[Federal Register Volume 81, Number 177 (Tuesday, September 13, 2016)]
[Notices]
[Pages 62910-62911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21969]



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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; 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 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); Guidance for Industry.'' The 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). Specifically, the guidance provides recommendations 
regarding 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 guidance announced in this notice 
finalizes the draft guidance of the same title dated December 2015. 
This guidance supplements the donor screening recommendations for WNV 
(which will remain in place) in sections IV.E. (recommendations 15 and 
16) and IV.F. (recommendation 5), and supersedes 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 
guidance before it begins work on the final version of the guidance, 
submit either electronic or written comments on the guidance by 
December 12, 2016.

SUPPLEMENTARY INFORMATION:
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); Guidance for 
Industry.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential 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 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 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 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.

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I. Background

    FDA is announcing the availability of a 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); Guidance for Industry.'' The guidance 
document provides establishments that make donor eligibility 
determinations for donors of HCT/Ps with recommendations for testing 
living donors for 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 as set forth in the guidance. 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 December 15, 2015 (80 FR 77645), FDA 
announced the availability of the draft guidance 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'' dated 
December 2015 (December 2015 draft guidance). FDA received several 
comments on the draft guidance and those comments were considered as 
the 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 guidance announced in this notice finalizes the December 2015 
draft guidance and supplements sections IV.E. (recommendations 15 and 
16) and IV.F. (recommendation 5), and supersedes the ``West Nile Virus 
(WNV)'' section in Appendix 6 of the 2007 Donor Eligibility Guidance.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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).'' 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 guidance at 
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: September 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21969 Filed 9-12-16; 8:45 am]
 BILLING CODE 4164-01-P