[Federal Register Volume 68, Number 53 (Wednesday, March 19, 2003)]
[Notices]
[Page 13316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-6491]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0258]


Revised Guidance for Industry on Bioavailability and 
Bioequivalence Studies for Orally Administered Drug Products--General 
Considerations; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a revised 
guidance for industry entitled ``Bioavailability and Bioequivalence 
Studies for Orally Administered Drug Products--General 
Considerations.'' This guidance revises the guidance of the same name 
that issued in October 2000.

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

ADDRESSES: Submit written requests for single copies of the revised 
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: Aida L. Sanchez, Center for Drug 
Evaluation and Research (HFD-650), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-5847.

SUPPLEMENTARY INFORMATION:

I. Background

    The agency is announcing the availability of a revised guidance for 
industry entitled ``Bioavailability and Bioequivalence Studies for 
Orally Administered Drug Products--General Considerations.'' This is a 
revision of the guidance of the same name issued in October 2000. The 
guidance is intended to provide information to sponsors and/or 
applicants planning to include bioavailability (BA) and bioequivalence 
(BE) information for orally administered drug products in 
investigational new drug applications (INDs), new drug applications 
(NDAs), and abbreviated new drug applications (ANDAs) and their 
supplements. Since the October 2000 guidance was issued there have been 
changes due to the following: (1) Agency thinking based, in part, on 
input from the Advisory Committee for Pharmaceutical Science, (2) 
experience with the guidance, and (3) outside comments. Therefore, the 
agency decided to revise the guidance.
    A draft of the revision was published in the Federal Register of 
July 11, 2002, (67 FR 45983). Comments on the draft submitted to the 
docket were considered carefully during the finalization of this 
guidance. Only minor, clarifying editorial changes have been made to 
this final version.

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 any 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: March 10, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-6491 Filed 3-18-03; 8:45 am]
BILLING CODE 4160-01-S