#aaeth ,,congress  #b;d ,session  ,h4   
,r4 #edgc  ,,an ,,act  ,to direct the   
,secretary of ,health and ,human        
,services to update or issue one or more
 guidances addressing alternative       
methods for data collection on opioid   
sparing and inclusion of such data in   
product labeling1 and for other         
purposes4  #a4 ,short title ,this ,act  
may be cited as the ,better ,pain       
,management ,through ,better ,data ,act 
of #bjah4  #b4 ,guidance addressing     
alternative approaches to data          
collection and labeling claims for      
opioid sparing  7a7 ,in general ,for    
purposes of assisting sponsors in       
collecting and incorporating            
opioid-sparing data in product labeling1
 the ,secretary of ,health and ,human   
,services 7referred to in this section  
as the ,secretary7 shall conduct a      
public meeting and update or issue one  
or more guidances in accordance with    
subsection 7b74  7b7 ,guidance  7#a7 ,in
 general ,the ,secretary of ,health and 

,human ,services1 acting through the    
,commissioner of ,food and ,drugs1 shall
 update or issue one or more guidances  
addressing-- 7,a7 alternative methods   
for data collection on opioid sparing2  
7,b7 alternative methods for inclusion  
of such data in product labeling2 and   
7,c7 investigations other than clinical 
trials1 including partially controlled  
studies and objective trials without    
matched controls such as historically   
controlled analyses1 open-label studies1
 and meta-analyses1 on opioid sparing   
for inclusion in product labeling4  7#b7
 ,contents ,the guidances under         
paragraph 7#a7 shall address-- 7,a7     
innovative clinical trial designs for   
ethically and efficiently collecting    
data on opioid sparing for inclusion in 
product labeling2  7,b7 primary and     
secondary endpoints for the reduction of
 opioid use while maintaining adequate  
pain control2  7,c7 use of real world   
evidence1 including patient registries1 
and patient reported outcomes to support

 inclusion of opioid-sparing data in    
product labeling2 and  7,d7 how sponsors
 may obtain feedback from the ,secretary
 relating to such issues prior to-- 7i7 
commencement of such data collection2 or
  7ii7 the submission of resulting data 
to the ,secretary4  7#c7 ,public meeting
 ,prior to updating or issuing the      
guidances required by paragraph 7#a71   
the ,secretary shall consult with       
stakeholders1 including representatives 
of regulated industry1 academia1        
patients1 and provider organizations1   
through a public meeting to be held not 
later than #ab months after the date of 
enactment of this ,act4  7#d7 ,timing   
,the ,secretary shall-- 7,a7 not later  
than #ab months after the date of the   
public meeting required by paragraph    
7#c71 update or issue the one or more   
draft guidances required by paragraph   
7#a72 and  7,b7 not later than #ab      
months after the date on which the      
public comment period for such draft    
guidances closes1 finalize such         

guidances4  7c7 ,definition ,in this    
section3  7#a7 ,the terms opioid sparing
 and opioid-sparing refer to the use of 
drugs or devices 7as defined in section 
#bja of the ,federal ,food1 ,drug1 and  
,cosmetic ,act 7#ba ,u4,s4,c4 #cba77    
that reduce pain while enabling the     
reduction1 replacement1 or avoidance of 
oral opioids4  7#b7 ,the term ,secretary
 means the ,secretary of ,health and    
,human ,services4  ,passed the ,house of
 ,representatives ,june #ab1            
#bjah4;,clerk4