[Federal Register Volume 67, Number 162 (Wednesday, August 21, 2002)]
[Notices]
[Pages 54219-54220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-21262]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0350]


Draft Guidance for Industry on Handling and Retention of 
Bioavailability and Bioequivalence Testing Samples; 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availability of a draft guidance for industry entitled ``Handling and 
Retention of Bioavailability and Bioequivalence Testing Samples.'' 
Inspection of clinical and analytical sites that perform 
bioavailability (BA) and bioequivalence (BE) studies frequently reveals 
the absence of reserve samples at the testing facilities where the 
studies are conducted. The draft guidance is intended to clarify how to 
distribute test articles and reference standards to testing facilities, 
how to randomly select reserve samples, and how to retain reserve 
samples.

EFFECTIVE DATE: Submit written or electronic comments on the draft 
guidance by September 20, 2002.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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Dockets Management Branch (HFA-305), Food 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. 
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draft guidance document.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: Martin Yau, Center for Drug Evaluation 
and Research (HFD-45), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-5458.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Handling and Retention of Bioavailability and Bioequivalence 
Testing Samples.'' Following the generic drug crisis in the 1980s, FDA 
issued regulations to deter possible bias and fraud in BA and BE 
testing by study sponsors and/or drug manufacturers (58 FR 25918, April 
28, 1993). In the preamble of the final rule, the agency stated that 
the study sponsor should not separate out the reserve samples of the 
test article and reference standard prior to sending the drug product 
to the testing facility. This is to ensure that the reserve samples are 
in fact representative of the same batches provided by the study 
sponsor for the testing. FDA's Division of Scientific Investigations 
and field investigators from the Office of Regulatory Affairs conduct 
inspections of clinical and analytical sites that perform BA and BE 
studies for sponsors and/or drug manufacturers seeking approval of 
generic and new drug products. A frequent finding from these 
inspections is the absence of reserve samples at the testing facility. 
This draft guidance clarifies the responsibilities of the involved 
parties for retention of samples used in BA and BE studies. It includes 
recommendations for sampling techniques and responsibilities in various 
study settings.
    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 retention of 
BA and BE testing samples. It does not create or confer any rights for 
or on any person and does not operate to bind FDA or the public. An

[[Page 54220]]

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 (see 
ADDRESSES) written comments on the draft 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. 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.
    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: August 13, 2002.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 02-21262 Filed 8-20-02; 8:45 am]
BILLING CODE 4160-01-S