```

[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1166-1168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31524]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Recommendations for Determining Eligibility of Donors of Human 
Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance 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the availability of a draft guidance document entitled 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 This draft 
guidance document includes general information on determining 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DATES: Submit either electronic or written comments on the draft 
guidance by February 6, 2025 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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

[[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

[[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
```