,,ii #aag? ,,congress #b;d ,session ,s4 #dece ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,july #ad1 #bjbb,mr4 ,burr introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to revise & ext5d ! us]-fee programs = prescription drugs1 m$ical devices1 g5]ic drugs1 & biosimil> biological products1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,food & ,drug ,adm9i/ration ,simple ,reau?orization ,act ( #bjbb or ! ,,fdasra ,act ( #bjbb4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4,,title ,i--,fees relat+ to drugs,sec4 #aja4 ,%ort title2 f9d+4,sec4 #ajb4 ,def9itions4,sec4 #ajc4 ,au?ority to assess & use drug fees4,sec4 #ajd4 ,reau?orization2 report+ requirem5t4,sec4 #aje4 ,sunset dates4,sec4 #ajf4 ,effective date4,sec4 #ajg4 ,sav+s clause4,,title ,,ii--,fees relat+ to devices,sec4 #bja4 ,%ort title2 f9d+4,sec4 #bjb4 ,def9itions4,sec4 #bjc4 ,au?ority to assess & use device fees4,sec4 #bjd4 ,reau?orization2 report+ requirem5t4,sec4 #bje4 ,accr$itation programs4,sec4 #bjf4 ,sunset dates4,sec4 #bjg4 ,effective date4,sec4 #bjh4 ,sav+s clause4,,title ,,iii--,fees relat+ to g5]ic drugs,sec4 #cja4 ,%ort title2 f9d+4,sec4 #cjb4 ,au?ority to assess & use human g5]ic drug fees4,sec4 #cjc4 ,reau?orization2 report+ requirem5ts4,sec4 #cjd4 ,sunset dates4,sec4 #cje4 ,effective date4,sec4 #cjf4 ,sav+s clause4,,title ,,iv--,fees relat+ to biosimil> biological products,sec4 #dja4 ,%ort title2 f9d+4,sec4 #djb4 ,def9itions4,sec4 #djc4 ,au?ority to assess & use biosimil> biological product fees4,sec4 #djd4 ,reau?orization2 report+ requirem5ts4,sec4 #dje4 ,sunset dates4,sec4 #djf4 ,effective date4,sec4 #djg4 ,sav+s clause4,,title ,v--,o!r reauthorizations,sec4 #eja4 ,reau?orization ( ! critical pa? public-private p>tn]%ip4,sec4 #ejb4 ,reau?orization ( ! be/ ph>maceuticals = *ildr5 program4,sec4 #ejc4 ,reau?orization ( ! humanit>ian device exemption inc5tive4,sec4 #ejd4 ,reau?orization ( ! p$iatric device consortia program4,sec4 #eje4 ,reau?orization ( provision p]ta9+ to drugs conta9+ s+le enantiom]s4,sec4 #ejf4 ,reau?orization ( orphan drug grants4,sec4 #ejg4 ,reau?orization ( c]ta9 device inspections4 ,i ,fees relat+ to drugs #aja4 ,%ort title2 f9d+ 7a7 ,%ort title ,?is title may be cit$ z ! ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjbb4 7b7 ,f9d+ ,congress f9ds t ! fees au?oriz$ by ! am5dm5ts made 9 ?is title w be d$icat$ t[>d exp$it+ ! drug developm5t process & ! process = ! review ( human drug applications1 includ+ po/m>ket drug safety activities1 z set =? 9 ! goals id5tifi$ = purposes ( "p #b ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g et seq471 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #ajb4 ,def9itions ,section #gce ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g7 is am5d$-- 7#a7 9 p>agraph 7#a71 9 ! matt] foll[+ subp>agraph 7,b71 by /rik+ an all]g5ic extract product1 or & ins]t+ does n include an application ) respect to an all]g5ic extract product lic5s$ be=e ,octob] #a1 #bjbb1 does n include an application ) respect to a /&>diz$ all]g5ic extract product submitt$ pursuant to a notification to ! applicant f ! ,secret>y reg>d+ ! exi/5ce ( a pot5cy te/ t measures ! all]g5ic activity ( an all]g5ic extract product lic5s$ by ! applicant be=e ,octob] #a1 #bjbb1 does n include an application ) respect to2 7#b7 9 p>agraph 7#c71 9 ! matt] foll[+ subp>agraph 7,c7-- 7,a7 by ins]t+ lic5s$ be=e ,octob] #a1 #bjbb1 a /&>diz$ all]g5ic extract product submitt$ pursuant to a notification to ! applicant f ! ,secret>y reg>d+ ! exi/5ce ( a pot5cy te/ t measures ! all]g5ic activity ( an all]g5ic extract product lic5s$ by ! applicant be=e ,octob] #a1 #bjbb1 aft] an all]g5ic extract product2 & 7,b7 by add+ at ! end ! foll[+3 ,if a writt5 reque/ to place a product 9 ! discont9u$ section ( ei!r ( ! li/s describ$ 9 subp>agraph 7,c7 is submitt$ to ! ,secret>y on behalf ( an applicant1 & ! reque/ id5tifies ! date ! product is1 or w be1 )drawn f sale1 !n1 = purposes ( assess+ ! prescription drug program fee "u section #gcf7;a77#b71 ! ,secret>y %all consid] su* product to h be5 includ$ 9 ! discont9u$ section on ! lat] ( 7i7 ! date su* reque/ 0 receiv$1 or 7ii7 if ! product w be )drawn f sale on a future date1 su* future date :5 ! product is )drawn f sale4 ,= purposes ( subp>agraph 7,c71 a product %all be consid]$ )drawn f sale once ! applicant has ceas$ its own di/ribution ( ! product1 :e!r or n ! applicant has ord]$ recall ( all previ\sly di/ribut$ lots ( ! product1 except t a r\t9e1 tempor>y int]ruption 9 supply %all n r5d] a product )drawn f sale42 & 7#c7 by add+ at ! end ! foll[+3 7#ab7 ,! t]m sk9-te/ diagno/ic product-- 7,a7 means a product-- 7i7 = prick1 scrat*1 intrad]mal1 or subcutane\s adm9i/ration2 7ii7 expect$ to produce a limit$1 local reaction at ! site ( adm9i/ration 7if positive71 r ?an a sy/emic effect2 7iii7 n int5d$ to be a prev5tive or !rapeutic int]v5tion2 & 7iv7 int5d$ to detect an imm$iate or delay$-type sk9 hyp]s5sitivity reaction to aid 9 ! diagnosis (-- 7,i7 an all]gy to an antimicrobial ag5t2 7,,ii7 an all]gy t is n to an antimicrobial ag5t1 if ! diagno/ic product 0 au?oriz$ = m>ket+ prior to ,octob] #a1 #bjbb2 or 7,,iii7 infection ) fungal or mycobact]ial pa?og5s2 & 7,b7 includes positive & negative controls requir$ to int]pret ! results ( a product describ$ 9 subp>agraph 7,a74 4 #ajc4 ,au?ority to assess & use drug fees 7a7 ,types ( fees ,section #gcf7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7a77 is am5d$-- 7#a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ #bjah & ins]t+ #bjbc2 7#b7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a71 by /rik+ subsection 7c77#e7 ea* place x appe>s & ins]t+ subsection 7c77#f72 7,b7 9 subp>agraph 7,c71 by ins]t+ prior to approval aft] or 0 )drawn2 & 7,c7 by add+ at ! end ! foll[+3 7,h7 ,exception = sk9-te/ diagno/ic products ,a human drug application = a sk9-te/ diagno/ic product %all n be subject to a fee "u subp>agraph 7,a74 2 & 7#c7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a7-- 7i7 by /rik+ subsection 7c77#e7 & ins]t+ subsection 7c77#f72 7ii7 by /rik+ ,except z provid$ & ins]t+ ! foll[+3 7i7 ,paym5t ( fees ,except z provid$ 2 & 7iii7 by add+ at ! end ! foll[+3 7ii7 ,previ\sly discont9u$ drug products ,if a drug product t is id5tifi$ 9 a human drug application approv$ z ( ,octob] #a ( a fiscal ye> is n a prescription drug product z ( t date because ! drug product is 9 ! discont9u$ section ( a li/ id5tifi$ 9 section #gce7c71 & on any subsequ5t day dur+ su* fiscal ye> ! drug product is a prescription drug product1 !n except z provid$ 9 subp>agraphs 7,b7 & 7,c71 ea* p]son :o is nam$ z ! applicant 9 a human drug application ) respect to su* product1 & :o1 aft] ,septemb] #a1 #aiib1 _h p5d+ be=e ! ,secret>y a human drug application or supplem5t1 %all pay ! annual prescription drug program fee e/abli%$ = a fiscal ye> "u subsection 7c77#f7 = su* prescription drug product4 ,su* fee %all be due on ! la/ bus9ess day ( su* fiscal ye> & %all be paid only once = ea* product = a fiscal ye> 9 :i* ! fee is payable4 2 & 7,b7 by am5d+ subp>agraph 7,b7 to read z foll[s3 7,b7 ,exception = c]ta9 prescription drug products ,a prescription drug program fee %all n be assess$ = a prescription drug product "u subp>agraph 7,a7 if su* product is-- 7i7 a l>ge volume p>5t]al product 7a /]ile aque\s drug product packag$ 9 a s+le-dose conta9] ) a volume great] ?an or equal to #ajj m,l1 n includ+ p[d]s = recon/itution or ph>macy bulk packages7 id5tifi$ on ! li/ compil$ "u section #eje7;j77#g72 7ii7 ph>maceutically equival5t 7z def9$ 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations771 to ano!r product on ! li/ ( products compil$ "u section #eje7;j77#g7 7n includ+ ! discont9u$ section ( su* li/72 or 7iii7 a sk9-te/ diagno/ic product4 4 7b7 ,fee rev5ue am\nts ,section #gcf7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7b77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 7,b7 by r$esignat+ subp>agraphs 7,c7 ?r\gh 7,f7 z subp>agraphs 7,d7 ?r\gh 7,g71 respectively2 7,c7 by ins]t+ aft] subp>agraph 7,b7 ! foll[+3 7,c7 ,! doll> am\nt equal to ! /rategic hir+ & ret5tion adju/m5t = ! fiscal ye> 7z det]m9$ "u subsection 7c77#b772 2 7,d7 9 subp>agraph 7,d71 z s r$esignat$1 by /rik+ 7c77#b7 & ins]t+ 7c77#c72 7,e7 9 subp>agraph 7,e71 z s r$esignat$1 by /rik+ 7c77#c7 & ins]t+ 7c77#d72 7,f7 9 subp>agraph 7,f71 z s r$esignat$1 by /rik+ 7c77#d7 & ins]t+ 7c77#e72 & 7,g7 9 subp>agraph 7,g71 z s r$esignat$1 by /rik+ clauses 7i7 ?r\gh 7v7 & ins]t+ ! foll[+3 7i7 #fe1ggc1fic = fiscal ye> #bjbc4 7ii7 #be1jig1fga = fiscal ye> #bjbd4 7iii7 #ad1aed1afi = fiscal ye> #bjbe4 7iv7 #d1hfd1hfj = fiscal ye> #bjbf4 7v7 #a1cad1fbj = fiscal ye> #bjbg4 2 & 7#b7 9 p>agraph 7#c7-- 7,a7 9 subp>agraph 7,a71 by /rik+ #bjah1 #hgh1eij1jjj & ins]t+ #bjbc1 #a1aea1ebb1ieh2 & 7,b7 9 subp>agraph 7,b7-- 7i7 by /rik+ #bjai ?r\gh #bjbb & ins]t+ #bjbd ?r\gh #bjbg2 & 7ii7 by /rik+ subsection 7c77#c7 or 7c77#d7 & ins]t+ subsection 7c77#d7 or 7c77#e74 7c7 ,adju/m5ts2 annual fee sett+ ,section #gcf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is am5d$-- 7#a7 9 p>agraph 7#a77;,b77ii71 by /rik+ ,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv & ins]t+ ,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 7#b7 by r$esignat+ p>agraphs 7#b7 ?r\gh 7#f7 z p>agraphs 7#c7 ?r\gh 7#g71 respectively2 7#c7 by ins]t+ aft] p>agraph 7#a7 ! foll[+3 7#b7 ,/rategic hir+ & ret5tion adju/m5t ,= ea* fiscal ye>1 aft] ! annual base rev5ue e/abli%$ 9 subsection 7b77#a77;,a7 is adju/$ = inflation 9 accordance ) p>agraph 7#a71 ! ,secret>y %all fur!r increase ! fee rev5ue & fees-- 7,a7 = fiscal ye> #bjbc1 by #i1jjj1jjj2 & 7,b7 = fiscal ye> #bjbd & ea* subsequ5t fiscal ye>1 by #d1jjj1jjj4 2 7#d7 9 p>agraph 7#c71 z s r$esignat$-- 7,a7 9 subp>agraph 7,a7-- 7i7 by /rik+ = inflation2 & 7ii7 by /rik+ p>agraph 7#a7 & ins]t+ p>agraphs 7#a7 & 7#b72 7,b7 by am5d+ subp>agraph 7,b7 to read z foll[s3 7,b7 ,me?odology ,= purposes ( ?is p>agraph1 ! ,secret>y %all employ ! capacity plann+ me?odology utiliz$ by ! ,secret>y 9 sett+ fees = fiscal ye> #bjba1 z describ$ 9 ! notice titl$ ,prescription ,drug ,us] ,fee ,rates = ,fiscal ,ye> #bjba 7#he ,f$4 ,reg4 #dffea2 ,augu/ #c1 #bjbj74 ,! workload categories us$ 9 =eca/+ %all include only ! activities describ$ 9 su* notice &1 z feasible1 additional activities t are directly relat$ to ! direct review ( applications & supplem5ts1 includ+ additional =mal meet+ types1 ! direct review ( po/m>ket+ commitm5ts & requirem5ts1 ! direct review ( risk evaluation & mitigation /rategies1 & ! direct review ( annual reports = approv$ prescription drug products4 ,subject to ! exceptions 9 ! prec$+ s5t5ce1 ! ,secret>y %all n include z workload categories 9 =eca/+ any non-core review activities1 includ+ any activities t ! ,secret>y ref]5c$ = pot5tial future use 9 su* notice b did n utilize 9 ! sett+ fees = fiscal ye> #bjba4 2 7,c7 by /rik+ subp>agraph 7,c72 7,d7 by r$esignat+ subp>agraphs 7,d7 & 7,e7 z subp>agraphs 7,c7 & 7,d71 respectively2 7,e7 9 subp>agraph 7,c71 z s r$esignat$-- 7i7 by /rik+ ye>7 & & ins]t+ ye>712 & 7ii7 by /rik+ ! p]iod & ins]t+ 1 & subsection 7b77#a77;,c7 7! doll> am\nt ( ! /rategic hir+ & ret5tion adju/m5t742 & 7,f7 9 subp>agraph 7,d71 z s r$esignat$1 by /rik+ p>agraph 7#e7 & ins]t+ p>agraph 7#f72 7#e7 9 p>agraph 7#d71 z s r$esignat$-- 7,a7 by am5d+ subp>agraph 7,a7 to read z foll[s3 7,a7 ,increase ,= fiscal ye> #bjbc & subsequ5t fiscal ye>s1 ! ,secret>y %all1 9 addition to adju/m5ts "u p>agraphs 7#a71 7#b71 & 7#c71 fur!r increase ! fee rev5ue & fees if su* an adju/m5t is necess>y to provide = at lea/ ! foll[+ am\nts ( op]at+ res]ves ( c>ryov] us] fees = ! process = ! review ( human drug applications = ea* fiscal ye>1 z foll[s3 7i7 ,= fiscal ye> #bjbc1 at lea/ #h weeks ( op]at+ res]ves4 7ii7 ,= fiscal ye> #bjbd1 at lea/ #i weeks ( op]at+ res]ves4 7iii7 ,= fiscal ye> #bjbe & subsequ5t fiscal ye>s1 at lea/ #aj weeks ( op]at+ res]ves4 2 & 7,b7 9 subp>agraph 7,c71 by /rik+ p>agraph 7#e7 & ins]t+ p>agraph 7#f72 7#f7 by am5d+ p>agraph 7#e71 z s r$esignat$1 to read z foll[s3 7#e7 ,additional direct co/ adju/m5t ,! ,secret>y %all1 9 addition to adju/m5ts "u p>agraphs 7#a71 7#b71 7#c71 & 7#d71 fur!r increase ! fee rev5ue & fees-- 7,a7 = fiscal ye> #bjbc1 by #dd1chf1aej2 & 7,b7 = fiscal ye>s #bjbd ?r\gh #bjbg1 by ! am\nt set =? 9 clauses 7i7 ?r\gh 7iv71 z applicable1 multipli$ by ! ,consum] ,price ,index = urban consum]s 7,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 ,n ,seasonally ,adju/$2 ,all ,items2 ,annual ,index7 = ! mo/ rec5t ye> ( available data1 divid$ by su* ,index = #bjba-- 7i7 = fiscal ye> #bjbd1 #fj1ifg1iic2 7ii7 = fiscal ye> #bjbe1 #ce1gii1cad2 7iii7 = fiscal ye> #bjbf1 #ce1gii1cad2 & 7iv7 = fiscal ye> #bjbg1 #ce1gii1cad4 2 & 7#g7 9 p>agraph 7#f71 z s r$esignat$1 by /rik+ #bjag & ins]t+ #bjbb4 7d7 ,cr$it+ & availability ( fees ,section #gcf7;g77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7g77#c77 is am5d$ by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 7e7 ,writt5 reque/s = waiv]s1 r$uctions1 & refunds ,section #gcf7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7i77 is am5d$ to read z foll[s3 7i7 ,writt5 reque/s = waiv]s1 r$uctions1 exemptions1 & returns2 disputes conc]n+ fees ,to qualify = consid]ation = a waiv] or r$uction "u subsection 7d71 an exemption "u subsection 7k71 or ! return ( any fee paid "u ?is section1 includ+ if ! fee is claim$ to h be5 paid 9 error1 a p]son %all submit to ! ,secret>y a writt5 reque/ ju/ify+ su* waiv]1 r$uction1 exemption1 or return n lat] ?an #ahj days aft] su* fee is due4 ,a reque/ submitt$ "u ?is p>agraph %all include any legal au?orities "u :i* ! reque/ is made4 4 7f7 ,orphan drugs ,section #gcf7k7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7k77 is am5d$-- 7#a7 9 p>agraph 7#a77;,b71 by /rik+ dur+ ! previ\s ye> & ins]t+ 1 z det]m9$ "u p>agraph 7#b72 & 7#b7 9 p>agraph 7#b71 by /rik+ t its gross annual rev5ues & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ support$ by tax returns submitt$ to ! ,int]nal ,rev5ue ,s]vice1 or1 z necess>y1 by o!r appropriate f9ancial in=mation1 t its gross annual rev5ues did n exce$ #ej1jjj1jjj = ! la/ cal5d> ye> end+ prior to ! fiscal ye> = :i* ! exemption is reque/$44 #ajd4 ,reau?orization2 report+ requirem5t ,section #gcf;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7 is am5d$-- 7#a7 by /rik+ #bjah ea* place x appe>s & ins]t+ #bjbc2 7#b7 by /rik+ ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjag ea* place x appe>s & ins]t+ ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjbb2 7#c7 9 subsection 7a77#d71 by /rik+ #bjbj & ins]t+ #bjbc2 & 7#d7 9 subsection 7f71 by /rik+ #bjbb ea* place x appe>s & ins]t+ #bjbg4 #aje4 ,sunset dates 7a7 ,au?orization ,sections #gce & #gcf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g2 #cgi;h7 %all cease to be effective ,octob] #a1 #bjbg4 7b7 ,report+ requirem5ts ,section #gcf;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7 %all cease to be effective ,janu>y #ca1 #bjbh4 7c7 ,previ\s sunset provision ,effective ,octob] #a1 #bjbb1 subsections 7a7 & 7b7 ( section #ajd ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 are repeal$4 #ajf4 ,effective date ,! am5dm5ts made by ?is title %all take effect on ,octob] #a1 #bjbb1 or ! date ( ! enactm5t ( ?is ,act1 :i*ev] is lat]1 except t fees "u "p #b ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g et seq47 %all be assess$ = all human drug applications receiv$ on or aft] ,octob] #a1 #bjbb1 reg>dless ( ! date ( ! enactm5t ( ?is ,act4 #ajg4 ,sav+s clause ,not)/&+ ! am5dm5ts made by ?is title1 "p #b ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g et seq471 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is title1 %all cont9ue to be 9 effect ) respect to human drug applications & supplem5ts 7z def9$ 9 su* "p z ( su* day7 t 7 accept$ by ! ,food & ,drug ,adm9i/ration = fil+ on or aft] ,octob] #a1 #bjag1 b be=e ,octob] #a1 #bjbb1 ) respect to assess+ & collect+ any fee requir$ by su* "p = a fiscal ye> prior to fiscal ye> #bjbc4 ,,ii ,fees relat+ to devices #bja4 ,%ort title2 f9d+ 7a7 ,%ort title ,?is title may be cit$ z ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb4 7b7 ,f9d+ ,congress f9ds t ! fees au?oriz$ "u ! am5dm5ts made by ?is title w be d$icat$ t[>d exp$it+ ! process = ! review ( device applications & = assur+ ! safety & effectiv5ess ( devices1 z set =? 9 ! goals id5tifi$ = purposes ( "p #c ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #bjb4 ,def9itions ,section #gcg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i7 is am5d$-- 7#a7 9 p>agraph 7#i7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ & prem>ket notification submissions & ins]t+ prem>ket notification submissions1 & de novo classification reque/s2 7,b7 9 subp>agraph 7,d71 by /rik+ & submissions & ins]t+ submissions1 & de novo classification reque/s2 7,c7 9 subp>agraph 7,f71 by /rik+ & prem>ket notification submissions & ins]t+ prem>ket notification submissions1 & de novo classification reque/s2 7,d7 9 subp>agraphs 7,g7 & 7,h71 by /rik+ or submissions ea* place x appe>s & ins]t+ submissions1 or reque/s2 & 7,e7 9 subp>agraph 7,k71 by /rik+ or prem>ket notification submissions & ins]t+ prem>ket notification submissions1 or de novo classification reque/s2 & 7#b7 9 p>agraph 7#aa71 by /rik+ #bjaf & ins]t+ #bjba4 #bjc4 ,au?ority to assess & use device fees 7a7 ,types ( fees ,section #gch7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7a77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ #bjah & ins]t+ #bjbc2 & 7#b7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! matt] prec$+ clause 7i71 by /rik+ #bjag & ins]t+ #bjbb2 7ii7 9 clause 7iii71 by /rik+ #ge p]c5t & ins]t+ #hj p]c5t2 & 7iii7 9 clause 7viii71 by /rik+ #c4d p]c5t & ins]t+ #d4e p]c5t2 7,b7 9 subp>agraph 7,b77iii71 by /rik+ or prem>ket notification submission & ins]t+ prem>ket notification submission1 or de novo classification reque/2 & 7,c7 9 subp>agraph 7,c71 by /rik+ or p]iodic report+ conc]n+ a class ,,iii device & ins]t+ p]iodic report+ conc]n+ a class ,,iii device1 or de novo classification reque/4 7b7 ,fee am\nts ,section #gch7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7b77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 7#b7 by am5d+ ! table 9 p>agraph 7#b7 to read z foll[s3 ,fee ,type,fiscal ,ye> #bjbc;,fiscal ,ye> #bjbd;,fiscal ,ye> #bjbe;,fiscal ,ye> #bjbf;,fiscal ,ye> #bjbg,prem>ket ,application#dbe1jjjdce1jjjdde1jjjdee1jj jdgj1jjj;,e/abli%m5t ,regi/ration#f1bejf1hgeg1ajjg1egeh1dfe 2 & 7#c7 9 p>agraph 7#c71 by am5d+ subp>agraphs 7,a7 ?r\gh 7,e7 to read z foll[s3 7,a7 #cab1fjf1jjj = fiscal ye> #bjbc4 7,b7 #cce1gej1jjj = fiscal ye> #bjbd4 7,c7 #cej1gdf1djj = fiscal ye> #bjbe4 7,d7 #cff1dhf1cjj = fiscal ye> #bjbf4 7,e7 #dah1cdc1jjj = fiscal ye> #bjbg4 4 7c7 ,annual fee sett+2 adju/m5ts ,section #gch7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7c77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ #bjag & ins]t+ #bjbb2 7#b7 9 p>agraph 7#b7-- 7,a7 by /rik+ #bjah ea* place x appe>s & ins]t+ #bjbc2 7,b7 9 subp>agraph 7,b77ii71 by /rik+ #bjaf & ins]t+ #bjbb2 7,c7 9 subp>agraph 7,c77i77,,ii71 by /rik+ ,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv & ins]t+ ,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 & 7,d7 9 subp>agraph 7,d71 by /rik+ #bjbb & ins]t+ #bjbg2 7#c7 9 p>agraph 7#c71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 7#d7 by r$esignat+ p>agraphs 7#d7 & 7#e7 z p>agraphs 7#g7 & 7#h71 respectively2 & 7#e7 by ins]t+ aft] p>agraph 7#c7 ! foll[+3 7#d7 ,p]=mance improvem5t adju/m5t 7,a7 ,9 g5]al ,= ea* ( fiscal ye>s #bjbe ?r\gh #bjbg1 aft] ! adju/m5t "u p>agraph 7#c71 ! base e/abli%m5t regi/ration fee am\nts = su* fiscal ye> %all be increas$ to reflect *anges 9 ! res\rce ne$s ( ! ,secret>y due to improv$ review p]=mance goals = ! process = ! review ( device applications id5tifi$ 9 ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb1 z ! ,secret>y det]m9es necess>y to a*ieve an increase 9 total fee collections = su* fiscal ye>1 equal to ! foll[+ am\nts1 z applicable3 7i7 ,= fiscal ye> #bjbe1 ! product (-- 7,i7 ! am\nt det]m9$ "u subp>agraph 7,b77i77,i72 & 7,,ii7 ! applicable inflation adju/m5t "u p>agraph 7#b77;,b7 = su* fiscal ye>4 7ii7 ,= fiscal ye> #bjbf1 ! product (-- 7,i7 ! sum ( ! am\nts det]m9$ "u subp>agraphs 7,b77i77,,ii71 7,b77ii77,i71 & 7,b77iii77,i72 & 7,,ii7 ! applicable inflation adju/m5t "u p>agraph 7#b77;,b7 = su* fiscal ye>4 7iii7 ,= fiscal ye> #bjbg1 ! product (-- 7,i7 ! sum ( ! am\nts det]m9$ "u subp>agraphs 7,b77i77,,iii71 7,b77ii77,,ii71 & 7,b77iii77,,ii72 & 7,,ii7 ! applicable inflation adju/m5t "u p>agraph 7#b77;,b7 = su* fiscal ye>4 7,b7 ,am\nts 7i7 ,presubmission am\nt ,= purposes ( subp>agraph 7,a71 ) respect to ! presubmission writt5 fe$back goal1 ! am\nts det]m9$ "u ?is subp>agraph are z foll[s3 7,i7 ,= fiscal ye> #bjbe1 #ae1cif1fjj if ! goal = fiscal ye> #bjbc is met4 7,,ii7 ,= fiscal ye> #bjbf-- 7aa7 #ae1cif1fjj if ! goal = fiscal ye> #bjbc is met & ! goal = fiscal ye> #bjbd is miss$2 or 7bb7 #cf1gib1bjj if ! goal = fiscal ye> #bjbd is met4 7,,iii7 ,= fiscal ye> #bjbg-- 7aa7 #ae1cif1fjj if ! goal = fiscal ye> #bjbc is met & ! goal = ea* ( fiscal ye>s #bjbd & #bjbe is miss$2 7bb7 #cf1gib1bjj if ! goal = fiscal ye> #bjbd is met & ! goal = fiscal ye> #bjbe is miss$2 or 7cc7 #dj1egb1fjj if ! goal = fiscal ye> #bjbe is met4 7ii7 ,de novo classification reque/ am\nt ,= purposes ( subp>agraph 7,a71 ) respect to ! de novo decision goal1 ! am\nts det]m9$ "u ?is subp>agraph are z foll[s3 7,i7 ,= fiscal ye> #bjbf1 #f1cbc1ejj if ! goal = fiscal ye> #bjbc is met4 7,,ii7 ,= fiscal ye> #bjbg-- 7aa7 #f1cbc1ejj if ! goal = fiscal ye> #bjbc is met & ! goal = fiscal ye> #bjbd is miss$2 or 7bb7 #aa1gfe1djj if ! goal = fiscal ye> #bjbd is met4 7iii7 ,prem>ket notification & prem>ket approval am\nt ,= purposes ( subp>agraph 7,a71 ) respect to ! #eaj7k7 decision goal1 #eaj7k7 %>$ outcome total "t to decision goal1 ,,pma decision goal1 & ,,pma %>$ outcome total "t to decision goal1 ! am\nts det]m9$ "u ?is subp>agraph are z foll[s3 7,i7 ,= fiscal ye> #bjbf1 #a1jbj1jjj if ! #d goals = fiscal ye> #bjbc are met4 7,,ii7 ,= fiscal ye> #bjbg-- 7aa7 #a1jbj1jjj if ! #d goals = fiscal ye> #bjbc are met & "o or m ( ! #d goals = fiscal ye> #bjbd is miss$2 or 7bb7 #c1ijf1jjj if ! #d goals = fiscal ye> #bjbd are met4 7,c7 ,p]=mance calculation ,= purposes ( ?is p>agraph1 p]=mance ( ! foll[+ goals %all be det]m9$ z specifi$ 9 ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb & bas$ on data available z ( ! applicable dates z foll[s3 7i7 ,! p]=mance ( ! presubmission writt5 fe$back goal-- 7,i7 = fiscal ye> #bjbc1 %all be bas$ on data available z ( ,m>* #ca1 #bjbd2 7,,ii7 = fiscal ye> #bjbd1 %all be bas$ on data available z ( ,m>* #ca1 #bjbe2 & 7,,iii7 = fiscal ye> #bjbe1 %all be bas$ on data available z ( ,m>* #ca1 #bjbf4 7ii7 ,! p]=mance ( ! de novo decision goal1 #eaj7k7 decision goal1 #eaj7k7 %>$ outcome total "t to decision goal1 ,,pma decision goal1 & ,,pma %>$ outcome total "t to decision goal-- 7,i7 = fiscal ye> #bjbc1 %all be bas$ on data available z ( ,m>* #ca1 #bjbe2 & 7,,ii7 = fiscal ye> #bjbd1 %all be bas$ on data available z ( ,m>* #ca1 #bjbf4 7,d7 ,def9itions ,= purposes ( ?is p>agraph1 ! t]ms presubmission writt5 fe$back goal1 de novo decision goal1 #eaj7k7 decision goal1 #eaj7k7 %>$ outcome total "t to decision goal1 ,,pma decision goal1 & ,,pma %>$ outcome total "t to decision goal h ! mean+s giv5 su* t]ms 9 ! goals id5tifi$ 9 ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb4 7#e7 ,hir+ adju/m5t 7,a7 ,9 g5]al ,= ea* ( fiscal ye>s #bjbe ?r\gh #bjbg1 aft] ! adju/m5ts "u p>agraphs 7#c7 & 7#d71 if applicable1 ! base e/abli%m5t regi/ration fee am\nts %all be decreas$ z ! ,secret>y det]m9es necess>y to a*ieve a r$uction 9 total fee collections equal to ! hir+ adju/m5t am\nt "u subp>agraph 7,b71 if ! numb] ( hires to support ! process = ! review ( device applications falls bel[ ! foll[+ ?re%olds = ! applicable fiscal ye>s3 7i7 ,= fiscal ye> #bjbe1 #he p]c5t ( ! hir+ goal specifi$ 9 subp>agraph 7,c7 = fiscal ye> #bjbc4 7ii7 ,= fiscal ye> #bjbf1 #ij p]c5t ( ! hir+ goal specifi$ 9 subp>agraph 7,c7 = fiscal ye> #bjbd4 7iii7 ,= fiscal ye> #bjbg1 #ij p]c5t ( ! hir+ goal specifi$ 9 subp>agraph 7,c7 = fiscal ye> #bjbe4 7,b7 ,hir+ adju/m5t am\nt ,! hir+ adju/m5t am\nt = fiscal ye> #bjbe & ea* subsequ5t fiscal ye> is ! product (-- 7i7 ! numb] ( hires by :i* ! hir+ goal specifi$ 9 subp>agraph 7,c7 = ! fiscal ye> be=e ! prior fiscal ye> 0 miss$2 7ii7 #gb1hgg2 & 7iii7 ! applicable inflation adju/m5t "u p>agraph 7#b77;,b7 = ! fiscal ye> = :i* ! hir+ goal 0 miss$4 7,c7 ,hir+ goals 7i7 ,9 g5]al ,= purposes ( subp>agraph 7,b71 ! hir+ goals = ea* ( fiscal ye>s #bjbc ?r\gh #bjbe are z foll[s3 7,i7 ,= fiscal ye> #bjbc1 #add hires4 7,,ii7 ,= fiscal ye> #bjbd1 #db hires4 7,,iii7 ,= fiscal ye> #bjbe-- 7aa7 #bd hires if ! base e/abli%m5t regi/ration fees are n increas$ by ! am\nt det]m9$ "u p>agraph 7#d77;,a77i72 or 7bb7 #hc hires if ! base e/abli%m5t regi/ration fees are increas$ by ! am\nt det]m9$ "u p>agraph 7#d77;,a77i74 7ii7 ,numb] ( hires ,= purposes ( ?is p>agraph1 ! numb] ( hires = a fiscal ye> %all be det]m9$ by ! ,secret>y1 z set =? 9 ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb4 7#f7 ,op]at+ res]ve adju/m5t 7,a7 ,9 g5]al ,= ea* ( fiscal ye>s #bjbc ?r\gh #bjbg1 aft] ! adju/m5ts "u p>agraphs 7#c71 7#d71 & 7#e71 if applicable1 if ! ,secret>y has op]at+ res]ves ( c>ryov] us] fees = ! process = ! review ( device applications 9 excess ( ! designat$ am\nt 9 subp>agraph 7,b71 ! ,secret>y %all decrease ! base e/abli%m5t regi/ration fee am\nts to provide = n m ?an su* designat$ am\nt ( op]at+ res]ves4 7,b7 ,designat$ am\nt ,subject to subp>agraph 7,c71 = ea* fiscal ye>1 ! designat$ am\nt 9 ?is subp>agraph is equal to ! sum (-- 7i7 #ac weeks ( op]at+ res]ves ( c>ryov] us] fees2 & 7ii7 ! #a mon? ( op]at+ res]ves describ$ 9 p>agraph 7#h74 7,c7 ,exclud$ am\nt ,= ! p]iod ( fiscal ye>s #bjbc ?r\gh #bjbf1 a total am\nt equal to #aah1jjj1jjj %all n be consid]$ "p ( ! designat$ am\nt "u subp>agraph 7,b7 & %all n be subject to ! decrease "u subp>agraph 7,a74 4 7d7 ,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 7e7 ,au?orization ( appropriations ,section #gch7;h77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7h77#c77 is am5d$ to read z foll[s3 7#c7 ,au?orization ( appropriations 7,a7 ,9 g5]al ,= ea* ( ! fiscal ye>s #bjbc ?r\gh #bjbg1 !re is au?oriz$ to be appropriat$ = fees "u ?is section an am\nt equal to ! rev5ue am\nt det]m9$ 9 subp>agraph 7,b71 less ! am\nt ( r$uctions det]m9$ 9 subp>agraph 7,c74 7,b7 ,rev5ue am\nt ,= purposes ( ?is p>agraph1 ! rev5ue am\nt = ea* fiscal ye> is ! sum (-- 7i7 ! total rev5ue am\nt "u subsection 7b77#c7 = ! fiscal ye>1 z adju/$ "u subsection 7c77#b72 & 7ii7 ! p]=mance improvem5t adju/m5t am\nt = ! fiscal ye> "u subsection 7c77#d77;,a71 if applicable4 7,c7 ,am\nt ( r$uctions ,= purposes ( ?is p>agraph1 ! am\nt ( r$uctions = ea* fiscal ye> is ! sum (-- 7i7 ! hir+ adju/m5t am\nt = ! fiscal ye> "u subsection 7c77#e71 if applicable2 & 7ii7 ! op]at+ res]ve adju/m5t am\nt = ! fiscal ye> "u subsection 7c77#f71 if applicable4 4 #bjd4 ,reau?orization2 report+ requirem5t 7a7 ,p]=mance reports ,section #gch;,a7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;a77 is am5d$-- 7#a7 by /rik+ fiscal ye> #bjah ea* place x appe>s & ins]t+ fiscal ye> #bjbc2 7#b7 by /rik+ ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjag ea* place x appe>s & ins]t+ ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb2 7#c7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a71 by r$esignat+ ! second clause 7iv7 7relat+ to analysis7 z clause 7v72 & 7,b7 9 subp>agraph 7,a77iv7 7relat+ to rationale = ,,mdufa program *anges71 by /rik+ fiscal ye> #bjbj & ins]t+ fiscal ye> #bjbc2 & 7#d7 9 p>agraph 7#d71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 7b7 ,reau?orization ,section #gch;,a7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;b77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ #bjbb & ins]t+ #bjbg2 & 7#b7 9 p>agraph 7#e71 by /rik+ #bjbb & ins]t+ #bjbg4 #bje4 ,accr$itation programs 7a7 ,accr$itation s*eme = con=mity assessm5t ,section #ead7;d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7d77 is am5d$-- 7#a7 9 ! subsection head+1 by /rik+ ,pilot2 7#b7 9 p>agraph 7#a7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ pilot2 7,b7 9 subp>agraph 7,a7-- 7i7 by ins]t+ meet+ crit]ia specifi$ by ! ,secret>y 9 guidance aft] te/+ laboratories2 7ii7 by ins]t+ 9 guidance aft] by ! ,secret>y2 & 7iii7 by /rik+ assess ! con=mance ( a device ) & ins]t+ conduct te/+ to support ! assessm5t ( ! con=mance ( a device to2 & 7,c7 9 subp>agraph 7,b7-- 7i7 by /rik+ det]m9ations & ins]t+ results2 7ii7 by ins]t+ to support aft] s accr$it$2 & 7iii7 by /rik+ a p>ticul> su* det]m9ation & ins]t+ p>ticul> su* results2 7#c7 9 p>agraph 7#b7-- 7,a7 9 ! p>agraph head+1 by /rik+ det]m9ations & ins]t+ results2 7,b7 9 subp>agraph 7,a7-- 7i7 by /rik+ det]m9ations by te/+ laboratories & all t foll[s ?r\gh su* det]m9ations or & ins]t+ results by te/+ laboratories accr$it$ pursuant to ?is subsection1 includ+ by conduct+ p]iodic audits ( su* results or ( !2 7ii7 by ins]t+ a comma aft] or te/+ laboratories2 7iii7 by ins]t+ or recognition ( an accr$itation body aft] accr$itation ( su* te/+ laboratory2 & 7iv7 by /rik+ su* device & ins]t+ a device2 & 7,c7 9 subp>agraph 7,b7-- 7i7 by /rik+ by a te/+ laboratory s accr$it$ & ins]t+ "u ?is subsection2 & 7ii7 by ins]t+ or recognition ( an accr$itation body be=e "u p>agraph 7#a77;,a72 7#d7 9 p>agraph 7#c77;,c7-- 7,a7 9 ! subp>agraph head+1 by ins]t+ & transition aft] initiation2 & 7,b7 by add+ at ! end ! foll[+3 ,aft] ,septemb] #cj1 #bjbc1 su* pilot program w be consid]$ to be complet$1 & ! ,secret>y %all h ! au?ority to cont9ue op]at+ a program consi/5t ) ?is subsection42 & 7#e7 by /rik+ p>agraph 7#d74 7b7 ,accr$it$ p]sons ,section #ebc7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjm7c77 is am5d$ by /rik+ #bjbb & ins]t+ #bjbg4 #bjf4 ,sunset dates 7a7 ,au?orization ,sections #gcg & #gch ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i2 #cgi;fj7 %all cease to be effective ,octob] #a1 #bjbg4 7b7 ,report+ requirem5ts ,section #gch;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7 %all cease to be effective ,janu>y #ca1 #bjbh4 7c7 ,previ\s sunset provision ,effective ,octob] #a1 #bjbb1 subsections 7a7 & 7b7 ( section #baj ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 are repeal$4 #bjg4 ,effective date ,! am5dm5ts made by ?is title %all take effect on ,octob] #a1 #bjbb1 or ! date ( ! enactm5t ( ?is ,act1 :i*ev] is lat]1 except t fees "u "p #c ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i et seq47 %all be assess$ = all submissions li/$ 9 section #gch7;a77#b77;,a7 ( su* ,act receiv$ on or aft] ,octob] #a1 #bjbb1 reg>dless ( ! date ( ! enactm5t ( ?is ,act4 #bjh4 ,sav+s clause ,not)/&+ ! am5dm5ts made by ?is title1 "p #c ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i et seq471 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is title1 %all cont9ue to be 9 effect ) respect to ! submissions li/$ 9 section #gch7;a77#b77;,a7 ( su* ,act 7z def9$ 9 su* "p z ( su* day7 t on or aft] ,octob] #a1 #bjag1 b be=e ,octob] #a1 #bjbb1 7 receiv$ by ! ,food & ,drug ,adm9i/ration ) respect to assess+ & collect+ any fee requir$ by su* "p = a fiscal ye> prior to fiscal ye> #bjbc4 ,,iii ,fees relat+ to g5]ic drugs #cja4 ,%ort title2 f9d+ 7a7 ,%ort title ,?is title may be cit$ z ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbb4 7b7 ,f9d+ ,! ,congress f9ds t ! fees au?oriz$ by ! am5dm5ts made 9 ?is title w be d$icat$ to human g5]ic drug activities1 z set =? 9 ! goals id5tifi$ = purposes ( "p #g ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #cjb4 ,au?ority to assess & use human g5]ic drug fees 7a7 ,types ( fees ,section #gdd;,b7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;a77 is am5d$-- 7#a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ #bjah & ins]t+ #bjbc2 7#b7 9 p>agraph 7#b77;,c71 by /rik+ fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ fiscal ye>s #bjbc ?r\gh #bjbg2 7#c7 9 p>agraph 7#c77;,b71 by /rik+ fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ fiscal ye>s #bjbc ?r\gh #bjbg2 7#d7 9 p>agraph 7#d77;,d71 by /rik+ fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ fiscal ye>s #bjbc ?r\gh #bjbg2 & 7#e7 9 p>agraph 7#e77;,d71 by /rik+ fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ fiscal ye>s #bjbc ?r\gh #bjbg4 7b7 ,fee rev5ue am\nts ,section #gdd;,b7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;b77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! head+1 by /rik+ #bjah & ins]t+ #bjbc2 7ii7 by /rik+ #bjah & ins]t+ #bjbc2 & 7iii7 by /rik+ #dic1fjj1jjj & ins]t+ #ehb1ejj1jjj2 & 7,b7 9 subp>agraph 7,b7-- 7i7 9 ! head+1 by /rik+ #bjai ?r\gh #bjbb & ins]t+ #bjbd ?r\gh #bjbg2 7ii7 by /rik+ ,= ea* & ins]t+ ! foll[+3 7i7 ,9 g5]al ,= ea* 2 7iii7 by /rik+ #bjai ?r\gh #bjbb & ins]t+ #bjbd ?r\gh #bjbg2 7iv7 by /rik+ #dic1fjj1jjj & ins]t+ ! base rev5ue am\nt "u clause 7ii72 & 7v7 by add+ at ! end ! foll[+3 7ii7 ,base rev5ue am\nt ,! base rev5ue am\nt = a fiscal ye> is ! total rev5ue am\nt e/abli%$ "u ?is p>agraph = ! previ\s fiscal ye>1 n includ+ any adju/m5ts made = su* previ\s fiscal ye> "u subsection 7c77#c74 2 & 7#b7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,c71 by /rik+ "o-?ird ! am\nt & ins]t+ #bd p]c5t2 7,b7 9 subp>agraph 7,d71 by /rik+ ,sev5 & ins]t+ ,six2 & 7,c7 9 subp>agraph 7,e77i71 by /rik+ ,?irty-five & ins]t+ ,?irty-six4 7c7 ,adju/m5ts ,section #gdd;,b7c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;c77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a7-- 7i7 by /rik+ #bjai & ins]t+ #bjbd2 & 7ii7 by /rik+ ! product ( ! total rev5ues e/abli%$ 9 su* notice = ! prior fiscal ye> & ins]t+ ! base rev5ue am\nt = ! fiscal ye> det]m9$ "u subsection 7b77#a77;,b77ii72 & 7,b7 9 subp>agraph 7,c71 by /rik+ ,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv & ins]t+ ,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 & 7#b7 by /rik+ p>agraph 7#b7 & ins]t+ ! foll[+3 7#b7 ,capacity plann+ adju/m5t 7,a7 ,9 g5]al ,beg9n+ ) fiscal ye> #bjbd1 ! ,secret>y %all1 9 addition to ! adju/m5t "u p>agraph 7#a71 fur!r increase ! fee rev5ue & fees "u ?is section = a fiscal ye>1 9 accordance ) ?is p>agraph1 to reflect *anges 9 ! res\rce capacity ne$s ( ! ,secret>y = human g5]ic drug activities4 7,b7 ,capacity plann+ me?odology ,! ,secret>y %all e/abli% a capacity plann+ me?odology = purposes ( ?is p>agraph1 :i* %all-- 7i7 be d]iv$ f ! me?odology & recomm5dations made 9 ! report titl$ ,indep5d5t ,evaluation ( ! ,,gdufa ,res\rce ,capacity ,plann+ ,adju/m5t ,me?odology3 ,evaluation & ,recomm5dations z ann\nc$ 9 ! ,f$]al ,regi/] on ,augu/ #c1 #bjbj 7#he ,f$4 ,reg4 #dffeh72 & 7ii7 incorporate approa*es & attributes det]m9$ appropriate by ! ,secret>y1 includ+ ^? made 9 su* report recomm5dations1 except ! workload categories us$ 9 =eca/+ res\rces %all only be ^? specifi$ 9 section ,,viii4,b4#b4;e4 ( ! lett]s describ$ 9 section #cja7;b7 ( ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbb4 7,c7 ,limitations 7i7 ,9 g5]al ,"u no circum/ances %all an adju/m5t "u ?is p>agraph result 9 fee rev5ue = a fiscal ye> t is less ?an ! sum ( ! am\nts "u subsection 7b77#a77;,b77ii7 7! base rev5ue am\nt = ! fiscal ye>7 & p>agraph 7#a7 7! doll> am\nt ( ! inflation adju/m5t = ! fiscal ye>74 7ii7 ,additional limitation ,an adju/m5t "u ?is p>agraph %all n exce$ #c p]c5t ( ! sum describ$ 9 clause 7i7 = ! fiscal ye>1 except t su* limitation %all be #d p]c5t if-- 7,i7 = purposes ( an adju/m5t = fiscal ye> #bjbd1 ! ,secret>y det]m9es t1 dur+ ! p]iod f ,april #a1 #bjba1 ?r\gh ,m>* #ca1 #bjbc-- 7aa7 ! total numb] ( abbreviat$ new drug applications submitt$ 0 great] ?an or equal to #b1jjj2 or 7bb7 ?irty-five p]c5t or m ( abbreviat$ new drug applications submitt$ relat$ to complex products 7z t t]m is def9$ 9 section ,,xi ( ! lett]s describ$ 9 section #cja7;b7 ( ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbb72 7,,ii7 = purposes ( an adju/m5t = fiscal ye> #bjbe1 ! ,secret>y det]m9es t1 dur+ ! p]iod f ,april #a1 #bjbb1 ?r\gh ,m>* #ca1 #bjbd-- 7aa7 ! total numb] ( abbreviat$ new drug applications submitt$ 0 great] ?an or equal to #b1cjj2 or 7bb7 ?irty-five p]c5t or m ( abbreviat$ new drug applications submitt$ relat$ to complex products 7z s def9$72 7,,iii7 = purposes ( an adju/m5t = fiscal ye> #bjbf1 ! ,secret>y det]m9es t1 dur+ ! p]iod f ,april #a1 #bjbc1 ?r\gh ,m>* #ca1 #bjbe-- 7aa7 ! total numb] ( abbreviat$ new drug applications submitt$ 0 great] ?an or equal to #b1cjj2 or 7bb7 ?irty-five p]c5t or m ( abbreviat$ new drug applications submitt$ relat$ to complex products 7z s def9$72 & 7,,iv7 = purposes ( an adju/m5t = fiscal ye> #bjbg1 ! ,secret>y det]m9es t1 dur+ ! p]iod f ,april #a1 #bjbd1 ?r\gh ,m>* #ca1 #bjbf-- 7aa7 ! total numb] ( abbreviat$ new drug applications submitt$ 0 great] ?an or equal to #b1cjj2 or 7bb7 ?irty-five p]c5t or m ( abbreviat$ new drug applications submitt$ relat$ to complex products 7z s def9$74 7,d7 ,publication 9 f$]al regi/] ,! ,secret>y %all publi% 9 ! ,f$]al ,regi/] notice "u subsection 7a71 ! fee rev5ue & fees result+ f ! adju/m5t & ! me?odology "u ?is p>agraph4 7#c7 ,op]at+ res]ve adju/m5t 7,a7 ,9 g5]al ,= fiscal ye> #bjbd & subsequ5t fiscal ye>s1 ! ,secret>y may1 9 addition to adju/m5ts "u p>agraphs 7#a7 & 7#b71 fur!r increase ! fee rev5ue & fees "u ?is section if su* an adju/m5t is necess>y to provide op]at+ res]ves ( c>ryov] us] fees = human g5]ic drug activities = n m ?an ! numb] ( weeks specifi$ 9 subp>agraph 7,b74 7,b7 ,numb] ( weeks ,! numb] ( weeks specifi$ 9 ?is subp>agraph is-- 7i7 #h weeks = fiscal ye> #bjbd2 7ii7 #i weeks = fiscal ye> #bjbe2 & 7iii7 #aj weeks = ea* ( fiscal ye> #bjbf & #bjbg4 7,c7 ,decrease ,if ! ,secret>y has c>ryov] balances = human g5]ic drug activities 9 excess ( #ab weeks ( ! op]at+ res]ves ref]r$ to 9 subp>agraph 7,a71 ! ,secret>y %all decrease ! fee rev5ue & fees ref]r$ to 9 su* subp>agraph to provide = n m ?an #ab weeks ( su* op]at+ res]ves4 7,d7 ,rationale = adju/m5t ,if an adju/m5t "u ?is p>agraph is made1 ! rationale = ! am\nt ( ! increase or decrease 7z applicable7 9 fee rev5ue & fees %all be conta9$ 9 ! annual ,f$]al ,regi/] notice "u subsection 7a7 publi%+ ! fee rev5ue & fees = ! fiscal ye> involv$4 4 7d7 ,annual fee sett+ ,section #gdd;,b7d77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;d77#a77 is am5d$-- 7#a7 9 ! head+1 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 7#b7 by /rik+ m & ins]t+ lat]2 & 7#c7 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 7e7 ,effect ( failure ,to pay fees ,! head+ ( p>agraph 7#c7 ( section #gdd;,b7g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;g77 is am5d$ by /rik+ & prior approval supplem5t fee4 7f7 ,cr$it+ & availability ( fees ,section #gdd;,b7i77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;i77#c77 is am5d$ by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 #cjc4 ,reau?orization2 report+ requirem5ts ,section #gdd;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 by /rik+ #bjah ea* place x appe>s & ins]t+ #bjbc2 & 7,b7 by /rik+ ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjag ea* place x appe>s & ins]t+ ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbb2 7#b7 9 subsection 7b71 by /rik+ #bjah & ins]t+ #bjbc2 7#c7 9 subsection 7c7-- 7,a7 by /rik+ #bjah & ins]t+ #bjbc2 & 7,b7 by /rik+ ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjag ea* place x appe>s & ins]t+ ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbb2 & 7#d7 9 subsection 7f7-- 7,a7 9 p>agraph 7#a71 by /rik+ #bjbb & ins]t+ #bjbg2 & 7,b7 9 p>agraph 7#e71 by /rik+ ,janu>y #ae1 #bjbb & ins]t+ ,janu>y #ae1 #bjbg4 #cjd4 ,sunset dates 7a7 ,au?orization ,sections #gdd;,a & #gdd;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da2 #cgi;j-#db7 %all cease to be effective ,octob] #a1 #bjbg4 7b7 ,report+ requirem5ts ,section #gdd;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7 %all cease to be effective ,janu>y #ca1 #bjbh4 7c7 ,previ\s sunset provision ,effective ,octob] #a1 #bjbb1 subsections 7a7 & 7b7 ( section #cje ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 are repeal$4 #cje4 ,effective date ,! am5dm5ts made by ?is title %all take effect on ,octob] #a1 #bjbb1 or ! date ( ! enactm5t ( ?is ,act1 :i*ev] is lat]1 except t fees "u "p #g ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da et seq47 %all be assess$ = all abbreviat$ new drug applications receiv$ on or aft] ,octob] #a1 #bjbb1 reg>dless ( ! date ( ! enactm5t ( ?is ,act4 #cjf4 ,sav+s clause ,not)/&+ ! am5dm5ts made by ?is title1 "p #g ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is title1 %all cont9ue to be 9 effect ) respect to abbreviat$ new drug applications 7z def9$ 9 su* "p z ( su* day7 t 7 receiv$ by ! ,food & ,drug ,adm9i/ration )9 ! mean+ ( section #eje7;j77#e77;,a7 ( su* ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,a771 prior approval supplem5ts t 7 submitt$1 & drug ma/] files = ,type ,,ii active ph>maceutical +r$i5ts t 7 fir/ ref]5c$ on or aft] ,octob] #a1 #bjag1 b be=e ,octob] #a1 #bjbb1 ) respect to assess+ & collect+ any fee requir$ by su* "p = a fiscal ye> prior to fiscal ye> #bjbc4 ,,iv ,fees relat+ to biosimil> biological products #dja4 ,%ort title2 f9d+ 7a7 ,%ort title ,?is title may be cit$ z ! ,biosimil> ,us] ,fee ,am5dm5ts ( #bjbb4 7b7 ,f9d+ ,congress f9ds t ! fees au?oriz$ by ! am5dm5ts made 9 ?is title w be d$icat$ to exp$it+ ! process = ! review ( biosimil> biological product applications1 includ+ po/m>ket safety activities1 z set =? 9 ! goals id5tifi$ = purposes ( "p #h ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea et seq471 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #djb4 ,def9itions ,section #gdd;,g ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea7 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 by /rik+ ,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv & ins]t+ ,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 7,b7 by /rik+ ,octob] ( & ins]t+ ,septemb] (2 & 7,c7 by /rik+ ,octob] #bjaa & ins]t+ ,septemb] #bjaa2 & 7#b7 9 p>agraph 7#d77;,b77iii7-- 7,a7 by /rik+ subclause 7,,ii72 & 7,b7 by r$esignat+ subclauses 7,,iii7 & 7,,iv7 z subclauses 7,,ii7 & 7,,iii71 respectively4 #djc4 ,au?ority to assess & use biosimil> biological product fees 7a7 ,types ( fees ,section #gdd;,h7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77 is am5d$-- 7#a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ #bjah & ins]t+ #bjbc2 7#b7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 clause 7iv77,i71 by /rik+ #e days & ins]t+ #g days2 & 7ii7 9 clause 7v77,,ii71 by /rik+ #e days & ins]t+ #g days2 7,b7 9 subp>agraph 7,b7-- 7i7 9 clause 7i71 by ins]t+ 1 except t1 9 ! case t su* product 7includ+1 :]e applicable1 own]%ip ( ! relevant inve/igational new drug application7 is transf]r$ to a lic5see1 assignee1 or successor ( su* p]son1 & writt5 notice ( su* transf] is provid$ to ! ,secret>y1 su* lic5see1 assignee or successor %all pay ! annual biosimil> biological product developm5t fee be=e ! p]iod2 7ii7 9 clause 7iii7-- 7,i7 9 subclause 7,i71 by /rik+ 2 or & ins]t+ a semicolon2 7,,ii7 9 subclause 7,,ii71 by /rik+ ! p]iod & ins]t+ 2 or2 & 7,,iii7 by add+ at ! end ! foll[+3 7,,iii7 be5 adm9i/ratively remov$ f ! biosimil> biological product developm5t program = ! product "u subp>agraph 7,e77v74 2 & 7iii7 9 clause 7iv71 by /rik+ accept$ = fil+ on or aft] ,octob] #a ( su* fiscal ye> & ins]t+ subsequ5tly accept$ = fil+2 7,c7 9 subp>agraph 7,d7-- 7i7 9 clause 7i7-- 7,i7 9 ! matt] prec$+ subclause 7,i71 by /rik+ %all1 if ! p]son seeks to resume p>ticipation 9 su* program1 pay & ins]t+ or :o has be5 adm9i/ratively remov$ f su* program = a product "u subp>agraph 7,e77v7 %all1 if ! p]son seeks to resume p>ticipation 9 su* program1 pay all annual biosimil> biological product developm5t fees previ\sly assess$ = su* product & /ill ow$ &2 7,,ii7 9 subclause 7,i7-- 7aa7 by /rik+ #e days & ins]t+ #g days2 & 7bb7 by ins]t+ or ! date ( adm9i/rative removal1 z applicable aft] discont9u$2 & 7,,iii7 9 subclause 7,,ii71 by ins]t+ or ! date ( adm9i/rative removal1 z applicable aft] discont9u$2 & 7ii7 9 clause 7ii71 by ins]t+ 1 except t1 9 ! case t su* product 7includ+1 :]e applicable1 own]%ip ( ! relevant inve/igational new drug application7 is transf]r$ to a lic5see1 assignee1 or successor ( su* p]son1 & writt5 notice ( su* transf] is provid$ to ! ,secret>y1 su* lic5see1 assignee or successor %all pay ! annual biosimil> biological product developm5t fee be=e ! p]iod at ! end2 & 7,d7 9 subp>agraph 7,e71 by add+ at ! end ! foll[+3 7v7 ,adm9i/rative removal f ! biosimil> biological product developm5t program ,if a p]son has fail$ to pay an annual biosimil> biological product developm5t fee = a product z requir$ "u subp>agraph 7,b7 = a p]iod ( #b consecutive fiscal ye>s1 ! ,secret>y may adm9i/ratively remove su* p]son f ! biosimil> biological product developm5t program = ! product4 ,at lea/ #cj days prior to adm9i/ratively remov+ a p]son f ! biosimil> biological product developm5t program = a product "u ?is clause1 ! ,secret>y %all provide writt5 notice to su* p]son ( ! int5d$ adm9i/rative removal4 2 7#c7 9 p>agraph 7#b77;,d71 by ins]t+ prior to approval aft] )drawn2 7#d7 9 p>agraph 7#c7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 clause 7i71 by /rik+ 2 & & ins]t+ a semicolon2 7ii7 by r$esignat+ clause 7ii7 z clause 7iii72 & 7iii7 by ins]t+ ! foll[+ aft] clause 7i73 7ii7 may be disp5s$ only "u prescription pursuant to section #ejc7;b72 & 2 & 7,b7 by add+ at ! end ! foll[+3 7,e7 ,movem5t to discont9u$ li/ 7i7 ,writt5 reque/ to place on discont9u$ li/ 7,i7 ,9 g5]al ,if a writt5 reque/ to place a product on ! li/ ( discont9u$ biosimil> biological products ref]r$ to 9 subp>agraph 7,a77iii7 is submitt$ to ! ,secret>y on behalf ( an applicant1 & ! reque/ id5tifies ! date ! product is1 or w be1 )drawn f sale1 !n = purposes ( assess+ ! biosimil> biological product program fee1 ! ,secret>y %all consid] su* product to h be5 includ$ on su* li/ on ! lat] (-- 7aa7 ! date su* reque/ 0 receiv$2 or 7bb7 if ! product w be )drawn f sale on a future date1 su* future date :5 ! product is )drawn f sale4 7,,ii7 ,)drawn f sale def9$ ,= purposes ( ?is clause1 a product %all be consid]$ )drawn f sale once ! applicant has ceas$ its own di/ribution ( ! product1 :e!r or n ! applicant has ord]$ recall ( all previ\sly di/ribut$ lots ( ! product1 except t a r\t9e1 tempor>y int]ruption 9 supply %all n r5d] a product )drawn f sale4 7ii7 ,products remov$ f discont9u$ li/ ,if a biosimil> biological product t is id5tifi$ 9 a biosimil> biological product application approv$ z ( ,octob] #a ( a fiscal ye> appe>s1 z ( ,octob] #a ( su* fiscal ye>1 on ! li/ ( discont9u$ biosimil> biological products ref]r$ to 9 subp>agraph 7,a77iii71 & on any subsequ5t day dur+ su* fiscal ye> ! biosimil> biological product does n appe> on su* li/1 except z provid$ 9 subp>agraph 7,d71 ea* p]son :o is nam$ z ! applicant 9 ! biosimil> biological product application %all pay ! annual biosimil> biological product program fee e/abli%$ = a fiscal ye> "u subsection 7c77#e7 = su* biosimil> biological product4 ,not)/&+ subp>agraph 7,b71 su* fee %all be due on ! la/ bus9ess day ( su* fiscal ye> & %all be paid only once = ea* product = ea* fiscal ye>4 2 & 7#e7 by /rik+ p>agraph 7#d74 7b7 ,fee rev5ue am\nts ,section #gdd;,h7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 77#ba ,u4,s4,c4 #cgi;j-#eb7;b77 is am5d$-- 7#a7 by /rik+ p>agraph 7#a72 7#b7 by r$esignat+ p>agraphs 7#b7 ?r\gh 7#d7 z p>agraphs 7#a7 ?r\gh 7#c71 respectively2 7#c7 9 p>agraph 7#a71 z s r$esignat$-- 7,a7 9 ! p>agraph head+1 by /rik+ ,subsequ5t fiscal ye>s & ins]t+ ,9 g5]al2 7,b7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ #bjai ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 7,c7 9 subp>agraph 7,a71 by /rik+ p>agraph 7#d7 & ins]t+ p>agraph 7#c72 7,d7 by r$esignat+ subp>agraphs 7,c7 & 7,d7 z subp>agraphs 7,d7 & 7,e71 respectively2 7,e7 by ins]t+ aft] subp>agraph 7,b7 ! foll[+3 7,c7 ! doll> am\nt equal to ! /rategic hir+ & ret5tion adju/m5t 7z det]m9$ "u subsection 7c77#b772 2 7,f7 9 subp>agraph 7,d71 z s r$esignat$1 by /rik+ subsection 7c77#b772 & & ins]t+ subsection 7c77#c7722 7,g7 9 subp>agraph 7,e71 z s r$esignat$1 by /rik+ subsection 7c77#c774 & ins]t+ subsection 7c77#d772 &2 & 7,h7 by add+ at ! end ! foll[+3 7,f7 = fiscal ye>s #bjbc & #bjbd1 additional doll> am\nts equal to-- 7i7 #d1dbh1hhf = fiscal ye> #bjbc2 & 7ii7 #cbj1efi = fiscal ye> #bjbd4 2 7#d7 9 p>agraph 7#b71 z s r$esignat$-- 7,a7 9 ! p>agraph head+1 by /rik+ 2 limitations on fee am\nts2 7,b7 by /rik+ subp>agraph 7,b72 & 7,c7 by r$esignat+ subap>agraphs 7,c7 & 7,d7 z subp>agraphs 7,b7 & 7,c71 respectively2 & 7#e7 by am5d+ p>agraph 7#c71 z s r$esignat$1 to read z foll[s3 7#c7 ,annual base rev5ue ,= purposes ( p>agraph 7#a71 ! doll> am\nt ( ! annual base rev5ue = a fiscal ye> %all be-- 7,a7 = fiscal ye> #bjbc1 #dc1cgf1ibb2 & 7,b7 = fiscal ye>s #bjbd ?r\gh #bjbg1 ! doll> am\nt ( ! total rev5ue am\nt e/abli%$ "u p>agraph 7#a7 = ! previ\s fiscal ye>1 exclud+ any adju/m5ts to su* rev5ue am\nt "u subsection 7c77#d74 4 7c7 ,adju/m5ts2 annual fee sett+ ,section #gdd;,h7c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 77#ba ,u4,s4,c4 #cgi;j-#eb7;c77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! matt] prec$+ clause 7i71 by /rik+ subsection 7b77#b77;,b7 & ins]t+ subsection 7b77#a77;,b72 & 7ii7 9 clause 7i71 by /rik+ subsection 7b7 & ins]t+ subsection 7b77#a77;,a72 & 7,b7 9 subp>agraph 7,b77ii71 by /rik+ ,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv & ins]t+ ,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 7#b7 by /rik+ p>agraph 7#d72 7#c7 by r$esignat+ p>agraphs 7#b7 & 7#c7 z p>agraphs 7#c7 & 7#d71 respectively2 7#d7 by ins]t+ aft] p>agraph 7#a7 ! foll[+3 7#b7 ,/rategic hir+ & ret5tion adju/m5t ,= ea* fiscal ye> beg9n+ 9 fiscal ye> #bjbc1 aft] ! annual base rev5ue "u subsection 7b77#a77;,a7 is adju/$ = inflation 9 accordance ) p>agraph 7#a71 ! ,secret>y %all fur!r increase ! fee rev5ue & fees by #aej1jjj4 2 7#e7 9 p>agraph 7#c71 z s r$esignat$-- 7,a7 9 subp>agraph 7,a7-- 7i7 by /rik+ ,beg9n+ ) ! fiscal ye> describ$ 9 subp>agraph 7,b77ii77,,ii7 & ins]t+ ,= ea* fiscal ye>2 & 7ii7 by /rik+ adju/m5t "u p>agraph 7#a71 fur!r increase & ins]t+ adju/m5ts "u p>agraphs 7#a7 & 7#b71 fur!r adju/2 7,b7 by am5d+ subp>agraph 7,b7 to read z foll[s3 7,b7 ,me?odology ,= purposes ( ?is p>agraph1 ! ,secret>y %all employ ! capacity plann+ me?odology utiliz$ by ! ,secret>y 9 sett+ fees = fiscal ye> #bjba1 z describ$ 9 ! notice titl$ ,biosimil> ,us] ,fee ,rates = ,fiscal ,ye> #bjba 7#he ,f$4 ,reg4 #dgbbj2 ,augu/ #d1 #bjbj74 ,! workload categories us$ 9 =eca/+ %all include only ! activities describ$ 9 su* notice &1 z feasible1 additional activities t are also directly relat$ to ! direct review ( biosimil> biological product applications & supplem5ts1 includ+ additional =mal meet+ types & ! direct review ( po/m>ket+ commitm5ts & requirem5ts1 ! direct review ( risk evaluation & mitigation /rategies1 & ! direct review ( annual reports = approv$ biosimil> biological products4 ,subject to ! exceptions 9 ! prec$+ s5t5ce1 ! ,secret>y %all n include z workload categories 9 =eca/+ any non-core review activities1 includ+ any activities t ! ,secret>y ref]5c$ = pot5tial future use 9 su* notice b did n utilize 9 sett+ fees = fiscal ye> #bjba4 2 & 7,c7 9 subp>agraph 7,c7-- 7i7 by /rik+ subsections 7b77#b77;,a7 & ins]t+ subsections 7b77#a77;,a72 7ii7 by /rik+ & 7b77#b77;,b7 & ins]t+ 1 7b77#a77;,b72 & 7iii7 by ins]t+ 1 & 7b77#a77;,c7 7! doll> am\nt ( ! /rategic hir+ & ret5tion adju/m5t7 be=e ! p]iod at ! end2 7#f7 by am5d+ p>agraph 7#d71 z s r$esignat$1 to read z foll[s3 7#d7 ,op]at+ res]ve adju/m5t 7,a7 ,increase ,= fiscal ye> #bjbc & subsequ5t fiscal ye>s1 ! ,secret>y %all1 9 addition to adju/m5ts "u p>agraphs 7#a71 7#b71 & 7#c71 fur!r increase ! fee rev5ue & fees if su* an adju/m5t is necess>y to provide = at lea/ #aj weeks ( op]at+ res]ves ( c>ryov] us] fees = ! process = ! review ( biosimil> biological product applications4 7,b7 ,decrease 7i7 ,fiscal ye> #bjbc ,= fiscal ye> #bjbc1 if ! ,secret>y has c>ryov] balances = ! process = ! review ( biosimil> biological product applications 9 excess ( #cc weeks ( su* op]at+ res]ves1 ! ,secret>y %all decrease su* fee rev5ue & fees to provide = n m ?an #cc weeks ( su* op]at+ res]ves4 7ii7 ,fiscal ye> #bjbd ,= fiscal ye> #bjbd1 if ! ,secret>y has c>ryov] balances = ! process = ! review ( biosimil> biological product applications 9 excess ( #bg weeks ( su* op]at+ res]ves1 ! ,secret>y %all decrease su* fee rev5ue & fees to provide = n m ?an #bg weeks ( su* op]at+ res]ves4 7iii7 ,fiscal ye> #bjbe & subsequ5t fiscal ye>s ,= fiscal ye> #bjbe & subsequ5t fiscal ye>s1 if ! ,secret>y has c>ryov] balances = ! process = ! review ( biosimil> biological product applications 9 excess ( #ba weeks ( su* op]at+ res]ves1 ! ,secret>y %all decrease su* fee rev5ue & fees to provide = n m ?an #ba weeks ( su* op]at+ res]ves4 7,c7 ,f$]al regi/] notice ,if an adju/m5t "u subp>agraph 7,a7 or 7,b7 is made1 ! rationale = ! am\nt ( ! increase or decrease 7z applicable7 9 fee rev5ue & fees %all be conta9$ 9 ! annual ,f$]al ,regi/] notice "u p>agraph 7#e77;,b7 e/abli%+ fee rev5ue & fees = ! fiscal ye> involv$4 2 & 7#g7 9 p>agraph 7#e71 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ #bjah & ins]t+ #bjbc4 7d7 ,cr$it+ & availability ( fees ,section #gdd;,h7f77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 77#ba ,u4,s4,c4 #cgi;j-#eb7;f77#c77 is am5d$ by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 7e7 ,writt5 reque/s = waiv]s & refunds ,subsection 7h7 ( section #gdd;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7 is am5d$ to read z foll[s3 7h7 ,writt5 reque/s = waiv]s & returns2 disputes conc]n+ fees ,to qualify = consid]ation = a waiv] "u subsection 7d71 or ! return ( any fee paid "u ?is section1 includ+ if ! fee is claim$ to h be5 paid 9 error1 a p]son %all submit to ! ,secret>y a writt5 reque/ ju/ify+ su* waiv] or return &1 except z o!rwise specifi$ 9 ?is section1 su* writt5 reque/ %all be submitt$ to ! ,secret>y n lat] ?an #ahj days aft] su* fee is due4 ,a reque/ submitt$ "u ?is p>agraph %all include any legal au?orities "u :i* ! reque/ is made4 4 #djd4 ,reau?orization2 report+ requirem5ts ,section #gdd;,i ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7 is am5d$-- 7#a7 by /rik+ #bjah ea* place x appe>s & ins]t+ #bjbc2 7#b7 by /rik+ ,biosimil> ,us] ,fee ,am5dm5ts ( #bjag ea* place x appe>s & ins]t+ ,biosimil> ,us] ,fee ,am5dm5ts ( #bjbb2 7#c7 9 subsection 7a77#d71 by /rik+ #bjbj & ins]t+ #bjbc2 & 7#d7 9 subsection 7f71 by /rik+ #bjbb ea* place x appe>s & ins]t+ #bjbg4 #dje4 ,sunset dates 7a7 ,au?orization ,sections #gdd;,g & #gdd;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea1 #cgi;j-#eb7 %all cease to be effective ,octob] #a1 #bjbg4 7b7 ,report+ requirem5ts ,section #gdd;,i ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7 %all cease to be effective ,janu>y #ca1 #bjbh4 7c7 ,previ\s sunset provision ,effective ,octob] #a1 #bjbb1 subsections 7a7 & 7b7 ( section #dje ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 are repeal$4 #djf4 ,effective date ,! am5dm5ts made by ?is title %all take effect on ,octob] #a1 #bjbb1 or ! date ( ! enactm5t ( ?is ,act1 :i*ev] is lat]1 except t fees "u "p #h ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea et seq47 %all be assess$ = all biosimil> biological product applications receiv$ on or aft] ,octob] #a1 #bjbb1 reg>dless ( ! date ( ! enactm5t ( ?is ,act4 #djg4 ,sav+s clause ,not)/&+ ! am5dm5ts made by ?is title1 "p #h ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea et seq471 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is title1 %all cont9ue to be 9 effect ) respect to biosimil> biological product applications & supplem5ts 7z def9$ 9 su* "p z ( su* day7 t 7 accept$ by ! ,food & ,drug ,adm9i/ration = fil+ on or aft] ,octob] #a1 #bjag1 b be=e ,octob] #a1 #bjbb1 ) respect to assess+ & collect+ any fee requir$ by su* "p = a fiscal ye> prior to fiscal ye> #bjbc4 ,v ,o!r reau?orizations #eja4 ,reau?orization ( ! critical pa? public-private p>tn]%ip ,section #eff7;f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#e7;f77 is am5d$ by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 #ejb4 ,reau?orization ( ! be/ ph>maceuticals = *ildr5 program ,section #dji;,i7d77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhdm7d77#a77 is am5d$ by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 #ejc4 ,reau?orization ( ! humanit>ian device exemption inc5tive ,section #ebj7m77#f77;,a77iv7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7m77#f77;,a77iv77 is am5d$ by /rik+ #bjbb & ins]t+ #bjbg4 #ejd4 ,reau?orization ( ! p$iatric device consortia program ,section #cje7;e7 ( ! ,food & ,drug ,adm9i/ration ,am5dm5ts ,act ( #bjjg 7,public ,law #aaj-he2 #db ,u4,s4,c4 #bhb note7 is am5d$ by /rik+ #e1bej1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ #g1jjj1jjj = ea* ( fiscal ye>s #bjbc ?r\gh #bjbg4 #eje4 ,reau?orization ( provision p]ta9+ to 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+ ,octob] #a1 #bjbb & ins]t+ ,octob] #a1 #bjbg4 #ejf4 ,reau?orization ( orphan drug grants ,section #e7;c7 ( ! ,orphan ,drug ,act 7#ba ,u4,s4,c4 #cfj;ee7c77 is am5d$ by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 #ejg4 ,reau?orization ( c]ta9 device inspections ,section #gjd7;g77#aa7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;g77#aa77 is am5d$ by /rik+ #bjbb & ins]t+ #bjbg4