,i  #aai? ,,congress  #b;d ,session  ,h4
 ,r4 #gjia  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,janu>y #ae1 #bjbf,mr4
 ,b]gman 7= himself & ,mr4 ,correa7     
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,vet]ans' ,affairs  ,a 
,,bill  ,to direct ! ,secret>y (        
,vet]ans ,affairs to e/abli% an         
inve/igational rese>* & ext5d$ access   
treatm5t program utiliz+ innovative     
treatm5ts & em]g+ !rapies to address    
conditions ) unmet m$ical ne$s1 & = o!r 
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,exp&+ ,vet]ans' ,access to
 ,em]g+ ,treatm5ts ,act4  #b4 ,s5se (   
congress ,x is ! s5se ( ,congress t--   
7#a7 ,_m conditions1 su* z *ronic pa91  
po/-traumatic /ress disord]1 & sub/ance 
use disord]s1 cont9ue to *all5ge !      
vet]an community amid a lack ( new      
innovative treatm5ts & em]g+ !rapies4   
7#b7 ,^! & o!r conditions repres5t an   
urg5t unmet m$ical ne$ among vet]ans4   
7#c7 ,! ,dep>tm5t ( ,vet]ans ,affairs   
%\ld cont9ue to advance rese>* &        

facilitate timely access to innovative  
treatm5ts & em]g+ !rapies1 includ+      
psy*$elic- & entactog5ic-assi/$ !rapies1
 = vet]ans ) su* unmet treatm5t ne$s4   
#c4 ,rese>* program ( ! ,dep>tm5t (     
,vet]ans ,affairs on innovative         
treatm5ts & em]g+ !rapies = c]ta9 cov]$ 
conditions  7a7 ,e/abli%m5t ,n lat] ?an 
#ij days aft] ! date ( enactm5t ( ?is   
,act1 ! ,secret>y ( ,vet]ans ,affairs   
%all develop an inve/igational rese>*   
program = ! treatm5t ( vet]ans diagnos$ 
) a cov]$ condition us+ innovative      
treatm5ts & em]g+ !rapies1 consi/5t )   
applicable ,f$]al law1 includ+ laws     
gov]n+ inve/igational m$ical products & 
controll$ sub/ances4 ,n lat] ?an #fj    
days aft] ! date ( ! enactm5t ( ?is     
,act1 ! ,secret>y %all designate a lead 
adm9i/rator to c>ry out ! rese>* &      
treatm5t program "u ?is section4  7b7   
,inve/igational rese>* program ,!       
,dep>tm5t ( ,vet]ans ,affairs may-- 7#a7
 conduct "o or m cl9ical trials = !     
treatm5t ( a cov]$ condition t include  

vet]ans z p>ticipants 9 ! cl9ical trial 
us+ innovative treatm5ts & em]g+        
!rapies1 :i* may be select$ foll[+ a    
review ( _! efficacy1 safety1 & ease (  
adm9i/ration2 &  7#b7 develop a         
compassionate or ext5d$ access protocol 
t facilitates consid]ation (1 & z       
appropriate access to1 innovative       
treatm5ts & em]g+ !rapies4  7c7         
,p>ticipation 9 cl9ical trials or ext5d$
 access ,! ,secret>y %all e/abli% a     
process "u :i* a vet]an diagnos$ ) a    
cov]$ condition may-- 7#a7 p>ticipate 9 
a cl9ical trial conduct$ "u ?is section2
 or  7#b7 be consid]$ = access to an    
innovative treatm5t or em]g+ !rapy "u a 
compassionate or ext5d$ access protocol1
 z cl9ically appropriate4  7d7          
,additional au?ority ,9 addition to     
c>ry+ out ! activities "u ?is section1 !
 ,secret>y may1 us+ am\nts o!rwise      
au?oriz$ to be appropriat$ & o!rwise    
available to ! ,dep>tm5t ( ,vet]ans     
,affairs1 support "o or m cl9ical rese>*
 trials us+ innovative treatm5ts & em]g+

 !rapies describ$ 9 subsection 7g74  7e7
 ,report requir$ ,n lat] ?an "o ye> aft]
 ! date ( ! enactm5t ( ?is ,act1 !      
,secret>y %all submit to ! ,committees  
on ,vet]ans' ,affairs ( ! ,h\se (       
,repres5tatives & ! ,s5ate a report1    
includ+ ! foll[+3 7#a7 ,id5tification ( 
cl9ics designat$ to ho/ activities "u   
su* a protocol "u ?is section & ! numb] 
( vet]ans expect$ to p>ticipate 9 a     
cl9ical trial conduct$ 9 subsection 7b72
  7#b7 ,in=mation on ! f9d+s & outcomes 
( su* cl9ical trials1 includ+ prelim9>y 
outcomes2 &  7#c7 ,a review ( all       
innovative treatm5ts & em]g+ !rapies    
utiliz$ = ! treatm5t ( cov]$ conditions1
 includ+ safety & efficacy /udies1 co/1 
regulatory1 & logi/ical consid]ations   
associat$ ) ea*4  7f7 ,sunset ,n lat]   
?an two ye>s aft] ! date ( enactm5t (   
?is ,act1 ! inve/igational program %all 
be review$ by ! ,secret>y ( ,vet]ans    
,affairs1 :o may !n *oose to ext5d or   
t]m9ate ! program at _! discretion4  7g7
 ,def9itions ,9 ?is section3 7#a7 ,! t]m

 innovative treatm5t means any ( !      
foll[+3 7,a7                            
#c1d-,me?yl5$ioxy-me?amphetam9e2  7,b7  
#e-,me?oxy-,n1,n-dime?yltryptam9e2  7,c7
 #e-,me?oxy-#b-;am9o9dane2  7,d7        
,iboga9e2  7,e7 ,ketam9e2  7,f7         
,psilocyb92 &  7,g7 ,su* o!r treatm5ts z
 may be designat$ by ! ,secret>y4  7#b7 
,! t]m em]g+ !rapies means any ( !      
foll[+3 7,a7 ,inve/igational            
ph>maceutical c&idates t meet !         
,gov]nm5t's ,def9ition ( ,recov]y2  7,b7
 ,inve/igational m$ical devices1 su* z  
deep bra9 neuro/imulation or hyp]b>ic   
oxyg5 !rapy2 &  7,c7 ,su* o!r !rapeutic 
int]v5tions z may be designat$ by !     
,secret>y4  7#c7 ,! t]m cov]$ condition 
means any ( ! foll[+3 7,a7 ,anxiety2    
7,b7 ,*ronic pa92  7,c7 ,depression2    
7,d7 ,po/-traumatic /ress disord]2  7,e7
 ,sub/ance use disord]s1 includ+ b n    
limit$ to alcohol use & coca9e use      
disord]s2  7,f7 ,traumatic bra9 injury2 
&  7,g7 ,su* o!r conditions z may be    
designat$ by ! ,secret>y4  7h7 ,rule (  

con/ruction ,no?+ 9 ?is section %all be 
con/ru$ to require or direct ! ,secret>y
 to act 9 a mann] inconsi/5t )          
applicable ,f$]al law1 includ+ laws     
gov]n+ inve/igational m$ical products & 
controll$ sub/ances4