[Federal Register Volume 75, Number 83 (Friday, April 30, 2010)]
[Notices]
[Pages 22814-22815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-10048]
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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this notice finalizes the draft guidance of the same title, dated July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]
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