81 FR 8504 - Recommendations for Donor Screening, Deferral, and Product Management To Reduce the Risk of Transfusion-Transmission of Zika Virus; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 33 (February 19, 2016)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry.'' The guidance document provides blood establishments that collect blood and blood components with recommendations for donor screening, donor deferral, and product management to reduce the risk of transfusion- transmitted Zika virus (ZIKV). The guidance applies to the collection of Whole Blood and blood components intended for transfusion. The guidance does not apply to the collection of Source Plasma.

[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Notices]
[Pages 8504-8505]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-03393]



[[Page 8504]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Recommendations for Donor Screening, Deferral, and Product 
Management To Reduce the Risk of Transfusion-Transmission of Zika 
Virus; 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 ``Recommendations for Donor 
Screening, Deferral, and Product Management to Reduce the Risk of 
Transfusion-Transmission of Zika Virus: Guidance for Industry.'' The 
guidance document provides blood establishments that collect blood and 
blood components with recommendations for donor screening, donor 
deferral, and product management to reduce the risk of transfusion-
transmitted Zika virus (ZIKV). The guidance applies to the collection 
of Whole Blood and blood components intended for transfusion. The 
guidance does not apply to the collection of Source Plasma.

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 ``Recommendations for Donor Screening, Deferral, 
and Product Management to Reduce the Risk of Transfusion-Transmission 
of Zika Virus; 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 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 draft 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 draft 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 draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: Valerie Butler, 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 guidance document entitled 
``Recommendations for Donor Screening, Deferral, and Product Management 
to Reduce the Risk of Transfusion-Transmission of Zika Virus; Guidance 
for Industry.'' The guidance document provides blood establishments 
that collect blood and blood components with recommendations for donor 
screening, donor deferral, and product management to reduce the risk of 
transfusion-transmitted ZIKV. The guidance applies to the collection of 
Whole Blood and blood components intended for transfusion. The guidance 
does not apply to the collection of Source Plasma, which is used for 
further manufacture of plasma-derived products. Viral inactivation and 
removal methods are currently used to clear

[[Page 8505]]

viruses in the manufacturing process for such plasma-derived products.
    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. In addition, intrauterine, perinatal, and sexual transmission 
of ZIKV has 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 have been associated with ZIKV disease outbreaks. 
Association of ZIKV infection with Guillain-Barr[eacute] syndrome cases 
has been reported during outbreaks in Polynesia and in Brazil. In 
Brazil there has also been a marked increase in the incidence of 
microcephaly in regions most affected by the ZIKV epidemic.
    ZIKV reached the Americas in early 2015 with local transmission 
first reported in Brazil and as of February 10, 2016, there are 30 
countries and territories worldwide with active local transmission of 
the virus. As of February 10, 2016, local mosquito-borne transmission 
of ZIKV has not been reported in the continental United States, but 
cases have been reported in travelers returning to the United States 
from areas with local transmission.
    Consistent with existing regulations and applicable guidance, 
donors must be in good health at the time of donation Sec.  640.3(b) 
(21 CFR 640.3(b)) as indicated by, among other things, freedom from any 
disease transmissible by blood transfusion, as can be determined by 
history and examination (Sec.  640.3(b)(6)). Standard operating 
procedures that are already in place should result in the deferral of 
individuals who have symptoms consistent with ZIKV infection at the 
time of donation. The recommendations in the guidance are intended to 
reduce the risk of collecting blood and blood components from at-risk 
donors who could be potentially infected with ZIKV and do not display 
clinical symptoms during the incubation period or have an asymptomatic 
infection.
    The guidance recommends that blood collection establishments in 
areas without active transmission of ZIKV defer donors at risk for ZIKV 
infection as follows: Defer for 4 weeks after the resolution of 
symptoms a donor with a history of ZIKV infection or a donor who 
reports symptoms suggestive of ZIKV within 2 weeks of departure from an 
area with active transmission of ZIKV; defer for 4 weeks after the last 
sexual contact a donor who has had sexual contact with a man who has 
been diagnosed with ZIKV or who traveled to or resided in an area with 
active transmission of ZIKV in the 3 months prior to that instance of 
sexual contact; and defer for 4 weeks from the date of his or her 
departure, a donor who has been a resident of or has travelled to an 
area with active transmission of ZIKV.
    For areas with active transmission of ZIKV, the guidance recommends 
that blood collection establishments obtain blood and blood components 
from areas of the United States without active transmission of ZIKV to 
fulfill orders. However, a blood establishment may collect platelets 
and plasma locally if the blood establishment implements FDA-approved 
pathogen reduction technology for platelets and plasma. Further, blood 
establishments in areas of active transmission may collect blood 
components locally provided the establishment tests blood donations 
with an FDA-licensed blood donor screening test for ZIKV, when such a 
test becomes available.
    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 ``Recommendations for Donor 
Screening, Deferral, and Product Management to Reduce the Risk of 
Transfusion-Transmission of Zika Virus.'' 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. 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 601.12 have been approved under 
OMB control number 0910-0338; and the collections of information in 21 
CFR 606.100(b), 606.160(b)(1), and 640.3(a) have been approved under 
OMB control number 0910-0116.

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: February 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03393 Filed 2-18-16; 8:45 am]
BILLING CODE 4164-01-P