#aai? ,,congress  #b;d ,session  ,h4 ,r4
 #hbje  ,,an ,,act  ,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  ,pass$ ! ,h\se (  

,repres5tatives ,july #bb1 #bjbf4;,cl]k4