,,ii ,cal5d> ,no4 #agd #aae? ,,congress #a/ ,session ,h4 ,r4 #bdcj ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,july #ac1 #bjag,receiv$2 read ! fir/ "t ,july #ag1 #bjag,read ! second "t & plac$ on ! cal5d> ,,an ,,act ,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 ! ,,fda ,reau?orization ,act ( #bjag4 #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 ,au?ority to assess & use drug fees4 ,sec4 #ajc4 ,reau?orization2 report+ requirem5ts4 ,sec4 #ajd4 ,sunset dates4 ,sec4 #aje4 ,effective date4 ,sec4 #ajf4 ,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 ( review4 ,sec4 #bjg4 ,electronic =mat = submissions4 ,sec4 #bjh4 ,sav+s clause4 ,sec4 #bji4 ,effective date4 ,sec4 #baj4 ,sunset dates4 ,title ,,iii--,fees relat+ to g5]ic drugs ,sec4 #cja4 ,%ort title2 f9d+4 ,sec4 #cjb4 ,def9itions4 ,sec4 #cjc4 ,au?ority to assess & use human g5]ic drug fees4 ,sec4 #cjd4 ,reau?orization2 report+ requirem5ts4 ,sec4 #cje4 ,sunset dates4 ,sec4 #cjf4 ,effective date4 ,sec4 #cjg4 ,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--,p$iatric drugs & devices ,sec4 #eja4 ,be/ ph>maceuticals = *ildr54 ,sec4 #ejb4 ,p$iatric devices4 ,sec4 #ejc4 ,e>ly meet+ on p$iatric /udy plan4 ,sec4 #ejd4 ,developm5t ( drugs & biological products = p$iatric canc]s4 ,sec4 #eje4 ,additional provisions on developm5t ( drugs & biological products = p$iatric use4 ,title ,,vi--,reau?orizations & improvem5ts relat$ to drugs ,sec4 #fja4 ,reau?orization ( provision relat+ to exclusivity ( c]ta9 drugs conta9+ s+le enantiom]s4 ,sec4 #fjb4 ,reau?orization ( ! critical pa? public-private p>tn]%ips4 ,sec4 #fjc4 ,reau?orization ( orphan grants program4 ,sec4 #fjd4 ,protect+ & /r5g!n+ ! drug supply *a94 ,sec4 #fje4 ,pati5t exp]i5ce data4 ,sec4 #fjf4 ,communication plans4 ,sec4 #fjg4 ,orphan drugs4 ,sec4 #fjh4 ,p$iatric in=mation add$ to label+4 ,sec4 #fji4 ,s5se ( ,congress on l[]+ ! co/ ( prescription drugs4 ,sec4 #faj4 ,exp&$ access4 ,sec4 #faa4 ,tropical disease product application4 ,title ,,vii--,device inspection & regulatory improvem5ts ,sec4 #gja4 ,risk-bas$ inspections = devices4 ,sec4 #gjb4 ,improvem5ts to inspections process = device e/abli%m5ts4 ,sec4 #gjc4 ,reau?orization ( inspection program4 ,sec4 #gjd4 ,c]tificates to =eign gov]nm5ts = devices4 ,sec4 #gje4 ,facilitat+ int]national h>monization4 ,sec4 #gjf4 ,fo/]+ innovation 9 m$ical imag+4 ,sec4 #gjg4 ,risk-bas$ classification ( accessories4 ,sec4 #gjh4 ,device pilot projects4 ,sec4 #gji4 ,regulation ( ov]-!-c\nt] he>+ aids4 ,sec4 #gaj4 ,report on s]vic+ ( devices4 ,title ,,viii--,improv+ g5]ic drug access ,sec4 #hja4 ,priority review ( g5]ic drugs4 ,sec4 #hjb4 ,enhanc+ regulatory transp>5cy to enhance g5]ic competition4 ,sec4 #hjc4 ,competitive g5]ic !rapies4 ,sec4 #hjd4 ,accurate in=mation ab\t drugs ) limit$ competition4 ,sec4 #hje4 ,suitability petitions4 ,sec4 #hjf4 ,inspections4 ,sec4 #hjg4 ,report+ on p5d+ g5]ic drug applications & priority review applications4 ,sec4 #hjh4 ,inc5tiviz+ competitive g5]ic drug developm5t4 ,sec4 #hji4 ,,gao /udy ( issues reg>d+ fir/ cycle approvals ( g5]ic m$ic9es4 ,title ,,ix--,additional provisions ,sec4 #ija4 ,te*nical corrections4 ,sec4 #ijb4 ,annual report on inspections4 ,sec4 #ijc4 ,/reaml9+ & improv+ consi/5cy 9 p]=mance report+4 ,sec4 #ijd4 ,analysis ( use ( funds4 ,sec4 #ije4 ,facilities managem5t4 ,i ,fees relat+ to drugs #aja4 ,%ort title2 f9d+ 7a7 ,%ort ,title ,?is title may be cit$ z ! ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjag4 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$]al ,food1 ,drug1 & ,cosmetic ,act1 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #ajb4 ,au?ority to assess & use drug fees 7a7 ,types ( fees 7#a7 ,9 g5]al ,section #gcf7;a7 ( ! ,f$]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> #bjac & ins]t+ fiscal ye> #bjah2 7,b7 9 ! head+ ( p>agraph 7#a71 by /rik+ & supplem5t2 7,c7 9 p>agraph 7#a71 by /rik+ or a supplem5t & or supplem5t ea* place ei!r appe>s2 7,d7 9 p>agraph 7#a77;,a7-- 7i7 9 clause 7i71 by /rik+ 7c77#d7 & ins]t+ 7c77#e72 & 7ii7 9 clause 7ii71 by /rik+ ,a fee e/abli%$ & all t foll[s ?r\gh are requir$4 & ins]t+ ! foll[+3 ,a fee e/abli%$ "u subsection 7c77#e7 = a human drug application = :i* cl9ical data 7o!r ?an bioavailability or bioequival5ce /udies7 ) respect to safety or effectiv5ess are n requir$ = approval42 7,e7 9 ! head+ ( p>agraph 7#a77;,c71 by /rik+ or supplem5t2 7,f7 9 p>agraph 7#a77;,f7-- 7i7 9 ! head+1 by /rik+ or indication2 & 7ii7 by /rik+ ! second s5t5ce2 7,g7 by /rik+ p>agraph 7#b7 7relat+ to a prescription drug e/abli%m5t fee72 7,h7 by r$esignat+ p>agraph 7#c7 z p>agraph 7#b72 7,i7 9 ! head+ ( p>agraph 7#b71 z s r$esignat$1 by /rik+ ,prescription drug product fee & ins]t+ ,prescription drug program fee2 7,j7 9 subp>agraph 7,a7 ( su* p>agraph 7#b71 by am5d+ ! fir/ s5t5ce to read z foll[s3 ,except z provid$ 9 subp>agraphs 7,b7 & 7,c71 ea* p]son :o is nam$ z ! applicant 9 a human drug application1 & :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#e7 = ea* prescription drug product t is id5tifi$ 9 su* a human drug application approv$ z ( ,octob] #a ( su* fiscal ye>4 2 7,k7 9 subp>agraph 7,b7 ( su* p>agraph 7#b7-- 7i7 9 ! head+ ( subp>agraph 7,b71 by ins]t+ aft] ,exception ! foll[+3 = c]ta9 prescription drug products2 & 7ii7 by /rik+ ,a prescription drug product %all n be assess$ a fee & ins]t+ ,a prescription drug program fee %all n be assess$ = a prescription drug product2 & 7,l7 by add+ at ! end ( su* p>agraph 7#b7 ! foll[+3 7,c7 ,limitation ,a p]son :o is nam$ z ! applicant 9 an approv$ human drug application %all n be assess$ m ?an #e prescription drug program fees = a fiscal ye> = prescription drug products id5tifi$ 9 su* approv$ human drug application4 4 7#b7 ,con=m+ am5dm5t ,subp>agraph 7,c7 ( section #gdj7;a77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7;a77#c77 is am5d$ to read z foll[s3 7,c7 ,limitation ,an e/abli%m5t %all be assess$ only "o fee p] fiscal ye> "u ?is section4 4 7b7 ,fee rev5ue am\nts ,subsection 7b7 ( section #gcf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7 is am5d$ to read z foll[s3 7b7 ,fee rev5ue am\nts 7#a7 ,9 g5]al ,= ea* ( ! fiscal ye>s #bjah ?r\gh #bjbb1 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 ! capacity plann+ adju/m5t = ! fiscal ye> 7z det]m9$ "u subsection 7c77#b772 7,d7 ! doll> am\nt equal to ! op]at+ res]ve adju/m5t = ! fiscal ye>1 if applicable 7z det]m9$ "u subsection 7c77#c772 7,e7 ! doll> am\nt equal to ! additional direct co/ adju/m5t = ! fiscal ye> 7z det]m9$ "u subsection 7c77#d772 & 7,f7 additional doll> am\nts = ea* fiscal ye> z foll[s3 7i7 #bj1jgg1gic = fiscal ye> #bjah4 7ii7 #ba1cag1dgb = fiscal ye> #bjai4 7iii7 #af1iec1cbi = fiscal ye> #bjbj4 7iv7 #e1dbf1hif = fiscal ye> #bjba4 7v7 #b1gfi1fji = fiscal ye> #bjbb4 7#b7 ,types ( fees ,( ! total rev5ue am\nt det]m9$ = a fiscal ye> "u p>agraph 7#a7-- 7,a7 #bj p]c5t %all be d]iv$ f human drug application fees "u subsection 7a77#a72 & 7,b7 #hj p]c5t %all be d]iv$ f prescription drug program fees "u subsection 7a77#b74 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> #bjah1 #hgh1eij1jjj2 & 7,b7 = fiscal ye>s #bjai ?r\gh #bjbb1 ! 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#c7 or 7c77#d74 4 7c7 ,adju/m5ts2 annual fee sett+ ,subsection 7c7 ( section #gcf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7 is am5d$ to read z foll[s3 7c7 ,adju/m5ts2 annual fee sett+ 7#a7 ,inflation adju/m5t 7,a7 ,9 g5]al ,= purposes ( subsection 7b77#a77;,b71 ! doll> am\nt ( ! inflation adju/m5t to ! annual base rev5ue = ea* fiscal ye> %all be equal to ! product (-- 7i7 su* annual base rev5ue = ! fiscal ye> "u subsection 7b77#a77;,a72 & 7ii7 ! inflation adju/m5t p]c5tage "u subp>agraph 7,b74 7,b7 ,inflation adju/m5t p]c5tage ,! inflation adju/m5t p]c5tage "u ?is subp>agraph = a fiscal ye> is equal to ! sum (-- 7i7 ! av]age annual p]c5t *ange 9 ! co/1 p] full-"t equival5t position ( ! ,food & ,drug ,adm9i/ration1 ( all p]sonnel comp5sation & b5efits paid ) respect to su* positions = ! fir/ #c ye>s ( ! prec$+ #d fiscal ye>s1 multipli$ by ! proportion ( p]sonnel comp5sation & b5efits co/s to total co/s ( ! process = ! review ( human drug applications 7z def9$ 9 section #gce7f77 = ! fir/ #c ye>s ( ! prec$+ #d fiscal ye>s2 & 7ii7 ! av]age annual p]c5t *ange t occurr$ 9 ! ,consum] ,price ,index = urban consum]s 7,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,n ,seasonally ,adju/$2 ,all items2 ,annual ,index7 = ! fir/ #c ye>s ( ! prec$+ #d ye>s ( available data multipli$ by ! proportion ( all co/s o!r ?an p]sonnel comp5sation & b5efits co/s to total co/s ( ! process = ! review ( human drug applications 7z def9$ 9 section #gce7f77 = ! fir/ #c ye>s ( ! prec$+ #d fiscal ye>s4 7#b7 ,capacity plann+ adju/m5t 7,a7 ,9 g5]al ,= ea* fiscal ye>1 aft] ! annual base rev5ue e/abli%$ 9 subsection 7b77#a77;,a7 is adju/$ = inflation 9 accordance ) p>agraph 7#a71 su* rev5ue %all be adju/$ fur!r = su* fiscal ye>1 9 accordance ) ?is p>agraph1 to reflect *anges 9 ! res\rce capacity ne$s ( ! ,secret>y = ! process = ! review ( human drug applications4 7,b7 ,int]im me?odology 7i7 ,9 g5]al ,until ! capacity plann+ me?odology describ$ 9 subp>agraph 7,c7 is effective1 ! adju/m5t "u ?is p>agraph = a fiscal ye> %all be bas$ on ! product (-- 7,i7 ! annual base rev5ue = su* ye>1 z adju/$ = inflation "u p>agraph 7#a72 & 7,,ii7 ! adju/m5t p]c5tage "u clause 7ii74 7ii7 ,adju/m5t p]c5tage ,! adju/m5t p]c5tage "u ?is clause = a fiscal ye> is ! weight$ *ange 9 ! #c-ye> av]age end+ 9 ! mo/ rec5t ye> = :i* data are available1 ov] ! #c-ye> av]age end+ 9 ! previ\s ye>1 =-- 7,i7 ! total numb] ( human drug applications1 efficacy supplem5ts1 & manufactur+ supplem5ts submitt$ to ! ,secret>y2 7,,ii7 ! total numb] ( active comm]cial inve/igational new drug applications2 & 7,,iii7 ! total numb] ( =mal meet+s s*$ul$ by ! ,secret>y1 & writt5 responses issu$ by ! ,secret>y 9 lieu ( su* =mal meet+s1 z id5tifi$ 9 section ,i4,h ( ! lett]s describ$ 9 section #aja7;b7 ( ! ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjag4 7,c7 ,capacity plann+ me?odology 7i7 ,developm5t2 evaluation & report ,! ,secret>y %all obta91 ?r\gh a contract ) an indep5d5t acc\nt+ or consult+ firm1 a report evaluat+ options & recomm5dations = a new me?odology to accurately assess *anges 9 ! res\rce & capacity ne$s ( ! process = ! review ( human drug applications4 ,! capacity plann+ me?odological options & recomm5dations pres5t$ 9 su* report %all utilize & be in=m$ by p]sonnel "t report+ data z an input4 ,! report %all be publi%$ = public comm5t no lat] ?an ! end ( fiscal ye> #bjbj4 7ii7 ,e/abli%m5t & implem5tation ,aft] review ( ! report describ$ 9 clause 7i7 & any public comm5ts !reon1 ! ,secret>y %all e/abli% a capacity plann+ me?odology = purposes ( ?is p>agraph1 :i* %all-- 7,i7 replace ! int]im me?odology "u subp>agraph 7,b72 7,,ii7 incorporate su* approa*es & attributes z ! ,secret>y det]m9es appropriate2 & 7,,iii7 be effective beg9n+ ) ! fir/ fiscal ye> = :i* fees are set aft] su* capacity plann+ me?odology is e/abli%$4 7,d7 ,limitation ,"u no circum/ances %all an adju/m5t "u ?is p>agraph result 9 fee rev5ue = a fiscal ye> t is less ?an ! sum ( ! am\nts "u subsections 7b77#a77;,a7 7! annual base rev5ue = ! fiscal ye>7 & 7b77#a77;,b7 7! doll> am\nt ( ! inflation adju/m5t = ! fiscal ye>74 7,e7 ,publication 9 f$]al regi/] ,! ,secret>y %all publi% 9 ! ,f$]al ,regi/] notice "u p>agraph 7#e7 ( ! fee rev5ue & fees result+ f ! adju/m5t & ! me?odologies "u ?is p>agraph4 7#c7 ,op]at+ res]ve adju/m5t 7,a7 ,increase ,= fiscal ye> #bjah & subsequ5t fiscal ye>s1 ! ,secret>y may1 9 addition to adju/m5ts "u p>agraphs 7#a7 & 7#b71 fur!r increase ! fee rev5ue & fees if su* an adju/m5t is necess>y to provide = n m ?an #ad weeks ( op]at+ res]ves ( c>ryov] us] fees = ! process = ! review ( human drug applications4 7,b7 ,decrease ,if ! ,secret>y has c>ryov] balances = su* process 9 excess ( #ad weeks ( su* op]at+ res]ves1 ! ,secret>y %all decrease su* fee rev5ue & fees to provide = n m ?an #ad weeks ( su* op]at+ res]ves4 7,c7 ,notice ( rationale ,if an adju/m5t "u subp>agraph 7,a7 or 7,b7 is made1 ! rationale = ! am\nt ( ! increase or decrease 7z applicable7 9 fee rev5ue & fees %all be conta9$ 9 ! annual ,f$]al ,regi/] notice "u p>agraph 7#e7 e/abli%+ fee rev5ue & fees = ! fiscal ye> involv$4 7#d7 ,additional direct co/ adju/m5t 7,a7 ,9 g5]al ,! ,secret>y %all1 9 addition to adju/m5ts "u p>agraphs 7#a71 7#b71 & 7#c71 fur!r increase ! fee rev5ue & fees-- 7i7 = fiscal ye> #bjah1 by #h1gcj1jjj2 & 7ii7 = fiscal ye> #bjai & subsequ5t fiscal ye>s1 by ! am\nt det]m9$ "u subp>agraph 7,b74 7,b7 ,am\nt ,! am\nt det]m9$ "u ?is subp>agraph is-- 7i7 #h1gcj1jjj1 multipli$ by 7ii7 ! ,consum] ,price ,index = urban consum]s 7,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,n ,seasonally ,adju/$2 ,all ,items2 ,annual ,index7 = ! mo/ rec5t ye> ( available data1 divid$ by su* ,index = #bjaf4 7#e7 ,annual fee sett+ ,! ,secret>y %all1 n lat] ?an #fj days be=e ! />t ( ea* fiscal ye> t beg9s aft] ,septemb] #cj1 #bjag-- 7,a7 e/abli%1 = ea* su* fiscal ye>1 human drug application fees & prescription drug program fees "u subsection 7a71 bas$ on ! rev5ue am\nts e/abli%$ "u subsection 7b7 & ! adju/m5ts provid$ "u ?is subsection2 & 7,b7 publi% su* fee rev5ue & fees 9 ! ,f$]al ,regi/]4 7#f7 ,limit ,! total am\nt ( fees *>g$1 z adju/$ "u ?is subsection1 = a fiscal ye> may n exce$ ! total co/s = su* fiscal ye> = ! res\rces allocat$ = ! process = ! review ( human drug applications4 4 7d7 ,fee waiv] or r$uction ,section #gcf7;d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7d77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 by ins]t+ or at ! end ( subp>agraph 7,b72 7,b7 by /rik+ subp>agraph 7,c72 & 7,c7 by r$esignat+ subp>agraph 7,d7 z subp>agraph 7,c72 7#b7 by /rik+ p>agraph 7#c7 7relat+ to use ( /&>d co/s72 7#c7 by r$esignat+ p>agraph 7#d7 z p>agraph 7#c72 & 7#d7 9 p>agraph 7#c71 z s r$esignat$-- 7,a7 9 subp>agraphs 7,a7 & 7,b71 by /rik+ p>agraph 7#a77;,d7 & ins]t+ p>agraph 7#a77;,c72 & 7,b7 9 subp>agraph 7,b7-- 7i7 by /rik+ clause 7ii72 7ii7 by /rik+ %all pay ?r\gh 7i7 application fees & ins]t+ %all pay application fees2 & 7iii7 by /rik+ 2 & at ! end & ins]t+ a p]iod4 7e7 ,effect ( failure ,to pay fees ,section #gcf7;e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7e77 is am5d$ by /rik+ all fees & ins]t+ all su* fees4 7f7 ,limitations ,section #gcf7;f77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7f77#b77 is am5d$ by /rik+ supplem5ts1 prescription drug e/abli%m5ts1 & prescription drug products & ins]t+ prescription drug program fees4 7g7 ,cr$it+ & availability ( fees ,section #gcf7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7g77 is am5d$-- 7#a7 9 p>agraph 7#c7-- 7,a7 by /rik+ #bjac ?r\gh #bjag & ins]t+ #bjah ?r\gh #bjbb2 & 7,b7 by /rik+ & p>agraph 7#d7 ( ?is subsection2 & 7#b7 by /rik+ p>agraph 7#d74 7h7 ,orphan drugs ,section #gcf7k7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7k77 is am5d$ by /rik+ product & e/abli%m5t fees ea* place x appe>s & ins]t+ prescription drug program fees4 #ajc4 ,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#a7-- 7,a7 9 ! matt] be=e subp>agraph 7,a71 by /rik+ #bjac & ins]t+ #bjah2 & 7,b7 9 subp>agraph 7,a71 by /rik+ ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjab & ins]t+ ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjag2 7#b7 9 subsection 7b71 by /rik+ #bjac & ins]t+ #bjah2 & 7#c7 9 subsection 7d71 by /rik+ #bjag ea* place x appe>s & ins]t+ #bjbb4 #ajd4 ,sunset dates 7a7 ,au?orization ,sections #gce & #gcf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g2 #cgi;h7 %all cease to be effective ,octob] #a1 #bjbb4 7b7 ,report+ ,requirem5ts ,section #gcf;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7 %all cease to be effective ,janu>y #ca1 #bjbc4 7c7 ,previ\s ,sunset ,provision ,effective ,octob] #a1 #bjag1 subsections 7a7 & 7b7 ( section #aje ( ! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act 7,public ,law #aab-add7 are repeal$4 #aje4 ,effective date ,! am5dm5ts made by ?is title %all take effect on ,octob] #a1 #bjag1 or ! date ( ! enactm5t ( ?is ,act1 :i*ev] is lat]1 except t fees "u "p #b ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act %all be assess$ = all human drug applications receiv$ on or aft] ,octob] #a1 #bjag1 reg>dless ( ! date ( ! enactm5t ( ?is ,act4 #ajf4 ,sav+s clause ,not)/&+ ! am5dm5ts made by ?is title1 "p #b ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is title1 %all cont9ue to be 9 effect ) respect to human drug applications & supplem5ts 7z def9$ 9 su* "p z ( su* day7 t on or aft] ,octob] #a1 #bjab1 b be=e ,octob] #a1 #bjag1 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> #bjah4 ,,ii ,fees relat+ to devices #bja4 ,%ort title2 f9d+ 7a7 ,%ort ,title ,?is title may be cit$ z ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjag4 7b7 ,f9d+ ,! ,congress f9ds t ! fees au?oriz$ "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$]al ,food1 ,drug1 & ,cosmetic ,act 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #bjb4 ,def9itions 7a7 ,9 g5]al ,section #gcg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i7 is am5d$-- 7#a7 by r$esignat+ p>agraphs 7#h7 ?r\gh 7#ac7 z p>agraphs 7#i7 ?r\gh 7#ad71 respectively2 7#b7 by ins]t+ aft] p>agraph 7#g7 ! foll[+ new p>agraph3 7#h7 ,! t]m de novo classification reque/ means a reque/ made "u section #eac7;f77#b77;,a7 ) respect to ! classification ( a device4 2 7#c7 9 subp>agraph 7,d7 ( p>agraph 7#aj7 7z r$esignat$ by p>agraph 7#a771 by /rik+ & submissions & ins]t+ submissions1 & de novo classification reque/s2 & 7#d7 9 p>agraph 7#aa7 7z r$esignat$ by p>agraph 7#a771 by /rik+ #bjaa & ins]t+ #bjaf4 7b7 ,con=m+ am5dm5t ,section #gad7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;d-#c7;b77#a77 is am5d$ by /rik+ #gcg7h7 & ins]t+ #gcg7i74 #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> #bjac & ins]t+ fiscal ye> #bjah2 & 7#b7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! matt] prec$+ clause 7i71 by /rik+ ,octob] #a1 #bjab & ins]t+ ,octob] #a1 #bjag2 7ii7 9 clause 7viii71 by /rik+ #b & ins]t+ #c4d2 & 7iii7 by add+ at ! end ! foll[+ new clause3 7xi7 ,= a de novo classification reque/1 a fee equal to #cj p]c5t ( ! fee t applies "u clause 7i74 2 & 7,b7 9 subp>agraph 7,b77v77,i71 by /rik+ or prem>ket notification submission & ins]t+ prem>ket notification submission1 or de novo classification reque/4 7b7 ,fee ,am\nts ,section #gch7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7b77 is am5d$ to read z foll[s3 7b7 ,fee ,am\nts 7#a7 ,9 ,g5]al ,subject to subsections 7c71 7d71 7e71 & 7h71 = ea* ( fiscal ye>s #bjah ?r\gh #bjbb1 fees "u subsection 7a7 %all be d]iv$ f ! base fee am\nts specifi$ 9 p>agraph 7#b71 to g5]ate ! total rev5ue am\nts specifi$ 9 p>agraph 7#c74 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> #bjah;,fiscal ,ye> #bjai;,fiscal ,ye> #bjbj;,fiscal ,ye> #bjba;,fiscal ,ye> #bjbb ,prem>ket ,application#bid1jjjcjj1jjjcaj1jjjcbh1jj jcbi1jjj ,e/abli%m5t ,regi/ration#d1cged1edhd1gfjd1iged1igh 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 #ahc1bhj1gef = fiscal ye> #bjah4 7,b7 #aij1fed1hge = fiscal ye> #bjai4 7,c7 #bjj1acb1jad = fiscal ye> #bjbj4 7,d7 #baa1gdh1ghi = fiscal ye> #bjba4 7,e7 #bac1fhg1ffj = fiscal ye> #bjbb4 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+ #bjab & ins]t+ #bjag2 7#b7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a71 by /rik+ #bjad & ins]t+ #bjah2 7,b7 by /rik+ subp>agraph 7,b7 & ins]t+ ! foll[+ new subp>agraph3 7,b7 ,applicable inflation adju/m5t ,! applicable inflation adju/m5t = fiscal ye> #bjah & ea* subsequ5t fiscal ye> is ! product (-- 7i7 ! base inflation adju/m5t "u subp>agraph 7,c7 = su* fiscal ye>2 & 7ii7 ! product ( ! base inflation adju/m5t "u subp>agraph 7,c7 = ea* ( ! fiscal ye>s prec$+ su* fiscal ye>1 beg9n+ ) fiscal ye> #bjaf4 2 7,c7 9 subp>agraph 7,c71 9 ! head+1 by /rik+ to total rev5ue am\nts2 & 7,d7 by am5d+ subp>agraph 7,d7 to read z foll[s3 7,d7 ,adju/m5t to base fee am\nts ,= ea* ( fiscal ye>s #bjah ?r\gh #bjbb1 ! ,secret>y %all-- 7i7 adju/ ! base fee am\nts specifi$ 9 subsection 7b77#b7 = su* fiscal ye> by multiply+ su* am\nts by ! applicable inflation adju/m5t "u subp>agraph 7,b7 = su* ye>2 & 7ii7 if ! ,secret>y det]m9es necess>y1 increase 79 addition to ! adju/m5t "u clause 7i77 su* base fee am\nts1 on a uni=m proportionate basis1 to g5]ate ! total rev5ue am\nts "u subsection 7b77#c71 z adju/$ = inflation "u subp>agraph 7,a74 2 & 7#c7 9 p>agraph 7#c7-- 7,a7 by /rik+ #bjad ?r\gh #bjag & ins]t+ #bjah ?r\gh #bjbb2 & 7,b7 by /rik+ fur!r adju/$ & ins]t+ increas$4 7d7 ,small bus9esses2 ,fee ,waiv] & ,fee ,r$uction ,reg>d+ ,prem>ket ,approval ,fees ,section #gch7;d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7d77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ specifi$ 9 clauses 7i7 ?r\gh 7v7 & clauses 7vii71 7ix71 & 7x7 & ins]t+ specifi$ 9 clauses 7i7 ?r\gh 7vii7 & clauses 7ix71 7x71 & 7xi72 & 7#b7 9 p>agraph 7#b77;,c7-- 7,a7 by /rik+ supplem5t1 or & ins]t+ supplem5t12 & 7,b7 by ins]t+ 1 or a de novo classification reque/ aft] class ,,iii device4 7e7 ,small ,bus9esses2 ,fee ,r$uction ,reg>d+ ,prem>ket ,notification ,submissions ,section #gch7;e77#b77;,c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7e77#b77;,c77 is am5d$ by /rik+ #ej & ins]t+ #be4 7f7 ,fee ,waiv] or ,r$uction 7#a7 ,repeal ,section #gch ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is am5d$ by /rik+ subsection 7f74 7#b7 ,con=m+ am5dm5ts 7,a7 ,section #eae7;c77#d77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7c77#d77;,a77 is am5d$ by /rik+ #gch7;h7 & ins]t+ #gch7;g74 7,b7 ,section #gch ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j71 z am5d$ by p>agraph 7#a71 is fur!r am5d$-- 7i7 by r$esignat+ subsections 7g7 ?r\gh 7l7 z subsections 7f7 ?r\gh 7k72 7ii7 9 subsection 7a77#b77;,a71 by /rik+ 7d71 7e71 & 7f7 & ins]t+ 7d7 & 7e72 & 7iii7 9 subsection 7a77#c77;,a71 by /rik+ & subsection 7f74 7g7 ,effect ( failure ,to pay fees ,subsection 7f77#a71 z s r$esignat$1 ( section #gch ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is am5d$-- 7#a7 by /rik+ or p]iodic report+ conc]n+ a class ,,iii device & ins]t+ p]iodic report+ conc]n+ a class ,,iii device1 or de novo classification reque/2 & 7#b7 by /rik+ all fees & ins]t+ all su* fees4 7h7 ,conditions ,subsection 7g77#a77;,a71 z s r$esignat$1 ( section #gch ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is am5d$ by /rik+ #bhj1ehg1jjj & ins]t+ #cbj1hbe1jjj4 7i7 ,cr$it+ & ,availability ( ,fees ,subsection 7h71 z s r$esignat$1 ( section #gch ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is am5d$-- 7#a7 9 p>agraph 7#c7-- 7,a7 by /rik+ #bjac ?r\gh #bjag & ins]t+ #bjah ?r\gh #bjbb2 & 7,b7 by /rik+ subsection 7c7 & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ subsection 7c742 & 7#b7 by /rik+ p>agraph 7#d74 #bjd4 ,reau?orization2 report+ requirem5ts 7a7 ,p]=mance ,reports ,section #gch;,a7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;a77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a7-- 7i7 by /rik+ #bjac & ins]t+ #bjah2 & 7ii7 by /rik+ ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjab & ins]t+ ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjag2 & 7,b7 9 subp>agraph 7,b71 by /rik+ ! ,m$ical ,device ,us] ,fee ,am5dm5ts ,act ( #bjab & ins]t+ ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjag2 & 7#b7 9 p>agraph 7#b71 by /rik+ #bjac ?r\gh #bjag & ins]t+ #bjah ?r\gh #bjbb4 7b7 ,reau?orization ,section #gch;,a7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;b77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ #bjag & ins]t+ #bjbb2 & 7#b7 9 p>agraph 7#e71 by /rik+ #bjag & ins]t+ #bjbb4 #bje4 ,con=mity assessm5t pilot program 7a7 ,9 g5]al ,section #ead ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7 is am5d$ by add+ at ! end ! foll[+3 7d7 ,pilot accr$itation s*eme = con=mity assessm5t 7#a7 ,9 g5]al ,! ,secret>y %all e/abli% a pilot program "u :i*-- 7,a7 te/+ laboratories may be accr$it$1 by accr$itation bodies meet+ crit]ia specifi$ by ! ,secret>y1 to assess ! con=mance ( a device ) c]ta9 /&>ds recogniz$ "u ?is section2 & 7,b7 subject to p>agraph 7#b71 det]m9ations by te/+ laboratories s accr$it$ t a device con=ms ) su* /&>d or /&>ds %all be accept$ by ! ,secret>y = purposes ( demon/rat+ su* con=mity "u ?is section unless ! ,secret>y f9ds t a p>ticul> su* det]m9ation %all n be s accept$4 7#b7 ,secret>ial review ( accr$it$ laboratory det]m9ations ,! ,secret>y may-- 7,a7 review det]m9ations by te/+ laboratories accr$it$ pursuant to ?is subsection1 includ+ by conduct+ p]iodic audits ( su* det]m9ations or processes ( accr$it$ bodies or te/+ laboratories &1 foll[+ su* review1 tak+ additional measures "u ?is ,act1 su* z susp5sion or )drawal ( accr$itation ( su* te/+ laboratory "u p>agraph 7#a77;,a7 or reque/+ additional in=mation ) respect to su* device1 z ! ,secret>y det]m9es appropriate2 & 7,b7 if ! ,secret>y becomes aw>e ( in=mation mat]ially be>+ on safety or effectiv5ess ( a device assess$ = con=mity by a te/+ laboratory s accr$it$1 take su* additional measures "u ?is ,act z ! ,secret>y det]m9es appropriate1 su* z susp5sion or )drawal ( accr$itation ( su* te/+ laboratory "u p>agraph 7#a77;,a71 or reque/+ additional in=mation ) reg>d to su* device4 7#c7 ,implem5tation & report+ 7,a7 ,public meet+ ,! ,secret>y %all publi% 9 ! ,f$]al ,regi/] a notice ( a public meet+ to be held no lat] ?an ,septemb] #cj1 #bjah1 to discuss & obta9 input & recomm5dations f /akehold]s reg>d+ ! goals & scope (1 & a suitable framework & proc$ures & requirem5ts =1 ! pilot program "u ?is subsection4 7,b7 ,pilot program guidance ,! ,secret>y %all-- 7i7 n lat] ?an ,septemb] #cj1 #bjai1 issue draft guidance reg>d+ ! goals & implem5tation ( ! pilot program "u ?is subsection2 & 7ii7 n lat] ?an ,septemb] #cj1 #bjba1 issue f9al guidance ) respect to ! implem5tation ( su* program4 7,c7 ,pilot program initiation ,n lat] ?an ,septemb] #cj1 #bjbj1 ! ,secret>y %all initiate ! pilot program "u ?is subsection4 7,d7 ,report ,! ,secret>y %all make available on ! int]net website ( ! ,food & ,drug ,adm9i/ration an annual report on ! progress ( ! pilot program "u ?is subsection4 7#d7 ,sunset ,z ( ,octob] #a1 #bjbb-- 7,a7 ! au?ority = accr$itation bodies to accr$it te/+ laboratories pursuant to p>agraph 7#a77;,a7 %all cease to h =ce or effect2 7,b7 ! ,secret>y-- 7i7 may n accept a det]m9ation pursuant to p>agraph 7#a77;,b7 made by a te/+ laboratory aft] su* date2 & 7ii7 may accept su* a det]m9ation made prior to su* date2 7,c7 except = purposes ( accept+ a det]m9ation describ$ 9 subp>agraph 7,b77ii71 ! ,secret>y %all n cont9ue to recognize ! accr$itation ( te/+ laboratories accr$it$ "u p>agraph 7#a77;,a72 & 7,d7 ! ,secret>y may take actions 9 accordance ) p>agraph 7#b7 ) respect to ! det]m9ations made prior to su* date & recognition ( ! accr$itation ( te/+ laboratories pursuant to det]m9ations made prior to su* date4 4 #bjf4 ,reau?orization ( review ,section #ebc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjm7 is am5d$-- 7#a7 9 subsection 7a77#c7-- 7,a7 9 subp>agraph 7,a71 by /rik+ clauses 7ii7 & 7iii7 & ins]t+ ! foll[+3 7ii7 a device classifi$ "u section #eac7;f77#b7 or designat$ "u section #eae;,c7d72 7iii7 a device t is int5d$ to be p]man5tly implantable1 life su/a9+1 or life support+1 unless o!rwise det]m9$ by ! ,secret>y 9 accordance ) subp>agraph 7,b77i77,,ii7 & li/$ z eligible = review "u subp>agraph 7,b77iii72 or 7iv7 a device t is ( a type1 or subset ( a type1 li/$ z n eligible = review "u subp>agraph 7,b77iii74 2 7,b7 by /rik+ subp>agraph 7,b7 & ins]t+ ! foll[+3 7,b7 ,designation = review ,! ,secret>y %all-- 7i7 issue draft guidance on ! factors ! ,secret>y w use 9 det]m9+ :e!r a class ,i or class ,,ii device type1 or subset ( su* device types1 is eligible = review by an accr$it$ p]son1 includ+-- 7,i7 ! risk ( ! device type1 or subset ( su* device type2 & 7,,ii7 :e!r ! device type1 or subset ( su* device type1 is p]man5tly implantable1 life su/a9+1 or life support+1 & :e!r !re is a detail$ public heal? ju/ification = p]mitt+ ! review by an accr$it$ p]son ( su* device type or subset2 7ii7 n lat] ?an #bd mon?s aft] ! date on :i* ! ,secret>y issues su* draft guidance1 f9alize su* guidance2 & 7iii7 beg9n+ on ! date su* guidance is f9aliz$1 designate & po/ on ! int]net website ( ! ,food & ,drug ,adm9i/ration1 an updat$ li/ ( class ,i & class ,,ii device types1 or subsets ( su* device types1 & ! ,secret>y's det]m9ation ) respect to :e!r ea* su* device type1 or subset ( a device type1 is eligible or n eligible = review by an accr$it$ p]son "u ?is section bas$ on ! factors describ$ 9 clause 7i74 2 & 7,c7 by add+ at ! end ! foll[+3 7,c7 ,int]im rule ,until ! date on :i* ! updat$ li/ is designat$ & po/$ 9 accordance ) subp>agraph 7,b77iii71 ! li/ 9 effect on ! date ( enactm5t ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjag %all be 9 effect4 2 7#b7 9 subsection 7b7-- 7,a7 9 p>agraph 7#b7-- 7i7 by /rik+ subp>agraph 7,d72 & 7ii7 by r$esignat+ subp>agraph 7,e7 z subp>agraph 7,d72 & 7,b7 9 p>agraph 7#c7-- 7i7 by r$esignat+ subp>agraph 7,e7 z subp>agraph 7,f72 7ii7 9 subp>agraph 7,f7 7z s r$esignat$71 by /rik+ ,! op]ations ( & all t foll[s ?r\gh x w-- & ins]t+ ,su* p]son %all agree1 at a m9imum1 to include 9 its reque/ = accr$itation a commitm5t to1 at ! "t ( accr$itation1 & at any "t x is p]=m+ any review pursuant to ?is section--2 & 7iii7 by ins]t+ aft] subp>agraph 7,d7 ! foll[+ new subp>agraph3 7,e7 ,! op]ations ( su* p]son %all be 9 accordance ) g5]ally accept$ pr(essional & e?ical bus9ess practices4 2 & 7#c7 9 subsection 7c71 by /rik+ #bjag & ins]t+ #bjbb4 #bjg4 ,electronic =mat = submissions ,section #gde;,a7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgik-#a7;b77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#c7 ,presubmissions & submissions solely 9 electronic =mat 7,a7 ,9 g5]al ,beg9n+ on su* date z ! ,secret>y specifies 9 f9al guidance issu$ "u subp>agraph 7,c71 presubmissions & submissions = devices describ$ 9 p>agraph 7#a7 7& any appeals ( action tak5 by ! ,secret>y ) respect to su* presubmissions or submissions7 %all be submitt$ solely 9 su* electronic =mat z specifi$ by ! ,secret>y 9 su* guidance4 7,b7 ,draft guidance ,! ,secret>y %all1 n lat] ?an ,octob] #a1 #bjai1 issue draft guidance provid+ =-- 7i7 any fur!r /&>ds = ! submission by electronic =mat requir$ "u subp>agraph 7,a72 7ii7 a timetable = ! e/abli%m5t by ! ,secret>y ( su* fur!r /&>ds2 & 7iii7 crit]ia = waiv]s ( & exemptions f ! requirem5ts ( ?is subsection4 7,c7 ,f9al guidance ,! ,secret>y %all1 n lat] ?an #a ye> aft] ! close ( ! public comm5t p]iod on ! draft guidance issu$ "u subp>agraph 7,b71 issue f9al guidance4 4 #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 #bjab1 b be=e ,octob] #a1 #bjag1 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> #bjah4 #bji4 ,effective date ,! am5dm5ts made by ?is title %all take effect on ,octob] #a1 #bjag1 or ! date ( ! enactm5t ( ?is ,act1 :i*ev] is lat]1 except t fees "u "p #c ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act %all be assess$ = all submissions li/$ 9 section #gch7;a77#b77;,a7 ( su* ,act receiv$ on or aft] ,octob] #a1 #bjag1 reg>dless ( ! date ( ! enactm5t ( ?is ,act4 #baj4 ,sunset dates 7a7 ,au?orization ,sections #gcg & #gch ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #gci;i2 #gci;j7 %all cease to be effective ,octob] #a1 #bjbb4 7b7 ,report+ requirem5ts ,section #gch;,a 7#ba ,u4,s4,c4 #gci;j-#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7reg>d+ reau?orization & report+ requirem5ts7 %all cease to be effective ,janu>y #ca1 #bjbc4 7c7 ,previ\s ,sunset ,provision ,effective ,octob] #a1 #bjag1 section #bjg7;a7 ( ! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act 7,public ,law #aab-add7 is repeal$4 ,,iii ,fees relat+ to g5]ic drugs #cja4 ,%ort title2 f9d+ 7a7 ,%ort title ,?is title may be cit$ z ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjag4 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$]al ,food1 ,drug1 & ,cosmetic ,act1 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #cjb4 ,def9itions ,section #gdd;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da7 is am5d$-- 7#a7 9 p>agraph 7#a77;,b71 by /rik+ application = a positron emission tomography drug4 & ins]t+ 8application-- 7i7 = a positron emission tomography drug2 or 7ii7 submitt$ by a ,/ate or ,f$]al gov]nm5tal entity = a drug t is n di/ribut$ comm]cially4 2 7#b7 by r$esignat+ p>agraphs 7#e7 ?r\gh 7#ab7 z p>agraphs 7#f7 ?r\gh 7#ac71 respectively2 & 7#c7 by ins]t+ aft] p>agraph 7#d7 ! foll[+3 7#e7 ,! t]m contract manufactur+ organization facility means a manufactur+ facility ( a f9i%$ dosage =m ( a drug approv$ pursuant to an abbreviat$ new drug application1 :]e su* manufactur+ facility is n id5tifi$ 9 an approv$ abbreviat$ new drug application held by ! own] ( su* facility or an affiliate ( su* own] or facility4 4 #cjc4 ,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$+ p>agraph 7#a71 by /rik+ fiscal ye> #bjac & ins]t+ fiscal ye> #bjah2 7#b7 9 p>agraph 7#a71 by add+ at ! end ! foll[+3 7,e7 ,sunset ,?is p>agraph %all cease to be effective ,octob] #a1 #bjbb4 2 7#c7 9 p>agraph 7#b7-- 7,a7 by am5d+ subp>agraph 7,c7 to read z foll[s3 7,c7 ,notice ,n lat] ?an #fj days be=e ! />t ( ea* ( fiscal ye>s #bjah ?r\gh #bjbb1 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/] ! am\nt ( ! drug ma/] file fee e/abli%$ by ?is p>agraph = su* fiscal ye>4 2 & 7,b7 9 subp>agraph 7,e7-- 7i7 9 clause 7i7-- 7,i7 by /rik+ no lat] ?an ! date & ins]t+ 8on ! e>li] (-- 7,i7 ! date 2 7,,ii7 by /rik+ ! p]iod & ins]t+ 2 or2 & 7,,iii7 by add+ at ! end ! foll[+3 7,,ii7 ! date on :i* ! drug ma/] file hold] reque/s ! initial complet5ess assessm5t4 2 & 7ii7 9 clause 7ii71 by /rik+ notice provid$ = 9 clause 7i7 or 7ii7 ( subp>agraph 7,c71 z applicable & ins]t+ notice provid$ = 9 subp>agraph 7,c72 7#d7 9 p>agraph 7#c7-- 7,a7 9 ! head+1 by /rik+ & prior approval supplem5t2 7,b7 9 subp>agraph 7,a71 by /rik+ or a prior approval supplem5t to an abbreviat$ new drug application2 7,c7 by am5d+ subp>agraphs 7,b7 & 7,c7 to read z foll[s3 7,b7 ,notice ,n lat] ?an #fj days be=e ! />t ( ea* ( fiscal ye>s #bjah ?r\gh #bjbb1 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/] ! am\nt ( ! fees "u subp>agraph 7,a7 = su* fiscal ye>4 7,c7 ,fee due date ,! fees requir$ by subp>agraphs 7,a7 & 7,f7 %all be due no lat] ?an ! date ( submission ( ! abbreviat$ new drug application or prior approval supplem5t = :i* su* fee applies4 2 7,d7 9 subp>agraph 7,d7-- 7i7 9 ! head+1 by ins]t+ 1 is )drawn prior to be+ receiv$1 or is no long] receiv$ aft] receiv$2 & 7ii7 by /rik+ ,! ,secret>y %all & all t foll[s ?r\gh ! p]iod & ins]t+ ! foll[+3 7i7 ,applications n consid]$ to h be5 receiv$ & applications )drawn prior to be+ receiv$ ,! ,secret>y %all refund #ge p]c5t ( ! fee paid "u subp>agraph 7,a7 = any abbreviat$ new drug application t ! ,secret>y consid]s n to h be5 receiv$ )9 ! mean+ ( section #eje7;j77#e77;,a7 = a cause o!r ?an failure to pay fees1 or t has be5 )drawn prior to be+ receiv$ )9 ! mean+ ( section #eje7;j77#e77;,a74 7ii7 ,applications no long] receiv$ ,! ,secret>y %all refund #ajj p]c5t ( ! fee paid "u subp>agraph 7,a7 = any abbreviat$ new drug application if ! ,secret>y initially receives ! application "u section #eje7;j77#e77;,a7 & subsequ5tly det]m9es t an exclusivity p]iod = a li/$ drug %\ld h prev5t$ ! ,secret>y f receiv+ su* application1 su* t ! abbreviat$ new drug application is no long] receiv$ )9 ! mean+ ( section #eje7;j77#e77;,a74 2 7,e7 9 subp>agraph 7,e71 by /rik+ or prior approval supplem5t2 & 7,f7 9 ! matt] prec$+ clause 7i7 ( subp>agraph 7,f7-- 7i7 by /rik+ #bjab & ins]t+ #bjag2 & 7ii7 by /rik+ subsection 7d77#c7 & ins]t+ subsection 7d77#b72 7#e7 9 p>agraph 7#d7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! matt] prec$+ clause 7i7 & 9 clause 7iii71 by /rik+ 1 or int5d$ to be id5tifi$1 9 at lea/ "o g5]ic drug submission t is p5d+ or & ins]t+ 9 at lea/ "o g5]ic drug submission t is2 7ii7 9 clause 7i71 by /rik+ or int5d$ to be id5tifi$ 9 at lea/ "o g5]ic drug submission t is p5d+ or & ins]t+ 9 at lea/ "o g5]ic drug submission t is2 7iii7 9 clause 7ii71 by /rik+ produces1 & all t foll[s ?r\gh su* a & ins]t+ is id5tifi$ 9 at lea/ "o g5]ic drug submission 9 :i* ! facility is approv$ to produce "o or m active ph>maceutical +r$i5ts or 9 a ,type ,,ii active ph>maceutical +r$i5t drug ma/] file ref]5c$ 9 at lea/ "o su*2 & 7iv7 9 clause 7iii71 by /rik+ to fees "u bo? su* clauses & ins]t+ only to ! fee attributable to ! manufacture ( ! f9i%$ dosage =ms2 & 7,b7 by am5d+ subp>agraphs 7,c7 & 7,d7 to read z foll[s3 7,c7 ,notice ,)9 ! timeframe specifi$ 9 subsection 7d77#a71 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/] ! am\nt ( ! fees "u subp>agraph 7,a7 = su* fiscal ye>4 7,d7 ,fee due date ,= ea* ( fiscal ye>s #bjah ?r\gh #bjbb1 ! fees "u subp>agraph 7,a7 = su* fiscal ye> %all be due on ! lat] (-- 7i7 ! fir/ bus9ess day on or aft] ,octob] #a ( ea* su* ye>2 or 7ii7 ! fir/ bus9ess day aft] ! enactm5t ( an appropriations ,act provid+ = ! collection & obligation ( fees = su* ye> "u ?is section = su* ye>4 2 7#f7 by r$esignat+ p>agraph 7#e7 z p>agraph 7#f72 & 7#g7 by ins]t+ aft] p>agraph 7#d7 ! foll[+3 7#e7 ,g5]ic drug applicant program fee 7,a7 ,9 g5]al ,a g5]ic drug applicant program fee %all be assess$ annually z describ$ 9 subsection 7b77#b77;,e74 7,b7 ,am\nt ,! am\nt ( fees e/abli%$ "u subp>agraph 7,a7 %all be e/abli%$ "u subsection 7d74 7,c7 ,notice ,)9 ! timeframe specifi$ 9 subsection 7d77#a71 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/] ! am\nt ( ! fees "u subp>agraph 7,a7 = su* fiscal ye>4 7,d7 ,fee due date ,= ea* ( fiscal ye>s #bjah ?r\gh #bjbb1 ! fees "u subp>agraph 7,a7 = su* fiscal ye> %all be due on ! lat] (-- 7i7 ! fir/ bus9ess day on or aft] ,octob] #a ( ea* su* fiscal ye>2 or 7ii7 ! fir/ bus9ess day aft] ! date ( enactm5t ( an appropriations ,act provid+ = ! collection & obligation ( fees = su* fiscal ye> "u ?is section = su* fiscal ye>4 4 7b7 ,fee rev5ue am\nts ,section #gdd;,b7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;b77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! head+1 by /rik+ #bjac & ins]t+ #bjah2 7ii7 by /rik+ #bjac & ins]t+ #bjah2 7iii7 by /rik+ #bii1jjj1jjj & ins]t+ #dic1fjj1jjj2 & 7iv7 by /rik+ ,( t am\nt & all t foll[s ?r\gh ! end ( clause 7ii72 & 7,b7 9 subp>agraph 7,b7-- 7i7 9 ! head+1 by /rik+ #bjad ?r\gh #bjag & ins]t+ #bjai ?r\gh #bjbb2 7ii7 by /rik+ #bjad ?r\gh #bjag & ins]t+ #bjai ?r\gh #bjbb2 7iii7 by /rik+ p>agraphs 7#b7 ?r\gh 7#d7 & ins]t+ p>agraphs 7#b7 ?r\gh 7#e72 & 7iv7 by /rik+ #bii1jjj1jjj & ins]t+ #dic1fjj1jjj2 & 7#b7 9 p>agraph 7#b7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a7-- 7i7 by /rik+ p>agraph 7#a77;,a77ii7 = fiscal ye> #bjac & p>agraph 7#a77;,b7 = ea* ( fiscal ye>s #bjad ?r\gh #bjag & ins]t+ su* p>agraph = a fiscal ye>2 & 7ii7 by /rik+ ?r\gh 7#d7 & ins]t+ ?r\gh 7#e72 7,b7 9 subp>agraph 7,a71 by /rik+ ,six p]c5t & ins]t+ ,five p]c5t2 7,c7 by am5d+ subp>agraphs 7,b7 & 7,c7 to read z foll[s3 7,b7 ,?irty-?ree p]c5t %all be d]iv$ f fees "u subsection 7a77#c7 7relat+ to abbreviat$ new drug applications74 7,c7 ,tw5ty p]c5t %all be d]iv$ f fees "u subsection 7a77#d77;,a77i7 7relat+ to g5]ic drug facilities74 ,! am\nt ( ! fee = a contract manufactur+ organization facility %all be equal to "o-?ird ! am\nt ( ! fee = a facility t is n a contract manufactur+ organization facility4 ,! am\nt ( ! fee = a facility locat$ outside ! ,unit$ ,/ates & its t]ritories & possessions %all be #ae1jjj high] ?an ! am\nt ( ! fee = a facility locat$ 9 ! ,unit$ ,/ates & its t]ritories & possessions4 2 7,d7 9 subp>agraph 7,d7-- 7i7 by /rik+ ,f\rte5 p]c5t & ins]t+ ,sev5 p]c5t2 7ii7 by /rik+ n less ?an #ae1jjj & n m ?an #cj1jjj & ins]t+ #ae1jjj2 & 7iii7 by /rik+ 1 z det]m9$ & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ a p]iod2 & 7,e7 by add+ at ! end ! foll[+3 7,e7 7i7 ,?irty-five p]c5t %all be d]iv$ f fees "u subsection 7a77#e7 7relat+ to g5]ic drug applicant program fees74 ,= purposes ( ?is subp>agraph1 if a p]son has affiliates1 a s+le program fee %all be assess$ ) respect to t p]son1 includ+ its affiliates1 & may be paid by t p]son or any "o ( its affiliates4 ,! ,secret>y %all det]m9e ! fees z foll[s3 7,i7 ,if a p]son 7includ+ its affiliates7 owns at lea/ "o b n m ?an #e approv$ abbreviat$ new drug applications on ! due date = ! fee "u ?is subsection1 ! p]son 7includ+ its affiliates7 %all be assess$ a small bus9ess g5]ic drug applicant program fee equal to "o-t5? ( ! l>ge size op]ation g5]ic drug applicant program fee4 7,,ii7 ,if a p]son 7includ+ its affiliates7 owns at lea/ #f b n m ?an #ai approv$ abbreviat$ new drug applications on ! due date = ! fee "u ?is subsection1 ! p]son 7includ+ its affiliates7 %all be assess$ a m$ium size op]ation g5]ic drug applicant program fee equal to two-fif?s ( ! l>ge size op]ation g5]ic drug applicant program fee4 7,,iii7 ,if a p]son 7includ+ its affiliates7 owns #bj or m approv$ abbreviat$ new drug applications on ! due date = ! fee "u ?is subsection1 ! p]son 7includ+ its affiliates7 %all be assess$ a l>ge size op]ation g5]ic drug applicant program fee4 7ii7 ,= purposes ( ?is subp>agraph1 an abbreviat$ new drug application %all be deem$ n to be approv$ if ! applicant has submitt$ a writt5 reque/ = )drawal ( approval ( su* abbreviat$ new drug application by ,april #a ( ! previ\s fiscal ye>4 4 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 by /rik+ #bjad & ins]t+ #bjai2 7,b7 by ins]t+ to equal ! product ( ! total rev5ues e/abli%$ 9 su* notice = ! prior fiscal ye> multipli$ aft] a fiscal ye>12 & 7,c7 by /rik+ ! flu% text foll[+ subp>agraph 7,c72 & 7#b7 9 p>agraph 7#b7-- 7,a7 by /rik+ #bjag ea* place x appe>s & ins]t+ #bjbb2 7,b7 by /rik+ ! fir/ #c mon?s ( fiscal ye> #bjah & ins]t+ ! fir/ #c mon?s ( fiscal ye> #bjbc2 & 7,c7 by /rik+ ,su* fees may only be us$ 9 fiscal ye> #bjah44 7d7 ,annual fee sett+ ,section #gdd;,b7d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;d77 is am5d$-- 7#a7 by /rik+ p>agraphs 7#a7 & 7#b7 & ins]t+ ! foll[+3 7#a7 ,fiscal ye>s #bjah ?r\gh #bjbb ,n m ?an #fj days be=e ! fir/ day ( ea* ( fiscal ye>s #bjah ?r\gh #bjbb1 ! ,secret>y %all e/abli% ! fees describ$ 9 p>agraphs 7#b7 ?r\gh 7#e7 ( subsection 7a71 bas$ on ! rev5ue am\nts e/abli%$ "u subsection 7b7 & ! adju/m5ts provid$ "u subsection 7c74 2 7#b7 by r$esignat+ p>agraph 7#c7 z p>agraph 7#b72 & 7#c7 9 p>agraph 7#b7 7z s r$esignat$71 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ fees "u p>agraphs 7#a7 & 7#b7 & ins]t+ fee "u p>agraph 7#a74 7e7 ,id5tification ( facilities ,section #gdd;,b7f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;f77 is am5d$-- 7#a7 by /rik+ p>agraph 7#a72 7#b7 by r$esignat+ p>agraphs 7#b7 ?r\gh 7#d7 z p>agraphs 7#a7 ?r\gh 7#c71 respectively2 7#c7 9 p>agraph 7#a7 7z s r$esignat$7-- 7,a7 by /rik+ p>agraph 7#d7 & ins]t+ p>agraph 7#c72 & 7,b7 by /rik+ ,su* in=mation %all & all t foll[s ?r\gh ! end ( subp>agraph 7,b7 & ins]t+ ,su* in=mation %all1 = ea* fiscal ye>1 be submitt$1 updat$1 or reconfirm$ on or be=e ,june #a ( ! previ\s fiscal ye>42 & 7#d7 9 p>agraph 7#b71 z s r$esignat$-- 7,a7 9 ! head+1 by /rik+ ,cont5ts ( notice & ins]t+ ,in=mation requir$ to be submitt$2 7,b7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ p>agraph 7#b7 & ins]t+ p>agraph 7#a72 7,c7 9 subp>agraph 7,a71 by /rik+ or int5d$ to be id5tifi$2 7,d7 9 subp>agraph 7,d71 by /rik+ & at ! end2 7,e7 9 subp>agraph 7,e71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,f7 by add+ at ! end ! foll[+3 7,f7 :e!r ! facility is a contract manufactur+ organization facility4 4 7f7 ,effect ( failure ,to pay fees ,section #gdd;,b7g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;g77 is am5d$-- 7#a7 9 p>agraph 7#a71 by add+ at ! end ! foll[+3 ,?is p>agraph %all cease to be effective on ,octob] #a1 #bjbb42 7#b7 9 p>agraph 7#b77;,c77ii71 by /rik+ ( #eje7;j77#e77;,a7 & ins]t+ ( section #eje7;j77#e77;,a72 & 7#c7 by add+ at ! end ! foll[+3 7#e7 ,g5]ic drug applicant program fee 7,a7 ,9 g5]al ,a p]son :o fails to pay a fee z requir$ "u subsection 7a77#e7 by ! date t is #bj cal5d> days aft] ! due date1 z specifi$ 9 subp>agraph 7,d7 ( su* subsection1 %all be subject to ! foll[+3 7i7 ,! ,secret>y %all place ! p]son on a publicly available arre>s li/4 7ii7 ,any abbreviat$ new drug application submitt$ by ! g5]ic drug applicant or an affiliate ( su* applicant %all n be receiv$1 )9 ! mean+ ( section #eje7;j77#e77;,a74 7iii7 ,all drugs m>ket$ pursuant to any abbreviat$ new drug application held by su* applicant or an affiliate ( su* applicant %all be deem$ misbr&$ "u section #ejb7;aa74 7,b7 ,application ( p5alties ,! p5alties "u subp>agraph 7,a7 %all apply until ! fee requir$ "u subsection 7a77#e7 is paid4 4 7g7 ,limitations ,section #gdd;,b7h77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;h77#b77 is am5d$ by /rik+ = ,type ,,ii active ph>maceutical +r$i5t drug ma/] files1 abbreviat$ new drug applications & prior approval supplem5ts1 & g5]ic drug facilities & active ph>maceutical +r$i5t facilities4 7h7 ,cr$it+ & availability ( fees ,section #gdd;,b7i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;i77 is am5d$-- 7#a7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a71 by /rik+ subp>agraphs 7,c7 & 7,d7 & ins]t+ subp>agraph 7,c72 7,b7 by /rik+ subp>agraph 7,c7 7relat+ to fee collection dur+ fir/ program ye>72 7,c7 9 subp>agraph 7,d7-- 7i7 9 ! head+1 by /rik+ 9 subsequ5t ye>s2 & 7ii7 by /rik+ 7aft] fiscal ye> #bjac72 & 7,d7 by r$esignat+ subp>agraph 7,d7 z subp>agraph 7,c72 & 7#b7 9 p>agraph 7#c71 by /rik+ fiscal ye>s #bjac ?r\gh #bjag & ins]t+ fiscal ye>s #bjah ?r\gh #bjbb4 7i7 ,in=mation on abbreviat$ new drug applications own$ by applicants & _! affiliates ,section #gdd;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7 is am5d$ by add+ at ! end ! foll[+3 7o7 ,in=mation on abbreviat$ new drug applications own$ by applicants & _! affiliates 7#a7 ,9 g5]al ,by ,april #a ( ea* ye>1 ea* p]son t owns an abbreviat$ new drug application1 or a designat$ affiliate ( su* p]son1 %all submit1 on behalf ( ! p]son & ! affiliates ( su* p]son1 to ! ,secret>y a li/ (-- 7,a7 all approv$ abbreviat$ new drug applications own$ by su* p]son2 & 7,b7 if any affiliate ( su* p]son also owns an abbreviat$ new drug application1 all affiliates t own any su* abbreviat$ new drug application & all approv$ abbreviat$ new drug applications own$ by any su* affiliate4 7#b7 ,=mat & me?od ,! ,secret>y %all specify 9 guidance ! =mat & me?od = submission ( li/s "u ?is subsection4 4 #cjd4 ,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+ #bjac & ins]t+ #bjah2 & 7,b7 by /rik+ ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjab & ins]t+ ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjag2 7#b7 9 subsection 7b71 by /rik+ #bjac & ins]t+ #bjah2 & 7#c7 9 subsection 7d71 by /rik+ #bjag ea* place x appe>s & ins]t+ #bjbb4 #cje4 ,sunset dates 7a7 ,au?orization ,sections #gdd;,a & #gdd;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da2 #cgi;j-#db7 %all cease to be effective ,octob] #a1 #bjbb4 7b7 ,report+ requirem5ts ,section #gdd;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7 %all cease to be effective ,janu>y #ca1 #bjbc4 7c7 ,previ\s sunset provision 7#a7 ,9 g5]al ,effective ,octob] #a1 #bjag1 section #cjd ( ! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act 7,public ,law #aab-add7 is repeal$4 7#b7 ,con=m+ am5dm5t ,! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act 7,public ,law #aab-add7 is am5d$ 9 ! table ( cont5ts 9 section #b by /rik+ ! item relat+ to section #cjd4 #cjf4 ,effective date ,! am5dm5ts made by ?is title %all take effect on ,octob] #a1 #bjag1 or ! date ( ! enactm5t ( ?is ,act1 :i*ev] is lat]1 except t fees "u "p #g ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act %all be assess$ = all abbreviat$ new drug applications receiv$ on or aft] ,octob] #a1 #bjag1 reg>dless ( ! date ( ! enactm5t ( ?is ,act4 #cjg4 ,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 #bjab1 b be=e ,octob] #a1 #bjag1 ) respect to assess+ & collect+ any fee requir$ by su* "p = a fiscal ye> prior to fiscal ye> #bjah4 ,,iv ,fees relat+ to biosimil> biological products #dja4 ,%ort title2 f9d+ 7a7 ,%ort ,title ,?is title may be cit$ z ! ,biosimil> ,us] ,fee ,am5dm5ts ( #bjag4 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$]al ,food1 ,drug1 & ,cosmetic ,act1 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #djb4 ,def9itions 7a7 ,adju/m5t factor ,section #gdd;,g7#a7 ( ! ,f$]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-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,n ,seasonally ,adju/$2 ,all items7 = ,octob] ( ! prec$+ fiscal ye> divid$ by su* ,index = ,octob] #bjaa4 4 7b7 ,biosimil> biological product ,section #gdd;,g7#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea7c77 is am5d$ by /rik+ means a product & ins]t+ means a specific /r5g? ( a biological product 9 f9al dosage =m4 #djc4 ,au?ority to assess & use biosimil> 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$+ p>agraph 7#a71 by /rik+ fiscal ye> #bjac & ins]t+ fiscal ye> #bjah2 7#b7 9 ! head+ ( p>agraph 7#a71 by /rik+ ,biosimil> & ins]t+ ,biosimil> biological product2 7#c7 9 p>agraph 7#a77;,a77i71 by /rik+ 7b77#a77;,a7 & ins]t+ 7c77#e72 7#d7 9 p>agraph 7#a77;,b77i71 by /rik+ 7b77#a77;,b7 = biosimil> biological product developm5t & ins]t+ 7c77#e7 = ! biosimil> biological product developm5t program2 7#e7 9 p>agraph 7#a77;,b77ii71 by /rik+ annual biosimil> biological product developm5t program fee & ins]t+ annual biosimil> biological product developm5t fee2 7#f7 9 p>agraph 7#a77;,b77iii71 by /rik+ annual biosimil> developm5t program fee & ins]t+ annual biosimil> biological product developm5t fee2 7#g7 9 p>agraph 7#a77;,b71 by add+ at ! end ! foll[+3 7iv7 ,refund ,if a p]son submits a m>ket+ application = a biosimil> biological product be=e ,octob] #a ( a fiscal ye> & su* application is accept$ = fil+ on or aft] ,octob] #a ( su* fiscal ye>1 ! p]son may reque/ a refund equal to ! annual biosimil> biological product developm5t fee paid by ! p]son = ! product = su* fiscal ye>4 ,to qualify = consid]ation = a refund "u ?is clause1 a p]son %all submit to ! ,secret>y a writt5 reque/ = su* refund n lat] ?an #ahj days aft] ! m>ket+ application is accept$ = fil+4 2 7#h7 9 p>agraph 7#a77;,c71 by /rik+ = a product effective ,octob] #a ( a fiscal ye> by1 & ins]t+ = a product1 effective ,octob] #a ( a fiscal ye>1 by12 7#i7 9 p>agraph 7#a77;,d7-- 7,a7 9 clause 7i7 9 ! matt] prec$+ subclause 7,i71 by ins]t+ 1 if ! p]son seeks to resume p>ticipation 9 su* program1 be=e pay a fee2 7,b7 9 clause 7i77,i71 by ins]t+ aft] grants a reque/ ! foll[+3 by su* p]son2 & 7,c7 9 clause 7i77,,ii71 by ins]t+ aft] discont9u$7 ! foll[+3 by su* p]son2 7#aj7 9 ! head+ ( p>agraph 7#a77;,e71 by /rik+ biosimil> developm5t program2 7#aa7 9 p>agraph 7#a77;,f7-- 7,a7 9 ! subp>agraph head+1 by /rik+ biosimil> developm5t program2 & 7,b7 by am5d+ clause 7i7 to read z foll[s3 7i7 ,refunds ,except z provid$ 9 subp>agraph 7,b77iv71 ! ,secret>y %all n refund any initial or annual biosimil> biological product developm5t fee paid "u subp>agraph 7,a7 or 7,b71 or any reactivation fee paid "u subp>agraph 7,d74 2 7#ab7 9 p>agraph 7#b7-- 7,a7 9 ! p>agraph head+1 by /rik+ & supplem5t2 7,b7 by am5d+ subp>agraphs 7,a7 & 7,b7 to read z foll[s3 7,a7 ,9 g5]al ,ea* p]son t submits1 on or aft] ,octob] #a1 #bjag1 a biosimil> biological product application %all be subject to ! foll[+ fees3 7i7 ,a fee e/abli%$ "u subsection 7c77#e7 = a biosimil> biological product application = :i* cl9ical data 7o!r ?an comp>ative bioavailability /udies7 ) respect to safety or effectiv5ess are requir$ = approval4 7ii7 ,a fee e/abli%$ "u subsection 7c77#e7 = a biosimil> biological product application = :i* cl9ical data 7o!r ?an comp>ative bioavailability /udies7 ) respect to safety or effectiv5ess are n requir$ = approval4 ,su* fee %all be equal to half ( ! am\nt ( ! fee describ$ 9 clause 7i74 7,b7 ,rule ( applicability2 treatm5t ( c]ta9 previ\sly paid fees ,any p]son :o pays a fee "u subp>agraph 7,a71 7,b71 or 7,d7 ( p>agraph 7#a7 = a product be=e ,octob] #a1 #bjag1 b submits a biosimil> biological product application = t product aft] su* date1 %all-- 7i7 be subject to any biosimil> biological product application fees t may be assess$ at ! "t :5 su* biosimil> biological product application is submitt$2 & 7ii7 be entitl$ to no r$uction ( su* application fees bas$ on ! am\nt ( fees paid = t product be=e ,octob] #a1 #bjag1 "u su* subp>agraph 7,a71 7,b71 or 7,d74 2 7,c7 9 ! head+ ( subp>agraph 7,d71 by /rik+ or supplem5t2 7,d7 9 subp>agraphs 7,c7 ?r\gh 7,f71 by /rik+ or supplem5t ea* place x appe>s2 & 7,e7 9 subp>agraph 7,d71 by /rik+ or a supplem5t2 7#ac7 by am5d+ p>agraph 7#c7 to read z foll[s3 7#c7 ,biosimil> biological product program fee 7,a7 ,9 g5]al ,ea* p]son :o is nam$ z ! applicant 9 a biosimil> biological product application %all pay ! annual biosimil> biological product program fee e/abli%$ = a fiscal ye> "u subsection 7c77#e7 = ea* biosimil> biological product t-- 7i7 is id5tifi$ 9 su* a biosimil> biological product application approv$ z ( ,octob] #a ( su* fiscal ye>2 & 7ii7 z ( ,octob] #a ( su* fiscal ye>1 does n appe> on a li/1 develop$ & ma9ta9$ by ! ,secret>y1 ( discont9u$ biosimil> biological products4 7,b7 ,due date ,! biosimil> biological product program fee = a fiscal ye> %all be due on ! lat] (-- 7i7 ! fir/ bus9ess day on or aft] ,octob] #a ( ea* su* ye>2 or 7ii7 ! fir/ bus9ess day aft] ! enactm5t ( an appropriations ,act provid+ = ! collection & obligation ( fees = su* ye> "u ?is section4 7,c7 ,"o fee p] product p] ye> ,! biosimil> biological product program fee %all be paid only once = ea* product = ea* fiscal ye>4 7,d7 ,limitation ,a p]son :o is nam$ z ! applicant 9 a biosimil> biological product application %all n be assess$ m ?an #e biosimil> biological product program fees = a fiscal ye> = biosimil> biological products id5tifi$ 9 su* biosimil> biological product application4 4 7b7 ,fee rev5ue am\nts ,subsection 7b7 ( section #gdd;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7 is am5d$ to read z foll[s3 7b7 ,fee rev5ue am\nts 7#a7 ,fiscal ye> #bjah ,= fiscal ye> #bjah1 fees "u subsection 7a7 %all be e/abli%$ to g5]ate a total rev5ue am\nt equal to ! sum (-- 7,a7 #de1jjj1jjj2 & 7,b7 ! doll> am\nt equal to ! fiscal ye> #bjah adju/m5t 7z det]m9$ "u subsection 7c77#d774 7#b7 ,subsequ5t fiscal ye>s ,= ea* ( ! fiscal ye>s #bjai ?r\gh #bjbb1 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#d772 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 ! capacity plann+ adju/m5t = ! fiscal ye> 7z det]m9$ "u subsection 7c77#b772 & 7,d7 ! doll> am\nt equal to ! op]at+ res]ve adju/m5t = ! fiscal ye>1 if applicable 7z det]m9$ "u subsection 7c77#c774 7#c7 ,allocation ( rev5ue am\nt among fees2 limitations on fee am\nts 7,a7 ,allocation ,! ,secret>y %all det]m9e ! p]c5tage ( ! total rev5ue am\nt = a fiscal ye> to be d]iv$ f1 respectively-- 7i7 initial & annual biosimil> biological product developm5t fees & reactivation fees "u subsection 7a77#a72 7ii7 biosimil> biological product application fees "u subsection 7a77#b72 & 7iii7 biosimil> biological product program fees "u subsection 7a77#c74 7,b7 ,limitations on fee am\nts ,until ! fir/ fiscal ye> = :i* ! capacity plann+ adju/m5t "u subsection 7c77#b7 is effective1 ! am\nt ( any fee "u subsection 7a7 = a fiscal ye> aft] fiscal ye> #bjah %all n exce$ #abe p]c5t ( ! am\nt ( su* fee = fiscal ye> #bjah4 7,c7 ,biosimil> biological product developm5t fees ,! initial biosimil> biological product developm5t fee "u subsection 7a77#a77;,a7 = a fiscal ye> %all be equal to ! annual biosimil> biological product developm5t fee "u subsection 7a77#a77;,b7 = t fiscal ye>4 7,d7 ,reactivation fee ,! reactivation fee "u subsection 7a77#a77;,d7 = a fiscal ye> %all be equal to twice ! am\nt ( ! annual biosimil> biological product developm5t fee "u subsection 7a77#a77;,b7 = t fiscal ye>4 7#d7 ,annual base rev5ue ,= purposes ( p>agraph 7#b71 ! doll> am\nt ( ! annual base rev5ue = a fiscal ye> %all be ! doll> am\nt ( ! total rev5ue am\nt = ! previ\s fiscal ye>1 exclud+ any adju/m5ts to su* rev5ue am\nt "u subsection 7c77#c74 4 7c7 ,adju/m5ts2 annual fee sett+ ,section #gdd;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7 is am5d$-- 7#a7 by r$esignat+ subsections 7c7 ?r\gh 7h7 z subsections 7d7 ?r\gh 7i71 respectively2 7#b7 9 subsections 7a77#b77;,f7 & 7h7 7z r$esignat$ by p>agraph 7#a771 by /rik+ subsection 7c7 & ins]t+ subsection 7d72 7#c7 9 subsection 7a77#d77;,a71 by /rik+ subsection 7b77#a77;,f7 & ins]t+ subsection 7c77#e72 & 7#d7 by ins]t+ aft] subsection 7b7 ! foll[+3 7c7 ,adju/m5ts2 annual fee sett+ 7#a7 ,inflation adju/m5t 7,a7 ,9 g5]al ,= purposes ( subsection 7b77#b77;,b71 ! doll> am\nt ( ! inflation adju/m5t to ! annual base rev5ue = ea* fiscal ye> %all be equal to ! product (-- 7i7 su* annual base rev5ue = ! fiscal ye> "u subsection 7b72 & 7ii7 ! inflation adju/m5t p]c5tage "u subp>agraph 7,b74 7,b7 ,inflation adju/m5t p]c5tage ,! inflation adju/m5t p]c5tage "u ?is subp>agraph = a fiscal ye> is equal to ! sum (-- 7i7 ! av]age annual p]c5t *ange 9 ! co/1 p] full-"t equival5t position ( ! ,food & ,drug ,adm9i/ration1 ( all p]sonnel comp5sation & b5efits paid ) respect to su* positions = ! fir/ #c ye>s ( ! prec$+ #d fiscal ye>s1 multipli$ by ! proportion ( p]sonnel comp5sation & b5efits co/s to total co/s ( ! process = ! review ( biosimil> biological product applications 7z def9$ 9 section #gdd;,g7#ac77 = ! fir/ #c ye>s ( ! prec$+ #d fiscal ye>s2 & 7ii7 ! av]age annual p]c5t *ange t occurr$ 9 ! ,consum] ,price ,index = urban consum]s 7,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,n ,seasonally ,adju/$2 ,all items2 ,annual ,index7 = ! fir/ #c ye>s ( ! prec$+ #d ye>s ( available data multipli$ by ! proportion ( all co/s o!r ?an p]sonnel comp5sation & b5efits co/s to total co/s ( ! process = ! review ( biosimil> biological product applications 7z def9$ 9 section #gdd;,g7#ac77 = ! fir/ #c ye>s ( ! prec$+ #d fiscal ye>s4 7#b7 ,capacity plann+ adju/m5t 7,a7 ,9 g5]al ,beg9n+ ) ! fiscal ye> describ$ 9 subp>agraph 7,b77ii77,,ii71 ! ,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> to reflect *anges 9 ! res\rce capacity ne$s ( ! ,secret>y = ! process = ! review ( biosimil> biological product applications4 7,b7 ,capacity plann+ me?odology 7i7 ,developm5t2 evaluation & report ,! ,secret>y %all obta91 ?r\gh a contract ) an indep5d5t acc\nt+ or consult+ firm1 a report evaluat+ options & recomm5dations = a new me?odology to accurately assess *anges 9 ! res\rce & capacity ne$s ( ! process = ! review ( biosimil> biological product applications4 ,! capacity plann+ me?odological options & recomm5dations pres5t$ 9 su* report %all utilize & be in=m$ by p]sonnel "t report+ data z an input4 ,! report %all be publi%$ = public comm5t n lat] ?an ,septemb] #cj1 #bjbj4 7ii7 ,e/abli%m5t & implem5tation ,aft] review ( ! report describ$ 9 clause 7i7 & receipt & review ( public comm5ts !reon1 ! ,secret>y %all e/abli% a capacity plann+ me?odology = purposes ( ?is p>agraph1 :i* %all-- 7,i7 incorporate su* approa*es & attributes z ! ,secret>y det]m9es appropriate2 & 7,,ii7 be effective beg9n+ ) ! fir/ fiscal ye> = :i* fees are set aft] su* capacity plann+ me?odology is e/abli%$4 7,c7 ,limitation ,"u no circum/ances %all an adju/m5t "u ?is p>agraph result 9 fee rev5ue = a fiscal ye> t is less ?an ! sum ( ! am\nts "u subsections 7b77#b77;,a7 7! annual base rev5ue = ! fiscal ye>7 & 7b77#b77;,b7 7! doll> am\nt ( ! inflation adju/m5t = ! fiscal ye>74 7,d7 ,publication 9 f$]al regi/] ,! ,secret>y %all publi% 9 ! ,f$]al ,regi/] notice "u p>agraph 7#e7 ! fee rev5ue & fees result+ f ! adju/m5t & ! me?odologies "u ?is p>agraph4 7#c7 ,op]at+ res]ve adju/m5t 7,a7 ,int]im application2 fee r$uction ,until ! fir/ fiscal ye> = :i* ! capacity plann+ adju/m5t "u p>agraph 7#b7 is effective1 ! ,secret>y may1 9 addition to ! adju/m5t "u p>agraph 7#a71 r$uce ! fee rev5ue & fees "u ?is section = a fiscal ye> z ! ,secret>y det]m9es appropriate = long-t]m f9ancial plann+ purposes4 7,b7 ,g5]al application & me?odology ,beg9n+ ) ! fir/ fiscal ye> = :i* ! capacity plann+ adju/m5t "u p>agraph 7#b7 is effective1 ! ,secret>y may1 9 addition to ! adju/m5ts "u p>agraphs 7#a7 & 7#b7-- 7i7 r$uce ! fee rev5ue & fees "u ?is section z ! ,secret>y det]m9es appropriate = long-t]m f9ancial plann+ purposes2 or 7ii7 increase ! fee rev5ue & fees "u ?is section if su* an adju/m5t is necess>y to provide = n m ?an #ba weeks ( op]at+ res]ves ( c>ryov] us] fees = ! process = ! review ( biosimil> biological product applications4 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 7#d7 ,fiscal ye> #bjah adju/m5t 7,a7 ,9 g5]al ,= fiscal ye> #bjah1 ! ,secret>y %all adju/ ! fee rev5ue & fees "u ?is section 9 su* am\nt 7if any7 z ne$$ to reflect an updat$ assessm5t ( ! workload = ! process = ! review ( biosimil> biological product applications4 7,b7 ,me?odology ,! ,secret>y %all publi% "u p>agraph 7#e77;,b7 a description ( ! me?odology us$ to calculate ! fiscal ye> #bjah adju/m5t "u ?is p>agraph 9 ! ,f$]al ,regi/] notice e/abli%+ fee rev5ue & fees = fiscal ye> #bjah4 7,c7 ,limitation ,no adju/m5t "u ?is p>agraph %all result 9 an increase 9 fee rev5ue & fees "u ?is section 9 excess ( #i1jjj1jjj4 7#e7 ,annual fee sett+ ,= fiscal ye> #bjah & ea* subsequ5t fiscal ye>1 ! ,secret>y %all1 n lat] ?an #fj days be=e ! />t ( ea* su* fiscal ye>-- 7,a7 e/abli%1 = ! fiscal ye>1 initial & annual biosimil> biological product developm5t fees & reactivation fees "u subsection 7a77#a71 biosimil> biological product application fees "u subsection 7a77#b71 & biosimil> biological product program fees "u subsection 7a77#c71 bas$ on ! rev5ue am\nts e/abli%$ "u subsection 7b7 & ! adju/m5ts provid$ "u ?is subsection2 & 7,b7 publi% su* fee rev5ue & fees 9 ! ,f$]al ,regi/]4 7#f7 ,limit ,! total am\nt ( fees assess$ = a fiscal ye> "u ?is section may n exce$ ! total co/s = su* fiscal ye> = ! res\rces allocat$ = ! process = ! review ( biosimil> biological product applications4 4 7d7 ,application fee waiv] = small bus9ess ,subsection 7d77#a7 ( section #gdd;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb71 z r$esignat$ by subsection 7c77#a71 is am5d$-- 7#a7 by /rik+ subp>agraph 7,b72 7#b7 by /rik+ 2 & at ! end ( subp>agraph 7,a7 & ins]t+ a p]iod2 & 7#c7 by /rik+ %all pay-- & all t foll[s ?r\gh application fees & ins]t+ %all pay application fees4 7e7 ,effect ( failure ,to pay fees ,subsection 7e7 ( section #gdd;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb71 z r$esignat$ by subsection 7c77#a71 is am5d$ by /rik+ all fees & ins]t+ all su* fees4 7f7 ,cr$it+ & availability ( fees ,subsection 7f7 ( section #gdd;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb71 z r$esignat$ by subsection 7c77#a71 is am5d$-- 7#a7 9 p>agraph 7#b7-- 7,a7 by /rik+ subp>agraph 7,c7 7relat+ to fee collection dur+ fir/ program ye>7 & ins]t+ ! foll[+3 7,c7 ,compliance ,! ,secret>y %all be consid]$ to h met ! requirem5ts ( subp>agraph 7,b7 9 any fiscal ye> if ! co/s describ$ 9 su* subp>agraph are n m ?an #ae p]c5t bel[ ! level specifi$ 9 su* subp>agraph4 2 & 7,b7 9 subp>agraph 7,d7-- 7i7 9 ! head+1 by /rik+ 9 subsequ5t ye>s2 & 7ii7 by /rik+ 7aft] fiscal ye> #bjac72 & 7#b7 9 p>agraph 7#c71 by /rik+ #bjac ?r\gh #bjag & ins]t+ #bjah ?r\gh #bjbb4 #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 7a7-- 7,a7 by /rik+ #bjac & ins]t+ #bjah2 & 7,b7 by /rik+ ,biosimil> ,us] ,fee ,act ( #bjab & ins]t+ ,biosimil> ,us] ,fee ,am5dm5ts ( #bjag2 7#b7 9 subsection 7b71 by /rik+ #bjac & ins]t+ #bjah2 7#c7 by /rik+ subsection 7d72 7#d7 by r$esignat+ subsection 7e7 z subsection 7d72 & 7#e7 9 subsection 7d71 z s r$esignat$1 by /rik+ #bjag ea* place x appe>s & ins]t+ #bjbb4 #dje4 ,sunset dates 7a7 ,au?orization ,sections #gdd;,g & #gdd;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act %all cease to be effective ,octob] #a1 #bjbb4 7b7 ,report+ ,requirem5ts ,section #gdd;,i ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act %all cease to be effective ,janu>y #ca1 #bjbc4 7c7 ,previ\s ,sunset ,provision 7#a7 ,9 g5]al ,effective ,octob] #a1 #bjag1 section #djd ( ! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act 7,public ,law #aab-add7 is repeal$4 7#b7 ,con=m+ am5dm5t ,! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act 7,public ,law #aab-add7 is am5d$ 9 ! table ( cont5ts 9 section #b by /rik+ ! item relat+ to section #djd4 #djf4 ,effective date ,! am5dm5ts made by ?is title %all take effect on ,octob] #a1 #bjag1 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 %all be assess$ = all biosimil> biological product applications receiv$ on or aft] ,octob] #a1 #bjag1 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 ,act1 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 #bjab1 b be=e ,octob] #a1 #bjag1 ) respect to assess+ & collect+ any fee requir$ by su* "p = a fiscal ye> prior to fiscal ye> #bjah4 ,v ,p$iatric drugs & devices #eja4 ,be/ ph>maceuticals = *ildr5 ,section #dji;,i ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhdm7 is am5d$-- 7#a7 9 subsection 7a77#b77;,a77ii71 by ins]t+ & id5tification ( biom>k]s = su* diseases1 disord]s1 or conditions1 aft] biologics12 7#b7 9 subsection 7c7-- 7,a7 9 p>agraph 7#f7-- 7i7 by am5d+ subp>agraph 7,b7 to read z foll[s3 7,b7 ,availability ( reports 7i7 ,9 g5]al ,ea* report submitt$ "u subp>agraph 7,a7 %all be consid]$ to be 9 ! public doma9 7subject to section #eje;,a7d77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act7 & n lat] ?an #ij days aft] submission ( su* report1 %all be-- 7,i7 po/$ on ! int]net website ( ! ,national ,in/itutes ( ,heal? 9 a mann] t is accessible & consi/5t ) all applicable ,f$]al laws & regulations1 includ+ su* laws & regulations = ! protection (-- 7aa7 human rese>* p>ticipants1 includ+ ) respect to privacy1 security1 in=m$ cons5t1 & protect$ heal? in=mation2 & 7bb7 propriet>y int]e/s1 confid5tial comm]cial in=mation1 & intellectual prop]ty rights2 & 7,,ii7 assign$ a docket numb] by ! ,commission] ( ,food & ,drugs & made available = ! submission ( public comm5ts4 7ii7 ,submission ( comm5ts ,an int]e/$ p]son may submit writt5 comm5ts conc]n+ su* p$iatric /udies to ! ,commission] ( ,food & ,drugs1 & ! submitt$ comm5ts %all become "p ( ! docket file ) respect to ea* ( ! drugs4 2 & 7ii7 9 subp>agraph 7,c71 by /rik+ appropriate action & all t foll[s ?r\gh ! p]iod & ins]t+ action 9 a timely & appropriate mann] 9 response to ! reports submitt$ "u subp>agraph 7,a71 & %all beg9 su* action ^u receipt ( ! report "u subp>agraph 7,a71 9 accordance ) p>agraph 7#g742 & 7,b7 9 p>agraph 7#g7-- 7i7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ ,dur+ & ins]t+ ,)92 7ii7 9 subp>agraph 7,c77i71 by /rik+ place & all t foll[s ?r\gh & ( & ins]t+ include 9 ! public docket file a ref]5ce to ! location ( ! report on ! int]net website ( ! ,national ,in/itutes ( ,heal? & a copy (2 & 7iii7 9 clause 7ii71 by /rik+ 9 ! ,f$]al ,regi/] &2 7#c7 by /rik+ subsection 7d72 7#d7 by r$esignat+ subsection 7e7 z subsection 7d72 & 7#e7 9 p>agraph 7#a7 ( subsection 7d71 z s r$esignat$1 by /rik+ #bjac ?r\gh #bjag & ins]t+ #bjah ?r\gh #bjbb4 #ejb4 ,p$iatric devices 7a7 ,p$iatric use ( devices ,section #eae;,a7a77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e-#a7;a77#c77 is am5d$-- 7#a7 by r$esignat+ subp>agraphs 7,b7 ?r\gh 7,d7 z subp>agraphs 7,d7 ?r\gh 7,f71 respectively2 7#b7 by ins]t+ aft] subp>agraph 7,a7 ! foll[+3 7,b7 any in=mation1 bas$ on a review ( data available to ! ,secret>y1 reg>d+ devices us$ 9 p$iatric pati5ts b n label$ = su* use = :i* ! ,secret>y det]m9es t approv$ p$iatric label+ c\ld conf] a b5efit to p$iatric pati5ts2 7,c7 ! numb] ( p$iatric devices t receive a humanit>ian use exemption "u section #ebj7m72 2 7#c7 9 subp>agraph 7,e71 z s r$esignat$1 by /rik+ 2 & & ins]t+ 22 7#d7 9 subp>agraph 7,f7 7z s r$esignat$71 by /rik+ 7,b71 & 7,c74 & ins]t+ 7,c71 7,d71 & 7,e722 & 7#e7 by add+ at ! end ! foll[+3 7,g7 ! numb] ( devices = :i* ! ,secret>y reli$ on data ) respect to adults to support a det]m9ation ( a reasonable assurance ( safety & effectiv5ess 9 p$iatric pati5ts2 & 7,h7 ! numb] ( devices = :i* ! ,secret>y reli$ on data f "o p$iatric subpopulation to support a det]m9ation ( a reasonable assurance ( safety & effectiv5ess 9 ano!r p$iatric subpopulation4 ,= ! items describ$ 9 ?is p>agraph1 su* report %all disaggregate ! numb] ( devices by p$iatric subpopulation4 4 7b7 ,humanit>ian device exemption ,section #ebj7m7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7m77 is am5d$-- 7#a7 9 p>agraph 7#d7-- 7,a7 9 subp>agraph 7,b71 by ins]t+ or an appropriate local committee aft] review committee ea* place su* t]m appe>s2 & 7,b7 9 ! matt] foll[+ subp>agraph 7,b71 by ins]t+ or an appropriate local committee aft] review committee ea* place su* t]m appe>s2 & 7#b7 9 p>agraph 7#f77;,a77iv71 by /rik+ #bjag & ins]t+ #bjbb4 7c7 ,demon/ration grants = improv+ p$iatric availability ,section #cje ( ! ,p$iatric ,m$ical ,device ,safety & ,improvem5t ,act ( #bjjg 7,public ,law #aaj-he2 #db ,u4,s4,c4 #bhb note77 is am5d$-- 7#a7 9 subsection 7c7-- 7,a7 9 p>agraph 7#d71 by /rik+ & at ! end2 7,b7 9 p>agraph 7#e71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+3 7#f7 provid+ regulatory consultation to device sponsors 9 support ( ! submission ( an application = a p$iatric device1 :]e appropriate4 2 & 7#b7 9 subsection 7e71 by /rik+ #bjac ?r\gh #bjag & ins]t+ #bjah ?r\gh #bjbb4 7d7 ,meet+ on p$iatric device developm5t 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all conv5e a public meet+ on ! developm5t1 approval or cle>ance1 & label+ ( p$iatric m$ical devices4 ,! ,secret>y %all invite to su* meet+ repres5tatives f ! m$ical device indu/ry1 academia1 recipi5ts ( fund+ "u section #cje ( ! ,p$iatric ,m$ical ,device ,safety & ,improvem5t ,act ( #bjjg 7,public ,law #aaj-he2 #db ,u4,s4,c4 #bhb note71 m$ical provid] organizations1 & organizations repres5t+ pati5ts & consum]s4 7#b7 ,topics ,! meet+ describ$ 9 p>agraph 7#a7 %all include consid]ation ( ways to-- 7,a7 improve rese>* infra/ructure & rese>* networks to facilitate ! conduct ( cl9ical /udies ( devices = p$iatric populations t w\ld result 9 ! approval or cle>ance1 & label+1 ( m$ical devices = su* populations2 7,b7 appropriately use extrapolation "u section #eae;,a7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e-#a7;b772 7,c7 enhance ! appropriate use ( po/m>ket regi/ries & data to increase p$iatric m$ical device label+2 7,d7 increase ,food & ,drug ,adm9i/ration assi/ance to m$ical device manufactur]s 9 develop+ devices = p$iatric populations t are approv$ or cle>$1 & label$1 = _! use2 & 7,e7 id5tify curr5t b>ri]s to p$iatric device developm5t & inc5tives to address su* b>ri]s4 7#c7 ,report ,! report submitt$ "u section #eae;,a7a77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e-#a7;a77#c77 ) respect to ! cal5d> ye> 9 :i* ! meet+ describ$ 9 p>agraph 7#a7 is held %all include a summ>y (1 & responses to1 recomm5dations rais$ 9 su* meet+4 #ejc4 ,e>ly meet+ on p$iatric /udy plan 7a7 ,9 g5]al ,clause 7i7 ( section #eje;,b7e77#b77;,c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7e77#b77;,c77 is am5d$ to read z foll[s3 7i7 %all meet ) ! applicant-- 7,i7 if reque/$ by ! applicant ) respect to a drug or biological product t is int5d$ to treat a s]i\s or life-?reat5+ disease or condition1 to discuss prep>ation ( ! initial p$iatric /udy plan1 n lat] ?an ! end-(-,phase #a meet+ 7z su* t]m is us$ 9 section #cab4hb7;b7 ( title #ba1 ,code ( ,f$]al ,regulations1 or successor regulations7 or )9 #cj cal5d> days ( receipt ( su* reque/1 :i*ev] is lat]2 7,,ii7 to discuss ! initial p$iatric /udy plan z soon z practicable1 b n lat] ?an #ij cal5d> days aft] ! receipt ( su* plan "u subp>agraph 7,a72 & 7,,iii7 to discuss ! bases = ! def]ral "u subsection 7a77#d7 or a full or p>tial waiv] "u subsection 7a77#e72 4 7b7 ,con=m+ *anges ,section #eje;,b7e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7e77 is am5d$-- 7#a7 9 ! head+ ( p>agraph 7#b71 by /rik+ meet+ & ins]t+ meet+s2 7#b7 9 ! head+ ( p>agraph 7#b77;,c71 by /rik+ ,meet+ & ins]t+ ,meet+s2 7#c7 9 clauses 7ii7 & 7iii7 ( p>agraph 7#b77;,c71 by /rik+ no meet+ ea* place x appe>s & ins]t+ no meet+ "u clause 7i77,,ii72 & 7#d7 9 p>agraph 7#c7 by /rik+ meet+ "u p>agraph 7#b77;,c77i7 & ins]t+ meet+ "u p>agraph 7#b77;,c77i77,,ii74 #ejd4 ,developm5t ( drugs & biological products = p$iatric canc]s 7a7 ,molecul> t>gets reg>d+ canc] drugs & biological products ,section #eje;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a7-- 7i7 by r$esignat+ subp>agraphs 7,a7 & 7,b7 z clauses 7i7 & 7ii71 respectively1 & adju/+ ! m>g9s accord+ly2 7ii7 by /rik+ ,a p]son & ins]t+ ! foll[+3 7,a7 ,g5]al requirem5ts ,except ) respect to an application = :i* subp>agraph 7,b7 applies1 a p]son 2 7iii7 9 clause 7i71 z s r$esignat$1 by /rik+ 1 or at ! end & ins]t+ 2 or2 & 7iv7 by add+ aft] subp>agraph 7,a71 z s designat$ by clause 7ii71 ! foll[+3 7,b7 ,c]ta9 molecul>ly t>get$ canc] indications ,a p]son t submits1 on or aft] ! date t is #c ye>s aft] ! date ( enactm5t ( ! ,,fda ,reau?orization ,act ( #bjag1 an orig9al application = a new active +r$i5t "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 %all submit ) ! application reports on ! inve/igation describ$ 9 p>agraph 7#c7 if ! drug or biological product t is ! subject ( ! application is-- 7i7 int5d$ = ! treatm5t ( an adult canc]2 & 7ii7 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 2 7,b7 9 p>agraph 7#b77;,a71 by /rik+ p>agraph 7#a7 & ins]t+ p>agraph 7#a77;,a72 7,c7 by r$esignat+ p>agraphs 7#c7 & 7#d7 z p>agraphs 7#d7 & 7#e71 respectively2 7,d7 by ins]t+ aft] p>agraph 7#b7 ! foll[+3 7#c7 ,molecul>ly t>get$ p$iatric canc] inve/igation 7,a7 ,9 g5]al ,) respect to a drug or biological product describ$ 9 p>agraph 7#a77;,b71 ! inve/igation describ$ 9 ?is p>agraph is a molecul>ly t>get$ p$iatric canc] inve/igation1 :i* %all be design$ to yield cl9ically mean+ful p$iatric /udy data1 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 7,b7 ,extrapolation ( data ,p>agraph 7#b77;,b7 %all apply to inve/igations describ$ 9 ?is p>agraph to ! same ext5t & 9 ! same mann] z p>agraph 7#b77;,b7 applies ) respect to ! assessm5ts requir$ "u p>agraph 7#a77;,a74 7,c7 ,def]rals & waiv]s ,def]rals & waiv]s "u p>agraphs 7#d7 & 7#e7 %all apply to inve/igations describ$ 9 ?is p>agraph to ! same ext5t & 9 ! same mann] z su* def]rals & waiv]s apply ) respect to ! assessm5ts "u p>agraph 7#b77;,b74 2 7,e7 9 p>agraph 7#d71 z s r$esignat$-- 7i7 by /rik+ assessm5ts requir$ "u p>agraph 7#a7 ea* place x appe>s & ins]t+ assessm5ts requir$ "u p>agraph 7#a77;,a7 or reports on ! inve/igation requir$ "u p>agraph 7#a77;,b72 7ii7 9 subp>agraph 7,a77ii77,i71 by ins]t+ or reports on ! inve/igation aft] assessm5ts2 7iii7 9 subp>agraph 7,b77ii71 by /rik+ assessm5t "u p>agraph 7#a7 & ins]t+ assessm5t "u p>agraph 7#a77;,a7 or reports on ! inve/igation "u p>agraph 7#a77;,b72 & 7iv7 9 subp>agraph 7,c77ii77,,ii71 by ins]t+ or inve/igation aft] assessm5t2 & 7,f7 9 p>agraph 7#e71 z s r$esignat$1 by ins]t+ or reports on ! inve/igation aft] assessm5ts ea* place x appe>s2 7#b7 9 subsection 7d7-- 7,a7 by /rik+ subsection 7a77#c7 ea* place x appe>s & ins]t+ subsection 7a77#d72 7,b7 by ins]t+ & reports on ! inve/igation aft] submission ( assessm5ts 9 ! head+2 & 7,c7 by ins]t+ or ! inve/igation describ$ 9 subsection 7a77#c7 aft] assessm5t describ$ 9 subsection 7a77#b7 ea* place x appe>s2 7#c7 9 subsection 7e7-- 7,a7 9 p>agraph 7#a71 by ins]t+ or ! inve/igation describ$ 9 subsection 7a77#c7 aft] "u subsection 7a77#b72 & 7,b7 9 p>agraph 7#b77;,a77i71 by ins]t+ or ! inve/igation describ$ 9 subsection 7a77#c7 aft] "u subsection 7a77#b72 & 7#d7 by add+ at ! end ! foll[+3 7m7 ,li/ ( prim>y molecul> t>gets 7#a7 ,9 g5]al ,)9 "o ye> ( ! date ( enactm5t ( ! ,,fda ,reau?orization ,act ( #bjag1 ! ,secret>y %all e/abli% & update regul>ly1 & %all publi% on ! int]net website ( ! ,food & ,drug ,adm9i/ration-- 7,a7 a li/ ( molecul> t>gets consid]$1 on ! basis ( data ! ,secret>y det]m9es to be adequate1 to be sub/antially relevant to ! gr[? & progression ( a p$iatric canc]1 & t may trigg] ! requirem5ts "u ?is section2 & 7,b7 a li/ ( molecul> t>gets ( new canc] drugs & biological products 9 developm5t = :i* p$iatric canc] /udy requirem5ts "u ?is section w be automatically waiv$4 7#b7 ,consultation ,9 e/abli%+ ! li/s describ$ 9 p>agraph 7#a71 ! ,secret>y %all consult ! ,national ,canc] ,in/itute1 memb]s ( ! int]nal committee "u section #eje;,c1 & ! ,p$iatric ,oncology ,subcommittee ( ! ,oncologic ,drugs ,advisory ,committee1 & %all take into acc\nt comm5ts f ! meet+ "u subsection 7c74 7#c7 ,rule ( con/ruction ,no?+ 9 p>agraph 7#a7 %all be con/ru$-- 7,a7 to require ! inclusion ( a molecul> t>get on ! li/ publi%$ "u su* p>agraph z a condition = trigg]+ ! requirem5ts "u subsection 7a77#a77;,b7 ) respect to a drug or biological product direct$ at su* molecul> t>get2 or 7,b7 to au?orize ! disclosure ( confid5tial comm]cial in=mation1 z prohibit$ "u section #cja7;j7 ( ?is ,act or section #aije ( title #ah1 ,unit$ ,/ates ,code4 4 7b7 ,orphan drugs ,section #eje;,b7k7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7k77 is am5d$ to read z foll[s3 7k7 ,relation to orphan drugs 7#a7 ,9 g5]al2 exemption = orphan indications ,unless ! ,secret>y requires o!rwise by regulation & except z provid$ 9 p>agraph 7#b71 ?is section does n apply to any drug or biological product = an indication = :i* orphan designation has be5 grant$ "u section #ebf4 7#b7 ,applicability despite orphan designation ( c]ta9 indications ,?is section %all apply ) respect to a drug or biological product = :i* an indication has be5 grant$ orphan designation "u #ebf if ! inve/igation describ$ 9 subsection 7a77#c7 applies to ! drug or biological product z describ$ 9 subsection 7a77#a77;,b74 4 7c7 ,meet+1 consultation1 & guidance 7#a7 ,meet+ ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is subsection z ! ,secret>y71 act+ ?r\gh ! ,commission] ( ,food & ,drugs & 9 collaboration ) ! ,director ( ! ,national ,canc] ,in/itute1 %all conv5e a public meet+ n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act to solicit fe$back f physicians & rese>*]s 7includ+ p$iatric oncologi/s & r>e disease speciali/s71 pati5ts1 & o!r /akehold]s to provide input on developm5t ( ! guidance "u p>agraph 7#b7 & ! li/ "u subsection 7m7 ( section #eje;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c71 z add$ by subsection 7a74 ,! ,secret>y %all seek input at su* meet+ on-- 7,a7 ! data necess>y to det]m9e t !re is sci5tific evid5ce t a drug or biological product is direct$ at a molecul> t>get t is consid]$ to be sub/antially relevant to ! gr[? or progression ( a p$iatric canc]2 7,b7 ! data necess>y to det]m9e t !re is sci5tific evid5ce t a molecul> t>get is consid]$ to be sub/antially relevant to ! gr[? or progression ( a p$iatric canc]2 7,c7 ! data ne$$ to meet ! requirem5t ( conduct+ an inve/igation describ$ 9 section #eje;,b7a77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z am5d$ by subsection 7a72 7,d7 consid]ations :5 develop+ ! li/ "u section #eje;,b7m7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act t conta9s molecul> t>gets %>$ betwe5 diff]5t tumor types2 7,e7 ! process ! ,secret>y %all utilize to update regul>ly a li/ ( molecul> t>gets t may trigg] a p$iatric /udy "u section #eje;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z s am5d$1 & h[ (t5 su* updates %all occur2 7,f7 h[ to ov]come ! *all5ges relat$ to p$iatric canc] drug & biological product developm5t1 includ+ issues relat$ to ! e?ical1 practical1 & o!r b>ri]s to conduct+ cl9ical trials 9 p$iatric canc] ) small pati5t populations2 7,g7 sci5tific or op]ational *all5ges associat$ ) p]=m+ an inve/igation describ$ 9 section #eje;,b7a77#a77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 includ+ ! effect on p$iatric /udies curr5tly und]way 9 a p$iatric pati5t population1 treatm5t ( a p$iatric pati5t population1 & ! ability to complete adult cl9ical trials2 7,h7 ! advantages & disadvantages ( innovative cl9ical trial designs 9 address+ ! developm5t ( canc] drugs or biological products direct$ at molecul> t>gets 9 p$iatric canc] pati5ts2 7,i7 ! ways 9 :i* ! ,secret>y c improve ! curr5t process outl9$ "u sections #eje;,a & #eje;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a1 #cee;c7 to enc\rage additional rese>* & developm5t ( p$iatric canc] treatm5ts2 7,j7 ! ways 9 :i* ! ,secret>y might /reaml9e & improve ! writt5 reque/ process1 includ+ :5 /udies conta9$ 9 a reque/ "u su* section #eje;,a are n feasible due to ! e?ical1 practical1 or o!r b>ri]s to conduct+ cl9ical trials 9 p$iatric canc] populations2 7,k7 h[ ! ,secret>y w facilitate collaboration among p$iatric networks1 academic c5t]s & exp]ts 9 p$iatric canc] to conduct an inve/igation describ$ 9 su* section #eje;,b7a77#c72 7,l7 h[ ! ,secret>y may facilitate collaboration among sponsors ( same-9-class drugs & biological products t w\ld be subject to ! requirem5ts = an inve/igation "u su* section #eje;,b bas$ on %>$ molecul> t>gets2 & 7,m7 ! ways 9 :i* ! ,secret>y w help to mitigate ! risks1 if any1 ( disc\rag+ ! rese>* & developm5t ( orphan drugs :5 implem5t+ su* section #eje;,b z am5d$4 7#b7 ,guidance ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all issue f9al guidance on implem5tation ( ! am5dm5ts to section #eje;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7 reg>d+ molecul>ly t>get$ canc] drugs made by ?is section1 includ+-- 7,a7 ! sci5tific crit]ia1 types ( data1 & regulatory consid]ations = det]m9+ :e!r a molecul> t>get is sub/antially relevant to ! gr[? or progression ( a p$iatric canc] & w\ld trigg] an inve/igation "u section #eje;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z am5d$2 7,b7 ! process by :i* ! ,secret>y w engage ) sponsors to discuss det]m9ations1 inve/igation requirem5ts1 def]rals1 waiv]s1 & any o!r issues t ne$ to be resolv$ to ensure t any requir$ inve/igation bas$ on a molecul> t>get c be reasonably conduct$2 7,c7 ! sci5tific or op]ational *all5ges = :i* ! ,secret>y may issue def]rals or waiv]s = an inve/igation describ$ 9 subsection 7a77#c7 ( su* section #eje;,b1 includ+ adv]se impacts on curr5t p$iatric /udies und]way 9 a p$iatric pati5t population1 /udies involv+ drugs designat$ z orphan drugs1 treatm5t ( a p$iatric pati5t population1 or ! ability to complete adult cl9ical trials2 7,d7 h[ ! ,secret>y & sponsors w facilitate collaboration among p$iatric networks1 academic c5t]s1 & exp]ts 9 p$iatric canc] to conduct an inve/igation describ$ 9 subsection 7a77#c7 ( su* section #eje;,b2 7,e7 sci5tific & regulatory consid]ations = /udy designs1 includ+ ! applicability ( innovative cl9ical trial designs = p$iatric canc] drug & biological product developm5ts "u sections #eje;,a & #eje;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a1 #cee;c72 7,f7 approa*es to /reaml9e & improve ! am5dm5t process1 includ+ :5 /udies conta9$ 9 a reque/ "u su* section #eje;,a are n feasible due to ! e?ical1 practical1 or o!r b>ri]s to conduct+ cl9ical trials 9 p$iatric canc] populations2 7,g7 ! process = submission ( an initial p$iatric /udy plan = ! inve/igation describ$ 9 section #eje;,b7a77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77#c771 includ+ ! process = a sponsor to meet & rea* agreem5t ) ! ,secret>y on ! initial p$iatric /udy plan2 & 7,h7 consid]ations = implem5tation ( su* section #eje;,b1 z s am5d$1 & waiv]s ( ! requirem5ts ( su* section #eje;,b ) reg>d to molecul> t>gets = :i* sev]al drugs or biological products may be "u inve/igation4 7d7 ,report to ,congress ,section #ejh7;b7 ( ! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act 7#ba ,u4,s4,c4 #cee;c-#a7;b77 is am5d$-- 7#a7 9 p>agraph 7#aj71 by /rik+ 2 & & ins]t+ 22 & 7#b7 by /rik+ p>agraph 7#aa7 & ins]t+ ! foll[+3 7#aa7 an assessm5t ( ! impact ( ! am5dm5ts to su* section #eje;,b made by ! ,,fda ,reau?orization ,act ( #bjag on p$iatric rese>* & label+ ( drugs & biological products & p$iatric label+ ( molecul>ly t>get$ drugs & biological products = ! treatm5t ( canc]2 7#ab7 an assessm5t ( ! ef=ts ( ! ,secret>y to implem5t ! plan develop$ "u section #eje;,c-#a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 reg>d+ e>li] submission ( p$iatric /udies "u sections #eje;,a & #eje;,b ( su* ,act & section #cea7m7 ( ! ,public ,heal? ,s]vice ,act1 includ+-- 7,a7 ! av]age l5g? ( "t aft] ! approval ( an application "u section #eje7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#a77 or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a77 be=e /udies conduct$ pursuant to su* section #eje;,a1 #eje;,b1 or section #cea7m7 are complet$1 submitt$1 & incorporat$ into label+2 7,b7 ! av]age l5g? ( "t aft] ! receipt ( a propos$ p$iatric /udy reque/ be=e ! ,secret>y responds to su* reque/2 7,c7 ! av]age l5g? ( "t aft] ! submission ( a propos$ p$iatric /udy reque/ be=e ! ,secret>y issues a writt5 reque/ = su* /udies2 7,d7 ! numb] ( writt5 reque/s issu$ = ea* inve/igational new drug or biological product prior to ! submission ( an application "u section #eje7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act2 & 7,e7 ! av]age numb]1 & range ( numb]s1 ( am5dm5ts to writt5 reque/s issu$1 & ! "t ! ,secret>y requires to review & act on propos$ am5dm5ts to writt5 reque/s2 7#ac7 a li/ ( sponsors ( applications or hold]s ( approv$ applications :o receiv$ exclusivity "u su* section #eje;,a or su* section #cea7m7 aft] receiv+ a lett] issu$ "u su* section #eje;,b7d77#a7 = any drug or biological product be=e ! /udies ref]r$ to 9 su* lett] 7 complet$ & submitt$2 7#ad7 a li/ ( assessm5ts & inve/igations requir$ "u su* section #eje;,b2 7#ae7 h[ _m reque/s "u su* section #eje;,a = molecul> t>get$ canc] drugs1 z def9$ by subsection 7a77#a77;,b7 ( su* section #eje;,b1 approv$ prior to #c ye>s aft] ! date ( enactm5t ( ! ,,fda ,reau?orization ,act ( #bjag1 h be5 issu$ by ! ,food & ,drug ,adm9i/ration1 & h[ _m su* reque/s h be5 complet$2 & 7#af7 ! ,secret>y's assessm5t ( ! ov]all impact ( ! am5dm5ts made by section #ejd ( ! ,,fda ,reau?orization ,act ( #bjag on ! conduct & effectiv5ess ( p$iatric canc] rese>* & ! orphan drug program1 z well any subsequ5t recomm5dations4 4 7e7 ,rule ( con/ruction ,no?+ 9 ?is section1 includ+ ! am5dm5ts made by ?is section1 %all limit ! au?ority ( ! ,secret>y ( ,heal? & ,human ,s]vices to issue writt5 reque/s "u section #eje;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7 or section #cea7m7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7m771 or to negotiate or implem5t am5dm5ts to su* reque/s propos$ by ! an applicant4 7f7 ,,gao report 7#a7 ,9 g5]al ,beg9n+ on ! date t is #e 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 ?is section1 9 ! developm5t ( drugs & biological products = p$iatric canc] indications4 ,! ,comptroll] ,g5]al %all exam9e-- 7,a7 ! indications & associat$ molecul> t>gets /udi$ 9 assessm5ts & inve/igations requir$ = drugs or biological products int5d$ = ! treatm5t ( an adult canc]2 7,b7 ! indication = :i* ! /udy 0 reque/$ z comp>$ to ! indication reque/$ "u ! new drug application fil$ by ! sponsor2 7,c7 ! numb] ( p$iatric canc] indications = :i* assessm5ts & inve/igations h be5 requir$ "u su* section #eje;,b2 7,d7 ! numb] ( reque/s = def]ral & waiv] ( p$iatric assessm5ts & inve/igations requir$ "u su* section & ! numb] ( su* def]ral & waiv] reque/s grant$ & d5i$2 7,e7 ! numb] ( orphan-designat$ indications = drugs & biological products = :i* assessm5ts & inve/igations 7 requir$ "u su* section2 7,f7 ! numb] ( drugs & biological products approv$ = ! treatm5t ( canc] 9 ! p$iatric population = :i* ! supportive /udies 7 requir$ to be conduct$ "u su* section2 7,g7 ! numb] ( writt5 reque/s made "u section #eje;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7 relat+ to inve/igations requir$ "u subsection 7a77#a77;,b7 ( su* section #eje;,b2 & 7,h7 any additional consid]ations by ! ,secret>y reg>d+ ! effectiv5ess ( requir+ p$iatric assessm5ts describ$ 9 su* section #eje;,b 9 ! developm5t ( drugs & biological products = p$iatric canc] indications4 7#b7 ,review ,! /udy "u p>agraph 7#a7 %all include a review ( ! ,food & ,drug ,adm9i/ration's use ( ! au?ority "u section #eje;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c71 z am5d$ by ?is section1 includ+ ! am5dm5ts to ! def]ral & waiv] crit]ia "u su* section & h[ su* crit]ia h be5 appli$4 7#c7 ,consultation ,9 conduct+ ! /udy "u p>agraph 7#a71 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all consult ) appropriate /akehold]s t may be requir$ to conduct ! trials "u section #eje;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 & ! ability ( su* /akehold]s to adh]e to ! reque/s issu$ by ! ,food & ,drug ,adm9i/ration4 7#d7 ,report ,n lat] ?an ! date t is #f ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit a report conta9+ ! results ( ! /udy "u p>agraph 7#a7 to ! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate1 & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 #eje4 ,additional provisions on developm5t ( drugs & biological products = p$iatric use 7a7 ,in=m+ int]nal review committee ,section #eje;,a7f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7f77 is am5d$ by add+ at ! end ! foll[+3 7#g7 ,in=m+ int]nal review committee ,! ,secret>y %all provide to ! committee ref]r$ to 9 p>agraph 7#a7 any response issu$ to an applicant or hold] ) respect to a propos$ p$iatric /udy reque/4 4 7b7 ,action on ,submissions 7#a7 ,9 g5]al ,section #eje;,a7d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7d77 is am5d$-- 7,a7 by r$esignat+ p>agraphs 7#c7 ?r\gh 7#e7 z p>agraphs 7#d7 ?r\gh 7#f71 respectively2 & 7,b7 by ins]t+ aft] p>agraph 7#b7 ! foll[+3 7#c7 ,action on submissions ,! ,secret>y %all review & act ^u a submission by a sponsor or hold] ( a propos$ p$iatric /udy reque/ or a propos$ am5dm5t to a writt5 reque/ = p$iatric /udies )9 #abj cal5d> days ( ! submission4 4 7#b7 ,con=m+ am5dm5ts 7,a7 ,f$]al ,food1 ,drug1 & ,cosmetic ,act ,section #eje;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a71 z am5d$ by p>agraph 7#a71 is fur!r am5d$ by /rik+ subsection 7d77#c7 ea* place x appe>s & ins]t+ 7d77#d74 7,b7 ,public ,heal? ,s]vice ,act ,p>agraphs 7#b71 7#c71 & 7#d7 ( section #cea7m7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7m77 are am5d$ by /rik+ section #eje;,a7d77#c7 ea* place x appe>s & ins]t+ section #eje;,a7d77#d74 7c7 ,plan ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! int]nal review committee e/abli%$ "u section #eje;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;d7 %all1 n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is ,act1 develop & implem5t a plan to a*ieve1 :5 appropriate1 e>li] submission ( p$iatric /udies "u section #eje;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7 or section #cea7m7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7m774 ,su* plan %all include recomm5dations to a*ieve-- 7#a7 e>li] discussion ( propos$ p$iatric /udy reque/s & writt5 reque/s ) sponsors1 & if appropriate1 discussion ( su* reque/s at ! meet+ requir$ "u section #eje;,b7e77#b77;,c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7e77#b77;,c771 z am5d$ by section #ejc7;a72 7#b7 e>li] issuance ( writt5 reque/s = a p$iatric /udy "u su* section #eje;,a1 includ+ = inve/igational new drugs prior to ! submission ( an application "u section #eje7;b77#a7 ( su* ,act 7#ba ,u4,s4,c4 #cee7;b77#a772 & 7#c7 %ort] timel9es1 :5 appropriate1 = ! completion ( /udies pursuant to a writt5 reque/ "u su* section #eje;,a or su* section #cea7m74 7d7 ,neonatology ,exp]tise 7#a7 ,9 g5]al ,section #f7;d7 ( ! ,be/ ,ph>maceuticals = ,*ildr5 ,act 7#ba ,u4,s4,c4 #cic;a7d77 is am5d$ by /rik+ ,= ! #e-ye> p]iod beg9n+ on ! date ( enactm5t ( ?is subsection1 at & ins]t+ ,at4 7#b7 ,draft guidance ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all issue draft guidance on cl9ical ph>macology consid]ations = neonatal /udies = drugs & biological products4 7e7 ,submission ( ,assessm5ts ,section #eje;,b7d77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7d77#a77 is am5d$ by add+ at ! end ! foll[+3 ,! ,secret>y %all in=m ! ,p$iatric ,advisory ,committee ( lett]s issu$ "u ?is p>agraph & responses to su* lett]s44 7f7 ,int]nal ,committee ,section #eje;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;d7 is am5d$ by ins]t+ or p$iatric r>e diseases aft] psy*iatry4 7g7 ,report on label+ ( orphan drugs 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ! ,committee on ,heal?1 ,education1 ,labor & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 & make publicly available1 includ+ ?r\gh po/+ on ! int]net website ( ! ,food & ,drug ,adm9i/ration1 a report on ! lack ( in=mation 9 ! label+ ( drugs = indications t h receiv$ an orphan designation "u section #ebf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7 ) respect to ! use ( su* drugs p$iatric populations4 7#b7 ,cont5ts ,! report describ$ 9 p>agraph 7#a7 %all include-- 7,a7 a li/ ( drugs = :i*-- 7i7 an indication 0 grant$ an orphan designation "u section #ebf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb72 7ii7 an application describ$ "u section #eje;,b7a77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77#a77 = su* indication 0 submitt$ to ! ,secret>y ( ,heal? & ,human ,s]vices on or aft] ,april #a1 #aiii2 & 7iii7 ! label+ = su* indication lacks important p$iatric in=mation1 includ+ in=mation relat$ to safety1 dos+1 & effectiv5ess2 7,b7 a description ( ! lack ( in=mation ref]r$ to 9 subp>agraph 7,a77iii7 = ea* drug = an indication on su* li/2 & 7,c7 ,f$]al policy recomm5dations to improve ! label+ ( drugs = indications t h receiv$ an orphan designation "u su* section #ebf ) respect to ! use ( su* drugs p$iatric populations40 ,,vi ,reau?orizations & improvem5ts relat$ to drugs #fja4 ,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+ #bjag & ins]t+ #bjbb4 #fjb4 ,reau?orization ( ! critical pa? public-private p>tn]%ips ,section #eff7;f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#e7;f77 is am5d$ by /rik+ #bjac ?r\gh #bjag & ins]t+ #bjah ?r\gh #bjbb4 #fjc4 ,reau?orization ( orphan grants program ,section #e7;c7 ( ! ,orphan ,drug ,act 7#ba ,u4,s4,c4 #cfj;ee7c77 is am5d$ by /rik+ #bjac ?r\gh #bjag & ins]t+ #bjah ?r\gh #bjbb4 #fjd4 ,protect+ & /r5g!n+ ! drug supply *a9 7a7 ,div]t$ drugs ,p>agraph 7#a7 ( section #hja7;d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;d77 is am5d$-- 7#a7 by /rik+ 7d77#a7 ,except z & ins]t+ 7d77#a77;,a7 ,except z2 & 7#b7 by add+ at ! end ! foll[+3 7,b7 ,except z au?oriz$ by ! ,secret>y 9 ! case ( a drug t appe>s on ! drug %ortage li/ "u section #ejf;,e or 9 ! case ( importation pursuant to section #hjd1 no drug t is subject to section #ejc7;b77#a7 may be import$ into ! ,unit$ ,/ates = comm]cial use if su* drug is manufactur$ outside ! ,unit$ ,/ates1 unless ! manufactur] has au?oriz$ ! drug to be m>ket$ 9 ! ,unit$ ,/ates & has caus$ ! drug to be label$ to be m>ket$ 9 ! ,unit$ ,/ates4 4 7b7 ,c\nt]feit drugs ,subsection 7b7 ( section #cjc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 is am5d$ by add+ at ! end ! foll[+3 7#h7 ,not)/&+ subsection 7a71 any p]son :o violates section #cja7;i77#c7 by kn[+ly mak+1 sell+ or disp5s+1 or hold+ = sale or disp5s+1 a c\nt]feit drug %all be imprison$ = n m ?an #aj ye>s or f9$ 9 accordance ) title #ah1 ,unit$ ,/ates ,code1 or bo?4 4 #fje4 ,pati5t exp]i5ce data ,section #efi;,c7c77#b77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c7c77#b77;,a77 is am5d$ by /rik+ impact ( su* disease or condition1 or a relat$ !rapy1 & ins]t+ impact 7includ+ physical & psy*osocial impacts7 ( su* disease or condition1 or a relat$ !rapy or cl9ical inve/igation4 #fjf4 ,communication plans ,section #eje-a7;e77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;e77#c77 is am5d$-- 7#a7 9 subp>agraph 7,b71 by /rik+ 2 or2 7#b7 9 subp>agraph 7,c71 by /rik+ ! p]iod & ins]t+ 2 or2 & 7#c7 by add+ at ! end ! foll[+3 7,d7 dissem9at+ in=mation to heal? c>e provid]s ab\t drug =mulations or prop]ties1 includ+ in=mation ab\t ! limitations or pati5t c>e implications ( su* =mulations or prop]ties1 & h[ su* =mulations or prop]ties may be relat$ to s]i\s adv]se drug ev5ts associat$ ) use ( ! drug4 4 #fjg4 ,orphan drugs 7a7 ,9 g5]al ,section #ebg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7 is am5d$-- 7#a7 9 subsection 7a71 9 ! matt] foll[+ p>agraph 7#b71 by /rik+ su* drug = su* disease or condition & ins]t+ ! same drug = ! same disease or condition2 7#b7 9 subsection 7b7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ ,if an application & all t foll[s ?r\gh su* lic5se if & ins]t+ ,dur+ ! #g-ye> p]iod describ$ 9 subsection 7a7 = an approv$ application "u section #eje or lic5se "u section #cea ( ! ,public ,heal? ,s]vice ,act1 ! ,secret>y may approve an application or issue a lic5se = a drug t is o!rwise ! same1 z det]m9$ by ! ,secret>y1 z ! already approv$ drug = ! same r>e disease or condition if2 7,b7 9 p>agraph 7#a71 by /rik+ notice & all t foll[s ?r\gh assure & ins]t+ ( exclusive approval or lic5sure notice & opportunity = ! submission ( views1 t dur+ su* p]iod ! hold] ( ! exclusive approval or lic5sure _c ensure2 & 7,c7 9 p>agraph 7#b71 by /rik+ su* hold] provides & ins]t+ ! hold] provides2 & 7#c7 by add+ at ! end ! foll[+3 7c7 ,condition ( cl9ical sup]iority 7#a7 ,9 g5]al ,if a sponsor ( a drug t is designat$ "u section #ebf & is o!rwise ! same1 z det]m9$ by ! ,secret>y1 z an already approv$ or lic5s$ drug is seek+ exclusive approval or exclusive lic5sure describ$ 9 subsection 7a7 = ! same r>e disease or condition z ! already approv$ drug1 ! ,secret>y %all require su* sponsor1 z a condition ( su* exclusive approval or lic5sure1 to demon/rate t su* drug is cl9ically sup]ior to any already approv$ or lic5s$ drug t is ! same drug4 7#b7 ,def9ition ,= purposes ( p>agraph 7#a71 ! t]m cl9ically sup]ior ) respect to a drug means t ! drug provides a significant !rapeutic advantage ov] & above an already approv$ or lic5s$ drug 9 t]ms ( great] efficacy1 great] safety1 or by provid+ a major contribution to pati5t c>e4 7d7 ,regulations ,! ,secret>y may promulgate regulations = ! implem5tation ( subsection 7c74 ,beg9n+ on ! date ( enactm5t ( ! ,,fda ,reau?orization ,act ( #bjag1 until su* "t z ! ,secret>y promulgates regulations 9 accordance ) ?is subsection1 ! ,secret>y may apply any def9itions set =? 9 regulations t 7 promulgat$ prior to su* date ( enactm5t1 to ! ext5t su* def9itions are n inconsi/5t ) ! t]ms ( ?is section1 z am5d$ by su* ,act4 7e7 ,demon/ration ( cl9ical sup]iority /&>d ,to assi/ sponsors 9 demon/rat+ cl9ical sup]iority z describ$ 9 subsection 7c71 ! ,secret>y-- 7#a7 ^u ! designation ( any drug "u section #ebf1 %all notify ! sponsor ( su* drug 9 writ+ ( ! basis = ! designation1 includ+1 z applicable1 any plausible hypo!sis (f]$ by ! sponsor & reli$ ^u by ! ,secret>y t ! drug is cl9ically sup]ior to a previ\sly approv$ drug2 & 7#b7 ^u grant+ exclusive approval or lic5sure "u subsection 7a7 on ! basis ( a demon/ration ( cl9ical sup]iority z describ$ 9 subsection 7c71 %all publi% a summ>y ( ! cl9ical sup]iority f9d+s4 4 7b7 ,rule ( ,con/ruction ,no?+ 9 ! am5dm5ts made by subsection 7a7 %all affect any det]m9ation "u sections #ebf & #ebg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb1 #cfj;cc7 made prior to ! date ( enactm5t ( ! ,,fda ,reau?orization ,act ( #bjag4 #fjh4 ,p$iatric in=mation add$ to label+ ,section #eje;,a7o7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7o77 is am5d$-- 7#a7 9 ! subsection head+1 by /rik+ ,"u ,section #eje7;j72 7#b7 9 p>agraph 7#a7-- 7,a7 by /rik+ "u section #eje7;j7 & ins]t+ "u subsection 7b77#b7 or 7j7 ( section #eje2 & 7,b7 by /rik+ or by exclusivity "u clause 7iii7 or 7iv7 ( section #eje7;j77#e77;,f7 & ins]t+ 1 or by exclusivity "u clause 7iii7 or 7iv7 ( section #eje7;j77#e77;,f71 clause 7iii7 or 7iv7 ( section #eje7;c77#c77;,e71 or section #ebg7;a71 or by an ext5sion ( su* exclusivity "u ?is section or section #eje;,e2 7#c7 9 p>agraph 7#b71 9 ! matt] prec$+ subp>agraph 7,a7-- 7,a7 by ins]t+ clauses 7iii7 & 7iv7 ( section #eje7;c77#c77;,e71 or section #ebg1 aft] section #eje7;j77#e77;,f712 & 7,b7 by /rik+ drug approv$ "u section #eje7;j7 & ins]t+ drug approv$ pursuant to an application submitt$ "u subsection 7b77#b7 or 7j7 ( section #eje2 & 7#d7 by am5d+ p>agraph 7#c7 to read z foll[s3 7#c7 ,pres]vation ( p$iatric exclusivity & ext5sions ,?is subsection does n affect-- 7,a7 ! availability or scope ( exclusivity "u-- 7i7 ?is section2 7ii7 section #eje = p$iatric =mulations2 or 7iii7 section #ebg2 7,b7 ! availability or scope ( an ext5sion to any su* exclusivity1 includ+ an ext5sion "u ?is section or section #eje;,e2 7,c7 ! "q ( ! eligibility = approval "u section #eje ( any application describ$ 9 subsection 7b77#b7 or 7j7 ( su* section t omits any o!r aspect ( label+ protect$ by exclusivity "u-- 7i7 clause 7iii7 or 7iv7 ( section #eje7;j77#e77;,f72 7ii7 clause 7iii7 or 7iv7 ( section #eje7;c77#c77;,e72 or 7iii7 section #ebg7;a72 or 7,d7 except z expressly provid$ 9 p>agraphs 7#a7 & 7#b71 ! op]ation ( section #eje or section #ebg4 4 #fji4 ,s5se ( ,congress on l[]+ ! co/ ( prescription drugs ,x is ! s5se ( ! ,congress t ! ,secret>y ( ,heal? & ,human ,s]vices %\ld commit to engag+ ) ! ,h\se ( ,repres5tatives & ! ,s5ate to take adm9i/rative actions & enact legislative *anges t-- 7#a7 w l[] ! co/ ( prescription drugs = consum]s & r$uce ! burd5 ( su* co/ on taxpay]s2 & 7#b7 9 l[]+ su* co/1 w-- 7,a7 balance ! ne$ to enc\rage innovation ) ! ne$ to improve af=dability2 & 7,b7 /rive to increase competition 9 ! ph>maceutical m>ket1 prev5t anticompetitive behavior1 & promote ! timely availability ( af=dable1 high-quality g5]ic drugs & biosimil>s4 #faj4 ,exp&$ access 7a7 ,pati5t access to inve/igational drugs 7#a7 ,public meet+ 7,a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y71 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 9 coord9ation ) ! ,director ( ! ,national ,in/itutes ( ,heal?1 & 9 consultation ) pati5ts1 heal? c>e provid]s1 drug sponsors1 bioe?ici/s1 & o!r /akehold]s1 %all1 n lat] ?an #bgj days aft] ! date ( enactm5t ( ?is ,act1 conv5e a public meet+ to discuss cl9ical trial inclusion & exclusion crit]ia to in=m ! guidance "u p>agraph 7#c74 ,! ,secret>y %all in=m ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates ( ! date :5 ! public meet+ w take place4 7,b7 ,topics ,! ,secret>y %all make available on ! int]net website ( ! ,food & ,drug ,adm9i/ration a report on ! topics discuss$ at ! meet+ describ$ 9 subp>agraph 7,a7 )9 #ij days ( su* meet+4 ,su* topics %all include discussion (-- 7i7 ! rationale =1 & pot5tial b>ri]s = pati5ts creat$ by1 rese>* cl9ical trial inclusion & exclusion crit]ia2 7ii7 h[ appropriate pati5t populations c b5efit f ! results ( trials t employ alt]native designs2 7iii7 b>ri]s to p>ticipation 9 cl9ical trials1 includ+-- 7,i7 in=mation reg>d+ any pot5tial risks & b5efits ( p>ticipation2 7,,ii7 regulatory1 geographical1 & socioeconomic b>ri]s2 & 7,,iii7 ! impact ( exclusion crit]ia on ! enrollm5t 9 cl9ical trials ( p>ticul> populations1 includ+ infants & *ildr51 pregnant & lactat+ wom51 s5iors1 individuals ) advanc$ disease1 & individuals ) co-morbid conditions2 7iv7 cl9ical trial designs & me?ods1 includ+ exp&$ access trials1 t increase enrollm5t ( m div]se pati5t populations1 :5 appropriate1 :ile facilitat+ ! collection ( data to e/abli% safe use & support sub/antial evid5ce ( effectiv5ess1 includ+ data obta9$ f exp&$ access trials2 & 7v7 h[ *anges to cl9ical trial inclusion & exclusion crit]ia may impact ! complexity & l5g? ( cl9ical trials1 ! data necess>y to demon/rate safety & effectiv5ess1 & pot5tial approa*es to mitigat+ ^? impacts4 7#b7 ,report ,n lat] ?an #a ye> aft] ! ,secret>y issues ! report "u p>agraph 7#a77;,b71 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives on individual access to inve/igational drugs ?r\gh ! exp&$ access program "u section #efa7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7b774 ,! report %all include-- 7,a7 a description ( actions tak5 by manufactur]s & di/ributors "u section #efa;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#j72 7,b7 consid]ation ( :e!r ,=m ,,fda #cibf & ! guidance docum5ts titl$ ,exp&$ ,access to ,inve/igational ,drugs = ,treatm5t ,use--,que/ions & ,answ]s & ,individual ,pati5t ,exp&$ ,access ,applications3 ,=m ,,fda #cibf1 issu$ by ! ,food & ,drug ,adm9i/ration 9 ,june #bjaf1 h r$uc$ application burd5 ) respect to individuals & physicians seek+ access to inve/igational new drugs pursuant to section #efa7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7 & improv$ cl>ity = pati5ts1 physicians1 & drug manufactur]s ab\t su* process2 7,c7 consid]ation ( :e!r ! guidance or regulations issu$ to implem5t section #efa ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7 h improv$ access = individual pati5ts to inve/igational drugs :o d n qualify = cl9ical trials ( su* inve/igational drugs1 & :at b>ri]s to su* access rema92 7,d7 an assessm5t ( me?ods pati5ts & heal? c>e provid]s use to engage ) ! ,food & ,drug ,adm9i/ration or drug sponsors on exp&$ access2 & 7,e7 an analysis ( ! ,secret>y's report "u p>agraph 7#a77;,b74 7#c7 ,guidance 7,a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! publication ( ! report "u p>agraph 7#a77;,b71 ! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all issue "o or m draft guidances reg>d+ eligibility crit]ia = cl9ical trials4 ,n lat] ?an #a ye> aft] ! public comm5t p]iod on ea* su* draft guidance ends1 ! ,secret>y %all issue a revis$ draft guidance or f9al guidance4 7,b7 ,cont5ts ,! guidance docum5ts describ$ 9 subp>agraph 7,a7 %all address me?odological approa*es t a manufactur] or sponsor ( an inve/igation ( a new drug may take to-- 7i7 broad5 eligibility crit]ia = cl9ical trials & exp&$ access trials1 especially ) respect to drugs = ! treatm5t ( s]i\s & life-?reat5+ conditions or diseases = :i* !re is an unmet m$ical ne$2 7ii7 develop eligibility crit]ia =1 & increase trial recruitm5t to1 cl9ical trials s t enrollm5t 9 su* trials m accurately reflects ! pati5ts mo/ likely to receive ! drug1 z applicable & z appropriate1 :ile e/abli%+ safe use & support+ f9d+s ( sub/antial evid5ce ( effectiv5ess2 & 7iii7 use ! crit]ia describ$ 9 clauses 7i7 & 7ii7 9 a mann] t is appropriate = drugs int5d$ = ! treatm5t ( r>e diseases or conditions4 7b7 ,improv+ in/itutional review bo>d review ( s+le pati5t exp&$ access protocol ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all issue guidance or regulations1 or revise exi/+ guidance or regulations1 to /reaml9e ! in/itutional review bo>d review ( individual pati5t exp&$ access protocols submitt$ "u #efa7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7b774 ,to facilitate ! use ( exp&$ access protocols1 any guidance or regulations s issu$ or revis$ may include a description ( ! process = any p]son act+ ?r\gh a physician lic5s$ 9 accordance ) ,/ate law to reque/ t an in/itutional review bo>d *air 7or designat$ memb] ( ! in/itutional review bo>d7 review a s+le pati5t exp&$ access protocol submitt$ "u su* section #efa7;b7 = a drug4 ,! ,secret>y %all update any relevant =ms associat$ ) individual pati5t exp&$ access reque/s "u su* section #efa7;b7 z necess>y4 7c7 ,exp&$ access policy transp>5cy ,section #efa;,a7f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#j7;f77 is am5d$-- 7#a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ lat] & ins]t+ e>li]2 7#b7 by /rik+ p>agraph 7#a72 7#c7 by r$esignat+ p>agraph 7#b7 z p>agraph 7#a72 7#d7 9 p>agraph 7#a7 z s r$esignat$1 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7#e7 by add+ at ! end ! foll[+3 7#b7 z applicable1 #ae days aft] ! drug receives a designation z a break?r\gh !rapy1 fa/ track product1 or reg5]ative advanc$ !rapy "u subsection 7a71 7b71 or 7g71 respectively1 ( section #ejf4 4 #faa4 ,tropical disease product application 7a7 ,9 g5]al ,subp>agraph 7,a7 ( section #ebd7;a77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjn7a77#d77 is am5d$-- 7#a7 9 clause 7i71 by /rik+ & at ! end2 & 7#b7 by add+ at ! end ! foll[+3 7iii7 t conta9s reports ( "o or m new cl9ical inve/igations 7o!r ?an bioavailability /udies7 t are ess5tial to ! approval ( ! application & conduct$ or sponsor$ by ! sponsor ( su* application2 & 7iv7 t conta9s an atte/ation f ! sponsor ( ! application t su* reports 7 n submitt$ z "p ( an application = m>ket+ approval or lic5sure by a regulatory au?ority 9 ,india1 ,brazil1 ,?ail&1 or any c\ntry t is a memb] ( ! ,ph>maceutical ,inspection ,conv5tion or ! ,ph>maceutical ,inspection ,coop]ation ,s*eme prior to ,septemb] #bg1 #bjjg4 4 7b7 ,effective date ,! am5dm5ts made by subsection 7a7 %all apply to human drug applications submitt$ aft] ,septemb] #cj1 #bjag4 ,,vii ,device inspection & regulatory improvem5ts #gja4 ,risk-bas$ inspections = devices 7a7 ,9 g5]al ,section #eaj7;h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;h77 is am5d$-- 7#a7 by /rik+ p>agraph 7#b7 & ins]t+ ! foll[+3 7#b7 ,risk-bas$ s*$ule = devices 7,a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh "o or m (fic]s or employees duly designat$ by ! ,secret>y1 %all inspect e/abli%m5ts describ$ 9 p>agraph 7#a7 t are engag$ 9 ! manufacture1 propagation1 comp\nd+1 or process+ ( a device or devices 7ref]r$ to 9 ?is subsection z device e/abli%m5ts7 9 accordance ) a risk-bas$ s*$ule e/abli%$ by ! ,secret>y4 7,b7 ,factors & consid]ations ,9 e/abli%+ ! risk-bas$ s*$ule "u subp>agraph 7,a71 ! ,secret>y %all-- 7i7 apply1 to ! ext5t applicable = device e/abli%m5ts1 ! factors id5tifi$ 9 p>agraph 7#d72 & 7ii7 consid] ! p>ticipation ( ! device e/abli%m5t1 z applicable1 9 int]national device audit programs 9 :i* ! ,unit$ ,/ates p>ticipates or ! ,unit$ ,/ates recognizes = purposes ( inspect+ device e/abli%m5ts4 2 & 7#b7 9 p>agraph 7#d7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ p>agraph 7#c7 & ins]t+ p>agraph 7#b7 or 7#c72 & 7,b7 9 subp>agraph 7,c71 by ins]t+ or device aft] drug4 7b7 ,=eign inspections ,section #hji7;a77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #chd;e7a77#a77 is am5d$ by /rik+ section #eaj7;h77#c7 & ins]t+ p>agraph 7#b7 or 7#c7 ( section #eaj7;h74 #gjb4 ,improvem5ts to inspections process = device e/abli%m5ts 7a7 ,9 g5]al ,section #gjd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7 is am5d$ by add+ at ! end ! foll[+3 7h7 7#a7 ,9 ! case ( inspections o!r ?an =-cause inspections1 ! ,secret>y %all review processes & /&>ds applicable to inspections ( dome/ic & =eign device e/abli%m5ts 9 effect z ( ! date ( ! enactm5t ( ?is subsection1 & update su* processes & /&>ds ?r\gh ! adoption ( uni=m processes & /&>ds applicable to su* inspections4 ,su* uni=m processes & /&>ds %all provide =-- 7,a7 exceptions to su* processes & /&>ds1 z appropriate2 7,b7 ann\nc+ ! inspection ( ! e/abli%m5t )9 a reasonable "t be=e su* inspection occurs1 includ+ by provid+ to ! own]1 op]ator1 or ag5t 9 *>ge ( ! e/abli%m5t a notification reg>d+ ! type & nature ( ! inspection2 7,c7 a reasonable e/imate ( ! timeframe = ! inspection1 an opportunity = advance communications betwe5 ! (fic]s or employees c>ry+ out ! inspection "u subsection 7a77#a7 & ! own]1 op]ator1 or ag5t 9 *>ge ( ! e/abli%m5t conc]n+ appropriate work+ h\rs dur+ ! inspection1 &1 to ! ext5t feasible1 advance notice ( "s records t w be reque/$2 & 7,d7 regul> communications dur+ ! inspection ) ! own]1 op]ator1 or ag5t 9 *>ge ( ! e/abli%m5t reg>d+ inspection /atus1 :i* may be record$ by ei!r p>ty ) advance notice & mutual cons5t4 7#b7 7,a7 ,! ,secret>y %all1 ) respect to a reque/ describ$ 9 subp>agraph 7,b71 provide nonb9d+ fe$back ) respect to su* reque/ n lat] ?an #de days aft] ! ,secret>y receives su* reque/4 7,b7 ,a reque/ describ$ 9 ?is subp>agraph is a reque/ = fe$back-- 7i7 t is made by ! own]1 op]ator1 or ag5t 9 *>ge ( su* e/abli%m5t 9 a timely mann]2 & 7ii7 ) respect to actions propos$ to be tak5 by a device e/abli%m5t 9 a response to a report receiv$ by su* e/abli%m5t pursuant to subsection 7b7 t involve a public heal? priority1 t implicate sy/emic or major actions1 or relate to em]g+ safety issues 7z det]m9$ by ! ,secret>y74 7#c7 ,no?+ 9 ?is subsection affects ! au?ority ( ! ,secret>y to conduct inspections o!rwise p]mitt$ "u ?is ,act 9 ord] to ensure compliance ) ?is ,act4 4 7b7 ,guidance 7#a7 ,draft guidance ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all issue draft guidance t-- 7,a7 specifies h[ ! ,food & ,drug ,adm9i/ration w implem5t ! processes & /&>ds describ$ 9 p>agraph 7#a7 ( subsection 7h7 ( section #gjd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd71 z add$ by subsection 7a71 & ! requirem5ts describ$ 9 p>agraph 7#b7 ( su* subsection 7h72 7,b7 provides = /&>diz$ me?ods = communications describ$ 9 su* p>agraphs2 7,c7 e/abli%es1 ) respect to inspections ( bo? dome/ic & =eign device e/abli%m5ts 7z ref]r$ to 9 section #eaj7;h77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z am5d$ by subsection 7a771 a /&>d timeframe = su* inspections-- 7i7 t occurs ov] consecutive days2 & 7ii7 to :i* ea* inve/igator conduct+ su* an inspection %all adh]e unless ! inve/igator id5tifies to ! e/abli%m5t involv$ a reason t m "t is ne$$ to conduct su* inve/igation2 & 7,d7 id5tifies practices = inve/igators & device e/abli%m5ts to facilitate ! cont9uity ( inspections ( su* e/abli%m5ts4 7#b7 ,f9al guidance ,n lat] ?an #a ye> aft] provid+ notice & opportunity = public comm5t on ! draft guidance issu$ "u p>agraph 7#a71 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue f9al guidance to implem5t subsection 7h7 ( section #gjd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd71 z add$ by subsection 7a74 7c7 ,adult]at$ devices ,subsection 7j7 ( section #eja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea7 is am5d$ by ins]t+ or device aft] drug4 #gjc4 ,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+ ,octob] #a1 #bjag & ins]t+ ,octob] #a1 #bjbb4 #gjd4 ,c]tificates to =eign gov]nm5ts = devices ,subsection 7e77#d7 ( section #hja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;e77#d77 is am5d$-- 7#a7 by add+ at ! end ! foll[+3 7,e7 7i7 7,i7 ,if ! ,secret>y d5ies a reque/ = c]tification "u subp>agraph 7,a77ii7 ) respect to a device manufactur$ 9 an e/abli%m5t 7=eign or dome/ic7 regi/]$ "u section #eaj1 ! ,secret>y %all provide 9 writ+ to ! p]son seek+ su* c]tification ! basis = su* d5ial1 & specifically id5tify ! f9d+ ^u :i* su* d5ial is bas$4 7,,ii7 ,if ! d5ial ( a reque/ z describ$ 9 subclause 7,i7 is bas$ on gr\nds o!r ?an an injunction proce$+ pursuant to section #cjb1 seizure action pursuant to section #cjd1 or a recall designat$ ,class ,i or ,class ,,ii pursuant to "p #g1 title #ba1 ,code ( ,f$]al ,regulations1 & is bas$ on ! facility be+ out ( compliance ) "p #hbj ( title #ba1 ,code ( ,f$]al ,regulations1 ! ,secret>y %all provide a sub/antive summ>y ( ! specific gr\nds = noncompliance id5tifi$ by ! ,secret>y4 7,,iii7 ,) respect to a device manufactur$ 9 an e/abli%m5t t has receiv$ a report "u section #gjd7;b71 ! ,secret>y %all n d5y a reque/ = c]tification z describ$ 9 subclause 7,i7 ) respect to a device bas$ solely on ! issuance ( t report if ! own]1 op]ator1 or ag5t 9 *>ge ( su* e/abli%m5t has agre$ to a plan ( correction 9 response to su* report4 7ii7 7,i7 ,! ,secret>y %all provide a process = a p]son :o is d5i$ a c]tification z describ$ 9 clause 7i77,i7 to reque/ a review t con=ms to ! /&>ds ( section #eag;,a7b74 7,,ii7 ,not)/&+ any previ\s review conduct$ pursuant to subclause 7,i71 a p]son :o has be5 d5i$ a c]tification z describ$ 9 clause 7i77,i7 may at any "t reque/ a review 9 ord] to pres5t new in=mation relat+ to actions tak5 by su* p]son to address ! reasons id5tifi$ by ! ,secret>y = ! d5ial ( c]tification1 includ+ evid5ce t corrective actions are be+ or h be5 implem5t$ to address gr\nds = noncompliance id5tifi$ by ! ,secret>y4 7,,iii7 ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,,fda ,reau?orization ,act ( #bjag1 ! ,secret>y %all issue guidance provid+ = a process to c>ry out ?is subp>agraph4 ,n lat] ?an #a ye> aft] ! close ( ! comm5t p]iod = su* guidance1 ! ,secret>y %all issue f9al guidance4 7iii7 7,i7 ,subject to subclause 7,,ii71 ?is subp>agraph applies to reque/s = c]tification on behalf ( any device e/abli%m5t regi/]$ "u section #eaj1 :e!r ! e/abli%m5t is locat$ inside or outside ( ! ,unit$ ,/ates1 & reg>dless ( :e!r su* devices are to be export$ f ! ,unit$ ,/ates4 7,,ii7 ,if an e/abli%m5t describ$ 9 subclause 7,i7 is n locat$ )9 ! ,unit$ ,/ates & does n demon/rate t ! devices manufactur$1 prep>$1 propagat$1 comp\nd$1 or process$ at su* e/abli%m5t are to be export$ f ! ,unit$ ,/ates1 ?is subp>agraph %all apply only if-- 7aa7 ! e/abli%m5t has be5 inspect$ by ! ,secret>y )9 #c ye>s ( ! date ( ! reque/2 or 7bb7 ! e/abli%m5t p>ticipates 9 an audit program 9 :i* ! ,unit$ ,/ates p>ticipates or ! ,unit$ ,/ates recognizes1 an audit "u su* program has be5 conduct$1 & ! f9d+s ( su* audit are provid$ to ! ,secret>y )9 #c ye>s ( ! date ( ! reque/4 2 & 7#b7 by mov+ ! m>g9s ( subp>agraphs 7,c7 & 7,d7 #d ems to ! left4 #gje4 ,facilitat+ int]national h>monization ,section #gjd7;g7 ( ! ,f$]al ,food1 ,drug & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7 is am5d$ by add+ at ! end ! foll[+3 7#ae7 7,a7 ,not)/&+ any o!r provision ( ?is subsection1 ! ,secret>y may recognize audit+ organizations t are recogniz$ by organizations e/abli%$ by gov]nm5ts to facilitate int]national h>monization = purposes ( conduct+ inspections (-- 7i7 e/abli%m5ts t manufacture1 prep>e1 propagate1 comp\nd1 or process devices 7o!r ?an types ( devices lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act71 z requir$ "u section #eaj7;h72 or 7ii7 e/abli%m5ts requir$ to regi/] pursuant to section #eaj7;i74 7,b7 ,no?+ 9 ?is p>agraph affects-- 7i7 ! au?ority ( ! ,secret>y to inspect any device e/abli%m5t pursuant to ?is ,act2 or 7ii7 ! au?ority ( ! ,secret>y to det]m9e ! (ficial classification ( an inspection4 4 #gjf4 ,fo/]+ innovation 9 m$ical imag+ 7a7 ,approval ( applications = c]ta9 diagno/ic m$ical imag+ devices ,section #ebj ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#db ,u4,s4,c4 #cfj;j7 is am5d$ by add+ at ! end ! foll[+3 7p7 ,diagno/ic imag+ devices int5d$ = use ) contra/ ag5ts 7#a7 ,9 g5]al ,! ,secret>y may1 subject to ! succe$+ provisions ( ?is subsection1 approve an application 7or a supplem5t to su* an application7 submitt$ "u section #eae ) respect to an applicable m$ical imag+ device1 or1 9 ! case ( an applicable m$ical imag+ device = :i* a notification is submitt$ "u section #eaj7k71 may make a sub/antial equival5ce det]m9ation ) respect to an applicable m$ical imag+ device1 or may grant a reque/ submitt$ "u section #eac7;f77#b7 = an applicable m$ical imag+ device1 if su* application1 notification1 or reque/ involves ! use ( a contra/ ag5t t is n-- 7,a7 9 a conc5tration1 rate ( adm9i/ration1 or r\te ( adm9i/ration t is diff]5t f ^? describ$ 9 ! approv$ label+ ( ! contra/ ag5t1 except t ! ,secret>y may approve su* application1 make su* sub/antial equival5ce det]m9ation1 or grant su* reque/ if ! ,secret>y det]m9es t su* diff]5ces 9 conc5tration1 rate ( adm9i/ration1 or r\te ( adm9i/ration exi/ b d n adv]sely affect ! safety & effectiv5ess ( ! contra/ ag5t :5 us$ ) ! device2 7,b7 9 a region1 organ1 or sy/em ( ! body t is diff]5t f ^? describ$ 9 ! approv$ label+ ( ! contra/ ag5t1 except t ! ,secret>y may approve su* application1 make su* sub/antial equival5ce det]m9ation1 or grant su* reque/ if ! ,secret>y det]m9es t su* diff]5ces 9 region1 organ1 or sy/em ( ! body exi/ b d n adv]sely affect ! safety & effectiv5ess ( ! contra/ ag5t :5 us$ ) ! device2 7,c7 9 a pati5t population t is diff]5t f ^? describ$ 9 ! approv$ label+ ( ! contra/ ag5t1 except t ! ,secret>y may approve su* application1 make su* sub/antial equival5ce det]m9ation1 or grant su* reque/ if ! ,secret>y det]m9es su* diff]5ces 9 pati5t population exi/ b d n adv]sely affect ! safety & effectiv5ess ( ! contra/ ag5t :5 us$ ) ! device2 or 7,d7 9 an imag+ modality t is diff]5t f ^? describ$ 9 ! approv$ label+ ( ! contra/ ag5t4 7#b7 ,prem>ket review ,! ag5cy c5t] *>g$ ) prem>ket review ( devices %all h prim>y jurisdiction ) respect to ! review ( an application1 notification1 or reque/ describ$ 9 p>agraph 7#a74 ,9 conduct+ su* review1 su* ag5cy c5t] may-- 7,a7 consult ) ! ag5cy c5t] *>g$ ) ! prem>ket review ( drugs or biological products2 & 7,b7 review in=mation & data provid$ to ! ,secret>y by ! sponsor ( a contra/ ag5t 9 an application submitt$ "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 s long z ! sponsor ( su* contra/ ag5t has provid$ to ! sponsor ( ! applicable m$ical imag+ device t is ! subject ( su* review a "r ( ref]5ce & ! application is submitt$ 9 accordance ) ?is subsection4 7#c7 ,applicable requirem5ts ,an application submitt$ "u section #eae1 a notification submitt$ "u section #eaj7k71 or a reque/ submitt$ "u section #eac7;f77#b71 z describ$ 9 p>agraph 7#a71 ) respect to an applicable m$ical imag+ device %all be subject to ! requirem5ts ( su* respective section4 ,su* application1 notification1 or reque/ %all only be subject to ! requirem5ts ( ?is ,act applicable to devices4 7#d7 ,def9itions ,= purposes ( ?is subsection-- 7,a7 ! t]m applicable m$ical imag+ device means a device int5d$ to be us$ 9 conjunction ) a contra/ ag5t 7or class ( contra/ ag5ts7 = an imag+ use t is n describ$ 9 ! approv$ label+ ( su* contra/ ag5t 7or ! approv$ label+ ( any contra/ ag5t 9 ! same class z su* contra/ ag5t72 & 7,b7 ! t]m contra/ ag5t means a drug t is approv$ "u section #eje or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act1 is int5d$ = use 9 conjunction ) an applicable m$ical imag+ device1 &-- 7i7 is a diagno/ic radioph>maceutical1 z def9$ 9 section #cae4b & #fja4ca ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations72 or 7ii7 is a diagno/ic ag5t t improves ! visualization ( /ructure or function )9 ! body by increas+ ! relative diff]5ce 9 signal int5sity )9 ! t>get tissue1 /ructure1 or fluid4 4 7b7 ,applications = approval ( contra/ ag5ts int5d$ = use ) c]ta9 diagno/ic m$ical imag+ devices ,section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is am5d$ by add+ at ! end ! foll[+3 7y7 ,contra/ ag5ts int5d$ = use ) applicable m$ical imag+ devices 7#a7 ,9 g5]al ,! sponsor ( a contra/ ag5t = :i* an application has be5 approv$ "u ?is section may submit a supplem5t to ! application seek+ approval = a new use foll[+ ! au?orization ( a prem>ket submission = an applicable m$ical imag+ device = t use ) ! contra/ ag5t pursuant to section #ebj7p77#a74 7#b7 ,review ( supplem5t ,9 review+ a supplem5t submitt$ "u ?is subsection1 ! ag5cy c5t] *>g$ ) ! prem>ket review ( drugs may-- 7,a7 consult ) ! c5t] *>g$ ) ! prem>ket review ( devices2 & 7,b7 review in=mation & data submitt$ to ! ,secret>y by ! sponsor ( an applicable m$ical imag+ device pursuant to section #eae1 #eaj7k71 or #eac7;f77#b7 s long z ! sponsor ( su* applicable m$ical imag+ device has provid$ to ! sponsor ( ! contra/ ag5t a "r ( ref]5ce4 7#c7 ,def9itions ,= purposes ( ?is subsection-- 7,a7 ! t]m new use means a use ( a contra/ ag5t t is describ$ 9 ! approv$ label+ ( an applicable m$ical imag+ device describ$ 9 section #ebj7p71 b t is n describ$ 9 ! approv$ label+ ( ! contra/ ag5t2 & 7,b7 ! t]ms applicable m$ical imag+ device & contra/ ag5t h ! mean+s giv5 su* t]ms 9 section #ebj7p74 4 #gjg4 ,risk-bas$ classification ( accessories 7a7 ,9 g5]al ,subsection 7f7 ( section #eac ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#f7 7,a7 ,subject to ! succe$+ subp>agraphs ( ?is p>agraph1 ! ,secret>y %all1 by writt5 ord]1 classify an accessory "u ?is section bas$ on ! risks ( ! accessory :5 us$ z int5d$ & ! level ( regulatory controls necess>y to provide a reasonable assurance ( safety & effectiv5ess ( ! accessory1 not)/&+ ! classification ( any o!r device ) :i* su* accessory is int5d$ to be us$4 7,b7 ,! classification ( any accessory di/9ct f ano!r device by regulation or writt5 ord] issu$ prior to ,decemb] #ac1 #bjaf1 %all cont9ue to apply unless & until ! accessory is reclassifi$ by ! ,secret>y1 not)/&+ ! classification ( any o!r device ) :i* su* accessory is int5d$ to be us$4 ,no?+ 9 ?is p>agraph %all preclude ! ,secret>y's au?ority to initiate ! classification ( an accessory ?r\gh regulation or writt5 ord]1 z appropriate4 7,c7 7i7 ,9 ! case ( a device int5d$ to be us$ ) an accessory1 :]e ! accessory has be5 includ$ 9 an application = prem>ket approval ( su* device "u section #eae or a report "u section #eaj7k7 = cle>ance ( su* device & ! ,secret>y has n classifi$ su* accessory di/9ctly f ano!r device 9 accordance ) subp>agraph 7,a71 ! p]son fil+ ! application or report 7z applicable7 at ! "t su* application or report is fil$-- 7,i7 may include a writt5 reque/ = ! prop] classification ( ! accessory pursuant to subp>agraph 7,a72 7,,ii7 %all include 9 any su* reque/ su* in=mation z may be necess>y = ! ,secret>y to evaluate1 bas$ on ! lea/ burd5some approa*1 ! appropriate class = ! accessory "u subsection 7a72 & 7,,iii7 %all1 if ! reque/ "u subclause 7,i7 is reque/+ classification ( ! accessory 9 class ,,ii1 include 9 ! application an initial draft proposal = special controls1 if special controls w\ld be requir$ pursuant to subsection 7a77#a77;,b74 7ii7 ,! ,secret>y's response "u section #eae7;d7 or section #eaj7n7 7z applicable7 to an application or report describ$ 9 clause 7i7 %all also conta9 ! ,secret>y's grant+ or d5ial ( ! reque/ = classification ( ! accessory involv$4 7iii7 ,! ,secret>y's evaluation ( an accessory "u clause 7i7 %all con/itute an ord] e/abli%+ a new classification = su* accessory = ! specifi$ int5d$ use or uses ( su* accessory & = any accessory ) ! same int5d$ use or uses z su* accessory4 7,d7 ,= accessories t h be5 grant$ m>ket+ au?orization z "p ( a submission = ano!r device ) :i* ! accessory involv$ is int5d$ to be us$1 ?r\gh an application = su* o!r device "u section #eae7;c71 a report "u section #eaj7k71 or a reque/ = classification "u p>agraph 7#b7 ( ?is subsection1 ! foll[+ %all apply3 7i7 ,n lat] ?an ! date t is "o ye> aft] ! date ( enactm5t ( ! ,,fda ,reau?orization ,act ( #bjag & at lea/ once e #e ye>s !reaft]1 & z ! ,secret>y o!rwise det]m9es appropriate1 pursuant to ?is p>agraph1 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/] a notice propos+ a li/ ( su* accessories t ! ,secret>y det]m9es may be suitable = a di/9ct classification 9 class ,i & ! propos$ regulations = su* classifications4 ,9 develop+ su* li/1 ! ,secret>y %all consid] recomm5dations f sponsors ( device submissions & o!r /akehold]s = accessories to be includ$ on su* li/4 ,! notices %all provide = a p]iod ( n less ?an #fj cal5d> days = public comm5t4 ,)9 #ahj days aft] ! end ( ! comm5t p]iod1 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/] a f9al action classify+ su* suitable accessories into class ,i4 7ii7 ,a manufactur] or import] ( an accessory t has be5 grant$ su* m>ket+ au?orization may submit to ! ,secret>y a writt5 reque/ = ! appropriate classification ( ! accessory bas$ on ! risks & appropriate level ( regulatory controls z describ$ 9 subp>agraph 7,a71 & %all1 if ! reque/ is reque/+ classification ( ! accessory 9 class ,,ii1 include 9 ! submission an initial draft proposal = special controls1 if special controls w\ld be requir$ pursuant to subsection 7a77#a77;,b74 ,su* reque/ %all include su* in=mation z may be necess>y = ! ,secret>y to evaluate1 bas$ on ! lea/ burd5some approa*1 ! appropriate class = ! accessory "u subsection 7a74 ,! ,secret>y %all provide an opportunity = a manufactur] or import] to meet ) appropriate p]sonnel ( ! ,food & ,drug ,adm9i/ration to discuss ! appropriate classification ( su* accessory prior to submitt+ a writt5 reque/ "u ?is clause = classification ( ! accessory4 7iii7 ,! ,secret>y %all respond to a reque/ made "u clause 7ii7 n lat] ?an #he cal5d> days aft] receiv+ su* reque/ by issu+ a writt5 ord] classify+ ! accessory or d5y+ ! reque/4 ,if ! ,secret>y does n agree ) ! recomm5dation = classification submitt$ by ! manufactur] or import]1 ! response %all include a detail$ description & ju/ification = su* det]m9ation4 ,)9 #cj cal5d> days aft] grant+ su* a reque/1 ! ,secret>y %all publi% a notice 9 ! ,f$]al ,regi/] ann\nc+ su* response4 7,e7 ,no?+ 9 ?is p>agraph may be con/ru$ z preclud+ a manufactur] ( an accessory ( a new type f us+ ! classification process describ$ 9 subsection 7f77#b7 to obta9 classification ( su* accessory 9 accordance ) ! crit]ia & requirem5ts set =? 9 t subsection4 4 7b7 ,con=m+ *ange ,section #eac7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7b77 is am5d$ by /rik+ p>agraph 7#i7 7relat+ to classification ( an accessory74 7c7 ,effective date ,! am5dm5ts made by subsections 7a7 & 7b7 %all take effect on ! date t is #fj days aft] ! date ( enactm5t ( ?is ,act4 #gjh4 ,device pilot projects 7a7 ,po/m>ket pilot ,section #eai ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;i7 is am5d$ by add+ at ! end ! foll[+3 7i7 ,po/m>ket pilot 7#a7 ,9 g5]al ,9 ord] to provide timely & reliable in=mation on ! safety & effectiv5ess ( devices approv$ "u section #eae1 cle>$ "u section #eaj7k71 or classifi$ "u section #eac7;f77#b71 includ+ responses to adv]se ev5ts & malfunctions1 & to advance ! objectives ( "p #hjc ( title #ba1 ,code ( ,f$]al ,regulations 7or successor regulations71 & advance ! objectives (1 & evaluate innovative new me?ods ( compliance )1 ?is section & section #ebb1 ! ,secret>y %all1 )9 "o ye> ( ! date ( enactm5t ( ! ,,fda ,reau?orization ,act ( #bjag1 initiate "o or m pilot projects = volunt>y p>ticipation by a manufactur] or manufactur]s ( a device or device type1 or cont9ue exi/+ projects1 9 accordance ) p>agraph 7#c71 t-- 7,a7 are design$ to effici5tly g5]ate reliable & timely safety & active surveillance data = use by ! ,secret>y or manufactur]s ( ! devices t are involv$ 9 ! pilot project2 7,b7 in=m ! developm5t ( me?ods1 sy/ems1 data crit]ia1 & programs t c\ld be us$ to support safety & active surveillance activities = devices includ$ or n includ$ 9 su* project2 7,c7 may be design$ & conduct$ 9 coord9ation ) a compreh5sive sy/em = evaluat+ m$ical device te*nology t op]ates "u a gov]n+ bo>d ) appropriate repres5tation ( /akehold]s1 includ+ pati5t gr\ps & device manufactur]s2 7,d7 use electronic heal? data includ+ claims data1 pati5t survey data1 or any o!r data1 z ! ,secret>y det]m9es appropriate2 & 7,e7 prioritize devices & device types t meet "o or m ( ! foll[+ crit]ia3 7i7 ,devices & device types = :i* ! collection & analysis ( real _w evid5ce reg>d+ a device's safety & effectiv5ess is likely to advance public heal?4 7ii7 ,devices & device types t are widely us$4 7iii7 ,devices & device types1 ! failure ( :i* has significant heal? consequ5ces4 7iv7 ,devices & device types = :i* ! ,secret>y-- 7,i7 has receiv$ public recomm5dations 9 accordance ) p>agraph 7#b77;,b72 & 7,,ii7 has det]m9$ to meet "o or m ( ! crit]ia "u clause 7i71 7ii71 or 7iii7 & is appropriate = su* a pilot project4 7#b7 ,p>ticipation ,! ,secret>y %all e/abli% ! conditions & processes-- 7,a7 "u :i* a manufactur] ( a device may volunt>ily p>ticipate 9 a pilot project describ$ 9 p>agraph 7#a72 & 7,b7 = facilitat+ public recomm5dations = devices to be prioritiz$ "u su* a pilot project1 includ+ requirem5ts = ! data necess>y to support su* a recomm5dation4 7#c7 ,cont9uation ( ongo+ projects ,! ,secret>y may cont9ue or exp& projects1 ) respect to provid+ timely & reliable in=mation on ! safety & effectiv5ess ( devices approv$ "u section #eae1 cle>$ "u section #eaj7k71 or classifi$ "u section #eac7;f77#b71 t are be+ c>ri$ out z ( ! date ( ! enactm5t ( ! ,,fda ,reau?orization ,act ( #bjag4 ,! ,secret>y %all1 beg9n+ on su* date ( enactm5t1 take su* /eps z may be necess>y-- 7,a7 to ensure su* projects meet ! requirem5ts ( subp>agraphs 7,a7 ?r\gh 7,e7 ( p>agraph 7#a72 & 7,b7 to increase ! volunt>y p>ticipation 9 su* projects ( manufactur]s ( devices & facilitate public recomm5dations = any devices prioritiz$ "u su* a project4 7#d7 ,implem5tation 7,a7 ,contract+ au?ority ,! ,secret>y may c>ry out a pilot project meet+ ! crit]ia specifi$ 9 subp>agraphs 7,a7 ?r\gh 7,e7 ( p>agraph 7#a7 or a project cont9u$ or exp&$ "u p>agraph 7#c7 by ent]+ into contracts1 coop]ative agreem5ts1 grants1 or o!r appropriate agreem5ts ) public or private entities t h a significant pres5ce 9 ! ,unit$ ,/ates & meet ! foll[+ conditions3 7i7 ,if su* an entity is a compon5t ( ano!r organization1 ! entity & ! organization h e/abli%$ an agreem5t "u :i* appropriate security measures are implem5t$ to ma9ta9 ! confid5tiality & privacy ( ! data describ$ 9 p>agraph 7#a77;,d7 & su* agreem5t ensures t ! entity w n make an unau?oriz$ disclosure ( su* data to ! o!r compon5ts ( ! organization 9 brea* ( requirem5ts ) respect to confid5tiality & privacy ( su* data e/abli%$ "u su* security measures4 7ii7 ,9 ! case ( ! t]m9ation or nonr5ewal ( su* a contract1 coop]ative agreem5t1 grant1 or o!r appropriate agreem5t1 ! entity or entities involv$ %all comply ) ea* ( ! foll[+3 7,i7 ,! entity or entities %all cont9ue to comply ) ! requirem5ts ) respect to confid5tiality & privacy ref]r$ to 9 clause 7i7 ) respect to all data disclos$ to ! entity "u su* an agreem5t4 7,,ii7 ,! entity or entities %all return any data disclos$ to su* entity pursuant to ?is subsection & to :i* x w\ld n o!rwise h access or1 if return+ su* data is n practicable1 de/roy ! data4 7iii7 ,! entity or entities %all h "o or m qualifications ) respect to-- 7,i7 rese>*1 /ati/ical1 epidemiologic1 or cl9ical capability & exp]tise to conduct & complete ! activities "u ?is subsection1 includ+ ! capability & exp]tise to provide ! ,secret>y access to de-id5tifi$ data consi/5t ) ! requirem5ts ( ?is subsection2 7,,ii7 an in=mation te*nology infra/ructure to support electronic data & op]ational /&>ds to provide security = su* data1 z appropriate2 7,,iii7 exp]i5ce )1 & exp]tise on1 ! developm5t ( rese>* on1 & surveillance (1 device safety & effectiv5ess us+ electronic heal? data2 or 7,,iv7 su* o!r exp]tise :i* ! ,secret>y det]m9es necess>y to c>ry out su* a project4 7,b7 ,review ( contract 9 ! ev5t ( a m]g] or acquisition ,! ,secret>y %all review any contract1 coop]ative agreem5t1 grant1 or o!r appropriate agreem5t ent]$ into "u ?is p>agraph ) an entity meet+ ! conditions specifi$ 9 subp>agraph 7,a7 9 ! ev5t ( a m]g] or acquisition ( ! entity 9 ord] to ensure t ! requirem5ts specifi$ 9 ?is subsection w cont9ue to be met4 7#e7 ,compliance ) requirem5ts = records or reports on devices ,! p>ticipation ( a manufactur] 9 pilot projects "u ?is subsection or a project cont9u$ or exp&$ "u p>agraph 7#c7 %all n affect ! eligibility ( su* manufactur] to p>ticipate 9 any qu>t]ly report+ program ) respect to devices c>ri$ out "u ?is section #eai or section #ebb4 ,! ,secret>y may det]m9e t1 = a specifi$ "t p]iod to be det]m9$ by ! ,secret>y1 a manufactur]'s p>ticipation 9 a pilot project "u ?is subsection or a project cont9u$ or exp&$ "u p>agraph 7#c7 may meet ! applicable requirem5ts ( ?is section or section #ebb1 if-- 7,a7 ! project has demon/rat$ success 9 captur+ relevant adv]se ev5t in=mation2 & 7,b7 ! ,secret>y has e/abli%$ proc$ures = mak+ adv]se ev5t & safety in=mation collect$ f su* project public1 to ! ext5t possible4 7#f7 ,privacy requirem5ts ,) respect to ! disclosure ( any heal? in=mation collect$ ?r\gh a project conduct$ "u ?is subsection-- 7,a7 individually id5tifiable heal? in=mation s collect$ %all n be disclos$ :5 pres5t+ any in=mation f su* project2 & 7,b7 any su* disclosure %all be made 9 compliance ) regulations issu$ pursuant to section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7#db ,u4,s4,c4 #acbj;d-#b note7 & sections #eeb & #eeb;a ( title #e1 ,unit$ ,/ates ,code4 7#g7 ,limitations ,no pilot project "u ?is subsection1 or 9 coord9ation ) ! compreh5sive sy/em describ$ 9 p>agraph 7#a77;,c71 may all[ = an entity p>ticipat+ 9 su* project1 o!r ?an ! ,secret>y1 to make det]m9ations ( safety or effectiv5ess1 or sub/antial equival5ce1 = purposes ( ?is ,act4 7#h7 ,o!r projects requir$ ,to comply ,p>agraphs 7#a77;,b71 7#d77;,a77i71 7#d77;,a77ii71 7#e71 7#f71 & 7#g7 %all apply ) respect to any pilot project und]tak5 9 coord9ation ) ! compreh5sive sy/em describ$ 9 p>agraph 7#a77;,c7 t relates to ! use ( real _w evid5ce = devices 9 ! same mann] & to ! same ext5t z su* p>agraphs apply ) respect to pilot projects conduct$ "u ?is subsection4 7#i7 ,report to congress ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 & annually !reaft]1 ! ,secret>y %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor & ,p5sions ( ! ,s5ate a report conta9+ a description ( ! pilot projects be+ conduct$ "u ?is subsection & projects cont9u$ or exp&$ pursuant to p>agraph 7#c71 includ+ = ea* su* project-- 7,a7 h[ ! project is be+ implem5t$ 9 accordance ) p>agraph 7#d71 includ+ h[ su* project is be+ implem5t$ ?r\gh a contract1 coop]ative agreem5t1 grant1 or o!r appropriate agreem5t1 if applicable2 7,b7 ! numb] ( manufactur]s t h agre$ to p>ticipate 9 su* project2 7,c7 ! data s\rces us$ to conduct su* project2 7,d7 ! devices or device categories involv$ 9 su* project2 7,e7 ! numb] ( pati5ts involv$ 9 su* project2 & 7,f7 ! f9d+s ( ! project 9 relation to device safety1 includ+ adv]se ev5ts1 malfunctions1 & o!r safety in=mation4 7#aj7 ,sunset ,! ,secret>y may n c>ry out a pilot project initiat$ by ! ,secret>y "u ?is subsection aft] ,octob] #a1 #bjbb4 4 7b7 ,report ,n lat] ?an ,janu>y #ca1 #bjba1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all conduct a review ?r\gh an indep5d5t ?ird p>ty to evaluate ! /r5g?s1 limitations1 & appropriate use ( evid5ce collect$ pursuant to real _w evid5ce pilot projects describ$ 9 ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjag & subsection 7i7 ( section #eai ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;i71 z am5d$ by subsection 7a71 = in=m+ prem>ket & po/m>ket decisionmak+ = multiple device types1 & to det]m9e :e!r ! me?ods1 sy/ems1 & programs 9 su* pilot projects effici5tly g5]ate reliable & timely evid5ce ab\t ! effectiv5ess or safety surveillance ( devices4 #gji4 ,regulation ( ov]-!-c\nt] he>+ aids 7a7 ,9 g5]al ,section #ebj ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j71 z am5d$ by section #gjh1 is fur!r am5d$ by add+ at ! end ! foll[+3 7q7 ,regulation ( ,ov]-!-,c\nt] he>+ aids 7#a7 ,def9ition 7,a7 ,9 g5]al ,9 ?is subsection1 ! t]m ov]-!-c\nt] he>+ aid means a device t-- 7i7 uses ! same fundam5tal sci5tific te*nology z air conduction he>+ aids 7z def9$ 9 section #hgd4ccjj ( title #ba1 ,code ( ,f$]al ,regulations7 7or any successor regulation7 or wireless air conduction he>+ aids 7z def9$ 9 section #hgd4ccje ( title #ba1 ,code ( ,f$]al ,regulations7 7or any successor regulation72 7ii7 is int5d$ to be us$ by adults age #ah & old] to comp5sate = p]ceiv$ mild to mod]ate he>+ impairm5t2 7iii7 ?r\gh tools1 te/s1 or s(tw>e1 all[s ! us] to control ! ov]-!-c\nt] he>+ aid & cu/omize x to ! us]'s he>+ ne$s2 7iv7 may-- 7,i7 use wireless te*nology2 or 7,,ii7 include te/s = self-assessm5t ( he>+ loss2 & 7v7 is available ov]-!-c\nt]1 )\t ! sup]vision1 prescription1 or o!r ord]1 involvem5t1 or int]v5tion ( a lic5s$ p]son1 to consum]s ?r\gh 9-p]son transactions1 by mail1 or onl9e4 7,b7 ,exception ,su* t]m does n include a p]sonal s\nd amplification product int5d$ to amplify s\nd = nonhe>+ impair$ consum]s 9 situations includ+ hunt+ & bird-wat*+4 7#b7 ,regulation ,an ov]-!-c\nt] he>+ aid %all be subject to ! regulations promulgat$ 9 accordance ) section #gji7;b7 ( ! ,,fda ,reau?orization ,act ( #bjag & %all be exempt f sections #hja4dbj & #hja4dba ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations74 4 7b7 ,regulations ,to e/abli% category 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y71 n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 %all promulgate propos$ regulations to e/abli% a category ( ov]-!-c\nt] he>+ aids1 z def9$ 9 subsection 7q7 ( section #ebj ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 z am5d$ by subsection 7a71 &1 n lat] ?an #ahj days aft] ! date on :i* ! public comm5t p]iod on ! propos$ regulations closes1 %all issue su* f9al regulations4 7#b7 ,requirem5ts ,9 promulgat+ ! regulations "u p>agraph 7#a71 ! ,secret>y %all-- 7,a7 include requirem5ts t provide reasonable assurances ( ! safety & effectiv5ess ( ov]-!-c\nt] he>+ aids2 7,b7 include requirem5ts t e/abli% or adopt output limits appropriate = ov]-!-c\nt] he>+ aids2 7,c7 include requirem5ts = appropriate label+ ( ov]-!-c\nt] he>+ aids1 includ+ requirem5ts t su* label+ include a conspicu\s /atem5t t ! device is only int5d$ = adults age #ah & old]1 in=mation on h[ consum]s may report adv]se ev5ts1 in=mation on any contra9dications1 conditions1 or symptoms ( m$ically treatable causes ( he>+ loss1 & advisem5ts to consult promptly ) a lic5s$ heal? c>e practition]2 & 7,d7 describe ! requirem5ts "u :i* ! sale ( ov]-!-c\nt] he>+ aids is p]mitt$1 )\t ! sup]vision1 prescription1 or o!r ord]1 involvem5t1 or int]v5tion ( a lic5s$ p]son1 to consum]s ?r\gh 9-p]son transactions1 by mail1 or onl9e4 7#c7 ,prem>ket notification ,! ,secret>y %all make f9d+s "u section #eaj7m7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7m77 to det]m9e :e!r ov]-!-c\nt] he>+ aids 7z def9$ 9 section #ebj7q7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j71 z am5d$ by subsection 7a77 require a report "u section #eaj7k7 to provide reasonable assurance ( safety & effectiv5ess4 7#d7 ,effect on /ate law ,no ,/ate or local gov]nm5t %all e/abli% or cont9ue 9 effect any law1 regulation1 ord]1 or o!r requirem5t specifically relat$ to he>+ products t w\ld re/rict or int]f]e ) ! s]vic+1 m>ket+1 sale1 disp5s+1 use1 cu/om] support1 or di/ribution ( ov]-!-c\nt] he>+ aids 7z def9$ 9 section #ebj7q7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j71 z am5d$ by subsection 7a77 ?r\gh 9-p]son transactions1 by mail1 or onl9e1 t is diff]5t f1 9 addition to1 or o!rwise n id5tical to1 ! regulations promulgat$ "u ?is subsection1 includ+ any ,/ate or local requirem5t = ! sup]vision1 prescription1 or o!r ord]1 involvem5t1 or int]v5tion ( a lic5s$ p]son = consum]s to access ov]-!-c\nt] he>+ aids4 7#e7 ,no effect on private rem$ies ,no?+ 9 ?is section %all be con/ru$ to modify or o!rwise affect ! ability ( any p]son to ex]cise a private "r ( action "u any ,/ate or ,f$]al product liability1 tort1 w>ranty1 contract1 or consum] protection law4 7c7 ,new guidance issu$ ,n lat] ?an ! date on :i* f9al regulations are issu$ "u subsection 7b71 ! ,secret>y %all update & f9alize ! draft guidance ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices entitl$ ,regulatory ,requirem5ts = ,he>+ ,aid ,devices & ,p]sonal ,s\nd ,amplification ,products1 issu$ on ,novemb] #g1 #bjac4 ,su* updat$ & f9aliz$ guidance %all cl>ify :i* products1 on ! basis ( claims or o!r m>ket+1 adv]tis+1 or label+ mat]ial1 meet ! def9ition ( a device 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 & :i* products meet ! def9ition ( a p]sonal s\nd amplification product1 z set =? 9 su* guidance4 7d7 ,report ,n lat] ?an #b ye>s aft] ! date on :i* ! f9al regulations describ$ 9 subsection 7b77#a7 are issu$1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ,congress a report analyz+ any adv]se ev5ts relat+ to ov]-!-c\nt] he>+ aids 7z def9$ 9 subsection 7q77#a7 ( section #ebj ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j774 #gaj4 ,report on s]vic+ ( devices 7a7 ,9 g5]al ,n lat] ?an #bgj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all po/ on ! int]net website ( ! ,food & ,drug ,adm9i/ration a report on ! cont9u$ quality1 safety1 & effectiv5ess ( devices 7z def9$ 9 section #bja7;h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;h777 ) respect to s]vic+ 7z def9$ 9 subsection 7c774 7b7 ,cont5ts ,! report submitt$ "u subsection 7a7 %all conta9-- 7#a7 ! /atus (1 & f9d+s to date1 ) respect to1 ! propos$ rule entitl$ ,refurbi%+1 ,recondition+1 ,rebuild+1 ,rem>ket+1 ,remanufactur+1 & ,s]vic+ ( ,m$ical ,devices ,p]=m$ by ,?ird-,p>ty ,entities & ,orig9al ,equipm5t ,manufactur]s2 ,reque/ = ,comm5ts publi%$ 9 ! ,f$]al ,regi/] by ! ,food & ,drug ,adm9i/ration on ,m>* #d1 #bjaf 7#ha ,f$4 ,reg4 #aadgg72 7#b7 in=mation pres5t$ dur+ ! ,octob] #bjaf public work%op entitl$ ,refurbi%+1 ,recondition+1 ,rebuild+1 ,rem>ket+1 ,remanufactur+1 & ,s]vic+ ( ,m$ical ,devices ,p]=m$ by ,?ird-,p>ty ,entities & ,orig9al ,equipm5t ,manufactur]s2 7#c7 a description ( ! /atutory & regulatory au?ority ( ! ,food & ,drug ,adm9i/ration ) respect to ! s]vic+ ( devices conduct$ by any entity1 includ+ orig9al equipm5t manufactur]s & ?ird p>ty entities2 7#d7 details reg>d+ h[ ! ,food & ,drug ,adm9i/ration curr5tly regulates devices ) respect to s]vic+ to ensure safety & effectiv5ess1 h[ ! ag5cy c\ld improve su* regulation us+ ! au?ority describ$ 9 p>agraph 7#c71 & :e!r additional au?ority is recomm5d$2 7#e7 in=mation on actions ! ,food & ,drug ,adm9i/ration c\ld take "u ! au?ority describ$ 9 p>agraphs 7#c7 & 7#d7 to assess ! s]vic+ ( devices1 includ+ ! size1 scope1 location1 & composition ( ?ird p>ty entities2 7#f7 in=mation on actions ! ,food & ,drug ,adm9i/ration c\ld take to track adv]se ev5ts caus$ by s]vic+ errors p]=m$ by any entity1 includ+ orig9al equipm5t manufactur]s & ?ird p>ty entities2 7#g7 in=mation reg>d+ ! regulation by ,/ates1 ! ,jo9t ,commission1 or o!r regulatory bodies ( device s]vic+ p]=m$ by any entity1 includ+ orig9al equipm5t manufactur]s & ?ird p>ty entities2 & 7#h7 any additional in=mation det]m9$ by ! ,secret>y 7act+ ?r\gh ! ,commission]7 to be relevant to ensur+ ! quality1 safety1 & effectiv5ess ( devices ) respect to s]vic+4 7c7 ,s]vic+ def9$ ,9 ?is section1 ! t]m s]vic+ includes1 ) respect to a device1 refurbi%+1 recondition+1 rebuild+1 rem>ket+1 repair+1 remanufactur+1 or o!r s]vic+ ( ! device4 ,,viii ,improv+ g5]ic drug access #hja4 ,priority review ( g5]ic drugs ,section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 is am5d$ by add+ at ! end ! foll[+3 7#aa7 7,a7 ,subject to subp>agraph 7,b71 ! ,secret>y %all prioritize ! review (1 & act )9 #h mon?s ( ! date ( ! submission (1 an orig9al abbreviat$ new drug application submitt$ = review "u ?is subsection t is = a drug-- 7i7 = :i* !re are n m ?an #c approv$ drug products li/$ "u p>agraph 7#g7 & = :i* !re are no block+ pat5ts & exclusivities2 or 7ii7 t has be5 includ$ on ! li/ "u section #ejf;,e4 7,b7 ,to qualify = priority review "u ?is p>agraph1 n lat] ?an #fj days prior to ! submission ( an application describ$ 9 subp>agraph 7,a7 or t ! ,secret>y may prioritize pursuant to subp>agraph 7,d71 ! applicant %all provide complete1 accurate in=mation reg>d+ facilities involv$ 9 manufactur+ processes & te/+ ( ! drug t is ! subject ( ! application1 includ+ facilities 9 correspond+ ,type ,,ii active ph>maceutical +r$i5ts drug ma/] files ref]5c$ 9 an application & sites or organizations involv$ 9 bioequival5ce & cl9ical /udies us$ to support ! application1 to enable ! ,secret>y to make a det]m9ation reg>d+ :e!r an inspection ( a facility is necess>y4 ,su* in=mation %all include ! relevant 7z det]m9$ by ! ,secret>y7 sections ( su* application1 :i* %all be un*ang$ relative to ! date ( ! submission ( su* application1 except to ! ext5t t a *ange is made to su* in=mation to exclude a facility t 0 n us$ to g5]ate data to meet any application requirem5ts = su* submission & t is n ! only facility int5d$ to conduct "o or m unit op]ations 9 comm]cial production4 ,in=mation provid$ by an applicant "u ?is subp>agraph %all n be consid]$ ! submission ( an application "u ?is subsection4 7,c7 ,! ,secret>y may exp$ite an inspection or re9spection "u section #gjd ( an e/abli%m5t t proposes to manufacture a drug describ$ 9 subp>agraph 7,a74 7,d7 ,no?+ 9 ?is p>agraph %all prev5t ! ,secret>y f prioritiz+ ! review ( o!r applications z ! ,secret>y det]m9es appropriate4 7#ab7 ,! ,secret>y %all publi% on ! int]net website ( ! ,food & ,drug ,adm9i/ration1 & update at lea/ once e #f mon?s1 a li/ ( all drugs approv$ "u subsection 7c7 = :i* all pat5ts & p]iods ( exclusivity "u ?is ,act h expir$ & = :i* no application has be5 approv$ "u ?is subsection4 4 #hjb4 ,enhanc+ regulatory transp>5cy to enhance g5]ic competition ,section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 z am5d$ by section #hja1 is fur!r am5d$ by add+ at ! end ! foll[+3 7#ac7 ,^u ! reque/ ( an applicant reg>d+ "o or m specifi$ p5d+ applications "u ?is subsection1 ! ,secret>y %all1 z appropriate1 provide review /atus updates indicat+ ! categorical /atus ( ! applications by ea* relevant review discipl9e4 4 #hjc4 ,competitive g5]ic !rapies 7a7 ,9 g5]al ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by ins]t+ aft] section #ejf;,g ! foll[+3 #ejf;,h4 ,competitive g5]ic !rapies 7a7 ,9 g5]al ,! ,secret>y may1 at ! reque/ ( an applicant ( a drug t is designat$ z a competitive g5]ic !rapy pursuant to subsection 7b71 exp$ite ! developm5t & review ( an abbreviat$ new drug application "u section #eje7;j7 = su* drug4 7b7 ,designation process 7#a7 ,reque/ ,! applicant may reque/ ! ,secret>y to designate ! drug z a competitive g5]ic !rapy4 7#b7 ,tim+ ,a reque/ "u p>agraph 7#a7 may be made concurr5tly )1 or at any "t prior to1 ! submission ( an abbreviat$ new drug application = ! drug "u section #eje7;j74 7#c7 ,crit]ia ,a drug is eligible = designation z a competitive g5]ic !rapy "u ?is section if ! ,secret>y det]m9es t !re is inadequate g5]ic competition4 7#d7 ,designation ,n lat] ?an #fj cal5d> days aft] ! receipt ( a reque/ "u p>agraph 7#a71 ! ,secret>y may-- 7,a7 det]m9e :e!r ! drug t is ! subject ( ! reque/ meets ! crit]ia describ$ 9 p>agraph 7#c72 & 7,b7 if ! ,secret>y f9ds t ! drug meets su* crit]ia1 designate ! drug z a competitive g5]ic !rapy4 7c7 ,actions ,9 exp$it+ ! developm5t & review ( an application "u subsection 7a71 ! ,secret>y may1 z reque/$ by ! applicant1 take actions includ+ ! foll[+3 7#a7 ,hold meet+s ) ! applicant & ! review team ?r\gh\t ! developm5t ( ! drug prior to submission ( ! application = su* drug "u section #eje7;j74 7#b7 ,provide timely advice to1 & int]active communication )1 ! applicant reg>d+ ! developm5t ( ! drug to ensure t ! developm5t program to ga!r ! data necess>y = approval is z effici5t z practicable4 7#c7 ,involve s5ior manag]s & exp]i5c$ review /aff1 z appropriate1 9 a collaborative1 coord9at$ review ( su* application1 includ+ ) respect to drug-device comb9ation products & o!r complex products4 7#d7 ,assign a cross-discipl9>y project lead-- 7,a7 to facilitate an effici5t review ( ! developm5t program & application1 includ+ manufactur+ inspections2 & 7,b7 to s]ve z a sci5tific liaison betwe5 ! review team & ! applicant4 7d7 ,report+ requirem5t ,n lat] ?an "o ye> aft] ! date ( ! approval ( an application "u section #eje7;j7 ) respect to a drug = :i* ! developm5t & review is exp$it$ "u ?is section1 ! sponsor ( su* drug %all report to ! ,secret>y on :e!r ! drug has be5 m>ket$ 9 int]/ate comm]ce s9ce ! date ( su* approval4 7e7 ,def9itions ,9 ?is section3 7#a7 ,! t]m g5]ic drug means a drug t is approv$ pursuant to section #eje7;j74 7#b7 ,! t]m inadequate g5]ic competition means1 ) respect to a drug1 !re is n m ?an "o approv$ drugs on ! li/ ( drugs describ$ 9 section #eje7;j77#g77;,a7 7n includ+ drugs on ! discont9u$ section ( su* li/7 t is-- 7,a7 ! ref]5ce li/$ drug2 or 7,b7 a g5]ic drug ) ! same ref]5ce li/$ drug z ! drug = :i* designation z a competitive g5]ic !rapy is s\ght4 7#c7 ,! t]m ref]5ce li/$ drug means ! li/$ drug 7z su* t]m is us$ 9 section #eje7;j77 = ! drug involv$4 4 7b7 ,guidance2 am5d$ regulations 7#a7 ,9 g5]al 7,a7 ,issuance ,! ,secret>y ( ,heal? & ,human ,s]vices %all-- 7i7 n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 issue draft guidance on section #ejf;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a72 & 7ii7 n lat] ?an #a ye> aft] ! close ( ! comm5t p]iod = ! draft guidance1 issue f9al guidance on su* section #ejf;,h4 7,b7 ,cont5ts ,! guidance issu$ "u ?is p>agraph %all-- 7i7 specify ! process & crit]ia by :i* ! ,secret>y makes a designation "u section #ejf;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a72 7ii7 specify ! actions ! ,secret>y may take to exp$ite ! developm5t & review ( a competitive g5]ic !rapy pursuant to su* a designation2 & 7iii7 include good review managem5t practices = competitive g5]ic !rapies4 7#b7 ,am5d$ regulations ,! ,secret>y ( ,heal? & ,human ,s]vices %all issue or revise any regulations z may be necess>y to c>ry out ?is section n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act4 #hjd4 ,accurate in=mation ab\t drugs ) limit$ competition ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by ins]t+ aft] section #ejf;,h1 z add$ by section #hjc1 ! foll[+3 #ejf;,i4 ,prompt reports ( m>ket+ /atus 7a7 ,notification ( )drawal ,! hold] ( an application approv$ "u subsection 7c7 or 7j7 ( section #eje %all notify ! ,secret>y 9 writ+ #ahj days prior to )draw+ ! approv$ drug f sale1 or if #ahj days is n practicable z soon z practicable b n lat] ?an ! date ( )drawal4 ,! hold] %all include ) su* notice !-- 7#a7 ,national ,drug ,code2 7#b7 id5tity ( ! drug by e/abli%$ "n & by propriet>y "n1 if any2 7#c7 new drug application numb] or abbreviat$ application numb]2 7#d7 /r5g? ( ! drug2 7#e7 date on :i* ! drug is expect$ to no long] be available = sale2 & 7#f7 reason = )drawal ( ! drug4 7b7 ,notification ( drug n available = sale ,! hold] ( an application approv$ "u subsection 7c7 or 7j7 %all notify ! ,secret>y 9 writ+ )9 #ahj cal5d> days ( ! date ( approval ( ! drug if ! drug w n be available = sale )9 #ahj cal5d> days ( su* date ( approval4 ,! hold] %all include ) su* notice !-- 7#a7 id5tity ( ! drug by e/abli%$ "n & by propriet>y "n1 if any2 7#b7 new drug application numb] or abbreviat$ application numb]2 7#c7 /r5g? ( ! drug2 7#d7 date on :i* ! drug w be available = sale1 if kn[n2 & 7#e7 reason = n m>ket+ ! drug aft] approval4 7c7 ,additional "o-"t report ,)9 #ahj days ( ! date ( enactm5t ( ?is section1 all hold]s ( applications approv$ "u subsection 7c7 or 7j7 ( section #eje %all review ! in=mation 9 ! li/ publi%$ "u subsection #eje7;j77#g77;,a7 & %all notify ! ,secret>y 9 writ+ t-- 7#a7 all ( ! application hold]'s drugs 9 ! active section ( ! li/ publi%$ "u subsection #eje7;j77#g77;,a7 are available = sale2 or 7#b7 "o or m ( ! application hold]'s drugs 9 ! active section ( ! li/ publi%$ "u subsection #eje7;j77#g77;,a7 h be5 )drawn f sale or h nev] be5 available = sale1 & include ) su* notice ! in=mation requir$ pursuant to subsection 7a7 or 7b71 z applicable4 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 move ! application hold]'s drugs f ! active section ( ! li/ publi%$ "u subsection #eje7;j77#g77;,a7 to ! discont9u$ section ( ! li/1 except t ! ,secret>y %all remove f ! li/ 9 accordance ) subsection #eje7;j77#g77;,c7 drugs ! ,secret>y det]m9es h be5 )drawn f sale = reasons ( safety ( effectiv5ess4 7e7 ,updates ,! ,secret>y %all update ! li/ publi%$ "u subsection #eje7;j77#g77;,a7 bas$ on ! in=mation provid$ "u subsections 7a71 7b71 & 7c7 by mov+ drugs t are n available = sale f ! active section to ! discont9u$ section ( ! li/1 except t drugs ! ,secret>y det]m9es h be5 )drawn f sale = reasons ( safety or effectiv5ess %all be remov$ f ! li/ 9 accordance ) subsection #eje7;j77#g77;,c74 ,! ,secret>y %all make mon?ly updates to ! li/ bas$ on ! in=mation provid$ pursuant to subsections 7a7 & 7b71 & %all update ! li/ bas$ on ! in=mation provid$ "u subsection 7c7 z soon z practicable4 7f7 ,limitation on use ( notices ,any notice submitt$ "u ?is section %all n be made public by ! ,secret>y & %all be us$ solely = ! purpose ( ! updates describ$ 9 subsection 7e74 4 #hje4 ,suitability petitions 7a7 ,9 g5]al ,x is ! s5se ( ,congress t ! ,food & ,drug ,adm9i/ration %all meet ! requirem5t "u section #eje7;j77#b77;,c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#b77;,c77 & section #cad4ic7;e7 ( title #ba1 ,code ( ,f$]al ,regulations1 ( respond+ to suitability petitions )9 #ij days ( submission4 7b7 ,report ,! ,secret>y ( ,heal? & ,human ,s]vices %all include 9 ! annual reports "u section #hjg-- 7#a7 ! numb] ( p5d+ petitions "u section #eje7;j77#b77;,c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#b77;,c772 & 7#b7 ! numb] ( su* petitions p5d+ a sub/antive response = m ?an #ahj days f ! date ( receipt4 #hjf4 ,inspections ,)9 #f mon?s ( ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all develop & implem5t a protocol = exp$it+ review ( timely responses to reports ( obs]vations f an inspection "u section #gjd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd74 ,su* protocol %all-- 7#a7 apply to responses to su* reports p]ta9+ to applications submitt$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7-- 7,a7 = :i* ! approval is dep5d5t ^u rem$iation ( conditions id5tifi$ 9 ! report2 7,b7 = :i* conc]ns relat$ to obs]vations f an inspection "u su* section #gjd are ! only b>ri] to approval2 & 7,c7 :]e ! drug t is ! subject ( ! application is a drug-- 7i7 = :i* !re are n m ?an #c o!r approv$ applications "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 t ref]5ce ! same li/$ drug & = :i* !re are less ?an #f abbreviat$ new drug applications t5tatively approv$2 or 7ii7 t is includ$ on ! li/ "u section #ejf;,e ( su* ,act 7#ba ,u4,s4,c4 #cef;e72 7#b7 address exp$it$ re-inspection ( facilities1 z appropriate2 & 7#c7 e/abli% a #f-mon? timel9e = completion ( review ( su* responses to su* reports4 #hjg4 ,report+ on p5d+ g5]ic drug applications & priority review applications ,n lat] ?an #ahj cal5d> days aft] ! date ( enactm5t ( ?is ,act1 & qu>t]ly !reaft] until ,octob] #a1 #bjbb1 ! ,secret>y ( ,heal? & ,human ,s]vices %all po/ on ! int]net website ( ! ,food & ,drug ,adm9i/ration a report t provides1 ) respect to ! mon?s cov]$ by ! report-- 7#a7 ) respect to applications fil$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 t1 dur+ ! mo/ rec5t cal5d> ye>1 7 subject to priority review "u p>agraph 7#aa7 ( su* section #eje7;j7 7z add$ by section #hja7 or exp$it$ developm5t & review "u section #ejf;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by section #hjc71 ! numb]s ( su* applications 7) d5otation ( su* applications t 7 fil$ prior to ,octob] #a1 #bjad7 t are-- 7,a7 await+ action by ! applicant2 7,b7 await+ action by ! ,secret>y2 & 7,c7 approv$ by ! ,secret>y2 7#b7 ! numb] ( applications fil$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 & prior approval supplem5ts )drawn 9 ea* mon?2 7#c7 ! mean & m$ian approval & t5tative approval times & ! numb] ( review cycles = su* applications2 7#d7 ! numb] & type ( meet+s reque/$ & held "u su* section #ejf;,h 7z add$ by section #hjc72 & 7#e7 ! numb] ( su* applications on :i* ! ,secret>y has tak5 action pursuant to subsection 7c7 ( su* section #ejf;,h 7z add$ by section #hjc7 & any effect su* section #ejf;,h may h on ! l5g? ( "t = approval ( applications "u su* section #eje7;j7 & ! numb] ( review cycles = su* approvals4 #hjh4 ,inc5tiviz+ competitive g5]ic drug developm5t ,section #eje7;j77#e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77 is am5d$-- 7#a7 9 subp>agraph 7,b71 by add+ at ! end ! foll[+3 7v7 #ahj-;day exclusivity p]iod = competitive g5]ic !rapies 7,i7 ,effectiv5ess ( application ,subject to subp>agraph 7,d77iv71 if ! application is = a drug t is ! same z a competitive g5]ic !rapy = :i* any fir/ approv$ applicant has comm5c$ comm]cial m>ket+1 ! application %all be made effective on ! date t is #ahj days aft] ! date ( ! fir/ comm]cial m>ket+ ( ! competitive g5]ic !rapy 7includ+ ! comm]cial m>ket+ ( ! li/$ drug7 by any fir/ approv$ applicant4 7,,ii7 ,limitation ,! exclusivity p]iod "u subclause 7,i7 %all n apply ) respect to a competitive g5]ic !rapy t has previ\sly receiv$ an exclusivity p]iod "u subclause 7,i74 7,,iii7 ,def9itions ,9 ?is clause & subp>agraph 7,d77iv73 7aa7 ,! t]m competitive g5]ic !rapy means a drug-- 7,,aa7 t is designat$ z a competitive g5]ic !rapy "u section #ejf;,h2 & 7,,bb7 = :i* !re are no unexpir$ pat5ts or exclusivities on ! li/ ( products describ$ 9 section #eje7;j77#g77;,a7 at ! "t ( submission4 7bb7 ,! t]m fir/ approv$ applicant means any applicant t has submitt$ an application t-- 7,,aa7 is = a competitive g5]ic !rapy t is approv$ on ! fir/ day on :i* any application = su* competitive g5]ic !rapy is approv$2 7,,bb7 is n eligible = a #ahj-;day exclusivity p]iod "u clause 7iv7 = ! drug t is ! subject ( ! application = ! competitive g5]ic !rapy2 & 7,,cc7 is n = a drug = :i* all drug v]sions h =feit$ eligibility = a #ahj-;day exclusivity p]iod "u clause 7iv7 pursuant to subp>agraph 7,d74 2 & 7#b7 9 subp>agraph 7,d71 by add+ at ! end ! foll[+3 7iv7 ,special =feiture rule = competitive g5]ic !rapy ,! #ahj-;day exclusivity p]iod describ$ 9 subp>agraph 7,b77v7 %all be =feit$ by a fir/ approv$ applicant if ! applicant fails to m>ket ! competitive g5]ic !rapy )9 #ge days aft] ! date on :i* ! approval ( ! fir/ approv$ applicant's application = ! competitive g5]ic !rapy is made effective4 4 #hji4 ,,gao /udy ( issues reg>d+ fir/ cycle approvals ( g5]ic m$ic9es 7a7 ,/udy by ,,gao ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy to det]m9e ! foll[+3 7#a7 ,! rate ( fir/ cycle approvals & t5tative approvals = applications submitt$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 dur+ ! p]iod beg9n+ on ,octob] #a1 #bjab1 & end+ on ,septemb] #cj1 #bjag4 ,! rate ( fir/ cycle approvals & t5tative approvals %all be det]m9$ & report$ p] ea* ,,gdufa cohort ye> dur+ ?is p]iod4 7#b7 ,if ! rate det]m9$ pursuant to p>agraph 7#a7 = any ,,gdufa cohort ye> is l[] ?an #bj p]c5t1 ! reasons contribut+ to ! relatively l[ rate ( fir/ cycle approvals & t5tative approvals = g5]ic drug applications %all be itemiz$1 assess$1 & report$4 ,9 mak+ ! assessm5t requir$ by ?is p>agraph1 ! ,comptroll] ,g5]al %all consid]1 among o!r ?+s1 ! role play$ by-- 7,a7 ! ,food & ,drug ,adm9i/ration's implem5tation ( approval /&>ds = g5]ic drug applications2 7,b7 ! ext5t to :i* ^? approval /&>ds are communicat$ cle>ly to indu/ry & appli$ consi/5tly dur+ ! review process2 7,c7 ! proc$ures = review+ g5]ic drug applications1 includ+ timel9es = review activities by ! ,food & ,drug ,adm9i/ration2 7,d7 ! ext5t to :i* ^? proc$ures are foll[$ consi/5tly 7& ^? timel9es are met7 by ! ,food & ,drug ,adm9i/ration2 7,e7 ! processes & practices = communication betwe5 ! ,food & ,drug ,adm9i/ration & sponsors ( g5]ic drug applications2 & 7,f7 ! complet5ess & quality ( orig9al g5]ic drug applications submitt$ to ! ,food & ,drug ,adm9i/ration4 7#c7 ,tak+ into acc\nt ! det]m9ations made pursuant to p>agraphs 7#a7 & 7#b7 & any review process improvem5ts implem5t$ pursuant to ?is ,act1 :e!r !re are ways ! review process = g5]ic drugs c\ld be improv$ to increase ! rate ( fir/ cycle approvals & t5tative approvals = g5]ic drug applications4 ,9 mak+ ?is det]m9ation1 ! ,comptroll] ,g5]al %all consid]1 among o!r ?+s1 options = increas+ review effici5cy & communication effectiv5ess4 7b7 ,completion date ,n lat] ?an ! expiration ( ! #b-ye> p]iod beg9n+ on ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al %all complete ! /udy "u subsection 7a7 & submit a report describ+ ! f9d+s & conclusions ( ! /udy to ! ,secret>y1 ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate4 7c7 ,def9itions ,= purposes ( ?is section3 7#a7 ,! t]m ,,gdufa cohort ye> means a fiscal ye>4 7#b7 ,! t]m g5]ic drug means a drug t is approv$ or is seek+ approval "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j774 7#c7 ,! t]m g5]ic drug application means an abbreviat$ new drug application = ! approval ( a g5]ic drug "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j774 7#d7 ,! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices4 7#e7 7,a7 ,! t]m fir/ cycle approvals & t5tative approvals means ! approval or t5tative approval ( a g5]ic drug application aft] ! ,food & ,drug ,adm9i/ration's complete review ( ! application & )\t issuance ( "o or m complete response lett]s4 7,b7 ,= purposes ( ?is p>agraph1 ! t]m complete response lett] means a writt5 communication to ! sponsor ( a g5]ic drug application or hold] ( a drug ma/] file f ! ,food & ,drug ,adm9i/ration describ+ all ( ! defici5cies t ! ,adm9i/ration has id5tifi$ 9 ! g5]ic drug application 7includ+ p5d+ am5dm5ts7 or drug ma/] file t mu/ be satisfactorily address$ be=e ! g5]ic drug application c be approv$4 ,,ix ,additional provisions #ija4 ,te*nical corrections 7a7 ,section #cjge7;a7 ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee7 is am5d$-- 7#a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ z am5d$ by section #bjgd & ins]t+ z am5d$ by section #cajb2 & 7#b7 9 p>agraph 7#b71 by /rik+ section #bjgd7a77;,c7 & ins]t+ section #cajb7a77;,c74 7b7 ,section #ejf;,g7b77#a77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;g7b77#a77;,a77 is am5d$ by /rik+ id5tity & ins]t+ id5tify4 7c7 ,section #eje;,f7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;g7b77 is am5d$ by /rik+ r&omiz$ & ins]t+ traditional4 7d7 ,section #eje;,f7d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;g7d77 is am5d$ by /rik+ #b & ins]t+ #c4 7e7 ,section #eaj7;h77#f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;h77#f77 is am5d$ by /rik+ ,febru>y #a & replac+ ) ,may #a4 7f7 ,effective z ( ! enactm5t ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee7-- 7#a7 section #cjea7;a7 ( su* ,act is am5d$ by /rik+ by ins]t+ aft] section #eae;,b & ins]t+ by ins]t+ aft] section #eae;,a2 & 7#b7 section #eae;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e-#c71 z ins]t$ by su* section #cjea7;a71 is r$esignat$ z section #eae;,b4 7g7 ,section #eae;,b7f77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e-#c7;f77#b771 z r$esignat$ by subsection 7e77#b7 ( ?is section1 is am5d$ by /rik+ a propos$ guidance & ins]t+ a draft v]sion ( t guidance4 7h7 ,section #eac7;b77#e77;,d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7b77#e77;,d77 is am5d$ by /rik+ m$ical device submissions & ins]t+ m$ical devices t may be specifically ! subject ( a review by a classification panel4 #ijb4 ,annual report on inspections ,n lat] ?an ,m>* #a ( ea* ye>1 ! ,secret>y ( ,heal? & ,human ,s]vices %all po/ on ! int]net website ( ! ,food & ,drug ,adm9i/ration in=mation relat$ to inspections ( facilities necess>y = approval ( a drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 approval ( a device "u section #eae ( su* ,act 7#ba ,u4,s4,c4 #cfj;e71 or cle>ance ( a device "u section #eaj7k7 ( su* ,act 7#ba ,u4,s4,c4 #cfj7k77 t 7 conduct$ dur+ ! previ\s cal5d> ye>4 ,su* in=mation %all include ! foll[+3 7#a7 ,! m$ian "t foll[+ a reque/ f /aff ( ! ,food & ,drug ,adm9i/ration review+ an application or report to ! beg9n+ ( ! inspection1 & ! m$ian "t f ! beg9n+ ( an inspection to ! issuance ( a report pursuant to section #gjd7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;b774 7#b7 ,! m$ian "t f ! issuance ( a report pursuant to su* section #gjd7;b7 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$4 7#c7 ,! m$ian "t f ! s5d+ ( a w>n+ lett]1 issuance ( an import al]t1 or hold+ ( a regulatory meet+ to resolution ( ! regulatory or en=cem5t action indicat$ = inspections = :i* ! ,secret>y conclud$ t su* action 0 indicat$4 7#d7 ,! numb] ( times t a facility 0 issu$ a report pursuant to su* section #gjd7;b7 & approval ( an application 0 delay$ due to ! issuance ( a )hold recomm5dation4 #ijc4 ,/reaml9+ & improv+ consi/5cy 9 p]=mance report+ 7a7 ,,pdufa ,section #gcf;,b7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7;a771 z am5d$ by section #ajc1 is fur!r am5d$ by ins]t+ aft] p>agraph 7#b7 ! foll[+3 7#c7 ,real "t report+ 7,a7 ,9 g5]al ,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]1 ! ,secret>y %all po/ ! data describ$ 9 subp>agraph 7,b7 on ! int]net website ( ! ,food & ,drug ,adm9i/ration = su* qu>t] & on a cumulative basis = su* fiscal ye>1 & may remove duplicative data f ! annual p]=mance report "u ?is subsection4 7,b7 ,data ,! ,secret>y %all po/ ! foll[+ data 9 accordance ) subp>agraph 7,a73 7i7 ,! numb] & titles ( draft & f9al guidance on topics relat$ to ! process = ! review ( human drug applications1 & :e!r su* guidances 7 issu$ z requir$ by /atute or pursuant to a commitm5t "u ! lett]s describ$ 9 section #aja7;b7 ( ! ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjag4 7ii7 ,! numb] & titles ( public meet+s held on topics relat$ to ! process = ! review ( human drug applications1 & :e!r su* meet+s 7 requir$ by /atute or pursuant to a commitm5t "u ! lett]s describ$ 9 section #aja7;b7 ( ! ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjag4 7iii7 ,! numb] ( new drug applications & biological lic5s+ applications approv$4 7iv7 ,! numb] ( new drug applications & biological lic5s+ applications fil$4 7#d7 ,rationale = ,,pdufa program *anges ,beg9n+ ) fiscal ye> #bjbj1 ! ,secret>y %all include 9 ! annual report "u p>agraph 7#a7-- 7,a7 data1 analysis1 & discussion ( ! *anges 9 ! numb] ( full-"t equival5ts hir$ z agre$ ^u 9 ! lett]s describ$ 9 section #aja7;b7 ( ! ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjag & ! numb] ( full "t equival5ts fund$ by budget au?ority at ! ,food & ,drug ,adm9i/ration by ea* division )9 ! ,c5t] = ,drug ,evaluation & ,rese>*1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 ! ,(fice ( ,regulatory ,affairs1 & ! ,(fice ( ! ,commission]2 7,b7 data1 analysis1 & discussion ( ! *anges 9 ! fee rev5ue am\nts & co/s = ! process = ! review ( human drugs1 includ+ id5tify+ driv]s ( su* *anges2 & 7,c7 = ea* ( ! ,c5t] = ,drug ,evaluation & ,rese>*1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 ! ,(fice ( ,regulatory ,affairs1 & ! ,(fice ( ! ,commission]1 ! numb] ( employees = :om "t report+ is requir$ & ! numb] ( employees = :om "t report+ is n requir$4 4 7b7 ,,mdufa ,section #gch;,a7a77#a77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;a77#a77;,a771 z am5d$ by section #bjd1 is fur!r am5d$-- 7#a7 by /rik+ ,beg9n+ ) & ins]t+ ! foll[+3 7i7 ,g5]al requirem5ts ,beg9n+ ) 2 & 7#b7 by add+ at ! end ! foll[+3 7ii7 ,additional in=mation ,beg9n+ ) fiscal ye> #bjah1 ! annual report "u ?is subp>agraph %all include ! progress ( ! ,c5t] = ,devices & ,radiological ,heal? 9 a*iev+ ! goals1 & future plans = meet+ ! goals1 includ+-- 7,i7 ! numb] ( prem>ket applications fil$ "u section #eae p] fiscal ye> = ea* review division2 7,,ii7 ! numb] ( reports submitt$ "u section #eaj7k7 p] fiscal ye> = ea* review division2 & 7,,iii7 ! numb] ( exp$it$ developm5t & priority review designations "u section #eae;,c p] fiscal ye>4 7iii7 ,real "t report+ 7,i7 ,9 g5]al ,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]1 ! ,secret>y %all po/ ! data describ$ 9 subclause 7,,ii7 on ! int]net website ( ! ,food & ,drug ,adm9i/ration = su* qu>t] & on a cumulative basis = su* fiscal ye>1 & may remove duplicative data f ! annual report "u ?is subp>agraph4 7,,ii7 ,data ,! ,secret>y %all po/ ! foll[+ data 9 accordance ) subclause 7,i73 7aa7 ,! numb] & titles ( draft & f9al guidance on topics relat$ to ! process = ! review ( devices1 & :e!r su* guidances 7 issu$ z requir$ by /atute or pursuant to ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjag2 & 7bb7 ,! numb] & titles ( public meet+s held on topics relat$ to ! process = ! review ( devices1 & if su* meet+s 7 requir$ by /atute or pursuant to a commitm5t "u ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjag4 7iv7 ,rationale = mdufa program *anges ,beg9n+ ) fiscal ye> #bjbj1 ! ,secret>y %all include 9 ! annual report "u p>agraph 7#a7-- 7,i7 data1 analysis1 & discussion ( ! *anges 9 ! numb] ( full-"t equival5ts hir$ z agre$ ^u 9 ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjag & ! numb] ( full "t equival5ts fund$ by budget au?ority at ! ,food & ,drug ,adm9i/ration by ea* division )9 ! ,c5t] = ,devices & ,radiological ,heal?1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 ! ,(fice ( ,regulatory ,affairs1 & ! ,(fice ( ! ,commission]2 7,,ii7 data1 analysis1 & discussion ( ! *anges 9 ! fee rev5ue am\nts & co/s = ! process = ! review ( devices1 includ+ id5tify+ driv]s ( su* *anges2 & 7,,iii7 = ea* ( ! ,c5t] = ,devices & ,radiological ,heal?1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 ! ,(fice ( ,regulatory ,affairs1 & ! ,(fice ( ! ,commission]1 ! numb] ( employees = :om "t report+ is requir$ & ! numb] ( employees = :om "t report+ is n requir$4 4 7c7 ,,gdufa ,section #gdd;,c7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7;a771 z am5d$ by section #cjd1 is fur!r am5d$-- 7#a7 by /rik+ ,beg9n+ ) & ins]t+ ! foll[+3 7#a7 ,g5]al requirem5ts ,beg9n+ ) 2 & 7#b7 by add+ at ! end ! foll[+3 7#b7 ,real "t report+ 7,a7 ,9 g5]al ,n lat] ?an #cj cal5d> days aft] ! end ( ! second qu>t] ( fiscal ye> #bjah1 & n lat] ?an #cj cal5d> days aft] ! end ( ea* qu>t] ( ea* fiscal ye> !reaft]1 ! ,secret>y %all po/ ! data describ$ 9 subp>agraph 7,b7 on ! int]net website ( ! ,food & ,drug ,adm9i/ration1 & may remove duplicative data f ! annual report "u ?is subsection4 7,b7 ,data ,! ,secret>y %all po/ ! foll[+ data 9 accordance ) subp>agraph 7,a73 7i7 ,! numb] & titles ( draft & f9al guidance on topics relat$ to human g5]ic drug activities & :e!r su* guidances 7 issu$ z requir$ by /atute or pursuant to a commitm5t "u ! lett]s describ$ 9 section #cja7;b7 ( ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjag4 7ii7 ,! numb] & titles ( public meet+s held on topics relat$ to human g5]ic drug activities & :e!r su* meet+s 7 requir$ by /atute or pursuant to a commitm5t "u ! lett]s describ$ 9 section #cja7;b7 ( ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjag4 7#c7 ,rationale = gdufa program *anges ,beg9n+ ) fiscal ye> #bjbj1 ! ,secret>y %all include 9 ! annual report "u p>agraph 7#a7-- 7,a7 data1 analysis1 & discussion ( ! *anges 9 ! numb] ( full-"t equival5ts hir$ z agre$ ^u 9 ! lett]s describ$ 9 section #cja7;b7 ( ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjag & ! numb] ( full "t equival5ts fund$ by budget au?ority at ! ,food & ,drug ,adm9i/ration by ea* division )9 ! ,c5t] = ,drug ,evaluation & ,rese>*1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 ! ,(fice ( ,regulatory ,affairs1 & ! ,(fice ( ! ,commission]2 7,b7 data1 analysis1 & discussion ( ! *anges 9 ! fee rev5ue am\nts & co/s = human g5]ic drug activities1 includ+ id5tify+ driv]s ( su* *anges2 & 7,c7 = ea* ( ! ,c5t] = ,drug ,evaluation & ,rese>*1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 ! ,(fice ( ,regulatory ,affairs1 & ! ,(fice ( ! ,commission]1 ! numb] ( employees = :om "t report+ is requir$ & ! numb] ( employees = :om "t report+ is n requir$4 4 7d7 ,bs,u,f,a ,section #gdd;,i7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7;a771 z am5d$ by section #djd1 is fur!r am5d$-- 7#a7 by /rik+ ,beg9n+ ) & ins]t+ ! foll[+3 7#a7 ,g5]al requirem5ts ,beg9n+ ) 2 & 7#b7 by add+ at ! end ! foll[+3 7#b7 ,additional in=mation ,beg9n+ ) fiscal ye> #bjah1 ! report "u ?is subsection %all include ! progress ( ! ,food & ,drug ,adm9i/ration 9 a*iev+ ! goals1 & future plans = meet+ ! goals1 includ+-- 7,a7 in=mation on all previ\s cohorts = :i* ! ,secret>y has n giv5 a complete response on all biosimil> biological product applications & supplem5ts 9 ! cohort2 7,b7 ! numb] ( orig9al biosimil> biological product applications fil$ p] fiscal ye>1 & ! numb] ( approvals issu$ by ! ag5cy = su* applications2 & 7,c7 ! numb] ( resubmitt$ orig9al biosimil> biological product applications fil$ p] fiscal ye> & ! numb] ( approvals lett]s issu$ by ! ag5cy = su* applications4 7#c7 ,real "t report+ 7,a7 ,9 g5]al ,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]1 ! ,secret>y %all po/ ! data describ$ 9 subp>agraph 7,b7 = su* qu>t] & on a cumulative basis = ! fiscal ye> on ! int]net website ( ! ,food & ,drug ,adm9i/ration1 & may remove duplicative data f ! annual report "u ?is subsection4 7,b7 ,data ,! ,secret>y %all po/ ! foll[+ data 9 accordance ) subp>agraph 7,a73 7i7 ,! numb] & titles ( draft & f9al guidance on topics relat$ to ! process = ! review ( biosimil>s1 & :e!r su* guidances 7 requir$ by /atute or pursuant to a commitm5t "u ! lett]s describ$ 9 section #dja7;b7 ( ! ,biosimil> ,us] ,fee ,am5dm5ts ( #bjag4 7ii7 ,! numb] & titles ( public meet+s held on topics relat$ to ! process = ! review ( biosimil>s1 & :e!r su* meet+s 7 requir$ by /atute or pursuant to a commitm5t "u ! lett]s describ$ 9 section #dja7;b7 ( ! ,biosimil> ,us] ,fee ,am5dm5ts ( #bjag4 7#d7 ,rationale = ,bs,u,f,a program *anges ,beg9n+ ) fiscal ye> #bjbj1 ! ,secret>y %all include 9 ! annual report "u p>agraph 7#a7-- 7,a7 data1 analysis1 & discussion ( ! *anges 9 ! numb] ( full-"t equival5ts hir$ z agre$ ^u 9 ! lett]s describ$ 9 section #dja7;b7 ( ! ,biosimil> ,us] ,fee ,am5dm5ts ( #bjag & ! numb] ( full "t equival5ts fund$ by budget au?ority at ! ,food & ,drug ,adm9i/ration by ea* division )9 ! ,c5t] = ,drug ,evaluation & ,rese>*1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 ! ,(fice ( ,regulatory ,affairs1 & ! ,(fice ( ! ,commission]2 7,b7 data1 analysis1 & discussion ( ! *anges 9 ! fee rev5ue am\nts & co/s = ! process = ! review ( biosimil> biological product applications1 includ+ id5tify+ driv]s ( su* *anges2 & 7,c7 = ea* ( ! ,c5t] = ,drug ,evaluation & ,rese>*1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 ! ,(fice ( ,regulatory ,affairs1 & ! ,(fice ( ! ,commission]1 ! numb] ( employees = :om "t report+ is requir$ & ! numb] ( employees = :om "t report+ is n requir$4 4 #ijd4 ,analysis ( use ( funds 7a7 ,,pdufa reports 7#a7 ,analysis 9 pdufa p]=mance reports ,section #gcf;,b7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7;a771 z am5d$ by section #ijc7;a71 is fur!r am5d$ by add+ at ! end ! foll[+3 7#e7 ,analysis ,= ea* fiscal ye>1 ! ,secret>y %all include 9 ! report "u p>agraph 7#a7 an analysis ( ! foll[+3 7,a7 ,! diff]5ce betwe5 ! aggregate numb] ( human drug applications fil$ & ! aggregate numb] ( approvals1 acc\nt+ =-- 7i7 su* applications fil$ dur+ "o fiscal ye> = :i* a decision is n s*$ul$ to be made until ! foll[+ fiscal ye>2 7ii7 ! aggregate numb] ( applications = ea* fiscal ye> t did n meet ! goals id5tifi$ 9 ! lett]s describ$ 9 section #aja7;b7 ( ! ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjag = ! applicable fiscal ye>4 7,b7 ,relevant data to det]m9e :e!r ! ,c5t] = ,drug ,evaluation & ,rese>* & ! ,c5t] = ,biologics ,evaluation & ,rese>* h met p]=mance enhancem5t goals id5tifi$ 9 ! lett]s describ$ 9 section #aja7;b7 ( ! ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjag = ! applicable fiscal ye>4 7,c7 ,! mo/ common causes & tr5ds ( ext]nal or o!r circum/ances affect+ ! ability ( ! ,c5t] = ,drug ,evaluation & ,rese>*1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 ,(fice ( ,regulatory ,affairs1 & ! ,food & ,drug ,adm9i/ration to meet ! review "t & p]=mance enhancem5t goals id5tifi$ 9 ! lett]s describ$ 9 section #aja7;b7 ( ! ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjag4 4 7#b7 ,issuance ( corrective action reports ,section #gcf;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7 is am5d$-- 7,a7 by r$esignat+ subsections 7c7 & 7d7 z subsections 7e7 & 7f71 respectively2 & 7,b7 by ins]t+ aft] subsection 7b7 ! foll[+3 7c7 ,corrective action report ,beg9n+ ) fiscal ye> #bjah1 = ea* fiscal ye> = :i* fees are collect$ "u ?is "p1 ! ,secret>y %all prep>e & submit a corrective action report to ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate4 ,! report %all include ! foll[+ in=mation1 z applicable3 7#a7 ,goals met ,= ea* fiscal ye>1 if ! ,secret>y det]m9es1 bas$ on ! analysis "u subsection 7a77#e71 t ea* ( ! goals id5tifi$ 9 ! lett]s describ$ 9 section #aja7;b7 ( ! ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjag = ! applicable fiscal ye> h be5 met1 ! corrective action report %all include recomm5dations on ways 9 :i* ! ,secret>y c improve & /reaml9e ! human drug application review process4 7#b7 ,goals miss$ ,= any ( ! goals id5tifi$ 9 ! lett]s describ$ 9 section #aja7;b7 ( ! ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjag = ! applicable fiscal ye> t ! ,secret>y det]m9es to n h be5 met1 ! corrective action report %all include-- 7,a7 a detail$ ju/ification = su* det]m9ation & a description1 z applicable1 ( ! types ( circum/ances & tr5ds "u :i* human drug applications t miss$ ! review goal "t 7 approv$ dur+ ! fir/ cycle review1 or application review goals 7 miss$2 & 7,b7 ) respect to p]=mance enhancem5t goals t 7 n a*iev$1 a description ( ef=ts ! ,food & ,drug ,adm9i/ration has put 9 place = ! fiscal ye> 9 :i* ! report is submitt$ to improve ! ability ( su* ag5cy to meet ea* su* goal = ! su* fiscal ye>4 7d7 ,enhanc$ communication 7#a7 ,communications ) congress ,ea* fiscal ye>1 z applicable & reque/$1 repres5tatives f ! ,c5t]s ) exp]tise 9 ! review ( human drugs %all meet ) repres5tatives f ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives to report on ! cont5ts describ$ 9 ! reports "u ?is section4 7#b7 ,p>ticipation 9 congressional he>+ ,ea* fiscal ye>1 z applicable & reque/$1 repres5tatives f ! ,food & ,drug ,adm9i/ration %all p>ticipate 9 a public he>+ be=e ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 to report on ! cont5ts describ$ 9 ! reports "u ?is section4 ,su* he>+ %all occur n lat] ?an #abj days aft] ! end ( ea* fiscal ye> = :i* fees are collect$ "u ?is "p4 4 7b7 ,,mdufa reports 7#a7 ,analysis 9 mdufa p]=mance reports ,section #gch;,a7a77#a77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;a77#a77;,a771 z am5d$ by section #ijc7;b71 is fur!r am5d$ by add+ at ! end ! foll[+3 7iv7 ,analysis ,= ea* fiscal ye>1 ! ,secret>y %all include 9 ! report "u clause 7i7 an analysis ( ! foll[+3 7,i7 ,! diff]5ce betwe5 ! aggregate numb] ( prem>ket applications fil$ "u section #eae & aggregate reports submitt$ "u section #eaj7k7 & ! aggregate numb] ( major defici5cy lett]s1 n approvable lett]s1 & d5ials = su* applications issu$ by ! ag5cy1 acc\nt+ =-- 7aa7 ! numb] ( applications fil$ & reports submitt$ dur+ "o fiscal ye> = :i* a decision is n s*$ul$ to be made until ! foll[+ fiscal ye>2 & 7bb7 ! aggregate numb] ( applications = ea* fiscal ye> t did n meet ! goals z id5tifi$ by ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjag = ! applicable fiscal ye>4 7,,ii7 ,relevant data to det]m9e :e!r ! ,c5t] = ,devices & ,radiological ,heal? has met p]=mance enhancem5t goals id5tifi$ by ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjag = ! applicable fiscal ye>4 7,,iii7 ,! mo/ common causes & tr5ds = ext]nal or o!r circum/ances affect+ ! ability ( ! ,c5t] = ,devices & ,radiological ,heal?1 ! ,(fice ( ,regulatory ,affairs1 or ! ,food & ,drug ,adm9i/ration to meet review "t & p]=mance enhancem5t goals id5tifi$ by ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjag4 4 7#b7 ,issuance ( corrective action reports ,section #gch;,a7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;a77 is am5d$-- 7,a7 by r$esignat+ p>agraphs 7#b7 & 7#c7 z p>agraphs 7#d7 & 7#e71 respectively2 & 7,b7 by ins]t+ aft] p>agraph 7#a7 ! foll[+3 7#b7 ,corrective action report ,beg9n+ ) fiscal ye> #bjah1 = ea* fiscal ye> = :i* fees are collect$ "u ?is "p1 ! ,secret>y %all prep>e & submit a corrective action report to ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate4 ,! report %all include ! foll[+ in=mation1 z applicable3 7,a7 ,goals met ,= ea* fiscal ye>1 if ! ,secret>y det]m9es1 bas$ on ! analysis "u p>agraph 7#a77;,a77iv71 t ea* ( ! goals id5tifi$ by ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjag = ! applicable fiscal ye> h be5 met1 ! corrective action report %all include recomm5dations on ways 9 :i* ! ,secret>y c improve & /reaml9e ! m$ical device application review process4 7,b7 ,goals miss$ ,= ea* ( ! goals id5tifi$ by ! lett]s describ$ 9 section #bja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjag = ! applicable fiscal ye> t ! ,secret>y det]m9es to n h be5 met1 ! corrective action report %all include-- 7i7 a ju/ification = su* det]m9ation2 7ii7 a description ( ! types ( circum/ances1 9 ! aggregate1 "u :i* applications or reports submitt$ "u section #eae or notifications submitt$ "u section #eaj7k7 miss$ ! review goal times b 7 approv$ dur+ ! fir/ cycle review1 z applicable2 7iii7 a summ>y & any tr5ds ) reg>d to ! circum/ances = :i* a review goal 0 miss$2 & 7iv7 ! p]=mance enhancem5t goals t 7 n a*iev$ dur+ ! previ\s fiscal ye> & a description ( ef=ts ! ,food & ,drug ,adm9i/ration has put 9 place = ! fiscal ye> 9 :i* ! report is submitt$ to improve ! ability ( su* ag5cy to meet ea* su* goal = ! su* fiscal ye>4 7#c7 ,enhanc$ communication 7,a7 ,communications ) congress ,ea* fiscal ye>1 z applicable & reque/$1 repres5tatives f ! ,c5t]s ) exp]tise 9 ! review ( devices %all meet ) repres5tatives f ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives to report on ! cont5ts describ$ 9 ! reports "u ?is section4 7,b7 ,p>ticipation 9 congressional he>+ ,ea* fiscal ye>1 z applicable & reque/$1 repres5tatives f ! ,food & ,drug ,adm9i/ration %all p>ticipate 9 a public he>+ be=e ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 to report on ! cont5ts describ$ 9 ! reports "u ?is section4 ,su* he>+ %all occur n lat] ?an #abj days aft] ! end ( ea* fiscal ye> = :i* fees are collect$ "u ?is "p4 4 7c7 ,,gdufa reports 7#a7 ,analysis 9 gdufa p]=mance reports ,section #gdd;,c7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7;a771 z am5d$ by section #ijc7;c7 is fur!r am5d$ by add+ at ! end ! foll[+3 7#d7 ,analysis ,= ea* fiscal ye>1 ! ,secret>y %all include 9 ! report an analysis ( ! foll[+3 7,a7 ,! diff]5ce betwe5 ! aggregate numb] ( abbreviat$ new drug applications fil$ & ! aggregate numb] ( approvals or aggregate numb] ( complete response lett]s issu$ by ! ag5cy1 acc\nt+ =-- 7i7 su* applications fil$ dur+ "o fiscal ye> = :i* a decision is n s*$ul$ to be made until ! foll[+ fiscal ye>2 & 7ii7 ! aggregate numb] ( applications = ea* fiscal ye> t did n meet ! goals id5tifi$ by ! lett]s describ$ 9 section #cja7;b7 ( ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjag = ! applicable fiscal ye>4 7,b7 ,relevant data to det]m9e :e!r ! ,food & ,drug ,adm9i/ration has met ! p]=mance enhancem5t goals id5tifi$ by ! lett]s describ$ 9 section #cja7;b7 ( ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjag = ! applicable fiscal ye>4 7,c7 ,! mo/ common causes & tr5ds = ext]nal or o!r circum/ances t affect$ ! ability ( ! ,secret>y to meet review "t & p]=mance enhancem5t goals id5tifi$ by ! lett]s describ$ 9 section #cja7;b7 ( ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjag4 4 7#b7 ,issuance ( corrective action reports ,section #gdd;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7 is am5d$-- 7,a7 by r$esignat+ subsections 7c7 & 7d7 z subsections 7e7 & 7f71 respectively2 & 7,b7 by ins]t+ aft] subsection 7b7 ! foll[+3 7c7 ,corrective action report ,beg9n+ ) fiscal ye> #bjah1 = ea* fiscal ye> = :i* fees are collect$ "u ?is "p1 ! ,secret>y %all prep>e & submit a corrective action report to ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate4 ,! report %all include ! foll[+ in=mation1 z applicable3 7#a7 ,goals met ,= ea* fiscal ye>1 if ! ,secret>y det]m9es1 bas$ on ! analysis "u subsection 7a77#d71 t ea* ( ! goals id5tifi$ by ! lett]s describ$ 9 section #cja7;b7 ( ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjag = ! applicable fiscal ye> h be5 met1 ! corrective action report %all include recomm5dations on ways 9 :i* ! ,secret>y c improve & /reaml9e ! abbreviat$ new drug application review process4 7#b7 ,goals miss$ ,= ea* ( ! goals id5tifi$ by ! lett]s describ$ 9 section #cja7;b7 ( ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjag = ! applicable fiscal ye> t ! ,secret>y det]m9es to n h be5 met1 ! corrective action report %all include-- 7,a7 a detail$ ju/ification = su* det]m9ation & a description1 z applicable1 ( ! types ( circum/ances & tr5ds "u :i* abbreviat$ new drug applications miss$ ! review goal times b 7 approv$ dur+ ! fir/ cycle review1 or review goals 7 miss$2 & 7,b7 ) respect to p]=mance enhancem5t goals t 7 n a*iev$1 a detail$ description ( ef=ts ! ,food & ,drug ,adm9i/ration has put 9 place = ! fiscal ye> 9 :i* ! report is submitt$ to improve ! ability ( su* ag5cy to meet ea* su* goal = ! su* fiscal ye>4 7d7 ,enhanc$ communication 7#a7 ,communications ) congress ,ea* fiscal ye>1 z applicable & reque/$1 repres5tatives f ! ,c5t]s ) exp]tise 9 ! review ( human drugs %all meet ) repres5tatives f ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives to report on ! cont5ts describ$ 9 ! reports "u ?is section4 7#b7 ,p>ticipation 9 congressional he>+ ,ea* fiscal ye>1 z applicable & reque/$1 repres5tatives f ! ,food & ,drug ,adm9i/ration %all p>ticipate 9 a public he>+ be=e ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 to report on ! cont5ts describ$ 9 ! reports "u ?is section4 ,su* he>+ %all occur n lat] ?an #abj days aft] ! end ( ea* fiscal ye> = :i* fees are collect$ "u ?is "p4 4 7d7 ,bs,u,f,a reports 7#a7 ,analysis 9 bsufa p]=mance reports ,section #gdd;,i7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7;a77 z am5d$ by section #ijc7;d7 is fur!r am5d$ by add+ at ! end ! foll[+3 7#e7 ,analysis ,= ea* fiscal ye>1 ! ,secret>y %all include 9 ! report an analysis ( ! foll[+3 7,a7 ,! diff]5ce betwe5 ! aggregate numb] ( biosimil> biological product applications & supplem5ts fil$ & ! aggregate numb] ( approvals issu$ by ! ag5cy1 acc\nt+ =-- 7i7 su* applications fil$ dur+ "o fiscal ye> = :i* a decision is n s*$ul$ to be made until ! foll[+ fiscal ye>2 & 7ii7 ! aggregate numb] ( applications = ea* fiscal ye> t did n meet ! goals id5tifi$ by ! lett]s describ$ 9 section #dja7;b7 ( ! ,biosimil> ,us] ,fee ,am5dm5ts ( #bjag = ! applicable fiscal ye>4 7,b7 ,relevant data to det]m9e :e!r ! ,c5t] = ,drug ,evaluation & ,rese>* & ! ,c5t] = ,biologics ,evaluation & ,rese>* h met ! p]=mance enhancem5t goals id5tifi$ by ! lett]s describ$ 9 section #dja7;b7 ( ! ,biosimil> ,us] ,fee ,am5dm5ts ( #bjag = ! applicable fiscal ye>4 7,c7 ,! mo/ common causes & tr5ds = ext]nal or o!r circum/ances affect+ ! ability ( ! ,secret>y to meet review "t & p]=mance enhancem5t goals id5tifi$ by ! lett]s describ$ 9 section #dja7;b7 ( ! ,biosimil> ,us] ,fee ,am5dm5ts ( #bjag4 4 7#b7 ,issuance ( corrective action reports ,section #gdd;,i ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec71 z am5d$ by section #djd1 is fur!r am5d$-- 7,a7 by r$esignat+ subsections 7c7 & 7d7 z subsections 7e7 & 7f71 respectively2 & 7,b7 by ins]t+ aft] subsection 7b7 ! foll[+3 7c7 ,corrective action report ,beg9n+ ) fiscal ye> #bjah1 & = ea* fiscal ye> = :i* fees are collect$ "u ?is "p1 ! ,secret>y %all prep>e & submit a corrective action report to ! ,committee on ,en]gy & ,comm]ce & ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ,committee on ,appropriations ( ! ,s5ate4 ,! report %all include ! foll[+ in=mation1 z applicable3 7#a7 ,goals met ,= ea* fiscal ye>1 if ! ,secret>y det]m9es1 bas$ on ! analysis "u subsection 7a77#e71 t ea* ( ! goals id5tifi$ by ! lett]s describ$ 9 section #dja7;b7 ( ! ,biosimil> ,us] ,fee ,am5dm5ts ( #bjag = ! applicable fiscal ye> h be5 met1 ! corrective action report %all include recomm5dations on ways 9 :i* ! ,secret>y c improve & /reaml9e ! biosimil> biological product application review process4 7#b7 ,goals miss$ ,= ea* ( ! goals id5tifi$ by ! lett]s describ$ 9 section #dja7;b7 ( ! ,biosimil> ,us] ,fee ,am5dm5ts ( #bjag = ! applicable fiscal ye> t ! ,secret>y det]m9es to n h be5 met1 ! corrective action report %all include-- 7,a7 a ju/ification = su* det]m9ation & a description ( ! types ( circum/ances & tr5ds1 z applicable1 "u :i* biosimil> biological product applications miss$ ! review goal times b 7 approv$ dur+ ! fir/ cycle review1 or review goals 7 miss$2 & 7,b7 ) respect to p]=mance enhancem5t goals t 7 n a*iev$1 a description ( ef=ts ! ,food & ,drug ,adm9i/ration has put 9 place = ! fiscal ye> 9 :i* ! report is submitt$ to improve ! ability ( su* ag5cy to meet ea* su* goal = ! su* fiscal ye>4 7d7 ,enhanc$ communication 7#a7 ,communications ) ,congress ,ea* fiscal ye>1 z applicable & reque/$1 repres5tatives f ! ,c5t]s ) exp]tise 9 ! review ( human drugs %all meet ) repres5tatives f ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives to report on ! cont5ts describ$ 9 ! reports "u ?is section4 7#b7 ,p>ticipation 9 congressional he>+ ,ea* fiscal ye>1 z applicable & reque/$1 repres5tatives f ! ,food & ,drug ,adm9i/ration %all p>ticipate 9 a public he>+ be=e ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 to report on ! cont5ts describ$ 9 ! reports "u ?is section4 ,su* he>+ %all occur n lat] ?an #abj days aft] ! end ( ea* fiscal ye> = :i* fees are collect$ "u ?is "p4 4 #ije4 ,facilities managem5t 7a7 ,evaluation 7#a7 ,/udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy on ! exp5ses incurr$ by ! ,food & ,drug ,adm9i/ration relat$ to facility ma9t5ance & r5ovation 9 fiscal ye>s #bjab ?r\gh #bjai4 ,! /udy "u ?is p>agraph %all include ! foll[+3 7,a7 ,a review ( pur*ases & exp5ses diff]5tiat$ by appropriat$ funds1 & res\rces au?oriz$ by ! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act 7,public ,law #aab-add7 & ?is ,act1 z applicable1 t contribut$ to-- 7i7 ! ma9t5ance ( sci5tific equipm5t & any exi/+ facility plan or plans to ma9ta9 previ\sly pur*as$ sci5tific equipm5t2 7ii7 ! r5ovation ( facilities 9 ! ,c5t] = ,drug ,evaluation & ,rese>*1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 & ! ,c5t] = ,devices & ,radiological ,heal?1 & ! purpose ( su* r5ovation includ+ ! ne$ = ! r5ovation2 7iii7 ! assets pur*as$ or repair$ "u ! repair ( facilities & acquisition au?ority "u p>ts #b1 #c1 #g1 & #h ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;f et seq472 7iv7 ! ma9t5ance & repair ( facilities & fixtures1 includ+ a description ( any unanticipat$ repairs & ma9t5ance z well z s*$ul$ repairs ma9t5ance1 & ! budget plan = ! s*$ul$ or anticipat$ ma9t5ance2 7v7 ! acquisition ( furniture1 a description ( ! furniture pur*as$1 & ! purpose ( ! furniture includ+ pur*ases = ! ,c5t] = ,drug ,evaluation & ,rese>*1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 & ! ,c5t] = ,devices & ,radiological ,heal?2 & 7vi7 ! acquisition ( o!r necess>y mat]ials & supplies by product category "u ! au?ority "u p>ts #b1 #c1 #g1 & #h ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;f et seq474 7,b7 ,an analysis ( ! ,food & ,drug ,adm9i/ration's ability to fur!r its public heal? mission & review m$ical products by incurr+ ! exp5ses li/$ 9 clauses 7i7 ?r\gh 7vi7 ( subp>agraph 7,a74 ,9 conduct+ ! analysis1 ! ,comptroll] ,g5]al %all reque/ in=mation f & consult ) appropriate employees1 includ+ /aff & ^? responsible = ! fiscal decisions reg>d+ facility ma9t5ance & r5ovation = ! ag5cy4 7#b7 ,report 7,a7 ,9 g5]al ,! ,comptroll] ,g5]al %all issue a report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives n lat] ?an ,july #cj1 #bjbj1 conta9+ ! results ( ! /udy "u p>agraph 7#a74 7,b7 ,recomm5dations ,z "p ( ! report "u ?is p>agraph1 ! ,comptroll] ,g5]al may provide recomm5dations1 z applicable1 on me?ods ?r\gh :i* ! ,food & ,drug ,adm9i/ration may improve plann+ =-- 7i7 ! ma9t5ance1 r5ovation1 & repair ( facilities2 7ii7 ! pur*ase ( furniture or o!r acquisitions2 & 7iii7 ways ! ,food & ,drug ,adm9i/ration may allocate ! exp5ses describ$ 9 clauses 7i7 & 7ii7 ( p>agraph 7#a77;,a71 z in=m$ by ! analysis "u p>agraph 7#a77;,b74 7b7 ,adm9i/ration 7#a7 ,,pdufa ,section #gcf7;f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7f77 is am5d$ by add+ at ! end ! foll[+3 7#c7 ,limitation ,beg9n+ on ,octob] #a1 #bjbc1 ! au?orities "u section #gce7g77;,c7 %all include only exp5ditures = leas+ & necess>y sci5tific equipm5t4 4 7#b7 ,,mdufa ,section #gch7;h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7h77 is am5d$ by add+ at ! end ! foll[+3 7#c7 ,limitation ,beg9n+ on ,octob] #a1 #bjbc1 ! au?orities "u section #gcg7i77;,c7 %all include only leas+ & necess>y sci5tific equipm5t4 4 7#c7 ,,gdufa ,section #gdd;,b7e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;e77 is am5d$-- 7,a7 9 ! subsection head+1 by /rik+ ,limit & ins]t+ ,limitations2 7,b7 by /rik+ ,! total am\nt & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,! total am\nt 2 & 7,c7 by add+ at ! end ! foll[+3 7#b7 ,leas+ & necess>y equipm5t ,beg9n+ on ,octob] #a1 #bjbc1 ! au?orities "u section #gdd;,a7#aa77;,c7 %all include only leas+ & necess>y sci5tific equipm5t4 4 7#d7 ,bs,u,f,a ,section #gdd;,h7e77#b77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;e77#b77;,b77 is am5d$-- 7,a7 9 ! subp>agraph head+1 by /rik+ limitation & ins]t+ limitations2 7,b7 by /rik+ ,! fees au?oriz$ & ins]t+ ! foll[+3 7i7 ,9 g5]al ,! fees au?oriz$ 2 & 7,c7 by add+ at ! end ! foll[+3 7ii7 ,leas+ & necess>y equipm5t ,beg9n+ on ,octob] #a1 #bjbc1 ! au?orities "u section #gdd;,g7#i77;,c7 %all include only leas+ & necess>y sci5tific equipm5t4 4 ,pass$ ! ,h\se ( ,repres5tatives ,july #ab1 #bjag4,k>5 ,l4 ,haas1,cl]k ,july #ag1 #bjag,read ! second "t & plac$ on ! cal5d>