#aae? ,,congress  #b;d ,session  ,h4 ,r4
 #edgc  ,,an ,,act  ,to direct !        
,secret>y ( ,heal? & ,human ,s]vices to 
update or issue "o or m guidances       
address+ alt]native me?ods = data       
collection on opioid sp>+ & inclusion ( 
su* data 9 product label+1 & = o!r      
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,bett] ,pa9 ,managem5t     
,?r\gh ,bett] ,data ,act ( #bjah4  #b4  
,guidance address+ alt]native approa*es 
to data collection & label+ claims =    
opioid sp>+  7a7 ,9 g5]al ,= purposes ( 
assi/+ sponsors 9 collect+ & incorporat+
 opioid-sp>+ data 9 product label+1 !   
,secret>y ( ,heal? & ,human ,s]vices    
7ref]r$ to 9 ?is section z ! ,secret>y7 
%all conduct a public meet+ & update or 
issue "o or m guidances 9 accordance )  
subsection 7b74  7b7 ,guidance  7#a7 ,9 
g5]al ,! ,secret>y ( ,heal? & ,human    
,s]vices1 act+ ?r\gh ! ,commission] (   
,food & ,drugs1 %all update or issue "o 
or m guidances address+-- 7,a7          
alt]native me?ods = data collection on  

opioid sp>+2  7,b7 alt]native me?ods =  
inclusion ( su* data 9 product label+2 &
  7,c7 inve/igations o!r ?an cl9ical    
trials1 includ+ p>tially controll$      
/udies & objective trials )\t mat*$     
controls su* z hi/orically controll$    
analyses1 op5-label /udies1 &           
meta-analyses1 on opioid sp>+ =         
inclusion 9 product label+4  7#b7       
,cont5ts ,! guidances "u p>agraph 7#a7  
%all address-- 7,a7 innovative cl9ical  
trial designs = e?ically & effici5tly   
collect+ data on opioid sp>+ = inclusion
 9 product label+2  7,b7 prim>y &       
second>y endpo9ts = ! r$uction ( opioid 
use :ile ma9ta9+ adequate pa9 control2  
7,c7 use ( real _w evid5ce1 includ+     
pati5t regi/ries1 & pati5t report$      
outcomes to support inclusion (         
opioid-sp>+ data 9 product label+2 &    
7,d7 h[ sponsors may obta9 fe$back f !  
,secret>y relat+ to su* issues prior    
to-- 7i7 comm5cem5t ( su* data          
collection2 or  7ii7 ! submission (     
result+ data to ! ,secret>y4  7#c7      

,public meet+ ,prior to updat+ or issu+ 
! guidances requir$ by p>agraph 7#a71 ! 
,secret>y %all consult ) /akehold]s1    
includ+ repres5tatives ( regulat$       
indu/ry1 academia1 pati5ts1 & provid]   
organizations1 ?r\gh a public meet+ to  
be held n lat] ?an #ab mon?s aft] ! date
 ( enactm5t ( ?is ,act4  7#d7 ,tim+ ,!  
,secret>y %all-- 7,a7 n lat] ?an #ab    
mon?s aft] ! date ( ! public meet+      
requir$ by p>agraph 7#c71 update or     
issue ! "o or m draft guidances requir$ 
by p>agraph 7#a72 &  7,b7 n lat] ?an #ab
 mon?s aft] ! date on :i* ! public      
comm5t p]iod = su* draft guidances      
closes1 f9alize su* guidances4  7c7     
,def9ition ,9 ?is section3  7#a7 ,! t]ms
 opioid sp>+ & opioid-sp>+ ref] to ! use
 ( drugs or devices 7z def9$ 9 section  
#bja ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cba77 t  
r$uce pa9 :ile enabl+ ! r$uction1       
replacem5t1 or avoidance ( oral opioids4
  7#b7 ,! t]m ,secret>y means !         
,secret>y ( ,heal? & ,human ,s]vices4   

,pass$ ! ,h\se ( ,repres5tatives ,june  
#ab1 #bjah4;,cl]k4