[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Draft Guidance for Industry on Nucleic Acid Testing for Human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 The draft guidance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 The draft guidance document is intended to encourage more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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers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 The draft guidance may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to the draft guidance document.
Submit written comments on the draft guidance to the Division of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://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://www.fda.gov/cber/guidelines.htm or 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]
BILLING CODE 4160-01-S