[Federal Register: July 27, 2005 (Volume 70, Number 143)]
[Notices]               
[Page 43439-43440]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jy05-97]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0261]

 
Draft Guidance for Industry on Nucleic Acid Testing for Human 
Immunodeficiency Virus Type 1 and Hepatitis C Virus: Testing, Product 
Disposition, and Donor Deferral and Reentry; 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: 
Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 
(HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and 
Donor Deferral and Reentry,'' dated July 2005. The draft guidance 
document provides information for blood and plasma establishments, 
manufacturers, and testing laboratories that are implementing a 
licensed method for NAT on pooled or individual samples of human blood 
and blood component donations for HIV-1 ribonucleic acid (RNA) and HCV 
RNA. The draft guidance document is intended to encourage more 
effective testing of whole blood and blood component samples, and 
improved product and donor management based on the results of NAT and 
concurrent serologic testing for markers of HIV and HCV infection on 
donated whole blood and blood components.

DATES: Submit written or electronic comments on the draft guidance by 
October 25, 2005 to ensure their adequate consideration in preparation 
of the final guidance. 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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, suite 200N, 
Rockville, MD 20852-1448. Send one self-addressed adhesive label to 
assist the office in processing your requests. The draft guidance may 
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. See the SUPPLEMENTARY INFORMATION section for electronic access 
to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 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.


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 draft document entitled 
``Guidance for

[[Page 43440]]

Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus 
Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product 
Disposition, and Donor Deferral and Reentry'' dated July 2005. There 
has been a dramatic reduction during the past decade in the 
transmission of HIV-1 and HCV by human blood and blood components. The 
reduction is a result of the implementation of sensitive tests for 
viral antibody, antigen (for HIV-1), and nucleic acids, and the use of 
effective virus removal and inactivation methods. The sources of 
remaining risk of HIV-1 and HCV transmission are marker-negative 
``window period'' donations, donors infected with immunovariant viral 
strains, persistent antibody-negative (immunosilent) carriers, and 
laboratory test procedure errors. Because donations during the window 
period constitute most of the risk of HIV-1 and HCV transmission, 
measures to close the ``window period'' further could reduce 
significantly the low residual risk of HIV-1 and HCV transmission by 
human blood and blood components. Studies using seroconversion panels 
indicate the value of NAT in reducing the ``window period'' for HIV-1 
and HCV.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent FDA'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

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Division of Dockets Management (see ADDRESSES) 
written or electronic comments regarding the draft guidance. Submit 
written or electronic comments to ensure adequate consideration in 
preparation of the final 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 draft 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 guidance at 
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.
    Dated: July 19, 2005.

Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-14746 Filed 7-26-05; 8:45 am]

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