,i  #aae? ,,congress  #b;d ,session  ,h4
 ,r4 #ehjf  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,may #ae1 #bjah,mr4   
,burgess 7= himself1 ,mr4 ,buc%on1 &    
,mr4 ,griffi?7 introduc$ ! foll[+ bill2 
:i* 0 ref]r$ to ! ,committee on ,en]gy &
 ,comm]ce  ,a ,,bill  ,to require !     
,secret>y ( ,heal? & ,human ,s]vices to 
issue guidance ) respect to ! exp$it$   
approval ( c]ta9 drugs1 & = o!r         
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! #ba/ ,c5tury ,tools = ,pa9 
& ,addiction ,treatm5t ,act4  #b4       
,cl>ify+ ,,fda regulation (             
non-addictive pa9 & addiction !rapies   
7a7 ,public meet+s ,n lat] ?an #a ye>   
aft] ! date ( enactm5t ( ?is ,act1 !    
,secret>y ( ,heal? & ,human ,s]vices1   
act+ ?r\gh ! ,commission] ( ,food &     
,drugs1 %all hold n less ?an "o public  
meet+ to address ! *all5ges & b>ri]s (  
develop+ non-addictive m$ical products  
int5d$ to treat pa9 or addiction1 :i*   
may include--  7#a7 ! application (     
novel cl9ical trial designs 7consi/5t ) 

section #cjba ( ! #ba/ ,c5tury ,cures   
,act 7,public ,law #aad-bee771 use (    
real _w evid5ce 7consi/5t ) section     
#eje;,f ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cee;g771 
& use ( pati5t exp]i5ce data 7consi/5t )
 section #efi;,c ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj;bbb-#h;c77 = ! developm5t (        
non-addictive m$ical products int5d$ to 
treat pa9 or addiction2 &  7#b7 !       
application ( eligibility crit]ia "u    
sections #ejf & #eae;,b ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cef1 #cfj;e-#c7 =            
non-addictive m$ical products int5d$ to 
treat pa9 or addiction4  7b7 ,guidance  
,n lat] ?an "o ye> aft] ! public meet+s 
are conduct$ "u subsection 7a7 !        
,secret>y %all issue "o or m f9al       
guidance docum5ts1 or update exi/+      
guidance docum5ts1 to help address      
*all5ges to develop+ non-addictive      
m$ical products to treat pa9 or         
addiction4 ,su* guidance docum5ts %all  

include in=mation reg>d+--  7#a7 h[ !   
,food & ,drug ,adm9i/ration may apply   
sections #ejf & #eae;,b ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cef1 #cfj;e-#c7 to           
non-addictive m$ical products int5d$ to 
treat pa9 or addiction1 includ+ !       
circum/ances "u :i* ! ,secret>y--  7,a7 
may apply ! eligibility crit]ia "u su*  
sections #ejf & #eae;,b to non-opioid or
 non-addictive m$ical products int5d$ to
 treat pa9 or addiction2  7,b7 consid]s 
! risk ( addiction ( controll$ sub/ances
 approv$ to treat pa9 :5 e/abli%+ unmet 
m$ical ne$2 &  7,c7 consid]s pa91 pa9   
control1 or pa9 managem5t 9 assess+ :e!r
 a disease or condition is a s]i\s or   
life-?reat5+ disease or condition2 &    
7#b7 ! me?ods by :i* sponsors may       
evaluate acute & *ronic pa91 endpo9ts = 
non-addictive m$ical products int5d$ to 
treat pa91 ! mann] 9 :i* endpo9ts &     
evaluations ( efficacy w be appli$      
across & )9 review divisions1 tak+ into 
consid]ation ! etiology ( ! und]ly+     

disease1 & ! mann] 9 :i* sponsors may   
use surrogate endpo9ts1 int]m$iate      
endpo9ts1 & real _w evid5ce4  7c7       
,m$ical product def9$ ,9 ?is section1 ! 
t]m m$ical product means a drug 7z def9$
 9 section #bja7;g77#a7 ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cba7;g77#a7771 biological    
product 7z def9$ 9 section #cea7;i7 ( ! 
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7;i7771 or device 7z def9$
 9 section #bja7;h7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cba7;h7774