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Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance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the availability of a draft guidance document entitled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 This draft
guidance document includes general information on determining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DATES: Submit either electronic or written comments on the draft
guidance by February 6, 2025 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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