,,ii #aac? ,,congress #a/ ,session ,s4 #fbg ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,m>* #bj1 #bjac ,mr4 ,s&]s introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to provide inc5tives = inve/m5t 9 rese>* & developm5t = new m$ic9es1 to enhance access to new m$ic9es1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,m$ical ,innovation ,prize ,fund ,act4 #b4 ,f9d+s ,congress makes ! foll[+ f9d+s3 7#a7 ,! developm5t ( new m$ic9es & vacc9es is necess>y to improve heal? c>e outcomes4 7#b7 ,m>ket exclusivity = new products is an exp5sive1 ineffici5t1 & unfair me*anism to rew>d inve/m5ts 9 new products4 7#c7 ,by de-l9k+ rese>* & developm5t inc5tives f product prices1 & by elim9at+ legal monopolies to sell products1 x is possible to induce inve/m5ts t are m$ically m important1 procure products at l[ prices f competitive suppli]s1 radically l[] pric+ b>ri]s = access to new m$ic9es1 r$uce wa/eful m>ket+ & rese>* & developm5t activities1 & dramatically l[] ! ov]all co/s ( acquir+ innovation1 :ile exp&+ access to t innovation4 7#d7 ,by fund+ innovation prizes at 4#ee p]c5t ( gross dome/ic product1 ! ,unit$ ,/ates w\ld provide m ?an #hf1jjj1jjj1jjj 9 rew>ds = successful innovation 9 #bjab4 7#e7 ,! developm5t ( new m$ic9es b5efits f great] %>+ ( k1 data1 mat]ials1 & te*nologies4 #c4 ,purpose ,x is ! purpose ( ?is ,act to provide inc5tives to enc\rage entities to inve/ 9 rese>* & developm5t ( new m$ic9es & to %>e k1 data1 mat]ials1 & te*nology1 ?r\gh ! e/abli%m5t ( a ,m$ical ,innovation ,prize ,fund1 :ile enhanc+ access to su* m$ic9es by elim9at+ legal monopolies on ! manufacture1 di/ribution1 & sale ( su* m$ic9es4 #d4 ,def9itions ,9 ?is ,act3 7#a7 ,biological product ,! t]m biological product has ! mean+ giv5 su* t]m 9 section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 7#b7 ,bo>d ,! t]m ,bo>d means ! ,bo>d ( ,tru/ees = ! ,fund = ,m$ical ,innovation ,prizes e/abli%$ "u section #g4 7#c7 ,drug ,! t]m drug has ! mean+ giv5 su* t]m 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba74 7#d7 ,fund ,! t]m ,fund means ! ,fund = ,m$ical ,innovation ,prizes e/abli%$ "u section #f4 7#e7 ,m>ket cle>ance ,! t]m m>ket cle>ance means ! approval ( an application "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or ! approval ( a biologics lic5se application "u subsection 7a7 ( section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 #e4 ,elim9ation ( exclusive rights to m>ket drugs & biological products 7a7 ,9 g5]al ,not)/&+ title #ce1 ,unit$ ,/ates ,code1 relevant provisions ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 7includ+ am5dm5ts made by ! ,drug ,price ,competition & ,pat5t ,t]m ,re/oration ,act ( #aihd 7,public ,law #ih-dag2 commonly ref]r$ to z ! ,hat*-,waxman ,act771 ! ,m$ic>e ,prescription ,drug1 ,improvem5t1 & ,mod]nization ,act ( #bjjc 7,public ,law #ajh-agc71 & any o!r provision ( law provid+ any pat5t "r or exclusive m>ket+ p]iod = any drug1 biological product1 or manufactur+ process = a drug or biological product 7su* z p$iatric ext5sions "u section #eje;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7 or orphan drug m>ket+ exclusivity "u sub*apt] ,b ( *apt] ,v ( su* ,act 7#ba ,u4,s4,c4 #cfj;aa et seq4771 no p]son %all h ! "r to exclusively manufacture1 di/ribute1 sell1 or use a drug1 a biological product1 or a manufactur+ process = a drug or biological product 9 int]/ate comm]ce1 includ+ ! exclusive "r to rely on heal? regi/ration data or ! #cj-mon? /ay-(-effectiv5ess p]iod = ,orange ,book pat5ts "u section #eje7;j7 ( su* ,act 7#ba ,u4,s4,c4 #cee7;j774 7b7 ,remun]ation ,a p]son t is eligible = prize paym5ts f ! ,fund z provid$ = 9 sections #i1 #aj1 or #aa %all receive su* paym5ts-- 7#a7 9 lieu ( any remun]ation ! p]son w\ld h o!rwise receiv$ = ! exclusive m>ket+1 di/ribution1 sale1 or use ( a drug1 biological product1 or manufactur+ process = a drug or biological product b = ! application ( subsection 7a72 & 7#b7 9 addition to any o!r remun]ation t su* p]son receives by reason ( ! nonexclusive m>ket+1 di/ribution1 sale1 or use ( ! drug1 biological product1 or manufactur+ process = a drug or biological product4 7c7 ,application ,?is section %all apply only ) respect to ! m>ket+1 di/ribution1 sale1 or use ( a drug1 a biological product1 or a manufactur+ process = a drug or biological product t occurs on or aft] ,octob] #a1 #bjad4 #f4 ,fund = m$ical innovation prizes 7a7 ,e/abli%m5t ,!re is h]eby e/abli%$ 9 ! ,treasury ( ! ,unit$ ,/ates a revolv+ fund to be kn[n z ! ,fund = ,m$ical ,innovation ,prizes1 :i* %all consi/ ( am\nts appropriat$ to ! ,fund & am\nts cr$it$ to ! ,fund "u subsection 7c74 7b7 ,availability ( funds ,am\nts 9 ! ,fund %all be available to ! ,bo>d1 subject to section #ag7;c71 = ! purpose ( c>ry+ out ?is ,act4 7c7 ,am\nts cr$it$ to ! ,fund ,! ,secret>y ( ! ,treasury %all cr$it to ! ,fund ! int]e/ on1 & ! proce$s f sale or r$emption (1 obligations held 9 ! ,fund4 #g4 ,bo>d ( tru/ees = ! ,fund 7a7 ,e/abli%m5t ,!re is h]eby e/abli%$ 7z a p]man5t1 indep5d5t e/abli%m5t 9 ! executive bran*7 a ,bo>d ( ,tru/ees = ! ,fund = ,m$ical ,innovation ,prizes4 7b7 ,memb]%ip ,! ,bo>d %all be compos$ ( #ac memb]s1 includ+-- 7#a7 ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices2 7#b7 ! ,commission] ( ,food & ,drugs2 7#c7 ! ,director ( ! ,national ,in/itutes ( ,heal?2 7#d7 ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion2 & 7#e7 #i individuals to be appo9t$ by ! ,presid5t1 ) ! advice & cons5t ( ! ,s5ate1 ( :i*-- 7,a7 #b %all be repres5tatives ( bus9esses t provide heal? insurance to employees2 7,b7 #b %all be repres5tatives ( entities t provide heal? insurance & contribute to ! co-fund+ ( ! ,fund = ,m$ical ,innovation ,prizes "u section #ag2 7,c7 #b %all be repres5tatives ( ! m$ical rese>* & developm5t sector1 includ+ at lea/ #a repres5tative ( ! nonpr(it private m$ical rese>* & developm5t sector2 & 7,d7 #c %all be repres5tatives ( consum] & pati5t int]e/s1 includ+ at lea/ "o repres5tative ( pati5ts suff]+ f orphan diseases4 7c7 ,t]ms 7#a7 ,9 g5]al ,except z provid$ 9 p>agraph 7#b71 ea* memb] appo9t$ to ! ,bo>d "u subsection 7b77#e7 %all be appo9t$ = a t]m ( #d ye>s4 7#b7 ,t]ms ( initial appo9tees ,z designat$ by ! ,presid5t at ! "t ( appo9tm5t1 ( ! memb]s fir/ appo9t$ to ! ,bo>d "u subsection 7b77#e7-- 7,a7 #e memb]s %all be appo9t$ = a t]m ( #d ye>s2 & 7,b7 #d memb]s %all be appo9t$ = a t]m ( #b ye>s4 7d7 ,vacancies ,any memb] ( ! ,bo>d appo9t$ to fill a vacancy occurr+ be=e ! expiration ( ! t]m = :i* ! memb]'s pr$ecessor 0 appo9t$ %all be appo9t$ only = ! rema9d] ( t t]m4 ,a memb] ( ! ,bo>d may s]ve aft] ! expiration ( t memb]'s t]m until a successor has tak5 (fice4 7e7 ,comp5sation & travel exp5ses 7#a7 ,comp5sation ,memb]s ( ! ,bo>d %all ea* be paid n less ?an ! daily equival5t ( level ,,iv ( ! ,executive ,s*$ule = ea* day 7includ+ travel "t7 dur+ :i* !y are engag$ 9 ! actual p]=mance ( ! duties ( ! ,bo>d4 7#b7 ,travel exp5ses ,ea* memb] ( ! ,bo>d %all receive travel exp5ses1 includ+ p] diem 9 lieu ( subsi/5ce1 9 accordance ) applicable provisions "u sub*apt] ,i ( *apt] #eg ( title #e1 ,unit$ ,/ates ,code4 7f7 ,*airp]son2 ,(fic]s ,! memb]s ( ! ,bo>d %all elect a ,*airp]son & any o!r (fic]s ( ! ,bo>d4 ,! ,*airp]son & any su* (fic]s %all be elect$ = a t]m ( #b ye>s4 7g7 ,/aff ,! ,bo>d may appo9t & fix ! pay ( su* additional p]sonnel z ! ,bo>d consid]s appropriate4 ,! /aff ( ! ,bo>d %all be appo9t$ subject to ! provisions ( title #e1 ,unit$ ,/ates ,code1 gov]n+ appo9tm5ts 9 ! competitive s]vice1 & %all be paid 9 accordance ) ! provisions ( *apt] #ea & sub*apt] ,,iii ( *apt] #ec ( su* title relat+ to classification & ,g5]al ,s*$ule pay rates4 7h7 ,exp]ts & consultants ,! ,bo>d may procure tempor>y & int]mitt5t s]vices "u section #caji7;b7 ( title #e1 ,unit$ ,/ates ,code4 #h4 ,p[]s & duties ( ! ,bo>d 7a7 ,duties ,! ,bo>d %all-- 7#a7 aw>d prize paym5ts = m$ical innovation 9 accordance ) ?is ,act2 & 7#b7 submit a report to ! ,congress "u section #af4 7b7 ,p[]s ( ,bo>d 7#a7 ,he>+s & sessions 7,a7 ,9 g5]al ,! ,bo>d may1 = ! purpose ( c>ry+ out ?is ,act1 hold he>+s1 sit & act at times & places1 take te/imony1 & receive evid5ce z ! ,bo>d consid]s appropriate4 7,b7 ,fir/ meet+ ,n lat] ?an #cj days aft] ! initial memb]s ( ! ,bo>d are appo9t$ "u section #g7;b77#e7 & confirm$1 ! ,bo>d %all conduct its fir/ meet+4 7#b7 ,policies & proc$ures 7,a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! initial memb]s ( ! ,bo>d are appo9t$ "u section #g7;b77#e7 & confirm$1 ! ,bo>d %all e/abli% su* policies & proc$ures z may be appropriate to c>ry out ?is ,act4 7,b7 ,majority vote ,! policies & proc$ures ( ! ,bo>d %all require t any det]m9ation ( ! ,bo>d be made by n less ?an a majority vote ( ! memb]s ( ! ,bo>d4 7,c7 ,adm9i/rative proc$ures ,! policies & proc$ures ( ! ,bo>d %all comply ) sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code4 7,d7 ,transp>5cy ,! policies & proc$ures ( ! ,bo>d %all-- 7i7 comply ) sections #eeb & #eeb;b ( title #e1 ,unit$ ,/ates ,code 7commonly ref]r$ to z ! ,fre$om ( ,in=mation ,act & ! ,gov]nm5t 9 ! ,sun%9e ,act1 respectively72 & 7ii7 ensure t ! proce$+s & delib]ations ( ! ,bo>d are transp>5t & are support$ by a description ( ! me?ods1 data s\rces1 assumptions1 outcomes1 & relat$ in=mation t w all[ ! public to und]/& h[ ! ,bo>d rea*es its crit]ia-sett+ & aw>d decisions4 7#c7 ,exp]t advisory committees ,to assi/ ! ,bo>d 9 c>ry+ out ?is ,act1 ! ,bo>d %all e/abli% indep5d5t exp]t advisory committees1 includ+ committees on ! foll[+3 7,a7 ,economic evaluation ( !rapeutic b5efits4 7,b7 ,bus9ess models & inc5tive /ructures = innovation4 7,c7 ,rese>* & developm5t priorities4 7,d7 ,orphan diseases4 7,e7 ,f9ancial control & audit+4 7,f7 ,op5 s\rce biom$ical sci5ce4 7#d7 ,p[]s ( memb]s & ag5ts ,any memb] or ag5t ( ! ,bo>d may1 if au?oriz$ by ! ,bo>d1 take any action :i* ! ,bo>d is au?oriz$ to take "u ?is ,act4 7#e7 ,mails ,! ,bo>d may use ! ,unit$ ,/ates mails 9 ! same mann] & "u ! same conditions z o!r dep>tm5ts & ag5cies ( ! ,unit$ ,/ates4 #i4 ,prize paym5ts = m$ical innovation 7a7 ,aw>d ,= fiscal ye> #bjae1 & ea* subsequ5t fiscal ye>1 ! ,bo>d %all aw>d to p]sons describ$ 9 subsection 7b7 prize paym5ts = m$ical innovation relat+ to a drug1 a biological product1 or a new manufactur+ process = a drug or biological product4 7b7 ,eligibility ,to be eligible to receive a prize paym5t "u subsection 7a7 = m$ical innovation relat+ to a drug1 a biological product1 or a manufactur+ process1 a p]son %all be-- 7#a7 9 ! case ( a drug or biological product1 ! fir/ p]son to receive m>ket cle>ance ) respect to ! drug or biological product2 7#b7 9 ! case ( a manufactur+ process1 ! hold] ( ! pat5t ) respect to su* process2 or 7#c7 9 ! case ( op5 s\rce contributions1 ! p]sons or communities t op5ly %>$ k1 data1 mat]ials1 & te*nology on a royalty-free & nondiscrim9atory basis4 7c7 ,crit]ia ,! ,bo>d %all1 by regulation1 e/abli% crit]ia = ! selection ( recipi5ts1 & = det]m9+ ! am\nt1 ( prize paym5ts "u ?is section4 ,su* crit]ia %all include consid]ation ( ! foll[+3 7#a7 ,! numb] ( pati5ts :o w\ld b5efit f ! drug1 biological product1 or manufactur+ process involv$1 includ+ 79 cases ( global neglect$ diseases1 global infecti\s diseases1 & o!r global public heal? priorities7 ! numb] ( non-,unit$ ,/ates pati5ts4 7#b7 ,! increm5tal !rapeutic b5efit ( ! drug1 biological product1 or manufactur+ process involv$ z comp>$ to exi/+ drugs1 biological products1 & manufactur+ processes available to treat ! same disease or condition1 except t ! ,bo>d %all provide = cases :]e drugs1 biological products1 or manufactur+ processes are develop$ at r\ghly ! same "t1 s t ! comp>ison is to products t 7 n rec5tly develop$4 7#c7 ,! degree to :i* ! drug1 biological product1 or manufactur+ process involv$ addresses priority heal? c>e ne$s1 includ+-- 7,a7 curr5t & em]g+ global infecti\s diseases2 7,b7 sev]e illnesses ) small cli5t populations 7su* z indications = :i* orphan designation has be5 grant$ "u section #ebf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb772 & 7,c7 neglect$ diseases t prim>ily afflict ! poor 9 develop+ c\ntries4 7#d7 ,improv$ effici5cy ( manufactur+ processes = drugs or biological processes4 7#e7 ,! ext5t to :i* k1 data1 mat]ials & te*nology t are op5ly %>$ h contribut$ to ! successful developm5t ( new products or improv$ processes = manufactur+ products4 7#f7 ,9 ! case ( antibiotics or o!r products = :i* drug resi/ance is a significant public heal? problem1 ! expect$ life cycle b5efits ( ! antibiotic or o!r product1 ) appropriate adju/m5ts t rew>d ! cons]vation ( ! res\rces1 tak+ into acc\nt drug resi/ance t is relat$ to use ( ! product4 7#g7 ,9 ! case ( products us$ 9 /ockpiles = pot5tial ?reats to ! public heal?1 ! risk adju/$ b5efits ( /ockpil+ ! products4 7d7 ,requirem5ts ,9 aw>d+ prize paym5ts "u ?is section1 ! ,bo>d %all comply ) ! foll[+3 7#a7 ,9 cases :]e a new drug1 biological product1 or manufactur+ process (f]s an improvem5t ov] an exi/+ drug1 biological product1 or manufactur+ process & ! new drug1 biological product1 or manufactur+ process competes ) or replaces ! exi/+ drug1 biological product1 or manufactur+ process1 ! ,bo>d %all cont9ue to make prize paym5ts = ! exi/+ drug1 biological product1 or manufactur+ process to ! degree t ! new drug1 biological product1 or manufactur+ process 0 bas$ on or b5efitt$ f ! developm5t ( ! exi/+ drug1 biological product1 or manufactur+ process4 7#b7 ,! ,bo>d may n make prize paym5ts bas$ on ! id5tity ( ! p]son :o manufactures1 di/ributes1 sells1 or uses ! drug1 biological product1 or manufactur+ process involv$4 7#c7 ,! ,bo>d may aw>d prize paym5ts = a drug1 a biological product1 or a manufactur+ process = n m ?an #aj fiscal ye>s1 reg>dless ( ! t]m ( any relat$ pat5ts4 7#d7 ,= any fiscal ye>1 ! ,bo>d may n aw>d a prize paym5t = any s+le drug1 biological product1 or manufactur+ process 9 an am\nt t exce$s #e p]c5t ( ! total am\nt appropriat$ to ! ,fund = t ye>4 7#e7 ,= e drug or biological product t receives m>ket cle>ance1 ! ,bo>d %all det]m9e :e!r & 9 :at am\nt to aw>d a prize paym5t = ! drug or biological product n lat] ?an ! end ( ! f\r? full cal5d>-ye> qu>t] foll[+ ! cal5d>-ye> qu>t] 9 :i* ! drug or biological product receives m>ket cle>ance4 #aj4 ,prizes = priority rese>* & developm5t 7a7 ,m9imum levels ( fund+ ,= fiscal ye> #bjae1 & ea* subsequ5t fiscal ye>1 ! ,bo>d %all e/abli% & may p]iodically modify m9imum levels ( fund+ "u section #i = priority rese>* & developm5t4 7b7 ,initial m9imum levels ,( ! am\nt appropriat$ to ! ,fund = a fiscal ye>1 ! ,bo>d %all use 7subject to ! e/abli%m5t or modification ( an applicable m9imum level ( fund+ "u subsection 7a77 n less ?an-- 7#a7 #d p]c5t ( su* am\nt = global neglect$ diseases2 7#b7 #aj p]c5t ( su* am\nt = orphan diseases2 & 7#c7 #d p]c5t ( su* am\nt = global infecti\s diseases & o!r global public heal? priorities1 includ+ rese>* on ,,aids1 ,,aids vacc9es1 & m$ic9es = respond+ to biot]rorism4 7c7 ,public input2 recomm5dations ,! advisory committee on rese>* & developm5t priorities 7e/abli%$ pursuant to section #h7;b77#c77 %all-- 7#a7 solicit public input on rese>* & developm5t priorities2 & 7#b7 p]iodically recomm5d to ! ,bo>d modifications 9 ! m9imum levels ( fund+ = prizes = priority rese>* & developm5t "u ?is section4 7d7 ,proc$ures ,! ,bo>d %all adopt proc$ures to e/abli% & p]iodically modify m9imum levels ( fund+ "u section #i = priority rese>* & developm5t4 #aa4 ,op5 s\rce divid5d prizes 7a7 ,9 g5]al ,9 ord] to induce great] access & ! op5 %>+ ( k1 data1 mat]ials & te*nology1 at lea/ #e p]c5t ( ! prize paym5ts f ! ,fund %all be d$icat$ to ,op5 ,s\rce ,divid5d prizes4 7b7 ,proc$ures 7#a7 ,9 g5]al ,! ,bo>d ( ,tru/ees %all adopt proc$ures = ! allocation ( ,op5 ,s\rce ,divid5d prizes4 ,su* proc$ures %all-- 7,a7 be fully transp>5t reg>d+ ! process = evaluat+ ! value ( op5 %>+ ( k1 data1 mat]ials1 & te*nology2 7,b7 rew>d ! op51 nondiscrim9atory & royalty-free %>+ ( k1 data1 mat]ials1 & te*nology t has contribut$ to ! developm5t ( ! new drugs1 biological products1 or manufactur+ processes t are rew>d$ "u sections #i & #aj2 7,c7 9 ! case ( rew>ds = contribut+ to ! developm5t ( new drugs1 biological products1 or manufactur+ processes rew>d$ "u sections #i & #aj1 provide = a "t-limit$ p]iod ( nom9ations = p]sons or communities ^: contributions 7 consid]$ useful1 includ+ ! evid5ce to support su* nom9ations to describe ! significance ( ! contribution2 & 7,d7 provide = rules & proc$ures to protect aga9/ conflicts ( int]e/4 7#b7 ,public availability ( nom9ations ,! nom9ations describ$ 9 p>agraph 7#a77;,c71 & ! evid5ce support+ su* nom9ations1 %all be public4 ,! public %all be all[$ to provide comm5t>y & additional evid5ce on su* nom9ations be=e aw>ds are made4 #ab4 ,competitive int]m$i>ies = fund+ int]im te*nologies 7a7 ,9 g5]al ,! ,bo>d ( ,tru/ees may au?orize multiple nonpr(it int]m$i>ies to rew>d projects = int]im rese>* & developm5t ( products1 or = op5 s\rce divid5d prizes4 ,su* int]m$i>ies %all compete = fund+ f non-,f$]al entities t co-fund ! ,fund4 7b7 ,availability ,prizes aw>d$ by competitive int]m$i>ies %all be available to p]sons or communities t provide op51 nondiscrim9atory & royalty-free lic5ses to relevant intellectual prop]ty rights4 7c7 ,rules ,! ,bo>d ( ,tru/ees %all adopt rules to ensure ! transp>5cy & acc\ntability ( any entities au?oriz$ to act z competitive int]m$i>ies "u subsection 7a74 #ac4 ,special transition rules 7a7 ,9 g5]al ,a drug or biological product t is on ! m>ket on ,octob] #a1 #bjad1 %all rema9 eligible = prize paym5ts = n m ?an #aj fiscal ye>s1 consi/5t ) section #i7;d77#c74 7b7 ,det]m9ation ( value ,9 det]m9+ ! am\nt ( a prize paym5t = a drug or biological product describ$ 9 subsection 7a71 ! ,bo>d %all calculate ! increm5tal value ( ! drug or biological product z ( ! date on :i* ! drug or biological product 0 fir/ introduc$ 9 ! m>ket4 7c7 ,maximum am\nt ,) respect to drugs & biological products describ$ 9 subsection 7a71 ! ,bo>d may aw>d-- 7#a7 ( ! am\nt appropriat$ to ! ,fund = fiscal ye> #bjae1 n m ?an #ij p]c5t ( su* am\nt2 & 7#b7 ( ! am\nt appropriat$ to ! ,fund = ea* ( ! succe$+ #i fiscal ye>s1 n m ?an a p]c5tage ( su* am\nt t is equal to #i p]c5t less ! p]c5tage applicable to ! prec$+ fiscal ye> "u ?is subsection4 #ad4 ,arbitration ,9 ! case ( a drug t is on ! m>ket on ,octob] #a1 #bjad1 & subject to pat5ts own$ by a p>ty o!r ?an ! p]son :o fir/ receiv$ m>ket cle>ance = ! drug1 ! ,bo>d %all e/abli% an arbitration proc$ure to det]m9e an equitable division ( any prize paym5ts "u ?is ,act among ! pat5t own]s & ! p]son :o fir/ receiv$ m>ket cle>ance = ! drug4 #ae4 ,annual audits by ,,gao 7a7 ,audits ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct an audit ( ! ,bo>d ea* fiscal ye> to det]m9e ! effectiv5ess ( ! ,bo>d-- 7#a7 9 br++ to m>ket drugs1 vacc9es & o!r biological products1 & new manufactur+ processes = m$ic9es 9 a co/-effective mann]2 & 7#b7 9 address+ society's m$ical ne$s1 includ+ global neglect$ diseases t afflict prim>ily ! poor 9 develop+ c\ntries1 indications = :i* orphan designation has be5 grant$ "u section #ebf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb71 & global infecti\s diseases & o!r global public heal? priorities4 7b7 ,reports ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit a report to ! ,congress ea* fiscal ye> on ! results ( ea* audit conduct$ "u subsection 7a74 #af4 ,report to ,congress ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,bo>d %all submit to ,congress a report conta9+ ! f9d+s1 conclusions1 & recomm5dations ( ! ,bo>d conc]n+ ! implem5tation & adm9i/ration ( ?is ,act1 includ+ recomm5dations = su* legislative & adm9i/rative action z ! ,bo>d det]m9es to be appropriate4 #ag4 ,fund+ 7a7 ,appropriations 7#a7 ,/>t-up co/s ,= fiscal ye> #bjae1 !re are au?oriz$ to be appropriat$ to ! ,fund1 su* sums z may be necess>y to c>ry out ?is ,act4 7#b7 ,program implem5tation ,= fiscal ye> #bjae & ea* subsequ5t fiscal ye>1 !re is appropriat$ to ! ,fund1 out ( any funds 9 ! ,treasury n o!rwise appropriat$1 an am\nt equal to ! am\nt t is 4#ee p]c5t ( ! gross dome/ic product ( ! ,unit$ ,/ates = ! prec$+ fiscal ye> 7z su* am\nt is det]m9$ by ! ,secret>y ( ,comm]ce74 7b7 ,availability ,funds appropriat$ to ! ,fund = a fiscal ye> %all rema9 available = exp5diture 9 accordance ) ?is ,act until ! end ( ! #c-ye> p]iod beg9n+ on ,octob] #a ( su* fiscal ye>4 ,any su* funds t are unexp5d$ at ! end ( su* p]iod %all rev]t to ! ,treasury4 #ah4 ,imposition ( annual fee on heal? insurance provid]s 7a7 ,imposition ( fee 7#a7 ,9 g5]al ,ea* cov]$ entity engag$ 9 ! bus9ess ( provid+ heal? insurance %all pay to ! ,secret>y n lat] ?an ! annual paym5t date ( ea* cal5d> ye> beg9n+ aft] #bjad a fee 9 an am\nt det]m9$ "u subsection 7b74 7#b7 ,annual paym5t date ,= purposes ( ?is section1 ! t]m annual paym5t date means1 ) respect to any cal5d> ye>1 a date det]m9$ by ! ,secret>y1 :i* 9 no ev5t1 may be lat] ?an ,septemb] #cj ( su* cal5d> ye>4 7b7 ,det]m9ation ( fee am\nt ,) respect to ea* cov]$ entity1 ! fee "u ?is section = any cal5d> ye> %all be equal to ! am\nt det]m9$ "u section #ag7;a77#b71 multipli$ by ! ratio ( ! cov]$ entity's net premiums writt5 ) respect to heal? insurance = any ,unit$ ,/ates heal? risk tak5 into acc\nt "u subsection 7c7 dur+ ! prec$+ cal5d> ye>1 to-- 7#a7 ! sum ( net premiums = all cov]$ entities2 & 7#b7 all ,f$]al outlays on heal? insurance or reimbursem5t ( heal? c>e co/s1 exclud+ ! co/s ( long t]m c>e4 7c7 ,am\nts tak5 into acc\nt ,= purposes ( p>agraph 7b71 ! net premiums writt5 ) respect to heal? insurance = any ,unit$ ,/ates heal? risk t are tak5 into acc\nt dur+ any cal5d> ye> ) respect to any cov]$ entity %all be det]m9$ z foll[s3 7#a7 ,) respect to a cov]$ entity's net premiums writt5 dur+ ! cal5d> ye> t are n m ?an #be1jjj1jjj1 ! p]c5tage ( net premiums writt5 t are tak5 into acc\nt is #j p]c5t4 7#b7 ,) respect to a cov]$ entity's net premiums writt5 dur+ ! cal5d> ye> t are m ?an #be1jjj1jjj b less ?an #ej1jjj1jjj1 ! p]c5tage ( net premiums writt5 t are tak5 into acc\nt is #ej p]c5t4 7#c7 ,) respect to a cov]$ entity's net premiums writt5 dur+ ! cal5d> ye> t are #ej1jjj1jjj or m1 ! p]c5tage ( net premiums writt5 t are tak5 into acc\nt is #ajj p]c5t4 7d7 ,cov]$ entity 7#a7 ,9 g5]al ,= purposes ( ?is section1 ! t]m cov]$ entity means any entity :i* provides heal? insurance = any ,unit$ ,/ates heal? risk4 7#b7 ,exclusion ,su* t]m does n include any gov]nm5tal entity4