,,ii #aah? ,,congress #b;d ,session ,s4 #dgci ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,july #bc1 #bjbd,mr4 ,blum5?al 7= himself1 ,mr4 ,re$1 ,mr4 ,b>rasso1 & ,mr4 ,r\nds7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to advance rese>* to a*ieve m$ical break?r\ghs 9 bra9 tumor treatm5t & improve aw>5ess & adequacy ( specializ$ canc] & bra9 tumor c>e4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,bol/]+ ,rese>* ,& ,innovation ,n[ ,act or ! ,,bra9 ,act4 7b7 ,table ( cont5ts ,! table ( cont5ts ( ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4,sec4 #b4 ,f9d+s2 purposes4,sec4 #c4 ,fo/]+ transp>5cy ( biospecim5 collections = bra9 canc] rese>*4,sec4 #d4 ,gliobla/oma ,!rapeutics ,network2 bra9 tumor ,,c>-,t team sci5ce aw>d4,sec4 #e4 ,cl9ical trials & biom>k] te/+ national public aw>5ess campaign4,sec4 #f4 ,pilot programs to develop1 /udy1 or evaluate approa*es to monitor+ & c>+ = bra9 tumor survivors4,sec4 #g4 ,,fda guidance to ensure bra9 tumor pati5t access to cl9ical trials4 #b4 ,f9d+s2 purposes 7a7 ,f9d+s ,congress f9ds z foll[s3 7#a7 ,accord+ to ! ,national ,bra9 ,tumor ,society bas$ on data analyz$ 9 #bjbd1 m ?an #a1jjj1jjj p 9 ! ,unit$ ,/ates are liv+ ) a bra9 tumor & approximately #id1jjj 7 e/imat$ to be diagnos$ ) a prim>y bra9 tumor 9 #bjbc4 7#b7 ,bra9 tumors d n discrim9ate & c affect p ( all races1 g5d]s1 & ages4 ,tragically1 p$iatric bra9 tumors are ! lead+ cause ( canc]-relat$ dea? among *ildr5 & "y adults ages #ai & y\ng]4 7#c7 ,= malignant bra9 tumors1 incid5ce & survival rates h rema9$ /agnant = #de ye>s1 ) an av]age #e-ye> relative survival rate ( #ce4g p]c5t & only #f4i p]c5t = gliobla/oma1 ! mo/ common prim>y malignant bra9 tumor4 7#d7 ,mo/ prim>y bra9 tumors are non-malignant1 b _m /ill require surg]y & radiation4 ,! results ( available treatm5t options c v>y f a successful return to normal life to possible disability or a life-?reat5+ condition4 7#e7 ,despite ! /ati/ics describ$ 9 p>agraphs 7#a7 ?r\gh 7#d71 !re h be5 v few treatm5ts ev] approv$ by ! ,food & ,drug ,adm9i/ration to treat bra9 tumors1 !reby result+ 9 little *ange 9 mortality rates = individuals ) bra9 tumors4 7#f7 ,z ( ! date ( enactm5t ( ?is ,act1 !re is no prev5tion & no e>ly detection protocol = bra9 tumors4 7#g7 ,all p 9 ! ,unit$ ,/ates h a /ake 9 r$uc+ & elim9at+ bra9 tumors4 7#h7 ,pati5ts liv+ ) a bra9 tumor & _! families want cures4 ,%ort ( cures1 !y want safe & effective ways to increase survival rates = su* pati5ts & improve ! quality ( life = su* pati5ts4 7b7 ,purposes ,! purposes ( ?is ,act are to-- 7#a7 /r5g!n rese>* & treatm5t developm5t reg>d+ bra9 tumors2 & 7#b7 improve ! adequacy & aw>5ess ( & access to specializ$ bra9 tumor heal? c>e4 #c4 ,fo/]+ transp>5cy ( biospecim5 collections = bra9 canc] rese>* ,"p ,a ( title ,,iv ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bha et seq47 is am5d$ by add+ at ! end ! foll[+3 #djd,p4 ,report+ ( bra9 tumor biospecim5 collections 7a7 ,def9ition ( cov]$ biospecim5 collection 7#a7 ,9 g5]al ,9 ?is section1 ! t]m cov]$ biospecim5 collection means a biospecim5 t 0 collect$ or acquir$ 9 :ole or 9 "p ?r\gh fund+ f ! ,national ,in/itutes ( ,heal?4 7#b7 ,biospecim5 ,= purposes ( p>agraph 7#a71 ! t]m biospecim5 means a bra9 tumor tissue1 c]ebral sp9al fluid1 or o!r specim5 type li/$ by ! ,specim5 ,res\rce ,locator ( ! ,national ,canc] ,in/itute 7or a successor database74 7b7 ,e/abli%m5t ,! ,secret>y1 act+ ?r\gh ! ,director ( ,,nih1 may e/abli% & ma9ta9 a se>*able website1 or multiple websites1 :i* may include websites exi/+ on ! day be=e ! date ( enactm5t ( ?is section1 = ! purpose ( mak+ accessible to ! public-- 7#a7 in=mation on ! exi/5ce & location ( cov]$ biospecim5 collections2 7#b7 a description ( su* collections2 & 7#c7 contact in=mation ) respect to su* collections4 7c7 ,report+ requirem5ts 7#a7 ,exi/+ collections ,any individual or entity t z ( ! date ( enactm5t ( ?is section ma9ta9s a cov]$ biospecim5 collection %all1 n lat] ?an #ahj days aft] su* date ( enactm5t1 submit a report to ! ,director ( ,,nih conta9+ in=mation ) respect to su* cov]$ biospecim5 collection z ! ,director ( ,,nih may specify1 includ+ at a m9imum ! in=mation ! ,national ,canc] ,in/itute requires = ! ,specim5 ,res\rce ,locator 7or a successor database74 7#b7 ,new collections ,any individual or entity t collects or acquires a cov]$ biospecim5 collection on or aft] ! date ( enactm5t ( ?is section %all1 n lat] ?an #fj days aft] ! date ( su* collection or acquisition1 submit a report to ! ,director ( ,,nih conta9+ ! in=mation requir$ "u p>agraph 7#a74 7d7 ,ov]sight ,! ,secret>y1 act+ ?r\gh ! ,director ( ,,nih1 %all e/abli% & c>ry out an ov]sight me*anism1 :i* %all include )hold+ fund+ to individuals or entities t h committ$ a repeat$ or egregi\s violation ( ! requirem5ts "u subsection 7c74 4 #d4 ,gliobla/oma ,!rapeutics ,network2 bra9 tumor ,,c>-,t team sci5ce aw>d 7a7 ,9 g5]al ,subp>t #a ( "p ,c ( title ,,iv ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhe et seq47 is am5d$ by add+ at ! end ! foll[+3 #dag;,h4 ,gliobla/oma ,!rapeutics ,network 7a7 ,9 g5]al ,! ,director ( ! ,in/itute %all c>ry out a rese>* program1 kn[n z ! ,gliobla/oma ,!rapeutics ,network1 by aw>d+1 on a competitive basis1 coop]ative agreem5ts1 or o!r aw>ds1 ?r\gh ! ,u#ai fund+ me*anism ( ! ,national ,in/itutes ( ,heal? = collaboration ( in/itutions to improve ! treatm5t ( gliobla/oma by evaluat+ !rapeutic ag5ts f pre-cl9ical developm5t /udies ?r\gh completion ( e>ly-phase cl9ical trials 9 humans4 7b7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ #ej1jjj1jjj = ea* ( fiscal ye>s #bjbf ?r\gh #bjcj1 to rema9 available until exp5d$1 to ! ,director ( ! ,in/itute to c>ry out ?is section4 #dag;,i4 ,bra9 tumor ,,c>-,t team sci5ce aw>d 7a7 ,9 g5]al ,9 ord] to take advantage ( significant advancem5t 9 ! developm5t ( *im]ic antig5 receptor-,t 7,,c>-,t7 cell !rapy approa*es 9 canc]1 includ+ _m su* approa*es previ\sly fund$ by ! ,national ,in/itutes ( ,heal?1 ! ,director ( ! ,in/itute %all make aw>ds1 on a competitive basis1 ?r\gh a ,u s]ies fund+ me*anism1 to support ! developm5t ( a multi-in/itutional team sci5ce approa* to us+ ,,c>-,t treatm5t = adult & p$iatric bra9 tumors4 7b7 ,use ( funds ,funds receiv$ ?r\gh an aw>d "u ?is section %all be us$-- 7#a7 to support collaborative multi-in/itutional rese>* activities1 includ+ pre-cl9ical & inve/igational new drug /udies2 & 7#b7 = ! purpose ( support+ cl9ical trials to evaluate ,,c>-,t !rapeutic approa*es to treat+ bra9 tumors4 7c7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ #aj1jjj1jjj = ea* ( fiscal ye>s #bjbf ?r\gh #bjcj1 to rema9 available until exp5d$1 to ! ,director ( ! ,in/itute to c>ry out ?is section4 4 7b7 ,transition = ! ,gliobla/oma ,!rapeutics ,network ,! ,director ( ! ,national ,canc] ,in/itute %all take su* /eps z may be necess>y = ! ord]ly transition f ! ,gliobla/oma ,!rapeutics ,network c>ri$ out by ! ,director1 z ( ! day be=e ! date ( enactm5t ( ?is ,act1 to ! rese>* program au?oriz$ "u section #dag;,h ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7a74 ,9 mak+ su* transition1 ! ,director %all ensure t ! program au?oriz$ "u su* section #dag;,h is bas$ ^u & consi/5t ) ! policies & proc$ures ( ! ,gliobla/oma ,!rapeutics ,network c>ri$ out by ! ,director z ( ! day be=e ! date ( enactm5t ( ?is ,act4 #e4 ,cl9ical trials & biom>k] te/+ national public aw>5ess campaign ,"p ,p ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is am5d$ by add+ at ! end ! foll[+3 #cii,v-#h4 ,cl9ical trials & biom>k] te/+ national public aw>5ess campaign 7a7 ,national campaign 7#a7 ,9 g5]al ,! ,secret>y %all c>ry out a national campaign to increase ! aw>5ess & k ( heal? c>e provid]s & individuals ) respect to ! importance ( cl9ical trials 9 ! treatm5t ( canc]4 7#b7 ,activities 7,a7 ,9 g5]al ,activities "u su* national campaign %all include ea* ( ! foll[+3 7i7 ,writt5 mat]ials ,ma9ta9+ a supply ( writt5 & digital mat]ials t provide in=mation to ! public on cl9ical trials1 & di/ribut+ su* mat]ials to memb]s ( ! public ^u reque/4 7ii7 ,public s]vice ann\ncem5ts2 public engagem5t ,provid+ public s]vice ann\ncem5ts1 9 accordance ) applicable law1 includ+ ?r\gh publi%+ mat]ials 9 digital or pr9t =m1 & c>ry+ out o!r public engagem5t initiatives4 ,su* public s]vice ann\ncem5ts & o!r public engagem5t initiatives %all include su* ann\ncem5ts & initiatives int5d$ to enc\rage individuals to discuss ) _! physicians-- 7,i7 :at cl9ical trials are2 7,,ii7 ! importance ( cl9ical trials 9 ! treatm5t ( canc]2 7,,iii7 h[ to enroll 9 cl9ical trials2 7,,iv7 :at biom>k] te/+ is2 7,v7 ! importance ( biom>k] te/+ 9 ! treatm5t ( canc]2 & 7,,vi7 h[ to access biom>k] te/+4 7,b7 ,t>get$ populations ,! ,secret>y %all ensure t ! national campaign includes communications1 includ+ public s]vice ann\ncem5ts & o!r public engagem5t initiatives "u subp>agraph 7,a77ii71 t are-- 7i7 culturally & l+ui/ically compet5t2 & 7ii7 t>get$ to-- 7,i7 specific populations t are at a high] risk ( canc]1 includ+ su* populations bas$ on factors includ+ race1 e?nicity1 level ( acculturation1 & family hi/ory2 7,,ii7 rural communities2 & 7,,iii7 su* o!r communities z ! ,secret>y det]m9es appropriate4 7#c7 ,consultation ,9 c>ry+ out ! national campaign "u ?is subsection1 ! ,secret>y %all consult )-- 7,a7 heal? c>e provid]s2 7,b7 nonpr(it organizations2 7,c7 ,/ate & local public heal? dep>tm5ts2 & 7,d7 elem5t>y & second>y s*ools & in/itutions ( high] education4 7b7 ,demon/ration projects reg>d+ outrea* & education /rategies = canc] & bra9 tumor pati5ts 7#a7 ,9 g5]al ,! ,secret>y %all c>ry out a program to aw>d grants or contracts to public or nonpr(it private entities = ! purpose ( c>ry+ out demon/ration projects to te/1 comp>e1 & evaluate diff]5t evid5ce-bas$ outrea* & education /rategies to increase ! aw>5ess & k ( canc]1 includ+ bra9 tumor biom>k] te/+ & bra9 tumor cl9ical trials4 ,su* projects %all focus on ! aw>5ess & k ( pati5ts 7& ! families ( pati5ts71 physicians1 nurses1 & o!r key heal? pr(essionals involv$ 9 bra9 tumor treatm5t4 7#b7 ,aw>ds ,9 mak+ aw>ds "u p>agraph 7#a71 ! ,secret>y %all-- 7,a7 ensure t in=mation provid$ ?r\gh demon/ration projects support$ by su* an aw>d is consi/5t ) ! be/ available m$ical in=mation2 & 7,b7 give pref]5ce to-- 7i7 applicants ) demon/rat$ exp]tise 9-- 7,i7 biom>k] te/+ & cl9ical trials 9 bra9 tumors & o!r recalcitrant canc]s2 7,,ii7 bra9 canc] & o!r recalcitrant canc] education or treatm5t2 7,,iii7 work+ ) gr\ps ( pati5ts & c>egiv]s2 & 7,,iv7 rea*+ geographic areas t h hi/orically l[ rates ( p>ticipation 9 canc] cl9ical trials2 & 7ii7 applicants t demon/rate 9 _! application submitt$ "u p>agraph 7#c7 t ! project = :i* !y are seek+ a grant or contract w involve & connect physicians1 nurses1 o!r key heal? pr(essionals1 heal? pr(ession /ud5ts1 hospitals1 & pay]s4 7#c7 ,applications ,to seek a grant or contract "u ?is subsection1 an entity %all submit an application to ! ,secret>y 9 su* =m1 9 su* mann]1 & conta9+ su* agreem5ts1 assurances1 & in=mation z ! ,secret>y may reasonably require4 7c7 ,au?orization ( appropriations ,= ! purpose ( c>ry+ out ?is section1 !re is au?oriz$ to be appropriat$ #aj1jjj1jjj = ! p]iod ( fiscal ye>s #bjbf ?r\gh #bjcj4 4 #f4 ,pilot programs to develop1 /udy1 or evaluate approa*es to monitor+ & c>+ = bra9 tumor survivors ,"p ,b ( title ,,iv ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhd et seq47 is am5d$ by add+ at ! end ! foll[+3 #dji,k4 ,pilot programs to develop1 /udy1 or evaluate approa*es to monitor+ & c>+ = bra9 tumor survivors 7a7 ,9 g5]al ,! ,director ( ,,nih may1 z appropriate1 make aw>ds to eligible entities to e/abli% pilot programs to develop1 /udy1 or evaluate approa*es1 includ+ prim>y c>e1 = monitor+ & c>+ = adult & p$iatric bra9 tumor survivors ?r\gh\t _! lifespan1 includ+ evaluat+ models = transition to po/-treatm5t c>e & c>e coord9ation4 7b7 ,aw>ds 7#a7 ,eligible entities 7,a7 ,9 g5]al ,= purposes ( ?is section1 an eligible entity is-- 7i7 a m$ical s*ool2 7ii7 a *ildr5's hospital2 7iii7 a canc] c5t]2 7iv7 a community-bas$ m$ical facility2 or 7v7 any o!r entity ) significant exp]i5ce & exp]tise 9 c>ry+ out ! activities describ$ 9 subsection 7a74 7,b7 ,types ( entities ,aw>ds "u ?is section %all be made1 to ! ext5t practical1 to-- 7i7 small1 m$ium1 & l>ge-siz$ eligible entities2 & 7ii7 sites locat$ 9 diff]5t geographic areas1 includ+ rural & urban areas4 7#b7 ,pe] review ,9 mak+ aw>ds "u ?is section1 ! ,director ( ,,nih %all comply ) ! pe] review requirem5ts 9 section #dib4 7#c7 ,use ( funds ,funds f aw>ds "u ?is section may be us$ to develop1 /udy1 or evaluate "o or m models = monitor+ & c>+ = bra9 tumor survivors1 :i* may include-- 7,a7 evaluat+ foll[-up c>e1 educational accommodations1 monitor+1 & o!r survivor%ip programs 7includ+ pe] support & m5tor+ programs72 7,b7 develop+ & evaluat+ models = provid+ multidiscipl9>y c>e2 7,c7 dissem9at+ in=mation to heal? c>e provid]s ab\t culturally & l+ui/ically appropriate foll[-up c>e = bra9 tumor survivors & _! families1 z appropriate & practicable2 7,d7 develop+ & evaluat+ exi/+ psy*osocial evaluations1 c\nsel+1 & support programs to improve ! quality ( life ( bra9 tumor survivors & _! families1 :i* may include pe] support & m5tor+ programs2 7,e7 design+ & evaluat+ tools to support ! secure electronic transf] ( treatm5t in=mation & c>e summ>ies f bra9 tumor c>e provid]s to o!r heal? c>e provid]s 7includ+ prim>y c>e provid]s71 :i* in=mation & c>e summ>ies %all include risk factors & a plan = recomm5d$ foll[-up c>e2 7,f7 develop+ & evaluat+ initiatives t promote ! coord9ation & effective transition ( c>e betwe5 bra9 tumor c>e provid]s1 prim>y c>e provid]s1 m5tal heal? pr(essionals1 & o!r heal? c>e pr(essionals1 z appropriate1 includ+ models t use a team-bas$ or multi-discipl9>y approa* to c>e2 & 7,g7 dissem9at+ in=mation describ$ 9 subp>agraphs 7,a7 ?r\gh 7,f71 includ+ ) respect to models1 evaluations1 programs1 sy/ems1 & initiatives describ$ 9 su* subp>agraphs1 to o!r heal? c>e provid]s 7includ+ prim>y c>e provid]s7 & to p$iatric bra9 tumor survivors & _! families1 :]e appropriate & 9 accordance ) ,f$]al & ,/ate law4 7c7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ to c>ry out ?is section #e1jjj1jjj = ea* ( fiscal ye>s #bjbf ?r\gh #bjcj4 4 #g4 ,,fda guidance to ensure bra9 tumor pati5t access to cl9ical trials ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all issue guidance to help id5tify ways to m9imize ! pot5tial = ! exclusion ( bra9 tumor pati5ts & pati5ts ) r>e & recalcitrant canc]s f cl9ical trials evaluat+ treatm5ts = o!r indications4