[Federal Register Volume 67, Number 21 (Thursday, January 31, 2002)]
[Notices]
[Pages 4719-4720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-2321]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0584]


Draft ``Guidance for Industry: 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''; 
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 Samples From Source Plasma Donors to 
Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 
and HCV'' dated December 2001. The draft guidance document, when 
finalized, would inform all establishments that manufacture Source 
Plasma that FDA has approved nucleic acid tests (NAT) to identify human 
immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) in 
Source Plasma donations. The draft document recommends that 
manufacturers submit a prior approval supplement to a biologics license 
application (BLA) to implement HIV-1 and HCV NAT by a specified date.

DATES:  Submit written or electronic comments on the draft guidance to 
ensure their adequate consideration in preparation of the final 
document by May 1, 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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for electronic access to the draft guidance document.
    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 Samples 
From Source Plasma Donors to Adequately and Appropriately Reduce the 
Risk of Transmission of HIV-1 and HCV'' dated December 2001. 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 
provision in 21 CFR 610.40(b) of the rule provides that manufacturers 
``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 availability of NAT to identify HIV-1 and HCV will change the 
testing protocol that should be used to adequately and appropriately 
reduce the risk of transmission of those diseases. The draft document 
recommends that manufacturers submit a prior approval supplement to a 
BLA to implement HIV-1 and HCV NAT by a specified date.
    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.

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 (address above) 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 May 1, 2002. Two copies of any 
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 
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.


[[Page 4720]]


    Dated: January 23, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-2321 Filed 1-30-02; 8:45 am]
BILLING CODE 4160-01-S