[Federal Register Volume 90, Number 85 (Monday, May 5, 2025)]
[Notices]
[Pages 18984-18985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-07752]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2024-D-3067; FDA-2024-D-3863]
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; Draft Guidances for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
withdrawing two 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)'' and reissuing them as draft
guidances.
DATES: Submit either electronic or written comments on the draft
guidances by July 7, 2025 to ensure that the Agency considers your
comment on the draft guidances before it begins work on the final
version of the guidances.
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.''
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.
[[Page 18985]]
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: Irma Sison, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-8190.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of two draft 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 draft guidance documents were originally published as final
guidance 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.'' On February 3, 2025, FDA
subsequently announced the availability of revised versions of these
guidances that recommended implementation of the guidance
recommendations on a longer timeframe, by May 4, 2025 (90 FR 8802).
FDA is withdrawing the 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)'' and reissuing them as draft
guidances.
The draft 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)'' provides
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. This guidance, when finalized, will
supersede information regarding sepsis included in the guidance
``Eligibility Determination for Donors of Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT/Ps), Guidance for Industry,''
dated August 2007 (August 2007 HCT/P DE Guidance), by updating
recommendations for making a donor eligibility determination when
screening a donor for clinical evidence of sepsis and clinical signs to
consider. The August 2007 HCT/P DE guidance identified sepsis as a
relevant communicable disease agent or disease under 21 CFR
1271.3(r)(2).
The draft 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)'' assists
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 draft guidances consistent with our good
guidance practices regulation (21 CFR 10.115). FDA has received
comments on the now-withdrawn final guidances issued in January 2025,
and the Agency has made certain revisions that have been incorporated
into the new draft guidances in response to those comments. The Agency
will continue to consider those comments, as well as any comments
received on these draft guidances, as we consider next steps. These
draft guidances, when finalized, will represent the current thinking of
FDA on ``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 guidances do not establish any rights for any person and are not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
As we develop any final guidance on this topic, FDA will consider
comments on the applicability of Executive Order 14192, per OMB
guidance M-25-20, and in particular, on any costs or cost savings.
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.
Dated: April 29, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-07752 Filed 5-2-25; 8:45 am]
BILLING CODE 4164-01-P