Document ID: FDA-2013-D-0045-0001
Agency: fda
Document Type: Notice
Title: Draft Guidances for Industry on Abuse-Deterrent Opioids-Evaluation and Labeling; Availability
Posted Date: 2013-01-14T05:00Z

[Federal Register Volume 78, Number 9 (Monday, January 14, 2013)]
[Notices]
[Pages 2676-2677]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00474]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0045]

Draft Guidance for Industry on Abuse-Deterrent Opioids--
Evaluation and Labeling; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Abuse-
Deterrent Opioids--Evaluation and Labeling.'' The draft guidance 
describes how abuse-deterrent properties of opioid analgesic products 
should be studied and evaluated, and what claims regarding such 
properties may be suitable for inclusion in labeling. In addition to 
general input on this draft guidance, FDA is seeking input on the 
research topics outlined in the final section of the draft guidance. 
FDA also intends to hold a public meeting to solicit additional input 
from affected stakeholders on the draft guidance.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 15, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Matthew Sullivan, Center for Drug 
Evaluation and Research (HFD-170), Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 22, rm. 3160, Silver Spring, MD 20993, 301-
796-1245, matthew.sullivan@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Abuse-Deterrent Opioids--Evaluation and Labeling.'' 
Prescription opioid analgesics are an important component of modern 
pain management, but abuse and misuse of these products remains a 
serious and growing public health problem. One important effort in 
reducing abuse and misuse is the development of opioid analgesics 
specially formulated to deter abuse. FDA considers development of 
abuse-deterrent opioid analgesics to be a public health priority and is 
encouraging their development.
    This draft guidance is intended to provide industry with a 
framework for evaluating and labeling abuse-deterrent opioid products. 
The draft guidance discusses how the potentially abuse-deterrent 
properties of an opioid analgesic formulated to deter abuse should be 
studied, specifically addressing in vitro studies, pharmacokinetic 
studies, human abuse potential studies, and postmarket studies. The 
draft guidance also describes the types of information and claims that 
may be suitable for inclusion in labeling.
    Providing a clear framework for the evaluation and labeling of the 
abuse-deterrent properties of opioid analgesics intended to deter abuse 
should help to incentivize the development of safer, less abusable 
opioid analgesics, and should also facilitate the dissemination of fair 
and accurate information regarding such products. FDA also expects that 
the publication of this draft guidance will stimulate a productive 
discussion among FDA, industry, and other stakeholders concerning the 
appropriate development, evaluation, and labeling of these products. In 
the final section of the draft guidance, FDA also lists several areas 
where additional scientific research and analysis would be especially 
helpful.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). FDA also intends to hold 
a public meeting to solicit additional input from affected stakeholders 
on the draft guidance. The guidance, when finalized, will represent the 
Agency's current thinking on evaluation and labeling of abuse-deterrent 
opioids. It does not create or confer any rights for or on any person 
and does not operate to bind FDA or the public. An alternative approach 
may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

[[Page 2677]]

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: January 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-00474 Filed 1-11-13; 8:45 am]
BILLING CODE 4160-01-P