Document ID: FDA-2009-D-0126-0007
Agency: fda
Document Type: Notice
Title: Guidance for Industry Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications; Availability
Posted Date: 2011-05-06T04:00Z

[Federal Register Volume 76, Number 88 (Friday, May 6, 2011)]
[Notices]
[Pages 26307-26308]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11102]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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 guidance for industry entitled ``Submission of 
Summary Bioequivalence Data for Abbreviated New Drug Applications.'' 
The guidance is intended to assist abbreviated new drug application 
(ANDA) applicants in complying with the requirements in the final rule 
on the submission of bioequivalence data that published in the Federal 
Register in January 2009 (74 FR 2849, January 16, 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 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: 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:  Aida L. Sanchez, Center for Drug 
Evaluation and Research (HFD-650),

[[Page 26308]]

Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 
240-276-8782.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Submission of Summary Bioequivalence Data for ANDAs.'' The 
guidance provides recommendations to applicants planning to include BE 
studies for submission in ANDAs. The guidance provides information on 
the following subjects:
     Types of ANDA submissions covered by the regulations on BE 
studies;
     Recommended format for summary reports of BE studies; and
     Types of formulations the Agency considers to be the same 
drug product formulation for different dosage forms based on 
differences in composition.

The guidance is applicable to BE studies conducted for ANDAs during 
both preapproval and postapproval periods.
    On April 17, 2009, FDA announced the availability of the draft 
version of this guidance (74 FR 17872). The public comment period 
closed on July 16, 2009. A few comments were received from the public, 
all of which the Agency considered carefully as it finalized the 
guidance and made appropriate changes. Changes to the guidance were 
minor and made to clarify statements in the draft guidance.
    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 submission of summary bioequivalence data 
for 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 this 
document. 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. Paperwork Reduction Act of 1995

    This 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.

IV. 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: May 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-11102 Filed 5-5-11; 8:45 am]
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