SEC. 
2. 
GUIDANCE 
ADDRESSING 
ALTERNATIVE 
AP-
PROACHES TO DATA COLLECTION AND LA-
BELING CLAIMS FOR OPIOID SPARING. 
(a) IN GENERAL.—For purposes of assisting spon-
sors in collecting and incorporating opioid-sparing data in 
product labeling, the Secretary of Health and Human 
Services (referred to in this section as the ‘‘Secretary’’) 
shall conduct a public meeting and update or issue one 
or more guidances in accordance with subsection (b). 
(b) GUIDANCE.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services, acting through the Commissioner 
of Food and Drugs, shall update or issue one or 
more guidances addressing— 
(A) alternative methods for data collection 
on opioid sparing; 
(B) alternative methods for inclusion of 
such data in product labeling; and 
(C) investigations other than clinical trials, 
including partially controlled studies and objec-
tive trials without matched controls such as his-
torically controlled analyses, open-label studies, 
and meta-analyses, on opioid sparing for inclu-
sion in product labeling. 
(2) CONTENTS.—The guidances under para-
graph (1) shall address— 
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(A) innovative clinical trial designs for 
ethically and efficiently collecting data on opioid 
sparing for inclusion in product labeling; 
(B) primary and secondary endpoints for 
the reduction of opioid use while maintaining 
adequate pain control; 
(C) use of real world evidence, including 
patient registries, and patient reported out-
comes to support inclusion of opioid-sparing 
data in product labeling; and 
(D) how sponsors may obtain feedback 
from the Secretary relating to such issues prior 
to— 
(i) commencement of such data collec-
tion; or 
(ii) the submission of resulting data to 
the Secretary. 
(3) PUBLIC
MEETING.—Prior to updating or 
issuing the guidances required by paragraph (1), the 
Secretary shall consult with stakeholders, including 
representatives of regulated industry, academia, pa-
tients, and provider organizations, through a public 
meeting to be held not later than 12 months after 
the date of enactment of this Act. 
(4) TIMING.—The Secretary shall— 
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(A) not later than 12 months after the 
date of the public meeting required by para-
graph (3), update or issue the one or more 
draft guidances required by paragraph (1); and 
(B) not later than 12 months after the 
date on which the public comment period for 
such draft guidances closes, finalize such guid-
ances. 
(c) DEFINITION.—In this section: 
(1) The terms ‘‘opioid sparing’’ and ‘‘opioid- 
sparing’’ refer to the use of drugs or devices (as de-
fined in section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321)) that reduce pain 
while enabling the reduction, replacement, or avoid-
ance of oral opioids. 
(2) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services. 
Æ 
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