiscal ye> #bjbd & ea* subsequ5t fiscal ye>1 to defray ! co/s ( ! res\rces allocat$ = ! process = ! review ( device applications 7includ+ su* co/s = an additional numb] ( full-"t equival5t positions 9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices to be engag$ 9 su* process71 only if ! sum ( ! am\nts allocat$ by ! ,secret>y = su* co/s1 exclud+ co/s paid f fees collect$ "u ?is section1 plus o!r co/s = ! ma9t5ance1 r5ovation1 & repair ( facilities & acquisition1 ma9t5ance1 & repair ( fixtures1 furniture & o!r necess>y mat]ials & supplies 9 connection ) ! process = ! review ( device applications1 is no less ?an ! am\nt allocat$ = su* co/s1 exclud+ any su* co/s paid f fees collect$ "u ?is section1 = fiscal ye> #bjji multipli$ by ! adju/m5t factor4 2 & 7,b7 9 subp>agraph 7,b77i71 9 ! matt] prec$+ subclause 7,i71 by /rik+ = ! process = ! review ( device applications & ins]t+ z describ$ 9 subclause 7,i7 or 7,,ii7 ( su* subp>agraph1 z applicable2 & 7#b7 9 subsection 7g77#c71 by /rik+ #gcg7i77;,c7 & ins]t+ #gcg7aj77;,c74 7e7 ,te*nical correction 7#a7 ,9 g5]al ,section #ije7;b77#b7 ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 is am5d$ by /rik+ ,section #gch7;h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7h77 is am5d$ & ins]t+ ,subsection 7g7 ( section #gch ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j71 z s r$esignat$ by section #bjc7;f77#b77;,b77i71 is am5d$4 7#b7 ,effective date ,! am5dm5t made by p>agraph 7#a7 %all take effect z ?\gh includ$ 9 ! enactm5t ( section #ije ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb74 #ijb4 ,annual report on inspections ,section #ijb ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 is am5d$1 9 ! matt] prec$+ p>agraph 7#a7-- 7#a7 by /rik+ ,m>* #a ( ea* ye> & ins]t+ #abj days aft] ! end ( ea* fiscal ye>2 & 7#b7 by /rik+ previ\s cal5d> ye> & ins]t+ previ\s fiscal ye>4 #ijc4 ,us] fee program transp>5cy & acc\ntability 7a7 ,,pdufa 7#a7 ,reau?orization2 report+ requirem5ts 7,a7 ,p]=mance report ,section #gcf;,b7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7;a77 is am5d$-- 7i7 9 p>agraph 7#a7-- 7,i7 9 subp>agraph 7,b7-- 7aa7 9 clause 7vii71 by /rik+ 2 & & ins]t+ a semicolon2 7bb7 9 clause 7viii71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7cc7 by add+ at ! end ! foll[+3 7ix7 ! numb] ( inve/igational new drug applications submitt$ p] fiscal ye>1 includ+ = ea* review division4 2 & 7,,ii7 by add+ at ! end ! foll[+ flu% text3 ,no?+ 9 subp>agraph 7,b7 %all be con/ru$ to au?orize ! disclosure ( confid5tial comm]cial in=mation or o!r in=mation consid]$ propriet>y or trade secret1 z prohibit$ "u section #cja7;j7 ( ?is ,act ( section #aije ( title #ah1 ,unit$ ,/ates ,code4 2 & 7ii7 9 p>agraph 7#d7-- 7,i7 by am5d+ subp>agraph 7,a7 to read z foll[s3 7,a7 data1 analysis1 & discussion ( ! *anges 9 ! numb] ( individuals hir$ z agre$ ^u 9 ! lett]s describ$ 9 section #aja7;b7 ( ! ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjbb & ! numb] ( rema9+ vacancies1 ! numb] ( full-"t equival5ts fund$ by fees collect$ pursuant to section #gcf1 & ! numb] ( full-"t equival5ts fund$ by budget au?ority at ! ,food & ,drug ,adm9i/ration by ea* division )9 ! ,c5t] = ,drug ,evaluation & ,rese>*1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 ! ,(fice ( ,regulatory ,affairs1 & ! ,(fice ( ! ,commission]2 2 7,,ii7 by am5d+ subp>agraph 7,b7 to read z foll[s3 7,b7 data1 analysis1 & discussion ( ! *anges 9 ! fee rev5ue am\nts & co/s = ! process = ! review ( human drug applications1 includ+ id5tify+-- 7i7 driv]s ( su* *anges2 & 7ii7 *anges 9 ! av]age total co/ p] full-"t equival5t 9 ! prescription drug review program2 2 7,,iii7 9 subp>agraph 7,c71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,,iv7 by add+ at ! end ! foll[+3 7,d7 data1 analysis1 & discussion ( ! *anges 9 ! av]age full-"t equival5t h\rs requir$ to complete review ( ea* type ( human drug application4 4 7#b7 ,reau?orization ,section #gcf;,b7f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7;f77 is am5d$-- 7,a7 by r$esignat+ p>agraphs 7#d7 ?r\gh 7#f7 z p>agraphs 7#e7 ?r\gh 7#g71 respectively2 7,b7 by ins]t+ aft] p>agraph 7#c7 ! foll[+3 7#d7 ,updates to ,congress ,! ,secret>y1 9 consultation ) regulat$ indu/ry1 %all provide regul> updates on negotiations on ! reau?orization ( ?is "p to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 2 & 7,c7 9 p>agraph 7#g71 z s r$esignat$-- 7i7 9 subp>agraph 7,a7-- 7,i7 by /rik+ ,be=e pres5t+ ! recomm5dations develop$ "u p>agraphs 7#a7 ?r\gh 7#e7 to ! ,congress1 ! & ins]t+ ,!2 & 7,,ii7 by ins]t+ 1 n lat] ?an #cj days aft] ea* su* negotiation meet+ be=e ! p]iod at ! end2 & 7ii7 9 subp>agraph 7,b71 by ins]t+ 1 9 suffici5t detail1 aft] %all summ>ize4 7b7 ,,mdufa 7#a7 ,reau?orization2 report+ requirem5ts 7,a7 ,reports ,section #gch;,a7a77#a77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;a77#a77;,a77 is am5d$-- 7i7 9 clause 7ii7-- 7,i7 9 subclause 7,,ii71 by /rik+ 2 & & ins]t+ a semicolon2 7,,ii7 9 subclause 7,,iii71 by /rik+ ! p]iod & ins]t+ a semicolon2 7,,iii7 by add+ at ! end ! foll[+3 7,,iv7 ! numb] ( inve/igational device exemption applications submitt$ "u section #ebj7;g7 p] fiscal ye>1 includ+ = ea* review division2 & 7,v7 ! numb] ( exp$it$ developm5t & priority review reque/s & designations "u section #eae;,b p] fiscal ye>1 includ+ = ea* review division4 2 & 7,,iv7 by add+ at ! end ! foll[+ flu% text3 ,no?+ 9 ?is clause %all be con/ru$ to au?orize ! disclosure ( confid5tial comm]cial in=mation or o!r in=mation consid]$ propriet>y or trade secret1 z prohibit$ "u section #cja7;j7 ( ?is ,act or section #aije ( title #ah1 ,unit$ ,/ates ,code4 2 7ii7 9 ! fir/ clause 7iv7 7relat+ to rationale = ,,mdufa program *anges7-- 7,i7 by am5d+ subclause 7,i7 to read z foll[s3 7,i7 data1 analysis1 & discussion ( ! *anges 9 ! numb] ( individuals hir$ z agre$ ^u 9 ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb & ! numb] ( rema9+ vacancies1 ! numb] ( full-"t equival5ts fund$ by fees collect$ pursuant to section #gch1 & ! numb] ( full "t equival5ts fund$ by budget au?ority at ! ,food & ,drug ,adm9i/ration by ea* division )9 ! ,c5t] = ,devices & ,radiological ,heal?1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 ! ,(fice ( ,regulatory ,affairs1 & ! ,(fice ( ! ,commission]2 2 7,,ii7 by am5d+ subclause 7,,ii7 to read z foll[s3 7,,ii7 data1 analysis1 & discussion ( ! *anges 9 ! fee rev5ue am\nts & co/s = ! process = ! review ( device applications1 includ+ id5tify+-- 7aa7 driv]s ( su* *anges2 & 7bb7 *anges 9 ! av]age total co/ p] full-"t equival5t 9 ! m$ical device review program2 2 7,,iii7 9 subclause 7,,iii71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,,iv7 by add+ at ! end ! foll[+3 7,,iv7 data1 analysis1 & discussion ( ! *anges 9 ! av]age full-"t equival5t h\rs requir$ to complete review ( m$ical device application types4 2 & 7iii7 by r$esignat+ ! second clause 7iv7 7relat+ to analysis7 z clause 7v74 7#b7 ,reau?orization ,section #gch;,a7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;b77 is am5d$-- 7,a7 by r$esignat+ p>agraphs 7#d7 ?r\gh 7#f7 z p>agraphs 7#e7 ?r\gh 7#g71 respectively2 7,b7 by ins]t+ aft] p>agraph 7#c7 ! foll[+3 7#d7 ,updates to ,congress ,! ,secret>y1 9 consultation ) regulat$ indu/ry1 %all provide regul> updates on negotiations on ! reau?orization ( ?is "p to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 2 & 7,c7 9 p>agraph 7#g71 z s r$esignat$-- 7i7 9 subp>agraph 7,a7-- 7,i7 by /rik+ ,be=e pres5t+ ! recomm5dations develop$ "u p>agraphs 7#a7 ?r\gh 7#e7 to ! ,congress1 ! & ins]t+ ,!2 & 7,,ii7 by ins]t+ 1 n lat] ?an #cj days aft] ea* su* negotiation meet+ be=e ! p]iod at ! end2 & 7ii7 9 subp>agraph 7,b71 by ins]t+ 1 9 suffici5t detail1 aft] %all summ>ize4 7c7 ,,gdufa 7#a7 ,reau?orization2 report+ requirem5ts 7,a7 ,p]=mance report ,section #gdd;,c7a77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7;a77#c77 is am5d$-- 7i7 by am5d+ subp>agraph 7,a7 to read z foll[s3 7,a7 data1 analysis1 & discussion ( ! *anges 9 ! numb] ( individuals hir$ z agre$ ^u 9 ! lett]s describ$ 9 section #cja7;b7 ( ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbb & ! numb] ( rema9+ vacancies1 ! numb] ( full-"t equival5ts fund$ by fees collect$ pursuant to section #gdd;,b1 & ! numb] ( full "t equival5ts fund$ by budget au?ority at ! ,food & ,drug ,adm9i/ration by ea* division )9 ! ,c5t] = ,drug ,evaluation & ,rese>*1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 ! ,(fice ( ,regulatory ,affairs1 & ! ,(fice ( ! ,commission]2 2 7ii7 by am5d+ subp>agraph 7,b7 to read z foll[s3 7,b7 data1 analysis1 & discussion ( ! *anges 9 ! fee rev5ue am\nts & co/s = human g5]ic drug activities1 includ+-- 7i7 id5tify+ driv]s ( su* *anges2 & 7ii7 *anges 9 ! total av]age co/ p] full-"t equival5t 9 ! g5]ic drug review program2 2 7iii7 9 subp>agraph 7,c71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7iv7 by add+ at ! end ! foll[+3 7,d7 data1 analysis1 & discussion ( ! *anges 9 ! av]age full-"t equival5t h\rs requir$ to complete review ( ea* type ( abbreviat$ new drug application4 4 7#b7 ,reau?orization ,section #gdd;,c7f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7;f77 is am5d$-- 7,a7 by r$esignat+ p>agraphs 7#d7 ?r\gh 7#f7 z p>agraphs 7#e7 ?r\gh 7#g71 respectively2 7,b7 by ins]t+ aft] p>agraph 7#c7 ! foll[+3 7#d7 ,updates to ,congress ,! ,secret>y1 9 consultation ) regulat$ indu/ry1 %all provide regul> updates on negotiations on ! reau?orization ( ?is "p to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 2 & 7,c7 9 p>agraph 7#g71 z s r$esignat$-- 7i7 9 subp>agraph 7,a7-- 7,i7 by /rik+ ,be=e pres5t+ ! recomm5dations develop$ "u p>agraphs 7#a7 ?r\gh 7#e7 to ! ,congress1 ! & ins]t+ ,!2 & 7,,ii7 by ins]t+ 1 n lat] ?an #cj days aft] ea* su* negotiation meet+ be=e ! p]iod at ! end2 & 7ii7 9 subp>agraph 7,b71 by ins]t+ 1 9 suffici5t detail1 aft] %all summ>ize4 7d7 ,,bsufa 7#a7 ,reau?orization2 report+ requirem5ts ,section #gdd;,i7a77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7;a77#d77 is am5d$-- 7,a7 by am5d+ subp>agraph 7,a7 to read z foll[s3 7,a7 data1 analysis1 & discussion ( ! *anges 9 ! numb] ( individuals hir$ z agre$ ^u 9 ! lett]s describ$ 9 section #dja7;b7 ( ! ,biosimil> ,us] ,fee ,am5dm5ts ( #bjbb & ! numb] ( rema9+ vacancies1 ! numb] ( full-"t equival5ts fund$ by fees collect$ pursuant to section #gdd;,h1 & ! numb] ( full "t equival5ts fund$ by budget au?ority at ! ,food & ,drug ,adm9i/ration by ea* division )9 ! ,c5t] = ,drug ,evaluation & ,rese>*1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 ! ,(fice ( ,regulatory ,affairs1 & ! ,(fice ( ! ,commission]2 2 7,b7 by am5d+ subp>agraph 7,b7 to read z foll[s3 7,b7 data1 analysis1 & discussion ( ! *anges 9 ! fee rev5ue am\nts & co/s = ! process = ! review ( biosimil> biological product applications1 includ+ id5tify+-- 7i7 driv]s ( su* *anges2 & 7ii7 *anges 9 ! av]age total co/ p] full-"t equival5t 9 ! biosimil> biological product review program2 2 7,c7 9 subp>agraph 7,c71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,d7 by add+ at ! end ! foll[+3 7,d7 data1 analysis1 & discussion ( ! *anges 9 ! av]age full-"t equival5t h\rs requir$ to complete review ( ea* type ( biosimil> biological product application4 4 7#b7 ,reau?orization ,section #gdd;,i7f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7;f77 is am5d$-- 7,a7 by r$esignat+ p>agraphs 7#b7 & 7#c7 z p>agraphs 7#e7 & 7#f71 respectively2 7,b7 by ins]t+ aft] p>agraph 7#a7 ! foll[+3 7#b7 ,prior public input ,prior to beg9n+ negotiations ) ! regulat$ indu/ry on ! reau?orization ( ?is "p1 ! ,secret>y %all-- 7,a7 publi% a notice 9 ! ,f$]al ,regi/] reque/+ public input on ! reau?orization2 7,b7 hold a public meet+ at :i* ! public may pres5t its views on ! reau?orization2 7,c7 provide a p]iod ( #cj days aft] ! public meet+ to obta9 writt5 comm5ts f ! public sugge/+ *anges to ?is "p2 & 7,d7 publi% ! comm5ts on ! ,food & ,drug ,adm9i/ration's website4 7#c7 ,p]iodic consultation ,n less frequ5tly ?an once e mon? dur+ negotiations ) ! regulat$ indu/ry1 ! ,secret>y %all hold discussions ) repres5tatives ( pati5t & consum] advocacy gr\ps to cont9ue discussions ( _! views on ! reau?orization & _! sugge/ions = *anges to ?is "p z express$ "u p>agraph 7#b74 7#d7 ,updates to ,congress ,! ,secret>y1 9 consultation ) regulat$ indu/ry1 %all provide regul> updates on negotiations on ! reau?orization ( ?is "p to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 2 & 7,c7 by add+ at ! end ! foll[+3 7#g7 ,m9utes ( negotiation meet+s 7,a7 ,public availability ,! ,secret>y %all make publicly available1 on ! public website ( ! ,food & ,drug ,adm9i/ration1 m9utes ( all negotiation meet+s conduct$ "u ?is subsection betwe5 ! ,food & ,drug ,adm9i/ration & ! regulat$ indu/ry1 n lat] ?an #cj days aft] ea* su* negotiation meet+4 7,b7 ,cont5t ,! m9utes describ$ "u subp>agraph 7,a7 %all summ>ize1 9 suffici5t detail1 any sub/antive proposal made by any p>ty to ! negotiations z well z significant controv]sies or diff]5ces ( op9ion dur+ ! negotiations & _! resolution4 4 #ijd4 ,,otc he>+ aids f9al rule ,n lat] ?an #cj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue a f9al rule to e/abli% a category ( ov]-!-c\nt] he>+ aids1 z def9$ 9 subsection 7q7 ( section #ebj ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j71 z describ$ 9 section #gji7;b7 ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb74 #ije4 ,enhance intra-ag5cy coord9ation & public heal? assessm5t ) reg>d to compliance activities 7a7 ,coord9ation ,section #ejf;,d ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;d7 is am5d$-- 7#a7 by add+ at ! end ! foll[+3 7g7 ,coord9ation ,! ,secret>y %all ensure timely & effective int]nal coord9ation & alignm5t among ! field inve/igators ( ! ,food & ,drug ,adm9i/ration & ! /aff ( ! ,c5t] = ,drug ,evaluation & ,rese>*'s ,(fice ( ,compliance & ,drug ,%ortage ,program reg>d+ ! reviews ( reports %>$ pursuant to section #gjd7;b77#b71 & any fe$back or corrective or prev5tive actions 9 response to su* reports4 2 & 7#b7 by am5d+ subsection 7f7 to read z foll[s3 7f7 ,tempor>y sunset ,subsection 7a7 %all cease to be effective on ! date t is #e ye>s aft] ! date ( enactm5t ( ! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act4 ,subsections 7b71 7c71 & 7e7 %all n be 9 effect dur+ ! p]iod beg9n+ #e ye>s aft] ! date ( enactm5t ( ! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act & end+ on ! date ( enactm5t ( ! ,food & ,drug ,adm9i/ration ,safety & ,l&m>k ,advancem5ts ,act ( #bjbb4 ,subsections 7b71 7c71 & 7e7 %all be 9 effect beg9n+ on ! date ( enactm5t ( ! ,food & ,drug ,adm9i/ration ,safety & ,l&m>k ,advancem5ts ,act ( #bjbb4 4 7b7 ,report+ ,section #ejf;,c-#a7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c-#a7;a77 is am5d$-- 7#a7 by r$esignat+ p>agraphs 7#c7 ?r\gh 7#g7 z p>agraphs 7#d7 ?r\gh 7#h71 respectively2 7#b7 by ins]t+ aft] p>agraph 7#b7 ! foll[+3 7#c7 provides ! numb] ( reports t 7 requir$ "u section #gjd7;b77#b7 to be s5t to ! appropriate (fices ( ! ,food & ,drug ,adm9i/ration ) exp]tise reg>d+ drug %ortages1 & ! numb] ( su* reports t 7 s5t2 2 & 7#c7 9 p>agraph 7#c77;,a71 by /rik+ p>agraph 7#g7 & ins]t+ p>agraph 7#h74 7c7 ,applicability 7#a7 ,subsection 7a7 ,! am5dm5ts made by subsection 7a7 %all apply beg9n+ on ! date ( enactm5t ( ?is ,act4 7#b7 ,subsection 7b7 ,! am5dm5ts made by subsection 7b7 %all apply beg9n+ on ! date t is #a ye> aft] ! date ( enactm5t ( ?is ,act4 7d7 ,report+ ( mutual recognition agreem5ts = inspections & review activities ,section #eaj7;h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;h77 is am5d$-- 7#a7 9 p>agraph 7#f7-- 7,a7 9 subp>agraph 7,a71 by /rik+ clause 7ii7 & ins]t+ ! foll[+3 7ii7 ! numb] ( su* regi/]$ e/abli%m5ts 9 ea* region ( int]e/2 7iii7 ! numb] ( su* dome/ic e/abli%m5ts & ! numb] ( su* =eign e/abli%m5ts1 includ+ ! numb] ( e/abli%m5ts 9 ea* region ( int]e/1 t ! ,secret>y inspect$ 9 ! previ\s cal5d> ye>2 7iv7 ! numb] ( inspections to support actions by ! ,secret>y on applications "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 includ+ ! numb] ( inspections to support actions by ! ,secret>y on supplem5tal applications1 includ+ *anges to manufactur+ processes1 ! ,secret>y conduct$ 9 ! previ\s fiscal ye>2 7v7 ! numb] ( r\t9e surveillance inspections ! ,secret>y conduct$ 9 ! previ\s fiscal ye>2 7vi7 ! numb] ( =-cause inspections ! ,secret>y conduct$ 9 ! previ\s fiscal ye>1 n includ+ inspections describ$ 9 clause 7iv72 & 7vii7 ! numb] ( inspections ! ,secret>y has recogniz$ pursuant to an agreem5t ent]$ into pursuant to section #hji1 or o!rwise recogniz$1 = ea* ( ! types ( inspections describ$ 9 clauses 7v7 & 7vi72 2 7,b7 9 subp>agraph 7,b71 by /rik+ 2 & & ins]t+ a semicolon2 7,c7 9 subp>agraph 7,c71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,d7 by add+ at ! end ! foll[+3 7,d7 ! /atus ( ! ef=ts ( ! ,food & ,drug ,adm9i/ration to exp& its recognition ( inspections conduct$ or recogniz$ by =eign regulatory au?orities "u section #hji1 includ+ any ob/acles to exp&+ ! use ( su* recognition4 2 & 7#b7 by add+ at ! end ! foll[+3 7#g7 ,region ( int]e/ ,= purposes ( p>agraph 7#f77;,a71 ! t]m region ( int]e/ means a =eign geographic region or c\ntry1 includ+ ! ,p's ,republic ( ,*9a1 ,india1 ! ,european ,union1 ! ,unit$ ,k+dom1 & any o!r c\ntry or geographic region1 z ! ,secret>y det]m9es appropriate4 4 7e7 ,enhanc+ transp>5cy ( drug facility inspection timel9es ,section #ijb ( ! ,,fda ,reau?orization ,act ( #bjag 7#ba ,u4,s4,c4 #cee note7 is am5d$ to read z foll[s3 #ijb4 ,annual report on inspections ,n lat] ?an ,m>* #a ( ea* ye>1 ! ,secret>y ( ,heal? & ,human ,s]vices %all po/ on ! website ( ! ,food & ,drug ,adm9i/ration in=mation relat$ to inspections ( facilities necess>y = approval ( a drug "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 approval ( a device "u section #eae ( su* ,act 7#ba ,u4,s4,c4 #cfj;e71 or cle>ance ( a device "u section #eaj7k7 ( su* ,act 7#ba ,u4,s4,c4 #cfj7k77 t 7 conduct$ dur+ ! previ\s cal5d> ye>4 ,su* in=mation %all include ! foll[+3 7#a7 ,! m$ian "t foll[+ a reque/ f /aff ( ! ,food & ,drug ,adm9i/ration review+ an application or report to ! beg9n+ ( ! inspection1 includ+-- 7,a7 ! m$ian "t = drugs describ$ 9 #eje7;j77#aa77;,a77i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#aa77;,a77i772 7,b7 ! m$ian "t = drugs describ$ 9 section #ejf;,c7a7 ( su* ,act 7#ba ,u4,s4,c4 #cef;c7a77 only2 & 7,c7 ! m$ian "t = drugs on ! drug %ortage li/ 9 effect "u section #ejf;,e ( su* ,act 7#ba ,u4,s4,c4 #cef;f74 7#b7 ,! m$ian "t f ! issuance ( a report pursuant to section #gjd7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;b77 to ! s5d+ ( a w>n+ lett]1 issuance ( an import al]t1 or hold+ ( a regulatory meet+ = inspections = :i* ! ,secret>y conclud$ t regulatory or en=cem5t action 0 indicat$1 includ+ ! m$ian "t = ea* category ( drugs li/$ 9 subp>agraphs 7,a7 ?r\gh 7,c7 ( p>agraph 7#a74 7#c7 ,! m$ian "t f ! s5d+ ( a w>n+ lett]1 issuance ( an import al]t1 or hold+ ( a regulatory meet+ relat$ to conditions obs]v$ by ! ,secret>y dur+ an inspection1 to ! "t at :i* ! ,secret>y concludes t corrective actions to resolve su* conditions h be5 tak54 7#d7 ,! m$ian "t sp5t by /aff ( ! ,food & ,drug ,adm9i/ration at a facility dur+ an inspection1 includ+-- 7,a7 ! m$ian "t :5 records 7 provid$ remotely 9 accordance ) a reque/ "u section #gjd7;a77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77#d77 9 advance ( ! inspection2 & 7,b7 ! m$ian "t :5 a reque/ = records pursuant to su* section #gjd7;a77#d7 0 n issu$1 or compli$ )1 9 advance ( ! inspection4 7#e7 ,! numb] & type ( violations id5tifi$ dur+ inspections :5 a reque/ = records pursuant to su* section #gjd7;a77#d7 0 issu$ & compli$ ) 9 advance ( ! inspection1 v]sus :5 a reque/ = records pursuant to su* section #gjd7;a77#d7 0 n issu$ or compli$ )4 7#f7 ,! numb] ( facilities t did n implem5t reque/$ corrective or prev5tive actions foll[+ a report issu$ pursuant to su* section #gjd7;b71 result+ 9 a )hold recomm5dation1 includ+ ! numb] ( su* times = ea* category ( drugs li/$ 9 subp>agraphs 7,a7 ?r\gh 7,c7 ( p>agraph 7#a74 4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,food & ,drug ,adm9i/ration ,safety & ,l&m>k ,advancem5ts ,act ( #bjbb or ! ,,fdasla ,act ( #bjbb4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4,,title ,i--,fees relat+ to drugs,sec4 #aja4 ,%ort title2 f9d+4,sec4 #ajb4 ,def9itions4,sec4 #ajc4 ,au?ority to assess & use drug fees4,sec4 #ajd4 ,reau?orization2 report+ requirem5t4,sec4 #aje4 ,sunset dates4,sec4 #ajf4 ,effective date4,sec4 #ajg4 ,sav+s clause4,,title ,,ii--,fees relat+ to devices,sec4 #bja4 ,%ort title2 f9d+4,sec4 #bjb4 ,def9itions4,sec4 #bjc4 ,au?ority to assess & use device fees4,sec4 #bjd4 ,reau?orization2 report+ requirem5t4,sec4 #bje4 ,accr$itation programs4,sec4 #bjf4 ,sunset dates4,sec4 #bjg4 ,effective date4,sec4 #bjh4 ,sav+s clause4,,title ,,iii--,fees relat+ to g5]ic drugs,sec4 #cja4 ,%ort title2 f9d+4,sec4 #cjb4 ,au?ority to assess & use human g5]ic drug fees4,sec4 #cjc4 ,reau?orization2 report+ requirem5ts4,sec4 #cjd4 ,sunset dates4,sec4 #cje4 ,effective date4,sec4 #cjf4 ,sav+s clause4,,title ,,iv--,fees relat+ to biosimil> biological products,sec4 #dja4 ,%ort title2 f9d+4,sec4 #djb4 ,def9itions4,sec4 #djc4 ,au?ority to assess & use biosimil> biological product fees4,sec4 #djd4 ,reau?orization2 report+ requirem5ts4,sec4 #dje4 ,sunset dates4,sec4 #djf4 ,effective date4,sec4 #djg4 ,sav+s clause4,,title ,v--,improv+ regulation ( drugs & biological products,sec4 #eja4 ,alt]natives to animal te/+4,sec4 #ejb4 ,saf] disposal ( opioids4,sec4 #ejc4 ,cl>ifications to exclusivity provisions = fir/ int]*angeable biosimil> biological products4,sec4 #ejd4 ,improvem5ts to ! ,purple ,book4,sec4 #eje4 ,!rapeutic equival5ce evaluations4,sec4 #ejf4 ,mod]niz+ accel]at$ approval4,sec4 #ejg4 ,r>e disease pilot program4,sec4 #ejh4 ,support+ review & developm5t ( drugs to treat r>e diseases4,sec4 #eji4 ,g5]ic drug label+ *anges4,sec4 #eaj4 ,limitations on exclusive approval or lic5sure ( orphan drugs4,sec4 #eaa4 ,ensur+ timely access to g5]ics4,sec4 #eab4 ,increas+ transp>5cy 9 g5]ic drug applications4,sec4 #eac4 ,,gao report on nonpr(it ph>maceutical organizations4,sec4 #ead4 ,,fda public meet+ on nonpr(it prescription drug manufactur]s4,sec4 #eae4 #ahj-;day exclusivity p]iod4,,title ,,vi--,o!r reauthorizations,sec4 #fja4 ,reau?orization ( ! critical pa? public-private p>tn]%ip4,sec4 #fjb4 ,reau?orization ( ! be/ ph>maceuticals = *ildr5 program4,sec4 #fjc4 ,reau?orization ( ! humanit>ian device exemption inc5tive4,sec4 #fjd4 ,reau?orization ( ! p$iatric device consortia program4,sec4 #fje4 ,reau?orization ( provision p]ta9+ to drugs conta9+ s+le enantiom]s4,sec4 #fjf4 ,reau?orization ( orphan drug grants4,sec4 #fjg4 ,reau?orization ( c]ta9 device inspections4,,title ,,vii--,enhanc+ ,,fda hir+ authorities,sec4 #gja4 ,enhanc+ ,,fda hir+ au?ority = sci5tific1 te*nical1 & pr(essional p]sonnel4,sec4 #gjb4 ,/rategic work=ce plan & report4,,title ,,viii--,advanc+ regulation ( cosmetics1 diet>y supplem5ts1 & 9 vitro cl9ical tests,subtitle ,a--,cosmetics,sec4 #hja4 ,%ort title4,sec4 #hjb4 ,am5dm5ts to cosmetic requirem5ts4,sec4 #hjc4 ,en=cem5t & con=m+ am5dm5ts4,sec4 #hjd4 ,records inspection4,sec4 #hje4 ,talc-conta9+ cosmetics4,sec4 #hjf4 ,,pfas 9 cosmetics4,sec4 #hjg4 ,s5se ( ! ,s5ate on animal te/+4,sec4 #hjh4 ,fund+4,subtitle ,b--,diet>y supplements,sec4 #haa4 ,regulation ( diet>y supplem5ts4,subtitle ,c--,9 vitro cl9ical tests,sec4 #hba4 ,%ort title4,sec4 #hbb4 ,def9itions4,sec4 #hbc4 ,regulation ( 9 vitro cl9ical te/s4,sec4 #hbd4 ,en=cem5t & o!r provisions4,sec4 #hbe4 ,transition4,sec4 #hbf4 ,em]g5cy use au?orization4,sec4 #hbg4 ,antimicrobial susceptibility te/s4,sec4 #hbh4 ,comb9ation products4,sec4 #hbi4 ,res\rces4,sec4 #hcj4 ,au?orization ( appropriations4,sec4 #hca4 ,guidance on ,diagno/ic ,innovation4,sec4 #hcb4 ,,gao report on unique consid]ations4,,title ,,ix--,o!r provisions,sec4 #ija4 ,facilities managem5t4,sec4 #ijb4 ,us] fee program transp>5cy & acc\ntability4,sec4 #ijc4 ,,otc he>+ aids f9al rule4,sec4 #ijd4 ,enhanc+ coord9ation & transp>5cy on inspections4,sec4 #ije4 ,c]tificates to =eign gov]nm5ts4,sec4 #ijf4 ,importation ( drugs4,sec4 #ijg4 ,improv+ in=mation te*nology sy/ems ( ! ,food & ,drug ,adm9i/ration4,sec4 #ijh4 ,regulation ( c]ta9 products z drugs4,sec4 #iji4 ,report+ on mailroom & ,(fice ( ! ,executive ,secret>iat ( ! ,food & ,drug ,adm9i/ration4,sec4 #iaj4 ,protect+ infants & improv+ =mula supply4,sec4 #iaa4 ,pr$et]m9$ *ange control plans = devices4,sec4 #iab4 ,prohibition aga9/ food packag+ conta9+ int5tionally add$ ,,pfas4,sec4 #iac4 ,requirem5ts reg>d+ conflicts ( int]e/4,sec4 #iad4 ,?ird p>ty data transp>5cy4,sec4 #iae4 ,bann$ devices4,sec4 #iaf4 ,m$ical device cyb]security4,sec4 #iag4 ,wom5's ,heal? ,rese>* ,roadmap4,sec4 #iah4 ,,gao report on dea?s due to ! co/ ( drugs 9 ! ,unit$ ,/ates4 ,i ,fees relat+ to drugs #aja4 ,%ort title2 f9d+ 7a7 ,%ort title ,?is title may be cit$ z ! ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjbb4 7b7 ,f9d+ ,congress f9ds t ! fees au?oriz$ by ! am5dm5ts made 9 ?is title w be d$icat$ t[>d exp$it+ ! drug developm5t process & ! process = ! review ( human drug applications1 includ+ po/m>ket drug safety activities1 z set =? 9 ! goals id5tifi$ = purposes ( "p #b ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g et seq471 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #ajb4 ,def9itions ,section #gce ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g7 is am5d$-- 7#a7 9 p>agraph 7#a71 9 ! matt] foll[+ subp>agraph 7,b71 by /rik+ an all]g5ic extract product1 or & ins]t+ does n include an application ) respect to an all]g5ic extract product lic5s$ be=e ,octob] #a1 #bjbb1 does n include an application ) respect to a /&>diz$ all]g5ic extract product submitt$ pursuant to a notification to ! applicant f ! ,secret>y reg>d+ ! exi/5ce ( a pot5cy te/ t measures ! all]g5ic activity ( an all]g5ic extract product lic5s$ by ! applicant be=e ,octob] #a1 #bjbb1 does n include an application ) respect to2 7#b7 9 p>agraph 7#c71 9 ! matt] foll[+ subp>agraph 7,c7-- 7,a7 by ins]t+ lic5s$ be=e ,octob] #a1 #bjbb1 a /&>diz$ all]g5ic extract product submitt$ pursuant to a notification to ! applicant f ! ,secret>y reg>d+ ! exi/5ce ( a pot5cy te/ t measures ! all]g5ic activity ( an all]g5ic extract product lic5s$ by ! applicant be=e ,octob] #a1 #bjbb1 aft] an all]g5ic extract product2 & 7,b7 by add+ at ! end ! foll[+3 ,if a writt5 reque/ to place a product 9 ! discont9u$ section ( ei!r ( ! li/s describ$ 9 subp>agraph 7,c7 is submitt$ to ! ,secret>y on behalf ( an applicant1 & ! reque/ id5tifies ! date ! product is1 or w be1 )drawn f sale1 !n1 = purposes ( assess+ ! prescription drug program fee "u section #gcf7;a77#b71 ! ,secret>y %all consid] su* product to h be5 includ$ 9 ! discont9u$ section on ! lat] ( 7i7 ! date su* reque/ 0 receiv$1 or 7ii7 if ! product w be )drawn f sale on a future date1 su* future date :5 ! product is )drawn f sale4 ,= purposes ( subp>agraph 7,c71 a product %all be consid]$ )drawn f sale once ! applicant has ceas$ its own di/ribution ( ! product1 :e!r or n ! applicant has ord]$ recall ( all previ\sly di/ribut$ lots ( ! product1 except t a r\t9e1 tempor>y int]ruption 9 supply %all n r5d] a product )drawn f sale42 & 7#c7 by add+ at ! end ! foll[+3 7#ab7 ,! t]m sk9-te/ diagno/ic product-- 7,a7 means a product-- 7i7 = prick1 scrat*1 intrad]mal1 or subcutane\s adm9i/ration2 7ii7 expect$ to produce a limit$1 local reaction at ! site ( adm9i/ration 7if positive71 r ?an a sy/emic effect2 7iii7 n int5d$ to be a prev5tive or !rapeutic int]v5tion2 & 7iv7 int5d$ to detect an imm$iate or delay$-type sk9 hyp]s5sitivity reaction to aid 9 ! diagnosis (-- 7,i7 an all]gy to an antimicrobial ag5t2 7,,ii7 an all]gy t is n to an antimicrobial ag5t1 if ! diagno/ic product 0 au?oriz$ = m>ket+ prior to ,octob] #a1 #bjbb2 or 7,,iii7 infection ) fungal or mycobact]ial pa?og5s2 & 7,b7 includes positive & negative controls requir$ to int]pret ! results ( a product describ$ 9 subp>agraph 7,a74 4 #ajc4 ,au?ority to assess & use drug fees 7a7 ,types ( fees ,section #gcf7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7a77 is am5d$-- 7#a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ #bjah & ins]t+ #bjbc2 7#b7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a71 by /rik+ subsection 7c77#e7 ea* place x appe>s & ins]t+ subsection 7c77#f72 7,b7 9 subp>agraph 7,c71 by ins]t+ prior to approval aft] or 0 )drawn2 & 7,c7 by add+ at ! end ! foll[+3 7,h7 ,exception = sk9-te/ diagno/ic products ,a human drug application = a sk9-te/ diagno/ic product %all n be subject to a fee "u subp>agraph 7,a74 2 & 7#c7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a7-- 7i7 by /rik+ subsection 7c77#e7 & ins]t+ subsection 7c77#f72 7ii7 by /rik+ ,except z provid$ & ins]t+ ! foll[+3 7i7 ,paym5t ( fees ,except z provid$ 2 & 7iii7 by add+ at ! end ! foll[+3 7ii7 ,previ\sly discont9u$ drug products ,if a drug product t is id5tifi$ 9 a human drug application approv$ z ( ,octob] #a ( a fiscal ye> is n a prescription drug product z ( t date because ! drug product is 9 ! discont9u$ section ( a li/ id5tifi$ 9 section #gce7c71 & on any subsequ5t day dur+ su* fiscal ye> ! drug product is a prescription drug product1 !n except z provid$ 9 subp>agraphs 7,b7 & 7,c71 ea* p]son :o is nam$ z ! applicant 9 a human drug application ) respect to su* product1 & :o1 aft] ,septemb] #a1 #aiib1 _h p5d+ be=e ! ,secret>y a human drug application or supplem5t1 %all pay ! annual prescription drug program fee e/abli%$ = a fiscal ye> "u subsection 7c77#f7 = su* prescription drug product4 ,su* fee %all be due on ! la/ bus9ess day ( su* fiscal ye> & %all be paid only once = ea* product = a fiscal ye> 9 :i* ! fee is payable4 2 & 7,b7 by am5d+ subp>agraph 7,b7 to read z foll[s3 7,b7 ,exception = c]ta9 prescription drug products ,a prescription drug program fee %all n be assess$ = a prescription drug product "u subp>agraph 7,a7 if su* product is-- 7i7 a l>ge volume p>5t]al product 7a /]ile aque\s drug product packag$ 9 a s+le-dose conta9] ) a volume great] ?an or equal to #ajj m,l1 n includ+ p[d]s = recon/itution or ph>macy bulk packages7 id5tifi$ on ! li/ compil$ "u section #eje7;j77#g72 7ii7 ph>maceutically equival5t 7z def9$ 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations771 to ano!r product on ! li/ ( products compil$ "u section #eje7;j77#g7 7n includ+ ! discont9u$ section ( su* li/72 or 7iii7 a sk9-te/ diagno/ic product4 4 7b7 ,fee rev5ue am\nts ,section #gcf7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7b77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 7,b7 by r$esignat+ subp>agraphs 7,c7 ?r\gh 7,f7 z subp>agraphs 7,d7 ?r\gh 7,g71 respectively2 7,c7 by ins]t+ aft] subp>agraph 7,b7 ! foll[+3 7,c7 ,! doll> am\nt equal to ! /rategic hir+ & ret5tion adju/m5t = ! fiscal ye> 7z det]m9$ "u subsection 7c77#b772 2 7,d7 9 subp>agraph 7,d71 z s r$esignat$1 by /rik+ 7c77#b7 & ins]t+ 7c77#c72 7,e7 9 subp>agraph 7,e71 z s r$esignat$1 by /rik+ 7c77#c7 & ins]t+ 7c77#d72 7,f7 9 subp>agraph 7,f71 z s r$esignat$1 by /rik+ 7c77#d7 & ins]t+ 7c77#e72 & 7,g7 9 subp>agraph 7,g71 z s r$esignat$1 by /rik+ clauses 7i7 ?r\gh 7v7 & ins]t+ ! foll[+3 7i7 #fe1ggc1fic = fiscal ye> #bjbc4 7ii7 #be1jig1fga = fiscal ye> #bjbd4 7iii7 #ad1aed1afi = fiscal ye> #bjbe4 7iv7 #d1hfd1hfj = fiscal ye> #bjbf4 7v7 #a1cad1fbj = fiscal ye> #bjbg4 2 & 7#b7 9 p>agraph 7#c7-- 7,a7 9 subp>agraph 7,a71 by /rik+ #bjah1 #hgh1eij1jjj & ins]t+ #bjbc1 #a1aea1ebb1ieh2 & 7,b7 9 subp>agraph 7,b7-- 7i7 by /rik+ #bjai ?r\gh #bjbb & ins]t+ #bjbd ?r\gh #bjbg2 & 7ii7 by /rik+ subsection 7c77#c7 or 7c77#d7 & ins]t+ subsection 7c77#d7 or 7c77#e74 7c7 ,adju/m5ts2 annual fee sett+ ,section #gcf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is am5d$-- 7#a7 9 p>agraph 7#a77;,b77ii71 by /rik+ ,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv & ins]t+ ,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 7#b7 by r$esignat+ p>agraphs 7#b7 ?r\gh 7#f7 z p>agraphs 7#c7 ?r\gh 7#g71 respectively2 7#c7 by ins]t+ aft] p>agraph 7#a7 ! foll[+3 7#b7 ,/rategic hir+ & ret5tion adju/m5t ,= ea* fiscal ye>1 aft] ! annual base rev5ue e/abli%$ 9 subsection 7b77#a77;,a7 is adju/$ = inflation 9 accordance ) p>agraph 7#a71 ! ,secret>y %all fur!r increase ! fee rev5ue & fees-- 7,a7 = fiscal ye> #bjbc1 by #i1jjj1jjj2 & 7,b7 = fiscal ye> #bjbd & ea* subsequ5t fiscal ye>1 by #d1jjj1jjj4 2 7#d7 9 p>agraph 7#c71 z s r$esignat$-- 7,a7 9 subp>agraph 7,a7-- 7i7 by /rik+ = inflation2 & 7ii7 by /rik+ p>agraph 7#a7 & ins]t+ p>agraphs 7#a7 & 7#b72 7,b7 by am5d+ subp>agraph 7,b7 to read z foll[s3 7,b7 ,me?odology ,= purposes ( ?is p>agraph1 ! ,secret>y %all employ ! capacity plann+ me?odology utiliz$ by ! ,secret>y 9 sett+ fees = fiscal ye> #bjba1 z describ$ 9 ! notice titl$ ,prescription ,drug ,us] ,fee ,rates = ,fiscal ,ye> #bjba 7#he ,f$4 ,reg4 #dffea2 ,augu/ #c1 #bjbj74 ,! workload categories us$ 9 =eca/+ %all include only ! activities describ$ 9 su* notice &1 z feasible1 additional activities t are directly relat$ to ! direct review ( applications & supplem5ts1 includ+ additional =mal meet+ types1 ! direct review ( po/m>ket+ commitm5ts & requirem5ts1 ! direct review ( risk evaluation & mitigation /rategies1 & ! direct review ( annual reports = approv$ prescription drug products4 ,subject to ! exceptions 9 ! prec$+ s5t5ce1 ! ,secret>y %all n include z workload categories 9 =eca/+ any non-core review activities1 includ+ any activities t ! ,secret>y ref]5c$ = pot5tial future use 9 su* notice b did n utilize 9 ! sett+ fees = fiscal ye> #bjba4 2 7,c7 by /rik+ subp>agraph 7,c72 7,d7 by r$esignat+ subp>agraphs 7,d7 & 7,e7 z subp>agraphs 7,c7 & 7,d71 respectively2 7,e7 9 subp>agraph 7,c71 z s r$esignat$-- 7i7 by /rik+ ye>7 & & ins]t+ ye>712 & 7ii7 by /rik+ ! p]iod & ins]t+ 1 & subsection 7b77#a77;,c7 7! doll> am\nt ( ! /rategic hir+ & ret5tion adju/m5t742 & 7,f7 9 subp>agraph 7,d71 z s r$esignat$1 by /rik+ p>agraph 7#e7 & ins]t+ p>agraph 7#f72 7#e7 9 p>agraph 7#d71 z s r$esignat$-- 7,a7 by am5d+ subp>agraph 7,a7 to read z foll[s3 7,a7 ,increase ,= fiscal ye> #bjbc & subsequ5t fiscal ye>s1 ! ,secret>y %all1 9 addition to adju/m5ts "u p>agraphs 7#a71 7#b71 & 7#c71 fur!r increase ! fee rev5ue & fees if su* an adju/m5t is necess>y to provide = at lea/ ! foll[+ am\nts ( op]at+ res]ves ( c>ryov] us] fees = ! process = ! review ( human drug applications = ea* fiscal ye>1 z foll[s3 7i7 ,= fiscal ye> #bjbc1 at lea/ #h weeks ( op]at+ res]ves4 7ii7 ,= fiscal ye> #bjbd1 at lea/ #i weeks ( op]at+ res]ves4 7iii7 ,= fiscal ye> #bjbe & subsequ5t fiscal ye>s1 at lea/ #aj weeks ( op]at+ res]ves4 2 & 7,b7 9 subp>agraph 7,c71 by /rik+ p>agraph 7#e7 & ins]t+ p>agraph 7#f72 7#f7 by am5d+ p>agraph 7#e71 z s r$esignat$1 to read z foll[s3 7#e7 ,additional direct co/ adju/m5t ,! ,secret>y %all1 9 addition to adju/m5ts "u p>agraphs 7#a71 7#b71 7#c71 & 7#d71 fur!r increase ! fee rev5ue & fees-- 7,a7 = fiscal ye> #bjbc1 by #dd1chf1aej2 & 7,b7 = fiscal ye>s #bjbd ?r\gh #bjbg1 by ! am\nt set =? 9 clauses 7i7 ?r\gh 7iv71 z applicable1 multipli$ by ! ,consum] ,price ,index = urban consum]s 7,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 ,n ,seasonally ,adju/$2 ,all ,items2 ,annual ,index7 = ! mo/ rec5t ye> ( available data1 divid$ by su* ,index = #bjba-- 7i7 = fiscal ye> #bjbd1 #fj1ifg1iic2 7ii7 = fiscal ye> #bjbe1 #ce1gii1cad2 7iii7 = fiscal ye> #bjbf1 #ce1gii1cad2 & 7iv7 = fiscal ye> #bjbg1 #ce1gii1cad4 2 & 7#g7 9 p>agraph 7#f71 z s r$esignat$1 by /rik+ #bjag & ins]t+ #bjbb4 7d7 ,cr$it+ & availability ( fees ,section #gcf7;g77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7g77#c77 is am5d$ by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 7e7 ,writt5 reque/s = waiv]s1 r$uctions1 & refunds ,section #gcf7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7i77 is am5d$ to read z foll[s3 7i7 ,writt5 reque/s = waiv]s1 r$uctions1 exemptions1 & returns2 disputes conc]n+ fees ,to qualify = consid]ation = a waiv] or r$uction "u subsection 7d71 an exemption "u subsection 7k71 or ! return ( any fee paid "u ?is section1 includ+ if ! fee is claim$ to h be5 paid 9 error1 a p]son %all submit to ! ,secret>y a writt5 reque/ ju/ify+ su* waiv]1 r$uction1 exemption1 or return n lat] ?an #ahj days aft] su* fee is due4 ,a reque/ submitt$ "u ?is p>agraph %all include any legal au?orities "u :i* ! reque/ is made4 4 7f7 ,orphan drugs ,section #gcf7k7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7k77 is am5d$-- 7#a7 9 p>agraph 7#a77;,b71 by /rik+ dur+ ! previ\s ye> & ins]t+ 1 z det]m9$ "u p>agraph 7#b72 & 7#b7 9 p>agraph 7#b71 by /rik+ t its gross annual rev5ues & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ support$ by tax returns submitt$ to ! ,int]nal ,rev5ue ,s]vice1 or1 z necess>y1 by o!r appropriate f9ancial in=mation1 t its gross annual rev5ues did n exce$ #ej1jjj1jjj = ! la/ cal5d> ye> end+ prior to ! fiscal ye> = :i* ! exemption is reque/$44 #ajd4 ,reau?orization2 report+ requirem5t ,section #gcf;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7 is am5d$-- 7#a7 by /rik+ #bjah ea* place x appe>s & ins]t+ #bjbc2 7#b7 by /rik+ ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjag ea* place x appe>s & ins]t+ ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjbb2 7#c7 9 subsection 7a77#d71 by /rik+ #bjbj & ins]t+ #bjbc2 & 7#d7 9 subsection 7f71 by /rik+ #bjbb ea* place x appe>s & ins]t+ #bjbg4 #aje4 ,sunset dates 7a7 ,au?orization ,sections #gce & #gcf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g2 #cgi;h7 %all cease to be effective ,octob] #a1 #bjbg4 7b7 ,report+ requirem5ts ,section #gcf;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7 %all cease to be effective ,janu>y #ca1 #bjbh4 7c7 ,previ\s sunset provision ,effective ,octob] #a1 #bjbb1 subsections 7a7 & 7b7 ( section #ajd ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 are repeal$4 #ajf4 ,effective date ,! am5dm5ts made by ?is title %all take effect on ,octob] #a1 #bjbb1 or ! date ( ! enactm5t ( ?is ,act1 :i*ev] is lat]1 except t fees "u "p #b ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g et seq47 %all be assess$ = all human drug applications receiv$ on or aft] ,octob] #a1 #bjbb1 reg>dless ( ! date ( ! enactm5t ( ?is ,act4 #ajg4 ,sav+s clause ,not)/&+ ! am5dm5ts made by ?is title1 "p #b ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g et seq471 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is title1 %all cont9ue to be 9 effect ) respect to human drug applications & supplem5ts 7z def9$ 9 su* "p z ( su* day7 t 7 accept$ by ! ,food & ,drug ,adm9i/ration = fil+ on or aft] ,octob] #a1 #bjag1 b be=e ,octob] #a1 #bjbb1 ) respect to assess+ & collect+ any fee requir$ by su* "p = a fiscal ye> prior to fiscal ye> #bjbc4 ,,ii ,fees relat+ to devices #bja4 ,%ort title2 f9d+ 7a7 ,%ort title ,?is title may be cit$ z ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb4 7b7 ,f9d+ ,congress f9ds t ! fees au?oriz$ "u ! am5dm5ts made by ?is title w be d$icat$ t[>d exp$it+ ! process = ! review ( device applications & = assur+ ! safety & effectiv5ess ( devices1 z set =? 9 ! goals id5tifi$ = purposes ( "p #c ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #bjb4 ,def9itions ,section #gcg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i7 is am5d$-- 7#a7 9 p>agraph 7#i7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ & prem>ket notification submissions & ins]t+ prem>ket notification submissions1 & de novo classification reque/s2 7,b7 9 subp>agraph 7,d71 by /rik+ & submissions & ins]t+ submissions1 & de novo classification reque/s2 7,c7 9 subp>agraph 7,f71 by /rik+ & prem>ket notification submissions & ins]t+ prem>ket notification submissions1 & de novo classification reque/s2 7,d7 9 subp>agraphs 7,g7 & 7,h71 by /rik+ or submissions ea* place x appe>s & ins]t+ submissions1 or reque/s2 & 7,e7 9 subp>agraph 7,k71 by /rik+ or prem>ket notification submissions & ins]t+ prem>ket notification submissions1 or de novo classification reque/s2 & 7#b7 9 p>agraph 7#aa71 by /rik+ #bjaf & ins]t+ #bjba4 #bjc4 ,au?ority to assess & use device fees 7a7 ,types ( fees ,section #gch7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7a77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ #bjah & ins]t+ #bjbc2 & 7#b7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! matt] prec$+ clause 7i71 by /rik+ #bjag & ins]t+ #bjbb2 7ii7 9 clause 7iii71 by /rik+ #ge p]c5t & ins]t+ #hj p]c5t2 & 7iii7 9 clause 7viii71 by /rik+ #c4d p]c5t & ins]t+ #d4e p]c5t2 7,b7 9 subp>agraph 7,b77iii71 by /rik+ or prem>ket notification submission & ins]t+ prem>ket notification submission1 or de novo classification reque/2 & 7,c7 9 subp>agraph 7,c71 by /rik+ or p]iodic report+ conc]n+ a class ,,iii device & ins]t+ p]iodic report+ conc]n+ a class ,,iii device1 or de novo classification reque/4 7b7 ,fee am\nts ,section #gch7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7b77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 7#b7 by am5d+ ! table 9 p>agraph 7#b7 to read z foll[s3 ,fee ,type,fiscal ,ye> #bjbc;,fiscal ,ye> #bjbd;,fiscal ,ye> #bjbe;,fiscal ,ye> #bjbf;,fiscal ,ye> #bjbg,prem>ket ,application#dbe1jjjdce1jjjdde1jjjdee1jj jdgj1jjj;,e/abli%m5t ,regi/ration#f1bejf1hgeg1ajjg1egeh1dfe 2 & 7#c7 9 p>agraph 7#c71 by am5d+ subp>agraphs 7,a7 ?r\gh 7,e7 to read z foll[s3 7,a7 #cab1fjf1jjj = fiscal ye> #bjbc4 7,b7 #cce1gej1jjj = fiscal ye> #bjbd4 7,c7 #cej1gdf1djj = fiscal ye> #bjbe4 7,d7 #cff1dhf1cjj = fiscal ye> #bjbf4 7,e7 #dah1cdc1jjj = fiscal ye> #bjbg4 4 7c7 ,annual fee sett+2 adju/m5ts ,section #gch7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7c77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ #bjag & ins]t+ #bjbb2 7#b7 9 p>agraph 7#b7-- 7,a7 by /rik+ #bjah ea* place x appe>s & ins]t+ #bjbc2 7,b7 9 subp>agraph 7,b77ii71 by /rik+ #bjaf & ins]t+ #bjbb2 7,c7 9 subp>agraph 7,c77i77,,ii71 by /rik+ ,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv & ins]t+ ,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 & 7,d7 9 subp>agraph 7,d71 by /rik+ #bjbb & ins]t+ #bjbg2 7#c7 9 p>agraph 7#c71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 7#d7 by r$esignat+ p>agraphs 7#d7 & 7#e7 z p>agraphs 7#g7 & 7#h71 respectively2 & 7#e7 by ins]t+ aft] p>agraph 7#c7 ! foll[+3 7#d7 ,p]=mance improvem5t adju/m5t 7,a7 ,9 g5]al ,= ea* ( fiscal ye>s #bjbe ?r\gh #bjbg1 aft] ! adju/m5t "u p>agraph 7#c71 ! base e/abli%m5t regi/ration fee am\nts = su* fiscal ye> %all be increas$ to reflect *anges 9 ! res\rce ne$s ( ! ,secret>y due to improv$ review p]=mance goals = ! process = ! review ( device applications id5tifi$ 9 ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb1 z ! ,secret>y det]m9es necess>y to a*ieve an increase 9 total fee collections = su* fiscal ye>1 equal to ! foll[+ am\nts1 z applicable3 7i7 ,= fiscal ye> #bjbe1 ! product (-- 7,i7 ! am\nt det]m9$ "u subp>agraph 7,b77i77,i72 & 7,,ii7 ! applicable inflation adju/m5t "u p>agraph 7#b77;,b7 = su* fiscal ye>4 7ii7 ,= fiscal ye> #bjbf1 ! product (-- 7,i7 ! sum ( ! am\nts det]m9$ "u subp>agraphs 7,b77i77,,ii71 7,b77ii77,i71 & 7,b77iii77,i72 & 7,,ii7 ! applicable inflation adju/m5t "u p>agraph 7#b77;,b7 = su* fiscal ye>4 7iii7 ,= fiscal ye> #bjbg1 ! product (-- 7,i7 ! sum ( ! am\nts det]m9$ "u subp>agraphs 7,b77i77,,iii71 7,b77ii77,,ii71 & 7,b77iii77,,ii72 & 7,,ii7 ! applicable inflation adju/m5t "u p>agraph 7#b77;,b7 = su* fiscal ye>4 7,b7 ,am\nts 7i7 ,presubmission am\nt ,= purposes ( subp>agraph 7,a71 ) respect to ! presubmission writt5 fe$back goal1 ! am\nts det]m9$ "u ?is subp>agraph are z foll[s3 7,i7 ,= fiscal ye> #bjbe1 #ae1cif1fjj if ! goal = fiscal ye> #bjbc is met4 7,,ii7 ,= fiscal ye> #bjbf-- 7aa7 #ae1cif1fjj if ! goal = fiscal ye> #bjbc is met & ! goal = fiscal ye> #bjbd is miss$2 or 7bb7 #cf1gib1bjj if ! goal = fiscal ye> #bjbd is met4 7,,iii7 ,= fiscal ye> #bjbg-- 7aa7 #ae1cif1fjj if ! goal = fiscal ye> #bjbc is met & ! goal = ea* ( fiscal ye>s #bjbd & #bjbe is miss$2 7bb7 #cf1gib1bjj if ! goal = fiscal ye> #bjbd is met & ! goal = fiscal ye> #bjbe is miss$2 or 7cc7 #dj1egb1fjj if ! goal = fiscal ye> #bjbe is met4 7ii7 ,de novo classification reque/ am\nt ,= purposes ( subp>agraph 7,a71 ) respect to ! de novo decision goal1 ! am\nts det]m9$ "u ?is subp>agraph are z foll[s3 7,i7 ,= fiscal ye> #bjbf1 #f1cbc1ejj if ! goal = fiscal ye> #bjbc is met4 7,,ii7 ,= fiscal ye> #bjbg-- 7aa7 #f1cbc1ejj if ! goal = fiscal ye> #bjbc is met & ! goal = fiscal ye> #bjbd is miss$2 or 7bb7 #aa1gfe1djj if ! goal = fiscal ye> #bjbd is met4 7iii7 ,prem>ket notification & prem>ket approval am\nt ,= purposes ( subp>agraph 7,a71 ) respect to ! #eaj7k7 decision goal1 #eaj7k7 %>$ outcome total "t to decision goal1 ,,pma decision goal1 & ,,pma %>$ outcome total "t to decision goal1 ! am\nts det]m9$ "u ?is subp>agraph are z foll[s3 7,i7 ,= fiscal ye> #bjbf1 #a1jbj1jjj if ! #d goals = fiscal ye> #bjbc are met4 7,,ii7 ,= fiscal ye> #bjbg-- 7aa7 #a1jbj1jjj if ! #d goals = fiscal ye> #bjbc are met & "o or m ( ! #d goals = fiscal ye> #bjbd is miss$2 or 7bb7 #c1ijf1jjj if ! #d goals = fiscal ye> #bjbd are met4 7,c7 ,p]=mance calculation ,= purposes ( ?is p>agraph1 p]=mance ( ! foll[+ goals %all be det]m9$ z specifi$ 9 ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb & bas$ on data available z ( ! applicable dates z foll[s3 7i7 ,! p]=mance ( ! presubmission writt5 fe$back goal-- 7,i7 = fiscal ye> #bjbc1 %all be bas$ on data available z ( ,m>* #ca1 #bjbd2 7,,ii7 = fiscal ye> #bjbd1 %all be bas$ on data available z ( ,m>* #ca1 #bjbe2 & 7,,iii7 = fiscal ye> #bjbe1 %all be bas$ on data available z ( ,m>* #ca1 #bjbf4 7ii7 ,! p]=mance ( ! de novo decision goal1 #eaj7k7 decision goal1 #eaj7k7 %>$ outcome total "t to decision goal1 ,,pma decision goal1 & ,,pma %>$ outcome total "t to decision goal-- 7,i7 = fiscal ye> #bjbc1 %all be bas$ on data available z ( ,m>* #ca1 #bjbe2 & 7,,ii7 = fiscal ye> #bjbd1 %all be bas$ on data available z ( ,m>* #ca1 #bjbf4 7,d7 ,def9itions ,= purposes ( ?is p>agraph1 ! t]ms presubmission writt5 fe$back goal1 de novo decision goal1 #eaj7k7 decision goal1 #eaj7k7 %>$ outcome total "t to decision goal1 ,,pma decision goal1 & ,,pma %>$ outcome total "t to decision goal h ! mean+s giv5 su* t]ms 9 ! goals id5tifi$ 9 ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb4 7#e7 ,hir+ adju/m5t 7,a7 ,9 g5]al ,= ea* ( fiscal ye>s #bjbe ?r\gh #bjbg1 aft] ! adju/m5ts "u p>agraphs 7#c7 & 7#d71 if applicable1 ! base e/abli%m5t regi/ration fee am\nts %all be decreas$ z ! ,secret>y det]m9es necess>y to a*ieve a r$uction 9 total fee collections equal to ! hir+ adju/m5t am\nt "u subp>agraph 7,b71 if ! numb] ( hires to support ! process = ! review ( device applications falls bel[ ! foll[+ ?re%olds = ! applicable fiscal ye>s3 7i7 ,= fiscal ye> #bjbe1 #he p]c5t ( ! hir+ goal specifi$ 9 subp>agraph 7,c7 = fiscal ye> #bjbc4 7ii7 ,= fiscal ye> #bjbf1 #ij p]c5t ( ! hir+ goal specifi$ 9 subp>agraph 7,c7 = fiscal ye> #bjbd4 7iii7 ,= fiscal ye> #bjbg1 #ij p]c5t ( ! hir+ goal specifi$ 9 subp>agraph 7,c7 = fiscal ye> #bjbe4 7,b7 ,hir+ adju/m5t am\nt ,! hir+ adju/m5t am\nt = fiscal ye> #bjbe & ea* subsequ5t fiscal ye> is ! product (-- 7i7 ! numb] ( hires by :i* ! hir+ goal specifi$ 9 subp>agraph 7,c7 = ! fiscal ye> be=e ! prior fiscal ye> 0 miss$2 7ii7 #gb1hgg2 & 7iii7 ! applicable inflation adju/m5t "u p>agraph 7#b77;,b7 = ! fiscal ye> = :i* ! hir+ goal 0 miss$4 7,c7 ,hir+ goals 7i7 ,9 g5]al ,= purposes ( subp>agraph 7,b71 ! hir+ goals = ea* ( fiscal ye>s #bjbc ?r\gh #bjbe are z foll[s3 7,i7 ,= fiscal ye> #bjbc1 #add hires4 7,,ii7 ,= fiscal ye> #bjbd1 #db hires4 7,,iii7 ,= fiscal ye> #bjbe-- 7aa7 #bd hires if ! base e/abli%m5t regi/ration fees are n increas$ by ! am\nt det]m9$ "u p>agraph 7#d77;,a77i72 or 7bb7 #hc hires if ! base e/abli%m5t regi/ration fees are increas$ by ! am\nt det]m9$ "u p>agraph 7#d77;,a77i74 7ii7 ,numb] ( hires ,= purposes ( ?is p>agraph1 ! numb] ( hires = a fiscal ye> %all be det]m9$ by ! ,secret>y1 z set =? 9 ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb4 7#f7 ,op]at+ res]ve adju/m5t 7,a7 ,9 g5]al ,= ea* ( fiscal ye>s #bjbc ?r\gh #bjbg1 aft] ! adju/m5ts "u p>agraphs 7#c71 7#d71 & 7#e71 if applicable1 if ! ,secret>y has op]at+ res]ves ( c>ryov] us] fees = ! process = ! review ( device applications 9 excess ( ! designat$ am\nt 9 subp>agraph 7,b71 ! ,secret>y %all decrease ! base e/abli%m5t regi/ration fee am\nts to provide = n m ?an su* designat$ am\nt ( op]at+ res]ves4 7,b7 ,designat$ am\nt ,subject to subp>agraph 7,c71 = ea* fiscal ye>1 ! designat$ am\nt 9 ?is subp>agraph is equal to ! sum (-- 7i7 #ac weeks ( op]at+ res]ves ( c>ryov] us] fees2 & 7ii7 ! #a mon? ( op]at+ res]ves describ$ 9 p>agraph 7#h74 7,c7 ,exclud$ am\nt ,= ! p]iod ( fiscal ye>s #bjbc ?r\gh #bjbf1 a total am\nt equal to #aah1jjj1jjj %all n be consid]$ "p ( ! designat$ am\nt "u subp>agraph 7,b7 & %all n be subject to ! decrease "u subp>agraph 7,a74 4 7d7 ,small bus9esses ,section #gch ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is am5d$-- 7#a7 9 subsection 7a77#c77;,b7-- 7,a7 by /rik+ ,no fee & ins]t+ ! foll[+3 7i7 ,9 g5]al ,no fee 2 & 7,b7 by add+ at ! end ! foll[+3 7ii7 ,small bus9esses fee waiv] 7,i7 ,def9ition ( small bus9ess ,= ! purposes ( ?is clause1 ! t]m small bus9ess means an entity t report$ #a1jjj1jjj or less ( gross receipts or sales 9 its mo/ rec5t ,f$]al income tax return = a taxable ye>1 includ+ su* returns ( all ( its affiliates4 7,,ii7 ,waiv] ,! ,secret>y may grant a waiv] ( ! fee requir$ "u subp>agraph 7,a7 = ! annual regi/ration 7exclud+ ! initial regi/ration7 ( an e/abli%m5t = a ye>1 if ! ,secret>y f9ds t ! e/abli%m5t is a small bus9ess & pay+ ! fee = su* ye> repres5ts a f9ancial h>d%ip to ! e/abli%m5t z det]m9$ on ! basis ( crit]ia e/abli%$ by ! ,secret>y4 7,,iii7 ,firms submitt+ tax returns to ! unit$ /ates int]nal rev5ue s]vice ,! e/abli%m5t %all support its claim t x meets ! def9ition "u subclause 7,i7 by submission ( a copy ( its mo/ rec5t ,f$]al income tax return = a taxable ye>1 & a copy ( su* returns ( its affiliates1 :i* %[ an am\nt ( gross sales or receipts t is less ?an ! maximum e/abli%$ 9 subclause 7,i74 ,! e/abli%m5t1 & ea* ( su* affiliates1 %all c]tify t ! in=mation provid$ is a true & accurate copy ( ! actual tax =ms !y submitt$ to ! ,int]nal ,rev5ue ,s]vice4 ,if no tax =ms are submitt$ = any affiliate1 ! e/abli%m5t %all c]tify t ! e/abli%m5t has no affiliates4 7,,iv7 ,firms n submitt+ tax returns to ! unit$ /ates int]nal rev5ue s]vice ,9 ! case ( an e/abli%m5t t has n previ\sly submitt$ a ,f$]al income tax return1 ! e/abli%m5t & ea* ( its affiliates %all demon/rate t x meets ! def9ition "u subclause 7,i7 by submission ( a sign$ c]tification1 9 su* =m z ! ,secret>y may direct ?r\gh a notice publi%$ 9 ! ,f$]al ,regi/]1 t ! e/abli%m5t or affiliate meets ! crit]ia = a small bus9ess & a c]tification1 9 ,engli%1 f ! national tax+ au?ority1 if extant1 ( ! c\ntry 9 :i* ! e/abli%m5t or1 if applicable1 affiliate is headqu>t]$4 ,! c]tification f su* tax+ au?ority %all be> ! (ficial seal ( su* tax+ au?ority & %all provide ! e/abli%m5t's or affiliate's gross receipts or sales = ! mo/ rec5t ye> 9 bo? ! local curr5cy ( su* c\ntry & 9 ,unit$ ,/ates doll>s1 ! ex*ange rate us$ 9 conv]t+ su* local curr5cy to doll>s1 & ! dates dur+ :i* ^! receipts or sales 7 collect$4 ,! e/abli%m5t %all also submit a /atem5t sign$ by ! head ( ! e/abli%m5t's firm or by its *ief f9ancial (fic] t ! e/abli%m5t has submitt$ c]tifications = all ( its affiliates1 or t ! e/abli%m5t has no affiliates4 7,v7 ,reque/ = waiv] ,an e/abli%m5t seek+ a fee waiv] = a ye> "u ?is clause %all submit support+ in=mation to ! ,secret>y at lea/ #fj days be=e ! fee is requir$ pursuant to subp>agraph 7,c74 ,! decision ( ! ,secret>y reg>d+ :e!r an entity may receive ! waiv] = su* ye> is n reviewable4 2 7#b7 9 subsection 7d77#b77;,b77iii71 by ins]t+ 1 if extant1 aft] national tax+ au?ority2 & 7#c7 9 subsection 7e77#b77;,b77iii71 by ins]t+ 1 if extant1 aft] national tax+ au?ority4 7e7 ,conditions ,section #gch7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7g77 is am5d$-- 7#a7 9 p>agraph 7#a77;,a71 by /rik+ #cbj1hbe1jjj & ins]t+ #cih1eff1jjj2 & 7#b7 9 p>agraph 7#b71 by ins]t+ de novo classification reque/s1 aft] class ,,iii device14 7f7 ,au?orization ( appropriations ,section #gch7;h77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7h77#c77 is am5d$ to read z foll[s3 7#c7 ,au?orization ( appropriations 7,a7 ,9 g5]al ,= ea* ( ! fiscal ye>s #bjbc ?r\gh #bjbg1 !re is au?oriz$ to be appropriat$ = fees "u ?is section an am\nt equal to ! rev5ue am\nt det]m9$ 9 subp>agraph 7,b71 less ! am\nt ( r$uctions det]m9$ 9 subp>agraph 7,c74 7,b7 ,rev5ue am\nt ,= purposes ( ?is p>agraph1 ! rev5ue am\nt = ea* fiscal ye> is ! sum (-- 7i7 ! total rev5ue am\nt "u subsection 7b77#c7 = ! fiscal ye>1 z adju/$ "u subsection 7c77#b72 & 7ii7 ! p]=mance improvem5t adju/m5t am\nt = ! fiscal ye> "u subsection 7c77#d77;,a71 if applicable4 7,c7 ,am\nt ( r$uctions ,= purposes ( ?is p>agraph1 ! am\nt ( r$uctions = ea* fiscal ye> is ! sum (-- 7i7 ! hir+ adju/m5t am\nt = ! fiscal ye> "u subsection 7c77#e71 if applicable2 & 7ii7 ! op]at+ res]ve adju/m5t am\nt = ! fiscal ye> "u subsection 7c77#f71 if applicable4 4 #bjd4 ,reau?orization2 report+ requirem5t 7a7 ,p]=mance reports ,section #gch;,a7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;a77 is am5d$-- 7#a7 by /rik+ fiscal ye> #bjah ea* place x appe>s & ins]t+ fiscal ye> #bjbc2 & 7#b7 by /rik+ ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjag ea* place x appe>s & ins]t+ ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb2 7#c7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a71 by r$esignat+ ! second clause 7iv7 7relat+ to analysis7 z clause 7v72 & 7,b7 9 subp>agraph 7,a77iv7 7relat+ to rationale = ,,mdufa program *anges71 by /rik+ fiscal ye> #bjbj & ins]t+ fiscal ye> #bjbc2 & 7#d7 9 p>agraph 7#d71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 7b7 ,reau?orization ,section #gch;,a7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;b77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ #bjbb & ins]t+ #bjbg2 & 7#b7 9 p>agraph 7#e71 by /rik+ #bjbb & ins]t+ #bjbg4 #bje4 ,accr$itation programs 7a7 ,accr$itation s*eme = con=mity assessm5t ,section #ead7;d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7d77 is am5d$-- 7#a7 9 ! subsection head+1 by /rik+ ,pilot2 7#b7 9 p>agraph 7#a7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ pilot2 7,b7 9 subp>agraph 7,a7-- 7i7 by ins]t+ meet+ crit]ia specifi$ by ! ,secret>y 9 guidance aft] te/+ laboratories2 7ii7 by ins]t+ 9 guidance aft] by ! ,secret>y2 & 7iii7 by /rik+ assess ! con=mance ( a device ) & ins]t+ conduct te/+ to support ! assessm5t ( ! con=mance ( a device to2 & 7,c7 9 subp>agraph 7,b7-- 7i7 by /rik+ det]m9ations & ins]t+ results2 7ii7 by ins]t+ to support aft] s accr$it$2 & 7iii7 by /rik+ a p>ticul> su* det]m9ation & ins]t+ p>ticul> su* results2 7#c7 9 p>agraph 7#b7-- 7,a7 9 ! p>agraph head+1 by /rik+ det]m9ations & ins]t+ results2 7,b7 9 subp>agraph 7,a7-- 7i7 by /rik+ det]m9ations by te/+ laboratories & all t foll[s ?r\gh su* det]m9ations or & ins]t+ results by te/+ laboratories accr$it$ pursuant to ?is subsection1 includ+ by conduct+ p]iodic audits ( su* results or ( !2 7ii7 by ins]t+ a comma aft] or te/+ laboratories2 7iii7 by ins]t+ or recognition ( an accr$itation body aft] accr$itation ( su* te/+ laboratory2 & 7iv7 by /rik+ su* device & ins]t+ a device2 & 7,c7 9 subp>agraph 7,b7-- 7i7 by /rik+ by a te/+ laboratory s accr$it$ & ins]t+ "u ?is subsection2 & 7ii7 by ins]t+ or recognition ( an accr$itation body be=e "u p>agraph 7#a77;,a72 7#d7 9 p>agraph 7#c77;,c7-- 7,a7 9 ! subp>agraph head+1 by ins]t+ & transition aft] initiation2 & 7,b7 by add+ at ! end ! foll[+3 ,aft] ,septemb] #cj1 #bjbc1 su* pilot program w be consid]$ to be complet$1 & ! ,secret>y %all h ! au?ority to cont9ue op]at+ a program consi/5t ) ?is subsection42 & 7#e7 by /rik+ p>agraph 7#d74 7b7 ,accr$it$ p]sons ,section #ebc7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjm7c77 is am5d$ by /rik+ #bjbb & ins]t+ #bjbg4 #bjf4 ,sunset dates 7a7 ,au?orization ,sections #gcg & #gch ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i2 #cgi;fj7 %all cease to be effective ,octob] #a1 #bjbg4 7b7 ,report+ requirem5ts ,section #gch;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7 %all cease to be effective ,janu>y #ca1 #bjbh4 7c7 ,previ\s sunset provision ,effective ,octob] #a1 #bjbb1 subsections 7a7 & 7b7 ( section #baj ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 are repeal$4 #bjg4 ,effective date ,! am5dm5ts made by ?is title %all take effect on ,octob] #a1 #bjbb1 or ! date ( ! enactm5t ( ?is ,act1 :i*ev] is lat]1 except t fees "u "p #c ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i et seq47 %all be assess$ = all submissions li/$ 9 section #gch7;a77#b77;,a7 ( su* ,act receiv$ on or aft] ,octob] #a1 #bjbb1 reg>dless ( ! date ( ! enactm5t ( ?is ,act4 #bjh4 ,sav+s clause ,not)/&+ ! am5dm5ts made by ?is title1 "p #c ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i et seq471 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is title1 %all cont9ue to be 9 effect ) respect to ! submissions li/$ 9 section #gch7;a77#b77;,a7 ( su* ,act 7z def9$ 9 su* "p z ( su* day7 t on or aft] ,octob] #a1 #bjag1 b be=e ,octob] #a1 #bjbb1 7 receiv$ by ! ,food & ,drug ,adm9i/ration ) respect to assess+ & collect+ any fee requir$ by su* "p = a fiscal ye> prior to fiscal ye> #bjbc4 ,,iii ,fees relat+ to g5]ic drugs #cja4 ,%ort title2 f9d+ 7a7 ,%ort title ,?is title may be cit$ z ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbb4 7b7 ,f9d+ ,! ,congress f9ds t ! fees au?oriz$ by ! am5dm5ts made 9 ?is title w be d$icat$ to human g5]ic drug activities1 z set =? 9 ! goals id5tifi$ = purposes ( "p #g ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #cjb4 ,au?ority to assess & use human g5]ic drug fees 7a7 ,types ( fees ,section #gdd;,b7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;a77 is am5d$-- 7#a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ #bjah & ins]t+ #bjbc2 7#b7 9 p>agraph 7#b77;,c71 by /rik+ fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ fiscal ye>s #bjbc ?r\gh #bjbg2 7#c7 9 p>agraph 7#c77;,b71 by /rik+ fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ fiscal ye>s #bjbc ?r\gh #bjbg2 7#d7 9 p>agraph 7#d77;,d71 by /rik+ fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ fiscal ye>s #bjbc ?r\gh #bjbg2 & 7#e7 9 p>agraph 7#e77;,d71 by /rik+ fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ fiscal ye>s #bjbc ?r\gh #bjbg4 7b7 ,fee rev5ue am\nts ,section #gdd;,b7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;b77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! head+1 by /rik+ #bjah & ins]t+ #bjbc2 7ii7 by /rik+ #bjah & ins]t+ #bjbc2 & 7iii7 by /rik+ #dic1fjj1jjj & ins]t+ #ehb1ejj1jjj2 & 7,b7 9 subp>agraph 7,b7-- 7i7 9 ! head+1 by /rik+ #bjai ?r\gh #bjbb & ins]t+ #bjbd ?r\gh #bjbg2 7ii7 by /rik+ ,= ea* & ins]t+ ! foll[+3 7i7 ,9 g5]al ,= ea* 2 7iii7 by /rik+ #bjai ?r\gh #bjbb & ins]t+ #bjbd ?r\gh #bjbg2 7iv7 by /rik+ #dic1fjj1jjj & ins]t+ ! base rev5ue am\nt "u clause 7ii72 & 7v7 by add+ at ! end ! foll[+3 7ii7 ,base rev5ue am\nt ,! base rev5ue am\nt = a fiscal ye> is ! total rev5ue am\nt e/abli%$ "u ?is p>agraph = ! previ\s fiscal ye>1 n includ+ any adju/m5ts made = su* previ\s fiscal ye> "u subsection 7c77#c74 2 & 7#b7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,c71 by /rik+ "o-?ird ! am\nt & ins]t+ #bd p]c5t2 7,b7 9 subp>agraph 7,d71 by /rik+ ,sev5 & ins]t+ ,six2 & 7,c7 9 subp>agraph 7,e77i71 by /rik+ ,?irty-five & ins]t+ ,?irty-six4 7c7 ,adju/m5ts ,section #gdd;,b7c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;c77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a7-- 7i7 by /rik+ #bjai & ins]t+ #bjbd2 & 7ii7 by /rik+ ! product ( ! total rev5ues e/abli%$ 9 su* notice = ! prior fiscal ye> & ins]t+ ! base rev5ue am\nt = ! fiscal ye> det]m9$ "u subsection 7b77#a77;,b77ii72 & 7,b7 9 subp>agraph 7,c71 by /rik+ ,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv & ins]t+ ,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 & 7#b7 by /rik+ p>agraph 7#b7 & ins]t+ ! foll[+3 7#b7 ,capacity plann+ adju/m5t 7,a7 ,9 g5]al ,beg9n+ ) fiscal ye> #bjbd1 ! ,secret>y %all1 9 addition to ! adju/m5t "u p>agraph 7#a71 fur!r increase ! fee rev5ue & fees "u ?is section = a fiscal ye>1 9 accordance ) ?is p>agraph1 to reflect *anges 9 ! res\rce capacity ne$s ( ! ,secret>y = human g5]ic drug activities4 7,b7 ,capacity plann+ me?odology ,! ,secret>y %all e/abli% a capacity plann+ me?odology = purposes ( ?is p>agraph1 :i* %all-- 7i7 be d]iv$ f ! me?odology & recomm5dations made 9 ! report titl$ ,indep5d5t ,evaluation ( ! ,,gdufa ,res\rce ,capacity ,plann+ ,adju/m5t ,me?odology3 ,evaluation & ,recomm5dations z ann\nc$ 9 ! ,f$]al ,regi/] on ,augu/ #c1 #bjbj 7#he ,f$4 ,reg4 #dffeh72 & 7ii7 incorporate approa*es & attributes det]m9$ appropriate by ! ,secret>y1 includ+ ^? made 9 su* report recomm5dations1 except ! workload categories us$ 9 =eca/+ res\rces %all only be ^? specifi$ 9 section ,,viii4,b4#b4;e4 ( ! lett]s describ$ 9 section #cja7;b7 ( ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbb4 7,c7 ,limitations 7i7 ,9 g5]al ,"u no circum/ances %all an adju/m5t "u ?is p>agraph result 9 fee rev5ue = a fiscal ye> t is less ?an ! sum ( ! am\nts "u subsection 7b77#a77;,b77ii7 7! base rev5ue am\nt = ! fiscal ye>7 & p>agraph 7#a7 7! doll> am\nt ( ! inflation adju/m5t = ! fiscal ye>74 7ii7 ,additional limitation ,an adju/m5t "u ?is p>agraph %all n exce$ #c p]c5t ( ! sum describ$ 9 clause 7i7 = ! fiscal ye>1 except t su* limitation %all be #d p]c5t if-- 7,i7 = purposes ( an adju/m5t = fiscal ye> #bjbd1 ! ,secret>y det]m9es t1 dur+ ! p]iod f ,april #a1 #bjba1 ?r\gh ,m>* #ca1 #bjbc-- 7aa7 ! total numb] ( abbreviat$ new drug applications submitt$ 0 great] ?an or equal to #b1jjj2 or 7bb7 ?irty-five p]c5t or m ( abbreviat$ new drug applications submitt$ relat$ to complex products 7z t t]m is def9$ 9 section ,,xi ( ! lett]s describ$ 9 section #cja7;b7 ( ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbb72 7,,ii7 = purposes ( an adju/m5t = fiscal ye> #bjbe1 ! ,secret>y det]m9es t1 dur+ ! p]iod f ,april #a1 #bjbb1 ?r\gh ,m>* #ca1 #bjbd-- 7aa7 ! total numb] ( abbreviat$ new drug applications submitt$ 0 great] ?an or equal to #b1cjj2 or 7bb7 ?irty-five p]c5t or m ( abbreviat$ new drug applications submitt$ relat$ to complex products 7z s def9$72 7,,iii7 = purposes ( an adju/m5t = fiscal ye> #bjbf1 ! ,secret>y det]m9es t1 dur+ ! p]iod f ,april #a1 #bjbc1 ?r\gh ,m>* #ca1 #bjbe-- 7aa7 ! total numb] ( abbreviat$ new drug applications submitt$ 0 great] ?an or equal to #b1cjj2 or 7bb7 ?irty-five p]c5t or m ( abbreviat$ new drug applications submitt$ relat$ to complex products 7z s def9$72 & 7,,iv7 = purposes ( an adju/m5t = fiscal ye> #bjbg1 ! ,secret>y det]m9es t1 dur+ ! p]iod f ,april #a1 #bjbd1 ?r\gh ,m>* #ca1 #bjbf-- 7aa7 ! total numb] ( abbreviat$ new drug applications submitt$ 0 great] ?an or equal to #b1cjj2 or 7bb7 ?irty-five p]c5t or m ( abbreviat$ new drug applications submitt$ relat$ to complex products 7z s def9$74 7,d7 ,publication 9 f$]al regi/] ,! ,secret>y %all publi% 9 ! ,f$]al ,regi/] notice "u subsection 7a71 ! fee rev5ue & fees result+ f ! adju/m5t & ! me?odology "u ?is p>agraph4 7#c7 ,op]at+ res]ve adju/m5t 7,a7 ,9 g5]al ,= fiscal ye> #bjbd & subsequ5t fiscal ye>s1 ! ,secret>y may1 9 addition to adju/m5ts "u p>agraphs 7#a7 & 7#b71 fur!r increase ! fee rev5ue & fees "u ?is section if su* an adju/m5t is necess>y to provide op]at+ res]ves ( c>ryov] us] fees = human g5]ic drug activities = n m ?an ! numb] ( weeks specifi$ 9 subp>agraph 7,b74 7,b7 ,numb] ( weeks ,! numb] ( weeks specifi$ 9 ?is subp>agraph is-- 7i7 #h weeks = fiscal ye> #bjbd2 7ii7 #i weeks = fiscal ye> #bjbe2 & 7iii7 #aj weeks = ea* ( fiscal ye> #bjbf & #bjbg4 7,c7 ,decrease ,if ! ,secret>y has c>ryov] balances = human g5]ic drug activities 9 excess ( #ab weeks ( ! op]at+ res]ves ref]r$ to 9 subp>agraph 7,a71 ! ,secret>y %all decrease ! fee rev5ue & fees ref]r$ to 9 su* subp>agraph to provide = n m ?an #ab weeks ( su* op]at+ res]ves4 7,d7 ,rationale = adju/m5t ,if an adju/m5t "u ?is p>agraph is made1 ! rationale = ! am\nt ( ! increase or decrease 7z applicable7 9 fee rev5ue & fees %all be conta9$ 9 ! annual ,f$]al ,regi/] notice "u subsection 7a7 publi%+ ! fee rev5ue & fees = ! fiscal ye> involv$4 4 7d7 ,annual fee sett+ ,section #gdd;,b7d77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;d77#a77 is am5d$-- 7#a7 9 ! head+1 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 7#b7 by /rik+ m & ins]t+ lat]2 & 7#c7 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 7e7 ,effect ( failure ,to pay fees ,! head+ ( p>agraph 7#c7 ( section #gdd;,b7g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;g77 is am5d$ by /rik+ & prior approval supplem5t fee4 7f7 ,cr$it+ & availability ( fees ,section #gdd;,b7i77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;i77#c77 is am5d$ by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 #cjc4 ,reau?orization2 report+ requirem5ts ,section #gdd;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 by /rik+ #bjah ea* place x appe>s & ins]t+ #bjbc2 & 7,b7 by /rik+ ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjag ea* place x appe>s & ins]t+ ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbb2 7#b7 9 subsection 7b71 by /rik+ #bjah & ins]t+ #bjbc2 7#c7 9 subsection 7c7-- 7,a7 by /rik+ #bjah & ins]t+ #bjbc2 & 7,b7 by /rik+ ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjag ea* place x appe>s & ins]t+ ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbb2 & 7#d7 9 subsection 7f7-- 7,a7 9 p>agraph 7#a71 by /rik+ #bjbb & ins]t+ #bjbg2 & 7,b7 9 p>agraph 7#e71 by /rik+ ,janu>y #ae1 #bjbb & ins]t+ ,janu>y #ae1 #bjbg4 #cjd4 ,sunset dates 7a7 ,au?orization ,sections #gdd;,a & #gdd;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da2 #cgi;j-#db7 %all cease to be effective ,octob] #a1 #bjbg4 7b7 ,report+ requirem5ts ,section #gdd;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7 %all cease to be effective ,janu>y #ca1 #bjbh4 7c7 ,previ\s sunset provision ,effective ,octob] #a1 #bjbb1 subsections 7a7 & 7b7 ( section #cje ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 are repeal$4 #cje4 ,effective date ,! am5dm5ts made by ?is title %all take effect on ,octob] #a1 #bjbb1 or ! date ( ! enactm5t ( ?is ,act1 :i*ev] is lat]1 except t fees "u "p #g ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da et seq47 %all be assess$ = all abbreviat$ new drug applications receiv$ on or aft] ,octob] #a1 #bjbb1 reg>dless ( ! date ( ! enactm5t ( ?is ,act4 #cjf4 ,sav+s clause ,not)/&+ ! am5dm5ts made by ?is title1 "p #g ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is title1 %all cont9ue to be 9 effect ) respect to abbreviat$ new drug applications 7z def9$ 9 su* "p z ( su* day7 t 7 receiv$ by ! ,food & ,drug ,adm9i/ration )9 ! mean+ ( section #eje7;j77#e77;,a7 ( su* ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,a771 prior approval supplem5ts t 7 submitt$1 & drug ma/] files = ,type ,,ii active ph>maceutical +r$i5ts t 7 fir/ ref]5c$ on or aft] ,octob] #a1 #bjag1 b be=e ,octob] #a1 #bjbb1 ) respect to assess+ & collect+ any fee requir$ by su* "p = a fiscal ye> prior to fiscal ye> #bjbc4 ,,iv ,fees relat+ to biosimil> biological products #dja4 ,%ort title2 f9d+ 7a7 ,%ort title ,?is title may be cit$ z ! ,biosimil> ,us] ,fee ,am5dm5ts ( #bjbb4 7b7 ,f9d+ ,congress f9ds t ! fees au?oriz$ by ! am5dm5ts made 9 ?is title w be d$icat$ to exp$it+ ! process = ! review ( biosimil> biological product applications1 includ+ po/m>ket safety activities1 z set =? 9 ! goals id5tifi$ = purposes ( "p #h ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea et seq471 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #djb4 ,def9itions ,section #gdd;,g ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea7 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 by /rik+ ,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv & ins]t+ ,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 7,b7 by /rik+ ,octob] ( & ins]t+ ,septemb] (2 & 7,c7 by /rik+ ,octob] #bjaa & ins]t+ ,septemb] #bjaa2 & 7#b7 9 p>agraph 7#d77;,b77iii7-- 7,a7 by /rik+ subclause 7,,ii72 & 7,b7 by r$esignat+ subclauses 7,,iii7 & 7,,iv7 z subclauses 7,,ii7 & 7,,iii71 respectively4 #djc4 ,au?ority to assess & use biosimil> biological product fees 7a7 ,types ( fees ,section #gdd;,h7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77 is am5d$-- 7#a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ #bjah & ins]t+ #bjbc2 7#b7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 clause 7iv77,i71 by /rik+ #e days & ins]t+ #g days2 & 7ii7 9 clause 7v77,,ii71 by /rik+ #e days & ins]t+ #g days2 7,b7 9 subp>agraph 7,b7-- 7i7 9 clause 7i71 by ins]t+ 1 except t1 9 ! case t su* product 7includ+1 :]e applicable1 own]%ip ( ! relevant inve/igational new drug application7 is transf]r$ to a lic5see1 assignee1 or successor ( su* p]son1 & writt5 notice ( su* transf] is provid$ to ! ,secret>y1 su* lic5see1 assignee or successor %all pay ! annual biosimil> biological product developm5t fee be=e ! p]iod2 7ii7 9 clause 7iii7-- 7,i7 9 subclause 7,i71 by /rik+ 2 or & ins]t+ a semicolon2 7,,ii7 9 subclause 7,,ii71 by /rik+ ! p]iod & ins]t+ 2 or2 & 7,,iii7 by add+ at ! end ! foll[+3 7,,iii7 be5 adm9i/ratively remov$ f ! biosimil> biological product developm5t program = ! product "u subp>agraph 7,e77v74 2 & 7iii7 9 clause 7iv71 by /rik+ accept$ = fil+ on or aft] ,octob] #a ( su* fiscal ye> & ins]t+ subsequ5tly accept$ = fil+2 7,c7 9 subp>agraph 7,d7-- 7i7 9 clause 7i7-- 7,i7 9 ! matt] prec$+ subclause 7,i71 by /rik+ %all1 if ! p]son seeks to resume p>ticipation 9 su* program1 pay & ins]t+ or :o has be5 adm9i/ratively remov$ f su* program = a product "u subp>agraph 7,e77v7 %all1 if ! p]son seeks to resume p>ticipation 9 su* program1 pay all annual biosimil> biological product developm5t fees previ\sly assess$ = su* product & /ill ow$ &2 7,,ii7 9 subclause 7,i7-- 7aa7 by /rik+ #e days & ins]t+ #g days2 & 7bb7 by ins]t+ or ! date ( adm9i/rative removal1 z applicable aft] discont9u$2 & 7,,iii7 9 subclause 7,,ii71 by ins]t+ or ! date ( adm9i/rative removal1 z applicable aft] discont9u$2 & 7ii7 9 clause 7ii71 by ins]t+ 1 except t1 9 ! case t su* product 7includ+1 :]e applicable1 own]%ip ( ! relevant inve/igational new drug application7 is transf]r$ to a lic5see1 assignee1 or successor ( su* p]son1 & writt5 notice ( su* transf] is provid$ to ! ,secret>y1 su* lic5see1 assignee or successor %all pay ! annual biosimil> biological product developm5t fee be=e ! p]iod at ! end2 & 7,d7 9 subp>agraph 7,e71 by add+ at ! end ! foll[+3 7v7 ,adm9i/rative removal f ! biosimil> biological product developm5t program ,if a p]son has fail$ to pay an annual biosimil> biological product developm5t fee = a product z requir$ "u subp>agraph 7,b7 = a p]iod ( #b consecutive fiscal ye>s1 ! ,secret>y may adm9i/ratively remove su* p]son f ! biosimil> biological product developm5t program = ! product4 ,at lea/ #cj days prior to adm9i/ratively remov+ a p]son f ! biosimil> biological product developm5t program = a product "u ?is clause1 ! ,secret>y %all provide writt5 notice to su* p]son ( ! int5d$ adm9i/rative removal4 2 7#c7 9 p>agraph 7#b77;,d71 by ins]t+ prior to approval aft] )drawn2 7#d7 9 p>agraph 7#c7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 clause 7i71 by /rik+ 2 & & ins]t+ a semicolon2 7ii7 by r$esignat+ clause 7ii7 z clause 7iii72 & 7iii7 by ins]t+ ! foll[+ aft] clause 7i73 7ii7 may be disp5s$ only "u prescription pursuant to section #ejc7;b72 & 2 & 7,b7 by add+ at ! end ! foll[+3 7,e7 ,movem5t to discont9u$ li/ 7i7 ,writt5 reque/ to place on discont9u$ li/ 7,i7 ,9 g5]al ,if a writt5 reque/ to place a product on ! li/ ( discont9u$ biosimil> biological products ref]r$ to 9 subp>agraph 7,a77iii7 is submitt$ to ! ,secret>y on behalf ( an applicant1 & ! reque/ id5tifies ! date ! product is1 or w be1 )drawn f sale1 !n = purposes ( assess+ ! biosimil> biological product program fee1 ! ,secret>y %all consid] su* product to h be5 includ$ on su* li/ on ! lat] (-- 7aa7 ! date su* reque/ 0 receiv$2 or 7bb7 if ! product w be )drawn f sale on a future date1 su* future date :5 ! product is )drawn f sale4 7,,ii7 ,)drawn f sale def9$ ,= purposes ( ?is clause1 a product %all be consid]$ )drawn f sale once ! applicant has ceas$ its own di/ribution ( ! product1 :e!r or n ! applicant has ord]$ recall ( all previ\sly di/ribut$ lots ( ! product1 except t a r\t9e1 tempor>y int]ruption 9 supply %all n r5d] a product )drawn f sale4 7ii7 ,products remov$ f discont9u$ li/ ,if a biosimil> biological product t is id5tifi$ 9 a biosimil> biological product application approv$ z ( ,octob] #a ( a fiscal ye> appe>s1 z ( ,octob] #a ( su* fiscal ye>1 on ! li/ ( discont9u$ biosimil> biological products ref]r$ to 9 subp>agraph 7,a77iii71 & on any subsequ5t day dur+ su* fiscal ye> ! biosimil> biological product does n appe> on su* li/1 except z provid$ 9 subp>agraph 7,d71 ea* p]son :o is nam$ z ! applicant 9 ! biosimil> biological product application %all pay ! annual biosimil> biological product program fee e/abli%$ = a fiscal ye> "u subsection 7c77#e7 = su* biosimil> biological product4 ,not)/&+ subp>agraph 7,b71 su* fee %all be due on ! la/ bus9ess day ( su* fiscal ye> & %all be paid only once = ea* product = ea* fiscal ye>4 2 & 7#e7 by /rik+ p>agraph 7#d74 7b7 ,fee rev5ue am\nts ,section #gdd;,h7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 77#ba ,u4,s4,c4 #cgi;j-#eb7;b77 is am5d$-- 7#a7 by /rik+ p>agraph 7#a72 7#b7 by r$esignat+ p>agraphs 7#b7 ?r\gh 7#d7 z p>agraphs 7#a7 ?r\gh 7#c71 respectively2 7#c7 9 p>agraph 7#a71 z s r$esignat$-- 7,a7 9 ! p>agraph head+1 by /rik+ ,subsequ5t fiscal ye>s & ins]t+ ,9 g5]al2 7,b7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ #bjai ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 7,c7 9 subp>agraph 7,a71 by /rik+ p>agraph 7#d7 & ins]t+ p>agraph 7#c72 7,d7 by r$esignat+ subp>agraphs 7,c7 & 7,d7 z subp>agraphs 7,d7 & 7,e71 respectively2 7,e7 by ins]t+ aft] subp>agraph 7,b7 ! foll[+3 7,c7 ! doll> am\nt equal to ! /rategic hir+ & ret5tion adju/m5t 7z det]m9$ "u subsection 7c77#b772 2 7,f7 9 subp>agraph 7,d71 z s r$esignat$1 by /rik+ subsection 7c77#b772 & & ins]t+ subsection 7c77#c7722 7,g7 9 subp>agraph 7,e71 z s r$esignat$1 by /rik+ subsection 7c77#c774 & ins]t+ subsection 7c77#d772 &2 & 7,h7 by add+ at ! end ! foll[+3 7,f7 = fiscal ye>s #bjbc & #bjbd1 additional doll> am\nts equal to-- 7i7 #d1dbh1 #hhf = fiscal ye> #bjbc2 & 7ii7 #cbj1efi = fiscal ye> #bjbd4 2 7#d7 9 p>agraph 7#b71 z s r$esignat$-- 7,a7 9 ! p>agraph head+1 by /rik+ 2 limitations on fee am\nts2 7,b7 by /rik+ subp>agraph 7,b72 & 7,c7 by r$esignat+ subap>agraphs 7,c7 & 7,d7 z subp>agraphs 7,b7 & 7,c71 respectively2 & 7#e7 by am5d+ p>agraph 7#c71 z s r$esignat$1 to read z foll[s3 7#c7 ,annual base rev5ue ,= purposes ( p>agraph 7#a71 ! doll> am\nt ( ! annual base rev5ue = a fiscal ye> %all be-- 7,a7 = fiscal ye> #bjbc1 #dc1cgf1ibb2 & 7,b7 = fiscal ye>s #bjbd ?r\gh #bjbg1 ! doll> am\nt ( ! total rev5ue am\nt e/abli%$ "u p>agraph 7#a7 = ! previ\s fiscal ye>1 exclud+ any adju/m5ts to su* rev5ue am\nt "u subsection 7c77#d74 4 7c7 ,adju/m5ts2 annual fee sett+ ,section #gdd;,h7c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 77#ba ,u4,s4,c4 #cgi;j-#eb7;c77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! matt] prec$+ clause 7i71 by /rik+ subsection 7b77#b77;,b7 & ins]t+ subsection 7b77#a77;,b72 & 7ii7 9 clause 7i71 by /rik+ subsection 7b7 & ins]t+ subsection 7b77#a77;,a72 & 7,b7 9 subp>agraph 7,b77ii71 by /rik+ ,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv & ins]t+ ,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 7#b7 by /rik+ p>agraph 7#d72 7#c7 by r$esignat+ p>agraphs 7#b7 & 7#c7 z p>agraphs 7#c7 & 7#d71 respectively2 7#d7 by ins]t+ aft] p>agraph 7#a7 ! foll[+3 7#b7 ,/rategic hir+ & ret5tion adju/m5t ,= ea* fiscal ye> beg9n+ 9 fiscal ye> #bjbc1 aft] ! annual base rev5ue "u subsection 7b77#a77;,a7 is adju/$ = inflation 9 accordance ) p>agraph 7#a71 ! ,secret>y %all fur!r increase ! fee rev5ue & fees by #aej1jjj4 2 7#e7 9 p>agraph 7#c71 z s r$esignat$-- 7,a7 9 subp>agraph 7,a7-- 7i7 by /rik+ ,beg9n+ ) ! fiscal ye> describ$ 9 subp>agraph 7,b77ii77,,ii7 & ins]t+ ,= ea* fiscal ye>2 & 7ii7 by /rik+ adju/m5t "u p>agraph 7#a71 fur!r increase & ins]t+ adju/m5ts "u p>agraphs 7#a7 & 7#b71 fur!r adju/2 & 7,b7 by am5d+ subp>agraph 7,b7 to read z foll[s3 7,b7 ,me?odology ,= purposes ( ?is p>agraph1 ! ,secret>y %all employ ! capacity plann+ me?odology utiliz$ by ! ,secret>y 9 sett+ fees = fiscal ye> #bjba1 z describ$ 9 ! notice titl$ ,biosimil> ,us] ,fee ,rates = ,fiscal ,ye> #bjba 7#he ,f$4 ,reg4 #dgbbj2 ,augu/ #d1 #bjbj74 ,! workload categories us$ 9 =eca/+ %all include only ! activities describ$ 9 su* notice &1 z feasible1 additional activities t are also directly relat$ to ! direct review ( biosimil> biological product applications & supplem5ts1 includ+ additional =mal meet+ types & ! direct review ( po/m>ket+ commitm5ts & requirem5ts1 ! direct review ( risk evaluation & mitigation /rategies1 & ! direct review ( annual reports = approv$ biosimil> biological products4 ,subject to ! exceptions 9 ! prec$+ s5t5ce1 ! ,secret>y %all n include z workload categories 9 =eca/+ any non-core review activities1 includ+ any activities t ! ,secret>y ref]5c$ = pot5tial future use 9 su* notice b did n utilize 9 sett+ fees = fiscal ye> #bjba4 2 & 7,c7 9 subp>agraph 7,c7-- 7i7 by /rik+ subsections 7b77#b77;,a7 & ins]t+ subsections 7b77#a77;,a72 7ii7 by /rik+ & 7b77#b77;,b7 & ins]t+ 1 7b77#a77;,b72 & 7iii7 by ins]t+ 1 & 7b77#a77;,c7 7! doll> am\nt ( ! /rategic hir+ & ret5tion adju/m5t7 be=e ! p]iod at ! end2 7#f7 by am5d+ p>agraph 7#d71 z s r$esignat$1 to read z foll[s3 7#d7 ,op]at+ res]ve adju/m5t 7,a7 ,increase ,= fiscal ye> #bjbc & subsequ5t fiscal ye>s1 ! ,secret>y %all1 9 addition to adju/m5ts "u p>agraphs 7#a71 7#b71 & 7#c71 fur!r increase ! fee rev5ue & fees if su* an adju/m5t is necess>y to provide = at lea/ #aj weeks ( op]at+ res]ves ( c>ryov] us] fees = ! process = ! review ( biosimil> biological product applications4 7,b7 ,decrease 7i7 ,fiscal ye> #bjbc ,= fiscal ye> #bjbc1 if ! ,secret>y has c>ryov] balances = ! process = ! review ( biosimil> biological product applications 9 excess ( #cc weeks ( su* op]at+ res]ves1 ! ,secret>y %all decrease su* fee rev5ue & fees to provide = n m ?an #cc weeks ( su* op]at+ res]ves4 7ii7 ,fiscal ye> #bjbd ,= fiscal ye> #bjbd1 if ! ,secret>y has c>ryov] balances = ! process = ! review ( biosimil> biological product applications 9 excess ( #bg weeks ( su* op]at+ res]ves1 ! ,secret>y %all decrease su* fee rev5ue & fees to provide = n m ?an #bg weeks ( su* op]at+ res]ves4 7iii7 ,fiscal ye> #bjbe & subsequ5t fiscal ye>s ,= fiscal ye> #bjbe & subsequ5t fiscal ye>s1 if ! ,secret>y has c>ryov] balances = ! process = ! review ( biosimil> biological product applications 9 excess ( #ba weeks ( su* op]at+ res]ves1 ! ,secret>y %all decrease su* fee rev5ue & fees to provide = n m ?an #ba weeks ( su* op]at+ res]ves4 7,c7 ,f$]al regi/] notice ,if an adju/m5t "u subp>agraph 7,a7 or 7,b7 is made1 ! rationale = ! am\nt ( ! increase or decrease 7z applicable7 9 fee rev5ue & fees %all be conta9$ 9 ! annual ,f$]al ,regi/] notice "u p>agraph 7#e77;,b7 e/abli%+ fee rev5ue & fees = ! fiscal ye> involv$4 2 & 7#g7 9 p>agraph 7#e71 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ #bjah & ins]t+ #bjbc4 7d7 ,cr$it+ & availability ( fees ,section #gdd;,h7f77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 77#ba ,u4,s4,c4 #cgi;j-#eb7;f77#c77 is am5d$ by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 7e7 ,writt5 reque/s = waiv]s & refunds ,subsection 7h7 ( section #gdd;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7 is am5d$ to read z foll[s3 7h7 ,writt5 reque/s = waiv]s & returns2 disputes conc]n+ fees ,to qualify = consid]ation = a waiv] "u subsection 7d71 or ! return ( any fee paid "u ?is section1 includ+ if ! fee is claim$ to h be5 paid 9 error1 a p]son %all submit to ! ,secret>y a writt5 reque/ ju/ify+ su* waiv] or return &1 except z o!rwise specifi$ 9 ?is section1 su* writt5 reque/ %all be submitt$ to ! ,secret>y n lat] ?an #ahj days aft] su* fee is due4 ,a reque/ submitt$ "u ?is p>agraph %all include any legal au?orities "u :i* ! reque/ is made4 4 #djd4 ,reau?orization2 report+ requirem5ts ,section #gdd;,i ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7 is am5d$-- 7#a7 by /rik+ #bjah ea* place x appe>s & ins]t+ #bjbc2 7#b7 by /rik+ ,biosimil> ,us] ,fee ,am5dm5ts ( #bjag ea* place x appe>s & ins]t+ ,biosimil> ,us] ,fee ,am5dm5ts ( #bjbb2 7#c7 9 subsection 7a77#d71 by /rik+ #bjbj & ins]t+ #bjbc2 & 7#d7 9 subsection 7f71 by /rik+ #bjbb ea* place x appe>s & ins]t+ #bjbg4 #dje4 ,sunset dates 7a7 ,au?orization ,sections #gdd;,g & #gdd;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea1 #cgi;j-#eb 7 %all cease to be effective ,octob] #a1 #bjbg4 7b7 ,report+ requirem5ts ,section #gdd;,i ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7 %all cease to be effective ,janu>y #ca1 #bjbh4 7c7 ,previ\s sunset provision ,effective ,octob] #a1 #bjbb1 subsections 7a7 & 7b7 ( section #dje ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 are repeal$4 #djf4 ,effective date ,! am5dm5ts made by ?is title %all take effect on ,octob] #a1 #bjbb1 or ! date ( ! enactm5t ( ?is ,act1 :i*ev] is lat]1 except t fees "u "p #h ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea et seq47 %all be assess$ = all biosimil> biological product applications receiv$ on or aft] ,octob] #a1 #bjbb1 reg>dless ( ! date ( ! enactm5t ( ?is ,act4 #djg4 ,sav+s clause ,not)/&+ ! am5dm5ts made by ?is title1 "p #h ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea et seq471 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is title1 %all cont9ue to be 9 effect ) respect to biosimil> biological product applications & supplem5ts 7z def9$ 9 su* "p z ( su* day7 t 7 accept$ by ! ,food & ,drug ,adm9i/ration = fil+ on or aft] ,octob] #a1 #bjag1 b be=e ,octob] #a1 #bjbb1 ) respect to assess+ & collect+ any fee requir$ by su* "p = a fiscal ye> prior to fiscal ye> #bjbc4 ,v ,improv+ regulation ( drugs & biological products #eja4 ,alt]natives to animal te/+ 7a7 ,9 g5]al ,section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is am5d$-- 7#a7 9 subsection 7i7-- 7,a7 9 p>agraph 7#a77;,a71 by /rik+ precl9ical te/s 7includ+ te/s on animals7 & ins]t+ noncl9ical te/s2 & 7,b7 9 p>agraph 7#b77;,b71 by /rik+ animal & ins]t+ noncl9ical te/s2 & 7#b7 aft] subsection 7y71 by ins]t+ ! foll[+3 7z7 ,noncl9ical te/ def9$ ,= purposes ( ?is section1 ! t]m noncl9ical te/ means a te/ conduct$ 9 vitro1 9 silico1 or 9 *emico1 or a non-human 9 vivo te/ t occurs be=e or dur+ ! cl9ical trial phase ( ! inve/igation ( ! safety & effectiv5ess ( a drug1 & may include animal te/s1 or non-animal or human biology-bas$ te/ me?ods1 su* z cell-bas$ assays1 microphysiological sy/ems1 or biopr9t$ or comput] models4 4 7b7 ,biosimil> biological product applications ,item 7bb7 ( section #cea7k77#b77;,a77i77,i7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77#b77;,a77i77,i77 is am5d$ to read z foll[s3 7bb7 an assessm5t ( toxicity 7:i* may rely on1 or consi/ (1 a /udy or /udies describ$ 9 item 7aa7 or 7cc772 & 4 #ejb4 ,saf] disposal ( opioids ,section #eje-a7;e77#d77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;e77#d77;,b77 is am5d$ by /rik+ = purposes ( r5d]+ drugs nonretrievable 7z def9$ 9 section #acjj4je ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulation774 #ejc4 ,cl>ifications to exclusivity provisions = fir/ int]*angeable biosimil> biological products ,section #cea7k77#f7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77#f77 is am5d$-- 7#a7 9 ! matt] prec$+ subp>agraph 7,a7-- 7,a7 by /rik+ ,^u review ( & ins]t+ ,! ,secret>y %all n make approval z an int]*angeable biological product effective ) respect to2 7,b7 by /rik+ rely+ on & ins]t+ t relies on2 & 7,c7 by /rik+ ! ,secret>y %all n make a det]m9ation "u p>agraph 7#d7 t ! second or subsequ5t biological product is int]*angeable = any condition ( use2 & 7#b7 9 ! flu% text t foll[s subp>agraph 7,c71 by /rik+ ! p]iod & ins]t+ 1 & ! t]m fir/ int]*angeable biosimil> biological product means any int]*angeable biosimil> biological product t is approv$ on ! fir/ day on :i* su* a product is approv$ z int]*angeable ) ! ref]5ce product44 #ejd4 ,improvem5ts to ! ,purple ,book 7a7 ,9 g5]al ,section #ejf;,i ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;i7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 by /rik+ ,! hold] ( an application approv$ "u subsection 7c7 or 7j7 ( section #eje & ins]t+ ,! hold] ( an application approv$ "u subsection 7c7 or 7j7 ( section #eje ( ?is ,act or subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act2 7,b7 9 p>agraph 7#b71 by ins]t+ 79 ! case ( a biological product1 ! prop] "n7 aft] e/abli%$ "n2 & 7,c7 9 p>agraph 7#c71 by /rik+ or abbreviat$ application numb] & ins]t+ 1 abbreviat$ application numb]1 or biologics lic5se application numb]2 & 7#b7 9 subsection 7b7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ ,! hold] ( an application approv$ "u subsection 7c7 or 7j7 & ins]t+ ,! hold] ( an application approv$ "u subsection 7c7 or 7j7 ( section #eje ( ?is ,act or subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act2 7,b7 9 p>agraph 7#a71 by ins]t+ 79 ! case ( a biological product1 ! prop] "n7 aft] e/abli%$ "n2 & 7,c7 9 p>agraph 7#b71 by /rik+ or abbreviat$ application numb] & ins]t+ 1 abbreviat$ application numb]1 or biologics lic5se application numb]4 7b7 ,additional "o-,"t report ,subsection 7c7 ( section #ejf;,i ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;i7 is am5d$ to read z foll[s3 7c7 ,additional "o-,"t report ,)9 #ahj days ( ! date ( enactm5t ( ! ,food & ,drug ,adm9i/ration ,safety & ,l&m>k ,advancem5ts ,act ( #bjbb1 all hold]s ( applications approv$ "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act %all review ! in=mation 9 ! li/ publi%$ "u section #cea7k77#i77;,a7 & %all submit a writt5 notice to ! ,secret>y-- 7#a7 /at+ t all ( ! application hold]'s biological products 9 ! li/ publi%$ "u section #cea7k77#i77;,a7 t are n li/$ z discont9u$ are available = sale2 or 7#b7 includ+ ! in=mation requir$ pursuant to subsection 7a7 or 7b71 z applicable1 = ea* ( ! application hold]'s biological products t are 9 ! li/ publi%$ "u section #cea7k77#i77;,a7 & n li/$ z discont9u$1 b h be5 discont9u$ f sale or nev] h be5 available = sale4 4 7c7 ,purple book ,section #ejf;,i ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;i7 is am5d$-- 7#a7 9 subsection 7d7-- 7,a7 by /rik+ or 7c71 ! ,secret>y & ins]t+ 8or 7c7-- 7#a7 ! ,secret>y 2 7,b7 by /rik+ ! p]iod at ! end1 & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+3 7#b7 ! ,secret>y may id5tify ! application hold]'s biological products z discont9u$ 9 ! li/ publi%$ "u section #cea7k77#i77;,a7 ( ! ,public ,heal? ,s]vice ,act1 except t ! ,secret>y %all remove f ! li/ 9 accordance ) section #cea7k77#i77;,b7 ( su* ,act any biological product = :i* a lic5se has be5 revok$ or susp5d$ = reasons ( safety1 purity1 or pot5cy4 2 & 7#b7 9 subsection 7e7-- 7,a7 by ins]t+ aft] ! fir/ s5t5ce ! foll[+3 ,! ,secret>y %all update ! li/ publi%$ "u section #cea7k77#i77;,a7 ( ! ,public ,heal? ,s]vice ,act bas$ on in=mation provid$ "u subsections 7a71 7b71 & 7c7 by id5tify+ z discont9u$ biological products t are n available = sale1 except t any biological product = :i* ! lic5se has be5 revok$ or susp5d$ = reasons ( safety1 purity1 or pot5cy %all be remov$ f ! li/ 9 accordance ) section #cea7k77#i77;,b7 ( ! ,public ,heal? ,s]vice ,act42 & 7,b7 9 ! la/ s5t5ce-- 7i7 by /rik+ updates to ! li/ & ins]t+ updates to ! li/s publi%$ "u section #eje7;j77#g77;,a7 ( ?is ,act & section #cea7k77#i77;,a7 ( ! ,public ,heal? ,s]vice ,act2 & 7ii7 by /rik+ update ! li/ & ins]t+ update su* li/s4 #eje4 ,!rapeutic equival5ce evaluations ,section #eje7;j77#g77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77;,a77 is am5d$ by add+ at ! end ! foll[+3 7v7 7,i7 ,) respect to an application submitt$ pursuant to subsection 7b77#b7 = a drug t is subject to section #ejc7;b7 = :i* ! sole diff]5ce f a li/$ drug reli$ ^u 9 ! application is a diff]5ce 9 inactive +r$i5ts n p]mitt$ "u clause 7iii7 or 7iv7 ( section #cad4id7;a77#i7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations71 ! ,secret>y %all make an evaluation ) respect to :e!r su* drug is a !rapeutic equival5t 7z def9$ 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations77 to ano!r approv$ drug product 9 ! prescription drug product section ( ! li/ "u ?is p>agraph z foll[s3 7aa7 ,) respect to su* an application submitt$ aft] ! date ( enactm5t ( ! ,food & ,drug ,adm9i/ration ,safety & ,l&m>k ,advancem5ts ,act ( #bjbb1 ! evaluation %all be made ) respect to a li/$ drug reli$ ^u 9 ! application pursuant to subsection 7b77#b7 t is a ph>maceutical equival5t 7z def9$ 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations77 to ! drug 9 ! application pursuant to subsection 7b77#b7 at ! "t ( approval ( su* application or n lat] ?an #ahj days aft] ! date ( su* approval1 provid$ t ! reque/ = su* an evaluation is made 9 ! orig9al application 7or 9 a resubmission to a complete response lett]71 & all necess>y data & in=mation are submitt$ 9 ! orig9al application 7or 9 a resubmission 9 response to a complete response lett]7 = ! !rapeutic equival5ce evaluation1 includ+ in=mation to demon/rate bioequival5ce1 9 a =m & mann] prescrib$ by ! ,secret>y4 7bb7 ,) respect to su* an application approv$ prior to or on ! date ( enactm5t ( ! ,food & ,drug ,adm9i/ration ,safety & ,l&m>k ,advancem5ts ,act ( #bjbb1 ! evaluation %all be made n lat] ?an #ahj days aft] receipt ( a reque/ = a !rapeutic equival5ce evaluation submitt$ z "p ( a supplem5t to su* application2 or ) respect to an application t 0 submitt$ prior to ! date ( enactm5t ( ! ,food & ,drug ,adm9i/ration ,safety & ,l&m>k ,advancem5ts ,act ( #bjbb b n approv$ z ( ! date ( enactm5t ( su* ,act1 ! evaluation %all be made n lat] ?an #ahj days aft] ! date ( approval ( su* application if a reque/ = su* evaluation is submitt$ z an am5dm5t to ! application1 provid$ t-- 7,,aa7 su* reque/ = a !rapeutic equival5ce evaluation is be+ s\ght ) respect to a li/$ drug reli$ ^u 9 ! application1 & ! reli$ ^u li/$ drug is 9 ! prescription drug product section ( ! li/ "u ?is p>agraph & is a ph>maceutical equival5t 7z def9$ 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations77 to ! drug = :i* a !rapeutic equival5ce evaluation is s\ght2 & 7,,bb7 ! am5dm5t or supplem5t1 z applicable1 conta9+ su* reque/1 or ! relevant application1 includes all necess>y data & in=mation = ! !rapeutic equival5ce evaluation1 includ+ in=mation to demon/rate bioequival5ce1 9 a =m & mann] prescrib$ by ! ,secret>y4 7,,ii7 ,:5 ! ,secret>y makes an evaluation "u subclause 7,i71 ! ,secret>y %all1 9 revisions made to ! li/ pursuant to clause 7ii71 include su* in=mation = su* drug4 4 #ejf4 ,mod]niz+ accel]at$ approval 7a7 ,9 g5]al ,section #ejf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;c77 is am5d$-- 7#a7 9 p>agraph 7#b7-- 7,a7 by r$esignat+ subp>agraphs 7,a7 & 7,b7 z clauses 7i7 & 7ii71 respectively1 & adju/+ ! m>g9s accord+ly2 7,b7 by /rik+ ,approval ( a product & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,approval ( a product 2 7,c7 9 clause 7i7 ( su* subp>agraph 7,a71 z s r$esignat$1 by /rik+ appropriate po/approval /udies & ins]t+ an appropriate po/approval /udy or /udies 7:i* may be augm5t$ or support$ by real _w evid5ce72 & 7,d7 by add+ at ! end ! foll[+3 7,b7 ,/udies n requir$ ,if ! ,secret>y does n require t ! sponsor ( a product approv$ "u accel]at$ approval conduct a po/approval /udy "u ?is p>agraph1 ! ,secret>y %all publi% on ! website ( ! ,food & ,drug ,adm9i/ration ! rationale = :y su* /udy is n appropriate or necess>y4 7,c7 ,po/approval /udy conditions ,n lat] ?an ! date ( approval ( a product "u accel]at$ approval1 ! ,secret>y %all specify ! conditions = a po/approval /udy or /udies requir$ to be conduct$ "u ?is p>agraph ) respect to su* product1 :i* may include enrollm5t t>gets1 ! /udy protocol1 & mile/ones1 includ+ ! t>get date ( /udy completion4 7,d7 ,/udies ,begun ,be=e ,approval ,! ,secret>y may require su* /udy or /udies to be und]way prior to approval ( ! applicable product4 2 & 7#b7 9 p>agraph 7#c7-- 7,a7 by r$esignat+ subp>agraphs 7,a7 ?r\gh 7,d7 z clauses 7i7 ?r\gh 7iv71 respectively & adju/+ ! m>g9s accord+ly2 7,b7 by /rik+ ,! ,secret>y may & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,! ,secret>y may 2 7,c7 9 clause 7i7 ( su* subp>agraph 7,a71 z s r$esignat$1 by /rik+ drug ) due dilig5ce & ins]t+ product ) due dilig5ce1 includ+ ) respect to conditions specifi$ by ! ,secret>y "u p>agraph 7#b77;,c72 7,d7 9 clause 7iii7 ( su* subp>agraph 7,a71 z s r$esignat$1 by ins]t+ %[n to be aft] product is n2 & 7,e7 by add+ at ! end ! foll[+3 7,b7 ,exp$it$ proc$ures describ$ ,exp$it$ proc$ures describ$ 9 ?is subp>agraph %all consi/ (1 prior to ! )drawal ( accel]at$ approval-- 7i7 provid+ ! sponsor )-- 7,i7 due notice2 7,,ii7 an explanation = ! propos$ )drawal2 7,,iii7 an opportunity = a meet+ ) ! ,commission] or ! ,commission]'s designee2 & 7,,iv7 an opportunity = writt5 appeal to-- 7aa7 ! ,commission]2 or 7bb7 a designee ( ! ,commission] :o has n p>ticipat$ 9 ! propos$ )drawal ( approval 7o!r ?an a meet+ pursuant to subclause 7,,iii77 & is n subord9ate ( an individual 7o!r ?an ! ,commission]7 :o p>ticipat$ 9 su* propos$ )drawal2 7ii7 provid+ an opportunity = public comm5t on ! proposal to )draw approval2 7iii7 ! publication ( a summ>y ( ! public comm5ts receiv$1 & ! ,secret>y's response to su* comm5ts1 on ! website ( ! ,food & ,drug ,adm9i/ration2 & 7iv7 conv5+ & consult+ an advisory committee on issues relat$ to ! propos$ )drawal1 if reque/$ by ! sponsor & if no su* advisory committee has previ\sly advis$ ! ,secret>y on su* issues ) respect to ! )drawal ( ! product prior to ! sponsor's reque/4 4 7b7 ,reports ( po/m>ket+ /udies ,section #ejf;,b7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;b7a77 is am5d$-- 7#a7 by r$esignat+ p>agraph 7#b7 z p>agraph 7#c72 & 7#b7 by ins]t+ aft] p>agraph 7#a7 ! foll[+3 7#b7 ,accel]at$ approval ,not)/&+ p>agraph 7#a71 a sponsor ( a drug approv$ pursuant to accel]at$ approval %all submit to ! ,secret>y a report ( ! progress ( any /udy requir$ "u section #ejf7;c71 includ+ progress t[>d enrollm5t t>gets1 mile/ones1 & o!r in=mation z requir$ by ! ,secret>y1 n lat] ?an #ahj days aft] ! approval ( su* drug & n less frequ5tly ?an e #ahj days !reaft]1 until ! /udy is complet$ or t]m9at$4 ,! ,secret>y %all promptly publi% on ! website ( ! ,food & ,drug ,adm9i/ration1 9 an easily se>*able =mat1 ! in=mation report$ "u ?is p>agraph4 4 7c7 ,en=cem5t ,section #cja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is am5d$ by add+ at ! end ! foll[+3 7fff7 ,! failure ( a sponsor ( a product approv$ "u accel]at$ approval pursuant to section #ejf7;c7-- 7#a7 to conduct ) due dilig5ce any po/approval /udy requir$ "u section #ejf7;c7 ) respect to su* product2 or 7#b7 to submit timely reports ) respect to su* product 9 accordance ) section #ejf;,b7a77#b74 4 7d7 ,guidance 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all issue guidance describ+-- 7,a7 h[ sponsor que/ions relat$ to ! id5tification ( novel surrogate or int]m$iate cl9ical endpo9ts may be address$ 9 e>ly-/age developm5t meet+s ) ! ,food & ,drug ,adm9i/ration2 7,b7 ! use ( novel cl9ical trial designs t may be us$ to conduct appropriate po/approval /udies z may be requir$ "u section #ejf7;c77#b77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z am5d$ by subsection 7a72 7,c7 ! exp$it$ proc$ures describ$ 9 section #ejf7;c77#c77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 & 7,d7 consid]ations relat$ to ! use ( surrogate or int]m$iate cl9ical endpo9ts t may support ! accel]at$ approval ( an application "u #ejf7;c77#a77;,a71 includ+ consid]ations 9 evaluat+ ! evid5ce relat$ to any su* endpo9ts4 7#b7 ,f9al guidance ,! ,secret>y %all issue-- 7,a7 draft guidance "u p>agraph 7#a7 n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act2 & 7,b7 f9al guidance n lat] ?an #a ye> aft] ! close ( ! public comm5t p]iod on su* draft guidance4 7e7 ,accel]at$ approval c\ncil 7#a7 ,g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all e/abli% an intra-ag5cy coord9at+ c\ncil )9 ! ,food & ,drug ,adm9i/ration to ensure ! consi/5t & appropriate use ( accel]at$ approval across ! ,food & ,drug ,adm9i/ration1 pursuant to section #ejf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;c774 7#b7 ,memb]%ip ,! memb]s ( ! ,c\ncil %all consi/ ( ! foll[+ s5ior (ficials1 or a designee ( su* (ficial1 f ! ,food & ,drug ,adm9i/ration & relevant ,c5t]s3 7,a7 ,! ,director ( ! ,c5t] = ,drug ,evaluation & ,rese>*4 7,b7 ,! ,director ( ! ,c5t] = ,biologics ,evaluation & ,rese>*4 7,c7 ,! ,director ( ! ,oncology ,c5t] ( ,excell5ce4 7,d7 ,! ,director ( ! ,(fice ( ,new ,drugs4 7,e7 ,! ,director ( ! ,(fice ( ,orphan ,products ,developm5t4 7,f7 ,! ,director ( ! ,(fice ( ,tissues & ,advanc$ ,!rapies4 7,g7 ,! ,director ( ! ,(fice ( ,m$ical ,policy4 7,h7 ,at lea/ #c directors ( review divisions or (fices ov]see+ products approv$ "u accel]at$ approval1 includ+ at lea/ "o director )9 ! ,(fice ( ,neurosci5ce4 7#c7 ,duties ( ! c\ncil 7,a7 ,meet+s ,! ,c\ncil %all conv5e n few] ?an #c times p] cal5d> ye> to discuss issues relat$ to accel]at$ approval1 includ+ any relevant cross-discipl9>y approa*es relat$ to product review ) respect to accel]at$ approval4 7,b7 ,policy developm5t ,! ,c\ncil %all directly engage ) product review teams to support ! consi/5t & appropriate use ( accel]at$ approval across ! ,food & ,drug ,adm9i/ration4 ,su* activities may include-- 7i7 develop+ guidance = ,food & ,drug ,adm9i/ration /aff & be/ practices =1 & across1 product review teams1 includ+ ) respect to communication betwe5 sponsors & ! ,food & ,drug ,adm9i/ration & ! review ( products "u accel]at$ approval2 7ii7 provid+ tra9+ = product review teams2 & 7iii7 advis+ review divisions on product-specific developm5t1 review1 & )drawal ( products "u accel]at$ approval4 7#d7 ,publication ( a report ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 & annually !reaft]1 ! c\ncil %all publi% on ! public website ( ! ,food & ,drug ,adm9i/ration a report on ! activities ( ! c\ncil4 7#e7 ,summ>y approval in=mation ,) respect to ea* new drug application = a new molecul> entity approv$ "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77 or biological product lic5s$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a77 pursuant to accel]at$ approval "u section #ejf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;c771 ! ,secret>y %all provide = ! drug or biologic action package a summ>y ( ! basis = approval1 includ+1 z relates to su* new molecul> entity1 :e!r an advisory committee meet+ 0 held & a rationale = a det]m9ation by ! ,secret>y t a surrogate endpo9t is reasonably likely to pr$ict cl9ical b5efit4 7f7 ,rule ( con/ruction ,no?+ 9 ?is section 7includ+ ! am5dm5ts made by ?is section7 %all be con/ru$ to affect products approv$ pursuant to section #ejf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;c77 prior to ! date ( enactm5t ( ?is ,act4 #ejg4 ,r>e disease pilot program 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all e/abli% a pilot program "u :i* ! ,secret>y e/abli%es proc$ures to provide increas$ int]action ) sponsors ( r>e disease drug developm5t programs = purposes ( advanc+ ! developm5t ( efficacy endpo9ts1 includ+ surrogate & int]m$iate endpo9ts1 = drugs int5d$ to treat r>e diseases1 includ+ ?r\gh-- 7#a7 det]m9+ eligibility ( p>ticipants = su* program2 & 7#b7 develop+ & implem5t+ a process = apply+ to1 & p>ticipat+ 91 su* a program4 7b7 ,public work%ops ,! ,secret>y %all conduct up to #c public work%ops1 :i* %all be complet$ n lat] ?an ,septemb] #cj1 #bjbf1 to discuss topics relevant to ! developm5t ( endpo9ts = r>e diseases1 :i* may include discussions ab\t-- 7#a7 novel endpo9ts develop$ ?r\gh ! pilot program e/abli%$ "u ?is section2 & 7#b7 z appropriate1 ! use ( real _w evid5ce & real _w data to support ! validation ( efficacy endpo9ts1 includ+ surrogate & int]m$iate endpo9ts1 = r>e diseases4 7c7 ,report ,n lat] ?an ,septemb] #cj1 #bjbf1 ! ,secret>y %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report describ+ ! outcomes ( ! pilot program e/abli%$ "u ?is section4 7d7 ,guidance ,n lat] ?an ,septemb] #cj1 #bjbg1 ! ,secret>y %all issue guidance describ+ be/ practices & /rategies = developm5t ( efficacy endpo9ts1 includ+ surrogate & int]m$iate endpo9ts1 = r>e diseases4 7e7 ,sunset ,! ,secret>y may n accept any new application or reque/ to p>ticipate 9 ! program e/abli%$ by ?is section on or aft] ,octob] #a1 #bjbg4 #ejh4 ,support+ review & developm5t ( drugs to treat r>e diseases 7a7 ,,gao report 7#a7 ,9 g5]al ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 a report assess+ ! policies1 practices1 & programs ( ! ,food & ,drug ,adm9i/ration ) respect to ! review ( applications = drugs & biological products int5d$ to treat r>e diseases & conditions 7z def9$ 9 section #ebf7;a77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb7a77#b7774 7#b7 ,cont5t ( report ,! report "u p>agraph 7#a7 %all-- 7,a7 describe ! activities ( ! ,food & ,drug ,adm9i/ration d$icat$ to ! developm5t & review ( drugs & biological products int5d$ to treat r>e diseases & conditions2 7,b7 describe *all5ges ) develop+ & obta9+ approval or lic5sure ( drugs & biological products int5d$ to treat r>e diseases & conditions1 su* z *all5ges relat$ to design+ & conduct+ cl9ical trials1 cl9ical trial subject recruitm5t & enrollm5t1 /udy endpo9ts1 & ensur+ data quality1 assess+ ! b5efit-risk pr(ile ( drugs & biological products int5d$ to treat r>e diseases & conditions1 & meet+ requirem5ts = approval or lic5sure2 7,c7 assess ! effectiv5ess ( policies & practices ( ! ,food & ,drug ,adm9i/ration relat$ to ! review ( applications = drugs & biological products int5d$ to treat r>e diseases & conditions1 includ+-- 7i7 initiatives to support ! developm5t & review ( drugs & biological products int5d$ to treat r>e diseases & conditions1 includ+ initiatives relat$ to regulatory sci5ce1 cl9ical trial design1 /ati/ical analysis1 & o!r relevant topics2 7ii7 consid]ation ( relevant pati5t-focus$ drug developm5t data & in=mation1 includ+ pati5t exp]i5ce data & ! views ( pati5ts1 pursuant to section #efi;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c72 7iii7 tra9+ & o!r ef=ts to ensure ! exp]tise ( p]sonnel ( ! ,food & ,drug ,adm9i/ration reg>d+ ! review ( applications = drugs & biological products int5d$ to treat r>e diseases & conditions2 & 7iv7 consultations & engagem5t ) /akehold]s1 includ+ pati5ts & pati5t gr\ps1 & ext]nal exp]ts pursuant to section #efi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h72 7,d7 assess ! ext5t to :i* ! ,food & ,drug ,adm9i/ration is apply+ ! policies & practices describ$ 9 subp>agraph 7,c7 consi/5tly across review divisions1 & ! factors t influ5ce ! ext5t to :i* su* application is consi/5t2 & 7,e7 include recomm5dations to address *all5ges & defici5cies id5tifi$1 includ+ recomm5dations to improve ! effectiv5ess1 consi/5cy1 & coord9ation ( policies1 practices1 & programs ( ! ,food & ,drug ,adm9i/ration relat$ to ! review ( applications = drugs & biological products int5d$ to treat r>e diseases & conditions4 7b7 ,,fda report 7#a7 ,9 g5]al ,n lat] ?an ,m>* #ca1 #bjbf1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is subsection z ! ,secret>y7 %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report assess+ ! policies1 practices1 & programs ( ! ,food & ,drug ,adm9i/ration ) respect to ! review ( applications = drugs & biological products int5d$ to treat r>e diseases & conditions 7z def9$ 9 section #ebf7;a77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb7a77#b7774 7#b7 ,cont5t ( report ,! report "u p>agraph 7#a7 %all include1 ) respect to ! p]iod ( fiscal ye>s #bjbc ?r\gh #bjbe1 brok5 d[n by fiscal ye> & by ! responsible review division ( ! ,food & ,drug ,adm9i/ration-- 7,a7 ! numb] ( drugs t h be5 designat$ z a drug = a r>e disease or condition "u section #ebf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb72 7,b7 ! numb] ( applications "u section #eje7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a77 = a drug designat$ "u section #ebf = a r>e disease or condition t 7 submitt$1 ! numb] ( su* applications t 7 approv$1 & ! approximate size ( ! affect$ population 9 ! ,unit$ ,/ates ^u :i* ! designation pursuant to section #ebf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb7 0 grant$ = ea* su* submitt$ & approv$ application2 7,c7 ! numb] ( applications = a drug or biological product = :i* ! sponsor reque/$ writt5 recomm5dations pursuant to section #ebe ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;aa71 & ! numb] ( su* applications = :i* ! sponsor receiv$ su* writt5 recomm5dations2 7,d7 ! numb] ( applications = :i* ! ,secret>y consult$ pati5ts & pati5t gr\ps pursuant to subsection 7a77#a7 ( section #efi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h7 & ! numb] ( applications = :i* ! ,secret>y consult$ exp]ts pursuant to subsection 7a77#b7 ( su* section #efi2 & 7,e7 ! numb] ( applications = :i* ! ,secret>y all[$ ! sponsor to rely ^u data & in=mation pursuant to section #ebi;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff-#a74 7#c7 ,cl>ification ,no?+ 9 ?is subsection %all be con/ru$ to au?orize ! disclosure ( confid5tial comm]cial in=mation or o!r in=mation consid]$ propriet>y or trade secret1 z prohibit$ "u section #cja7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7;j77 or section #aije ( title #ah1 ,unit$ ,/ates ,code4 7c7 ,guidance ,n lat] ?an #i mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all publi% f9al guidance relat$ to ! draft guidance titl$1 ,r>e ,diseases3 ,common ,issues 9 ,drug ,developm5t issu$ on ,febru>y #a1 #bjai4 7d7 ,review process 7#a7 ,consultation ) /akehold]s ,section #efi7;a77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h7;a77#a77 is am5d$-- 7,a7 by /rik+ at a "t & ins]t+ at any "t2 7,b7 by /rik+ ,consi/5t ) sections & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,consi/5t ) sections 2 & 7,c7 by add+ at ! end ! foll[+3 7,b7 ,consultation ) pati5ts & pati5t gr\ps 7i7 ,9 g5]al ,! ,secret>y may1 z appropriate1 consult ) pati5ts & relevant pati5t gr\ps impact$ by ! r>e disease or condition1 toge!r ) at lea/ "o exp]t includ$ on ! li/ "u p>agraph 7#b77;,a7 & select$ by su* gr\ps1 z applicable1 dur+ meet+s betwe5 ! ,food & ,drug ,adm9i/ration & sponsors prior to ! submission ( an application = a new drug or biological product = a r>e disease or condition or a drug or biological product t is g5etically t>get$4 7ii7 ,conflicts ( int]e/ ,= purposes ( clause 7i71 to be eligible = consultation pursuant to clause 7i71 pati5ts & relevant pati5t gr\ps may n h any f9ancial int]e/ 9 ! applicable drug or biological product1 & ext]nal exp]ts %all be 9 compliance ) applicable law1 includ+ section #bjh ( title #ah1 ,unit$ ,/ates ,code4 7,c7 ,consultation ) disproportionately affect$ communities ,to ! ext5t an application = a new drug or biological product relates to a r>e disease or condition t disproportionately affects communities ( color or o!r hi/orically und]repres5t$ & vuln]able populations1 ! ,secret>y is enc\rag$ to consult ) pati5ts ( t subpopulation1 or "o or m pati5t gr\ps t repres5t t subpopulation4 4 7#b7 ,requir+ appropriate exp]t consultation ,section #efi7;a77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h7;a77#b77 is am5d$-- 7,a7 9 subp>agraph 7,a71 by /rik+ ! second s5t5ce2 & 7,b7 by /rik+ subp>agraph 7,b7 & ins]t+ ! foll[+3 7,b7 ,consultation ,) respect to any application "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act = a drug designat$ "u section #ebf = a r>e disease or condition or a drug or biological product t is g5etically t>get$1 ! ,secret>y may1 z appropriate1 consult-- 7i7 ) an exp]t ) respect to ! disease or condition ref]5c$ 9 ! application :o appe>s on ! li/ describ$ 9 subp>agraph 7,a72 or 7ii7 if no su* exp]t is available1 includ+ because ( conflicts ( int]e/1 ) an exp]t on ! li/ describ$ 9 subp>agraph 7,a7 9 ! sci5ce ( small population /udies4 7,c7 ,availability at meet+s ,9 connection ) ea* drug product advisory committee meet+ conc]n+ a drug or biological product = a r>e disease or condition1 ! ,secret>y may1 z appropriate-- 7i7 include-- 7,i7 an exp]t 9 ! r>e disease or condition2 or 7,,ii7 if no su* exp]t is available1 includ+ because ( conflicts ( int]e/1 an exp]t 9 ! sci5ce ( small population /udies2 & 7ii7 invite at lea/ "o disease or condition exp]t id5tifi$ by ! relevant pati5t gr\ps to p>ticipate z a nonvot+ memb] ( ! advisory committee4 4 7#c7 ,additional topic = consultation ,section #efi7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h7;b77 is am5d$-- 7,a7 9 p>agraph 7#f71 by /rik+ 2 & & ins]t+ 22 7,b7 9 p>agraph 7#g71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+3 7#h7 ! sci5ce ( small population /udies4 4 #eji4 ,g5]ic drug label+ *anges ,section #eje7;j77#aj77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#aj77;,a77 is am5d$ by /rik+ clauses 7i7 ?r\gh 7iii7 & ins]t+ ! foll[+3 7i7 a revision to ! label+ ( ! li/$ drug has be5 approv$ by ! ,secret>y )9 #ij days ( :5 ! application is o!rwise eligible = approval "u ?is subsection2 7ii7 ! sponsor ( ! application agrees to submit revis$ label+ = ! drug t is ! subject ( ! application n lat] ?an #fj days aft] approval "u ?is subsection ( ! application2 7iii7 ! label+ revision describ$ "u clause 7i7 does n include a *ange to ! ,w>n+s section ( ! label+2 & 4 #eaj4 ,limitations on exclusive approval or lic5sure ( orphan drugs 7a7 ,9 g5]al ,section #ebg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7 is am5d$-- 7#a7 9 subsection 7a71 9 ! matt] foll[+ p>agraph 7#b71 by /rik+ same disease or condition & ins]t+ same approv$ use or indication )9 su* r>e disease or condition2 7#b7 9 subsection 7b7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ same r>e disease or condition & ins]t+ same approv$ use or indication = :i* su* #g-ye> p]iod applies to su* already approv$ drug2 & 7,b7 9 p>agraph 7#a71 by ins]t+ 1 relat+ to ! approv$ use or indication1 aft] ! ne$s2 7#c7 9 subsection 7c77#a71 by /rik+ same r>e disease or condition z ! already approv$ drug & ins]t+ same use or indication = :i* ! already approv$ or lic5s$ drug 0 approv$ or lic5s$2 & 7#d7 by add+ at ! end ! foll[+3 7f7 ,approv$ use or indication def9$ ,9 ?is section1 ! t]m approv$ use or indication means ! use or indication approv$ "u section #eje ( ?is ,act or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act = a drug designat$ "u section #ebf = a r>e disease or condition4 4 7b7 ,application ( am5dm5ts ,! am5dm5ts made by subsection 7a7 %all apply ) respect to any drug designat$ "u section #ebf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb71 reg>dless ( ! date on :i* ! drug 0 s designat$1 & reg>dless ( ! date on :i* ! drug 0 approv$ "u section #eje ( su* ,act 7#ba ,u4,s4,c4 #cee7 or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 #eaa4 ,ensur+ timely access to g5]ics ,section #eje7q7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7q77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a77i71 by ins]t+ 1 #aj4ca1 aft] #aj4cj2 7,b7 9 subp>agraph 7,e7-- 7i7 by /rik+ application & & ins]t+ application or2 7ii7 by /rik+ ,if ! ,secret>y & ins]t+ ! foll[+3 7i7 ,9 g5]al ,if ! ,secret>y 2 & 7iii7 by /rik+ ! second s5t5ce & ins]t+ ! foll[+3 7ii7 ,prim>y purpose ( delay+ 7,i7 ,9 g5]al ,9 det]m9+ :e!r a petition 0 submitt$ ) ! prim>y purpose ( delay+ an application1 ! ,secret>y may consid] ! foll[+ factors3 7aa7 ,:e!r ! petition 0 submitt$ 9 accordance ) p>agraph 7#b77;,b71 bas$ on :5 ! petition] knew or reasonably %\ld h kn[n ! relevant in=mation reli$ ^u to =m ! basis ( su* petition4 7bb7 ,:e!r ! petition] has submitt$ multiple or s]ial petitions or supplem5ts to petitions rais+ issues t reasonably c\ld h be5 kn[n to ! petition] at ! "t ( submission ( ! e>li] petition or petitions4 7cc7 ,:e!r ! petition 0 submitt$ close 9 "t to a kn[n1 fir/ date ^u :i* an application "u subsection 7b77#b7 or 7j7 ( ?is section or section #cea7k7 ( ! ,public ,heal? ,s]vice ,act c\ld be approv$4 7dd7 ,:e!r ! petition 0 submitt$ )\t relevant data or in=mation 9 support ( ! sci5tific positions =m+ ! basis ( su* petition4 7ee7 ,:e!r ! petition raises ! same or sub/antially simil> issues z a prior petition to :i* ! ,secret>y has respond$ sub/antively already1 includ+ if ! subsequ5t submission foll[s su* response f ! ,secret>y closely 9 "t4 7ff7 ,:e!r ! petition reque/s *ang+ ! applicable /&>ds t o!r applicants are requir$ to meet1 includ+ reque/+ te/+1 data1 or label+ /&>ds t are m on]\s or rigor\s ?an ! /&>ds ! ,secret>y has det]m9$ to be applicable to ! li/$ drug1 ref]5ce product1 or petition]'s v]sion ( ! same drug4 7gg7 ,! petition]'s record ( submitt+ petitions to ! ,food & ,drug ,adm9i/ration t h be5 det]m9$ by ! ,secret>y to h be5 submitt$ ) ! prim>y purpose ( delay4 7hh7 ,o!r relevant & appropriate factors1 :i* ! ,secret>y %all describe 9 guidance4 7,,ii7 ,guidance ,! ,secret>y may issue or update guidance1 z appropriate1 to describe factors ! ,secret>y consid]s 9 accordance ) subclause 7,i74 2 7,c7 by add+ at ! end ! foll[+3 7iii7 ,ref]ral to ! ,f$]al ,trade ,commission ,! ,secret>y %all e/abli% proc$ures = ref]r+ to ! ,f$]al ,trade ,commission any petition or supplem5t to a petition t ! ,secret>y det]m9es 0 submitt$ ) ! prim>y purpose ( delay+ approval ( an application4 ,su* proc$ures %all include notification to ! petition] by ! ,secret>y4 2 7,d7 by /rik+ subp>agraph 7,f72 7,e7 by r$esignat+ subp>agraphs 7,g7 ?r\gh 7,i7 z subp>agraphs 7,f7 ?r\gh 7,h71 respectively2 & 7,f7 9 subp>agraph 7,h71 z s r$esignat$1 by /rik+ submission ( ?is petition & ins]t+ submission ( ?is docum5t2 7#b7 9 p>agraph 7#b7-- 7,a7 by r$esignat+ subp>agraphs 7,a7 ?r\gh 7,c7 z subp>agraphs 7,c7 ?r\gh 7,e71 respectively2 7,b7 by ins]t+ be=e subp>agraph 7,c71 z s r$esignat$1 ! foll[+3 7,a7 ,9 g5]al ,a p]son %all submit a petition to ! ,secret>y "u p>agraph 7#a7 be=e fil+ a civil action 9 :i* ! p]son seeks to set aside1 delay1 resc9d1 )draw1 or prev5t submission1 review1 or approval ( an application submitt$ "u subsection 7b77#b7 or 7j7 ( ?is section or section #cea7k7 ( ! ,public ,heal? ,s]vice ,act4 ,su* petition & any supplem5t to su* a petition %all describe all in=mation & argum5ts t =m ! basis ( ! relief reque/$ 9 any civil action describ$ 9 ! previ\s s5t5ce4 7,b7 ,timely submission ( citiz5 petition ,a petition & any supplem5t to a petition %all be submitt$ )9 #fj days aft] ! p]son knew1 or reasonably %\ld h kn[n1 ! in=mation t =ms ! basis ( ! reque/ made 9 ! petition or supplem5t4 2 7,c7 9 subp>agraph 7,c71 z s r$esignat$-- 7i7 9 ! head+1 by /rik+ )9 #aej days2 7ii7 9 clause 7i71 by /rik+ dur+ ! #aej-;day p]iod ref]r$ to 9 p>agraph 7#a77;,f712 & 7iii7 by am5d+ clause 7ii7 to read z foll[s3 7ii7 on or aft] ! date t is #aea days aft] ! date ( submission ( ! petition1 ! ,secret>y approves or has approv$ ! application t is ! subject ( ! petition )\t hav+ made su* a f9al decision4 2 7,d7 by am5d+ subp>agraph 7,d71 z s r$esignat$1 to read z foll[s3 7,d7 ,dismissal ( c]ta9 civil actions 7i7 ,petition ,if a p]son files a civil action aga9/ ! ,secret>y 9 :i* a p]son seeks to set aside1 delay1 resc9d1 )draw1 or prev5t submission1 review1 or approval ( an application submitt$ "u subsection 7b77#b7 or 7j7 ( ?is section or section #cea7k7 ( ! ,public ,heal? ,s]vice ,act )\t comply+ ) ! requirem5ts ( subp>agraph 7,a71 ! c\rt %all dismiss )\t prejudice ! action = failure to exhau/ adm9i/rative rem$ies4 7ii7 ,timel9ess ,if a p]son files a civil action aga9/ ! ,secret>y 9 :i* a p]son seeks to set aside1 delay1 resc9d1 )draw1 or prev5t submission1 review1 or approval ( an application submitt$ "u subsection 7b77#b7 or 7j7 ( ?is section or section #cea7k7 ( ! ,public ,heal? ,s]vice ,act )\t comply+ ) ! requirem5ts ( subp>agraph 7,b71 ! c\rt %all dismiss ) prejudice ! action = failure to timely file a petition4 7iii7 ,f9al response ,if a civil action is fil$ aga9/ ! ,secret>y ) respect to any issue rais$ 9 a petition timely fil$ "u p>agraph 7#a7 9 :i* ! petition] reque/s t ! ,secret>y take any =m ( action t c\ld1 if tak51 set aside1 delay1 resc9d1 )draw1 or prev5t submission1 review1 or approval ( an application submitt$ "u subsection 7b77#b7 or 7j7 ( ?is section or section #cea7k7 ( ! ,public ,heal? ,s]vice ,act be=e ! ,secret>y has tak5 f9al ag5cy action on ! petition )9 ! mean+ ( subp>agraph 7,c71 ! c\rt %all dismiss )\t prejudice ! action = failure to exhau/ adm9i/rative rem$ies4 2 & 7,e7 9 clause 7iii7 ( subp>agraph 7,e71 z s r$esignat$1 by /rik+ z def9$ "u subp>agraph 7#b77;,a7 & ins]t+ )9 ! mean+ ( subp>agraph 7,c72 & 7#c7 9 p>agraph 7#d7-- 7,a7 by /rik+ ,exceptions & all t foll[s ?r\gh ,?is subsection does & ins]t+ ,exceptions4--,?is subsection does2 7,b7 by /rik+ subp>agraph 7,b72 & 7,c7 by r$esignat+ clauses 7i7 & 7ii7 z subp>agraphs 7,a7 & 7,b71 respectively1 & adju/+ ! m>g9s accord+ly4 #eab4 ,increas+ transp>5cy 9 g5]ic drug applications 7a7 ,9 g5]al ,section #eje7;j77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#c77 is am5d$ by add+ at ! end ! foll[+3 7,h7 7i7 ,^u reque/ 79 controll$ correspond5ce or o!rwise7 by a p]son t has submitt$ or int5ds to submit an abbreviat$ application "u ?is subsection = a drug t is g5]ally requir$ by regulation or recomm5d$ 9 guidance to conta9 ! same inactive +r$i5ts 9 ! same conc5tration z ! li/$ drug ref]r$ to or = :i* !re is a sci5tific ju/ification t an 9 vitro approa* c be us$ to demon/rate bioequival5ce bas$ on c]ta9 qualitative or quantitative crit]ia ) respect to an inactive +r$i5t1 or on ! ,secret>y's own initiative dur+ ! review ( an application "u ?is subsection = su* a drug1 ! ,secret>y %all in=m ! p]son :e!r su* drug is qualitatively & quantitatively ! same z ! li/$ drug4 7ii7 ,if ! ,secret>y det]m9es t su* drug is n qualitatively or quantitatively ! same z ! li/$ drug1 ! ,secret>y %all id5tify & disclose to ! p]son-- 7,i7 ! +r$i5t or +r$i5ts t cause ! drug n to be qualitatively or quantitatively ! same z ! li/$ drug2 & 7,,ii7 = any +r$i5t = :i* !re is an id5tifi$ quantitative deviation1 ! am\nt ( su* deviation4 7iii7 ,if ! ,secret>y det]m9es t su* drug is qualitatively & quantitatively ! same z ! li/$ drug1 ! ,secret>y %all n *ange or resc9d su* det]m9ation aft] ! submission ( an abbreviat$ application = su* drug "u ?is subsection unless-- 7,i7 ! =mulation ( ! li/$ drug has be5 *ang$ & ! ,secret>y has det]m9$ t ! prior li/$ drug =mulation 0 )drawn = reasons ( safety or effectiv5ess2 or 7,,ii7 ! ,secret>y makes a writt5 det]m9ation t ! prior det]m9ation mu/ be *ang$ because an error has be5 id5tifi$4 7iv7 ,if ! ,secret>y makes a writt5 det]m9ation describ$ 9 clause 7iii77,,ii71 ! ,secret>y %all provide notice & a copy ( ! writt5 det]m9ation to ! p]son mak+ ! reque/ "u clause 7i74 7v7 ,! disclosures requir$ by ?is subp>agraph are disclosures au?oriz$ by law1 includ+ = purposes ( section #aije ( title #ah1 ,unit$ ,/ates ,code4 4 7b7 ,guidance 7#a7 ,9 g5]al ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue draft guidance1 or update guidance1 describ+ h[ ! ,secret>y w det]m9e :e!r a drug is qualitatively & quantitatively ! same z ! li/$ drug 7z su* t]ms are us$ 9 section #eje7;j77#c77;,h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a771 includ+ ) respect to assess+ p,h adju/]s4 7#b7 ,process ,9 issu+ guidance "u ?is subsection1 ! ,secret>y ( ,heal? & ,human ,s]vices %all-- 7,a7 publi% draft guidance2 7,b7 provide a p]iod ( at lea/ #fj days = comm5t on ! draft guidance2 & 7,c7 aft] consid]+ any comm5ts receiv$ & n lat] ?an "o ye> aft] ! close ( ! comm5t p]iod on ! draft guidance1 publi% f9al guidance4 7c7 ,applicability ,section #eje7;j77#c77;,h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a71 applies beg9n+ on ! date ( enactm5t ( ?is ,act1 irrespective ( ! date on :i* ! guidance requir$ by subsection 7b7 is f9aliz$4 #eac4 ,,gao report on nonpr(it ph>maceutical organizations 7a7 ,,gao review ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 7ref]r$ to 9 ?is section z ! ,comptroll] ,g5]al7 %all prep>e a report on-- 7#a7 :at is kn[n ab\t nonpr(it ph>maceutical manufactur+ organizations1 includ+ ! impact ( su* organizations on ! developm5t1 availability1 & co/ ( prescription drugs 9 ! ,unit$ ,/ates1 :i* may include in=mation ) respect to ! capacity & capability to help prev5t or mitigate %ortages ( su* drugs1 & any *all5ges to manufactur+ or o!r op]ations2 & 7#b7 recomm5dations to address su* *all5ges4 7b7 ,report ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al %all submit ! report describ$ 9 subsection 7a7 to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 #ead4 ,,fda public meet+ on nonpr(it prescription drug manufactur]s 7a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all-- 7#a7 hold a public meet+ on nonpr(it manufactur]s ( prescription drugs1 :i* %all include public te/imony f relevant /akehold]s & academics2 & 7#b7 op5 a docket = public comm5t relat$ to su* meet+4 7b7 ,topics ,! public meet+ "u subsection 7a7 %all focus on ! foll[+ topics3 7#a7 ,! ext5t to :i* gr[? 9 ! nonpr(it prescription drug sector c help address pati5t access *all5ges 9 ! curr5t prescription drug m>ketplace1 su* z drug %ortages1 limit$ m$ication alt]natives & competition1 supply *a9 resili5cy1 & specific products :]e !re is insuffici5t m>ket dem& to induce manufactur]s to cont9ue to (f] c]ta9 prescription drugs4 7#b7 ,:e!r1 & to :at ext5t1 ! ,secret>y ( ,heal? & ,human ,s]vices %\ld consid] *anges to future us] fee /ructures & processes = nonpr(it manufactur]s ( prescription drugs4 #eae4 #ahj-;day exclusivity p]iod 7a7 ,9 g5]al ,section #eje7;j77#e77;,b77iv7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,b77iv77 is am5d$-- 7#a7 9 subclause 7,i7-- 7,a7 by ins]t+ & subclause 7,,iii7 aft] subp>agraph 7,d72 & 7,b7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 or an applicant ^: application 0 approv$ pursuant to subclause 7,,iii74 ,if an applicant describ$ 9 subclause 7,,iii7 is eligible = effective approval on ! same day a t5tatively approv$ fir/ applicant :o has reque/$ f9al approval is det]m9$ by ! ,secret>y to be eligible = effective approval by meet+ all ! approval requirem5ts ( ?is subsection1 su* applicant may n receive effective approval until #ahj days aft] ! fir/ applicant beg9s comm]cial m>ket+ ( ! drug42 & 7#b7 by add+ at ! end ! foll[+ new subclause3 7,,iii7 ,applicant approval ,! ,secret>y may approve an application conta9+ a c]tification describ$ 9 p>agraph 7#b77;,a77vii77,,iv7 t is = a drug = :i* a fir/ applicant has submitt$ an application conta9+ su* a c]tification1 not)/&+ ! eligibility ( a fir/ applicant = ! #ahj-;day exclusivity p]iod describ$ 9 subclause 7,,ii77aa71 if ea* ( ! foll[+ conditions is met3 7aa7 ,! approval ( su* application c\ld be made effective1 b = ! eligibility ( a fir/ applicant = #ahj-;day exclusivity "u ?is clause4 7bb7 ,! applicant ( su* application has submitt$ a c]tification to ! abbreviat$ new drug application t !re are no conditions t w\ld prev5t ! applicant f comm]cial m>ket+ )9 #ge days aft] ! date ( approval & t ! applicant int5ds to s m>ket ! drug4 7cc7 ,at lea/ #cc mon?s h pass$ s9ce ! date ( submission ( an application = ! drug by at lea/ "o fir/ applicant4 7dd7 ,approval ( an application = ! drug submitt$ by at lea/ "o fir/ applicant is n preclud$ "u clause 7iii74 7ee7 ,no application = ! drug submitt$ by any fir/ applicant is effectively approv$ on ! date t ! conditions "u items 7aa71 7bb71 7cc71 & 7dd7 are all met & ma9ta9$4 4 7b7 ,special approval /atus rule = c]ta9 subsequ5t applicants ,section #eje7;j77#e77;,d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee 7j77#e77;,d77 is am5d$ at ! end by add+ ! foll[+3 7v7 ,special approval /atus rule = c]ta9 subsequ5t applicants ,an application t is approv$ pursuant to subclause 7,,iii7 ( subp>agraph 7,b77iv7 is deem$ to be t5tatively approv$ & to no long] h an effective approval pursuant to su* subclause 7,,iii7 on ! date t is #gf days aft] ! date on :i* ! approval has be5 made effective pursuant to su* subclause 7,,iii7 if ! applicant fails to comm]cially m>ket su* drug )9 ! #ge-;day p]iod aft] ! date on :i* ! approval is made effective4 ,if ! applicant ( an application approv$ pursuant to su* subclause 7,,iii7 submits a notification t x c no long] comm5ce comm]cial m>ket+ )9 #ge days aft] ! date ( approval1 z requir$ "u subp>agraph 7,b77iv77,,iii77bb71 its application is deem$ to be t5tatively approv$ & to no long] be effectively approv$ on ! date t su* a notification is receiv$4 ,if an applicant does n comm5ce comm]cial m>ket+ )9 ! #ge-;day p]iod1 x %all n be eligible = a subsequ5t effective approval = ! application "u subclause 7,,iii7 ( subp>agraph 7,b77iv7 unless1 9 addition to meet+ ea* ( ! conditions 9 su* subclause 7,,iii71 x submits a c]tification to its abbreviat$ new drug application t an ev5t t c\ld n h be5 reasonably =ese5 by ! applicant prev5t$ x f comm5c+ comm]cial m>ket+ & t x has fully resolv$ ?is issue4 ,! applicant %all submit notification to ! abbreviat$ new drug application confirm+ t su* applicant has comm5c$ comm]cial m>ket+ ( ! drug n lat] ?an "o bus9ess day aft] comm5c+ su* m>ket+4 4 7c7 ,applicability ,! am5dm5ts made by subsections 7a7 & 7b7 %all apply only ) respect to an application fil$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 aft] ! date ( enactm5t ( ?is ,act t id5tifies a li/$ drug = :i* no c]tification "u p>agraph 7#b77;,a77vii77,,iv7 ( su* section 0 made be=e su* date ( enactm5t4 ,,vi ,o!r reau?orizations #fja4 ,reau?orization ( ! critical pa? public-private p>tn]%ip ,section #eff7;f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#e7;f77 is am5d$ by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 #fjb4 ,reau?orization ( ! be/ ph>maceuticals = *ildr5 program ,section #dji;,i7d77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhdm7d77#a77 is am5d$ by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 #fjc4 ,reau?orization ( ! humanit>ian device exemption inc5tive ,section #ebj7m77#f77;,a77iv7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7m77#f77;,a77iv77 is am5d$ by /rik+ #bjbb & ins]t+ #bjbg4 #fjd4 ,reau?orization ( ! p$iatric device consortia program ,section #cje7;e7 ( ! ,food & ,drug ,adm9i/ration ,am5dm5ts ,act ( #bjjg 7,public ,law #aaj-he2 #db ,u4,s4,c4 #bhb note7 is am5d$ by /rik+ #e1bej1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ #g1jjj1jjj = ea* ( fiscal ye>s #bjbc ?r\gh #bjbg4 #fje4 ,reau?orization ( provision p]ta9+ to drugs conta9+ s+le enantiom]s ,section #eje7u7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7u77 is am5d$ by-- 7#a7 9 p>agraph 7#a77;,a77ii77,,ii71 by add+ 7o!r ?an bioavailability /udies7 aft] any cl9ical inve/igations2 & 7#b7 9 p>agraph 7#d71 by /rik+ ,octob] #a1 #bjbb & ins]t+ ,octob] #a1 #bjbg4 #fjf4 ,reau?orization ( orphan drug grants ,section #e7;c7 ( ! ,orphan ,drug ,act 7#ba ,u4,s4,c4 #cfj;ee7c77 is am5d$ by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 #fjg4 ,reau?orization ( c]ta9 device inspections ,section #gjd7;g77#aa7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;g77#aa77 is am5d$ by /rik+ #bjbb & ins]t+ #bjbg4 ,,vii ,enhanc+ ,,fda hir+ au?orities #gja4 ,enhanc+ ,,fda hir+ au?ority = sci5tific1 te*nical1 & pr(essional p]sonnel ,section #gad;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;d-#c;a7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 by ins]t+ 1 includ+ cross-cutt+ op]ational positions1 aft] pr(essional positions2 & 7,b7 by ins]t+ & ! regulation ( food aft] m$ical products2 & 7#b7 9 subsection 7d77#a7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a7-- 7i7 by /rik+ ! #ba/ ,c5tury ,cures ,act & ins]t+ ! ,food & ,drug ,adm9i/ration ,safety & ,l&m>k ,advancem5ts ,act ( #bjbb2 & 7ii7 by /rik+ t exam9es ! ext5t & all t foll[s ?r\gh 1 includ+ & ins]t+ t addresses2 7,b7 9 subp>agraph 7,a7-- 7i7 by ins]t+ updat$ be=e analysis2 & 7ii7 by /rik+ 2 & & ins]t+ a semicolon2 7,c7 by r$esignat+ subp>agraph 7,b7 z subp>agraph 7,c72 7,d7 by ins]t+ aft] subp>agraph 7,a7 ! foll[+3 7,b7 an analysis ( h[ ! ,secret>y has us$ ! au?orities provid$ "u ?is section1 & a plan = h[ ! ,secret>y w use ! au?ority "u ?is section1 & o!r applicable hir+ au?orities1 = employees ( ! ,food & ,drug ,adm9i/ration2 & 2 & 7,e7 9 ! matt] prec$+ clause 7i7 ( subp>agraph 7,c71 z s r$esignat$1 by /rik+ a recruitm5t & ins]t+ an updat$ recruitm5t4 #gjb4 ,/rategic work=ce plan & report ,*apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cga et seq47 is am5d$ by ins]t+ aft] section #gad;,a ! foll[+3 #gad;,b4 ,/rategic work=ce plan & report 7a7 ,9 g5]al ,n lat] ?an ,septemb] #cj1 #bjbc1 & at lea/ e #d ye>s !reaft]1 ! ,secret>y %all develop & submit to ! appropriate committees ( ,congress & po/ on ! website ( ! ,food & ,drug ,adm9i/ration1 a coord9at$ /rategy & report to provide direction = ! activities & programs ( ! ,secret>y to recruit1 hire1 tra91 develop1 & reta9 ! work=ce ne$$ to fulfill ! public heal? mission ( ! ,food & ,drug ,adm9i/ration1 includ+ to facilitate collaboration across c5t]s1 to keep pace ) new biom$ical1 te*nological1 & sci5tific advancem5ts1 & support ! developm5t1 review1 & regulation ( m$ical products4 ,ea* su* report %all be kn[n z ! ,food & ,drug ,adm9i/ration ,/rategic ,work=ce ,plan4 7b7 ,use ( ! ,food & ,drug ,adm9i/ration /rategic work=ce plan ,ea* c5t] )9 ! ,food & ,drug ,adm9i/ration %all develop & update1 z appropriate1 a /rategic plan t w be in=m$ by ! ,food & ,drug ,adm9i/ration ,/rategic ,work=ce ,plan develop$ & updat$ "u ?is subsection4 7c7 ,cont5ts ( ! food & drug adm9i/ration /rategic work=ce plan ,ea* ,food & ,drug ,adm9i/ration ,/rategic ,work=ce ,plan "u subsection 7a7 %all-- 7#a7 include ag5cy-wide /rategic goals & priorities = recruit+1 hir+1 tra9+1 develop+1 & reta9+ a qualifi$ work=ce = ! ,food & ,drug ,adm9i/ration2 7#b7 e/abli% specific activities ! ,secret>y w take to a*ieve its /rategic goals & priorities & address ! work=ce ne$s ( ! ,food & ,drug ,adm9i/ration 9 ! =?com+ fiscal ye>s2 7#c7 id5tify *all5ges & risks ! ,secret>y w face 9 meet+ its /rategic goals & priorities1 & ! activities ! ,secret>y w und]take to ov]come ^? *all5ges & mitigate ^? risks2 7#d7 e/abli% metrics & mile/ones t ! ,secret>y w use to measure progress 9 a*iev+ its /rategic goals & priorities2 & 7#e7 def9e functions1 capabilities1 & gaps 9 su* work=ce & id5tify /rategies to recruit1 hire1 tra91 develop1 & reta9 su* work=ce4 7d7 ,consid]ations ,9 develop+ ea* ,food & ,drug ,adm9i/ration ,/rategic ,work=ce ,plan "u subsection 7a71 ! ,secret>y %all consid]-- 7#a7 ! numb] ( employees1 employee exp]tise1 & employ+ c5t] ( employees1 includ+ s5ior lead]%ip & non-s5ior lead]%ip employees1 eligible = retirem5t2 7#b7 ! vacancy & turnov] rates = employees ) diff]5t types ( exp]tise & f diff]5t c5t]s1 includ+ any *anges or tr5ds relat$ to su* rates2 7#c7 ! results ( ! ,f$]al ,employee ,viewpo9t ,survey = employees ( ! ,food & ,drug ,adm9i/ration1 includ+ any *anges or tr5ds relat$ to su* results2 7#d7 rates ( pay = diff]5t types ( positions1 includ+ rates = diff]5t types ( exp]tise )9 ! same field 7su* z diff]5ces 9 pay betwe5 diff]5t m$ical speciali/s71 & h[ su* rates ( pay impact ! ability ( ! ,secret>y to a*ieve /rategic goals & priorities2 & 7#e7 ! /atutory hir+ au?orities us$ to hire ,food & ,drug ,adm9i/ration employees1 & ! "t to hire across diff]5t hir+ au?orities4 7e7 ,evaluation ( progress ,ea* ,food & ,drug ,adm9i/ration ,/rategic ,work=ce ,plan issu$ pursuant to subsection 7a71 ) ! exception ( ! fir/ su* ,food & ,drug ,adm9i/ration ,/rategic ,work=ce ,plan1 %all include an evaluation ( ! progress ! ,secret>y has made1 bas$ on ! metrics1 b5*m>ks1 & o!r mile/ones t measure successful recruitm5t1 hir+1 tra9+1 developm5t1 & ret5tion activities2 & :e!r su* actions improv$ ! capacity ( ! ,food & ,drug ,adm9i/ration to a*ieve ! /rategic goals & priorities set =? 9 ! previ\s ,food & ,drug ,adm9i/ration ,/rategic ,work=ce ,plan4 7f7 ,additional consid]ations ,! ,food & ,drug ,adm9i/ration ,/rategic ,work=ce ,plan issu$ 9 fiscal ye> #bjbc %all address ! effect ( ! ,,covid-#ai p&emic on hir+1 ret5tion1 & o!r work=ce *all5ges = ! ,food & ,drug ,adm9i/ration1 includ+ protect+ su* work=ce dur+ public heal? em]g5cies4 4 ,,viii ,advanc+ regulation ( cosmetics1 diet>y supplem5ts1 & 9 vitro cl9ical te/s ,a ,cosmetics #hja4 ,%ort title ,?is subtitle may be cit$ z ! ,mod]nization ( ,cosmetics ,regulation ,act ( #bjbb4 #hjb4 ,am5dm5ts to cosmetic requirem5ts ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq47 is am5d$ by add+ at ! end ! foll[+3 #fjd4 ,def9itions ,9 ?is *apt]3 7#a7 ,adv]se ev5t ,! t]m adv]se ev5t means any heal?-relat$ ev5t associat$ ) ! use ( a cosmetic product t is adv]se4 7#b7 ,cosmetic product ,! t]m cosmetic product means a prep>ation ( cosmetic +r$i5ts ) a qualitatively & quantitatively set composition = use 9 a f9i%$ product4 7#c7 ,facility 7,a7 ,9 g5]al ,! t]m facility includes any e/abli%m5t 7includ+ an e/abli%m5t ( an import]7 t manufactures or processes cosmetic products di/ribut$ 9 ! ,unit$ ,/ates4 7,b7 ,su* t]m does n include any ( ! foll[+3 7i7 ,beauty %ops & salons1 unless su* e/abli%m5t manufactures or processes cosmetic products at t location4 7ii7 ,cosmetic product retail]s1 includ+ individual sales repres5tatives1 direct sell]s 7z def9$ 9 section #cejh7;b77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf71 retail di/ribution facilities1 & ph>macies1 unless su* e/abli%m5t manufactures or processes cosmetic products t are n sold directly to consum]s at t location4 7iii7 ,hospitals1 physicians' (fices1 & heal? c>e cl9ics4 7iv7 ,public heal? ag5cies & o!r nonpr(it entities t provide cosmetic products directly to ! consum]4 7v7 ,entities 7su* z hotels & airl9es7 t provide complim5t>y cosmetic products to cu/om]s incid5tal to o!r s]vices4 7vi7 ,trade %[s & o!r v5ues :]e cosmetic product samples are provid$ free ( *>ge4 7vii7 ,an e/abli%m5t t manufactures or processes cosmetic products t are solely = use 9 rese>* or evaluation1 includ+ = production te/+ & n (f]$ = retail sale4 7viii7 ,an e/abli%m5t t solely p]=ms "o or m ( ! foll[+ ) respect to cosmetic products3 7,i7 ,label+4 7,,ii7 ,relabel+4 7,,iii7 ,packag+4 7,,iv7 ,repackag+4 7,v7 ,hold+4 7,,vi7 ,di/ribut+4 7,c7 ,cl>ification ,= ! purposes ( subp>agraph 7,b77viii71 ! t]ms packag+ & repackag+ d n include fill+ a product conta9] ) a cosmetic product4 7#d7 ,responsible p]son ,! t]m responsible p]son means ! manufactur]1 pack]1 or di/ributor ( a cosmetic product ^: "n appe>s on ! label ( su* cosmetic product 9 accordance ) section #fji7;a7 ( ?is ,act or section #d7;a7 ( ! ,fair ,packag+ & ,label+ ,act4 7#e7 ,s]i\s adv]se ev5t ,! t]m s]i\s adv]se ev5t means an adv]se ev5t t-- 7,a7 results 9-- 7i7 dea?2 7ii7 a life-?reat5+ exp]i5ce2 7iii7 inpati5t hospitalization2 7iv7 a p]si/5t or significant disability or incapacity2 7v7 a cong5ital anomaly or bir? defect2 or 7vi7 significant disfigurem5t 7includ+ s]i\s & p]si/5t ra%es or infections1 second- or ?ird-degree burns1 significant hair loss1 or p]man5t or significant alt]ation ( appe>ance71 o!r ?an z int5d$1 "u conditions ( use t are cu/om>y or usual2 or 7,b7 requires1 bas$ on reasonable m$ical judgm5t1 a m$ical or surgical int]v5tion to prev5t an outcome describ$ 9 subp>agraph 7,a74 #fje4 ,adv]se ev5ts 7a7 ,s]i\s adv]se ev5t report+ requirem5ts ,! responsible p]son %all submit to ! ,secret>y any report receiv$ ( a s]i\s adv]se ev5t associat$ ) ! use1 9 ! ,unit$ ,/ates1 ( a cosmetic product manufactur$1 pack$1 or di/ribut$ by su* p]son4 7b7 ,submission ( reports 7#a7 ,s]i\s adv]se ev5t report ,! responsible p]son %all submit to ! ,secret>y a s]i\s adv]se ev5t report accompani$ by a copy ( ! label on or )9 ! retail packag+ ( su* cosmetic product no lat] ?an #ae bus9ess days aft] ! report is receiv$ by ! responsible p]son4 7#b7 ,new m$ical in=mation ,! responsible p]son %all submit to ! ,secret>y any new & mat]ial m$ical in=mation1 relat$ to a s]i\s adv]se ev5t report submitt$ to ! ,secret>y 9 accordance ) p>agraph 7#a71 t is receiv$ by ! responsible p]son )9 #a ye> ( ! initial report to ! ,secret>y1 no lat] ?an #ae bus9ess days aft] su* in=mation is receiv$ by su* responsible p]son4 7#c7 ,consolidation ( reports ,! ,secret>y %all develop sy/ems to enable responsible p]sons to submit a s+le report t includes duplicate reports (1 or new m$ical in=mation relat$ to1 a s]i\s adv]se ev5t4 7c7 ,exemptions ,! ,secret>y may e/abli% by regulation an exemption to any ( ! requirem5ts ( ?is section if ! ,secret>y det]m9es t su* exemption w\ld h no significant adv]se effect on public heal?4 7d7 ,contact in=mation ,! responsible p]son %all receive reports ( adv]se ev5ts ?r\gh ! dome/ic address1 dome/ic telephone numb]1 or electronic contact in=mation includ$ on ! label 9 accordance ) section #fji7;a74 7e7 ,ma9t5ance & inspection ( adv]se ev5t records 7#a7 ,ma9t5ance ,! responsible p]son %all ma9ta9 records relat$ to ea* report ( an adv]se ev5t associat$ ) ! use1 9 ! ,unit$ ,/ates1 ( a cosmetic product manufactur$ or di/ribut$ by su* p]son receiv$ by su* p]son1 = a p]iod ( #f ye>s4 7#b7 ,inspection 7,a7 ,9 g5]al ,! responsible p]son %all p]mit an au?oriz$ p]son to h access to records requir$ to be ma9ta9$ "u ?is section dur+ an inspection pursuant to section #gjd4 7,b7 ,au?oriz$ p]son ,= purposes ( ?is p>agraph1 ! t]m au?oriz$ p]son means an (fic] or employee ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices :o has-- 7i7 appropriate cr$5tials1 z det]m9$ by ! ,secret>y2 & 7ii7 be5 duly designat$ by ! ,secret>y to h access to ! records requir$ "u ?is section4 7f7 ,fragrance & flavor +r$i5ts ,if ! ,secret>y has reasonable gr\nds to believe t an +r$i5t or comb9ation ( +r$i5ts 9 a fragrance or flavor has caus$ or contribut$ to a s]i\s adv]se ev5t requir$ to be report$ "u ?is section1 ! ,secret>y may reque/ 9 writ+ a li/ ( +r$i5ts or categories ( +r$i5ts 9 ! specific fragrances or flavors 9 ! cosmetic product1 f ! responsible p]son4 ,! responsible p]son %all ensure t ! reque/$ in=mation is submitt$ to ! ,secret>y )9 #cj days ( su* reque/4 ,9 response to a reque/ "u section #eeb ( title #e1 ,unit$ ,/ates ,code1 in=mation submitt$ to ! ,secret>y "u ?is subsection %all be )held "u section #eeb7;b77#c7 ( title #e1 ,unit$ ,/ates ,code4 7g7 ,protect$ in=mation ,a s]i\s adv]se ev5t report submitt$ to ! ,secret>y "u ?is section1 includ+ any new m$ical in=mation submitt$ "u subsection 7b77#b71 or an adv]se ev5t report1 or any new in=mation1 volunt>ily submitt$ to ! ,secret>y %all be consid]$ to be-- 7#a7 a safety report "u section #gef & may be accompani$ by a /atem5t1 :i* %all be a "p ( any report t is releas$ = public disclosure1 t d5ies t ! report or ! records con/itute an admission t ! product involv$ caus$ or contribut$ to ! adv]se ev5t2 & 7#b7 a record ab\t an individual "u section #eeb;a ( title #e1 ,unit$ ,/ates ,code 7commonly ref]r$ to z ! ,privacy ,act ( #aigd7 & a m$ical or simil> file ! disclosure ( :i* w\ld con/itute a violation ( section #eeb ( su* title #e 7commonly ref]r$ to z ! ,fre$om ( ,in=mation ,act71 & %all n be publicly disclos$ unless all p]sonally id5tifiable in=mation is r$act$4 7h7 ,effect ( section 7#a7 ,9 g5]al ,no?+ 9 ?is section %all affect ! au?ority ( ! ,secret>y to provide adv]se ev5t reports & in=mation to any heal?1 food1 or drug (fic] or employee ( any ,/ate1 t]ritory1 or political subdivision ( a ,/ate or t]ritory1 "u a memor&um ( und]/&+ betwe5 ! ,secret>y & su* ,/ate1 t]ritory1 or political subdivision4 7#b7 ,p]sonally id5tifiable in=mation ,not)/&+ any o!r provision ( law1 p]sonally-id5tifiable in=mation 9 adv]se ev5t reports provid$ by ! ,secret>y to any heal?1 food1 or drug (fic] or employee ( any ,/ate1 t]ritory1 or political subdivision ( a ,/ate or t]ritory1 %all n-- 7,a7 be made publicly available pursuant to any ,/ate or o!r law requir+ disclosure ( in=mation or records2 or 7,b7 o!rwise be disclos$ or di/ribut$ to any p>ty )\t ! writt5 cons5t ( ! ,secret>y & ! p]son submitt+ su* in=mation to ! ,secret>y4 7#c7 ,use ( reports ,no?+ 9 ?is section %all p]mit a ,/ate1 t]ritory1 or political subdivision ( a ,/ate or t]ritory1 to use any safety report receiv$ f ! ,secret>y 9 a mann] inconsi/5t ) ?is section4 7#d7 ,rule ( con/ruction ,! submission ( any report 9 compliance ) ?is section %all n be con/ru$ z an admission t ! cosmetic product involv$ caus$ or contribut$ to ! relevant adv]se ev5t4 #fjf4 ,good manufactur+ practice 7a7 ,9 g5]al ,! ,secret>y %all by regulation e/abli% good manufactur+ practices = facilities t are consi/5t1 to ! ext5t practicable1 & appropriate1 ) national & int]national /&>ds1 9 accordance ) section #fja4 ,any su* regulations %all be int5d$ to protect ! public heal? & ensure t cosmetic products are n adult]at$4 ,su* regulations may all[ = ! ,secret>y to inspect records necess>y to demon/rate compliance ) good manufactur+ practices prescrib$ by ! ,secret>y "u ?is p>agraph dur+ an inspection conduct$ "u section #gjd4 7b7 ,consid]ations ,9 e/abli%+ regulations = good manufactur+ practices "u ?is section1 ! ,secret>y %all take into acc\nt ! size & scope ( ! bus9esses engag$ 9 ! manufacture ( cosmetics1 & ! risks to public heal? pos$ by su* cosmetics1 & provide suffici5t flexibility to be practicable = all sizes & types ( facilities to :i* su* regulations w apply4 ,su* regulations %all include simplifi$ good manufactur+ practice requirem5ts = small] bus9esses1 z appropriate1 to ensure t su* regulations d n impose undue economic h>d%ip = small] bus9esses1 & may include long] compliance times = small] bus9esses4 ,be=e issu+ regulations to implem5t subsection 7a71 ! ,secret>y %all consult ) cosmetics manufactur]s1 includ+ small] bus9esses1 consum] organizations1 & o!r exp]ts select$ by ! ,secret>y4 7c7 ,timeframe ,! ,secret>y %all publi% a notice ( propos$ rulemak+ n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,mod]nization ( ,cosmetics ,regulation ,act ( #bjbb & %all publi% a f9al su* rule n lat] ?an #c ye>s aft] su* date ( enactm5t4 #fjg4 ,regi/ration & product li/+ 7a7 ,submission ( regi/ration 7#a7 ,initial regi/ration 7,a7 ,exi/+ facilities ,e p]son t1 on ! date ( enactm5t ( ! ,mod]nization ( ,cosmetics ,regulation ,act ( #bjbb1 owns or op]ates a facility t engages 9 ! manufactur+ or process+ ( a cosmetic product = di/ribution 9 ! ,unit$ ,/ates %all regi/] ea* facility ) ! ,secret>y n lat] ?an #a ye> aft] date ( enactm5t ( su* ,act4 7,b7 ,new facilities ,e p]son t owns or op]ates a facility t fir/ engages1 aft] ! date ( enactm5t ( ! ,mod]nization ( ,cosmetics ,regulation ,act ( #bjbb1 9 manufactur+ or process+ ( a cosmetic product = di/ribution 9 ! ,unit$ ,/ates1 %all regi/] ) ! ,secret>y su* facility )9 #fj days ( fir/ engag+ 9 su* activity or #fj days aft] ! deadl9e = regi/ration "u subp>agraph 7,a71 :i*ev] is lat]4 7#b7 ,bi5nial r5ewal ( regi/ration ,a p]son requir$ to regi/] a facility "u p>agraph 7#a7 %all r5ew su* regi/rations ) ! ,secret>y bi5nially4 7#c7 ,contract manufactur]s ,if a facility manufactures or processes cosmetic products on behalf ( a responsible p]son1 ! ,secret>y %all require only a s+le regi/ration = su* facility ev5 if su* facility is manufactur+ or process+ its own cosmetic products or cosmetic products on behalf ( m ?an "o responsible p]son4 ,su* s+le regi/ration may be submitt$ to ! ,secret>y by su* facility or any responsible p]son ^: products are manufactur$ or process$ at su* facility4 7#d7 ,updates to cont5t ,a p]son t is requir$ to regi/] "u subsection 7a77#a7 %all notify ! ,secret>y )9 #fj days ( any *anges to in=mation requir$ "u subsection 7b77#b74 7#e7 ,abbreviat$ r5ewal regi/rations ,! ,secret>y %all provide = an abbreviat$ regi/ration r5ewal process = any p]son t owns or op]ates a facility t has n be5 requir$ to submit updates "u p>agraph 7#d7 = a regi/]$ facility s9ce submission ( ! mo/ rec5t regi/ration ( su* facility "u p>agraph 7#a7 or 7#b74 7b7 ,=mat2 cont5ts ( regi/ration 7#a7 ,9 g5]al ,regi/ration in=mation "u ?is section may be submitt$ at su* "t & 9 su* mann] z ! ,secret>y may prescribe4 7#b7 ,cont5ts ,! regi/ration "u subsection 7a7 %all conta9-- 7,a7 ! facility's "n1 physical address1 email address1 & telephone numb]2 7,b7 ) respect to any =eign facility1 ! contact = ! ,unit$ ,/ates ag5t ( ! facility1 &1 if available1 ! electronic contact in=mation2 7,c7 ! facility regi/ration numb]1 if any1 previ\sly assign$ by ! ,secret>y "u subsection 7d72 7,d7 all br& names "u :i* cosmetic products manufactur$ or process$ 9 ! facility are sold2 & 7,e7 ! product category or categories & responsible p]son = ea* cosmetic product manufactur$ or process$ at ! facility4 7c7 ,cosmetic product li/+ 7#a7 ,9 g5]al ,= ea* cosmetic product1 ! responsible p]son %all submit to ! ,secret>y a cosmetic product li/+1 or ensure t su* submission is made1 at su* "t & 9 su* mann] z ! ,secret>y may prescribe4 7#b7 ,cosmetic product li/+ ,! responsible p]son ( a cosmetic product t is m>ket$ on ! date ( enactm5t ( ! ,mod]nization ( ,cosmetics ,regulation ,act ( #bjbb %all submit to ! ,secret>y a cosmetic product li/+ n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,mod]nization ( ,cosmetics ,regulation ,act ( #bjbb1 or = a cosmetic product t is fir/ m>ket$ aft] ! date ( enactm5t ( su* ,act1 )9 #abj days ( m>ket+ su* product 9 int]/ate comm]ce4 ,!reaft]1 any updates to su* li/+ %all be made annually1 consi/5t ) p>agraphs 7#d7 & 7#e74 7#c7 ,abbreviat$ r5ewal ,! ,secret>y %all provide = an abbreviat$ process = ! r5ewal ( any cosmetic product li/+ "u ?is subsection ) respect to :i* !re has be5 no *ange s9ce ! responsible p]son submitt$ ! previ\s li/+4 7#d7 ,cont5ts ( li/+ 7,a7 ,9 g5]al ,ea* su* cosmetic product li/+ %all include-- 7i7 ! facility regi/ration numb] ( ea* facility :]e ! cosmetic product is manufactur$ or process$2 7ii7 ! "n & contact numb] ( ! responsible p]son & ! "n = ! cosmetic product1 z su* "n appe>s on ! label2 7iii7 ! applicable cosmetic category or categories = ! cosmetic product2 7iv7 a li/ ( +r$i5ts 9 ! cosmetic product1 includ+ any fragrances1 flavors1 or colors1 ) ea* +r$i5t id5tifi$ by ! "n1 z requir$ "u section #gja4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations71 or by ! common or usual "n ( ! +r$i5t2 & 7v7 ! product li/+ numb]1 if any previ\sly assign$ by ! ,secret>y "u subsection 7d74 7,b7 ,flexible li/+s ,a s+le li/+ submission = a cosmetic product may include multiple cosmetic products ) id5tical =mulations1 or =mulations t diff] only ) respect to colors1 fragrances or flavors1 or quantity ( cont5ts4 7#e7 ,updates to cont5t ,a responsible p]son t is requir$ to submit a cosmetic product li/+ %all submit any updates to su* cosmetic product li/+ annually4 7#f7 ,submission ,a responsible p]son may submit product li/+ in=mation z "p ( a facility regi/ration or sep>ately4 7d7 ,facility regi/ration & product li/+ numb]s ,at ! "t ( ! initial regi/ration ( any facility "u subsection 7a77#a7 or initial li/+ ( any cosmetic product "u 7c77#a71 ! ,secret>y %all assign a facility regi/ration numb] to ! facility & a product li/+ numb] to ea* cosmetic product4 ,! ,secret>y %all n make su* product li/+ numb] publicly available4 7e7 ,confid5tiality ,9 response to a reque/ "u section #eeb ( title #e1 ,unit$ ,/ates ,code1 in=mation describ$ 9 subsection 7b77#b77;,d7 or 7c77#d77;,a77i7 t is d]iv$ f a regi/ration or li/+ "u ?is section %all be )held "u section #eeb7;b77#c7 ( title #e1 ,unit$ ,/ates ,code4 7f7 ,susp5sions 7#a7 ,susp5sion ( regi/ration ( a facility ,! ,secret>y may susp5d ! regi/ration ( a facility if ! ,secret>y det]m9es t a cosmetic product manufactur$ or process$ by a regi/]$ facility & di/ribut$ 9 ! ,unit$ ,/ates has a reasonable probability ( caus+ s]i\s adv]se heal? consequ5ces or dea? to humans & ! ,secret>y has a reasonable belief t o!r products manufactur$ or process$ by ! facility may be simil>ly affect$ because ( a failure t _c be isolat$ to a product or products1 or is suffici5tly p]vasive to raise conc]ns ab\t o!r products manufactur$ 9 ! facility4 7#b7 ,notice ( susp5sion ,be=e susp5d+ a facility regi/ration "u ?is section1 ! ,secret>y %all provide-- 7,a7 notice to ! facility regi/rant ( ! cosmetic product or o!r responsible p]son1 z appropriate1 ( ! int5t to susp5d ! facility regi/ration1 :i* %all specify ! basis ( ! det]m9ation by ! ,secret>y t ! facility regi/ration %\ld be susp5d$2 & 7,b7 an opportunity1 )9 #e bus9ess days ( ! notice provid$ "u subp>agraph 7,a71 = ! responsible p]son to provide a plan = address+ ! reasons = possible susp5sion ( ! facility regi/ration4 7#c7 ,he>+ on susp5sion ,! ,secret>y %all provide ! regi/rant subject to an ord] "u p>agraph 7#a7 or 7#b7 ) an opportunity = an in=mal he>+1 to be held z soon z possible b n lat] ?an #e bus9ess days aft] ! issuance ( ! ord]1 or su* o!r "t p]iod agre$ ^u by ! ,secret>y & ! regi/rant1 on ! actions requir$ = re9/atem5t ( regi/ration & :y ! regi/ration t is subject to ! susp5sion %\ld be re9/at$4 ,! ,secret>y %all re9/ate a regi/ration if ! ,secret>y det]m9es1 bas$ on evid5ce pres5t$1 t adequate gr\nds d n exi/ to cont9ue ! susp5sion ( ! regi/ration4 7#d7 ,po/-he>+ corrective action plan ,if1 aft] provid+ opportunity = an in=mal he>+ "u p>agraph 7#c71 ! ,secret>y det]m9es t ! susp5sion ( regi/ration rema9s necess>y1 ! ,secret>y %all require ! regi/rant to submit a corrective action plan to demon/rate h[ ! regi/rant plans to correct ! conditions f\nd by ! ,secret>y4 ,! ,secret>y %all review su* plan n lat] ?an #ad bus9ess days aft] ! submission ( ! corrective action plan or su* o!r "t p]iod z det]m9$ by ! ,secret>y1 9 consultation ) ! regi/rant4 7#e7 ,vacat+ ( ord]2 re9/atem5t ,^u a det]m9ation by ! ,secret>y t adequate gr\nds d n exi/ to cont9ue ! susp5sion actions1 ! ,secret>y %all promptly vacate ! susp5sion & re9/ate ! regi/ration ( ! facility4 7#f7 ,effect ( susp5sion ,if ! regi/ration ( ! facility is susp5d$ "u ?is section1 no p]son %all introduce or deliv] = introduction into comm]ce 9 ! ,unit$ ,/ates cosmetic products f su* facility4 7#g7 ,no delegation ,! au?ority conf]r$ by ?is section to issue an ord] to susp5d a regi/ration or vacate an ord] ( susp5sion %all n be delegat$ to any (fic] or employee o!r ?an ! ,commission]4 #fjh4 ,safety sub/antiation 7a7 ,sub/antiation ( safety ,a responsible p]son = a cosmetic product %all ensure1 & ma9ta9 records support+1 t !re is adequate sub/antiation ( safety ( su* cosmetic product4 7b7 ,coal-,t> hair dye ,subsection 7a7 %all n apply to coal-t> hair dye t o!rwise complies ) ! requirem5ts ( section #fja7;a74 ,a responsible p]son = a coal-t> hair dye %all ma9ta9 records relat$ to ! safety ( su* product4 7c7 ,def9itions ,= purposes ( ?is section3 7#a7 ,adequate sub/antiation ( safety ,! t]m adequate sub/antiation ( safety means te/s or /udies1 rese>*1 analyses1 or o!r evid5ce or in=mation t is consid]$1 among exp]ts qualifi$ by sci5tific tra9+ & exp]i5ce to evaluate ! safety ( cosmetic products & _! +r$i5ts1 suffici5t to support a reasonable c]ta9ty t a cosmetic product is safe4 7#b7 ,safe ,! t]m safe means t ! cosmetic product1 includ+ any +r$i5t !re(1 is n injuri\s to us]s "u ! conditions ( use prescrib$ 9 ! label+ !re(1 or "u su* conditions ( use z are cu/om>y or usual4 ,! ,secret>y %all n consid] a cosmetic +r$i5t or cosmetic product injuri\s to us]s solely because x c cause m9or & transi5t reactions or m9or & transi5t sk9 irritations 9 "s us]s4 ,9 det]m9+ = purposes ( ?is section :e!r a cosmetic product is safe1 ! ,secret>y may consid]1 z appropriate & available1 ! cumulative or o!r relevant exposure to ! cosmetic product1 includ+ any +r$i5t !re(4 #fji4 ,label+ 7a7 ,g5]al requirem5t ,ea* cosmetic product %all be> a label t includes a dome/ic address1 dome/ic phone numb]1 or electronic contact in=mation1 :i* may include a website1 ?r\gh :i* ! responsible p]son c receive adv]se ev5t reports ) respect to su* cosmetic product4 7b7 ,fragrance all]g5s ,! responsible p]son %all id5tify on ! label ( a cosmetic product ea* fragrance all]g5 includ$ 9 su* cosmetic product4 ,sub/ances t are fragrance all]g5s = purposes ( ?is subsection %all be det]m9$ by ! ,secret>y by regulation4 ,! ,secret>y %all issue a notice ( propos$ rulemak+ promulgat+ ! regulation implem5t+ ?is requirem5t n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ! ,mod]nization ( ,cosmetics ,regulation ,act ( #bjbb1 & n lat] ?an #ahj days aft] ! date on :i* ! public comm5t p]iod on ! propos$ rulemak+ closes1 %all issue a f9al rulemak+4 ,9 promulgat+ regulations implem5t+ ?is subsection1 ! ,secret>y %all consid] int]national1 ,/ate1 & local requirem5ts = all]g5 disclosure1 includ+ ! sub/ance & =mat ( requirem5ts 9 ! ,european ,union1 & may e/abli% ?re%old levels ( am\nts ( sub/ances subject to disclosure pursuant to su* regulations4 7c7 ,cosmetic products = pr(essional use 7#a7 ,def9ition ( pr(essional ,= purposes ( ?is subsection1 ! t]m pr(essional means an individual :o is lic5s$ by an (ficial ,/ate au?ority to practice 9 ! field ( cosmetology1 nail c>e1 b>b]+1 or e/hetics4 7#b7 ,pr(essional use label+ ,a cosmetic product introduc$ into int]/ate comm]ce & int5d$ to be us$ only by a pr(essional %all be> a label t-- 7,a7 conta9s a cle> & prom95t /atem5t t ! product %all be adm9i/]$ or us$ only by lic5s$ pr(essionals2 & 7,b7 is 9 con=mity ) ! requirem5ts ( ! ,secret>y = cosmetics label+ "u ?is ,act & section #d7;a7 ( ! ,fair ,packag+ & ,label+ ,act4 #faj4 ,records 7a7 ,9 g5]al ,if ! ,secret>y has a reasonable belief t a cosmetic product1 includ+ an +r$i5t 9 su* cosmetic product1 & any o!r cosmetic product t ! ,secret>y reasonably believes is likely to be affect$ 9 a simil> mann]1 is likely to be adult]at$ su* t ! use or exposure to su* product pres5ts a ?reat ( s]i\s adv]se heal? consequ5ces or dea? to humans1 ea* responsible p]son & facility %all1 at ! reque/ ( an (fic] or employee duly designat$ by ! ,secret>y1 p]mit su* (fic] or employee1 ^u pres5tation ( appropriate cr$5tials & a writt5 notice to su* p]son1 at reasonable times & )9 reasonable limits & 9 a reasonable mann]1 to h access to & copy all records relat+ to su* cosmetic product1 & to any o!r cosmetic product t ! ,secret>y reasonably believes is likely to be affect$ 9 a simil> mann]1 t are ne$$ to assi/ ! ,secret>y 9 det]m9+ :e!r ! cosmetic product is adult]at$ & pres5ts a ?reat ( s]i\s adv]se heal? consequ5ces or dea? to humans4 ,?is subsection %all n be con/ru$ to ext5d to recipes or =mulas = cosmetics1 f9ancial data1 pric+ data1 p]sonnel data 7o!r ?an data z to qualification ( te*nical & pr(essional p]sonnel p]=m+ functions subject to ?is ,act71 rese>* data 7o!r ?an safety sub/antiation data = cosmetic products & _! +r$i5ts71 or sales data 7o!r ?an %ipm5t data reg>d+ sales74 7b7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to limit ! au?ority ( ! ,secret>y to inspect records or require e/abli%m5t & ma9t5ance ( records "u any o!r provision ( ?is ,act1 includ+ section #fje or #fjf4 #faa4 ,m&atory recall au?ority 7a7 ,9 g5]al ,if ! ,secret>y det]m9es t !re is a reasonable probability t a cosmetic is adult]at$ "u section #fja or misbr&$ "u section #fjb & ! use ( or exposure to su* cosmetic w cause s]i\s adv]se heal? consequ5ces or dea?1 ! ,secret>y %all provide ! responsible p]son ) an opportunity to volunt>ily cease di/ribution & recall su* article4 ,if ! responsible p]son refuses to or does n volunt>ily cease di/ribution or recall su* cosmetic )9 ! "t & mann] prescrib$ by ! ,secret>y 7if s prescrib$71 ! ,secret>y may1 by ord]1 require1 z ! ,secret>y det]m9es necess>y1 su* p]son to imm$iately cease di/ribution ( su* article4 7b7 ,he>+ ,! ,secret>y %all provide ! responsible p]son :o is subject to an ord] "u subsection 7a7 ) an opportunity = an in=mal he>+1 to be held n lat] ?an #aj days aft] ! date ( issuance ( ! ord]1 on :e!r adequate evid5ce exi/s to ju/ify ! ord]4 7c7 ,ord] resolution ,aft] an ord] is issu$ accord+ to ! process "u subsections 7a7 & 7b71 ! ,secret>y %all1 except z provid$ 9 subsection 7d7-- 7#a7 vacate ! ord]1 if ! ,secret>y det]m9es t inadequate gr\nds exi/ to support ! actions requir$ by ! ord]2 7#b7 cont9ue ! ord] ceas+ di/ribution ( ! cosmetic until a date specifi$ 9 su* ord]2 or 7#c7 am5d ! ord] to require a recall ( ! cosmetic1 includ+ any requirem5ts to notify appropriate p]sons1 a timetable = ! recall to occur1 & a s*$ule = updates to be provid$ to ! ,secret>y reg>d+ su* recall4 7d7 ,action foll[+ ord] ,any p]son :o is subject to an ord] pursuant to p>agraph 7#b7 or 7#c7 ( subsection 7c7 %all imm$iately cease di/ribution ( or recall1 z applicable1 ! cosmetic & provide notification z requir$ by su* ord]4 7e7 ,notice to p]sons affect$ ,if ! ,secret>y det]m9es necess>y1 ! ,secret>y may require ! p]son subject to an ord] pursuant to subsection 7a7 or an am5d$ ord] pursuant to p>agraph 7#b7 or 7#c7 ( subsection 7c7 to provide ei!r a notice ( a recall ord] =1 or an ord] to cease di/ribution (1 su* cosmetic1 z applicable1 "u ?is section to appropriate p]sons1 includ+ p]sons :o manufacture1 di/ribute1 import1 or (f] = sale su* product t is ! subject ( an ord] & to ! public4 7f7 ,public notification ,9 conduct+ a recall "u ?is section1 ! ,secret>y %all-- 7#a7 ensure t a press release is publi%$ reg>d+ ! recall1 & t al]ts & public notices are issu$1 z appropriate1 9 ord] to provide notification-- 7,a7 ( ! recall to consum]s & retail]s to :om su* cosmetic 01 or may h be51 di/ribut$2 & 7,b7 t includes1 at a m9imum-- 7i7 ! "n ( ! cosmetic subject to ! recall2 7ii7 a description ( ! risk associat$ ) su* article2 & 7iii7 to ! ext5t practicable1 in=mation = consum]s ab\t simil> cosmetics t are n affect$ by ! recall2 & 7#b7 ensure publication1 z appropriate1 on ! website ( ! ,food & ,drug ,adm9i/ration ( an image ( ! cosmetic t is ! subject ( ! press release describ$ 9 p>agraph 7#a71 if available4 7g7 ,no delegation ,! au?ority conf]r$ by ?is section to ord] a recall or vacate a recall ord] %all n be delegat$ to any (fic] or employee o!r ?an ! ,commission]4 7h7 ,effect ,no?+ 9 ?is section %all affect ! au?ority ( ! ,secret>y to reque/ or p>ticipate 9 a volunt>y recall1 or to issue an ord] to cease di/ribution or to recall "u any o!r provision ( ?is *apt]4 #fab4 ,small bus9esses 7a7 ,9 g5]al ,responsible p]sons1 & own]s & op]ators ( facilities1 ^: av]age gross annual sales 9 ! ,unit$ ,/ates ( cosmetic products = ! previ\s #c-ye> p]iod is less ?an #a1jjj1jjj1 adju/$ = inflation1 & :o d n engage 9 ! manufactur+ or process+ ( ! cosmetic products describ$ 9 subsection 7b71 %all be consid]$ small bus9esses & n subject to ! requirem5ts ( section #fjf or #fjg4 7b7 ,requirem5ts applicable to all manufactur]s & processors ( cosmetics ,! exemptions "u subsection 7a7 %all n apply to any responsible p]son or facility engag$ 9 ! manufactur+ or process+ ( any ( ! foll[+ products3 7#a7 ,cosmetic products t regul>ly come into contact ) mucus membrane ( ! eye "u conditions ( use t are cu/om>y or usual4 7#b7 ,cosmetic products t are inject$4 7#c7 ,cosmetic products t are int5d$ = int]nal use4 7#d7 ,cosmetic products t are int5d$ to alt] appe>ance = m ?an #bd h\rs "u conditions ( use t are cu/om>y or usual & removal by ! consum] is n "p ( su* conditions ( use t are cu/om>y or usual4 #fac4 ,exemption = c]ta9 products & facilities 7a7 ,9 g5]al ,not)/&+ any o!r provision ( law1 except z provid$ 9 subsection 7b71 a cosmetic product or facility t is also subject to ! requirem5ts ( *apt] ,v %all be exempt f ! requirem5ts ( sections #fje1 #fjf1 #fjg1 #fjh1 #fji7;a71 #faj1 & #faa4 7b7 ,exception ,a facility describ$ 9 subsection 7a7 t also manufactures or processes cosmetic products t are n subject to ! requirem5ts ( *apt] ,v %all n be exempt f ! requirem5ts ( sections #fje1 #fjf1 #fjg1 #fjh1 #fji7;a71 #faj1 & #faa1 ) respect to su* cosmetic products4 #fad4 ,preemption 7a7 ,9 g5]al ,no ,/ate or political subdivision ( a ,/ate may e/abli% or cont9ue 9 effect any law1 regulation1 ord]1 or o!r requirem5t = cosmetics t is diff]5t f or 9 addition to1 or o!rwise n id5tical )1 any requirem5t applicable "u ?is *apt] ) respect to regi/ration & product li/+1 good manufactur+ practice1 recordkeep+1 recalls1 adv]se ev5t report+1 or safety sub/antiation4 7b7 ,limitation ,no?+ 9 ! am5dm5ts to ?is ,act made by ! ,mod]nization ( ,cosmetics ,regulation ,act ( #bjbb %all be con/ru$ to preempt any ,/ate /atute1 public initiative1 ref]5dum1 regulation1 or o!r ,/ate action1 except z expressly provid$ 9 subsection 7a74 ,not)/&+ subsection 7a71 no?+ 9 ?is section %all be con/ru$ to prev5t any ,/ate f prohibit+ ! use or limit+ ! am\nt ( an +r$i5t 9 a cosmetic product1 or f cont9u+ 9 effect a requirem5t ( any ,/ate t is 9 effect at ! "t ( enactm5t ( ! ,mod]nization ( ,cosmetics ,regulation ,act ( #bjbb = ! report+ to ! ,/ate ( an +r$i5t 9 a cosmetic product4 7c7 ,sav+s ,no?+ 9 ! am5dm5ts to ?is ,act made by ! ,mod]nization ( ,cosmetics ,regulation ,act ( #bjbb1 nor any /&>d1 rule1 requirem5t1 regulation1 or adv]se ev5t report %all be con/ru$ to modify1 preempt1 or displace any action = damages or ! liability ( any p]son "u ! law ( any ,/ate1 :e!r /atutory or bas$ 9 common law4 7d7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to am5d1 exp&1 or limit ! provisions "u section #geb4 4 #hjc4 ,en=cem5t & con=m+ am5dm5ts 7a7 ,9 g5]al 7#a7 ,prohibit$ acts ,section #cja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca71 z am5d$ by section #ejf1 is fur!r am5d$-- 7,a7 by add+ at ! end ! foll[+3 7ggg7 ,! failure to regi/] or submit li/+ in=mation 9 accordance ) section #fjg4 7hhh7 ,! refusal or failure to foll[ an ord] "u section #faa4 2 & 7,b7 9 p>agraph 7d71 by /rik+ or #efd & ins]t+ 1 #efd1 or #fjg4 7#b7 ,adult]at$ products ,section #fja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa7 is am5d$ by add+ at ! end ! foll[+3 7f7 ,if x has be5 manufactur$ or process$ "u conditions t d n meet good manufactur+ practice regulations1 z prescrib$ by ! ,food & ,drug ,adm9i/ration 9 accordance ) section #fjf4 7g7 ,if x is a cosmetic product1 & ! cosmetic product1 includ+ ea* +r$i5t 9 ! cosmetic product1 does n h adequate sub/antiation = safety1 z def9$ 9 section #fjh7;c74 4 7#c7 ,misbr&$ cosmetics ,section #fjb7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfb7;b77 is am5d$-- 7,a7 by /rik+ & 7#b7 & ins]t+ 7#b72 & 7,b7 by ins]t+ aft] num]ical c\nt ! foll[+3 2 & 7#c7 ! in=mation requir$ "u section #fji4 7#d7 ,adv]se ev5t report+ ,! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 is am5d$-- 7,a7 9 section #cja7;e7 7#ba ,u4,s4,c4 #cca7;e77-- 7i7 by /rik+ #efd1 #gjc & ins]t+ #efd1 #fje1 #gjc2 & 7ii7 by /rik+ #efd1 #gfj & ins]t+ #efd1 #fje1 #faa1 #gfj2 7,b7 9 section #cja7;ii7 7#ba ,u4,s4,c4 #cca7;ii77-- 7i7 by /rik+ #gfj or #gfa7 or & ins]t+ #fjd1 #gfj1 or #gfa7 or2 & 7ii7 by ins]t+ or requir$ "u section #fje7;a7 aft] report 7z def9$ "u section #gfj or #gfa2 7,c7 9 section #hja7;a7 7#ba ,u4,s4,c4 #cha7;a77-- 7i7 by /rik+ "u section #gfj or #gfa & ins]t+ "u section #fje1 #gfj1 or #gfa2 7ii7 by /rik+ def9$ 9 su* section #gfj or #gfa & ins]t+ def9$ 9 section #fjd1 #gfj1 or #gfa2 7iii7 by /rik+ ( su* section #gfj or #gfa & ins]t+ ( su* section #fje1 #gfj1 or #gfa2 & 7iv7 by /rik+ describ$ 9 su* section #gfj or #gfa & ins]t+ describ$ 9 su* section #fje1 #gfj1 or #gfa2 & 7,d7 9 section #hja7;b7 7#ba ,u4,s4,c4 #cha7;b77-- 7i7 by /rik+ requirem5ts ( sections #gfj or #gfa1 & ins]t+ requirem5ts ( section #fje1 #gfj1 or #gfa2 7ii7 by /rik+ z def9$ 9 section #gfj or #gfa & ins]t+ z def9$ 9 section #fjd1 #gfj1 or #gfa2 & 7iii7 by /rik+ ) section #gfj or #gfa & ins]t+ ) section #fje1 #gfj1 or #gfa4 7b7 ,effective dates 7#a7 ,9 g5]al ,! am5dm5ts made by subsection 7a7 %all take effect on ! date t is #a ye> aft] ! date ( enactm5t ( ?is ,act4 7#b7 ,label+ requirem5t ,section #fji7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #hjb1 %all take effect on ! date t is #b ye>s aft] ! date ( enactm5t ( ?is ,act4 7c7 ,confid5tiality 7#a7 ,9 g5]al ,! ,secret>y %all take appropriate measures to ensure t !re are 9 effect effective proc$ures to prev5t ! unau?oriz$ disclosure ( any trade secret or confid5tial comm]cial in=mation t is obta9$ by ! ,secret>y ( ,heal? & ,human ,s]vices pursuant to ?is subtitle1 includ+ ! am5dm5ts made by ?is subtitle4 7#b7 ,cl>ification ,no?+ 9 ?is subtitle1 includ+ ! am5dm5ts made by ?is subtitle1 %all be con/ru$ to au?orize ! disclosure ( in=mation t is prohibit$ f disclosure "u section #cja7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7;j77 or section #aije ( title #ah1 ,unit$ ,/ates ,code1 or t is subject to )hold+ "u section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code4 #hjd4 ,records inspection ,section #gjd7;a77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77#a77 is am5d$ by ins]t+ aft] ! second s5t5ce ! foll[+3 ,9 ! case ( a facility 7z def9$ 9 section #fjd7 t manufactures or processes cosmetic products1 ! inspection %all ext5d to all records & o!r in=mation describ$ 9 sections #fje1 #fjf1 & #faj1 :5 ! /&>d = records inspection "u su* section applies44 #hje4 ,talc-conta9+ cosmetics ,! ,secret>y ( ,heal? & ,human ,s]vices-- 7#a7 n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is ,act1 %all promulgate propos$ regulations to e/abli% & require /&>diz$ te/+ me?ods = detect+ & id5tify+ asbe/os 9 talc-conta9+ cosmetic products2 & 7#b7 n lat] ?an #ahj days aft] ! date on :i* ! public comm5t p]iod on ! propos$ regulations closes1 %all issue su* f9al regulations4 #hjf4 ,,pfas 9 cosmetics 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all assess ! use ( p]fluoroalkyl & polyfluoroalkyl sub/ances 9 cosmetic products & ! sci5tific evid5ce reg>d+ ! safety ( su* use 9 cosmetic products1 includ+ any risks associat$ ) su* use4 ,9 conduct+ su* assessm5t1 ! ,secret>y may1 z appropriate1 consult ) ! ,national ,c5t] = ,toxicological ,rese>*4 7b7 ,report ,n lat] ?an #c ye>s aft] enactm5t ( ?is ,act1 ! ,secret>y %all publi% on ! website ( ! ,food & ,drug ,adm9i/ration a report summ>iz+ ! results ( ! assessm5t conduct$ "u subsection 7a74 #hjg4 ,s5se ( ! ,s5ate on animal te/+ ,x is ! s5se ( ! ,s5ate t animal te/+ %\ld n be us$ = ! purposes ( safety te/+ on cosmetic products & %\ld be phas$ out ) ! exception ( appropriate all[ances4 #hjh4 ,fund+ ,!re is au?oriz$ to be appropriat$ #ad1bjj1jjj = fiscal ye> #bjbc1 #be1ifj1jjj = fiscal ye> #bjbd1 & #da1hij1jjj = ea* ( fiscal ye>s #bjbe ?r\gh #bjbg1 = purposes ( conduct+ ! activities "u ?is subtitle 7includ+ ! am5dm5ts made by ?is subtitle7 & hir+ p]sonnel requir$ to c>ry out ?is subtitle 7includ+ ! am5dm5ts made by ?is subtitle74 ,b ,diet>y supplem5ts #haa4 ,regulation ( diet>y supplem5ts 7a7 ,9 g5]al ,*apt] ,,iv ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cda et seq47 is am5d$ by add+ aft] section #djc;,c ( su* ,act 7#ba ,u4,s4,c4 #cdc-c7 ! foll[+3 #djc;,d4 ,diet>y supplem5t li/+ requirem5t 7a7 ,9 g5]al ,beg9n+ on ! date specifi$ 9 subsection 7b77#d71 ea* diet>y supplem5t m>ket$ 9 ! ,unit$ ,/ates %all be li/$ ) ! ,secret>y 9 accordance ) ?is section4 ,ea* su* li/+ %all include1 ) respect to ! diet>y supplem5t1 ! in=mation specifi$ 9 subsection 7b77#a74 7b7 ,requirem5ts 7#a7 ,9 g5]al ,! manufactur]1 pack]1 or di/ributor ( a diet>y supplem5t ^: "n 7pursuant to section #djc7;e77#a77 appe>s on ! label ( a diet>y supplem5t m>ket$ 9 ! ,unit$ ,/ates 7ref]r$ to 9 ?is section z ! responsible p]son71 or if ! responsible p]son is a =eign entity1 ! ,unit$ ,/ates ag5t ( su* p]son1 %all submit to ! ,secret>y 9 accordance ) ?is section ! foll[+ in=mation = a diet>y supplem5t t is m>ket$3 7,a7 ,any "n ( ! diet>y supplem5t & ! /atem5t ( id5tity1 includ+ br& "n & specifi$ flavors1 if applicable4 7,b7 ,! "n & address ( ! responsible p]son & ! "n & email address ( ! own]1 op]ator1 or ag5t 9 *>ge ( ! responsible p]son4 7,c7 ,! "n1 dome/ic address1 & email address = ! ,unit$ ,/ates ag5t1 if ! responsible p]son is a =eign entity4 7,d7 ,! bus9ess "n & full address ( all locations at :i* ! responsible p]son manufactures1 packages1 labels1 or holds ! diet>y supplem5t4 7,e7 ,a li/ ( all +r$i5ts 9 ea* su* diet>y supplem5t requir$ "u sections #aja4d & #aja4cf1 title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations7 to appe> on ! label ( a diet>y supplem5t1 includ+-- 7i7 :]e applicable1 +r$i5ts 9 a propriet>y bl5d z describ$ 9 section #aja4cf7;c7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations72 7ii7 ! am\nt p] s]v+ ( ea* li/$ diet>y +r$i5t2 7iii7 if requir$ by section #aja4cf ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations71 ! p]c5t ( ! daily value ( ea* li/$ diet>y +r$i5t2 & 7iv7 ! am\nt p] s]v+ ( diet>y +r$i5ts )9 a propriet>y bl5d4 7,f7 ,! numb] ( s]v+s p] conta9] = ea* conta9] size4 7,g7 ,! directions = use4 7,h7 ,w>n+s1 notice1 & safe h&l+ /atem5ts1 z requir$ by section #aja4ag ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7,i7 ,all]g5 /atem5ts = major food all]g5s 7pursuant to sections #djc7w7 & #djc7x774 7,j7 ,! =m ( ! diet>y supplem5t 7su* z tablets1 capsules1 p[d]s1 liquids1 s(tgels1 & gummies74 7,k7 ,any heal? claims or /ructure or function claims4 7,l7 ,! diet>y supplem5t product li/+ numb] = ! diet>y supplem5t provid$ by ! ,secret>y 9 accordance ) subsection 7c74 7#b7 ,=mat ,! ,secret>y may require t a li/+ submitt$ "u p>agraph 7#a7 be submitt$ 9 an electronic =mat4 ,^u receipt ( a complete li/+ "u p>agraph 7#a71 ! ,secret>y %all promptly notify ! responsible p]son ( ! receipt ( su* li/+4 7#c7 ,li/+ cont5t ,a s+le li/+ submission = a diet>y supplem5t "u p>agraph 7#a7 may include multiple diet>y supplem5ts ) id5tical =mulations & =ms1 or =mulations ( ! same =m1 t diff] only ) respect to color1 excipi5ts1 or flavor+s1 :e!r (f]$ 9 a s+le package size or 9 multiple package sizes4 7#d7 ,tim+ 7,a7 ,9 g5]al 7i7 ,diet>y supplem5ts on ! m>ket ,9 ! case ( a diet>y supplem5t t is be+ (f]$ 9 int]/ate comm]ce on or be=e ,janu>y #a1 #bjbd1 a li/+ = ea* su* diet>y supplem5t introduc$ or deliv]$ = introduction into int]/ate comm]ce %all be submitt$ by ! responsible p]son to ! ,secret>y "u ?is subsection n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ! ,food & ,drug ,adm9i/ration ,safety & ,l&m>k ,advancem5ts ,act ( #bjbb4 7ii7 ,new diet>y supplem5ts ,9 ! case ( a diet>y supplem5t t is n be+ (f]$ 9 int]/ate comm]ce on or be=e ,janu>y #a1 #bjbd1 a li/+ = ea* su* diet>y supplem5t introduc$ or deliv]$ = introduction into int]/ate comm]ce t has n be5 includ$ 9 any li/+ previ\sly submitt$ by ! responsible p]son to ! ,secret>y "u ?is subsection %all be submitt$ to ! ,secret>y at ! "t ( introduction into int]/ate comm]ce4 7,b7 ,discont9u$ diet>y supplem5ts ,! responsible p]son %all notify ! ,secret>y )9 "o ye> ( ! date ( discont9uance ( a diet>y supplem5t requir$ to be li/$ ) ! ,secret>y "u p>agraph 7#a7 = :i* ! responsible p]son has discont9u$ comm]cial m>ket+4 7,c7 ,*anges to exi/+ li/+s ,! responsible p]son %all submit to ! ,secret>y a *ange or modification to li/+ in=mation submitt$ "u p>agraph 7#a7 includ$ on ! label = a diet>y supplem5t at ! "t ! diet>y supplem5t ) ! *ange or modification is introduc$ into int]/ate comm]ce4 7#e7 ,additional in=mation ,! responsible p]son %all provide ^u reque/ f ! ,secret>y1 )9 #aj cal5d> days ( su* reque/1 ! full bus9ess "n & physical & mail+ address f :i* ! responsible p]son receives a diet>y +r$i5t or comb9ation ( diet>y +r$i5ts t ! responsible p]son uses 9 ! manufacture ( ! diet>y supplem5t or1 if applicable1 f :i* ! responsible p]son receives ! diet>y supplem5t4 7c7 ,product li/+ numb] & diet>y supplem5t electronic database 7#a7 ,diet>y supplem5t product li/+ numb] ,! ,secret>y %all provide ea* diet>y supplem5t li/$ 9 accordance ) subsection 7b77#a7 a diet>y supplem5t product li/+ numb]1 :i* may apply to multiple diet>y supplem5ts ) id5tical =mulations1 or =mulations t diff] only ) respect to color1 excipi5ts1 or flavor+s1 includ+ diet>y supplem5ts (f]$ 9 a s+le package size or 9 multiple package sizes4 ,! ,secret>y %all provide a process = a responsible p]son to res]ve diet>y supplem5t li/+ numb]s 9 advance ( li/+ "u subsection 7b77#a74 7#b7 ,electronic database ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,food & ,drug ,adm9i/ration ,safety & ,l&m>k ,advancem5ts ,act ( #bjbb1 ! ,secret>y %all e/abli% & ma9ta9 an electronic database t is publicly available & conta9s in=mation submitt$ "u subsection 7b77#a7 7except = ! in=mation submitt$ "u subp>agraphs 7,d7 & 7,e77iv7 ( su* subsection74 ,! ,secret>y %all make su* in=mation ma9ta9$ 9 ! electronic database publicly se>*able1 includ+ by diet>y supplem5t product li/+ numb]1 & by any field ( in=mation or comb9ation ( fields ( in=mation provid$ "u subsection 7b77#a74 7#c7 ,confid5tial in=mation ,9 response to a reque/ "u section #eeb ( title #e1 ,unit$ ,/ates ,code1 in=mation describ$ 9 subp>agraph 7,d7 or 7,e77iv7 ( subsection 7b77#a7 t is d]iv$ f a li/+ "u ?is section %all be )held "u section #eeb7;b77#c7 ( title #e1 ,unit$ ,/ates ,code4 7d7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$-- 7#a7 to limit ! au?ority ( ! ,secret>y to inspect or copy records or to require ! e/abli%m5t & ma9t5ance ( records "u any o!r provision ( ?is ,act2 7#b7 to au?orize ! disclosure ( in=mation t is prohibit$ f disclosure "u section #cja7;j7 ( ?is ,act or section #aije ( title #ah1 ,unit$ ,/ates ,code1 or t is subject to )hold+ "u section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code2 or 7#c7 to grant ! ,secret>y au?ority to require ! approval ( a diet>y supplem5t prior to m>ket+4 7e7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ #g1dih1jhj = fiscal ye> #bjbc1 & #f1cjj1jjj = ea* ( fiscal ye>s #bjbd ?r\gh #bjbg1 = purposes ( conduct+ ! activities "u ?is section & hir+ p]sonnel requir$ to c>ry out ?is section4 4 7b7 ,guidance ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all publi% f9al guidance relat$ to ! draft guidance titl$1 ,diet>y ,supplem5ts3 ,new ,diet>y ,+r$i5t ,notifications & ,relat$ ,issues2 ,revis$ ,draft ,guidance = ,indu/ry1 issu$ ,augu/ #ab1 #bjaf1 consi/5t ) section #djc;,d ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a74 7c7 ,inspections = c]ta9 diet>y supplem5ts ,! ,secret>y ( ,heal? & ,human ,s]vices %all direct res\rces to inspections ( facilities1 suppli]s1 & diet>y supplem5t types t pres5t a high risk to public heal? 7z id5tifi$ by ! ,secret>y74 7d7 ,misbr&+ ,section #djc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7 is am5d$ by add+ at ! end ! foll[+3 7z7 ,if x is a diet>y supplem5t = :i* a responsible p]son or ! ,unit$ ,/ates ag5t ( su* a p]son is requir$ "u section #djc;,d to file a li/+1 file a *ange to an exi/+ li/+1 or provide additional in=mation to ! ,secret>y1 & su* p]son or ag5t has fail$ to comply ) any su* requirem5ts "u section #djc;,d ) respect to su* diet>y supplem5t4 4 7e7 ,new prohibit$ act ,section #cja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca71 z am5d$ by section #hjc7;a71 is fur!r am5d$ by add+ at ! end ! foll[+3 7iii7 ,! introduction or deliv]y = introduction into int]/ate comm]ce ( any product m>ket$ z a diet>y supplem5t t does n meet ! def9ition ( a diet>y supplem5t "u section #bja7;ff74 7jjj7 ,! introduction or deliv]y = introduction into int]/ate comm]ce ( a diet>y supplem5t t has be5 prep>$1 pack$1 or held us+ ! assi/ance (1 or at ! direction (1 a p]son deb>r$ "u section #cjf4 4 ,c ,9 vitro cl9ical te/s #hba4 ,%ort title 7a7 ,%ort title ,?is subtitle may be cit$ z ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbb or ! ,,valid ,act ( #bjbb4 #hbb4 ,def9itions 7a7 ,9 g5]al ,section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is am5d$-- 7#a7 by add+ at ! end ! foll[+3 7ss7 7#a7 ,! t]m 9 vitro cl9ical te/ means an article specifi$ 9 subp>agraph 7#b7 t is int5d$ to be us$ 9 ! collection1 prep>ation1 analysis1 or 9 vitro cl9ical exam9ation ( specim5s tak5 or d]iv$ f ! human body = ! purpose (-- 7,a7 id5tify+ or diagnos+ a disease or condition2 7,b7 provid+ in=mation = diagnos+1 scre5+1 measur+1 detect+1 pr$ict+1 prognos+1 analyz+1 or monitor+ a disease or condition1 includ+ by mak+ a det]m9ation ( an individual's /ate ( heal?2 or 7,c7 select+1 monitor+1 or in=m+ !rapy or treatm5t = a disease or condition4 7#b7 ,an article specifi$ 9 ?is subp>agraph is-- 7,a7 a te/ kit2 7,b7 a te/ sy/em2 7,c7 a te/ protocol or laboratory te/ protocol2 7,d7 an in/rum5t 7z def9$ 9 section #ehg7aa772 7,e7 a specim5 receptacle 7z def9$ 9 section #ehg7af772 7,f7 s(tw>e1 exclud+ s(tw>e t is exclud$ by section #ebj7o7 f ! def9ition ( a device "u section #bja7;h71 t-- 7i7 is a compon5t or "p ( ano!r 9 vitro cl9ical te/ or analyzes1 processes1 or int]prets a signal or patt]n f ano!r 9 vitro cl9ical te/2 & 7ii7 does n analyze1 process1 or int]pret a signal1 patt]n1 or m$ical image f a device2 & 7,g7 subject to subp>agraph 7#c71 a compon5t or "p ( a te/1 a te/ protocol1 an in/rum5t1 an article1 or s(tw>e describ$ 9 any ( clauses 7,a7 ?r\gh 7,d7 ( su* subp>agraph1 :e!r alone or 9 comb9ation1 includ+ reag5ts1 calibrators1 & controls4 7#c7 ,not)/&+ subp>agraph 7#b77;,g71 an article int5d$ to be us$ z a compon5t or "p ( an 9 vitro cl9ical te/ describ$ 9 subp>agraph 7#a7 is exclud$ f ! def9ition 9 subp>agraph 7#a7 if ! article consi/s ( any ( ! foll[+3 7,a7 ,blood1 blood compon5ts1 or human cells or tissues1 f ! "t ( acquisition1 donation1 or recov]y ( su* article1 includ+ det]m9ation ( donor eligibility1 z applicable1 until su* "t z ! article is releas$ z a compon5t or "p ( an 9 vitro cl9ical te/ by ! e/abli%m5t t collect$ su* article4 7,b7 ,an article us$ = invasive sampl+1 a ne$le1 or a lancet1 except to ! ext5t su* article1 ne$le1 or lancet is an integral compon5t ( an article = hold+1 /or+1 or transport+ a specim54 7,c7 ,g5]al purpose laboratory equipm5t4 2 7#b7 by add+ at ! end ( section #bja7;g7 ! foll[+3 7#c7 ,! t]m drug does n include an 9 vitro cl9ical te/4 2 & 7#c7 9 section #bja7;h77#a71 9 ! matt] foll[+ clause 7,c71 by /rik+ section #ebj7o7 & ins]t+ section #ebj7o7 or an 9 vitro cl9ical te/4 7b7 ,exclusion f def9ition ( biological product ,section #cea7;i77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;i77#a77 is am5d$-- 7#a7 by /rik+ 7#a7 ,! t]m biological product means & ins]t+ 7#a77;,a7 ,! t]m biological product means2 & 7#b7 by add+ at ! end ! foll[+3 7,b7 ,! t]m biological product does n include an 9 vitro cl9ical te/ z def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 4 7c7 ,9 vitro cl9ical te/ def9ition ,9 ?is subtitle1 ! t]m 9 vitro cl9ical te/ has ! mean+ giv5 su* t]m 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a74 #hbc4 ,regulation ( 9 vitro cl9ical te/s ,! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 is am5d$-- 7#a7 by am5d+ ! head+ ( *apt] ,v to read z foll[s3 ,drugs1 ,devices1 & ,9 ,vitro ,cl9ical ,te/s2 & 7#b7 by add+ at ! end ( *apt] ,v ! foll[+3 ,j ,9 ,vitro ,cl9ical ,te/s #ehg4 ,def9itions ,9 ?is sub*apt]3 7#a7 ,analytical validity ,! t]m analytical validity means1 ) respect to an 9 vitro cl9ical te/1 ! ability ( ! 9 vitro cl9ical te/1 to id5tify1 measure1 detect1 calculate1 or analyze 7or assi/ 9 su* id5tification1 measurem5t1 detection1 calculation1 or analysis (7 "o or m analytes1 biom>k]s1 sub/ances1 or o!r t>gets int5d$ to be id5tifi$1 measur$1 detect$1 calculat$1 or analyz$ by ! te/4 7#b7 ,applicable /&>d ,! t]m applicable /&>d1 ) respect to an 9 vitro cl9ical te/1 means a reasonable assurance ( analytical & cl9ical validity = its indications = use1 & a reasonable assurance ( safety = individuals :o come into contact ) su* 9 vitro cl9ical te/1 except t su* t]m1 ) respect to specim5 receptacles & te/ in/rum5ts1 means a reasonable assurance ( analytical validity = its indications = use & safety = individuals :o come into contact ) su* specim5 receptacle or te/ in/rum5t4 7#c7 ,cl9ical use ,! t]m cl9ical use means ! op]ation1 application1 or function+ ( an 9 vitro cl9ical te/ = ! purpose = :i* x is int5d$ z describ$ 9 section #bja7ss77#a74 7#d7 ,cl9ical validity ,! t]m cl9ical validity means ! ability ( an 9 vitro cl9ical te/ to a*ieve ! purpose = :i* x is int5d$ z describ$ 9 section #bja7ss77#a74 7#e7 ,compon5t or "p ,! t]m compon5t or "p means a sub/ance1 piece1 "p1 raw mat]ial1 s(tw>e1 firmw>e1 label+1 or assembly1 includ+ reag5ts1 t is int5d$ to be includ$ z an aspect ( an 9 vitro cl9ical te/ describ$ 9 section #bja7ss77#a74 7#f7 ,develop ,! t]m develop1 ) respect to an 9 vitro cl9ical te/1 means-- 7,a7 design+1 validat+1 produc+1 manufactur+1 remanufactur+1 label+1 adv]tis+1 propagat+1 import+1 or assembl+ an 9 vitro cl9ical te/2 7,b7 modify+ an 9 vitro cl9ical te/1 includ+ modify+ ! indications = use ( ! 9 vitro cl9ical te/1 or modify+ an article to be an 9 vitro cl9ical te/2 or 7,c7 e/abli%+ a te/ sy/em z describ$ or includ$ 9 a te/ protocol develop$ by ano!r entity unless su* te/ protocol is li/$ z an 9 vitro cl9ical te/ 9 ! compreh5sive te/ in=mation sy/em e/abli%$ "u section #ehg,t by t o!r entity4 7#g7 ,develop] ,! t]m develop] means a p]son :o engages 9 developm5t z describ$ 9 p>agraph 7#f71 except ! t]m does n include a laboratory t-- 7,a7 is c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act2 & 7,b7 assembles = use solely )9 t laboratory1 )\t o!rwise develop+1 an 9 vitro cl9ical te/ appropriately li/$ 9 ! compreh5sive te/ in=mation sy/em e/abli%$ "u section #ehg,t by a diff]5t p]son4 7#h7 ,fir/-(-a-k9d ,! t]m fir/-(-a-k9d1 ) respect to an 9 vitro cl9ical te/1 means t su* te/ has any novel comb9ation ( ! elem5ts specifi$ 9 p>agraph 7#aj7 t diff]s f 9 vitro cl9ical te/s t already are legally available 9 ! ,unit$ ,/ates1 except = su* te/s (f]$ "u section #ehg;,c7a77#c71 #ehg;,c7a77#d71 or #ehg;,g4 7#i7 ,high-risk ,! t]m high-risk1 ) respect to an 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s1 means t an undetect$ inaccurate result f su* te/1 or su* category ( te/s1 :5 us$ z int5d$-- 7,a7 7i7 has ! sub/antial likelihood to result 9 s]i\s or irrev]sible h>m or dea? to a pati5t or pati5ts1 or w\ld o!rwise cause s]i\s h>m to ! public heal?2 or 7ii7 is reasonably likely to result 9 ! abs5ce1 significant delay1 or discont9uation ( life-support+ or life-su/a9+ m$ical treatm5t2 & 7,b7 suffici5t mitigat+ measures are n able to be e/abli%$ & appli$ to prev5t1 mitigate1 or detect ! inaccurate result1 or o!rwise mitigate ! risk result+ f an undetect$ inaccurate result describ$ 9 subp>agraph 7,a71 su* t ! te/ w\ld be mod]ate-risk or l[-risk4 7#aj7 ,indications = use ,! t]m indications = use1 ) respect to an 9 vitro cl9ical te/1 means ! foll[+ elem5ts3 7,a7 ,sub/ance or sub/ances measur$ by ! 9 vitro cl9ical te/1 su* z an analyte1 prote91 or pa?og54 7,b7 ,te/ me?od4 7,c7 ,te/ purpose or purposes1 z describ$ 9 section #bja7ss77#a74 7,d7 ,diseases or conditions = :i* ! 9 vitro cl9ical te/ is int5d$ = use1 includ+ int5d$ pati5t populations4 7,e7 ,context ( use1 su* z 9 a cl9ical laboratory1 9 a heal? c>e facility1 prescription home use1 ov]-!-c\nt] use1 or direct-to-consum] te/+4 7#aa7 ,in/rum5t 7,a7 ,9 g5]al ,! t]m in/rum5t means an analytical or pre-analytical in/rum5t4 7,b7 ,analytic in/rum5t ,! t]m analytic in/rum5t means an 9 vitro cl9ical te/ t is h>dw>e int5d$ by ! h>dw>e develop] to be us$ ) "o or m o!r 9 vitro cl9ical te/s to g5]ate a cl9ical te/ result1 includ+ s(tw>e us$ to effectuate ! functionality ( ! h>dw>e4 7,c7 ,pre-analytical in/rum5t ,! t]m pre-analytical in/rum5t means an 9 vitro cl9ical te/ t is h>dw>e int5d$ by ! h>dw>e develop] solely to g5]ate an output = use exclusively ) "o or m analytical in/rum5ts z def9$ 9 subp>agraph 7,b7 & :i* does n itself g5]ate a cl9ical te/ result4 ,su* t]m may include s(tw>e us$ to effectuate ! h>dw>e's functionality4 7#ab7 ,in/rum5t family ,! t]m in/rum5t family means m ?an "o in/rum5t develop$ by ! same develop] = :i* ! develop] demon/rates & docum5ts1 ) respect to all su* in/rum5ts1 t all-- 7,a7 h ! same basic ar*itecture1 design1 & p]=mance *>act]i/ics2 7,b7 h ! same indications = use & capabilities2 7,c7 %>e ! same measurem5t pr9ciples1 detection me?ods1 & reaction conditions1 z applicable2 & 7,d7 produce ! same or simil> analytical results f samples ( ! same specim5 type or types4 7#ac7 ,laboratory op]ations ,! t]m laboratory op]ations-- 7,a7 means ! conduct ( a laboratory exam9ation or o!r laboratory proc$ure on mat]ials d]iv$ f ! human body1 includ+ ! conduct ( an 9 vitro cl9ical te/ & associat$ activities )9 or "u ! ov]sight ( a laboratory & n relat$ to ! design ( an 9 vitro cl9ical te/2 & 7,b7 includes-- 7i7 p]=m+ pre-analytical & po/-analytical processes = an 9 vitro cl9ical te/2 7ii7 /&>d op]at+ proc$ures & ! conduct !re(2 & 7iii7 prep>+ reag5ts or o!r te/ mat]ials t d n meet ! def9ition ( an 9 vitro cl9ical te/ = cl9ical use "u section #bja7ss74 7#ad7 ,l[-risk ,! t]m l[-risk1 ) respect to an 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s1 means t an undetect$ inaccurate result f su* 9 vitro cl9ical te/1 or su* category ( 9 vitro cl9ical te/s1 :5 us$ z int5d$-- 7,a7 w\ld cause only m9imal or imm$iately rev]sible h>m1 & w\ld lead to only a remote risk ( adv]se pati5t impact or adv]se public heal? impact2 or 7,b7 suffici5t mitigat+ measures are able to be e/abli%$ & appli$ su* t ! 9 vitro cl9ical te/ meets ! /&>d describ$ 9 subp>agraph 7,a74 7#ae7 ,mitigat+ measures ,! t]m mitigat+ measures-- 7,a7 means controls1 /&>ds1 & o!r requirem5ts t ! ,secret>y det]m9es1 bas$ on evid5ce1 are necess>y-- 7i7 = an 9 vitro cl9ical te/1 or a category ( 9 vitro cl9ical te/s1 to meet ! applicable /&>d2 or 7ii7 to mitigate ! risk ( h>m ensu+ f an undetect$ inaccurate result or mis9t]pretation ( a result2 & 7,b7 may include1 z requir$ by ! ,secret>y1 z appropriate1 applicable requirem5ts reg>d+ label+1 con=mance to p]=mance /&>ds & cons5sus /&>ds1 p]=mance te/+1 submission ( cl9ical data1 adv]tis+1 website po/+ ( in=mation1 cl9ical /udies1 po/m>ket surveillance1 us] compreh5sion /udies1 tra9+1 & confirmatory laboratory1 cl9ical f9d+s1 ! role ( a heal? pr(essional 9 ! te/+ process1 or te/+4 7#af7 ,mod]ate-risk ,! t]m mod]ate-risk1 ) respect to an 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s1 means a te/ or category ( te/s-- 7,a7 t1 :5 us$ z int5d$1 meets ! crit]ia specifi$ 9 p>agraph 7#i77;,a7 = classification z high-risk1 b "o or m mitigat+ measures are able to be e/abli%$ & appli$ to prev5t or detect an inaccurate result or o!rwise suffici5tly mitigate su* risk1 b are n suffici5t su* t ! te/ is l[-risk "u ! crit]ia 9 p>agraph 7#ac72 or 7,b7 = :i*1 :5 us$ z int5d$-- 7i7 an undetect$ inaccurate result w\ld cause only non-life-?reat5+ h>m1 h>m t is m$ically rev]sible1 or ! abs5ce1 significant delay1 or discont9uation ( necess>y treatm5t t is n life-support+ or life-su/a9+2 & 7ii7 mitigat+ measures are n able to be e/abli%$ & appli$ to prev5t or detect su* inaccurate result or o!rwise suffici5tly mitigate ! risk ( su* inaccurate result su* t ! te/ w\ld be l[-risk "u ! crit]ia 9 p>agraph 7#ac74 7#ag7 ,specim5 receptacle ,! t]m specim5 receptacle means an 9 vitro cl9ical te/ int5d$ = tak+1 collect+1 hold+1 /or+1 or transport+ ( specim5s d]iv$ f ! human body or = 9 vitro exam9ation = purposes describ$ 9 subp>agraph 7,a7 or 7,b7 ( section #bja7ss77#a74 7#ah7 ,te*nology ,! t]m te*nology-- 7,a7 means a set ( control me*anisms1 en]gy s\rces1 or op]at+ pr9ciples-- 7i7 t d n diff] significantly among multiple 9 vitro cl9ical te/s2 & 7ii7 = :i* design & developm5t 7includ+ analytical & cl9ical validation1 z applicable7 ( ! te/s w\ld be address$ 9 a simil> mann] or ?r\gh simil> proc$ures2 & 7,b7 may include clot detection1 colorimetric 7non-immunoassay71 electro*emical 7non-immunoassay71 enzymatic 7non-immunoassay71 fl[ cytometry1 fluorometry 7non-immunoassay71 immunoassay1 mass spectrometry or *romatography1 microbial culture1 next g5]ation sequ5c+1 nephlometric or turbidimetric 7non-immunoassay71 s+leplex or multiplex non-,,ngs nucleic acid analysis1 slide-bas$ te*nology1 spectroscopy1 & any o!r te*nology1 z ! ,secret>y det]m9es appropriate4 7#ai7 ,te/ ,! t]m te/1 unless o!rwise provid$1 means an 9 vitro cl9ical te/4 7#bj7 ,valid sci5tific evid5ce ,! t]m valid sci5tific evid5ce-- 7,a7 means1 ) respect to an 9 vitro cl9ical te/1 evid5ce t-- 7i7 has be5 g5]at$ & evaluat$ by p]sons qualifi$ by tra9+ or exp]i5ce to d s1 us+ proc$ures g5]ally accept$ by o!r p]sons s qualifi$2 & 7ii7 =ms an appropriate basis = conclud+ by qualifi$ exp]ts :e!r ! applicable /&>d has be5 met by ! 9 vitro cl9ical te/2 & 7,b7 may include evid5ce describ$ 9 subp>agraph 7,a7 consi/+ (-- 7i7 pe]-review$ lit]ature2 7ii7 cl9ical guidel9es2 7iii7 reports ( significant human exp]i5ce ) an 9 vitro cl9ical te/2 7iv7 b5* /udies2 7v7 case /udies or hi/ories2 7vi7 cl9ical data2 7vii7 cons5sus /&>ds2 7viii7 ref]5ce /&>ds2 7ix7 data regi/ries2 7x7 po/m>ket data2 7xi7 real _w data2 7xii7 cl9ical trials2 & 7xiii7 data collect$ 9 c\ntries o!r ?an ! ,unit$ ,/ates if su* data are demon/rat$ to be appropriate = ! purpose ( mak+ a regulatory det]m9ation "u ?is sub*apt]4 #ehg;,a4 ,regulation ( 9 vitro cl9ical te/s 7a7 ,9 g5]al ,no p]son %all introduce or deliv] = introduction into int]/ate comm]ce any 9 vitro cl9ical te/1 unless-- 7#a7 an approval ( an application fil$ pursuant to subsection 7a7 or 7b7 ( section #ehg;,b is effective ) respect to su* 9 vitro cl9ical te/2 7#b7 ! 9 vitro cl9ical te/ is (f]$ "u a te*nology c]tification ord] 9 effect "u section #ehg;,d7b77#a72 or 7#c7 ! te/ is exempt "u sections #ehg;,c or #ehg;,g f ! requirem5ts ( section #ehg;,b4 7b7 ,transf] or sale ( ,9 vitro cl9ical te/s 7#a7 ,transf] & assumption ( regulatory obligations ,if own]%ip ( an 9 vitro cl9ical te/ is sold or transf]r$ 9 su* mann] t ! develop] transf]s ! regulatory submissions & obligations applicable "u ?is sub*apt] ) respect to ! te/1 ! transf]ee or pur*as] becomes ! develop] ( ! te/ & %all h all regulatory obligations applicable to su* a te/ "u ?is sub*apt]4 ,! transf]ee or pur*as] %all update ! regi/ration & li/+ in=mation "u section #ehg;,j = ! 9 vitro cl9ical te/4 7#b7 ,transf] or sale ( prem>ket approval 7,a7 ,notice requir$ ,if a develop] ( an 9 vitro cl9ical te/ transf]s or sells ! approval ( ! 9 vitro cl9ical te/1 ! transf]or or sell] %all-- 7i7 submit a notice ( ! transf] or sale to ! ,secret>y & update ! regi/ration & li/+ in=mation "u section #ehg;,j = ! 9 vitro cl9ical te/2 & 7ii7 submit a supplem5t to an application if requir$ "u section #ehg;,b7h74 7,b7 ,effective date ( approval transf] ,a transf] or sale describ$ 9 subp>agraph 7,a7 %all become effective ^u completion ( a transf] or sale describ$ 9 p>agraph 7#a7 or ! approval ( a supplem5t to an application "u section #ehg;,b7h7 if requir$1 :i*ev] is lat]4 ,! transf]ee or pur*as] %all update ! regi/ration & li/+ in=mation "u section #ehg;,j = ! 9 vitro cl9ical te/ )9 #ae cal5d> days ( ! effective date ( ! transf] or sale4 7#c7 ,transf] or sale ( te*nology c]tification 7,a7 ,requirem5ts = transf] or sale ( te*nology c]tification ,an unexpir$ te*nology c]tification c be transf]r$ or sold if ! transf]ee or pur*as]-- 7i7 is an eligible p]son "u section #ehg;,d7a77#b72 & 7ii7 ma9ta9s1 ^u su* transf] or sale1 te/ design & quality requirem5ts1 processes & proc$ures "u ! scope ( te*nology c]tification1 & scope ( ! te*nology c]tification id5tifi$ 9 ! applicable te*nology c]tification ord]4 7,b7 ,notice requir$ ,if a develop] ( an 9 vitro cl9ical te/ transf]s or sells a te*nology c]tification ord] t has n expir$1 ! transf]or or sell] %all submit a notice ( ! transf] or sale to ! ,secret>y & %all update ! regi/ration & li/+ in=mation "u section #ehg;,j = all 9 vitro cl9ical te/s cov]$ by ! te*nology c]tification4 7,c7 ,effective date ( te*nology c]tification transf] ,! transf] ( a te*nology c]tification %all become effective ^u completion ( a transf] or sale describ$ 9 subp>agraph 7,a74 ,! transf]ee or pur*as] %all update ! regi/ration & li/+ in=mation "u section #ehg;,j = ! 9 vitro cl9ical te/ )9 #cj cal5d> days ( ! effective date ( ! te*nology c]tification transf]4 7,d7 ,new te*nology c]tification requir$ ,if ! requirem5ts ( subp>agraph 7,a77ii7 are n met1 ! te*nology c]tification ord] may n be transf]r$ & ! transf]ee or pur*as] ( an 9 vitro cl9ical te/ is requir$ to submit an application = te*nology c]tification & obta9 a te*nology c]tification ord] prior to (f]+ ! te/ = cl9ical use4 7c7 ,regulations ,! ,secret>y may issue regulations to implem5t ?is sub*apt]4 #ehg;,b4 ,prem>ket review 7a7 ,application 7#a7 ,fil+ ,any develop] may file ) ! ,secret>y an application = prem>ket approval ( an 9 vitro cl9ical te/ "u ?is subsection4 7#b7 ,transp>5cy & pr$ictability ,if a develop] files a prem>ket application "u ?is section & provides any additional docum5tation requir$ "u section #ehg;,d1 ! 9 vitro cl9ical te/ t is ! subject ( ! prem>ket application may be utiliz$ z ! repres5tative 9 vitro cl9ical te/ review$ by ! ,secret>y to support a te*nology c]tification ord] "u section #ehg;,d4 7#c7 ,application cont5t ,an application submitt$ "u p>agraph 7#a7 %all include ! foll[+1 9 su* =mat z ! ,secret>y specifies3 7,a7 ,g5]al in=mation reg>d+ ! 9 vitro cl9ical te/1 includ+-- 7i7 ! "n & address ( ! applicant2 7ii7 ! table ( cont5ts = ! application & ! id5tification ( ! in=mation ! applicant claims z trade secret or confid5tial comm]cial or f9ancial in=mation2 7iii7 a description ( ! te/'s design & int5d$ use1 includ+ ! indications = use2 & 7iv7 a description reg>d+ te/ function & p]=mance *>act]i/ics4 7,b7 ,a summ>y ( ! data & in=mation 9 ! application = ! 9 vitro cl9ical te/1 includ+-- 7i7 a brief description ( ! =eign & dome/ic m>ket+ hi/ory ( ! te/1 if any1 includ+ a li/ ( all c\ntries 9 :i* ! te/ has be5 m>ket$ & a li/ ( all c\ntries 9 :i* ! te/ has be5 )drawn f m>ket+ = any reason relat$ to ! ability ( ! 9 vitro cl9ical te/ to meet ! applicable /&>d1 if kn[n by ! applicant2 7ii7 a description ( b5efit & risk consid]ations relat$ to ! 9 vitro cl9ical te/1 includ+ a description ( any applicable adv]se effects ( ! te/ on heal? & h[ su* adv]se effects h be51 or w be1 mitigat$2 7iii7 a risk assessm5t ( ! te/2 & 7iv7 a description ( h[ ! data & in=mation 9 ! application con/itute valid sci5tific evid5ce & support a %[+ t ! te/ meets ! applicable /&>d "u section #ehg7b74 7,c7 ,! signature ( ! develop] fil+ ! prem>ket application or an au?oriz$ repres5tative4 7,d7 ,a bibliography ( applicable publi%$ reports reli$ ^u by ! applicant & a description ( any /udies conduct$1 includ+ any unpubli%$ /udies relat$ to su* te/1 t are kn[n or t %\ld reasonably be kn[n to ! applicant1 & a description ( data & in=mation relevant to ! evaluation ( :e!r ! te/ meets ! applicable /&>d4 7,e7 ,applicable in=mation reg>d+ ! me?ods us$ 91 & ! facilities or controls us$ =1 ! developm5t ( ! te/ to demon/rate compliance ) ! applicable quality requirem5ts "u section #ehg,k4 7,f7 ,in=mation demon/rat+ compliance ) any relevant & applicable-- 7i7 mitigat+ measures "u section #ehg;,e2 & 7ii7 /&>ds e/abli%$ or recogniz$ "u section #ead prior to ! date ( enactm5t ( ! ,,valid ,act ( #bjbb1 or1 aft] applicable /&>ds are e/abli%$ or recogniz$ "u section #ehg,q1 ) su* /&>ds4 7,g7 ,valid sci5tific evid5ce to support t ! te/ meets ! applicable /&>d1 :i* %all include-- 7i7 summ>y in=mation = all support+ validation /udies p]=m$1 includ+ a description ( ! objective ( ! /udy1 a description ( ! exp]im5tal design ( ! /udy1 a description ( any limitations ( ! /udy1 a brief description ( h[ ! data 7 collect$ & analyz$1 a brief description ( ! results ( ea* /udy1 & conclusions drawn f ea* /udy2 7ii7 raw data = ea* /udy1 :i* may include1 z applicable1 tabulations ( data & results2 & 7iii7 = noncl9ical laboratory /udies involv+ ! te/1 if applicable1 a /atem5t t /udies 7 conduct$ 9 compliance ) applicable good laboratory practices4 7,h7 ,to ! ext5t ! application seeks au?orization to make modifications to ! te/ )9 ! scope ( ! approval t are n o!rwise p]mitt$ )\t prem>ket review "u ?is sub*apt]1 a propos$ *ange protocol t includes validation proc$ures & acceptance crit]ia = anticipat$ modifications t c\ld be made to ! te/ )9 ! scope ( ! approval4 7,i7 ,propos$ label+1 9 accordance ) ! requirem5ts ( section #ehg,l4 7,j7 ,su* o!r data or in=mation z ! ,secret>y may require 9 accordance ) ! lea/ burd5some requirem5ts "u section #ehg;,,aa7c74 7#d7 ,guidance = prem>ket & abbreviat$ prem>ket applications ,9 accordance ) section #hbe ( ! ,,valid ,act ( #bjbb1 ! ,secret>y %all issue draft guidance detail+ ! in=mation to be provid$ 9 a prem>ket application & abbreviat$ prem>ket application "u ?is section4 ,! ,secret>y %all issue f9al guidance detail+ ! in=mation to be provid$ 9 a prem>ket application & abbreviat$ prem>ket application "u ?is section n lat] ?an #a ye> prior to ! effective date ( su* ,act4 7#e7 ,refuse to file a prem>ket or abbreviat$ prem>ket application ,! ,secret>y may refuse to file an application "u ?is section only = lack ( complet5ess or legibility ( ! application4 ,if1 aft] receipt ( an application "u ?is section1 ! ,secret>y refuses to file su* an application1 ! ,secret>y %all provide to ! develop]1 )9 #de cal5d> days ( receipt ( su* application submitt$ "u ?is subsection or )9 #cj cal5d> days ( receipt ( an application submitt$ "u subsection 7b71 a description ( ! reason = su* refusal1 & id5tify ! in=mation requir$1 if any1 to all[ = ! fil+ ( ! application4 7#f7 ,sub/antive review = defici5t application ,if1 aft] receipt ( an application "u ?is section1 ! ,secret>y det]m9es t any portion ( su* application is mat]ially defici5t1 ! ,secret>y %all provide to ! applicant a description ( su* mat]ial defici5cies & ! in=mation requir$ to resolve su* defici5cies4 7#g7 ,inspections ,) respect to an application "u p>agraph 7#a71 preapproval inspections au?oriz$ by an employee ( ! ,food & ,drug ,adm9i/ration or a p]son accr$it$ "u section #ehg,q ne$ n occur unless reque/$ by ! ,secret>y4 7b7 ,abbreviat$ prem>ket review 7#a7 ,9 g5]al ,any develop] may file ) ! ,secret>y an application = abbreviat$ prem>ket approval =-- 7,a7 an in/rum5t2 7,b7 a specim5 receptacle2 7,c7 an 9 vitro cl9ical te/ t is mod]ate-risk2 or 7,d7 an 9 vitro cl9ical te/ t is det]m9$ by ! ,secret>y to be eligible = abbreviat$ prem>ket review "u section #ehg;,f7a77#a77;,b74 7#b7 ,application cont5t ,an application "u p>agraph 7#a7 %all include-- 7,a7 ! in=mation requir$ = applications submitt$ "u subsection 7a77#c71 except t applications "u p>agraph 7#a7 ne$ n include-- 7i7 quality requirem5t in=mation2 or 7ii7 raw data1 unless explicitly reque/$ by ! ,secret>y2 & 7,b7 data1 z applicable1 to support s(tw>e validation1 electromagnetic compatibility1 & electrical safety1 & in=mation demon/rat+ compliance ) ma9ta9+ quality sy/ems docum5tation4 7#c7 ,safety in=mation ,! develop] ( an 9 vitro cl9ical te/ specim5 receptacle review$ "u ?is subsection %all ma9ta9 safety in=mation = su* specim5 receptacle4 7#d7 ,inspections ,) respect to an application "u p>agraph 7#a71 preapproval inspections au?oriz$ by an employee ( ! ,food & ,drug ,adm9i/ration or a p]son accr$it$ "u section #ehg,q ne$ n occur unless reque/$ by ! ,secret>y4 7c7 ,in/rum5ts & in/rum5t families 7#a7 ,9 g5]al ,a develop] ( an in/rum5t family %all file ) ! ,secret>y an application = prem>ket approval ( "o v]sion ( an in/rum5t "u ?is subsection4 ,any modifi$ v]sions ( ! in/rum5t t g5]ate a new in/rum5t )9 ! same in/rum5t family %all be exempt f prem>ket review requirem5ts ( ?is section1 provid$ t ! develop] ( su* in/rum5t or in/rum5t family-- 7,a7 ma9ta9s docum5tation t ! new in/rum5t is "p ( ! in/rum5t family1 z def9$ 9 section #ehg2 7,b7 p]=ms1 docum5ts1 & ma9ta9s a risk assessm5t 7z describ$ 9 subsection 7a77#c77;,b77iii77 ( ! new in/rum5t comp>$ to ! in/rum5t approv$ "u subsection 7b7 & no new risks are id5tifi$2 7,c7 p]=ms1 docum5ts1 & ma9ta9s validation & v]ification activities = ! new in/rum5t2 7,d7 makes su* docum5tation available to ! ,secret>y ^u reque/2 & 7,e7 regi/]s & li/s ! new in/rum5t 9 accordance ) section #ehg;,j4 7#b7 ,te/ kits & te/ protocols ,a te/ kit or te/ protocol t is approv$ "u ?is section = use on an approv$ in/rum5t or an in/rum5t exempt f prem>ket review1 includ+ an in/rum5t )9 an in/rum5t family "u ?is section1 a submission "u ?is section %all n be requir$ = su* te/ kit or te/ protocol 9 ord] = x to be us$ on a new in/rum5t )9 its in/rum5t family1 provid$ t-- 7,a7 use ( ! te/ kit or te/ protocol ) ! new in/rum5t does n-- 7i7 *ange ! claims = ! te/ kit or te/ protocol1 except z applicable1 claims reg>d+ an in/rum5t or in/rum5ts t c be us$ ) su* te/ kit or te/ protocol2 7ii7 adv]sely affect p]=mance ( ! te/ kit or te/ protocol2 or 7iii7 cause ! te/ kit or te/ protocol to no long] con=m ) p]=mance /&>ds requir$ "u section #ehg,r or comply ) any applicable mitigat+ measures "u section #ehg;,e1 conditions ( approval "u subsection 7e77#b77;,b71 or re/rictions "u section #ehg,o2 7,b7 ! te/ develop] does n id5tify any new risks = ! te/ kit or te/ protocol :5 us+ ! new in/rum5t2 7,c7 ! te/ develop] validates ! use ( ! new in/rum5t ) ! te/ kit or te/ protocol & ma9ta9s validation docum5tation2 7,d7 ! te/ kit or te/ protocol is n int5d$ = use-- 7i7 9 sett+s = :i* a c]tificate ( waiv] is 9 effect "u section #cec ( ! ,public ,heal? ,s]vice ,act2 7ii7 )\t a prescription2 7iii7 at home2 or 7iv7 9 te/+ donors1 donations1 & recipi5ts ( blood1 blood compon5ts1 human cells1 tissues1 cellul>-bas$ products1 or tissue-bas$ products2 7,e7 ! te/ develop] makes ! docum5tation describ$ "u subp>agraph 7,c7 available to ! ,secret>y ^u reque/2 & 7,f7 ! te/ develop] updates ! li/+ in=mation = ! te/ kit or te/ protocol1 z applicable4 7d7 ,am5dm5ts to an application ,an applicant %all am5d an application submitt$ "u subsection 7a71 7b71 or 7f7 if ! applicant becomes aw>e ( in=mation t c\ld reasonably affect an evaluation "u subsection 7e7 ( :e!r ! approval /&>d has be5 met4 7e7 ,action on an application = prem>ket approval 7#a7 ,review 7,a7 ,disposition ,z promptly z possible1 b n lat] ?an #ij cal5d> days aft] an application "u subsection 7a7 is accept$ = submission 7unless ! ,secret>y det]m9es t an ext5sion is necess>y to review "o or m major am5dm5ts to ! application71 or n lat] ?an #fj cal5d> days aft] an application "u subsection 7b7 is accept$ = submission or a supplem5tal application "u subsection 7f7 is accept$ = submission1 ! ,secret>y1 aft] consid]+ any applicable report & recomm5dations pursuant to advisory committees "u section #ehg;,h1 %all issue an ord] approv+ ! application1 unless ! ,secret>y f9ds t ! gr\nds = approval 9 p>agraph 7#b7 are n met4 7,b7 ,reliance on propos$ label+ ,9 det]m9+ :e!r to approve or d5y an application "u p>agraph 7#a71 ! ,secret>y %all rely on ! indications = use includ$ 9 ! propos$ label+1 provid$ t su* label+ is n false or mislead+ bas$ on a fair evaluation ( all mat]ial facts4 7#b7 ,approval ( an application 7,a7 ,9 g5]al ,! ,secret>y %all approve an application submitt$ "u subsection 7a7 or 7b7 ) respect to an 9 vitro cl9ical te/ if ! ,secret>y f9ds t ! applicable /&>d is met1 &-- 7i7 ! applicant is 9 compliance ) applicable quality requirem5ts 9 section #ehg,k2 7ii7 ! application does n conta9 a false /atem5t or misrepres5tation ( mat]ial fact2 7iii7 bas$ on a fair evaluation ( all mat]ial facts1 ! propos$ label+ is tru?ful & non-mislead+ & complies ) ! requirem5ts ( section #ehg,l2 7iv7 ! applicant p]mits1 if reque/$1 au?oriz$ employees ( ! ,food & ,drug ,adm9i/ration & p]sons accr$it$ "u section #ehg,q an opportunity to inspect pursuant to section #gjd2 7v7 ! te/ con=ms ) any applicable p]=mance /&>ds requir$ "u section #ehg,r & any applicable mitigat+ measures "u section #ehg;,e2 7vi7 all noncl9ical laboratory /udies & cl9ical inve/igations involv+ human subjects t are describ$ 9 ! application 7 conduct$ 9 a mann] t meets ! applicable requirem5ts ( ?is sub*apt]2 & 7vii7 o!r data & in=mation ! ,secret>y may require "u subsection 7a77#c77;,j7 support approval4 7,b7 ,conditions ( approval ,an ord] approv+ an application pursuant to ?is section may require reasonable conditions ( approval = ! 9 vitro cl9ical te/1 :i* may include con=mance ) applicable mitigat+ measures "u section #ehg;,e1 re/rictions "u section #ehg,o1 & p]=mance /&>ds "u section #ehg,r4 7,c7 ,publication ,! ,secret>y %all publi% an ord] = ea* application approv$ pursuant to ?is p>agraph on ! public website ( ! ,food & ,drug ,adm9i/ration & make publicly available a summ>y ( ! data us$ to approve su* application4 ,9 mak+ ! ord] & summ>y publicly available1 ! ,secret>y %all n disclose any in=mation t-- 7i7 is confid5tial comm]cial in=mation or trade secret in=mation subject to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code2 or 7ii7 c\ld compromise national security4 7#c7 ,review ( d5ials ,an applicant ^: application submitt$ "u ?is section has be5 d5i$ approval "u ?is subsection may1 by petition fil$ n m ?an #fj cal5d> days aft] ! date on :i* ! applicant receives notice ( su* d5ial1 obta9 review ( ! d5ial 9 accordance ) section #ehg,p4 7f7 ,supplem5ts to an approv$ application 7#a7 ,risk analysis ,prior to implem5t+ any modification to an 9 vitro cl9ical te/1 ! hold] ( ! application approv$ "u subsection 7e7 = su* te/ %all p]=m risk analyses 9 accordance ) ?is subsection1 unless su* modification is includ$ 9 ! *ange protocol submitt$ by ! applicant & approv$ "u ?is section or exempt "u section #ehg;,c4 7#b7 ,supplem5t requirem5t 7,a7 ,9 g5]al ,if ! hold] ( an application ( an approv$ 9 vitro cl9ical te/ makes a modification to su* 9 vitro cl9ical te/1 except z provid$ 9 subp>agraph 7,c71 or o!rwise specifi$ by ! ,secret>y1 ! hold] ( ! application approv$ "u subsection 7e7 = an 9 vitro cl9ical te/ %all submit a supplem5tal application to ! ,secret>y4 ,! hold] ( ! application may n implem5t su* modification to ! 9 vitro cl9ical te/ until su* supplem5tal application is approv$4 ,! in=mation requir$ 9 a supplem5tal application is limit$ to :at is ne$$ to support ! *ange4 7,b7 ,adju/m5ts to *ange protocol ,! hold] ( an approv$ application may submit "u ?is p>agraph a supplem5tal application to modify ! *ange protocol ( ! te/ at any "t aft] ! application is submitt$ "u subsection 7a7 or 7b74 7,c7 ,exceptions ,not)/&+ subp>agraphs 7,a7 & 7,b71 & s long z ! hold] ( an approv$ application submitt$ "u subsection 7a7 or 7b7 = an 9 vitro cl9ical te/ does n add a manufactur+ site1 or *ange activities at an exi/+ manufactur+ site1 ) respect to ! te/1 ! hold] ( an approv$ application may1 )\t submission ( a supplem5tal application1 implem5t ! foll[+ modifications to ! te/3 7i7 ,modifications 9 accordance ) an approv$ *ange protocol "u subsection 7a77#c77;,h74 7ii7 ,modifications t are exempt "u section #ehg;,c7a77#f74 7iii7 ,label+ *anges t are appropriate to address a safety conc]n1 except su* label+ *anges t include any ( ! foll[+ rema9 subject to subp>agraph 7,a73 7,i7 ,a *ange to ! indications = use ( ! te/4 7,,ii7 ,a *ange to ! p]=mance claims made ) respect to ! te/4 7,,iii7 ,a *ange t adv]sely affects p]=mance ( ! te/4 7,d7 ,report+ = c]ta9 modifications made pursuant to a *ange protocol ,! hold] ( an application approv$ "u subsection 7e71 ) an approv$ *ange protocol "u subsection 7a77#b77;,h7 = su* 9 vitro cl9ical te/ %all-- 7i7 report any modification to su* te/ made pursuant to su* *ange protocol approv$ "u subsection 7a77#c77;,h7 9 a submission "u section #ehg;,j7c77#b77;,b72 & 7ii7 include 9 su* report-- 7,i7 a description ( ! modification2 7,,ii7 ! rationale = implem5t+ su* modification2 & 7,,iii7 z applicable1 a summ>y ( ! evid5ce support+ t ! te/1 z modifi$1 meets ! applicable /&>d1 complies ) p]=mance /&>ds requir$ "u section #ehg,q1 & complies ) any mitigat+ measures e/abli%$ "u section #ehg;,e & any re/rictions "u section #ehg,o4 7,e7 ,report+ = c]ta9 safety relat$ label+ *anges ,! hold] ( ! application = an 9 vitro cl9ical te/ approv$ "u subsection 7e7 %all-- 7i7 report to ! ,secret>y any modification to ! te/ describ$ 9 subp>agraph 7,c77iii7 n m ?an #cj days aft] ! date on :i* ! te/1 ) ! modification1 is introduc$ into int]/ate comm]ce2 & 7ii7 include 9 ! report-- 7,i7 a description ( ! *ange or *anges2 7,,ii7 ! rationale = implem5t+ su* *ange or *anges2 & 7,,iii7 a description ( h[ ! *ange or *anges 7 evaluat$4 7#c7 ,cont5ts ( supplem5t ,unless o!rwise specifi$ by ! ,secret>y1 a supplem5t "u ?is subsection %all include-- 7,a7 = modifications o!r ?an manufactur+ site *anges requir+ a supplem5t-- 7i7 a description ( ! modification2 7ii7 data relevant to ! modification to demon/rate t ! applicable /&>d is met1 n to exce$ data requirem5ts = ! orig9al submission2 7iii7 acceptance crit]ia2 & 7iv7 any revis$ label+2 & 7,b7 = manufactur+ site *anges-- 7i7 ! in=mation li/$ 9 subp>agraph 7,a72 & 7ii7 in=mation reg>d+ ! me?ods us$ 91 or ! facilities or controls us$ =1 ! developm5t ( ! te/ to demon/rate compliance ) ! applicable quality requirem5ts "u section #ehg,k4 7#d7 ,additional data ,! ,secret>y may require1 :5 necess>y1 data to evaluate a modification to an 9 vitro cl9ical te/ t is 9 addition to ! data o!rwise requir$ "u ! prec$+ p>agraphs if ! data reque/ is 9 accordance ) ! lea/ burd5some requirem5ts "u section #ehg;,,aa7c74 7#e7 ,conditions ( approval ,9 an ord] approv+ a supplem5t "u ?is subsection1 ! ,secret>y may require conditions ( approval = ! 9 vitro cl9ical te/1 includ+ compliance ) re/rictions "u section #ehg,o & con=mance to p]=mance /&>ds "u section #ehg,r4 7#f7 ,approval ,! ,secret>y %all approve a supplem5t "u ?is subsection if-- 7,a7 ! data demon/rate t ! modifi$ 9 vitro cl9ical te/ meets ! applicable /&>d2 & 7,b7 ! hold] ( ! application approv$ "u subsection 7e7 = ! te/ has demon/rat$ compliance ) applicable quality & inspection requirem5ts1 z applicable & appropriate4 7#g7 ,publication ,! ,secret>y %all publi% on ! public website ( ! ,food & ,drug ,adm9i/ration notice ( any ord] approv+ a supplem5t "u ?is subsection provid$ t do+ s does n disclose any in=mation t-- 7,a7 is trade secret or confid5tial comm]cial or f9ancial in=mation2 or 7,b7 c\ld compromise national security4 7#h7 ,review ( d5ial ,an applicant ^: supplem5t "u ?is subsection has be5 d5i$ approval may1 by petition fil$ on or be=e ! #fj? cal5d> day aft] ! date ^u :i* ! applicant receives notice ( su* d5ial1 obta9 review ( ! d5ial 9 accordance ) section #ehg,p4 7g7 ,)drawal & tempor>y susp5sion ( approval 7#a7 ,ord] )draw+ approval 7,a7 ,9 g5]al ,! ,secret>y may1 aft] provid+ due notice & an opportunity = an in=mal he>+ to ! hold] ( an approv$ application = an 9 vitro cl9ical te/ "u ?is section1 issue an ord] )draw+ approval ( ! application if ! ,secret>y f9ds t-- 7i7 ! gr\nds = approval "u subsection 7e7 are no long] met2 7ii7 !re is a reasonable likelihood t ! te/ w\ld cause dea? or s]i\s adv]se heal? consequ5ces1 includ+ by caus+ ! abs5ce1 significant delay1 or discont9uation ( life-sav+ or life su/a9+ m$ical treatm5t2 7iii7 ! hold] ( ! approv$ application-- 7,i7 has fail$ to1 or repeat$ly or delib]ately fail$ to1 ma9ta9 records to make reports1 z requir$ "u section #ehg,m2 7,,ii7 has refus$ to p]mit access to1 or copy+ or v]ification ( su* records1 z requir$ "u section #gjd2 7,,iii7 has n compli$ ) ! requirem5ts ( section #ehg,k2 or 7,,iv7 has n compli$ ) any mitigat+ measure requir$ "u section #ehg;,e or re/riction "u section #ehg,o2 or 7iv7 ! label+ ( su* 9 vitro cl9ical te/1 bas$ on a fair evaluation ( all mat]ial facts1 is false or mislead+ 9 any p>ticul> & 0 n correct$ )9 a reasonable "t aft] receipt ( writt5 notice f ! ,secret>y ( su* fact4 7,b7 ,cont5t ,an ord] "u subp>agraph 7,a7 )draw+ approval ( an application %all /ate ea* gr\nd = )drawal & %all notify ! hold] ( su* application #fj cal5d> days prior to issu+ su* ord]4 7,c7 ,publication ,! ,secret>y %all publi% any ord] "u subp>agraph 7,a7 on ! public website ( ! ,food & ,drug ,adm9i/ration provid$ t do+ s does n disclose-- 7i7 any in=mation t is trade secret or confid5tial comm]cial or f9ancial in=mation2 or 7ii7 any o!r in=mation t ! ,secret>y det]m9es1 if publi%$1 c\ld compromise national security4 7#b7 ,ord] ( tempor>y susp5sion ,if1 aft] provid+ due notice & an opportunity = an in=mal he>+ to ! hold] ( an approv$ application = an 9 vitro cl9ical te/ "u ?is section1 ! ,secret>y det]m9es1 bas$ on sci5tific evid5ce1 t !re is a reasonable likelihood t ! 9 vitro cl9ical te/ w\ld cause dea? or s]i\s adv]se heal? consequ5ces1 su* z by caus+ ! abs5ce1 significant delay1 or discont9uation ( life-sav+ or life-su/a9+ m$ical treatm5t1 ! ,secret>y %all1 by ord]1 tempor>ily susp5d ! approval ( ! application4 ,if ! ,secret>y issues su* an ord]1 ! ,secret>y %all proce$ exp$iti\sly "u p>agraph 7#a7 to )draw approval ( su* application4 7#c7 ,appeal )draw+ approval & ord]s ( tempor>y susp5sions ,an ord] ( )drawal or an ord] ( tempor>y susp5sion may be appeal$ "u #ehg,p4 #ehg;,c4 ,exemptions 7a7 ,9 g5]al ,! foll[+ 9 vitro cl9ical te/s are exempt f prem>ket review "u section #ehg;,b1 & may be lawfully m>ket$ subject to o!r applicable requirem5ts ( ?is ,act3 7#a7 ,te/s exempt f section #eaj7k7 7,a7 ,exemption ,an 9 vitro cl9ical te/ is exempt f prem>ket review "u section #ehg;,b & may be lawfully m>ket$ subject to ! o!r applicable requirem5ts ( ?is ,act1 if ! develop] ( ! 9 vitro cl9ical te/-- 7i7 ma9ta9s docum5tation demon/rat+ t ! te/ meets & cont9ues to meet ! crit]ia set =? 9 subp>agraph 7,b72 & 7ii7 makes su* docum5tation available to ! ,secret>y ^u reque/4 7,b7 ,crit]ia = exemption ,an 9 vitro cl9ical te/ is exempt z specifi$ 9 subp>agraph 7,a7 if su* te/-- 7i7 7,i7 7aa7 0 (f]$ = cl9ical use prior to ! date ( enactm5t ( ! ,,valid ,act ( #bjbb2 & 7bb7 imm$iately prior to su* date ( enactm5t 0 exempt pursuant to subsection 7l7 or 7m77#b7 ( section #eaj f ! requirem5ts = submission ( a report "u section #eaj7k72 or 7,,ii7 7aa7 0 n (f]$ = cl9ical use prior to su* date ( enactm5t2 7bb7 is n an in/rum5t2 & 7cc7 falls )9 a category ( te/s t 0 exempt f ! requirem5ts = submission ( a report "u section #eaj7k7 z ( su* date ( enactm5t 7includ+ class ,,ii devices & exclud+ class ,i devices describ$ 9 section #eaj7l772 7ii7 meets ! applicable /&>d z describ$ 9 section #ehg7b72 7iii7 is n (f]$ ) label+ & adv]tis+ t is false or mislead+2 & 7iv7 is n likely to cause or contribute to s]i\s adv]se heal? consequ5ces4 7,c7 ,effect on special controls ,= any 9 vitro cl9ical te/1 or category ( 9 vitro cl9ical te/s1 t is exempt f prem>ket review bas$ on ! crit]ia 9 subp>agraph 7,b71 any special control t appli$ to a device )9 a pr$ecessor category imm$iately prior to ! date ( enactm5t ( ! ,,valid ,act ( #bjbb %all be deem$ a mitigat+ measure applicable "u section #ehg;,e to an 9 vitro cl9ical te/ )9 ! successor category1 except to ! ext5t su* mitigat+ measure is )drawn or *ang$ 9 accordance ) section #ehg;,e4 7,d7 ,ne>-pati5t te/+ ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbb1 ! ,secret>y %all issue draft guidance indicat+ categories ( te/s t %all be exempt f prem>ket review "u section #ehg;,b :5 (f]$ = ne>-pati5t te/+ 7po9t ( c>e71 :i* 7 n exempt f submission ( a report "u section #eaj7k7 pursuant to subsection 7l7 or 7m77#b7 ( section #eaj & regulations impos+ limitations on exemption = 9 vitro devices int5d$ = ne>-pati5t te/+ 7po9t ( c>e74 7#b7 ,l[-risk te/s 7,a7 ,exemption ,an 9 vitro cl9ical te/ is exempt f prem>ket review "u section #ehg;,b & may be lawfully m>ket$ subject to ! o!r applicable requirem5ts ( ?is ,act1 includ+ section #ehg;,j7b71 if su* te/ meets ! def9ition ( l[-risk "u section #ehg & if ! develop] ( ! te/-- 7i7 ma9ta9s docum5tation demon/rat+ t ! 9 vitro cl9ical te/ meets & cont9ues to meet ! crit]ia set =? 9 subp>agraph 7,b72 & 7ii7 makes su* docum5tation available to ! ,secret>y ^u reque/4 7,b7 ,crit]ia = exemption ,an 9 vitro cl9ical te/ is exempt z specifi$ 9 subp>agraph 7,a7 if-- 7i7 ! 9 vitro cl9ical te/ meets ! applicable /&>d z describ$ 9 #ehg7b72 7ii7 ! label+ & adv]tis+ are n false or mislead+2 7iii7 ! 9 vitro cl9ical te/ is n likely to cause or contribute to s]i\s adv]se heal? consequ5ces2 & 7iv7 ! 9 vitro cl9ical te/ falls )9 a category ( te/s li/$ z describ$ 9 subp>agraph 7,c74 7,c7 ,li/ ( l[-risk te/s 7i7 ,9 g5]al ,! ,secret>y %all ma9ta91 & make publicly available on ! website ( ! ,food & ,drug ,adm9i/ration1 a li/ ( 9 vitro cl9ical te/s1 & categories ( 9 vitro cl9ical te/s1 t are l[-risk 9 vitro cl9ical te/s = purposes ( ! exemption "u ?is p>agraph4 7ii7 ,inclusion ,! li/ "u clause 7i7 %all consi/ (-- 7,i7 all 9 vitro cl9ical te/s & categories ( 9 vitro cl9ical te/s t are exempt f prem>ket review pursuant to p>agraph 7#a7 or ?is p>agraph2 & 7,,ii7 all 9 vitro cl9ical te/s & categories ( 9 vitro cl9ical te/s t are designat$ by ! ,secret>y pursuant to subp>agraph 7,d7 z l[-risk = purposes ( ?is p>agraph4 7,d7 ,designation ( te/s & categories ,)\t reg>d to sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code1 ! ,secret>y may designate1 9 addition to ! te/s & categories describ$ 9 subp>agraph 7,c77i71 additional 9 vitro cl9ical te/s1 & categories ( 9 vitro cl9ical te/s1 z l[-risk 9 vitro cl9ical te/s = purposes ( ! exemption "u ?is p>agraph4 ,! ,secret>y may make su* a designation on ! ,secret>y's own initiative or 9 response to a reque/ by a develop] pursuant to subsection 7a7 or 7b7 ( section #ehg;,f4 ,9 mak+ su* a designation = a te/ or category ( te/s1 ! ,secret>y %all consid]-- 7i7 :e!r ! te/1 or category ( te/s1 is l[-risk2 7ii7 ! exi/5ce ( & ability to develop mitigat+ measures suffici5t = su* te/ category to meet ! l[-risk /&>d2 & 7iii7 su* o!r factors z ! ,secret>y det]m9es to be appropriate = ! protection ( ! public heal?4 7#c7 ,humanit>ian te/ exemption 7,a7 ,9 g5]al ,an 9 vitro cl9ical te/ t meets ! crit]ia "u subp>agraph 7,b7 is exempt f prem>ket review "u section #ehg;,b & may be lawfully (f]$ subject to ! o!r applicable requirem5ts ( ?is sub*apt]1 if ! develop] ( ! te/-- 7i7 ma9ta9s docum5tation 7:i* may include lit]ature citations 9 specializ$ m$ical j\rnals1 textbooks1 specializ$ m$ical society proce$+s1 & gov]nm5tal /ati/ics publications1 or1 if no su* /udies or lit]ature citations exi/1 cr$ible conclusions f appropriate rese>* or surveys7 demon/rat+ t su* te/ meets & cont9ues to meet ! crit]ia describ$ 9 ?is subsection2 & 7ii7 makes su* docum5tation available to ! ,secret>y ^u reque/4 7,b7 ,crit]ia = exemption ,an 9 vitro cl9ical te/ is exempt z describ$ 9 subp>agraph 7,a7 if-- 7i7 ! 9 vitro cl9ical te/ is int5d$ by ! develop] = use = a diagno/ic purpose = a disease or condition t affects n m ?an #aj1jjj 7or su* o!r high] numb] det]m9$ by ! ,secret>y7 individuals 9 ! ,unit$ ,/ates p] ye>2 7ii7 ! 9 vitro cl9ical te/ meets ! applicable /&>d describ$ 9 section #ehg7b72 7iii7 ! label+ & adv]tis+ = ! 9 vitro cl9ical te/ are n false or mislead+2 7iv7 ! 9 vitro cl9ical te/ is n likely to cause or contribute to s]i\s adv]se heal? consequ5ces2 & 7v7 ! 9 vitro cl9ical te/ is n int5d$ = scre5+4 7,c7 ,exception = c]ta9 te/s ,an 9 vitro cl9ical te/ int5d$ to in=m ! use ( a specific individual or specific type ( biological product1 drug1 or device %all be eligible = an exemption f prem>ket review "u ?is subsection only if1 ! develop] submits a reque/ "u section #ehg;,f7e7 = in=mal fe$back & ! ,secret>y det]m9es t su* 9 vitro cl9ical te/ is eligible = an exemption f prem>ket review "u ?is subsection4 7#d7 ,cu/om te/s & l[-,volume te/s ,an 9 vitro cl9ical te/ is exempt f prem>ket review "u section #ehg;,b1 quality requirem5ts "u section #ehg,k1 & li/+ requirem5ts "u section #ehg;,j1 & may be lawfully m>ket$ subject to ! o!r applicable requirem5ts ( ?is ,act1 if-- 7,a7 su* 9 vitro cl9ical te/-- 7i7 is a te/ protocol p]=m$ = n m ?an #e pati5ts p] ye> 7or su* o!r high] numb] det]m9$ by ! ,secret>y71 9 a laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act t-- 7,i7 meets ! requirem5ts to p]=m te/s ( high-complexity 9 :i* ! te/ protocol 0 develop$2 or 7,,ii7 meets ! requirem5ts to p]=m te/s ( high-complexity )9 ! same corporate organization & hav+ common own]%ip by ! same p>5t corporation z ! laboratory 9 :i* su* te/ protocol 0 develop$2 or 7ii7 is an 9 vitro cl9ical te/ develop$ or modifi$ to diagnose a unique pa?ology or physical condition ( a specific pati5t or pati5ts1 ^u ord] ( a heal? pr(essional or o!r specially qualifi$ p]son designat$ "u regulations1 = :i* no o!r 9 vitro cl9ical te/ is comm]cially available 9 ! ,unit$ ,/ates1 & is-- 7,i7 n int5d$ = use ) respect to m ?an #e 7or su* o!r high] numb] det]m9$ by ! ,secret>y7 o!r pati5ts2 & 7,,ii7 aft] ! developm5t ( su* te/1 n includ$ 9 any te/ m5u or template te/ report or o!r promotional mat]ials1 & is n o!rwise adv]tis$2 & 7,b7 ! develop] ( ! 9 vitro cl9ical te/-- 7i7 ma9ta9s docum5tation demon/rat+ t su* te/ meets ! applicable crit]ia describ$ 9 subp>agraph 7,a72 7ii7 makes su* docum5tation1 su* z a prescription ord] reque/+ ! cu/om te/ = an individual pati5t1 available to ! ,secret>y ^u reque/2 & 7iii7 in=ms ! ,secret>y1 on an annual basis1 9 a mann] prescrib$ by ! ,secret>y by guidance1 t su* te/ 0 (f]$4 7#e7 ,9 vitro cl9ical te/s "u a te*nology c]tification ord] ,an 9 vitro cl9ical te/ t is )9 ! scope ( a te*nology c]tification ord]1 z describ$ 9 section #ehg;,d7a71 is exempt f prem>ket review "u section #ehg;,b4 4 7#f7 ,modifi$ te/s 7,a7 ,9 g5]al ,an 9 vitro cl9ical te/ t is modifi$ is exempt f prem>ket review "u section #ehg;,b if-- 7i7 ! modification is made by-- 7,i7 ! develop] t obta9$ prem>ket approval = ! unmodifi$ v]sion ( ! te/ "u section #ehg;,b2 or 7,,ii7 a cl9ical laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act t meets ! requirem5ts = p]=m+ high complexity te/+1 to a lawfully (f]$ 9 vitro cl9ical te/1 includ+ ano!r develop]'s lawfully (f]$ 9 vitro cl9ical te/1 exclud+ inve/igational 9 vitro cl9ical te/s (f]$ "u section #ehg,s1 & ! modifi$ te/ is p]=m$-- 7aa7 9 ! same cl9ical laboratory 9 :i* x 0 develop$ = :i* a c]tification is /ill 9 effect "u section #cec t meets ! requirem5ts to p]=m te/s ( high complexity2 7bb7 by ano!r cl9ical laboratory = :i* a c]tificate is 9 effect "u section #cec t meets ! requirem5ts to p]=m te/s ( high complexity1 is )9 ! same corporate organization1 & has common own]%ip by ! same p>5t corporation z ! laboratory 9 :i* ! te/ 0 develop$2 or 7cc7 by a cl9ical laboratory = :i* a c]tificate is 9 effect "u section #cec t meets ! requirem5ts to p]=m te/s ( high complexity & is )9 a public heal? laboratory network coord9at$ or manag$ by ! ,c5t]s = ,disease ,control & ,prev5tion1 if ! te/ 0 develop$ by ! ,c5t]s = ,disease ,control & ,prev5tion or ano!r laboratory )9 su* public heal? laboratory network2 & 7ii7 ! modification does n-- 7,i7 con/itute a significant *ange to ! indications = use2 7,,ii7 cause ! te/ to no long] comply ) applicable mitigat+ measures "u section #ehg;,e or re/rictions "u section #ehg,o2 7,,iii7 significantly & adv]sely *ange p]=mance claims or significantly & adv]sely *ange p]=mance1 unless provid$ = "u an approv$ *ange protocol "u section #ehg;,b7a77#c77;,h72 or 7,,iv7 con/itute an adv]se *ange 9 ! safety ( ! 9 vitro cl9ical te/ = individuals :o come 9 contact ) ! 9 vitro cl9ical te/2 7iii7 ! te/ meets ! applicable /&>d z describ$ 9 section #ehg7b72 7iv7 ! label+ & adv]tis+ are n false or mislead+2 & 7v7 ! te/ is n likely to cause or contribute to s]i\s adv]se heal? consequ5ces4 7,b7 ,c]ta9 modifications ,a modification to ext5d specim5 /ability is exempt f prem>ket review "u section #ehg;,b if ! modifi$ te/ meets ! requirem5ts 9 clauses 7ii7 ?r\gh 7iv7 ( subp>agraph 7,a74 7,c7 ,modifications "u a *ange protocol ,not)/&+ subp>agraph 7,a71 a modification made "u a *ange protocol pursuant to subsection 7a77#b77;,h7 ( section #ehg;,b is exempt f review "u su* section4 7,d7 ,docum5tation ,a p]son :o modifies an 9 vitro cl9ical te/ 9 a mann] t is a modification describ$ 9 subp>agraph 7,a7 %all-- 7i7 docum5t ! modification t 0 made & ! basis = det]m9+ t ! modification1 consid]+ ! *anges individually & collectively1 is a type ( modification describ$ 9 subp>agraph 7,a71 7,b71 or 7,c72 & 7ii7 provide su* docum5tation to ! ,secret>y ^u reque/ or inspection4 7,e7 ,guidance ,n lat] ?an #cj mon?s aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbb1 ! ,secret>y %all issue guidance reg>d+ ! 9 vitro cl9ical te/s t are modifi$ & exempt f prem>ket review "u section #ehg;,b pursuant to ?is p>agraph4 7b7 ,manual te/s 7#a7 ,exemption ,an 9 vitro cl9ical te/ is exempt f all requirem5ts ( ?is sub*apt] if ! output ( su* 9 vitro cl9ical te/ is ! result ( direct1 manual obs]vation1 )\t ! use ( automat$ in/rum5tation or s(tw>e = int]m$iate or f9al int]pretation1 by a qualifi$ laboratory pr(essional1 & su* 9 vitro cl9ical te/-- 7,a7 is develop$ & us$ )9 a s+le cl9ical laboratory = :i* a c]tificate is 9 effect "u section #cec ( ! ,public ,heal? ,s]vice ,act t meets ! requirem5ts "u section #cec = p]=m+ high-complexity te/+2 7,b7 is n a specim5 receptacle1 in/rum5t1 or an 9 vitro cl9ical te/ t includes an in/rum5t or specim5 receptacle t is n approv$ "u or exempt f section #ehg;,b2 7,c7 is n a high-risk te/1 or is a high-risk te/ t ! ,secret>y has det]m9$ meets at lea/ "o condition 9 p>agraph 7#b7 & is o!rwise appropriate = ?is exemption2 & 7,d7 is n int5d$ = te/+ donors1 donations1 or recipi5ts ( blood1 blood compon5ts1 human cells1 tissues1 cellul>-bas$ products1 or tissue-bas$ products4 7#b7 ,high-risk te/ limitation or condition ,a high-risk te/ may be exempt "u p>agraph 7#a7 f ! requirem5ts ( ?is sub*apt] only if-- 7,a7 no compon5ts or p>ts ( su* te/1 includ+ any reag5t1 is introduc$ into int]/ate comm]ce "u ! exemption "u subsection 7e71 & any article = tak+ or d]iv+ specim5s f ! human body us$ 9 conjunction ) ! te/ rema9s subject to ! requirem5ts ( ?is sub*apt]2 or 7,b7 ! te/ has be5 develop$ 9 accordance ) ! applicable te/ design & quality requirem5ts "u section #ehg,k4 7c7 ,public heal? surveillance activities 7#a7 ,9 g5]al ,! provisions ( ?is sub*apt] %all n apply to a te/ int5d$ by ! develop] to be us$ solely = public heal? surveillance activities4 7#b7 ,exclusion ,an 9 vitro cl9ical te/ us$ = public heal? surveillance activities is n exclud$ f ! provisions ( ?is sub*apt] pursuant to ?is subsection if su* te/ is int5d$ = use 9 mak+ cl9ical decisions = individual pati5ts4 7d7 ,g5]al laboratory equipm5t ,any in/rum5t t does n produce an analytical result1 & t functions z a compon5t ( pre-analytical proc$ures relat$ to 9 vitro cl9ical te/s1 is n subject to ! requirem5ts ( ?is sub*apt]1 provid$ t ! in/rum5t is op]at+ 9 a cl9ical laboratory t is c]tifi$ "u section #cec ( ! ,public ,heal? ,s]vice ,act4 7e7 ,compon5ts & ,p>ts 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 a compon5t or "p describ$ 9 section #bja7ss77#b77;,g7 is-- 7,a7 exempt f ! requirem5ts ( ?is sub*apt] if x is int5d$ = fur!r developm5t z describ$ 9 p>agraph 7#c72 or 7,b7 subject to ! requirem5ts ( ?is sub*apt] & regulat$ bas$ on its risk :5 us$ z int5d$ by ! develop]1 not)/&+ its subsequ5t use by a develop] z a compon5t1 "p1 or raw mat]ial ( ano!r 9 vitro cl9ical te/4 7#b7 ,inapplicability to o!r te/s ,not)/&+ p>agraph 7#a71 an 9 vitro cl9ical te/ t is describ$ 9 section #bja7ss77#a77;,b7 & t uses a compon5t or "p describ$ 9 su* subp>agraph %all be subject to ! requirem5ts ( ?is sub*apt]1 unless ! te/ is o!rwise exempt "u ?is section4 7#c7 ,fur!r developm5t ,a compon5t1 "p1 or raw mat]ial 7z describ$ 9 p>agraph 7#a77 is int5d$ = fur!r developm5t 7= purposes ( su* p>agraph7 if-- 7,a7 x is int5d$ solely = use 9 ! developm5t ( ano!r 9 vitro cl9ical te/2 & 7,b7 9 ! case ( su* a te/ t is introduc$ or deliv]$ = introduction into int]/ate comm]ce aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbb1 ! label+ ( su* te/ be>s ! foll[+ /atem5t3 ,?is product is int5d$ solely = fur!r developm5t ( an 9 vitro cl9ical te/ & is exempt f ,,fda regulation4 ,?is product mu/ be evaluat$ by ! 9 vitro cl9ical te/ develop] if x is us$ ) or 9 ! developm5t ( an 9 vitro cl9ical te/44 7f7 ,g5]al exemption au?ority ,! ,secret>y may1 by ord] publi%$ 9 ! ,f$]al ,regi/] foll[+ notice & an opportunity = comm5t1 exempt a class ( p]sons f any section "u ?is sub*apt] ^u a f9d+ t su* exemption is appropriate = ! protection ( ! public heal? & o!r relevant consid]ations4 7g7 ,exemption ,an 9 vitro cl9ical te/ t is int5d$ solely = use 9 =5sic analysis or law en=cem5t activity is exempt f ! requirem5ts ( ?is sub*apt]4 ,an 9 vitro cl9ical te/ t is int5d$ = use 9 mak+ cl9ical decisions = individual pati5ts1 or ^: individually id5tifiable results may be report$ back to an individual pati5t or ! pati5t's heal? c>e provid]1 ev5 if also int5d$ = =5sic analysis or law en=cem5t purposes1 is n int5d$ solely = =5sic analysis or law en=cem5t = purposes ( ?is subsection4 7h7 ,revocation 7#a7 ,9 g5]al ,! ,secret>y may revoke any exemption "u ?is section ) respect to 9 vitro cl9ical te/s ) ! same indications = use if new cl9ical in=mation indicates t ! exemption ( an 9 vitro cl9ical te/ or te/s f prem>ket review "u section #ehg;,b has a reasonable probability ( sev]e adv]se heal? consequ5ces1 includ+ ! abs5ce1 delay1 or discont9uation ( appropriate m$ical treatm5t4 7#b7 ,process ,any action "u p>agraph 7#a7 %all be made by publication ( a notice ( su* propos$ action on ! website ( ! ,food & ,drug ,adm9i/ration1 ! consid]ation ( comm5ts to a public docket on su* proposal1 & publication ( a f9al action on su* website )9 #fj cal5d> days ( ! close ( ! comm5t p]iod po/$ to su* public docket1 not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code4 7i7 ,pre-,analytical in/rum5t ,a pre-analytical in/rum5t is exempt f prem>ket review "u section #ehg;,b & may be lawfully (f]$ subject to ! o!r applicable requirem5ts ( ?is ,act1 if ei!r ( ! foll[+ applies3 7#a7 ,su* in/rum5t provides additional in=mation reg>d+ ! sample or p]=ms an action on ! sample b is n prep>+ or process+ ! sample & does n p]=m any function ( an analytical in/rum5t4 ,su* types ( pre-analytical in/rum5ts include b>code read]s1 sample mov]s1 & sample id5tifi]s4 7#b7 ,su* in/rum5t processes or prep>es ! sample prior to use on an analytical in/rum5t1 does n p]=m any function ( an analytical in/rum5t1 & does n select1 isolate1 or prep>e a "p ( a sample bas$ on specific prop]ties4 ,su* types ( pre-analytical in/rum5ts may include sample mix]s1 ,,dna extractors & ^? us$ to dilute samples4 #ehg;,d4 ,te*nology c]tification 7a7 ,def9itions ,9 ?is section3 7#a7 ,eligible 9 vitro cl9ical te/ ,! t]m eligible 9 vitro cl9ical te/ means an 9 vitro cl9ical te/ t is n-- 7,a7 a compon5t or "p ( an 9 vitro cl9ical te/ z describ$ 9 section #bja7ss77#b77;,g7 unless x is a compon5t or "p & is regulat$ bas$ on its own risk "u section #ehg;,c7e77#a77;,b7 or z "p ( an o!rwise eligible 9 vitro cl9ical te/2 7,b7 an in/rum5t "u section #bja7ss77#b77;,d7 or an 9 vitro cl9ical te/ t includes an in/rum5t t is subject to section #ehg;,b1 b is n approv$ "u1 or exempt f1 section #ehg;,b2 7,c7 a specim5 receptacle "u section #bja7ss77#b77;,e7 or an 9 vitro cl9ical te/ t includes a specim5 receptacle t is subject to section #ehg;,b1 b is n approv$ "u1 or exempt f1 section #ehg;,b2 7,d7 an 9 vitro cl9ical te/1 includ+ reag5ts us$ 9 su* te/s1 int5d$ = use = te/+ donors1 donations1 & recipi5ts ( blood1 blood compon5ts1 human cells1 tissues1 cellul>-bas$ products1 or tissue-bas$ products2 7,e7 high-risk2 7,f7 a comb9ation product unless su* te/ has be5 det]m9$ to be eligible to be introduc$ into int]/ate comm]ce "u a te*nology c]tification ord] pursuant to ! regulatory pa?way designation process describ$ 9 section #ehg;,f1 or z describ$ 9 subsection 7k72 or 7,g7 a fir/-(-a-k9d 9 vitro cl9ical te/1 unless su* te/ has be5 det]m9$ to be eligible to be introduc$ into int]/ate comm]ce "u a te*nology c]tification ord] pursuant to ! regulatory pa?way designation process describ$ 9 section #ehg;,f1 or z describ$ 9 subsection 7k74 7#b7 ,eligible p]son ,! t]m eligible p]son means an 9 vitro cl9ical te/ develop] unless su* develop]-- 7,a7 is a laboratory subject to section #cec ( ! ,public ,heal? ,s]vice ,act & does n h 9 effect a c]tificate applicable to ! category ( laboratory exam9ation or o!r proc$ure2 7,b7 0 a laboratory1 or an own] or op]ator or any employee ( a laboratory1 f\nd to h committ$ a significant violation ( section #cec ( ! ,public ,heal? ,s]vice ,act t result$ 9 a susp5d$1 revok$1 or limit$ c]tificate )9 ! #b-ye> p]iod prec$+ ! date ( ! submission ( ! application = a te*nology c]tificate "u subsection 7c7 & su* violation has n be5 resolv$2 or 7,c7 has be5 f\nd to h submitt$ in=mation to ! ,secret>y1 or o!rwise dissem9at$ in=mation1 t-- 7i7 made false or mislead+ /atem5ts relevant to ! requirem5ts ( ?is sub*apt]2 or 7ii7 violat$ any requirem5t ( ?is ,act1 :]e su* violation expos$ individuals to s]i\s risk ( illness1 injury1 or dea?1 unless-- 7,i7 su* violation has be5 resolv$2 or 7,,ii7 su* violation is n p]t95t to any 9 vitro cl9ical te/ )9 ! scope ( ! te*nology c]tification t su* develop] seeks4 7b7 ,applicability 7#a7 ,9 g5]al ,an 9 vitro cl9ical te/ is n subject to section #ehg;,b & may be introduc$ into int]/ate comm]ce if ! 9 vitro cl9ical te/-- 7,a7 is an eligible 9 vitro cl9ical te/2 7,b7 is develop$ by an eligible p]son2 7,c7 falls )9 ! scope ( a te*nology c]tification ord] issu$ "u ?is section & t is 9 effect2 7,d7 complies ) ! conditions ( ! te*nology c]tification ord]1 includ+ ) applicable mitigat+ measures "u section #ehg;,e1 re/rictions "u section #ehg,o1 & p]=mance /&>ds "u section #ehg,r2 & 7,e7 meets ! applicable /&>d describ$ 9 section #ehg7b74 7#b7 ,scope 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 ! scope ( a te*nology c]tification ord] issu$ "u ?is section %all apply to "o or m te*nologies ) multiple 9 vitro cl9ical te/s utiliz+ a te*nology t does n significantly diff] 9 control me*anisms1 en]gy s\rces1 or op]at+ pr9ciples & = :i* developm5t1 includ+ design1 & analytical & cl9ical validation1 ( ! 9 vitro cl9ical te/s w\ld be address$ ?r\gh simil> proc$ures1 & be no broad] ?an-- 7i7 a s+le te*nology type2 or 7ii7 a fix$ comb9ation ( te*nologies4 7,b7 ,te*nology type ,a te*nology type describ$ 9 ?is p>agraph may include clot detection1 colorimetric 7non-immunoassay71 electro*emical 7non-immunoassay71 enzymatic 7non-immunoassay71 fl[ cytometry1 fluorometry 7non-immunoassay71 immunoassay1 mass spectrometry or *romatography1 microbial culture1 next g5]ation sequ5c+1 nephlometric or turbidimetric 7non-immunoassay71 s+leplex or multiplex non-,,ngs nucleic acid analysis1 slide-bas$ te*nology1 spectroscopy1 & any o!r te*nology1 z ! ,secret>y det]m9es appropriate4 7c7 ,application = te*nology c]tification 7#a7 ,9 g5]al ,a develop] seek+ a te*nology c]tification ord] %all submit an application "u ?is subsection1 :i* %all conta9 ! in=mation specifi$ "u p>agraph 7#b74 7#b7 ,cont5t ( application ,a develop] t submits an application = a te*nology c]tification %all include all necess>y in=mation to make a %[+ t all eligible 9 vitro cl9ical te/s develop$ )9 ! scope ( ! te*nology c]tification ord] w meet ! applicable /&>d1 includ+-- 7,a7 ! "n & address ( ! develop]2 7,b7 a table ( cont5ts = ! application & ! id5tification ( ! in=mation ! develop] claims z trade secret or confid5tial comm]cial or f9ancial in=mation2 7,c7 ! signature ( ! individual fil+ ! application or an au?oriz$ repres5tative2 7,d7 a /atem5t id5tify+ ! scope ( ! propos$ te*nology c]tification int5d$ to be introduc$ into int]/ate comm]ce "u ! application2 7,e7 in=mation e/abli%+ t ! develop] submitt+ ! application is an eligible p]son2 7,f7 quality proc$ures %[+ t eligible 9 vitro cl9ical te/s cov]$ "u ! te*nology c]tification w con=m to ! applicable quality requirem5ts ( section #ehg,k ) respect to-- 7i7 design controls1 includ+ relat$ pur*as+ controls & acceptance activities2 7ii7 compla9t inve/igation1 adv]se ev5t report+1 & corrections & removals2 & 7iii7 process validation1 z applicable2 7,g7 proc$ures = analytical & cl9ical validation1 includ+ all proc$ures = validation1 v]ification1 & acceptance crit]ia1 & an explanation z to h[ su* proc$ures1 :5 us$1 provide a %[+ t eligible 9 vitro cl9ical te/s )9 ! propos$ scope ( ! te*nology c]tification ord] are analytically & cl9ically valid2 7,h7 proc$ures t provide a %[+ t 9 vitro cl9ical te/s cov]$ by ! propos$ scope ( ! te*nology c]tification ord] w be safe = individuals :o come into contact ) 9 vitro cl9ical te/s cov]$ by su* ord]2 7,i7 a propos$ li/+ submission "u section #ehg;,j7b7 = 9 vitro cl9ical te/s t ! develop] int5ds to introduce into int]/ate comm]ce ^u receiv+ a te*nology c]tification ord]1 :i* %all n be con/ru$ to limit ! develop] f introduc+ additional te/s n includ$ 9 su* submission "u ! same te*nology c]tification ord]2 7,j7 in=mation conc]n+ "o or m repres5tative 9 vitro cl9ical te/s1 includ+-- 7i7 a te/ )9 ! scope ( ! te*nology c]tification application ) ! appropriate analytical complexity at ! "t ( ! submission ( ! application "u ?is section to s]ve z ! repres5tative te/2 7ii7 ! in=mation specifi$ 9 subsection 7a7 or 7b7 ( section #ehg;,b1 z applicable1 = ! repres5tative 9 vitro cl9ical te/ or te/s1 includ+ in=mation & data requir$ pursuant to subsection 7a77#b77;,g7 ( section #ehg;,b1 unless ! ,secret>y det]m9es t su* in=mation is n necess>y2 7iii7 a summ>y ( a risk assessm5t ( ! 9 vitro cl9ical te/2 7iv7 an explanation ( ! *oice ( ! repres5tative 9 vitro cl9ical te/ or te/s = ! te*nology c]tification application & h[ su* te/ adequately demon/rates ! range ( proc$ures t ! develop] includes 9 ! application "u subp>agraphs 7,f71 7,g71 7,h71 & 7,i72 & 7v7 a brief explanation ( ! ways 9 :i* ! proc$ures includ$ 9 ! application "u subp>agraphs 7,f71 7,g71 7,h71 & 7,i7 h be5 appli$ to ! repres5tative 9 vitro cl9ical te/ or te/s2 & 7,k7 su* o!r in=mation necess>y to make a det]m9ation on a te*nology c]tification application z ! ,secret>y may det]m9e necess>y4 7#c7 ,ref]5ce to exi/+ applications ,) respect to ! cont5t requirem5ts 9 ! te*nology c]tification application describ$ 9 p>agraph 7#b71 a develop] may incorporate by ref]5ce any cont5t ( an application previ\sly submitt$ by ! develop]4 7d7 ,action on an application = te*nology c]tification 7#a7 ,secret>y response 7,a7 ,9 g5]al ,z promptly z practicable1 & n lat] ?an #ij days aft] receipt ( an application "u subsection 7c71 ! ,secret>y %all-- 7i7 issue a te*nology c]tification ord] grant+ ! application1 :i* %all specify ! scope ( ! te*nology c]tification1 if ! ,secret>y f9ds t all ( ! gr\nds 9 p>agraph 7#c7 are met2 or 7ii7 d5y ! application if ! ,secret>y f9ds 7& sets =? ! basis ( su* f9d+ z "p ( or accompany+ su* d5ial7 t "o or m gr\nds = grant+ ! application specifi$ 9 p>agraph 7#c7 are n met4 7,b7 ,ext5sion ,! timel9e describ$ 9 subp>agraph 7,a7 may be ext5d$ by mutual agreem5t betwe5 ! ,secret>y & ! applicant4 7#b7 ,defici5t applications 7,a7 ,9 g5]al ,if1 aft] receipt ( an application "u ?is section1 ! ,secret>y det]m9es t any portion ( su* application is defici5t1 ! ,secret>y1 n lat] ?an #fj days aft] receipt ( su* application1 %all provide to ! applicant a description ( su* defici5cies & id5tify ! in=mation requir$ to resolve su* defici5cies4 7,b7 ,conv]t+ to prem>ket applications ,:5 respond+ to ! defici5cy lett]1 ! develop] may conv]t ! application = te*nology c]tification "u subsection 7c7 into a prem>ket application "u section #ehg;,b4 7#c7 ,te*nology c]tification ord] ,! ,secret>y %all issue an ord] grant+ a te*nology c]tification "u ?is section if1 on ! basis ( ! in=mation submitt$ to ! ,secret>y z "p ( ! application & any o!r in=mation ) respect to su* applicant1 ! ,secret>y f9ds t-- 7,a7 !re is a %[+ t 9 vitro cl9ical te/s )9 ! scope ( ! te*nology c]tification ord] w meet ! applicable /&>d2 7,b7 ! me?ods us$ 91 & ! facilities or controls us$ =1 ! developm5t ( eligible 9 vitro cl9ical te/s cov]$ by ! propos$ scope ( ! te*nology c]tification con=m to ! applicable requirem5ts ( section #ehg,k ) respect to-- 7i7 design controls1 includ+ relat$ pur*as+ controls & acceptance activities2 7ii7 compla9t inve/igation1 adv]se ev5t report+1 & corrections & removals2 & 7iii7 process validation1 z applicable2 7,c7 bas$ on a fair evaluation ( all mat]ial facts1 ! applicant's propos$ label+ & adv]tis+ are n false or mislead+ 9 any p>ticul>2 7,d7 ! application does n conta9 a false /atem5t ( mat]ial fact2 7,e7 !re is a %[+ t ! repres5tative 9 vitro cl9ical te/ or te/s-- 7i7 meet ! applicable /&>d2 & 7ii7 reasonably repres5t ! range ( proc$ures requir$ to be submitt$ 9 ! application2 7,f7 ! applicant has agre$ to p]mit1 ^u reque/1 au?oriz$ employees ( ! ,food & ,drug ,adm9i/ration or p]sons accr$it$1 or recogniz$ "u ?is ,act1 an opportunity to inspect at a reasonable "t & 9 a reasonable mann] ! facilities & all p]t95t equipm5t1 f9i%$ & unf9i%$ mat]ials1 conta9]s1 & label+ !re91 includ+ all ?+s 7includ+ records1 files1 pap]s1 & controls7 be>+ on :e!r an 9 vitro cl9ical te/ is adult]at$1 misbr&$1 or o!rwise 9 violation ( ?is ,act1 & p]mits su* au?oriz$ employees or p]sons accr$it$ "u ?is ,act to view & to copy & v]ify all records p]t95t to ! application & ! 9 vitro cl9ical te/2 & 7,g7 bas$ on o!r data & in=mation ! ,secret>y may require "u subsection 7c77#b77,k71 ! ,secret>y f9ds t su* data & in=mation support grant+ a te*nology c]tification ord]4 7#d7 ,review ( d5ials ,an applicant ^: application has be5 d5i$ "u ?is subsection may obta9 review ( su* d5ial "u section #ehg,p4 7e7 ,supplem5ts 7#a7 ,supplem5tal applications 7,a7 ,9 g5]al ,) respect to any ( ! foll[+ *anges relat$ to an 9 vitro cl9ical te/ "u a te*nology c]tification ord]1 a supplem5tal application to a te*nology c]tification ord] %all be submitt$ by ! hold] ( ! te*nology c]tification ord] describ+ su* propos$ *anges1 prior to introduc+ ! 9 vitro cl9ical te/ t is ! subject ( ! te*nology c]tification ord] into int]/ate comm]ce-- 7i7 any significant *ange to ! proc$ures provid$ 9 support ( ! application = te*nology c]tification submitt$ "u subp>agraph 7,g7 or 7,h7 ( subsection 7c77#b72 or 7ii7 any significant *ange to ! proc$ures provid$ 9 support ( ! application = te*nology c]tification submitt$ "u subp>agraph 7,f7 ( subsection 7c77#b74 7,b7 ,secret>y action on supplem5tal applications ,any action by ! ,secret>y on a supplem5tal application %all be 9 accordance ) subsection 7d71 & any ord] result+ f su* supplem5t %all be treat$ z an am5dm5t to a te*nology c]tification ord]4 7#b7 ,cont5t ( application 7,a7 ,9 g5]al ,a supplem5tal application = a *ange to an 9 vitro cl9ical te/ "u a te*nology c]tification ord] %all-- 7i7 conta9 all necess>y in=mation to make a %[+ t any 9 vitro cl9ical te/ affect$ by su* *ange t is )9 ! scope ( ! te*nology c]tification ord] w meet ! applicable /&>d2 & 7ii7 be limit$ to su* in=mation t is ne$$ to support ! *ange4 7,b7 ,cont5t ,unless o!rwise specifi$ by ! ,secret>y1 a supplem5tal application "u ?is subsection %all include-- 7i7 a description ( ! *ange1 includ+ a rationale = implem5t+ su* *ange2 7ii7 a description ( h[ ! *ange 0 evaluat$2 7iii7 data f a repres5tative 9 vitro cl9ical te/ or te/s t supports a %[+ t1 9 us+ ! modifi$ proc$ure or proc$ures1 all eligible 9 vitro cl9ical te/s )9 ! scope ( ! te*nology c]tification w meet ! applicable /&>d2 7iv7 z applicable1 in=mation to demon/rate t ! modifi$ proc$ure or proc$ures submitt$ "u subsection 7c77#b77;,f7 cont9ue to con=m to applicable requirem5ts "u section #ehg,k2 & 7v7 any o!r in=mation reque/$ by ! ,secret>y4 7#c7 ,*anges 9 response to a public heal? risk 7,a7 ,9 g5]al ,if ! hold] ( a te*nology c]tification makes a *ange to an 9 vitro cl9ical te/ or te/s to address a pot5tial risk to public heal? by add+ a new specification or te/ me?od1 su* hold] may imm$iately implem5t su* *ange & %all submit a notification = su* *ange to ! ,secret>y )9 #cj days4 7,b7 ,cont5t ,any notification to ! ,secret>y "u ?is p>agraph %all include-- 7i7 a summ>y ( ! relevant *ange2 7ii7 ! rationale = implem5t+ su* *ange2 7iii7 7,i7 if su* a *ange necessitates a *ange to ! proc$ures review$ z "p ( ! grant$ te*nology c]tification ord]1 ! modifi$ proc$ures2 or 7,,ii7 if ! proc$ures 7 n *ang$1 an explanation z to :y !y 7 n *ang$2 & 7iv7 if su* a *ange necessitates a *ange to ! proc$ures review$ z "p ( ! grant$ te*nology c]tification ord]1 data f a repres5tative 9 vitro cl9ical te/ or te/s t support a %[+ t1 9 us+ ! modifi$ proc$ures1 all eligible 9 vitro cl9ical te/s )9 ! scope ( ! te*nology c]tification w meet ! applicable /&>d4 7f7 ,tempor>y hold 7#a7 ,9 g5]al ,subject to ! process specifi$ 9 p>agraph 7#b71 & bas$ on "o or m f9d+s "u p>agraph 7#d71 ! ,secret>y may issue a tempor>y hold prohibit+ any hold] ( a te*nology c]tification ord] issu$ "u ?is section f introduc+ into int]/ate comm]ce an 9 vitro cl9ical te/ t 0 n previ\sly ! subject ( a li/+ "u section #ehg;,j4 ,! tempor>y hold %all id5tify ! gr\nds = ! tempor>y hold "u p>agraph 7#d7 & ! rationale = su* f9d+4 7#b7 ,process = issu+ a tempor>y hold ,if ! ,secret>y makes a f9d+ t a tempor>y hold may be w>rant$ bas$ on "o or m gr\nds specifi$ 9 p>agraph 7#d71 ! ,secret>y %all promptly notify ! hold] ( ! te*nology c]tification ord] ( su* f9d+ & provide #cj cal5d> days = ! develop] to come into compliance ) or o!rwise resolve ! f9d+4 7#c7 ,writt5 reque/s ,any writt5 reque/ to ! ,secret>y f ! hold] ( a te*nology c]tification ord] t a tempor>y hold "u p>agraph 7#a7 be remov$ %all receive a decision1 9 writ+ & specify+ ! reasons !re=e1 )9 #ij days aft] receipt ( su* reque/4 ,any su* reque/ %all include in=mation to support ! removal ( ! tempor>y hold4 7#d7 ,gr\nds = tempor>y hold ,! ,secret>y may initiate a tempor>y hold "u ?is subsection ^u a f9d+ t ! hold] ( a te*nology c]tification ord]-- 7,a7 is n 9 compliance ) ! conditions ( ! te*nology c]tification ord] pursuant to subsection 7b77#a77;,d72 7,b7 (f]s "o or m 9 vitro cl9ical te/s ) adv]tis+ or label+ t is false or mislead+2 7,c7 has report$ a correction or removal ( an 9 vitro cl9ical te/ t is (f]$ "u a te*nology c]tification ord] "u ?is section & has fail$ to demon/rate t ! issue or issues caus+ ! correction or removal does n adv]sely impact ! ability ( o!r 9 vitro cl9ical te/s (f]$ "u ! same te*nology c]tification ord] to meet ! applicable /&>d2 or 7,d7 has introduc$ into int]/ate comm]ce an 9 vitro cl9ical te/ "u a te*nology c]tification ord] & su* te/ is adult]at$ or misbr&$1 bas$ on a det]m9ation by ! ,secret>y1 & has fail$ to demon/rate t ! issue or issues caus+ ! adult]ation or misbr&+ does n adv]sely impact ! ability ( o!r 9 vitro cl9ical te/s (f]$ "u ! same te*nology c]tification grant$ "u ?is section to meet ! applicable /&>d4 7g7 ,)drawal ,! ,secret>y may1 aft] due notice & opportunity = an in=mal he>+1 issue an ord] )draw+ a te*nology c]tification ord] includ+ all te/s introduc$ into int]/ate comm]ce "u ! te*nology c]tification ord] if ! ,secret>y f9ds t-- 7#a7 ! application1 supplem5t1 or report "u subsection 7h7 conta9s false or mislead+ in=mation or fails to reveal a mat]ial fact2 7#b7 su* hold] fails to correct false or mislead+ label+ or adv]tis+ ^u ! reque/ ( ! ,secret>y2 7#c7 9 connection ) a te*nology c]tification1 ! hold] provides false or mislead+ in=mation to ! ,secret>y2 or 7#d7 ! hold] ( su* te*nology c]tification ord] fails to correct ! gr\nds = a tempor>y hold )9 a timeframe specifi$ 9 ! tempor>y hold ord]4 7h7 ,reports to ,congress 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! effective date ( ! ,,valid ,act ( #bjbb1 & annually !reaft] = ! next #d ye>s1 ! ,secret>y %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 & make publicly available1 includ+ ?r\gh po/+ on ! website ( ! ,food & ,drug ,adm9i/ration1 a report conta9+ ! in=mation describ$ 9 p>agraph 7#b74 7#b7 ,cont5t 7,a7 ,9 g5]al ,ea* report "u p>agraph 7#a7 %all address1 at a m9imum-- 7i7 ! total numb] ( applications = te*nology c]tifications fil$1 issu$1 )drawn1 & d5i$2 7ii7 ! total numb] ( te*nology c]tification ord]s ! ,secret>y put on tempor>y hold "u subsection 7h7 & ! numb] ( te*nology c]tification ord]s )drawn "u subsection 7i72 7iii7 ! types ( te*nologies = :i* ! ,secret>y issu$ te*nology c]tification ord]s2 7iv7 ! total numb] ( hold]s ( te*nology c]tification ord]s t are 9 effect2 & 7v7 ! total numb] ( 9 vitro cl9ical te/ categories t requir$ prem>ket review "u section #ehg;,b t 7 r$esignat$ z eligible 9 vitro cl9ical te/s "u ?is section4 7,b7 ,f9al report ,! fif? report submitt$ "u p>agraph 7#a7 %all include a summ>y (1 & responses to1 comm5ts rais$ 9 ! docket4 7,c7 ,p]=mance reports ,! reports requir$ "u ?is section may be issu$ ) p]=mance reports z requir$ "u section #hbi ( ! ,,valid ,act ( #bjbb4 7i7 ,public meet+ & input 7#a7 ,public docket ,n lat] ?an #cj days aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbb1 ! ,secret>y %all e/abli% a public docket to receive comm5ts conc]n+ recomm5dations = implem5tation ( ?is section1 includ+ crit]ia & proc$ures = subsections 7c7 ?r\gh 7h74 ,! public docket %all rema9 op5 = at lea/ #a ye> aft] ! e/abli%m5t ( ! public docket4 7#b7 ,public meet+ ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbb1 ! ,secret>y %all conv5e a public meet+ to :i* /akehold]s f organizations repres5t+ pati5ts & consum]s1 academia1 & ! 9 vitro cl9ical te/ indu/ry are invit$ to discuss ! te*nology c]tification process includ+ application requirem5ts1 inspections1 alignm5t ) ?ird-p>ty accr$itors1 & ! def9ition ( ! t]m te*nology "u section #ehg4 7j7 ,regulations ,! ,secret>y %all issue regulations reg>d+ ! te*nology c]tification process1 includ+ describ+ crit]ia or proc$ures relat+ to te*nology c]tification "u ?is section1 :i* %all be subject to public comm5t = a m9imum ( #fj days f issuance prior to f9aliz+ su* regulations aft] consid]+ ! comm5ts receiv$4 ,! regulation %all include an outl9e ( ! application process1 opportunities to meet ) (ficials ( ! ,food & ,drug ,adm9i/ration1 & plans to /reaml9e inspections4 7k7 ,notification 7#a7 ,9 g5]al ,not)/&+ subsection 7a77#a71 a fir/-(-a-k9d 9 vitro cl9ical te/ or a comb9ation product t meets ! def9ition ( a mod]ate-risk te/ "u section #ehg;,a may be introduc$ into int]/ate comm]ce "u a te*nology c]tification ord] t has be5 issu$ by ! ,secret>y1 subject to o!r applicable requirem5ts if-- 7,a7 ! develop] provides notification to ! ,secret>y #fj days prior to introduc+ su* te/s into int]/ate comm]ce t includes in=mation demon/rat+ t ! te/ is mod]ate-risk & )9 ! scope ( ! applicable te*nology c]tification ord]2 & 7,b7 ! ,secret>y has n issu$ a notification to ! develop] "u p>agraph 7#b7 be=e su* "t has elaps$4 7#b7 ,notification f ,secret>y ,! ,secret>y %all issue a notification to ! develop] t su* te/ may n be introduc$ into int]/ate comm]ce "u su* ord] if ! ,secret>y det]m9es t-- 7,a7 su* te/-- 7i7 does n meet ! def9ition ( a mod]ate-risk te/ "u section #ehg;,a2 7ii7 is n eligible to be introduc$ into int]/ate comm]ce "u any ( subp>agraphs 7,a7 ?r\gh 7,e7 ( subsection 7a77#a72 or 7iii7 is n eligible to be introduc$ into int]/ate comm]ce "u ! ref]5c$ te*nology c]tification ord] issu$ by ! ,secret>y because x is n )9 ! scope ( ! te*nology c]tification ord] "u subsection 7b77#b72 or 7,b7 bas$ on ! in=mation includ$ 9 ! notification submitt$ by ! develop] pursuant to ?is subsection1 !re is insuffici5t in=mation = ! ,secret>y to make ! det]m9ations describ$ 9 clauses 7i71 7ii71 & 7iii7 ( subp>agraph 7,a74 #ehg;,e4 ,mitigat+ measures 7a7 ,e/abli%m5t ( mitigat+ measures 7#a7 ,e/abli%+1 *ang+1 or )draw+ 7,a7 ,e/abli%m5t ,! ,secret>y may e/abli% & require1 on ! basis ( evid5ce1 mitigat+ measures = any 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s ) ! same indications = use t is introduc$ or deliv]$ = introduction into int]/ate comm]ce aft] ! e/abli%m5t ( su* mitigat+ measures4 7,b7 ,me?ods ( e/abli%m5t ,! ,secret>y may e/abli% mitigat+ measures-- 7i7 "u ! process set =? 9 subp>agraph 7,d72 7ii7 z provid$ "u section #ehg;,f2 or 7iii7 ?r\gh a prem>ket approval or te*nology c]tification ord]1 :i* may e/abli% mitigat+ measures = an individual 9 vitro cl9ical te/ or a category ( 9 vitro cl9ical te/s4 7,c7 ,me?ods ( *ange or )drawal ,! ,secret>y may *ange or )draw mitigat+ measures-- 7i7 "u ! process set =? 9 subp>agraph 7,d72 or 7ii7 z provid$ "u section #ehg;,f4 7,d7 ,process = e/abli%m5t1 *ange1 or )drawal ,not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code1 ! ,secret>y may1 ^u ! initiative ( ! ,secret>y or ^u petition ( an int]e/$ p]son-- 7i7 e/abli%1 *ange1 or )draw mitigat+ measures = an 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s by-- 7,i7 publi%+ a propos$ ord] 9 ! ,f$]al ,regi/]2 7,,ii7 provid+ an opportunity = public comm5t = a p]iod ( n less ?an #cj #fj cal5d> days2 & 7,,iii7 aft] consid]ation ( any comm5ts submitt$1 publi%+ a f9al ord] 9 ! ,f$]al ,regi/] t responds to ! comm5ts submitt$1 & :i* %all include a reasonable transition p]iod4 7,e7 ,effect ( mitigat+ measures on gr&fa!r$ te/s ,a mitigat+ measure %all n be requir$ by ! ,secret>y = an 9 vitro cl9ical te/ subject to section #ehg;,g7a74 7#b7 ,9 vitro cl9ical te/s previ\sly cle>$ or exempt z devices ) special controls 7,a7 ,9 g5]al ,any special controls applicable to an 9 vitro cl9ical te/ previ\sly cle>$ or exempt "u section #eaj7k71 or classifi$ "u section #eac7;f77#b7 prior to date ( enactm5t ( ! ,,valid ,act ( #bjbb1 includ+ any su* special controls e/abli%$ dur+ ! p]iod beg9n+ on ! date ( enactm5t ( ! ,,valid ,act ( #bjbb & end+ on ! effective date ( su* ,act 7z describ$ 9 section #e7;b7 ( su* ,act7-- 7i7 %all cont9ue to apply to su* 9 vitro cl9ical te/ aft] su* effective date2 & 7ii7 are deem$ to be mitigat+ measures z ( ! effective date specifi$ 9 section #hbe7;a77#a77;,a7 ( ! ,,valid ,act ( #bjbb4 7,b7 ,*anges ,not)/&+ subp>agraph 7,a71 ! ,secret>y may e/abli%1 *ange1 or )draw mitigat+ measures = su* te/s or category ( te/s us+ ! proc$ures "u p>agraph 7#a74 7b7 ,docum5tation 7#a7 ,9 vitro cl9ical te/s subject to prem>ket review ,! develop] ( an 9 vitro cl9ical te/ subject to prem>ket review "u section #ehg;,b & to :i* mitigat+ measures apply %all-- 7,a7 9 accordance ) section #ehg;,b7c77#b77;,g77i71 submit docum5tation to ! ,secret>y z "p ( ! application = ! te/ "u subsection 7c7 or 7d7 ( section #ehg;,b demon/rat+ t su* mitigat+ measures h be5 met2 7,b7 if su* application is approv$1 ma9ta9 docum5tation demon/rat+ t su* mitigat+ measures cont9ue to be met foll[+ a te/ modification by ! develop]2 & 7,c7 make su* docum5tation available to ! ,secret>y ^u reque/ or inspection4 7#b7 ,o!r te/s ,! develop] ( an 9 vitro cl9ical te/ t is (f]$ "u a te*nology c]tification ord] or o!r exemption f prem>ket review "u section #ehg;,b & to :i* mitigat+ measures apply %all-- 7,a7 ma9ta9 docum5tation 9 accordance ) ! applicable quality requirem5ts "u section #ehg;,j demon/rat+ t su* mitigat+ measures cont9ue to be met foll[+ a te/ modification by ! develop]2 7,b7 make su* docum5tation available to ! ,secret>y ^u reque/ or inspection2 & 7,c7 include 9 ! p]=mance summ>y = su* te/ a brief description ( h[ su* mitigat+ measures are met1 if applicable4 #ehg;,f4 ,regulatory pa?way designation 7a7 ,pa?way det]m9ations 7#a7 ,9 g5]al ,aft] consid]+ available evid5ce ) respect to an 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s ) ! same int5d$ use1 includ+ ! id5tification1 e/abli%m5t1 & implem5tation ( mitigat+ measures "u section #ehg;,e1 z appropriate1 ! ,secret>y may1 ^u ! initiative ( ! ,secret>y or ^u reque/ ( a develop]1 det]m9e t-- 7,a7 su* 9 vitro cl9ical te/ is high-risk & subject to prem>ket review "u section #ehg;,b2 7,b7 su* 9 vitro cl9ical te/s1 includ+ a fir/-(-a-k9d te/1 is mod]ate-risk & subject to abbreviat$ prem>ket review "u section #ehg;,b7b7 or te*nology c]tification "u section #ehg;,d7a77#a72 or 7,c7 su* 9 vitro cl9ical te/1 includ+ a fir/-(-a-k9d te/ is l[-risk or o!rwise exempt f prem>ket review "u section #ehg;,b4 7#b7 ,reque/s 7,a7 ,submissions by develop]s 7i7 ,abbreviat$ prem>ket review2 te*nology c]tification ,a develop] submitt+ a reque/ t ! ,secret>y make a det]m9ation z describ$ 9 p>agraph 7#a77;,b7 %all submit in=mation to support t ! 9 vitro cl9ical te/ is mod]ate-risk or propose mitigat+ measures1 if applicable1 t w\ld support su* a det]m9ation4 7ii7 ,l[-risk2 exempt f prem>ket review ,a develop] submitt+ a reque/ t ! ,secret>y make a det]m9ation z describ$ 9 p>agraph 7#a77;,c7 %all submit in=mation t ! 9 vitro cl9ical te/ is l[-risk1 or o!rwise appropriate = exemption f prem>ket review "u section #ehg;,b & propose mitigat+ measures1 if applicable1 t w\ld support su* a det]m9ation4 7,b7 ,response by ! ,secret>y ,n lat] ?an #cj days aft] receiv+ a reque/ "u clause 7i7 or 7ii7 ( subp>agraph 7,a71 ! ,secret>y %all provide a timely response describ+ :e!r or n ! ,secret>y w initiate ! process = mak+ a det]m9ation "u p>agraph 7#a77;,b7 or 7#a77;,c7 z describ$ 9 p>agraph 7#d74 7#c7 ,suffici5cy ( mitigat+ measures ,:5 det]m9+ :e!r mitigat+ measures = an 9 vitro cl9ical te/1 or category ( 9 vitro cl9ical te/s1 are suffici5t to make su* te/ mod]ate-risk or l[-risk1 ! ,secret>y %all take into acc\nt ! foll[+3 7,a7 ,! degree to :i* ! te*nology = ! int5d$ use ( ! 9 vitro cl9ical te/ is well-*>act]iz$1 tak+ into consid]ation factors t include "o or m ( ! foll[+3 7i7 ,pe]-review$ lit]ature4 7ii7 ,practice guidel9es4 7iii7 ,cons5sus /&>ds4 7iv7 ,recogniz$ /&>ds ( c>e4 7v7 ,use ( su* te*nology1 includ+ hi/orical use4 7vi7 ,multiple sci5tific publications by diff]5t au?ors4 7vii7 ,adoption by ! sci5tific or cl9ical community4 7viii7 ,real _w evid5ce4 7,b7 ,:e!r ! crit]ia = p]=mance ( ! te/ are well-e/abli%$ to be suffici5t = ! int5d$ use4 7,c7 ,! cl9ical circum/ances "u :i* ! 9 vitro cl9ical te/ is us$1 includ+ :e!r ! 9 vitro cl9ical te/ is ! sole det]m9ate = ! diagnosis or treatm5t ( ! t>get$ disease1 & ! availability ( o!r te/s 7su* z confirmatory or adjunctive te/s7 or relevant mat]ial /&>ds4 7,d7 ,:e!r su* mitigat+ measures suffici5tly mitigate ! risk ( h>m su* t ! te/ or category ( te/s is mod]ate-risk or l[-risk4 7#d7 ,process 7,a7 ,9 g5]al ,= a te/ t is n fir/-(-a-k9d1 any action "u p>agraph 7#a7 %all be made by publication ( a notice ( su* propos$ action on ! website ( ! ,food & ,drug ,adm9i/ration1 ! consid]ation ( comm5ts to a public docket on su* proposal1 & publication ( a f9al action on su* website )9 #fj cal5d> days ( ! close ( ! comm5t p]iod po/$ to su* public docket1 not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code4 7,b7 ,process = fir/-(-a-k9d te/ ,9 ! case ( an 9 vitro cl9ical te/ t is fir/-(-a-k9d1 ! process is z foll[s3 7i7 ,any det]m9ation t ! te/ is subject to prem>ket approval or abbreviat$ prem>ket review "u subp>agraph 7,a7 or 7,b7 ( p>agraph 7#a7 %all be publi%$ on ! website ( ! ,food & ,drug ,adm9i/ration1 not)/&+ subclause ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code1 only aft] ! 9 vitro cl9ical te/ is approv$ "u section #ehg;,b4 ,until t "t1 ! det]m9ation %all n be b9d+ on o!r 9 vitro cl9ical te/s4 7ii7 ,any det]m9ation o!r ?an ^? made "u clause 7i7 %all be made by publication ( a notice ( f9al action on ! website ( ! ,food & ,drug ,adm9i/ration1 not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code4 7#e7 ,no effect on gr&fa!r+ det]m9ations ,a det]m9ation "u p>agraph 7#a7 %all h no effect on ! applicability ( section #ehg;,g to an 9 vitro cl9ical te/s4 7b7 ,transition p]iod ,^u a decision by ! ,secret>y to *ange a regulatory pa?way designation1 or reclassifies an 9 vitro cl9ical te/1 or category ( 9 vitro cl9ical te/s1 ! ,secret>y %all provide an appropriate transition p]iod ) respect to any new requirem5ts4 7c7 ,appeals ,a decision by ! ,secret>y "u ?is section %all be deem$ a significant decision subject to appeal "u section #ehg,p4 7d7 ,advisory committee ,! ,secret>y may reque/ recomm5dations f an advisory committee "u section #ehg;,h pursuant to c>ry+ out ?is section4 7e7 ,reque/ = in=mal fe$back ,be=e submitt+ a prem>ket application or te*nology c]tification application = an 9 vitro cl9ical te/-- 7#a7 ! develop] ( ! te/ may submit to ! ,secret>y a writt5 reque/ = a meet+1 conf]5ce1 or writt5 fe$back to discuss & provide in=mation relat+ to ! regulation ( su* 9 vitro cl9ical te/ :i* may include-- 7,a7 ! submission process & ! type & am\nt ( evid5ce expect$ to demon/rate ! applicable /&>d2 7,b7 :i* regulatory pa?way is appropriate = an 9 vitro cl9ical te/2 & 7,c7 an inve/igation plan = an 9 vitro cl9ical te/1 includ+ a cl9ical protocol2 & 7#b7 ^u receipt ( su* a reque/1 ! ,secret>y %all-- 7,a7 if a meet+ is reque/$-- 7i7 )9 #fj cal5d> days aft] su* receipt1 or )9 su* "t p]iod z may be agre$ to by ! develop]1 meet or conf] ) ! develop] submitt+ ! reque/2 & 7ii7 )9 #ae cal5d> days aft] su* meet+ or conf]5ce1 provide to ! develop] a writt5 record or response describ+ ! issues discuss$ & conclusions rea*$ 9 ! meet+ or conf]5ce2 & 7,b7 if writt5 fe$back is reque/$1 provide fe$back to ! reque/or )9 #ge days aft] su* receipt4 #ehg;,g4 ,gr&fa!r$ 9 vitro cl9ical te/s 7a7 ,9 g5]al ,subject to subsection 7d71 an 9 vitro cl9ical te/ is exempt f ! requirem5ts ( ?is sub*apt] specifi$ 9 subsection 7b7 if-- 7#a7 ! te/ 0 fir/ (f]$ = cl9ical use1 & 0 n int5d$ solely = inve/igational use1 be=e ! date ( enactm5t ( ! ,,valid ,act ( #bjbb2 7#b7 ! te/ 0 develop$ by a cl9ical laboratory = :i* a c]tificate 0 9 effect "u section #cec ( ! ,public ,heal? ,s]vice ,act t meets ! requirem5ts = p]=m+ te/s ( high complexity2 7#c7 ! te/ is p]=m$-- 7,a7 9 ! same cl9ical laboratory 9 :i* ! te/ 0 develop$ = :i* a c]tification is /ill 9 effect "u section #cec ( ! ,public ,heal? ,s]vice ,act t meets ! requirem5ts to p]=m te/s ( high complexity2 7,b7 by ano!r cl9ical laboratory = :i* a c]tificate is 9 effect "u section #cec ( su* ,act t meets ! requirem5ts to p]=m te/s ( high complexity1 & t is )9 ! same corporate organization & hav+ common own]%ip by ! same p>5t corporation z ! laboratory 9 :i* ! te/ 0 develop$2 or 7,c7 9 ! case ( a te/ t 0 develop$ by ! ,c5t]s = ,disease ,control & ,prev5tion or ano!r laboratory 9 a public heal? laboratory network coord9at$ or manag$ by ! ,c5t]s = ,disease ,control & ,prev5tion1 by a cl9ical laboratory = :i* a c]tificate is 9 effect "u section #cec ( su* ,act t meets ! requirem5ts to p]=m te/s ( high complexity1 & t is )9 a public heal? laboratory network coord9at$ or manag$ by ! ,c5t]s = ,disease ,control & ,prev5tion2 7#d7 ! te/ does n h 9 effect an approval "u section #eae1 a cle>ance "u section #eaj7k71 an au?orization "u section #eac7;f77#b71 or an exemption "u section #ebj7m71 or lic5sure "u section #cea ( ! ,public ,heal? ,s]vice ,act2 7#e7 any modification to ! te/ on or aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbb is made by ! initial develop]1 con=ms ) section #ehg;,c7a77#f77;,a77ii71 & does n meet ! crit]ia 9 subsection 7d77#a72 7#f7 :5 us$ z an inve/igational 9 vitro cl9ical te/1 su* te/ complies ) section #ehg,s1 z applicable2 7#g7 ! te/ is (f]$ ) an ord] f an au?oriz$ p]son z requir$ "u section #cec ( ! ,public ,heal? ,s]vice ,act1 & 0 (f]$ ) a prescription requir$ "u section #hji4cj7;f7 ( title #ba1 ,code ( ,f$]al ,regulations prior to ! effective date ( ?is sub*apt]2 7#h7 ! te/ is n = use ) home specim5 collection1 unless ! specim5 is collect$ ) a collection conta9]1 receptacle1 or kit t-- 7,a7 has be5 approv$1 cle>$1 or au?oriz$ by ! ,secret>y = home specim5 collection & ! collection is p]=m$ pursuant to ! approv$1 cle>$1 or au?oriz$ label+1 includ+ any indication = use z prescription use or ov]-!-c\nt] use1 or 7,b7 is exempt f prem>ket review & its use is consi/5t ) applicable limitations on ! exemption2 7#i7 ! te/ is n a specim5 receptacle or in/rum5t2 7#aj7 ea* te/ report = ! te/ be>s a /atem5t t reads z foll[s3 ,?is 9 vitro cl9ical te/ 0 introduc$ into comm]ce prior to ! application ( ! ,,valid ,act & is exempt f ,,fda prem>ket review42 & 7#aa7 ! develop] ( ! te/-- 7,a7 ma9ta9s docum5tation demon/rat+ t ! te/ meets & cont9ues to meet ! crit]ia set =? 9 ?is subsection2 & 7,b7 makes su* docum5tation available to ! ,secret>y ^u reque/4 7b7 ,exemptions applicable to gr&fa!r$ te/s ,an 9 vitro cl9ical te/ t meets ! crit]ia specifi$ 9 subsection 7a7 is exempt f prem>ket review "u #ehg;,b1 label+ requirem5ts "u #ehg,l1 & te/ design requirem5ts & quality requirem5ts "u #ehg,k1 & may be lawfully (f]$ subject to ! o!r applicable requirem5ts ( ?is ,act4 7c7 ,modifications ,9 ! case ( an 9 vitro cl9ical te/ t meets ! crit]ia specifi$ 9 subsection 7a71 su* te/ cont9ues to qualify = ! exemptions describ$ 9 subsection 7b7 if ! te/ is modifi$ & ! modification is ( a type describ$ 9 subsection 7a77#e71 & ! p]son modify+ su* 9 vitro cl9ical te/-- 7#a7 docum5ts ea* su* modification & ma9ta9s docum5tation ( ! basis = su* det]m9ation2 7#b7 provides su* docum5tation relat+ to ! *ange to ! ,secret>y ^u reque/ or inspection2 & 7#c7 does n modify ! 9 vitro cl9ical te/ su* t x no long] meets ! crit]ia "u subsection 7a74 7d7 ,reque/ = in=mation 7#a7 ,crit]ia ,! crit]ia describ$ 9 ?is p>agraph are any ( ! foll[+3 7,a7 ,!re is a lack ( valid sci5tific evid5ce to support t ! 9 vitro cl9ical te/ is analytically valid or cl9ically valid4 7,b7 ,su* 9 vitro cl9ical te/ is be+ (f]$ by its develop] ) any false or mislead+ analytical or cl9ical claims4 7,c7 ,x is probable t su* 9 vitro cl9ical te/ w cause s]i\s adv]se heal? consequ5ces4 7#b7 ,process 7,a7 ,writt5 reque/ = in=mation ,! ,secret>y may issue a writt5 reque/ to a develop] id5tify+ specific sci5tific conc]ns1 bas$ on cr$ible in=mation1 ) an 9 vitro cl9ical te/1 :i* indicate t "o or m ( ! crit]ia describ$ 9 p>agraph 7#a7 apply to su* 9 vitro cl9ical te/4 ,su* writt5 reque/ %all include specific in=mation reque/s p]ta9+ to su* crit]ia4 7,b7 ,deadl9e = submitt+ in=mation ,n lat] ?an #de days aft] receiv+ a reque/ = in=mation "u subp>agraph 7,a7-- 7i7 ! develop] ( an 9 vitro cl9ical te/-- 7,i7 may seek a teleconf]5ce prior to ! submission ( in=mation "u subclause 7,,ii7 to discuss ! ,secret>y's reque/2 & 7,,ii7 %all submit ! in=mation reque/$ pursuant to subp>agraph 7,a71 & may include 9 su* submission a reque/ = a teleconf]5ce2 & 7ii7 ! ,secret>y %all-- 7,i7 s*$ule a teleconf]5ce reque/$ "u clause 7i77,i72 & 7,,ii7 hold a teleconf]5ce if reque/$ )9 #aj days ( ! ,secret>y's receipt ( ! in=mation submitt$ "u clause 7i77,,ii74 7,c7 ,review deadl9e ,^u receiv+ a submission "u subp>agraph 7,b71 ! ,secret>y %all-- 7i7 review ! submitt$ in=mation )9 #de cal5d> days ( su* receipt1 :i* may include communication ) ! develop]2 & 7ii7 det]m9e :e!r ! crit]ia li/$ 9 p>agraph 7#a7 apply to ! 9 vitro cl9ical te/ & communicate su* det]m9ation to ! develop] z describ$ 9 subp>agraph 7,d74 7,d7 ,communication & results ( det]m9ation ,! ,secret>y %all notify ! develop]1 9 writ+1 ( ! ,secret>y's det]m9ation "u subp>agraph 7,c71 z foll[s3 7i7 ,if ! ,secret>y det]m9es t none ( ! crit]ia li/$ 9 p>agraph 7#a7 apply to ! 9 vitro cl9ical te/1 su* te/ %all be exempt f relevant requirem5ts ( ?is sub*apt]1 z set =? 9 subsection 7b71 subject to applicable limitation4 7ii7 ,if ! ,secret>y det]m9es t "o or m ( ! crit]ia li/$ 9 subp>agraph 7#a7 apply to ! te/ b su* a det]m9ation may be resolv$ )9 a reasonable "t1 & ! te/ has n be5 previ\sly subject to ?is subsection on ! basis ( ! same or sub/antially simil> sci5tific conc]ns id5tifi$ 9 ! writt5 reque/ issu$ "u p>agraph 7d77#b77;,a7-- 7,i7 ! ,secret>y %all notify ! develop] ( su* a det]m9ation & all[ ! develop] to seek a teleconf]5ce to discuss ! f9d+2 7,,ii7 ! develop] %all submit in=mation demon/rat+ resolution ( ! det]m9ation )9 #ae days ( receiv+ ! notification2 & 7,,iii7 ! ,secret>y %all make a det]m9ation )9 #cj days ( ! submission ( in=mation z to :e!r ! crit]ia "u p>agraph 7#a7 apply to ! te/4 7iii7 ,if ! ,secret>y det]m9es t none ( ! crit]ia li/$ 9 p>agraph 7#a7 apply to ! te/1 su* te/ %all be exempt f relevant requirem5ts ( ! sub*apt] z set =? 9 subsection 7b71 subject to applicable limitations4 7iv7 ,if ! ,secret>y det]m9es t "o or m ( ! crit]ia li/$ 9 p>agraph 7#a7 apply to ! 9 vitro cl9ical te/1 su* te/ is n exempt z set =? 9 ?is section & %all n be (f]$ unless approv$ "u section #ehg;,b1 or1 ^u a det]m9ation by ! ,secret>y pursuant to section #ehg;,f1 (f]$ "u a te*nology c]tification ord] "u section #ehg;,d or (f]$ z a l[-risk te/4 7v7 ,if ! ,secret>y det]m9es t "o or m ( ! crit]ia li/$ 9 p>agraph 7#a7 apply to ! 9 vitro cl9ical te/ & clause 7ii7 does n apply1 ! 9 vitro cl9ical te/ is n exempt z set =? 9 section & %all n be (f]$ unless approv$ "u section #ehg;,b1 or ^u a det]m9ation by ! ,secret>y pursuant to section #ehg;,f1 (f]$ "u a te*nology c]tification ord] "u section #ehg;,d or (f]$ z a l[-risk te/4 #ehg;,h4 ,advisory committees 7a7 ,9 g5]al ,! ,secret>y may e/abli% advisory committees or use advisory committee panels ( exp]ts e/abli%$ be=e ! date ( enactm5t ( ! ,,valid ,act ( #bjbb 7includ+ a device classification panel "u section #eac7 = ! purposes ( provid+ exp]t sci5tific advice & mak+ recomm5dations relat$ to-- 7#a7 ! approval ( an application = an 9 vitro cl9ical te/ submitt$ "u ?is sub*apt]1 includ+ = evaluat+1 z applicable1 ! analytical validity1 cl9ical validity1 & safety ( 9 vitro cl9ical te/s2 7#b7 ! pot5tial effectiv5ess ( mitigat+ measures = a det]m9ation ( ! applicable regulatory pa?way "u section #ehg;,f7b7 or risk evaluation = an 9 vitro cl9ical te/ or te/s2 7#c7 quality requirem5ts "u section #ehg,k or apply+ su* requirem5ts to 9 vitro cl9ical te/s develop$ or import$ by develop]s2 7#d7 appeals "u section #ehg,p2 or 7#e7 su* o!r purposes z ! ,secret>y det]m9es appropriate4 7b7 ,appo9tm5ts 7#a7 ,vot+ memb]s ,! ,secret>y %all appo9t to ea* committee e/abli%$ "u subsection 7a71 z vot+ memb]s1 individuals :o are qualifi$ by tra9+ & exp]i5ce to evaluate 9 vitro cl9ical te/s ref]r$ to ! committee = ! purposes specifi$ 9 subsection 7a71 includ+ individuals )1 to ! ext5t feasible1 sci5tific exp]tise 9 ! developm5t ( su* 9 vitro cl9ical te/s1 laboratory op]ations1 & ! use ( 9 vitro cl9ical te/s4 ,! ,secret>y %all designate "o memb] ( ea* committee to s]ve z *air4 7#b7 ,nonvot+ memb]s ,9 addition to ! individuals appo9t$ pursuant to p>agraph 7#a71 ! ,secret>y %all appo9t to ea* committee e/abli%$ "u subsection 7a71 z nonvot+ memb]s-- 7,a7 a repres5tative ( consum] int]e/s2 & 7,b7 a repres5tative ( int]e/s ( 9 vitro cl9ical te/ develop]s n directly affect$ by ! matt] to be br\ght be=e ! committee4 7#c7 ,limitation ,no individual :o is a regul> full-"t employee ( ! ,unit$ ,/ates & engag$ 9 ! adm9i/ration ( ?is ,act may be a memb] ( any advisory committee e/abli%$ "u subsection 7a74 7#d7 ,education & tra9+ ,! ,secret>y %all1 z appropriate1 provide education & tra9+ to ea* new committee memb] be=e su* memb] p>ticipates 9 a committee's activities1 includ+ education reg>d+ requirem5ts "u ?is ,act & relat$ regulations ( ! ,secret>y1 & ! adm9i/rative processes & proc$ures relat$ to committee meet+s4 7#e7 ,meet+s ,! ,secret>y %all ensure t sci5tific advisory committees meet regul>ly & at appropriate int]vals s t any matt] to be review$ by su* a committee c be pres5t$ to ! committee n m ?an #fj cal5d> days aft] ! matt] is ready = su* review4 ,meet+s ( ! committee may be held us+ electronic or telephonic communication to conv5e ! meet+s4 7#f7 ,comp5sation ,memb]s ( an advisory committee e/abli%$ "u subsection 7a71 :ile att5d+ meet+s or conf]5ces or o!rwise engag$ 9 ! bus9ess ( ! advisory committee-- 7,a7 %all be entitl$ to receive comp5sation at rates to be fix$ by ! ,secret>y1 b n to exce$ ! daily equival5t ( ! rate 9 effect = positions classifi$ above level ,,gs-#ae ( ! ,g5]al ,s*$ule2 & 7,b7 may be all[$ travel exp5ses z au?oriz$ by section #egjc ( title #e1 ,unit$ ,/ates ,code1 = employees s]v+ int]mitt5tly 9 ! ,gov]nm5t s]vice4 7c7 ,guidance ,! ,secret>y may issue guidance on ! policies & proc$ures gov]n+ advisory committees e/abli%$ "u subsection 7a74 #ehg;,i4 ,break?r\gh 9 vitro cl9ical te/s 7a7 ,9 g5]al ,! purpose ( ?is section is to enc\rage ! ,secret>y1 & provide ! ,secret>y ) suffici5t au?ority1 to apply effici5t & flexible approa*es to exp$ite ! developm5t (1 & prioritize ! review (1 9 vitro cl9ical te/s t repres5t break?r\gh te*nologies4 7b7 ,e/abli%m5t ( program ,! ,secret>y %all e/abli% a program to exp$ite ! developm5t (1 & provide = ! priority review (1 9 vitro cl9ical te/s4 7c7 ,eligibility ,! program develop$ "u subsection 7b7 %all be available = any 9 vitro cl9ical te/ t-- 7#a7 provides or enables m effective treatm5t or diagnosis ( life-?reat5+ or irrev]sibly debilitat+ human disease or conditions comp>$ to exi/+ approv$ or cle>$ 9 vitro cl9ical te/s1 includ+ an 9 vitro cl9ical te/ (f]$ "u a te*nology c]tification ord]2 & 7#b7 is a te/-- 7,a7 t repres5ts a break?r\gh te*nology2 7,b7 = :i* no approv$ or cle>$ alt]native 9 vitro cl9ical te/ exi/s1 includ+ no 9 vitro cl9ical te/ (f]$ "u a te*nology c]tification ord]2 7,c7 t (f]s a cl9ically mean+ful advantage ov] exi/+ alt]native 9 vitro cl9ical te/s t are approv$ or cle>$ 7includ+ 9 vitro cl9ical te/s (f]$ "u a te*nology c]tification ord]71 includ+ ! pot5tial to r$uce or elim9ate ! ne$ = hospitalization1 improve pati5t quality ( life1 facilitate pati5ts' ability to manage _! own c>e 7su* z ?r\gh self-direct$ p]sonal assi/ance71 or e/abli% long-t]m cl9ical effici5cies2 or 7,d7 ! availability ( :i* is 9 ! be/ int]e/ ( pati5ts or public heal?4 7d7 ,designation 7#a7 ,reque/ ,to receive break?r\gh designation "u ?is section1 an applicant may reque/ t ! ,secret>y designate ! 9 vitro cl9ical te/ = exp$it$ developm5t & priority review4 ,any su* reque/ = designation may be made at any "t prior to1 or at ! "t (1 ! submission ( an application "u section #ehg;,b or #ehg;,d1 & %all include in=mation demon/rat+ t ! te/ meets ! crit]ia describ$ 9 subsection 7c74 7#b7 ,det]m9ation ,n lat] ?an #fj cal5d> days aft] ! receipt ( a reque/ "u p>agraph 7#a71 ! ,secret>y %all det]m9e :e!r ! 9 vitro cl9ical te/ t is ! subject ( ! reque/ meets ! crit]ia describ$ 9 subsection 7c74 ,if ! ,secret>y det]m9es t ! te/ meets ! crit]ia1 ! ,secret>y %all designate ! te/ = exp$it$ developm5t & priority review4 7#c7 ,review ,review ( a reque/ "u p>agraph 7#a7 %all be und]tak5 by a team t is compos$ ( exp]i5c$ /aff & s5ior manag]s ( ! ,food & ,drug ,adm9i/ration4 7#d7 ,)drawal 7,a7 ,9 g5]al ,! designation ( an 9 vitro cl9ical te/ "u ?is subsection is deem$ to be )drawn1 & su* 9 vitro cl9ical te/ %all no long] be eligible = designation "u ?is section1 if an application = approval = su* te/ "u section #ehg;,b or #ehg;,d is d5i$4 ,su* te/ %all be eligible = break?r\gh designation ^u a new reque/ = su* designation4 7,b7 ,exception ,! ,secret>y may n )draw a designation grant$ "u ?is subsection bas$ on ! subsequ5t approval or te*nology c]tification ( ano!r 9 vitro cl9ical te/ t-- 7i7 is designat$ "u ?is section2 or 7ii7 0 giv5 priority review "u section #eae;,b4 7e7 ,actions ,= purposes ( exp$it+ ! developm5t & review ( 9 vitro cl9ical te/s "u ?is section1 ! ,secret>y may take ! actions & additional actions set =? 9 p>agraphs 7#a7 & 7#b71 respectively1 ( section #eae;,b7e7 :5 review+ su* te/s4 ,any ref]5ce or au?orization 9 section #eae;,b7e7 ) respect to a device %all be deem$ a ref]5ce or au?orization ) respect to an 9 vitro cl9ical te/ = purposes ( ?is section4 7f7 ,guidance ,n lat] ?an ! date specifi$ = f9al guidance "u section #hbe ( ! ,,valid ,act ( #bjbb1 ! ,secret>y %all issue f9al guidance on ! implem5tation ( ?is section4 ,su* guidance %all-- 7#a7 set =? ! process by :i* a p]son may seek a designation "u subsection 7d72 7#b7 provide a template = reque/ "u subsection 7d72 7#c7 id5tify ! crit]ia ! ,secret>y w use 9 evaluat+ a reque/ = designation2 & 7#d7 id5tify ! crit]ia & processes ! ,secret>y w use to assign a team ( /aff1 includ+ team lead]s1 to review 9 vitro cl9ical te/s designat$ = exp$it$ developm5t & priority review1 includ+ any tra9+ requir$ = su* p]sonnel to ensure effective & effici5t review4 7g7 ,rules ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to affect-- 7#a7 ! crit]ia & /&>ds = evaluat+ an application pursuant to section #ehg;,b or #ehg;,d1 includ+ ! recognition ( valid sci5tific evid5ce z describ$ 9 section #ehg7bj7 & consid]ation & application ( ! lea/ burd5some means describ$ "u section #ehg;,,aa7c72 7#b7 ! au?ority ( ! ,secret>y ) respect to cl9ical holds "u section #ehg,s2 7#c7 ! au?ority ( ! ,secret>y to act on an application pursuant to section #ehg;,b be=e completion ( an e/abli%m5t inspection1 z ! ,secret>y det]m9es appropriate2 or 7#d7 ! au?ority ( ! ,secret>y ) respect to po/m>ket surveillance "u section #ehg,x4 #ehg;,j4 ,regi/ration & li/+ 7a7 ,regi/ration requirem5t 7#a7 ,9 g5]al ,ea* p]son describ$ 9 subsection 7b77#a7 %all-- 7,a7 dur+ ! p]iod beg9n+ on ,octob] #a & end+ on ,decemb] #ca ( ea* ye>1 regi/] ) ! ,secret>y ! "n ( su* p]son1 places ( bus9ess ( su* p]son1 all e/abli%m5ts engag$ 9 ! activities specifi$ "u ?is p>agraph1 ! e/abli%m5t regi/ration numb] ( ea* su* e/abli%m5t1 & a po9t ( contact = ea* su* e/abli%m5t1 includ+ an electronic po9t ( contact2 & 7,b7 submit an initial regi/ration conta9+ ! in=mation requir$ "u subp>agraph 7,a7 n lat] ?an-- 7i7 ! effective date ( ?is section if su* e/abli%m5t is engag$ 9 any activity describ$ 9 subsection 7b77#a7 on su* effective date1 unless ! ,secret>y e/abli%es by guidance a date lat] ?an su* implem5tation date = all or a category ( su* e/abli%m5ts2 or 7ii7 #cj days prior to engag+ 9 any activity describ$ 9 subsection 7b77#a71 if su* e/abli%m5t is n engag$ 9 any activity describ$ 9 ?is p>agraph on su* effective date4 7#b7 ,regi/ration numb]s ,! ,secret>y may assign a regi/ration numb] to any p]son or an e/abli%m5t regi/ration numb] to any e/abli%m5t regi/]$ 9 accordance ) ?is section4 ,regi/ration in=mation %all be made publicly available by publication on ! website ma9ta9$ by ! ,food & ,drug ,adm9i/ration1 9 accordance ) subsection 7d74 7#c7 ,inspection ,ea* p]son or e/abli%m5t t is requir$ to be regi/]$ ) ! ,secret>y "u ?is section %all be subject to inspection pursuant to section #gjd4 7b7 ,li/+ ,in=mation = ,9 ,vitro ,cl9ical ,te/s 7#a7 ,9 g5]al ,ea* p]son :o-- 7,a7 is a develop]2 & 7,b7 introduces or proposes to beg9 ! introduction or deliv]y = introduction into int]/ate comm]ce ?r\gh an exemption "u subsection 7a77#a71 7a77#b71 7a77#c71 or 7g7 ( section #ehg;,c or section #ehg;,g or ?r\gh ! fil+ ( an application "u section #ehg;,b or section #ehg;,d1 %all submit a li/+ to ! ,secret>y conta9+ ! in=mation describ$ 9 p>agraph 7#b71 7#d71 or 7#e71 z applicable1 9 accordance ) ! applicable s*$ule describ$ "u subsection 7c74 ,su* li/+ %all be prep>$ 9 su* =m & mann] z ! ,secret>y may specify 9 guidance4 ,li/+ in=mation %all be submitt$ ?r\gh ! compreh5sive te/ in=mation sy/em 9 accordance ) section #ehg,t1 z appropriate4 7#b7 ,submissions ,ea* develop] submitt+ a li/+ "u p>agraph 7#a7 %all electronically submit to ! compreh5sive te/ in=mation sy/em describ$ 9 section #ehg,t ! foll[+ in=mation1 z applicable1 = ea* 9 vitro cl9ical te/ = :i* su* p]son is a develop] 9 ! =m & mann] prescrib$ by ! ,secret>y1 tak+ into acc\nt ! lea/ burd5some requirem5ts "u section #ehg;,,aa7c73 7,a7 ,"n ( ! e/abli%m5t & its e/abli%m5t regi/ration numb]4 7,b7 ,contact in=mation = ! (ficial correspond5t = ! li/+4 7,c7 ,"n 7common "n & trade "n1 if applicable7 ( ! 9 vitro cl9ical te/ & its te/ li/+ numb] 7:5 available74 7,d7 ,! c]tificate numb] = any laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act t meets ! requirem5ts to p]=m high-complexity te/+ & t is ! develop] ( ! 9 vitro cl9ical te/1 & ! c]tificate numb] "u su* section = any laboratory t is p]=m+ ! te/1 is )9 ! same corporate organization1 & has common own]%ip by ! same p>5t corporation4 7,e7 ,:e!r ! 9 vitro cl9ical te/ is1 z applicable1 (f]$ z a te/ approv$ "u section #ehg;,b1 cle>$ to be (f]$ "u a grant$ te*nology c]tification ord]1 or (f]$ z an exempt 9 vitro cl9ical te/ "u section #ehg;,c ( #ehg;,g4 7,f7 ,indications = use in=mation "u section #ehg7aj74 7,g7 ,a brief summ>y ( ! analytical & cl9ical p]=mance ( ! 9 vitro cl9ical te/1 & z applicable1 ! lot release crit]ia4 7,h7 ,a brief description ( con=mance ) any applicable mitigat+ measures1 re/rictions1 & /&>ds4 7,i7 ,repres5tative label+ = ! 9 vitro cl9ical te/1 z appropriate4 7#c7 ,te/ li/+ numb] ,! ,secret>y may assign a te/ li/+ numb] to ea* 9 vitro cl9ical te/ t is ! subject ( a li/+ "u ?is section4 ,! process = assign+ te/ li/+ numb]s may be e/abli%$ ?r\gh guidance1 & may include ! recognition ( /&>ds1 =mats1 or conv5tions develop$ by a ?ird-p>ty organization4 7#d7 ,abbreviat$ li/+ ,a p]son :o is n a develop] b is o!rwise requir$ to regi/] pursuant to subsection 7a7 %all submit an abbreviat$ li/+ to ! ,secret>y conta9+ ! in=mation describ$ 9 subp>agraphs 7,a7 ?r\gh 7,c7 ( p>agraph 7#b71 & ! "n ( ! develop]4 ,! in=mation %all be submitt$ 9 accordance ) ! applicable s*$ule describ$ "u subsection 7c74 ,su* abbreviat$ li/+ %all be prep>$ 9 su* =m & mann] z ! ,secret>y may specify ?r\gh guidance4 ,li/+ in=mation %all be submitt$ to ! compreh5sive te/ in=mation sy/em 9 accordance ) section #ehg,t1 z appropriate4 7#e7 ,gr&fa!r$ te/s ,a develop] (f]+ a te/ t is a gr&fa!r$ 9 vitro cl9ical te/ "u section #ehg;,g7a7 %all submit li/+ in=mation requir$ "u subp>agraphs 7,a7 ?r\gh 7,f7 ( p>agraph 7#b71 & may submit a /atem5t ( ! p]=mance specifications = su* 9 vitro cl9ical te/s4 7#f7 ,exempt te/s ,a develop] ( an 9 vitro cl9ical te/ :o introduces or proposes to beg9 ! introduction or deliv]y = introduction into int]/ate comm]ce t is o!rwise exempt f ! requirem5t to submit li/+ in=mation pursuant to an exemption "u section #ehg;,c may submit li/+ in=mation "u ?is subsection4 7c7 ,timel9es = submission ( li/+ in=mation 7#a7 ,9 g5]al ,! timel9es = submission ( regi/ration & li/+ "u subsections 7a7 & 7b7 are z foll[s3 7,a7 ,= an 9 vitro cl9ical te/ t 0 li/$ z a device "u section #eaj7;j7 prior to ! effective date ( ?is section1 a p]son %all ma9ta9 a device li/+ "u section #eaj until su* "t z ! sy/em = submitt+ ! li/+ in=mation requir$ "u subsection 7b7 becomes available & !reaft] %all submit ! li/+ in=mation n lat] ?an ! lat] ( #a ye> aft] ! sy/em = submitt+ ! li/+ "u ?is section becomes available or ! effective date ( ?is section4 7,b7 ,= an 9 vitro cl9ical te/ t is subject to gr&fa!r+ "u section #ehg;,g7a7 a p]son %all submit ! li/+ in=mation requir$ "u subsection 7b77#e7 n lat] t ! lat] ( #a ye> aft] ! sy/em = submitt+ ! li/+ "u ?is section becomes available or ! effective date ( ?is section4 7,c7 ,= an 9 vitro cl9ical te/ t is n describ$ 9 subp>agraph 7,a7 or 7,b71 a p]son %all submit ! requir$ li/+ in=mation z foll[s3 7i7 ,= an 9 vitro cl9ical te/ t is n exempt f prem>ket approval "u section #ehg;,b1 a p]son %all submit ! requir$ li/+ in=mation1 prior to (f]+ ! 9 vitro cl9ical te/ & n lat] ?an #cj bus9ess days aft] ! date ( approval ( ! prem>ket approval application4 7ii7 ,= an 9 vitro cl9ical te/ t is exempt f prem>ket review "u section #ehg;,c1 ! requir$ li/+ in=mation %all be submitt$ prior to (f]+ ! 9 vitro cl9ical te/4 7#b7 ,updates 7,a7 ,updates aft] *anges ,ea* develop] requir$ to submit li/+ in=mation "u ?is section %all update su* in=mation )9 #aj bus9ess days ( any *ange t causes any previ\sly li/$ in=mation to be inaccurate or incomplete4 7,b7 ,annual updates ,ea* develop] requir$ to submit li/+ in=mation "u ?is section %all update its in=mation annually dur+ ! p]iod beg9n+ on ,octob] #a & end+ on ,decemb] #ca ( ea* ye>4 7d7 ,public availability ( li/+ in=mation 7#a7 ,9 g5]al ,li/+ in=mation submitt$ pursuant to ?is section %all be made publicly available on ! website ( ! ,food & ,drug ,adm9i/ration 9 accordance ) p>agraph 7#c74 7#b7 ,confid5tiality ,li/+ in=mation = an 9 vitro cl9ical te/ t is subject to prem>ket approval or te*nology c]tification %all rema9 confid5tial until su* date z ! 9 vitro cl9ical te/ receives ! applicable prem>ket approval or ! develop] receives a te*nology c]tification ord] & = subsequ5t te/s introduc$ "u a te*nology c]tification ord] until _! introduction4 7#c7 ,exceptions f public availability requirem5ts ,! public li/+ requirem5ts ( ?is subsection %all n apply to any regi/ration & li/+ in=mation submitt$ "u subsection 7a7 or 7b71 if ! ,secret>y det]m9es t su* in=mation-- 7,a7 is a trade secret or confid5tial comm]cial or f9ancial in=mation2 or 7,b7 if po/$1 w\ld pres5t a risk to national security4 7e7 ,submission ( in=mation by accr$it$ p]sons ,if agre$ ^u by ! develop]1 ! in=mation requir$ "u ?is section may be submitt$ by a p]son accr$it$ "u section #ehg,q4 #ehg,k4 ,te/ design & quality requirem5ts 7a7 ,applicability 7#a7 ,9 g5]al ,ea* develop] & ea* o!r p]son requir$ to regi/] "u section #ehg;,j7b77#a7 %all e/abli% & ma9ta9 quality requirem5ts 9 accordance ) ! applicable requirem5ts set =? 9 subsection 7b74 7#b7 ,c]tifi$ laboratory requirem5ts ,a develop] %all e/abli% & ma9ta9 quality requirem5t "u subsection 7b77#b7 or 7b77#c71 z applicable1 if su* develop] is a cl9ical laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act t-- 7,a7 is c]tifi$ to p]=m high-complexity te/+2 7,b7 develops an 9 vitro cl9ical te/ t is = use only-- 7i7 )9 ! laboratory c]tifi$ by ! ,secret>y "u su* section #cec 9 :i* su* te/ 0 develop$2 or 7ii7 )9 ano!r laboratory c]tifi$ by ! ,secret>y "u su* section #cec if su* laboratory is-- 7,i7 )9 ! same corporate organization & has common own]%ip by ! same p>5t corporation z ! laboratory 9 :i* ! te/ 0 develop$2 or 7,,ii7 )9 a public heal? laboratory network coord9at$ or manag$ by ! ,c5t]s = ,disease ,control & ,prev5tion1 if ! te/ is develop$ by a public heal? laboratory or ! ,c5t]s = ,disease ,control & ,prev5tion2 & 7,c7 does n manufacture1 produce1 or di/ribute 9 vitro cl9ical te/s o!r ?an laboratory te/ protocols4 7#c7 ,regulations ,! ,secret>y %all promulgate quality sy/em regulations implem5t+ ?is section4 ,9 promulgat+ su* regulations "u ?is section1 ! ,secret>y %all consid] :e!r1 & to :at ext5t1 int]national h>monization is appropriate4 7#d7 ,quality sy/ems = hybrid develop]s ( bo? laboratory te/ protocols & o!r 9 vitro cl9ical te/s ,an entity t develops bo? f9i%$ products & laboratory te/ protocols & o!r 9 vitro cl9ical te/s %all comply ) subsection 7b77#a7 = activities relat$ to ! developm5t ( any 9 vitro cl9ical te/ t is n a laboratory te/ protocol & ) subsection 7b77#b7 or 7b77#c71 z applicable1 = activities relat$ to ! developm5t ( any laboratory te/ protocol4 7b7 ,quality requirem5ts 7#a7 ,9 g5]al ,! quality requirem5ts applicable "u ?is section %all-- 7,a7 avoid duplication ( regulations & guidance "u section #cec ( ! ,public ,heal? ,s]vice ,act2 7,b7 n apply to laboratory op]ations2 & 7,c7 include ! foll[+1 z applicable1 subject to subp>agraphs 7,a7 & 7,b7 & p>agraphs 7#b7 & 7#c7-- 7i7 managem5t responsibilities2 7ii7 quality audits2 7iii7 p]sonnel2 7iv7 design controls2 7v7 docum5t controls2 7vi7 pur*as+ controls2 7vii7 id5tification & traceability2 7viii7 production & process controls2 7ix7 acceptance activities2 7x7 noncon=m+ 9 vitro cl9ical te/s2 7xi7 corrective & prev5tive action2 7xii7 label+ & packag+ controls2 7xiii7 h&l+1 /orage1 di/ribution1 & in/allation2 7xiv7 compla9ts & records2 7xv7 s]vic+2 & 7xvi7 /ati/ical te*niques4 7#b7 ,exception = laboratory te/ protocols ,develop]s t are develop+ te/ protocols = use z describ$ 9 subsection 7a77#b77;,b77i7 are exempt f ! requirem5ts "u p>agraph 7#a77;,c7 except = ! requirem5ts describ$ 9 clauses 7iv71 7ix71 7xi71 & 7xiv7 ( su* p>agraph4 7#c7 ,quality requirem5ts = c]ta9 laboratories di/ribut+ laboratory te/ protocols )9 organizations or public heal? networks ,quality requirem5ts applicable to ! develop] :o is di/ribut+ a laboratory te/ protocol z describ$ 9 subsection 7a77#b77;,b77ii7 %all consi/ ( ! foll[+3 7,a7 ,clauses 7iv71 7ix71 7xi71 7xiv71 7xii7 ( p>agraph 7#a77;,b74 7,b7 ,! requirem5t to ma9ta9 records ( ! laboratories to :i* ! laboratory te/ protocol is di/ribut$4 7c7 ,regulations ,9 implem5t+ quality requirem5ts = te/ develop]s t p>ticipate 9 int]national audit programs "u ?is section1 ! ,secret>y %all-- 7#a7 = purposes ( facilitat+ int]national h>monization1 consid] :e!r ! develop] p>ticipates 9 an int]national audit program 9 :i* ! ,unit$ ,/ates p>ticipates & recognizes compliance )1 or con=mance to1 su* /&>ds recogniz$ by ! ,secret>y2 & 7#b7 ensure a lea/ burd5some approa* describ$ 9 section #ehg;,,aa7c7 by lev]ag+1 to ! ext5t applicable1 ! quality assurance requirem5ts applicable to develop]s c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act4 #ehg,l4 ,label+ requirem5ts 7a7 ,9 g5]al ,an 9 vitro cl9ical te/ %all be> or be accompani$ by label+1 z applicable1 t meets ! requirem5ts set =? 9 subsections 7b7 & 7c71 unless su* te/ is exempt "u subsection 7d7 or 7e74 7b7 ,labels 7#a7 ,9 g5]al ,! label ( an 9 vitro cl9ical te/1 %all meet ! requirem5ts set =? 9 p>agraph 7#b7 if !re is an imm$iate conta9] to :i* ! label is appli$4 7#b7 ,regulations ,! label ( an 9 vitro cl9ical te/ %all /ate ! "n & place ( bus9ess ( its develop] & meet ! requirem5ts set =? 9 regulations promulgat$ 9 accordance ) ?is section4 7c7 ,label+ 7#a7 ,9 g5]al ,label+ ( an 9 vitro cl9ical te/1 includ+ label+ 9 ! =m ( a package ins]t1 website1 /&alone laboratory ref]5ce docum5t1 or o!r simil> docum5t %all include-- 7,a7 adequate directions = use & %all meet ! requirem5ts set =? 9 regulations promulgat$ "u ?is section1 except z provid$ 9 subsection 7d7 or 7e72 & 7,b7 ! in=mation describ$ 9 p>agraph 7#b71 z applicable4 7#b7 ,cont5t ,label+ ( an 9 vitro cl9ical te/ %all include-- 7,a7 ! te/ li/+ numb] t 0 provid$ to ! develop] at ! "t ( li/+2 7,b7 in=mation to facilitate report+ an adv]se ev5t2 7,c7 in=mation reg>d+ access+ ! p]=mance summ>y data display$ 9 ! li/+ database = ! te/2 7,d7 ! indications = use ( ! 9 vitro cl9ical te/2 & 7,e7 any w>n+s1 contra9dications1 or limitations4 7#c7 ,public availability ( in=mation ,! ,secret>y %all make all ( ! in=mation describ$ 9 p>agraph 7#b7 ) respect to ea* 9 vitro cl9ical te/ available to ! public1 z applicable1 9 accordance ) section #ehg,t1 except to ! ext5t t ! ,secret>y det]m9es t su* in=mation-- 7,a7 is trade secret or confid5tial comm]cial or f9ancial in=mation2 or 7,b7 if po/$1 c\ld compromise national security4 7#d7 ,additional requirem5ts ,label+ = an 9 vitro cl9ical te/ us$ = immunohematology te/+ %all meet ! applicable requirem5ts set =? 9 "p #ffj ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations71 relat$ to ! label+ ( blood gr\p+ reag5ts1 reag5t r$ blood cells1 & anti-human globul94 7d7 ,exemptions & alt]native requirem5ts 7#a7 ,9 g5]al 7,a7 ,9 g5]al ,) respect to an 9 vitro cl9ical te/ t meets ! crit]ia ( subp>agraph 7,b71 ! /ate 9 "o place regulations "u section #hji4aj7;b7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations7 may be satisfi$ by ! laboratory po/+ su* in=mation on its website or 9 multiple docum5ts1 if su* docum5ts are ma9ta9$ & accessible 9 "o place4 7,b7 ,applicable te/s ,an 9 vitro cl9ical te/ meets ! crit]ia ( ?is subp>agraph if su* te/ is-- 7i7 develop$ by a laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act t meets ! requirem5ts to p]=m te/s ( high-complexity2 & 7ii7 p]=m$ 9-- 7,i7 ! same laboratory 9 :i* su* te/ 0 develop$2 or 7,,ii7 by ano!r laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act t-- 7aa7 meets ! requirem5ts to p]=m te/s ( high complexity2 & 7bb7 is "u common own]%ip & control z ! laboratory t develop$ ! te/4 7#b7 ,te/ in/rum5t label+ ,unless ! in/rum5t is ! entire te/ sy/em1 ! label+ = an in/rum5t is n requir$ to be> ! in=mation indicat$ 9 p>agraphs 7#c71 7#d71 7#e71 7#g71 7#h71 7#i71 7#aj71 7#aa71 7#ab71 & 7#ac7 ( section #hji4aj7;b7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7#c7 ,reag5t label+ ,= purposes ( compliance ) subsection 7c77#a71 ! label+ = a reag5t int5d$ = use z a replacem5t 9 an 9 vitro cl9ical te/ may be limit$ to t in=mation necess>y to id5tify ! reag5t adequately & to describe its prop] use 9 ! te/4 7#d7 ,inve/igational use ,a %ipm5t or o!r deliv]y ( an 9 vitro cl9ical te/ = inve/igational use pursuant to section #ehg,s %all be exempt f ! label+ requirem5ts ( subsections 7b7 & 7c77#a7 & f any /&>d promulgat$ ?r\gh regulations1 except z requir$ "u section #cec ( ! ,public ,heal? ,s]vice ,act or section #ehg,r ( ?is ,act4 7#e7 ,g5]al purpose laboratory reag5ts ,! label+ ( g5]al purpose laboratory reag5ts 7su* z hydro*loric acid7 ^: uses are g5]ally kn[n by p]sons tra9$ 9 _! use ne$ n be> ! directions = use requir$ by subsection 7c77#a77;,a74 7#f7 ,ov]-!-c\nt] te/ specim5 receptacle label+ ,! label+ = ov]-!-c\nt] te/ specim5 receptacles = drugs ( abuse te/+ %all be> ! "n & place ( bus9ess ( ! develop] includ$ 9 ! regi/ration "u section #ehg;,j & any in=mation specifi$ 9 applicable regulations promulgat$ "u ?is section1 9 language appropriate = ! int5d$ us]s4 7e7 ,te/s 9 ! /rategic national /ockpile 7#a7 ,9 g5]al ,! ,secret>y may grant an exception or alt]native to any provision li/$ 9 ?is section1 unless explicitly requir$ by a /atutory provision outside ?is sub*apt]1 = specifi$ lots1 bat*es1 or o!r units ( an 9 vitro cl9ical te/1 if ! ,secret>y det]m9es t compliance ) su* label+ requirem5t c\ld adv]sely affect ! availability ( su* products t are1 or w be1 includ$ 9 ! ,/rategic ,national ,/ockpile "u section #cai;,f-#b ( ! ,public ,heal? ,s]vice ,act4 7#b7 ,regulations ,! ,secret>y may issue regulations am5d+ section #hji4aa ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulation7 to apply 9 full or 9 "p to 9 vitro cl9ical te/s & 9 vitro cl9ical te/ develop]s4 7f7 ,regulations ,! ,secret>y %all issue or revise regulations relat$ to /&>diz$1 g5]al cont5t & =mat = 9 vitro cl9ical te/ label+ pursuant to ?is subsection4 #ehg,m4 ,adv]se ev5t report+ 7a7 ,9 g5]al ,ea* 9 vitro cl9ical te/ develop] %all e/abli% & ma9ta9 a sy/em = e/abli%+ & ma9ta9+ records ( adv]se ev5ts & report+ adv]se ev5ts 9 accordance ) ?is section4 7b7 ,submission ( individual reports ,a develop] %all submit an individual adv]se ev5t n lat] ?an #e cal5d> days aft] ! develop] receives or becomes aw>e ( an adv]se ev5t t reasonably sugge/s t an 9 vitro cl9ical te/ may-- 7#a7 h caus$ or contribut$ to a pati5t or us] dea?2 or 7#b7 pres5t an imm95t ?reat to public heal?4 7c7 ,submission ( qu>t]ly reports ,z applicable1 a develop] %all submit qu>t]ly reports t include any 9 vitro cl9ical te/ errors & s]i\s injuries t occurr$ dur+ ! applicable qu>t]4 ,su* qu>t]ly reports %all be submitt$ n lat] ?an ! end ( ! qu>t] foll[+ ! qu>t] 9 :i* ! develop] receives or becomes aw>e ( su* adv]se ev5ts4 7d7 ,def9itions ,= ! purposes ( ?is section-- 7#a7 ! t]m 9 vitro cl9ical te/ error means a failure ( an 9 vitro cl9ical te/ to meet its p]=mance specifications1 or to o!rwise p]=m z int5d$ by ! develop]1 includ+ an inaccurate result result+ f su* failure2 & 7#b7 ! t]m s]i\s injury means-- 7,a7 a significant delay 9 a diagnosis t results 9 ! abs5ce1 delay1 or discont9uation ( critical m$ical treatm5t or t irrev]sibly or s]i\sly & negatively alt]s ! c\rse ( a disease or condition2 or 7,b7 an injury t-- 7i7 is life ?reat5+2 7ii7 results 9 p]man5t impairm5t ( a body function or p]man5t damage to a body /ructure2 or 7iii7 necessitates m$ical or surgical int]v5tion to preclude p]man5t impairm5t ( a body function or p]man5t damage to a body /ructure4 7e7 ,regulations ,! ,secret>y %all promulgate regulations to implem5t ?is section4 #ehg,n4 ,corrections & removals 7a7 ,regulations ,! ,secret>y %all promulgate regulations1 or am5d exi/+ regulations1 z appropriate1 to implem5t ?is section4 7b7 ,reports ( corrections & removals 7#a7 ,9 g5]al ,ea* 9 vitro cl9ical te/ develop] %all report to ! ,secret>y any correction or removal ( an 9 vitro cl9ical te/ und]tak5 by su* develop] if ! correction or removal 0 und]tak5-- 7,a7 to r$uce ! risk to heal? pos$ by ! 9 vitro cl9ical te/2 or 7,b7 to rem$y a violation ( ?is ,act caus$ by ! 9 vitro cl9ical te/ :i* may pres5t a risk to heal?4 7#b7 ,exception = 9 vitro cl9ical te/s (f]$ "u a te*nology c]tification ord] ,= any eligible te/ (f]$ "u a te*nology c]tification ord] "u section #ehg;,d1 a correction & removal report = any correction or removal ( an 9 vitro cl9ical te/ %\ld demon/rate t ! issue or issues caus+ ! correction or removal d n adv]sely impact ! ability ( o!r 9 vitro cl9ical te/s (f]$ "u ! same te*nology c]tification ord] to meet ! applicable /&>d4 7c7 ,tim+ ,a develop] %all submit any report requir$ "u ?is subsection to ! ,secret>y )9 #ae bus9ess days ( initiat+ su* correction or removal4 7d7 ,recordkeep+ ,a develop] ( an 9 vitro cl9ical te/ t und]takes a correction or removal ( an 9 vitro cl9ical te/ :i* is n requir$ to be report$ "u ?is subsection %all keep a record ( su* correction or removal4 7e7 ,recall communications ,^u ! report+ ( a correction or removal by ! develop]-- 7#a7 ! ,secret>y %all classify su* correction or removal "u ?is section )9 #de cal5d> days2 & 7#b7 n lat] ?an #gj cal5d> days aft] ! develop] or o!r responsible p>ty notifies ! ,secret>y t x has complet$ a recall action1 ! ,secret>y %all provide ! develop] or o!r responsible p>ty ) a writt5 /atem5t clos+ ! recall action or /at+ ! reasons ! ,secret>y _c close ! recall at t "t4 #ehg,o4 ,re/rict$ 9 vitro cl9ical te/s 7a7 ,applicability 7#a7 ,9 g5]al ,= ! types ( 9 vitro cl9ical te/s describ$ 9 p>agraph 7#c71 ! ,secret>y may require1 9 issu+ an approval ( an 9 vitro cl9ical te/ "u section #ehg;,b1 grant+ a te*nology c]tification ord] "u section #ehg;,d1 or 9 issu+ a det]m9ation "u section #ehg;,f7a71 or by issu+ a regulation1 t su* te/1 or category ( te/s1 be re/rict$ to sale1 di/ribution1 or use ^u su* conditions z ! ,secret>y may prescribe "u p>agraph 7#b74 7#b7 ,conditions ,! ,secret>y may prescribe conditions "u ?is section1 bas$ on available evid5ce1 ) respect to an 9 vitro cl9ical te/ describ$ 9 p>agraph 7#c71 t are det]m9$ to be ne$$ due to ! pot5tial = h>mful effect ( su* te/ 7includ+ any result+ abs5ce1 significant delay1 or discont9uation ( appropriate m$ical treatm5t71 & are necess>y to ensure t ! te/ meets ! applicable /&>d4 7#c7 ,9 vitro cl9ical te/s subject to re/rictions ,! re/rictions or conditions au?oriz$ "u ?is section may be appli$ by ! ,secret>y to any high-risk or mod]ate-risk 9 vitro cl9ical te/1 prescription home-use 9 vitro cl9ical te/1 direct-to-consum] 9 vitro cl9ical te/1 or ov]-!-c\nt] 9 vitro cl9ical te/4 7b7 ,label+ & adv]tis+ ( a re/rict$ 9 vitro cl9ical te/ ,! label+ & adv]tis+ ( an 9 vitro cl9ical te/ to :i* re/rictions apply "u subsection 7a7 %all be> su* appropriate /atem5ts ( ! re/rictions z ! ,secret>y may prescribe 9 an approval "u section #ehg;,b1 an ord] "u section #ehg;,d1 a det]m9ation "u section #ehg;,f7a71 or 9 regulation1 z applicable4 7c7 ,device re/rictions ,an 9 vitro cl9ical te/ t 0 (f]$ z a re/rict$ device prior to ! date ( enactm5t ( ?is sub*apt]-- 7#a7 %all cont9ue to comply ) ! applicable re/rictions "u section #eae or section #ebj7;e7 until ?is sub*apt] takes effect2 & 7#b7 except = 9 vitro cl9ical te/s requir$ to meet ! requirem5ts ( section #hji4cj ( title #ba1 ,code ( ,f$]al ,regulations prior to ! effective date ( ?is sub*apt] specifi$ 9 section #hbe7;a77#a77;,a7 ( ! ,,valid ,act ( #bjbb1 su* re/rictions describ$ 9 p>agraph 7#a7 %all be deem$ to be re/rictions "u ?is sub*apt] z ( su* effective date4 #ehg,p4 ,appeals 7a7 ,significant decision 7#a7 ,9 g5]al ,! ,secret>y %all-- 7,a7 ma9ta9 a sub/antive summ>y ( ! sci5tific & regulatory rationale = any significant decision ( ! ,food & ,drug ,adm9i/ration pursuant to section #ehg;,f1 reg>d+-- 7i7 ! submission ( an application =1 or a review (1 an 9 vitro cl9ical te/ "u section #ehg;,b or section #ehg;,d2 7ii7 an exemption "u section #ehg;,c2 or 7iii7 any requirem5ts = mitigation measures to an 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s2 & 7,b7 include 9 su* summ>ies docum5tation ( significant controv]sies or diff]5ces ( op9ion & ! resolution ( su* controv]sies or diff]5ces ( op9ion4 7#b7 ,provision ( docum5tation ,^u reque/1 ! ,secret>y %all furni% a sub/antive summ>y describ$ 9 p>agraph 7#a7 to ! p]son :o has made1 or is seek+ to make1 a submission describ$ 9 su* p>agraph4 7#c7 ,application ( lea/ burd5some requirem5ts ,! sub/antive summ>y requir$ "u ?is subsection %all include a brief /atem5t reg>d+ h[ ! lea/ burd5some requirem5ts 7 consid]$ & appli$ consi/5t ) section #ehg;,,aa7c71 z applicable4 7b7 ,review ( significant decisions 7#a7 ,reque/ = sup]visory review ( significant decision ,a develop] may reque/ a sup]visory review ( ! significant decision describ$ 9 subsection 7a77#a74 ,su* review may be conduct$ at ! next sup]visory level or high] above ! ag5cy (ficial :o made ! significant decision4 7#b7 ,submission ( reque/ ,a develop] reque/+ a sup]visory review "u p>agraph 7#a7 %all submit su* reque/ to ! ,secret>y n lat] ?an #cj days aft] ! decision = :i* ! review is reque/$ & %all indicate 9 ! reque/ :e!r su* develop] seeks an 9-p]son meet+ or a teleconf]5ce review4 7#c7 ,timeframe ,! ,secret>y %all s*$ule an 9-p]son or teleconf]5ce review1 if s reque/$1 n lat] ?an #cj days aft] su* reque/ is made4 ,! ,secret>y %all issue a decision to ! develop] reque/+ a review "u ?is subsection n lat] ?an #de days aft] ! reque/ is made "u p>agraph 7#a71 or1 9 ! case ( a develop] :o reque/s an 9-p]son meet+ or teleconf]5ce1 #cj days aft] su* meet+ or teleconf]5ce4 7c7 ,advisory panels ,! process e/abli%$ "u subsection 7a7 %all p]mit ! appellant to reque/ review by an advisory committee e/abli%$ "u section #ehg;,g :5 !re is a dispute involv+ sub/antial sci5tific fact4 ,if an advisory panel meet+ is held1 ! ,secret>y %all make a det]m9ation "u ?is subsection n lat] ?an #de days aft] ! reque/$ advisory committee meet+ has conclud$4 7d7 ,lea/ burd5some review ,any develop] :o has submitt$ an application "u section #ehg;,b or #ehg;,d may reque/ a sup]visory review ( a reque/ = additional in=mation dur+ an evaluation ( su* submission )9 #fj cal5d> days ( receipt ( ! additional in=mation reque/ f ! ,secret>y4 7e7 ,availability ( all rem$ies ,! proc$ures set =? 9 ?is section %all be 9 addition to1 & n 9 lieu (1 o!r rem$ies available to ! develop]4 #ehg,q4 ,accr$it$ p]sons 7a7 ,9 g5]al 7#a7 ,au?orization ,beg9n+ on ! date ( enactm5t ( ! ,,valid ,act ( #bjbb1 ! ,secret>y %all accr$it p]sons = any ( ! foll[+ purposes3 7,a7 ,review+ applications = prem>ket approval "u section #ehg;,b & mak+ f9d+s ) respect to su* applications4 7,b7 ,review+ applications = te*nology c]tification "u section #ehg;,d & mak+ recomm5dations to ! ,secret>y ) respect to su* applications4 7,c7 ,conduct+ inspections z specifi$ 9 subsection 7c7 ( 9 vitro cl9ical te/ develop]s & o!r p]sons requir$ to regi/] pursuant to section #ehg;,j4 7#b7 ,p]sons submitt+ applications ,a p]son submitt+ an application = prem>ket approval "u section #ehg;,b or an application = te*nology c]tification "u section #ehg;,d may submit su* application to ! ,secret>y or to a p]son accr$it$ pursuant to subp>agraph 7,a7 or 7,b7 ( p>agraph 7#a74 7b7 ,accr$it$ p]sons application reviews1 f9d+s & recomm5dations 7#a7 ,requirem5ts = prem>ket application 7,a7 ,review & f9d+ requirem5ts ,an accr$it$ p]son receiv+ an application = prem>ket approval "u section #ehg;,b %all ei!r-- 7i7 provide to ! ,secret>y1 toge!r ) ! application = prem>ket approval submitt$ by ! applicant1 a f9d+ t ! crit]ia = approval ( ! application "u section #ehg;,b7e77#b77;,a7 are met & issue a copy ( su* f9d+ to ! applicant1 :i* f9d+ %all pla9ly /ate-- 7,i7 ! basis = ! accr$it$ p]son's f9d+ t ! crit]ia "u section #ehg;,b7e77#b77;,a7 are met2 & 7,,ii7 any propos$ re/rictions1 mitigat+ measures1 or conditions ( approval "u section #ehg;,b7e77#b77;,b71 z applicable2 or 7ii7 provide a notification to ! applicant t ! accr$it$ p]son _c f9d t ! crit]ia = approval ( ! application "u section #ehg;,b7e77#b77;,a7 are met & ! reasons = su* decision4 7,b7 ,reque/+ miss+ or cl>ify+ in=mation ,aft] receipt ( an application f a develop] "u ?is section1 ! ,secret>y may reque/ miss+ or cl>ify+ in=mation f ! applicant conc]n+ ! application1 :i* ! develop] %all promptly provide4 7,c7 ,secret>y action on f9d+ t approval crit]ia are met ,if ! accr$it$ p]son transmits a f9d+ to ! ,secret>y "u subp>agraph 7,a77i71 !n prior to ! date t is #de cal5d> days aft] ! transmittal date1 ! ,secret>y %all-- 7i7 approve ! application = prem>ket approval "u section #ehg;,b7e77#b7 ) appropriate re/rictions1 mitigat+ measures1 or conditions ( approval1 z applicable2 or 7ii7 d5y approval ( ! application by issu+ a writt5 notice t reflects appropriate managem5t input & concurr5ce to ! accr$it$ p]son & ! applicant detail+ ! sci5tific basis = ! ,secret>y's det]m9ation t ! crit]ia = issuance ( an approval "u section #ehg;,b7e77#b77;,a7 h n be5 met4 7,d7 ,effect ( inaction on f9d+ ,if ! ,secret>y fails to take an action "u subp>agraph 7,c7 ! ,secret>y %all-- 7i7 )9 #de cal5d> days aft] ! transmittal date1 provide writt5 fe$back to ! applicant t-- 7,i7 includes all out/&+ issues ) ! application prev5t+ ! ,secret>y f tak+ an action "u subp>agraph 7,b72 7,,ii7 reflects appropriate managem5t input & concurr5ce2 & 7,,iii7 includes action items = ! ,secret>y1 ! applicant1 or bo?1 z appropriate1 ) an e/imat$ date ( completion = ! ,secret>y & ! applicant to complete _! respective tasks1 z applicable2 & 7ii7 promptly s*$ule a meet+ or teleconf]5ce to discuss ! fe$back provid$ "u clause 7i71 unless ! ,secret>y & applicant agree t ! out/&+ issues are adequately pres5t$ ?r\gh writt5 correspond5ce & a meet+ or teleconf]5ce is n necess>y4 7#b7 ,requirem5ts = te*nology c]tification 7,a7 ,review & recomm5dation requirem5ts ,an accr$it$ p]son receiv+ an application = te*nology c]tification "u section #ehg;,d %all ei!r-- 7i7 provide to ! ,secret>y1 toge!r ) ! application = te*nology c]tification submitt$ by ! applicant1 a recomm5dation t ! crit]ia = issuance ( a te*nology c]tification ord] "u section #ehg;,d7d77#c7 are met & issue a copy ( su* recomm5dation to ! applicant1 :i* recomm5dation %all pla9ly /ate ! basis = ! accr$it$ p]son's recomm5dation t ! crit]ia "u section #ehg;,d7d77#c7 are met2 or 7ii7 provide a notification to ! applicant t ! accr$it$ p]son _c recomm5d t ! crit]ia = issuance ( a te*nology c]tification ord] "u section #ehg;,d7d77#c7 are met & ! reasons = su* decision4 7,b7 ,reque/+ miss+ or cl>ify+ in=mation ,aft] receipt ( an application "u ?is section1 ! accr$it$ p]son may reque/ miss+ or cl>ify+ in=mation f ! applicant conc]n+ ! application1 :i* ! applicant %all promptly provide4 7,c7 ,secret>y action on recomm5dation = issuance ( a te*nology c]tification ord] ,if ! accr$it$ p]son transmits a recomm5dation to ! ,secret>y "u clause 7i7 ( subp>agraph 7,a71 !n prior to ! date t is #fj cal5d> days aft] ! transmittal date ! ,secret>y %all-- 7i7 issue ! te*nology c]tification ord] "u section #ehg;,d7d77#c71 consi/5t ) su* recomm5dation f ! accr$it$ p]son2 or 7ii7 d5y approval ( ! application by issu+ a writt5 notice to ! accr$it$ p]son & ! applicant detail+ ! sci5tific basis = a det]m9ation by ! ,secret>y t ! crit]ia = issuance ( a te*nology c]tification ord] "u section #ehg;,d7d77#c7 h n be5 met4 7c7 ,requirem5ts = inspections 7#a7 ,9 g5]al ,:5 conduct+ inspection1 p]sons accr$it$ "u subsection 7a77#a77;,b7 %all record 9 writ+ _! specific obs]vations & %all pres5t _! obs]vations to ! designat$ repres5tative ( ! inspect$ e/abli%m5t4 7#b7 ,inspection report requirem5ts ,ea* p]son accr$it$ "u subsection 7a77#a77;,c7 %all prep>e & submit to ! ,secret>y an inspection report 9 a =m & mann] designat$ by ! ,secret>y = conduct+ inspections4 ,any /atem5t or repres5tation made by an employee or ag5t ( an e/abli%m5t to a p]son accr$it$ to conduct inspections "u subsection 7a77#a77;,c7 %all be subject to section #ajja ( title #ah1 ,unit$ ,/ates ,code4 7#c7 ,sav+s clause ,no?+ 9 ?is section affects ! au?ority ( ! ,secret>y to inspect any 9 vitro cl9ical te/ develop] or o!r p]son regi/]$ "u section #ehg;,j or recognize inspections conduct$ by audit+ organizations z describ$ "u section #gjd7;g77#ae74 7#d7 ,inspection limitations ,! ,secret>y %all ensure t inspections c>ri$ out "u ?is section are n duplicative ( inspections c>ri$ out "u section #cec ( ! ,public ,heal? ,s]vice ,act4 ,inspections "u ?is section %all be limit$ to ! data & in=mation necess>y-- 7,a7 = r\t9e surveillance activities ( facilities associat$ ) an approv$ application "u section #ehg;,b or issuance ( a te*nology c]tification ord] "u section #ehg;,d2 or 7,b7 to meet ! requirem5ts = prem>ket approval "u section #ehg;,b or issuance ( a te*nology c]tification ord] "u section #ehg;,d1 z applicable4 7d7 ,accr$itation 7#a7 ,accr$itation program ,! ,secret>y may provide = accr$itation "u ?is section ?r\gh programs adm9i/]$ by ! ,food & ,drug ,adm9i/ration1 by o!r non-,f$]al gov]nm5t ag5cies1 or by qualifi$ nongov]nm5tal organizations4 ,a p]son may be accr$it$ = ! review ( applications submitt$ "u sections #ehg;,b z describ$ 9 subsection 7a77#a77;,a71 = ! review ( applications submitt$ "u section #ehg;,d z describ$ 9 subsection 7a77#a77;,b71 & to conduct inspection activities "u subsection 7a77#a77;,c71 or = a subset ( su* reviews or activities4 7#b7 ,eligible p]sons 7,a7 ,m9imum qualifications ,an accr$it$ p]son1 at a m9imum1 %all-- 7i7 n be an employee ( ! ,f$]al ,gov]nm5t2 7ii7 n engage 9 ! activities ( a develop]1 z def9$ 9 section #ehg7g72 7iii7 n be a p]son requir$ to regi/] "u section #ehg;,j1 unless su* p]son has e/abli%$ suffici5t processes & protocols to sep>ate activities to develop 9 vitro cl9ical te/s & ! activities = :i* su* p]son w\ld be accr$it$ "u subsection 7a7 & discloses applicable in=mation "u ?is section2 7iv7 n be own$ or controll$ by1 & %all h no organizational1 mat]ial1 or f9ancial affiliation )1 an 9 vitro cl9ical te/ develop] or o!r p]son requir$ to regi/] "u section #ehg;,j2 7v7 be a legally con/itut$ entity p]mitt$ to conduct ! activities = :i* x seeks accr$itation2 7vi7 ensure t ! op]ations ( su* p]son are 9 accordance ) g5]ally accept$ pr(essional & e?ical bus9ess practices2 & 7vii7 include 9 its reque/ = accr$itation a commitm5t to1 at ! "t ( accr$itation & at any "t x is p]=m+ activities pursuant to ?is section-- 7,i7 c]tify t ! in=mation report$ to ! ,secret>y accurately reflects ! data or protocol review$1 & ! docum5t$ inspection f9d+s1 z applicable2 7,,ii7 limit "w to t = :i* compet5ce & capacity are available2 7,,iii7 treat in=mation receiv$ or le>n$1 records1 reports1 & recomm5dations z propriet>y in=mation ( ! p]son submitt+ su* in=mation2 & 7,,iv7 9 conduct+ ! activities = :i* ! p]son is accr$it$ 9 respect to a p>ticul> 9 vitro cl9ical te/1 protect aga9/ ! use ( any employee or consultant :o has a f9ancial conflict ( int]e/ reg>d+ t 9 vitro cl9ical te/4 7,b7 ,waiv] ,! ,secret>y may waive any requirem5ts 9 clauses 7i71 7ii71 7iii71 or 7iv7 ( subp>agraph 7,a7 ^u mak+ a det]m9ation t su* p]son has implem5t$ o!r appropriate controls suffici5t to ensure a compet5t & imp>tial review4 7#c7 ,accr$itation process 7,a7 ,accr$itation process guidance & regulations ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbb1 ! ,secret>y %all issue draft guidance specify+ ! process = submitt+ a reque/ = accr$itation & reaccr$itation "u ?is section1 includ+ ! =m & cont5t ( in=mation to be submitt$1 includ+ ! crit]ia t ! ,secret>y w consid] to accr$it or d5y accr$itation &1 n lat] ?an #a ye> aft] ! close ( ! comm5t p]iod = ! draft guidance1 issue f9al guidance4 7,b7 ,response to reque/ ,! ,secret>y %all respond to a reque/ = accr$itation or reaccr$itation )9 #fj cal5d> days ( ! receipt ( ! reque/4 ,! ,secret>y's response may be to accr$it or reaccr$it ! p]son1 to d5y accr$itation1 or to reque/ additional in=mation 9 support ( ! reque/4 ,if ! ,secret>y reque/s additional in=mation1 ! ,secret>y %all respond )9 #fj cal5d> days ( receipt ( su* additional in=mation to accr$it or d5y ! accr$itation4 7,c7 ,type ( accr$itation ,! accr$itation or reaccr$itation ( a p]son %all specify ! p>ticul> activity or activities "u subsection 7a7 = :i* su* p]son is accr$it$1 & %all include any limitation to c]ta9 eligible 9 vitro cl9ical te/s4 7,d7 ,public li/ ,! ,secret>y %all publi% on ! website ( ! ,food & ,drug ,adm9i/ration a li/ ( p]sons :o are accr$it$ "u ?is section4 ,su* li/ %all be updat$ on at lea/ a mon?ly basis4 ,! li/ %all specify ! p>ticul> activity or activities "u ?is section = :i* ! p]son is accr$it$4 7,e7 ,audit ,! ,secret>y may audit ! p]=mance ( p]sons accr$it$ "u ?is section = purposes ( ensur+ t su* p]sons cont9ue to meet ! publi%$ crit]ia = accr$itation1 & may modify ! scope or p>ticul> activities = :i* a p]son is accr$it$ if ! ,secret>y det]m9es t su* p]son fails to meet "o or m crit]ia = accr$itation4 7,f7 ,susp5sion or )drawal ,! ,secret>y may susp5d or )draw accr$itation ( any p]son accr$it$ "u ?is section1 aft] provid+ notice & an opportunity = an in=mal he>+1 :5 su* p]son is sub/antially n 9 compliance ) ! requirem5ts ( ?is section or ! publi%$ crit]ia = accr$itation1 or poses a ?reat to public heal?1 or fails to act 9 a mann] t is consi/5t ) ! purposes ( ?is section4 7,g7 ,reaccr$itation ,accr$it$ p]sons may be initially accr$it$ = up to #c ye>s4 ,aft] expiration ( su* initial p]iod1 p]sons may be reaccr$it$ = unlimit$ additional #e-ye> p]iods1 z det]m9$ by ! ,secret>y4 7e7 ,comp5sation ( accr$it$ p]sons ,comp5sation ( an accr$it$ p]son %all be det]m9$ by agreem5t betwe5 ! accr$it$ p]son & ! p]son :o engages ! s]vices ( ! accr$it$ p]son1 & %all be paid by ! p]son :o engages su* s]vices4 7f7 ,int]national h>monization ,not)/&+ any o!r provision ( ?is section1 to facilitate int]national h>monization ! ,secret>y may recognize p]sons accr$it$ or recogniz$ by gov]nm5ts1 :o h also ent]$ into in=mation %>+ agreem5ts1 includ+ confid5tiality commitm5ts1 ) ! ,commission] ( ,food & ,drugs4 7g7 ,in=mation %>+ agreem5ts ,an accr$it$ p]son may ent] into an agreem5t ) a te/ develop] to provide in=mation to ! compreh5sive te/ in=mation sy/em "u section #ehg,t1 includ+ any requirem5ts "u section #ehg;,j4 7h7 ,reports ,n lat] ?an #b ye>s aft] ! effective date ( ! ,,valid ,act ( #bjbb1 & annually !reaft] = ! next #d ye>s1 ! ,secret>y %all po/ on ! website ( ! ,food & ,drug ,adm9i/ration1 a report describ+ ! ,secret>y's p]=mance 9 implem5t+ ?is section1 includ+ ! ,secret>y's progress 9 m9imiz+ duplicative reviews ( applications = :i* an accr$it$ p]son f9ds ! crit]ia = approval are met4 ,su* reports %all include1 = ea* p]iod-- 7#a7 ) reg>d to prem>ket approval applications-- 7,a7 ! total numb] ( f9d+s transmitt$ to ! ,secret>y "u subsection 7b77#a77;,a77i72 7,b7 ! total numb] ( det]m9ations made by ! ,secret>y "u subsection 7b77#a77;,b77i7 )9 #cj cal5d> days ( ! transmittal date to approve an application2 7,c7 ! total numb] ( det]m9ations made by ! ,secret>y "u subsection 7b77#a77;,b77ii7 )9 #cj cal5d> days ( ! transmittal date to d5y approval ( an application2 & 7,d7 ! total numb] ( applications t 7 approv$ & ! total numb] ( applications t 7 d5i$ approval1 aft] ! ,secret>y fail$ to make a det]m9ation )9 #cj cal5d> days ( ! transmittal date "u subsection 7b77#a77;,b72 & 7#b7 ) reg>d to applications = te*nology c]tification-- 7,a7 ! total numb] ( recomm5dations transmitt$ to ! ,secret>y "u subsection 7b77#b77;,a77i72 7,b7 ! total numb] ( det]m9ations made by ! ,secret>y "u subsection 7b77#b77;,b77i7 to issue a te*nology c]tification ord]1 includ+ det]m9ations made )9 #cj days ( ! transmittal date2 7,c7 ! total numb] ( det]m9ations made by ! ,secret>y "u subsection 7b77#b77;,b77ii7 to d5y ! application = te*nology c]tification1 includ+ det]m9ations made )9 #cj cal5d> days ( ! transmittal date2 & 7,d7 ! total numb] ( te*nology c]tification ord]s issu$1 & ! total numb] ( applications = te*nology c]tification t 7 d5i$1 includ+ applications d5i$ aft] ! ,secret>y fail$ to make a det]m9ation )9 #cj cal5d> days ( ! transmittal date "u subsection 7b77#b77;,b74 #ehg,r4 ,recogniz$ /&>ds 7a7 ,9 g5]al ,! ,secret>y may recognize all or "p ( appropriate /&>ds e/abli%$ by nationally or int]nationally recogniz$ /&>ds developm5t organizations = :i* a p]son may submit a decl>ation ( con=mity 9 ord] to meet a requirem5t "u ?is sub*apt] to :i* t /&>d is applicable4 ,/&>ds = 9 vitro diagno/ic devices previ\sly recogniz$ "u section #ead7;c7 %all be consid]$ recogniz$ /&>ds "u ?is section4 ,recogniz$ & propos$ /&>ds %all be accessible to ! public at no *>ge4 ,! application ( any su* cons5sus /&>d %all only apply prospectively4 ,! ,secret>y %all issue regulations e/abli%+ ! crit]ia & process1 = su* recognition & adoption4 7b7 ,am5dm5t process ,! proc$ures e/abli%$ 9 ?is section or 9 regulation or guidance issu$ "u ?is section %all apply to am5dm5t ( an exi/+ /&>d4 #ehg,s4 ,inve/igational use 7a7 ,9 g5]al ,subject to ! conditions prescrib$ 9 subsections 7c71 7d71 7e71 7f71 & 7g71 an 9 vitro cl9ical te/ = inve/igational use %all be exempt f ! requirem5ts ( ?is sub*apt]1 o!r ?an sections #ehg;,a1 #ehg,p1 #ehg,t1 & #ehg,v4 ,! ,secret>y may am5d p>ts #ej1 #ed1 & #ef ( title #ba ( ! ,code ( ,f$]al ,regulations to apply to 9 vitro cl9ical te/s to p]mit ! inve/igational use ( su* te/s by exp]ts qualifi$ by sci5tific tra9+ & exp]i5ce4 7b7 ,regulations 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbb1 ! ,secret>y %all promulgate regulations1 or am5d exi/+ regulations1 to implem5t ?is section4 7#b7 ,v>iation ,! requirem5ts 9 ! regulations promulgat$ "u ?is section %all take into acc\nt v>iations bas$ on-- 7,a7 ! scope & duration ( cl9ical te/+ to be conduct$ "u inve/igation t is ! subject ( su* application2 7,b7 ! numb] ( human subjects t are to be involv$ 9 su* te/+2 7,c7 ! ne$ to p]mit *anges to be made to ! 9 vitro cl9ical te/ involv$ dur+ te/+ conduct$ 9 accordance ) a plan requir$ "u subsection 7c77#f72 or 7,d7 :e!r ! cl9ical te/+ ( su* 9 vitro cl9ical te/ is = ! purpose ( develop+ data to obta9 approval to (f] su* te/4 7c7 ,application = inve/igational use ,! foll[+ %all apply ) respect to 9 vitro cl9ical te/s = inve/igational use3 7#a7 ,significant risk & o!r /udies ,9 ! case ( an 9 vitro cl9ical te/ ! inve/igational use ( :i* poses a significant risk to ! human subject or involves an exception f in=m$ cons5t = em]g5cy rese>*1 a sponsor ( an inve/igation ( su* a te/ seek+ an inve/igational use exemption %all submit to ! ,secret>y an inve/igational use application ) respect to ! 9 vitro cl9ical te/ 9 accordance ) p>agraphs 7#c7 & 7#d74 7#b7 ,non-significant risk /udies ,9 ! case ( an 9 vitro cl9ical te/1 ! inve/igational use ( :i* is n describ$ 9 p>agraph 7#a7-- 7,a7 ! sponsor ( su* inve/igation %all-- 7i7 ensure su* inve/igation is conduct$ 9 compliance ) an inve/igational plan approv$ by an in/itutional review committee & ! label+ ( ! 9 vitro cl9ical te/ involv$ cle>ly & conspicu\sly /ates1 ,= inve/igational use only1 z specifi$ 9 p>agraph 7#d77;,a77ii72 7ii7 ensure ea* inve/igator obta9s in=m$ cons5t z requir$ "u "p #ej1 #ed1 & #ef ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations71 subject to ! exceptions set =? 9 p>agraph 7#f77;,c72 7iii7 e/abli% & ma9ta9 records ) respect to all requirem5ts 9 ?is subp>agraph2 7iv7 ma9ta9 records & make reports z requir$ by ! ,secret>y pursuant to regulations issu$ "u subsection 7b72 & 7v7 ensure t inve/igators monitor inve/igations1 ma9ta9 records & make reports z requir$ by ! ,secret>y pursuant to regulations issu$ "u subsection 7b72 & 7,b7 ! sponsor may rely on any exception or exemption describ$ 9 p>agraph 7#d7 or z e/abli%$ by ! ,secret>y 9 regulations issu$ "u subsection 7b74 7#c7 ,application ,an inve/igational use application %all be submitt$ 9 su* "t & mann] & conta9 su* in=mation z ! ,secret>y may require 9 regulation1 & %all include an inve/igational plan = propos$ cl9ical te/+ & assurances t ! sponsor submitt+ ! application w-- 7,a7 e/abli% & ma9ta9 records relevant to ! inve/igation ( su* 9 vitro cl9ical te/2 & 7,b7 submit to ! ,secret>y annual reports ( data obta9$ z a result ( ! inve/igational use ( ! 9 vitro cl9ical te/ dur+ ! p]iod cov]$ by ! exemption t ! ,secret>y reasonably det]m9es w enable ! ,secret>y-- 7i7 to ensure compliance ) ! conditions = ! exemption specifi$ 9 p>agraph 7#d72 7ii7 to review ! progress ( ! inve/igation involv$2 & 7iii7 to evaluate ! ability to meet ! applicable /&>d4 7#d7 ,conditions = exemption 7,a7 ,9 g5]al ,an application = an inve/igational use exemption ) respect to a significant risk /udy %all be grant$ if ea* ( ! foll[+ conditions is met3 7i7 ,! risks to ! subjects ( ! 9 vitro cl9ical te/ are outweigh$ by ! anticipat$ b5efits ( ! te/ to ! subjects & ! importance ( ! k to be ga9$1 & adequate assurance ( in=m$ cons5t is provid$ 9 accordance ) p>agraphs 7#f77;,b7 & 7#f77;,c74 7ii7 ,! propos$ label+ = ! 9 vitro cl9ical te/ involv$ cle>ly & conspicu\sly /ates ,= inve/igational use only4 7iii7 ,su* o!r requirem5ts ! ,secret>y det]m9es-- 7,i7 are necess>y = ! protection ( ! public heal? & safety2 & 7,,ii7 d n unduly delay inve/igation4 7,b7 ,c]ta9 significant risk /udies ( 9 vitro cl9ical te/s = an unmet ne$ ,! ,secret>y %all n impose a limit on ! sample size = a significant risk /udy ( an 9 vitro cl9ical te/ t has receiv$ break?r\gh designation "u section #ehg;,i4 7#e7 ,coord9ation ) inve/igational new drug applications ,any requirem5t = ! submission ( a report to ! ,secret>y pursuant to an application = an inve/igational new drug exemption involv+ an 9 vitro cl9ical te/ %all sup]s$e ! report+ requirem5t "u p>agraph 7#c77;,b71 b only to ! ext5t ! requirem5t ) respect to ! application = exemption ) respect to ! drug is duplicative ( ! report+ requirem5t "u su* p>agraph4 7#f7 ,inve/igational plan1 proc$ures1 & conditions ,) respect to an inve/igational plan submitt$ "u p>agraph 7#c71 ! sponsor submitt+ su* plan %all-- 7,a7 promptly notify ! ,secret>y ( ! approval or ! susp5sion or t]m9ation ( ! approval ( su* plan by an in/itutional review committee2 7,b7 9 ! case ( an 9 vitro cl9ical te/ made available to inve/igators = cl9ical te/+1 obta9 agreem5ts f ea* inve/igator t any te/+ ( ! 9 vitro cl9ical te/ involv+ human subjects w be "u su* inve/igator's sup]vision & 9 accordance ) p>agraph 7,c7 & submit su* agreem5ts to ! ,secret>y t ensure-- 7i7 all inve/igators w comply ) ?is section1 regulations promulgat$ or revis$ "u ?is section1 & applicable human subjects regulations2 & 7ii7 ! inve/igator w ensure t-- 7,i7 in=m$ cons5t is obta9$ z requir$ "u "p #ej ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations71 am5d$ to apply to 9 vitro cl9ical te/s2 & 7,,ii7 ! requirem5ts = in/itutional review bo>d "u "p #ef ( title #ba ( ! ,code ( ,f$]al ,regulations 7or successor regulations71 am5d$ to apply to 9 vitro cl9ical te/s1 are met2 & 7,c7 ensure t in=m$ cons5t w be obta9$ f ea* human subject 7or ! repres5tative ( su* subject7 ( propos$ cl9ical te/+ involv+ su* 9 vitro cl9ical te/1 except :]e1 subject to su* o!r conditions z ! ,secret>y may prescribe-- 7i7 ! propos$ cl9ical te/+ poses no m ?an m9imal risk to ! human subject & includes appropriate safegu>ds to protect ! rights1 safety1 & welf>e ( ! human subject2 or 7ii7 ! inve/igator conduct+ or sup]vis+ ! cl9ical te/+ det]m9es 9 writ+ t !re exi/s a life-?reat5+ situation involv+ ! human subject ( su* te/+ :i* necessitates ! use ( su* 9 vitro cl9ical te/ & x is n feasible to obta9 in=m$ cons5t f ! subject & !re is n suffici5t "t to obta9 su* cons5t f a repres5tative ( su* subject4 7#g7 ,concurr$ by lic5s$ physician ,! det]m9ation requir$ by p>agraph 7#f77;,c77ii7 %all be concurr$ 9 writ+ by a lic5s$ physician :o is n involv$ 9 ! te/+ ( ! human subject ) respect to :i* su* det]m9ation is made unless imm$iate use ( ! 9 vitro cl9ical te/ is requir$ to save ! life ( ! human subject ( su* te/+ & !re is n suffici5t "t to obta9 su* concurr5ce4 7#h7 ,significant risk ,= purposes ( ?is subsection1 ! t]m significant risk means1 ) respect to an 9 vitro cl9ical te/1 t ! use ( su* 9 vitro cl9ical te/-- 7,a7 is ( sub/antial importance 9 p]=m+ an activity or activities describ$ 9 section #bja7ss77#a7 =1 a s]i\s or life-?reat5+ disease or condition )\t confirmation ( ! diagnosis by a m$ically e/abli%$ diagno/ic product or proc$ure2 7,b7 requires an invasive sampl+ proc$ure t pres5ts a significant risk to ! human subject1 provid$ t r\t9e v5ipuncture %all n be consid]$ an invasive sampl+ proc$ure2 or 7,c7 o!rwise pres5ts a pot5tial = s]i\s risk to ! heal? ( a human subject4 7d7 ,review ( applications 7#a7 ,9 g5]al ,! ,secret>y may issue an ord] approv+ an inve/igation z propos$1 approv+ x ) conditions or modifications1 or disapprov+ x4 7#b7 ,failure to act ,unless ! ,secret>y1 n lat] ?an #cj cal5d> days aft] ! date ( ! submission ( an application = an inve/igational use exemption t meets ! requirem5ts ( subsection 7c71 issues an ord] "u p>agraph 7#a7 & notifies ! sponsor submitt+ ! application1 ! application %all be treat$ z approv$ z ( su* date )\t fur!r action by ! ,secret>y4 7#c7 ,d5ial ,! ,secret>y may d5y an inve/igational use application submitt$ "u ?is subsection if ! ,secret>y det]m9es t ! inve/igation ) respect to :i* ! application is submitt$ does n con=m to ! requirem5ts ( subsection 7c74 ,a notification ( su* d5ial submitt$ to ! sponsor ) respect to su* a reque/ %all conta9 ! ord] ( disapproval & a complete /atem5t ( ! reasons = ! ,secret>y's d5ial ( ! application4 7e7 ,)drawal ( exemption 7#a7 ,9 g5]al ,! ,secret>y may1 by adm9i/rative ord]1 )draw an exemption approv$ "u ?is section ) respect to an 9 vitro cl9ical te/1 includ+ an exemption treat$ z approv$ bas$ on ! ,secret>y's failure to act pursuant to subsection 7d77#b71 if ! ,secret>y det]m9es t an inve/igation conduct$ "u su* an exemption does n meet ! applicable conditions "u subsection 7c77#c7 = su* exemption4 7#b7 ,opportunity to be he>d 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 an ord] )draw+ an inve/igational use exemption grant$ "u ?is section may be issu$ only aft] ! ,secret>y provides ! sponsor ( ! 9 vitro cl9ical te/ ) an opportunity = an in=mal he>+4 7,b7 ,exception ,an ord] ref]r$ to 9 subp>agraph 7,a7 ) respect to an inve/igational use exemption grant$ "u ?is section may be issu$ on a prelim9>y basis be=e ! provision ( an opportunity = an in=mal he>+ if ! ,secret>y det]m9es t ! cont9uation ( te/+ "u ! exemption w result 9 an unreasonable risk to ! public heal?4 ,! ,secret>y w provide an opportunity = an in=mal he>+ promptly foll[+ any prelim9>y action "u ?is subp>agraph4 7f7 ,*anges 7#a7 ,9 g5]al ,! regulations promulgat$ "u subsection 7b7 %all provide1 ) respect to an 9 vitro cl9ical te/ = :i* an exemption "u ?is subsection is 9 effect1 proc$ures & conditions "u :i* *anges are all[$ )\t ! additional approval ( an application = an exemption or submission ( a supplem5t to su* an application4 ,su* regulations %all provide t su* a *ange may be made if-- 7,a7 ! sponsor det]m9es1 on ! basis ( cr$ible in=mation 7z def9$ 9 regulations7 t ! *ange meets ! conditions specifi$ 9 p>agraph 7#b72 & 7,b7 ! sponsor submits to ! ,secret>y1 n lat] ?an #e cal5d> days aft] mak+ ! *ange1 a notice ( ! *ange4 7#b7 ,conditions ,! conditions specifi$ 9 ?is p>agraph are t-- 7,a7 9 ! case ( developm5tal *anges to an 9 vitro cl9ical te/1 includ+ manufactur+ *anges1 ! *anges-- 7i7 d n con/itute a significant *ange 9 design or 9 basic pr9ciples ( op]ation2 7ii7 d n affect ! rights1 safety1 or welf>e ( ! human subjects involv$ 9 ! inve/igation2 & 7iii7 are made 9 response to in=mation ga!r$ dur+ ! c\rse ( an inve/igation2 & 7,b7 9 ! case ( *anges to cl9ical protocols applicable to ! te/1 ! *anges d n affect-- 7i7 ! validity ( data or in=mation result+ f ! completion ( an approv$ cl9ical protocol1 or ! relation%ip ( likely pati5t risk to b5efit reli$ ^u to approve a product2 7ii7 ! sci5tific s\ndness ( a plan submitt$ "u subsection 7c77#c72 or 7iii7 ! rights1 safety1 or welf>e ( ! human subjects involv$ 9 ! inve/igation4 7g7 ,cl9ical hold 7#a7 ,9 g5]al ,at any "t1 ! ,secret>y may impose a cl9ical hold ) respect to an inve/igation ( an 9 vitro cl9ical te/ if ! ,secret>y makes a writt5 det]m9ation describ$ 9 p>agraph 7#b74 ,! ,secret>y %all1 9 impos+ su* cl9ical hold1 specify ! basis = ! cl9ical hold1 includ+ ! specific in=mation available to ! ,secret>y :i* s]v$ z ! basis = su* cl9ical hold1 & confirm su* det]m9ation 9 writ+4 ,! applicant may imm$iately appeal any su* det]m9ation pursuant to section #ehg,p4 7#b7 ,det]m9ation 7,a7 ,9 g5]al ,= purposes ( p>agraph 7#a71 a det]m9ation describ$ 9 ?is subp>agraph ) respect to a cl9ical hold is a det]m9ation t1 bas$ on cr$ible evid5ce1 ! 9 vitro cl9ical te/ involv$ repres5ts an unreasonable risk to ! safety ( ! p]sons :o are ! subjects ( ! cl9ical inve/igation1 tak+ into acc\nt ! qualifications ( ! cl9ical inve/igators1 in=mation ab\t ! 9 vitro cl9ical te/1 ! design ( ! cl9ical inve/igation1 ! condition = :i* ! 9 vitro cl9ical te/ is to be inve/igat$1 & ! heal? /atus ( ! subjects involv$4 7,b7 ,removal ( cl9ical hold ,any writt5 reque/ to ! ,secret>y f ! sponsor ( an inve/igation t a cl9ical hold be remov$ %all receive a decision1 9 writ+ & specify+ ! reasons !re=1 )9 #cj days aft] receipt ( su* reque/4 ,any su* reque/ %all include suffici5t in=mation to support ! removal ( su* cl9ical hold4 #ehg,t4 ,compreh5sive te/ in=mation sy/em 7a7 ,e/abli%m5t ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbb1 ! ,secret>y %all make available a compreh5sive te/ in=mation sy/em = 9 vitro cl9ical te/s t is design$ to-- 7#a7 provide a transp>5t int]face on ! website ( ! ,food & ,drug ,adm9i/ration = /akehold]s1 to ! ext5t p]mitt$ by applicable law1 :i* may include access to !-- 7,a7 regulatory pa?way designation in=mation = ea* 9 vitro cl9ical te/ or te/s ) ! same indications = use2 7,b7 regi/ration & li/+ in=mation provid$ by develop]s "u section #ehg;,j1 includ+ ! use ( a l9k = labels2 7,c7 adv]se ev5t reports submitt$ "u section #ehg,m1 z appropriate2 7,d7 reports ( corrections & removals submitt$ "u section #ehg,n2 & 7,e7 o!r in=mation p]ta9+ to an 9 vitro cl9ical te/ or te/s ) ! same indications = use1 z ! ,secret>y det]m9es appropriate2 & 7#b7 provide a secure portal = electronic submission1 includ+ applications & o!r 9 vitro cl9ical te/ submissions1 regi/ration & li/+ in=mation1 & adv]se ev5t reports1 :i* provides protections f unau?oriz$ disclosure ( in=mation1 includ+ (-- 7,a7 trade secret or confid5tial comm]cial or f9ancial in=mation2 & 7,b7 in=mation t c\ld compromise national security4 7b7 ,submission function ,! compreh5sive te/ in=mation sy/em %all s]ve z ! electronic submission s]vice = te/ develop]s submitt+ in=mation = applications "u sections #ehg;,b & #ehg;,d4 #ehg,u4 ,preemption 7a7 ,9 g5]al ,except z provid$ 9 subsection 7b71 no ,/ate1 ,tribal1 or local gov]nm5t 7or political subdivision !re(7 may e/abli% or cont9ue 9 effect any requirem5t-- 7#a7 t is diff]5t f1 or 9 addition to1 any requirem5t applicable to an 9 vitro cl9ical te/ "u ?is ,act2 or 7#b7 ) respect to ! analytical validity1 cl9ical validity1 or safety = individuals :o come into contact ) su* an 9 vitro cl9ical te/4 7b7 ,exceptions ,subsection 7a7 %all n be con/ru$ to affect ! au?ority ( a ,/ate1 ,tribal1 or local gov]nm5t to d any ( ! foll[+3 7#a7 ,to lic5se laboratory p]sonnel1 heal? c>e practition]s1 or heal? c>e facilities or to regulate any aspect ( a heal? c>e practition]-pati5t relation%ip4 7#b7 ,to en=ce laws ( g5]al applicability1 su* z zon+ laws1 environm5tal laws1 labor laws1 & g5]al bus9ess laws4 7#c7 ,to au?orize laboratories to develop & p]=m an 9 vitro cl9ical te/1 pursuant to a law enact$ by a ,/ate prior to ,janu>y #a1 #bjbb1 z long z su* law does n impose requirem5ts t are diff]5t f any requirem5t applicable to an 9 vitro cl9ical te/ "u ?is ,act4 ,if a ,/ate has enact$ su* a law1 ! ,secret>y %all exempt su* te/ = laboratories 9 t ,/ate f compliance ) ?is sub*apt]4 7c7 ,cl>ification ,no?+ 9 ?is section %all be con/ru$ to-- 7#a7 modify any action = damages or ! liability ( any p]son "u ! law ( any ,/ate2 or 7#b7 %ift liability to heal? c>e practition]s or o!r us]s4 #ehg,v4 ,adult]ation ,an 9 vitro cl9ical te/ %all be deem$ to be adult]at$3 7#a7 ,if x consi/s 9 :ole or 9 "p ( any fil?y1 putrid1 or decompos$ sub/ance4 7#b7 ,if x has be5 develop$1 prep>$1 pack$1 or held "u insanit>y conditions :]eby x may h be5 contam9at$ ) fil?1 or :]eby x may h be5 r5d]$ injuri\s to heal?4 7#c7 ,if its conta9] or package is compos$1 9 :ole or 9 "p1 ( any poison\s or delet]i\s sub/ance :i* may r5d] ! cont5ts injuri\s to heal?4 7#d7 ,if x be>s or conta9s1 = purposes ( color+ only1 a color additive :i* is unsafe )9 ! mean+ ( section #gba7;a74 7#e7 ,if its analytical or cl9ical validity1 z applicable1 or ) respect to a specim5 receptacle1 its safety1 falls bel[ t :i* x purports or is repres5t$ to possess4 7#f7 ,if x is requir$ to be1 decl>$ to be1 purports to be1 or is repres5t$ z be+1 9 con=mity ) any p]=mance /&>d e/abli%$ or recogniz$ "u section #ehg,r & is n 9 con=mity ) su* /&>d4 7#g7 ,if x is requir$ to be 9 compliance ) mitigat+ measures e/abli%$ "u section #ehg;,e & is n 9 con=mity ) su* mitigat+ measures4 7#h7 ,if x fails to h 9 effect an approv$ prem>ket application "u section #ehg;,b1 unless su* 9 vitro cl9ical te/ is 9 compliance ) ! requirem5ts =-- 7,a7 (f]+ )\t an approv$ prem>ket application "u section #ehg;,d7b77#a72 7,b7 an exemption f prem>ket approval "u section #ehg;,c or #ehg;,g2 or 7,c7 inve/igational use pursuant to section #ehg,s4 7#i7 ,if x is n 9 con=mity ) any condition e/abli%$ "u section #ehg;,b or #ehg;,d4 7#aj7 ,if x purports to be an 9 vitro cl9ical te/ subject to an exemption "u section #ehg;,c & x fails to meet or ma9ta9 any crit]ia1 condition1 or requirem5t ( su* exemption4 7#aa7 ,if x has be5 grant$ an exemption "u section #ehg,s = inve/igational use1 & ! p]son grant$ su* exemption or any inve/igator :o uses su* 9 vitro cl9ical te/ "u su* exemption fails to comply ) a requirem5t prescrib$ by or "u su* section4 7#ab7 ,if x fails to meet ! quality requirem5ts prescrib$ 9 or e/abli%$ "u section #ehg,k 7z applicable71 or ! me?ods us$ 91 or facilities or controls us$ =1 its developm5t1 packag+1 /orage1 or in/allation are n 9 con=mity ) applicable requirem5ts e/abli%$ "u su* section4 7#ac7 ,if x has be5 develop$1 process$1 packag$1 or held 9 any e/abli%m5t1 factory1 or w>eh\se & ! own]1 op]ator or ag5t ( su* e/abli%m5t1 factory1 or w>eh\se delays1 d5ies1 or limits an inspection1 or refuses to p]mit entry or inspection4 7#ad7 ,if x is n 9 compliance ) any re/riction requir$ "u section #ehg,o4 #ehg,w4 ,misbr&+ ,an 9 vitro cl9ical te/ %all be deem$ to be misbr&$3 7#a7 ,if its label+ is false or mislead+ 9 any p>ticul>4 7#b7 ,if 9 a package =m unless x be>s a label conta9+-- 7,a7 ! "n & place ( bus9ess ( ! te/ develop]1 packag]1 or di/ributor2 & 7,b7 an accurate /atem5t ( ! quantity ( cont5ts 9 t]ms ( weight1 measure1 or num]ical c\nt ) respect to small packages1 unless an exemption is grant$ by ! ,secret>y by ! issuance ( guidance4 7#c7 ,if any ^w1 /atem5t1 or o!r in=mation requir$ by or "u au?ority ( ?is ,act to appe> on ! label or label+1 includ+ a te/ report1 is n prom95tly plac$ !reon ) su* conspicu\sness 7z comp>$ ) o!r words1 /atem5ts1 designs1 or devices1 9 ! label+7 & 9 su* t]ms z to r5d] x likely to be read & und]/ood by ! ord9>y individual "u cu/om>y conditions ( pur*ase & use4 7#d7 ,unless its label+ be>s adequate directions = use & su* adequate w>n+s z are necess>y = ! protection ( us]s ( ! 9 vitro cl9ical te/ & recipi5ts ( ! results ( su* 9 vitro cl9ical te/1 includ+ pati5ts1 consum]s1 donors1 & relat$ heal? c>e pr(essionals4 ,requir$ label+ = 9 vitro cl9ical te/s int5d$ = use 9 heal? c>e facilities1 blood e/abli%m5ts1 or by a heal? c>e pr(essional may be made available solely by electronic means1 provid$ t ! label+ complies ) all applicable requirem5ts ( law1 & t ! te/ develop]1 or di/ributor af=ds su* us]s ! opportunity to reque/ ! label+ 9 pap] =m1 & aft] su* reque/1 promptly provides ! reque/$ in=mation )\t additional co/4 7#e7 ,if !re is a reasonable probability t x c\ld cause s]i\s or adv]se heal? consequ5ces or dea?1 includ+ ?r\gh abs5ce1 delay1 or discont9uation 9 diagnosis or treatm5t1 :5 us$ 9 ! mann] prescrib$1 recomm5d$1 or sugge/$ 9 ! label+ !re(4 7#f7 ,if x 0 develop$1 /]iliz$1 packag$1 repackag$1 relabel$1 in/all$1 or import$ 9 an e/abli%m5t n duly regi/]$ "u section #ehg;,j or x 0 n includ$ 9 a li/+ "u section #ehg;,j1 9 accordance ) timely report+ requirem5ts "u ?is sub*apt]4 7#g7 ,9 ! case ( any 9 vitro cl9ical te/ subject to re/rictions "u section #ehg,o1 7#a7 if its adv]tis+ is false or mislead+ 9 any p>ticul>1 7#b7 if x is (f]$ = cl9ical use1 sold1 di/ribut$1 or us$ 9 violation ( su* re/rictions1 or 7#c7 unless ! te/ develop] or di/ributor includes 9 all adv]tisem5ts & o!r descriptive pr9t$ matt] t su* p]son issues or causes to be issu$1 a brief /atem5t ( ! indications = use ( ! 9 vitro cl9ical te/ & relevant w>n+s1 precautions1 side effects1 & contra9dications4 ,?is p>agraph %all n be applicable to any pr9t$ matt] t ! ,secret>y det]m9es to be label+ z def9$ 9 section #bja7m74 7#h7 ,if x is subject to a mitigat+ measure e/abli%$ "u section #ehg;,e & does n be> su* label+ z may be prescrib$ 9 su* mitigat+ measure4 7#i7 ,if x is subject to a /&>d e/abli%$ "u section #ehg,r & x does n be> su* label+ z may be prescrib$ 9 su* /&>d4 7#aj7 ,unless x be>s su* label+ z may be requir$ by or e/abli%$ "u an applicable label+ requirem5t "u ?is ,act4 7#aa7 ,if !re 0 a failure to comply ) any requirem5t prescrib$ 9 or "u section #ehg;,d1 #ehg;,j1 #ehg,k1 #ehg,l1 #ehg,m1 #ehg,n1 #ehg,x1 #ehg,y1 #ehg,z1 or to provide any report1 mat]ial1 or o!r in=mation requir$ ) respect to 9 vitro cl9ical te/s "u ?is sub*apt]4 #ehg,x4 ,po/m>ket surveillance 7a7 ,9 g5]al 7#a7 ,9 g5]al ,9 addition to o!r applicable requirem5ts "u ?is ,act1 ! ,secret>y may issue an ord] requir+ a develop] ( a high-risk or mod]ate-risk 9 vitro cl9ical te/ to conduct po/m>ket surveillance ( su* 9 vitro cl9ical te/1 if ! failure ( ! 9 vitro cl9ical te/ is reasonably likely to result 9 s]i\s adv]se heal? consequ5ces or dea? f use ( su* 9 vitro cl9ical te/4 7#b7 ,consid]ation ,9 det]m9+ :e!r to require a develop] to conduct po/m>ket surveillance ( an 9 vitro cl9ical te/1 ! ,secret>y %all take into consid]ation ! b5efits & risks = ! pati5t & ! lea/ burd5some requirem5ts "u section #ehg;,,aa7c74 7b7 ,surveillance approval 7#a7 ,9 g5]al ,ea* develop] requir$ to conduct surveillance ( an 9 vitro cl9ical te/ %all submit1 )9 #cj days ( receiv+ an ord] f ! ,secret>y1 a plan = ! requir$ surveillance4 ,! ,secret>y1 )9 #fj days ( ! receipt ( su* plan1 %all det]m9e if ! p]son designat$ to conduct ! surveillance has ! appropriate qualifications & exp]i5ce to und]take su* surveillance & if ! plan w result 9 useful data t c reveal un=ese5 adv]se ev5ts or o!r in=mation necess>y to protect ! heal? ( pati5ts or ! public4 7#b7 ,timel9e ,! develop] %all comm5ce surveillance "u ?is section n lat] ?an #ae mon?s aft] ! day on :i* ! ,secret>y ord]s su* po/m>ket surveillance1 unless ! ,secret>y det]m9es m "t is ne$$ to comm5ce surveillance4 7#c7 ,prospective surveillance ,! ,secret>y may ord] a prospective surveillance p]iod ( up to #c ye>s4 ,any det]m9ation by ! ,secret>y t a long] p]iod is necess>y %all be made by mutual agreem5t betwe5 ! ,secret>y & ! develop] or1 if no agreem5t c be rea*$1 ^u ! completion ( a dispute resolution process pursuant to section #efb4 #ehg,y4 ,electronic =mat = submissions 7a7 ,9 g5]al ,all submissions to ! ,food & ,drug ,adm9i/ration ) respect to an 9 vitro cl9ical te/1 unless o!rwise agre$ to by ! ,secret>y1 %all-- 7#a7 be made electronically2 & 7#b7 ) respect to ! in=mation requir$ "u sections #ehg;,b & #ehg;,d1 utilize ! sy/em describ$ 9 section #ehg,t4 7b7 ,electronic =mat ,beg9n+ on su* date z ! ,secret>y specifies 9 f9al guidance issu$ "u subsection 7c71 submissions = 9 vitro cl9ical te/s1 includ+ recomm5dations submitt$ by accr$it$ & recogniz$ p]sons "u section #ehg,q1 & any appeals ( action tak5 by ! ,secret>y ) respect to su* submissions1 %all be submitt$ 9 su* electronic =mat z specifi$ by ! ,secret>y 9 su* guidance4 7c7 ,guidance ,! ,secret>y %all issue guidance implem5t+ ?is section4 ,su* guidance may-- 7#a7 provide /&>ds = ! electronic submission requir$ "u subsection 7a7 or ! submission 9 electronic =mat requir$ "u subsection 7b72 7#b7 set =? crit]ia = waiv]s (1 or exemptions f1 ! requirem5ts ( subsection 7a7 or 7b72 & 7#c7 provide any o!r in=mation = ! effici5t implem5tation & en=cem5t ( ?is section4 #ehg,z4 ,po/m>ket rem$ies 7a7 ,safety ,notice 7#a7 ,9 g5]al ,if ! ,secret>y det]m9es t an 9 vitro cl9ical te/ pres5ts an unreasonable risk ( sub/antial h>m to ! public heal?1 & notification "u ?is subsection is necess>y to elim9ate ! unreasonable risk ( su* h>m & no m practicable means is available "u ! provisions ( ?is ,act 7o!r ?an ?is section7 to elim9ate ! risk1 ! ,secret>y may issue su* ord] z may be necess>y to ensure t adequate safety notice is provid$ 9 an appropriate =m1 by ! p]sons & means be/ suit$ "u ! circum/ances1 to all heal? c>e pr(essionals :o prescribe1 ord]1 or use ! 9 vitro cl9ical te/ & to any o!r p]son 7includ+ develop]s1 import]s1 di/ributors1 retail]s1 & us]s7 :o %\ld prop]ly receive su* notice4 7#b7 ,notice to individuals ,an ord] "u ?is subsection %all require t ! individuals subject to ! risk ) respect to :i* ! ord] is to be issu$ be includ$ 9 ! p]sons to be notifi$ ( ! risk unless ! ,secret>y det]m9es t notice to su* individuals w\ld pres5t a great] dang] to ! heal? ( su* individuals ?an no su* notice4 ,if ! ,secret>y makes su* a det]m9ation ) respect to su* individuals1 ! ord] %all require ! heal? c>e pr(essionals :o prescrib$1 ord]$1 or us$ ! 9 vitro cl9ical te/ provide notification to ! individuals = :om ! heal? pr(essionals prescrib$1 ord]$1 or us$ su* te/1 ( ! risk pres5t$ by su* 9 vitro cl9ical te/ & ( any action :i* may be tak5 by or on behalf ( su* individuals to elim9ate or r$uce su* risk4 ,be=e issu+ an ord] "u ?is subsection1 ! ,secret>y %all consult ) ! p]sons requir$ to give notice "u ! ord]4 7b7 ,repair1 ,replacem5t1 or ,refund 7#a7 ,det]m9ation aft] an in=mal he>+ 7,a7 ,9 g5]al ,if1 aft] af=d+ opportunity = an in=mal he>+1 ! ,secret>y det]m9es t-- 7i7 an 9 vitro cl9ical te/ pres5ts an unreasonable risk ( sub/antial h>m to ! public heal?2 7ii7 !re are reasonable gr\nds to believe t ! 9 vitro cl9ical te/ 0 n prop]ly develop$ or manufactur$ consid]+ ! /ate ( ! art z x exi/$ at ! "t ( its developm5t2 7iii7 !re are reasonable gr\nds to believe t ! unreasonable risk 0 n caus$ by failure ( a p]son o!r ?an a develop]1 import]1 di/ributor1 or retail] ( ! 9 vitro cl9ical te/ to ex]cise due c>e 9 ! in/allation1 ma9t5ance1 repair1 or use ( ! 9 vitro cl9ical te/2 & 7iv7 ! notice au?oriz$ by subsection 7a7 w\ld n by itself be suffici5t to elim9ate ! unreasonable risk & action describ$ 9 p>agraph 7#b7 ( ?is subsection is necess>y to elim9ate su* risk1 ! ,secret>y may ord] ! develop]1 import]1 or any di/ributor ( su* 9 vitro cl9ical te/1 or any comb9ation ( su* p]sons1 to submit to him )9 a reasonable "t a plan = tak+ "o or m ( ! actions describ$ 9 p>agraph 7#b74 ,an ord] issu$ "u ! prec$+ s5t5ce :i* is direct$ to m ?an "o p]son %all specify :i* p]son may decide :i* action %all be tak5 "u su* plan & ! p]son specifi$ %all be ! p]son :o ! ,secret>y det]m9es be>s ! pr9cipal1 ultimate f9ancial responsibility = action tak5 "u ! plan unless ! ,secret>y _c det]m9e :o be>s su* responsibility or ! ,secret>y det]m9es t ! protection ( ! public heal? requires t su* decision be made by a p]son 7includ+ a heal? pr(essional or us] ( ! 9 vitro cl9ical te/7 o!r ?an ! p]son ! ,secret>y det]m9es be>s su* responsibility4 7,b7 ,secret>y approval ( plan ,! ,secret>y %all approve a plan submitt$ pursuant to an ord] issu$ "u subp>agraph 7,a7 unless ! ,secret>y det]m9es 7aft] af=d+ opportunity = an in=mal he>+7 t ! action or actions to be tak5 "u ! plan or ! mann] 9 :i* su* action or actions are to be tak5 "u ! plan w n assure t ! unreasonable risk ) respect to :i* su* ord] 0 issu$ w be elim9at$4 ,if ! ,secret>y disapproves a plan1 ! ,secret>y %all ord] a revis$ plan to be submitt$ )9 a reasonable "t4 ,if ! ,secret>y det]m9es 7aft] af=d+ opportunity = an in=mal he>+7 t ! revis$ plan is unsatisfactory or if no revis$ plan or no initial plan has be5 submitt$ to ! ,secret>y )9 ! prescrib$ "t1 ! ,secret>y %all-- 7i7 prescribe a plan to be c>ri$ out by ! p]son or p]sons to :om ! ord] issu$ "u subp>agraph 7,a7 0 direct$2 or 7ii7 aft] af=d+ an opportunity = an in=mal he>+1 by ord] prescribe a plan to be c>ri$ out by a p]son :o is a develop]1 import]1 di/ributor1 or retail] ( ! 9 vitro cl9ical te/ ) respect to :i* ! ord] 0 issu$ b to :om ! ord] "u subp>agraph 7,a7 0 n direct$4 7#b7 ,actions on a plan ,! actions t may be tak5 "u a plan submitt$ "u an ord] issu$ "u p>agraph 7#a77;,a7 are z foll[s3 7,a7 ,to repair ! 9 vitro cl9ical te/ s t x does n pres5t ! unreasonable risk ( sub/antial h>m ) respect to :i* ! ord] "u p>agraph 7#a77;,a7 0 issu$4 7,b7 ,to replace ! 9 vitro cl9ical te/ ) a l or equival5t te/ :i* is 9 con=mity ) all applicable requirem5ts ( ?is ,act4 7,c7 ,to refund ! pur*ase price ( ! 9 vitro cl9ical te/ 7less a reasonable all[ance = use if su* 9 vitro cl9ical te/ has be5 9 ! possession ( ! us] = "o ye> or m at ! "t ( notice ord]$ "u subsection 7a71 or at ! "t ! us] receives actual notice ( ! unreasonable risk ) respect to :i* ! ord] 0 issu$ "u p>agraph 7#a77;,a71 :i*ev] occurs fir/74 7#c7 ,no *>ge ,no *>ge %all be made to any p]son 7o!r ?an a develop]1 import]1 di/ributor1 or retail]7 = us+ a rem$y describ$ 9 p>agraph 7#b7 & provid$ "u an ord] issu$ "u p>agraph 7#a71 & ! p]son subject to ! ord] %all reimburse ea* p]son 7o!r ?an a develop]1 manufactur]1 import]1 di/ributor1 or retail]7 :o is entitl$ to su* a rem$y = any reasonable & =eseeable exp5ses actually incurr$ by su* p]son 9 us+ su* rem$y4 7c7 ,reimbursem5t ,an ord] issu$ "u subsection 7b77#a77;,a7 ) respect to an 9 vitro cl9ical te/ may require any p]son :o is a develop]1 import]1 di/ributor1 or retail] ( ! 9 vitro cl9ical te/ to reimburse any o!r p]son :o is a develop]1 import]1 di/ributor1 or retail] ( su* 9 vitro cl9ical te/ = su* o!r p]son's exp5ses actually incurr$ 9 connection ) c>ry+ out ! ord] if ! ,secret>y det]m9es su* reimbursem5t is requir$ = ! protection ( ! public heal?4 ,any su* requirem5t %all n affect any rights or obligations "u any contract to :i* ! p]son receiv+ reimbursem5t or ! p]son mak+ su* reimbursem5t is a p>ty4 7d7 ,recall ,au?ority 7#a7 ,9 g5]al ,if ! ,secret>y f9ds t !re is a reasonable probability t an 9 vitro cl9ical te/ approv$ "u section #ehg;,b or (f]$ "u a te*nology c]tification ord] "u section #ehg;,d w\ld cause s]i\s1 adv]se heal? consequ5ces or dea?1 includ+ by ! abs5ce1 significant delay1 or discont9uation ( appropriate m$ical treatm5t1 ! ,secret>y %all issue an ord] requir+ ! appropriate p]son 7includ+ ! develop]s1 import]s1 di/ributors1 or retail]s ( ! 9 vitro cl9ical te/7-- 7,a7 to imm$iately cease di/ribution ( su* 9 vitro cl9ical te/2 & 7,b7 to imm$iately notify heal? pr(essionals & applicable 9 vitro cl9ical te/ us] facilities ( ! ord] & to in/ruct su* pr(essionals & facilities to cease use ( su* 9 vitro cl9ical te/4 7#b7 ,in=mal he>+ ,! ord] issu$ "u p>agraph 7#a77;,a71 %all provide ! p]son subject to ! ord] ) an opportunity = an in=mal he>+1 to be held n lat] ?an #aj cal5d> days aft] ! date ( ! issuance ( ! ord]1 on ! actions requir$ by ! ord] & on :e!r ! ord] %\ld be am5d$ to require a recall ( su* 9 vitro cl9ical te/4 ,if1 aft] provid+ an opportunity = su* a he>+1 ! ,secret>y det]m9es t inadequate gr\nds exi/ to support ! actions requir$ by ! ord]1 ! ,secret>y %all vacate ! ord]4 7#c7 ,am5d$ ord] 7,a7 ,9 g5]al ,if1 aft] provid+ an opportunity = an in=mal he>+ "u p>agraph 7#b71 ! ,secret>y det]m9es t ! ord] %\ld be am5d$ to include a recall ( ! 9 vitro cl9ical te/ ) respect to :i* ! ord] 0 issu$1 ! ,secret>y %all1 except z provid$ 9 subp>agraph 7,b71 am5d ! ord] to require a recall4 ,! ,secret>y %all specify a timetable 9 :i* ! recall w occur & %all require p]iodic reports describ+ ! progress ( ! recall4 7,b7 ,requirem5ts ,an am5d$ ord] "u subp>agraph 7,a7-- 7i7 %all n include recall ( ! 9 vitro cl9ical te/ f individuals2 7ii7 %all n include recall ( an 9 vitro cl9ical te/ f te/ us] facilities if ! ,secret>y det]m9es t ! risk ( recall+ su* 9 vitro cl9ical te/ f ! facilities pres5ts a great] heal? risk ?an ! heal? risk ( n recall+ ! 9 vitro cl9ical te/ f use2 & 7iii7 %all provide = notice to individuals subject to ! risks associat$ ) ! use ( su* 9 vitro cl9ical te/4 ,9 provid+ ! notice requir$ by ?is clause1 ! ,secret>y may use ! assi/ance ( heal? pr(essionals :o prescrib$1 ord]$1 or us$ su* an 9 vitro cl9ical te/ = individuals4 7#d7 ,cl>ification ,! rem$y provid$ by ?is subsection %all be 9 addition to rem$ies provid$ by subsections 7a71 7b71 & 7c74 #ehg;,,aa4 ,applicability 7a7 ,9 g5]al ,an 9 vitro cl9ical te/ %all be subject to ! requirem5ts ( ?is sub*apt]1 except z o!rwise provid$ 9 ?is sub*apt]4 ,laboratory op]ations %all n be subject to ! requirem5ts ( ?is sub*apt]4 7b7 ,int]/ate comm]ce ,any 9 vitro cl9ical te/ t is (f]$1 includ+ by mak+ available = cl9ical use 9 ! ,unit$ ,/ates is deem$ to be an act t con/itutes introduction into int]/ate comm]ce = purposes ( en=c+ ! requirem5ts ( ?is ,act4 7c7 ,lea/ burd5some requirem5ts 7#a7 ,9 g5]al ,9 c>ry+ out ?is sub*apt]1 ! ,secret>y %all consid] ! lea/ burd5some means necess>y to meet ! applicable /&>d1 & o!r regulatory requirem5ts1 z det]m9$ by ! ,secret>y4 7#b7 ,necess>y def9$ ,= purposes ( p>agraph 7#a71 ! t]m necess>y means ! m9imum requir$ in=mation t w\ld support a det]m9ation by ! ,secret>y t ! application meet ! applicable /&>d or regulatory requirem5t1 z det]m9$ by ! ,secret>y4 7d7 ,s]vice ( ord]s ,ord]s ( ! ,secret>y "u ?is section ) respect to applications "u subsection 7a7 or 7b7 ( section #ehg;,b or supplem5ts "u subsection 7f7 ( su* section %all be s]v$-- 7#a7 9 p]son by any (fic] or employee ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices designat$ by ! ,secret>y2 or 7#b7 by mail+ ! ord] by regi/]$ mail or c]tifi$ mail or electronic equival5t address$ to ! applicant at ! la/ kn[n address 9 ! records ( ! ,secret>y4 7e7 ,laboratories & blood & tissue e/abli%m5ts 7#a7 ,relation to laboratory c]tification pursuant to section #cec ( ! ,public ,heal? ,s]vice ,act ,no?+ 9 ?is sub*apt] %all be con/ru$ to modify ! au?ority ( ! ,secret>y ) respect to laboratories or cl9ical laboratories "u section #cec ( ! ,public ,heal? ,s]vice ,act4 7#b7 ,avoid+ duplication ,9 implem5t+ ?is sub*apt]1 ! ,secret>y %all avoid issu+ or en=c+ regulations or guidance t are duplicative ( regulations or guidance "u section #cec ( ! ,public ,heal? ,s]vice ,act4 7#c7 ,blood & tissue ,no?+ 9 ?is sub*apt] %all be con/ru$ to modify ! au?ority ( ! ,secret>y ) respect to laboratories1 e/abli%m5ts1 or o!r facilities to ! ext5t !y are engag$ 9 ! propagation1 manufacture1 or prep>ation1 includ+ fill+1 label+1 packag+1 & /orage1 ( blood1 blood compon5ts1 human cells1 tissues1 or tissue products pursuant to any requirem5ts "u ?is ,act or section #cea or #cfa ( ! ,public ,heal? ,s]vice ,act4 7f7 ,n comb9ation product ,a product con/itut$ ( a device & an 9 vitro cl9ical te/ is n a comb9ation product & %all be regulat$ z a device4 7g7 ,practice ( m$ic9e ,no?+ 9 ?is sub*apt] %all be con/ru$ to limit or int]f]e ) ! au?ority ( a heal? c>e practition] to prescribe or adm9i/] any lawfully (f]$ 9 vitro cl9ical te/ = any condition or disease )9 a legitimate heal? c>e practition]-pati5t relation%ip pursuant to applicable ,f$]al or ,/ate law4 7h7 ,sale1 di/ribution1 label+ ,no?+ 9 ?is section %all be con/ru$ to limit ! au?ority ( ! ,secret>y to e/abli% or en=ce re/rictions on ! sale1 di/ribution1 or label+ ( an 9 vitro cl9ical te/ "u ?is ,act4 7i7 ,promotion ( unapprov$ uses ,no?+ 9 ?is section %all be con/ru$ to alt] any prohibition on ! promotion ( unapprov$ uses ( legally m>ket$ 9 vitro cl9ical te/s4 #ehg;,,bb4 ,judicial review 7a7 ,9 g5]al ,n lat] ?an #cj days aft] an ord] issu$ pursuant to sections #ehg;,b or #ehg;,d1 any p]son adv]sely affect$ by su* ord] may file a petition ) ! ,unit$ ,/ates ,c\rt ( ,appeals = ! ,di/rict ( ,columbia or = ! circuit :]e9 su* p]son resides or has a pr9cipal place ( bus9ess = judicial review ( su* ord]1 9 accordance ) ! proc$ure set =? 9 section #eag7;a74 7b7 ,application ( provisions ,subsections 7a7 ?r\gh 7e7 ( section #eag %all apply ) respect to a petition "u subsection 7a7 ( ?is section 9 ! same mann] su* subsections apply to a petition "u section #eag4 ,subsection 7f7 ( section #eag %all apply to an ord] issu$ "u section #ehg;,b or #ehg;,d4 4 #hbd4 ,en=cem5t & o!r provisions 7a7 ,prohibit$ acts ,section #cja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca71 z am5d$ by section #haa1 is fur!r am5d$-- 7#a7 9 p>agraphs 7a71 7b71 7c71 7g71 7h71 7k71 7q71 7r71 & 7y71 by ins]t+ 9 vitro cl9ical te/1 aft] device1 ea* place x appe>s2 7#b7 9 p>agraph 7g71 by ins]t+ aft] misbr&$1 1 & ! developm5t )9 any ,t]ritory ( any 9 vitro cl9ical te/ t is adult]at$ or misbr&$2 7#c7 9 p>agraph 7y71 by ins]t+ or #ehg,q aft] section #ebc ea* place x appe>s2 7#d7 9 p>agraph 7ff71 by /rik+ or device & ins]t+ 1 device1 or 9 vitro cl9ical te/2 & 7#e7 by add+ at ! end1 ! foll[+3 7kkk7 7#a7 ,=g+1 c\nt]feit+1 simulat+1 or falsely repres5t+1 or )\t prop] au?ority us+ any m>k1 /amp1 tag1 label1 or o!r id5tification ^u any 9 vitro cl9ical te/ or conta9]1 packag+1 or label+ !re( s z to r5d] su* 9 vitro cl9ical te/ a c\nt]feit 9 vitro cl9ical te/4 7#b7 ,mak+1 sell+1 dispos+ (1 or keep+ 9 possession1 control1 or cu/ody1 or conceal+ any pun*1 die1 plate1 /one1 or o!r ?+ design$ to pr9t1 impr9t1 or reproduce ! tradem>k1 trade "n1 or o!r id5tify+ m>k or impr9t ( ano!r or any lik5ess ( any ( ! =ego+ ^u any 9 vitro cl9ical te/ or conta9]1 packag+1 or label+ !re( s z to r5d] su* 9 vitro cl9ical te/ a c\nt]feit 9 vitro cl9ical te/4 7#c7 ,! do+ ( any act :i* causes an 9 vitro cl9ical te/ to be a c\nt]feit 9 vitro cl9ical te/1 or ! sale or disp5s+1 or ! hold+ = sale or disp5s+1 ( a c\nt]feit 9 vitro cl9ical te/4 7lll7 7#a7 ,! introduction or deliv]y = introduction into int]/ate comm]ce ( an 9 vitro cl9ical te/ 9 violation ( section #ehg;,a7a74 7#b7 ,! mak+ ( a false1 fraudul5t1 or deceptive /atem5t ab\t an 9 vitro cl9ical te/ t is exempt f prem>ket review "u section #ehg;,c4 7#c7 ,! failure to ma9ta9 complete & accurate docum5tation = an exemption z requir$ "u section #ehg;,c or ! failure to provide label+ requir$ "u section #ehg,l4 7#d7 ,) respect to an 9 vitro cl9ical te/1 ! submission ( any report or li/+ "u ?is ,act t is false or mislead+ 9 any mat]ial respect4 7#e7 ,! failure to comply ) a condition ( approval1 or re/riction requir$ "u an approv$ application "u section #ehg;,b2 ! failure to p]=m a risk analysis requir$ by section #ehg;,b2 ! failure to submit an annual update requir$ "u section #ehg;,j7c77#b77;,b72 or ! failure to complete po/m>ket surveillance z requir$ "u section #ehg,x4 7#f7 ,! failure to comply ) applicable requirem5ts to submit an application or report "u section #ehg;,d7e74 7#g7 ,! failure to comply ) applicable mitigat+ measures e/abli%$ "u section #ehg;,e or to submit1 ma9ta91 or make available ! docum5tation requir$ "u section #ehg;,e7b72 or ! failure to comply ) applicable p]=mance /&>ds e/abli%$ "u section #ehg,r4 7#h7 ,! failure to regi/] 9 accordance ) section #ehg;,j1 ! failure to provide in=mation requir$ "u section #ehg;,j7b71 or ! failure to ma9ta9 or submit in=mation requir$ "u section #ehg;,j7c74 7#i7 ,! failure to comply ) requirem5ts "u section #ehg,m or #ehg,n1 ! failure to comply ) a re/riction requir$ "u section #ehg,o1 or ! failure to comply ) label+ & adv]tis+ requirem5ts "u section #ehg,o7b74 7#aj7 ,! failure to comply ) ! requirem5ts ( section #ehg,q4 7#aa7 ,! failure to comply ) any requirem5t ( section #ehg,s2 ! failure to furni% any notification1 in=mation1 mat]ial1 or report requir$ "u section #ehg,s2 or ! failure to comply ) an ord] issu$ "u section #ehg,s4 7#ab7 ,! failure to furni% in=mation reque/$ by ! ,secret>y "u #ehg;,g7d77#b74 4 7b7 ,p5alties ,section #cjc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 is am5d$-- 7#a7 9 subsection 7b77#h71 by ins]t+ or c\nt]feit 9 vitro cl9ical te/ aft] c\nt]feit drug2 7#b7 9 subsection 7c7-- 7,a7 by /rik+ 2 or 7#e7 & ins]t+ 2 7#e72 & 7,b7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 2 or 7#f7 = hav+ violat$ section #cja7kkk77#b7 if su* p]son act$ 9 good fai? & _h no reason to believe t use ( ! pun*1 die1 plate1 /one1 or o!r ?+ involv$ w\ld result 9 an 9 vitro cl9ical te/ be+ a c\nt]feit 9 vitro cl9ical te/1 or = hav+ violat$ section #cja7kkk77#c7 if ! p]son do+ ! act or caus+ x to be done act$ 9 good fai? & _h no reason to believe t ! 9 vitro cl9ical te/ 0 a c\nt]feit 9 vitro cl9ical te/2 & 7#c7 9 subsection 7f77#a7-- 7,a7 9 subp>agraph 7,a7-- 7i7 by ins]t+ or 9 vitro cl9ical te/s aft] :i* relates to devices2 7ii7 by ins]t+ or section #ehg,q7a77#a7 aft] section #gjd7;g72 & 7iii7 by ins]t+ or 9 vitro cl9ical te/s1 z applicable be=e ! p]iod at ! end ( ! second s5t5ce2 & 7,b7 9 subp>agraph 7,b77i71 by /rik+ or #ebj7;f7 & ins]t+ 1 #ebj7;f71 #ehg,k1 or #ehg,m14 7c7 ,seizure ,section #cjd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccd7 is am5d$-- 7#a7 9 subsection 7a77#b7-- 7,a7 by /rik+ 1 & 7,e7 & ins]t+ 1 7,e72 & 7,b7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 & 7,f7 ,any 9 vitro cl9ical te/ t is a c\nt]feit 9 vitro cl9ical te/1 7,g7 ,any conta9]1 packag+1 or label+ ( a c\nt]feit 9 vitro cl9ical te/1 & 7,h7 ,any pun*1 die1 plate1 /one1 label+1 conta9]1 or o!r ?+ us$ or design$ = use 9 mak+ a c\nt]feit 9 vitro cl9ical te/2 7#b7 9 subsection 7d77#a71 by ins]t+ 9 vitro cl9ical te/1 aft] device12 & 7#c7 9 subsection 7g7-- 7,a7 9 p>agraph 7#a71 by ins]t+ 1 9 vitro cl9ical te/1 aft] device ea* place x appe>s2 & 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,a71 by ins]t+ 1 9 vitro cl9ical te/1 aft] device2 & 7ii7 9 subp>agraph 7,b71 by ins]t+ or 9 vitro cl9ical te/ aft] device ea* place x appe>s4 7d7 ,deb>m5t1 tempor>y d5ial ( approval1 & susp5sion ,section #cjf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cce;a7 is am5d$ by add+ at ! end ! foll[+3 7n7 ,9 vitro cl9ical te/s2 m&atory deb>m5t reg>d+ ?ird-,p>ty inspections & reviews 7#a7 ,9 g5]al ,if ! ,secret>y f9ds t a p]son has be5 convict$ ( a felony = a violation ( section #cja7;gg7 or #cja7kkk77#a71 ! ,secret>y %all deb> su* p]son f be+ accr$it$ "u section #ehg,q & f c>ry+ out activities "u an agreem5t describ$ 9 section #hjc7;b74 7#b7 ,deb>m5t p]iod ,! ,secret>y %all deb> a p]son "u p>agraph 7#a7 = ! foll[+ p]iods3 7,a7 ,! p]iod ( deb>m5t ( a p]son 7o!r ?an an individual7 %all n be less ?an #a ye> or m ?an #aj ye>s1 b if an act lead+ to a subsequ5t deb>m5t "u su* p>agraph occurs )9 #aj ye>s aft] su* p]son has be5 deb>r$ "u su* p>agraph1 ! p]iod ( deb>m5t %all be p]man5t4 7,b7 ,! deb>m5t ( an individual %all be p]man5t4 7#c7 ,t]m9ation ( deb>m5t2 judicial review2 o!r matt]s ,subsections 7c77#c71 7d71 7e71 7i71 7j71 & 7l77#a7 apply ) respect to a p]son 7o!r ?an an individual7 or an individual :o is deb>r$ "u p>agraph 7#a7 to ! same ext5t & 9 ! same mann] z su* subsections apply ) respect to a p]son :o is deb>r$ "u subsection 7a77#a71 or an individual :o is deb>r$ "u subsection 7a77#b71 respectively4 4 7e7 ,exp&$ access to unapprov$ !rapies & diagno/ics ,section #efa ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7 is am5d$-- 7#a7 9 subsections 7a7 ?r\gh 7d7-- 7,a7 by /rik+ or inve/igational devices ea* place x appe>s & ins]t+ 1 inve/igational devices1 or inve/igational 9 vitro cl9ical te/s2 & 7,b7 by /rik+ or inve/igational device ea* place x appe>s 7o!r ?an ! second su* place 9 p>agraph 7#c77;,a77 ( subsection 7c77 & ins]t+ 1 inve/igational device1 or inve/igational 9 vitro cl9ical te/2 7#b7 9 subsection 7b77#d7 by /rik+ or #ebj7;g7 ea* place x appe>s & ins]t+ 1 #ebj7;g71 or #ehg,s2 7#c7 9 subsection 7c7-- 7,a7 by am5d+ ! subsection head+ to read3 ,treatm5t ,inve/igational ,new ,drug ,applications1 ,treatm5t ,inve/igational ,device ,exemptions1 & ,treatm5t ,inve/igational 9 ,vitro ,cl9ical ,te/ ,exemptions42 7,b7 9 p>agraph 7#c77;,a71 by /rik+ or inve/igational device exemption 9 effect "u section #ebj7;g7 & ins]t+ 1 inve/igational device exemption 9 effect "u section #ebj7;g71 or inve/igational 9 vitro cl9ical te/ exemption "u section #ehg,s2 7,c7 by /rik+ or treatm5t inve/igational device exemption ea* place x appe>s & ins]t+ 1 treatm5t inve/igational device exemption1 or treatm5t inve/igational 9 vitro cl9ical te/ exemption2 7,d7 9 p>agraph 7#e71 by /rik+ or #ebj7;g7 & ins]t+ 1 #ebj7;g71 or #ehg,s2 & 7,e7 9 ! matt] foll[+ p>agraph 7#g7 by /rik+ or #ebj7;g7 ea* place x appe>s & ins]t+ 1 #ebj7;g71 or #ehg,s2 & 7#d7 by am5d+ subsection 7e7 to read z foll[s3 7e7 ,def9itions ,9 ?is section1 ! t]ms inve/igational drug1 inve/igational device1 inve/igational 9 vitro cl9ical te/1 treatm5t inve/igational new drug application1 treatm5t inve/igational device exemption1 & treatm5t inve/igational 9 vitro cl9ical te/ exemption %all h ! mean+s giv5 ! t]ms 9 regulations prescrib$ by ! ,secret>y4 4 7f7 ,optimiz+ global cl9ical trials ,section #efi;,a7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;a7b77 is am5d$-- 7#a7 by /rik+ subsection ea* place x appe>s & ins]t+ p>agraph2 & 7#b7 by ins]t+ an 9 vitro cl9ical te/1 z def9$ 9 p>agraph 7ss7 ( su* section1 be=e or a biological product4 7g7 ,pati5t p>ticipation 9 m$ical product discussion ,! head+ ( subsection 7a7 ( section #efi;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c7 is am5d$ by /rik+ drugs & devices & ins]t+ drugs1 devices1 & 9 vitro cl9ical te/s4 7h7 ,regulations & he>+s ,clause 7ii7 ( section #gja7;h77#a77;,c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cga7;h77#a77;,c77 is am5d$-- 7#a7 by ins]t+ & 9 vitro cl9ical te/s aft] devices2 & 7#b7 by mov+ ! m>g9 ( su* clause #b ems to ! left4 7i7 ,records ,section #gjc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgc7 is am5d$-- 7#a7 by ins]t+ 9 vitro cl9ical te/s1 aft] devices1 ea* place su* t]m appe>s2 & 7#b7 by ins]t+ 9 vitro cl9ical te/1 aft] device1 ea* place su* t]m appe>s4 7j7 ,factory inspection ,section #gjd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7 7o!r ?an subsection 7g77 is am5d$-- 7#a7 by /rik+ drugs or devices ea* place x appe>s & ins]t+ drugs1 devices1 or 9 vitro cl9ical te/s2 7#b7 9 subsection 7a77#a71 9 ! f\r? s5t5ce1 by /rik+ or *apt] ,,ix & ins]t+ section #ehg,s1 section #ehg,m1 section #ehg,n1 or *apt] ,,ix2 7#c7 aft] mak+ ! am5dm5ts 9 p>agraphs 7#a7 & 7#b71 by ins]t+ 9 vitro cl9ical te/s1 aft] devices1 ea* place x appe>s2 7#d7 9 subsection 7a77#b77;,b7-- 7,a7 by ins]t+ or 9 vitro cl9ical te/s aft] prescribe or use devices2 & 7,b7 by ins]t+ or 9 vitro cl9ical te/s aft] process devices2 7#e7 by ins]t+ 9 vitro cl9ical te/1 aft] device1 ea* place x appe>s2 7#f7 9 subsection 7e71 by ins]t+ 1 or section #ehg,m1 #ehg,n1 or #ehg,s1 aft] section #eai or #ebj7;g72 7#g7 9 subsection 7f77#c7-- 7,a7 9 subp>agraph 7,a71 by /rik+ or at ! end2 7,b7 9 subp>agraph 7,b71 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7,c7 aft] subp>agraph 7,b71 by ins]t+ ! foll[+3 7,c7 is accr$it$ "u section #ehg,q4 2 & 7#h7 by add+ at ! end ! foll[+3 7i7 ,= purposes ( ?is section1 ! t]m e/abli%m5t includes a laboratory p]=m+ an 9 vitro cl9ical te/4 4 7k7 ,publicity ,section #gje7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cge7;b77 is am5d$ by ins]t+ 9 vitro cl9ical te/s1 aft] devices14 7l7 ,presumption ,section #gji ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;a7 is am5d$ by ins]t+ 9 vitro cl9ical te/1 aft] device14 7m7 ,li/+ & c]tification ( color additives = foods1 drugs1 & cosmetics ,section #gba7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;e7a77 is am5d$-- 7#a7 9 ! matt] prec$+ p>agraph 7#a71 by ins]t+ or 9 vitro cl9ical te/s aft] or devices2 & 7#b7 9 ! flu% text foll[+ p>agraph 7#b7-- 7,a7 by ins]t+ or an 9 vitro cl9ical te/ aft] a device2 & 7,b7 by ins]t+ or 9 vitro cl9ical te/s aft] devices4 7n7 ,imports & exports ,section #hja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 by ins]t+ 9 vitro cl9ical te/s1 aft] devices1 ea* place x appe>s2 & 7,b7 by ins]t+ 9 ! case ( an 9 vitro cl9ical te/1 ! te/ does n con=m to ! applicable requirem5ts ( section #ehg,k1 or aft] requirem5ts ( section #ebj7;f71 or2 7#b7 9 subsection 7d77#c7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! matt] prec$+ clause 7i71 by ins]t+ & no compon5t ( an 9 vitro cl9ical te/ or o!r article ( 9 vitro cl9ical te/ t requires fur!r process+1 aft] heal?-relat$ purposes2 7ii7 9 clause 7i71 by /rik+ drug or device & ins]t+ drug1 device1 or 9 vitro cl9ical te/2 & 7iii7 9 clause 7i77,i71 by ins]t+ 9 vitro cl9ical te/1 aft] device12 & 7,b7 9 subp>agraph 7,b71 by ins]t+ 9 vitro cl9ical te/1 aft] device12 7#c7 9 subsection 7e77#a71 by ins]t+ 9 vitro cl9ical te/1 aft] device12 & 7#d7 9 subsection 7o7-- 7,a7 by ins]t+ or 9 vitro cl9ical te/ aft] device2 & 7,b7 by ins]t+ 1 or "u section #ehg;,j ( ea* =eign e/abli%m5t1 aft] section #eaj7;i7 ( ea* e/abli%m5t4 7o7 ,(fice ( int]national relations ,section #hjc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #chc7 is am5d$-- 7#a7 9 subsection 7b7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by ins]t+ & 9 vitro cl9ical te/s aft] devices2 & 7,b7 9 p>agraph 7#a71 by /rik+ 1 & & ins]t+ & quality requirem5ts e/abli%$ "u section #ehg,k2 &2 & 7#b7 9 subsection 7c7-- 7,a7 9 p>agraph 7#b71 by ins]t+ 9 vitro cl9ical te/s1 aft] devices12 & 7,b7 9 p>agraph 7#d71 by ins]t+ or 9 vitro cl9ical te/s aft] devices4 7p7 ,recognition ( =eign gov]nm5t inspections ,section #hji7;a77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #chd;e7a77#a77 is am5d$ by ins]t+ 1 or ( =eign e/abli%m5ts regi/]$ "u section #ehg;,j aft] #eaj7;h74 7q7 ,food & drug adm9i/ration ,section #ajjc7;b77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cic7;b77#b77 is am5d$-- 7#a7 9 subp>agraph 7,d71 by /rik+ & at ! end2 7#b7 9 subp>agraph 7,e71 by /rik+ ! semicolon at ! end & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7,f7 9 vitro cl9ical te/s are analytically & cl9ically valid2 4 7r7 ,(fice ( wom5's heal? ,section #ajaa7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cii;b7b77 is am5d$-- 7#a7 9 p>agraph 7#a71 by ins]t+ 9 vitro cl9ical te/s1 aft] devices12 & 7#b7 9 p>agraph 7#d71 by /rik+ & device manufactur]s & ins]t+ device manufactur]s1 & 9 vitro cl9ical te/ develop]s4 7s7 ,c\nt]measure provisions ( ! public heal? s]vice act ,title ,,iii ( ! ,public ,heal? ,s]vice ,act is am5d$-- 7#a7 9 section #cai;,f-#a7;a77#b77;,a7 7#db ,u4,s4,c4 #bdg;d-#f;a7a77#b77;,a77-- 7,a7 9 ! matt] prec$+ clause 7i7-- 7i7 by /rik+ or device & ins]t+ device2 & 7ii7 by ins]t+ or an 9 vitro cl9ical te/s 7z t t]m is def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7ss7771 aft] ,act 7#ba ,u4,s4,c4 #cba7;h77712 & 7,b7 9 ea* ( clauses 7ii7 & 7iii71 by /rik+ or device & ins]t+ device1 or 9 vitro cl9ical te/2 7#b7 9 section #cai;,f-#b7;c77#a77;,b7 7#db ,u4,s4,c4 #bdg;d-#f;b7c77#a77;,b77-- 7,a7 by /rik+ or device & ins]t+ device2 & 7,b7 by ins]t+ 1 or an 9 vitro cl9ical te/ 7z t t]m is def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7ss777 aft] ,act 7#ba ,u4,s4,c4 #cba7;h77712 & 7#c7 9 section #cai;,f-#c7;i77#g7 7#db ,u4,s4,c4 #bdg;d-#f;d7i77#g77-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a7-- 7i7 by /rik+ or device & ins]t+ device2 & 7ii7 by ins]t+ or an 9 vitro cl9ical te/s 7z t t]m is def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7ss7771 aft] ,act 7#ba ,u4,s4,c4 #cba7;h772 7,b7 9 subp>agraph 7,a7-- 7i7 by mov+ ! m>g9 ( clause 7iii7 #b ems to ! left2 & 7ii7 9 clause 7iii71 by /rik+ or device & ins]t+ device1 or 9 vitro cl9ical te/2 & 7,c7 9 subp>agraph 7,b7-- 7i7 9 clause 7i71 by ins]t+ or (f]$ "u a te*nology c]tification ord] aft] approv$ or cle>$2 & 7ii7 9 clause 7ii71 by /rik+ or #ebj7;g7 & ins]t+ 1 #ebj7;g71 or #ehg,s4 #hbe4 ,transition 7a7 ,implem5tation 7#a7 ,effective date 7,a7 ,9 g5]al ,except z o!rwise provid$ 9 ?is section1 ! am5dm5ts made by ?is ,act %all take effect on ,octob] #a1 #bjbg 79 ?is section & 9 sub*apt] ,j ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act1 ref]r$ to 9 ?is section z ! effective date ( ?is ,act74 7,b7 ,exceptions 7i7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 may take ! actions describ$ 9 p>agraph 7#b71 & may exp5d su* funds z ! ,secret>y det]m9es necess>y to ensure an ord]ly transition1 includ+ prior to ! effect date ( ?is ,act4 7ii7 ,implem5tation ( c]ta9 provisions ,! ,secret>y may implem5t sections #ehg;,j & #ehg,u ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by section #hbc7 beg9n+ on ,octob] #a1 #bjbd1 & su* sections may take effect n e>li] ?an ,octob] #a1 #bjbg1 to ! ext5t & = ! purposes indicat$ 9 su* sections4 ,9 ! case ( a develop] :o1 betwe5 ,octob] #a1 #bjbd1 & ! effective date ( ?is ,act1 regi/]s "u su* section #ehg;,j ) respect to an article t is an 9 vitro cl9ical te/1 su* develop] %all n be requir$ to regi/] ) respect to su* article "u section #eaj ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj74 7#b7 ,actions ,! ,secret>y-- 7,a7 %all-- 7i7 )9 #a ye> ( ! date ( enactm5t ( ?is ,act1 hold ! public meet+s describ$ 9 section #ehg;,d7i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by section #hbc72 7ii7 )9 #c ye>s ( ! date ( enactm5t ( ?is ,act1 promulgate f9al regulations requir$ "u ! am5dm5ts made by ?is ,act2 & 7iii7 )9 #cj mon?s ( ! date ( enactm5t ( ?is ,act1 issue f9al guidance on applicability requirem5ts "u am5dm5ts made by ?is ,act2 & 7,b7 may take additional actions aft] ! date ( enactm5t t ! ,secret>y det]m9es necess>y to ensure an ord]ly transition1 includ+-- 7i7 e/abli%m5t ( mitigat+ measures = an 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s1 :i* may n take effect until aft] ! effective date describ$ 9 p>agraph 7#a77;,a72 & 7ii7 e/abli%m5t ( ! compreh5sive te/ in=mation sy/em "u section #ehg,t ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #hbc4 7#c7 ,applicability ( guidance & regulations ,not)/&+ ! date on :i* guidance or regulations are issu$ "u p>agraph 7#b7 & section #ehg,k ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #hbc1 no guidance or regulations issu$ pursuant to ! am5dm5ts made by ?is ,act %all be implem5t$ or take effect until ! effective date ( ?is ,act1 except z o!rwise specifi$ 9 ?is ,act 7includ+ ! am5dm5ts made by ?is ,act74 7b7 ,application ( au?orities to 9 vitro cl9ical te/s "u review on ! effective date ( ?is act ,= any 9 vitro cl9ical te/ = :i* a submission = approval "u section #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e71 cle>ance "u section #eaj7k7 ( su* ,act 7#ba ,u4,s4,c4 #cfj7k771 au?orization "u section #eac7;f77#b7 ( su* ,act 7#ba ,u4,s4,c4 #cfj;c7f77#b771 or lic5sure "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 is p5d+ on ! effective date ( ?is ,act1 includ+ transitional 9 vitro cl9ical te/s z describ$ 9 subsection 7c71 ! ,secret>y may review & take action on su* submission aft] ! effective date ( ?is ,act accord+ to ! /atutory provision "u :i* su* submission 0 submitt$4 7c7 ,application ( au?orities to transitional ,9 vitro cl9ical te/s 7#a7 ,def9ition ,= purposes ( ?is section1 ! t]m transitional 9 vitro cl9ical te/ means an 9 vitro cl9ical te/ t-- 7,a7 is fir/ (f]$ = cl9ical use dur+ ! p]iod beg9n+ on ! date ( enactm5t ( ?is ,act & end+ on ! effective date ( ?is ,act2 7,b7 is develop$ by a cl9ical laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfc;a7 t meets ! requirem5ts = p]=m+ high-complexity te/+ & p]=m$-- 7i7 9 ! same cl9ical laboratory 9 :i* ! te/ 0 develop$ & = :i* a c]tification is /ill 9 effect "u su* section #cec t meets ! requirem5ts to p]=m te/s ( high complexity2 7ii7 by ano!r laboratory = :i* a c]tificate is 9 effect "u su* section #cec t meets ! requirem5ts to p]=m te/s ( high complexity1 is )9 ! same corporate organization1 & has common own]%ip by ! same p>5t corporation z ! laboratory 9 :i* ! te/ 0 develop$2 or 7iii7 9 ! case ( a te/ t 0 develop$ by ! ,c5t]s = ,disease ,control & ,prev5tion or ano!r laboratory 9 a public heal? laboratory network coord9at$ or manag$ by ! ,c5t]s = ,disease ,control & ,prev5tion1 by a cl9ical laboratory = :i* a c]tificate is 9 effect "u su* section #cec t meets ! requirem5ts to p]=m te/s ( high complexity1 & t is )9 a public heal? laboratory network coord9at$ or manag$ by ! ,c5t]s = ,disease ,control & ,prev5tion2 & 7,c7 :5 fir/ (f]$1 is n approv$ "u section #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 cle>$ "u section #eaj7k7 ( su* ,act1 au?oriz$ "u section #eac7;f77#b7 ( su* ,act1 subject to a humanit>ian device exemption "u section #ebj7m7 ( su* ,act 7#ba ,u4,s4,c4 #cfj;j7m771 subject to an exemption = inve/igation use "u section #ebj7;g7 ( su* ,act 7#ba ,u4,s4,c4 #cfj;j7g771 au?oriz$ "u section #efd ( su* ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c71 or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 7#b7 ,prem>ket review or te*nology c]tification ,a transitional 9 vitro cl9ical te/ t is ! subject ( an application = prem>ket review "u section #ehg;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or te*nology c]tification application "u section #ehg;,d ( su* ,act1 z add$ by ?is ,act1 may cont9ue to be (f]$1 sold1 or di/ribut$ )\t m>ket+ au?orization until completion ( ! ,secret>y's review ( ! prem>ket application or te*nology c]tification application1 if su* application is submitt$ no lat] ?an #ij days aft] ! effective date ( ?is ,act4 7#c7 ,te/s approv$ by new york /ate ,not)/&+ p>agraph 7#b71 a transitional 9 vitro cl9ical te/ t has be5 approv$ by ! ,new ,york ,/ate ,dep>tm5t ( ,heal? may cont9ue to be (f]$1 sold1 or di/ribut$ aft] ! effective date if-- 7,a7 />t+ on ! effective date ( ?is ,act1 ! 9 vitro cl9ical te/ complies ) ! requirem5ts ( sub*apt] ,j ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act1 except = section #ehg;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #hbc1 & design control provisions ( section #ehg,k ( su* ,act2 7,b7 ea* te/ report template = ! te/ be>s a /atem5t ( adequate prom95ce t reads z foll[s3 ,?is 9 vitro cl9ical te/ 0 develop$ & fir/ introduc$ prior to ! effective date ( ! ,,valid ,act ( #bjbb4 ,?is te/ 0 approv$ by ! ,new ,york ,/ate ,dep>tm5t ( ,heal?1 b ! te/ has n be5 review$ by ! ,food & ,drug ,adm9i/ration42 7,c7 a prem>ket application "u section #ehg;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #hbc1 or te*nology c]tification application "u section #ehg;,d ( su* ,act1 z add$ by section #hbc1 is submitt$ no lat] ?an-- 7i7 #e ye>s aft] ! effective date ( ?is ,act1 if ! 9 vitro cl9ical te/ is approv$ by ! ,new ,york ,/ate ,dep>tm5t ( ,heal? z a g5etic te/+ molecul> te/1 a microbiology molecul> te/1 an oncology molecul> te/1 or any o!r type ( molecul> te/2 or 7ii7 #b ye>s aft] ! effective date ( ?is ,act1 if ! 9 vitro cl9ical te/ is approv$ by ! ,new ,york ,/ate ,dep>tm5t ( ,heal? z a type ( te/ n describ$ 9 clause 7i72 & 7,d7 a te/ 9 compliance ) ?is p>agraph may cont9ue to be (f]$1 sold1 or di/ribut$ until ! completion ( ! ,secret>y's review ( ! prem>ket application or te*nology c]tification application describ$ 9 subp>agraph 7,c74 7d7 ,conv]sion 7#a7 ,deem$ prem>ket approval ,beg9n+ on ! effective date ( ?is ,act-- 7,a7 any 9 vitro cl9ical te/ ) a prem>ket approval "u section #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7 or a lic5sure "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 is deem$ to be approv$ pursuant to an application "u section #ehg;,b7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act2 & 7,b7 any 9 vitro cl9ical te/ 7z s def9$7 t 0 cle>$ "u section #eaj7k7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7k77 or au?oriz$ "u section #eac7;f77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7f77#b77 is deem$ to be approv$ pursuant to an application "u section #ehg;,b7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act4 7#b7 ,deem$ inve/igational use exemption ,any 9 vitro cl9ical te/ t has an inve/igational device exemption 9 effect "u section #ebj7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7g77 is deem$ to h an inve/igational use exemption 9 effect "u section #ehg,s ( su* ,act1 z add$ by ?is ,act1 beg9n+ on ! effective date ( ?is ,act4 7#c7 ,deem$ humanit>ian device exemption ,any 9 vitro cl9ical te/ t has an approv$ humanit>ian device exemption "u section #ebj7m7 ( su* ,act is deem$ to h a humanit>ian te/ exemption "u section #ehg;,a7g7 ( su* ,act1 z add$ by ?is ,act1 beg9n+ on ! effective date ( ?is ,act4 7#d7 ,deem$ designat$ break?r\gh ,any 9 vitro cl9ical te/ t has receiv$ a break?r\gh device designation "u section #eae;,b7e77#a77;,d7 ( su* ,act 7#ba ,u4,s4,c4 #cfj;e-#c7;e77#a77;,d77 is deem$ to h a break?r\gh 9 vitro cl9ical te/ designation "u section #ehg;,c ( su* ,act1 z add$ by ?is ,act1 beg9n+ on ! effective date ( ?is ,act4 7#e7 ,deem$ reque/ = in=mal fe$back ,) reg>d to any 9 vitro cl9ical te/ t is ! subject ( a pre-submission reque/ describ$ 9 ! guidance1 ,reque/s = ,fe$back & ,meet+s = ,m$ical ,device ,submissions3 ,! ,q-,submission ,program1 issu$ by ! ,food & ,drug ,adm9i/ration on ,janu>y #f1 #bjba1 su* reque/ is deem$ to con/itute a reque/ = in=mal fe$back "u section #ehg;,f ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #hbc1 beg9n+ on ! effective date ( ?is ,act4 7e7 ,previ\sly classifi$ devices ,not)/&+ section #ehg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #hbc1 = purposes ( sub*apt] ,j ( *apt] ,v ( su* ,act1 z add$ by section #hbc1 ! foll[+ apply3 7#a7 ,9 ! case ( an 9 vitro cl9ical te/ type t has be5 classifi$ by ! ,secret>y z a class ,i device pursuant to section #eac ( su* ,act 7#ba ,u4,s4,c4 #cfj;c71 su* 9 vitro cl9ical te/ %all be l[-risk1 unless ! 9 vitro cl9ical te/ is a te/ describ$ 9 section #eaj7l7 ( su* ,act or ! te/ is r$esignat$ by ! ,secret>y pursuant to section #ehg;,f ( su* ,act4 7#b7 ,9 ! case ( an 9 vitro cl9ical te/ type t has be5 classifi$ by ! ,secret>y z a class ,,ii device pursuant to section #eac ( su* ,act 7#ba ,u4,s4,c4 #cfj;c71 su* 9 vitro cl9ical te/ %all be mod]ate-risk1 unless inaccurate results f ! te/ w\ld be imm$iately life ?reat5+ or ! te/ is r$esignat$ by ! ,secret>y pursuant to section #ehg;,f ( su* ,act4 7#c7 ,9 ! case ( an 9 vitro cl9ical te/ type t has be5 classifi$ by ! ,secret>y z a class ,,iii device pursuant to section #eac ( su* ,act 7#ba ,u4,s4,c4 #cfj;c7 or an 9 vitro cl9ical te/ lic5s$ pursuant to section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb71 su* 9 vitro cl9ical te/ %all be high-risk1 unless r$esignat$ by ! ,secret>y pursuant to section #ehg;,f ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 #hbf4 ,em]g5cy use au?orization 7a7 ,9 g5]al ,section #efd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7 is am5d$-- 7#a7 by ins]t+ or develop] aft] manufactur]1 ea* place su* t]m appe>s2 7#b7 9 subsection 7a7-- 7,a7 9 p>agraphs 7#a7 & 7#d77;,c71 by ins]t+ 9 vitro cl9ical te/1 be=e or biological product ea* place su* t]m appe>s2 7,b7 9 p>agraph 7#b77;,a71 by /rik+ or #eae & ins]t+ #eae1 or #ehg;,b2 & 7,c7 by add+ at ! end ! foll[+3 7,f7 ,! t]ms develop & develop]1 ) respect to an 9 vitro cl9ical te/1 h ! mean+s giv5 su* t]ms 9 section #ehg4 2 7#c7 9 subsection 7b71 by ins]t+ or develop] aft] manufactur] ea* place su* t]m appe>s2 7#d7 9 subsection 7e7-- 7,a7 by ins]t+ or develop]s aft] manufactur]s ea* place su* t]m appe>s2 7,b7 9 p>agraph 7#b77;,b77ii71 by ins]t+ or develop aft] n manufacture2 7,c7 9 p>agraph 7#c7-- 7i7 9 subp>agraph 7,a71 by /rik+ or #ebj7;f77#a7 & ins]t+ 1 #ebj7;f77#a71 or #ehg,v2 7ii7 9 subp>agraph 7,b71 by /rik+ & at ! end2 7iii7 9 subp>agraph 7,c71 by /rik+ ! p]iod & ins]t+ or #ehg,o2 &2 & 7iv7 by add+ at ! end ! foll[+3 7,d7 quality requirem5ts 7) respect to 9 vitro cl9ical te/s7 "u section #ehg,k4 2 & 7,d7 9 p>agraph 7#d7-- 7i7 9 subp>agraph 7,a71 by /rik+ 2 or & ins]t+ a semicolon2 7ii7 9 subp>agraph 7,b71 by /rik+ ! p]iod & ins]t+ 2 or2 & 7iii7 by add+ at ! end ! foll[+3 7,c7 ) respect to 9 vitro cl9ical te/s1 requirem5ts applicable to re/rict$ 9 vitro cl9ical te/s pursuant to section #ehg,o4 2 7#e7 9 subsection 7k71 by /rik+ or #ebj7;g7 & ins]t+ #ebj7;g71 or #ehg,s2 & 7#f7 9 subsection 7m7-- 7,a7 9 ! subsection head+1 by /rik+ ,laboratory te/s associat$ ) devices ins]t+ 9 vitro cl9ical te/s aft] devices2 & 7,b7 9 p>agraph 7#a7-- 7i7 by /rik+ to a device & ins]t+ to an 9 vitro cl9ical te/2 & 7ii7 by /rik+ su* device & ins]t+ su* 9 vitro cl9ical te/4 7b7 ,em]g5cy use ( m$ical products ,section #efd;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c;a7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#b71 by ins]t+ 9 vitro cl9ical te/1 aft] device12 & 7,b7 by add+ at ! end ! foll[+3 7#c7 ,develop] ,! t]m develop]1 ) respect to an 9 vitro cl9ical te/1 has ! mean+ giv5 su* t]m 9 section #ehg4 2 7#b7 by ins]t+ or develop] aft] manufactur] ea* place x appe>s2 & 7#c7 9 subsection 7c77#a7-- 7,a7 by ins]t+ or quality requirem5ts aft] good manufactur+ practice requirem5ts2 & 7,b7 by /rik+ or #ebj7;f77#a7 & ins]t+ 1 #ebj7;f77#a71 or #ehg,k4 7c7 ,products held = em]g5cy use ,section #efd;,b7#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c;b7#b77 is am5d$-- 7#a7 9 subp>agraph 7,a71 by /rik+ or #eae & ins]t+ #eae1 or #ehg;,b2 & 7#b7 9 subp>agraph 7,b71 by /rik+ or #ebj & ins]t+ #ebj1 or #ehg,s4 #hbg4 ,antimicrobial susceptibility te/s ,section #eaa;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;a-#b7 is am5d$-- 7#a7 9 subsection 7a77#a77;,c7-- 7,a7 by /rik+ cle> "u section #eaj7k71 classify "u section #eac7;f77#b71 or approve "u section #eae & ins]t+ approve "u section #ehg;,b1 exempt f prem>ket review "u section #ehg;,c1 or grant a te*nology c]tification ord] "u section #ehg;,d2 & 7,b7 by /rik+ te/+ devices & ins]t+ 9 vitro cl9ical te/s2 7#b7 9 subsection 7c77#e7-- 7,a7 by /rik+ drug or device & ins]t+ drug1 device1 or 9 vitro cl9ical te/2 & 7,b7 by /rik+ ! drug or ! device & ins]t+ ! drug1 device1 or 9 vitro cl9ical te/2 7#c7 9 subsection 7e7-- 7,a7 9 ! head+1 by /rik+ te/+ devices & ins]t+ ,9 vitro cl9ical te/s2 7,b7 9 p>agraph 7#a7-- 7i7 by /rik+ #eaj1 #eac1 & #eae1 & ins]t+ #ehg;,b1 & #ehg;,d2 7ii7 by /rik+ antimicrobial susceptibility te/+ device & ins]t+ antimicrobial susceptibility 9 vitro cl9ical te/2 & 7iii7 by /rik+ su* device & ins]t+ su* 9 vitro cl9ical te/2 & 7,c7 9 p>agraph 7#b7-- 7i7 9 ! head+1 by /rik+ te/+ devices & ins]t+ 9 vitro cl9ical te/s2 7ii7 9 subp>agraphs 7,a7 & 7,b7 7o!r ?an clause 7iii7 ( su* subp>agraph 7,b771 by /rik+ device ea* place x appe>s & ins]t+ 9 vitro cl9ical te/2 7iii7 9 subp>agraph 7,b77iii71 by /rik+ a device & ins]t+ an 9 vitro cl9ical te/2 & 7iv7 by am5d+ subp>agraph 7,c7 to read z foll[s3 7,c7 ,! antimicrobial susceptibility 9 vitro cl9ical te/ meets all o!r requirem5ts to be approv$ "u section #ehg;,b1 to be exempt$ f prem>ket review "u section #ehg;,c1 or to be (f]$ "u a te*nology c]tification ord] "u section #ehg;,d4 2 7#d7 9 subsection 7f71 by am5d+ p>agraph 7#a7 to read z foll[s3 7#a7 ,! t]m antimicrobial susceptibility 9 vitro cl9ical te/ means an 9 vitro cl9ical te/ t utilizes susceptibility te/ int]pretive crit]ia to det]m9e & report ! 9 vitro susceptibility ( c]ta9 microorganisms to a drug 7or drugs74 2 & 7#e7 9 subsection 7g77#b7-- 7,a7 by am5d+ ! matt] prec$+ subp>agraph 7,a7 to read z foll[s3 7#b7 ) respect to approv+ an application "u section #ehg;,b or grant+ a te*nology c]tification ord] "u section #ehg;,d-- 2 & 7,b7 9 subp>agraph 7,a7-- 7i7 by /rik+ device & ins]t+ 9 vitro cl9ical te/2 & 7ii7 by /rik+ antimicrobial susceptibility te/+ device & ins]t+ antimicrobial susceptibility 9 vitro cl9ical te/4 #hbh4 ,comb9ation products 7a7 ,9 g5]al ,section #ejc7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;g77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a71 by /rik+ or biological product & ins]t+ 9 vitro cl9ical te/1 or biological product 7except = a product con/itut$ ( a device & an 9 vitro cl9ical te/72 7,b7 9 subp>agraph 7,b71 by add+ at ! end ! foll[+3 ,= purposes ( ?is ,act1 a product t con/itutes a comb9ation ( a device & an 9 vitro cl9ical te/ is n a comb9ation product )9 ! mean+ ( ?is subsection42 & 7,c7 9 subp>agraph 7,d77ii7-- 7i7 by ins]t+ or 9 vitro cl9ical te/ aft] device2 & 7ii7 by ins]t+ & 9 vitro cl9ical te/s be=e %all2 7#b7 9 p>agraph 7#c71 by /rik+ safety & effectiv5ess or sub/antial equival5ce & ins]t+ safety & effectiv5ess1 sub/antial equival5ce1 or analytical validity & cl9ical validity be=e = ! approv$ con/itu5t "p2 7#c7 9 p>agraph 7#d7-- 7,a7 9 subp>agraph 7,a71 by /rik+ or #eac7;f77#b7 7submitt$ 9 accordance ) p>agraph 7#e77 & ins]t+ #eac7;f77#b7 7submitt$ 9 accordance ) p>agraph 7#e771 #ehg;,b1 or #ehg;,d1 or an exempt te/ "u section #ehg;,c1 z applicable2 & 7,b7 9 subp>agraph 7,b71 by ins]t+ 1 #ehg;,b1 or #ehg;,d aft] section #eae2 7#d7 9 p>agraph 7#e77;,a71 by /rik+ or #eaj7k7 & ins]t+ 1 #eaj7k71 #ehg;,b1 or #ehg;,d2 7#e7 9 p>agraph 7#g71 by /rik+ or sub/antial equival5ce & ins]t+ 1 sub/antial equival5ce1 or analytical validity & cl9ical validity2 7#f7 9 p>agraph 7#h71 by add+ at ! end ! foll[+3 7,i7 ,?is p>agraph %all n apply to a product con/itut$ ( a device & an 9 vitro cl9ical te/4 2 & 7#g7 9 p>agraph 7#i7-- 7,a7 9 subp>agraph 7,c77i71 by /rik+ or #ebj7;g7 & ins]t+ #ebj7;g71 #ehg;,b1 or #ehg;,d2 & 7,b7 9 subp>agraph 7,d71 by /rik+ or #ebj & ins]t+ #ebj1 #ehg;,b1 or #ehg;,d4 7b7 ,classification ( products ,section #efc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#b7 is am5d$ by add+ at ! end ! foll[+3 7d7 ,exemption ,?is section %all n apply to a product con/itut$ ( a device & an 9 vitro cl9ical te/4 4 #hbi4 ,res\rces 7a7 ,f9d+s ,congress f9ds t ! fees au?oriz$ by ?is section w be d$icat$ to meet+ ! goals id5tifi$ 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 7b7 ,e/abli%m5t ( us] fee program 7#a7 ,developm5t ( us] fees = 9 vitro cl9ical te/s 7,a7 ,9 g5]al ,beg9n+ n lat] ?an ,octob] #a1 #bjbe1 ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all develop recomm5dations to pres5t to ,congress ) respect to ! goals1 & plans = meet+ ! goals1 = ! process = ! review ( 9 vitro cl9ical te/ submissions & applications "u sub*apt] ,j ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act1 = ! fir/ #e fiscal ye>s aft] fiscal ye> #bjbg & = ! au?orization ( ! ,9 ,vitro ,cl9ical ,te/ ,us] ,fee ,program1 z describ$ 9 ?is section1 = su* fiscal ye>s4 ,9 develop+ su* recomm5dations1 ! ,secret>y %all consult )-- 7i7 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate2 7ii7 ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 7iii7 sci5tific & academic exp]ts2 7iv7 heal? c>e pr(essionals2 7v7 repres5tatives ( pati5t & consum] advocacy gr\ps2 & 7vi7 ! regulat$ indu/ry4 7,b7 ,prior public input ,prior to beg9n+ negotiations ) ! regulat$ indu/ry on ! au?orization ( ! ,9 ,vitro ,cl9ical ,te/ ,us] ,fee ,program1 z describ$ 9 ?is section1 ! ,secret>y %all-- 7i7 publi% a notice 9 ! ,f$]al ,regi/] reque/+ public input on ! au?orization ( us] fees2 7ii7 hold a public meet+ at :i* ! public may pres5t its views on ! au?orization1 includ+ specific sugge/ions = ! recomm5dations submitt$ "u subp>agraph 7,e72 7iii7 provide a p]iod ( #cj days aft] ! public meet+ to obta9 writt5 comm5ts f ! public sugge/+ *anges to ! au?orization ( ! ,9 ,vitro ,cl9ical ,te/ ,us] ,fee ,program1 z describ$ 9 ?is section2 & 7iv7 publi% any comm5ts receiv$ "u clause 7iii7 on ! website ( ! ,food & ,drug ,adm9i/ration4 7,c7 ,p]iodic consultation ,n less frequ5tly ?an once e mon? dur+ negotiations ) ! regulat$ indu/ry1 ! ,secret>y %all hold discussions ) repres5tatives ( pati5t & consum] advocacy gr\ps to cont9ue discussions ( ! au?orization ( ! ,9 ,vitro ,cl9ical ,te/ ,us] ,fee ,program & to solicit sugge/ions to be includ$ 9 ! recomm5dations transmitt$ to ,congress "u subp>agraph 7,e74 7,d7 ,public review ( recomm5dations ,aft] negotiations ) ! regulat$ indu/ry1 ! ,secret>y %all-- 7i7 pres5t ! recomm5dations develop$ "u subp>agraph 7,a7 to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 7ii7 publi% su* recomm5dations 9 ! ,f$]al ,regi/]2 7iii7 provide = a p]iod ( #cj days = ! public to provide writt5 comm5ts on su* recomm5dations2 7iv7 hold a meet+ at :i* ! public may pres5t its views on su* recomm5dations2 & 7v7 aft] consid]ation ( su* public views & comm5ts1 revise su* recomm5dations z necess>y4 7,e7 ,transmittal ( recomm5dations 7i7 ,9 g5]al ,n lat] ?an ,janu>y #ae1 #bjbg1 ! ,secret>y %all transmit to ,congress ! revis$ recomm5dations "u subp>agraph 7,a71 a summ>y ( ! views & comm5ts receiv$ "u su* subp>agraph1 & any *anges made to ! recomm5dations 9 response to su* views & comm5ts4 7ii7 ,recomm5dation requirem5ts ,! recomm5dations transmitt$ "u ?is subp>agraph %all-- 7,i7 include ! numb] ( full-"t equival5t employees p] fiscal ye> t are agre$ to be hir$ to c>ry out ! goals includ$ 9 su* recomm5dations = ea* ye> ( ! #e-ye> p]iod2 7,,ii7 provide t ! am\nt ( op]at+ res]ve balance 9 ! us] fee program e/abli%$ "u ?is section is n m ?an ! equival5t ( #aj weeks ( op]at+ res]ve2 7,,iii7 require ! developm5t ( a /rategic plan = any surplus )9 ! op]at+ res]ve acc\nt above ! #aj-week op]at+ res]ve )9 #b ye>s ( ! e/abli%m5t ( ! program2 7,,iv7 include an op]at+ res]ve adju/m5t su* t1 if ! ,secret>y has an op]at+ res]ve balance 9 excess ( #aj weeks ( su* op]at+ res]ves1 ! ,secret>y %all decrease su* fee rev5ue & fees to provide = n m ?an #aj weeks ( su* op]at+ res]ves2 7,v7 if an adju/m5t is made z describ$ 9 subclause 7,,iv71 provide ! rationale = ! am\nt ( ! decrease 9 fee rev5ue & fees %all be conta9$ 9 ! ,f$]al ,regi/]2 & 7,,vi7 provide t ! fees assess$ & collect$ = ! full-"t equival5t employees at ! ,c5t] = ,devices & ,radiological ,heal?1 ) respect to :i* ! majority ( "t report+ data indicates are d$icat$ to ! process = ! review ( 9 vitro cl9ical te/ submissions & applications "u p>agraph 7#e71 are n support$ by ! funds au?oriz$ to be collect$ & assess$ "u section #gch ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j74 7,f7 ,publication ( recomm5dations ,! ,secret>y %all publi% on ! website ( ! ,food & ,drug ,adm9i/ration ! revis$ recomm5dations "u subp>agraph 7,a71 a summ>y ( ! views & comm5ts receiv$ "u subp>agraphs 7,b7 ?r\gh 7,d71 & any *anges made to ! recomm5dations orig9ally propos$ by ! ,secret>y 9 response to su* views & comm5ts4 7,g7 ,m9utes ( negotiation meet+s 7i7 ,public availability ,! ,secret>y %all make publicly available1 on ! website ( ! ,food & ,drug ,adm9i/ration1 m9utes ( all negotiation meet+s conduct$ "u ?is subsection betwe5 ! ,food & ,drug ,adm9i/ration & ! regulat$ indu/ry n lat] ?an #cj days aft] su* meet+4 7ii7 ,cont5t ,! m9utes describ$ "u clause 7i7 %all summ>ize any sub/antive proposal made by any p>ty to ! negotiations1 any significant controv]sies or diff]5ces ( op9ion dur+ ! negotiations1 & ! resolution ( any su* controv]sy or diff]5ce ( op9ion4 7#b7 ,e/abli%m5t ( us] fee program ,effective on ,octob] #a1 #bjbg1 provid$ t ! ,secret>y transmits ! recomm5dations "u p>agraph 7#a77;,e71 ! ,secret>y is au?oriz$ to collect us] fees relat+ to ! review ( 9 vitro cl9ical te/ submissions & applications submitt$ "u sub*apt] ,j ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act4 ,fees "u su* program %all be assess$ & collect$ only if ! requirem5ts "u p>agraph 7#d7 are met4 7#c7 ,audit 7,a7 ,9 g5]al ,on ! date t is #b ye>s aft] fir/ receiv+ a us] fee applicable to submission ( an 9 vitro cl9ical te/ application submitt$ "u sub*apt] ,j ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act1 & on a bi5nial basis !reaft]1 ! ,secret>y %all p]=m an audit ( ! co/s ( review+ su* applications "u su* sub*apt] ,j4 ,su* an audit %all comp>e ! co/s ( review+ su* applications "u su* sub*apt] ,j to ! am\nt ( ! us] fee applicable to su* applications4 7,b7 ,alt]ation ( us] fee ,if ! audit p]=m$ "u subp>agraph 7,a7 indicates t ! us] fees applicable to applications submitt$ "u su* sub*apt] ,j exce$ #di p]c5t ( ! co/s ( review+ su* applications1 ! ,secret>y %all alt] ! us] fees applicable to applications submitt$ "u su* sub*apt] ,j su* t ! us] fees d n exce$ su* p]c5tage4 7,c7 ,acc\nt+ /&>ds ,! ,secret>y %all p]=m an audit "u subp>agraph 7,a7 9 con=mance ) ! acc\nt+ pr9ciples1 /&>ds1 & requirem5ts prescrib$ by ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates "u section #ceaa ( title #ca1 ,unit$ ,/ates ,code1 to ensure ! validity ( any pot5tial v>iability4 7#d7 ,conditions ,! us] fee program describ$ 9 ?is subsection %all take effect only if ! ,food & ,drug ,adm9i/ration issues draft guidance relat$ to ! review requirem5ts = 9 vitro diagno/ic te/s t w\ld be subject to prem>ket review "u section #ehg;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #hbc1 ! review requirem5ts = te/ categories eligible = te*nology c]tification "u section #ehg;,d ( su* ,act1 z add$ by section #hbc1 & ! p>amet]s = ! te/ categories t w\ld be exempt f any review "u sub*apt] ,j ( *apt] ,v ( su* ,act4 7#e7 ,us] fee program def9itions & res\rce requirem5ts 7,a7 ,9 g5]al ,! t]m process = ! review ( 9 vitro cl9ical te/ submissions & applications means ! foll[+ activities ( ! ,secret>y ) respect to ! review ( 9 vitro cl9ical te/ prem>ket & te*nology c]tification applications includ+ supplem5ts = su* applications3 7i7 ,! activities necess>y = ! review ( prem>ket applications1 prem>ket reports1 te*nology c]tification applications1 & supplem5ts to su* applications4 7ii7 ,actions relat$ to submissions 9 connection ) 9 vitro cl9ical te/ developm5t1 ! issuance ( action lett]s t all[ ! m>ket+ ( 9 vitro cl9ical te/s or :i* set =? 9 detail ! specific defici5cies 9 su* applications1 reports1 supplem5ts1 or submissions &1 :]e appropriate1 ! actions necess>y to support ! developm5t ( 9 vitro cl9ical te/s4 7iii7 ,! inspection ( manufactur+ e/abli%m5ts & o!r facilities und]tak5 z "p ( ! ,secret>y's review ( p5d+ prem>ket applications1 te*nology c]tifications1 & supplem5ts4 7iv7 ,monitor+ ( rese>* conduct$ 9 connection ) ! review ( su* applications1 supplem5ts1 & submissions4 7v7 ,review ( 9 vitro cl9ical te/ applications subject to section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 & activities conduct$ 9 anticipation ( ! submission ( su* applications = inve/igational use "u section #ehg,s ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by section #hbc74 7vi7 ,! developm5t ( guidance1 policy docum5ts1 or regulations to improve ! process = ! review ( prem>ket applications1 te*nology c]tification applications1 & supplem5ts4 7vii7 ,! developm5t ( volunt>y te/ me?ods1 cons5sus /&>ds1 or m&atory p]=mance /&>ds 9 connection ) ! review ( su* applications1 supplem5ts1 or submissions & relat$ activities4 7viii7 ,! provision ( te*nical assi/ance to 9 vitro cl9ical te/ develop]s 9 connection ) ! submission ( su* applications1 reports1 supplem5ts1 or submissions4 7ix7 ,any activity und]tak5 9 connection ) ! initial classification or reclassification ( an 9 vitro cl9ical te/ 9 connection ) any requirem5t = approval or eligibility = an exemption f prem>ket review ( an 9 vitro cl9ical te/4 7x7 ,any activity und]tak5 9 connection ) mak+ a pa?way det]m9ation ( an 9 vitro cl9ical te/1 includ+ ! id5tification1 e/abli%m5t1 & implem5tation ( mitigation measures4 7xi7 ,evaluation ( po/m>ket /udies requir$ z a condition ( an approval ( a prem>ket application ( an 9 vitro cl9ical te/ & ensur+ su* /udies are conduct$ z requir$4 7xii7 ,any activity und]tak5 9 connection ) ensur+ 9 vitro cl9ical te/s m>ket$ "u an exemption f prem>ket review pursuant to section #ehg;,c or #ehg;,g meet ! crit]ia = su* exemption & ! applicable /&>d4 7xiii7 ,compil+1 develop+1 & review+ in=mation on 9 vitro cl9ical te/s necess>y to id5tify issues ) ! ability ( 9 vitro cl9ical te/s to meet ! applicable /&>d1 z applicable4 7,b7 ,res\rce requirem5ts ,fees collect$ & assess$ "u ?is section %all be us$ = ! process = ! review ( 9 vitro cl9ical te/ applications1 z describ$ 9 subp>agraph 7,a71 & %all-- 7i7 be subject to ! limitation "u section #gch7;g77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7g77#c771 9 ! same mann] t fees collect$ & assess$ "u section #gcg7i77;,c7 ( su* ,act 7#ba ,u4,s4,c4 #cgi;i7#i77;,c77 are subject to su* limitation2 7ii7 include travel exp5ses = (fic]s & employees ( ! ,food & ,drug ,adm9i/ration only if ! ,secret>y det]m9es t su* travel is directly relat$ to an activity describ$ 9 subp>agraph 7,a72 & 7iii7 n be allocat$ to purposes describ$ "u section #gbb7;a7 ( ! ,consolidat$ ,appropriations ,act1 #bjah 7,public ,law #aae-ada74 7c7 ,reports 7#a7 ,p]=mance report 7,a7 ,9 g5]al 7i7 ,g5]al requirem5ts ,beg9n+ ) fiscal ye> #bjbh1 = ea* fiscal ye> = :i* fees are collect$ "u ?is section1 ! ,secret>y %all prep>e & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives annual reports conc]n+ ! progress ( ! ,food & ,drug ,adm9i/ration 9 a*iev+ ! goals id5tifi$ 9 ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,e7 dur+ su* fiscal ye> & ! future plans ( ! ,food & ,drug ,adm9i/ration = meet+ ! goals4 7ii7 ,additional in=mation ,beg9n+ ) fiscal ye> #bjbh1 ! annual report "u ?is subp>agraph %all include ! progress ( ! ,food & ,drug ,adm9i/ration 9 a*iev+ ! goals1 & future plans = meet+ ! goals1 includ+-- 7,i7 ! numb] ( prem>ket applications fil$ "u section #ehg;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act dur+ ! applicable fiscal ye>2 7,,ii7 ! numb] ( te*nology c]tification applications submitt$ "u section #ehg;,d ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act dur+ ! applicable fiscal ye> = ea* review division2 7,,iii7 ! numb] ( break?r\gh designations "u section #ehg;,i ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act dur+ ! applicable fiscal ye>2 & 7,,iv7 ! numb] ( in=mation reque/s reque/$ by ! ,secret>y pursuant to section #ehg;,g7d7 ( su* ,act4 7iii7 ,real-"t report+ 7,i7 ,9 g5]al ,n lat] ?an #cj cal5d> days aft] ! end ( ! second qu>t] ( fiscal ye> #bjbh1 & n lat] ?an #cj cal5d> days aft] ! end ( ea* qu>t] ( ea* fiscal ye> !reaft]1 ! ,secret>y %all po/ ! data describ$ 9 subclause 7,,ii7 on ! website ( ! ,food & ,drug ,adm9i/ration = su* qu>t] & on a cumulative basis = su* fiscal ye>1 & may remove duplicative data f ! annual report "u ?is subp>agraph4 7,,ii7 ,data ,! ,secret>y %all po/ ! foll[+ data 9 accordance ) subclause 7,i73 7aa7 ,! numb] & titles ( draft & f9al regulations on topics relat$ to ! process = ! review ( 9 vitro cl9ical te/ submissions & applications1 & :e!r su* regulations 7 requir$ by /atute or pursuant to ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,e74 7bb7 ,! numb] & titles ( draft & f9al guidance on topics relat$ to ! process = ! review ( 9 vitro cl9ical te/ submissions & applications1 & :e!r su* guidances 7 issu$ z requir$ by /atute or pursuant to ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,e74 7cc7 ,! numb] & titles ( public meet+s held on topics relat$ to ! process = ! review ( 9 vitro cl9ical te/s1 & if su* meet+s 7 requir$ by /atute or pursuant to ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,e74 7iv7 ,rationale = ,,ivct us] fee program *anges ,beg9n+ ) fiscal ye> #bjbh1 ! ,secret>y %all include 9 ! annual p]=mance report "u p>agraph 7#a7-- 7,i7 data1 analysis1 & discussion ( ! *anges 9 ! numb] ( full-"t equival5ts hir$ z agre$ ^u 9 ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,e7 & ! numb] ( full-"t equival5ts fund$ by budget au?ority at ! ,food & ,drug ,adm9i/ration by ea* division )9 ! ,c5t] = ,devices & ,radiological ,heal?1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 ! ,(fice ( ,regulatory ,affairs1 & ! ,(fice ( ! ,commission]2 7,,ii7 data1 analysis1 & discussion ( ! *anges 9 ! fee rev5ue am\nts & co/s = ! process = ! review ( 9 vitro cl9ical te/ submissions & applications1 includ+ id5tify+ driv]s ( su* *anges2 & 7,,iii7 = ea* ( ! ,c5t] = ,devices & ,radiological ,heal?1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 ! ,(fice ( ,regulatory ,affairs1 & ! ,(fice ( ! ,commission]1 ! numb] ( employees = :om "t report+ is requir$ & ! numb] ( employees = :om "t report+ is n requir$4 7v7 ,analysis ,= ea* fiscal ye>1 ! ,secret>y %all include 9 ! report "u clause 7i7 an analysis ( ! foll[+3 7,i7 ,! diff]5ce betwe5 ! aggregate numb] ( prem>ket applications fil$ "u section #ehg;,b or section #ehg;,d ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act & ! aggregate numb] ( major defici5cy lett]s1 n approvable lett]s1 & d5ials = su* applications issu$ by ! ag5cy1 acc\nt+ =-- 7aa7 ! numb] ( applications fil$ "u ea* ( sections #ehg;,b & #ehg;,d ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act dur+ "o fiscal ye> = :i* a decision is n s*$ul$ to be made until ! foll[+ fiscal ye>2 & 7bb7 ! aggregate numb] ( applications "u ea* ( sections #ehg;,b & #ehg;,d ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act = ea* fiscal ye> t did n meet ! goals z id5tifi$ by ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,e74 7,,ii7 ,relevant data to det]m9e :e!r ! ,c5t] = ,devices & ,radiological ,heal? has met p]=mance enhancem5t goals id5tifi$ by ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,e74 7,,iii7 ,! mo/ common causes & tr5ds = ext]nal or o!r circum/ances affect+ ! ability ( ! ,food & ,drug ,adm9i/ration to meet review "t & p]=mance enhancem5t goals id5tifi$ by ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,e74 7,b7 ,publication ,) reg>d to in=mation to be report$ by ! ,food & ,drug ,adm9i/ration to indu/ry on a qu>t]ly & annual basis pursuant to recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,e71 ! ,secret>y %all make su* in=mation publicly available on ! website ( ! ,food & ,drug ,adm9i/ration n lat] ?an #fj days aft] ! end ( ea* qu>t] or #abj days aft] ! end ( ea* fiscal ye>1 respectively1 to :i* su* in=mation applies4 7,c7 ,updates ,! ,secret>y %all include 9 ea* report "u subp>agraph 7,a7 in=mation on all previ\s cohorts = :i* ! ,secret>y has n giv5 a complete response on all 9 vitro cl9ical te/ prem>ket applications & te*nology c]tification ord]s & supplem5ts1 prem>ket1 & te*nology c]tification notifications 9 ! cohort4 7#b7 ,corrective action report ,beg9n+ ) fiscal ye> #bjbb1 = ea* fiscal ye> = :i* fees are collect$ "u ?is section1 ! ,secret>y %all prep>e & submit a corrective action report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives4 ,! report %all include ! foll[+ in=mation1 z applicable3 7,a7 ,goals met ,= ea* fiscal ye>1 if ! ,secret>y det]m9es1 bas$ on ! analysis "u p>agraph 7#a77;,a77v71 t ea* ( ! goals id5tifi$ by ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,e7 = ! applicable fiscal ye> h be5 met1 ! corrective action report %all include recomm5dations on ways 9 :i* ! ,secret>y c improve & /reaml9e ! 9 vitro cl9ical te/ prem>ket application & te*nology c]tification review process4 7,b7 ,goals miss$ ,= ea* ( ! goals id5tifi$ by ! lett]s describ$ 9 recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,e7 = ! applicable fiscal ye> t ! ,secret>y det]m9es to n h be5 met1 ! corrective action report %all include-- 7i7 a ju/ification = su* det]m9ation2 7ii7 a description ( ! types ( circum/ances1 9 ! aggregate1 "u :i* applications or reports submitt$ "u sections #ehg;,b & #ehg;,d ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act miss$ ! review goal times b 7 approv$ dur+ ! fir/ cycle review1 z applicable2 7iii7 a summ>y & any tr5ds ) reg>d to ! circum/ances = :i* a review goal 0 miss$2 & 7iv7 ! p]=mance enhancem5t goals t 7 n a*iev$ dur+ ! previ\s fiscal ye> & a description ( ef=ts ! ,food & ,drug ,adm9i/ration has put 9 place = ! fiscal ye> 9 :i* ! report is submitt$ to improve ! ability ( su* ag5cy to meet ea* su* goal = ! su* fiscal ye>4 7#c7 ,fiscal report 7,a7 ,9 g5]al ,= fiscal ye>s #bjbh & annually !reaft]1 n lat] ?an #abj days aft] ! end ( ea* fiscal ye> dur+ :i* fees are collect$ "u ?is section1 ! ,secret>y %all prep>e & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 a report on ! implem5tation ( ! au?ority = su* fees dur+ su* fiscal ye> & ! use1 by ! ,food & ,drug ,adm9i/ration1 ( ! fees collect$ dur+ su* fiscal ye> = :i* ! report is made4 7,b7 ,cont5ts ,su* report %all include exp5ditures del9eat$ by budget au?ority & us] fee doll>s relat$ to adm9i/rative exp5ses & in=mation te*nology infra/ructure contracts & exp5ditures4 7,c7 ,op]at+ res]ve ,su* report %all provide ! am\nt ( op]at+ res]ves ( c>ryov] us] fees available ea* ye>1 & any plann$ allocations or obligations ( su* balance ( op]at+ res]ves = ! program4 7#d7 ,public availability ,! ,secret>y %all make ! reports requir$ "u p>agraphs 7#a7 ?r\gh 7#c7 available to ! public on ! website ( ! ,food & ,drug ,adm9i/ration4 7#e7 ,enhanc$ communication 7,a7 ,communications ) ,congress ,ea* fiscal ye>1 z applicable & reque/$1 repres5tatives f ! ,c5t]s ) exp]tise 9 ! review ( 9 vitro cl9ical te/s %all meet ) repres5tatives f ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives to report on ! cont5ts describ$ 9 ! reports "u ?is section4 7,b7 ,p>ticipation 9 congressional he>+ ,ea* fiscal ye>1 z applicable & reque/$1 repres5tatives f ! ,food & ,drug ,adm9i/ration %all p>ticipate 9 a public he>+ be=e ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 to report on ! cont5ts describ$ 9 ! reports "u ?is section4 ,su* he>+ %all occur n lat] ?an #abj days aft] ! end ( ea* fiscal ye> = :i* fees are collect$ "u ?is section4 #hcj4 ,au?orization ( appropriations ,= purposes ( fund+ implem5tation ( ?is subtitle 7includ+ ! am5dm5ts made by ?is subtitle71 includ+ und]tak+ activities = ! developm5t ( regulations & guidances1 hir+ ( necess>y /aff1 & ! developm5t ( te*nology sy/ems to implem5t ?is subtitle 7includ+ ! am5dm5ts made by ?is subtitle7 9 a timely1 effective1 & effici5t mann]1 !re is au?oriz$ to be appropriat$ #dhj1jjj1jjj1 to rema9 available ?r\gh ! end ( fiscal ye> #bjbh4 #hca4 ,guidance on ,diagno/ic ,innovation ,n lat] ?an ,janu>y #a1 #bjbe1 ! ,secret>y %all issue guidance to assi/ develop]s ( 9 vitro cl9ical te/s int5d$ to id5tify or diagnose r>e diseases & 9 vitro cl9ical te/s int5d$ to address an unmet m$ical ne$4 ,su* guidance %all include consid]ations = address+ b>ri]s to develop+ suffici5t data to demon/rate cl9ical validity = su* te/s1 su* z *all5ges associat$ ) data collection & ob/acles to ! timely g5]ation ( evid5ce4 #hcb4 ,,gao report on unique consid]ations ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report-- 7#a7 evaluat+ ! unique consid]ations = hospital-bas$ laboratories1 laboratories s]v+ academic m$ical c5t]s1 & o!r heal? c>e practition]s1 z appropriate1 9 implem5t+ ?is subtitle1 includ+ ! am5dm5ts made by ?is subtitle2 & 7#b7 includ+ recomm5dations bas$ on ! f9d+s ( ! report4 ,,ix ,o!r provisions #ija4 ,facilities managem5t 7a7 ,,pdufa au?ority ,section #gcf7;g77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7g77#b77 is am5d$-- 7#a7 9 subp>agraph 7,a77ii7-- 7,a7 by /rik+ %all be available to defray & ins]t+ ! foll[+3 8%all be available-- 7,i7 = fiscal ye> #bjbc1 to defray 2 7,b7 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+3 7,,ii7 = fiscal ye> #bjbd & ea* subsequ5t fiscal ye>1 to defray ! co/s ( ! res\rces allocat$ = ! process = ! review ( human drug applications 7includ+ su* co/s = an additional numb] ( full-"t equival5t positions 9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices to be engag$ 9 su* process71 only if ! sum ( ! am\nts allocat$ by ! ,secret>y = su* co/s1 exclud+ co/s paid f fees collect$ "u ?is section1 plus o!r co/s = ! ma9t5ance1 r5ovation1 & repair ( facilities & acquisition1 ma9t5ance1 & repair ( fixtures1 furniture1 & o!r necess>y mat]ials & supplies 9 connection ) ! process = ! review ( human drug applications1 is no less ?an ! am\nt allocat$ = su* co/s1 exclud+ any su* co/s paid f fees collect$ "u ?is section1 = fiscal ye> #aiig1 multipli$ by ! adju/m5t factor4 2 & 7#b7 9 subp>agraph 7,b71 by /rik+ = ! process = ! review ( human drug applications & ins]t+ z describ$ 9 subclause 7,i7 or 7,,ii7 ( su* subp>agraph1 z applicable4 7b7 ,bs,u,f,a au?ority ,section #gdd;,h7f77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;f77#b77 is am5d$-- 7#a7 9 subp>agraph 7,b77i7-- 7,a7 by /rik+ available = a fiscal ye> beg9n+ aft] fiscal ye> #bjab & ins]t+ ! foll[+3 8available-- 7,i7 = fiscal ye> #bjbc 2 7,b7 by /rik+ ! fiscal ye> involv$4 & ins]t+ su* fiscal ye>2 &2 & 7,c7 by add+ at ! end ! foll[+3 7,,ii7 = fiscal ye> #bjbd & ea* subsequ5t fiscal ye>1 to defray ! co/s ( ! process = ! review ( biosimil> biological product applications 7includ+ su* co/s = an additional numb] ( full-"t equival5t positions 9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices to be engag$ 9 su* process71 only if ! sum ( ! am\nts allocat$ by ! ,secret>y = su* co/s1 exclud+ co/s paid f fees collect$ "u ?is section1 plus o!r co/s = ! ma9t5ance1 r5ovation1 & repair ( facilities & acquisition1 ma9t5ance1 & repair ( fixtures1 furniture1 & o!r necess>y mat]ials & supplies 9 connection ) ! process = ! review ( biosimil> biological product applications1 is no less ?an #bj1jjj1jjj1 multipli$ by ! adju/m5t factor applicable to ! fiscal ye> involv$4 2 & 7#b7 9 subp>agraph 7,c71 by /rik+ subp>agraph 7,b7 9 any fiscal ye> if ! co/s describ$ 9 su* subp>agraph & ins]t+ subp>agraph 7,b77i7 9 any fiscal ye> if ! co/s allocat$ z describ$ 9 subclause 7,i7 or 7,,ii7 ( su* subp>agraph1 z applicable14 7c7 ,,gdufa au?ority ,section #gdd;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7 is am5d$-- 7#a7 9 subsection 7e77#b71 by /rik+ #gdd;,a7#aa77;,c7 & ins]t+ #gdd;,a7#ab77;,c72 & 7#b7 9 subsection 7i77#b7-- 7,a7 9 subp>agraph 7,a77ii7-- 7i7 by /rik+ available = a fiscal ye> beg9n+ aft] fiscal ye> #bjab & ins]t+ ! foll[+3 8available-- 7,i7 = fiscal ye> #bjbc 2 7ii7 by /rik+ ! fiscal ye> involv$4 & ins]t+ su* fiscal ye>2 &2 & 7iii7 by add+ at ! end ! foll[+3 7,,ii7 = fiscal ye> #bjbd & ea* subsequ5t fiscal ye>1 to defray ! co/s ( human g5]ic drug activities 7includ+ su* co/s = an additional numb] ( full-"t equival5t positions 9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices to be engag$ 9 su* activities71 only if ! sum ( ! am\nts allocat$ by ! ,secret>y = su* co/s1 exclud+ co/s paid f fees collect$ "u ?is section1 plus o!r co/s = ! ma9t5ance1 r5ovation1 & repair ( facilities & acquisition1 ma9t5ance1 & repair ( fixtures1 furniture1 & o!r necess>y mat]ials & supplies 9 connection ) human g5]ic drug activities1 is no less ?an #ig1jjj1jjj multipli$ by ! adju/m5t factor def9$ 9 section #gdd;,a7#c7 applicable to ! fiscal ye> involv$4 2 & 7,b7 9 subp>agraph 7,b71 by /rik+ = human g5]ic activities & ins]t+ z describ$ 9 subclause 7,i7 or 7,,ii7 ( su* subp>agraph1 z applicable14 7d7 ,,mdufa au?ority ,section #gch ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is am5d$-- 7#a7 9 subsection 7h77#b7-- 7,a7 9 subp>agraph 7,a77ii7-- 7i7 by /rik+ %all be available to defray & ins]t+ ! foll[+3 8%all be available-- 7,i7 = fiscal ye> #bjbc1 to defray 2 7ii7 by /rik+ ! p]iod & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+3 7,,ii7 = fiscal ye> #bjbd & ea* subsequ5t fiscal ye>1 to defray ! co/s ( ! res\rces allocat$ = ! process = ! review ( device applications 7includ+ su* co/s = an additional numb] ( full-"t equival5t positions 9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices to be engag$ 9 su* process71 only if ! sum ( ! am\nts allocat$ by ! ,secret>y = su* co/s1 exclud+ co/s paid f fees collect$ "u ?is section1 plus o!r co/s = ! ma9t5ance1 r5ovation1 & repair ( facilities & acquisition1 ma9t5ance1 & repair ( fixtures1 furniture & o!r necess>y mat]ials & supplies 9 connection ) ! process = ! review ( device applications1 is no less ?an ! am\nt allocat$ = su* co/s1 exclud+ any su* co/s paid f fees collect$ "u ?is section1 = fiscal ye> #bjji multipli$ by ! adju/m5t factor4 2 & 7,b7 9 subp>agraph 7,b77i71 9 ! matt] prec$+ subclause 7,i71 by /rik+ = ! process = ! review ( device applications & ins]t+ z describ$ 9 subclause 7,i7 or 7,,ii7 ( su* subp>agraph1 z applicable2 & 7#b7 9 subsection 7g77#c71 by /rik+ #gcg7i77;,c7 & ins]t+ #gcg7aj77;,c74 7e7 ,te*nical correction 7#a7 ,9 g5]al ,section #ije7;b77#b7 ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 is am5d$ by /rik+ ,section #gch7;h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7h77 is am5d$ & ins]t+ ,subsection 7g7 ( section #gch ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j71 z s r$esignat$ by section #bjc7;f77#b77;,b77i71 is am5d$4 7#b7 ,effective date ,! am5dm5t made by p>agraph 7#a7 %all take effect z ?\gh includ$ 9 ! enactm5t ( section #ije ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb74 #ijb4 ,us] fee program transp>5cy & acc\ntability 7a7 ,,pdufa 7#a7 ,reau?orization2 report+ requirem5ts ,section #gcf;,b7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7;a77 is am5d$-- 7,a7 9 p>agraph 7#a7-- 7i7 9 subp>agraph 7,b7-- 7,i7 9 clause 7vii71 by /rik+ 2 & & ins]t+ a semicolon2 7,,ii7 9 clause 7viii71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,,iii7 by add+ at ! end ! foll[+3 7ix7 ! numb] ( inve/igational new drug applications submitt$ p] fiscal ye>1 includ+ = ea* review division4 2 & 7ii7 by add+ at ! end ! foll[+ flu% text3 ,no?+ 9 subp>agraph 7,b7 %all be con/ru$ to au?orize ! disclosure ( in=mation t is prohibit$ f disclosure "u section #cja7;j7 ( ?is ,act or section #aije ( title #ah1 ,unit$ ,/ates ,code1 or t is subject to )hold+ "u section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code4 2 & 7,b7 9 p>agraph 7#d7-- 7i7 by am5d+ subp>agraph 7,a7 to read z foll[s3 7,a7 data1 analysis1 & discussion ( ! *anges 9 ! numb] ( individuals hir$ z agre$ ^u 9 ! lett]s describ$ 9 section #aja7;b7 ( ! ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjbb & ! numb] ( rema9+ vacancies1 ! numb] ( full-"t equival5ts fund$ by fees collect$ pursuant to section #gcf1 & ! numb] ( full-"t equival5ts fund$ by budget au?ority at ! ,food & ,drug ,adm9i/ration by ea* division )9 ! ,c5t] = ,drug ,evaluation & ,rese>*1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 ! ,(fice ( ,regulatory ,affairs1 & ! ,(fice ( ! ,commission]2 2 7ii7 by am5d+ subp>agraph 7,b7 to read z foll[s3 7,b7 data1 analysis1 & discussion ( ! *anges 9 ! fee rev5ue am\nts & co/s = ! process = ! review ( human drug applications1 includ+ id5tify+-- 7i7 driv]s ( su* *anges2 & 7ii7 *anges 9 ! av]age total co/ p] full-"t equival5t 9 ! prescription drug review program2 2 7iii7 9 subp>agraph 7,c71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7iv7 by add+ at ! end ! foll[+3 7,d7 data1 analysis1 & discussion ( ! *anges 9 ! av]age full-"t equival5t h\rs requir$ to complete review ( ea* type ( human drug application4 4 7#b7 ,reau?orization ,section #gcf;,b7f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7;f77 is am5d$-- 7,a7 by r$esignat+ p>agraphs 7#d7 ?r\gh 7#f7 z p>agraphs 7#e7 ?r\gh 7#g71 respectively2 7,b7 by ins]t+ aft] p>agraph 7#c7 ! foll[+3 7#d7 ,updates to ,congress ,! ,secret>y1 9 consultation ) regulat$ indu/ry1 %all provide regul> updates on negotiations on ! reau?orization ( ?is "p to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 2 & 7,c7 9 p>agraph 7#g71 z s r$esignat$-- 7i7 9 subp>agraph 7,a7-- 7,i7 by /rik+ ,be=e pres5t+ ! recomm5dations develop$ "u p>agraphs 7#a7 ?r\gh 7#e7 to ! ,congress1 ! & ins]t+ ,!2 & 7,,ii7 by ins]t+ 1 n lat] ?an #cj days aft] ea* su* negotiation meet+ be=e ! p]iod at ! end2 & 7ii7 9 subp>agraph 7,b71 by ins]t+ 1 9 suffici5t detail1 aft] %all summ>ize4 7b7 ,,mdufa 7#a7 ,reau?orization2 report+ requirem5ts ,section #gch;,a7a77#a77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;a77#a77;,a771 z am5d$ by section #bjd1 is fur!r am5d$-- 7,a7 9 clause 7ii7-- 7i7 9 subclause 7,,ii71 by /rik+ 2 & & ins]t+ a semicolon2 7ii7 9 subclause 7,,iii71 by /rik+ ! p]iod & ins]t+ a semicolon2 & 7iii7 by add+ at ! end ! foll[+3 7,,iv7 ! numb] ( inve/igational device exemption applications submitt$ "u section #ebj7;g7 p] fiscal ye>1 includ+ = ea* review division2 & 7,v7 ! numb] ( exp$it$ developm5t & priority review reque/s & designations "u section #eae;,b p] fiscal ye>1 includ+ = ea* review division4 ,no?+ 9 ?is clause %all be con/ru$ to au?orize ! disclosure ( in=mation t is prohibit$ f disclosure "u section #cja7;j7 ( ?is ,act or section #aije ( title #ah1 ,unit$ ,/ates ,code1 or t is subject to )hold+ "u section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code4 2 & 7,b7 9 clause 7iv7 7relat+ to rationale = ,,mdufa program *anges7-- 7i7 by am5d+ subclause 7,i7 to read z foll[s3 7,i7 data1 analysis1 & discussion ( ! *anges 9 ! numb] ( individuals hir$ z agre$ ^u 9 ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb & ! numb] ( rema9+ vacancies1 ! numb] ( full-"t equival5ts fund$ by fees collect$ pursuant to section #gch1 & ! numb] ( full "t equival5ts fund$ by budget au?ority at ! ,food & ,drug ,adm9i/ration by ea* division )9 ! ,c5t] = ,devices & ,radiological ,heal?1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 ! ,(fice ( ,regulatory ,affairs1 & ! ,(fice ( ! ,commission]2 2 7ii7 by am5d+ subclause 7,,ii7 to read z foll[s3 7,,ii7 data1 analysis1 & discussion ( ! *anges 9 ! fee rev5ue am\nts & co/s = ! process = ! review ( device applications1 includ+ id5tify+-- 7aa7 driv]s ( su* *anges2 & 7bb7 *anges 9 ! av]age total co/ p] full-"t equival5t 9 ! m$ical device review program2 2 7iii7 9 subclause 7,,iii71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7iv7 by add+ at ! end ! foll[+3 7,,iv7 data1 analysis1 & discussion ( ! *anges 9 ! av]age full-"t equival5t h\rs requir$ to complete review ( m$ical device application types4 4 7#b7 ,reau?orization ,section #gch;,a7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;b771 z am5d$ by section #bjd1 is fur!r am5d$-- 7,a7 by r$esignat+ p>agraphs 7#d7 ?r\gh 7#f7 z p>agraphs 7#e7 ?r\gh 7#g71 respectively2 7,b7 by ins]t+ aft] p>agraph 7#c7 ! foll[+3 7#d7 ,updates to ,congress ,! ,secret>y1 9 consultation ) regulat$ indu/ry1 %all provide regul> updates on negotiations on ! reau?orization ( ?is "p to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 2 & 7,c7 9 p>agraph 7#g71 z s r$esignat$-- 7i7 9 subp>agraph 7,a7-- 7,i7 by /rik+ ,be=e pres5t+ ! recomm5dations develop$ "u p>agraphs 7#a7 ?r\gh 7#e7 to ! ,congress1 ! & ins]t+ ,!2 & 7,,ii7 by ins]t+ 1 n lat] ?an #cj days aft] ea* su* negotiation meet+ be=e ! p]iod at ! end2 & 7ii7 9 subp>agraph 7,b71 by ins]t+ 1 9 suffici5t detail1 aft] %all summ>ize4 7c7 ,,gdufa 7#a7 ,reau?orization2 report+ requirem5ts ,section #gdd;,c7a77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7;a77#c77 is am5d$-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ fiscal ye> #bjbj & ins]t+ fiscal ye> #bjbc2 7,b7 by am5d+ subp>agraph 7,a7 to read z foll[s3 7,a7 data1 analysis1 & discussion ( ! *anges 9 ! numb] ( individuals hir$ z agre$ ^u 9 ! lett]s describ$ 9 section #cja7;b7 ( ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbb & ! numb] ( rema9+ vacancies1 ! numb] ( full-"t equival5ts fund$ by fees collect$ pursuant to section #gdd;,b1 & ! numb] ( full "t equival5ts fund$ by budget au?ority at ! ,food & ,drug ,adm9i/ration by ea* division )9 ! ,c5t] = ,drug ,evaluation & ,rese>*1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 ! ,(fice ( ,regulatory ,affairs1 & ! ,(fice ( ! ,commission]2 2 7,c7 by am5d+ subp>agraph 7,b7 to read z foll[s3 7,b7 data1 analysis1 & discussion ( ! *anges 9 ! fee rev5ue am\nts & co/s = human g5]ic drug activities1 includ+-- 7i7 id5tify+ driv]s ( su* *anges2 & 7ii7 *anges 9 ! total av]age co/ p] full-"t equival5t 9 ! g5]ic drug review program2 2 7,d7 9 subp>agraph 7,c71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,e7 by add+ at ! end ! foll[+3 7,d7 data1 analysis1 & discussion ( ! *anges 9 ! av]age full-"t equival5t h\rs requir$ to complete review ( ea* type ( abbreviat$ new drug application4 4 7#b7 ,reau?orization ,section #gdd;,c7f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7;f77 is am5d$-- 7,a7 by r$esignat+ p>agraphs 7#d7 ?r\gh 7#f7 z p>agraphs 7#e7 ?r\gh 7#g71 respectively2 7,b7 by ins]t+ aft] p>agraph 7#c7 ! foll[+3 7#d7 ,updates to ,congress ,! ,secret>y1 9 consultation ) regulat$ indu/ry1 %all provide regul> updates on negotiations on ! reau?orization ( ?is "p to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 2 & 7,c7 9 p>agraph 7#g71 z s r$esignat$-- 7i7 9 subp>agraph 7,a7-- 7,i7 by /rik+ ,be=e pres5t+ ! recomm5dations develop$ "u p>agraphs 7#a7 ?r\gh 7#e7 to ! ,congress1 ! & ins]t+ ,!2 & 7,,ii7 by ins]t+ 1 n lat] ?an #cj days aft] ea* su* negotiation meet+ be=e ! p]iod at ! end2 & 7ii7 9 subp>agraph 7,b71 by ins]t+ 1 9 suffici5t detail1 aft] %all summ>ize4 7d7 ,bs,u,f,a 7#a7 ,reau?orization2 report+ requirem5ts ,section #gdd;,i7a77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7;a77#d77 is am5d$-- 7,a7 by am5d+ subp>agraph 7,a7 to read z foll[s3 7,a7 data1 analysis1 & discussion ( ! *anges 9 ! numb] ( individuals hir$ z agre$ ^u 9 ! lett]s describ$ 9 section #dja7;b7 ( ! ,biosimil> ,us] ,fee ,am5dm5ts ( #bjbb & ! numb] ( rema9+ vacancies1 ! numb] ( full-"t equival5ts fund$ by fees collect$ pursuant to section #gdd;,h1 & ! numb] ( full "t equival5ts fund$ by budget au?ority at ! ,food & ,drug ,adm9i/ration by ea* division )9 ! ,c5t] = ,drug ,evaluation & ,rese>*1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 ! ,(fice ( ,regulatory ,affairs1 & ! ,(fice ( ! ,commission]2 2 7,b7 by am5d+ subp>agraph 7,b7 to read z foll[s3 7,b7 data1 analysis1 & discussion ( ! *anges 9 ! fee rev5ue am\nts & co/s = ! process = ! review ( biosimil> biological product applications1 includ+ id5tify+-- 7i7 driv]s ( su* *anges2 & 7ii7 *anges 9 ! av]age total co/ p] full-"t equival5t 9 ! biosimil> biological product review program2 2 7,c7 9 subp>agraph 7,c71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,d7 by add+ at ! end ! foll[+3 7,d7 data1 analysis1 & discussion ( ! *anges 9 ! av]age full-"t equival5t h\rs requir$ to complete review ( ea* type ( biosimil> biological product application4 4 7#b7 ,reau?orization ,section #gdd;,i7f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7;f77 is am5d$-- 7,a7 by r$esignat+ p>agraphs 7#b7 & 7#c7 z p>agraphs 7#e7 & 7#f71 respectively2 7,b7 by ins]t+ aft] p>agraph 7#a7 ! foll[+3 7#b7 ,prior public input ,prior to beg9n+ negotiations ) ! regulat$ indu/ry on ! reau?orization ( ?is "p1 ! ,secret>y %all-- 7,a7 publi% a notice 9 ! ,f$]al ,regi/] reque/+ public input on ! reau?orization2 7,b7 hold a public meet+ at :i* ! public may pres5t its views on ! reau?orization2 7,c7 provide a p]iod ( #cj days aft] ! public meet+ to obta9 writt5 comm5ts f ! public sugge/+ *anges to ?is "p2 & 7,d7 publi% ! comm5ts on ! ,food & ,drug ,adm9i/ration's website4 7#c7 ,p]iodic consultation ,n less frequ5tly ?an once e mon? dur+ negotiations ) ! regulat$ indu/ry1 ! ,secret>y %all hold discussions ) repres5tatives ( pati5t & consum] advocacy gr\ps to cont9ue discussions ( _! views on ! reau?orization & _! sugge/ions = *anges to ?is "p z express$ "u p>agraph 7#b74 7#d7 ,updates to ,congress ,! ,secret>y1 9 consultation ) regulat$ indu/ry1 %all provide regul> updates on negotiations on ! reau?orization ( ?is "p to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 2 & 7,c7 by add+ at ! end ! foll[+3 7#g7 ,m9utes ( negotiation meet+s 7,a7 ,public availability ,! ,secret>y %all make publicly available1 on ! public website ( ! ,food & ,drug ,adm9i/ration1 m9utes ( all negotiation meet+s conduct$ "u ?is subsection betwe5 ! ,food & ,drug ,adm9i/ration & ! regulat$ indu/ry1 n lat] ?an #cj days aft] ea* su* negotiation meet+4 7,b7 ,cont5t ,! m9utes describ$ "u subp>agraph 7,a7 %all summ>ize1 9 suffici5t detail1 any sub/antive proposal made by any p>ty to ! negotiations z well z significant controv]sies or diff]5ces ( op9ion dur+ ! negotiations & _! resolution4 4 #ijc4 ,,otc he>+ aids f9al rule ,n lat] ?an #cj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue a f9al rule to e/abli% a category ( ov]-!-c\nt] he>+ aids1 z def9$ 9 subsection 7q7 ( section #ebj ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j71 z describ$ 9 section #gji7;b7 ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb74 #ijd4 ,enhanc+ coord9ation & transp>5cy on inspections 7a7 ,coord9ation ,section #ejf;,d ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;d7 is am5d$-- 7#a7 by add+ at ! end ! foll[+3 7g7 ,coord9ation ,! ,secret>y %all ensure timely & effective int]nal coord9ation & alignm5t among ! field inve/igators ( ! ,food & ,drug ,adm9i/ration & ! /aff ( ! ,c5t] = ,drug ,evaluation & ,rese>*'s ,(fice ( ,compliance & ,drug ,%ortage ,program reg>d+ ! reviews ( reports %>$ pursuant to section #gjd7;b77#b71 & any fe$back or corrective or prev5tive actions 9 response to su* reports4 2 & 7#b7 by am5d+ subsection 7f7 to read z foll[s3 7f7 ,tempor>y sunset ,subsection 7a7 %all cease to be effective on ! date t is #e ye>s aft] ! date ( enactm5t ( ! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act4 ,subsections 7b71 7c71 & 7e7 %all n be 9 effect dur+ ! p]iod beg9n+ #e ye>s aft] ! date ( enactm5t ( ! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act & end+ on ! date ( enactm5t ( ! ,food & ,drug ,adm9i/ration ,safety & ,l&m>k ,advancem5ts ,act ( #bjbb4 ,subsections 7b71 7c71 & 7e7 %all be 9 effect beg9n+ on ! date ( enactm5t ( ! ,food & ,drug ,adm9i/ration ,safety & ,l&m>k ,advancem5ts ,act ( #bjbb4 4 7b7 ,report+ ,section #ejf;,c-#a7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c-#a7;a77 is am5d$-- 7#a7 by r$esignat+ p>agraphs 7#c7 ?r\gh 7#g7 z p>agraphs 7#d7 ?r\gh 7#h71 respectively2 7#b7 by ins]t+ aft] p>agraph 7#b7 ! foll[+3 7#c7 provides ! numb] ( reports t 7 requir$ "u section #gjd7;b77#b7 to be s5t to ! appropriate (fices ( ! ,food & ,drug ,adm9i/ration ) exp]tise reg>d+ drug %ortages1 & ! numb] ( su* reports t 7 s5t2 2 & 7#c7 9 p>agraph 7#d77;,a71 z s r$esignat$1 by /rik+ p>agraph 7#g7 & ins]t+ p>agraph 7#h74 7c7 ,applicability 7#a7 ,subsection 7a7 ,! am5dm5ts made by subsection 7a7 %all apply beg9n+ on ! date ( enactm5t ( ?is ,act4 7#b7 ,subsection 7b7 ,! am5dm5ts made by subsection 7b7 %all apply beg9n+ on ! date t is #a ye> aft] ! date ( enactm5t ( ?is ,act4 7d7 ,report+ ( mutual recognition agreem5ts = inspections & review activities ,section #eaj7;h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;h77 is am5d$-- 7#a7 9 p>agraph 7#f7-- 7,a7 9 subp>agraph 7,a71 by /rik+ clauses 7i7 & 7ii7 & ins]t+ ! foll[+3 7i7 ! numb] ( dome/ic & =eign e/abli%m5ts regi/]$ pursuant to ?is section 9 ! previ\s fiscal ye>2 7ii7 ! numb] ( su* regi/]$ e/abli%m5ts 9 ea* region ( int]e/2 7iii7 ! numb] ( su* dome/ic e/abli%m5ts & ! numb] ( su* =eign e/abli%m5ts1 includ+ ! numb] ( e/abli%m5ts 9 ea* region ( int]e/1 t ! ,secret>y inspect$ 9 ! previ\s fiscal ye>2 7iv7 ! numb] ( inspections to support actions by ! ,secret>y on applications "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 includ+ ! numb] ( inspections to support actions by ! ,secret>y on supplem5tal applications1 includ+ *anges to manufactur+ processes1 ! ,secret>y conduct$ 9 ! previ\s fiscal ye>2 7v7 ! numb] ( r\t9e surveillance inspections ! ,secret>y conduct$ 9 ! previ\s fiscal ye>1 includ+ 9 ea* region ( int]e/2 7vi7 ! numb] ( =-cause inspections ! ,secret>y conduct$ 9 ! previ\s fiscal ye>1 n includ+ inspections describ$ 9 clause 7iv71 includ+ 9 ea* region ( int]e/2 & 7vii7 ! numb] ( inspections ! ,secret>y has recogniz$ pursuant to an agreem5t ent]$ into pursuant to section #hji1 or o!rwise recogniz$1 = ea* ( ! types ( inspections describ$ 9 clauses 7v7 & 7vi71 includ+ = inspections ( e/abli%m5ts 9 ea* region ( int]e/4 2 7,b7 9 subp>agraph 7,b71 by /rik+ 2 & & ins]t+ a semicolon2 7,c7 9 subp>agraph 7,c71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,d7 by add+ at ! end ! foll[+3 7,d7 ! /atus ( ! ef=ts ( ! ,food & ,drug ,adm9i/ration to exp& its recognition ( inspections conduct$ or recogniz$ by =eign regulatory au?orities "u section #hji1 includ+ any ob/acles to exp&+ ! use ( su* recognition4 2 & 7#b7 by add+ at ! end ! foll[+3 7#g7 ,region ( int]e/ ,= purposes ( p>agraph 7#f77;,a71 ! t]m region ( int]e/ means a =eign geographic region or c\ntry1 includ+ ! ,p's ,republic ( ,*9a1 ,india1 ! ,european ,union1 ! ,unit$ ,k+dom1 & any o!r c\ntry or geographic region1 z ! ,secret>y det]m9es appropriate4 4 7e7 ,enhanc+ transp>5cy ( drug facility inspection timel9es ,section #ijb ( ! ,,fda ,reau?orization ,act ( #bjag 7#ba ,u4,s4,c4 #cee note7 is am5d$ to read z foll[s3 #ijb4 ,annual report on inspections ,n lat] ?an #abj days aft] ! end ( ea* fiscal ye>1 ! ,secret>y ( ,heal? & ,human ,s]vices %all po/ on ! website ( ! ,food & ,drug ,adm9i/ration in=mation relat$ to inspections ( facilities necess>y = approval ( a drug "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or approval ( a device "u section #eae ( su* ,act 7#ba ,u4,s4,c4 #cfj;e7 t 7 conduct$ dur+ ! previ\s fiscal ye>4 ,su* in=mation %all include ! foll[+3 7#a7 ,! m$ian "t foll[+ a reque/ f /aff ( ! ,food & ,drug ,adm9i/ration review+ an application or report to ! beg9n+ ( ! inspection1 includ+-- 7,a7 ! m$ian "t = drugs describ$ 9 #eje7;j77#aa77;,a77i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#aa77;,a77i772 7,b7 ! m$ian "t = drugs = :i* a notification has be5 submitt$ 9 accordance ) section #ejf;,c7a7 ( su* ,act 7#ba ,u4,s4,c4 #cef;c7a77 dur+ ! previ\s fiscal ye>2 & 7,c7 ! m$ian "t = drugs on ! drug %ortage li/ 9 effect "u section #ejf;,e ( su* ,act 7#ba ,u4,s4,c4 #cef;e7 at ! "t ( su* reque/4 7#b7 ,! m$ian "t f ! issuance ( a report pursuant to section #gjd7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;b77 to ! s5d+ ( a w>n+ lett]1 issuance ( an import al]t1 or hold+ ( a regulatory meet+ = inspections = :i* ! ,secret>y conclud$ t regulatory or en=cem5t action 0 indicat$1 includ+ ! m$ian "t = ea* category ( drugs li/$ 9 subp>agraphs 7,a7 ?r\gh 7,c7 ( p>agraph 7#a74 7#c7 ,! m$ian "t f ! s5d+ ( a w>n+ lett]1 issuance ( an import al]t1 or hold+ ( a regulatory meet+ relat$ to conditions obs]v$ by ! ,secret>y dur+ an inspection1 to ! "t at :i* ! ,secret>y concludes t corrective actions to resolve su* conditions h be5 tak54 7#d7 ,! m$ian "t sp5t by /aff ( ! ,food & ,drug ,adm9i/ration at a facility dur+ an inspection1 includ+-- 7,a7 ! m$ian "t :5 records 7 provid$ remotely 9 accordance ) a reque/ "u section #gjd7;a77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77#d77 9 advance ( ! inspection2 & 7,b7 ! m$ian "t :5 a reque/ = records pursuant to su* section #gjd7;a77#d7 0 n issu$1 or compli$ )1 9 advance ( ! inspection4 7#e7 ,! numb] & type ( violations id5tifi$ dur+ inspections :5 a reque/ = records pursuant to su* section #gjd7;a77#d7 0 issu$ & compli$ ) 9 advance ( ! inspection1 v]sus :5 a reque/ = records pursuant to su* section #gjd7;a77#d7 0 n issu$ or compli$ )4 7#f7 ,! numb] ( facilities t did n implem5t adequate corrective or prev5tive actions foll[+ a report issu$ pursuant to su* section #gjd7;b71 result+ 9 a )hold recomm5dation = an application "u review1 includ+ ! numb] ( su* facilities manufactur+ ea* category ( drugs li/$ 9 subp>agraphs 7,a7 ?r\gh 7,c7 ( p>agraph 7#a74 4 #ije4 ,c]tificates to =eign gov]nm5ts ,section #hja7;e77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;e77#d77 is am5d$-- 7#a7 9 subp>agraph 7,e71 by /rik+ clause 7iii72 & 7#b7 by add+ at ! end ! foll[+3 7,f7 7i7 ,?is p>agraph applies to reque/s = c]tification "u ?is subp>agraph ( a device manufactur$ by a device e/abli%m5t locat$ outside ( ! ,unit$ ,/ates t is regi/]$ "u section #eaj1 if ! device is li/$ pursuant to section #eaj7;j71 ! device has be5 cle>$1 approv$1 or is n requir$ to submit a prem>ket report pursuant to subsection 7l7 or 7m7 ( section #eaj1 & ! device is import$ or (f]$ = import into ! ,unit$ ,/ates4 7ii7 ,! ,secret>y %all issue ! c]tification z describ$ 9 clause 7iii7 if ! device or devices = :i* c]tification is reque/$ "u ?is subp>agraph meet ! applicable requirem5ts ( ?is ,act4 7iii7 7,i7 ,a c]tification = a device describ$ 9 clause 7i7 %all be subject to ! fee describ$ 9 subp>agraph 7,b74 7,,ii7 ,not)/&+ subp>agraph 7,c71 a c]tification = a device describ$ 9 clause 7i7 %all address & include ! same mat]ial in=mation z a ,c]tificate to ,=eign ,gov]nm5t & %all h a docum5t title includ+ ! words ,c]tificate to ,=eign ,gov]nm5t4 7iv7 ,! requirem5ts & proc$ures ( subp>agraph 7,e7 %all apply to a d5ial ( a c]tification "u ?is subp>agraph4 4 #ijf4 ,importation ( drugs 7a7 ,9 g5]al ,section #hjd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #chd7 is am5d$ to read z foll[s3 #hjd4 ,importation ( prescription drugs 7a7 ,def9itions ,9 ?is section3 7#a7 ,=eign sell] ,! t]m =eign sell] means an e/abli%m5t )9 ,canada engag$ 9 ! di/ribution ( an eligible prescription drug t is import$ or (f]$ = importation into ! ,unit$ ,/ates1 t-- 7,a7 has an active ,drug ,e/abli%m5t ,lic5se to :olesale drugs by ! appropriate ,canadian regulatory au?ority2 7,b7 is regi/]$ ) ! applicable regulatory au?orities to di/ribute drugs approv$ by ! appropriate ,canadian regulatory au?ority2 7,c7 is n lic5s$ by a regulatory au?ority ) an int]national ph>macy lic5se t all[s x to di/ribute drugs t are approv$ by c\ntries o!r ?an ,canada & t are n approv$ by ! appropriate ,canadian regulatory au?ority = di/ribution 9 ,canada2 & 7,d7 is regi/]$ ) ! ,secret>y "u ?is section4 7#b7 ,import] ,! t]m import] means a ph>maci/ or :olesal]4 7#c7 ,ph>maci/ ,! t]m ph>maci/ means a p]son lic5s$ by a ,/ate to practice ph>macy1 includ+ ! disp5s+ & sell+ ( prescription drugs4 7#d7 ,prescription drug ,! t]m prescription drug means a drug subject to section #ejc7;b71 o!r ?an-- 7,a7 a controll$ sub/ance 7z def9$ 9 section #ajb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hjb772 7,b7 a biological product 7z def9$ 9 section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb772 7,c7 an infus$ drug 7includ+ a p]itoneal dialysis solution72 7,d7 an intrav5\sly inject$ drug2 7,e7 a drug t is inhal$ dur+ surg]y2 7,f7 an intra!cally or intraocul>ly inject$ drug2 7,g7 a drug t is subject to a risk evaluation & mitigation /rategy "u section #eje-a2 7,h7 a drug t is n a product = purposes ( section #ehb z def9$ 9 section #eha7ac72 7,i7 a comp\nd$ drug2 or 7,j7 a drug ! importation ( :i* pursuant to subsection 7b7 is det]m9$ by ! ,secret>y to pose a ?reat to ! public heal?4 7#e7 ,qualify+ laboratory ,! t]m qualify+ laboratory means a laboratory 9 ! ,unit$ ,/ates t complies ) ! applicable curr5t good manufactur+ practice requirem5ts & has be5 approv$ by ! ,secret>y = ! purposes ( ?is section4 7#f7 ,section #hjd importation program sponsor ,! t]m section #hjd importation program sponsor means a ,/ate or ,indian ,tribe t regulates :olesale drug di/ribution & ! practice ( ph>macy1 or a ph>maci/ or :olesal] t is n ! import]1 z ! ,secret>y may det]m9e1 t submits a proposal to ! ,secret>y t describes a program to facilitate ! importation ( prescription drugs f ,canada "u ?is section & is responsible = ov]sight ( ! implem5tation ( ! program4 7#g7 ,:olesal] ,! t]m :olesal]-- 7,a7 means a p]son lic5s$ 7z def9$ 9 section #eha7i77;,a77 z a :olesale di/ributor 7z def9$ 9 section #eha7bi772 & 7,b7 excludes a p]son au?oriz$ to import drugs "u section #hja7;d77#a74 7b7 ,regulations ,! ,secret>y1 aft] consultation ) ! ,unit$ ,/ates ,trade ,repres5tative & ! ,commission] ( ,cu/oms1 %all promulgate regulations p]mitt+ "t-limit$ section #hjd importation programs1 :i* %all be au?oriz$ by ! ,secret>y & manag$ by ,/ates or ,indian ,tribes1 or 9 c]ta9 circum/ances by ph>maci/s & :olesal]s1 to import prescription drugs f ,canada into ! ,unit$ ,/ates4 ,! "t limit = a section #hjd importation program au?oriz$ by ! ,secret>y may be ext5d$ = a p]iod n to exce$ ! initial "t limit au?oriz$ by ! ,secret>y4 7c7 ,limitation ,! regulations "u subsection 7b7 %all-- 7#a7 require t safegu>ds be 9 place to ensure t ea* prescription drug import$ "u ! regulations complies ) section #eje 7includ+ ) respect to be+ safe & effective = ! int5d$ use ( ! prescription drug71 ) sections #eja & #ejb1 & ) o!r applicable requirem5ts ( ?is ,act2 7#b7 require t a section #hjd importation program sponsor & an import] ( a prescription drug "u ! regulations comply ) subsections 7d77#a71 7d77#b71 7d77#c71 & 7e72 7#c7 require t ! section #hjd importation program sponsor demon/rates t ! importation program meets ! c]tification requirem5ts "u subsection 7l77#a72 & 7#d7 conta9 any additional provisions det]m9$ by ! ,secret>y to be appropriate z a safegu>d to protect ! public heal? or z a means to facilitate ! importation ( prescription drugs4 7d7 ,in=mation & records 7#a7 ,9 g5]al ,! regulations "u subsection 7b7 %all require an import] ( a prescription drug "u subsection 7b7 to submit to ! ,secret>y ! foll[+ in=mation & docum5tation3 7,a7 ,! "n & quantity ( ! active +r$i5t ( ! prescription drug4 7,b7 ,a description ( ! dosage =m ( ! prescription drug4 7,c7 ,! date on :i* ! prescription drug is %ipp$4 7,d7 ,! quantity ( ! prescription drug t is %ipp$4 7,e7 ,! po9t ( orig9 & de/9ation ( ! prescription drug4 7,f7 ,! price paid by ! import] = ! prescription drug4 7,g7 ,docum5tation f ! =eign sell] specify+-- 7i7 ! orig9al s\rce ( ! prescription drug2 & 7ii7 ! quantity ( ea* lot ( ! prescription drug orig9ally receiv$ by ! sell] f t s\rce4 7,h7 ,! lot or control numb] assign$ to ! prescription drug by ! manufactur] ( ! prescription drug4 7,i7 ,! "n1 address1 telephone numb]1 & pr(essional lic5se numb] 7if any7 ( ! import]4 7,j7 ,docum5tation demon/rat+ t ! prescription drug 0 receiv$ by ! =eign sell] f ! manufactur] & subsequ5tly %ipp$ by ! =eign sell] to ! import]4 7,k7 ,docum5tation ( ! quantity ( ea* lot ( ! prescription drug receiv$ by ! =eign sell] demon/rat+ t ! quantity be+ import$ into ! ,unit$ ,/ates is n m ?an ! quantity t 0 receiv$ by ! =eign sell]4 7,l7 7i7 ,9 ! case ( an initial import$ %ipm5t1 docum5tation demon/rat+ t ea* bat* ( ! prescription drug 9 ! %ipm5t 0 /ati/ically sampl$ & te/$ = au!nticity & degradation4 7ii7 ,9 ! case ( any subsequ5t %ipm5t1 docum5tation demon/rat+ t a /ati/ically valid sample ( ! %ipm5t 0 te/$ = au!nticity & degradation4 7,m7 ,docum5tation t ea* supply *a9 "u a section #hjd importation program proposal is limit$ to "o manufactur]1 "o =eign sell]1 & "o import]4 7,n7 ,= ea* prescription drug import$ "u a section #hjd importation program1 docum5tation t ! prescription drug 0 pur*as$ directly f ! manufactur] by ! =eign sell] & t ! =eign sell] sold ! prescription drug directly to ! import]4 7,o7 ,c]tification f ! import] t ! prescription drug-- 7i7 is approv$ = m>ket+ 9 ! ,unit$ ,/ates & is n adult]at$ or misbr&$2 & 7ii7 is relabel$ aft] ! ,secret>y has accept$ ! results ( te/+ requir$ by subp>agraphs 7,j7 ?r\gh 7,p77 & meets all label+ requirem5ts "u ?is ,act4 7,p7 ,laboratory records1 includ+ complete data d]iv$ f all te/s necess>y to ensure t ! prescription drug is 9 compliance ) e/abli%$ specifications & /&>ds4 7,q7 ,docum5tation demon/rat+ t ! te/+ requir$ by subp>agraphs 7,j7 ?r\gh 7,p7 0 conduct$ at a qualify+ laboratory 9 ! ,unit$ ,/ates4 7,r7 ,any o!r in=mation t ! ,secret>y det]m9es is necess>y to ensure ! protection ( ! public heal?4 7#b7 ,section #hjd importation program proposal ,! regulations "u subsection 7b7 %all require a sponsor ( a "t-limit$ section #hjd importation program au?oriz$ "u su* subsection to submit to ! ,secret>y ! foll[+ in=mation & docum5tation 9 its proposal to ! ,secret>y3 7,a7 ,! names ( all p>ticipants 9 ! supply *a91 includ+-- 7i7 ! =eign sell]2 7ii7 ! import]2 7iii7 ! repackag] or relabel]1 if diff]5t f ! import]1 t w relabel ! eligible prescription drugs2 & 7iv7 ! qualify+ laboratory t w conduct te/+ = ! import]4 7,b7 ,in=mation ab\t h[ ! section #hjd importation program sponsor w ensure t-- 7i7 ! prescription drug meets ! te/+ requirem5ts 9 subp>agraphs 7,j7 ?r\gh 7,p7 ( p>agraph 7#a72 7ii7 ! supply *a9 is secure2 7iii7 ! prescription drug w meet ! label+ requirem5ts ( ?is ,act2 7iv7 ! adv]se ev5t-relat$ requirem5ts ( ?is ,act are met2 & 7v7 ! section #hjd importation program w result 9 a significant r$uction 9 ! co/ to ! ,am]ican consum] ( ! prescription drug4 7,c7 ,a compliance plan4 7,d7 ,in=mation ab\t h[ ! section #hjd importation sponsor w ensure t any trade secrets or comm]cial or f9ancial in=mation t is privileg$ or confid5tial t ! manufactur] supplies are kept 9 /rict confid5ce & us$ only = ! purposes ( te/+ or o!rwise comply+ ) ,f$]al law4 7#c7 ,pre -import reque/ ,! regulations "u subsection 7b7 %all require an import] "u a program au?oriz$ "u su* subsection to submit a pre-import reque/ to ! ,secret>y at lea/ #cj cal5d> days be=e ! s*$ul$ date ( arrival or entry = consumption ( a %ipm5t conta9+ a prescription drug cov]$ by ! section #hjd importation program1 :i*ev] is e>li]4 7#d7 ,ma9t5ance by ! secret>y ,! ,secret>y %all ma9ta9 in=mation & docum5tation submitt$ "u p>agraphs 7#a71 7#b71 & 7#c7 = su* p]iod ( "t z ! ,secret>y det]m9es to be necess>y4 7e7 ,te/+ ,! regulations "u subsection 7b7 %all require-- 7#a7 t te/+ describ$ 9 subp>agraphs 7,j7 ?r\gh 7,p7 ( subsection 7d77#a7 be conduct$ by ! import] or by ! manufactur] ( ! prescription drug at a qualifi$ laboratory2 7#b7 if ! te/s are conduct$ by ! import]-- 7,a7 t in=mation ne$$ to-- 7i7 au!nticate ! prescription drug be+ te/$2 & 7ii7 confirm t ! label+ ( ! prescription drug complies ) label+ requirem5ts "u ?is ,act1 be suppli$ by ! manufactur] ( ! prescription drug to ! ph>maci/ or :olesal]2 & 7,b7 t ! in=mation suppli$ "u subp>agraph 7,a7 be kept 9 /rict confid5ce & us$ only = purposes ( te/+ or o!rwise comply+ ) ?is ,act2 & 7#c7 su* additional provisions z ! ,secret>y det]m9es to be appropriate to provide = ! protection ( trade secrets & comm]cial or f9ancial in=mation t is privileg$ or confid5tial4 7f7 ,regi/ration ( =eign sell]s ,any e/abli%m5t )9 ,canada engag$ 9 ! di/ribution ( a prescription drug t is import$ or (f]$ = importation into ! ,unit$ ,/ates %all regi/] ) ! ,secret>y ! "n & place ( bus9ess ( ! e/abli%m5t & ! "n ( ! ,unit$ ,/ates ag5t = ! e/abli%m5t4 7g7 ,susp5sion ( importation ,! ,secret>y %all require t importations ( a specific prescription drug or importations by a specific import] "u subsection 7b7 be imm$iately susp5d$ on discov]y ( a patt]n ( importation ( t specific prescription drug or by t specific import] ( drugs t are c\nt]feit or 9 violation ( any requirem5t "u ?is section1 until an inve/igation is complet$ & ! ,secret>y det]m9es t ! public is adequately protect$ f c\nt]feit & violative prescription drugs be+ import$ "u subsection 7b74 7h7 ,approv$ label+ ,! manufactur] ( a prescription drug %all provide an import] writt5 au?orization = ! import] to use1 at no co/1 ! approv$ label+ = ! prescription drug4 7i7 ,*>itable contributions ,not)/&+ any o!r provision ( ?is section1 section #hja7;d77#a7 cont9ues to apply to a prescription drug t is donat$ or o!rwise suppli$ at no *>ge by ! manufactur] ( ! drug to a *>itable or humanit>ian organization 7includ+ ! ,unit$ ,nations & affiliates7 or to a gov]nm5t ( a =eign c\ntry4 7j7 ,importation = p]sonal use 7#a7 ,decl>ations ,congress decl>es t1 9 implem5t+ ! provisions "u ?is section1 ! ,secret>y may-- 7,a7 focus en=cem5t on cases 9 :i* ! importation by an individual poses a significant ?reat to public heal?2 & 7,b7 ex]cise discretion to p]mit individuals to make su* importations 9 circum/ances 9 :i*-- 7i7 ! importation is cle>ly = p]sonal use2 & 7ii7 ! prescription drug or device import$ does n appe> to pres5t an unreasonable risk to ! individual4 7#b7 ,regulations 7,a7 ,9 g5]al ,! ,secret>y may1 by regulation1 p]mit importation ( a prescription drug1 or class ( prescription drugs1 = p]sonal use1 provid$ t su* importation-- 7i7 does n increase ! public's exposure to c\nt]feit prescription drug products2 7ii7 does n pose a risk ( creat+1 exac]bat+1 or prolong+ an opioid epidemic1 includ+ by increas+ ! public's exposure to c\nt]feit prescription opioid drug products1 su* z c\nt]feit f5tanyl1 or increas+ ! public's misuse ( prescription opioid drug products2 7iii7 meets ! c]tification requirem5ts "u subsection 7l77#a72 & 7iv7 meets su* o!r conditions z ! ,secret>y det]m9es to be appropriate4 7,b7 ,requirem5ts ,regulations describ$ 9 subp>agraph 7,a7 may p]mit importation into ! ,unit$ ,/ates ( a prescription drug t-- 7i7 is import$ 9 a quantity t does n exce$ a #ij-;day supply2 7ii7 is = p]sonal use by an individual1 n = resale2 7iii7 is accompani$ by a copy ( a valid prescription issu$ by a heal? c>e practition] lic5s$ by a ,/ate to practice 9 ! ,unit$ ,/ates to adm9i/] ! drug1 & is n di/ribut$ to anyone o!r ?an ! individual = :om su* prescription is writt52 7iv7 is import$ f ,canada1 f a lic5s$ ph>macy physically locat$ 9 ,canada & regi/]$ ) ! ,secret>y2 7v7 is a prescription drug t complies ) section #eje 7includ+ ) respect to be+ safe & effective = ! int5d$ use ( ! prescription drug71 ) sections #eja & #ejb1 & ) o!r applicable requirem5ts ( ?is ,act2 7vi7 is accompani$ by an electronic import entry = su* prescription drug reg>dless ( its values1 submitt$ us+ an au?oriz$ electronic data int]*ange sy/em2 7vii7 is 9 ! =m ( a f9al f9i%$ dosage t 0 manufactur$ 9 an e/abli%m5t regi/]$ "u section #eaj2 & 7viii7 is import$ "u su* o!r conditions z ! ,secret>y det]m9es to be necess>y to ensure public safety4 7,c7 ,proc$ure ,! ,secret>y %all-- 7i7 proce$ 9 accordance ) section #eec ( title #e 7)\t reg>d to any ref]5ce 9 su* section to sections #eef & #eeg ( su* title7 :5 promulgat+ a regulation "u subp>agraph 7,a71 & %all-- 7,i7 publi% a notice ( propos$ rulemak+ /at+ ) p>ticul>ity ! reason = ! propos$ rule2 7,,ii7 all[ int]e/$ p]sons to submit writt5 data1 views1 & argum5ts1 & make all su* submissions publicly available2 7,,iii7 hold a public meet+2 & 7,,iv7 promulgate a f9al rule bas$ on ! matt] 9 ! rulemak+ record2 7ii7 consult ) ! ,unit$ ,/ates ,trade ,repres5tative1 ! ,commission] ( ! ,u4,s4 ,cu/oms & ,bord] ,protection1 & ! ,adm9i/rator ( ! ,drug ,en=cem5t ,adm9i/ration prior to propos+ & f9aliz+ a rule "u subp>agraph 7,a72 7iii7 include 9 ! preamble to ! propos$ rule "u subp>agraph 7,a7 a cle> & complete description ( h[ ! ,secret>y made ea* ( ! det]m9ations 9 subp>agraph 7,a71 includ+ associat$ analyses1 assumptions1 & in=mation s\rces us$ to make ea* su* det]m9ation1 & a description ( any key limitations or unc]ta9ties t c\ld affect ea* det]m9ation2 & 7iv7 publi% ! propos$ rule & f9al rule "u subp>agraph 7,a7 9 ! ,f$]al ,regi/] & concurr5tly publi% ! record ( ! consultations describ$ 9 clause 7ii7 & ! descriptions describ$ 9 clause 7iii74 7k7 ,con/ruction ,no?+ 9 ?is section limits ! au?ority ( ! ,secret>y relat+ to ! importation ( prescription drugs1 includ+ ! ,secret>y's au?ority to refuse admission ( a drug "u section #hja7;a71 o!r ?an ) respect to section #hja7;d77#a7 z provid$ 9 ?is section4 7l7 ,effectiv5ess ( section 7#a7 ,comm5cem5t ( program ,?is section %all become effective only if ! ,secret>y c]tifies to ,congress t ! implem5tation ( ?is section w-- 7,a7 pose no additional risk to ! public's heal? & safety2 7,b7 result 9 a significant r$uction 9 ! co/ ( cov]$ products to ! ,am]ican consum]2 & 7,c7 be subject to adequate & consi/5t ov]sight by ! ,secret>y4 7m7 ,t]m9ation ( program ,if1 aft] ! date t is #a ye> aft] ! effective date ( ! regulations "u subsection 7b7 or 7j71 ! ,secret>y submits to ,congress a c]tification t1 9 ! option ( ! ,secret>y1 ! b5efits ( implem5tation ( ei!r or bo? su* subsections d n outweigh any detrim5t ( implem5tation ( su* subsection or subsections & any regulations promulgat$ !reund]1 su* subsection or subsections %all cease to be effective z ( ! date t is #cj days aft] ! date on :i* ! ,secret>y submits ! c]tification4 7n7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ su* sums z are necess>y to c>ry out ?is section4 4 7b7 ,requirem5t ,! ,secret>y ( ,heal? & ,human ,s]vices %all reissue1 or am5d1 z appropriate1 ! regulations publi%$ at "p #bea ( title #ba ( ! ,code ( ,f$]al ,regulations pursuant to section #hjd7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #chd7;b771 z 9 effect on ! day be=e ! date ( enactm5t ( ?is ,act4 #ijg4 ,improv+ in=mation te*nology sy/ems ( ! ,food & ,drug ,adm9i/ration 7a7 ,,fda /rategic in=mation te*nology plan 7#a7 ,9 g5]al ,n lat] ?an ,septemb] #cj1 #bjbc1 & at lea/ e #d ye>s !reaft]1 ! ,secret>y ( ,heal? & ,human ,s]vices %all develop & submit to ! appropriate committees ( ,congress & po/ on ! website ( ! ,food & ,drug ,adm9i/ration1 a coord9at$ in=mation te*nology /rategic plan to mod]nize ! in=mation te*nology sy/ems ( ! ,food & ,drug ,adm9i/ration4 ,ea* su* report %all be kn[n z ! ,food & ,drug ,adm9i/ration ,/rategic ,in=mation ,te*nology ,plan44 ,! fir/ su* report may include ! ,data & ,te*nology ,mod]nization ,/rategy1 z set =? 9 ! lett]s describ$ 9 section #aja7;b7 ( ! ,food & ,drug ,adm9i/ration ,safety & ,l&m>k ,advancem5ts ,act ( #bjbb4 7#b7 ,cont5t ( /rategic plan ,! ,food & ,drug ,adm9i/ration ,/rategic ,in=mation ,te*nology ,plan "u p>agraph 7#a7 %all include-- 7,a7 ag5cy-wide /rategic goals & priorities = mod]niz+ ! in=mation te*nology sy/ems ( ! ,food & ,drug ,adm9i/ration to maximize ! effici5cy & effectiv5ess ( su* sy/ems = enabl+ ! ,food & ,drug ,adm9i/ration to fulfill its public heal? mission2 7,b7 specific activities & /rategies = a*iev+ ! goals & priorities id5tifi$ "u subp>agraph 7,a71 & specific mile/ones1 metrics1 & p]=mance measures = assess+ progress aga9/ ! /rategic goals & priorities 9 subp>agraph 7,a72 7,c7 specific activities & /rategies = improv+ & /reaml9+ int]nal coord9ation & communication )9 ! ,food & ,drug ,adm9i/ration1 includ+ = activities & communications relat$ to signals ( pot5tial public heal? conc]ns2 7,d7 *all5ges & risks ! ,food & ,drug ,adm9i/ration w face 9 meet+ its /rategic goals & priorities1 & ! activities ! ,food & ,drug ,adm9i/ration w und]take to ov]come ^? *all5ges & mitigate ^? risks2 7,e7 ! ways 9 :i* ! ,food & ,drug ,adm9i/ration w use ! plan to guide & coord9ate ! projects & activities ( ! ,food & ,drug ,adm9i/ration across its (fices & c5t]s2 & 7,f7 a skills inv5tory1 ne$s assessm5t1 gap analysis1 & initiatives to address skills gaps z "p ( a /rategic approa* to in=mation te*nology human capital plann+4 7#c7 ,evaluation ( progress ,ea* ,food & ,drug ,adm9i/ration ,/rategic ,in=mation ,te*nology ,plan issu$ pursuant to ?is subsection1 ) ! exception ( ! fir/ su* ,food & ,drug ,adm9i/ration ,/rategic ,in=mation ,te*nology ,plan1 %all include an evaluation (-- 7,a7 ! progress ! ,secret>y has made1 bas$ on ! metrics1 b5*m>ks1 & o!r mile/ones t measure successful developm5t & implem5tation ( in=mation te*nology sy/ems2 & 7,b7 :e!r su* actions improv$ ! capacity ( ! ,food & ,drug ,adm9i/ration to a*ieve ! /rategic goals & priorities set =? 9 ! previ\s ,food & ,drug ,adm9i/ration ,/rategic ,in=mation ,te*nology ,plan4 7b7 ,,gao report 7#a7 ,9 g5]al ,n lat] ?an ,septemb] #cj1 #bjbf1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report assess+ ! implem5tation ( ! ,food & ,drug ,adm9i/ration ,/rategic ,in=mation ,te*nology ,plan adopt$ pursuant to subsection 7a74 7#b7 ,cont5t ( report ,! report requir$ "u p>agraph 7#a7 %all include an assessm5t (-- 7,a7 ! developm5t & implem5tation ( ! ,food & ,drug ,adm9i/ration ,/rategic ,in=mation ,te*nology ,plan1 includ+ ! suffici5cy ( ! plan1 progress ( ! ,food & ,drug ,adm9i/ration 9 meet+ ! results-ori5t$ goals1 mile/ones1 & p]=mance measures id5tifi$ 9 su* plan & any gaps 9 su* implem5tation2 7,b7 ! effici5cy & effectiv5ess ( ! ,food & ,drug ,adm9i/ration's exp5ditures on in=mation te*nology sy/ems ov] ! prec$+ #aj fiscal ye>s1 includ+ ! implem5tation by ! ,food & ,drug ,adm9i/ration ( ! ,te*nology ,mod]nization ,action ,plan & ,data ,mod]nization ,action ,plan2 7,c7 *all5ges pos$ by ! in=mation te*nology sy/ems ( ! ,food & ,drug ,adm9i/ration = c>ry+ out ! ,food & ,drug ,adm9i/ration's public heal? mission1 includ+ on meet+ us] fee agreem5t p]=mance goals1 conduct+ inspections1 respond+ to id5tifi$ safety conc]ns1 & keep+ pace ) new sci5tific & m$ical advances2 & 7,d7 recomm5dations = ! ,food & ,drug ,adm9i/ration to address ! id5tifi$ *all5ges1 improve its implem5tation ( ! ,food & ,drug ,adm9i/ration ,/rategic ,in=mation ,te*nology ,plan1 & to o!rwise improve ! ,food & ,drug ,adm9i/ration's in=mation te*nology sy/ems4 #ijh4 ,regulation ( c]ta9 products z drugs ,section #ejc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7 is am5d$ by add+ at ! end ! foll[+3 7h7 ,deem+ c]ta9 products z drugs 7#a7 ,9 g5]al ,any contra/ ag5t1 radioactive drug1 ,,otc monograph drug1 or oph?almic drug article %all be deem$ to be a drug "u section #bja7;g7 & n a device "u section #bja7;h74 7#b7 ,def9itions ,= purposes ( ?is subsection-- 7,a7 ! t]m contra/ ag5t means an article t is int5d$ = use 9 conjunction ) a m$ical imag+ device1 & t-- 7i7 is a diagno/ic radioph>maceutical1 z def9$ 9 section #cae4b & #fja4ca ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations71 includ+ ,,pet drugs1 z def9$ 9 section #bab4a ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations7 & positron emission tomography radiotrac]s2 or 7ii7 is a diagno/ic ag5t t improves ! visualization ( /ructure or function )9 ! body by increas+ ! relative diff]5ce 9 signal int5sity )9 ! t>get tissue1 /ructure1 or fluid2 7,b7 ! t]m oph?almic drug article means any eye cup1 eye dropp]1 or o!r simil> disp5s] int5d$ = oph?almic use if packag$ ) ! drug ) :i* su* article is int5d$ to be us$2 7,c7 ! t]m ,,otc monograph drug has ! mean+ giv5 su* t]m 9 section #gdd,l2 & 7,d7 ! t]m radioactive drug has ! mean+ giv5 su* t]m 9 section #caj4c7n7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations71 except t su* t]m does n include-- 7i7 implants or articles simil> to an implant2 7ii7 articles t apply radiation f outside ( ! body2 or 7iii7 ! radiation s\rce ( an article describ$ 9 clause 7i7 or 7ii74 7#c7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all be con/ru$ z all[+ = ! classification ( a product z a drug 7z def9$ 9 section #bja7;g77 if su* product-- 7,a7 is n describ$ 9 p>agraph 7#a72 & 7,b7 meets ! def9ition ( a device "u section #bja7;h71 unless ano!r provision ( ?is ,act o!rwise indicates a diff]5t classification4 7#d7 ,fees ,! ,secret>y %all waive ! application fee "u sections #gcf & #gdd;,b = applications = products t are1 on ! date ( enactm5t ( ! ,food & ,drug ,adm9i/ration ,safety & ,l&m>k ,advancem5ts ,act ( #bjbb1 legally m>ket$ z m$ical devices & t are deem$ drugs pursuant to p>agraph 7#a74 4 #iji4 ,report+ on mailroom & ,(fice ( ! ,executive ,secret>iat ( ! ,food & ,drug ,adm9i/ration 7a7 ,report ,n lat] ?an #ij days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives on-- 7#a7 in=mation relat$ to policies1 proc$ures1 & activities ( ! mailroom & ! ,(fice ( ! ,executive ,secret>iat ( ! ,food & ,drug ,adm9i/ration1 includ+-- 7,a7 tak+ receipt1 track+1 manag+1 & prioritiz+ confid5tial in=mant compla9ts2 7,b7 tak+ receipt ( common c>ri] packages to ! ,food & ,drug ,adm9i/ration2 7,c7 ! organizational /ructure & managem5t ( ! mailroom2 7,d7 ! organizational /ructure & managem5t ( ! ,(fice ( ! ,executive ,secret>iat2 7,e7 ! total numb] ( employees & contractors 9 ! mailroom includ+ ^? work+ remotely & ^? work+ 9 p]son2 7,f7 ! total numb] ( employees & contractors 9 ! ,(fice ( ! ,executive ,secret>iat2 7,g7 ! numb] ( vacant positions 9 ! mailroom2 7,h7 ! numb] ( vacant positions 9 ! ,(fice ( ! ,executive ,secret>iat2 7,i7 ! av]age numb] ( days = response to correspond5ce receiv$ by ! ,(fice ( ! ,secret>iat2 7,j7 ! ext5t to :i* !re is a backlog ( common c>ri] packages receiv$ by ! mailroom & ! numb] ( common c>ri] packages 9 any backlog2 7,k7 ! ext5t to :i* !re is a backlog ( correspond5ce 9 ! ,(fice ( ! ,executive ,secret>iat t has n be5 appropriately respond$ to by ! ,food & ,drug ,adm9i/ration & ! numb] ( correspond5ce or common c>ri] packages 9 any backlog2 7,l7 a rationale = ! failure ( ! ,(fice ( ! ,executive ,secret>iat to respond to correspond5ce 9 any backlog & ! position ( ! decision-mak+ (ficial :o det]m9$ n to respond to su* correspond5ce2 7,m7 ! numb] ( :i/lebl[] correspond5ce receiv$1 includ+ )9 ea* ag5cy c5t]2 7,n7 ! am\nt ( res\rces exp5d$ = ! mailroom1 includ+ a breakd[n ( budget au?ority & us] fee doll>s2 7,o7 ! am\nt ( res\rces exp5d$ = ! ,(fice ( ! ,executive ,secret>iat & correspond5ce-relat$ activities1 includ+ a breakd[n ( budget au?ority & us] fee doll>s2 & 7,p7 ! p]=mance ( ?ird-p>ty contractors responsible = correspond5ce-relat$ activities ) respect to ! receipt & track+ ( correspond5ce1 & ef=ts by ! ,food & ,drug ,adm9i/ration to improve p]=mance by su* contractors2 & 7#b7 ! developm5t & implem5tation ( new or revis$ policies & proc$ures ( ! ,food & ,drug ,adm9i/ration to monitor & ensure-- 7,a7 ! effective receipt1 track+1 manag+1 & prioritization ( su* compla9ts2 & 7,b7 ! effective receipt ( common c>ri] packages to ! ,food & ,drug ,adm9i/ration4 7b7 ,qu>t]ly report+ ,beg9n+ on ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all issue a report ea* qu>t] ?r\gh ,septemb] #cj1 #bjbd1 to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives on ! implem5tation ( ! new or revis$ policies ( ! ,food & ,drug ,adm9i/ration report$ "u subsection 7a77#b71 & s9ce su* implem5tation-- 7#a7 ! volume ( incom+ common c>ri] packages to ! mailroom2 7#b7 ! volume ( incom+ correspond5ce to ! ,(fice ( ! ,executive ,secret>iat2 7#c7 ! ext5t to :i* new backlogs occur 9 ! process+ ( common c>ri] packages receiv$ by ! mailroom2 7#d7 ! ext5t to :i* new backlogs occur 9 ! process+ ( correspond5ce receiv$ by ! ,(fice ( ! ,executive ,secret>iat2 7#e7 ! l5g? ( "t requir$ to resolve ea* su* backlog2 7#f7 any kn[n issues ( unreasonable delays 9 correspond5ce be+ provid$ to ! int5d$ recipi5t1 or 9 correspond5ce be+ lo/1 & ! measures tak5 to rem$y su* delays or lo/ items2 7#g7 ! av]age numb] ( days x takes to respond to correspond5ce receiv$ by ! ,(fice ( ! ,executive ,secret>iat2 7#h7 ! res\rces exp5d$ by ! mailroom1 includ+ a breakd[n ( budget au?ority & us] fee doll>s2 & 7#i7 ! res\rces exp5d$ by ! ,(fice ( ! ,executive ,secret>iat on correspond5ce-relat$ activities1 includ+ a breakd[n ( budget au?ority & us] fee doll>s4 7c7 ,,gao report ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report assess+ ! policies & practices ( ! ,division ( ,executive ,op]ations ( ! ,(fice ( ! ,executive ,secret>iat ( ! ,food & ,drug ,adm9i/ration ) respect to ! receipt1 track+1 manag+1 & prioritization ( correspond5ce4 #iaj4 ,protect+ infants & improv+ =mula supply 7a7 ,def9itions 7#a7 ,9 g5]al ,9 ?is section-- 7,a7 ! t]m infant =mula has ! mean+ giv5 su* t]m 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba72 & 7,b7 ! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices4 7#b7 ,critical food ,section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba71 z am5d$ by section #hbb1 is fur!r am5d$ by add+ at ! end ! foll[+3 7tt7 ,! t]m critical food means a food t-- 7#a7 is an infant =mula2 7#b7 is a m$ical food1 z def9$ 9 section #e7;b77#c7 ( ! ,orphan ,drug ,act2 or 7#c7 is int5d$ = use by individuals ) c]ta9 inborn errors ( metabolism or o!r conditions requir+ a m$ical food4 4 7b7 ,(fice ( critical foods 7#a7 ,9 g5]al ,! ,secret>y %all e/abli% )9 ! ,c5t] = ,food ,safety & ,appli$ ,nutrition an (fice to be kn[n z ! ,(fice ( ,critical ,foods4 ,! ,secret>y %all appo9t a ,director to lead su* ,(fice4 7#b7 ,duties ,! ,(fice ( ,critical ,foods %all be responsible = ov]sight1 coord9ation1 & facilitation ( activities relat$ to critical foods1 z def9$ 9 section #bja7tt7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a77#b71 & any o!r food det]m9$ by ! ,secret>y to be critical4 7c7 ,prem>ket submissions ( infant =mula to address %ortages ,section #dab ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a7 is am5d$ by add+ at ! end ! foll[+3 7j7 ,prem>ket submissions to address %ortages 7#a7 ,9 g5]al ,! ,secret>y %all waive ! #ij day prem>ket submission requirem5t "u section #dab7;c7 & apply a #cj-;day prem>ket submission requirem5t1 = any p]son :o int5ds to introduce or deliv] = introduction into int]/ate comm]ce any new infant =mula4 7#b7 ,effective p]iod ,! waiv] au?ority "u ?is subsection %all rema9 9 effect = #ij days beg9n+ on ! date t ! ,secret>y di/ributes in=mation "u section #dbd7;a77#b71 or su* long] p]iod z ! ,secret>y det]m9es appropriate to prev5t or mitigate a %ortage ( infant =mula4 7#c7 ,report ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ! ,food & ,drug ,adm9i/ration ,safety & ,l&m>k ,advancem5ts ,act ( #bjbb1 ! ,secret>y %all submit a report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives t includes-- 7,a7 ! numb] ( prem>ket submissions = new infant =mula ! ,secret>y has receiv$ "u subsection 7d7 ea* ye> s9ce #bjab2 7,b7 h[ _m ( su* submissions receiv$ reque/s f ! ,secret>y = additional in=mation2 7,c7 h[ long aft] receiv+ su* submissions ! ,secret>y s5t su* reque/s = additional in=mation2 7,d7 :at additional in=mation ! ,secret>y reque/$ ( ! p]sons submitt+ su* submissions2 & 7,e7 ! date ea* new infant =mula product describ$ 9 subp>agraph 7,a7 0 fir/ m>ket$1 if available4 4 7d7 ,infant =mula flexibilities ,! ,secret>y %all publi% a li/ on ! website ( ! ,food & ,drug ,adm9i/ration detail+ :i* infant =mula products may be appropriate sub/itutes = infant =mula products 9 %ortage t are reli$ ^u by infants & o!r individuals ) am9o-acid & metabolic conditions4 7e7 ,int]national h>monization ( infant =mula requirem5ts 7#a7 ,9 g5]al ,! ,secret>y-- 7,a7 %all p>ticipate 9 meet+s ) repres5tatives f o!r c\ntries to discuss me?ods & approa*es to h>moniz+ regulatory requirem5ts = infant =mula1 includ+ ) respect to inspections1 label+1 & nutritional requirem5ts2 & 7,b7 may ent] into agreem5ts reg>d+ su* requirem5ts ) o!r c\ntries1 z appropriate4 7#b7 ,/udy on infant =mula 7,a7 ,9 g5]al ,n lat] ?an #fj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all seek to ent] into an agreem5t ) ! ,national ,academies ( ,sci5ces1 ,eng9e]+1 & ,m$ic9e 7ref]r$ to 9 ?is p>agraph z ! ,national ,academies7 to exam9e & report on *all5ges 9 supply1 m>ket competition1 & regulation ( infant =mula 9 ! ,unit$ ,/ates4 7,b7 ,requirem5ts ( =eign c\ntries ,! report develop$ pursuant to ! agreem5t "u subp>agraph 7,a7 %all assess & evaluate infant =mula m>ket$ 9 ! ,unit$ ,/ates1 any *all5ges 9 supply1 m>ket competition1 & any diff]5ces 9 infant =mula m>ket$ 9 ! ,european ,union1 includ+ ) respect to nutritional cont5t & applicable label+ & o!r regulatory requirem5ts4 7,c7 ,f9al report ,! agreem5t "u subp>agraph 7,a7 %all specify t ! ,national ,academies %all1 n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 complete su* /udy & submit a report on ! results ( su* /udy to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 7f7 ,transp>5cy & acc\ntability to support infant =mula innovation 7#a7 ,congressional notification ( recall 7,a7 ,9 g5]al ,n lat] ?an #bd h\rs aft] ! initiation ( a recall ( infant =mula z describ$ 9 section #dab7;e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;e7e771 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all submit to ,congress a notification ( su* recall4 7,b7 ,cont5ts ,a notification "u subp>agraph 7,a7 %all include ! foll[+3 7i7 ,if ! recall is requir$ by ! ,food & ,drug ,adm9i/ration1 a summ>y ( ! det]m9ation ( a case ( adult]at$ or misbr&$ infant =mula t pres5ts a risk to human heal?4 7ii7 ,if ! recall is volunt>ily initiat$ by ! manufactur]1 a summ>y ( ! in=mation provid$ to ! ,food & ,drug ,adm9i/ration by ! manufactur] reg>d+ infant =mula t has left ! control ( ! manufactur] t may be adult]at$ or misbr&$4 7iii7 ,specification ( :5 ! ,food & ,drug ,adm9i/ration 0 fir/ made aw>e ( ! in/ance or circum/ances surr\nd+ ! recall4 7iv7 ,an initial e/imate ( ! disruption 9 dome/ic production t may result f ! recall4 7#b7 ,annual report to ,congress ,section #dab ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a71 z am5d$ by subsection 7c71 is fur!r am5d$ by add+ at ! end ! foll[+3 7k7 ,annual report to congress 7#a7 ,9 g5]al ,n lat] ?an ,m>* #cj ( ea* ye>1 ! ,secret>y %all submit a report to ,congress conta9+1 ) respect to ! prec$+ cal5d> ye>1 ! foll[+ in=mation3 7,a7 ,! numb] ( submissions receiv$ by ! ,secret>y "u subsection 7d74 7,b7 ,! numb] ( submissions t includ$ any new +r$i5ts t 7 n includ$ 9 any infant =mula already on ! m>ket4 7,c7 ,! numb] ( inspections conduct$ by ! ,food & ,drug ,adm9i/ration or any ag5t !re( to evaluate compliance ) ! requirem5ts = infant =mulas "u subsection 7b77#b74 7,d7 ,! "t betwe5 any inspection ref]r$ to 9 subp>agraph 7,c7 & any necess>y re9spection to evaluate compliance ) ! requirem5ts = infant =mulas "u subsection 7b77#b74 7,e7 ,a breakd[n ( ! in=mation describ$ 9 subp>agraphs 7,a7 ?r\gh 7,d7 betwe5 =eign & dome/ic manufactur]s & facilities4 7#b7 ,confid5tiality ,! ,secret>y %all ensure t ! reports "u p>agraph 7#a7 d n include any in=mation t is a trade secret or confid5tial in=mation subject to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code4 4 7#c7 ,m>ket+ submissions ,section #dab ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a71 z am5d$ by p>agraph 7#b71 is fur!r am5d$ by add+ at ! end ! foll[+3 7l7 ,m>ket+ submissions 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 ! ,secret>y %all respond to a submission "u subsection 7d7 = infant =mula n lat] ?an #fe days aft] receiv+ su* submission4 7#b7 ,exp$it$ response ,! ,secret>y %all respond to a submission "u subsection 7d7 = infant =mula n lat] ?an #de days aft] receiv+ su* notification if x-- 7,a7 is submitt$ by a manufactur] t is n already m>ket+ infant =mula 9 ! ,unit$ ,/ates2 or 7,b7 is a new infant =mula1 z def9$ 9 subsection 7c77#b74 4 7#d7 ,li/ ( nutri5ts ,section #dab7;i77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a7i77 is am5d$ by /rik+ or1 if revis$ by ! ,secret>y "u p>agraph 7#c71 z s revis$ & ins]t+ ! foll[+3 1 :i* %all be review$ by ! ,secret>y e #d ye>s z appropriate4 ,9 review+ su* table1 ! ,secret>y %all consid] any new sci5tific data or in=mation relat$ to infant =mula nutri5ts1 includ+ int]national infant =mula /&>ds4 ,! ,secret>y may revise ! li/ ( nutri5ts & ! requir$ level = any nutri5t requir$ by ! table4 7#e7 ,te*nical correction ,section #dab7;c77#a77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a7c77#a77;,b77 is am5d$ by /rik+ subsection 7c77#a7 & ins]t+ subsection 7d77#a74 7g7 ,response to recall 7#a7 ,manufactur] submission 7,a7 ,9 g5]al ,promptly aft] ! initiation ( a recall ( infant =mula1 ! manufactur] ( ! recall$ infant =mula %all submit in=mation to ! ,secret>y reg>d+ su* recall4 7,b7 ,cont5ts ,a submission "u subp>agraph 7,a7 %all include ! foll[+3 7i7 ,a plan 7includ+ an e/imat$ timel9e1 z applicable7 ( actions ! manufactur] w take1 suit$ to ! individual circum/ances ( ! p>ticul> recall1 includ+-- 7,i7 to id5tify & address any cause ( adult]ation or misbr&+2 & 7,,ii7 if appropriate1 to re/ore op]ation ( ! impact$ facilities4 7ii7 ,9 ! case t a recall ( ! manufactur]'s infant =mula products1 & subsequ5t actions to respond to su* recall1 impacts ov] #aj p]c5t ( ! production ( ! infant =mula int5d$ = sale 9 ! ,unit$ ,/ates1 a plan to backfill ! supply ( ! manufactur]'s infant =mula supply if ! curr5t dome/ic supply ( su* infant =mula has fall51 or is expect$ to fall1 bel[ ! expect$ dem& = ! =mula4 7#b7 ,report to ,congress 7,a7 ,9 g5]al ,promptly aft] a submission "u p>agraph 7#a7 is receiv$1 ! ,secret>y %all provide su* submission1 toge!r ) ! in=mation specifi$ 9 subp>agraph 7,b71 9 a report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 7,b7 ,cont5ts ,a submission "u subp>agraph 7,a7 %all include ! foll[+3 7i7 ,in=mation conc]n+ ! curr5t dome/ic supply ( infant =mula1 includ+-- 7,i7 a breakd[n ( ! specific types ( =mula involv$2 & 7,,ii7 an e/imate ( h[ long curr5t supplies w la/4 7ii7 ,9 ! case t a submission or submissions "u p>agraph 7#a7 %[ t ! recall & subsequ5t actions to respond to ! recall impact ov] #aj p]c5t ( ! dome/ic production ( infant =mula int5d$ = sale 9 ! ,unit$ ,/ates-- 7,i7 actions to "w ) ! impact$ manufactur] or o!r manufactur]s to increase production2 & 7,,ii7 specification (-- 7aa7 any additional au?orities ne$$ reg>d+ production or importation to fill a supply gap2 & 7bb7 any supplem5tal fund+ necess>y to address ! %ortage4 7#c7 ,sunset ,?is subsection %all cease to h =ce or effect on ( ,septemb] #cj1 #bjbf4 7h7 ,coord9ation ) manufactur] 7#a7 ,9 g5]al 7,a7 ,communication foll[+ inspection ,^u complet+ an inspection ( an infant =mula manufactur+ facility impact$ by a recall1 ! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all provide ! manufactur] involv$ a li/ ( any actions necess>y to-- 7i7 address defici5cies contribut+ to ! pot5tial adult]ation or misbr&+ ( product at ! facility2 & 7ii7 safely re/>t production at ! facility4 7,b7 ,response to ,manufactur] ,n lat] ?an #g days aft] receiv+ a writt5 communication f a manufactur] ( infant =mula reg>d+ safely re/or+ production foll[+ a recall ( su* product1 ! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all provide a sub/antive response to su* communication1 includ+ any necess>y next /eps4 7#b7 ,inspections ,! ,secret>y %all ensure timely communication ) a manufactur] ( infant =mula foll[+ an inspection ( a facility engag$ 9 ! manufactur+ ( infant =mula = consumption 9 ! ,unit$ ,/ates4 ,if a re9spection ( a manufactur] ( an infant =mula is requir$ to ensure t su* manufactur] complet$ any rem$iation actions or address$ any defici5cies1 ! ,secret>y %all re9spect su* facility 9 a timely mann]4 ,! ,secret>y %all prioritize & exp$ite an inspection or re9spection ( an e/abli%m5t t c\ld help mitigate or prev5t a %ortage ( an infant =mula4 7#c7 ,annual inspections ,n lat] ?an #f mon?s aft] ! date ( enactm5t ( ?is ,act1 & n less ?an once p] cal5d> ye> !reaft]1 ! ,secret>y %all conduct inspections1 includ+ unann\nc$ inspections1 ( ! facilities 7includ+ =eign facilities7 ( ea* manufactur] ( an infant =mula requir$ to be regi/]$ "u section #dab7;c77#a77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a7c77#a77;,a771 9 accordance ) a risk bas$ approa* & ensure timely & effective int]nal coord9ation & alignm5t among ! inve/igators & ! ,c5t] = ,food ,safety & ,appli$ ,nutrition4 7i7 ,national /rategy on infant =mula 7#a7 ,9 g5]al ,! ,secret>y1 9 consultation ) ! ,secret>y ( ,agriculture & o!r heads ( relevant dep>tm5ts & ag5cies1 %all develop & issue1 n lat] ?an #ij days aft] ! date ( enactm5t ( ?is ,act1 a national /rategy on infant =mula to increase ! resili5cy ( ! infant =mula supply *a91 protect aga9/ future contam9ation & o!r pot5tial causes ( %ortages1 & ensure p>5ts & c>egiv]s h access to =mula & in=mation !y ne$4 7#b7 ,national /rategy ,! national /rategy "u p>agraph 7#a7 %all-- 7,a7 increase ! resili5cy ( ! infant =mula supply *a9 9 ! %ort-t]m by-- 7i7 assess+ causes ( ! curr5t %ortage & pot5tial causes ( future %ortages1 7ii7 assess+ & address+ imm$iate infant =mula ne$s associat$ ) ! %ortage1 & 7iii7 develop+ a plan to increase infant =mula supply1 includ+ ?r\gh increas$ competition2 7,b7 improve prep>$ness aga9/ infant =mula %ortages 9 ! long-t]m by-- 7i7 outl9+ me?ods to improve in=mation-%>+ betwe5 ! ,f$]al ,gov]nm5t & ,/ate & local gov]nm5ts1 & o!r entities z appropriate1 reg>d+ %ortages2 7ii7 recomm5d+ measures = protect+ ! integrity ( infant =mula supply & prev5t+ contam9ation2 7iii7 outl9+ me?ods to inc5tivize new infant =mula manufactur]s to increase supply & mitigate future %ortages2 & 7iv7 recomm5d+ o!r necess>y au?orities to ga9 insight into ! supply *a9 & risk = %ortages1 & to inc5tivize new infant =mula manufactur]s2 & 7,c7 ensure ! developm5t & updat+ ( education & communication mat]ials = p>5ts & c>egiv]s t cov]-- 7i7 :]e & h[ to f9d infant =mula2 7ii7 comp>able infant =mulas on ! m>ket1 7iii7 :at to d if a m$ical or specialty infant =mula is unavailable2 7iv7 safe practices = h&l+ infant =mula2 & 7v7 o!r topics1 z appropriate4 7j7 ,mean+ful disruption 9 ! production ( critical food ,*apt] ,,iv ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cda et seq47 is am5d$ by add+ at ! end ! foll[+3 #dbd4 ,requirem5ts = critical food 7a7 ,notification ( mean+ful disruption = critical food 7#a7 ,9 g5]al ,a manufactur] ( a critical food 7z def9$ 9 section #bja7tt77 %all notify ! ,secret>y ( a p]man5t discont9uance 9 ! manufacture or an int]ruption ( ! manufacture ( su* food t is likely to lead to a mean+ful disruption 9 ! supply ( su* food 9 ! ,unit$ ,/ates1 & ! reasons = su* discont9uance or int]ruption1 z soon z practicable1 b n lat] ?an #e bus9ess days aft] su* discont9uance or su* int]ruption4 7#b7 ,di/ribution ( in=mation ,n lat] ?an #e cal5d> days aft] receiv+ a notification "u p>agraph 7#a71 ! ,secret>y %all di/ribute1 to ! ,secret>y ( ,agriculture & to ! maximum ext5t practicable to ! appropriate entities1 z det]m9$ by ! ,secret>y ?r\gh su* means z ! ,secret>y det]m9es appropriate1 in=mation on ! mean+ful disruption ( a critical food report$ "u ?is subsection4 7#c7 ,confid5tiality ,no?+ 9 ?is subsection au?orizes ! ,secret>y to disclose any in=mation t is a trade secret or confid5tial in=mation subject to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code4 7#d7 ,mean+ful disruption ,9 ?is subsection1 ! t]m mean+ful disruption-- 7,a7 means a *ange 9 production t is reasonably likely to lead to a significant r$uction 9 ! supply ( a critical food by a manufactur] t affects ! ability ( ! manufactur] to meet expect$ dem& = its product2 & 7,b7 does n include int]ruptions 9 manufactur+ due to matt]s su* z r\t9e ma9t5ance or insignificant *anges 9 manufactur+ s long z ! manufactur] expects to resume op]ations 9 a %ort p]iod ( "t4 7b7 ,risk managem5t plans ,ea* manufactur] ( a critical food %all develop1 ma9ta91 & implem5t1 z appropriate1 a r$undancy risk managem5t plan t id5tifies & evaluates risks to ! supply ( ! food1 z applicable1 = ea* e/abli%m5t 9 :i* su* food is manufactur$4 ,a risk managem5t plan "u ?is subsection-- 7#a7 may id5tify & evaluate risks to ! supply ( m ?an "o critical food1 or critical food category1 manufactur$ at ! same e/abli%m5t2 & 7#b7 %all be subject to inspection & copy+ by ! ,secret>y pursuant to an inspection "u section #gjd4 7c7 ,failure to meet requirem5ts 7#a7 ,9 g5]al ,if a p]son fails to submit in=mation requir$ "u1 & 9 accordance )1 subsection 7a7-- 7,a7 ! ,secret>y %all issue a lett] to su* p]son in=m+ su* p]son ( su* failure2 & 7,b7 n lat] ?an #de cal5d> days aft] ! issuance ( a lett] "u subp>agraph 7,a71 subject to p>agraph 7#b71 ! ,secret>y %all make available to ! public on ! website ( ! ,food & ,drug ,adm9i/ration1 ) appropriate r$actions made to protect ! in=mation describ$ 9 subsection 7a77#c7-- 7i7 ! lett] issu$ "u subp>agraph 7,a72 & 7ii7 at ! reque/ ( su* p]son1 any response to su* lett] su* p]son submitt$ to ! ,secret>y4 7#b7 ,exception ,if ! ,secret>y det]m9es t ! lett] "u p>agraph 7#a7 0 issu$ 9 error or1 aft] review ( su* response1 ! p]son _h a reasonable basis = n submitt+ a notification z requir$ "u subsection 7m71 ! requirem5ts ( p>agraph 7#a77;,b7 %all n apply4 4 7k7 ,specialty infant =mula = importation ,section #dab ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a71 z am5d$ by subsection 7f77#b71 is fur!r am5d$ by add+ at ! end ! foll[+3 7m7 ,waiv] ( requirem5ts = importation ( specialty infant =mula 7#a7 ,9 g5]al ,! ,secret>y may1 dur+ a %ortage ( specialty infant =mula z det]m9$ by ! ,secret>y1 waive any requirem5t "u ?is ,act applicable to facilitate ! importation ( specialty infant =mula4 ,su* a waiv] may be applicable to-- 7,a7 ! importation ( specialty infant =mula f any c\ntry t is det]m9$ by ! ,secret>y to be implem5t+ & en=c+ requirem5ts = infant =mula t provide a simil> assurance ( safety z ! regulatory requirem5ts ( ?is ,act2 or 7,b7 ! di/ribution & sale ( su* import$ specialty infant =mula4 7#b7 ,rule ( con/ruction ,no?+ 9 p>agraph 7#a7 %all be con/ru$ to limit ! au?ority ( ! ,secret>y to require a recall (1 or o!rwise impose re/rictions & requirem5ts "u ?is ,act ) respect to1 specialty infant =mula t is subject to a waiv] "u p>agraph 7#a74 7#c7 ,def9ition ( specialty infant =mula ,9 ?is subsection1 ! t]m specialty infant =mula means infant =mula1 includ+ am9o acid-bas$ =mula1 int5d$ = use by individuals :o h inborn errors ( metabolism or l[ bir? weight1 or :o o!rwise h unusual m$ical or diet>y problems4 4 7l7 ,importation = p]sonal use 7#a7 ,9 g5]al ,not)/&+ any o!r provision ( law1 dur+ ! #ij-;day p]iod beg9n+ on ! date ( enactm5t ( ?is ,act1 a p]son may1 )\t prior notice to ! ,food & ,drug ,adm9i/ration1 import up to a #c-mon? supply ( infant =mula = p]sonal use f-- 7,a7 ,canada2 7,b7 any c\ntry 9 ! ,european ,union2 or 7,c7 any o!r c\ntry t is det]m9$ by ! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 to h safety /&>ds = infant =mula simil> to su* /&>ds applicable "u ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 7#b7 ,limitations ,infant =mula may be import$ pursuant to p>agraph 7#a7 only if ! infant =mula-- 7,a7 is exclusively = p]sonal use & w n be comm]cializ$ or promot$2 & 7,b7 does n pres5t an unreasonable risk to human heal?4 7#c7 ,report+ ( adv]se ev5ts ,if a heal? c>e provid] becomes aw>e ( any adv]se ev5t :i* ! heal? c>e provid] reasonably suspects to be associat$ ) infant =mula import$ pursuant to p>agraph 7#a71 ! heal? c>e provid] %all report su* adv]se ev5t to ! ,commission] ( ,food & ,drugs4 7#d7 ,public notice ,! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all po/ on ! public website ( ! ,food & ,drug ,adm9i/ration notice t-- 7,a7 infant =mula import$ pursuant to p>agraph 7#a7 may n h be5 manufactur$ 9 a facility t has be5 inspect$ by ! ,food & ,drug ,adm9i/ration2 7,b7 ! label+ ( su* infant =mula may n meet ! /&>ds & o!r requirem5ts applicable ) respect to infant =mula "u ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq472 & 7,c7 ! nutritional cont5t ( ! infant =mula may v>y f t ( infant =mula meet+ su* /&>ds & o!r requirem5ts4 7#e7 ,s5se ( ,congress ,x is ! s5se ( ,congress t p]sons consid]+ ! p]sonal importation ( infant =mula %\ld consult ) _! p$iatrician ab\t su* importation4 #iaa4 ,pr$et]m9$ *ange control plans = devices 7a7 ,9 g5]al ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by ins]t+ aft] section #eae;,b 7#ba ,u4,s4,c4 #cfj;e-#c7 ! foll[+3 #eae;,c4 ,pr$et]m9$ *ange control plans = devices 7a7 ,approv$ devices 7#a7 ,9 g5]al ,not)/&+ section #eae7;d77#e77;,a71 a supplem5tal application %all n be requir$ = a *ange to a device approv$ "u section #eae1 if su* *ange is consi/5t ) a pr$et]m9$ *ange control plan t is approv$ pursuant to p>agraph 7#b74 7#b7 ,pr$et]m9$ *ange control plan ,! ,secret>y may approve a pr$et]m9$ *ange control plan submitt$ 9 an application1 includ+ a supplem5tal application1 "u section #eae t describes plann$ *anges t may be made to ! device 7& t w\ld o!rwise require a supplem5tal application "u section #eae71 if ! device rema9s safe & effective )\t any *ange4 7#c7 ,scope ,! ,secret>y may require t a *ange control plan include label+ requir$ = safe & effective use ( ! device z su* device *anges pursuant to su* plan1 notification requirem5ts if ! device does n function z int5d$ pursuant to su* plan1 & p]=mance requirem5ts = *anges made "u ! plan4 7b7 ,cle>$ devices 7#a7 ,9 g5]al ,not)/&+ section #eaj7k71 a prem>ket notification %all n be requir$ = a *ange to a device cle>$ "u section #eaj7k71 if su* *ange is consi/5t ) an e/abli%$ pr$et]m9$ *ange control plan grant$ pursuant to p>agraph 7#b74 7#b7 ,pr$et]m9$ *ange control plan ,! ,secret>y may cle> a pr$et]m9$ *ange control plan submitt$ 9 a notification submitt$ "u section #eaj7k7 t describes plann$ *anges t may be made to ! device 7& t w\ld o!rwise require a new notification71 if-- 7,a7 ! device rema9s safe & effective )\t any su* *ange2 & 7,b7 ! device w\ld rema9 sub/antially equival5t to ! pr$icate4 7#c7 ,scope ,! ,secret>y may require t a *ange control plan include label+ requir$ = safe & effective use ( ! device z su* device *anges pursuant to su* plan1 notification requirem5ts if ! device does n function z int5d$ pursuant to su* plan1 & p]=mance requirem5ts = *anges made "u ! plan4 7c7 ,pr$icate devices ,9 mak+ a det]m9ation ( sub/antial equival5ce pursuant to section #eac7;i71 ! ,secret>y %all n comp>e a device to *ang$ v]sions ( a device implem5t$ 9 accordance ) an e/abli%$ pr$et]m9$ *ange control plan z a pr$icate device4 ,only ! v]sion ( ! device cle>$ or approv$1 prior to *anges made "u ! pr$et]m9$ *ange control plan1 may be us$ by a sponsor z a pr$icate device4 4 7b7 ,con=m+ am5dm5ts 7#a7 ,cle>$ devices ,section #eaj7l77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7l77#a77 is am5d$1 9 ! fir/ s5t5ce1 by ins]t+ 1 or ) respect to a *ange t is consi/5t ) a pr$et]m9$ *ange control plan cle>$ "u section #eae;,c be=e ! p]iod at ! end4 7#b7 ,approv$ devices ,section #eae7;d77#e77;,a77i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7d77#e77;,a77i77 is am5d$ by /rik+ ,a supplem5tal & ins]t+ ,unless ! *ange is consi/5t ) a pr$et]m9$ *ange control plan approv$ "u section #eae;,c1 a supplem5tal4 7#c7 ,docum5tation ( rationale = significant decisions ,section #eag;,a7a77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;g-#a7;a77#a77 is am5d$ to read z foll[s3 7#a7 ,9 g5]al ,! ,secret>y %all provide a sub/antive summ>y ( ! sci5tific & regulatory rationale = any significant decision ( ! ,c5t] = ,devices & ,radiological ,heal? reg>d+ submission or review ( a report "u section #eaj7k71 a petition = classification "u section #eac7;f71 an application "u section #eae1 or an application = an exemption "u section #ebj7;g71 includ+ docum5tation ( significant controv]sies or diff]5ces ( op9ion & ! resolution ( su* controv]sies or diff]5ces ( op9ion4 4 #iab4 ,prohibition aga9/ food packag+ conta9+ int5tionally add$ ,,pfas 7a7 ,9 g5]al ,section #cja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca71 z am5d$ by section #hbd7;a71 is fur!r am5d$ by add+ at ! end ! foll[+3 7mmm7 7#a7 ,! introduction or deliv]y = introduction into int]/ate comm]ce ( food packag+ conta9+ int5tionally add$ ,,pfas4 7#b7 ,! t]m ,,pfas means a p]fluoroalkyl sub/ance or a polyfluoroalkyl sub/ance t is man-made ) at lea/ #a fully fluor9at$ c>bon atom4 4 7b7 ,applicability ,! am5dm5t made by subsection 7a7 applies beg9n+ on ,janu>y #a1 #bjbd4 #iac4 ,requirem5ts reg>d+ conflicts ( int]e/ 7a7 ,ongo+ report+ ( contractor conflicts ( int]e/ 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all require entities t contract ) ! ,food & ,drug ,adm9i/ration-- 7,a7 to disclose1 on an ongo+ basis dur+ ! t]m ( ! contract1 any in=mation relat$ to pot5tial & actual conflicts ( int]e/1 includ+ conflicts ( int]e/ conc]n+ ! contractor's p]sonnel1 consultants1 & subcontractors2 & 7,b7 dur+ ! t]m ( ! contract1 to refra9 f ent]+ into consult+ or o!r contractual arrangem5ts ) any p]son to p]=m "w t may reasonably create a pot5tial or actual conflict ( int]e/1 )\t receiv+ ! writt5 approval ( ! contract+ (fic] be=e ! execution ( ! contractual arrangem5t4 7#b7 ,regulations ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y1 9 consultation ) ! ,f$]al ,acquisition ,regulatory ,c\ncil1 %all issue regulations to c>ry out p>agraph 7#a74 7b7 ,re/rictions on ,,fda contractors 7#a7 ,prohibition aga9/ c]ta9 contracts 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 ! ,secret>y %all n aw>d a contract relat+ to ! duties ( ! ,food & ,drug ,adm9i/ration to any p]son provid+ consult+ s]vices 7ref]r$ to 9 ?is subsection z a consult+ firm7 unless su* contract provides t1 dur+ ! re/rict$ p]iod describ$ 9 subp>agraph 7,c71 subject to subp>agraph 7,b71 no individual employee or subcontractor ( su* consult+ firm may provide s]vices to bo?-- 7i7 ! ,food & ,drug & ,adm9i/ration "u ! consult+ firm's contract2 & 7ii7 7,i7 a p]son engag$ 9 ! developm5t or manufactur+ ( a device1 drug1 or biological product2 or 7,,ii7 any o!r private entity engag$ 9 activities regulat$ by ! ,food & ,drug ,adm9i/ration4 7,b7 ,exception 7i7 ,9 g5]al ,! ,secret>y may issue an exception to ! requirem5t "u subp>agraph 7,a7 ) respect to an employee or subcontractor ( a consult+ firm only if ! ,secret>y or designee det]m9es 9 writ+ t !re is a compell+ reason to aw>d a contract ) su* consult+ firm ) su* exception4 ,! ,secret>y %all n delegate ! au?ority to issue exceptions "u ?is clause bel[ ! level ( head ( a contract+ activity4 7ii7 ,report+ ,n lat] ?an #ad days aft] issu+ an exception "u clause 7i71 ! ,secret>y %all publi%1 on ! website ( ! ,food & ,drug ,adm9i/ration1 a notification ( ! exception4 ,su* notification %all be made publicly available 9 an easily accessible =mat1 & %all include-- 7,i7 ! "n ( ! contract2 7,,ii7 ! consult+ firm receiv+ ! exception1 & ! employee or subcontractor to :om ! exception applies2 7,,iii7 ! o!r contracts or cli5ts t w\ld1 9 ! abs5ce ( ! exception1 cause ! consult+ firm to be 9 violation ( subp>agraph 7,a72 & 7,,iv7 ! ef=ts t ! consult+ firm plans to take to mitigate any pot5tial or actual conflict ( int]e/ aris+ f ! o!r "w ( its employees or subcontractors4 7,c7 ,re/rict$ p]iod 7i7 ,9 g5]al ,= purposes ( subp>agraph 7,a71 ! re/rict$ p]iod is ! p]iod t-- 7,i7 beg9s :5 ! applicable employee or subcontractor ( ! consult+ firm fir/ provides s]vices "u ! consult+ firm's contract2 & 7,,ii7 ends n less ?an ! applicable p]iod specifi$ 9 clause 7ii7 aft] ! la/ date on :i* su* employee or subcontractor provides s]vices "u ! consult+ firm's contract4 7ii7 ,applicable p]iod specifi$ ,= purposes ( clause 7i77,,ii71 ! applicable p]iod specifi$ 9 ?is clause is-- 7,i7 #cj days2 or 7,,ii7 su* long] p]iod ( "t z ! ,secret>y may specify aft] consultation ) ! ,f$]al ,acquisition ,regulatory ,c\ncil1 :i* %all apply ) respect to all exceptions issu$ "u subp>agraph 7,b74 7#b7 ,regulations ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y1 9 consultation ) ! ,f$]al ,acquisition ,regulatory ,c\ncil1 %all issue regulations to c>ry out p>agraph 7#a74 7c7 ,requirem5ts reg>d+ waiv]s relat+ to organizational conflicts ( int]e/ 7#a7 ,9 g5]al ,! ,secret>y %all1 n lat] ?an #ad days aft] aw>d+ a contract relat+ to ! ,food & ,drug ,adm9i/ration1 publi%1 on ! website ( ! ,food & ,drug ,adm9i/ration1 a notification ( any waiv] ( any requirem5ts reg>d+ a pot5tial or actual organizational conflict ( int]e/ grant$ to ! contractor4 ,su* notification %all be made publicly available 9 an easily accessible =mat1 & %all include ! "n ( ! contract1 ! contractor receiv+ ! waiv]1 ! o!r contracts or cli5ts t creat$ ! pot5tial or actual organizational conflict ( int]e/1 & ! ef=ts t ! contractor plans to take to mitigate ! pot5tial or actual organizational conflict ( int]e/4 7#b7 ,regulations ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y1 9 consultation ) ! ,f$]al ,acquisition ,regulatory ,c\ncil1 %all issue regulations to c>ry out p>agraph 7#a74 #iad4 ,?ird p>ty data transp>5cy 7a7 ,9 g5]al ,to ! ext5t ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 seeks to rely on any data1 analysis1 or o!r in=mation or f9d+s provid$ by entities t has be5 fund$ 9 :ole or 9 "p by1 or o!rwise p]=m$ "u contract )1 ! ,food & ,drug ,adm9i/ration1 9 regulatory decision-mak+ ) respect to devices1 ! ,secret>y %all-- 7#a7 reque/ access to ! datasets1 inputs1 cl9ical or o!r assumptions1 me?ods1 analytical code1 results1 & o!r compon5ts und]ly+ or compris+ ! analysis1 conclusions1 or o!r f9d+s ^u :i* ! ,secret>y seeks to rely2 & 7#b7 9 ! ev5t t in=mation describ$ 9 p>agraph 7#a7 is us$ to support regulatory decision-mak+1 & z o!rwise appropriate1 to ! ext5t practicable1 provide ! manufactur] or manufactur]s subject to su* decision a summ>y ( su* in=mation1 subject to protection ( confid5tial comm]cial in=mation or trade secret in=mation or p]sonally id5tifiable in=mation4 7b7 ,report ,n lat] ?an ,septemb] #cj1 #bjbc1 & bi5nially !reaft]1 ! ,secret>y %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 & publi% on ! website ( ! ,food & ,drug ,adm9i/ration1 a report on ! numb] ( po/m>ket device signals communications issu$ by ! ,secret>y1 ! s\rces ( data = su* signals1 & h[ su* signals 7 revis$ or resolv$4 #iae4 ,bann$ devices 7a7 ,9 g5]al ,section #eaf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;f7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a71 by ins]t+ = "o or m ( its int5d$ uses be=e ! semicolon2 & 7,b7 9 ! flu% text foll[+ p>agraph 7#b71 by ins]t+ = any su* int5d$ use or uses be=e ! p]iod2 & 7#b7 by add+ at ! end ! foll[+3 7c7 ,specific devices ,adv]se condition+ devices1 includ+ electrical /imulation devices1 t apply a noxi\s electrical /imulation to an individual's sk9 int5d$ to r$uce or cease self-injuri\s or aggressive behavior are deem$ to be bann$ devices1 z describ$ 9 subsection 7a71 )\t ! ne$ = ! ,secret>y to promulgate a regulation ) respect to su* devices z describ$ 9 su* subsection4 4 7b7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to limit ! au?ority ( ! ,secret>y ( ,heal? & ,human ,s]vices to am5d1 9 accordance ) section #eaf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;f7 & *apt] #e ( title #e1 ,unit$ ,/ates ,code1 regulations promulgat$ pursuant to su* section #eaf4 #iaf4 ,device cyb]security 7a7 ,guidance = indu/ry & ,,fda /aff on device cyb]security ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 & p]iodically !reaft] z appropriate1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y71 9 consultation ) ! ,director ( ! ,cyb]security & ,infra/ructure ,security ,ag5cy1 %all review &1 z appropriate & aft] solicit+ & receiv+ fe$back f device manufactur]s1 heal? c>e provid]s1 ?ird p>ty device s]vic]s1 pati5t advocates1 & o!r appropriate /akehold]s1 update ! guidance entitl$ ,cont5t ( ,prem>ket ,submissions = ,managem5t ( ,cyb]security 9 ,m$ical ,devices 7or a successor docum5t74 7b7 ,res\rces reg>d+ cyb]security ( devices ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 & n less ?an annually !reaft]1 ! ,secret>y %all update public in=mation provid$ by ! ,food & ,drug ,adm9i/ration1 includ+ on ! website ( ! ,food & ,drug ,adm9i/ration1 ) in=mation reg>d+ improv+ cyb]security ( devices4 ,su* in=mation %all include in=mation on id5tify+ & address+ cyb] vuln]abilities = heal? c>e provid]s1 heal? sy/ems1 & device manufactur]s1 & h[ su* entities may access support ?r\gh ! ,cyb]security & ,infra/ructure ,security ,ag5cy & o!r ,f$]al entities1 includ+ ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 to improve cyb]security ( devices4 7c7 ,,gao report ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all publi% a report id5tify+ *all5ges 9 cyb]security = devices1 includ+ legacy devices t may n support c]ta9 s(tw>e security updates4 ,?r\gh su* report1 ! ,comptroll] ,g5]al %all exam9e-- 7#a7 *all5ges = device manufactur]s1 heal? c>e provid]s1 heal? sy/ems1 & pati5ts 9 access+ ,f$]al support to address vuln]abilities across ,f$]al ag5cies2 7#b7 h[ ,f$]al ag5cies c /r5g!n coord9ation to bett] support cyb]security = devices2 & 7#c7 /atutory limitations & opportunities = improv+ cyb]security = devices4 7d7 ,def9ition ,9 ?is section1 ! t]m device has ! mean+ giv5 su* t]m 9 section #bja7;h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;h774 #iag4 ,wom5's ,heal? ,rese>* ,roadmap ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,(fice ( ,wom5's ,heal? ( ! ,food & ,drug ,adm9i/ration1 e/abli%$ "u section #ajaa ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cii;b71 %all-- 7#a7 review &1 z appropriate1 update ! ,wom5's ,heal? ,rese>* ,roadmap issu$ 9 ,decemb] #bjae2 & 7#b7 brief ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives on ! review &1 z appropriate1 any result+ update4 #iah4 ,,gao report on dea?s due to ! co/ ( drugs 9 ! ,unit$ ,/ates ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all publi% a /udy on ! numb] ( individuals 9 ! ,unit$ ,/ates :o die ea* ye> because !y _c af=d to pur*ase ! m$ic9e prescrib$ by _! heal? c>e provid]s4 ,july #ac1 #bjbb,report$ ) an am5dm5t