[Federal Register Volume 69, Number 208 (Thursday, October 28, 2004)]
[Notices]
[Pages 62902-62903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24067]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2001D-0584]
``Guidance for Industry: Use of Nucleic Acid Tests on Pooled and
Individual Samples From Donors of Whole Blood and Blood Components
(Including Source Plasma and Source Leukocytes) to Adequately and
Appropriately Reduce the Risk of Transmission of Human Immunodeficiency
Virus Type 1 and Hepatitis C Virus;'' 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 document entitled ``Guidance for Industry: Use of
Nucleic Acid Tests on Pooled and Individual Samples From Donors of
Whole Blood and Blood Components (Including Source Plasma and Source
Leukocytes) to Adequately and Appropriately Reduce the Risk of
Transmission of HIV-1 and HCV,'' dated October 2004. The guidance
provides recommendations to all establishments that manufacture Whole
Blood and blood components (including Source Plasma and Source
Leukocytes) on the implementation of licensed nucleic acid tests (NAT)
to identify human immunodeficiency virus type 1 (HIV-1) ribonucleic
acid (RNA), and hepatitis C virus (HCV) RNA in donations of Whole Blood
and blood components to reduce the risk of transmission of these
agents; and the reporting to FDA of such implementation. The guidance
announced in this notice finalizes the draft guidances entitled ``Use
of Nucleic Acid Tests on Pooled Samples From Source Plasma Donors to
Adequately and Appropriately Reduce the Risk of Transmission of HIV-1
and HCV,'' dated December 2001 and ``Use of Nucleic Tests on Pooled and
Individual Samples From Donors of Whole Blood and Blood Components for
Transfusion to Adequately and Appropriately Reduce the Risk of
Transmission of HIV-1 and HCV,'' dated March 2002.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Communication, Training, and Manufacturers Assistance
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and
Drug
[[Page 62903]]
Administration, suite 200N, 1401 Rockville Pike, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The guidance may also be obtained by mail by
calling 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.
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://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, suite 200N, 1401 Rockville Pike, Rockville, MD 20852-
1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a document entitled
``Guidance for Industry: Use of Nucleic Acid Tests on Pooled and
Individual Samples From Donors of Whole Blood and Blood Components to
Adequately and Appropriately Reduce the Risk of Transmission of HIV-1
and HCV,'' dated October 2004. FDA's final rule (66 FR 31146, June 11,
2001) entitled ``Requirements for Testing Human Blood Donors for
Evidence of Infection Due to Communicable Diseases'' became effective
on December 10, 2001. The regulations under Sec. 610.40(b) (21 CFR
610.40(b)) require that establishments that collect or manufacture
Whole Blood and blood components ``must perform one or more screening
tests to adequately and appropriately reduce the risk of transmission
of communicable disease agents'' (66 FR 31146 at 31162). As we noted in
the preamble to the final rule, the standard for adequate and
appropriate testing will change as new testing technology is approved
by FDA. We explained, ``* * * we intend to regularly issue guidance
describing those tests that we believe would adequately and
appropriately reduce the risk of transmission of communicable disease
agents'' (66 FR 31146 at 31149).
The guidance announced in this notice finalizes the draft guidances
entitled ``Use of Nucleic Acid Tests on Pooled Samples From Source
Plasma Donors to Adequately and Appropriately Reduce the Risk of
Transmission of HIV-1 and HCV,'' dated December 2001, and ``Use of
Nucleic Tests on Pooled and Individual Samples From Donors of Whole
Blood and Blood Components for Transfusion to Adequately and
Appropriately Reduce the Risk of Transmission of HIV-1 and HCV,'' dated
March 2002. This guidance recommends that establishments implement
these recommendations as soon as feasible, but not later than 6 months
after publication of this notice.
The 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 this topic. 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. The Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 601.12 and Sec. 610.40 of this
guidance were approved under OMB control numbers 0910-0315 and 0910-
0472.
III. Comments
Interested persons may, at any time, submit written or electronic
comments to the Division of Dockets Management (see ADDRESSES)
regarding this guidance. Submit a single copy of electronic comments or
two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments are to be identified with the docket
number found in the brackets in the heading of this document. A copy of
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.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.
Dated: October 20, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-24067 Filed 10-27-04; 8:45 am]
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