[Federal Register Volume 77, Number 226 (Friday, November 23, 2012)]
[Notices]
[Pages 70167-70168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-28430]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry on Vaginal Microbicides: Development 
for the Prevention of Human Immunodeficiency Virus Infection; 
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availability of a draft guidance for industry entitled ``Vaginal 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 for the prevention of human 
immunodeficiency virus (HIV) infection. The guidance outlines the types 
of nonclinical studies and clinical trials recommended throughout the 
drug development process to support approval of vaginal microbicides.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 21, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: 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    FDA is announcing the availability of a draft guidance for industry 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 provides some information on approaches for developing 
combination microbicide products such as drug-drug combinations, drug-
device combinations containing a microbicide, or combination products 
containing a microbicide that are intended for multiple indications. 
With the recent approval of oral emtricitabine/tenofovir for HIV pre-
exposure prophylaxis (PrEP), the effect of oral PrEP on microbicide 
trial designs is an emerging topic. The guidance discusses this issue; 
however, it should be noted the pertinent sections may be revised as 
FDA takes into consideration evolving opinions in the prevention field 
as well as public comments on this topic.
    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 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 draft 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 part 312 have been 
approved under OMB control number 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 OMB control number 
0910-0581.

III. Comments

    Interested persons may submit either written comments regarding the 
draft guidance to the Division of Dockets

[[Page 70168]]

Management (see ADDRESSES) or electronic comments to http://www.regulations.gov. 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: November 19, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28430 Filed 11-21-12; 8:45 am]
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