
[Federal Register: February 10, 2009 (Volume 74, Number 26)]
[Notices]
[Page 6640-6641]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10fe09-83]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0626]


Draft Guidance for Industry on Bioequivalence Recommendation for
Vancomycin HCl; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is extending to March
19, 2009, the comment period for the draft guidance for industry
entitled ``Bioequivalence Recommendation for Vancomycin HCl'' that
published in the Federal Register of December 16, 2008 (73 FR 76362).
The draft guidance provides specific guidance on the design of
bioequivalence (BE) studies to support abbreviated new drug
applications (ANDAs) for vancomycin HCl capsules. FDA is taking this
action in response to requests for an extension of the comment period
to allow interested persons additional time to submit comments.

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draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by March 19, 2009.

ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Doan T. Nguyen, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-9314.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 16, 2008 (73 FR 76362), FDA
published a notice announcing the availability of a draft guidance for
industry entitled ``Bioequivalence Recommendation for Vancomycin HCl.''
As described in the notice, the draft guidance further clarifies FDA's
recommendations on the design of BE studies to support ANDAs for
vancomycin HCl capsules. As also described in the notice, FDA will
consider comments on the draft guidance as it finalizes its BE
recommendations and addresses the complicated issues raised in
ViroPharma Inc.'s (ViroPharma's) petitions for stay of action
challenging FDA's revised BE recommendations (Docket No. FDA-2006-P-
0007).
    By letter dated December 19, 2008, ViroPharma requested that FDA
extend the comment period for the draft guidance by 60 days. In support
of its request, ViroPharma provided several reasons that explained why
it believes an extension is appropriate, including that the issues
involved with the draft guidance are complex and that the current 60-
day comment period for the notice includes the months of December and
early January when many interested persons are on holiday vacation.
While ViroPharma acknowledges that the Federal Register notice
announcing the availability of this draft guidance indicates that
comments to guidance documents may be submitted at any time, ViroPharma
states that it is essential that FDA be able to review and consider
comprehensive comments from all stakeholders before finalizing the
guidance. In addition, by letter dated January 23, 2009, the
Biotechnology Industry Organization (BIO) requested that FDA extend the
comment period for the draft guidance to provide interested persons
additional time to submit comments, and by letter dated February 2,
2009, Akorn Inc. objected to BIO's extension request.
    FDA has considered ViroPharma's and BIO's requests and Akorn's
objection. FDA does not believe that a 60-day extension as requested by
ViroPharma is warranted, but in response to ViroPharma's and BIO's
requests, FDA is extending the comment period for the draft guidance
for 30 days, until March 19, 2009. This extension will provide
interested

[[Page 6641]]

persons with a total of 90 days to submit comments before FDA begins
work on the final version of the guidance. The agency believes that
this 30-day extension allows adequate time for interested persons to
submit comments without significantly delaying FDA consideration of
these important issues.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on this document. Submit
a single copy of electronic comments or two paper copies of any mailed
comments, except that individuals may submit one paper copy. Comments
are to be identified 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder/guidance/index.htm or http://
www.regulations.gov.

    Dated: February 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-2800 Filed 2-9-09; 8:45 am]

BILLING CODE 4160-01-S
