,,ii  #aag? ,,congress  #a/ ,session    
,s4 #ahac  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,may #be1 #bjba ,mr4   
,coons 7= himself & ,ms4 ,murk[ski7     
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to direct ! ,secret>y (     
,heal? & ,human ,s]vices to support     
rese>* on1 & exp&$ access to1           
inve/igational drugs = 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 = rese>* on 
!rapies = ,,als  7a7 ,9 g5]al ,!        
,secret>y ( ,heal? & ,human ,s]vices    
7ref]r$ to 9 ?is section z ! ,secret>y7 
%all aw>d grants to p>ticipat+ entities 
= purposes ( exp&$ access = individuals 
to inve/igational drugs = ! prev5tion1  
diagnosis1 mitigation1 treatm5t1 or cure
 ( amyotrophic lat]al scl]osis4 ,9 !    
case ( an applicant seek+ su* a grant1  
an exp&$ access reque/ mu/ be submitt$1 

& all[$ to proce$ by ! ,secret>y1 "u    
section #efa ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7 
& "p #cab ( title #ba1 ,code ( ,f$]al   
,regulations 7or any successor          
regulations71 be=e ! application = su*  
grant is submitt$4  7b7 ,application    
7#a7 ,9 g5]al ,a p>ticipat+ entity seek+
 a grant "u ?is section %all submit to !
 ,secret>y an application at su* "t1 9  
su* mann]1 & conta9+ su* in=mation z !  
,secret>y %all specify4  7#b7 ,use (    
data ,an application submitt$ "u        
p>agraph 7#a7 %all include a description
 ( h[ data g5]at$ ?r\gh an exp&$ access 
reque/ "u section #efa ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cfj;bbb7 ) respect to ! inve/igational 
drug involv$ may be us$ by ! ,secret>y  
to support rese>* or developm5t relat$  
to ! prev5tion1 diagnosis1 mitigation1  
treatm5t1 or cure ( amyotrophic lat]al  
scl]osis or o!r r>e neurodeg5]ative     
diseases4  7c7 ,selection ,n lat] ?an   
#abj days aft] ! date ( submission ( an 

application = a grant "u ?is section1 ! 
,secret>y %all det]m9e :e!r to aw>d !   
grant1 tak+ into consid]ation-- 7#a7    
:e!r aw>d+ su* grant w support a rese>* 
objective relat+ to exp&+ access to     
inve/igational drugs 7z describ$ 9      
subsection 7a772 &  7#b7 :e!r aw>d+ su* 
a grant may h ! effect ( dim9i%+        
eligibility =1 or imp$+ enrollm5t (1    
ongo+ cl9ical inve/igations4  7d7 ,use (
 funds ,a p>ticipat+ entity may use     
funds receiv$ ?r\gh ! grant--  7#a7 to  
pay ! manufactur] or sponsor = ! direct 
co/s ( su* drug 7z au?oriz$ "u section  
#cab4h7;d7 ( title #ba1 ,code ( ,f$]al  
,regulations 7or successor              
regulations771 if su* co/s are ju/ifi$ z
 "p ( pe] review ( ! grant2  7#b7 = !   
entity's direct co/s incurr$ 9 provid+  
su* drug consi/5t ) ! rese>* mission ( !
 grant2 or  7#c7 = ! direct & indirect  
co/s ( ! entity 9 conduct+ rese>* )     
respect to ! drug involv$4  7e7         
,def9itions ,9 ?is section3  7#a7 ,! t]m
 p>ticipat+ entity means a p>ticipat+   

cl9ical trial site or sites sponsor$ by 
a small bus9ess conc]n 7z def9$ 9       
section #c7;a7 ( ! ,small ,bus9ess ,act 
7#ae ,u4,s4,c4 #fcb7;a77 t is ! sponsor 
( a drug t is ! subject ( an            
inve/igational new drug application "u  
section #eje7;i7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;i774  7#b7 ,! t]m p>ticipat+      
cl9ical trial means a phase #c cl9ical  
trial conduct$ 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 prev5t1 diagnose1 mitigate1  
treat1 or cure amyotrophic lat]al       
scl]osis4  7#c7 ,! t]m p>ticipat+       
cl9ical trial site means a nonpr(it or  
public heal? c>e facility1 or network ( 
facilities1 at :i* pati5ts p>ticipat+ 9 
a p>ticipat+ cl9ical trial receive an   
inve/igational drug ?r\gh su* trial4    
#c4 ,,hhs public-private p>tn]%ip = r>e 

neurodeg5]ative diseases  7a7           
,e/abli%m5t ,n lat] ?an "o ye> aft] !   
date ( enactm5t ( ?is ,act1 ! ,secret>y 
( ,heal? & ,human ,s]vices 7ref]r$ to 9 
?is section z ! ,secret>y7 %all e/abli% 
& implem5t a ,public-,private ,p>tn]%ip 
= ,neurodeg5]ative ,diseases betwe5 !   
,national ,in/itutes ( ,heal?1 ! ,food &
 ,drug ,adm9i/ration1 & "o or m eligible
 entities 7to be kn[n & ref]r$ to 9 ?is 
section z ! ,p>tn]%ip7 ?r\gh coop]ative 
agreem5ts1 contracts1 or o!r appropriate
 in/rum5ts ) su* eligible entities1 = ! 
purpose ( develop+ treatm5ts =          
amytrophic lat]al scl]osis & o!r r>e    
neurodeg5]ative diseases4 ,! ,p>tn]%ip  
%all--  7#a7 e/abli% p>tn]%ips1         
consortia1 & collaborations ) o!r public
 & private entities & individuals )     
exp]tise 9 amyotrophic lat]al scl]osis &
 o!r r>e neurodeg5]ative diseases = !   
purposes describ$ 9 ?is subsection2     
7#b7 focus on advanc+ regulatory sci5ce 
& sci5tific rese>* t w support &        
accel]ate ! developm5t & review ( drugs 

= pati5ts ) amyotrophic lat]al scl]osis 
& o!r r>e neurodeg5]ative diseases2 &   
7#c7 fo/] ! developm5t ( effective drugs
 t improve ! lives ( p t suff] f        
amyotrophic lat]al scl]osis & o!r r>e   
neurodeg5]ative diseases4  7b7 ,eligible
 entity ,9 ?is section1 ! t]m eligible  
entity means an entity t--  7#a7 is--   
7,a7 an in/itution ( high] education 7z 
su* t]m is def9$ 9 section #ajja ( !    
,high] ,education ,act ( #aife 7#bj     
,u4,s4,c4 #ajja77 or a consortium ( su* 
in/itutions2 or  7,b7 an organization   
describ$ 9 section #eja7;c77#c7 ( !     
,int]nal ,rev5ue ,code ( #aihf & exempt 
f tax "u subsection 7a7 ( su* section2  
7#b7 has exp]i5c$ p]sonnel & demon/rat$ 
connection to ! pati5t population2  7#c7
 demon/rates to ! ,secret>y's           
satisfaction t ! entity is capable (    
id5tify+ & e/abli%+ collaborations      
betwe5 public & private entities &      
individuals ) exp]tise 9 neurodeg5]ative
 diseases1 includ+ pati5ts1 9 ord] to   
facilitate-- 7,a7 developm5t & critical 

evaluation ( tools1 me?ods1 &           
processes--  7i7 to *>act]ize           
neurodeg5]ative diseases & _! natural   
hi/ory2  7ii7 to id5tify drug t>gets =  
neurodeg5]ative diseases2 &  7iii7 to   
increase effici5cy1 pr$ictability1 &    
productivity ( cl9ical developm5t (     
!rapies1 includ+ advancem5t ( rational  
!rapeutic developm5t & e/abli%m5t (     
cl9ical trial networks2 &  7,b7 secur+  
fund+ = ! ,p>tn]%ip f ,f$]al &          
non-,f$]al gov]nm5tal s\rces1           
f\ndations1 & private individuals2 &    
7#d7 provides an assurance t ! entity w 
n accept fund+ = a ,p>tn]%ip project f  
any organization t manufactures or      
di/ributes products regulat$ by ! ,food 
& ,drug ,adm9i/ration unless ! entity   
provides assurances 9 its agreem5t ) !  
,secret>y t ! results ( ! project w n be
 influ5c$ by any s\rce ( fund+4  7c7    
,gifts  7#a7 ,9 g5]al ,! ,p>tn]%ip may  
solicit & accept gifts1 grants1 & o!r   
donations1 e/abli% acc\nts1 & inve/ &   
exp5d funds 9 support ( pre-competitive 

rese>* & rese>* associat$ ) phase #c    
cl9ical trials conduct$ ) respect to    
inve/igational drugs t are ! subjects ( 
exp&$ access applications "u section    
#efa ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb74
  7#b7 ,use ,9 addition to any am\nts   
appropriat$ = purposes ( c>ry+ out ?is  
section1 ! ,p>tn]%ip may use1 )\t fur!r 
appropriation1 any funds d]iv$ f a gift1
 grant1 or o!r donation accept$ pursuant
 to p>agraph 7#a74  #d4 ,,als & o!r r>e 
neurodeg5]ative disease action plan  7a7
 ,9 g5]al ,n lat] ?an #f mon?s aft] !   
date ( enactm5t ( ?is ,act1 ! ,secret>y 
( ,heal? & ,human ,s]vices %all publi%  
on ! website ( ! ,dep>tm5t ( ,heal? &   
,human ,s]vices an action plan describ+ 
actions ! ,food & ,drug ,adm9i/ration   
int5ds to take dur+ ! #e-ye> p]iod      
foll[+ publication ( ! plan ) respect to
 program enhancem5ts1 policy developm5t1
 regulatory sci5ce initiatives1 & o!r   
appropriate initiatives to--  7#a7 fo/] 
! developm5t ( safe & effective drugs t 

improve or ext5d1 or bo?1 ! lives ( p   
liv+ ) amyotrophic lat]al scl]osis & o!r
 r>e neurodeg5]ative diseases z quickly 
z possible2 &  7#b7 facilitate access to
 inve/igational drugs = amyotrophic     
lat]al scl]osis & o!r r>e               
neurodeg5]ative diseases4  7b7 ,cont5ts 
,! initial action plan publi%$ "u       
subsection 7a7 %all-- 7#a7 id5tify      
appropriate repres5tation f )9 ! ,food &
 ,drug ,adm9i/ration to be responsible =
 implem5tation ( su* action plan2  7#b7 
include elem5ts to facilitate-- 7,a7    
int]actions & collaboration betwe5 !    
,food & ,drug ,adm9i/ration1 includ+ !  
review c5t]s !re(1 & /akehold]s includ+ 
pati5ts1 sponsors1 & ! ext]nal biom$ical
 rese>* community2  7,b7 consid]ation ( 
cross-cutt+ cl9ical & regulatory policy 
issues1 includ+ consi/5cy ( regulatory  
advice & decision mak+2  7,c7           
id5tification ( key regulatory sci5ce & 
policy issues critical to advanc+       
developm5t ( safe & effective drugs2 &  
7,d7 enhancem5t ( collaboration &       

engagem5t by /aff ( ! relevant c5t]s ( !
 ,food & ,drug ,adm9i/ration & o!r      
relevant (fices ( ! ,food & ,drug       
,adm9i/ration ) o!r op]at+ divisions )9 
! ,dep>tm5t ( ,heal? & ,human ,s]vices1 
! ,p>tn]%ip1 & ! broad] neurodeg5]ative 
disease community2 &  7#c7 be subject to
 revision1 z det]m9$ appropriate by !   
,secret>y ( ,heal? & ,human ,s]vices4   
#e4 ,,fda r>e neurodeg5]ative disease   
grant program ,! ,secret>y ( ,heal? &   
,human ,s]vices %all use funds made     
available "u section #f to aw>d grants &
 contracts to public & private entities 
to cov] ! co/s ( rese>* on1 & developm5t
 ( int]v5tions int5d$ to prev5t1        
diagnose1 mitigate1 treat1 or cure1     
amyotrophic lat]al scl]osis & o!r r>e   
life-?reat5+ or sev]ely debilitat+      
neurodeg5]ative diseases 9 adults &     
*ildr51 includ+ co/s incurr$ ) respect  
to ! developm5t & critical evaluation ( 
tools1 me?ods1 & processes-- 7#a7 to    
*>act]ize su* neurodeg5]ative diseases &
 _! natural hi/ory2  7#b7 to id5tify    

molecul> t>gets = su* neurodeg5]ative   
diseases2 &  7#c7 to increase effici5cy 
& productivity ( cl9ical developm5t (   
!rapies1 includ+ advanc+ rational       
!rapeutic developm5t & work+ to e/abli% 
new or lev]age exi/+ cl9ical trial      
networks4  #f4 ,au?orization (          
appropriations ,= purposes ( c>ry+ out  
?is ,act1 !re are au?oriz$ to be        
appropriat$ #ajj1jjj1jjj = ea* ( fiscal 
ye>s #bjbb ?r\gh #bjbf4