[Federal Register Volume 76, Number 88 (Friday, May 6, 2011)]
[Notices]
[Pages 26307-26308]
From the Federal Register Online via the Government Publishing 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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