,,ib ,union ,cal5d> ,no4 #bfb #aag? ,,congress #b;d ,session ,h4 ,r4 #gffg ,report ,no4 #aag-cdh ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,may #f1 #bjbb,ms4 ,e%oo 7= h]self1 ,mr4 ,gu?rie1 ,mr4 ,pallone1 & ,mrs4 ,rodg]s ( ,wa%+ton7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,june #g1 #bjbb,report$ ) an am5dm5t1 committ$ to ! ,committee ( ! ,:ole ,h\se on ! ,/ate ( ! ,union1 & ord]$ to be printed,strike out all aft] ! enact+ clause & ins]t ! "p pr9t$ 9 italic,for text ( introduc$ bill1 see copy ( bill z introduc$ on ,may #f1 #bjbb ,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 title ,?is ,act may be cit$ z ! ,food & ,drug ,am5dm5ts ( #bjbb4 #b4 ,table ( cont5ts ,! table ( cont5ts ( ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title4,sec4 #b4 ,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+ requirem5ts4,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+ requirem5ts4,sec4 #bje4 ,con=mity assessm5t pilot program4,sec4 #bjf4 ,reau?orization ( ?ird-p>ty review program4,sec4 #bjg4 ,sunset dates4,sec4 #bjh4 ,effective date4,sec4 #bji4 ,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> fees4,sec4 #djd4 ,reau?orization2 report+ requirem5ts4,sec4 #dje4 ,sunset dates4,sec4 #djf4 ,effective date4,sec4 #djg4 ,sav+s clause4,title ,v--,improv+ ,div]sity 9 ,cl9ical ,studies,sec4 #eja4 ,div]sity action plans = cl9ical /udies4,sec4 #ejb4 ,evaluation ( ! ne$ = ,,fda au?ority to m&ate po/approval /udies or po/m>ket surveillance due to insuffici5t demographic subgr\p data4,sec4 #ejc4 ,public work%ops to enhance cl9ical /udy div]sity4,sec4 #ejd4 ,annual summ>y report on progress to increase div]sity 9 cl9ical /udies4,sec4 #eje4 ,public meet+ on cl9ical /udy flexibilities initiat$ 9 response to ,,covid-#ai p&emic4,sec4 #ejf4 ,dec5traliz$ cl9ical /udies4,title ,,vi--,g5]ic ,drug ,competition,sec4 #fja4 ,increas+ transp>5cy 9 g5]ic drug applications4,sec4 #fjb4 ,enhanc+ access to af=dable m$ic9es4,title ,,vii--,rese>*1 ,developm5t1 & ,supply ,*a9 ,improvements,subtitle ,a--,9 ,general,sec4 #gja4 ,animal te/+ alt]natives4,sec4 #gjb4 ,em]g+ te*nology program4,sec4 #gjc4 ,improv+ ! treatm5t ( r>e diseases & conditions4,sec4 #gjd4 ,antifungal rese>* & developm5t4,sec4 #gje4 ,advanc+ qualifi$ infecti\s disease product innovation4,sec4 #gjf4 ,advanc$ manufactur+ te*nologies designation pilot program4,sec4 #gjg4 ,public work%op on cell !rapies4,sec4 #gjh4 ,reau?orization ( be/ ph>maceuticals = *ildr54,sec4 #gji4 ,reau?orization = humanit>ian device exemption & demon/ration grants = improv+ p$iatric availability4,sec4 #gaj4 ,reau?orization ( provision relat$ to exclusivity ( c]ta9 drugs conta9+ s+le enantiom]s4,sec4 #gaa4 ,reau?orization ( ! critical pa? public-private p>tn]%ip program4,sec4 #gab4 ,reau?orization ( orphan drug grants4,sec4 #gac4 ,rese>* into p$iatric uses ( drugs2 additional au?orities ( ,food & ,drug ,adm9i/ration reg>d+ molecul>ly t>get$ canc] drugs4,subtitle ,b--,inspections,sec4 #gba4 ,factory inspection4,sec4 #gbb4 ,uses ( c]ta9 evid5ce4,sec4 #gbc4 ,improv+ ,,fda inspections4,sec4 #gbd4 ,,gao report on inspections ( =eign e/abli%m5ts manufactur+ drugs4,sec4 #gbe4 ,unann\nc$ =eign facility inspections pilot program4,sec4 #gbf4 ,reau?orization ( inspection program4,sec4 #gbg4 ,enhanc+ intra-ag5cy coord9ation & public heal? assessm5t ) reg>d to compliance activities4,sec4 #gbh4 ,report+ ( mutual recognition agreem5ts = inspections & review activities4,sec4 #gbi4 ,enhanc+ transp>5cy ( drug facility inspection timel9es4,title ,,viii--,transp>5cy1 ,program ,integrity1 & ,regulatory ,improvements,sec4 #hja4 ,prompt reports ( m>ket+ /atus by hold]s ( approv$ applications = biological products4,sec4 #hjb4 ,enc\rag+ blood donation4,sec4 #hjc4 ,regulation ( c]ta9 products z drugs4,sec4 #hjd4 ,po/approval /udies & program integrity = accel]at$ approval drugs4,sec4 #hje4 ,facilitat+ ! use ( real _w evid5ce4,sec4 #hjf4 ,dual ,submission = ,c]ta9 ,devices4,sec4 #hjg4 ,m$ical ,devices ,advisory ,committee meet+s4,sec4 #hjh4 ,ensur+ cyb]security ( m$ical devices4,sec4 #hji4 ,public docket on propos$ *anges to ?ird-p>ty v5dors4,sec4 #haj4 ,facilitat+ ex*ange ( product in=mation prior to approval4,sec4 #haa4 ,bans ( devices = "o or m int5d$ uses4,sec4 #hab4 ,cl>ify+ application ( exclusive approval1 c]tification1 or lic5sure = drugs designat$ = r>e diseases or conditions4,sec4 #hac4 ,,gao report on ?ird-p>ty review4,sec4 #had4 ,report+ on p5d+ g5]ic drug applications & priority review applications4,sec4 #hae4 ,,fda ,work=ce ,improvem5ts4 ,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 by ?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$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g et seq471 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #ajb4 ,def9itions 7a7 ,human drug application ,section #gce7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g7#a77 is am5d$ 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 to4 7b7 ,prescription drug product ,section #gce7c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g7#c77 is am5d$-- 7#a7 by r$esignat+ subp>agraphs 7,a71 7,b71 & 7,c7 z clauses 7i71 7ii71 & 7iii71 respectively2 7#b7 by /rik+ 7#c7 ,! t]m & ins]t+ 7#c77;,a7 ,! t]m2 7#c7 by /rik+ ,su* t]m does n include :ole blood & ins]t+ ! foll[+3 7,b7 ,su* t]m does n include :ole blood 2 7#d7 by /rik+ an all]g5ic extract product1 & ins]t+ an all]g5ic extract product lic5s$ 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 #bjbb12 & 7#e7 by add+ at ! end ! foll[+3 7,c7 7i7 ,if a writt5 reque/ to place a product 9 ! discont9u$ section ( ei!r ( ! li/s ref]5c$ 9 subp>agraph 7,a77iii7 is submitt$ to ! ,secret>y on behalf ( an applicant1 & ! reque/ id5tifies ! date ! product is )drawn f sale1 !n = 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] (-- 7,i7 ! date su* reque/ 0 receiv$2 or 7,,ii7 if ! product w be )drawn f sale on a future date1 su* future date :5 ! product is )drawn f sale4 7ii7 ,= purposes ( ?is subp>agraph1 a product %all be consid]$ )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 4 7c7 ,sk9-,te/ diagno/ic product ,section #gce ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g7 is am5d$ 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 7#a7 ,human drug application fee ,section #gcf7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7a77 is am5d$-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ fiscal ye> #bjah & ins]t+ fiscal ye> #bjbc2 7,b7 9 p>agraph 7#a77;,a71 by /rik+ 7c77#e7 ea* place x appe>s & ins]t+ 7c77#f72 7,c7 9 p>agraph 7#a77;,c71 by ins]t+ prior to approval aft] or 0 )drawn2 & 7,d7 9 p>agraph 7#a71 by add+ at ! end ! foll[+3 7,h7 ,exception = sk9-te/ diagno/ic products ,a human drug application = a sk9-te/ diagno/ic product %all n be subject to a fee "u subp>agraph 7,a74 4 7#b7 ,prescription drug program fee ,section #gcf7;a77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7a77#b77 is am5d$-- 7,a7 9 subp>agraph 7,a7-- 7i7 by /rik+ ,except z provid$ 9 subp>agraphs 7,b7 & 7,c7 & ins]t+ ! foll[+3 7i7 ,fee ,except z provid$ 9 subp>agraphs 7,b7 & 7,c7 2 7ii7 by /rik+ subsection 7c77#e7 & ins]t+ subsection 7c77#f72 & 7iii7 by add+ at ! end ! foll[+3 7ii7 ,special rule ,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/ ref]5c$ 9 section #gce7c77;,a77iii71 & 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 supplem5t ) respect to su* product1 %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* su* 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$]al ,regulations 7or any successor regulation77 to ano!r product on ! li/ ( products compil$ "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 7#a7 ,9 g5]al ,p>agraph 7#a7 ( section #gcf7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7b77 is am5d$ to read z foll[s3 7#a7 ,9 g5]al ,= ea* ( ! fiscal ye>s #bjbc ?r\gh #bjbg1 fees "u subsection 7a7 %all1 except z provid$ 9 subsections 7c71 7d71 7f71 & 7g71 be e/abli%$ to g5]ate a total rev5ue am\nt "u su* subsection t is equal to ! sum (-- 7,a7 ! annual base rev5ue = ! fiscal ye> 7z det]m9$ "u p>agraph 7#c772 7,b7 ! doll> am\nt equal to ! inflation adju/m5t = ! fiscal ye> 7z det]m9$ "u subsection 7c77#a772 7,c7 ! doll> am\nt equal to ! /rategic hir+ & ret5tion adju/m5t = ! fiscal ye> 7z det]m9$ "u subsection 7c77#b772 7,d7 ! doll> am\nt equal to ! capacity plann+ adju/m5t = ! fiscal ye> 7z det]m9$ "u subsection 7c77#c772 7,e7 ! doll> am\nt equal to ! op]at+ res]ve adju/m5t = ! fiscal ye>1 if applicable 7z det]m9$ "u subsection 7c77#d772 7,f7 ! doll> am\nt equal to ! additional direct co/ adju/m5t = ! fiscal ye> 7z det]m9$ "u subsection 7c77#e772 & 7,g7 additional doll> am\nts = ea* fiscal ye> z foll[s3 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 4 7#b7 ,annual base rev5ue ,p>agraph 7#c7 ( section #gcf7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7b77 is am5d$ 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 #a1aea1ebb1ieh2 & 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 n includ+ any adju/m5ts made "u subsection 7c77#d7 or 7c77#e74 4 7c7 ,adju/m5ts2 annual fee sett+ 7#a7 ,inflation adju/m5t ,section #gcf7;c77#a77;,b77ii7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77#a77;,b77ii77 is am5d$ by /rik+ ,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv & ins]t+ ,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv4 7#b7 ,/rategic hir+ & ret5tion adju/m5t ,section #gcf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is am5d$-- 7,a7 by r$esignat+ p>agraphs 7#b7 ?r\gh 7#f7 z p>agraphs 7#c7 ?r\gh 7#g71 respectively2 & 7,b7 by ins]t+ aft] p>agraph 7#a7 ! foll[+3 7#b7 ,/rategic hir+ & ret5tion adju/m5t ,= ea* fiscal ye>1 aft] ! annual base rev5ue e/abli%$ 9 subsection 7b77#a77;,a7 is adju/$ = inflation 9 accordance ) p>agraph 7#a71 ! ,secret>y %all fur!r increase ! fee rev5ue & fees by ! foll[+ am\nts3 7,a7 ,= fiscal ye> #bjbc1 #i1jjj1jjj4 7,b7 ,= ea* ( fiscal ye>s #bjbd ?r\gh #bjbg1 #d1jjj1jjj4 4 7#c7 ,capacity plann+ adju/m5t ,p>agraph 7#c71 z r$esignat$1 ( section #gcf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is am5d$ to read z foll[s3 7#c7 ,capacity plann+ adju/m5t 7,a7 ,9 g5]al ,= ea* fiscal ye>1 aft] ! annual base rev5ue e/abli%$ 9 subsection 7b77#a77;,a7 is adju/$ 9 accordance ) p>agraphs 7#a7 & 7#b71 su* rev5ue %all be adju/$ fur!r = su* fiscal ye>1 9 accordance ) ?is p>agraph1 to reflect *anges 9 ! res\rce capacity ne$s ( ! ,secret>y = ! process = ! review ( human drug applications4 7,b7 ,me?odology ,= purposes ( ?is p>agraph1 ! ,secret>y %all employ ! capacity plann+ me?odology utiliz$ by ! ,secret>y 9 sett+ fees = fiscal ye> #bjba1 z describ$ 9 ! notice titl$ ,prescription ,drug ,us] ,fee ,rates = ,fiscal ,ye> #bjba publi%$ 9 ! ,f$]al ,regi/] on ,augu/ #c1 #bjbj 7#he ,f$4 ,reg4 #dffea74 ,! workload categories us$ 9 apply+ su* me?odology 9 =eca/+ %all include only ! activities describ$ 9 t notice &1 z feasible1 additional activities t are also 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$+ s5t5ce1 ! ,secret>y %all n include z workload categories 9 apply+ su* me?odology 9 =eca/+ any non-core review activities1 includ+ ^? activities t ! ,secret>y ref]5c$ = pot5tial future use 9 su* notice b did n utilize 9 sett+ fees = fiscal ye> #bjba4 7,c7 ,limitation ,"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 subsections 7b77#a77;,a7 7! annual base rev5ue = ! fiscal ye>71 7b77#a77;,b7 7! doll> am\nt ( ! inflation adju/m5t = ! fiscal ye>71 & 7b77#a77;,c7 7! doll> am\nt ( ! /rategic hir+ & ret5tion adju/m5t = ! fiscal ye>74 7,d7 ,publication 9 ,f$]al ,regi/] ,! ,secret>y %all publi% 9 ! ,f$]al ,regi/] notice "u p>agraph 7#f7 ( ! fee rev5ue & fees result+ f ! adju/m5t & ! me?odologies "u ?is p>agraph4 4 7#d7 ,op]at+ res]ve adju/m5t ,p>agraph 7#d71 z r$esignat$1 ( section #gcf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is am5d$-- 7,a7 by am5d+ subp>agraph 7,a7 to read z foll[s3 7,a7 ,increase ,= fiscal ye> #bjbc & subsequ5t fiscal ye>s1 ! ,secret>y %all1 9 addition to adju/m5ts "u p>agraphs 7#a71 7#b71 & 7#c71 fur!r increase ! fee rev5ue & fees if su* an adju/m5t is necess>y to provide = op]at+ res]ves ( c>ryov] us] fees = ! process = ! review ( human drug applications = ea* fiscal ye> 9 at lea/ ! foll[+ am\nts3 7i7 ,= fiscal ye> #bjbc1 at lea/ #h weeks ( op]at+ res]ves4 7ii7 ,= fiscal ye> #bjbd1 at lea/ #i weeks ( op]at+ res]ves4 7iii7 ,= fiscal ye> #bjbe & subsequ5t fiscal ye>s1 at lea/ #aj weeks ( op]at+ res]ves4 2 & 7,b7 9 subp>agraph 7,c71 by /rik+ p>agraph 7#e7 & ins]t+ p>agraph 7#f74 7#e7 ,additional direct co/ adju/m5t ,p>agraph 7#e71 z r$esignat$1 ( section #gcf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is am5d$ to read z foll[s3 7#e7 ,additional direct co/ adju/m5t 7,a7 ,increase ,! ,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-- 7i7 = fiscal ye> #bjbc1 by #dd1chf1aej2 & 7ii7 = ea* ( fiscal ye>s #bjbd ?r\gh #bjbg1 by ! am\nt set =? 9 clauses 7i7 ?r\gh 7iv7 ( subp>agraph 7,b71 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 = #bjba4 7,b7 ,applicable am\nts ,! am\nts ref]r$ to 9 subp>agraph 7,a77ii7 are ! foll[+3 7i7 ,= fiscal ye> #bjbd1 #fj1ifg1iic4 7ii7 ,= fiscal ye> #bjbe1 #ce1gii1cad4 7iii7 ,= fiscal ye> #bjbf1 #ce1gii1 #cad4 7iv7 ,= fiscal ye> #bjbg1 #ce1gii1cad4 4 7#f7 ,annual fee sett+ ,p>agraph 7#f71 z r$esignat$1 ( section #gcf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is am5d$ by /rik+ ,septemb] #cj1 #bjag & ins]t+ ,septemb] #cj1 #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+ fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ fiscal ye>s #bjbc ?r\gh #bjbg4 7e7 ,writt5 reque/s = waiv]s1 r$uctions1 exemptions1 & returns2 disputes conc]n+ fees ,section #gcf7;i7 ( ! ,f$]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-- 7#a7 n lat] ?an #ahj days aft] su* fee is due1 submit to ! ,secret>y a writt5 reque/ ju/ify+ su* waiv]1 r$uction1 exemption1 or return2 & 7#b7 include 9 ! reque/ any legal au?orities "u :i* ! reque/ is made4 4 7f7 ,orphan drugs ,section #gcf7k7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7k77 is am5d$-- 7#a7 9 p>agraph 7#a77;,b71 by /rik+ dur+ ! previ\s ye> & ins]t+ z det]m9$ "u p>agraph 7#b72 & 7#b7 by am5d+ p>agraph 7#b7 to read z foll[s3 7#b7 ,evid5ce ( qualification ,an exemption "u p>agraph 7#a7 applies ) respect to a drug only if ! applicant involv$ submits a c]tification t ! applicant's gross annual rev5ues did n exce$ #ej1jjj1jjj = ! la/ cal5d> ye> end+ prior to ! fiscal ye> = :i* ! exemption is reque/$4 ,su* c]tification %all be support$ by-- 7,a7 tax returns submitt$ to ! ,unit$ ,/ates ,int]nal ,rev5ue ,s]vice2 or 7,b7 z necess>y1 o!r appropriate f9ancial in=mation4 4 #ajd4 ,reau?orization2 report+ requirem5ts ,section #gcf;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7 is am5d$-- 7#a7 9 subsection 7a77#a71 by /rik+ ,beg9n+ ) fiscal ye> #bjah1 n & ins]t+ ,n2 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#c77;,a71 by /rik+ ,n lat] ?an #cj cal5d> days aft] ! end ( ! second qu>t] ( fiscal ye> #bjah1 & n lat] ?an #cj cal5d> days aft] ! end ( ea* qu>t] ( ea* fiscal ye> !reaft] & ins]t+ ,n lat] ?an #cj cal5d> days aft] ! end ( ea* qu>t] ( ea* fiscal ye> = :i* fees are collect$ "u ?is "p2 7#d7 9 subsection 7a77#c77;,b71 by add+ at ! end ! foll[+3 7v7 ,= fiscal ye>s #bjbc & #bjbd1 ( ! meet+ reque/s f sponsors = :i* ! ,secret>y has det]m9$ t a face-to-face meet+ is appropriate1 ! numb] ( face-to-face meet+s reque/$ by sponsors to be conduct$ 9 p]son 79 su* mann] z ! ,secret>y %all prescribe on ! int]net website ( ! ,food & ,drug ,adm9i/ration71 & ! numb] ( su* 9-p]son meet+s grant$ by ! ,secret>y4 2 7#e7 9 subsection 7a77#d71 by /rik+ ,beg9n+ ) fiscal ye> #bjbj1 ! & ins]t+ ,!2 7#f7 9 subsection 7b71 by /rik+ ,beg9n+ ) fiscal ye> #bjah1 n & ins]t+ ,n2 7#g7 9 subsection 7c71 by /rik+ ,beg9n+ ) fiscal ye> #bjah1 = & ins]t+ ,=2 & 7#h7 9 subsection 7f7-- 7,a7 9 p>agraph 7#a71 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ fiscal ye> #bjbb & ins]t+ fiscal ye> #bjbg2 & 7,b7 9 p>agraph 7#e71 by /rik+ ,janu>y #ae1 #bjbb & ins]t+ ,janu>y #ae1 #bjbg4 #aje4 ,sunset dates 7a7 ,au?orization ,sections #gce & #gcf ( ! ,f$]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 on or aft] ,octob] #a1 #bjag1 b be=e ,octob] #a1 #bjbb1 7 accept$ by ! ,food & ,drug ,adm9i/ration = fil+ ) 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$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i et seq471 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #bjb4 ,def9itions ,section #gcg ( ! ,f$]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 & 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 ea* ( subp>agraphs 7,g7 & 7,h71 by /rik+ or submissions & 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+ fiscal ye> #bjah & ins]t+ fiscal ye> #bjbc2 & 7#b7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! matt] prec$+ clause 7i71 by /rik+ ,octob] #a1 #bjag & ins]t+ ,octob] #a1 #bjbb2 7ii7 9 clause 7iii71 by /rik+ #ge p]c5t & ins]t+ #hj p]c5t2 & 7iii7 9 clause 7viii71 by /rik+ #c4d p]c5t & ins]t+ #d4e p]c5t2 7,b7 9 subp>agraph 7,b77iii71 by /rik+ or prem>ket notification submission & ins]t+ prem>ket notification submission1 or de novo classification reque/2 & 7,c7 9 subp>agraph 7,c71 by /rik+ or p]iodic report+ conc]n+ a class ,,iii device & ins]t+ p]iodic report+ conc]n+ a class ,,iii device1 or de novo classification reque/4 7b7 ,fee ,am\nts ,section #gch7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7b77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 7#b7 by am5d+ p>agraph 7#b7 to read z foll[s3 7#b7 ,base fee am\nts specifi$ ,= purposes ( p>agraph 7#a71 ! base fee am\nts specifi$ 9 ?is p>agraph are 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 by am5d+ p>agraph 7#c7 to read z foll[s3 7#c7 ,total rev5ue am\nts specifi$ ,= purposes ( p>agraph 7#a71 ! total rev5ue am\nts specifi$ 9 ?is p>agraph are 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 9 subp>agraph 7,a71 by /rik+ #bjah & ins]t+ #bjbc2 7,b7 9 subp>agraph 7,b7-- 7i7 9 ! matt] prec$+ clause 7i71 by /rik+ fiscal ye> #bjah & ins]t+ fiscal ye> #bjbc2 & 7ii7 9 clause 7ii71 by /rik+ fiscal ye> #bjaf & ins]t+ fiscal ye> #bjbb2 7,c7 9 subp>agraph 7,c71 by /rik+ ,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv & ins]t+ ,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 & 7,d7 9 subp>agraph 7,d71 9 ! matt] prec$+ clause 7i71 by /rik+ fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ fiscal ye>s #bjbc ?r\gh #bjbg2 7#c7 9 p>agraph 7#c71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 7#d7 by r$esignat+ p>agraphs 7#d7 & 7#e7 z p>agraphs 7#g7 & 7#h71 respectively2 & 7#e7 by ins]t+ aft] p>agraph 7#c7 ! foll[+3 7#d7 ,p]=mance improvem5t adju/m5t 7,a7 ,9 g5]al ,= ea* ( fiscal ye>s #bjbe ?r\gh #bjbg1 aft] ! adju/m5ts "u p>agraphs 7#b7 & 7#c71 ! base e/abli%m5t regi/ration fee am\nts = su* fiscal ye> %all be increas$ 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$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb1 z ! ,secret>y det]m9es necess>y to a*ieve an increase 9 total fee collections = su* fiscal ye> equal to ! foll[+ am\nts3 7i7 ,= fiscal ye> #bjbe1 ! product (-- 7,i7 ! am\nt det]m9$ "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 ,pre-submission am\nt ,= purposes ( subp>agraph 7,a71 ) respect to ! pre-submission writt5 fe$back goal1 ! am\nts det]m9$ "u ?is subp>agraph are z foll[s3 7,i7 ,= fiscal ye> #bjbe1 #ae1cif1fjj if su* goal = fiscal ye> #bjbc is met4 7,,ii7 ,= fiscal ye> #bjbf3 7aa7 #ae1cif1fjj if su* goal = fiscal ye> #bjbc is met & su* goal = fiscal ye> #bjbd is n met4 7bb7 #cf1gib1bjj if su* goal = fiscal ye> #bjbd is met4 7,,iii7 ,= fiscal ye> #bjbg3 7aa7 #ae1cif1fjj if su* goal = fiscal ye> #bjbc is met & su* goal = ea* ( fiscal ye>s #bjbd & #bjbe is n met4 7bb7 #cf1gib1bjj if su* goal = fiscal ye> #bjbd is met & su* goal = fiscal ye> #bjbe is n met4 7cc7 #dj1egb1fjj if su* goal = fiscal ye> #bjbe is met4 7ii7 ,de novo classification 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 su* goal = fiscal ye> #bjbc is met4 7,,ii7 ,= fiscal ye> #bjbg3 7aa7 #f1cbc1ejj if su* goal = fiscal ye> #bjbc is met & su* goal = fiscal ye> #bjbd is n met4 7bb7 #aa1gfe1djj if su* 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 ! f\r goals = fiscal ye> #bjbc are met4 7,,ii7 ,= fiscal ye> #bjbg3 7aa7 #a1jbj1jjj if ! f\r goals = fiscal ye> #bjbc are met & "o or m ( ! f\r goals = fiscal ye> #bjbd are n met4 7bb7 #c1ijf1jjj if ! f\r goals = fiscal ye> #bjbd are met4 7,c7 ,p]=mance calculation ,= purposes ( ?is p>agraph1 p]=mance ( ! goals li/$ 9 subp>agraph 7,d7 %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 ( ! foll[+ dates3 7i7 ,! p]=mance ( ! pre-submission writt5 fe$back goal %all be bas$ on data available z (-- 7,i7 = fiscal ye> #bjbc1 ,m>* #ca1 #bjbd2 7,,ii7 = fiscal ye> #bjbd1 ,m>* #ca1 #bjbe2 & 7,,iii7 = fiscal ye> #bjbe1 ,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 %all be bas$ on data available z (-- 7,i7 = fiscal ye> #bjbc1 ,m>* #ca1 #bjbe2 & 7,,ii7 = fiscal ye> #bjbd1 ,m>* #ca1 #bjbf4 7,d7 ,goals def9$ ,= purposes ( ?is p>agraph1 ! t]ms pre-submission 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 ref] to ! goals id5tifi$ by ! same names 9 ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb4 7#e7 ,hir+ adju/m5t 7,a7 ,9 g5]al ,= ea* ( fiscal ye>s #bjbe ?r\gh #bjbg1 aft] ! adju/m5ts "u p>agraphs 7#b71 7#c71 & 7#d71 if applicable1 if ! numb] ( hires to support ! process = ! review ( device applications falls bel[ ! ?re%olds specifi$ 9 subp>agraph 7,b7 = ! applicable fiscal ye>s1 ! base e/abli%m5t regi/ration fee am\nts %all be decreas$ z ! ,secret>y det]m9es necess>y to a*ieve a r$uction 9 total fee collections equal to ! hir+ adju/m5t am\nt "u subp>agraph 7,c74 7,b7 ,?re%olds ,! ?re%olds specifi$ 9 ?is subp>agraph are z foll[s3 7i7 ,= fiscal ye> #bjbe1 ! ?re%old is #abc hires = fiscal ye> #bjbc4 7ii7 ,= fiscal ye> #bjbf1 ! ?re%old is #ch hires = fiscal ye> #bjbd4 7iii7 ,= fiscal ye> #bjbg1 ! ?re%old is-- 7,i7 #bb hires = fiscal ye> #bjbe if ! base e/abli%m5t regi/ration fees are n increas$ by ! am\nt det]m9$ "u p>agraph 7#d77;,a77i72 or 7,,ii7 #ge hires = fiscal ye> #bjbe if su* fees are s increas$4 7,c7 ,hir+ adju/m5t am\nt ,! hir+ adju/m5t am\nt = fiscal ye> #bjbe & ea* subsequ5t fiscal ye> is ! product (-- 7i7 ! numb] ( hires by :i* ! hir+ goal specifi$ 9 subp>agraph 7,d7 = ! fiscal ye> be=e ! prior fiscal ye> 0 n met2 7ii7 #gb1hgg2 & 7iii7 ! applicable inflation adju/m5t "u p>agraph 7#b77;,b7 = ! fiscal ye> = :i* ! hir+ goal 0 n met4 7,d7 ,hir+ goals ,! hir+ goals = ea* ( fiscal ye>s #bjbc ?r\gh #bjbe are z foll[s3 7i7 ,= fiscal ye> #bjbc1 #add hires4 7ii7 ,= fiscal ye> #bjbd1 #db hires4 7iii7 ,= fiscal ye> #bjbe3 7,i7 #bd hires if ! base e/abli%m5t regi/ration fees are n increas$ by ! am\nt det]m9$ "u p>agraph 7#d77;,a77i74 7,,ii7 #hc hires if ! base e/abli%m5t regi/ration fees are increas$ by ! am\nt det]m9$ "u p>agraph 7#d77;,a77i74 7,e7 ,numb] ( hires ,= purposes ( ?is p>agraph1 ! numb] ( hires %all be det]m9$ by ! ,secret>y z set =? 9 ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb4 7#f7 ,op]at+ res]ve adju/m5t 7,a7 ,9 g5]al ,= ea* ( fiscal ye>s #bjbc ?r\gh #bjbg1 aft] ! adju/m5ts "u p>agraphs 7#b71 7#c71 7#d71 & 7#e71 if applicable1 if ! ,secret>y has op]at+ res]ves ( c>ryov] us] fees = ! process = ! review ( device applications 9 excess ( ! designat$ 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 ma9ta9$ pursuant to 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$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is am5d$ 9 ea* ( subsections 7d77#b77;,b77iii7 & 7e77#b77;,b77iii7 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 ,cr$it+ & ,availability ( ,fees ,section #gch7;h77#c7 ( ! ,f$]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$ "u subp>agraph 7,b71 less ! am\nt ( r$uctions det]m9$ "u 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 p>agraphs 7#b7 & 7#c7 ( subsection 7c72 & 7ii7 ! p]=mance improvem5t adju/m5t am\nt = ! fiscal ye> "u subsection 7c77#d71 if applicable4 7,c7 ,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+ requirem5ts 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$esignat+ ! second clause 7iv7 7relat+ to analysis7 z clause 7v72 & 7,b7 9 subp>agraph 7,a77iv71 by /rik+ fiscal ye> #bjbj & ins]t+ fiscal ye> #bjbc2 & 7#d7 9 p>agraph 7#d71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 7b7 ,reau?orization ,section #gch;,a7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;b77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ #bjbb & ins]t+ #bjbg2 & 7#b7 9 p>agraph 7#e71 by /rik+ #bjbb & ins]t+ #bjbg4 #bje4 ,con=mity assessm5t pilot program ,section #ead7;d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7d77 is am5d$ to read z foll[s3 7d7 ,accr$itation s*eme = con=mity assessm5t 7#a7 ,9 g5]al ,! ,secret>y %all e/abli% a program "u :i*-- 7,a7 te/+ laboratories meet+ crit]ia specifi$ 9 guidance by ! ,secret>y may be accr$it$ by accr$itation bodies meet+ crit]ia specifi$ 9 guidance by ! ,secret>y1 to conduct te/+ to support ! assessm5t ( ! con=mity ( a device to c]ta9 /&>ds recogniz$ "u ?is section2 & 7,b7 subject to p>agraph 7#b71 results f te/s conduct$ to support ! assessm5t ( con=mity ( devices z describ$ 9 subp>agraph 7,a7 conduct$ by te/+ laboratories accr$it$ pursuant to ?is subsection %all be accept$ by ! ,secret>y = purposes ( demon/rat+ su* con=mity unless ! ,secret>y f9ds t c]ta9 results ( su* te/s %\ld n be s accept$4 7#b7 ,secret>ial review ( accr$it$ laboratory results ,! ,secret>y may-- 7,a7 review ! results ( te/s conduct$ by te/+ laboratories accr$it$ pursuant to ?is subsection1 includ+ by conduct+ p]iodic audits ( su* results or ( ! processes ( accr$it$ bodies or te/+ laboratories2 7,b7 foll[+ su* review1 take additional measures "u ?is ,act1 z ! ,secret>y det]m9es appropriate1 su* z-- 7i7 susp5sion or )drawal ( accr$itation ( a te/+ laboratory or recognition ( an accr$itation body "u p>agraph 7#a77;,a72 or 7ii7 reque/+ additional in=mation ) respect to a device2 & 7,c7 if ! ,secret>y becomes aw>e ( in=mation mat]ially be>+ on ! safety or effectiv5ess ( a device = :i* an assessm5t ( con=mity 0 support$ by te/+ conduct$ by a te/+ laboratory accr$it$ "u ?is subsection1 take su* additional measures "u ?is ,act1 z ! ,secret>y det]m9es appropriate1 su* z-- 7i7 susp5sion or )drawal ( accr$itation ( a te/+ laboratory or recognition ( an accr$itation body "u p>agraph 7#a77;,a72 or 7ii7 reque/+ additional in=mation ) reg>d to su* device4 7#c7 ,implem5tation & report+ 7,a7 ,pilot program transition ,aft] ,septemb] #cj1 #bjbc1 ! pilot program previ\sly initiat$ "u ?is subsection1 z 9 effect prior to ! date ( enactm5t ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb1 %all be consid]$ to be complet$1 & ! ,secret>y may cont9ue op]at+ a program consi/5t ) ?is subsection4 7,b7 ,report ,! ,secret>y %all make available on ! int]net website ( ! ,food & ,drug ,adm9i/ration an annual report on ! progress ( ! pilot program "u ?is subsection4 4 #bjf4 ,reau?orization ( ?ird-p>ty review program ,section #ebc7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjm7c77 is am5d$ by /rik+ #bjbb & ins]t+ #bjbg4 #bjg4 ,sunset dates 7a7 ,au?orization ,sections #gcg & #gch ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i2 #cgi;j7 %all cease to be effective ,octob] #a1 #bjbg4 7b7 ,report+ requirem5ts ,section #gch;,a 7#ba ,u4,s4,c4 #cgi;j- #a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7reg>d+ reau?orization & report+ requirem5ts7 %all cease to be effective ,janu>y #ca1 #bjbh4 7c7 ,previ\s sunset provisions ,effective ,octob] #a1 #bjbb1 subsections 7a7 & 7b7 ( section #baj ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 are repeal$4 #bjh4 ,effective date ,! am5dm5ts made by ?is title %all take effect on ,octob] #a1 #bjbb1 or ! date ( ! enactm5t ( ?is ,act1 :i*ev] is lat]1 except t fees "u "p #c ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]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 #bji4 ,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 by ?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$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da et seq471 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #cjb4 ,au?ority to assess & use human g5]ic drug fees 7a7 ,types ( fees ,section #gdd;,b7a7 ( ! ,f$]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+ fiscal ye> #bjah & ins]t+ fiscal ye> #bjbc2 7#b7 9 p>agraph 7#b77;,c71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 7#c7 9 p>agraph 7#c77;,b71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 7#d7 9 p>agraph 7#d77;,d71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 & 7#e7 9 p>agraph 7#e77;,d71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #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 by am5d+ subp>agraph 7,b7 to read z foll[s3 7,b7 ,fiscal ye>s #bjbd ?r\gh #bjbg 7i7 ,9 g5]al ,= ea* ( ! fiscal ye>s #bjbd ?r\gh #bjbg1 fees "u p>agraphs 7#b7 ?r\gh 7#e7 ( subsection 7a7 %all be e/abli%$ to g5]ate a total e/imat$ rev5ue am\nt "u su* subsection t is equal to ! base rev5ue am\nt = ! fiscal ye> "u clause 7ii71 z adju/$ pursuant to subsection 7c74 7ii7 ,base rev5ue am\nt ,! base rev5ue am\nt = a fiscal ye> ref]r$ to 9 clause 7i7 is equal to ! 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+ tw5ty-f\r p]c5t2 7,b7 9 subp>agraph 7,d71 by /rik+ ,sev5 p]c5t & ins]t+ ,six p]c5t2 & 7,c7 9 subp>agraph 7,e77i71 by /rik+ ,?irty-five p]c5t & ins]t+ ,?irty-six p]c5t4 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$+ subp>agraph 7,a7-- 7i7 by /rik+ #bjai & ins]t+ #bjbd2 & 7ii7 by /rik+ to equal ! product ( ! total rev5ues e/abli%$ 9 su* notice = ! prior fiscal ye> multipli$ & ins]t+ to equal ! base rev5ue am\nt = ! fiscal ye> 7z specifi$ 9 subsection 7b77#a77;,b77 multipli$2 & 7,b7 9 subp>agraph 7,c71 by /rik+ ,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv & ins]t+ ,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 & 7#b7 by /rik+ p>agraph 7#b7 & ins]t+ ! foll[+3 7#b7 ,capacity plann+ adju/m5t 7,a7 ,9 g5]al ,beg9n+ ) fiscal ye> #bjbd1 ! ,secret>y %all1 9 addition to ! adju/m5t "u p>agraph 7#a71 fur!r increase ! fee rev5ue & fees "u ?is section = a fiscal ye>1 9 accordance ) ?is p>agraph1 to reflect *anges 9 ! res\rce capacity ne$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 ann\nc$ 9 ! ,f$]al ,regi/] on ,augu/ #c1 #bjbj2 7ii7 incorporate approa*es & attributes det]m9$ appropriate by ! ,secret>y1 includ+ approa*es & attributes made 9 su* report1 except t 9 incorporat+ su* approa*es & attributes ! workload categories us$ 9 =eca/+ res\rces %all only be ! workload categories specifi$ 9 section ,,viii4,b4#b4;e4 ( ! lett]s describ$ 9 section #cja7;b7 ( ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbb2 & 7iii7 be effective beg9n+ ) fiscal ye> #bjbd4 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 ,p]c5tage limitation ,an adju/m5t "u ?is p>agraph %all n exce$ ?ree p]c5t ( ! sum describ$ 9 clause 7i7 = ! fiscal ye>1 except t su* limitation %all be f\r p]c5t if-- 7,i7 = purposes ( a fiscal ye> #bjbd adju/m5t1 ! ,secret>y det]m9es t 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 ( a fiscal ye> #bjbe adju/m5t1 ! ,secret>y det]m9es t 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$72 7,,iii7 = purposes ( a fiscal ye> #bjbf adju/m5t1 ! ,secret>y det]m9es t dur+ ! p]iod f ,april #a1 #bjbc1 ?r\gh ,m>* #ca1 #bjbe-- 7aa7 ! total numb] ( abbreviat$ 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$72 & 7,,iv7 = purposes ( a fiscal ye> #bjbg adju/m5t1 ! ,secret>y det]m9es t dur+ ! p]iod f ,april #a1 #bjbd1 ?r\gh ,m>* #ca1 #bjbf-- 7aa7 ! total numb] ( abbreviat$ 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$]al ,regi/] notice ref]r$ to 9 subsection 7a7 ! 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 & ea* subsequ5t fiscal ye>1 ! ,secret>y may1 9 addition to adju/m5ts "u p>agraphs 7#a7 & 7#b71 fur!r increase ! fee rev5ue & fees "u ?is section = su* fiscal ye> 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,b7 ) respect to t fiscal ye>4 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$-- 7#a7 9 ! p>agraph head+1 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 & 7#b7 by /rik+ m ?an #fj days be=e ! fir/ day ( ea* ( fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ lat] ?an #fj days be=e ! fir/ day ( ea* ( fiscal ye>s #bjbc ?r\gh #bjbg4 7e7 ,cr$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+ fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ fiscal ye>s #bjbc ?r\gh #bjbg4 7f7 ,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 #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 7a77#a71 by /rik+ ,beg9n+ ) fiscal ye> #bjah1 n & ins]t+ ,n2 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#c7 9 subsection 7a77#b71 by /rik+ ,n lat] ?an #cj cal5d> days aft] ! end ( ! second qu>t] ( fiscal ye> #bjah1 & n lat] ?an #cj cal5d> days aft] ! end ( ea* qu>t] ( ea* fiscal ye> !reaft] & ins]t+ ,n lat] ?an #cj cal5d> days aft] ! end ( ea* qu>t] ( ea* fiscal ye> = :i* fees are collect$ "u ?is "p2 7#d7 9 subsection 7a77#c71 by /rik+ ,beg9n+ ) fiscal ye> #bjbj1 ! & ins]t+ ,!2 7#e7 9 subsection 7b71 by /rik+ ,beg9n+ ) fiscal ye> #bjah1 n & ins]t+ ,n2 7#f7 9 subsection 7c71 by /rik+ ,beg9n+ ) fiscal ye> #bjah1 = & ins]t+ ,=2 & 7#g7 9 subsection 7f7-- 7,a7 9 p>agraph 7#a71 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ fiscal ye> #bjbb & ins]t+ fiscal ye> #bjbg2 & 7,b7 9 p>agraph 7#e71 by /rik+ ,janu>y #ae1 #bjbb & ins]t+ ,janu>y #ae1 #bjbg4 #cjd4 ,sunset dates 7a7 ,au?orization ,sections #gdd;,a & #gdd;,b ( ! ,f$]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$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da et seq471 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is title1 %all cont9ue to be 9 effect ) respect to abbreviat$ 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 by ?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$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea et seq471 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #djb4 ,def9itions 7a7 ,adju/m5t factor ,section #gdd;,g7#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea7a77 is am5d$ to read z foll[s3 7#a7 ,! t]m adju/m5t factor applicable to a fiscal ye> is ! ,consum] ,price ,index = urban consum]s 7,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 ,n ,seasonally ,adju/$2 ,all items2 ,annual ,index7 = ,septemb] ( ! prec$+ fiscal ye> divid$ by su* ,index = ,septemb] #bjaa4 4 7b7 ,biosimil> biological product application ,section #gdd;,g7#d77;,b77iii7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea7d77;,b77iii77 is am5d$-- 7#a7 by /rik+ subclause 7,,ii7 7relat+ to an all]g5ic extract product72 & 7#b7 by r$esignat+ subclauses 7,,iii7 & 7,,iv7 z subclauses 7,,ii7 & 7,,iii71 respectively4 #djc4 ,au?ority to assess & use biosimil> fees 7a7 ,types ( fees 7#a7 ,9 g5]al ,! matt] prec$+ p>agraph 7#a7 9 section #gdd;,h7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77 is am5d$ by /rik+ fiscal ye> #bjah & ins]t+ fiscal ye> #bjbc4 7#b7 ,initial biosimil> biological product developm5t fee ,clauses 7iv77,i7 & 7v77,,ii7 ( section #gdd;,h7a77#a77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#a77;,a77 are ea* am5d$ by /rik+ #e days & ins]t+ #g days4 7#c7 ,annual biosimil> biological product developm5t fee ,section #gdd;,h7a77#a77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#a77;,b77 is am5d$-- 7,a7 9 clause 7i71 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 except :]e 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 9 :i* case su* lic5see1 assignee1 or successor %all pay ! annual biosimil> biological product developm5t fee2 7,b7 9 clause 7iii7-- 7i7 9 subclause 7,i71 by /rik+ or at ! end2 7ii7 9 subclause 7,,ii71 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7iii7 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 & 7,c7 9 clause 7iv71 by /rik+ is accept$ = fil+ on or aft] ,octob] #a ( su* fiscal ye> & ins]t+ is subsequ5tly accept$ = fil+4 7#d7 ,reactivation fee ,section #gdd;,h7a77#a77;,d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#a77;,d77 is am5d$ to read z foll[s3 7,d7 ,reactivation fee 7i7 ,9 g5]al ,a p]son t has discont9u$ p>ticipation 9 ! biosimil> biological product developm5t program = a product "u subp>agraph 7,c71 or :o has be5 adm9i/ratively remov$ f ! biosimil> biological product developm5t program = a product "u subp>agraph 7,e77v71 %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$ & a fee 7ref]r$ to 9 ?is section z reactivation fee7 by ! e>li] ( ! foll[+3 7,i7 ,n lat] ?an #g days aft] ! ,secret>y grants a reque/ by su* p]son = a biosimil> biological product developm5t meet+ = ! product 7aft] ! date on :i* su* p>ticipation 0 discont9u$ or ! date ( adm9i/rative removal1 z applicable74 7,,ii7 ,^u ! date ( submission 7aft] ! date on :i* su* p>ticipation 0 discont9u$ or ! date ( adm9i/rative removal1 z applicable7 by su* p]son ( an inve/igational new drug application describ+ an inve/igation t ! ,secret>y det]m9es is int5d$ to support a biosimil> biological product application = t product4 7ii7 ,application ( annual fee ,a p]son t pays a reactivation fee = a product %all pay = su* product1 beg9n+ 9 ! next fiscal ye>1 ! annual biosimil> biological product developm5t fee "u subp>agraph 7,b71 except :]e 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 9 :i* case su* lic5see1 assignee1 or successor %all pay ! annual biosimil> biological product developm5t fee4 4 7#e7 ,effect ( failure to pay fees ,section #gdd;,h7a77#a77;,e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#a77;,e77 is am5d$ 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 ( two 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 4 7#f7 ,biosimil> biological product application fee ,section #gdd;,h7a77#b77;,d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#b77;,d77 is am5d$ by ins]t+ aft] or 0 )drawn ! foll[+3 prior to approval4 7#g7 ,biosimil> biological product program fee ,section #gdd;,h7a77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#c77 is am5d$-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 clause 7i71 by /rik+ & at ! end2 7ii7 by r$esignat+ clause 7ii7 z clause 7iii72 & 7iii7 by ins]t+ aft] clause 7i7 ! foll[+3 7ii7 may be disp5s$ only "u prescription pursuant to section #ejc7;b72 & 2 & 7,b7 by add+ at ! end ! foll[+3 7,e7 ,movem5t to discont9u$ li/ 7i7 ,date ( inclusion ,if a writt5 reque/ to place a product on ! li/ ref]5c$ 9 subp>agraph 7,a7 ( discont9u$ biosimil> biological products is submitt$ to ! ,secret>y on behalf ( an applicant1 & ! reque/ id5tifies ! date ! product is )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] (-- 7,i7 ! date su* reque/ 0 receiv$2 or 7,,ii7 if ! product w be )drawn f sale on a future date1 su* future date :5 ! product is )drawn f sale4 7ii7 ,treatm5t z )drawn f sale ,= purposes ( clause 7i71 a product %all be consid]$ )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 7iii7 ,special rule ,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/ ref]5c$ 9 subp>agraph 7,a7 ( discont9u$ biosimil> biological products1 & on any subsequ5t day dur+ su* fiscal ye> ! biosimil> biological product does n appe> on su* li/1 !n except z provid$ 9 subp>agraph 7,d71 ea* p]son :o is nam$ z ! applicant 9 a biosimil> biological product application ) respect to su* product %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* su* product = ea* fiscal ye>4 4 7#h7 ,biosimil> biological product fee ,section #gdd;,h7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77 is am5d$ by /rik+ p>agraph 7#d74 7c7 ,fee rev5ue am\nts ,subsection 7b7 ( section #gdd;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7 is am5d$-- 7#a7 by /rik+ p>agraph 7#a72 7#b7 by r$esignat+ p>agraphs 7#b7 ?r\gh 7#d7 z p>agraphs 7#a7 ?r\gh 7#c71 respectively2 7#c7 by am5d+ p>agraph 7#a7 7z s r$esignat$7 to read z foll[s3 7#a7 ,9 g5]al ,= ea* ( ! fiscal ye>s #bjbc ?r\gh #bjbg1 fees "u subsection 7a7 %all1 except z provid$ 9 subsection 7c71 be e/abli%$ to g5]ate a total rev5ue am\nt equal to ! sum (-- 7,a7 ! annual base rev5ue = ! fiscal ye> 7z det]m9$ "u p>agraph 7#c772 7,b7 ! doll> am\nt equal to ! inflation adju/m5t = ! fiscal ye> 7z det]m9$ "u subsection 7c77#a772 7,c7 ! doll> am\nt equal to ! /rategic hir+ & ret5tion adju/m5t 7z det]m9$ "u subsection 7c77#b772 7,d7 ! doll> am\nt equal to ! capacity plann+ adju/m5t = ! fiscal ye> 7z det]m9$ "u subsection 7c77#c772 7,e7 ! doll> am\nt equal to ! op]at+ res]ve adju/m5t = ! fiscal ye>1 if applicable 7z det]m9$ "u subsection 7c77#d772 7,f7 = fiscal ye> #bjbc an additional am\nt ( #d1dbh1hhf2 & 7,g7 = fiscal ye> #bjbd an additional am\nt ( #cbj1efi4 2 7#d7 9 p>agraph 7#b7 7z s r$esignat$7-- 7,a7 9 ! p>agraph head+1 by /rik+ 2 limitations on fee am\nts2 7,b7 by /rik+ subp>agraph 7,b72 & 7,c7 by r$esignat+ subp>agraphs 7,c7 & 7,d7 z subp>agraphs 7,b7 & 7,c71 respectively2 & 7#e7 by am5d+ p>agraph 7#c7 7z s r$esignat$7 to read z foll[s3 7#c7 ,annual base rev5ue ,= purposes ( p>agraph 7#a71 ! doll> am\nt ( ! annual base rev5ue = a fiscal ye> %all be-- 7,a7 = fiscal ye> #bjbc1 #dc1cgf1ibb2 & 7,b7 = fiscal ye>s #bjbd ?r\gh #bjbg1 ! doll> am\nt ( ! total rev5ue am\nt e/abli%$ "u p>agraph 7#a7 = ! previ\s fiscal ye>1 exclud+ any adju/m5ts to su* rev5ue am\nt "u subsection 7c77#d74 4 7d7 ,adju/m5ts2 annual fee sett+ ,section #gdd;,h7c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;c77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! matt] prec$+ clause 7i71 by /rik+ subsection 7b77#b77;,b7 & ins]t+ subsection 7b77#a77;,b72 & 7ii7 9 clause 7i71 by /rik+ subsection 7b7 & ins]t+ subsection 7b77#a77;,a72 & 7,b7 9 subp>agraph 7,b77ii71 by /rik+ ,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv & ins]t+ ,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 7#b7 by /rik+ p>agraphs 7#b7 ?r\gh 7#d7 & ins]t+ ! foll[+3 7#b7 ,/rategic hir+ & ret5tion adju/m5t ,= ea* fiscal ye>1 aft] ! annual base rev5ue "u subsection 7b77#a77;,a7 is adju/$ = inflation 9 accordance ) p>agraph 7#a71 ! ,secret>y %all fur!r increase ! fee rev5ue & fees by #aej1jjj4 7#c7 ,capacity plann+ adju/m5t 7,a7 ,9 g5]al ,= ea* fiscal ye>1 ! ,secret>y %all1 9 addition to ! adju/m5ts "u p>agraphs 7#a7 & 7#b71 fur!r adju/ ! fee rev5ue & fees "u ?is section = a fiscal ye> to reflect *anges 9 ! res\rce capacity ne$s ( ! ,secret>y = ! process = ! review ( biosimil> biological product applications4 7,b7 ,me?odology ,= purposes ( ?is p>agraph1 ! ,secret>y %all employ ! capacity plann+ me?odology utiliz$ by ! ,secret>y 9 sett+ fees = fiscal ye> #bjba1 z describ$ 9 ! notice titl$ ,biosimil> ,us] ,fee ,rates = ,fiscal ,ye> #bjba publi%$ 9 ! ,f$]al ,regi/] on ,augu/ #d1 #bjbj 7#he ,f$4 ,reg4 #dgbbj74 ,! workload categories us$ 9 apply+ su* me?odology 9 =eca/+ %all include only ! activities describ$ 9 t notice &1 z feasible1 additional activities t are also directly relat$ to ! direct review ( biosimil> biological product 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$ biosimil> biological products4 ,subject to ! exceptions 9 ! prec$+ s5t5ce1 ! ,secret>y %all n include z workload categories 9 apply+ su* me?odology 9 =eca/+ any non-core review activities1 includ+ ^? activities t ! ,secret>y ref]5c$ = pot5tial future use 9 su* notice b did n utilize 9 sett+ fees = fiscal ye> #bjba4 7,c7 ,limitations ,"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 subsections 7b77#a77;,a7 7! annual base rev5ue = ! fiscal ye>71 7b77#a77;,b7 7! doll> am\nt ( ! inflation adju/m5t = ! fiscal ye>71 & 7b77#a77;,c7 7! doll> am\nt ( ! /rategic hir+ & ret5tion adju/m5t74 7,d7 ,publication 9 ,f$]al ,regi/] ,! ,secret>y %all publi% 9 ! ,f$]al ,regi/] notice "u p>agraph 7#e7 ! fee rev5ue & fees result+ f ! adju/m5t & ! me?odologies "u ?is p>agraph4 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 = su* process 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 = su* process 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 = su* process 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$]al ,regi/] notice ,if an adju/m5t "u subp>agraph 7,a7 or 7,b7 is made1 ! rationale = ! am\nt ( ! increase or decrease 9 fee rev5ue & fees %all be conta9$ 9 ! annual ,f$]al ,regi/] notice "u p>agraph 7#e77;,b7 e/abli%+ fee rev5ue & fees = ! fiscal ye> involv$4 2 & 7#c7 9 p>agraph 7#e71 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ #bjah & ins]t+ #bjbc4 7e7 ,cr$it+ & availability ( fees ,subsection 7f77#c7 ( section #gdd;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;f77#c77 is am5d$ by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 7f7 ,writt5 reque/s = waiv]s & returns2 disputes conc]n+ fees ,section #gdd;,h7h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;h77 is am5d$ 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 9 subsection 7a77#a71 by /rik+ ,beg9n+ ) fiscal ye> #bjah1 n & ins]t+ ,n2 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#b71 by /rik+ ,beg9n+ ) fiscal ye> #bjah1 ! & ins]t+ ,!2 7#d7 9 subsection 7a77#c77;,a71 by /rik+ ,n lat] ?an #cj cal5d> days aft] ! end ( ! second qu>t] ( fiscal ye> #bjah1 & n lat] ?an #cj cal5d> days aft] ! end ( ea* qu>t] ( ea* fiscal ye> !reaft] & ins]t+ ,n lat] ?an #cj cal5d> days aft] ! end ( ea* qu>t] ( ea* fiscal ye> = :i* fees are collect$ "u ?is "p2 7#e7 9 subsection 7b71 by /rik+ ,n lat] ?an #abj days aft] ! end ( fiscal ye> #bjah & ea* subsequ5t fiscal ye> = :i* fees are collect$ "u ?is "p & ins]t+ ,n lat] ?an #abj days aft] ! end ( ea* fiscal ye> = :i* fees are collect$ "u ?is "p2 7#f7 9 subsection 7c71 by /rik+ ,beg9n+ ) fiscal ye> #bjah1 & = & ins]t+ ,=2 & 7#g7 9 subsection 7f7-- 7,a7 9 p>agraph 7#a71 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ fiscal ye> #bjbb & ins]t+ fiscal ye> #bjbg2 & 7,b7 9 p>agraph 7#c71 by /rik+ ,janu>y #ae1 #bjbb & ins]t+ ,janu>y #ae1 #bjbg4 #dje4 ,sunset dates 7a7 ,au?orization ,sections #gdd;,g & #gdd;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea1 #cgi;j-#eb7 %all cease to be effective ,octob] #a1 #bjbg4 7b7 ,report+ ,requirem5ts ,section #gdd;,i ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act %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+ ,div]sity 9 ,cl9ical ,/udies #eja4 ,div]sity action plans = cl9ical /udies 7a7 ,drugs ,section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i77 is am5d$ by add+ at ! end ! foll[+3 7#e7 7,a7 ,9 ord] = a new drug t is be+ /udi$ 9 a phase #c /udy1 z def9$ 9 section #cab4ba7;c7 ( title #ba1 ,code ( ,f$]al ,regulations 7or successor regulations71 or o!r pivotal /udy 7o!r ?an bioavailability or bioequival5ce /udies71 to be exempt pursuant to ?is subsection1 ! sponsor ( a cl9ical inve/igation ( su* new drug %all submit to ! ,secret>y a div]sity action plan4 7,b7 ,su* div]sity action plan %all include-- 7i7 ! sponsor's goals = enrollm5t 9 su* cl9ical /udy2 7ii7 ! sponsor's rationale = su* goals2 & 7iii7 an explanation ( h[ ! sponsor int5ds to meet su* goals4 7,c7 ,! sponsor %all submit su* div]sity action plan 9 ! =m & mann] specifi$ 9 ! guidance requir$ by section #ebd;,b z soon z practicable b no lat] ?an :5 ! sponsor seeks fe$back reg>d+ su* a phase #c /udy or o!r pivotal /udy ( ! drug4 7,d7 ,! ,secret>y may waive ! requirem5t 9 subp>agraph 7,a7 if ! ,secret>y det]m9es t a waiv] is necess>y bas$ on :at is kn[n ab\t ! preval5ce ( ! disease 9 t]ms ( ! pati5t population t may use ! new drug4 7,e7 ,no div]sity action plan %all be requir$ = a submission describ$ 9 section #efa4 4 7b7 ,devices ,section #ebj7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7g77 is am5d$ by add+ at ! end ! foll[+3 7#i7 7,a7 7i7 ,9 ord] = a device 9 a cl9ical /udy = :i* submission ( an application = an inve/igational device exemption is requir$ to be exempt "u ?is subsection1 ! sponsor ( su* /udy %all submit to ! ,secret>y 9 su* application a div]sity action plan 9 ! =m & mann] specifi$ 9 ! guidance requir$ by section #ebd;,b4 7ii7 ,9 ord] = a device 9 a cl9ical /udy = :i* submission ( an application = an inve/igational device exemption is n requir$1 except = a device be+ /udi$ z describ$ 9 section #hab4b7;c7 ( title #ba1 ,code ( ,f$]al ,regulations 7or successor regulations71 to be exempt "u ?is subsection1 ! sponsor ( su* /udy %all develop & implem5t a div]sity action plan4 ,su* div]sity action plan %all be submitt$ to ! ,secret>y 9 any prem>ket notification "u section #eaj7k71 reque/ = classification "u section #eac7;f77#b71 or application = prem>ket approval "u section #eae = su* device4 7,b7 ,a div]sity action plan "u clause 7i7 or 7ii7 ( subp>agraph 7,a7 %all include-- 7i7 ! sponsor's goals = enrollm5t 9 ! cl9ical /udy2 7ii7 ! sponsor's rationale = su* goals2 & 7iii7 an explanation ( h[ ! sponsor int5ds to meet su* goals4 7,c7 ,! ,secret>y may waive ! requirem5t 9 subp>agraph 7,a7 or 7,b7 if ! ,secret>y det]m9es t a waiv] is necess>y bas$ on :at is kn[n ab\t ! preval5ce ( ! disease 9 t]ms ( ! pati5t population t may use ! device4 7,d7 ,no div]sity action plan %all be requir$ = a submission describ$ 9 section #efa4 4 7c7 ,guidance ,sub*apt] ,a ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by add+ at ! end ! foll[+3 #ebd;,b4 ,guidance on div]sity action plans = cl9ical /udies 7a7 ,9 g5]al ,! ,secret>y %all issue guidance relat+ to-- 7#a7 ! =mat & cont5t ( ! div]sity action plans requir$ by sections #eje7;i77#e7 & #ebj7;g77#i7 p]ta9+ to ! sponsor's goals = cl9ical /udy enrollm5t1 disaggregat$ by age gr\p1 sex1 race1 geographic location1 socioeconomic /atus1 & e?nicity1 includ+ ) respect to-- 7,a7 ! rationale = ! sponsor's enrollm5t goals1 :i* may include-- 7i7 ! e/imat$ preval5ce or incid5ce 9 ! ,unit$ ,/ates ( ! disease or condition = :i* ! drug or device is be+ develop$ or inve/igat$1 if su* e/imat$ preval5ce or incid5ce is kn[n or c be det]m9$ bas$ on available data2 7ii7 :at is kn[n ab\t ! disease or condition = :i* ! drug or device is be+ develop$ or inve/igat$2 7iii7 any relevant ph>macok9etic or ph>macog5omic data2 7iv7 :at is kn[n ab\t ! pati5t population = su* disease or condition1 includ+1 to ! ext5t data is available-- 7,i7 demographic in=mation1 includ+ age gr\p1 sex1 race1 geographic location1 socioeconomic /atus1 & e?nicity2 7,,ii7 non-demographic factors1 includ+ co-morbidities affect+ ! pati5t population2 & 7,,iii7 pot5tial b>ri]s to enroll+ div]se p>ticipants1 su* z pati5t population size1 geographic location1 & socioeconomic /atus2 & 7v7 any o!r data or in=mation relevant to select+ appropriate enrollm5t goals1 disaggregat$ by demographic subgr\p1 su* z ! inclusion ( pregnant & lactat+ wom52 7,b7 an explanation = h[ ! sponsor int5ds to meet su* goals1 includ+ demographic-specific outrea* & enrollm5t /rategies1 /udy-site selection1 cl9ical /udy inclusion & exclusion practices1 & any div]sity tra9+ = /udy p]sonnel2 & 7,c7 proc$ures = ! public po/+ ( key in=mation f ! div]sity action plan t w\ld be useful to pati5ts & provid]s on ! sponsor's website1 z appropriate2 & 7#b7 h[ sponsors %\ld include 9 regul> reports to ! ,secret>y-- 7,a7 ! sponsor's progress 9 meet+ ! goals ref]r$ to 9 p>agraph 7#a77;,a72 & 7,b7 if ! sponsor does n expect to meet su* goals-- 7i7 any updates ne$$ to be made to a div]sity action plan ref]r$ to 9 p>agraph 7#a7 to help meet su* goals2 & 7ii7 ! sponsor's reasons = :y ! sponsor does n expect to meet su* goals4 7b7 ,issuance ,! ,secret>y %all-- 7#a7 n lat] ?an #ab mon?s aft] ! date ( enactm5t ( ?is section1 issue new draft guidance or update exi/+ draft guidance describ$ 9 subsection 7a72 & 7#b7 n lat] ?an #i mon?s aft] clos+ ! comm5t p]iod on su* draft guidance1 f9alize su* guidance4 4 7d7 ,applicability ,sections #eje7;i77#e7 & #ebj7;g77#i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsections 7a7 & 7b7 ( ?is section1 apply only ) respect to cl9ical inve/igations ) respect to :i* enrollm5t comm5ces aft] ! date t is #ahj days aft] ! publication ( f9al guidance "u section #ebd;,b7b77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7c74 #ejb4 ,evaluation ( ! ne$ = ,,fda au?ority to m&ate po/approval /udies or po/m>ket surveillance due to insuffici5t demographic subgr\p data 7a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( publication ( f9al guidance pursuant to section #ebd;,b7b77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #eja7;c7 ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all comm5ce an evaluation to assess :e!r additions or *anges to /atutes or regulations are w>rant$ to ensure t sponsors conduct po/-approval /udies or po/m>ket surveillance :]e-- 7#a7 prem>ket /udies collect$ insuffici5t data = und]repres5t$ subgr\ps accord+ to ! goals specifi$ 9 ! div]sity action plans ( su* sponsors2 & 7#b7 ! ,secret>y has reque/$ additional /udies be conduct$4 7b7 ,det]m9ation & report+ ,n lat] ?an #ahj days aft] ! comm5cem5t ( ! evaluation "u subsection 7a71 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit a report to ! ,congress on ! outcome ( su* evaluation1 includ+ any recomm5dations relat$ to additional ne$$ au?orities4 #ejc4 ,public work%ops to enhance cl9ical /udy div]sity 7a7 ,9 g5]al ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 9 consultation ) drug sponsors1 m$ical device manufactur]s1 pati5ts1 & o!r /akehold]s1 %all conv5e "o or m public work%ops to solicit input f /akehold]s on increas+ ! enrollm5t ( hi/orically und]repres5t$ populations 9 cl9ical /udies & enc\rag+ cl9ical /udy p>ticipation t reflects ! preval5ce ( ! disease or condition among demographic subgr\ps1 :]e appropriate1 & o!r topics1 includ+-- 7#a7 h[ & :5 to collect & pres5t ! preval5ce or incid5ce data on a disease or condition by demographic subgr\p1 includ+ possible s\rces = su* data & me?odologies = assess+ su* data2 7#b7 consid]ations = ! dissem9ation1 aft] approval1 ( in=mation to ! public on cl9ical /udy enrollm5t demographic data2 7#c7 ! e/abli%m5t ( goals = enrollm5t 9 cl9ical trials1 includ+ ! relevance ( ! e/imat$ preval5ce or incid5ce1 z applicable1 9 ! ,unit$ ,/ates ( ! disease or condition = :i* ! drug or device is be+ develop$2 & 7#d7 approa*es to support inclusion ( und]repres5t$ populations & to enc\rage cl9ical /udy p>ticipation t reflects ! population expect$ to use ! drug or device "u /udy1 includ+ ) respect to-- 7,a7 ! e/abli%m5t ( inclusion & exclusion crit]ia = c]ta9 subgr\ps1 su* z pregnant & lactat+ wom5 & individuals ) disabilities1 includ+ intellectual or developm5tal disabilities or m5tal illness2 7,b7 consid]ations reg>d+ in=m$ cons5t ) respect to individuals ) intellectual or developm5tal disabilities or m5tal illness1 includ+ e?ical & sci5tific consid]ations2 7,c7 ! appropriate use ( dec5traliz$ trials or digital heal? tools2 7,d7 cl9ical endpo9ts2 7,e7 biom>k] selection2 & 7,f7 /udy+ analysis4 7b7 ,public docket ,! ,secret>y ( ,heal? & ,human ,s]vices %all e/abli% a public comm5t p]iod to receive writt5 comm5ts relat$ to ! topics address$ dur+ ea* public work%op conv5$ "u ?is section4 ,! public comm5t p]iod %all rema9 op5 = #fj days foll[+ ! date on :i* ea* public work%op is conv5$4 7c7 ,report ,n lat] ?an #ahj days aft] ! close ( ! public comm5t p]iod = ea* public work%op conv5$ "u ?is section1 ! ,secret>y ( ,heal? & ,human ,s]vices %all make available on ! public website ( ! ,food & ,drug ,adm9i/ration a report on ! topics discuss$ at su* work%op4 ,! report %all include a summ>y (1 & response to1 recomm5dations rais$ 9 su* work%op4 #ejd4 ,annual summ>y report on progress to increase div]sity 9 cl9ical /udies 7a7 ,9 g5]al ,beg9n+ n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 & ea* ye> !reaft]1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ! ,congress1 & publi% on ! public website ( ! ,food & ,drug ,adm9i/ration1 a report t-- 7#a7 summ>izes1 9 aggregate1 ! div]sity action plans receiv$ pursuant to section #eje7;i77#e7 or #ebj7;g77#i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a7 or 7b7 ( section #eja ( ?is ,act2 & 7#b7 conta9s in=mation on-- 7,a7 = drugs1 biological products1 & devices approv$1 lic5s$1 cle>$1 or classifi$ "u section #eje1 #eae1 #eaj7k71 or #eac7;f77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee2 #cfj;e2 #cfj7k72 & #cfj7;f77#b771 or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a771 :e!r ! cl9ical /udies conduct$ ) respect to su* applications met ! demographic subgr\p enrollm5t goals f ! div]sity action plan submitt$ = su* applications2 7,b7 ! reasons provid$ = :y enrollm5t goals f submitt$ div]sity action plans 7 n met2 & 7,c7 any po/m>ket /udies ( a drug or device 9 a demographic subgr\p or subgr\ps requir$ or recomm5d$ by ! ,secret>y bas$ on inadequate prem>ket cl9ical /udy div]sity or bas$ on o!r reasons :]e a prem>ket /udy lack$ adequate div]sity1 includ+ ! /atus & completion date ( any su* /udy4 7b7 ,confid5tiality ,no?+ 9 ?is section %all be con/ru$ z au?oriz+ ! ,secret>y ( ,heal? & ,human ,s]vices 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 #eje4 ,public meet+ on cl9ical /udy flexibilities initiat$ 9 response to ,,covid-#ai p&emic 7a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date on :i* ! ,,covid-#ai em]g5cy p]iod ends1 ! ,secret>y ( ,heal? & ,human ,s]vices %all conv5e a public meet+ to discuss ! recomm5dations provid$ by ! ,food & ,drug ,adm9i/ration dur+ ! ,,covid-#ai em]g5cy p]iod to mitigate disruption ( cl9ical /udies1 includ+ recomm5dations detail$ 9 ! guidance entitl$ ,conduct ( ,cl9ical ,trials ( ,m$ical ,products ,dur+ ! ,,covid-#ai ,public ,heal? ,em]g5cy1 ,guidance = ,indu/ry1 ,inve/igators1 & ,in/itutional ,review ,bo>ds1 z updat$ on ,augu/ #h1 #bjba1 & by any subsequ5t updates to su* guidance4 ,! ,secret>y ( ,heal? & ,human ,s]vices %all invite to su* meet+ repres5tatives f ! ph>maceutical & m$ical device indu/ries :o sponsor$ cl9ical /udies dur+ ! ,,covid-#ai em]g5cy p]iod & organizations repres5t+ pati5ts4 7b7 ,topics ,n lat] ?an #ij days aft] ! date on :i* ! public meet+ "u subsection 7a7 is conv5$1 ! ,secret>y ( ,heal? & ,human ,s]vices %all make available on ! public website ( ! ,food & ,drug ,adm9i/ration a report on ! topics discuss$ at su* meet+4 ,su* topics %all include discussion (-- 7#a7 ! actions drug sponsors took to utilize su* recomm5dations & ! frequ5cy at :i* su* recomm5dations 7 employ$2 7#b7 ! *>act]i/ics ( ! sponsors1 /udies1 & pati5t populations impact$ by su* recomm5dations2 7#c7 a consid]ation ( h[ recomm5dations int5d$ to mitigate disruption ( cl9ical /udies dur+ ! ,,covid-#ai em]g5cy p]iod1 includ+ any recomm5dations to consid] dec5traliz$ cl9ical /udies :5 appropriate1 may h affect$ access to cl9ical /udies = c]ta9 pati5t populations1 especially unrepres5t$ racial & e?nic m9orities2 & 7#d7 recomm5dations = incorporat+ c]ta9 cl9ical /udy disruption mitigation recomm5dations into curr5t or additional guidance to improve cl9ical /udy access & enrollm5t ( div]se pati5t populations4 7c7 ,,covid-#ai em]g5cy p]iod def9$ ,9 ?is section1 ! t]m ,,covid-#ai em]g5cy p]iod has ! mean+ giv5 ! t]m em]g5cy p]iod 9 section #aace7;g77#a77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#e7;g77#a77;,b774 #ejf4 ,dec5traliz$ cl9ical /udies 7a7 ,guidance ,! ,secret>y ( ,heal? & ,human ,s]vices %all-- 7#a7 n lat] ?an #ab mon?s aft] ! date ( enactm5t ( ?is ,act1 issue draft guidance t addresses consid]ations = dec5traliz$ cl9ical /udies1 includ+ consid]ations reg>d+ ! engagem5t1 enrollm5t1 & ret5tion ( a mean+fully div]se cl9ical population1 ) respect to race1 e?nicity1 age1 sex1 & geographic location1 :5 appropriate2 & 7#b7 n lat] ?an #a ye> aft] clos+ ! comm5t p]iod on su* draft guidance1 f9alize su* guidance4 7b7 ,cont5t ( guidance ,! guidance "u subsection 7a7 %all address ! foll[+3 7#a7 ,recomm5dations = h[ digital heal? te*nology or o!r remote assessm5t options1 su* z teleheal?1 c\ld support dec5traliz$ cl9ical /udies1 includ+ guidance on consid]ations = select+ te*nological plat=ms & m$iums1 data collection & use1 data integrity & security1 & communication to /udy p>ticipants ?r\gh digital te*nology4 7#b7 ,recomm5dations = subject recruitm5t & ret5tion1 includ+ consid]ations = sponsors to m9imize or r$uce burd5s = cl9ical /udy p>ticipants ?r\gh ! use ( digital heal? te*nology1 teleheal?1 local heal? c>e provid]s & laboratories1 or o!r means4 7#c7 ,recomm5dations ) respect to ! evaluation ( data collect$ )9 a dec5traliz$ cl9ical /udy sett+4 7c7 ,def9ition ,9 ?is section1 ! t]m dec5traliz$ cl9ical /udy means a cl9ical /udy 9 :i* "s or all ( ! /udy-relat$ activities occur at a location sep>ate f ! inve/igator's location4 ,,vi ,g5]ic ,drug ,competition #fja4 ,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 = a new drug "u ?is subsection = :i* ! ,secret>y has specifi$ 9 regulation1 includ+ "u section #cad4id7;a77#i71 title #ba1 ,code ( ,f$]al ,regulations 7or a successor regulation71 or recomm5d$ 9 applicable guidance1 c]ta9 qualitative or quantitative crit]ia ) respect to an inactive +r$i5t1 or on ! ,secret>y's own initiative dur+ ! review ( su* abbreviat$ application1 ! ,secret>y %all in=m ! p]son :e!r su* new drug is qualitatively & quantitatively ! same z ! li/$ drug4 7ii7 ,not)/&+ section #cja7;j71 if ! ,secret>y det]m9es t su* new 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 ! new 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* new drug is qualitatively & quantitatively ! same z ! li/$ drug1 ! ,secret>y %all n *ange or resc9d su* det]m9ation aft] ! submission ( an abbreviat$ application = su* new 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 law includ+ = purposes ( section #aije ( title #ah1 ,unit$ ,/ates ,code4 4 7b7 ,guidance 7#a7 ,9 g5]al ,n lat] ?an #a 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 new 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 z requir$ by p>agraph 7#a71 ! ,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$1 & n lat] ?an "o ye> aft] ! close ( ! comm5t p]iod on ! draft guidance1 publi% f9al guidance4 7c7 ,applicability ,section #eje7;j77#c77;,h7 ( ! ,f$]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$4 #fjb4 ,enhanc+ access to af=dable m$ic9es ,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 ,,vii ,rese>*1 ,developm5t1 & ,supply ,*a9 ,improvem5ts ,a ,9 ,g5]al #gja4 ,animal te/+ alt]natives ,section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is am5d$-- 7#a7 9 subsection 7b77#e77;,b77i77,,ii71 by /rik+ animal & ins]t+ noncl9ical te/s2 7#b7 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#c7 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 nonhuman 9 vivo te/1 t occurs be=e or dur+ ! cl9ical trial phase ( ! inve/igation ( ! safety & effectiv5ess ( a drug4 ,su* te/ may include ! foll[+3 7#a7 ,cell-bas$ assays4 7#b7 ,organ *ips & microphysiological sy/ems4 7#c7 ,comput] model+4 7#d7 ,o!r nonhuman or human biology-bas$ te/ me?ods4 7#e7 ,animal te/s4 4 #gjb4 ,em]g+ te*nology program ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #bja et seq47 is am5d$ by ins]t+ aft] section #eff ( su* ,act 7#ba ,u4,s4,c4 #cfj;bbb-#e7 ! foll[+3 #eff;,a4 ,em]g+ te*nology program 7a7 ,program e/abli%m5t 7#a7 ,9 g5]al ,! ,secret>y %all e/abli% a program to support ! adoption (1 & improve ! developm5t (1 innovative approa*es to drug product design & manufactur+4 7#b7 ,actions ,9 c>ry+ out ! program "u p>agraph 7#a71 ! ,secret>y may-- 7,a7 facilitate & increase communication betwe5 public & private entities1 consortia1 & individuals ) respect to innovative drug product design & manufactur+2 7,b7 solicit in=mation reg>d+1 & conduct or support rese>* on1 innovative approa*es to drug product design & manufactur+2 7,c7 conv5e meet+s ) repres5tatives ( indu/ry1 academia1 o!r ,f$]al ag5cies1 int]national ag5cies1 & o!r int]e/$ p]sons1 z appropriate2 7,d7 conv5e work+ gr\ps to support drug product design & manufactur+ rese>* & developm5t2 7,e7 support education & tra9+ = regulatory /aff & sci5ti/s relat$ to innovative approa*es to drug product design & manufactur+2 7,f7 advance regulatory sci5ce relat$ to ! developm5t & review ( innovative approa*es to drug product design & manufactur+2 7,g7 conv5e or p>ticipate 9 work+ gr\ps to support ! h>monization ( int]national regulatory requirem5ts relat$ to innovative approa*es to drug product design & manufactur+2 & 7,h7 aw>d grants or contracts to c>ry out or support ! program "u p>agraph 7#a74 7#c7 ,grants & contracts ,to seek a grant or contract "u ?is section1 an entity %all submit an application-- 7,a7 9 su* =m & mann] z ! ,secret>y may require2 & 7,b7 conta9+ su* in=mation z ! ,secret>y may require1 includ+ a description (-- 7i7 h[ ! entity w conduct ! activities to be support$ ?r\gh ! grant or contract2 & 7ii7 h[ su* activities w fur!r rese>* & developm5t relat$ to1 or adoption (1 innovative approa*es to drug product design & manufactur+4 7b7 ,guidance ,! ,secret>y %all-- 7#a7 issue or update guidance to help facilitate ! adoption (1 & advance ! developm5t (1 innovative approa*es to drug product design & manufactur+2 & 7#b7 include 9 su* guidance descriptions (-- 7,a7 any regulatory requirem5ts relat$ to ! developm5t or review ( te*nologies relat$ to innovative approa*es to drug product design & manufactur+1 includ+ updates & improvem5ts to su* te*nologies aft] product approval2 & 7,b7 data t c be us$ to demon/rate ! id5tity1 safety1 purity1 & pot5cy ( drugs manufactur$ us+ su* te*nologies4 7c7 ,report to ,congress ,n lat] ?an #d ye>s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report conta9+-- 7#a7 an annual acc\nt+ ( ! allocation ( funds made available to c>ry out ?is section2 7#b7 a description ( h[ ,food & ,drug ,adm9i/ration /aff 7 utiliz$ to c>ry out ?is section &1 z applicable1 any *all5ges or limitations relat$ to /aff+2 7#c7 ! numb] ( public meet+s held or p>ticipat$ 9 by ! ,food & ,drug ,adm9i/ration pursuant to ?is section1 includ+ meet+s conv5$ z "p ( a work+ gr\p describ$ 9 subp>agraph 7,d7 or 7,g7 ( subsection 7a77#b71 & ! topics ( ea* su* meet+2 & 7#d7 ! numb] ( drug products approv$ or lic5s$1 aft] ! date ( enactm5t ( ?is section1 us+ an innovative approa* to drug product design & manufactur+4 7d7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re is au?oriz$ to be appropriat$ #bj1jjj1jjj = ea* fiscal ye> #bjbc ?r\gh #bjbg4 4 #gjc4 ,improv+ ! treatm5t ( r>e diseases & conditions 7a7 ,report on orphan drug program 7#a7 ,9 g5]al ,n lat] ?an ,septemb] #cj1 #bjbf1 ! ,secret>y %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report summ>iz+ ! activities ( ! ,food & ,drug ,adm9i/ration relat$ to designat+ drugs "u section #ebf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb7 = a r>e disease or condition & approv+ su* drugs "u section #eje ( su* ,act 7#ba ,u4,s4,c4 #cee7 or lic5s+ su* drugs "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb71 includ+-- 7,a7 ! numb] ( applications = su* drugs "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 receiv$ by ! ,food & ,drug ,adm9i/ration1 ! numb] ( su* applications accept$ & reject$ = fil+1 & ! numb] ( su* applications p5d+1 approv$1 & disapprov$ by ! ,food & ,drug ,adm9i/ration2 7,b7 a description ( tr5ds 9 drug approvals = r>e diseases & conditions across review divisions at ! ,food & ,drug ,adm9i/ration2 7,c7 ! ext5t to :i* ! ,food & ,drug ,adm9i/ration is consult+ ) ext]nal exp]ts pursuant to section #efi7;a77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h7;a77#b77 on topics p]ta9+ to drugs = a r>e disease or condition1 includ+ h[ & :5 any su* consultation is occurr+2 & 7,d7 ! ,food & ,drug ,adm9i/ration's ef=ts to promote be/ practices 9 ! developm5t ( novel treatm5ts = r>e diseases1 includ+-- 7i7 review] tra9+ on r>e disease-relat$ policies1 me?ods1 & tools2 & 7ii7 new regulatory sci5ce & coord9at$ support = pati5t & /akehold] engagem5t4 7#b7 ,public availability ,! ,secret>y %all make ! report "u p>agraph 7#a7 available to ! public1 includ+ by po/+ ! report on ! website ( ! ,food & ,drug ,adm9i/ration4 7#c7 ,in=mation disclosure ,no?+ 9 ?is subsection %all be con/ru$ to au?orize ! disclosure ( in=mation t is prohibit$ f disclosure "u section #aije ( title #ah1 ,unit$ ,/ates ,code1 or subject to )hold+ "u p>agraph 7#d7 ( section #eeb7;b7 ( title #e1 ,unit$ ,/ates ,code 7commonly ref]r$ to z ! ,fre$om ( ,in=mation ,act74 7b7 ,/udy on ,european ,union safety & efficacy reviews ( drugs = r>e diseases & conditions 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all ent] into a contract ) an appropriate entity to conduct a /udy on processes = evaluat+ ! safety & efficacy ( drugs = r>e diseases or conditions 9 ! ,unit$ ,/ates & ! ,european ,union1 includ+-- 7,a7 flexibilities1 au?orities1 or me*anisms available to regulators 9 ! ,unit$ ,/ates & ! ,european ,union specific to r>e diseases or conditions2 7,b7 ! consid]ation & use ( supplem5tal data submitt$ dur+ review processes 9 ! ,unit$ ,/ates & ! ,european ,union1 includ+ data associat$ ) op5 label ext5sion /udies & exp&$ access programs specific to r>e diseases or conditions2 7,c7 an assessm5t ( collaborative ef=ts betwe5 ,unit$ ,/ates & ,european ,union regulators relat$ to-- 7i7 product developm5t programs "u review2 7ii7 policies "u developm5t rec5tly issu$2 & 7iii7 sci5tific in=mation relat$ to product developm5t or regulation2 & 7,d7 recomm5dations = h[ ,congress c support collaborative ef=ts describ$ 9 subp>agraph 7,c74 7#b7 ,consultation ,! contract "u p>agraph 7#a7 %all provide = consultation ) relevant /akehold]s1 includ+-- 7,a7 repres5tatives f ! ,food & ,drug ,adm9i/ration & ! ,european ,m$ic9es ,ag5cy2 7,b7 r>e disease or condition pati5ts2 & 7,c7 pati5t gr\ps t-- 7i7 repres5t r>e disease or condition pati5ts2 & 7ii7 h int]national pati5t outrea*4 7#c7 ,report ,! contract "u p>agraph 7#a7 %all provide =1 n lat] ?an #b ye>s aft] ! date ( ent]+ into su* contract-- 7,a7 ! completion ( ! /udy "u p>agraph 7#a72 & 7,b7 ! submission ( a report on ! results ( su* /udy to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate4 7#d7 ,public availability ,! contract "u p>agraph 7#a7 %all provide = ! appropriate entity ref]r$ to 9 p>agraph 7#a7 to make ! report "u p>agraph 7#c7 available to ! public1 includ+ by po/+ ! report on ! website ( ! appropriate entity4 7c7 ,public meet+ 7#a7 ,9 g5]al ,n lat] ?an ,decemb] #ca1 #bjbc1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all conv5e "o or m public meet+s to solicit input f /akehold]s reg>d+ ! approa*es describ$ 9 p>agraph 7#b74 7#b7 ,approa*es ,! public meet+ or meet+s "u p>agraph 7#a7 %all address approa*es to increas+ & improv+ engagem5t ) r>e disease or condition pati5ts1 gr\ps repres5t+ su* pati5ts1 r>e disease or condition exp]ts1 & exp]ts on small population /udies1 9 ord] to improve ! und]/&+ ) respect to r>e diseases or conditions (-- 7,a7 pati5t burd52 7,b7 treatm5t options2 & 7,c7 side effects ( treatm5ts1 includ+-- 7i7 comp>+ ! side effects ( treatm5ts2 & 7ii7 und]/&+ ! risks ( side effects relative to ! heal? /atus ( ! pati5t & ! progression ( ! disease or condition4 7#c7 ,public docket ,! ,secret>y ( ,heal? & ,human ,s]vices %all e/abli% a public docket to receive writt5 comm5ts relat$ to ! approa*es address$ dur+ ea* public meet+ "u p>agraph 7#a74 ,su* public docket %all rema9 op5 = #fj days foll[+ ! date ( ea* su* public meet+4 7#d7 ,reports ,n lat] ?an #ahj days aft] ea* public meet+ "u p>agraph 7#a71 ! ,commission] ( ,food & ,drugs %all develop & publi% on ! website ( ! ,food & ,drug ,adm9i/ration a report on-- 7,a7 ! approa*es discuss$ at ! public meet+2 & 7,b7 any relat$ recomm5dations4 7d7 ,consultation on ! sci5ce ( small population /udies ,section #efi7;a77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h7;a77#b77 is am5d$ by add+ at ! end ! foll[+3 7,c7 ,small population /udies ,! ext]nal exp]ts on ! li/ ma9ta9$ pursuant to subp>agraph 7,a7 may include exp]ts on ! sci5ce ( small population /udies4 4 7e7 ,/udy on suffici5cy & use ( ,,fda me*anisms = incorporat+ ! pati5t & cl9ician p]spective 9 ,,fda processes relat$ to applications conc]n+ drugs = r>e diseases or conditions 7#a7 ,9 g5]al ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy on ! use ( ,food & ,drug ,adm9i/ration me*anisms & tools to ensure t pati5t & physician p]spectives are consid]$ & incorporat$ ?r\gh\t ! processes ( ! ,food & ,drug ,adm9i/ration-- 7,a7 = approv+ or lic5s+ "u section #eje ( ! ,f$]al ,food1 ,drug1 or ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 a drug designat$ z a drug = a r>e disease or condition "u section #ebf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb72 & 7,b7 9 mak+ any det]m9ation relat$ to su* a drug's approval1 includ+ assessm5t ( ! drug's-- 7i7 safety or effectiv5ess2 or 7ii7 po/approval safety monitor+4 7#b7 ,topics ,! /udy "u p>agraph 7#a7 %all-- 7,a7 id5tify & comp>e ! processes t ! ,food & ,drug ,adm9i/ration has =mally put 9 place & utiliz$ to ga!r ext]nal exp]tise 7includ+ pati5ts1 pati5t gr\ps1 & physicians7 relat$ to applications = r>e diseases or conditions2 7,b7 exam9e tools or me*anisms to improve ef=ts & initiatives ( ! ,food & ,drug ,adm9i/ration to collect & consid] su* ext]nal exp]tise ) respect to applications = r>e diseases or conditions ?r\gh\t ! application review & approval or lic5sure processes1 includ+ )9 int]nal b5efit-risk assessm5ts1 advisory committee processes1 & po/approval safety monitor+2 & 7,c7 exam9e processes or alt]natives to address or resolve conflicts ( int]e/ t imp$e ! ,food & ,drug ,adm9i/ration 9 ga9+ ext]nal exp]t input on r>e diseases or conditions ) a limit$ set ( cl9ical & rese>* exp]ts4 7#c7 ,report ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all-- 7,a7 complete ! /udy "u p>agraph 7#a72 7,b7 submit a report on ! results ( su* /udy to ! ,congress2 & 7,c7 include 9 su* report recomm5dations1 if appropriate1 = *anges to ! processes & au?orities ( ! ,food & ,drug ,adm9i/ration to improve ! collection & consid]ation ( ext]nal exp]t op9ions ( pati5ts1 pati5t gr\ps1 & physicians ) exp]tise 9 r>e diseases or conditions4 7f7 ,def9ition ,9 ?is section1 ! t]m r>e disease or condition has ! mean+ giv5 su* t]m 9 section #ebf7;a77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb7a77#b774 #gjd4 ,antifungal rese>* & developm5t 7a7 ,draft guidance ,n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all issue draft guidance = indu/ry = ! purposes ( assi/+ entities seek+ approval "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or lic5sure "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 ( antifungal !rapies design$ to treat coccidioidomycosis 7commonly kn[n z ,valley ,fev]74 7b7 ,f9al guidance ,n lat] ?an #ah mon?s aft] ! close ( ! public comm5t p]iod on ! draft guidance issu$ pursuant to subsection 7a71 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all f9alize ! draft guidance4 7c7 ,work%op ,to assi/ entities develop+ prev5tive vacc9es = fungal infections & coccidioidomycosis1 ! ,secret>y ( ,heal? & ,human ,s]vices %all hold a public work%op4 #gje4 ,advanc+ qualifi$ infecti\s disease product innovation 7a7 ,9 g5]al ,section #eje;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;f7 is am5d$-- 7#a7 9 subsection 7c7-- 7,a7 9 p>agraph 7#b71 by /rik+ or at ! end2 7,b7 9 p>agraph 7#c71 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7,c7 by add+ at ! end ! foll[+3 7#d7 an application pursuant to section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act4 2 7#b7 9 subsection 7d77#a71 by ins]t+ ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act aft] section #eje7;b72 & 7#c7 by am5d+ subsection 7g7 to read z foll[s3 7g7 ,qualifi$ infecti\s disease product ,! t]m qualifi$ infecti\s disease product means a drug1 includ+ an antibact]ial or antifungal drug or a biological product1 = human use t-- 7#a7 acts directly on bact]ia or fungi or on sub/ances produc$ by su* bact]ia or fungi2 & 7#b7 is int5d$ to treat a s]i\s or life-?reat5+ infection1 includ+ su* an infection caus$ by-- 7,a7 an antibact]ial or antifungal resi/ant pa?og51 includ+ novel or em]g+ infecti\s pa?og5s2 or 7,b7 qualify+ pa?og5s li/$ by ! ,secret>y "u subsection 7f74 4 7b7 ,priority review ,section #ebd;,a7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjn-#a7;a77 is am5d$ by ins]t+ ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act t requires cl9ical data 7o!r ?an bioavailability /udies7 to demon/rate safety or effectiv5ess be=e ! p]iod at ! end4 #gjf4 ,advanc$ manufactur+ te*nologies designation pilot program ,sub*apt] ,a ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by ins]t+ aft] section #ejf;,j 7#ba ,u4,s4,c4 #cef;j7 ! foll[+3 #ejf,k4 ,advanc$ manufactur+ te*nologies designation pilot program 7a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all initiate a pilot program "u :i* p]sons may reque/ designation ( an advanc$ manufactur+ te*nology z describ$ 9 subsection 7b74 7b7 ,designation process ,! ,secret>y %all e/abli% a process = ! designation "u ?is section ( me?ods ( manufactur+ drugs1 includ+ biological products1 & active ph>maceutical +r$i5ts ( su* drugs1 z advanc$ manufactur+ te*nologies4 ,a me?od ( manufactur+1 or a comb9ation ( manufactur+ me?ods1 is eligible = designation z an advanc$ manufactur+ te*nology if su* me?od or comb9ation ( me?ods incorporates a novel te*nology1 or uses an e/abli%$ te*nique or te*nology 9 a novel way1 t w sub/antially improve ! manufactur+ process = a drug & ma9ta9 equival5t or provide sup]ior drug quality1 includ+ by-- 7#a7 r$uc+ developm5t "t = a drug us+ ! designat$ manufactur+ me?od2 or 7#b7 increas+ or ma9ta9+ ! supply (-- 7,a7 a drug t is describ$ 9 section #ejf;,c7a7 & is int5d$ to treat a s]i\s or life-?reat5+ condition2 or 7,b7 a drug t is on ! drug %ortage li/ "u section #ejf;,e4 7c7 ,evaluation & designation ( an advanc$ manufactur+ te*nology 7#a7 ,submission ,a p]son :o reque/s designation ( a me?od ( manufactur+ z an advanc$ manufactur+ te*nology "u ?is section %all submit to ! ,secret>y data or in=mation demon/rat+ t ! me?od ( manufactur+ meets ! crit]ia describ$ 9 subsection 7b7 9 a p>ticul> context ( use4 ,! ,secret>y may facilitate ! developm5t & review ( su* data or in=mation by-- 7,a7 provid+ timely advice to1 & int]active communication )1 su* p]son reg>d+ ! developm5t ( ! me?od ( manufactur+2 & 7,b7 involv+ s5ior manag]s & exp]i5c$ /aff ( ! ,food & ,drug ,adm9i/ration1 z appropriate1 9 a collaborative1 cross-discipl9>y review ( ! me?od ( manufactur+1 z applicable4 7#b7 ,evaluation & designation ,n lat] ?an #ahj cal5d> days aft] ! receipt ( a reque/ "u p>agraph 7#a71 ! ,secret>y %all det]m9e :e!r to designate su* me?od ( manufactur+ z an advanc$ manufactur+ te*nology1 9 a p>ticul> context ( use1 bas$ on ! data & in=mation submitt$ "u p>agraph 7#a7 & ! crit]ia describ$ 9 subsection 7b74 7d7 ,review ( advanc$ manufactur+ te*nologies ,if ! ,secret>y designates a me?od ( manufactur+ z an advanc$ manufactur+ te*nology1 ! ,secret>y %all-- 7#a7 exp$ite ! developm5t & review ( an application submitt$ "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 includ+ supplem5tal applications1 = drugs t are manufactur$ us+ a designat$ advanc$ manufactur+ te*nology & c\ld help mitigate or prev5t a %ortage or sub/antially improve manufactur+ processes = a drug & ma9ta9 equival5t or provide sup]ior drug quality1 z describ$ 9 subsection 7b72 & 7#b7 all[ ! hold] ( an advanc$ te*nology designation1 or a p]son au?oriz$ by ! advanc$ manufactur+ te*nology designation hold]1 to ref]5ce or rely ^u1 9 an application submitt$ "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 includ+ a supplem5tal application1 data & in=mation ab\t ! designat$ advanc$ manufactur+ te*nology = use 9 manufactur+ drugs 9 ! same context ( use = :i* ! designation 0 grant$4 7e7 ,implem5tation & evaluation ( advanc$ manufactur+ te*nologies pilot 7#a7 ,public meet+ ,! ,secret>y %all publi% 9 ! ,f$]al ,regi/] a notice ( a public meet+1 to be held n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is section1 to discuss & obta9 input & recomm5dations f relevant /akehold]s reg>d+-- 7,a7 ! goals & scope ( ! pilot program1 & a suitable framework1 proc$ures1 & requirem5ts = su* program2 & 7,b7 ways 9 :i* ! ,food & ,drug ,adm9i/ration w support ! use ( advanc$ manufactur+ te*nologies & o!r innovative manufactur+ approa*es = drugs4 7#b7 ,pilot program guidance 7,a7 ,9 g5]al ,! ,secret>y %all-- 7i7 n lat] ?an #ahj days aft] ! public meet+ "u p>agraph 7#a71 issue draft guidance reg>d+ ! goals & implem5tation ( ! pilot program "u ?is section2 & 7ii7 n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is section1 issue f9al guidance reg>d+ ! implem5tation ( su* program4 7,b7 ,cont5t ,! guidance describ$ 9 subp>agraph 7,a7 %all address-- 7i7 ! process by :i* a p]son may reque/ a designation "u subsection 7b72 7ii7 ! data & in=mation t a p]son reque/+ su* a designation is requir$ to submit "u subsection 7c71 & h[ ! ,secret>y int5ds to evaluate su* submissions2 7iii7 ! process to exp$ite ! developm5t & review ( applications "u subsection 7d72 & 7iv7 ! crit]ia describ$ 9 subsection 7b7 = eligibility = su* a designation4 7#c7 ,report ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is section & annually !reaft]1 ! ,secret>y %all publi% on ! website ( ! ,food & ,drug ,adm9i/ration & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report conta9+ a description & evaluation ( ! pilot program be+ conduct$ "u ?is section1 includ+ ! types ( innovative manufactur+ approa*es support$ "u ! program4 ,su* report %all include ! foll[+3 7,a7 ,! numb] ( p]sons t h reque/$ designations & t h be5 grant$ designations4 7,b7 ,! numb] ( me?ods ( manufactur+ t h be5 ! subject ( designation reque/s & t h be5 grant$ designations4 7,c7 ,! av]age numb] ( cal5d> days = completion ( evaluations "u subsection 7c77#b74 7,d7 ,an analysis ( ! factors 9 data submissions t are relevant to det]m9ations to designate & n to designate aft] evaluation "u subsection 7c77#b74 7,e7 ,! numb] ( applications receiv$ "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 includ+ supplem5tal applications1 t h includ$ an advanc$ manufactur+ te*nology designat$ "u ?is section1 & ! numb] ( su* applications approv$4 7f7 ,sunset ,! ,secret>y-- 7#a7 may n consid] any reque/s = designation submitt$ "u subsection 7c7 aft] ,octob] #a1 #bjbi2 & 7#b7 may cont9ue all activities "u ?is section ) respect to advanc$ manufactur+ te*nologies t 7 designat$ pursuant to subsection 7d7 prior to su* date1 if ! ,secret>y det]m9es su* activities are 9 ! int]e/ ( ! public heal?4 4 #gjg4 ,public work%op on cell !rapies ,n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all conv5e a public work%op ) relevant /akehold]s to discuss be/ practices on g5]at+ sci5tific data necess>y to fur!r facilitate ! developm5t ( c]ta9 human cell-1 tissue-1 & cellul>-bas$ m$ical products 7& ! late/ sci5tific in=mation ab\t su* products7 t are regulat$ z drugs "u ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 & biological products "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb71 namely1 /em-cell & o!r cellul> !rapies4 #gjh4 ,reau?orization ( be/ ph>maceuticals = *ildr5 ,section #dji;,i7d77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhdm7d77#a77 is am5d$ by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 #gji4 ,reau?orization = humanit>ian device exemption & demon/ration grants = improv+ p$iatric availability 7a7 ,humanit>ian device exemption ,section #ebj7m77#f77;,a77iv7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7m77#f77;,a77iv77 is am5d$ by /rik+ #bjbb & ins]t+ #bjbg4 7b7 ,p$iatric ,m$ical ,device ,safety & ,improvem5t ,act ,section #cje7;e7 ( ! ,p$iatric ,m$ical ,device ,safety & ,improvem5t ,act ( #bjjg 7,public ,law #aaj-he7 is am5d$ by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 #gaj4 ,reau?orization ( provision relat$ to exclusivity ( c]ta9 drugs conta9+ s+le enantiom]s ,section #eje7u77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7u77#d77 is am5d$ by /rik+ #bjbb & ins]t+ #bjbg4 #gaa4 ,reau?orization ( ! critical pa? public-private p>tn]%ip program ,section #eff7;f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#e7;f77 is am5d$ by /rik+ #f1jjj1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ #aj1jjj1jjj = ea* ( fiscal ye>s #bjbc ?r\gh #bjbg4 #gab4 ,reau?orization ( orphan drug grants ,section #e ( ! ,orphan ,drug ,act 7#ba ,u4,s4,c4 #cfj;ee7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 by /rik+ & 7#c7 & ins]t+ 7#c72 & 7,b7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 & 7#d7 develop+ regulatory sci5ce p]ta9+ to ! *emi/ry1 manufactur+1 & controls ( individualiz$ m$ical products to treat individuals ) r>e diseases or conditions2 & 7#b7 9 subsection 7c71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 #gac4 ,rese>* into p$iatric uses ( drugs2 additional au?orities ( ,food & ,drug ,adm9i/ration reg>d+ molecul>ly t>get$ canc] drugs 7a7 ,9 g5]al 7#a7 ,additional active +r$i5t = application drug2 limitation reg>d+ novel-comb9ation application drug ,section #eje;,b7a77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77#c77 is am5d$-- 7,a7 by r$esignat+ subp>agraphs 7,b7 & 7,c7 z subp>agraphs 7,c7 & 7,d71 respectively2 & 7,b7 by /rik+ subp>agraph 7,a7 & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,= purposes ( p>agraph 7#a77;,b71 ! inve/igation describ$ 9 ?is p>agraph is 7z det]m9$ by ! ,secret>y7 a molecul>ly t>get$ p$iatric canc] inve/igation (-- 7i7 ! drug or biological product = :i* ! application ref]r$ to 9 su* p>agraph is submitt$2 or 7ii7 su* drug or biological product 9 comb9ation )-- 7,i7 an active +r$i5t ( a drug or biological product-- 7aa7 = :i* an approv$ application "u section #eje7;j7 "u ?is ,act or "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act is 9 effect2 & 7bb7 t is det]m9$ by ! ,secret>y to be ! /&>d ( c>e = treat+ a p$iatric canc]2 or 7,,ii7 an active +r$i5t ( a drug or biological product-- 7aa7 = :i* an approv$ application "u section #eje7;b7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act to treat an adult canc] is 9 effect & is held by ! same p]son submitt+ ! application "u p>agraph 7#a77;,b72 & 7bb7 t is direct$ at a molecul> t>get t ! ,secret>y det]m9es to be sub/antially relevant to ! gr[? or progression ( a p$iatric canc]4 7,b7 ,additional requirem5ts 7i7 ,design ( inve/igation ,a molecul>ly t>get$ p$iatric canc] inve/igation ref]r$ to 9 subp>agraph 7,a7 %all be design$ to yield cl9ically mean+ful p$iatric /udy data t is ga!r$ us+ appropriate =mulations = ea* age gr\p = :i* ! /udy is requir$1 reg>d+ dos+1 safety1 & prelim9>y efficacy to in=m pot5tial p$iatric label+4 7ii7 ,limitation ,an inve/igation describ$ 9 subp>agraph 7,a77ii7 may be requir$ only if ! drug or biological product = :i* ! application ref]r$ to 9 p>agraph 7#a77;,b7 conta9s ei!r-- 7,i7 a s+le new active +r$i5t2 or 7,,ii7 m ?an "o active +r$i5t1 if an application = ! comb9ation ( active +r$i5ts has n previ\sly be5 approv$ b ea* active +r$i5t has be5 previ\sly approv$ to treat an adult canc]4 7iii7 ,results ( already-complet$ precl9ical /udies ( application drug ,! ,secret>y may require t reports on an inve/igation requir$ pursuant to p>agraph 7#a77;,b7 include ! results ( all precl9ical /udies on :i* ! decision to conduct su* inve/igation 0 bas$4 7iv7 ,rule ( con/ruction reg>d+ inactive +r$i5ts ,) respect to a comb9ation ( active +r$i5ts ref]r$ to 9 subp>agraph 7,a77ii71 su* subp>agraph %all n be con/ru$ z address+ ! use ( inactive +r$i5ts ) su* comb9ation4 4 7#b7 ,det]m9ation ( applicable requirem5ts ,section #eje;,b7e77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7e77#a77 is am5d$ by add+ at ! end ! foll[+3 ,! ,secret>y %all det]m9e :e!r subp>agraph 7,a7 or 7,b7 ( subsection 7a77#a7 %all apply ) respect to an application be=e ! date on :i* ! applicant is requir$ to submit ! initial p$iatric /udy plan "u p>agraph 7#b77;,a744 7#c7 ,cl>ify+ applicability ,section #eje;,b7a77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77#a77 is am5d$ by add+ at ! end ! foll[+3 7,c7 ,rule ( con/ruction ,no application t is subject to ! requirem5ts ( subp>agraph 7,b7 %all be subject to ! requirem5ts ( subp>agraph 7,a71 & no application 7or supplem5t to an application7 t is subject to ! requirem5ts ( subp>agraph 7,a7 %all be subject to ! requirem5ts ( subp>agraph 7,b74 4 7#d7 ,con=m+ am5dm5ts ,section #eje;,b7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77 is am5d$-- 7,a7 9 p>agraph 7#c77;,c71 z r$esignat$ by p>agraph 7#a77;,a7 ( ?is subsection1 by /rik+ inve/igations describ$ 9 ?is p>agraph & ins]t+ inve/igations ref]r$ to 9 subp>agraph 7,a72 & 7,b7 9 p>agraph 7#c77;,d71 z r$esignat$ by p>agraph 7#a77;,a7 ( ?is subsection1 by /rik+ ! assessm5ts "u p>agraph 7#b77;,b7 & ins]t+ ! assessm5ts requir$ "u p>agraph 7#a77;,a74 7b7 ,guidance ,! ,secret>y %all-- 7#a7 n lat] ?an #f mon?s aft] ! date ( enactm5t ( ?is ,act1 issue draft guidance on ! implem5tation ( ! requirem5ts 9 subsection 7a72 & 7#b7 n lat] ?an #ab mon?s aft] clos+ ! comm5t p]iod on su* draft guidance1 f9alize su* guidance4 7c7 ,applicability ,! am5dm5ts made by ?is section apply ) respect to any application "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i77 & any application "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb71 t is submitt$ on or aft] ! date t is #c ye>s aft] ! date ( enactm5t ( ?is ,act4 7d7 ,reports to ,congress 7#a7 ,secret>y ( ,heal? & ,human ,s]vices ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report on ! ,secret>y's ef=ts1 9 coord9ation ) indu/ry1 to ensure implem5tation ( ! am5dm5ts made by subsection 7a74 7#b7 ,,gao /udy & report 7,a7 ,/udy ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy ( ! effectiv5ess ( requir+ assessm5ts & inve/igations describ$ 9 section #eje;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4#cee;c71 z am5d$ by subsection 7a71 9 ! developm5t ( drugs & biological products = p$iatric canc] indications4 7,b7 ,f9d+s ,n lat] ?an #d ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report conta9+ ! f9d+s ( ! /udy conduct$ "u subp>agraph 7,a74 ,b ,inspections #gba4 ,factory inspection 7a7 ,9 g5]al ,section #gjd7;a77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77#a77 is am5d$ by /rik+ re/rict$ devices ea* place x appe>s & ins]t+ devices4 7b7 ,records or o!r in=mation 7#a7 ,e/abli%m5ts ,section #gjd7;a77#d77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77#d77;,a77 is am5d$-- 7,a7 by /rik+ an e/abli%m5t t is engag$ 9 ! manufacture1 prep>ation1 propagation1 comp\nd+1 or process+ ( a drug & ins]t+ an e/abli%m5t t is engag$ 9 ! manufacture1 prep>ation1 propagation1 comp\nd+1 or process+ ( a drug or device1 or t is subject to inspection "u p>agraph 7#e77;,c712 & 7,b7 by ins]t+ aft] a suffici5t description ( ! records reque/$ ! foll[+3 & a rationale = reque/+ su* records or o!r in=mation 9 advance (1 or 9 lieu (1 an inspection4 7#b7 ,guidance 7,a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all issue or update guidance describ+-- 7i7 circum/ances 9 :i* ! ,secret>y int5ds to issue reque/s = records or o!r in=mation 9 advance (1 or 9 lieu (1 an inspection "u section #gjd7;a77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z am5d$ by p>agraph 7#a72 7ii7 processes = respond+ to su* reque/s electronically or 9 physical =m2 & 7iii7 factors ! ,secret>y int5ds to consid] 9 evaluat+ :e!r su* records & o!r in=mation are provid$ )9 a reasonable timeframe1 )9 reasonable limits1 & 9 a reasonable mann]1 acc\nt+ = res\rce & o!r limitations t may exi/1 includ+ = small bus9esses4 7,b7 ,tim+ ,! ,secret>y ( ,heal? & ,human ,s]vices %all-- 7i7 n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 issue draft guidance "u subp>agraph 7,a72 & 7ii7 n lat] ?an #a ye> aft] ! close ( ! comm5t p]iod = su* draft guidance1 issue f9al guidance "u subp>agraph 7,a74 7c7 ,biorese>* monitor+ inspections 7#a7 ,9 g5]al ,section #gjd7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77 is am5d$ by add+ at ! end ! foll[+3 7#e7 ,biorese>* monitor+ inspections 7,a7 ,9 g5]al ,! ,secret>y may1 to ensure ! accuracy & reliability ( /udies & records or o!r in=mation describ$ 9 subp>agraph 7,b7 & to assess compliance ) applicable requirem5ts "u ?is ,act or ! ,public ,heal? ,s]vice ,act1 ent] sites & facilities specifi$ 9 subp>agraph 7,c7 9 ord] to inspect su* records or o!r in=mation4 7,b7 ,in=mation subject to inspection ,an inspection "u ?is p>agraph %all ext5d to all records & o!r in=mation relat$ to ! /udies & submissions describ$ 9 subp>agraph 7,e71 includ+ records & in=mation relat$ to ! conduct1 results1 & analyses (1 & ! protection ( human & animal trial p>ticipants p>ticipat+ 91 su* /udies4 7,c7 ,sites & facilities subject to inspection 7i7 ,sites & facilities describ$ ,! sites & facilities subject to inspection by ! ,secret>y "u ?is p>agraph are ^? own$ or op]at$ by a p]son describ$ 9 clause 7ii7 & :i* are 7or 77 utiliz$ by su* p]son 9 connection )-- 7,i7 develop+ an application or o!r submission to ! ,secret>y "u ?is ,act or ! ,public ,heal? ,s]vice ,act relat$ to m>ket+ au?orization = a product describ$ 9 p>agraph 7#a72 7,,ii7 prep>+1 conduct+1 or analyz+ ! results ( a /udy describ$ 9 subp>agraph 7,e72 or 7,,iii7 hold+ any records or o!r in=mation describ$ 9 subp>agraph 7,b74 7ii7 ,p]sons describ$ ,a p]son describ$ 9 ?is clause is-- 7,i7 ! sponsor ( an application or submission specifi$ 9 subp>agraph 7,e72 7,,ii7 a p]son engag$ 9 any activity describ$ 9 clause 7i7 on behalf ( su* a sponsor1 ?r\gh a contract1 grant1 or o!r bus9ess arrangem5t ) su* sponsor2 7,,iii7 an in/itutional review bo>d1 or o!r individual or entity1 engag$ by contract1 grant1 or o!r bus9ess arrangem5t ) a nonsponsor 9 prep>+1 collect+1 or analyz+ records or o!r in=mation describ$ 9 subp>agraph 7,b72 or 7,,iv7 any p]son n o!rwise describ$ 9 ?is clause t conducts1 or has conduct$1 a /udy describ$ 9 subp>agraph 7,e7 yield+ records or o!r in=mation describ$ 9 subp>agraph 7,b74 7,d7 ,conditions ( inspection 7i7 ,access to in=mation subject to inspection ,subject to clause 7ii71 an entity t owns or op]ates any site or facility subject to inspection "u ?is p>agraph %all provide ! ,secret>y ) access to records & o!r in=mation describ$ 9 subp>agraph 7,b7 t is held by or "u ! control ( su* entity1 includ+-- 7,i7 p]mitt+ ! ,secret>y to record or copy su* in=mation = purposes ( ?is p>agraph2 7,,ii7 provid+ ! ,secret>y ) access to any electronic in=mation sy/em utiliz$ by su* entity to hold1 process1 analyze1 or transf] any records or o!r in=mation describ$ 9 subp>agraph 7,b72 & 7,,iii7 p]mitt+ ! ,secret>y to inspect ! facilities1 equipm5t1 writt5 proc$ures1 processes1 & conditions ?r\gh :i* records or o!r in=mation describ$ 9 subp>agraph 7,b7 is or 0 g5]at$1 held1 process$1 analyz$1 or transf]r$4 7ii7 ,no effect on applicability ( provisions = protection ( propriet>y in=mation or trade secrets ,no?+ 9 clause 7i7 %all negate1 sup]s$e1 or o!rwise affect ! applicability ( provisions1 "u ?is or any o!r ,act1 prev5t+ or limit+ ! disclosure ( confid5tial comm]cial in=mation or o!r in=mation consid]$ propriet>y or trade secret4 7iii7 ,reasonabl5ess ( inspections ,an inspection "u ?is p>agraph %all be conduct$ at reasonable times & )9 reasonable limits & 9 a reasonable mann]4 7,e7 ,/udies & submissions describ$ ,! /udies & submissions describ$ 9 ?is subp>agraph are ea* ( ! foll[+3 7i7 ,cl9ical & noncl9ical /udies submitt$ to ! ,secret>y 9 support (1 or o!rwise relat$ to1 applications & o!r submissions to ! ,secret>y "u ?is ,act or ! ,public ,heal? ,s]vice ,act = m>ket+ au?orization ( a product describ$ 9 p>agraph 7#a74 7ii7 ,po/m>ket safety activities conduct$ "u ?is ,act or ! ,public ,heal? ,s]vice ,act4 7iii7 ,any o!r cl9ical inve/igation (-- 7,i7 a drug subject to section #eje or #eab ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act2 or 7,,ii7 a device subject to section #ebj7;g74 7iv7 ,any o!r submissions made "u ?is ,act or ! ,public ,heal? ,s]vice ,act ) respect to :i* ! ,secret>y det]m9es an inspection "u ?is p>agraph is w>rant$ 9 ! int]e/ ( public heal?4 7,f7 ,cl>ification ,?is p>agraph cl>ifies ! au?ority ( ! ,secret>y to conduct inspections ( ! type describ$ 9 ?is p>agraph & %all n be con/ru$ z a basis = inf]r+ t1 prior to ! date ( enactm5t ( ?is p>agraph1 ! ,secret>y lack$ ! au?ority to conduct su* inspections1 includ+ "u ?is ,act or ! ,public ,heal? ,s]vice ,act4 4 7#b7 ,review ( processes & practices2 guidance = indu/ry 7,a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all-- 7i7 review processes & practices 9 effect z ( ! date ( enactm5t ( ?is ,act applicable to inspections ( =eign & dome/ic sites & facilities describ$ 9 subp>agraph 7,c77i7 ( section #gjd7;a77#e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by p>agraph 7#a72 & 7ii7 evaluate :e!r any updates are ne$$ to facilitate ! consi/5cy ( su* processes & practices4 7,b7 ,guidance 7i7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all issue guidance describ+ ! processes & practices applicable to inspections ( sites & facilities describ$ 9 subp>agraph 7,c77i7 ( section #gjd7;a77#e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by p>agraph 7#a71 includ+ ) respect to ! types ( records & in=mation requir$ to be provid$1 be/ practices = communication betwe5 ! ,food & ,drug ,adm9i/ration & indu/ry 9 advance ( or dur+ an inspection or reque/ = records or o!r in=mation1 & o!r inspections-relat$ conduct1 to ! ext5t n specifi$ 9 exi/+ publicly available ,food & ,drug ,adm9i/ration guides & manuals = su* inspections4 7ii7 ,tim+ ,! ,secret>y ( ,heal? & ,human ,s]vices %all-- 7,i7 n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 issue draft guidance "u clause 7i72 & 7,,ii7 n lat] ?an #a ye> aft] ! close ( ! public comm5t p]iod = su* draft guidance1 issue f9al guidance "u clause 7i74 #gbb4 ,uses ( c]ta9 evid5ce ,section #gjc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgc7 is am5d$ by add+ at ! end ! foll[+3 7c7 ,applicability ,! limitations on ! ,secret>y's use ( evid5ce obta9$ "u ?is section1 or any evid5ce :i* is directly or indirectly d]iv$ f su* evid5ce1 9 a crim9al prosecution ( ! p]son f :om su* evid5ce 0 obta9$ %all n apply to evid5ce1 includ+ records or o!r in=mation1 obta9$ "u au?orities o!r ?an ?is section1 unless su* limitations are specifically incorporat$ by ref]5ce 9 su* o!r au?orities4 4 #gbc4 ,improv+ ,,fda inspections 7a7 ,risk factors = e/abli%m5ts ,section #eaj7;h77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;h77#d77 is am5d$-- 7#a7 by r$esignat+ subp>agraph 7,f7 z subp>agraph 7,g72 & 7#b7 by ins]t+ aft] subp>agraph 7,e7 ! foll[+3 7,f7 ,! compliance hi/ory ( e/abli%m5ts 9 ! c\ntry or region 9 :i* ! e/abli%m5t is locat$ t are subject to regulation "u ?is ,act1 includ+ ! hi/ory ( violations relat$ to products export$ f su* c\ntry or region t are subject to su* regulation4 4 7b7 ,use ( records ,section #gjd7;a77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77#d77 is am5d$-- 7#a7 by r$esignat+ subp>agraph 7,c7 z subp>agraph 7,d72 & 7#b7 by ins]t+ aft] subp>agraph 7,b7 ! foll[+3 7,c7 ,! ,secret>y may rely on any records or o!r in=mation t ! ,secret>y may inspect "u ?is section to satisfy requirem5ts t may p]ta9 to a preapproval or risk-bas$ surveillance inspection1 or to resolve defici5cies id5tifi$ dur+ su* inspections1 if applicable & appropriate4 4 7c7 ,recognition ( =eign gov]nm5t inspections ,section #hji ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #chd;e7 is am5d$-- 7#a7 9 subsection 7a77#a71 by ins]t+ preapproval or be=e risk-bas$ inspections2 & 7#b7 by add+ at ! end ! foll[+3 7c7 ,p]iodic review 7#a7 ,9 g5]al ,beg9n+ n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ! ,food & ,drug ,am5dm5ts ( #bjbb1 ! ,secret>y %all p]iodically assess :e!r additional arrangem5ts & agreem5ts ) a =eign gov]nm5t or an ag5cy ( a =eign gov]nm5t1 z all[$ "u ?is section1 are appropriate4 7#b7 ,reports to ,congress ,beg9n+ n lat] ?an #d ye>s aft] ! date ( ! enactm5t ( ! ,food & ,drug ,am5dm5ts ( #bjbb1 & e #d ye>s !reaft]1 ! ,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+ ! f9d+s & conclusions ( ea* review conduct$ "u p>agraph 7#a74 4 #gbd4 ,,gao report on inspections ( =eign e/abli%m5ts manufactur+ drugs 7a7 ,9 g5]al ,n lat] ?an #ah mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report on inspections conduct$ by-- 7#a7 ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 ( =eign e/abli%m5ts pursuant to subsections 7h7 & 7i7 ( section #eaj & section #gjd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj2 #cgd72 or 7#b7 a =eign gov]nm5t or an ag5cy ( a =eign gov]nm5t pursuant to section #hji ( su* ,act 7#ba ,u4,s4,c4 #chd;e74 7b7 ,cont5ts ,! report conduct$ "u subsection 7a7 %all include-- 7#a7 :at alt]native tools1 includ+ remote inspections or remote evaluations1 o!r c\ntries are utiliz+ to facilitate inspections ( =eign e/abli%m5ts2 7#b7 h[ frequ5tly tru/$ =eign regulators conduct inspections ( =eign facilities t c\ld be useful to ! ,food & ,drug ,adm9i/ration to review 9 lieu ( its own inspections2 7#c7 h[ frequ5tly & "u :at circum/ances1 includ+ = :at types ( inspections1 ! ,secret>y utilizes exi/+ agreem5ts or arrangem5ts "u section #hji ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #chd;e7 & :e!r ! use ( su* agreem5ts c\ld be appropriately exp&$2 7#d7 :e!r ! ,secret>y has accept$ reports ( inspections ( facilities 9 ,*9a & ,india conduct$ by entities ) :i* !y h ent]$ into su* an agreem5t or arrangem5t2 7#e7 :at additional =eign gov]nm5ts or ag5cies ( =eign gov]nm5ts ! ,secret>y has consid]$ ent]+ into a mutual recognition agreem5t ) &1 if applicable1 reasons :y ! ,secret>y decl9$ to ent] into a mutual recognition agreem5t ) su* =eign gov]nm5ts or ag5cies2 7#f7 :at tools1 if any1 ! ,secret>y us$ to facilitate inspections ( dome/ic facilities t c\ld also be effectively utiliz$ to appropriately inspect =eign facilities2 7#g7 :at /eps ! ,secret>y has tak5 to id5tify & evaluate tools & /rategies ! ,secret>y may use to cont9ue ov]sight ) respect to inspections :5 9-p]son inspections are disrupt$2 7#h7 h[ ! ,secret>y is consid]+ incorporat+ alt]native tools into ! inspection activities conduct$ pursuant to ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq472 & 7#i7 :at /eps ! ,secret>y has tak5 to id5tify & evaluate h[ ! ,secret>y may use alt]native tools to address work=ce %ortages to c>ry out su* inspection activities4 #gbe4 ,unann\nc$ =eign facility inspections pilot program 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all conduct a pilot program "u :i* ! ,secret>y increases ! conduct ( unann\nc$ surveillance inspections ( =eign human drug e/abli%m5ts & evaluates ! diff]5ces betwe5 su* inspections ( dome/ic & =eign human drug e/abli%m5ts1 includ+ ! impact ( ann\nc+ inspections to p]sons :o own or op]ate =eign human drug e/abli%m5ts 9 advance ( an inspection4 ,su* pilot program %all evaluate-- 7#a7 diff]5ces 9 ! numb] & type ( violations ( section #eja7;a77#b77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea7;a77#b77;,b77 id5tifi$ z a result ( unann\nc$ & ann\nc$ inspections ( =eign human drug e/abli%m5ts & any o!r significant diff]5ces betwe5 ea* type ( inspection2 7#b7 co/s & b5efits associat$ ) conduct+ ann\nc$ & unann\nc$ inspections ( =eign human drug e/abli%m5ts2 7#c7 b>ri]s to conduct+ unann\nc$ inspections ( =eign human drug e/abli%m5ts & any *all5ges to a*iev+ p>ity betwe5 dome/ic & =eign human drug e/abli%m5t inspections2 & 7#d7 approa*es = mitigat+ any negative effects ( conduct+ ann\nc$ inspections ( =eign human drug e/abli%m5ts4 7b7 ,pilot program scope ,! inspections evaluat$ "u ! pilot program "u ?is section %all be r\t9e surveillance inspections & %all n include inspections conduct$ z "p ( ! ,secret>y's evaluation ( a reque/ = approval to m>ket a drug submitt$ "u ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 or ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bja et seq474 7c7 ,pilot program initiation ,! ,secret>y %all initiate ! pilot program "u ?is section n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act4 7d7 ,report ,! ,secret>y %all1 n lat] ?an #ahj days foll[+ ! completion ( ! pilot program "u ?is section1 make available on ! website ( ! ,food & ,drug ,adm9i/ration a f9al report on ! pilot program "u ?is section1 includ+-- 7#a7 f9d+s & any associat$ recomm5dations ) respect to ! evaluation "u subsection 7a71 includ+ any recomm5dations to address id5tifi$ b>ri]s to conduct+ unann\nc$ inspections ( =eign human drug e/abli%m5ts2 7#b7 f9d+s & any associat$ recomm5dations reg>d+ h[ ! ,secret>y may a*ieve p>ity betwe5 dome/ic & =eign human drug inspections2 & 7#c7 ! numb] ( unann\nc$ inspections dur+ ! pilot program t w\ld n be unann\nc$ "u exi/+ practices4 #gbf4 ,reau?orization ( inspection program ,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 #gbg4 ,enhanc+ 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$ 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+-- 7#a7 ! reviews ( reports %>$ pursuant to section #gjd7;b77#b72 & 7#b7 any fe$back or corrective or prev5tive actions 9 response to su* reports4 4 7b7 ,report+ 7#a7 ,9 g5]al ,section #ejf;,c-#a7;a77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c-#a7;a77#b77 is am5d$ to read z foll[s3 7#b7 7,a7 describes ! communication betwe5 ! field inve/igators ( ! ,food & ,drug ,adm9i/ration & ! /aff ( ! ,c5t] = ,drug ,evaluation & ,rese>*'s ,(fice ( ,compliance & ,drug ,%ortage ,program1 includ+ ! ,food & ,drug ,adm9i/ration's proc$ures = enabl+ & ensur+ su* communication2 7,b7 provides ! numb] ( reports describ$ 9 section #gjd7;b77#b7 t 7 requir$ to be s5t to ! appropriate (fices ( ! ,food & ,drug ,adm9i/ration & ! numb] ( su* reports t 7 s5t2 & 7,c7 describes ! coord9ation & alignm5t activities und]tak5 pursuant to section #ejf;,d7g72 4 7#b7 ,applicability ,! am5dm5t made by p>agraph 7#a7 %all apply ) respect to reports submitt$ on or aft] ,m>* #ca1 #bjbc4 #gbh4 ,report+ ( mutual recognition agreem5ts = inspections & review activities 7a7 ,9 g5]al ,n lat] ?an ,decemb] #ca1 #bjbb1 & annually !reaft]1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all publi% a report on ! public website ( ! ,food & ,drug ,adm9i/ration on ! utilization ( agreem5ts ent]$ into pursuant to section #hji ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #chd;e7 or o!rwise ent]$ into by ! ,secret>y 9 ! previ\s fiscal ye> to recognize inspections betwe5 drug regulatory au?orities across c\ntries & int]national regions ) analog\s review crit]ia to ! ,food & ,drug ,adm9i/ration1 su* z ! ,ph>maceutical ,inspection ,co-,op]ation ,s*eme1 ! ,mutual ,recognition ,agreem5t ) ! ,european ,union1 & ! ,au/ralia-,canada-,s+apore-,switz]l&-,un it$ ,k+dom ,consortium4 7b7 ,cont5t ,! report "u subsection 7a7 %all include ea* ( ! foll[+3 7#a7 ,! total numb] ( e/abli%m5ts t are regi/]$ "u section #eaj7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;i771 & ! numb] ( su* e/abli%m5ts 9 ea* region ( int]e/4 7#b7 ,! total numb] ( inspections conduct$ at e/abli%m5ts describ$ 9 p>agraph 7#a71 disaggregat$ by inspections conduct$-- 7,a7 pursuant to an agreem5t or o!r recognition describ$ 9 subsection 7a72 & 7,b7 by employees or contractors ( ! ,food & ,drug ,adm9i/ration4 7#c7 ,( ! inspections describ$ 9 p>agraph 7#b71 ! total numb] ( inspections 9 ea* region ( int]e/4 7#d7 ,( ! inspections 9 ea* region ( int]e/ report$ pursuant to p>agraph 7#c71 ! numb] ( inspections 9 ea* ,,fda inspection category4 7#e7 ,( ! numb] ( inspections report$ "u ea* ( p>agraphs 7#c7 & 7#d7-- 7,a7 ! numb] ( inspections :i* h be5 conduct$ pursuant to an agreem5t or o!r recognition describ$ 9 subsection 7a72 & 7,b7 ! numb] ( inspections :i* h be5 conduct$ by employees or contractors ( ! ,food & ,drug ,adm9i/ration4 7c7 ,def9itions ,9 ?is section3 7#a7 ,,fda inspection category ,! t]m ,,fda inspection category means ! foll[+ inspection categories3 7,a7 ,inspections to support approvals ( *anges to ! manufactur+ process ( drugs approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 7,b7 ,surveillance inspections4 7,c7 ,=-cause inspections4 7#b7 ,region ( int]e/ ,! t]m region ( int]e/ means ,*9a1 ,india1 ! ,european ,union1 & any o!r geographic region z ! ,secret>y det]m9es appropriate4 #gbi4 ,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 ! public 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 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 section #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;e74 7#b7 ,! m$ian "t f ! issuance ( a report pursuant to section #gjd7;b7 ( su* ,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+ to resolution ( ! actions indicat$ to address ! conditions or practices obs]v$ dur+ an inspection4 7#d7 ,! numb] ( facilities t fail$ to implem5t adequate corrective or prev5tive actions foll[+ a report 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 ,,viii ,transp>5cy1 ,program ,integrity1 & ,regulatory ,improvem5ts #hja4 ,prompt reports ( m>ket+ /atus by hold]s ( approv$ applications = biological products 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 9 ! matt] prec$+ p>agraph 7#a71 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 /rik+ e/abli%$ "n & ins]t+ e/abli%$ "n 7= biological products1 by prop] "n72 & 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 /rik+ e/abli%$ "n & ins]t+ e/abli%$ "n 7= biological products1 by prop] "n72 & 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 ,am5dm5ts ( #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 by /rik+ subsection 7d7 & ins]t+ ! foll[+3 7d7 ,failure ,to meet requirem5ts ,if a hold] ( an approv$ application fails to submit ! in=mation requir$ "u subsection 7a71 7b71 or 7c71 ! ,secret>y may-- 7#a7 move ! application hold]'s drugs f ! active section ( ! li/ publi%$ "u section #eje7;j77#g77;,a7 to ! discont9u$ section ( ! li/1 except t ! ,secret>y %all remove f ! li/ 9 accordance ) section #eje7;j77#g77;,c7 drugs ! ,secret>y det]m9es h be5 )drawn f sale = reasons ( safety or effectiv5ess2 & 7#b7 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 biological products = :i* ! 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 biological products = :i* ! lic5se has be5 revok$ or susp5d$ = safety1 purity1 or pot5cy reasons %all be remov$ f ! li/ 9 accordance ) section #cea7k77#i77;,b7 ( ! ,public ,heal? ,s]vice ,act42 7,b7 by /rik+ mon?ly updates to ! li/ & ins]t+ mon?ly updates to ! li/s ref]r$ to 9 ! prec$+ s5t5ces2 & 7,c7 by /rik+ & %all update ! li/ bas$ on & ins]t+ & %all update su* li/s bas$ on4 7d7 ,te*nical corrections ,section #ejf;,i7e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;i7e77 is am5d$-- 7#a7 by /rik+ subsection #eje7;j77#g77;,a7 & ins]t+ section #eje7;j77#g77;,a72 & 7#b7 by /rik+ subsection #eje7;j77#g77;,c7 & ins]t+ section #eje7;j77#g77;,c74 #hjb4 ,enc\rag+ blood donation 7a7 ,/reaml9+ pati5t & blood donor input ,section #cjjc ( ! #ba/ ,c5tury ,cures ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c note7 is am5d$ to read z foll[s3 #cjjc4 ,/reaml9+ pati5t & blood donor input ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to ! collection ( in=mation to :i* a response is volunt>y1 to solicit-- 7#a7 ! views & p]spectives ( pati5ts "u section #efi;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c7 7z am5d$ by section #cjja7 or section #cjjb2 or 7#b7 in=mation f blood donors or pot5tial blood donors to support ! developm5t ( recomm5dations by ! ,secret>y ( ,heal? & ,human ,s]vices act+ ?r\gh ! ,commission] ( ,food & ,drugs conc]n+ blood donation4 4 7b7 ,cl]ical am5dm5t ,! table ( cont5ts 9 section #a7;b7 ( ! #ba/ ,c5tury ,cures ,act is am5d$ by /rik+ ! item relat+ to section #cjjc & ins]t+ ! foll[+3 ,sec4 #cjjc4 ,/reaml9+ pati5t & blood donor input4 4 #hjc4 ,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 7#a7 ,any contra/ ag5t1 radioactive drug1 or ,,otc monograph drug %all be deem$ to be a drug "u section #bja7;g7 & n a device "u section #bja7;h74 7#b7 ,= purposes ( ?is subsection3 7,a7 ,! t]m contra/ ag5t means an article t is int5d$ = use 9 conjunction ) a m$ical imag+ device1 &-- 7i7 is a diagno/ic radioph>maceutical1 z def9$ 9 sections #cae4b & #fja4ca ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations72 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 fluid4 7,b7 ,! t]m #8radioactive 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 an implant or article simil> to an implant2 7ii7 an article t applies radiation f outside ( ! body2 or 7iii7 ! radiation s\rce ( an article describ$ 9 clause 7i7 or 7ii74 7,c7 ,! t]m #8,,otc monograph drug' has ! mean+ giv5 su* t]m 9 section #gdd,l4 7#c7 ,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 4 #hjd4 ,po/approval /udies & program integrity = accel]at$ approval drugs 7a7 ,9 g5]al ,section #ejf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;c77 is am5d$-- 7#a7 by /rik+ p>agraph 7#b7 & ins]t+ ! foll[+3 7#b7 ,limitation 7,a7 ,9 g5]al ,approval ( a product "u ?is subsection may be subject to #a or bo? ( ! foll[+ requirem5ts3 7i7 ,t ! sponsor conduct an appropriate po/approval /udy or /udies 7:i* may be augm5t$ or support$ by real _w evid5ce7 to v]ify & describe ! pr$ict$ effect on irrev]sible morbidity or mortality or o!r cl9ical b5efit4 7ii7 ,t ! sponsor submit copies ( all promotional mat]ials relat$ to ! product dur+ ! preapproval review p]iod &1 foll[+ approval & = su* p]iod !reaft] z ! ,secret>y det]m9es to be appropriate1 at lea/ #cj days prior to dissem9ation ( ! mat]ials4 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 by /rik+ p>agraph 7#c7 & ins]t+ ! foll[+3 7#c7 ,exp$it$ )drawal ( approval 7,a7 ,9 g5]al ,! ,secret>y may )draw approval ( a product approv$ "u accel]at$ approval us+ exp$it$ proc$ures describ$ 9 subp>agraph 7,b71 if-- 7i7 ! sponsor fails to conduct any requir$ po/approval /udy ( ! product ) due dilig5ce1 includ+ ) respect to conditions specifi$ by ! ,secret>y "u p>agraph 7#b77;,c72 7ii7 a /udy requir$ to v]ify & describe ! pr$ict$ effect on irrev]sible morbidity or mortality or o!r cl9ical b5efit ( ! product fails to v]ify & describe su* effect or b5efit2 7iii7 o!r evid5ce demon/rates t ! product is n %[n to be safe or effective "u ! conditions ( use2 or 7iv7 ! sponsor dissem9ates false or mislead+ promotional mat]ials ) respect to ! product4 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] ( ,food & ,drugs or ! ,commission]'s designee2 & 7,,iv7 an opportunity = writt5 appeal to-- 7aa7 ! ,commission] ( ,food & ,drugs2 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 a subord9ate ( an individual 7o!r ?an ! ,commission]7 :o p>ticipat$ 9 su* propos$ )drawal2 7ii7 provid+ an opportunity = public comm5t on ! notice propos+ 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 7#d7 ,label+ 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 ! label+ = a product approv$ "u accel]at$ approval %all include-- 7i7 a /atem5t indicat+ t ! product 0 approv$ "u accel]at$ approval2 7ii7 a /atem5t indicat+ t cont9u$ approval ( ! product is subject to po/m>ket+ /udies to v]ify cl9ical b5efit2 7iii7 id5tification ( ! surrogate or int]m$iate endpo9t or endpo9ts t support$ approval & any kn[n limitations ( su* surrogate or int]m$iate endpo9t or endpo9ts 9 det]m9+ cl9ical b5efit2 & 7iv7 a succ9ct description ( ! product & any unc]ta9ty ab\t anticipat$ cl9ical b5efit & a discussion ( available evid5ce ) respect to su* cl9ical b5efit4 7,b7 ,applicability ,! label+ requirem5ts ( subp>agraph 7,a7 %all apply only to products approv$ "u accel]at$ approval = :i* ! pr$ict$ effect on irrev]sible morbidity or mortality or o!r cl9ical b5efit has n be5 v]ifi$4 7,c7 ,rule ( con/ruction ,) respect to any application p5d+ be=e ! ,secret>y on ! date ( enactm5t ( ! ,food & ,drug ,am5dm5ts ( #bjbb1 ! ,secret>y %all all[ any applicable *anges to ! product label+ requir$ to comply ) subp>agraph 7,a7 to be made by supplem5t aft] ! approval ( su* application4 7#e7 ,report+ ,n lat] ?an ,septemb] #cj1 #bjbe1 ! ,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+ circum/ances 9 :i* ! ,secret>y consid]$ real _w evid5ce submitt$ to support po/approval /udies requir$ "u ?is subsection t 7 complet$ aft] ! date ( enactm5t ( ! ,food & ,drug ,am5dm5ts ( #bjbb4 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$ "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 ,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 ,act 7#ba ,u4,s4,c4 #cef7;c77#b77;,a771 z am5d$ by subsection 7a72 & 7,c7 ! exp$it$ proc$ures describ$ 9 section #ejf7;c77#c77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;c77#c77;,b774 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 7d7 ,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* a 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 #hje4 ,facilitat+ ! use ( real _w evid5ce 7a7 ,guidance ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue1 or revise exi/+1 guidance on consid]ations = ! use ( real _w data & real _w evid5ce to support regulatory decisionmak+1 z foll[s3 7#a7 ,) respect to drugs1 su* guidance %all address-- 7,a7 ! use ( su* data & evid5ce to support ! approval ( a drug application "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or a biological product application "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb71 or to support an inve/igational use exemption "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea7;a77#c7 ( ! ,public ,heal? ,s]vice ,act2 & 7,b7 ! use ( su* data & evid5ce obta9$ z a result ( ! use ( drugs au?oriz$ = em]g5cy use "u section #efd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7 9 su* applications1 submissions1 or reque/s2 & 7,c7 /&>ds & me?odologies :i* may be us$ = collection & analysis ( real _w evid5ce includ$ 9 su* applications1 submissions1 or reque/s1 z appropriate4 7#b7 ,) respect to devices1 su* guidance %all address-- 7,a7 ! use ( su* data & evid5ce to support ! approval1 cle>ance1 or classification ( a device pursuant to an application or submission submitt$ "u section #eaj7k71 #eac7;f77#b71 or #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7k71 #cfj;c7f77#b71 #cfj;e71 or to support an inve/igational use exemption "u section #ebj7;g7 ( su* ,act 7#ba ,u4,s4,c4 #cfj;j7g772 7,b7 ! use ( su* data & evid5ce obta9$ z a result ( ! use ( devices au?oriz$ = em]g5cy use "u section #efd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c71 9 su* applications1 submissions1 or reque/s2 & 7,c7 /&>ds & me?odologies :i* may be us$ = collection & analysis ( real _w evid5ce includ$ 9 su* applications1 submissions1 or reque/s1 z appropriate4 7b7 ,report to ,congress ,n lat] ?an #b ye>s aft] ! t]m9ation ( ! public heal? em]g5cy det]m9ation by ! ,secret>y ( ,heal? & ,human ,s]vices "u section #efd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7 on ,febru>y #d1 #bjbj1 ) respect to ! ,coronavirus ,disease #bjai 7,,covid-#ai71 ! ,secret>y %all submit a report to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate on-- 7#a7 ! numb] ( applications1 submissions1 or reque/s submitt$ = cle>ance or approval "u section #eje1 #eaj7k71 #eac7;f77#b71 or #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee1 #cfj7k71 #cfj;c7f77#b71 #cfj;e7 or section #cea ( ! ,public ,heal? ,s]vice ,act1 = :i* an au?orization "u section #efd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7 0 previ\sly grant$2 7#b7 ( ! numb] ( applications s submitt$1 ! numb] ( su* applications-- 7,a7 = :i* real _w evid5ce 0 submitt$ & us$ to support a regulatory decision2 & 7,b7 = :i* real _w evid5ce 0 submitt$ & det]m9$ to be insuffici5t to support a regulatory decision2 & 7#c7 a summ>y explanation ( :y1 9 ! case ( applications describ$ 9 p>agraph 7#b77;,b71 real _w evid5ce c\ld n be us$ to support regulatory decisions4 7c7 ,in=mation disclosure ,no?+ 9 ?is section %all be con/ru$ to au?orize ! disclosure ( in=mation t is prohibit$ f disclosure "u section #aije ( title #ah1 ,unit$ ,/ates ,code1 or subject to )hold+ "u subsection 7b77#d7 ( section #eeb ( title #e1 ,unit$ ,/ates ,code 7commonly ref]r$ to z ! ,fre$om ( ,in=mation ,act74 #hjf4 ,dual ,submission = ,c]ta9 ,devices ,section #eac ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7 is am5d$ by add+ at ! end ! foll[+3 7k7 ,= a device au?oriz$ = em]g5cy use "u section #efd = :i*1 9 accordance ) section #efd7m71 ! ,secret>y has deem$ a laboratory exam9ation or proc$ure associat$ ) su* device to be 9 ! category ( exam9ations & proc$ures describ$ 9 section #cec7;d77#c7 ( ! ,public ,heal? ,s]vice ,act1 ! sponsor ( su* device may1 :5 submitt+ a reque/ = classification "u section #eac7;f77#b71 submit a s+le submission conta9+-- 7#a7 ! in=mation ne$$ = su* a reque/2 & 7#b7 suffici5t in=mation to enable ! ,secret>y to det]m9e :e!r su* laboratory exam9ation or proc$ure satisfies ! crit]ia to be categoriz$ "u section #cec7;d77#c7 ( ! ,public ,heal? ,s]vice ,act4 4 #hjg4 ,m$ical ,devices ,advisory ,committee meet+s 7a7 ,9 g5]al ,! ,secret>y %all conv5e "o or m panels ( ! ,m$ical ,devices ,advisory ,committee n less ?an once p] ye> = ! purpose ( provid+ advice to ! ,secret>y on topics relat$ to m$ical devices us$ 9 p&emic prep>$ness & response1 includ+ topics relat$ to 9 vitro diagno/ics4 7b7 ,requir$ panel memb] ,a panel conv5$ "u subsection 7a7 %all include at lea/ #a population heal?-specific repres5tative4 7c7 ,sunset ,?is section %all cease to be effective on ,octob] #a1 #bjbg4 #hjh4 ,ensur+ cyb]security ( m$ical devices 7a7 ,9 g5]al ,sub*apt] ,a ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq471 z am5d$ by section #eja1 is fur!r am5d$ by add+ at ! end ! foll[+3 #ebd;,c4 ,ensur+ cyb]security ( devices 7a7 ,9 g5]al ,= purposes ( ensur+ cyb]security ?r\gh\t ! lifecycle ( a cyb] device1 any p]son :o submits a prem>ket submission = ! cyb] device %all include su* in=mation z ! ,secret>y may require to ensure t ! cyb] device meets su* cyb]security requirem5ts z ! ,secret>y det]m9es to be appropriate to demon/rate a reasonable assurance ( safety & effectiv5ess1 includ+ at a m9imum ! cyb]security requirem5ts "u subsection 7b74 7b7 ,cyb]security requirem5ts ,at a m9imum1 ! manufactur] ( a cyb] device %all meet ! foll[+ cyb]security requirem5ts3 7#a7 ,! manufactur] %all h a plan to appropriately monitor1 id5tify1 & address 9 a reasonable "t po/m>ket cyb]security vuln]abilities & exploits1 includ+ coord9at$ vuln]ability disclosure & proc$ures4 7#b7 ,! manufactur] %all design1 develop1 & ma9ta9 processes & proc$ures to ensure ! device & relat$ sy/ems are cyb]secure1 & %all make available updates & pat*es to ! cyb] device & relat$ sy/ems ?r\gh\t ! lifecycle ( ! cyb] device to address-- 7,a7 on a reasonably ju/ifi$ regul> cycle1 kn[n unacceptable vuln]abilities2 & 7,b7 z soon z possible out ( cycle1 critical vuln]abilities t c\ld cause uncontroll$ risks4 7#c7 ,! manufactur] %all provide 9 ! label+ ( ! cyb] device a s(tw>e bill ( mat]ials1 includ+ comm]cial1 op5-s\rce1 & (f-!-%elf s(tw>e compon5ts4 7#d7 ,! manufactur] %all comply ) su* o!r requirem5ts z ! ,secret>y may require to demon/rate reasonable assurance ( ! safety & effectiv5ess ( ! device = purposes ( cyb]security1 :i* ! ,secret>y may require by an ord] publi%$ 9 ! ,f$]al ,regi/]4 7c7 ,sub/antial equival5ce ,9 mak+ a det]m9ation ( sub/antial equival5ce "u section #eac7;i7 = a cyb] device1 ! ,secret>y may-- 7#a7 f9d t cyb]security in=mation = ! cyb] device describ$ 9 ! relevant prem>ket submission 9 ! cyb] device's use environm5t is inadequate2 & 7#b7 issue a nonsub/antial equival5ce det]m9ation bas$ on ?is f9d+4 7d7 ,def9ition ,9 ?is section3 7#a7 ,cyb] device ,! t]m cyb] device means a device t-- 7,a7 includes s(tw>e1 includ+ s(tw>e z or 9 a device2 7,b7 has ! ability to connect to ! int]net2 or 7,c7 conta9s any su* te*nological *>act]i/ics t c\ld be vuln]able to cyb]security ?reats4 7#b7 ,lifecycle ( ! cyb] device ,! t]m lifecycle ( ! cyb] device includes ! po/m>ket lifecycle ( ! cyb] device4 7#c7 ,prem>ket submission ,! t]m prem>ket submission means any submission "u section #eaj7k71 #eac1 #eae7;c71 #eae7;f71 or #ebj7m74 7e7 ,exemption ,! ,secret>y may id5tify devices or types ( devices t are exempt f meet+ ! cyb]security requirem5ts e/abli%$ by ?is section & regulations promulgat$ pursuant to ?is section4 ,! ,secret>y %all publi% 9 ! ,f$]al ,regi/]1 & update1 z appropriate1 a li/ ( ! devices & types ( devices s id5tifi$ by ! ,secret>y4 4 7b7 ,prohibit$ act ,section #cja7q7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7q77 is am5d$ by add+ at ! end ! foll[+3 7#c7 ,! failure to comply ) any requirem5t "u section #ebd;,c 7relat+ to ensur+ device cyb]security74 4 7c7 ,adult]ation ,section #eja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea7 is am5d$ by ins]t+ aft] p>agraph 7j7 ! foll[+3 7k7 ,if x is a device subject to ! requirem5ts set =? 9 section #ebd;,c 7relat+ to ensur+ device cyb]security7 & fails to comply ) any requirem5t "u t section4 4 7d7 ,misbr&+ ,section #ejb7t7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7t77 is am5d$-- 7#a7 by /rik+ or 7#c7 & ins]t+ 7#c72 & 7#b7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 or 7#d7 to furni% a s(tw>e bill ( mat]ials z requir$ "u section #ebd;,c 7relat+ to ensur+ device cyb]security74 #hji4 ,public docket on propos$ *anges to ?ird-p>ty v5dors 7a7 ,9 g5]al 7#a7 ,op5+ public docket ,n lat] ?an #ij days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all op5 a s+le public docket to solicit comm5ts on factors t g5]ally %\ld be consid]$ by ! ,secret>y :5 review+ reque/s f sponsors ( drugs subject to risk evaluation & mitigation /rategies to *ange ?ird-p>ty v5dors engag$ by sponsors to aid 9 implem5tation & managem5t ( ! /rategies4 7#b7 ,factors ,su* factors include ! pot5tial effects ( *anges 9 ?ird-p>ty v5dors on-- 7,a7 pati5t access2 & 7,b7 prescrib+ & adm9i/ration ( ! drugs by heal? c>e provid]s4 7#c7 ,clos+ public docket ,! ,secret>y ( ,heal? & ,human ,s]vices may close su* public docket n e>li] ?an #ij days aft] su* docket is op5$4 7#d7 ,no delay ,no?+ 9 ?is section %all delay ag5cy action on any modification to a risk evaluation & mitigation /rategy4 7b7 ,,gao report ,n lat] ?an ,decemb] #ca1 #bjbf1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report on-- 7#a7 ! numb] ( *anges 9 ?ird-p>ty v5dors 7engag$ by sponsors to aid implem5tation & managem5t ( risk evaluation & mitigation /rategies7 = an approv$ risk evaluation & mitigation /rategy ! ,secret>y ( ,heal? & ,human ,s]vices has approv$ "u section #eje-a7;h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;h772 7#b7 any issues affect+ pati5t access to ! drug t is subject to ! /rategy or consid]ations ) respect to ! adm9i/ration or prescrib+ ( su* drug by heal? c>e provid]s t arose z a result ( su* modifications2 & 7#c7 h[ su* issues 7 resolv$1 z applicable4 #haj4 ,facilitat+ ex*ange ( product in=mation prior to approval 7a7 ,9 g5]al ,section #ejb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is am5d$-- 7#a7 9 p>agraph 7a7-- 7,a7 by /rik+ drugs = cov]age & ins]t+ drugs or devices = cov]age2 & 7,b7 by /rik+ drug ea* place x appe>s & ins]t+ drug or device1 respectively2 7#b7 9 p>agraphs 7a77#a7 & 7a77#b77;,b71 by /rik+ "u section #eje or "u section #cea ( ! ,public ,heal? ,s]vice ,act & ins]t+ "u section #eje1 #eaj7k71 #eac7;f77#b71 or #eae ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act2 7#c7 9 p>agraph 7a77#a7-- 7,a7 by /rik+ "u section #eje or "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act & ins]t+ "u section #eje1 #eaj7k71 #eac7;f77#b71 or #eae ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act2 & 7,b7 by /rik+ 9 section #eje7;a7 or 9 subsections 7a7 & 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act & ins]t+ 9 section #eje1 #eaj7k71 #eac7;f77#b71 or #eae ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act2 & 7#d7 by add+ at ! end ! foll[+3 7gg7 7#a7 ,unless its label+ be>s adequate directions = use 9 accordance ) p>agraph 7f71 except t 79 addition to drugs or devices t con=m ) exemptions pursuant to su* p>agraph7 no drug or device %all be deem$ to be misbr&$ "u su* p>agraph ?r\gh ! provision ( product in=mation to a payor1 =mul>y committee1 or o!r simil> entity ) k & exp]tise 9 ! area ( heal? c>e economic analysis c>ry+ out its responsibilities = ! selection ( drugs or devices = cov]age or reimbursem5t if ! product in=mation relates to an inve/igational drug or device or inve/igational use ( a drug or device t is approv$1 cle>$1 grant$ m>ket+ au?orization1 or lic5s$ "u section #eje1 #eaj7k71 #eac7;f77#b71 or #eae ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act 7z applicable71 provid$-- 7,a7 ! product in=mation includes-- 7i7 a cle> /atem5t t ! inve/igational drug or device or inve/igational use ( a drug or device has n be5 approv$1 cle>$1 grant$ m>ket+ au?orization1 or lic5s$ "u section #eje1 #eaj7k71 #eac7;f77#b71 or #eae ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act 7z applicable7 & t ! safety & effectiv5ess ( ! drug or device or use has n be5 e/abli%$2 7ii7 in=mation relat$ to ! /age ( developm5t ( ! drug or device involv$1 su* z-- 7,i7 ! /atus ( any /udy or /udies 9 :i* ! inve/igational drug or device or inve/igational use is be+ inve/igat$2 7,,ii7 h[ ! /udy or /udies relate to ! ov]all plan = ! developm5t ( ! drug or device2 & 7,,iii7 :e!r an application1 prem>ket notification1 or reque/ = classification = ! inve/igational drug or device or inve/igational use has be5 submitt$ to ! ,secret>y & :5 su* a submission is plann$2 7iii7 9 ! case ( in=mation t includes factual pres5tations ( results f /udies1 :i* %all n be selectively pres5t$1 a description (-- 7,i7 all mat]ial aspects ( /udy design1 me?odology1 & results2 & 7,,ii7 all mat]ial limitations relat$ to ! /udy design1 me?odology1 & results2 7iv7 :]e applicable1 a prom95t /atem5t disclos+ ! indication or indications = :i* ! ,secret>y has approv$1 grant$ m>ket+ au?orization1 cle>$1 or lic5s$ ! product pursuant to section #eje1 #eaj7k71 #eac7;f77#b71 or #eae ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 & a copy ( ! mo/ curr5t requir$ label+2 & 7v7 updat$ in=mation1 if previ\sly communicat$ in=mation becomes mat]ially outdat$ z a result ( significant *anges or z a result ( new in=mation reg>d+ ! product or its review /atus2 & 7,b7 ! product in=mation does n include-- 7i7 in=mation t repres5ts t an unapprov$ product-- 7,i7 has be5 approv$1 cle>$1 grant$ m>ket+ au?orization1 or lic5s$ "u section #eje1 #eaj7k71 #eac7;f77#b71 or #eae ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act 7z applicable72 or 7,,ii7 has o!rwise be5 det]m9$ to be safe or effective = ! purpose or purposes = :i* ! drug or device is be+ /udi$2 or 7ii7 in=mation t repres5ts t an unapprov$ use ( a drug or device t has be5 s approv$1 grant$ m>ket+ au?orization1 cle>$1 or lic5s$-- 7,i7 is s approv$1 grant$ m>ket+ au?orization1 cle>$1 or lic5s$2 or 7,,ii7 t ! product is safe or effective = ! use or uses = :i* ! drug or device is be+ /udi$4 7#b7 ,= purposes ( ?is p>agraph1 ! t]m product in=mation includes-- 7,a7 in=mation describ+ ! drug or device 7su* z drug class1 device description1 & features72 7,b7 in=mation ab\t ! indication or indications be+ inve/igat$2 7,c7 ! anticipat$ timel9e = a possible approval1 cle>ance1 m>ket+ au?orization1 or lic5sure pursuant to section #eje1 #eaj7k71 #eac1 or #eae ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act2 7,d7 drug or device pric+ in=mation2 7,e7 pati5t utilization projections2 7,f7 product-relat$ programs or s]vices2 & 7,g7 factual pres5tations ( results f /udies t d n *>act]ize or make conclusions reg>d+ safety or efficacy4 4 7b7 ,,gao /udy & report ,beg9n+ on ! date t is #e ye>s & #f mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy on ! provision & use ( in=mation pursuant to section #ejb7;gg7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is subsection 7a71 betwe5 manufactur]s ( drugs & devices 7z def9$ 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba77 & entities describ$ 9 su* section #ejb7;gg74 ,su* /udy %all include an analysis ( ! foll[+3 7#a7 ,! types ( in=mation communicat$ betwe5 su* manufactur]s & payors4 7#b7 ,! mann] ( communication betwe5 su* manufactur]s & payors4 7#c7 7,a7 ,:e!r su* manufactur]s file an application = approval1 m>ket+ au?orization1 cle>ance1 or lic5s+ ( a new drug or device or ! new use ( a drug or device t is ! subject ( communication betwe5 su* manufactur]s & payors "u section #ejb7;gg7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a74 7,b7 ,h[ frequ5tly ! ,food & ,drug ,adm9i/ration approves1 grants m>ket+ au?orization1 cle>s1 or lic5ses ! new drug or device or new use4 7,c7 ,! timeframe betwe5 ! initial communications p]mitt$ "u section #ejb7;gg7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a71 reg>d+ an inve/igational drug or device or inve/igational use1 & ! initial m>ket+ ( su* drug or device4 #haa4 ,bans ( devices = "o or m int5d$ uses 7a7 ,9 g5]al ,section #eaf7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;f7a77 is am5d$-- 7#a7 9 p>agraph 7#a71 by ins]t+ = "o or m int5d$ use be=e ! semicolon at ! end2 & 7#b7 9 ! matt] foll[+ p>agraph 7#b71 by ins]t+ = any su* int5d$ use or uses4 ,a device t is bann$ = "o or m int5d$ uses is n a legally m>ket$ device "u section #ajjf :5 int5d$ = su* use or uses aft] bann$ device4 7b7 ,specific devices deem$ bann$ ,section #eaf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;f7 is fur!r am5d$ by add+ at ! end ! foll[+3 7c7 ,specific device bann$ ,electrical /imulation devices t apply a noxi\s electrical /imulus to a p]son's sk9 int5d$ to r$uce or cease self-injuri\s behavior or aggressive behavior are deem$ to be bann$ devices1 z describ$ 9 subsection 7a74 7d7 ,rev]sal by regulation ,devices bann$ "u ?is section are bann$ devices unless or until ! ,secret>y promulgates a regulation to make su* devices or use ( su* devices no long] bann$ bas$ on a f9d+ t su* devices or use ( su* devices does n pres5t sub/antial deception or an unreasonable & sub/antial risk ( illness or injury1 or t su* risk c be correct$ or elim9at$ by label+4 4 #hab4 ,cl>ify+ application ( exclusive approval1 c]tification1 or lic5sure = drugs designat$ = r>e diseases or conditions 7a7 ,application ( exclusive approval1 c]tification1 or lic5sure = drugs designat$ = r>e diseases or conditions ,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$ indication or use )9 su* r>e disease or condition2 7#b7 9 subsection 7b7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ same r>e disease or condition & ins]t+ same indication or use = :i* ! ,secret>y has approv$ or lic5s$ su* drug2 & 7,b7 9 p>agraph 7#a71 by /rik+ ) ! disease or condition = :i* ! drug 0 designat$ & ins]t+ = :om ! drug is indicat$2 & 7#c7 9 subsection 7c71 by /rik+ same r>e disease or condition & ins]t+ same indication or use4 7b7 ,application ( am5dm5ts ,! am5dm5ts made by subsection 7a7 %all apply ) respect to any drug designat$ "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 #hac4 ,,gao report on ?ird-p>ty review ,n lat] ?an ,septemb] #cj1 #bjbf1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report on ! ?ird-p>ty review program describ$ 9 section #ebc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjm74 ,su* report %all include-- 7#a7 a description ( ! f9ancial & /aff+ res\rces us$ to c>ry out su* program2 7#b7 a description ( actions tak5 by ! ,secret>y pursuant section #ebc7;b77#b77;,c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjm7b77#b77;,c772 & 7#c7 ! results ( an audit ( ! p]=mance ( select p]sons accr$it$ "u su* program4 #had4 ,report+ on p5d+ g5]ic drug applications & priority review applications ,section #hjg ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 is am5d$1 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ #bjbb & ins]t+ #bjbg4 #hae4 ,,fda ,work=ce ,improvem5ts ,section #gad;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;d-#c;a7 is am5d$-- 7#a7 9 subsection 7a71 by /rik+ m$ical products & ins]t+ products regulat$ by ! ,food & ,drug ,adm9i/ration2 & 7#b7 by /rik+ subsection 7d7 & ins]t+ ! foll[+3 7d7 ,ag5cy-wide /rategic work=ce plan 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,food & ,drug ,am5dm5ts ( #bjbb1 ! ,commission] ( ,food & ,drugs %all develop & beg9 implem5tation ( an ag5cy-wide /rategic work=ce plan at ! ,food & ,drug ,adm9i/ration1 :i* %all include-- 7,a7 ag5cy-wide human capital goals & /rategies2 7,b7 p]=mance measures1 b5*m>ks1 or o!r elem5ts to facilitate ! monitor+ & evaluation ( ! progress made t[>d su* goals & ! effectiv5ess ( su* /rategies2 & 7,c7 a process = updat+ su* plan bas$ on timely & relevant in=mation on an ongo+ basis4 7#b7 ,report to ,congress ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ! ,food & ,drug ,am5dm5ts ( #bjbb1 ! ,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+ ! plan "u p>agraph 7#a7 & ! /atus ( its implem5tation4 4 ,june #g1 #bjbb,report$ ) an am5dm5t1 committ$ to ! ,committee ( ! ,:ole ,h\se on ! ,/ate ( ! ,union1 & ord]$ to be pr9t$