80 FR 17765 - Abuse-Deterrent Opioids-Evaluation and Labeling; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 63 (April 2, 2015)

Page Range		17765-17765
FR Document		2015-07562

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Abuse-Deterrent Opioids--Evaluation and Labeling''. This guidance explains FDA's current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties. This guidance also makes recommendations about how those studies should be performed and evaluated, and discusses how to describe those studies and their implications in product labeling. It is intended to assist sponsors who wish to develop opioid drug products with potentially abuse-deterrent properties and is not intended to apply to products that are not opioids or opioid products that do not have the potential for abuse.

Federal Register, Volume 80 Issue 63 (Thursday, April 2, 2015)

[Federal Register Volume 80, Number 63 (Thursday, April 2, 2015)]
[Notices]
[Page 17765]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07562]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Abuse-Deterrent Opioids--Evaluation and Labeling; Guidance for 
Industry; 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 guidance for industry entitled ``Abuse-Deterrent 
Opioids--Evaluation and Labeling''. This guidance explains FDA's 
current thinking about the studies that should be conducted to 
demonstrate that a given formulation has abuse-deterrent properties. 
This guidance also makes recommendations about how those studies should 
be performed and evaluated, and discusses how to describe those studies 
and their implications in product labeling. It is intended to assist 
sponsors who wish to develop opioid drug products with potentially 
abuse-deterrent properties and is not intended to apply to products 
that are not opioids or opioid products that do not have the potential 
for abuse.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, 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 guidance document.
    Submit electronic comments on the 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: Brutrinia D. Cain, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-4633, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Abuse-Deterrent Opioids--Evaluation and Labeling.'' 
Prescription opioid products are an important component of modern pain 
management. However, abuse and misuse of these products have created a 
serious and growing public health problem. One potentially important 
step towards the goal of creating safer opioid analgesics has been the 
development of opioids that are formulated with some properties 
intended to deter abuse. FDA considers development of these products a 
high public health priority.
    The guidance is intended to provide industry with a framework for 
evaluating and labeling abuse-deterrent opioid products. The 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, clinical abuse 
potential studies, and postmarket studies. The guidance also describes 
the types of information 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.
    In the Federal Register of January 14, 2013 (78 FR 2676), FDA 
announced the availability of a draft version of this guidance and 
provided interested parties an opportunity to submit comments. The 
Agency has carefully reviewed and considered the comments it received 
in developing this final version of the guidance. The Agency has made 
revisions to the guidance as it deemed appropriate.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on the evaluation and labeling of abuse-
deterrent opioids. It does not establish any rights for any person and 
is not binding on FDA or the public. You can use an alternative 
approach if it 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.

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: March 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07562 Filed 4-1-15; 8:45 am]
BILLING CODE CODE 4164-01-P

Federal Register / Vol. 80, No. 63 / Thursday, April 2, 2015 / Notices 17765

Elimination of Tuberculosis, 0002. Send one self-addressed adhesive version of the guidance. The Agency has
Department of Health and Human label to assist that office in processing made revisions to the guidance as it
Services, 1600 Clifton Road NE., your requests. See the SUPPLEMENTARY deemed appropriate.
Mailstop E–10, Atlanta, Georgia 30333, INFORMATION section for electronic This guidance is being issued
telephone 404/639–8000 or fax 404/ access to the guidance document. consistent with FDA’s good guidance
639–8600. Submit electronic comments on the practices regulation (21 CFR 10.115).
The Director, Management Analysis guidance to http://www.regulations.gov. The guidance represents the current
and Services Office, has been delegated Submit written comments to the thinking of FDA on the evaluation and
the authority to sign Federal Register Division of Dockets Management (HFA– labeling of abuse-deterrent opioids. It
notices pertaining to announcements of 305), Food and Drug Administration, does not establish any rights for any
meetings and other committee 5630 Fishers Lane, Rm. 1061, Rockville, person and is not binding on FDA or the
management activities, for both the MD 20852. public. You can use an alternative
Centers for Disease Control and FOR FURTHER INFORMATION CONTACT: approach if it satisfies the requirements
Prevention and the Agency for Toxic Brutrinia D. Cain, Center for Drug of the applicable statutes and
Substances and Disease Registry. Evaluation and Research, Food and regulations.
Elaine L. Baker, Drug Administration, 10903 New II. Comments
Hampshire Ave., Silver Spring, MD
Director, Management Analysis and Services Interested persons may submit either
Office, Centers for Disease Control and 20993, 301–796–4633, Brutrinia.Cain@
fda.hhs.gov. electronic comments regarding this
Prevention.
document to http://www.regulations.gov
[FR Doc. 2015–07541 Filed 4–1–15; 8:45 am] SUPPLEMENTARY INFORMATION:
or written comments to the Division of
BILLING CODE CODE 4163–18–P
I. Background Dockets Management (see ADDRESSES). It
FDA is announcing the availability of is only necessary to send one set of
a guidance for industry entitled ‘‘Abuse- comments. Identify comments with the
DEPARTMENT OF HEALTH AND
Deterrent Opioids—Evaluation and docket number found in brackets in the
HUMAN SERVICES
Labeling.’’ Prescription opioid products heading of this document. Received
Food and Drug Administration are an important component of modern comments may be seen in the Division
pain management. However, abuse and of Dockets Management between 9 a.m.
[Docket No. FDA–2013–D–0045] and 4 p.m., Monday through Friday, and
misuse of these products have created a
serious and growing public health will be posted to the docket at http://
Abuse-Deterrent Opioids—Evaluation
problem. One potentially important step www.regulations.gov.
and Labeling; Guidance for Industry;
Availability towards the goal of creating safer opioid III. Electronic Access
analgesics has been the development of
AGENCY: Food and Drug Administration, Persons with access to the Internet
opioids that are formulated with some
HHS. may obtain the document at either
properties intended to deter abuse. FDA
ACTION: Notice. http://www.fda.gov/Drugs/Guidance
considers development of these
ComplianceRegulatoryInformation/
products a high public health priority.
SUMMARY: The Food and Drug Guidances/default.htm or http://www.
The guidance is intended to provide
Administration (FDA) is announcing the regulations.gov.
industry with a framework for
availability of a guidance for industry evaluating and labeling abuse-deterrent Dated: March 27, 2015.
entitled ‘‘Abuse-Deterrent Opioids— opioid products. The guidance Leslie Kux,
Evaluation and Labeling’’. This discusses how the potentially abuse- Associate Commissioner for Policy.
guidance explains FDA’s current deterrent properties of an opioid [FR Doc. 2015–07562 Filed 4–1–15; 8:45 am]
thinking about the studies that should analgesic formulated to deter abuse BILLING CODE CODE 4164–01–P
be conducted to demonstrate that a should be studied, specifically
given formulation has abuse-deterrent addressing in vitro studies,
properties. This guidance also makes pharmacokinetic studies, clinical abuse
recommendations about how those DEPARTMENT OF HOMELAND
potential studies, and postmarket SECURITY
studies should be performed and studies. The guidance also describes the
evaluated, and discusses how to types of information that may be
describe those studies and their U.S. Citizenship and Immigration
suitable for inclusion in labeling. Services
implications in product labeling. It is Providing a clear framework for the
intended to assist sponsors who wish to evaluation and labeling of the abuse- [OMB Control Number 1615–0005]
develop opioid drug products with deterrent properties of opioid analgesics
potentially abuse-deterrent properties Agency Information Collection
intended to deter abuse should help to Activities: Application for Family Unity
and is not intended to apply to products incentivize the development of safer,
that are not opioids or opioid products Benefits, Form I–817; Revision of a
less abusable opioid analgesics, and Currently Approved Collection
that do not have the potential for abuse. should also facilitate the dissemination
DATES: Submit either electronic or of fair and accurate information AGENCY: U.S. Citizenship and
written comments on Agency guidances regarding such products. Immigration Services (USCIS),
at any time. In the Federal Register of January 14, Department of Homeland Security
tkelley on DSK3SPTVN1PROD with NOTICES

ADDRESSES: Submit written requests for 2013 (78 FR 2676), FDA announced the (DHS).
single copies of this guidance to the availability of a draft version of this ACTION: 60-Day notice.
Division of Drug Information, Center for guidance and provided interested
Drug Evaluation and Research, Food parties an opportunity to submit SUMMARY: DHS, USCIS invites the
and Drug Administration, 10001 New comments. The Agency has carefully general public and other Federal
Hampshire Ave., Hillandale Building, reviewed and considered the comments agencies to comment upon this
4th Floor, Silver Spring, MD 20993– it received in developing this final proposed revision of a currently

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Document Created: 2018-02-21 10:03:48
Document Modified: 2018-02-21 10:03:48

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on Agency guidances at any time.
Contact		Brutrinia D. Cain, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-4633, [email protected]
FR Citation		80 FR 17765

80 FR 17765 - Abuse-Deterrent Opioids-Evaluation and Labeling; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 63 (April 2, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration