[Federal Register Volume 67, Number 133 (Thursday, July 11, 2002)]
[Notices]
[Page 45983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17403]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0258]


Draft 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 the 
availability of a draft revised guidance for industry entitled 
``Bioavailability and Bioequivalence for Orally Administered Drug 
Products--General Considerations.'' FDA's Biopharmaceutics Coordinating 
Committee determined that a revision of the guidance was necessary as a 
result of experience with implementation of the guidance, input from 
the Advisory Committee for Pharmaceutical Science at a meeting held on 
November 28 and 29, 2001, and changes in agency thinking based on new 
data. This revision should provide better guidance to sponsors 
conducting bioavailability (BA) and bioequivalence (BE) studies for 
orally administered drug products.

DATES: Submit written or electronic comments on the draft revised 
guidance by August 12, 2002. General comments on agency guidance 
documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of this draft 
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 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: FDA is announcing the availability of a 
draft revised guidance for industry entitled ``Bioavailability and 
Bioequivalence for Orally Administered Drug Products--General 
Considerations.'' This document is intended to provide information to 
sponsors and/or applicants planning to include BA and BE information 
for orally administered drug products in investigational new drug 
applications (INDs), new drug applications (NDAs), abbreviated new drug 
applications (ANDAs), and their supplements. This draft revises the 
guidance published as a final guidance in the Federal Register on 
October 27, 2000 (65 FR 64449). It is being revised as a result of 
changes in agency thinking based, in part, on input from the Advisory 
Committee for Pharmaceutical Science, experience with the guidance, and 
comments from industry. This draft revision of the guidance does the 
following: (1) Changes recommendations for the use of replicate and 
nonreplicate study designs for extended-release products and includes 
recommendations regarding dissolution methods development (section III, 
Methods to Document BA and BE), (2) changes to the use of only the 
average BE approach for BE comparisons, (section IV, Comparison of BA 
Measures in BE Studies), (3) clarifies the definitions of 
proportionality (section V, Documentation of BA and BE) in the 
documentation of BA and BE in response to comments from industry, (4) 
changes recommendations regarding waivers of BE studies (subsection 
V.C.2, Waivers of In Vivo BE Studies (Biowaivers)) in certain 
situations, and (5) makes other changes such as use of the more general 
term ``modified release'' as opposed to ``extended'' or ``delayed 
release'' (subsections V.D.2 and V.D.3) and minor corrections to 
citations of the regulations. This draft revision should provide better 
guidance to sponsors conducting BA and BE studies for orally 
administered drug products.
    This draft revised guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft revised 
guidance, when finalized, will represent the agency's current thinking 
on submitting BA and BE information to 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 statutes 
and regulations.
    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written comments on the draft revised guidance. 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. This draft revised 
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.
    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: June 28, 2002.
 Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-17403 Filed 7-10-02; 8:45 am]
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