[Federal Register Volume 67, Number 202 (Friday, October 18, 2002)]
[Notices]
[Pages 64401-64402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-26475]


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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Draft Guidance for Industry on Handling and Retention of 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; 
Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until 
December 17, 2002, the comment period for the draft guidance for 
industry entitled ``Handling and Retention of Bioavailability and 
Bioequivalence Testing Samples.'' This draft guidance is intended to 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. FDA published a notice of availability of the 
draft guidance in the Federal Register of August 21, 2002 (67 FR 
54219). The agency is taking this action in response to a request for 
an extension of the comment period and to allow interested parties 
additional time to submit comments.

DATES: Submit written or electronic comments on the draft guidance by 
December 17, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Dockets Management Branch (HFA-305), Food 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access to the draft guidance document.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: 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

    In the Federal Register of August 21, 2002 (67 FR 54219), FDA 
announced the availability of a draft guidance for industry entitled 
``Handling and Retention of Bioavailability and Bioequivalence Testing 
Samples.'' The draft guidance had a 30-day comment period. The draft 
guidance clarifies the responsibilities of the involved parties for 
retention of samples used in bioavailability and bioequivalence 
studies. It includes recommendations for sampling techniques and 
responsibilities in various study settings.
    In a letter dated September 20, 2002, FDA received a request from 
an interested party to extend the comment period. The party indicated 
that issues of importance to the pharmaceutical industry had been 
raised that warrant further discussion before filing comments. In 
response to this request, and to provide all interested persons 
additional time to comment on this draft guidance, FDA is reopening the 
comment period for 60 days.

[[Page 64402]]

II. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/ohrms/dockets/default.htm or http://www.fda.gov/cder/guidance/index.htm.

    Dated: October 10, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-26475 Filed 10-17-02; 8:45 am]
BILLING CODE 4160-01-S