,,ii #aac? ,,congress #a/ ,session ,s4 #abea ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,june #bg1 #bjac ,mr4 ,re$ 7= himself1 ,mrs4 ,fis*]1 ,mr4 ,m55dez1 ,mr4 ,casey1 ,mr4 ,frank51 & ,ms4 ,klobu*>7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to e/abli% programs ) respect to *ildhood1 adolesc5t1 & "y adult canc]4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,c>ol9e ,pryce ,walk] ,conqu] ,*ildhood ,canc] ,reau?orization ,act4 #b4 ,f9d+s ,congress f9ds z foll[s3 7#a7 ,e ye>1 #ac1ejj *ildr5 9 ! ,unit$ ,/ates are diagnos$ ) canc]4 7#b7 ,:ile ! cure rates = "s *ildhood canc]s are n[ ov] #hj p]c5t1 ! survival rates = _m types ( canc]s 9 *ildr5 rema9 extremely l[4 7#c7 ,accord+ to ! ,c5t]s = ,disease ,control & ,prev5tion1 canc] cont9ues to be ! lead+ cause ( dea? by disease 9 *ildr5 & adolesc5ts "u ! age ( #ad4 7#d7 ,!re are curr5tly m ?an #cfj1jjj *ildhood canc] survivors liv+ 9 ! ,unit$ ,/ates4 7#e7 ,z _m z two-?irds ( *ildhood canc] survivors exp]i5ce at lea/ "o long-t]m heal? effect ( _! canc] treatm5t1 includ+ second>y malignancies1 c>diopulmon>y damage1 physical & intellectual developm5tal impairm5ts1 endocr9e disord]s1 & o!rs4 7#f7 ,collection ( biospecim5s & cl9ical & demographic data on ! maximum possible numb] ( *ildr5 ) canc] 9 ! ,unit$ ,/ates is necess>y to improve *ildhood canc] treatm5ts & cures4 ,curr5tly biospecim5s & "s demographic data are collect$ = less ?an half ( *ildr5 ) canc]4 #c4 ,compreh5sive *ildr5's canc] biorepositories 7a7 ,9 g5]al ,section #dag;,e ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhe;a-#aa7 is am5d$-- 7#a7 by r$esignat+ subsections 7c7 & 7d7 z subsections 7k7 & 7l71 respectively2 7#b7 by /rik+ subsections 7a7 & 7b7 & ins]t+ ! foll[+3 7a7 ,compreh5sive *ildr5's canc] biorepositories ,! ,secret>y1 act+ ?r\gh ! ,director ( ,,nih1 may make an aw>d = a duration ( at lea/ #e ye>s to an entity or entities describ$ 9 subsection 7d7 to build ^u exi/+ initiatives to collect biospecim5s & cl9ical & demographic in=mation = at lea/ #ij p]c5t ( all *ildr51 adolesc5ts1 & "y adults ) canc] 9 #a or m ,compreh5sive ,*ildr5's ,canc] ,biorepositories to a*ieve a bett] und]/&+ ( ! cause ( su* canc]s & ! effects ( treatm5ts = su* canc]s4 7b7 ,use ( funds ,am\nts receiv$ "u ! aw>d "u subsection 7a7 may be us$ to c>ry out ! foll[+3 7#a7 ,prospectively acquire1 pres]ve1 & /ore high quality1 donat$ biospecim5s & associat$ cl9ical & demographic in=mation on *ildr51 adolesc5ts1 & "y adults diagnos$ ) canc] 9 ! ,unit$ ,/ates4 7#b7 ,ma9ta9 a secure se>*able database on /or$ biospecim5s & associat$ cl9ical & demographic data f *ildr51 adolesc5ts1 & "y adults ) canc] = ! conduct ( rese>* by sci5ti/s & qualifi$ heal? c>e pr(essionals4 7#c7 ,e/abli% proc$ures = evaluat+ applications = access to su* biospecim5s & cl9ical & demographic data f rese>*]s & o!r qualifi$ heal? c>e pr(essionals4 7#d7 ,make available & di/ribute biospecim5s & cl9ical & demographic data f *ildr51 adolesc5ts1 & "y adults ) canc] to rese>*]s & qualifi$ heal? c>e pr(essionals = pe]-review$ rese>* at a m9imal co/4 7c7 ,no requirem5t ,no *ild1 adolesc5t1 or "y adult ) canc] %all be requir$ to contribute a specim5 to a ,biorepository or %>e cl9ical or demographic data4 7d7 ,application2 consid]ations 7#a7 ,application ,to be eligible to receive an aw>d "u subsection 7a7 an entity %all submit an application to ! ,secret>y at su* a "t1 9 su* a mann]1 & conta9+ su* in=mation z ! ,secret>y may reasonably require4 7#b7 ,consid]ations ,9 evaluat+ ! applications 9 p>agraph 7#a71 ! ,secret>y %all consid] ! exi/+ infra/ructure ( ! entity t w\ld all[ = ! timely capture ( biospecim5s & relat$ cl9ical & demographic in=mation = *ildr51 adolesc5ts1 & "y adults ) canc]4 7e7 ,privacy protections2 cons5t 7#a7 ,9 g5]al ,! ,secret>y may n make an aw>d "u subsection 7a7 to an entity unless ! ,secret>y ensures t su* entity-- 7,a7 collects biospecim5s & associat$ cl9ical & demographic in=mation f *ildr5 ) appropriate p]mission f p>5ts or legal gu>dians 9 accordance ) ,f$]al & ,/ate law2 & 7,b7 adh]es to /rict confid5tiality to protect ! id5tity & privacy ( pati5ts 9 accordance ) ,f$]al & ,/ate law4 7#b7 ,cons5t ,! ,secret>y %all e/abli% an appropriate process = a*iev+ cons5t f ! pati5t1 p>5t1 or legal gu>dian4 7f7 ,s+le po9t ( access2 /&>d data2 guidel9es & ov]sight 7#a7 ,s+le po9t ( access ,! ,secret>y %all ensure t a ,biorepository e/abli%$ "u subsection 7a7 has electronically se>*able data = use by rese>*]s & o!r qualifi$ heal? c>e pr(essionals 9 ! mann] & to ! ext5t def9$ by ! ,secret>y4 7#b7 ,/&>d data ,! ,secret>y %all require all recipi5ts ( an aw>d "u ?is section to make available a /&>d dataset = ! purposes ( p>agraph 7#a7 9 a /&>d electronic =mat t enables rese>*]s & qualifi$ heal? c>e pr(essionals to se>*4 7#c7 ,guidel9es & ov]sight ,! ,secret>y %all develop & dissem9ate appropriate guidel9es = ! developm5t & ma9t5ance ( ! biorepositories au?oriz$ "u ?is section1 includ+ appropriate ov]sight4 7g7 ,def9itions 7#a7 ,aw>d ,! t]m aw>d includes a grant1 contract1 coop]ative agreem5t1 or o!r me*anism det]m9$ by ! ,secret>y4 7#b7 ,biospecim5 ,! t]m biospecim5 includes-- 7,a7 solid tumor tissue or bone m>r[2 7,b7 normal or control tissue2 7,c7 blood_/plasma2 7,d7 ,,dna & ,,rna extractions2 7,e7 familial ,,dna2 & 7,f7 any o!r sample requir$ by ! ,secret>y4 7#c7 ,cl9ical & demographic in=mation ,! t]m cl9ical & demographic in=mation %all include-- 7,a7 date ( diagnosis2 7,b7 age at diagnosis2 7,c7 pati5t's g5d]1 race & e?nicity2 7,d7 ext5t ( disease at enrollm5t2 7,e7 site ( meta/ases2 7,f7 location ( prim>y tumor cod$2 7,g7 hi/ologic diagnosis2 7,h7 tumor m>k] data :5 available2 7,i7 treatm5t & outcome data2 7,j7 in=mation relat$ to specim5 quality2 & 7,k7 any o!r in=mation requir$ by ! ,secret>y4 7h7 ,coord9ation ,! ,secret>y %all ensure t cl9ical & demographic in=mation collect$ 9 accordance ) ?is section is collect$ 9 coord9ation ) ! in=mation collect$ "u section #cii;,e-#a4 7i7 ,prohibition on use ( funds ,funds made available "u ?is section %all n be us$ to acquire1 pres]ve1 or ma9ta9 a biospecim5 collect$ f a pati5t if su* activity is already cov]$ by funds available f ! ,national ,canc] ,in/itute = su* purpose4 7j7 ,report ,n lat] ?an #d ye>s aft] ! date ( enactm5t ( ! ,c>ol9e ,pryce ,walk] ,conqu] ,*ildhood ,canc] ,reau?orization ,act1 ! ,secret>y %all submit to ,congress a report on-- 7#a7 ! numb] ( biospecim5s & correspond+ cl9ical demographic data collect$ ?r\gh ! ,compreh5sive ,*ildr5's ,canc] ,biorepositories e/abli%$ "u subsection 7a72 7#b7 ! numb] ( biospecim5s & correspond+ cl9ical demographic data reque/$ = use by rese>*]s2 7#c7 any b>ri]s to ! collection ( biospecim5s & correspond+ cl9ical demographic data2 7#d7 any b>ri]s exp]i5c$ by rese>*]s or heal? c>e pr(essionals 9 access+ ! biospecim5s & correspond+ cl9ical demographic data necess>y = use 9 rese>*2 & 7#e7 any recomm5dations ) respect to improv+ ! ,compreh5sive ,*ildr5's ,canc] ,biorepository program "u ?is section4 2 & 7#c7 9 subsection 7l71 z s r$esignat$1 by /rik+ ! fir/ s5t5ce & ins]t+ ! foll[+3 ,= purposes ( c>ry+ out ?is section & section #cii;,e-#a1 !re are au?oriz$ to be appropriat$ su* sums z may be necess>y = ea* ( fiscal ye>s #bjad ?r\gh #bjah44 7b7 ,improv+ ,*ildhood ,canc] ,surveillance ,section #cii;,e-#a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;e-#c;a7 is am5d$-- 7#a7 by r$esignat+ subsection 7b7 z subsection 7d72 & 7#b7 by /rik+ subsection 7a7 & ins]t+ ! foll[+3 7a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all aw>d grants to ,/ate canc] regi/ries to enhance & exp& infra/ructure to track ! epidemiology ( canc] 9 *ildr51 adolesc5ts1 & "y adults4 ,su* regi/ries %all be updat$ to include ea* occurr5ce ( su* canc]s )9 a p]iod ( "t designat$ by ! ,secret>y4 7b7 ,activities ,! grants describ$ 9 subsection 7a7 may be us$ =-- 7#a7 id5tify+1 recruit+1 & tra9+ all pot5tial s\rces = report+ *ildhood1 adolesc5t1 & "y adult canc] cases2 7#b7 develop+ proc$ures to implem5t e>ly inclusion ( *ildhood1 adolesc5t1 & "y adult canc] cases on ,/ate canc] regi/ries ?r\gh ! use ( electronic report+2 7#c7 pur*as+ infra/ructure to support ! e>ly inclusion ( *ildhood1 adolesc5t1 & "y adult canc] cases on su* regi/ries2 7#d7 submitt+ deid5tifi$ data to ! ,c5t]s = ,disease ,control & ,prev5tion = inclusion 9 a national database ( *ildhood1 adolesc5t1 & "y adult canc]s2 & 7#e7 track+ ! late effects ( *ildhood1 adolesc5t1 & "y adult canc]s4 7c7 ,coord9ation ,! ,secret>y %all ensure t in=mation collect$ ?r\gh ,/ate canc] regi/ries "u ?is section is collect$ 9 coord9ation ) cl9ical & demographic in=mation collect$ "u section #dag;,e4 4 #d4 ,report to improve developm5t ( new drugs & biologic products to treat *ildhood canc]s 7a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all report to ,congress on b>ri]s to /udy+ oncologic !rapies 9 p$iatric populations "u section #eje;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c74 7b7 ,cont5t ,! report "u subsection 7a7 %all include-- 7#a7 an assessm5t ( ! feasibility ( requir+ /udies = a p$iatric oncologic indication "u section #eje;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7 if ! !rapeutic t>get ( a drug or biologic product = an adult oncologic indication is highly relevant to any p$iatric canc] to :i* x c\ld apply2 7#b7 recomm5dations to ov]come any b>ri]s id5tifi$ 9 ! report on h[ to improve rese>*1 developm5t & access to new oncologic !rapies = use 9 p$iatric pati5ts2 & 7#c7 an assessm5t ( ! pot5tial impact ( alt]+ ! exemption "u subsection 7k7 ( su* section #eje;,b4 7c7 ,/akehold] ,input ,! report "u subsection 7a7 %all be develop$ ) input f relevant /akehold]s4