[Federal Register Volume 66, Number 229 (Wednesday, November 28, 2001)]
[Notices]
[Page 59433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-29510]



[[Page 59433]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0488]


Draft Guidance for Industry on Food-Effect Bioavailability and 
Fed Bioequivalence Studies: Study Design, Data Analysis, and Labeling; 
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availability of a draft guidance for industry entitled ``Food-Effect 
Bioavailability and Fed Bioequivalence Studies: Study Design, Data 
Analysis, and Labeling.'' The draft guidance is intended for sponsors 
planning to conduct food-effect bioavailability (BA) and fed 
bioequivalence (BE) studies for oral immediate-release and modified-
release dosage forms as part of investigational new drug applications 
(INDs), new drug applications (NDAs), abbreviated new drug applications 
(ANDAs), and supplements to these applications. The draft guidance 
provides recommendations for study design, data analysis, and product 
labeling, and also indicates when food-effect BA and fed BE studies 
should be performed.

DATES:  Submit written or electronic comments on the draft guidance by 
January 28, 2002. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Dockets Management Branch (HFA-305), Food 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access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Lawrence J. Lesko, Center for Drug 
Evaluation and Research (HFD-850), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5690.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Food-Effect Bioavailability and Fed Bioequivalence Studies: 
Study Design, Data Analysis, and Labeling.'' This draft guidance is a 
revision of an October 1997 draft guidance entitled ``Food-Effect 
Bioavailability and Bioequivalence Studies.''
    Food can delay gastric emptying, stimulate bile flow, change 
gastrointestinal (GI) pH, and increase splanchnic blood flow, thereby 
altering the BA of a drug product. Food can also change luminal 
metabolism of a drug substance and can physically or chemically 
interact with a dosage form or a drug substance to alter BA. Changes in 
BA can sometimes call for dosage adjustments or specific dosing 
instructions in relation to administration with meals. The 
physiological changes incurred due to food intake can influence the 
demonstration of BE between test and reference products.
    Several study design variables may have an impact on the outcome of 
a food-effect BA or fed BE study. This draft guidance provides general 
information on study design and data analysis to assess the magnitude 
of food impact on the BA and BE of a drug product and indicates how 
this information can be appropriately addressed in the labeling. In 
addition, the draft guidance makes recommendations on when food-effect 
BA and fed BE should be performed.
    This 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 food-effect 
bioavailability and fed bioequivalence studies. 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 Dockets Management Branch 
(address above) written or electronic comments on the draft guidance. 
Two copies of any 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 draft 
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: November 15, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-29510 Filed 11-27-01; 8:45 am]
BILLING CODE 4160-01-S