,i  #aafth ,,congress  #b;d ,session    
,h4 ,r4 #gjga  ,,in ,,the ,,house ,,of  
,,representatives  ,june #a1 #bjbj,mr4  
,fortenberry 7for himself and ,mr4      
,quigley7 introduced the following bill2
 which was referred to the ,committee on
 ,energy and ,commerce  ,a ,,bill  ,to  
provide for the acceleration of access  
to clinical therapies for the treatment 
of amyotrophic lateral sclerosis1 and   
for other purposes4  #a4 ,short title   
,this ,act may be cited as the          
,accelerating ,access to ,critical      
,therapies for ,,als ,act4  #b4 ,grants 
for rapid development of therapies for  
,,als and other rapidly progressing     
neurodegenerative diseases  7a7 ,in     
general ,the ,secretary of ,health and  
,human ,services shall award grants to  
eligible entities for the provision of  
investigational drugs through an        
expanded access program pursuant to     
section #efa of the ,federal ,food1     
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cfj;bbb7 for individuals for the      

prevention1 diagnosis1 mitigation1      
treatment1 or cure of amyotrophic       
lateral sclerosis or another rapidly    
progressing neurodegenerative disease4  
7b7 ,vested authority ,for purposes of  
development of an investigational drug  
pursuant to subsection 7a71 the         
,secretary may vest authority in the    
participating clinical trial site or    
sites to make the determination under   
subsection 7b77#b71 7c77#f71 or 7c77#g71
 as applicable1 of the ,federal ,food1  
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cfj;bbb74  7c7 ,timing ,not later than
 #fj days after the date of submission  
of an application for a grant under this
 section-- 7#a7 the ,secretary1 acting  
through the ,director of the ,national  
,institutes of ,health1 shall determine 
whether to award the grant2 and  7#b7   
the ,secretary acting through the       
,commissioner of ,food and ,drugs 7or by
 vesting authority in the participating 
clinical trial site1 as applicable7     
shall make the determinations required  

of the ,secretary under subsection 7b7  
or 7c71 as applicable1 of section #efa  
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7 
for the provision of the investigational
 drug to occur4  7d7 ,definitions ,in   
this section3 7#a7 ,the term ,director  
means the ,director of the ,national    
,institutes of ,health4  7#b7 ,the term 
eligible entity means an entity that    
is-- 7,a7 a small business concern 7as  
defined in section #c7;a7 of the ,small 
,business ,act 7#ae ,u4,s4,c4 #fcb7;a777
 that is the sponsor of a drug that is  
the subject of an investigational new   
drug application under section #eje7;i7 
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i772
 or  7,b7 a participating clinical trial
 site for such an applicant4  7#c7 ,the 
term participating clinical trial means 
a phase #b or phase #c clinical trial   
conducted pursuant to an exemption under
 section #eje7;i7 of the ,federal ,food1
 ,drug1 and ,cosmetic ,act 7#ba         

,u4,s4,c4 #cee7;i77 or section #cea7;a7 
of the ,public ,health ,service ,act    
7#db ,u4,s4,c4 #bfb7;a77 to investigate 
a drug intended to treat amyotrophic    
lateral sclerosis or another rapidly    
progressing neurodegenerative disease4  
7#d7 ,the term participating clinical   
trial site means a health care facility 
at which patients participating in a    
participating clinical trial receive    
treatment through such trial4  7#e7 ,the
 term ,secretary means the ,secretary of
 ,health and ,human ,services4  7e7     
,funding  7#a7 ,authorization of        
appropriations ,there are authorized to 
be appropriated to carry out this       
section-- 7,a7 #ge1jjj1jjj for each of  
fiscal years #bjba and #bjbb2 and  7,b7 
#aej1jjj1jjj for each of fiscal years   
#bjbc and #bjbd4  7#b7 ,gifts1 grants1  
and other donations to ,foundation  7,a7
 ,acceptance ,pursuant to section       
#dii7;c7 of the ,public ,health ,service
 ,act 7#db ,u4,s4,c4 #bij;b7c771 the    
,foundation for the ,national           

,institutes of ,health may solicit and  
accept gifts1 grants1 and other         
donations1 establish accounts1 and      
invest and expend funds in support of   
carrying out this section4  7,b7 ,use   
,in addition to the amounts made        
available pursuant to the authorizations
 of appropriations in paragraph 7#a71   
the ,director may use1 without further  
appropriation1 any funds derived from a 
gift1 grant1 or other donation accepted 
pursuant to subparagraph 7,a74  7f7     
,review and expansion ,not later than   
#ah months after the date of the        
enactment of this ,act-- 7#a7 the       
,secretary of ,health and ,human        
,services shall convene an independent  
review panel that includes              
representatives of patients1            
researchers1 drug sponsors1 and         
government agencies2 and  7#b7 the      
independent review panel 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 on the findings and conclusions  
of the panel with respect to the design 
and implementation of the program under 
this section for #bjbc and #bjbd4  #c4  
,,fda ,center of ,excellence for        
,neurodegenerative ,diseases ,chapter ,x
 of the ,federal ,food1 ,drug1 and      
,cosmetic ,act 7#ba ,u4,s4,c4 #cia et   
seq47 is amended by adding at the end   
the following3  #ajae4 ,center of       
,excellence for ,neurodegenerative      
,diseases  7a7 ,establishment ,not later
 than ,september #bjba1 the ,secretary  
shall establish within the ,food and    
,drug ,administration a center of       
excellence1 to be known as the ,center  
of ,excellence for ,neurodegenerative   
,diseases 7in this section referred to  
as the ,center of ,excellence74  7b7    
,duties and authorities ,the ,center of 
,excellence shall have duties and       
authorities similar to those of the     
,center of ,excellence for ,oncology    
established under section #ajad1        

including the duties and authorities of 
the ,center of ,excellence for ,oncology
 with respect to ,project ,facilitate4  
4