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, 62910-62911 [2016-21969]

Download as PDF 62910 Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Notices Electronic Submissions 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. 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 The guidance announced in this notice finalizes the draft guidance of the same title dated December 2015.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). SUMMARY: 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. Lhorne on DSK30JT082PROD with NOTICES DATES: SUPPLEMENTARY INFORMATION: ADDRESSES: You may submit comments as follows: VerDate Sep<11>2014 15:27 Sep 12, 2016 Jkt 238001 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 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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. E:\FR\FM\13SEN1.SGM 13SEN1 Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Notices Lhorne on DSK30JT082PROD with NOTICES 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 VerDate Sep<11>2014 15:27 Sep 12, 2016 Jkt 238001 (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/ GuidanceComplianceRegulatory Information/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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Healthy Start Evaluation and Quality Improvement Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. DATES: Comments on this ICR should be received no later than October 13, 2016. ADDRESSES: Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to OIRA_ submission@omb.eop.gov or by fax to 202–395–5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443–1984. SUPPLEMENTARY INFORMATION: Information Collection Request Title: Healthy Start Evaluation and Quality Improvement OMB No. 0915–0338— Revision SUMMARY: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 62911 Abstract: The National Healthy Start Program, funded through HRSA’s Maternal and Child Health Bureau (MCHB), has the goal of reducing disparities in infant mortality and adverse perinatal outcomes. The program began as a demonstration project with 15 grantees in 1991 and has expanded over the past 2 decades to 100 grantees across 37 states and Washington, DC. Healthy Start grantees operate in communities with rates of infant mortality at least 1.5 times the U.S. national average and high rates for other adverse perinatal outcomes. These communities are geographically, racially, ethnically, and linguistically diverse low-income areas. Healthy Start covers services during the perinatal period (before, during, after pregnancy) and follows the woman and infant through 2 years after the end of the pregnancy. The Healthy Start program has five approaches including: (1) Improving women’s health; (2) promoting quality services; (3) strengthening family resilience; (4) achieving collective impact; and (5) increasing accountability through quality assurance, performance monitoring, and evaluation. MCHB seeks to implement a uniform set of data elements for monitoring and conducting a mixed-methods evaluation to assess the effectiveness of the program on individual, organizational, and community-level outcomes. Data collection instruments will include a National Healthy Start Program Survey; Community Action Network Survey; Healthy Start Site Visit Protocol; Healthy Start Participant Focus Group Protocol—these instruments have not been changed. The Preconception, Pregnancy and Parenting (3Ps) Information Form will also be used as a data collection instrument; however the 3Ps Information Form has been redesigned from one form into six forms. The six forms include: (1) Demographic Intake Form; (2) Pregnancy Status/History; (3) Preconception; (4) Prenatal; (5) Postpartum; and (6) Interconception/ Parenting. The purpose of this redesign is to enhance the 3Ps Information Form to ensure collected data is meaningful for monitoring and evaluation, as well as screening and care coordination, and streamline previously separate data systems. The 3Ps Information Form was also redesigned to allow questions to be administered in accordance with the participant’s enrollment/service delivery status and perinatal period. In addition to redesigning the 3Ps Information Form, HRSA deleted questions that are neither critical for E:\FR\FM\13SEN1.SGM 13SEN1

Agencies

[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]



[[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