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[Federal Register Volume 90, Number 11 (Friday, January 17, 2025)]
[Notices]
[Pages 5890-5891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-01200]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2025-N-0121]

Cell Therapies and Tissue-Based Products: A Public Workshop on 
Generating Scientific Evidence to Facilitate Development; Public 
Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following virtual public workshop entitled ``Cell 
Therapies and Tissue-Based Products: A Public Workshop on Generating 
Scientific Evidence to Facilitate Development.'' The purpose of this 
workshop is to discuss the current state of the science for development 
and testing of certain cellular therapies and tissue-based products. In 
particular, FDA is convening this public workshop with relevant 
stakeholders to discuss best practices on generating scientific data 
necessary to further facilitate the development of cellular therapies, 
including stem cell products.

DATES: The public workshop will be held virtually on February 25, 2025, 
from 8:30 a.m. to 5 p.m. Eastern Time. Either electronic or written 
comments on this public workshop must be submitted by March 18, 2025. 
See the SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: The public workshop will be virtual.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of March 18, 2025. Comments received by mail/hand 
delivery/courier (for written/paper submissions) will be considered 
timely if they are received on or before that date.

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-2025-N-0121 for ``Cell Therapies and

[[Page 5891]]

Tissue-Based Products: A Public Workshop on Generating Scientific 
Evidence to Facilitate Development; Public Workshop; Request for 
Comments.'' Received comments, those filed in a timely manner (see 
ADDRESSES), 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.

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's Center for Biologics Evaluation and Research (CBER) protects 
and enhances the public health by ensuring the safety, purity, potency, 
and effectiveness of biological products, including vaccines, 
allergenics, blood and blood products, and cellular and gene therapies 
for the prevention, treatment, or cure of human diseases or conditions. 
CBER's Office of Therapeutic Products (OTP) regulates, among others, 
regenerative medicine products, including human cells, tissues, and 
cellular and tissue-based products (HCT/Ps) intended to treat or cure 
diseases or medical conditions. The purpose of this workshop is to 
discuss the current state of the science for development and testing of 
certain cellular therapies and tissue-based products. In particular, 
FDA is convening this public workshop with relevant stakeholders to 
discuss best practices on generating scientific data necessary to 
further facilitate the development of cellular therapies, including 
stem cell products. Within 6 months after the meeting, FDA will issue a 
transcript of the meeting. This workshop will fulfill the requirement 
under the Food and Drug Omnibus Reform Act of 2022, section 3205.

II. Topics for Discussion at the Public Workshop

    The workshop will include presentations and panel discussions with 
experts from research and academic institutions to identify and discuss 
scientific considerations, opportunities, and challenges to help inform 
the development of cellular therapies and tissue-based products. Topics 
discussed during the workshop include:
    1. The current state of the science for tissue and cell-derived 
therapies and explore what challenges remain as the field continues to 
mature.
    2. Nonclinical work to assess the safety of cell therapy products 
in support of product development.
    3. Considerations for characterization of cell therapy products to 
help ensure manufacturing quality during product development and 
through commercialization.
    4. Clinical considerations and future directions for locally-
administered cell therapies under investigation for niche indications
    5. Considerations for a revised risk-based HCT/P framework
    During the workshop, attendees will be able to submit questions to 
the speakers and panelists for consideration during the panel 
discussions.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following website to register: https://www.fda.gov/news-events/otp-events-meetings-and-workshops/cell-therapies-and-tissue-based-products-public-workshop-generating-scientific-evidence-facilitate. Please 
provide complete contact information for each attendee, including name, 
affiliation, and email.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by February 25, 2025, at 8:30 a.m. Eastern Time. 
Early registration is recommended. Registrants will receive 
confirmation when they have registered for the event.
    If you need special accommodations due to a disability, please 
Claire Simon ([email protected]) no later than January 24, 2025.
    No commercial or promotional material will be permitted to be 
presented or distributed at the public workshop.
    Streaming Webcast of the Public Workshop: This public workshop will 
be webcast. Registration is available on FDA.gov: https://www.fda.gov/news-events/otp-events-meetings-and-workshops/cell-therapies-and-tissue-based-products-public-workshop-generating-scientific-evidence-facilitate. A recording will be available on https://www.fda.gov/news-events/otp-events-meetings-and-workshops/cell-therapies-and-tissue-based-products-public-workshop-generating-scientific-evidence-facilitate.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. A link to the transcript will also be available on 
the internet at https://www.fda.gov/news-events/otp-events-meetings-and-workshops/cell-therapies-and-tissue-based-products-public-workshop-generating-scientific-evidence-facilitate.
    Notice of this meeting is given pursuant to 21 CFR 10.65.

    Dated: January 14, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-01200 Filed 1-16-25; 8:45 am]
BILLING CODE 4164-01-P
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