[Federal Register Volume 67, Number 68 (Tuesday, April 9, 2002)]
[Notices]
[Page 17077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-8464]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0096]


Draft ``Guidance for Industry: Use of Nucleic Acid 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;'' 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 draft document entitled ``Guidance for Industry: Use 
of Nucleic Acid 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. The draft guidance document would inform all establishments 
that manufacture Whole Blood that FDA has licensed a nucleic acid test 
(NAT) to identify human immunodeficiency virus type 1 (HIV-1) and 
hepatitis C virus (HCV) in Whole Blood donations. The draft document 
recommends that manufacturers implement licensed HIV-1 and HCV NAT 
within 6 months of issuance of a final guidance and notify FDA of such 
implementation by specified procedures.

DATES: Submit written or electronic comments on the draft guidance to 
ensure their adequate consideration in preparation of the final 
document by July 8, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 
Assistance (HFM-40), Center for Biologics Evaluation and Research 
(CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448. Send one self-addressed adhesive label to assist the 
office in processing your requests. The document may also be obtained 
by mail by calling the CBER Voice Information System at 1-800-835-4709 
or 301-827-1800, or by fax by calling the FAX Information System at 1-
888-CBER-FAX or 301-827-3844. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the draft guidance.
    Submit written comments on the document 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.

FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Guidance for Industry: Use of Nucleic Acid 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. FDA's final rule (66 
FR 31146, June 11, 2001) entitled ``Requirements for Testing Human 
Blood Donors for Evidence of Infection Due to Communicable Disease 
Agents'' became effective on December 10, 2001. Under 21 CFR 610.40(b), 
manufacturers ``must perform one or more such [screening] tests as 
necessary to reduce adequately and appropriately the risk of 
transmission of communicable disease'' (66 FR 31146 at 31162). In the 
preamble to the final rule, we said that the standard for adequate and 
appropriate testing will change as FDA approves new testing technology. 
We explained that, ``* * * 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 availability of NAT to identify HIV-1 and HCV will change the 
testing protocol for adequately and appropriately reducing the risk of 
transmission of those diseases. The draft document recommends that 
manufacturers implement HIV-1 and HCV nucleic acid testing within 6 
months of issuance of a final guidance. The draft guidance specifies 
how you should notify FDA of such implementation as required under 21 
CFR 601.12.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). This draft guidance 
document 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 requirement of the applicable statutes 
and regulations. As with other guidance documents, FDA does not intend 
this document to be all-inclusive and cautions that not all information 
may be applicable to all situations. The document is intended to 
provide information and does not set forth requirements.

II. Comments

    This draft document is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Dockets Management Branch (see ADDRESSES) written or 
electronic comments regarding this draft guidance document. Submit 
written or electronic comments to ensure adequate consideration in 
preparation of the final document by July 8, 2002. Two copies of any 
written comments are to be submitted, except individuals may submit one 
copy. Comments should be identified with the docket number found in the 
brackets in the heading of this document. A copy of the document 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 
http://www.fda.gov/cber/guidelines.htm or http://www/fda.gov/ohrms/dockets/default.htm.

    Dated: March 29, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-8464 Filed 4-8-02; 8:45 am]
BILLING CODE 4160-01-S