
[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)]
[Notices]
[Pages 11808-11810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04893]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0768]


Donor Screening Recommendations To Reduce the Risk of 
Transmission of Zika Virus by 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 ``Donor Screening 
Recommendations to Reduce the Risk of Transmission of Zika Virus by 
Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance 
for Industry.'' The guidance document provides establishments that make 
donor eligibility (DE) determinations for donors of human cells, 
tissues, and cellular and tissue-based products (HCT/Ps) with 
recommendations for screening donors for evidence of, and risk factors 
for, infection with Zika virus (ZIKV). The guidance identifies ZIKV as 
a relevant communicable disease agent or disease (RCDAD) and adds to 
recommendations contained in the guidance entitled ``Eligibility 
Determination for Donors of Human Cells, Tissues, and Cellular and 
Tissue-Based Products (HCT/Ps)'' dated August 2007.

DATES: The Agency is soliciting public comment, but is implementing 
this guidance immediately because the Agency has determined that prior 
public participation is not feasible or appropriate. Submit either 
electronic or written comments on Agency guidances at any time.

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-2016-D-0545 for ``Donor Screening Recommendations to Reduce the 
Risk of Transmission of Zika Virus by Human Cells, Tissues, and 
Cellular and Tissue-Based Products; 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

[[Page 11809]]

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.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a document entitled ``Donor 
Screening Recommendations to Reduce the Risk of Transmission of Zika 
Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; 
Guidance for Industry.'' The guidance provides establishments that make 
DE determinations for donors of HCT/Ps with recommendations for 
screening donors for evidence of, and risk factors for, infection with 
ZIKV. The guidance identifies ZIKV as a RCDAD as defined in 21 CFR part 
1271. The guidance adds to recommendations contained in the guidance 
entitled ``Eligibility Determination for Donors of Human Cells, 
Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated August 
2007.
    ZIKV is an arbovirus from the Flaviviridae family, genus 
Flavivirus. It is transmitted to humans primarily by the Aedes aegypti 
mosquito, but it may also be transmitted by the Aedes albopictus 
mosquito, among others. In addition, intrauterine, perinatal, and 
sexual transmissions of ZIKV have been reported. Two instances of 
possible transfusion-transmission of ZIKV in Brazil have been described 
in media announcements.
    The most common ZIKV disease symptoms include fever, arthralgia, 
maculopapular rash, and conjunctivitis. Neurological manifestations and 
congenital anomalies may also be associated with ZIKV disease 
outbreaks. For example, possible association of ZIKV infection with 
Guillain-Barr[eacute] syndrome cases has been reported during outbreaks 
in French Polynesia and Brazil. There has also been a marked increase 
in the reported incidence of microcephaly in regions of Brazil most 
affected by the ZIKV epidemic, though a direct connection has yet to be 
confirmed.
    ZIKV reached the Americas in early 2015 with local transmission 
first reported in Brazil. According to the Centers for Disease Control 
and Prevention (CDC), as of February 23, 2016, there are 34 countries 
and territories worldwide with active local transmission of the virus. 
To date, local mosquito-borne transmission of ZIKV has not been 
reported in the continental United States, but at least 82 cases have 
been reported in travelers returning to the United States from areas 
with local transmission.
    In general, an area is considered to have active transmission of 
ZIKV when locally transmitted, mosquito-borne ZIKV has been reported. 
For the purpose of the guidance, an area with ``active ZIKV 
transmission'' is an area included on the CDC Web site listing of 
countries and U.S. States and territories with local vector-borne 
(i.e., mosquito-acquired) transmission of ZIKV: http://www.cdc.gov/zika/geo/index.html.
    As noted above, FDA has identified that ZIKV is an RCDAD as defined 
in Sec.  1271.3(r)(2). Therefore, review of relevant medical records, 
as defined in Sec.  1271.3(s), must indicate that a potential donor of 
HCT/Ps is free from risk factors for, or clinical evidence of, ZIKV 
infection for the purpose of determining donor eligibility. The 
recommendations in the guidance are intended to reduce the risk of 
transmission of ZIKV by HCT/Ps. Living donors of HCT/Ps should be 
considered ineligible if they have any of the following risk factors: 
(1) Medical diagnosis of ZIKV infection in the past 6 months; (2) 
residence in, or travel to, an area with active ZIKV transmission 
within the past 6 months; or (3) sex within the past 6 months with a 
male who has either of the risk factors identified in items 1 or 2, 
above. Additionally, donors of umbilical cord, placenta, or other 
gestational tissues should be considered ineligible if the birth mother 
who seeks to donate gestational tissues has any of the following risk 
factors: (4) Medical diagnosis of ZIKV infection at any point during 
that pregnancy; (5) residence in, or travel to, an area with active 
ZIKV transmission at any point during that pregnancy; or (6) sex at any 
point during that pregnancy with a male who has either of the risk 
factors listed in items 1 or 2 above. Additionally, a non-heart beating 
(cadaveric) donor should be considered ineligible if the donor had a 
medical diagnosis of ZIKV infection in the past 6 months.
    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. The guidance 
represents the current thinking of FDA on ``Donor Screening 
Recommendations to Reduce the Risk of Transmission of Zika Virus by 
Human Cells, Tissues, and Cellular and Tissue-Based Products.'' 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.

[[Page 11810]]

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 part 1271 have been approved under OMB 
control number 0910-0543.

III. 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: March 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04893 Filed 3-4-16; 8:45 am]
 BILLING CODE 4164-01-P


