,,ii  #aaith ,,congress  #b;d ,session  
,s4 #ddgb  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,april #cj1    
#bjbf,ms4 ,murkowski 7for herself and   
,mr4 ,coons7 introduced the following   
bill2 which was read twice and referred 
to the ,committee on ,health1           
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,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 ,clinical trial
 status 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 ,clinical  
trial status review  7,a7 ,in general   
,in reviewing applications for renewals 
of a grant awarded under this section   
with respect to an investigational drug1
 the ,secretary shall assess the status 
of a clinical trial carried out for such
 drug with respect to data on enrollment
 of patients in such clinical trial4    
7,b7 ,interim clinical trial data ,to   
enable the ,secretary to make the       
assessment under subparagraph 7,a7 with 
respect to an investigational drug1 the 
,secretary shall request that the       
manufacturer of the investigational drug

 share interim clinical trial data with 
respect to such drug with the           
,secretary4  4  7b7 ,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   
and a planned phase #c clinical trial   
that is not yet enrolling participants4 
4  #d4 ,report on ,,als and other rare  
neurodegenerative disease action plans  
,section #d of the ,accelerating ,access
 to ,critical ,therapies for ,,als ,act 
7#ba ,u4,s4,c4 #cfj;aa note7 is amended 
by adding at the end the following3  7c7
 ,report on ,,als and other rare        
neurodegenerative disease action plans  
,not later than one year 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 contains-- 7#a7 an updated action 
plan1 including-- 7,a7 a description of 
the actions the ,food and ,drug         
,administration intends to take during  
the #e-year period following publication
 of the plan with respect to the program
 enhancements1 policy development1      
regulatory science initiatives1 and     
other appropriate initiatives described 
in subsection 7a72  7,b7 a description  
of the resources necessary to implement 
each section of the plan within such    
#e-year period2 and  7,c7 specific      
approaches the ,commissioner will take  
to improve coordination of              
implementation of the plan with rare    
neurodegenerative disease communities   
that are not specifically ,,als         
communities2 and  7#b7 with respect to  
the ,action ,plan for ,rare             
,neurodegenerative ,diseases including  
,amyotrophic ,lateral ,sclerosis 7,,als7

 published by the ,food and ,drug       
,administration on ,june #bc1 #bjbb     
7referred to in this section as the     
#bjbb ,action ,plan71 a description of--
 7,a7 the actions taken by the ,food and
 ,drug ,administration under the #bjbb  
,action ,plan2  7,b7 the effect of the  
implementation of the #bjbb ,action     
,plan on the development of therapies   
and regulatory consideration of         
therapies for ,,als and other rare      
neurodegenerative diseases2  7,c7 any   
programs and initiatives that           
established or carried out as part of   
the implementation of the #bjbb ,action 
,plan2 and  7,d7 the extent to which the
 #bjbb ,action ,plan was implemented    
with respect to rare neurodegenerative  
diseases that are not amyotrophic       
lateral sclerosis4  4  #e4 ,,gao report 
,section #f of the ,accelerating ,access
 to ,critical ,therapies for ,,als ,act 
7,public ,law #aag-gi7 is amended1 in   
the matter preceding paragraph 7#a7--   
7#a7 by striking #d years after the date

 of the enactment of this ,act and      
inserting #e years after the date of    
enactment of the ,accelerating ,access  
to ,critical ,therapies for ,,als       
,reauthorization ,act of #bjbf2 and     
7#b7 by inserting 1 with respect to the 
#aj-year period starting on the date of 
enactment of this ,act after containing4