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)

Page Range		8504-8505
FR Document		2016-03393

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 Issue 33 (Friday, February 19, 2016)

[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.

-----------------------------------------------------------------------

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

Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices 8505

viruses in the manufacturing process for an area with active transmission of III. Electronic Access
such plasma-derived products. ZIKV; defer for 4 weeks after the last Persons with access to the Internet
ZIKV is an arbovirus from the sexual contact a donor who has had may obtain the guidance at either
Flaviviridae family, genus Flavivirus. It sexual contact with a man who has been http://www.fda.gov/BiologicsBlood
is transmitted to humans primarily by diagnosed with ZIKV or who traveled to Vaccines/GuidanceCompliance
the Aedes aegypti mosquito, but it may or resided in an area with active RegulatoryInformation/Guidances/
also be transmitted by the Aedes transmission of ZIKV in the 3 months default.htm or http://
albopictus mosquito. In addition, prior to that instance of sexual contact; www.regulations.gov.
intrauterine, perinatal, and sexual and defer for 4 weeks from the date of
transmission of ZIKV has been reported. Dated: February 12, 2016.
his or her departure, a donor who has
Two instances of possible transfusion- been a resident of or has travelled to an Leslie Kux,
transmission of ZIKV in Brazil have area with active transmission of ZIKV. Associate Commissioner for Policy.
been described in media [FR Doc. 2016–03393 Filed 2–18–16; 8:45 am]
announcements. For areas with active transmission of
BILLING CODE 4164–01–P
The most common ZIKV disease ZIKV, the guidance recommends that
symptoms include fever, arthralgia, blood collection establishments obtain
maculopapular rash, and conjunctivitis. blood and blood components from areas DEPARTMENT OF HEALTH AND
Neurological manifestations and of the United States without active HUMAN SERVICES
congenital anomalies have been transmission of ZIKV to fulfill orders.
associated with ZIKV disease outbreaks. However, a blood establishment may Food and Drug Administration
Association of ZIKV infection with collect platelets and plasma locally if
[Docket No. FDA–2013–N–0190]
Guillain-Barré syndrome cases has been the blood establishment implements
reported during outbreaks in Polynesia FDA-approved pathogen reduction Agency Information Collection
and in Brazil. In Brazil there has also technology for platelets and plasma. Activities; Proposed Collection;
been a marked increase in the incidence Further, blood establishments in areas Comment Request; Requirements
of microcephaly in regions most affected of active transmission may collect blood Under the Comprehensive Smokeless
by the ZIKV epidemic. components locally provided the Tobacco Health Education Act of 1986,
ZIKV reached the Americas in early establishment tests blood donations as Amended by the Family Smoking
2015 with local transmission first with an FDA-licensed blood donor Prevention and Tobacco Control Act
reported in Brazil and as of February 10, screening test for ZIKV, when such a
2016, there are 30 countries and test becomes available. AGENCY: Food and Drug Administration,
territories worldwide with active local HHS.
This guidance is being issued
transmission of the virus. As of consistent with FDA’s good guidance ACTION: Notice.
February 10, 2016, local mosquito-borne practices regulation (21 CFR 10.115).
transmission of ZIKV has not been SUMMARY: The Food and Drug
FDA is issuing this guidance for Administration (FDA) is announcing an
reported in the continental United
immediate implementation in opportunity for public comment on the
States, but cases have been reported in
accordance with 21 CFR 10.115(g)(2) proposed collection of certain
travelers returning to the United States
without initially seeking prior comment information by the Agency. Under the
from areas with local transmission.
Consistent with existing regulations because the Agency has determined that Paperwork Reduction Act of 1995 (the
and applicable guidance, donors must prior public participation is not feasible PRA), Federal Agencies are required to
be in good health at the time of donation or appropriate. The guidance represents publish notice in the Federal Register
§ 640.3(b) (21 CFR 640.3(b)) as indicated the current thinking of FDA on concerning each proposed collection of
by, among other things, freedom from ‘‘Recommendations for Donor information, including each proposed
any disease transmissible by blood Screening, Deferral, and Product extension of an existing collection of
transfusion, as can be determined by Management to Reduce the Risk of information, and to allow 60 days for
history and examination (§ 640.3(b)(6)). Transfusion-Transmission of Zika public comment in response to the
Standard operating procedures that are Virus.’’ It does not establish any rights notice. This notice solicits comments on
already in place should result in the for any person and is not binding on submission of rotational plans for health
deferral of individuals who have FDA or the public. You can use an warning label statements for smokeless
symptoms consistent with ZIKV alternative approach if it satisfies the tobacco products.
infection at the time of donation. The requirements of the applicable statutes DATES: Submit either electronic or
recommendations in the guidance are and regulations. written comments on the collection of
intended to reduce the risk of collecting II. Paperwork Reduction Act of 1995 information by April 19, 2016.
blood and blood components from at- ADDRESSES: You may submit comments
risk donors who could be potentially This guidance refers to previously as follows:
infected with ZIKV and do not display approved collections of information
clinical symptoms during the found in FDA regulations. These Electronic Submissions
incubation period or have an collections of information are subject to Submit electronic comments in the
asymptomatic infection. review by the Office of Management and following way:
The guidance recommends that blood Budget (OMB) under the Paperwork • Federal eRulemaking Portal: http://
asabaliauskas on DSK5VPTVN1PROD with NOTICES

collection establishments in areas Reduction Act of 1995 (44 U.S.C. 3501– www.regulations.gov. Follow the
without active transmission of ZIKV 3520). The collections of information in instructions for submitting comments.
defer donors at risk for ZIKV infection 21 CFR 601.12 have been approved Comments submitted electronically,
as follows: Defer for 4 weeks after the under OMB control number 0910–0338; including attachments, to http://
resolution of symptoms a donor with a and the collections of information in 21 www.regulations.gov will be posted to
history of ZIKV infection or a donor CFR 606.100(b), 606.160(b)(1), and the docket unchanged. Because your
who reports symptoms suggestive of 640.3(a) have been approved under comment will be made public, you are
ZIKV within 2 weeks of departure from OMB control number 0910–0116. solely responsible for ensuring that your

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Document Created: 2018-02-02 14:31:58
Document Modified: 2018-02-02 14:31:58

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
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.
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.
FR Citation		81 FR 8504

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 SERVICESFood and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration