[Federal Register Volume 74, Number 73 (Friday, April 17, 2009)]
[Notices]
[Pages 17872-17873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-8833]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0126]


Draft Guidance for Industry on the Submission of Summary 
Bioequivalence Data for Abbreviated New Drug Applications; 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availability of a draft guidance for

[[Page 17873]]

industry entitled ``Submission of Summary Bioequivalence Data for 
ANDAs.'' The draft guidance is intended to assist abbreviated new drug 
application (ANDA) applicants in complying with the new requirements in 
the final rule on the submission of bioequivalence data published in 
the Federal Register in January 2009. The final rule requires ANDA 
applicants to submit data from all bioequivalence studies (BE studies) 
the applicant conducts on a drug product formulation submitted for 
approval, including both studies that demonstrate and studies that fail 
to demonstrate that a generic product meets the current bioequivalence 
criteria. The draft guidance provides recommendations to applicants 
planning to include BE studies for submission in ANDAs, and is 
applicable to BE studies conducted during both preapproval and 
postapproval periods.

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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by July 16, 2009.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Division of Drug Information, Center for Drug 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. Submit written comments on the draft guidance to the 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:  Aida L. Sanchez, Center for Drug 
Evaluation and Research (HFD-650), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-5847.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 29, 2003 (68 FR 61640), FDA 
published a proposed rule to require an ANDA applicant to submit data 
from all BE studies that the applicant conducts on a drug product 
formulation submitted for approval. The agency's final rule amending 
its bioequivalence regulations was published in the Federal Register on 
January 16, 2009 (74 FR 2849). All BE studies conducted on the same 
drug product formulation, including studies that demonstrate and 
studies that fail to demonstrate that a generic product meets the 
current bioequivalence criteria, must be submitted to the agency. 
Information from all BE studies is important to the agency for the 
following reasons:
    <bullet> Data contained in any BE study could be important to FDA's 
assessment of bioequivalence for a specific product; and
    <bullet> Even when additional BE studies are not critical to the 
agency's bioequivalence determination for the specific product being 
reviewed, the data provide valuable scientific information that 
increases the agency's knowledge and understanding of bioequivalence 
and generic drug development and promotes further development of 
science-based bioequivalence policies.

II. The Draft Guidance

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Submission of Summary Bioequivalence Data for ANDAs.'' The 
draft guidance provides recommendations to applicants planning to 
include BE studies for submission in ANDAs. The draft guidance provides 
information on the following subjects:
    <bullet> The types of ANDA submissions covered by the new 
regulations on BE studies;
    <bullet> A recommended format for summary reports of BE studies; 
and
    <bullet> What formulations FDA considers the ``same drug product 
formulation'' for different dosage forms based on differences in 
composition.
The draft guidance is applicable to BE studies conducted for ANDAs 
during both preapproval and postapproval periods.
    The 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 summary 
bioequivalence data reports to be submitted in 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.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the draft 
guidance. 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.

IV. Paperwork Reduction Act of 1995

    The draft guidance refers to information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 314.94(a)(7), 314.96(a)(1), and 
314.97 have been approved under OMB control number 0910-0630.

V. 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: April 9, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-8833 Filed 4-16-09; 8:45 am]
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