,,ii  #aag? ,,congress  #a/ ,session    
,h4 ,r4 #cecg  ,,9 ,,! ,,s5ate ,,( ,,!  
,,unit$ ,,/ates  ,decemb] #i1           
#bjba,receiv$  ,,an ,,act  ,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 ( sci5tific rese>* utiliz+   
data f exp&$ access to inve/igational   
drugs = individuals :o are n o!rwise    
eligible = cl9ical trials = ! prev5tion1
 diagnosis1 mitigation1 treatm5t1 or    
cure ( amyotrophic lat]al scl]osis4 ,9 !
 case ( a p>ticipat+ entity 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$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7 
) respect to ! inve/igational drug      
involv$ w be us$ to support rese>* or   
developm5t relat$ to ! prev5tion1       
diagnosis1 mitigation1 treatm5t1 or cure
 ( amyotrophic lat]al scl]osis4  7#c7   
,non9t]f]5ce ) cl9ical trials ,an       
application submitt$ "u p>agraph 7#a7   
%all include a description ( h[ !       
propos$ exp&$ access program w be       

design$ s z n to int]f]e ) pati5t       
enrollm5t 9 ongo+ cl9ical trials =      
inve/igational !rapies = ! prev5tion1   
diagnosis1 mitigation1 treatm5t1 or cure
 ( amyotrophic lat]al scl]osis4  7c7    
,selection ,consi/5t ) sections #djf &  
#dib ( ! ,public ,heal? ,s]vice ,act    
7#db ,u4,s4,c4 #bhd;a1 #bhi;a71 !       
,secret>y %all1 9 det]m9+ :e!r to aw>d a
 grant "u ?is section1 confirm t-- 7#a7 
su* grant w be us$ to support a         
sci5tific rese>* objective relat+ to !  
prev5tion1 diagnosis1 mitigation1       
treatm5t1 or cure ( amyotrophic lat]al  
scl]osis 7z describ$ 9 subsection 7a772 
7#b7 su* grant %all n h ! effect (      
dim9i%+ eligibility =1 or imp$+         
enrollm5t (1 ongo+ cl9ical trials = !   
prev5tion1 diagnosis1 mitigation1       
treatm5t1 or cure ( amyotrophic lat]al  
scl]osis by det]m9+ t individuals :o    
receive exp&$ access to inve/igational  
drugs ?r\gh su* a grant are n eligible =
 enrollm5t 9-- 7,a7 ongo+ cl9ical trials
 t are regi/]$ on ,clinical,trials4gov  

7or successor website71 ) respect to a  
drug = ! prev5tion1 diagnosis1          
mitigation1 treatm5t1 or cure (         
amyotrophic lat]al scl]osis2 or  7,b7   
cl9ical trials = ! prev5tion1 diagnosis1
 mitigation1 treatm5t1 or cure (        
amyotrophic lat]al scl]osis = :i* an    
exemption "u section #eje7;i7 ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cee7;i77 has be5 grant$ by ! 
,food & ,drug ,adm9i/ration & :i* are   
expect$ to beg9 enrollm5t )9 "o ye>2 &  
7#c7 ! result+ project fund$ by su*     
grant w all[ = equitable access to      
inve/igational drugs by m9ority &       
und]s]v$ populations4  7d7 ,use ( funds 
,a p>ticipat+ entity %all use funds     
receiv$ ?r\gh ! grant-- 7#a7 to pay !   
manufactur] or sponsor = ! direct co/s (
 ! inve/igational drug1 z au?oriz$ "u   
section #cab4h7;d7 ( title #ba1 ,code ( 
,f$]al ,regulations 7or successor       
regulations71 to prev5t1 diagnose1      
mitigate1 treat1 or cure amyotrophic    
lat]al scl]osis t is ! subject ( an     

exp&$ access reque/ describ$ 9          
subsection 7a71 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 su* drug4  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;a777 t is ! sponsor ( a drug t is
 ! subject ( an inve/igational new drug 
application "u section #eje7;i7 ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;i77 to prev5t1     
diagnose1 mitigate1 treat1 or cure      
amyotrophic lat]al scl]osis4  7#b7 ,!   
t]m p>ticipat+ cl9ical trial means a    
phase #c cl9ical trial conduct$ 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 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  7f7 ,sunset ,!   
,secret>y may n aw>d grants "u ?is      
section on or aft] ,septemb] #cj1 #bjbf4
  #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

 me*anisms ) su* eligible entities1 = ! 
purpose ( advanc+ ! und]/&+ (           
neurodeg5]ative diseases & fo/]+ !      
developm5t ( treatm5ts = amytrophic     
lat]al scl]osis & o!r r>e               
neurodeg5]ative diseases4 ,! ,p>tn]%ip  
%all-- 7#a7 e/abli% p>tn]%ips &         
consortia ) 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 ) cl9ical & o!r te*nical       
exp]tise 9 ! field ( biom$ical sci5ces &
 demon/rat$ 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        
molecul> 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 ( basic rese>* & rese>*        
associat$ ) phase #c cl9ical trials     
conduct$ ) respect to inve/igational    
drugs t are ! subjects ( exp&$ access   
reque/s "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 !           
,commission] ( ,food & ,drugs %all      
publi% on ! website ( ! ,food & ,drug   
,adm9i/ration 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 diseases2 &  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$ical
 rese>* community2  7,b7 consid]ation ( 
cross-cutt+ cl9ical & regulatory policy 
issues1 includ+ consi/5cy ( regulatory  
advice & decisionmak+2  7,c7            
id5tification ( key regulatory sci5ce & 
policy issues critical to advanc+       
developm5t ( safe & effective drugs2 &  
7,d7 enhancem5t ( collaboration &       
engagem5t ( ! relevant c5t]s & (fices ( 
! ,food & ,drug ,adm9i/ration ) o!r     
op]at+ divisions )9 ! ,dep>tm5t ( ,heal?
 & ,human ,s]vices1 ! ,p>tn]%ip1 & !    
broad] neurodeg5]ative disease          
community2 &  7#c7 be subject to        
revision1 z det]m9$ appropriate by !    
,secret>y ( ,heal? & ,human ,s]vices4   
#e4 ,,fda r>e neurodeg5]ative disease   

grant program ,! ,secret>y ( ,heal? &   
,human ,s]vices1 act+ ?r\gh !           
,commission] ( ,food & ,drugs1 %all 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 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+ ?r\gh-- 7,a7 ! use (   
ma/] protocols & adaptive & add-on      
cl9ical trial designs2 &  7,b7 ef=ts to 
e/abli% new or lev]age exi/+ cl9ical    
trial networks4  #f4 ,,gao report ,n    
lat] ?an #d ye>s aft] ! date ( !        
enactm5t ( ?is ,act1 ! ,comptroll]      
,g5]al ( ! ,unit$ ,/ates %all submit to 

! ,committee on ,en]gy & ,comm]ce ( !   
,h\se ( ,repres5tatives & ! ,committee  
on ,heal?1 ,education1 ,labor1 &        
,p5sions ( ! ,s5ate a report conta9+--  
7#a7 ) respect to grants aw>d$ "u !     
program e/abli%$ "u section #b-- 7,a7 an
 analysis ( :at is kn[n ab\t ! impact ( 
su* grants on rese>* or developm5t      
relat$ to ! prev5tion1 diagnosis1       
mitigation1 treatm5t1 or cure (         
amyotrophic lat]al scl]osis2 &  7,b7    
data conc]n+ su* grants1 includ+-- 7i7 !
 numb] ( grants aw>d$2  7ii7 !          
p>ticipat+ entities to :om grants 7     
aw>d$2  7iii7 ! value ( ea* su* grant2  
7iv7 a description ( ! rese>* ea* su*   
grant 0 us$ to fur!r2  7v7 ! numb] (    
pati5ts :o receiv$ exp&$ access to an   
inve/igational drug to prev5t1 diagnose1
 mitigate1 treat1 or cure amyotrophic   
lat]al scl]osis "u ea* grant2  7vi7 :e!r
 ! inve/igational drug t 0 ! subject (  
su* a grant 0 approv$ by ! ,food & ,drug
 ,adm9i/ration2 &  7vii7 ! av]age numb] 
( days betwe5 :5 a grant application is 

submitt$ & :5 a grant is aw>d$2 &  7#b7 
) respect to grants aw>d$ "u ! program  
e/abli%$ "u section #e-- 7,a7 an        
analysis ( :at is kn[n ab\t ! impact (  
su* grants on rese>* or developm5t      
relat$ to ! prev5tion1 diagnosis1       
mitigation1 treatm5t1 or cure (         
amyotrophic lat]al scl]osis2  7,b7 an   
analysis ( :at is kn[n ab\t h[ su*      
grants increas$ effici5cy & productivity
 ( ! cl9ical developm5t ( !rapies1      
includ+ ?r\gh ! use ( cl9ical trials t  
op]at$ ) common ma/] protocols1 or _h   
adaptive or add-on cl9ical trial        
designs2 &  7,c7 data conc]n+ su*       
grants1 includ+-- 7i7 ! numb] ( grants  
aw>d$2  7ii7 ! p>ticipat+ entities to   
:om grants 7 aw>d$2  7iii7 ! value ( ea*
 su* grant2  7iv7 a description ( !     
rese>* ea* su* grant 0 us$ to fur!r2 &  
7v7 :e!r ! inve/igational drug t 0 !    
subject ( su* a grant receiv$ approval  
by ! ,food & ,drug ,adm9i/ration4  #g4  
,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  
,pass$ ! ,h\se ( ,repres5tatives        
,decemb] #h1 #bjba4;,*]yl ,l4           
,johnson1,cl]k4