,,ii ,cal5d> ,no4 #dfa #aai? ,,congress 
#b;d ,session  ,s4 #ddgb  ,,9 ,,!       
,,s5ate ,,( ,,! ,,unit$ ,,/ates  ,april 
#cj1 #bjbf,ms4 ,murk[ski 7= h]self1 ,mr4
 ,coons1 ,ms4 ,coll9s1 ,ms4 ,klobu*>1   
,mr4 ,padilla1 ,mrs4 ,capito1 ,mr4      
,curtis1 ,mrs4 ,gillibr&1 ,ms4 ,hassan1 
,mr4 ,banks1 ,mr4 ,m>key1 & ,mr4 ,da9es7
 introduc$ ! foll[+ bill2 :i* 0 read    
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,july #af1 #bjbf,report$ by ,mr4        
,cassidy1 ) an amendment,strike out all 
aft] ! enact+ clause & ins]t ! "p pr9t$ 
9 italic  ,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 
,cl9ical trial /atus 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 ,cl9ical trial
 /atus review  7,a7 ,9 g5]al ,9 review+ 
applications = r5ewals ( a grant aw>d$  
"u ?is section ) respect to an          
inve/igational drug1 ! ,secret>y %all   
assess ! /atus ( a cl9ical trial c>ri$  
out = su* drug ) respect to data on     
enrollm5t ( pati5ts 9 su* cl9ical trial4
  7,b7 ,int]im cl9ical trial data ,to   
enable ! ,secret>y to make ! assessm5t  
"u subp>agraph 7,a7 ) respect to an     
inve/igational drug1 ! ,secret>y %all   

reque/ t ! manufactur] ( !              
inve/igational drug %>e int]im cl9ical  
trial data ) respect to su* drug ) !    
,secret>y4  4  7b7 ,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 & a plann$     
phase #c cl9ical trial t is n yet       
enroll+ p>ticipants4  4  #d4 ,report on 
,,als & o!r r>e neurodeg5]ative disease 
action plans ,section #d ( ! ,accel]at+ 
,access to ,critical ,!rapies = ,,als   
,act 7#ba ,u4,s4,c4 #cfj;aa note7 is    
am5d$ by add+ at ! end ! foll[+3  7c7   
,report on ,,als & o!r r>e              
neurodeg5]ative disease action plans ,n 
lat] ?an "o ye> 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 conta9s--
 7#a7 an updat$ action plan1 includ+--  
7,a7 a description ( ! 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 describ$ 9 subsection 7a72  
7,b7 a description ( ! res\rces necess>y
 to implem5t ea* section ( ! plan )9 su*
 #e-ye> p]iod2 &  7,c7 specific         
approa*es ! ,commission] w take to      
improve coord9ation ( implem5tation ( ! 
plan ) r>e neurodeg5]ative disease      
communities t are n specifically ,,als  
communities2 &  7#b7 ) respect to !     
,action ,plan = ,r>e ,neurodeg5]ative   
,diseases includ+ ,amyotrophic ,lat]al  
,scl]osis 7,,als7 publi%$ by ! ,food &  
,drug ,adm9i/ration on ,june #bc1 #bjbb 
7ref]r$ to 9 ?is section z ! #bjbb      
,action ,plan71 a description (-- 7,a7 !
 actions tak5 by ! ,food & ,drug        
,adm9i/ration "u ! #bjbb ,action ,plan2 

7,b7 ! effect ( ! implem5tation ( !     
#bjbb ,action ,plan on ! developm5t (   
!rapies & regulatory consid]ation (     
!rapies = ,,als & o!r r>e               
neurodeg5]ative diseases2  7,c7 any     
programs & initiatives t e/abli%$ or    
c>ri$ out z "p ( ! implem5tation ( !    
#bjbb ,action ,plan2 &  7,d7 ! ext5t to 
:i* ! #bjbb ,action ,plan 0 implem5t$ ) 
respect to r>e neurodeg5]ative diseases 
t are n amyotrophic lat]al scl]osis4  4 
#e4 ,,gao report ,section #f ( !        
,accel]at+ ,access to ,critical ,!rapies
 = ,,als ,act 7,public ,law #aag-gi7 is 
am5d$1 9 ! matt] prec$+ p>agraph 7#a7-- 
7#a7 by /rik+ #d ye>s aft] ! date ( !   
enactm5t ( ?is ,act & ins]t+ #e ye>s    
aft] ! date ( enactm5t ( ! ,accel]at+   
,access to ,critical ,!rapies = ,,als   
,reau?orization ,act ( #bjbf2 &  7#b7 by
 ins]t+ 1 ) respect to ! #aj-ye> p]iod  
/>t+ on ! date ( enactm5t ( ?is ,act    
aft] conta9+4  #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+
 #bjbb ?r\gh #bjbf & ins]t+ #bjbg ?r\gh 
#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 ,section #b ( 
! ,accel]at+ ,access to ,critical       
,!rapies = ,,als ,act 7#ba ,u4,s4,c4    
#cfj;ee note7 is am5d$-- 7#a7 9         
subsection 7a71 by ins]t+ 7ref]r$ to 9  
?is section z exp&$ access grants7 be=e 
! p]iod at ! end ( ! fir/ s5t5ce2  7#b7 
9 subsection 7b7-- 7,a7 by /rik+ 7b7    
,application-- & all t foll[s ?r\gh ,a  
p>ticipat+ 9 p>agraph 7#a7 & ins]t+ !   
foll[+3  7b7 ,application ,a p>ticipat+ 
2  7,b7 by r$esignat+ p>agraphs 7#b7 &  

7#c7 z p>agraphs 7#a7 & 7#b7            
respectively2  7,c7 9 ! matt] prec$+    
p>agraph 7#a71 z s r$esignat$1 by /rik+ 
! p]iod at ! end & ins]t+ includ+--2    
7,d7 by am5d+ p>agraph 7#a71 z s        
r$esignat$1 to read z foll[s3  7#a7 a   
description ( h[ data g5]at$ ?r\gh !    
propos$ exp&$ access grant w be us$ to  
support rese>* or developm5t relat$ to !
 prev5tion1 diagnosis1 mitigation1      
treatm5t1 or cure ( amyotrophic lat]al  
scl]osis2  2  7,e7 9 p>agraph 7#b71 z s 
r$esignat$-- 7i7 by /rik+ ,non9t]f]5ce )
 cl9ical trials-- & all t foll[s ?r\gh  
%all include2  7ii7 by /rik+ program &  
ins]t+ grant2 &  7iii7 by /rik+ ! p]iod 
at ! end & ins]t+ 2 &2 &  7,f7 by add+  
at ! end ! foll[+3  7#c7 an assurance t 
su* entity w promptly report to !       
,secret>y available safety data f any   
ongo+ cl9ical trial ( ! inve/igational  
drug z set =? 9 ! t]ms & conditions ( ! 
grant4  2  7#c7 9 subsection 7c7-- 7,a7 
by r$esignat+ subp>agraphs 7,a7 & 7,b7 (
 p>agraph 7#b7 z clauses 7i7 & 7ii71    

respectively1 & adju/+ ! m>g9s          
accord+ly2  7,b7 by r$esignat+ p>agraphs
 7#a7 ?r\gh 7#c7 z subp>agraphs 7,a7    
?r\gh 7,c71 respectively1 & adju/+ !    
m>g9s accord+ly2  7,c7 9 subp>agraph    
7,c71 z s r$esignat$1 by /rik+ ! p]iod  
at ! end & ins]t+ 2 &2  7,d7 9 ! matt]  
prec$+ subp>agraph 7,a71 z s r$esignat$1
 by /rik+ ?is section1 confirm t-- &    
ins]t+ ! foll[+3 8?is section--  7#a7   
confirm t--  2 &  7,e7 by add+ at ! end 
! foll[+3  7#b7 9 ! case ( a r5ewal (   
su* a grant1 reque/ f ! sponsor ( !     
inve/igational new drug application     
involv$1 & assess1 ! enrollm5t1 safety1 
& any available efficacy data ( ! drug  
relat$ to ! prev5tion1 diagnosis1       
mitigation1 treatm5t1 or cure (         
amyotrophic lat]al scl]osis4  2  7#d7 9 
subsection 7d77#a71 by /rik+ reque/     
describ$ 9 subsection 7a7 & ins]t+      
grant2 &  7#e7 9 subsection 7e7-- 7,a7 9
 p>agraph 7#b71 by ins]t+ 1 & t beg9s   
enrollm5t )9 a timeframe z det]m9$ by ! 
,secret>y ?r\gh ! t]ms & conditions ( ! 

grant be=e ! p]iod at ! end2 &  7,b7 by 
add+ at ! end ! foll[+3  7#d7 ,! t]m    
phase #c cl9ical trial includes a phase 
#b_/c comb9$ trial & a plann$ phase #c  
cl9ical trial t is n yet enroll+        
p>ticipants4  4  #d4 ,report on ,,als & 
o!r r>e neurodeg5]ative disease action  
plans ,section #d ( ! ,accel]at+ ,access
 to ,critical ,!rapies = ,,als ,act 7#ba
 ,u4,s4,c4 #cfj;aa note7 is am5d$-- 7#a7
 9 ! section head+1 by /rik+ ,,als & o!r
 & ins]t+ ,,fda2  7#b7 9 subsection 7a71
 9 ! matt] prec$+ p>agraph 7#a7-- 7,a7  
by ins]t+ & n lat] ?an #a ye> aft] !    
date ( enactm5t ( ! ,accel]at+ ,access  
to ,critical ,!rapies = ,,als           
,reau?orization ,act ( #bjbf & e #e ye>s
 !reaft]1 aft] ?is ,act12 &  7,b7 by    
ins]t+ develop1 or update1 z applicable1
 & be=e publi% on2  7#c7 9 subsection   
7b7-- 7,a7 9 ! matt] prec$+ p>agraph    
7#a71 by /rik+ initial2  7,b7 9 p>agraph
 7#b7-- 7i7 9 subp>agraph 7,a71 by      
ins]t+ ( relevant inve/igational new    
drug applications aft] sponsors2  7ii7 9

 subp>agraph 7,c7 by ins]t+ = !         
prev5tion1 diagnosis1 mitigation1       
treatm5t1 or cure ( r>e neurodeg5]ative 
diseases be=e ! semicolon2 &  7iii7 9   
subp>agraph 7,d71 by /rik+ 2 & & ins]t+ 
a semicolon2  7,c7 9 p>agraph 7#c71 by  
/rik+ ! p]iod at ! end & ins]t+ 2 &2 &  
7,d7 by add+ at ! end ! foll[+3  7#d7 = 
ea* action plan publi%$ aft] ! date (   
enactm5t ( ! ,accel]at+ ,access to      
,critical ,!rapies = ,,als              
,reau?orization ,act ( #bjbf1 include a 
description (-- 7,a7 previ\s actions    
tak5 by ! ,food & ,drug ,adm9i/ration to
 implem5t ! previ\s action plan publi%$ 
"u subsection 7a72  7,b7 any o!r plann$ 
actions to implem5t su* action plan2 &  
7,c7 any b>ri]s to implem5t+ su* action 
plan & relat$ recomm5dations1 :i* may   
include an e/imate ( res\rces necess>y  
to address su* b>ri]s4  4  #e4 ,reports 
,section #f ( ! ,accel]at+ ,access to   
,critical ,!rapies = ,,als ,act 7,public
 ,law #aag-gi7 is am5d$-- 7#a7 9 !      
head+1 by /rik+ ,,gao ,report & ins]t+  

,reports2  7#b7 by /rik+ ,n lat] ?an &  
ins]t+ ! foll[+3  7a7 ,,gao report ,n   
lat] ?an  2  7#c7 9 ! matt] prec$+      
p>agraph 7#a7 ( subsection 7a71 z s     
designat$1 by /rik+ ?is ,act & ins]t+ ! 
,accel]at+ ,access to ,critical ,!rapies
 = ,,als ,reau?orization ,act ( #bjbf2 &
  7#d7 by add+ at ! end ! foll[+3  7b7  
,,hhs report ,n lat] ?an #d ye>s aft] ! 
date ( enactm5t ( ! ,accel]at+ ,access  
to ,critical ,!rapies = ,,als           
,reau?orization ,act ( #bjbf1 !         
,secret>y ( ,heal? & ,human ,s]vices    
%all1 9 a mann] t does n duplicate !    
in=mation describ$ 9 ! action plan      
publi%$ pursuant to section #d1 submit  
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions ( ! ,s5ate & !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives a report assess+
 ! effectiv5ess ( ! activities c>ri$ out
 "u sections #b1 #c1 & #e & mak+        
recomm5dations to improve su*           
activities4  4  #f4 ,te*nical am5dm5ts  
,section #c ( ! ,accel]at+ ,access to   

,critical ,!rapies = ,,als ,act 7#db    
,u4,s4,c4 #bhj;g-#g;b7 is am5d$-- 7#a7 9
 subsection 7a71 9 ! matt] prec$+       
p>agraph 7#a71 by /rik+ amytrophic &    
ins]t+ amyotrophic2 &  7#b7 9 subsection
 7b77#c77;,a77iii71 by /rik+ rational4  
,july #af1 #bjbf,report$ ) an am5dm5t