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 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-Barré 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 § 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.

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 .