Document ID: FDA-2005-D-0140-0007
Agency: fda
Document Type: Notice
Title: Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV), etc.
Posted Date: 2010-04-30T04:00Z

[Federal Register: April 30, 2010 (Volume 75, Number 83)]
[Notices]               
[Page 22814-22815]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap10-93]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-D-0140] (formerly Docket No. FDA-2005D-0261)

 
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; 
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: 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 May 2010. The guidance document provides 
recommendations to blood and plasma establishments, manufacturers, and 
testing laboratories that are implementing a licensed method for Human 
Immunodeficiency Virus Type 1 (HIV-1) Nucleic Acid Test (NAT) and 
Hepatitis C Virus (HCV) NAT, on testing individual samples or pooled 
samples from donors of human blood and blood components for HIV-1 
ribonucleic acid (RNA) and HCV RNA. This guidance also contains 
recommendations regarding product disposition and donor management 
based on the results of NAT and serologic testing for markers of HIV-1 
and HCV infection on samples, collected at the time of donation, from 
donors of human blood and blood components. The guidance announced in 
this notice finalizes the draft guidance of the same title, dated July 
2005. This guidance also supersedes the recommendations for reentry of 
donors deferred because of anti-HIV-1 test results, HIV-1 p24 antigen 
test results, and anti-HCV test results that were provided in the FDA 
memoranda entitled ``Revised Recommendations for the Prevention of 
Human Immunodeficiency Virus (HIV-1) Transmission by Blood and Blood 
Products,'' April 23, 1992; ``Revised Recommendations for Testing Whole 
Blood, Blood Components, Source Plasma and Source Leukocytes for 
Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV),'' August 5, 
1993; ``Recommendations for Donor Screening with a Licensed Test for 
HIV-1 Antigen,'' August 8, 1995.

DATES:  Submit electronic or written comments on agency guidances at 
any time.

ADDRESSES:  Submit written requests for single copies of the guidance 
to the Office of Communication, Outreach and Development (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 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 guidance document.
    Submit electronic or written comments on the guidance. Submit 
electronic comments to http://www.regulations.gov. Submit written 
comments to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Paul Levine, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a 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 
May 2010. The guidance document provides recommendations to blood and 
plasma establishments, manufacturers, and testing laboratories that are 
implementing a licensed method for Human Immunodeficiency Virus Type 1 
(HIV-1) Nucleic Acid Test (NAT) and Hepatitis C Virus (HCV) NAT, on 
testing individual samples or pooled samples from donors of human blood 
and blood components for HIV-1 ribonucleic acid (RNA) and HCV RNA. This 
guidance also contains recommendations regarding product disposition 
and donor management based on the results of NAT and serologic testing 
for markers of HIV-1 and HCV infection on samples, collected at the 
time of donation, from donors of human blood and blood components. The 
guidance announced in this notice finalizes the draft guidance of the 
same title, dated July 19, 2005. This guidance also supersedes the 
recommendations for reentry of donors deferred because of anti-HIV-1 
test results, HIV-1 p24 antigen test results, and anti-HCV test results 
that were provided in the FDA memoranda entitled, ``Revised 
Recommendations for the Prevention of Human Immunodeficiency Virus 
(HIV-1) Transmission by Blood and Blood Products,'' April 23, 1992; 
``Revised Recommendations for Testing Whole Blood, Blood Components, 
Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus 
Encoded Antigen (Anti-HCV),'' August 5, 1993; ``Recommendations for 
Donor Screening with a Licensed Test for HIV-1 Antigen,'' August 8, 
1995.
    In the Federal Register of July 27, 2005 (70 FR 43439), FDA 
announced the availability of the draft guidance of the same title. FDA 
received several comments on the draft guidance and those comments were 
considered as the guidance was finalized. The guidance announced in 
this notice finalizes the draft guidance dated July 2005.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
regarding the guidance. Submit a single copy of electronic comments or 
two paper copies of any mailed comments, except

[[Page 22815]]

that individuals may submit one paper copy. Comments are to be 
identified with the docket number found in 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.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either: http://www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http:/
/www.regulations.gov.

    Dated: April 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10048 Filed 4-29-10; 8:45 am]
BILLING CODE 4160-01-S