81 FR 11808 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 44 (March 7, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 44 (March 7, 2016)
| Page Range | 11808-11810 | |
| FR Document | 2016-04893 |
[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)] [Notices] [Pages 11808-11810] From the Federal Register Online [www.thefederalregister.org] [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: 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. [[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 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] BILLING CODE 4164-01-P
![11808 Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices
Disease, or Primary Dystonia, rather collections of information in 21 CFR ADDRESSES: You may submit comments
than their symptoms. This draft part 50 have been approved under OMB as follows:
guidance is intended to apply to control number 0910–0755; and the
Electronic Submissions
neurological medical devices that are collections of information in the
designed to slow, stop, or reverse the guidance document entitled ‘‘Request Submit electronic comments in the
progression of disease and result in for Feedback on Medical Device following way:
clinically meaningful patient outcomes. Submissions: The Pre-submission • Federal eRulemaking Portal: http://
This draft guidance provides general Program and Meetings With Food and www.regulations.gov. Follow the
study design considerations for clinical Drug Administration Staff’’ have been instructions for submitting comments.
trials that investigate neurological approved under OMB control number Comments submitted electronically,
devices using biological markers and 0910–0756. including attachments, to http://
clinical outcome assessments. www.regulations.gov will be posted to
Dated: March 1, 2016.
the docket unchanged. Because your
II. Significance of Guidance Leslie Kux, comment will be made public, you are
This draft guidance is being issued Associate Commissioner for Policy. solely responsible for ensuring that your
consistent with FDA’s good guidance [FR Doc. 2016–04947 Filed 3–4–16; 8:45 am] comment does not include any
practices regulation (21 CFR 10.115). BILLING CODE 4164–01–P confidential information that you or a
The draft guidance, when finalized, will third party may not wish to be posted,
represent the current thinking of FDA such as medical information, your or
on ‘‘Clinical Considerations for DEPARTMENT OF HEALTH AND anyone else’s Social Security number, or
Investigational Device Exemptions HUMAN SERVICES confidential business information, such
(IDEs) for Neurological Devices as a manufacturing process. Please note
Targeting Disease Progression and Food and Drug Administration that if you include your name, contact
Clinical Outcomes.’’ It does not [Docket No. FDA–2016–D–0768] information, or other information that
establish any rights for any person and identifies you in the body of your
is not binding on FDA or the public. Donor Screening Recommendations comments, that information will be
You can use an alternative approach if To Reduce the Risk of Transmission of posted on http://www.regulations.gov.
it satisfies the requirements of the Zika Virus by Human Cells, Tissues, • If you want to submit a comment
applicable statutes and regulations. and Cellular and Tissue-Based with confidential information that you
Products; Guidance for Industry; do not wish to be made available to the
III. Electronic Access
Availability public, submit the comment as a
Persons interested in obtaining a copy written/paper submission and in the
of the draft guidance may do so by AGENCY: Food and Drug Administration,
manner detailed (see ‘‘Written/Paper
downloading an electronic copy from HHS.
Submissions’’ and ‘‘Instructions’’).
the Internet. A search capability for all ACTION: Notice of availability.
Center for Devices and Radiological Written/Paper Submissions
Health guidance documents is available SUMMARY: The Food and Drug
Submit written/paper submissions as
at http://www.fda.gov/ MedicalDevices/ Administration (FDA or Agency) is
follows:
DeviceRegulationandGuidance/ announcing the availability of a • Mail/Hand delivery/Courier (for
GuidanceDocuments/default.htm. document entitled ‘‘Donor Screening written/paper submissions): Division of
Guidance documents are also available Recommendations to Reduce the Risk of Dockets Management (HFA–305), Food
at http://www.regulations.gov. Persons Transmission of Zika Virus by Human and Drug Administration, 5630 Fishers
unable to download an electronic copy Cells, Tissues, and Cellular and Tissue- Lane, Rm. 1061, Rockville, MD 20852.
of ‘‘Clinical Considerations for Based Products; Guidance for Industry.’’ • For written/paper comments
Investigational Device Exemptions The guidance document provides submitted to the Division of Dockets
(IDEs) for Neurological Devices establishments that make donor Management, FDA will post your
Targeting Disease Progression and eligibility (DE) determinations for comment, as well as any attachments,
Clinical Outcomes’’ may send an email donors of human cells, tissues, and except for information submitted,
request to CDRH-Guidance@fda.hhs.gov cellular and tissue-based products marked and identified, as confidential,
to receive an electronic copy of the (HCT/Ps) with recommendations for if submitted as detailed in
document. Please use the document screening donors for evidence of, and ‘‘Instructions.’’
number 1500021 to identify the risk factors for, infection with Zika virus Instructions: All submissions received
guidance you are requesting. (ZIKV). The guidance identifies ZIKV as must include the Docket No. FDA–
a relevant communicable disease agent 2016–D–0545 for ‘‘Donor Screening
IV. Paperwork Reduction Act of 1995 or disease (RCDAD) and adds to Recommendations to Reduce the Risk of
This draft guidance refers to recommendations contained in the Transmission of Zika Virus by Human
previously approved collections of guidance entitled ‘‘Eligibility Cells, Tissues, and Cellular and Tissue-
information found in FDA regulations. Determination for Donors of Human Based Products; Guidance for Industry.’’
These collections of information are Cells, Tissues, and Cellular and Tissue- Received comments will be placed in
subject to review by the Office of Based Products (HCT/Ps)’’ dated August the docket and, except for those
Management and Budget (OMB) under 2007. submitted as ‘‘Confidential
asabaliauskas on DSK3SPTVN1PROD with NOTICES
the Paperwork Reduction Act of 1995 DATES: The Agency is soliciting public Submissions,’’ publicly viewable at
(44 U.S.C. 3501–3520). The collections comment, but is implementing this http://www.regulations.gov or at the
of information in 21 CFR part 812 have guidance immediately because the Division of Dockets Management
been approved under OMB control Agency has determined that prior public between 9 a.m. and 4 p.m., Monday
number 0910–0078; the collections of participation is not feasible or through Friday.
information in 21 CFR parts 801 and appropriate. Submit either electronic or • Confidential Submissions—To
809 have been approved under OMB written comments on Agency guidances submit a comment with confidential
control number 0910–0485; the at any time. information that you do not wish to be
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![11810 Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices
II. Paperwork Reduction Act of 1995 • Federal eRulemaking Portal: http:// Agency will review this copy, including
This guidance refers to previously www.regulations.gov. Follow the the claimed confidential information, in
approved collections of information instructions for submitting comments. its consideration of comments. The
found in FDA regulations. These Comments submitted electronically, second copy, which will have the
collections of information are subject to including attachments, to http:// claimed confidential information
review by the Office of Management and www.regulations.gov will be posted to redacted/blacked out, will be available
Budget (OMB) under the Paperwork the docket unchanged. Because your for public viewing and posted on
Reduction Act of 1995 (44 U.S.C. 3501– comment will be made public, you are http://www.regulations.gov. Submit
3520). The collections of information in solely responsible for ensuring that your both copies to the Division of Dockets
part 1271 have been approved under comment does not include any Management. If you do not wish your
OMB control number 0910–0543. confidential information that you or a name and contact information to be
third party may not wish to be posted, made publicly available, you can
III. Electronic Access such as medical information, your or provide this information on the cover
Persons with access to the Internet anyone else’s Social Security number, or sheet and not in the body of your
may obtain the guidance at either http:// confidential business information, such comments and you must identify this
www.fda.gov/BiologicsBloodVaccines/ as a manufacturing process. Please note information as ‘‘confidential.’’ Any
GuidanceComplianceRegulatory that if you include your name, contact information marked as ‘‘confidential’’
Information/Guidances/default.htm or information, or other information that will not be disclosed except in
http://www.regulations.gov. identifies you in the body of your accordance with 21 CFR 10.20 and other
comments, that information will be applicable disclosure law. For more
Dated: March 1, 2016. posted on http://www.regulations.gov. information about FDA’s posting of
Leslie Kux, • If you want to submit a comment comments to public dockets, see 80 FR
Associate Commissioner for Policy. with confidential information that you 56469, September 18, 2015, or access
[FR Doc. 2016–04893 Filed 3–4–16; 8:45 am] do not wish to be made available to the the information at: http://www.fda.gov/
BILLING CODE 4164–01–P public, submit the comment as a regulatoryinformation/dockets/
written/paper submission and in the default.htm.
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘Instructions’’). read background documents or the
HUMAN SERVICES electronic and written/paper comments
Written/Paper Submissions
Food and Drug Administration received, go to http://
Submit written/paper submissions as
www.regulations.gov and insert the
[Docket No. FDA–2014–D–1849] follows:
docket number, found in brackets in the
• Mail/Hand delivery/Courier (for
heading of this document, into the
Medical Devices and Clinical Trial written/paper submissions): Division of
‘‘Search’’ box and follow the prompts
Design for the Treatment or Dockets Management (HFA–305), Food
and/or go to the Division of Dockets
Improvement in the Appearance of and Drug Administration, 5630 Fishers
Management, 5630 Fishers Lane, Rm.
Fungally-Infected Nails; Guidance for Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments 1061, Rockville, MD 20852.
Industry and Food and Drug An electronic copy of the guidance
Administration Staff; Availability submitted to the Division of Dockets
Management, FDA will post your document is available for download
AGENCY: Food and Drug Administration, comment, as well as any attachments, from the Internet. See the
HHS. SUPPLEMENTARY INFORMATION section for
except for information submitted,
ACTION: Notice of availability. marked and identified, as confidential, information on electronic access to the
if submitted as detailed in guidance. Submit written requests for a
SUMMARY: The Food and Drug ‘‘Instructions.’’ single hard copy of the guidance
Administration (FDA or Agency) is Instructions: All submissions received document entitled ‘‘Medical Devices
announcing the availability of the must include the Docket No. FDA– and Clinical Trial Design for the
guidance entitled ‘‘Medical Devices and 2014–D–1849 for ‘‘Medical Devices and Treatment or Improvement in the
Clinical Trial Design for the Treatment Clinical Trial Design for the Treatment Appearance of Fungally-Infected Nails’’
or Improvement in the Appearance of or Improvement in the Appearance of to the Office of the Center Director,
Fungally-Infected Nails.’’ This guidance Fungally-Infected Nails.’’ Received Guidance and Policy Development,
is intended to provide recommendations comments will be placed in the docket Center for Devices and Radiological
regarding clinical trial design for and, except for those submitted as Health, Food and Drug Administration,
medical devices intended either to ‘‘Confidential Submissions,’’ publicly 10903 New Hampshire Ave., Bldg. 66,
provide improvement in the appearance viewable at http://www.regulations.gov Rm. 5431, Silver Spring, MD 20993–
of nails affected by onychomycosis or to or at the Division of Dockets 0002. Send one self-addressed adhesive
treat onychomycosis (fungal nail Management between 9 a.m. and 4 p.m., label to assist that office in processing
infection). Monday through Friday. your request.
DATES: Submit either electronic or • Confidential Submissions—To FOR FURTHER INFORMATION CONTACT:
written comments on this guidance at submit a comment with confidential Shlomit Halachmi, Center for Devices
any time. General comments on Agency information that you do not wish to be and Radiological Health, Food and Drug
asabaliauskas on DSK3SPTVN1PROD with NOTICES
guidance documents are welcome at any made publicly available, submit your Administration, 10903 New Hampshire
time. comments only as a written/paper Ave., Bldg. 66, Rm. G439, Silver Spring,
ADDRESSES: You may submit comments submission. You should submit two MD 20993–0002, 301–796–6338.
as follows: copies total. One copy will include the SUPPLEMENTARY INFORMATION:
information you claim to be confidential
Electronic Submissions with a heading or cover note that states I. Background
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS FDA is announcing the availability of
following way: CONFIDENTIAL INFORMATION.’’ The a guidance for industry and FDA staff
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Document Created: 2018-02-02 15:07:36
Document Modified: 2018-02-02 15:07:36
| 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 | 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. | |
| FR Citation | 81 FR 11808 |
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