,,ii  #aai? ,,congress  #b;d ,session   
,s4 #ddgb  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,april #cj1 #bjbf,ms4  
,murk[ski 7= h]self & ,mr4 ,coons7      
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,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