Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Notices 5909 

the MA program for which limited data 

are currently available. 

III. Collection of Information 

Requirements 

This is a request for information (RFI) 

only. In accordance with the 

implementing regulations of the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501 et seq.), specifically 5 

CFR 1320.3(h)(4), this general 

solicitation is exempt from the PRA. 

Facts or opinions submitted in response 

to general solicitations of comments 

from the public, published in the 

Federal Register or other publications, 

regardless of the form or format thereof, 

provided that no person is required to 

supply specific information pertaining 

to the commenter, other than that 

necessary for self-identification, as a 

condition of the agency’s full 

consideration, are not generally 

considered information collections and 

therefore not subject to the PRA. 

This RFI is issued solely for 

information and planning purposes; it 

does not constitute a Request for 

Proposal (RFP), applications, proposal 

abstracts, or quotations. This RFI does 

not commit the U.S. Government to 

contract for any supplies or services or 

make a grant award. Further, we are not 

seeking proposals through this RFI and 

will not accept unsolicited proposals. 

Responders are advised that the U.S. 

Government will not pay for any 

information or administrative costs 

incurred in response to this RFI; all 

costs associated with responding to this 

RFI will be solely at the interested 

party’s expense. In addition, this RFI 

does not commit the Government to any 

policy decision and CMS will follow 

established methods for proposing 

future policy changes, including the MA 

Advance Notice and Rate 

Announcement process. We note that 

not responding to this RFI does not 

preclude participation in any future 

procurement or rulemaking, if 

conducted. It is the responsibility of the 

potential responders to monitor this RFI 

announcement for additional 

information pertaining to this request. 

In addition, we note that CMS will not 

respond to questions about the policy 

issues raised in this RFI. 

Chiquita Brooks-LaSure, 

Administrator of the Centers for 

Medicare & Medicaid Services, 

approved this document on January 22, 

2024. 

Dated: January 25, 2024. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2024–01832 Filed 1–25–24; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for Office of Management 

and Budget Review; Office of Human 

Services Emergency Preparedness 

and Response Disaster Human 

Services Case Management Intake 

Assessment, Resource Referral, and 

Case Management Plan 

AGENCY: Office of Human Services 

Emergency Preparedness and Response, 

Administration for Children and 

Families, U.S. Department of Health and 

Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Office of Human Services 

Emergency Preparedness and Response 

(OHSEPR), Administration for Children 

and Families (ACF), U.S. Department of 

Health and Human Services (HHS), is 

requesting an extension for approval of 

the following information collection: 

OHSEPR Disaster Human Services Case 

Management Intake Assessment, 

Resource Referral, and Case 

Management Plan; OMB No.: 0970– 

0619. This information collection was 

originally approved for 6 months 

through an emergency approval. 

DATES: Comments due within 30 days of 

publication. OMB is required to make a 

decision concerning the collection of 

information between 30 and 60 days 

after publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. You can also obtain 

copies of the proposed collection of 

information by emailing infocollection@

acf.hhs.gov. All emailed requests should 

be identified by the title of the 

information collection. 

SUPPLEMENTARY INFORMATION: 

Description: OHSEPR is seeking to 

continue data collection with all forms 

approved under OMB No. 0970–0619, 

which OMB recently approved through 

an emergency approval for 6 months. 

OHSEPR’s Disaster Human Services 

Intake Assessment, Resource Referral, 

and Case Management Plan collection is 

part of a system of tools that OHSEPR 

utilizes to support disaster survivors 

during response missions. OHSEPR’s 

case managers would use this collection 

during an intake assessment to identify 

a disaster survivor’s unmet needs and to 

work with the survivor to develop a case 

management plan based on the 

survivor’s responses. 

Respondents: Disaster survivors. 

ANNUAL BURDEN ESTIMATES

Data collection 

Annual 

number of 

respondents 

Total number 

of responses 

per respondent 

Average 

burden hours 

per response 

Annual 

burden hours 

Disaster Human Services Case Management Intake Assessment—Survivor ........................................................................................................ 9,000 1 1.5 13,500

Case Management Plan—Case Manager ................................................. 180 50 1 9,000 

Resource Referral Form—Case Manager ................................................. 180 50 1 9,000 

Case Record Notes—Case Manager ........................................................ 180 50 1 9,000 

Survivor Satisfaction Survey—Survivor ..................................................... 9,000 1 .25 2,250 

Estimated Total Annual Burden Hours: .............................................. ........................ .............................. ........................ 42,750 

Authority: The Disaster Human 

Services Case Management Program is 

authorized through appropriations 

language under the Children and 

Families Services account. It is operated 

by the ACF Office of Human Services 


khammond on DSKJM1Z7X2PROD with NOTICES
5910 Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Notices 

Emergency Preparedness and Response, 

which is the lead in HHS for human 

service preparation for, response to, and 

recovery from, natural disasters. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–01728 Filed 1–29–24; 8:45 am] 

BILLING CODE 4184–PC–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–0404] 

Considerations for the Development of 

Chimeric Antigen Receptor T Cell 

Products; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance entitled ‘‘Considerations for 

the Development of Chimeric Antigen 

Receptor (CAR) T Cell Products; 

Guidance for Industry.’’ The guidance is 

intended to assist sponsors, including 

industry and academic sponsors, 

developing ex vivo-manufactured CAR 

T cell products. The guidance provides 

CAR T cell specific recommendations 

regarding chemistry, manufacturing, 

and control (CMC), pharmacology and 

toxicology, and design of clinical 

studies for oncology indications 

(including hematologic malignancies 

and solid tumors). The guidance 

announced in this notice finalizes the 

draft guidance of the same title dated 

March 2022. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 30, 2024. 

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– 

2021–D–0404 for ‘‘Considerations for 

the Development of Chimeric Antigen 

Receptor (CAR) T Cell Products; 

Guidance for Industry.’’ 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 guidance to the Office of 

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 label to 

assist the office in processing your 

requests. The guidance 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 

document. 

FOR FURTHER INFORMATION CONTACT: 

Tami Belouin, 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 

a document entitled ‘‘Considerations for 

the Development of Chimeric Antigen 

Receptor (CAR) T Cell Products; 

Guidance for Industry.’’ The guidance is 

intended to assist sponsors, including 

industry and academic sponsors, 

developing ex vivo-manufactured CAR 

T cell products. The guidance provides 

CAR T cell specific recommendations 

regarding CMC, pharmacology and 

toxicology, and design of clinical 

studies for oncology indications 

(including hematologic malignancies 

and solid tumors). Recommendations 


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