[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]
BILLING CODE 4160-01-S