[Federal Register Volume 68, Number 21 (Friday, January 31, 2003)]
[Notices]
[Pages 5026-5027]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-2214]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0488]


Guidance for Industry on Food-Effect Bioavailability and Fed 
Bioequivalence Studies; 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 ``Food-Effect 
Bioavailability and Fed Bioequivalence Studies.'' This guidance 
provides recommendations to sponsors and/or applicants planning to 
conduct food-effect bioavailability (BA) and fed bioequivalence (BE) 
studies for orally administered drug products as part of 
investigational new drug applications (INDs), new drug applications 
(NDAs) and abbreviated new drug applications (ANDAs), and supplemental 
applications.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the guidance to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT: Ameeta Parekh, Center for Drug 
Evaluation and Research (HFD-870), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-5919.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Food-Effect Bioavailability and Fed Bioequivalence 
Studies.'' This guidance document is intended to provide information to 
sponsors and/or applicants planning to include food-effect BA and fed 
BE studies for orally

[[Page 5027]]

administered drug products in INDs, NDAs, ANDAs, and supplemental 
applications. This guidance provides recommendations for when studies 
are appropriate, as well as recommendations on study design, data 
analysis, and product labeling.
    In the Federal Register of November 28, 2001 (66 FR 59433), FDA 
published a draft guidance entitled ``Food-Effect Bioavailability and 
Fed Bioequivalence Studies: Study Design, Data Analysis, and 
Labeling.'' Based on comments received on the draft guidance and the 
refinement of agency thinking on the conduct of such studies, FDA has 
revised the 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 submitting food-effect BA and fed BE 
information as part of INDs, NDAs, and 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 statute and regulations.

II. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the guidance at any time. 
Two copies of mailed comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
guidance and received comments are available for public examination in 
the Dockets Management Branch 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.fda.gov/ohrms/dockets/default.htm.

    Dated: January 21, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-2214 Filed 1-30-03; 8:45 am]
BILLING CODE 4160-01-S