,i  #aaf? ,,congress  #b;d ,session  ,h4
 ,r4 #gjga  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,june #a1 #bjbj,mr4   
,=t5b]ry 7= himself & ,mr4 ,quigley7    
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to provide = ! accel]ation (   
access to cl9ical !rapies = ! treatm5t (
 amyotrophic lat]al scl]osis1 & = o!r   
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,accel]at+ ,access to      
,critical ,!rapies = ,,als ,act4  #b4   
,grants = rapid developm5t ( !rapies =  
,,als & o!r rapidly progress+           
neurodeg5]ative diseases  7a7 ,9 g5]al  
,! ,secret>y ( ,heal? & ,human ,s]vices 
%all aw>d grants to eligible entities = 
! provision ( inve/igational drugs ?r\gh
 an exp&$ access program pursuant to    
section #efa ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7 
= individuals = ! prev5tion1 diagnosis1 
mitigation1 treatm5t1 or cure (         
amyotrophic lat]al scl]osis or ano!r    
rapidly progress+ neurodeg5]ative       

disease4  7b7 ,ve/$ au?ority ,= purposes
 ( developm5t ( an inve/igational drug  
pursuant to subsection 7a71 ! ,secret>y 
may ve/ au?ority 9 ! p>ticipat+ cl9ical 
trial site or sites to make !           
det]m9ation "u subsection 7b77#b71      
7c77#f71 or 7c77#g71 z applicable1 ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;bbb74  7c7 ,tim+ ,n 
lat] ?an #fj days aft] ! date (         
submission ( an application = a grant "u
 ?is section-- 7#a7 ! ,secret>y1 act+   
?r\gh ! ,director ( ! ,national         
,in/itutes ( ,heal?1 %all det]m9e :e!r  
to aw>d ! grant2 &  7#b7 ! ,secret>y    
act+ ?r\gh ! ,commission] ( ,food &     
,drugs 7or by ve/+ au?ority 9 !         
p>ticipat+ cl9ical trial site1 z        
applicable7 %all make ! det]m9ations    
requir$ ( ! ,secret>y "u subsection 7b7 
or 7c71 z applicable1 ( section #efa ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cfj;bbb7 = ! provision (
 ! inve/igational drug to occur4  7d7   
,def9itions ,9 ?is section3 7#a7 ,! t]m 

,director means ! ,director ( !         
,national ,in/itutes ( ,heal?4  7#b7 ,! 
t]m eligible entity means an entity t   
is-- 7,a7 a small bus9ess conc]n 7z     
def9$ 9 section #c7;a7 ( ! ,small       
,bus9ess ,act 7#ae ,u4,s4,c4 #fcb7;a777 
t is ! sponsor ( a drug t is ! subject (
 an inve/igational new drug application 
"u section #eje7;i7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;i772 or  7,b7 a p>ticipat+ cl9ical
 trial site = su* an applicant4  7#c7 ,!
 t]m p>ticipat+ cl9ical trial means a   
phase #b or phase #c cl9ical trial      
conduct$ pursuant to an exemption "u    
section #eje7;i7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;i77 or section #cea7;a7 ( !       
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7;a77 to inve/igate a drug
 int5d$ to treat amyotrophic lat]al     
scl]osis or ano!r rapidly progress+     
neurodeg5]ative disease4  7#d7 ,! t]m   
p>ticipat+ cl9ical trial site means a   
heal? c>e facility at :i* pati5ts       

p>ticipat+ 9 a p>ticipat+ cl9ical trial 
receive treatm5t ?r\gh su* trial4  7#e7 
,! t]m ,secret>y means ! ,secret>y (    
,heal? & ,human ,s]vices4  7e7 ,fund+   
7#a7 ,au?orization ( appropriations ,!re
 are au?oriz$ to be appropriat$ to c>ry 
out ?is section-- 7,a7 #ge1jjj1jjj = ea*
 ( fiscal ye>s #bjba & #bjbb2 &  7,b7   
#aej1jjj1jjj = ea* ( fiscal ye>s #bjbc &
 #bjbd4  7#b7 ,gifts1 grants1 & o!r     
donations to ,f\ndation  7,a7           
,acceptance ,pursuant to section        
#dii7;c7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bij;b7c771 ! ,f\ndation
 = ! ,national ,in/itutes ( ,heal? may  
solicit & accept gifts1 grants1 & o!r   
donations1 e/abli% acc\nts1 & inve/ &   
exp5d funds 9 support ( c>ry+ out ?is   
section4  7,b7 ,use ,9 addition to !    
am\nts made available pursuant to !     
au?orizations ( appropriations 9        
p>agraph 7#a71 ! ,director may use1 )\t 
fur!r appropriation1 any funds d]iv$ f a
 gift1 grant1 or o!r donation accept$   
pursuant to subp>agraph 7,a74  7f7      

,review & expansion ,n lat] ?an #ah     
mon?s aft] ! date ( ! enactm5t ( ?is    
,act-- 7#a7 ! ,secret>y ( ,heal? &      
,human ,s]vices %all conv5e an indep5d5t
 review panel t includes repres5tatives 
( pati5ts1 rese>*]s1 drug sponsors1 &   
gov]nm5t ag5cies2 &  7#b7 ! indep5d5t   
review panel %all submit to ! ,committee
 on ,en]gy & ,comm]ce ( ! ,h\se (       
,repres5tatives & ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate a report on ! f9d+s &         
conclusions ( ! panel ) respect to !    
design & implem5tation ( ! program "u   
?is section = #bjbc & #bjbd4  #c4 ,,fda 
,c5t] ( ,excell5ce = ,neurodeg5]ative   
,diseases ,*apt] ,x ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cia et seq47 is am5d$ by add+ at ! end 
! foll[+3  #ajae4 ,c5t] ( ,excell5ce =  
,neurodeg5]ative ,diseases  7a7         
,e/abli%m5t ,n lat] ?an ,septemb] #bjba1
 ! ,secret>y %all e/abli% )9 ! ,food &  
,drug ,adm9i/ration a c5t] ( excell5ce1 
to be kn[n z ! ,c5t] ( ,excell5ce =     

,neurodeg5]ative ,diseases 79 ?is       
section ref]r$ to z ! ,c5t] (           
,excell5ce74  7b7 ,duties & au?orities  
,! ,c5t] ( ,excell5ce %all h duties &   
au?orities simil> to ^? ( ! ,c5t] (     
,excell5ce = ,oncology e/abli%$ "u      
section #ajad1 includ+ ! duties &       
au?orities ( ! ,c5t] ( ,excell5ce =     
,oncology ) respect to ,project         
,facilitate4  4