,,ib ,union ,cal5d> ,no4 #adh #aag? ,,congress #a/ ,session ,h4 ,r4 #cecg ,report ,no4 #aag-bjg ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,may #be1 #bjba,mr4 ,quigley 7= himself1 ,mr4 ,=t5b]ry1 ,mr4 ,br5dan ,f4 ,boyle ( ,p5nsylvania1 ,mr4 ,m\lton1 ,mr4 ,g>cia ( ,cali=nia1 ,mr4 ,c>bajal1 ,mr4 ,l>son ( ,connecticut1 ,ms4 ,jackson ,lee1 ,ms4 ,dean1 ,mr4 ,suozzi1 ,ms4 ,velzquez1 ,mr4 ,lev9 ( ,cali=nia1 ,mr4 ,deut*1 ,ms4 ,norton1 ,mr4 ,timmons1 ,mr4 ,brady1 ,mr4 ,mc,kinley1 ,mr4 ,van ,drew1 ,mr4 ,calv]t1 ,mr4 ,keat+1 ,mr4 ,diaz-,bal>t1 ,mr4 ,c>t] ( ,georgia1 ,mrs4 ,mc,bath1 ,mr4 ,smi? ( ,miss\ri1 ,mr4 ,turn]1 ,mr4 ,duncan1 ,mr4 ,hice ( ,georgia1 ,mr4 ,"y1 ,mr4 ,smi? ( ,nebraska1 ,mr4 ,gro?man1 ,mr4 ,rupp]sb]g]1 ,mr4 ,ru!r=d1 ,mr4 ,s*weik]t1 ,mr4 ,ryan1 ,mr4 ,cr[1 ,mr4 ,gu?rie1 ,mr4 ,fitzpatrick1 ,ms4 ,mc,collum1 ,mr4 ,au/9 ,scott ( ,georgia1 ,mr4 ,baird1 ,mr4 ,rodney ,davis ( ,ill9ois1 ,mr4 ,valadao1 ,mr4 ,mool5a>1 ,mr4 ,mal9[ski1 ,ms4 ,roybal-,all>d1 ,mr4 ,payne1 ,mr4 ,lyn*1 ,ms4 ,h]r]a ,beutl]1 ,mr4 ,buck1 ,mr4 ,mull91 ,mr4 ,grijalva1 ,mr4 ,coop]1 ,mr4 ,panetta1 ,mr4 ,kim ( ,new ,j]sey1 ,mr4 ,sires1 ,ms4 ,lee ( ,cali=nia1 ,ms4 ,moore ( ,wiscons91 ,ms4 ,s*ak[sky1 ,mr4 ,?ompson ( ,cali=nia1 ,mr4 ,gallego1 ,mrs4 ,axne1 ,mrs4 ,napolitano1 ,mr4 ,espaillat1 ,ms4 ,pressley1 ,mr4 ,fleis*mann1 ,mr4 ,res*5?al]1 ,mr4 ,cicill9e1 ,ms4 ,de,gette1 ,mr4 ,bur*ett1 ,mr4 ,la,malfa1 ,ms4 ,m5g1 ,ms4 ,br[nley1 ,mr4 ,trone1 ,ms4 ,ku/]1 ,mr4 ,connolly1 ,mr4 ,meeks1 ,mrs4 ,kirkpatrick1 ,mrs4 ,dem+s1 ,mr4 ,o',hall]an1 ,mr4 ,lieu1 ,mr4 ,de,saulnier1 ,mr4 ,g>am5di1 ,mr4 ,kilm]1 ,mr4 ,ru%1 ,mr4 ,mc,caul1 ,mr4 ,mc,clintock1 ,mr4 ,mfume1 ,mr4 ,lamb1 ,mr4 ,gre5 ( ,texas1 ,mr4 ,swalwell1 ,mr4 ,got!im]1 ,ms4 ,p+ree1 ,ms4 ,kaptur1 ,mr4 ,f]guson1 ,ms4 ,scanlon1 ,mr4 ,bacon1 ,mr4 ,wittman1 ,mr4 ,morelle1 ,mr4 ,amodei1 & ,mr4 ,waltz7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,decemb] #h1 #bjba;,additional sponsors3 ,ms4 ,sewell1 ,ms4 ,%]rill1 ,mr4 ,posey1 ,mr4 ,cole1 ,mr4 ,curtis1 ,mr4 ,c>son1 ,mr4 ,gonzalez ( ,ohio1 ,ms4 ,cl>k ( ,massa*usetts1 ,ms4 ,h\lahan1 ,ms4 ,newman1 ,mr4 ,smi? ( ,new ,j]sey1 ,mr4 ,la,hood1 ,mr4 ,co/a1 ,mr4 ,%]man1 ,mr4 ,*abot1 ,mr4 ,aguil>1 ,mrs4 ,beatty1 ,ms4 ,wass]man ,s*ultz1 ,ms4 ,davids ( ,kansas1 ,mr4 ,hill1 ,mrs4 ,c>olyn ,b4 ,maloney ( ,new ,york1 ,mr4 ,vic5te ,gonzalez ( ,texas1 ,ms4 ,wexton1 ,mr4 ,huffman1 ,mr4 ,tonko1 ,mrs4 ,luria1 ,mr4 ,bi%op ( ,georgia1 ,mr4 ,correa1 ,mr4 ,katko1 ,mr4 ,fo/]1 ,ms4 ,wild1 ,mr4 ,womack1 ,ms4 ,ross1 ,ms4 ,lois ,frankel ( ,florida1 ,mr4 ,kell]1 ,mr4 ,/ew>t1 ,mr4 ,brooks1 ,mr4 ,au*9closs1 ,mr4 ,wel*1 ,mr4 ,wilson ( ,s\? ,c>ol9a1 ,ms4 ,salaz>1 ,mrs4 ,trahan1 ,ms4 ,/efanik1 ,ms4 ,matsui1 ,mr4 ,c>twright1 ,mr4 ,y>mu?1 ,mr4 ,s*neid]1 ,mr4 ,delgado1 ,mr4 ,we/]man1 ,mr4 ,g>ca ( ,ill9ois1 ,ms4 ,mann+1 ,ms4 ,port]1 ,mr4 ,craw=d1 ,mr4 ,de,fazio1 ,mr4 ,langev91 ,miss ,rice ( ,new ,york1 ,mr4 ,gold51 ,mr4 ,sessions1 ,mr4 ,h>d] ( ,cali=nia1 ,mr4 ,l[5?al1 ,mr4 ,soto1 ,mr4 ,rask91 ,mr4 ,joyce ( ,ohio1 ,mr4 ,lamborn1 ,mr4 ,johnson ( ,georgia1 ,ms4 ,b>ragn1 ,mr4 ,dunn1 ,mr4 ,c\rtney1 ,mr4 ,c>t] ( ,l\isiana1 ,mr4 ,lucas1 ,mr4 ,emm]1 ,mr4 ,graves ( ,miss\ri1 ,ms4 ,om>1 ,mr4 ,pet]s1 ,ms4 ,craig1 ,mr4 ,danny ,k4 ,davis ( ,ill9ois1 ,mr4 ,b]a1 ,mr4 ,bilirakis1 ,ms4 ,/rickl&1 ,mr4 ,gibbs1 ,mr4 ,meus]1 ,mr4 ,higg9s ( ,new ,york1 ,mr4 ,gallagh]1 ,mr4 ,lawson ( ,florida1 ,mr4 ,ow5s1 ,mrs4 ,mill]-,meeks1 ,mr4 ,crd5as1 ,mr4 ,w5/rup1 ,ms4 ,jacobs ( ,cali=nia1 ,mr4 ,p]lmutt]1 ,mrs4 ,h>tzl]1 ,mr4 ,/aub]1 ,mr4 ,kri%namoor?i1 ,mr4 ,kildee1 ,ms4 ,slotk91 ,mr4 ,s>banes1 ,mr4 ,griffi?1 ,ms4 ,spanb]g]1 ,mr4 ,mc,govern1 ,mr4 ,khanna1 ,mr4 ,mann1 ,mr4 ,biggs1 ,mr4 ,sean ,patrick ,maloney ( ,new ,york1 ,mr4 ,?ompson ( ,p5nsylvania1 ,ms4 ,del,bene1 ,mr4 ,nadl]1 ,ms4 ,sn*ez1 ,mr4 ,mc,nerney1 ,mrs4 ,watson ,coleman1 ,mrs4 ,flet*]1 ,mr4 ,ma/1 ,mr4 ,/anton1 ,mr4 ,smi? ( ,wa%+ton1 ,mr4 ,web] ( ,texas1 ,ms4 ,kelly ( ,ill9ois1 ,mr4 ,jones1 ,mr4 ,neguse1 ,mr4 ,kahele1 ,mr4 ,himes1 ,mr4 ,huiz5ga1 ,mr4 ,higg9s ( ,l\isiana1 ,mr4 ,b]gman1 ,mr4 ,bald]son1 ,mr4 ,david ,scott ( ,georgia1 ,mr4 ,ad]holt1 ,mr4 ,arm/rong1 ,mr4 ,des,jarlais1 ,mr4 ,moore ( ,alabama1 ,mr4 ,s*iff1 ,mr4 ,?ompson ( ,mississippi1 ,mrs4 ,kim ( ,cali=nia1 ,mr4 ,fe5/ra1 ,ms4 ,adams1 ,mr4 ,kelly ( ,mississippi1 ,mr4 ,allr$1 ,mr4 ,coh51 ,mr4 ,br[n ( ,m>yl&1 ,mr4 ,johnson ( ,ohio1 ,mrs4 ,murphy ( ,florida1 ,mr4 ,luetkemey]1 ,ms4 ,williams ( ,georgia1 ,mr4 ,gos>1 ,mr4 ,tiffany1 ,mr4 ,ca/51 ,ms4 ,*5ey1 ,mrs4 ,hayes1 ,mr4 ,jeffries1 ,mr4 ,smuck]1 ,ms4 ,l(gr51 ,mr4 ,h]n1 ,ms4 ,t5ney1 ,ms4 ,bonamici1 ,mrs4 ,/eel1 ,mr4 ,g>b>9o1 ,mr4 ,norcross1 ,ms4 ,escob>1 ,mrs4 ,cammack1 ,mr4 ,gomez1 ,mr4 ,torres ( ,new ,york1 ,mr4 ,b[man1 ,ms4 ,tlaib1 ,ms4 ,bass1 ,ms4 ,wilson ( ,florida1 ,ms4 ,cl>ke ( ,new ,york1 ,mr4 ,lev9 ( ,mi*igan1 ,ms4 ,/ev5s1 ,ms4 ,leg] ,f]n&ez1 ,ms4 ,wat]s1 ,mr4 ,k9d1 ,mr4 ,cuell>1 ,mr4 ,phillips1 ,mr4 ,hag$orn1 ,mr4 ,palazzo1 ,ms4 ,blunt ,ro*e/]1 ,mr4 ,moore ( ,utah1 ,mr4 ,blum5au]1 ,ms4 ,grang]1 ,ms4 ,jayapal1 ,mr4 ,hors=d1 ,mr4 ,cl9e1 ,ms4 ,spei]1 ,mr4 ,c>l1 ,mr4 ,caw?orn1 ,mr4 ,murphy ( ,nor? ,c>ol9a1 ,mr4 ,ob]nolte1 ,mr4 ,kelly ( ,p5nsylvania1 ,mr4 ,scalise1 ,ms4 ,malliotakis1 ,mr4 ,evans1 ,mr4 ,zeld91 ,mr4 ,simpson1 ,mr4 ,/eube1 ,mr4 ,johnson ( ,l\isiana1 ,mr4 ,l\d]milk1 ,mrs4 ,h9son1 ,mr4 ,la,turner1 ,ms4 ,b\rdeaux1 ,ms4 ,johnson ( ,texas1 ,mr4 ,case1 ,mr4 ,jacobs ( ,new ,york1 ,mrs4 ,bice ( ,oklahoma1 ,mrs4 ,wagn]1 ,mr4 ,good5 ( ,texas1 ,mr4 ,h>ris1 ,mr4 ,jackson1 ,mr4 ,mooney1 ,mr4 ,burgess1 ,ms4 ,letl[1 ,mr4 ,upton1 ,ms4 ,s*ri]1 ,mr4 ,butt]field1 ,mr4 ,b5tz1 ,mrs4 ,fis*ba*1 ,mr4 ,graves ( ,l\isiana1 ,mr4 ,walb]g1 ,mr4 ,good ( ,virg9ia1 ,mrs4 ,torres ( ,cali=nia1 ,mr4 ,pappas1 ,mrs4 ,mc,clain1 ,mr4 ,gue/1 ,mr4 ,c4 ,scott ,frankl9 ( ,florida1 ,mr4 ,gohm]t1 ,mr4 ,r\z]1 ,mr4 ,bo/1 ,mr4 ,williams ( ,texas1 ,mr4 ,banks1 ,mrs4 ,lawr5ce1 ,mr4 ,cri/1 ,ms4 ,ca/or ( ,florida1 ,ms4 ,e%oo1 ,mr4 ,cr5%aw1 & ,mr4 ,ne:\se ,decemb] #h1 #bjba,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 #be1 #bjba ,a ,,bill ,to direct ! ,secret>y ( ,heal? & ,human ,s]vices to support rese>* on1 & exp&$ access to1 inve/igational drugs = amyotrophic lat]al scl]osis1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,accel]at+ ,access to ,critical ,!rapies = ,,als ,act4 #b4 ,grants = rese>* on !rapies = ,,als 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all aw>d grants to p>ticipat+ entities = purposes ( sci5tific rese>* utiliz+ data f exp&$ access to inve/igational drugs = individuals :o are n o!rwise eligible = cl9ical trials = ! prev5tion1 diagnosis1 mitigation1 treatm5t1 or cure ( amyotrophic lat]al scl]osis4 ,9 ! case ( a p>ticipat+ entity seek+ su* a grant1 an exp&$ access reque/ mu/ be submitt$1 & all[$ to proce$ by ! ,secret>y1 "u section #efa ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7 & "p #cab ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations71 be=e ! application = su* grant is submitt$4 7b7 ,application 7#a7 ,9 g5]al ,a p>ticipat+ entity seek+ a grant "u ?is section %all submit to ! ,secret>y an application at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y %all specify4 7#b7 ,use ( data ,an application submitt$ "u p>agraph 7#a7 %all include a description ( h[ data g5]at$ ?r\gh an exp&$ access reque/ "u section #efa ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7 ) respect to ! inve/igational drug involv$ w be us$ to support rese>* or developm5t relat$ to ! prev5tion1 diagnosis1 mitigation1 treatm5t1 or cure ( amyotrophic lat]al scl]osis4 7#c7 ,non9t]f]5ce ) cl9ical trials ,an application submitt$ "u p>agraph 7#a7 %all include a description ( h[ ! propos$ exp&$ access program w be design$ s z n to int]f]e ) pati5t enrollm5t 9 ongo+ cl9ical trials = inve/igational !rapies = ! prev5tion1 diagnosis1 mitigation1 treatm5t1 or cure ( amyotrophic lat]al scl]osis4 7c7 ,selection ,consi/5t ) sections #djf & #dib ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhd;a1 #bhi;a71 ! ,secret>y %all1 9 det]m9+ :e!r to aw>d a grant "u ?is section1 confirm t-- 7#a7 su* grant w be us$ to support a sci5tific rese>* objective relat+ to ! prev5tion1 diagnosis1 mitigation1 treatm5t1 or cure ( amyotrophic lat]al scl]osis 7z describ$ 9 subsection 7a772 7#b7 su* grant %all n h ! effect ( dim9i%+ eligibility =1 or imp$+ enrollm5t (1 ongo+ cl9ical trials = ! prev5tion1 diagnosis1 mitigation1 treatm5t1 or cure ( amyotrophic lat]al scl]osis by det]m9+ t individuals :o receive exp&$ access to inve/igational drugs ?r\gh su* a grant are n eligible = enrollm5t 9-- 7,a7 ongo+ cl9ical trials t are regi/]$ on ,clinical,trials4gov 7or successor website71 ) respect to a drug = ! prev5tion1 diagnosis1 mitigation1 treatm5t1 or cure ( amyotrophic lat]al scl]osis2 or 7,b7 cl9ical trials = ! prev5tion1 diagnosis1 mitigation1 treatm5t1 or cure ( amyotrophic lat]al scl]osis = :i* an exemption "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i77 has be5 grant$ by ! ,food & ,drug ,adm9i/ration & :i* are expect$ to beg9 enrollm5t )9 "o ye>2 & 7#c7 ! result+ project fund$ by su* grant w all[ = equitable access to inve/igational drugs by m9ority & und]s]v$ populations4 7d7 ,use ( funds ,a p>ticipat+ entity %all use funds receiv$ ?r\gh ! grant-- 7#a7 to pay ! manufactur] or sponsor = ! direct co/s ( ! inve/igational drug1 z au?oriz$ "u section #cab4h7;d7 ( title #ba1 ,code ( ,f$]al ,regulations 7or successor regulations71 to prev5t1 diagnose1 mitigate1 treat1 or cure amyotrophic lat]al scl]osis t is ! subject ( an exp&$ access reque/ describ$ 9 subsection 7a71 if su* co/s are ju/ifi$ z "p ( pe] review ( ! grant2 7#b7 = ! entity's direct co/s incurr$ 9 provid+ su* drug consi/5t ) ! rese>* mission ( ! grant2 or 7#c7 = ! direct & indirect co/s ( ! entity 9 conduct+ rese>* ) respect to su* drug4 7e7 ,def9itions ,9 ?is section3 7#a7 ,! t]m p>ticipat+ entity means a p>ticipat+ cl9ical trial site or sites sponsor$ by a small bus9ess conc]n 7z def9$ 9 section #c7;a7 ( ! ,small ,bus9ess ,act 7#ae ,u4,s4,c4 #fcb7;a777 t is ! sponsor ( a drug t is ! subject ( an inve/igational new drug application "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i77 to prev5t1 diagnose1 mitigate1 treat1 or cure amyotrophic lat]al scl]osis4 7#b7 ,! t]m p>ticipat+ cl9ical trial means a phase #c cl9ical trial conduct$ pursuant to an exemption "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i77 or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a77 to inve/igate a drug int5d$ to prev5t1 diagnose1 mitigate1 treat1 or cure amyotrophic lat]al scl]osis4 7#c7 ,! t]m p>ticipat+ cl9ical trial site means a heal? c>e facility1 or network ( facilities1 at :i* pati5ts p>ticipat+ 9 a p>ticipat+ cl9ical trial receive an inve/igational drug ?r\gh su* trial4 7f7 ,sunset ,! ,secret>y may n aw>d grants "u ?is section on or aft] ,septemb] #cj1 #bjbf4 #c4 ,,hhs public-private p>tn]%ip = r>e neurodeg5]ative diseases 7a7 ,e/abli%m5t ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all e/abli% & implem5t a ,public-,private ,p>tn]%ip = ,neurodeg5]ative ,diseases betwe5 ! ,national ,in/itutes ( ,heal?1 ! ,food & ,drug ,adm9i/ration1 & "o or m eligible entities 7to be kn[n & ref]r$ to 9 ?is section z ! ,p>tn]%ip7 ?r\gh coop]ative agreem5ts1 contracts1 or o!r appropriate me*anisms ) su* eligible entities1 = ! purpose ( advanc+ ! und]/&+ ( neurodeg5]ative diseases & fo/]+ ! developm5t ( treatm5ts = amytrophic lat]al scl]osis & o!r r>e neurodeg5]ative diseases4 ,! ,p>tn]%ip %all-- 7#a7 e/abli% p>tn]%ips & consortia ) o!r public & private entities & individuals ) exp]tise 9 amyotrophic lat]al scl]osis & o!r r>e neurodeg5]ative diseases = ! purposes describ$ 9 ?is subsection2 7#b7 focus on advanc+ regulatory sci5ce & sci5tific rese>* t w support & accel]ate ! developm5t & review ( drugs = pati5ts ) amyotrophic lat]al scl]osis & o!r r>e neurodeg5]ative diseases2 & 7#c7 fo/] ! developm5t ( effective drugs t improve ! lives ( p t suff] f amyotrophic lat]al scl]osis & o!r r>e neurodeg5]ative diseases4 7b7 ,eligible entity ,9 ?is section1 ! t]m eligible entity means an entity t-- 7#a7 is-- 7,a7 an in/itution ( high] education 7z su* t]m is def9$ 9 section #ajja ( ! ,high] ,education ,act ( #aife 7#bj ,u4,s4,c4 #ajja77 or a consortium ( su* in/itutions2 or 7,b7 an organization describ$ 9 section #eja7;c77#c7 ( ! ,int]nal ,rev5ue ,code ( #aihf & exempt f tax "u subsection 7a7 ( su* section2 7#b7 has exp]i5c$ p]sonnel ) cl9ical & o!r te*nical exp]tise 9 ! field ( biom$ical sci5ces & demon/rat$ connection to ! pati5t population2 7#c7 demon/rates to ! ,secret>y's satisfaction t ! entity is capable ( id5tify+ & e/abli%+ collaborations betwe5 public & private entities & individuals ) exp]tise 9 neurodeg5]ative diseases1 includ+ pati5ts1 9 ord] to facilitate-- 7,a7 developm5t & critical evaluation ( tools1 me?ods1 & processes-- 7i7 to *>act]ize neurodeg5]ative diseases & _! natural hi/ory2 7ii7 to id5tify molecul> t>gets = neurodeg5]ative diseases2 & 7iii7 to increase effici5cy1 pr$ictability1 & productivity ( cl9ical developm5t ( !rapies1 includ+ advancem5t ( rational !rapeutic developm5t & e/abli%m5t ( cl9ical trial networks2 & 7,b7 secur+ fund+ = ! ,p>tn]%ip f ,f$]al & non-,f$]al gov]nm5tal s\rces1 f\ndations1 & private individuals2 & 7#d7 provides an assurance t ! entity w n accept fund+ = a ,p>tn]%ip project f any organization t manufactures or di/ributes products regulat$ by ! ,food & ,drug ,adm9i/ration unless ! entity provides assurances 9 its agreem5t ) ! ,secret>y t ! results ( ! project w n be influ5c$ by any s\rce ( fund+4 7c7 ,gifts 7#a7 ,9 g5]al ,! ,p>tn]%ip may solicit & accept gifts1 grants1 & o!r donations1 e/abli% acc\nts1 & inve/ & exp5d funds 9 support ( basic rese>* & rese>* associat$ ) phase #c cl9ical trials conduct$ ) respect to inve/igational drugs t are ! subjects ( exp&$ access reque/s "u section #efa ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb74 7#b7 ,use ,9 addition to any am\nts appropriat$ = purposes ( c>ry+ out ?is section1 ! ,p>tn]%ip may use1 )\t fur!r appropriation1 any funds d]iv$ f a gift1 grant1 or o!r donation accept$ pursuant to p>agraph 7#a74 #d4 ,,als & o!r r>e neurodeg5]ative disease action plan 7a7 ,9 g5]al ,n lat] ?an #f mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,commission] ( ,food & ,drugs %all publi% on ! website ( ! ,food & ,drug ,adm9i/ration an action plan describ+ actions ! ,food & ,drug ,adm9i/ration int5ds to take dur+ ! #e-ye> p]iod foll[+ publication ( ! plan ) respect to program enhancem5ts1 policy developm5t1 regulatory sci5ce initiatives1 & o!r appropriate initiatives to-- 7#a7 fo/] ! developm5t ( safe & effective drugs t improve or ext5d1 or bo?1 ! lives ( p liv+ ) amyotrophic lat]al scl]osis & o!r r>e neurodeg5]ative diseases2 & 7#b7 facilitate access to inve/igational drugs = amyotrophic lat]al scl]osis & o!r r>e neurodeg5]ative diseases4 7b7 ,cont5ts ,! initial action plan publi%$ "u subsection 7a7 %all-- 7#a7 id5tify appropriate repres5tation f )9 ! ,food & ,drug ,adm9i/ration to be responsible = implem5tation ( su* action plan2 7#b7 include elem5ts to facilitate-- 7,a7 int]actions & collaboration betwe5 ! ,food & ,drug ,adm9i/ration1 includ+ ! review c5t]s !re(1 & /akehold]s includ+ pati5ts1 sponsors1 & ! ext]nal biom$ical rese>* community2 7,b7 consid]ation ( cross-cutt+ cl9ical & regulatory policy issues1 includ+ consi/5cy ( regulatory advice & decisionmak+2 7,c7 id5tification ( key regulatory sci5ce & policy issues critical to advanc+ developm5t ( safe & effective drugs2 & 7,d7 enhancem5t ( collaboration & engagem5t ( ! relevant c5t]s & (fices ( ! ,food & ,drug ,adm9i/ration ) o!r op]at+ divisions )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,p>tn]%ip1 & ! broad] neurodeg5]ative disease community2 & 7#c7 be subject to revision1 z det]m9$ appropriate by ! ,secret>y ( ,heal? & ,human ,s]vices4 #e4 ,,fda r>e neurodeg5]ative disease grant program ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all aw>d grants & contracts to public & private entities to cov] ! co/s ( rese>* on1 & developm5t ( int]v5tions int5d$ to prev5t1 diagnose1 mitigate1 treat1 or cure1 amyotrophic lat]al scl]osis & o!r r>e neurodeg5]ative diseases 9 adults & *ildr51 includ+ co/s incurr$ ) respect to ! developm5t & critical evaluation ( tools1 me?ods1 & processes-- 7#a7 to *>act]ize su* neurodeg5]ative diseases & _! natural hi/ory2 7#b7 to id5tify molecul> t>gets = su* neurodeg5]ative diseases2 & 7#c7 to increase effici5cy & productivity ( cl9ical developm5t ( !rapies1 includ+ ?r\gh-- 7,a7 ! use ( ma/] protocols & adaptive & add-on cl9ical trial designs2 & 7,b7 ef=ts to e/abli% new or lev]age exi/+ cl9ical trial networks4 #f4 ,,gao report ,n lat] ?an #d 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+-- 7#a7 ) respect to grants aw>d$ "u ! program e/abli%$ "u section #b-- 7,a7 an analysis ( :at is kn[n ab\t ! impact ( su* grants on rese>* or developm5t relat$ to ! prev5tion1 diagnosis1 mitigation1 treatm5t1 or cure ( amyotrophic lat]al scl]osis2 & 7,b7 data conc]n+ su* grants1 includ+-- 7i7 ! numb] ( grants aw>d$2 7ii7 ! p>ticipat+ entities to :om grants 7 aw>d$2 7iii7 ! value ( ea* su* grant2 7iv7 a description ( ! rese>* ea* su* grant 0 us$ to fur!r2 7v7 ! numb] ( pati5ts :o receiv$ exp&$ access to an inve/igational drug to prev5t1 diagnose1 mitigate1 treat1 or cure amyotrophic lat]al scl]osis "u ea* grant2 7vi7 :e!r ! inve/igational drug t 0 ! subject ( su* a grant 0 approv$ by ! ,food & ,drug ,adm9i/ration2 & 7vii7 ! av]age numb] ( days betwe5 :5 a grant application is submitt$ & :5 a grant is aw>d$2 & 7#b7 ) respect to grants aw>d$ "u ! program e/abli%$ "u section #e-- 7,a7 an analysis ( :at is kn[n ab\t ! impact ( su* grants on rese>* or developm5t relat$ to ! prev5tion1 diagnosis1 mitigation1 treatm5t1 or cure ( amyotrophic lat]al scl]osis2 7,b7 an analysis ( :at is kn[n ab\t h[ su* grants increas$ effici5cy & productivity ( ! cl9ical developm5t ( !rapies1 includ+ ?r\gh ! use ( cl9ical trials t op]at$ ) common ma/] protocols1 or _h adaptive or add-on cl9ical trial designs2 & 7,c7 data conc]n+ su* grants1 includ+-- 7i7 ! 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