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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 [www.gpo.gov]
[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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the 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.''

[[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 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 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 
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.

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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