81 FR 62910 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 177 (September 13, 2016)

Page Range		62910-62911
FR Document		2016-21969

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 The guidance announced in this notice finalizes the draft guidance of the same title dated December 2015.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).

Federal Register, Volume 81 Issue 177 (Tuesday, September 13, 2016)

[Federal Register Volume 81, Number 177 (Tuesday, September 13, 2016)]
[Notices]
[Pages 62910-62911]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-21969]

[[Page 62910]]

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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.

-----------------------------------------------------------------------

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.

[[Page 62911]]

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

Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Notices 62911

I. Background (HCT/Ps).’’ It does not establish any Abstract: The National Healthy Start
FDA is announcing the availability of rights for any person and is not binding Program, funded through HRSA’s
a document entitled ‘‘Use of Nucleic on FDA or the public. You can use an Maternal and Child Health Bureau
Acid Tests to Reduce the Risk of alternative approach if it satisfies the (MCHB), has the goal of reducing
Transmission of West Nile Virus From requirements of the applicable statutes disparities in infant mortality and
Living Donors of Human Cells, Tissues, and regulations. adverse perinatal outcomes. The
and Cellular and Tissue-Based Products II. Electronic Access program began as a demonstration
(HCT/Ps); Guidance for Industry.’’ The project with 15 grantees in 1991 and has
Persons with access to the Internet expanded over the past 2 decades to 100
guidance document provides may obtain the guidance at either http://
establishments that make donor grantees across 37 states and
www.fda.gov/BiologicsBloodVaccines/ Washington, DC. Healthy Start grantees
eligibility determinations for donors of GuidanceComplianceRegulatory
HCT/Ps with recommendations for operate in communities with rates of
Information/Guidances/default.htm or infant mortality at least 1.5 times the
testing living donors for WNV. The http://www.regulations.gov.
guidance does not provide U.S. national average and high rates for
recommendations regarding testing of Dated: September 8, 2016. other adverse perinatal outcomes. These
cadaveric HCT/P donors for WNV. FDA Leslie Kux, communities are geographically,
believes that the use of an FDA-licensed Associate Commissioner for Policy. racially, ethnically, and linguistically
NAT will reduce the risk of [FR Doc. 2016–21969 Filed 9–12–16; 8:45 am] diverse low-income areas. Healthy Start
transmission of WNV from living donors BILLING CODE 4164–01–P
covers services during the perinatal
of HCT/Ps and therefore recommends period (before, during, after pregnancy)
that you use an FDA-licensed NAT for and follows the woman and infant
testing living donors of HCT/Ps for DEPARTMENT OF HEALTH AND through 2 years after the end of the
infection with WNV as set forth in the HUMAN SERVICES pregnancy. The Healthy Start program
guidance. The 2007 Donor Eligibility has five approaches including: (1)
Health Resources and Services Improving women’s health; (2)
Guidance indicated that FDA may
Administration promoting quality services; (3)
recommend routine use of an
appropriate, licensed donor screening strengthening family resilience; (4)
Agency Information Collection achieving collective impact; and (5)
test(s) to detect acute infections with Activities: Submission to OMB for
WNV using NAT technology, once such increasing accountability through
Review and Approval; Public Comment quality assurance, performance
tests were available. Request; Healthy Start Evaluation and
In the Federal Register of December monitoring, and evaluation.
Quality Improvement
15, 2015 (80 FR 77645), FDA announced MCHB seeks to implement a uniform
the availability of the draft guidance AGENCY: Health Resources and Services set of data elements for monitoring and
entitled ‘‘Use of Nucleic Acid Tests to Administration (HRSA), Department of conducting a mixed-methods evaluation
Reduce the Risk of Transmission of Health and Human Services. to assess the effectiveness of the
West Nile Virus from Living Donors of ACTION: Notice. program on individual, organizational,
Human Cells, Tissues, and Cellular and and community-level outcomes. Data
Tissue-Based Products (HCT/Ps); Draft SUMMARY: In compliance with section collection instruments will include a
Guidance for Industry’’ dated December 3507(a)(1)(D) of the Paperwork National Healthy Start Program Survey;
Reduction Act of 1995, HRSA has Community Action Network Survey;
2015 (December 2015 draft guidance).
submitted an Information Collection Healthy Start Site Visit Protocol;
FDA received several comments on the
Request (ICR) to the Office of Healthy Start Participant Focus Group
draft guidance and those comments
Management and Budget (OMB) for Protocol—these instruments have not
were considered as the guidance was
review and approval. Comments been changed. The Preconception,
developed.
submitted during the first public review Pregnancy and Parenting (3Ps)
In the Federal Register of February
of this ICR will be provided to OMB. Information Form will also be used as
28, 2007 (72 FR 9007), FDA announced
OMB will accept further comments from a data collection instrument; however
the availability of the 2007 Donor
the public during the review and the 3Ps Information Form has been
Eligibility Guidance. FDA issued a
approval period. redesigned from one form into six
revised version of this guidance under
the same title, dated August 2007 (2007 DATES: Comments on this ICR should be forms. The six forms include: (1)
Donor Eligibility Guidance). received no later than October 13, 2016. Demographic Intake Form; (2)
The guidance announced in this ADDRESSES: Submit your comments, Pregnancy Status/History; (3)
notice finalizes the December 2015 draft including the Information Collection Preconception; (4) Prenatal; (5)
guidance and supplements sections Request Title, to the desk officer for Postpartum; and (6) Interconception/
IV.E. (recommendations 15 and 16) and HRSA, either by email to OIRA_ Parenting. The purpose of this redesign
IV.F. (recommendation 5), and submission@omb.eop.gov or by fax to is to enhance the 3Ps Information Form
supersedes the ‘‘West Nile Virus 202–395–5806. to ensure collected data is meaningful
(WNV)’’ section in Appendix 6 of the FOR FURTHER INFORMATION CONTACT: To for monitoring and evaluation, as well
2007 Donor Eligibility Guidance. request a copy of the clearance requests as screening and care coordination, and
The guidance is being issued submitted to OMB for review, email the streamline previously separate data
consistent with FDA’s good guidance HRSA Information Collection Clearance systems. The 3Ps Information Form was
Officer at paperwork@hrsa.gov or call
Lhorne on DSK30JT082PROD with NOTICES

practices regulation (21 CFR 10.115). also redesigned to allow questions to be
The guidance represents the current (301) 443–1984. administered in accordance with the
thinking of FDA on ‘‘Use of Nucleic SUPPLEMENTARY INFORMATION: participant’s enrollment/service
Acid Tests to Reduce the Risk of Information Collection Request Title: delivery status and perinatal period. In
Transmission of West Nile Virus from Healthy Start Evaluation and Quality addition to redesigning the 3Ps
Living Donors of Human Cells, Tissues, Improvement OMB No. 0915–0338— Information Form, HRSA deleted
and Cellular and Tissue-Based Products Revision questions that are neither critical for

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Document Modified: 2018-02-09 13:16:47

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
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.
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. I. Background
FR Citation		81 FR 62910

81 FR 62910 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 177 (September 13, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration