[Federal Register: May 26, 2004 (Volume 69, Number 102)]
[Page 29959-29960]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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 

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.


[[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

    Dated: May 18, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-11828 Filed 5-25-04; 8:45 am]