[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.
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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]
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