,i  #aai? ,,congress  #b;d ,session  ,h4
 ,r4 #iedg  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,june #cj1 #bjbf,mr4  
,hamadeh ( ,arizona 7= himself1 ,mr4    
,bacon1 ,mr4 ,cr5%aw1 & ,mr4 ,m\lton7   
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,arm$ ,s]vices  ,a     
,,bill  ,to direct ! ,secret>y ( ,def5se
 to submit to ,congress a report on     
em]g+ inve/igational treatm5t options = 
treatm5t-resi/ant po/-traumatic /ress   
disord] 9 vet]ans1 memb]s ( ! ,arm$     
,=ces1 & memb]s transition+ to civilian 
life1 & = o!r purposes4  #a4 ,%ort title
 ,?is ,act may be cit$ z ! ,vet]ans &   
,s]vicememb]s ,,ptsd ,em]g+ ,treatm5t   
,review ,act ( #bjbf4  #b4 ,report on   
em]g+ treatm5t options =                
treatm5t-resi/ant po/-traumatic /ress   
disord]  7a7 ,f9d+s ,congress f9ds !    
foll[+3  7#a7 ,po/-traumatic /ress      
disord] (t5 orig9ates dur+ milit>y      
s]vice & c h p]si/5t effects on =ce     
heal?1 m$ical read9ess1 ret5tion1 family
 /ability1 & successful transition f    

milit>y s]vice to civilian life4  7#b7  
,memb]s ( ! res]ve compon5ts & ,national
 ,gu>d may also s]ve 9 civilian fir/    
respond] roles1 result+ 9 cumulative    
trauma exposure t may comp\nd           
s]vice-connect$ m5tal heal? burd5s4     
7#c7 ,exi/+ !rapies = po/-traumatic     
/ress disord] are n effective = all     
pati5ts1 & treatm5t-resi/ant cases may  
be associat$ ) elevat$ risks ( *ronic   
impairm5t1 sub/ance misuse1 suicidality1
 & r$uc$ read9ess4  7#d7 ,rigor\s1      
e?ical cl9ical rese>* conduct$ 9        
accordance ) ,f$]al law & =ce heal?     
protection /&>ds is necess>y to evaluate
 em]g+ treatm5ts = s]vice-connect$ m5tal
 heal? conditions :]e exi/+ !rapies h   
prov5 insuffici5t4  7#e7 ,! ,/ate (     
,arizona has enabl$ regulatory &        
adm9i/rative support = cl9ical trials   
au?oriz$ by ! ,food & ,drug             
,adm9i/ration evaluat+ naturally d]iv$1 
:ole-mu%room psilocyb9 adm9i/]$ )9 a    
/ructur$ gr\p-!rapy sett+ = ! treatm5t (
 po/-traumatic /ress disord] 9 vet]ans &

 fir/ respond]s4  7#f7 ,private-sector  
innovators & public-private p>tn]%ips   
play a c5tral role 9 develop+1 supply+1 
& evaluat+ f$]ally lawful inve/igational
 products us$ 9 su* cl9ical trials4     
7#g7 ,cl9ical data f ! r&omiz$ controll$
 ,phase ,i ,passage ,trial & ! ,phase   
,,ii ,=titude ,trial sponsor$ by ! ,/ate
 ( ,arizona may provide relevant        
in=mation reg>d+ safety1 dos+1 adv]se   
ev5ts1 feasibility1 & op]ational        
consid]ations = future rese>* involv+   
vet]ans1 s]vicememb]s1 & transition+    
s]vicememb]s4  7#h7 ,c>eful review by ! 
,dep>tm5t ( ,def5se ( safety1 dos+1     
feasibility1 & cont9uity-(-c>e          
consid]ations associat$ ) em]g+         
inve/igational !rapies is appropriate to
 in=m future =ce heal? protection       
policy1 m$ical read9ess plann+1 suicide 
prev5tion ef=ts1 & milit>y-to-civilian  
transition support4  7#i7 ,any pot5tial 
exp&$ access pa?way or pilot activity   
involv+ an inve/igational ,s*$ule ,i    
sub/ance mu/ be evaluat$ 9 accordance ) 

applicable ,f$]al law & regulations1    
includ+ requirem5ts adm9i/]$ by ! ,food 
& ,drug ,adm9i/ration & ! ,drug         
,en=cem5t ,adm9i/ration1 & applicable   
regulatory ag5cies %\ld act 9 a timely  
mann] to issue or update regulations1   
guidance1 au?orizations1 & proc$ures    
necess>y to enable lawful rese>* &      
access = eligible pati5ts1 consi/5t ) ! 
,f$]al ,"r to ,try ,act1 exp&$ access   
au?orities1 & ! ,april #ah1 #bjbf1      
,executive ,ord] titl$ ,accel]at+       
,m$ical ,treatm5ts = ,s]i\s ,m5tal      
,illness1 :ile ma9ta9+ appropriate      
safety1 security1 & div]sion-control    
safegu>ds4  7#aj7 ,congress has a       
responsibility to ensure t ! ,dep>tm5t (
 ,def5se assesses :e!r em]g+ cl9ical    
rese>* may (f] future b5efit =          
active-duty s]vicememb]s1 res]ve        
compon5t memb]s1 vet]ans1 & transition+ 
s]vicememb]s ) treatm5t-resi/ant        
po/-traumatic /ress disord]4  7b7       
,report ,n lat] ?an #ahj days aft] !    
date ( ! enactm5t ( ?is ,act1 !         

,assi/ant ,secret>y ( ,def5se = ,heal?  
,affairs %all submit to ! congressional 
def5se committees a report on !         
op]ational relevance1 safety1 dos+1 &   
feasibility ( data f ! cov]$ cl9ical    
trial z su* data w\ld apply to memb]s ( 
! ,arm$ ,=ces1 includ+ su* memb]s       
transition+ to civilian life4  7c7      
,elem5ts ,! report "u subsection 7b7    
%all include ! foll[+3  7#a7 ,a summ>y (
 ! safety1 dos+1 & adv]se ev5t data f ! 
cov]$ cl9ical trial t has be5 review$ by
 any relevant dep>tm5t or ag5cy ( !     
,f$]al ,gov]nm5t1 or t is o!rwise       
available to ! ,dep>tm5t ( ,def5se1 & an
 analysis by ! ,dep>tm5t ( ,def5se ( !  
applicability ( su* data to memb]s ( !  
,arm$ ,=ces4  7#b7 ,an assessm5t ( !    
implications ( su* data = =ce heal?     
protection1 m$ical read9ess1 & suicide  
prev5tion /rategies1 includ+            
id5tification ( any gaps 9 exi/+        
treatm5t options = memb]s ( ! ,arm$     
,=ces ) treatm5t-resi/ant po/-traumatic 
/ress disord]4  7#c7 ,a description ( ! 

legal & regulatory requirem5ts = any    
pot5tial exp&$ access pa?way involv+ an 
inve/igational ,s*$ule ,i sub/ance1     
includ+ coord9ation requirem5ts ) !     
,food & ,drug ,adm9i/ration & ! ,drug   
,en=cem5t ,adm9i/ration4  7#d7 ,an      
assessm5t ( ! applicability ( ! ,f$]al  
"r to try ! pa?way "u section #efa;,b ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cfj;bbb-#j;a7 & "u      
,executive ,ord] ,no4 #addja 7#ia ,f$4  
,reg4 #bagji2 relat+ to accel]at+ m$ical
 treatm5ts = s]i\s m5tal illness7 ! =   
treatm5t-resi/ant po/-traumatic /ress   
disord] & associat$ comorbidities1      
includ+ elevat$ suicide risk dur+       
po/-deploym5t & transition p]iods4  7#e7
 ,an assessm5t ( consid]ations necess>y 
to ensure cont9uity ( c>e = memb]s ( !  
,arm$ ,=ces transition+ f receiv+ heal? 
c>e at milit>y m$ical treatm5t          
facilities to receiv+ heal? c>e furni%$ 
by ! ,vet]ans ,heal? ,adm9i/ration1     
includ+-- 7,a7 eligibility crit]ia2     
7,b7 cl9ical treatm5t ov]sight2  7,c7   

in=m$ cons5t proc$ures2  7,d7 safety    
monitor+2 &  7,e7 adv]se ev5t report+4  
7#f7 ,an assessm5t ( ! f9ancial         
res\rces1 work=ce1 & infra/ructure      
requirem5ts1 & a propos$ timel9e1 = any 
pot5tial pilot activities or exp&$      
cl9ical rese>* beg9n+ 9 fiscal ye>      
#bjbg1 & = any broad] implem5tation     
occurr+ !reaft]1 z appropriate4  7d7    
,coord9ation & consultation ,! ,assi/ant
 ,secret>y ( ,def5se = ,heal? ,affairs  
%all develop ! report "u subsection 7b7 
9 coord9ation ) ! ,director ( ! ,def5se 
,heal? ,ag5cy & 9 consultation ) !      
,secret>y ( ,vet]ans ,affairs1 !        
,secret>y ( ,heal? & ,human ,s]vices1 ! 
,commission] ( ,food & ,drugs1 & ! heads
 ( o!r dep>tm5ts & ag5cies ( ! ,f$]al   
,gov]nm5t ! ,assi/ant ,secret>y det]m9es
 appropriate4  7e7 ,=m ,! report requir$
 "u subsection 7b7 %all be submitt$ 9   
unclassifi$ =m1 b may include a         
classifi$ annex if necess>y4  7f7       
,def9itions ,9 ?is section3  7#a7 ,! t]m
 congressional def5se committees has !  

mean+ giv5 t t]m 9 section #aja7;a77#af7
 ( title #aj1 ,unit$ ,/ates ,code4  7#b7
 ,! t]m cov]$ cl9ical trial means !     
cl9ical trial conduct$ 9 #bjbf titl$ ,an
 ,op5-,label1 ,phase #a ,/udy ( !       
,safety ,ph>macok9etic ,pr(ile1 &       
,prelim9>y ,efficacy1 ( ,organic ,:ole  
,psilocyb9-,conta9+ ,mu%rooms 9 ,pati5ts
 ,suff]+ ,f ,,ptsd4