[Federal Register Volume 79, Number 223 (Wednesday, November 19, 2014)]
[Notices]
[Pages 68890-68891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27287]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1120]


Vaginal Microbicides: Development for the Prevention of Human 
Immunodeficiency Virus Infection; 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 ``Vaginal 
Microbicides: Development for the Prevention of HIV Infection.'' The 
purpose of this guidance is to assist sponsors in all phases of 
development of vaginal microbicides, defined as vaginal drug products 
that prevent human immunodeficiency virus (HIV) acquisition. The 
guidance outlines the types of nonclinical studies and clinical trials 
recommended throughout the drug development process to support approval 
of vaginal microbicides. This guidance finalizes the draft guidance 
issued on November 23, 2012.

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, 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 
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov.

[[Page 68891]]

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: Charu Mullick, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6365, Silver Spring, MD 20993-0002, 301-
796-1500.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Vaginal Microbicides: Development for the Prevention of HIV 
Infection.'' This guidance addresses nonclinical development, early 
phases of clinical development, phase 3 trial considerations, and 
safety considerations in vaginal microbicide development including 
safety considerations in adolescent and pregnant populations. The 
guidance also outlines development of combination microbicide products 
such as drug-drug combinations, drug-device combinations, or 
combination products that include microbicide and are intended for 
multiple indications. This guidance finalizes the draft guidance issued 
on November 23, 2012 (77 FR 70167). The majority of public comments 
submitted to the docket were related to clinical trial considerations 
and nonclinical pharmacology/toxicology issues. This guidance 
incorporates FDA responses to the public comments.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on developing vaginal microbicides for 
preventing HIV transmission. 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 under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). 
The collections of information in 21 CFR part 312 have been approved 
under 0910-0014, and the collections of information referred to in the 
guidance for clinical trial sponsors entitled ``Establishment and 
Operation of Clinical Trial Data Monitoring Committees'' have been 
approved under 0910-0581.

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: November 13, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27287 Filed 11-18-14; 8:45 am]
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