#aad? ,,congress  #b;d ,session  ,h4 ,r4
 #digf  ,,an ,,act  ,to require !       
,commission] ( ,food & ,drugs to seek   
recomm5dations f an advisory committee (
 ! ,food & ,drug ,adm9i/ration be=e     
approval ( c]ta9 new drugs t are opioids
 )\t abuse-det]r5t prop]ties1 & = o!r   
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,opioid ,review            
,mod]nization ,act ( #bjaf4  #b4 ,,fda  
opioid action plan ,*apt] ,v ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act is am5d$ 
by ins]t+ aft] section #efi ( su* ,act  
7#ba ,u4,s4,c4 #cej;bbb-#h7 ! foll[+3   
#efi-a4 ,opioid action plan  7a7 ,new   
drug application  7#a7 ,9 g5]al ,subject
 to p>agraph 7#b71 prior to ! approval  
pursuant to an application "u section   
#eje7;b7 ( a new drug t is an opioid &  
does n h abuse-det]r5t prop]ties1 !     
,secret>y %all ref] ! application to an 
advisory committee ( ! ,food & ,drug    
,adm9i/ration to seek recomm5dations f  
su* advisory committee4  7#b7 ,public   
heal? exemption ,a ref]ral to an        

advisory committee "u p>agraph 7#a7 is n
 requir$ ) respect to a new drug if !   
,secret>y--  7,a7 f9ds t su* a ref]ral  
is n 9 ! int]e/ ( protect+ & promot+    
public heal?2  7,b7 f9ds t su* a ref]ral
 is n necess>y bas$ on a review ( !     
relevant sci5tific in=mation2 &  7,c7   
submits a notice conta9+ ! rationale =  
su* f9d+s to ! ,committee on ,heal?1    
,education1 ,labor1 & ,p5sions ( !      
,s5ate & ! ,committee on ,en]gy &       
,comm]ce ( ! ,h\se ( ,repres5tatives4   
7b7 ,p$iatric opioid label+ ,! ,secret>y
 %all conv5e ! ,p$iatric ,advisory      
,committee ( ! ,food & ,drug            
,adm9i/ration to seek recomm5dations f  
su* ,committee reg>d+ a framework = !   
inclusion ( in=mation 9 ! label+ ( drugs
 t are opioids relat+ to ! use ( su*    
drugs 9 p$iatric populations be=e !     
,secret>y approves any label+ or *ange  
to label+ = any drug t is an opioid     
int5d$ = use 9 a p$iatric population4   
7c7 ,sunset ,! requirem5ts ( subsections
 7a7 & 7b7 %all cease to be effective on

 ,octob] #a1 #bjbb4  4  #c4 ,prescrib]  
education ,n lat] ?an #a ye> aft] ! date
 ( ! enactm5t ( ?is ,act1 ! ,secret>y ( 
,heal? & ,human ,s]vices1 act+ ?r\gh !  
,commission] ( ,food & ,drugs1 z "p ( ! 
,food & ,drug ,adm9i/ration's evaluation
 ( ! ,ext5d$-,release_/,long-,act+      
,opioid ,analgesics ,risk ,evaluation & 
,mitigation ,/rategy1 & 9 consultation )
 relevant /akehold]s1 %all develop      
recomm5dations reg>d+ education programs
 = prescrib]s ( opioids pursuant to     
section #eje-a ( ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a71
 includ+ recomm5dations on--  7#a7 :i*  
prescrib]s %\ld p>ticipate 9 su*        
programs2 &  7#b7 h[ (t5 p>ticipation 9 
su* programs is necess>y4  #d4 ,guidance
 on evaluat+ ! abuse det]r5ce ( g5]ic   
solid oral opioid drug products ,n lat] 
?an #b ye>s aft] ! end ( ! p]iod =      
public comm5t on ! draft guidance       
entitl$ ,g5]al ,pr9cipals = ,evaluat+ ! 
,abuse ,det]r5ce ( ,g5]ic ,solid ,oral  
,opioid ,drug ,products issu$ by ! ,c5t]

 = ,drug ,evaluation & ,rese>* ( ! ,food
 & ,drug ,adm9i/ration 9 ,m>* #bjaf1 !  
,commission] ( ,food & ,drugs %all      
publi% 9 ! ,f$]al ,regi/] a f9al v]sion 
( su* guidance4  ,pass$ ! ,h\se (       
,repres5tatives ,may #aa1 #bjaf4;,cl]k4