Document ID: FDA-2013-D-1143-0049
Agency: fda
Document Type: Notice
Title: Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile
Virus From Living Donors of Human Cells, Tissues, and Cellular and
Tissue-Based Products; Draft Guidance for Industry; Availability
Posted Date: 2015-12-15T05:00Z

[Federal Register Volume 80, Number 240 (Tuesday, December 15, 2015)]
[Notices]
[Pages 77645-77646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31405]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Use of Nucleic Acid Tests To Reduce the Risk of Transmission of 
West Nile Virus From Living Donors of Human Cells, Tissues, and 
Cellular and Tissue-Based Products; Draft Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft document entitled ``Use of Nucleic Acid 
Tests to Reduce the Risk of Transmission of West Nile Virus from Living 
Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products 
(HCT/Ps); Draft Guidance for Industry.'' The draft guidance document 
provides establishments that make donor eligibility determinations for 
donors of HCT/Ps with recommendations for testing living donors for 
West Nile Virus (WNV). The draft guidance recommends the use of an FDA-
licensed nucleic acid test (NAT) to test living donors of HCT/Ps for 
evidence of infection with WNV. The guidance does not provide 
recommendations regarding testing of cadaveric HCT/P donors for WNV. 
The draft guidance replaces the draft guidance entitled ``Draft 
Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of 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 (HCT/Ps)'' dated October 2013. 
The donor testing recommendations in the draft guidance, when 
finalized, will supplement the donor screening recommendations for WNV 
(which will remain in place) and supersede the ``West Nile Virus 
(WNV)'' section in Appendix 6 of 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 March 14, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-D-1143 for ``Use of Nucleic Acid Tests to Reduce the Risk of 
Transmission of West Nile Virus from Living Donors of Human Cells, 
Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft 
Guidance for Industry.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential

[[Page 77646]]

Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
10903 New Hampshire Ave. Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. 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 240-402-8010. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: Jonathan McKnight, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave. Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft document entitled 
``Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West 
Nile Virus From Living Donors of Human Cells, Tissues, and Cellular and 
Tissue-Based Products (HCT/Ps); Draft Guidance for Industry.'' The 
draft guidance document provides establishments that make donor 
eligibility determinations for donors of HCT/Ps with recommendations 
for testing living donors for WNV. The draft guidance recommends an 
FDA-licensed NAT to test living donors of HCT/Ps for evidence of 
infection with WNV. The guidance does not provide recommendations 
regarding testing of cadaveric HCT/P donors for WNV. FDA believes that 
the use of an FDA-licensed NAT will reduce the risk of transmission of 
WNV from living donors of HCT/Ps and therefore recommends that you use 
an FDA-licensed NAT for testing living 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.
    In the Federal Register of October 24, 2013 (78 FR 63476), FDA 
announced the availability of the draft guidance entitled ``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 (HCT/Ps)'' dated October 2013 
(October 2013 draft guidance). FDA received several comments on the 
draft guidance and those comments were considered as this draft 
guidance was developed.
    In the Federal Register of February 28, 2007 (72 FR 9007), FDA 
announced the availability of the 2007 Donor Eligibility Guidance. FDA 
issued a revised version of this guidance under the same title, dated 
August 2007 (2007 Donor Eligibility Guidance).
    The draft guidance announced in this notice replaces the October 
2013 draft guidance and when finalized, will supplement sections IV.E. 
(recommendations 15 and 16), IV.F. (recommendation 5), and supersede 
the ``West Nile Virus (WNV)'' section in Appendix 6 of the 2007 Donor 
Eligibility Guidance.
    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 the current thinking of FDA on ``Use of 
Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile 
Virus from Living Donors of Human Cells, Tissues, and Cellular and 
Tissue-Based Products (HCT/Ps); Draft Guidance for Industry.'' It does 
not establish any rights for any person and is not binding on FDA or 
the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

II. 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: December 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-31405 Filed 12-14-15; 8:45 am]
 BILLING CODE 4164-01-P