[Federal Register Volume 75, Number 112 (Friday, June 11, 2010)]
[Notices]
[Pages 33311-33312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-14036]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0433] (formerly Docket No. 2007D-0169)


Guidance for Industry on Bioequivalence Recommendations for 
Specific Products; 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 ``Bioequivalence 
Recommendations for Specific Products.'' This guidance describes a new 
process for making available recommendations on how to design product-
specific bioequivalence (BE) studies to support abbreviated new drug 
applications (ANDAs). Under this process, applicants planning to carry 
out such studies in support of their ANDAs are able to access BE study 
guidance on the FDA Web site. FDA believes that making this information 
available on the Internet will streamline the guidance process and will 
provide a meaningful opportunity for the public to consider and comment 
on product-specific BE study recommendations.

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. 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: 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

    FDA is announcing the availability of a guidance for industry 
entitled ``Bioequivalence Recommendations for Specific Products.'' This 
guidance describes a new process for making available recommendations 
on how to design product-specific BE studies to support ANDAs. Under 
this process, draft and final BE recommendations are posted on FDA's 
Web site (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, 
Individual Product Bioequivalence Recommendations) and announced 
periodically in the Federal Register. For draft BE recommendations, the 
Federal Register notice will identify a comment period. The public is 
encouraged to submit comments on the draft BE recommendations, and the 
agency will consider received comments in developing final BE 
recommendations. FDA adopted this process as a means to develop and 
disseminate product-specific BE recommendations and provide an 
opportunity for the public to consider and comment on those 
recommendations.
    In the Federal Register of May 31, 2007 (72 FR 30388), FDA 
announced the availability of a draft version of this guidance entitled 
``Bioequivalence Recommendations for Specific

[[Page 33312]]

Products.'' The May 2007 draft guidance gave interested persons an 
opportunity to submit comments through August 29, 2007. The agency is 
finalizing the guidance after considering comments received on the 
draft guidance. Minor changes were made to the draft guidance to update 
FDA Web site information.
    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 a new process for making available to 
sponsors FDA guidance on how to design product-specific bioequivalence 
studies to support ANDAs. 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 to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding the 
guidance. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

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: June 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-14036 Filed 6-10-10; 8:45 am]
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