,i  #aaith ,,congress  #b;d ,session    
,h4 ,r4 #hbje  ,,in ,,the ,,house ,,of  
,,representatives  ,april #f1 #bjbf,mr4 
,quigley 7for himself and ,mr4 ,calvert7
 introduced the following bill2 which   
was referred to the ,committee on       
,energy and ,commerce  ,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  7c7
 ,sense of ,congress ,the ,committee on 
,energy and ,commerce of the ,house of  
,representatives expresses support for  
directly appropriating funds to carry   
out each section of the ,accelerating   
,access to ,critical ,therapies for     
,,als ,act 7,public ,law #aag-gi74  #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 
,not later than #d years after the date 
of enactment of this ,act1 the          
,comptroller ,general of the ,united    
,states shall submit to the ,committee  
on ,energy and ,commerce of the ,house  
of ,representatives and the ,committee  
on ,health1 ,education1 ,labor1 and     
,pensions of the ,senate a report       
containing the analyses and data        
described in section #f of the          
,accelerating ,access to ,critical      
,therapies for ,,als ,act 7,public ,law 
#aag-gi7 7as in effect on the date of   
enactment of this ,act74