Notice: Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce 
the Risk of Transmission of West Nile Virus from Donors of Whole Blood 
and Blood Components Intended for Transfusion and Donors of Human 
Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); 
Availability

Federal Register: April 28, 2008 (Volume 73, Number 82)           
                  Page 22958-22959

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Guidance for Industry: Use 
of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile 
Virus from Donors of Whole Blood and Blood Components Intended for 
Transfusion and Donors of Human Cells, Tissues, and Cellular and 
Tissue-Based Products (HCT/Ps)'' dated April 2008. This draft guidance 
is intended for establishments that collect Whole Blood and blood 
components intended for transfusion and establishments that make donor 
eligibility determinations for donors of human cells, tissues, and 
cellular and tissue-based products (HCT/Ps). The document provides 
recommendations for testing of donations of Whole Blood and blood 
components and HCT/P donor specimens for West Nile Virus (WNV) using an 
FDA-licensed donor screening assay. FDA believes that the use of a 
licensed nucleic acid test (NAT) will reduce the risk of transmission 
of WNV, and therefore recommend use of a licensed NAT to screen donors 
of Whole Blood and blood components intended for transfusion and for 
testing donors of HCT/Ps for infection with WNV. FDA recommends the use 
of licensed NAT testing for WNV within 6 months after a final guidance 
is issued.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by July 28, 2008.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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 The draft guidance may 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.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Tami Belouin, 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 draft document entitled 
``Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk 
of Transmission of West Nile Virus from Donors of Whole Blood and Blood 
Components Intended for Transfusion and Donors of Human Cells, Tissues, 
and Cellular and Tissue-Based Products (HCT/Ps)'' dated April 2008. 
This draft guidance is intended for establishments that collect Whole 
Blood and blood components intended for transfusion and establishments 
that make donor eligibility determinations for donors of human cells, 
tissues, and cellular and tissue-based products HCT/Ps. The document 
provides recommendations for testing of donations of Whole Blood and 
blood components and HCT/P donor specimens for WNV using an FDA-
licensed donor screening assay. FDA believes that the use of a licensed 
NAT will reduce the risk of transmission of WNV, and therefore 
recommend use of a licensed NAT to screen donors of Whole Blood and 
blood components intended for transfusion and for testing donors of 
HCT/Ps for infection with WNV. FDA recommends the use of licensed NAT 
testing for WNV within 6 months after a final guidance is issued.

[[Page 22959]]

    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. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 312 have been approved under 
0910-0014; 21 CFR part 601 have been approved under 0910-0338; CFR part 
606 have been approved under 0910-0116; and 21 CFR part 7, subpart C, 
have been approved under 0910-0249.

III. 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 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 

IV. Electronic Access

    Persons with access to the Internet may obtain the draft 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.regulations.gov. 

    Dated: April 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-9253 Filed 4-25-08; 8:45 am]

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