,,ib ,union ,cal5d> ,no4 #gce #aai? ,,congress #b;d ,session ,h4 ,r4 #fiic ,report ,no4 #aai-hch ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,janu>y #i1 #bjbf,mr4 ,b]gman 7= himself1 ,ms4 ,elfre?1 ,ms4 ,k+-,h9ds1 ,mr4 ,davis ( ,nor? ,c>ol9a1 ,mr4 ,van ,ord51 & ,mr4 ,luttrell7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,vet]ans' ,affairs ,octob] #a1 #bjbf;,additional sponsors3 ,mr4 ,subramanyam1 ,mr4 ,la,lota1 ,ms4 ,sewell1 ,mr4 ,pflug]1 ,mr4 ,sor5s51 ,mr4 ,crank1 ,mr4 ,olszewski1 & ,mr4 ,van ,drew ,octob] #a1 #bjbf,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 ,janu>y #i1 #bjbf ,a ,,bill ,to direct ! ,secret>y ( ,vet]ans ,affairs to c>ry out programs to aw>d grants to eligible entities to conduct rese>* ) respect to treatm5ts = traumatic bra9 injury prospective r&omiz$ control trials = neurorehabilitation treatm5ts1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,vet]ans ,,tbi ,break?r\gh ,exploration ( ,adaptive ,c>e ,opportunities ,nationwide ,act ( #bjbf or ! ,,beacon ,act ( #bjbf4 #b4 ,dep>tm5t ( ,vet]ans ,affairs grant program = supplem5tal neurorehabilitation approa*es to *ronic mild ,,tbi treatm5t 7a7 ,grant program 7#a7 ,9 g5]al ,! ,secret>y ( ,vet]ans ,affairs %all c>ry out a ?ree-ye> program 7to be kn[n z ! ,,tbi ,innovation ,grant ,program7 "u :i* ! ,secret>y %all aw>d grants to eligible entities describ$ 9 subsection 7b7 = ! developm5t1 implem5tation1 & evaluation ( approa*es & me?odologies = prospective r&omiz$ control trials = neurorehabilitation treatm5ts = ! treatm5t ( *ronic mild traumatic bra9 injury 79 ?is ,act ref]r$ to z m,t,b,i7 9 vet]ans4 7#b7 ,relation%ip to o!r ,dep>tm5t activities ,! grant program requir$ "u p>agraph 7#a7 %all be c>ri$ out 9 a mann] t-- 7,a7 supplem5ts1 & does n supplant1 o!r cl9ical c>e & rese>* ( ! ,dep>tm5t ( ,vet]ans ,affairs relat+ to m,t,b,i2 & 7,b7 facilitates1 z practicable1 coord9ation ) ,vet]ans ,heal? ,adm9i/ration facilities = ref]ral1 cont9uity ( c>e1 & dissem9ation ( f9d+s4 7b7 ,eligible entities describ$ ,an eligible entity describ$ 9 ?is subsection is any ( ! foll[+3 7#a7 ,a nonpr(it organization ) demon/rat$ capability to conduct cl9ical trials & to deliv] or rese>* effective neurorehabilitation treatm5ts = m,t,b,i1 includ+ ?r\gh pati5t c>e deliv]y4 7#b7 ,an academic in/itution t conducts significant rese>* on m,t,b,i & has demon/rat$ capability to conduct cl9ical trials relat+ to neurorehabilitation treatm5ts4 7#c7 ,a non-,dep>tm5t heal? c>e provid] ) exp]tise 9 neurorehabilitative !rapies & demon/rat$ capability to conduct cl9ical trials & to evaluate m,t,b,i treatm5ts ?r\gh pati5t c>e deliv]y4 7#d7 ,a p>tn]%ip or consortium ( two or m entities describ$ 9 p>agraphs 7#a7 ?r\gh 7#c74 7c7 ,use ( funds ,an eligible entity 9 receipt ( a grant "u ?is section %all use su* grant to support activities t include-- 7#a7 design+ & te/+ novel or integrative treatm5ts = m,t,b,i t prioritize pati5t-c5t]$ c>e1 includ+ non-ph>macological !rapies2 7#b7 conduct+ cl9ical /udies & assessm5ts to measure ! effectiv5ess ( fund$ approa*es to-- 7,a7 improve m5tal heal? outcomes among vet]ans2 7,b7 r$uce suicidality1 & common risk factors = complet+ suicide1 includ+ depression & sub/ance use disord]s among vet]ans2 & 7,c7 mitigate long-t]m effects ( m,t,b,i &1 to ! ext5t outcomes are collect$ "u ! applicable cl9ical protocol1 measure durability ( outcomes at approximately six mon?s foll[+ completion ( treatm5t2 7#c7 provid+ tra9+ = cl9icians & outrea* to vet]ans & _! families to improve aw>5ess & accessibility ( innovative m,t,b,i treatm5ts1 includ+ in=mation on available ,dep>tm5t res\rces & pa?ways to access su* res\rces2 & 7#d7 e/abli%+ p>tn]%ips ) community organizations1 academic in/itutions1 & heal? c>e facilities1 includ+1 z practicable1 coord9ation ) ,vet]ans ,heal? ,adm9i/ration facilities to facilitate ref]ral ( eligible vet]ans1 cont9uity ( c>e1 & dissem9ation ( aggregate f9d+s4 7d7 ,limitation on grant am\nt ,! ,secret>y may n aw>d an eligible entity a grant "u ?is section 9 an am\nt t exce$s #e1jjj1jjj = any fiscal ye>4 7e7 ,program adm9i/ration 7#a7 ,applications ,an eligible entity desir+ a grant "u ?is section %all submit to ! ,secret>y an application 9 su* =m1 at su* "t1 & conta9+ su* in=mation & assurances z ! ,secret>y det]m9es appropriate1 includ+ a detail$ description (-- 7,a7 activities propos$ to be conduct$ us+ ! grant2 7,b7 expect$ outcomes ( su* activities2 7,c7 plans = evaluat+ ! effectiv5ess ( su* activities2 7,d7 h[ ! eligible entity w coord9ate1 z practicable1 ) ,vet]ans ,heal? ,adm9i/ration facilities = ref]ral & cont9uity ( c>e = vet]ans :o p>ticipate 9 activities c>ri$ out us+ grant funds1 & = dissem9ation ( aggregate f9d+s2 7,e7 ! budget ( ! entity = ! use ( ! grant1 includ+ a n>rative ju/ification & an id5tification ( ! e/imat$ am\nt ( grant funds to be us$ = adm9i/rative or ov]head co/s2 & 7,f7 assurances ( compliance ) applicable ,f$]al laws & regulations relat+ to human subjects protections & pati5t safety4 7#b7 ,priority ,9 aw>d+ grants "u ?is section1 ! ,secret>y %all give priority to eligible entities t h demon/rat$ ! capacity to coord9ate ) ! ,dep>tm5t to facilitate ref]ral & cont9uity ( c>e = vet]ans :o p>ticipate 9 activities c>ri$ out us+ grant funds4 7#c7 ,p]iodic reports ,z a condition ( receiv+ a grant "u ?is section1 an eligible entity %all1 n less frequ5tly ?an annually dur+ ! grant p]iod & n lat] ?an #ahj days aft] ! end ( ! grant p]iod1 submit to ! ,secret>y a report t includes1 ) respect to ! p]iod cov]$ by ! report-- 7,a7 a description ( h[ ! eligible entity us$ su* grant2 7,b7 a summ>y ( ! progress ( activities fund$ ) am\nts f su* grant2 7,c7 measur$ outcomes relat+ to su* activities2 7,d7 a detail$ acc\nt+ ( exp5ditures ( grant funds1 includ+ adm9i/rative or ov]head co/s2 7,e7 to ! ext5t collect$ "u ! applicable cl9ical protocol or 9 ! ord9>y c\rse ( c>e1 a description ( any adv]se ev5ts & s]i\s adv]se ev5ts1 includ+ self-h>m or suicide-relat$ ev5ts2 & 7,f7 a description ( actions tak5 pursuant to ! coord9ation plan describ$ 9 p>agraph 7#a77;,d74 7#d7 ,ov]sight2 annual evaluations ,! ,secret>y %all-- 7,a7 ensure rigor\s ov]sight ( ! grant program "u ?is section1 includ+ by monitor+ f9ancial compliance & timely receipt ( ! reports requir$ "u p>agraph 7#b72 & 7,b7 on an annual basis until ! t]m9ation date specifi$ 9 subsection 7i77#a71 evaluate ! efficacy ( activities c>ri$ out us+ grant funds bas$ on ! reports submitt$ "u p>agraph 7#b7 & o!r appropriate in=mation4 7#e7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to au?orize ! ,secret>y to require prior approval (1 or *anges to1 any cl9ical protocol1 /udy design1 outcome measures1 or foll[-up s*$ule ( an eligible entity t receives a grant "u ?is section1 except z necess>y to ensure compliance ) applicable ,f$]al laws & regulations relat+ to human subjects protections & pati5t safety4 7#f7 ,en=cem5t au?ority ,! ,secret>y may susp5d1 modify1 or t]m9ate a grant aw>d$ "u ?is section1 if ! ,secret>y det]m9es t ! recipi5t ( su* grant has fail$ to comply ) report+ requirem5ts "u p>agraph 7#b7 or o!r applicable t]ms & conditions ( ! grant4 7f7 ,available am\nts2 au?orization ( appropriations 7#a7 ,available am\nts ,! ,secret>y may c>ry out ! program "u ?is section us+ am\nts available to ! ,secret>y = g5]al m5tal heal? c>e programs1 if ! use ( su* am\nts supplem5ts1 & does n supplant1 am\nts o!rwise available = ,dep>tm5t m5tal heal? & traumatic bra9 injury programs4 7#b7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ to ! ,secret>y #aj1jjj1jjj = ea* ( fiscal ye>s #bjbf ?r\gh #bjbh to c>ry out ?is section4 7g7 ,duration2 annual review 7#a7 ,duration ,! au?ority ( ! ,secret>y to c>ry out ! grant program "u ?is section %all t]m9ate on ! date t is ?ree ye>s aft] ! date ( ! enactm5t ( ?is ,act1 except t ! ,secret>y may cont9ue to use am\nts made available to c>ry out ?is section aft] su* date solely = ! purpose ( adm9i/]+ activities & obligations incurr$ be=e su* t]m9ation date4 7#b7 ,annual review ,dur+ su* ?ree-ye> p]iod1 ! ,secret>y %all1 on an annual basis1 review ! effectiv5ess ( ! grant program to det]m9e ! pot5tial ( su* grant program = cont9uation or expansion4 #c4 ,dep>tm5t ( ,vet]ans ,affairs grant program = indep5d5t ?ird-p>ty rese>* /udies & treatm5t ) respect to supplem5tal neurorehabilitation treatm5ts = m,t,b,i 7a7 ,e/abli%m5t ,! ,secret>y ( ,vet]ans ,affairs %all e/abli% & c>ry out a rese>* grant program to aw>d grants to eligible entities describ$ 9 subsection 7b7 to be us$ to c>ry out /udies & appli$ programs on approa*es & me?odologies = ! treatm5t ( m,t,b,i 9 vet]ans4 7b7 ,eligible entities describ$ ,an eligible entity describ$ 9 ?is subsection is any ( ! foll[+3 7#a7 ,a nonpr(it organization t has demon/rat$ ! capability to conduct cl9ical trials & to evaluate traumatic bra9 injury treatm5ts ?r\gh pati5t c>e deliv]y4 7#b7 ,an academic in/itution t conducts significant rese>* on traumatic bra9 injury & has demon/rat$ ! capability to conduct cl9ical trials relat+ to neurorehabilitation treatm5ts 7#c7 ,a p>tn]%ip or consortium ( two or m entities describ$ 9 p>agraphs 7#a7 & 7#b74 7c7 ,applications ,an eligible entity desir+ a grant "u ?is section %all submit to ! ,secret>y an application 9 su* =m1 at su* "t1 & conta9+ su* in=mation & assurances z ! ,secret>y det]m9es appropriate1 includ+ a summ>y (-- 7#a7 ! rese>* & treatm5t activities propos$ to be c>ri$ out us+ grant funds2 7#b7 ! me?odology to be us$ = su* activities2 7#c7 ! expect$ outcomes ( su* activities2 7#d7 h[ ! eligible entity w coord9ate1 z practicable1 ) ,vet]ans ,heal? ,adm9i/ration facilities = ref]ral & cont9uity ( c>e = vet]ans :o p>ticipate 9 activities c>ri$ out us+ grant funds1 & = dissem9ation ( aggregate f9d+s2 7#e7 ! budget ( ! entity = ! use ( ! grant1 includ+ a n>rative ju/ification & an id5tification ( ! e/imat$ am\nt ( grant funds to be us$ = adm9i/rative or ov]head co/s2 & 7#f7 assurances ( compliance ) applicable ,f$]al laws & regulations relat+ to human subjects protections & pati5t safety4 7d7 ,adm9i/ration 7#a7 ,grant categories ,9 c>ry+ out ! grant program "u ?is section1 ea* fiscal ye> ! ,secret>y %all-- 7,a7 subject to ! requirem5t "u p>agraph 7#b71 aw>d f\r grants = exploratory or pilot rese>* & treatm5t projects1 ea* ( :i* %all be 9 an am\nt ( n m ?an #fbe1jjj2 & 7,b7 aw>d five grants = collaborative or multidiscipl9>y rese>* & treatm5t initiatives1 ea* ( :i* %all be 9 an am\nt ( n m ?an #a1ejj1jjj4 7#b7 ,priority ,( ! grants aw>d$ "u p>agraph 7#a77;,a71 ! ,secret>y %all aw>d n few] ?an ?ree to nonpr(it organizations4 7#c7 ,en=cem5t au?ority ,! ,secret>y may susp5d1 modify1 or t]m9ate a grant aw>d$ "u ?is section1 if ! ,secret>y det]m9es t ! recipi5t ( su* grant has fail$ to comply ) ! applicable t]ms & conditions ( ! grant4 7e7 ,agreem5t ) indep5d5t organization 7#a7 ,9 g5]al ,! ,secret>y %all seek to ent] into an agreem5t ) an indep5d5t organization t is n a compon5t ( ! ,dep>tm5t & t has demon/rat$ exp]tise 9 r&omiz$ controll$ trials1 neurorehabilitation outcomes evaluation1 & rese>* integrity1 "u :i* ! organization agrees to-- 7,a7 adm9i/] ! rese>* grant program "u ?is section2 7,b7 c>ry out /udies & implem5t ef=ts t include-- 7i7 analyz+ data f m,t,b,i treatm5t me?odologies develop$ pursuant to ! rese>* grant program to assess ! effect1 among vet]ans1 ( su* me?odologies on enhanc$ bra9 heal? outcomes1 m5tal heal?1 & long-t]m recov]y1 includ+1 to ! ext5t outcomes are collect$ "u ! applicable cl9ical protocol1 durability ( outcomes at approximately six mon?s foll[+ completion ( treatm5t2 7ii7 id5tify+ data-driv5 be/ practices & provid+ recomm5dations = fur!r rese>* or cl9ical application1 includ+ recomm5dations = dissem9ation to ,vet]ans ,heal? ,adm9i/ration cl9icians & facilities 7z appropriate72 & 7iii7 r&omiz$1 controll$ cl9ical trials to-- 7,i7 validate & deliv] treatm5ts2 7,,ii7 e/abli% a /&>d ( c>e2 & 7,,iii7 improve access to su* treatm5ts = vet]ans2 7,c7 submit to ! ,secret>y n less frequ5tly ?an annually a report describ+ activities c>ri$ out "u ?is section1 includ+ outcome data & me?odology2 & 7,d7 make available to ! ,secret>y all data & f9d+s f ! grants made "u ?is section1 consi/5t ) applicable ,f$]al law1 regulation1 & ,dep>tm5t policies relat+ to pati5t protections1 data security1 & privacy4 7#b7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to au?orize ! ,secret>y1 or an indep5d5t organization t ent]s into an agreem5t ) ! ,secret>y "u p>agraph 7#a71 to require prior approval (1 or *anges to1 any cl9ical protocol1 /udy design1 outcome measures1 or foll[-up s*$ule e/abli%$ by an eligible entity t receives a grant "u ?is section1 except z necess>y to ensure compliance ) applicable ,f$]al laws & regulations relat+ to human subjects protections & pati5t safety4 7#c7 ,report ,an agreem5t "u p>agraph 7#a7 %all include a requirem5t t ! indep5d5t organization submits to ,congress & ! ,secret>y a compreh5sive report t includes-- 7,a7 ! f9d+s ( ! /udies requir$ "u su* agreem5t2 7,b7 recomm5dations ) respect to ! expansion ( successful ,,tbi treatm5t me?odologies & /&>d ( c>e recomm5dations1 if any1 develop$ pursuant to ! rese>* grant program2 & 7,c7 to ! ext5t available f ! reports & /udy mat]ials ( grant recipi5ts1 a summ>y (-- 7i7 ! durability ( outcomes at approximately six mon?s foll[+ completion ( treatm5t1 if collect$ "u ! applicable cl9ical protocol2 7ii7 adv]se ev5ts & s]i\s adv]se ev5ts1 includ+ self-h>m or suicide-relat$ ev5ts1 if collect$ "u ! applicable cl9ical protocol or 9 ! ord9>y c\rse ( c>e2 & 7iii7 aggregate exp5ditures ( grant funds1 includ+ adm9i/rative or ov]head co/s4 7#d7 ,surveys ,! ,secret>y may conduct surveys ( any indep5d5t organization t ent]s into an agreem5t ) ! ,secret>y "u p>agraph 7#a7 9 ord] to assess ! effectiv5ess ( su* organization 9 adm9i/]+ ! rese>* grant program "u ?is section4 7f7 ,available am\nts2 au?orization ( appropriations 7#a7 ,available am\nts ,! ,secret>y may use am\nts available to ! ,secret>y = ! op]at+ budget ( ! ,national ,c5t] = ,po/traumatic ,/ress ,disord] to c>ry out ! rese>* grant program "u ?is section1 if ! use ( su* am\nts supplem5ts1 & does n supplant1 am\nts o!rwise available = ,dep>tm5t programs & s]vices4 7#b7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ to ! ,secret>y #aj1jjj1jjj = ea* ( fiscal ye>s #bjbf ?r\gh #bjbh to c>ry out ?is section4 7g7 ,t]m9ation date ,! au?ority ( ! ,secret>y to c>ry out ! rese>* grant program "u ?is section %all t]m9ate on ! date t is ?ree ye>s aft] ! date ( ! enactm5t ( ?is ,act4 #d4 ,reports to ,congress ,n lat] ?an two ye>s aft] ! date on :i* ! ,secret>y comm5ces ! rese>* grant program "u tsection #b1 & on an annual basis !reaft] until ! t]m9ation date specifi$ 9 subsection 7h7 ( su* section1 ! ,secret>y %all submit to ,congress a report on ! grant programs "u sections #b & #c4 ,ea* su* report %all include-- 7#a7 ! f9d+s ( ! /udies "u section #b7;f77#b72 7#b7 a description ( any agreem5t ent]$ into by ! ,secret>y "u section #c7;e77#a72 7#c7 recomm5dations ( ! ,secret>y ) respect to policy & programmatic improvem5ts to s]vices ( ! ,dep>tm5t to treat m,t,b,i among vet]ans2 7#d7 any f9d+s d]iv$ f surveys conduct$ "u section #c7;e77#d71 includ+ any recomm5dations ( ! ,secret>y = improvem5ts to ! /ructure1 ov]sight1 adm9i/ration1 or p]=mance ( ! indep5d5t organization t ent]s into an agreem5t ) ! ,secret>y "u section #c7;e77#a72 & 7#e7 su* o!r matt]s z ! ,secret>y det]m9es appropriate4 #e4 ,modification ( c]ta9 h\s+ loan fees ,! loan fee table 9 section #cgbi7;b77#b7 ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ ,june #i1 #bjcd ea* place x appe>s & ins]t+ ,july #ad1 #bjcd4 #f4 ,def9itions ,9 ?is ,act3 7#a7 ,! t]ms *ronic mild traumatic bra9 injury & m,t,b,i mean a mild traumatic bra9 injury ) symptoms t p]si/ = n few] ?an six mon?s aft] ! incit+ injury1 z det]m9$ us+ validat$ cl9ical crit]ia4 7#b7 ,! t]m nonpr(it organization-- 7,a7 means an organization describ$ 9 section #eja7;c77#c7 ( ! ,int]nal ,rev5ue ,code ( #aihf & exempt f taxation "u section #eja7;a7 ( su* ,code2 & 7,b7 includes su* an organization t is a hospital1 nonpr(it heal? sy/em1 academic m$ical c5t]1 or cl9ic t deliv]s neurorehabilitation c>e or conducts cl9ical rese>* relat+ to m,t,b,i4 7#c7 ,! t]m vet]an has ! mean+ giv5 su* t]m 9 section #aja ( title #ch1 ,unit$ ,/ates ,code4 ,octob] #a1 #bjbf,report$ ) an am5dm5t1 committ$ to ! ,committee ( ! ,:ole ,h\se on ! ,/ate ( ! ,union1 & ord]$ to be pr9t$