Notice2025-02167
Guidance for Industry; Recommendations To Reduce the Risk of Transmission of Disease Agents Associated With Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products; Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis by Human Cells, Tissues, and Cellular and Tissue-Based Products
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 3, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The final guidances entitled "Recommendations To Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" and "Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue- Based Products (HCT/Ps)" are being revised to change the time by which FDA recommends implementation of the recommendations in the guidances.
Full Text
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<title>Federal Register, Volume 90 Issue 21 (Monday, February 3, 2025)</title>
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[Federal Register Volume 90, Number 21 (Monday, February 3, 2025)]
[Notices]
[Pages 8802-8804]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-02167]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2024-D-3067; FDA-2024-D-3863]
Guidance for Industry; Recommendations To Reduce the Risk of
Transmission of Disease Agents Associated With Sepsis by Human Cells,
Tissues, and Cellular and Tissue-Based Products; Recommendations To
Reduce the Risk of Transmission of Mycobacterium Tuberculosis by Human
Cells, Tissues, and Cellular and Tissue-Based Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The final guidances entitled ``Recommendations To Reduce the
Risk of Transmission of Disease Agents Associated with Sepsis by Human
Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' and
``Recommendations To Reduce the Risk of Transmission of Mycobacterium
Tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-
Based Products (HCT/Ps)'' are being revised to change the time by which
FDA recommends implementation of the recommendations in the guidances.
DATES: The announcement of these guidances is published in the Federal
Register on February 3, 2025.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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.''
[[Page 8803]]
Instructions: All submissions received must include the Docket No.
FDA-2024-D-3067 for ``Recommendations To Reduce the Risk of
Transmission of Disease Agents Associated with Sepsis by Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' or the
Docket No. FDA-2024-D-3863 for ``Recommendations To Reduce the Risk of
Transmission of Mycobacterium Tuberculosis (Mtb) by Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' as
appropriate. Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 guidances to the
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 labels to assist that office in processing
your requests. The guidances 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 documents.
FOR FURTHER INFORMATION CONTACT: James Myers, 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 two revised final guidances,
``Recommendations to Reduce the Risk of Transmission of Disease Agents
Associated with Sepsis by Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps)'' and ``Recommendations to Reduce the
Risk of Transmission of Mycobacterium Tuberculosis (Mtb) by Human
Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).''
These guidance documents were originally published in the Federal
Register on January 7, 2025 (90 FR 1141; 90 FR 1170). Both guidances
recommended that establishments making donor eligibility determinations
(establishments) implement the recommendations in the guidances ``as
soon as feasible, but not later than 4 weeks after the guidance issue
date.''
FDA is revising final guidances ``Recommendations To Reduce the
Risk of Transmission of Disease Agents Associated with Sepsis by Human
Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' and
``Recommendations To Reduce the Risk of Transmission of Mycobacterium
Tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-
Based Products (HCT/Ps)'' to recommend implementation of the guidance
recommendations on a longer timeframe, by May 4, 2025. The revised
implementation date will permit FDA to consider the comments received
thus far prior to the implementation date. Permitting the Agency
additional time to further review and consider the guidances, including
comments received, as well as seek additional comments is consistent
with the President's January 20, 2025, memorandum entitled,
``Regulatory Freeze Pending Review.'' See paragraph 3 (directing
agencies to consider postponing effective dates of certain rules ``for
the purpose of reviewing any questions of fact, law, and policy that
the rules may raise''; ``where appropriate and consistent with
applicable law, consider opening a comment period to allow interested
parties to provide comments about issues of fact, law, and policy
raised by the rules postponed under this memorandum''; and consider
further delaying such rules ``where necessary to continue to review
these questions of fact, law, and policy'').
FDA issued the guidance entitled ``Recommendations To Reduce the
Risk of Transmission of Disease Agents Associated with Sepsis by Human
Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' to
provide establishments making donor eligibility determinations with
recommendations to reduce the risk of transmission of disease agents
associated with sepsis for donors of human cells, tissues, and cellular
and tissue-based products.
FDA issued the guidance entitled ``Recommendations To Reduce the
Risk of Transmission of Mycobacterium Tuberculosis (Mtb) by Human
Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' to
assist establishments that make donor eligibility determinations for
donors of human cells, tissues, and cellular and tissue-based products,
with recommendations for screening donors for evidence of, and risk
factors for, infection with Mtb, the organism that causes tuberculosis.
FDA is issuing these revised guidances consistent with our good
guidance practices regulation (Sec. 10.115 (21 CFR 10.115)). We are
implementing these revisions without prior public comment because we
have determined that prior public participation is not feasible or
appropriate (see Sec. 10.115(g)(2) and section 701(h)(1)(C) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)). We made
this determination because the revisions present a less burdensome
policy that is consistent with public health. Although these guidance
documents are being implemented immediately, you can comment on any
guidance at any time (Sec. 10.115(g)(5)). FDA has already received
comments on the guidances discussed above, and the Agency
[[Page 8804]]
intends to consider those comments. Please submit any additional
comments regarding the guidances that you wish the Agency to consider,
including whether it would be appropriate to reissue these guidances in
draft form or consider a later implementation date.
II. Paperwork Reduction Act of 1995
While these guidance documents contain no collection of
information, they do 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 1271 relating to HCT/Ps, including
establishing and maintaining records, investigation and reporting of
adverse actions and documentation of methods used in facilities related
to HCT/Ps, which, includes but is not limited to donor screening, donor
testing, and labeling have been approved under OMB control number 0910-
0543.
III. Electronic Access
Persons with access to the internet may obtain the guidances at
<a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dorothy A. Fink,
Acting Secretary, Department of Health and Human Services.
[FR Doc. 2025-02167 Filed 1-31-25; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on February 3, 2025.
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