Document ID: FDA-2015-D-0152-0001
Agency: fda
Document Type: Notice
Title: Alcoholism: Developing Drugs for Treatment; Draft Guidance for
Industry; Availability
Posted Date: 2015-02-12T05:00Z

[Federal Register Volume 80, Number 29 (Thursday, February 12, 2015)]
[Notices]
[Pages 7871-7872]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02908]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-0152]

Alcoholism: Developing Drugs for Treatment; Draft Guidance for 
Industry; 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availability of a draft guidance for industry entitled ``Alcoholism: 
Developing Drugs for Treatment.'' The purpose of this guidance is to 
assist sponsors in the development of drugs for the treatment of 
alcoholism.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 13, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, 10001 New 
Hampshire Ave., Hillandale Bldg., 4th Floor, Silver Spring, MD 20993. 
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electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Rachel Skeete, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 3191, Silver Spring, MD 20993-0002, 301-
796-2280.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Alcoholism: Developing Drugs for Treatment.'' There is a 
need for additional pharmacologic treatments for alcoholism. 
Traditionally, alcoholism treatments have been assessed based on the 
number of patients who refrain from drinking altogether. Patients who 
attain and sustain complete abstinence from alcohol may be assumed to 
accrue clinical benefit. However, other patterns of drinking also may 
be valid surrogates for clinical benefit. This guidance provides 
supporting information for endpoints based on patterns of drinking that 
may be considered appropriate measures of clinical benefit.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on the 
development of drugs for the treatment of alcoholism and appropriate 
endpoints for clinical trials of drugs to treat alcoholism. 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. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 312 and 314 have 
been approved under OMB

[[Page 7872]]

control numbers 0910-0014 and 0910-0001, respectively.

III. 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.

IV. 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: February 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02908 Filed 2-11-15; 8:45 am]
BILLING CODE 4164-01-P