[Federal Register: May 26, 2004 (Volume 69, Number 102)]
[Notices]
[Page 29959-29960]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26my04-71]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2002D-0350]
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 guidance for industry entitled ``Handling and
Retention of BA and BE Testing Samples.'' The guidance is intended to
provide recommendations for study sponsors and/or drug manufacturers,
contract research organizations, site management organizations,
clinical investigators, and independent third parties on the procedure
for handling reserve samples from bioavailability (BA) and
bioequivalence (BE) studies. The guidance clarifies how to distribute
test articles and reference standards to testing facilities, how to
randomly select reserve samples, and how to retain reserve samples.
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 Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
See the SUPPLEMENTARY INFORMATION section for electronic
access to the 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:
[[Page 29960]]
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Handling and Retention of BA and BE Testing Samples.''
Following the generic drug crisis in the 1980s, FDA issued regulations
to prevent 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 to 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. In the Federal Register of August 21,
2002 (67 FR 54219), the agency issued a draft guidance entitled
``Handling and Retention of Bioavailability and Bioequivalence Testing
Samples'' to clarify the responsibilities of the involved parties for
retention of samples used in BA and BE studies. That draft guidance
included recommendations for sampling techniques and responsibilities
in various study settings. All comments received during the comment
period have been carefully reviewed and changes were made to this final
guidance where appropriate.
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 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 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 Division of Dockets Management
(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 Division of Dockets Management 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www
.fda.gov/ohrms/dockets/default/htm.
Dated: May 18, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-11828 Filed 5-25-04; 8:45 am]
BILLING CODE 4160-01-S