,i  #aai? ,,congress  #b;d ,session  ,h4
 ,r4 #ieei  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,june #cj1 #bjbf,mr4  
,luttrell 7= himself1 ,mr4 ,mc,caul1    
,mr4 ,b]gman1 & ,mr4 ,correa7 introduc$ 
! foll[+ bill2 :i* 0 ref]r$ to !        
,committee on ,en]gy & ,comm]ce1 & 9    
addition to ! ,committees on !          
,judici>y1 & ,vet]ans' ,affairs1 = a    
p]iod to be subsequ5tly det]m9$ by !    
,speak]1 9 ea* case = consid]ation ( su*
 provisions z fall )9 ! jurisdiction ( !
 committee conc]n$  ,a ,,bill  ,to      
accel]ate ! developm5t (1 & access to1  
psy*$elic drugs t c\ld save lives &     
rev]se ! crisis ( s]i\s m5tal illness 9 
! ,unit$ ,/ates1 & = o!r purposes4  #a4 
,%ort title ,?is ,act may be cit$ z !   
,initiat+ ,biom$ical ,outcomes to ,g>n] 
,advancem5ts into ,innovative           
,neuropla/og5 ,efficacy ,act or !       
,,iboga9e ,act4  #b4 ,table ( cont5ts ,!
 table ( cont5ts ( ?is ,act is z foll[s3
  ,sec4 #a4 ,%ort title4 ,sec4 #b4      
,table ( cont5ts4 ,sec4 #c4 ,def9itions4

 ,sec4 #d4 ,national ,heal? ,priority   
,v\*] ,pilot ,program4 ,sec4 #e4        
,am5dm5t to ! ,f$]al "r to try law4     
,sec4 #f4 ,special regi/ration          
requirem5ts relat$ to "r to try4 ,sec4  
#g4 ,revis+ consid]ations = ,,dea quota 
requirem5ts4 ,sec4 #h4 ,f$]al-,/ate     
collaboration4 ,sec4 #i4 ,int]ag5cy     
collaboration ) ! private sector4 ,sec4 
#aj4 ,timely res*$ul+4 ,sec4 #aa4       
,designation ( s5ior (ficial = em]g+    
!rapeutic int]v5tions )9 ! ,dep>tm5t (  
,vet]ans ,affairs4 ,sec4 #ab4 ,em]g+    
!rapeutic int]v5tions at ! ,dep>tm5t (  
,vet]ans ,affairs4 ,sec4 #ac4 ,report on
 accel]at+ m$ical treatm5ts = s]i\s     
m5tal illness4  #c4 ,def9itions ,section
 #ajb ( ! ,controll$ ,sub/ances ,act    
7#ba ,u4,s4,c4 #hjb7 is am5d$ by add+ at
 ! end ! foll[+3  7#fa7 ,! t]m iboga9e  
means--  7,a7 all p>ts ( ! plant        
,tab]nan! iboga2 &  7,b7 any simil>     
comp\nd or analog t--  7i7 acts on      
neuropla/icity1 opioid receptors1 or    
s]oton]gic pa?ways t--  7,i7 int]rupt   

addiction cycles2 &  7,,ii7 re/ore      
neurological function disrupt$ by       
trauma1 *ronic sub/ance use1 or         
traumatic bra9 injury2 &  7ii7 are      
di/9ct 9 me*anism f ! break?r\gh !rapies
 designat$ "u section #ejf ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act4  4  #d4 
,national ,heal? ,priority ,v\*] ,pilot 
,program ,sub*apt] ,a ( *apt] ,v ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by
 add+ at ! end ! foll[+3  #ebd;,c4      
,national ,heal? ,priority ,v\*] ,pilot 
,program  7a7 ,def9itions ,9 ?is        
section3  7#a7 ,priority review ,! t]m  
priority review1 ) respect to a human   
drug application z def9$ 9 section      
#gce7a71 means review & action by !     
,secret>y on su* application n lat] ?an 
#f mon?s aft] receipt by ! ,secret>y (  
su* application1 z describ$ 9 ! ,manual 
( ,policies & ,proc$ures ( ! ,food &    
,drug ,adm9i/ration & goals id5tifi$ 9 !
 lett]s describ$ 9 section #aja7;c7 ( ! 
,food & ,drug ,adm9i/ration ,am5dm5ts   

,act ( #bjjg4  7#b7 ,national heal?     
priority review v\*] ,! t]m national    
heal? priority review v\*] means a v\*] 
issu$ by ! ,secret>y to ! sponsor ( a   
national heal? priority product         
application t entitles ! hold] ( su*    
v\*] to priority review ( a s+le human  
drug application submitt$ "u section    
#eje7;b77#a7 ( ?is ,act or section #cea 
( ! ,public ,heal? ,s]vice ,act aft] !  
date ( approval ( ! national heal?      
priority product application4  7#c7     
,national heal? priority product  ,! t]m
 national heal? priority product means  
any ( ! foll[+3  7,a7  ,public heal?    
crisis response  ,a product to treat or 
prev5t an urg5t or em]g+ ?reat t !      
,secret>y has id5tifi$ z hav+ a         
significant impact on ! population ( !  
,unit$ ,/ates4  7,b7  ,break?r\gh       
!rapies  ,a drug t-- 7i7 is designat$ z 
a break?r\gh !rapy "u section #ejf7;a72 
&  7ii7 is a trans=mative treatm5t ) "o 
or m novel me*anisms t fundam5tally     
*ange ! managem5t ( "o or m diseases or 

conditions4  7,c7  ,l>ge unmet m$ical   
ne$s  ,a !rapy = a disease or condition 
= :i* exi/+ treatm5ts inadequately      
address pati5t outcomes4  7,d7  ,on%or+ 
& supply *a9 resili5ce  ,a product ^:   
developm5t or manufacture 9 ! ,unit$    
,/ates w\ld /r5g!n ! ,nation's dome/ic  
capacity1 r$uce =eign dep5d5cy1 &       
improve national security ) respect to !
 drug supply *a94  7,e7  ,af=dability   
,a product t-- 7i7 improves ov]all value
 ?r\gh r$uc$ co/s to ! heal? c>e sy/em2 
or  7ii7 enhances access to important   
heal? c>e products4  7,f7 ,o!r products 
,any o!r national heal? priority product
 ^: approval w\ld--  7i7 address a heal?
 crisis 9 ! ,unit$ ,/ates2  7ii7 deliv] 
an innovative cure2  7iii7 address an   
unmet public heal? ne$2 &  7iv7 increase
 dome/ic drug manufactur+ z a matt] (   
national security4  7#d7 ,national heal?
 priority product application ,! t]m    
national heal? priority product         
application means an application t--    
7,a7 is a human drug application z def9$

 9 section #gce7a72 &  7,b7 is = a      
national heal? priority product4  7b7   
,priority review v\*]  7#a7 ,9 g5]al ,! 
,secret>y %all aw>d a national heal?    
priority review v\*] to ! sponsor ( a   
national heal? priority product         
application ^u approval by ! ,secret>y (
 su* application4  7#b7 ,prohibition on 
transf]ability ,! sponsor ( a national  
heal? priority product t receives a     
national heal? priority review v\*] may 
n transf] ! entitlem5t to su* v\*]1     
except t if own]%ip ( ! sponsor is      
transf]r$ to a diff]5t entity !         
entitlem5t to su* v\*] may be transf]r$ 
to su* entity z "p ( ! *ange 9 own]%ip4 
7#c7 ,limitations ,a sponsor ( a        
national heal? priority product         
application may n--  7,a7 receive m ?an 
"o national heal? priority review v\*]  
dur+ any #bd-mon? p]iod2 or  7,b7 apply 
= an additional national heal? priority 
review v\*] :ile 9 possession ( su* a   
v\*]4  7c7 ,priority v\*] us] fee  7#a7 
,9 g5]al ,! ,secret>y may e/abli% a us] 

fee program "u :i* a sponsor ( a human  
drug application t is ! subject ( a     
national heal? priority review v\*] %all
 pay to ! ,secret>y a fee det]m9$ "u    
p>agraph 7#b74 ,su* fee %all be 9       
addition to any fee requir$ to be       
submitt$ by ! sponsor "u *apt] ,,vii4   
7#b7 ,fee am\nt ,! am\nt ( ! us] fee "u 
p>agraph 7#a7 %all be det]m9$ ea* fiscal
 ye> by ! ,secret>y & bas$ on ! av]age  
co/ incurr$ by ! ag5cy 9 ! review ( a   
human drug application subject to       
priority review 9 ! previ\s fiscal ye>4 
7#c7 ,annual fee sett+ ,! ,secret>y %all
 e/abli%1 be=e ! beg9n+ ( ea* fiscal ye>
 beg9n+ aft] ,septemb] #cj1 #bjbf1 = t  
fiscal ye>1 ! am\nt ( ! us] fee "u      
p>agraph 7#a74  7#d7 ,(fsett+           
collections ,fees collect$ pursuant to  
?is subsection = any fiscal ye>--  7,a7 
%all be deposit$ & cr$it$ z (fsett+     
collections to ! acc\nt provid+         
appropriations to ! ,food & ,drug       
,adm9i/ration2 &  7,b7 %all n be        
collect$ = any fiscal ye> except to !   

ext5t provid$ 9 advance 9 appropriation 
,acts4  7d7 ,eligibility = o!r programs 
,no?+ 9 ?is section precludes a sponsor 
:o seeks a national heal? priority      
review v\*] f p>ticipat+ 9 any o!r      
inc5tive program1 includ+ "u ?is ,act1  
except t no sponsor ( a national        
priority heal? product application may  
receive m ?an "o national heal? priority
 review v\*] ) respect to ! drug = :i* !
 application is made4  7e7 ,relation to 
o!r provisions ,! provisions ( ?is      
section %all supplem5t1 n supplant1 any 
o!r provisions ( ?is ,act or ! ,public  
,heal? ,s]vice ,act t enc\rage !        
developm5t ( drugs = tropical diseases1 
r>e p$iatric diseases1 or national heal?
 priority products4  7f7 ,advice ,!     
,secret>y %all provide prompt advice to 
! sponsor ( a national heal? priority   
product application = :i* ! sponsor     
seeks a v\*] "u ?is section to enable ! 
sponsor-- 7#a7 to plan a developm5t     
program to obta9 ! necess>y data =      
approval ( ! national heal? priority    

product t is ! subject ( su*            
application2 &  7#b7 to conduct any     
additional /udies t w\ld be requir$ =   
approval ( su* product = use 9 a broad] 
population4  7g7 ,,gao /udy & report    
7#a7 ,/udy  7,a7 ,9 g5]al ,! ,comptroll]
 ,g5]al ( ! ,unit$ ,/ates %all conduct a
 /udy ( ! effectiv5ess ( aw>d+ national 
heal? priority review v\*]s 9 !         
developm5t ( human drug products4  7,b7 
,cont5ts ( /udy ,9 conduct+ ! /udy "u   
subp>agraph 7,a71 ! ,comptroll] ,g5]al  
%all exam9e ! foll[+3 7i7 ,) respect to 
ea* national heal? priority review v\*] 
aw>d$3  7,i7 ,:e!r1 & to :at ext5t1 an  
unmet ne$ relat$ to ! treatm5t or       
prev5tion ( a disease or condition 0 met
 ?r\gh ! approval ( a national heal?    
priority product4  7,,ii7 ,id5tification
 ( ea* drug = :i* ! v\*] 0 us$4  7,,iii7
 ,! l5g? ( ! p]iod ( "t betwe5 ! date on
 :i* ! v\*] 0 aw>d$ & ! date on :i* x 0 
us$4  7ii7 ,:e!r ! pa?way "u ?is section
 has help$ to provide safe & effective  
treatm5ts = pati5ts4  7iii7 ,:e!r a     

simil> v\*] program w\ld be appropriate 
= o!r categories ( drugs4  7#b7 ,report 
,n lat] ?an #a ye> aft] ! date (        
enactm5t ( ?is section1 ! ,comptroll]   
,g5]al %all submit to ! ,committee on   
,en]gy & ,comm]ce ( ! ,h\se (           
,repres5tatives & ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate1 a report conta9+ ! results ( 
! /udy "u p>agraph 7#a74  7h7 ,t]m9ation
 ( au?ority ,! ,secret>y may n aw>d a   
v\*] "u ?is section aft] ,septemb] #cj1 
#bjbi4  4  #e4 ,am5dm5t to ! ,f$]al "r  
to try law ,section #efa;,b7b7 ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;bbb-#j;a7b77 is     
am5d$ by ins]t+ any provision ( !       
,controll$ ,sub/ances ,act 7#ba         
,u4,s4,c4 #hja et seq47 t prohibits !   
unau?oriz$ use1 possession1 di/ribution1
 disp5sation1 or transportation ( an    
eligible inve/igational drug1 be=e &    
p>ts4  #f4 ,special regi/ration         
requirem5ts relat$ to "r to try  7a7    
,am5dm5t ,section #cjc ( ! ,controll$   

,sub/ances ,act 7#ba ,u4,s4,c4 #hbc7 is 
am5d$ by add+ at ! end ! foll[+3  7p7   
,special regi/ration = s*$ule ,i        
eligible inve/igational drugs "u "r to  
try  7#a7 ,def9itions ,9 ?is subsection1
 ! t]ms eligible inve/igational drug &  
eligible pati5t h ! mean+s giv5 ^? t]ms 
9 section #efa;,b ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj;bbb-#j;a74  7#b7 ,special          
regi/ration process ,! ,attorney ,g5]al 
%all regi/] physicians to directly      
adm9i/] eligible inve/igational drugs 9 
s*$ule ,i to eligible pati5ts "u section
 #efa;,b ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4           
#cfj;bbb-#j;a7 9 accordance ) p>agraphs 
7#c7 ?r\gh 7#f7 ( ?is subsection4  7#c7 
,requirem5ts  7,a7 ,application ,a      
physician desir+ a regi/ration to       
directly adm9i/] an eligible            
inve/igational drug z describ$ 9        
p>agraph 7#b7 %all submit to ! ,attorney
 ,g5]al an application conta9+--  7i7   
evid5ce ( a valid regi/ration to disp5se

 or adm9i/] controll$ sub/ances 9       
s*$ules ,,ii ?r\gh ,v2  7ii7 evid5ce (  
compliance ) section #efa;,b ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;bbb-#j;a71 includ+--     
7,i7 docum5tation f ! manufactur] or    
sponsor v]ify+ ! inve/igational drug 9  
s*$ule ,i is an eligible inve/igational 
drug2  7,,ii7 an agreem5t f !           
manufactur] or sponsor to supply !      
eligible inve/igational drug1 along )   
guidance on its adm9i/ration1 to !      
reque/+ physician = ! treatm5t (        
eligible pati5ts2 &  7,,iii7 an         
affirmation t ! physician w only        
directly adm9i/] ! eligible             
inve/igational drug to treat eligible   
pati5ts 9 a mann] consi/5t ) ! guidance 
provid$ by ! manufactur] or sponsor2    
7iii7 ! quantity ( ! eligible           
inve/igational drug to be suppli$ by !  
manufactur] or sponsor to ! physician to
 treat eligible pati5ts2  7iv7 evid5ce t
 ! physician is all[$ to treat pati5ts  
"u ! laws ( ! ,/ate 9 :i* ! treatm5t w  

take place2  7v7 a description ( ! site 
at :i* ! physician int5ds to /ore &     
adm9i/] ! eligible inve/igational drug2 
&  7vi7 any additional in=mation !      
,attorney ,g5]al det]m9es necess>y to   
prev5t div]sion4  7,b7 ,approval ,n lat]
 ?an #de days aft] receiv+ an           
application conta9+ ! in=mation requir$ 
"u subp>agraph 7,a71 ! ,attorney ,g5]al 
%all--  7i7 regi/] ! applicant2 or  7ii7
 s]ve an ord] to %[ cause ^u ! applicant
 9 accordance ) section #cjd7;c74  7#d7 
,electronic submissions ,! ,attorney    
,g5]al %all provide a means = a         
physician to submit an application "u   
p>agraph 7#c77;,a7 electronically4  7#e7
 ,limitation on am\nts ,a physician     
treat+ eligible pati5ts ) an eligible   
inve/igational drug 9 s*$ule ,i "u ?is  
subsection may only possess ! am\nts ( !
 eligible inve/igational drug id5tifi$  
9--  7,a7 ! application submitt$ to !   
,attorney ,g5]al "u p>agraph 7#c77;,a72 
or  7,b7 a supplem5tal notification t ! 
physician may submit to ! ,attorney     

,g5]al if ! physician ne$s additional   
am\nts ( ! eligible inve/igational drug 
= ! treatm5t ( eligible pati5ts1 :i*    
supplem5tal notification--  7i7 %all    
include-- 7,i7 ! "n ( ! physician2      
7,,ii7 ! additional quantity ( !        
eligible inve/igational drug ne$$2 &    
7,,iii7 an atte/ation t ! treatm5t ) !  
eligible inve/igational drug is consi/5t
 ) ! scope ( treatm5t t 0 ! subject ( ! 
application "u p>agraph 7#c77;,a72 &    
7ii7 %all be deem$ approv$ on ! date t  
is #cj days aft] ! date on :i* !        
physician submits ! supplem5tal         
notification to ! ,attorney ,g5]al1     
unless ! ,attorney ,g5]al s]ves an ord] 
to %[ cause ^u ! applicant 9 accordance 
) section #cjd7;c74  7#f7 ,s+le         
regi/ration = relat$ treatm5t sites ,a  
physician may treat eligible pati5ts )  
an eligible inve/igational drug 9 s*$ule
 ,i "u a s+le regi/ration "u ?is        
subsection if--  7,a7 ! treatm5t occurs 
exclusively on sites all ( :i* are-- 7i7
 )9 ! same city or c\nty2 &  7ii7 "u !  

control ( ! same in/itution1            
organization1 or ag5cy2 &  7,b7 be=e    
comm5c+ ! treatm5t1 ! physician notifies
 ! ,attorney ,g5]al ( ea* site :]e !    
eligible inve/igational drug w be /or$  
or adm9i/]$ 9 accordance ) p>agraph     
7#c77;,a77vi74  4  7b7 ,rulemak+        
,not)/&+ ! requirem5ts ( section #eec ( 
title #e1 ,unit$ ,/ates ,code1 n lat]   
?an #bdj days aft] ! date ( enactm5t (  
?is ,act1 ! ,attorney ,g5]al %all issue 
an int]im f9al rule to implem5t         
subsection 7p7 7z add$ by ?is section7 (
 section #cjc ( ! ,controll$ ,sub/ances 
,act 7#ba ,u4,s4,c4 #hbc71 includ+ )    
respect to-- 7#a7 ! mann] 9 :i* an      
eligible inve/igational drug may be     
deliv]$ to an approv$ regi/rant2  7#b7 !
 /orage & security ( an eligible        
inve/igational drug2  7#c7 ! ma9t5ance (
 records = an approv$ regi/rant2  7#d7 !
 process = r5ewal1 susp5sion1 or        
revocation ( a regi/ration2 &  7#e7 any 
o!r matt]s necess>y to ensure effective 
controls aga9/ div]sion4  7c7 ,f9al rule

 ,n lat] ?an #b ye>s aft] issu+ an      
int]im f9al rule "u subsection 7b71 !   
,attorney ,g5]al %all issue a f9al rule 
to implem5t subsection 7p7 7z add$ by   
?is section7 ( section #cjc ( !         
,controll$ ,sub/ances ,act 7#ba         
,u4,s4,c4 #hbc7 9 accordance ) section  
#eec ( title #e1 ,unit$ ,/ates ,code4   
#g4 ,revis+ consid]ations = ,,dea quota 
requirem5ts  7a7 ,9 g5]al ,section #cjf 
( ! ,controll$ ,sub/ances ,act 7#ba     
,u4,s4,c4 #hbf7 is am5d$--  7#a7 9      
subsection 7a7-- 7,a7 9 p>agraph 7#a7-- 
7i7 by /rik+ total2  7ii7 by ins]t+     
cl9ical1 aft] rese>*12 &  7iii7 by      
ins]t+ & p>agraph 7#c7 aft] 7#b72  7,b7 
9 p>agraph 7#b71 by ins]t+ 1 9          
consultation ) ! ,secret>y ( ,heal? &   
,human ,s]vices1 aft] if ! ,attorney    
,g5]al det]m9es2 &  7,c7 by add+ at !   
end ! foll[+3  7#c7 ,! ,attorney ,g5]al 
%all revise ! annually e/abli%$         
production quotas )9 #ij days = any     
basic class ( controll$ sub/ance 9      
s*$ule ,i1 & )9 #fj days = any basic    

class ( controll$ sub/ance 9 s*$ule     
,,ii1 if any ( ! foll[+ trigg]+ ev5ts   
occurs dur+ ! cal5d> ye>3  7,a7 ,a      
controll$ sub/ance 9 s*$ule ,i or ,,ii  
is transf]r$ or plac$ into ano!r class (
 controll$ sub/ances 9 accordance )     
applicable law4  7,b7 ,a controll$      
sub/ance 9 s*$ule ,i or ,,ii is approv$ 
or cle>$ by ! ,food & ,drug             
,adm9i/ration 9 accordance ) ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act4  7,c7 ,a
 controll$ sub/ance 9 s*$ule ,i or ,,ii 
is designat$ z a break?r\gh !rapy "u    
section #ejf ( su* ,act4  7,d7 ,an      
exemption = inve/igational use is grant$
 = a drug 9 s*$ule ,i or ,,ii           
inve/igational use "u section #eje7;i7 (
 su* ,act4  7,e7 ,a drug 9 s*$ule ,i or 
,,ii is approv$ by ! ,food & ,drug      
,adm9i/ration = use 9 a phase #c cl9ical
 trial4  2  7#b7 9 subsection 7c71 by   
add+ at ! end ! foll[+3 ,^u ! occurr5ce 
( a trigg]+ ev5t li/$ 9 subsection      
7a77#c7 ) respect to a controll$        
sub/ance1 a regi/]$ manufactur] may     

apply = an exp$it$ mid-ye> adju/m5t ( ! 
manufactur+ quota det]m9$ = su*         
manufactur] "u ?is subsection ) respect 
to su* controll$ sub/ance42 &  7#c7 by  
add+ at ! end ! foll[+3  7j7 ,!         
,attorney ,g5]al %all e/abli% annual    
suffici5cy /&>ds = ea* e/abli%$         
production quota at levels necess>y to  
meet ! legitimate m$ical1 sci5tific1    
rese>*1 cl9ical1 & indu/rial ne$s ( !   
,unit$ ,/ates4  4  #h4 ,f$]al-,/ate     
collaboration  7a7 ,9 g5]al ,us+ funds  
allocat$ pursuant to subsection 7c71 !  
,secret>y ( ,heal? & ,human ,s]vices 79 
?is section ref]r$ to z ! ,secret>y71   
act+ ?r\gh ! ,director ( ! ,advanc$     
,rese>* ,projects ,ag5cy--,heal?1 !     
,director ( ! ,national ,in/itutes (    
,heal?1 & ! ,assi/ant ,secret>y = ,m5tal
 ,heal? & ,sub/ance ,use1 may p>tn] )   
,/ates1 t]ritories1 & ,indian ,tribes to
 implem5t programs to advance rese>* on1
 & developm5t (1 psy*$elic drugs1       
includ+ iboga9e1 = treat+ s]i\s m5tal   
illnesses4  7b7 ,p>tn]%ips ,a p>tn]%ip  

"u subsection 7a7 may include--  7#a7 ! 
aw>d ( ,f$]al funds2  7#b7 ! provision (
 te*nical assi/ance2 &  7#c7 subject to 
applicable privacy & o!r law1 %>+ data4 
#i4 ,int]ag5cy collaboration ) ! private
 sector  7a7 ,program ,! ,secret>y (    
,heal? & ,human ,s]vices 79 ?is section 
ref]r$ to z ! ,secret>y71 9             
collaboration ) ! ,secret>y ( ,vet]ans  
,affairs1 %all c>ry out a program to    
collaborate ) ! private sector to       
increase cl9ical trial p>ticipation1    
data %>+1 & real-_w evid5ce g5]ation    
reg>d+ psy*$elic drugs4  7b7 ,prioritiz+
 break?r\gh !rapies ,9 c>ry+ out !      
program "u subsection 7a71 ! ,secret>y  
%all prioritize collaboration reg>d+    
psy*$elic drugs t are designat$ z a     
break?r\gh !rapy "u section #ejf7;a7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cef7;a774  7c7          
,provision ( ,,hhs & ,,va data f cl9ical
 /udies to ,,fda  7#a7 ,int]ag5cy       
agreem5t ,subject to p>agraph 7#b71 !   
,secret>y ( ,heal? & ,human ,s]vices1 ! 

,secret>y ( ,vet]ans ,affairs1 & ! heads
 ( o!r ,f$]al dep>tm5ts & ag5cies1 %all 
ent] into agreem5ts to provide data f   
f$]ally conduct$ or support$ cl9ical    
trials to ! ,food & ,drug ,adm9i/ration 
to facilitate ! timely evaluation &     
approval or lic5sure 7z applicable7 (   
drugs 7includ+ biological products7 "u  
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cea7 or  
section #cea ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #cea74  7#b7        
,applicable provisions ,! provision (   
data "u p>agraph 7#a7 %all be subject to
 o!r applicable law1 includ+ any privacy
 re/rictions "u ! ,privacy ,act ( #aigd 
7#e ,u4,s4,c4 #eeb;a7 & ! ,heal?        
,insurance ,portability & ,acc\ntability
 ,act ( #aiif 7,public ,law #ajd-aia74  
#aj4 ,timely res*$ul+  7a7 ,9 g5]al     
,section #bja ( ! ,controll$ ,sub/ances 
,act 7#ba ,u4,s4,c4 #haa7 is am5d$ by   
add+ at ! end ! foll[+3  7k7  7#a7 ,^u  
successful completion ( phase #c cl9ical
 trials = a drug 9 s*$ule ,i int5d$ to  

treat a s]i\s m5tal heal? disord]1 !    
,attorney ,g5]al1 9 consultation ) !    
,secret>y ( ,heal? & ,human ,s]vices1   
%all initiate & complete proce$+s "u    
subsection 7a7 to det]m9e :e!r to place 
su* drug 9 ano!r s*$ule4  7#b7 ,!       
,attorney ,g5]al %all complete proce$+s 
"u subsection 7a7 = a drug z quickly z  
practicable4  7#c7 ,9 ?is subsection1 ! 
t]m phase #c cl9ical trial means phase  
#c cl9ical inve/igations conduct$       
pursuant to an exemption =              
inve/igational use "u section #eje7;i7 (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 or section #cea7;a77#c7 ( ! ,public    
,heal? ,s]vice ,act4  4  7b7 ,necess>y  
/eps = res*$ul+ det]m9ation ,not)/&+    
section #bja & subsections 7a7 & 7b7 (  
section #bjb ( ! ,controll$ ,sub/ances  
,act 7#ba ,u4,s4,c4 #haa1 #hab7 respect+
 ! s*$ul+ ( controll$ sub/ances1 !      
,attorney ,g5]al %all1 by ord]1 n lat]  
?an #fj days aft] ! date ( enactm5t (   
?is ,act1 take all necess>y /eps to     
det]m9e :e!r to transf] iboga9e &       

iboga9e comp\nds f s*$ule ,i ( su* ,act 
to s*$ule ,,ii ( su* ,act4  #aa4        
,designation ( s5ior (ficial = em]g+    
!rapeutic int]v5tions )9 ! ,dep>tm5t (  
,vet]ans ,affairs  7a7 ,designation ,n  
lat] ?an #ij days aft] ! date ( enactm5t
 ( ?is ,act1 ! ,"u ,secret>y = ,heal? ( 
! ,dep>tm5t ( ,vet]ans ,affairs %all    
designate a s5ior (ficial ( ! ,dep>tm5t 
to ov]see policy1 programs1 & o!r       
activities relat$ to em]g+ !rapeutic    
int]v5tions4  7b7 ,role1 responsibility1
 & au?ority ,! ,"u ,secret>y = ,heal?1 9
 consultation ) ! ,secret>y ( ,vet]ans  
,affairs1 %all prescribe ! roles1       
responsibilities1 & au?orities ( !      
(ficial designat$ "u subsection 7a71    
includ+--  7#a7 assi/+ ! ,secret>y (    
,vet]ans ,affairs1 ! ,deputy ,secret>y (
 ,vet]ans ,affairs1 & ! ,"u ,secret>y = 
,heal? ) policies1 op]ations1 programs1 
& activities relat+ to em]g+ !rapeutic  
int]v5tions2  7#b7 work+ 9 coord9ation )
 ! ,secret>y ( ,heal? & ,human ,s]vices1
 ! ,commission] ( ,food & ,drugs1 !     

,secret>y ( ,def5se1 & ! ,attorney      
,g5]al to improve ! effici5cy &         
effectiv5ess ( all activities relat$ to 
em]g+ !rapeutic int]v5tions )9 !        
,dep>tm5t ( ,vet]ans ,affairs2 &  7#c7  
work+ ) ,f$]al ag5cies1 ,/ate & local   
gov]nm5ts1 & nongov]nm5tal organizations
 to improve ! deliv]y (1 & access to1   
em]g+ !rapeutic int]v5tions4  7c7       
,brief+ on designation & implem5tation  
,n lat] ?an #ij days aft] ! date (      
enactm5t ( ?is ,act1 ! ,secret>y (      
,vet]ans ,affairs %all provide a brief+ 
to ! ,committees on ,vet]ans' ,affairs (
 ! ,h\se ( ,repres5tatives & ,s5ate on--
  7#a7 ! /atus ( ! designation ( !      
(ficial "u subsection 7a72 &  7#b7 !    
implem5tation ( ! roles1                
responsibilities1 & ! au?orities ( !    
(ficial "u subsection 7b74  #ab4 ,em]g+ 
!rapeutic int]v5tions at ! ,dep>tm5t (  
,vet]ans ,affairs  7a7 ,report  7#a7 ,9 
g5]al ,n lat] ?an #fj days aft] ! date (
 enactm5t ( ?is ,act1 & biannually      
!reaft]1 ! ,"u ,secret>y = ,heal? ( !   

,dep>tm5t ( ,vet]ans ,affairs %all      
submit to ! ,committees on ,vet]ans'    
,affairs ( ! ,h\se ( ,repres5tatives &  
,s5ate a report on ! activities ( !     
,dep>tm5t ) respect to em]g+ !rapeutic  
int]v5tions1 includ+ psy*$elic-assi/$   
!rapies4  7#b7 ,cont5ts ,at a m9imum1   
ea* report "u p>agraph 7#a7 %all1 )     
respect to em]g+ !rapeutic int]v5tions1 
include--  7,a7 a summ>y ( rese>*       
activities1 includ+ a li/ ( active &    
plann$ cl9ical trials1 ( ! ,dep>tm5t    
relat+ to em]g+ !rapeutic int]v5tions2  
7,b7 an id5tification ( key f9d+s f     
cl9ical outcomes & pati5t-report$       
outcomes made dur+ cl9ical trials       
conduct$ or support$ by ! ,dep>tm5t2    
7,c7 ! numb] ( vet]ans enroll$ 9        
treatm5t programs & cl9ical trials      
relat$ to em]g+ !rapeutic int]v5tions2  
7,d7 int]ag5cy coord9ation ef=ts ( !    
,dep>tm5t1 includ+ ) ! ,food & ,drug    
,adm9i/ration1 ! ,drug ,en=cem5t ,ag5cy1
 & o!r relevant gov]nm5t ag5cies2  7,e7 
recomm5dations to improve ! deliv]y (   

innovative !rapies to vet]ans1 includ+  
psy*$elic-assi/$ !rapies2 &  7,f7       
recomm5dations = legislative or         
adm9i/rative actions relat+ to em]g+    
!rapeutic int]v5tions4  7b7 ,work=ce    
read9ess ,! ,"u ,secret>y = ,heal? ( !  
,dep>tm5t ( ,vet]ans ,affairs %all      
develop a work=ce implem5tation-read9ess
 plan = em]g+ !rapeutic int]v5tions     
7includ+ psy*$elic-assi/$ !rapies71     
includ+-- 7#a7 conduct+ a               
work=ce-read9ess assessm5t to id5tify   
cl9icians & pe] support speciali/s )    
prior tra9+ or c]tification relevant to 
em]g+ !rapeutic int]v5tions & gaps 9    
tra9+1 sup]vision1 & cl9ical capacity   
necess>y to support safe & effective    
implem5tation ( su* int]v5tions2  7#b7  
develop+ a /&>diz$1 compet5cy-bas$ tra9+
 framework = cl9icians & pe] support    
speciali/s p>ticipat+ 9 em]g+ !rapeutic 
int]v5tions1 includ+ safety monitor+1   
sup]vision /&>ds1 compet5t c>e1         
int]discipl9>y collaboration1 & o!r     
areas :]e appropriate2 &  7#c7 develop+ 

& implem5t+ a plan to ensure tra9+1 us+ 
su* framework1 is conduct$1 & cr$5tial+ 
/&>ds are appli$1 ) respect to !        
appropriate cl9icians & m$ical c5t]s ( !
 ,dep>tm5t1 includ+ any c5t]s (         
excell5ce1 9 a mann] design$ to ensure  
access across ea* ,vet]ans ,integrat$   
,s]vice ,network4  #ac4 ,report on      
accel]at+ m$ical treatm5ts = s]i\s m5tal
 illness  7a7 ,9 g5]al ,n lat] ?an #ahj 
days aft] ! date ( enactm5t ( ?is ,act1 
! ,secret>y ( ,vet]ans ,affairs1 9      
collaboration ) ! ,commission] ( ,food &
 ,drugs & ! ,adm9i/rator ( ! ,drug      
,en=cem5t ,ag5cy1 %all provide a report 
to ! appropriate committees ( ,congress 
on ! implem5tation ( ,executive ,ord]   
#addja 7#ia ,f$4 ,reg4 #bagji1 relat+ to
 accel]at+ m$ical treatm5ts = s]i\s     
m5tal illness74  7b7 ,appropriate       
committees ( ,congress ,9 ?is section1 !
 t]m appropriate committees ( ,congress 
means--  7#a7 ! ,committee on ,en]gy &  
,comm]ce ( ! ,h\se ( ,repres5tatives2   
7#b7 ! ,committee on ,vet]ans' ,affairs 

( ! ,h\se ( ,repres5tatives2  7#c7 !    
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions ( ! ,s5ate2 &  7#d7 !
 ,committee on ,vet]ans' ,affairs ( !   
,s5ate4