Document ID: FDA-2013-D-1143-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry:  Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability
Posted Date: 2013-10-24T04:00Z

[Federal Register Volume 78, Number 206 (Thursday, October 24, 2013)]
[Notices]
[Pages 63476-63477]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24940]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1143]

Draft Guidance for Industry: Use of Nucleic Acid Tests To Reduce 
the Risk of Transmission of West Nile Virus From Donors of Human Cells, 
Tissues, and Cellular and Tissue-Based Products; 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: Use 
of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile 
Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-
Based Products (HCT/Ps),'' dated October 2013. The draft guidance 
document provides establishments that make donor eligibility 
determinations for donors of HCT/Ps, with recommendations for donor 
testing for West Nile Virus (WNV) using an FDA-licensed donor screening 
test. The guidance recommends the use of an FDA-licensed nucleic acid 
test

[[Page 63477]]

(NAT) for testing donors of HCT/Ps for infection with WNV. The draft 
guidance replaces the draft guidance entitled ``Guidance for Industry: 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, with respect to HCT/
Ps. The testing recommendations in the guidance, when finalized, will 
supplement the donor screening recommendations for WNV (which will 
remain in place) that were made in the guidance entitled ``Guidance for 
Industry: Eligibility Determination for Donors of Human Cells, Tissues, 
and Cellular and Tissue-Based Products (HCT/Ps)'' dated August 2007 
(2007 Donor Eligibility Guidance).

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 either electronic or written comments on the draft 
guidance by January 22, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
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 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 electronic comments on the draft guidance 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: Benjamin A. Chacko, 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 Human Cells, Tissues, 
and Cellular and Tissue-Based Products (HCT/Ps),'' dated October 2013. 
FDA is providing establishments that make donor eligibility 
determinations for donors of HCT/Ps with recommendations for donor 
testing for WNV using an FDA-licensed donor screening test. FDA 
believes that the use of an FDA-licensed NAT will reduce the risk of 
transmission of WNV from donors of HCT/Ps and therefore recommends that 
you use an FDA-licensed NAT for testing donors of HCT/Ps for infection 
with WNV. The 2007 Donor Eligibility Guidance indicated that FDA may 
recommend routine use of an appropriate, licensed donor screening 
test(s) to detect acute infections with WNV using NAT technology, once 
such tests were available.
    The draft guidance announced in this notice replaces the draft 
guidance 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 (April 28, 2008; 73 FR 22958), with respect to HCT/Ps. The 
testing recommendations in the guidance, when finalized, will 
supplement the donor screening recommendations for WNV (which remain in 
place) that were made in the 2007 Donor Eligibility Guidance.
    The draft 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 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 either electronic comments regarding this document http://www.regulations.gov or written comments to the Division of Dockets 
Management (see ADDRESSES). It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

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

    Dated: October 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-24940 Filed 10-23-13; 8:45 am]
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