[Federal Register Volume 81, Number 169 (Wednesday, August 31, 2016)]
[Notices]
[Pages 60005-60007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20914]


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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 document entitled ``Revised Recommendations for 
Reducing the Risk of Zika Virus Transmission by Blood and Blood 
Components; Guidance for Industry.'' The guidance document is notifying 
blood establishments that collect Whole Blood and blood components, 
that FDA has determined Zika virus (ZIKV) to be a relevant transfusion-
transmitted infection (RTTI) and provides FDA's assessment. The 
guidance also provides recommendations to reduce the risk of 
transmission of ZIKV by Whole Blood and blood components. The guidance 
applies to the collection of Whole Blood and blood components. The 
guidance does not apply to the collection of Source Plasma. The 
guidance supersedes the February 2016 document entitled, 
``Recommendations for Donor Screening, Deferral, and Product Management 
to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance 
for Industry'' (February 2016 guidance), and the March 2016 document 
entitled, ``Questions and Answers Regarding `Recommendations for Donor 
Screening, Deferral, and Product Management to Reduce the Risk of 
Transfusion-Transmission of Zika Virus: Guidance for Industry' '' no 
later than 12 weeks after the date of the issuance of this guidance. 
Implementation of the guidance will be immediate for blood 
establishments that collect Whole Blood and blood components in States 
and territories with local transmission of ZIKV by mosquitos, and will 
be phased in over 4 to 12 weeks in other States and territories using a 
tiered, risk-based approach. Blood establishments should follow the 
recommendations in the February 2016 guidance until the recommendations 
in the guidance document have been fully implemented.

DATES: The Agency is soliciting public comment, but is implementing 
this guidance immediately because the

[[Page 60006]]

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 ``Revised Recommendations for Reducing the Risk 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.
    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 guidance entitled ``Revised 
Recommendations for Reducing the Risk of Zika Virus Transmission by 
Blood and Blood Components; Guidance for Industry.'' The guidance is 
notifying blood establishments that collect Whole Blood and blood 
components that FDA has determined ZIKV to be an RTTI under 21 CFR 
630.3(h)(2) and provides FDA's assessment. The guidance provides 
recommendations to reduce the risk of transmission of ZIKV by Whole 
Blood and blood components. The guidance does not apply to the 
collection of Source Plasma, which is used for further manufacture of 
plasma-derived products. If, based upon the available scientific 
evidence, the risk of ZIKV transmission by blood and blood components 
significantly changes, FDA may update the recommendations as warranted. 
In making this determination, FDA will consider available epidemiologic 
and other scientific evidence.
    The guidance supersedes the February 2016 guidance entitled, 
``Recommendations for Donor Screening, Deferral, and Product Management 
to Reduce the Risk of Transfusion-Transmission of Zika Virus; Guidance 
for Industry'' and the March 2016 guidance entitled, ``Questions and 
Answers Regarding `Recommendations for Donor Screening, Deferral, and 
Product Management to Reduce the Risk of Transfusion-Transmission of 
Zika Virus: Guidance for Industry' '' no later than 12 weeks after the 
date of the issuance of this guidance. Implementation of the guidance 
will be immediate for blood establishments that collect Whole Blood and 
blood components in States and territories with local transmission of 
ZIKV by mosquitos, and will be phased in over 4 to 12 weeks in other 
States and territories using a tiered, risk-based approach. Blood 
establishments should follow the recommendations in the February 2016 
guidance until they fully implement the recommendations in the guidance 
document currently being issued.
    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.
    The global ZIKV epidemic expanded in the region of the Americas by 
early

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2015 when the first local transmission was reported in Brazil. Local 
transmission of ZIKV has also been reported in areas outside of the 
Americas, including the Pacific Islands of Samoa, American Samoa, 
Marshall Islands and Tonga, and Cape Verde in Africa, and there are now 
at least 50 countries and territories worldwide with active local 
transmission of the virus.
    The first local transmission of ZIKV in the United States was 
reported from Puerto Rico in December 2015, and soon thereafter local 
transmission was also reported in American Samoa and the U.S. Virgin 
Islands. In July 2016, the first cases of local transmission of ZIKV 
occurring in the continental United States were reported from Miami-
Dade County in Florida. The possibility of further geographic spread of 
ZIKV exists in regions where the Aedes aegypti, and possibly the Aedes 
albopictus, mosquito is present. In January 2016, ZIKV disease was 
added to the list of nationally notifiable conditions in the United 
States as a subtype of Arboviral diseases.
    The most common ZIKV disease symptoms include fever, arthralgia, 
maculopapular rash, and conjunctivitis. In addition, neurological 
manifestations and congenital anomalies have been associated with ZIKV 
disease outbreaks. ZIKV infection has been associated with Guillain-
Barr[eacute] syndrome. ZIKV infection during pregnancy is a cause of 
microcephaly and other serious fetal brain anomalies. Other problems 
have been detected in pregnancies and among fetuses and infants 
infected with ZIKV before birth, such as miscarriage, stillbirth, 
absent or poorly developed brain structures, defects of the eye, 
hearing deficits, and impaired growth; however, the full clinical 
spectrum of the effects of ZIKV infection during pregnancy is not yet 
known.
    FDA has identified ZIKV as a transfusion-transmitted infection 
under Sec.  630.3(l) and RTTI under Sec.  630.3(h)(2). This 
determination is based on the severity of the disease, risk of 
transfusion-transmission by blood and blood components, the 
availability of appropriate screening measures, and significant 
incidence and prevalence affecting the potential donor population.
    The guidance recommends that blood establishments test all 
donations collected in the United States and its territories with an 
investigational individual donor nucleic acid test (ID-NAT) for ZIKV 
under an investigational new drug application (IND), or when available, 
a licensed test. Alternatively, blood establishments may implement 
pathogen reduction technology for platelets and plasma using an FDA-
approved pathogen reduction device as specified in the Instructions for 
Use of the device. If an FDA-approved pathogen reduction device becomes 
available for Whole Blood or red blood cells, blood establishments may 
implement pathogen reduction technology for such products rather than 
testing the donations. Blood establishments implementing these measures 
may discontinue providing donor educational material with respect to 
ZIKV and screening donors for ZIKV risk factors such as travel history 
and deferring them as previously recommended in the February 2016 
guidance. Under 21 CFR 630.10(a), if a donor volunteers a recent 
history of ZIKV infection, a blood establishment must not collect blood 
or blood components from that donor. For such donors, the guidance 
recommends a deferral period of 120 days after a positive viral test or 
the resolution of symptoms, whichever timeframe is longer.
    FDA recommends that blood establishments implement the 
recommendations in the guidance as follows: (1) Blood establishments 
that collect Whole Blood and blood components in U.S. States and 
territories with one or more reported locally acquired mosquito-borne 
cases of ZIKV should implement the recommendations immediately. Blood 
establishments should cease blood collection until testing or the use 
of pathogen reduction technology is implemented, consistent with the 
recommendations in the guidance. As of the date of issuance of the 
guidance, the recommendations applies to blood establishments that 
collect Whole Blood and blood components in Florida and Puerto Rico; 
(2) because of their proximity to areas with locally acquired mosquito-
borne cases of ZIKV or because of other epidemiological linkage to 
ZIKV, such as the number of travel-associated cases reported in a 
State, blood establishments that collect Whole Blood and blood 
components in Alabama, Arizona, California, Georgia, Hawaii, Louisiana, 
Mississippi, New Mexico, New York, South Carolina, and Texas should 
implement the recommendations as soon as feasible, but not later than 4 
weeks after the guidance issue date; and (3) blood establishments that 
collect Whole Blood and blood components in all other States and 
territories should implement the recommendations as soon as feasible, 
but not later than 12 weeks after the date of the issuance of this 
guidance.
    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 ``Revised Recommendations for 
Reducing the Risk of Zika Virus Transmission by Blood and Blood 
Components.'' 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; the collections of information in 21 CFR 
606.100(b) and 606.160(b)(1) have been approved under OMB control 
number 0910-0795; and the collections of information in 21 CFR 606.122 
and 630.30 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: August 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-20914 Filed 8-30-16; 8:45 am]
 BILLING CODE 4164-01-P