5890 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Notices 

eligible States, territories, and Tribes in 

response to the consequences of major 

disasters and emergencies declared 

pursuant to the Robert T. Stafford 

Disaster Relief and Emergency 

Assistance Act (42 U.S.C. 5121 et seq.) 

occurring in 2023 and 2024. 

OCC will be requesting information 

from eligible Child Care and 

Development Fund (CCDF) Lead 

Agencies who are interested in receiving 

these funds. The information requested 

includes the relevant major disaster or 

emergency declaration; a detailed 

description of the affected area; a 

detailed description of the impact on 

children, families, staff, and child care 

services; a description of each proposed 

activity; information on previous 

expenses incurred related to the disaster 

or emergency; and the total amount of 

funds requested. OCC will use the 

information received to inform 

decisions about distribution of funds. 

Respondents: State, territory, and 

Tribal Lead Agencies. 

Annual Burden Estimates 

Respondents would provide one 

response to this request and 

information. The following burden 

estimates reflect the total estimated 

burden, which is expected within the 

first year of approval. 

Instrument Total number 

of respondents 

Total number 

of responses 

per 

respondent 

Average burden hours per 

response 

Total burden 

hours 

ACF–OCC–CCDF–PI–2025–X (Disaster Supplemental Funds for Child 

Care—2023 and 2024 major disasters and emergencies) .......................... 70 1 80 5,600 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

In addition, The Department solicits 

public comment on whether OCC 

should, in advance of receiving Lead 

Agency applications for funding, 

establish funding ranges for the size of 

grants based on certain factors, and if so, 

what those ranges and factors should be. 

Authority: Public Law 118–158. 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2025–01221 Filed 1–16–25; 8:45 am] 

BILLING CODE 4184–87–P 

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. 

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 


KHAMMOND on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Notices 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 riskbased 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-andworkshops/cell-therapies-and-tissuebased-products-public-workshopgenerating-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 

(Claire.Simon@fda.hhs.gov) 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/newsevents/otp-events-meetings-andworkshops/cell-therapies-and-tissuebased-products-public-workshopgenerating-scientific-evidence-facilitate. 

A recording will be available on https:// 

www.fda.gov/news-events/otp-eventsmeetings-and-workshops/cell-therapiesand-tissue-based-products-publicworkshop-generating-scientificevidence-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/otpevents-meetings-and-workshops/celltherapies-and-tissue-based-productspublic-workshop-generating-scientificevidence-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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