[Federal Register Volume 78, Number 9 (Monday, January 14, 2013)]
[Notices]
[Pages 2676-2677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-00474]
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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Draft Guidance for Industry on Abuse-Deterrent Opioids--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.
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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availability of a draft guidance for industry entitled ``Abuse-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 The draft guidance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general input on this draft guidance, FDA is seeking input on the
research topics outlined in the final section of the draft guidance.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from affected stakeholders on the draft guidance.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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 15, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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, [email protected].
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