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, 11808-11810 [2016-04893]

Download as PDF 11808 Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices Disease, or Primary Dystonia, rather than their symptoms. This draft guidance is intended to apply to neurological medical devices that are designed to slow, stop, or reverse the progression of disease and result in clinically meaningful patient outcomes. This draft guidance provides general study design considerations for clinical trials that investigate neurological devices using biological markers and clinical outcome assessments. II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes.’’ 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. asabaliauskas on DSK3SPTVN1PROD with NOTICES III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/ MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1500021 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations.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 part 812 have been approved under OMB control number 0910–0078; the collections of information in 21 CFR parts 801 and 809 have been approved under OMB control number 0910–0485; the VerDate Sep<11>2014 18:37 Mar 04, 2016 Jkt 238001 collections of information in 21 CFR part 50 have been approved under OMB control number 0910–0755; and the collections of information in the guidance document entitled ‘‘Request for Feedback on Medical Device Submissions: The Pre-submission Program and Meetings With Food and Drug Administration Staff’’ have been approved under OMB control number 0910–0756. Dated: March 1, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–04947 Filed 3–4–16; 8:45 am] BILLING CODE 4164–01–P 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. 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 TissueBased 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 TissueBased 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. SUMMARY: PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://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 TissueBased Products; Guidance for Industry.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://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 E:\FR\FM\07MRN1.SGM 07MRN1 asabaliauskas on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices 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 https:// 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: https://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 https:// 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. VerDate Sep<11>2014 18:37 Mar 04, 2016 Jkt 238001 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 TissueBased 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-Barre 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 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 11809 ‘‘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., mosquitoacquired) transmission of ZIKV: https:// www.cdc.gov/zika/geo/. As noted above, FDA has identified that ZIKV is an RCDAD as defined in § 1271.3(r)(2). Therefore, review of relevant medical records, as defined in § 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. E:\FR\FM\07MRN1.SGM 07MRN1 11810 Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices 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 https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm or https://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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–1849] Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ‘‘Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails.’’ This guidance is intended to provide recommendations regarding clinical trial design for medical devices intended either to provide improvement in the appearance of nails affected by onychomycosis or to treat onychomycosis (fungal nail infection). DATES: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. ADDRESSES: You may submit comments as follows: asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: Electronic Submissions Submit electronic comments in the following way: VerDate Sep<11>2014 18:37 Mar 04, 2016 Jkt 238001 • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://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– 2014–D–1849 for ‘‘Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://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 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 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 https://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: https://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 https:// 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. An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled ‘‘Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Shlomit Halachmi, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G439, Silver Spring, MD 20993–0002, 301–796–6338. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry and FDA staff E:\FR\FM\07MRN1.SGM 07MRN1

Agencies

[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]

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

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.

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

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: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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 https://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 https://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: https://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 https://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: https://www.cdc.gov/zika/geo/.
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 https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://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

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.