,i #aag? ,,congress #b;d ,session ,h4 ,r4 #figb ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,m>* #h1 #bjbb,mr4 ,butt]field 7= himself & ,mr4 ,mc,caul7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to e/abli% additional au?orities ( ! ,food & ,drug ,adm9i/ration reg>d+ ! conduct ( p$iatric inve/igations ( molecul>ly t>get$ drugs to treat canc]1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,give ,kids a ,*ance ,act ( #bjbb4 #b4 ,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 ,au?ority reg>d+ inve/igation ( novel comb9ation drugs ,section #eje;,b7a77#a77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77#a77;,b77 is am5d$1 9 ! matt] prec$+ clause 7i71 by ins]t+ aft] ,public ,heal? ,s]vice ,act1 ! foll[+3 or an application "u su* section #eje or su* section #cea = a drug or biological product t conta9s a novel comb9ation ( two or m active +r$i5ts 7subject to p>agraph 7#c77;,b77iii774 7#b7 ,additional active +r$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$2 or 7ii7 ! active +r$i5t or +r$i5ts ( su* drug or biological product 9 comb9ation )-- 7,i7 an active +r$i5t ( a drug = :i* an approv$ application "u section #eje7;j7 is 9 effect or an active +r$i5t ( a biological product = :i* an approv$ application "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act is 9 effect1 :i* drug or biological product is det]m9$ by ! ,secret>y to be ! /&>d ( c>e = treat+ a p$iatric canc]2 7,,ii7 an active +r$i5t ( a drug = :i* an approv$ application "u section #eje7;b7 is 9 effect to treat an adult canc]1 or an active +r$i5t ( a biological product = :i* an approv$ application "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act is 9 effect to treat an adult canc]1 :i* approv$ application is held by ! same p]son submitt+ ! application ref]r$ to 9 p>agraph 7#a77;,b72 or 7,,iii7 an active +r$i5t ( a drug or biological product = :i* !re is 9 effect an exemption = inve/igational use "u section #eje7;i71 :i* drug or biological product is "u su* exemption be+ /udi$ jo9tly by ! p]son submitt+ ! application ref]r$ to 9 p>agraph 7#a77;,b7 & by ano!r p]son pursuant to an agreem5t betwe5 su* p]sons4 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$iatric /udy data1 ga!r$ us+ appropriate =mulations = ea* age gr\p = :i* ! /udy is requir$1 reg>d+ dos+1 safety1 & prelim9>y efficacy4 7ii7 ,purpose ( inve/igation ,! purpose ( a molecul>ly t>get$ p$iatric canc] inve/igation ref]r$ to 9 subp>agraph 7,a7 %all be-- 7,i7 9 ! case ( su* an inve/igation conduct$ ) respect to a drug or biological product ref]r$ to 9 clause 7i7 ( su* subp>agraph1 to in=m pot5tial p$iatric label+ ( ! drug or biological product = :i* ! application ref]r$ to 9 p>agraph 7#a77;,b7 is submitt$2 & 7,,ii7 9 ! case ( su* an inve/igation conduct$ ) respect to a comb9ation ( active +r$i5ts describ$ to 9 clause 7ii7 ( su* subp>agraph1 to assi/ 9 det]m9+ ! relevance ( its molecul> t>get to ! gr[? or progression ( a p$iatric canc]4 7iii7 ,limitation reg>d+ inve/igation ( novel comb9ation ,= purposes ( p>agraph 7#a77;,b71 a novel comb9ation is a comb9ation ( two or m active +r$i5ts = :i* an application "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act = su* comb9ation has n previ\sly be5 approv$4 ,a p$iatric inve/igation "u ?is p>agraph ( su* novel comb9ation is requir$ only if ea* ( ! active +r$i5ts 9 ! comb9ation has be5 approv$ "u su* section #eje or su* section #cea to treat an adult canc]4 7iv7 ,precl9ical data ,! ,secret>y may require t reports on an inve/igation requir$ pursuant to p>agraph 7#a77;,b7 %all include ! results ( all precl9ical /udies on :i* ! decision to conduct su* inve/igation 0 bas$4 7v7 ,rule ( con/ruction reg>d+ inactive +r$i5ts ,) respect to a comb9ation ( active +r$i5ts ref]r$ to 9 subp>agraph 7,a77ii71 su* subp>agraph may n be con/ru$ z address+ ! use ( inactive +r$i5ts ) su* comb9ation4 4 7#c7 ,cl>ify+ applicability ( c]ta9 provisions ,section #eje;,b7a77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77#c771 z am5d$ by p>agraph 7#b71 is fur!r am5d$ by add+ at ! end ! foll[+3 7,e7 ,int]nal committee review2 label+ *anges2 dissem9ation ( in=mation2 adv]se ev5ts2 scope ( au?ority ,subsections 7f7 ?r\gh 7j7 %all apply ) respect to inve/igations describ$ 9 ?is p>agraph to ! same ext5t & 9 ! same mann] z su* subsections apply ) respect to ! assessm5ts requir$ "u p>agraph 7#a77;,a71 except t subsection 7g7 does n apply ) respect to an inve/igation ref]r$ to 9 subp>agraph 7,a77ii7 ( ?is p>agraph4 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#b77;,a7 ( ?is subsection1 by /rik+ inve/igations describ$ 9 ?is p>agraph & ins]t+ inve/igations ref]r$ to 9 subp>agraph 7,a77i72 7,b7 9 p>agraph 7#c77;,d71 z r$esignat$ by p>agraph 7#b77;,a7 ( ?is subsection1 by /rik+ ! assessm5ts "u p>agraph 7#b77;,b7 & ins]t+ ! assessm5ts requir$ "u p>agraph 7#a77;,a72 & 7,c7 9 p>agraph 7#e77;,d71 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 except ?is subp>agraph is n applicable to an inve/igation ref]r$ to 9 p>agraph 7#c77;,a77ii74 7b7 ,au?ority reg>d+ precl9ical /udies ,section #eje;,b7a77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77#a771 z am5d$ by subsection 7a77#a71 is fur!r am5d$ by add+ at ! end ! foll[+3 7,c7 ,precl9ical /udies g5]ally 7i7 ,9 g5]al ,) respect to an application = an exemption = inve/igational use "u section #eje7;i7 = a drug or biological product t is int5d$ = ! treatm5t ( an adult canc]1 ! ,secret>y may require1 z a condition ( p]mitt+ ! exemption to g into effect1 t ! sponsor involv$ ent] into an agreem5t ) ! ,secret>y to conduct n m ?an two precl9ical /udies ( ! drug or biological product 9 ord] to assi/ 9 det]m9+ ! relevance ( its molecul> t>get to ! gr[? or progression ( a p$iatric canc]4 7ii7 ,timeframe = precl9ical /udies ,) respect to ! drug or biological product involv$1 an agreem5t "u clause 7i7 = a precl9ical /udy %all specify ! date by :i* an initial plan = ! /udy w be submitt$ to ! ,secret>y except t ! ,secret>y may n require ! submission ( su* plan any e>li] ?an "o ye> aft] ! exemption ref]r$ to 9 clause 7i7 goes into effect4 ,! results ( ! precl9ical /udy %all be submitt$ to ! ,secret>y 9 accordance ) a timeframe to :i* ! ,secret>y & ! sponsor involv$ h agre$4 ,su* timeframe %all provide = def]rals equival5t to def]rals "u p>agraph 7#d74 4 7c7 ,applicability ,! am5dm5ts made by ?is section apply ) respect to any application "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i771 any application "u section #eje ( su* ,act 7#ba ,u4,s4,c4 #cee71 & any application "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb71 t is submitt$ on or aft] ! expiration ( ! #c-ye> p]iod beg9n+ on ! date ( ! enactm5t ( ?is ,act4