,,ib ,union ,cal5d> ,no4 #eid #aah? ,,congress #b;d ,session ,h4 ,r4 #cdcc ,report ,no4 #aah-gjj ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,may #ag1 #bjbc,mr4 ,mc,caul 7= himself1 ,ms4 ,e%oo1 ,mr4 ,kelly ( ,p5nsylvania1 ,mrs4 ,kim ( ,cali=nia1 ,mr4 ,smi? ( ,new ,j]sey1 ,ms4 ,s*ri]1 ,mr4 ,bacon1 ,mr4 ,moylan1 ,mr4 ,bu*anan1 ,mr4 ,fitzpatrick1 ,mr4 ,huiz5ga1 ,mr4 ,gro?man1 ,mr4 ,johnson ( ,ohio1 & ,mr4 ,phillips7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,septemb] #bj1 #bjbd;,additional sponsors3 ,ms4 ,ku/]1 ,mr4 ,wilson ( ,s\? ,c>ol9a1 ,ms4 ,salaz>1 ,mr4 ,neguse1 ,mr4 ,la,lota1 ,mr4 ,valadao1 ,mr4 ,mull91 ,mr4 ,waltz1 ,mr4 ,allr$1 ,mr4 ,lawl]1 ,ms4 ,ca/or ( ,florida1 ,ms4 ,ross1 ,ms4 ,l(gr51 ,mr4 ,crd5as1 ,mr4 ,calv]t1 ,mr4 ,kilm]1 ,mr4 ,r\z]1 ,mr4 ,davis ( ,nor? ,c>ol9a1 ,ms4 ,mace1 ,ms4 ,pett]s51 ,ms4 ,leg] ,f]n&ez1 ,ms4 ,p]ez1 ,ms4 ,c>aveo1 ,mr4 ,pappas1 ,mr4 ,jackson ( ,nor? ,c>ol9a1 ,mr4 ,ru!r=d1 ,mr4 ,ow5s1 ,mr4 ,baird1 ,mr4 ,nehls1 ,mr4 ,s*neid]1 ,mr4 ,van ,drew1 ,mr4 ,smi? ( ,nebraska1 ,mr4 ,bean ( ,florida1 ,mr4 ,we/]man1 ,mr4 ,f]guson1 ,mr4 ,yakym1 ,ms4 ,sewell1 ,mr4 ,kean ( ,new ,j]sey1 ,mr4 ,ca/51 ,ms4 ,de ,la ,cruz1 ,mr4 ,/eube1 ,mr4 ,lamborn1 ,mr4 ,coh51 ,ms4 ,titus1 ,ms4 ,br[n1 ,mr4 ,veasey1 ,ms4 ,slotk91 ,mr4 ,g>b>9o1 ,mr4 ,luetkemey]1 ,mr4 ,pet]s1 ,mr4 ,mc,garvey1 ,mr4 ,lieu1 ,mr4 ,z9ke1 ,mr4 ,h>d] ( ,cali=nia1 ,mr4 ,good5 ( ,texas1 ,mr4 ,grijalva1 ,mr4 ,norman1 ,ms4 ,blunt ,ro*e/]1 ,mr4 ,mc,govern1 ,mr4 ,m\lton1 ,mr4 ,quigley1 ,mr4 ,cr[1 ,mr4 ,la,hood1 ,mr4 ,?an$>1 ,mr4 ,got!im]1 ,mr4 ,mosk[itz1 ,mr4 ,swalwell1 ,mr4 ,au/9 ,scott ( ,georgia1 ,mr4 ,b]a1 ,mr4 ,diaz-,bal>t1 ,ms4 ,budz9ski1 ,mr4 ,ad]holt1 ,ms4 ,tokuda1 ,ms4 ,grang]1 ,mr4 ,cl9e1 ,mr4 ,f9/ad1 ,ms4 ,velzquez1 ,mr4 ,nunn ( ,i[a1 ,ms4 ,wass]man ,s*ultz1 ,mr4 ,trone1 ,mr4 ,tonko1 ,mrs4 ,trahan1 ,mr4 ,c>l1 ,ms4 ,matsui1 ,mr4 ,keat+1 ,ms4 ,h\lahan1 ,mrs4 ,mill] ( ,we/ ,virg9ia1 ,mrs4 ,f\%ee1 ,mrs4 ,watson ,coleman1 ,mr4 ,?ompson ( ,p5nsylvania1 ,mr4 ,c>ey1 ,mr4 ,nickel1 ,mr4 ,fleis*mann1 ,mr4 ,donalds1 ,ms4 ,wat]s1 ,mr4 ,ivey1 ,mr4 ,sablan1 ,mrs4 ,*]filus-,mc,cormick1 ,mrs4 ,napolitano1 ,mr4 ,lyn*1 ,mr4 ,correa1 ,mr4 ,goldman ( ,new ,york1 ,mr4 ,deluzio1 ,mr4 ,rask91 ,mr4 ,mike ,g>cia ( ,cali=nia1 ,mr4 ,l>son ( ,connecticut1 ,mr4 ,panetta1 ,ms4 ,del,bene1 ,mrs4 ,flet*]1 ,mr4 ,arr+ton1 ,ms4 ,br[nley1 ,mr4 ,sessions1 ,mr4 ,la,malfa1 ,mr4 ,amodei1 ,mr4 ,d',esposito1 ,mr4 ,scott ,frankl9 ( ,florida1 ,ms4 ,jacobs1 ,mr4 ,co/a1 ,mr4 ,graves ( ,miss\ri1 ,ms4 ,m5g1 ,ms4 ,wild1 ,ms4 ,norton1 ,mr4 ,kim ( ,new ,j]sey1 ,mr4 ,de,saulnier1 ,ms4 ,p+ree1 ,mr4 ,takano1 ,ms4 ,cl>ke ( ,new ,york1 ,mr4 ,khanna1 ,ms4 ,lee ( ,p5nsylvania1 ,mr4 ,kildee1 ,mrs4 ,d+ell1 ,ms4 ,malliotakis1 ,mr4 ,mills1 ,ms4 ,spanb]g]1 ,ms4 ,/ansbury1 ,mr4 ,bur*ett1 ,mr4 ,kelly ( ,mississippi1 ,mr4 ,jackson ( ,ill9ois1 ,mr4 ,soto1 ,mr4 ,ca/ro ( ,texas1 ,mrs4 ,bice1 ,mr4 ,mooney1 ,mr4 ,mann1 ,ms4 ,scanlon1 ,ms4 ,port]1 ,mr4 ,buc%on1 ,ms4 ,craig1 ,mr4 ,ruiz1 ,mr4 ,cuell>1 ,mr4 ,c>t] ( ,l\isiana1 ,mr4 ,flood1 ,mrs4 ,hayes1 ,mr4 ,clyde1 ,ms4 ,jayapal1 ,mr4 ,la,turner1 ,ms4 ,letl[1 ,ms4 ,kamlag]-,dove1 ,mr4 ,pocan1 ,ms4 ,wexton1 ,ms4 ,%]rill1 ,ms4 ,/rickl&1 ,mrs4 ,kiggans ( ,virg9ia1 ,ms4 ,b>ragn1 ,mr4 ,higg9s ( ,l\isiana1 ,mr4 ,sor5s51 ,ms4 ,crockett1 ,mr4 ,ciscomani1 ,mr4 ,al=d1 ,mr4 ,kiley1 ,mr4 ,smuck]1 ,mr4 ,mc,henry1 ,mr4 ,james1 ,ms4 ,/efanik1 ,mr4 ,mc,cormick1 ,mrs4 ,mill] ( ,ill9ois1 ,mr4 ,meus]1 ,mrs4 ,h>%b>g]1 ,ms4 ,davids ( ,kansas1 ,mr4 ,williams ( ,new ,york1 ,mr4 ,kri%namoor?i1 ,mr4 ,morelle1 ,ms4 ,t5ney1 ,mr4 ,posey1 ,mr4 ,web] ( ,texas1 ,mr4 ,s*weik]t1 ,mr4 ,gim5ez1 ,mr4 ,vic5te ,gonzalez ( ,texas1 ,ms4 ,bu%1 ,mrs4 ,h9son1 ,mr4 ,des,jarlais1 ,mr4 ,mill] ( ,ohio1 ,mr4 ,jackson ( ,texas1 ,mr4 ,boyle ( ,p5nsylvania1 ,ms4 ,williams ( ,georgia1 ,mr4 ,rob]t ,g>cia ( ,cali=nia1 ,ms4 ,de,gette1 ,mrs4 ,luna1 ,mr4 ,c>bajal1 ,mr4 ,?ompson ( ,mississippi1 ,mr4 ,suozzi1 ,mr4 ,g>am5di1 ,ms4 ,bonamici1 ,ms4 ,kaptur1 ,ms4 ,mc,collum1 ,ms4 ,jackson ,lee1 ,mr4 ,cleav]1 ,mr4 ,espaillat1 ,ms4 ,moore ( ,wiscons91 ,mr4 ,nadl]1 ,mr4 ,s>banes1 ,ms4 ,sal9as1 ,mrs4 ,beatty1 ,mr4 ,g>ca ( ,ill9ois1 ,mr4 ,norcross1 ,ms4 ,mc,clellan1 ,ms4 ,lee ( ,cali=nia1 ,mr4 ,bilirakis1 ,ms4 ,s*ak[sky1 ,mr4 ,evans1 ,ms4 ,s*olt51 ,mr4 ,lev91 & ,mr4 ,wittman ,septemb] #bj1 #bjbd,report$ ) an am5dm5t1 committ$ to ! ,committee ( ! ,:ole ,h\se on ! ,/ate ( ! ,union1 & ord]$ to be printed,strike out all aft] ! enact+ clause & ins]t ! "p pr9t$ 9 italic,for text ( introduc$ bill1 see copy ( bill z introduc$ on ,may #ag1 #bjbc ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act ) respect to molecul>ly t>get$ p$iatric canc] inve/igations1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,give ,kids a ,*ance ,act ( #bjbd4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4,title ,i--,give ,kids a ,chance,sec4 #aja4 ,rese>* into p$iatric uses ( drugs2 additional au?orities ( ,food & ,drug ,adm9i/ration reg>d+ molecul>ly t>get$ canc] drugs4,sec4 #ajb4 ,ensur+ completion ( p$iatric /udy requirem5ts4,sec4 #ajc4 ,,fda report on ,,prea en=cem5t4,sec4 #ajd4 ,ext5sion ( au?ority to issue priority review v\*]s to enc\rage treatm5ts = r>e p$iatric diseases4,sec4 #aje4 ,limitations on exclusive approval or lic5sure ( orphan drugs4,sec4 #ajf4 ,program = p$iatric /udies ( drugs4,title ,,ii--,unit$ ,/ates-,abraham ,accords ,coop]ation & ,security,sec4 #bja4 ,e/abli%m5t ( ,abraham ,accords ,(fice )9 ,food & ,drug ,adm9i/ration4,title ,,iii--,organ ,procurem5t & ,transplantation ,network,sec4 #cja4 ,regi/ration fees4 ,i ,give ,kids a ,*ance #aja4 ,rese>* into p$iatric uses ( drugs2 additional au?orities ( ,food & ,drug ,adm9i/ration reg>d+ molecul>ly t>get$ canc] drugs 7a7 ,9 g5]al 7#a7 ,additional active +r$i5t = application drug2 limitation reg>d+ novel-comb9ation application drug ,section #eje;,b7a77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77#c77 is am5d$-- 7,a7 by r$esignat+ subp>agraphs 7,b7 & 7,c7 z subp>agraphs 7,c7 & 7,d71 respectively2 & 7,b7 by /rik+ subp>agraph 7,a7 & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,= purposes ( p>agraph 7#a77;,b71 ! inve/igation describ$ 9 ?is p>agraph is 7z det]m9$ by ! ,secret>y7 a molecul>ly t>get$ p$iatric canc] inve/igation (-- 7i7 ! drug or biological product = :i* ! application ref]r$ to 9 su* p>agraph is submitt$2 or 7ii7 su* drug or biological product 9 comb9ation )-- 7,i7 an active +r$i5t ( a drug or biological product-- 7aa7 = :i* an approv$ application "u section #eje7;j7 "u ?is ,act or "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act is 9 effect2 & 7bb7 t is det]m9$ by ! ,secret>y to be ! /&>d ( c>e = treat+ a p$iatric canc]2 or 7,,ii7 an active +r$i5t ( a drug or biological product-- 7aa7 = :i* an approv$ application "u section #eje7;b7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act to treat an adult canc] is 9 effect & is held by ! same p]son submitt+ ! application "u p>agraph 7#a77;,b72 & 7bb7 t is direct$ at a molecul> t>get t ! ,secret>y det]m9es to be sub/antially relevant to ! gr[? or progression ( a p$iatric canc]4 7,b7 ,additional requirem5ts 7i7 ,design ( inve/igation ,a molecul>ly t>get$ p$iatric canc] inve/igation ref]r$ to 9 subp>agraph 7,a7 %all be design$ to yield cl9ically mean+ful p$iatric /udy data t is ga!r$ us+ appropriate =mulations = ea* age gr\p = :i* ! /udy is requir$1 reg>d+ dos+1 safety1 & prelim9>y efficacy to in=m pot5tial p$iatric label+4 7ii7 ,limitation ,an inve/igation describ$ 9 subp>agraph 7,a77ii7 may be requir$ only if ! drug or biological product = :i* ! application ref]r$ to 9 p>agraph 7#a77;,b7 conta9s ei!r-- 7,i7 a s+le new active +r$i5t2 or 7,,ii7 m ?an "o active +r$i5t1 if an application = ! comb9ation ( active +r$i5ts has n previ\sly be5 approv$ b ea* active +r$i5t has be5 previ\sly approv$ to treat an adult canc]4 7iii7 ,results ( already-complet$ precl9ical /udies ( application drug ,! ,secret>y may require t reports on an inve/igation requir$ pursuant to p>agraph 7#a77;,b7 include ! results ( all precl9ical /udies on :i* ! decision to conduct su* inve/igation 0 bas$4 7iv7 ,rule ( con/ruction reg>d+ inactive +r$i5ts ,) respect to a comb9ation ( active +r$i5ts ref]r$ to 9 subp>agraph 7,a77ii71 su* subp>agraph %all n be con/ru$ z address+ ! use ( inactive +r$i5ts ) su* comb9ation4 4 7#b7 ,det]m9ation ( applicable requirem5ts ,section #eje;,b7e77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7e77#a77 is am5d$ by add+ at ! end ! foll[+3 ,! ,secret>y %all det]m9e :e!r subp>agraph 7,a7 or 7,b7 ( subsection 7a77#a7 %all apply ) respect to an application be=e ! date on :i* ! applicant is requir$ to submit ! initial p$iatric /udy plan "u p>agraph 7#b77;,a744 7#c7 ,cl>ify+ applicability ,section #eje;,b7a77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77#a77 is am5d$ by add+ at ! end ! foll[+3 7,c7 ,rule ( con/ruction ,no application t is subject to ! requirem5ts ( subp>agraph 7,b7 %all be subject to ! requirem5ts ( subp>agraph 7,a71 & no application 7or supplem5t to an application7 t is subject to ! requirem5ts ( subp>agraph 7,a7 %all be subject to ! requirem5ts ( subp>agraph 7,b74 4 7#d7 ,con=m+ am5dm5ts ,section #eje;,b7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77 is am5d$-- 7,a7 9 p>agraph 7#c77;,c71 z r$esignat$ by p>agraph 7#a77;,a7 ( ?is subsection1 by /rik+ inve/igations describ$ 9 ?is p>agraph & ins]t+ inve/igations ref]r$ to 9 subp>agraph 7,a72 & 7,b7 9 p>agraph 7#c77;,d71 z r$esignat$ by p>agraph 7#a77;,a7 ( ?is subsection1 by /rik+ ! assessm5ts "u p>agraph 7#b77;,b7 & ins]t+ ! assessm5ts requir$ "u p>agraph 7#a77;,a74 7b7 ,guidance ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all-- 7#a7 n lat] ?an #ab mon?s aft] ! date ( enactm5t ( ?is ,act1 issue draft guidance on ! implem5tation ( ! am5dm5ts made by subsection 7a72 & 7#b7 n lat] ?an #ab mon?s aft] clos+ ! comm5t p]iod on su* draft guidance1 f9alize su* guidance4 7c7 ,applicability ,! am5dm5ts made by ?is section apply ) respect to any application "u section #eje7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 & any application "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a771 t is submitt$ on or aft] ! date t is #c ye>s aft] ! date ( enactm5t ( ?is ,act4 7d7 ,reports to ,congress 7#a7 ,secret>y ( ,heal? & ,human ,s]vices ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report on ! ,secret>y's ef=ts1 9 coord9ation ) indu/ry1 to ensure implem5tation ( ! am5dm5ts made by subsection 7a74 7#b7 ,,gao /udy & report 7,a7 ,/udy ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy ( ! effectiv5ess ( requir+ assessm5ts & inve/igations describ$ 9 section #eje;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4#cee;c71 z am5d$ by subsection 7a71 9 ! developm5t ( drugs & biological products = p$iatric canc] indications4 7,b7 ,f9d+s ,n lat] ?an #g ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report conta9+ ! f9d+s ( ! /udy conduct$ "u subp>agraph 7,a74 #ajb4 ,ensur+ completion ( p$iatric /udy requirem5ts 7a7 ,equal acc\ntability = p$iatric /udy requirem5ts ,section #eje;,b7d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7d77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ ,beg9n+ #bgj & ins]t+ ,noncompliance lett]4--,beg9n+ #bgj2 7#b7 9 p>agraph 7#b7-- 7,a7 by /rik+ ,! drug or & ins]t+ ,effect ( noncompliance4--,! drug or2 & 7,b7 by /rik+ 7except t ! drug or biological product %all n be subject to action "u section #cjc7 & ins]t+ 7except t ! drug or biological product %all be subject to action "u section #cjc only if su* p]son demon/rat$ a lack ( due dilig5ce 9 satisfy+ ! applicable requirem5t72 & 7#c7 by add+ at ! end ! foll[+3 7#c7 ,limitation ,! ,secret>y %all n issue en=cem5t actions "u section #cjc = failures "u ?is subsection 9 ! case ( a drug or biological product t is no long] m>ket$4 4 7b7 ,due dilig5ce ,section #eje;,b7d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7d771 z am5d$ by subsection 7a71 is fur!r am5d$ by add+ at ! end ! foll[+3 7#d7 ,due dilig5ce ,be=e ! ,secret>y may conclude t a p]son fail$ to submit or o!rwise meet a requirem5t z describ$ 9 ! matt] prec$+ p>agraph 7#a71 ! ,secret>y %all-- 7,a7 issue a noncompliance lett] pursuant to p>agraph 7#a72 7,b7 provide su* p]son ) a #de-;day p]iod beg9n+ on ! date ( receipt ( su* noncompliance lett] to respond 9 writ+ z set =? 9 su* p>agraph2 & 7,c7 aft] review+ su* writt5 response1 det]m9e :e!r ! p]son demon/rat$ a lack ( due dilig5ce 9 satisfy+ su* requirem5t4 4 7c7 ,con=m+ am5dm5ts ,section #cjc7;f77#d77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;f77#d77;,a77 is am5d$ by /rik+ or #eje-a & ins]t+ #eje-a1 or #eje;,b4 7d7 ,transition rule ,! ,secret>y ( ,heal? & ,human ,s]vices may take en=cem5t action "u section #cjc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 only = failures describ$ 9 section #eje;,b7d7 ( su* ,act 7#ba ,u4,s4,c4 #cee;c7d77 t occur on or aft] ! date t is #ahj days aft] ! date ( enactm5t ( ?is ,act4 #ajc4 ,,fda report on ,,prea en=cem5t ,section #ejh7;b7 ( ! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act 7#ba ,u4,s4,c4 #cee;c-#a7;b77 is am5d$-- 7#a7 9 p>agraph 7#aa71 by /rik+ ! semicolon at ! end & ins]t+ 1 includ+ an evaluation ( compliance ) deadl9es provid$ = 9 def]rals & def]ral ext5sions22 7#b7 9 p>agraph 7#ae71 by /rik+ & at ! end2 7#c7 9 p>agraph 7#af71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#d7 by add+ at ! end ! foll[+3 7#ag7 a li/+ ( p5alties1 settlem5ts1 or paym5ts "u section #cjc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7 = failure to comply ) requirem5ts "u su* section #eje;,b1 includ+1 = ea* p5alty1 settlem5t1 or paym5t1 ! "n ( ! drug1 ! sponsor !re(1 & ! am\nt ( ! p5alty1 settlem5t1 or paym5t impos$2 & 4 #ajd4 ,ext5sion ( au?ority to issue priority review v\*]s to enc\rage treatm5ts = r>e p$iatric diseases 7a7 ,ext5sion ,p>agraph 7#e7 ( section #ebi7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7b77 is am5d$ by /rik+ ,septemb] #cj1 #bjbd1 unless & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ ,septemb] #cj1 #bjbi44 7b7 ,,gao report on effectiv5ess ( r>e p$iatric disease priority v\*] aw>ds 9 inc5tiviz+ r>e p$iatric disease drug developm5t 7#a7 ,,gao /udy 7,a7 ,/udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy ( ! effectiv5ess ( aw>d+ r>e p$iatric disease priority v\*]s "u section #ebi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff71 z am5d$ by subsection 7a71 9 ! developm5t ( human drug products t treat or prev5t r>e p$iatric diseases 7z def9$ 9 su* section #ebi74 7,b7 ,cont5ts ( /udy ,9 conduct+ ! /udy "u subp>agraph 7,a71 ! ,comptroll] ,g5]al %all exam9e ! foll[+3 7i7 ,! indications = ea* drug or biological product t-- 7,i7 is ! subject ( a r>e p$iatric disease product application 7z def9$ 9 section #ebi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff77 = :i* a priority review v\*] 0 aw>d$2 & 7,,ii7 0 approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#db ,u4,s4,c4 #cee7 or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 7ii7 ,:e!r1 & to :at ext5t1 an unmet ne$ relat$ to ! treatm5t or prev5tion ( a r>e p$iatric disease 0 met ?r\gh ! approval or lic5sure ( su* a drug or biological product4 7iii7 ,! size ( ! company to :i* a priority review v\*] 0 aw>d$ "u section #ebi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7 = su* a drug or biological product4 7iv7 ,! value ( su* priority review v\*] if transf]r$4 7v7 ,id5tification ( ea* drug = :i* a priority review v\*] aw>d$ "u su* section #ebi 0 us$4 7vi7 ,! size ( ! company us+ ea* priority review v\*] aw>d$ "u su* section #ebi4 7vii7 ,! l5g? ( ! p]iod ( "t betwe5 ! date on :i* a priority review v\*] 0 aw>d$ "u su* section #ebi & ! date on :i* x 0 us$4 7viii7 ,:e!r1 & to :at ext5t1 an unmet ne$ relat$ to ! treatm5t or prev5tion ( a r>e p$iatric disease 0 met ?r\gh ! approval "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#db ,u4,s4,c4 #cee7 or lic5sure "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 ( a drug = :i* a priority review v\*] 0 us$4 7ix7 ,:e!r1 & to :at ext5t1 companies 7 motivat$ by ! availability ( priority review v\*]s "u section #ebi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7 to attempt to develop a drug = a r>e p$iatric disease4 7x7 ,:e!r1 & to :at ext5t1 p$iatric review v\*]s aw>d$ "u su* section 7 successful 9 /imulat+ developm5t & exp$it$ pati5t access to drug products = treatm5t or prev5tion ( a r>e p$iatric disease t w\ldn't o!rwise take place )\t ! inc5tive provid$ by su* v\*]s4 7xi7 ,! impact ( su* priority review v\*]s on ! workload1 review process1 & public heal? prioritization ef=ts ( ! ,food & ,drug ,adm9i/ration4 7xii7 ,any o!r inc5tives 9 ,f$]al law t exi/ = companies develop+ drugs or biological products describ$ 9 clause 7i74 7#b7 ,report on f9d+s ,n lat] ?an #e ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report conta9+ ! f9d+s ( ! /udy conduct$ "u p>agraph 7#a74 #aje4 ,limitations on exclusive approval or lic5sure ( orphan drugs 7a7 ,9 g5]al ,section #ebg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7 is am5d$-- 7#a7 9 subsection 7a71 9 ! matt] foll[+ p>agraph 7#b71 by /rik+ same disease or condition & ins]t+ same approv$ use or indication )9 su* r>e disease or condition2 7#b7 9 subsection 7b7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ same r>e disease or condition & ins]t+ same approv$ use or indication = :i* su* #g-ye> p]iod applies to su* already approv$ or lic5s$ drug2 & 7,b7 9 p>agraph 7#a71 by ins]t+ 1 relat+ to ! approv$ use or indication1 aft] ! ne$s2 7#c7 9 subsection 7c77#a71 by /rik+ same r>e disease or condition z ! already approv$ drug & ins]t+ same use or indication = :i* ! already approv$ or lic5s$ drug 0 approv$ or lic5s$2 & 7#d7 by add+ at ! end ! foll[+3 7f7 ,approv$ use or indication def9$ ,9 ?is section1 ! t]m approv$ use or indication means ! use or indication approv$ "u section #eje ( ?is ,act or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act = a drug designat$ "u section #ebf = a r>e disease or condition4 4 7b7 ,application ( am5dm5ts ,! am5dm5ts made by subsection 7a7 %all apply ) respect to any drug designat$ "u section #ebf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb71 reg>dless ( ! date on :i* ! drug 0 s designat$1 & reg>dless ( ! date on :i* ! drug 0 approv$ "u section #eje ( su* ,act 7#ba ,u4,s4,c4 #cee7 or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 #ajf4 ,program = p$iatric /udies ( drugs ,section #dji;,i7d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhdm7d77 is am5d$ to read z foll[s3 7d7 ,fund+ ,( ! am\nt made available = p$iatric rese>* to ea* national rese>* in/itute & national c5t] "u ?is title = ea* ( fiscal ye>s #bjbe1 #bjbf1 & #bjbg1 ! ,director ( ,,nih is au?oriz$ to make available up to "o p]c5t ( su* am\nt = p$iatric rese>* "u ?is section4 4 ,,ii ,unit$ ,/ates-,abraham ,accords ,coop]ation & ,security #bja4 ,e/abli%m5t ( ,abraham ,accords ,(fice )9 ,food & ,drug ,adm9i/ration 7a7 ,9 g5]al ,*apt] ,x ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cia et seq47 is am5d$ by add+ at ! end ! foll[+3 #ajae4 ,abraham ,accords ,(fice 7a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all e/abli% )9 ! ,food & ,drug ,adm9i/ration an (fice1 to be kn[n z ! ,abraham ,accords ,(fice1 to be head$ by a director4 7b7 ,(fice ,n lat] ?an two ye>s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all-- 7#a7 9 consultation ) ! gov]nm5ts ( ,abraham ,accords c\ntries1 z well z appropriate ,unit$ ,/ates ,gov]nm5t diplomatic & security p]sonnel-- 7,a7 select ! location ( ! ,abraham ,accords ,(fice 9 an ,abraham ,accords c\ntry2 & 7,b7 e/abli% su* (fice2 & 7#b7 assign to su* (fice su* p]sonnel ( ! ,food & ,drug ,adm9i/ration z ! ,secret>y det]m9es necess>y to c>ry out ! functions ( su* (fice4 7c7 ,duties ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,abraham ,accords ,(fice1 %all-- 7#a7 aft] ! ,abraham ,accords ,(fice is e/abli%$-- 7,a7 z "p ( ! ,food & ,drug ,adm9i/ration's "w to /r5g!n ! int]national ov]sight ( regulat$ commodities1 provide te*nical assi/ance to regulatory p>tn]s 9 ,abraham ,accords c\ntries on /r5g!n+ regulatory ov]sight & conv]g+ regulatory requirem5ts = ! ov]sight ( regulat$ products1 includ+ good manufactur+ practices & o!r issues relevant to manufactur+ m$ical products t are regulat$ by ! ,food & ,drug ,adm9i/ration2 7,b7 facilitate int]actions betwe5 ! ,food & ,drug ,adm9i/ration & int]e/$ p>ties 9 ,abraham ,accords c\ntries1 includ+ by %>+ relevant in=mation reg>d+ ,unit$ ,/ates regulatory pa?ways ) su* p>ties2 & 7,c7 facilitate fe$back betwe5 ! ,food & ,drug ,adm9i/ration & su* p>ties locat$ )9 ,abraham ,accords c\ntries prior to submission ( an application "u section #eje7;b71 #eje7;j71 or #eae ( ?is ,act or section #cea7;a7 or #cea7k7 ( ! ,public ,heal? ,s]vice ,act1 or a notification "u section #eaj7k7 ( ?is ,act1 su* z fe$back on rese>*1 developm5t1 & manufactur+ ( drugs1 biologics1 & m$ical devices2 & 7#b7 c>ry out o!r functions & activities z ! ,secret>y det]m9es to be necess>y to c>ry out ?is section4 7d7 ,abraham ,accords c\ntry def9$ ,9 ?is section1 ! t]m ,abraham ,accords c\ntry means a c\ntry id5tifi$ by ! ,dep>tm5t ( ,/ate z hav+ sign$ ! ,abraham ,accords ,decl>ation4 4 7b7 ,report to ,congress 7#a7 ,9 g5]al ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ! ,congress a report on ! ,abraham ,accords ,(fice1 includ+-- 7,a7 an evaluation ( h[ ! ,(fice has advanc$ progress t[>d con=mance ) ,food & ,drug ,adm9i/ration regulatory requirem5ts by manufactur]s 9 ! ,abraham ,accords c\ntries2 7,b7 a num]ical c\nt ( p>ties t ! ,(fice has help$ facilitate int]actions or fe$back pursuant to subp>agraphs 7,b7 & 7,c7 ( section #ajae7;c77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by subsection 7a772 7,c7 a summ>y ( te*nical assi/ance provid$ to regulatory p>tn]s 9 ,abraham ,accords c\ntries pursuant to subp>agraph 7,a7 ( su* section #ajae7;c77#a72 & 7,d7 recomm5dations = increas+ & improv+ coord9ation betwe5 ! ,food & ,drug ,adm9i/ration & entities 9 ,abraham ,accords c\ntries4 7#b7 ,abraham ,accords c\ntry def9$ ,9 ?is subsection1 ! t]m ,abraham ,accords c\ntry has ! mean+ giv5 su* t]m 9 section #ajae7;d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by subsection 7a774 ,,iii ,organ ,procurem5t & ,transplantation ,network #cja4 ,regi/ration fees ,section #cgb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bgd7 is am5d$ by add+ at ! end ! foll[+3 7d7 ,regi/ration fees 7#a7 ,9 g5]al ,! ,secret>y may collect regi/ration fees f any memb] ( ! ,organ ,procurem5t & ,transplantation ,network = ea* transplant c&idate su* memb] places on ! li/ describ$ 9 subsection 7b77#b77;,a77i74 ,su* regi/ration fees %all only be collect$ & di/ribut$ to support ! op]ation ( ! ,organ ,procurem5t & ,transplantation ,network4 ,su* regi/ration fees are au?oriz$ to rema9 available until exp5d$4 7#b7 ,collection ,! ,secret>y may collect ! regi/ration fees "u p>agraph 7#a7 directly or ?r\gh aw>ds made "u subsection 7b77#a77;,a74 7#c7 ,di/ribution ,! ,secret>y may di/ribute su* fees among ! aw>dees describ$ 9 subsection 7b77#a77;,a74 7#d7 ,transp>5cy ,! ,secret>y %all-- 7,a7 promptly po/ on ! ,int]net website ( ! ,organ ,procurem5t & ,transplant ,network-- 7i7 ! am\nt ( regi/ration fees collect$ "u ?is subsection f ea* memb] ( ! ,organ ,procurem5t & ,transplantation ,network2 & 7ii7 a li/ ( activities su* fees are us$ to support2 & 7,b7 update ! in=mation po/$ pursuant to subp>agraph 7,a71 z applicable = ea* cal5d> qu>t] = :i* fees are collect$ "u p>agraph 7#a74 7#e7 ,,gao review ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is subsection1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all1 to ! ext5t data are available-- 7,a7 conduct a review conc]n+ ! activities "u ?is subsection2 & 7,b7 submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,f9ance ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 a report on su* review1 includ+ relat$ recomm5dations1 z applicable4 4 ,septemb] #bj1 #bjbd,report$ ) an am5dm5t1 committ$ to ! ,committee ( ! ,:ole ,h\se on ! ,/ate ( ! ,union1 & ord]$ to be pr9t$