[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 This guidance finalizes the draft guidance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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