[Federal Register Volume 83, Number 131 (Monday, July 9, 2018)]
[Notices]
[Pages 31760-31762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14537]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0545]


Revised Recommendations for Reducing the Risk of Zika Virus 
Transmission by Blood and Blood Components; 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 final guidance for industry entitled ``Revised 
Recommendations for Reducing the Risk of Zika Virus Transmission by 
Blood and Blood Components; Guidance for Industry.'' The guidance 
document provides blood establishments that collect Whole Blood and 
blood components with revised recommendations to reduce the risk of 
transmission of Zika virus (ZIKV) by blood and blood components. The 
guidance does not apply to the collection of Source Plasma. The 
guidance announced in this notice supersedes the document of the same 
title dated August 2016 (August 2016 Guidance).

DATES: The announcement of the guidance is published in the Federal 
Register on July 9, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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,

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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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2016-D-0545 for ``Revised Recommendations for Reducing the Risk of 
Zika Virus Transmission by Blood and Blood Components; Guidance for 
Industry.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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: Tami Belouin, 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 document entitled ``Revised 
Recommendations for Reducing the Risk of Zika Virus Transmission by 
Blood and Blood Components; Guidance for Industry.'' The guidance 
provides blood establishments that collect Whole Blood and blood 
components with revised recommendations to reduce the risk of 
transmission of ZIKV by blood and blood components. The guidance does 
not apply to the collection of Source Plasma. This guidance supersedes 
the August 2016 Guidance.
    In the August 2016 Guidance, FDA recognized ZIKV as a relevant 
transfusion-transmitted infection under 21 CFR 630.3(h) and recommended 
universal individual donation nucleic acid testing (ID NAT) for ZIKV or 
the use of an FDA-approved pathogen reduction device. Since 2016, the 
number of ZIKV disease cases in the U.S. States and territories has 
decreased considerably. In addition, FDA has licensed a nucleic acid 
screening test(s) for the detection of ZIKV in individual or pooled 
samples. Considering the changing epidemiology of ZIKV in the United 
States and the availability of licensed screening tests, FDA is 
revising the recommendations contained in the August 2016 Guidance. In 
this guidance FDA explains that, in order to comply with the testing 
requirements in 21 CFR 610.40(a)(3), blood establishments must test all 
donations collected in the United States and its territories with a 
licensed nucleic acid test for ZIKV, using either ID NAT or minipool 
(MP) NAT. The guidance explains the basis for FDA's determination that 
universal MP NAT screening, with certain conditions identified to 
trigger ID NAT when local mosquito-borne ZIKV transmission is presumed 
in a collection area, provides an adequate and appropriate safeguard 
against the current and future risk of ZIKV transmission through blood 
transfusion. Alternatively, blood establishments can use an FDA-
approved pathogen reduction device. The revised recommendations are 
less burdensome for blood establishments because fewer tests will be 
performed when donations are tested by MP NAT compared to ID NAT. 
However, the recommendations are consistent with public health 
considering the changing course of the ZIKV epidemic in the United 
States and the sensitivity of the licensed test(s) to detect ZIKV in 
blood donation.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). FDA is issuing this guidance for 
immediate implementation in accordance with 21 CFR 10.115(g)(2) without 
initially seeking prior comment because the Agency has determined that 
prior public participation is not feasible or appropriate. 
Specifically, we are not seeking comments because the guidance presents 
a less burdensome policy for reducing the risk of transfusion-
transmitted ZIKV that is consistent with public health. The guidance 
represents the current thinking of FDA on recommendations for reducing 
the risk of Zika virus transmission by blood and blood components. It 
does not establish

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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. This guidance is not subject to 
Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR parts 601 and 640, and Form FDA 
356h have been approved under OMB control number 0910-0338; and the 
collections of information in 21 CFR parts 606 and 630 have been 
approved under OMB control number 0910-0116.

III. Electronic Access

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

    Dated: June 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14537 Filed 7-6-18; 8:45 am]
 BILLING CODE 4164-01-P


