[Federal Register Volume 78, Number 61 (Friday, March 29, 2013)]
[Notices]
[Page 19271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07296]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369; (Formerly Docket No. 2007D-0168)]


Draft Guidance for Industry on Bioequivalence Recommendations for 
Metronidazole Vaginal Gel; 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availability of a draft guidance for industry entitled ``Bioequivalence 
Recommendations for Metronidazole Vaginal Gel.'' The guidance provides 
specific recommendations on the design of bioequivalence (BE) studies 
to support abbreviated new drug applications (ANDAs) for metronidazole 
vaginal gel.

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 comments 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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 28, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Kris Andre, Center for Drug Evaluation 
and Research (HFD-600), Food and Drug Administration, 7519 Standish 
Pl., Rockville, MD 20855, 240-276-9326.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311; FDA-2007-D-
0433), FDA announced the availability of a guidance for industry 
entitled ``Bioequivalence Recommendations for Specific Products,'' 
which explained the process that would be used to make product-specific 
bioequivalence (BE) recommendations available to the public on FDA's 
Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As 
described in that guidance, FDA adopted this process as a means to 
develop and disseminate product-specific BE recommendations and provide 
a meaningful opportunity for the public to consider and comment on 
those recommendations. This notice announces the availability of draft 
BE recommendations for metronidazole vaginal gel.
    New drug application 020208 for MetroGel-Vaginal (metronidazole) 
vaginal gel, 0.75%, was initially approved by FDA in August 1992. On 
October 31, 2006, FDA approved ANDA 077264 for a generic version of 
MetroGel-Vaginal 0.75% (metronidazole). FDA is now issuing a draft 
guidance for industry on BE recommendations for generic metronidazole 
vaginal gel (Draft Metronidazole Vaginal Gel BE Recommendations).
    In March 2006, Foley & Lardner LLP (the petitioner) submitted a 
citizen petition requesting that FDA require that any ANDA referencing 
Metro-Gel Vaginal meet certain conditions, including conditions related 
to demonstrating BE (Docket No. FDA-2006-P-0080). FDA is reviewing the 
issues raised in the petition. FDA will consider any comments on the 
Draft Metronidazole Vaginal Gel BE Recommendations in responding to the 
citizen petition.
    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 design 
of BE studies to support ANDAs for metronidazole vaginal gel. 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. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets 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.

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 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-07296 Filed 3-28-13; 8:45 am]
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