[Federal Register: January 31, 2003 (Volume 68, Number 21)]

[Notices]               

[Page 5026-5027]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr31ja03-90]                         





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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.

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