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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2022-D-0464]

# 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance document entitled “Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).” This draft guidance document includes general information on determining eligibility for donors of HCT/Ps. In addition, FDA intends to issue separate guidance documents with recommendations regarding reducing the risk of transmission of specific communicable disease agents and diseases for donors of HCT/Ps. These guidance documents are intended to update an existing guidance.

# DATES:

Submit either electronic or written comments on the draft guidance by February 6, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

# ADDRESSES:

You may submit comments on any guidance at any time as follows:

### Electronic Submissions

Submit electronic comments in the following way:
      -  Federal eRulemaking Portal: https://www.regulations.gov . Follow the                            ( print page 1167)                          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):                      Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.                
      - For written/paper comments submitted to the Dockets Management Staff, 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-2022-D-0464 for “Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).” 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 Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.                
      - 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 https://www.regulations.gov . Submit both copies to the Dockets Management Staff. 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.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf .                

*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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.                

You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

                    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:

Victoria Wagman, 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 draft document entitled “Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).” This draft guidance document is intended to update an existing guidance document to assist establishments making donor eligibility determinations in understanding the requirements for determining donor eligibility, including donor screening and testing, for donors of HCT/Ps.

The draft guidance “Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” includes general information on determining eligibility for donors of HCT/Ps. Updates to existing guidance recommendations include, but are not limited to, revised exceptions applicable to certain HCT/Ps, 21 CFR 1271.90 (81 FR 40517, June 22, 2016); clarifications surrounding the donor medical history interview; and additional considerations regarding specimens for donor testing to avoid false negative test results.

                    FDA intends to issue separate, additional guidance documents with recommendations regarding reducing the risk of transmission of specific communicable disease agents and diseases for donors of HCT/Ps as follows: human immunodeficiency virus, hepatitis B virus, hepatitis C virus,                     *Mycobacterium tuberculosis*                     (Mtb), sepsis, human transmissible spongiform encephalopathies, cytomegalovirus,                     *Chlamydia trachomatis*                     and                     *Neisseria gonorrhoeae,*                     human T-lymphotropic virus,                     *Treponema pallidum*                     (syphilis), vaccinia virus, West Nile virus, and communicable disease risk associated with xenotransplantation. Please note that FDA has withdrawn the 2018 guidance for industry “Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products.” FDA has determined that Zika virus (ZIKV) is no longer a relevant communicable disease agent or disease because the available evidence demonstrates that ZIKV no longer has sufficient incidence and/or prevalence to affect the potential HCT/P donor population.                

The draft of the general guidance document and the associated specific guidance documents, when finalized, are intended to supersede the following guidance documents:
    - “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), Guidance for Industry,” dated August 2007;
    - “Use of Donor Screening Tests To Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum       ( print page 1168)                          (Syphilis), Guidance for Industry” dated September 2015;                
    - “Use of Nucleic Acid Tests To Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products, Guidance for Industry” dated August 2016;
    - “Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), Guidance for Industry” dated September 2016 and corrected May 2017; and
    - “Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates, Guidance for Industry” dated November 2016.

When the general guidance and the associated specific guidances are finalized, FDA intends to collate information from the guidances and provide comprehensive lists of recommendations on the FDA website regarding conditions and behaviors that increase the donor's relevant communicable disease risk, examples of clinical evidence of relevant communicable disease, examples of physical evidence of relevant communicable disease or high-risk behavior associated with these diseases, disease agents for which all donors of HCT/Ps must be tested, and the types of tests we currently consider to be adequate and appropriate to meet the requirements in 21 CFR 1271.80(c). The comprehensive lists will cite to the applicable guidance(s) where the recommendations are provided.

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 “Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).” 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

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 1271 have been approved under OMB control number 0910-0543.

## III. Electronic Access

                    Persons with access to the internet may obtain the draft guidance at                     *https://www.fda.gov/​vaccines-blood-biologics/​guidance-compliance-regulatory-information-biologics/​biologics-guidances, https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents,*                     or                     *https://www.regulations.gov.*

Dated: December 26, 2024.

Kimberlee Trzeciak,

Deputy Commissioner for Policy, Legislation, and International Affairs.

[FR Doc. 2024-31524 Filed 1-6-25; 8:45 am]

BILLING CODE 4164-01-P