,,ib ,union ,cal5d> ,no4 #fcg #aai? ,,congress #b;d ,session ,h4 ,r4 #hbje ,report ,no4 #aai-gcc ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,april #f1 #bjbf,mr4 ,quigley 7= himself & ,mr4 ,calv]t7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,july #i1 #bjbf;,additional sponsors3 ,mr4 ,fitzpatrick1 ,ms4 ,s*ak[sky1 ,mr4 ,mc,caul1 ,mr4 ,au*9closs1 ,mr4 ,des,jarlais1 ,ms4 ,craig1 ,mr4 ,valadao1 ,mr4 ,cr[1 ,mr4 ,?ompson ( ,p5nsylvania1 ,ms4 ,moore ( ,wiscons91 ,mr4 ,hurd ( ,colorado1 ,mr4 ,s*neid]1 ,mr4 ,joyce ( ,ohio1 ,mr4 ,veasey1 ,ms4 ,salaz>1 ,ms4 ,bonamici1 ,mr4 ,bilirakis1 ,mr4 ,%]man1 ,mr4 ,g>b>9o1 ,mr4 ,lyn*1 ,mr4 ,bacon1 ,mr4 ,coh51 ,mr4 ,sessions1 ,mr4 ,smi? ( ,wa%+ton1 ,mr4 ,ob]nolte1 ,ms4 ,dean ( ,p5nsylvania1 ,mr4 ,cole1 ,mrs4 ,f\%ee1 ,mr4 ,ru!r=d1 ,ms4 ,sewell1 ,mr4 ,wilson ( ,s\? ,c>ol9a1 ,mr4 ,davis ( ,ill9ois1 ,mr4 ,ad]holt1 ,mr4 ,torres ( ,new ,york1 ,mr4 ,mann1 ,ms4 ,norton1 ,mr4 ,van ,drew1 ,mr4 ,kri%namoor?i1 ,mr4 ,al=d1 ,ms4 ,und]wood1 ,mr4 ,la,lota1 ,ms4 ,s*ri]1 ,mrs4 ,kim1 ,ms4 ,matsui1 ,mr4 ,edw>ds1 ,mrs4 ,d+ell1 ,mr4 ,walb]g1 ,ms4 ,tlaib1 ,mr4 ,web] ( ,texas1 ,mr4 ,?ompson ( ,cali=nia1 ,mr4 ,bo/1 ,mr4 ,tonko1 ,mrs4 ,bice1 ,ms4 ,del,bene1 ,mr4 ,diaz-,bal>t1 ,mr4 ,correa1 ,mr4 ,la,hood1 ,mr4 ,k5n$y ( ,new ,york1 ,mr4 ,womack1 ,mr4 ,:itesides1 ,mr4 ,r\z]1 ,mr4 ,bi%op1 ,ms4 ,letl[1 ,ms4 ,kelly ( ,ill9ois1 ,mr4 ,amodei ( ,nevada1 ,mr4 ,got!im]1 ,mr4 ,moore ( ,nor? ,c>ol9a1 ,mr4 ,cleav]1 ,mr4 ,c>t] ( ,texas1 ,mr4 ,/anton1 ,mr4 ,wittman1 ,mr4 ,v9dman1 ,mr4 ,gue/1 ,ms4 ,bynum1 ,mrs4 ,mill] ( ,we/ ,virg9ia1 ,mrs4 ,hayes1 ,mr4 ,latim]1 ,mr4 ,davis ( ,nor? ,c>ol9a1 ,ms4 ,mc,bride1 ,mr4 ,riley ( ,new ,york1 ,mr4 ,conaway1 ,ms4 ,/ansbury1 ,ms4 ,ross1 ,ms4 ,p+ree1 ,mr4 ,himes1 ,mrs4 ,watson ,coleman1 ,mr4 ,ca/51 ,mr4 ,l&sman1 ,mrs4 ,grijalva1 ,ms4 ,mejia1 ,mr4 ,l>son ( ,connecticut1 ,mr4 ,sor5s51 ,mr4 ,pet]s1 ,mr4 ,jackson ( ,ill9ois1 ,ms4 ,adams1 ,ms4 ,budz9ski1 ,mrs4 ,beatty1 ,mr4 ,magaz9]1 ,ms4 ,kaptur1 ,mr4 ,c>t] ( ,l\isiana1 ,mr4 ,suozzi1 & ,ms4 ,scanlon ,july #i1 #bjbf,report$ ) 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 ,april #f1 #bjbf ,a ,,bill ,to am5d ! ,accel]at+ ,access to ,critical ,!rapies = ,,als ,act to reau?orize ! provisions ( su* ,act ?r\gh fiscal ye> #bjca1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,accel]at+ ,access to ,critical ,!rapies = ,,als ,reau?orization ,act ( #bjbf4 #b4 ,reau?orization ( ,accel]at+ ,access to ,critical ,!rapies = ,,als ,act 7a7 ,9 g5]al ,section #g ( ! ,accel]at+ ,access to ,critical ,!rapies = ,,als ,act 7,public ,law #aag-gi7 is am5d$ by /rik+ #bjbf & ins]t+ #bjca4 7b7 ,grants = ,,als rese>* ,section #b7;f7 ( ! ,accel]at+ ,access to ,critical ,!rapies = ,,als ,act 7#ba ,u4,s4,c4 #cfj;ee note7 is am5d$ by /rik+ #bjbf & ins]t+ #bjca4 #c4 ,improvem5ts to program = grants = rese>* on !rapies = ,,als 7a7 ,r5ewal ( grants = rese>* on !rapies = ,,als review ,section #b7;b7 ( ! ,accel]at+ ,access to ,critical ,!rapies = ,,als ,act 7#ba ,u4,s4,c4 #cfj;ee note7 is am5d$ by add+ at ! end ! foll[+3 7#d7 ,r5ewal ( grants = rese>* on !rapies = ,,als review ,9 review+ applications = r5ewals ( a grant aw>d$ "u ?is section ) respect to an inve/igational drug1 ! ,secret>y %all reque/ f ! manufactur] or sponsor1 & assess1 ! enrollm5t1 safety1 & any available efficacy data relat+ to ! inve/igational drug 9 ! prev5tion1 diagnosis1 mitigation1 treatm5t1 or cure ( amyotrophic lat]al scl]osis4 4 7b7 ,report+ safety data ,section #b7;c7 ( ! ,accel]at+ ,access to ,critical ,!rapies = ,,als ,act 7#ba ,u4,s4,c4 #cfj;ee note7 is am5d$-- 7#a7 9 p>agraph 7#b77;,b71 by /rik+ & at ! end2 7#b7 9 p>agraph 7#c71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7#d7 ! entity seek+ su* grant w promptly report any new & s]i\s adv]se ev5ts & safety in=mation t is consid]$ to be unexpect$ ) respect to ! phase #c trial to ! grant-mak+ in/itution1 9 addition to comply+ ) ! safety report+ requirem5ts "u section #cab4cb ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations74 4 7c7 ,cl>ify+ p>ticipat+ cl9ical trial def9ition ,section #b7;e7 ( ! ,accel]at+ ,access to ,critical ,!rapies = ,,als ,act 7#ba ,u4,s4,c4 #cfj;ee note7 is am5d$ by add+ at ! end ! foll[+3 7#d7 ,! t]m phase #c1 ) respect to a cl9ical trial1 includes a phase #b_/c comb9$ trial t beg9s enrollm5t )9 a timeframe1 det]m9$ by ! ,secret>y ?r\gh ! t]ms & conditions ( ! grant aw>d$ "u ?is section4 4 #d4 ,,fda r>e neurodeg5]ative disease action plan ,section #d ( ! ,accel]at+ ,access to ,critical ,!rapies = ,,als ,act 7#ba ,u4,s4,c4 #cfj;aa note7 is am5d$-- 7#a7 9 ! section head+1 by /rik+ ,,als & o!r r>e neurodeg5]ative disease action plan & ins]t+ ,,fda r>e neurodeg5]ative disease action plan2 & 7#b7 by add+ at ! end ! foll[+3 7c7 ,,fda r>e neurodeg5]ative disease action plan 7#a7 ,9 g5]al ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ! ,accel]at+ ,access to ,critical ,!rapies = ,,als ,reau?orization ,act ( #bjbf1 ! ,commission] ( ,food & ,drugs %all publi% on ! website ( ! ,food & ,drug ,adm9i/ration an action plan t includes a description ( ! actions t ! ,food & ,drug ,adm9i/ration int5ds to take dur+ ! #e-ye> p]iod foll[+ publication ( ! action plan ) respect to ! program enhancem5ts1 policy developm5t1 regulatory sci5ce initiatives1 & o!r appropriate initiatives describ$ 9 subsection 7a74 7#b7 ,report ,n lat] ?an #e ye>s aft] ! date ( enactm5t ( ! ,accel]at+ ,access to ,critical ,!rapies = ,,als ,reau?orization ,act ( #bjbf1 ! ,commission] ( ,food & ,drugs %all publi% on ! website ( ! ,food & ,drug ,adm9i/ration a report t describes ! actions tak5 by ! ,food & ,drug ,adm9i/ration "u ! action plan publi%$ "u p>agraph 7#a7 & ! ext5t to :i* su* action plan meets ! requirem5ts specifi$ 9 p>agraph 7#a74 4 ,july #i1 #bjbf,report$ ) an am5dm5t1 committ$ to ! ,committee ( ! ,:ole ,h\se on ! ,/ate ( ! ,union1 & ord]$ to be pr9t$