[Federal Register Volume 74, Number 26 (Tuesday, February 10, 2009)]
[Notices]
[Pages 6640-6641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-2800]


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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Draft Guidance for Industry on Bioequivalence Recommendation for 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.

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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19, 2009, the comment period for the draft guidance for industry 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The draft guidance provides specific guidance on the design of 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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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electronic access to the draft guidance document.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published a notice announcing the availability of a draft guidance for 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As described in the notice, the draft guidance further clarifies FDA's 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]
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