,,ii ,calendar ,no4 #dff #aaith         
,,congress  #b;d ,session  ,h4 ,r4 #hbje
  ,,in ,,the ,,senate ,,of ,,the        
,,united ,,states  ,july #bc1 #bjbf     
,received2 read twice and placed on the 
calendar  ,,an ,,act  ,to amend the     
,accelerating ,access to ,critical      
,therapies for ,,als ,act to reauthorize
 the provisions of such ,act through    
fiscal year #bjca1 and for other        
purposes4  #a4 ,short title ,this ,act  
may be cited as the ,accelerating       
,access to ,critical ,therapies for     
,,als ,reauthorization ,act of #bjbf4   
#b4 ,reauthorization of ,accelerating   
,access to ,critical ,therapies for     
,,als ,act  7a7 ,in general ,section #g 
of the ,accelerating ,access to         
,critical ,therapies for ,,als ,act     
7,public ,law #aag-gi7 is amended by    
striking #bjbf and inserting #bjca4  7b7
 ,grants for ,,als research ,section    
#b7;f7 of the ,accelerating ,access to  
,critical ,therapies for ,,als ,act 7#ba
 ,u4,s4,c4 #cfj;ee note7 is amended by  

striking #bjbf and inserting #bjca4  #c4
 ,improvements to program for grants for
 research on therapies for ,,als  7a7   
,renewal of grants for research on      
therapies for ,,als review ,section     
#b7;b7 of the ,accelerating ,access to  
,critical ,therapies for ,,als ,act 7#ba
 ,u4,s4,c4 #cfj;ee note7 is amended by  
adding at the end the following3  7#d7  
,renewal of grants for research on      
therapies for ,,als review ,in reviewing
 applications for renewals of a grant   
awarded under this section with respect 
to an investigational drug1 the         
,secretary shall request from the       
manufacturer or sponsor1 and assess1 the
 enrollment1 safety1 and any available  
efficacy data relating to the           
investigational drug in the prevention1 
diagnosis1 mitigation1 treatment1 or    
cure of amyotrophic lateral sclerosis4  
4  7b7 ,reporting safety data ,section  
#b7;c7 of the ,accelerating ,access to  
,critical ,therapies for ,,als ,act 7#ba
 ,u4,s4,c4 #cfj;ee note7 is amended--   

7#a7 in paragraph 7#b77;,b71 by striking
 and at the end2  7#b7 in paragraph     
7#c71 by striking the period at the end 
and inserting 2 and2 and  7#c7 by adding
 at the end the following3  7#d7 the    
entity seeking such grant will promptly 
report any new and serious adverse      
events and safety information that is   
considered to be unexpected with respect
 to the phase #c trial to the           
grant-making institution1 in addition to
 complying with the safety reporting    
requirements under section #cab4cb of   
title #ba1 ,code of ,federal            
,regulations 7or any successor          
regulations74  4  7c7 ,clarifying       
participating clinical trial definition 
,section #b7;e7 of the ,accelerating    
,access to ,critical ,therapies for     
,,als ,act 7#ba ,u4,s4,c4 #cfj;ee note7 
is amended by adding at the end the     
following3  7#d7 ,the term phase #c1    
with respect to a clinical trial1       
includes a phase #b_/c combined trial   
that begins enrollment within a         

timeframe1 determined by the ,secretary 
through the terms and conditions of the 
grant awarded under this section4  4    
#d4 ,,fda rare neurodegenerative disease
 action plan ,section #d of the         
,accelerating ,access to ,critical      
,therapies for ,,als ,act 7#ba ,u4,s4,c4
 #cfj;aa note7 is amended-- 7#a7 in the 
section heading1 by striking ,,als and  
other rare neurodegenerative disease    
action plan and inserting ,,fda rare    
neurodegenerative disease action plan2  
and  7#b7 by adding at the end the      
following3  7c7 ,,fda rare              
neurodegenerative disease action plan   
7#a7 ,in general ,not later than #ah    
months after the date of enactment of   
the ,accelerating ,access to ,critical  
,therapies for ,,als ,reauthorization   
,act of #bjbf1 the ,commissioner of     
,food and ,drugs shall publish on the   
website of the ,food and ,drug          
,administration an action plan that     
includes a description of the actions   
that the ,food and ,drug ,administration

 intends to take during the #e-year     
period following publication of the     
action plan with respect to the program 
enhancements1 policy development1       
regulatory science initiatives1 and     
other appropriate initiatives described 
in subsection 7a74  7#b7 ,report ,not   
later than #e years after the date of   
enactment of the ,accelerating ,access  
to ,critical ,therapies for ,,als       
,reauthorization ,act of #bjbf1 the     
,commissioner of ,food and ,drugs shall 
publish on the website of the ,food and 
,drug ,administration a report that     
describes the actions taken by the ,food
 and ,drug ,administration under the    
action plan published under paragraph   
7#a7 and the extent to which such action
 plan meets the requirements specified  
in paragraph 7#a74  4  ,passed the      
,house of ,representatives ,july #bb1   
#bjbf4,kevin ,f4 ,mc,cumber1,clerk4     
,july #bc1 #bjbf,received2 read twice   
and placed on the calendar