7722 Federal Register / Vol. 89, No. 24 / Monday, February 5, 2024 / Notices 

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. Identify all emailed 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: State child support 

agencies are required to establish and 

operate a federally approved statewide 

Automated Data Processing (ADP) and 

information retrieval system to assist in 

child support services. The APD 

process, established at 45 CFR part 95, 

subpart F, is the procedure by which 

states request and obtain approval for 

Federal Financial Participation (FFP) in 

their cost of acquiring ADP equipment 

and services. The ACF OCSS Division of 

State and Tribal Systems (DSTS) 

oversees this process. 

States are required to submit an initial 

APD, containing information to assist 

the Secretary of the Department of 

Health and Human Services (HHS) in 

determining if the state computerized 

support enforcement project planning 

and implementation meets federal 

certification requirements for approving 

FFP. States are then required to submit 

annual APD updates to HHS to report 

project status and request ongoing FFP 

for systems development, 

enhancements, operations, and 

maintenance. As-needed APDs are also 

submitted to acquire FFP when major 

milestones are missed or significant 

changes to project schedules occur. 

Based on an assessment of the 

information provided in the APD, states 

that do not meet the federal 

requirements necessary for approval are 

required to conduct periodic 

independent verification and validation 

services for high-risk project oversight. 

In addition to the APDs providing 

HHS/ACF/OCSS with the information 

necessary to determine the allowable 

level of federal funding for state systems 

projects, states also submit associated 

procurement and data security 

documents, such as requests for 

proposals (RFPs), contracts, contract 

amendments, and the biennial security 

review reports. 

Respondents: State child support 

agencies. 

ANNUAL BURDEN ESTIMATES

Instrument Total number 

of respondents 

Total number 

of responses 

per 

respondent 

Average 

burden hours 

per response 

Total 

burden hours 

Annual 

burden hours 

RFP and Contract ................................................................ 50 4.5 4 900 300 

Emergency Funding Request .............................................. 21 1 2 42 14 

Biennial Reports ................................................................... 54 1.5 1.5 121.5 40.5 

Advance Planning Document .............................................. 44 3.6 120 19,008 6,336 

Operational Advance Planning Document ........................... 10 3 30 900 300 

Independent Verification and Validation (ongoing) .............. 3 12 10 360 120 

Independent Verification and Validation (semiannually) ..... 4 6 16 384 128 

Independent Verification and Validation (quarterly) ............ 10 12 30 3,600 1,200 

System Certification ............................................................. 3 3 240 2,160 720 

Estimated Total Annual Burden 

Hours: 9,158.50. 

Authority: 45 CFR part 95, subpart F. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–02166 Filed 2–2–24; 8:45 am] 

BILLING CODE 4184–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–0018] 

Oncologic Drugs Advisory Committee; 

Notice of Meeting; Establishment of a 

Public Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Oncologic Drugs 

Advisory Committee (the Committee). 

The general function of the Committee 

is to provide advice and 

recommendations to FDA on regulatory 

issues. The meeting will be open to the 

public. FDA is establishing a docket for 

public comment on this document. 

DATES: The meeting will be held on 

March 15, 2024, from 8:30 a.m. to 5:30 

p.m. eastern time. 

ADDRESSES: All meeting participants 

will be heard, viewed, captioned, and 

recorded for this advisory committee 

meeting via an online teleconferencing 

and/or video conferencing platform. 

Answers to commonly asked 

questions about FDA advisory 

committee meetings may be accessed at: 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2024–N–0018. 

The docket will close on March 14, 

2024. 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 14, 2024. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Comments received on or before 

March 1, 2024, will be provided to the 

Committee. Comments received after 

that date will be taken into 

consideration by FDA. In the event that 

the meeting is cancelled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments 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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 24 / Monday, February 5, 2024 / Notices 7723 

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–N–0018 for ‘‘Oncologic Drugs 

Advisory Committee; Notice of Meeting; 

Establishment of a Public Docket; 

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.’’ FDA 

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 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 the 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: 

Joyce Frimpong, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 240– 

402–5343, email: ODAC@fda.hhs.gov, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area). A notice in 

the Federal Register about last-minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

FDA’s website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing and/or video 

conferencing platform. During the 

morning session, the Committee will 

discuss supplemental biologics license 

application (sBLA) 125746.74 for 

CARVYKTI (ciltacabtagene autoleucel), 

suspension for intravenous infusion, 

submitted by Janssen Biotech, Inc. The 

proposed indication for this product is 

for the treatment of adult patients with 

relapsed or refractory multiple 

myeloma, who have received at least 

one prior line of therapy, including a 

proteasome inhibitor, and an 

immunomodulatory agent, and are 

refractory to lenalidomide. The 

Committee will have a general 

discussion focused on the overall 

survival data in the Study MMY3002 

(CARTITUDE–4) and the risk and 

benefit of ciltacabtagene autoleucel in 

the intended population. During the 

afternoon session, the Committee will 

discuss sBLA 125736.218 for ABECMA 

(idecabtagene vicleucel), suspension for 

intravenous infusion, submitted by 

Celgene Corp., a Bristol-Myers Squibb 

Co. The proposed indication is for the 

treatment of adult patients with 

relapsed or refractory multiple myeloma 

who have received an 

immunomodulatory agent, a proteasome 

inhibitor, and an anti-CD38 monoclonal 

antibody. The Committee will have a 

general discussion focused on the 

overall survival data in the Study MM– 

003 (KarMMa–3) and the risk and 

benefit of idecabtagene vicleucel in the 

intended population. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference and/or video conference 

meeting will be available at https://

www.fda.gov/AdvisoryCommittees/ 

Calendar/default.htm. Scroll down to 

the appropriate advisory committee 

meeting link. The meeting will include 

slide presentations with audio and 

video components to allow the 

presentation of materials in a manner 

that most closely resembles an in-person 

advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the Committee. All electronic and 

written submissions to the Docket (see 

ADDRESSES) on or before March 1, 2024, 

will be provided to the Committee. Oral 

presentations from the public will be 

scheduled between approximately 11:10 

a.m. to 11:40 a.m. and 4 p.m. to 4:30 

p.m. eastern time. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before February 

22, 2024. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 


lotter on DSK11XQN23PROD with NOTICES1
7724 Federal Register / Vol. 89, No. 24 / Monday, February 5, 2024 / Notices 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by February 23, 2024. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Joyce 

Frimpong (see FOR FURTHER INFORMATION

CONTACT) at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.). This meeting notice 

also serves as notice that, pursuant to 21 

CFR 10.19, the requirements in 21 CFR 

14.22(b), (f), and (g) relating to the 

location of advisory committee meetings 

are hereby waived to allow for this 

meeting to take place using an online 

meeting platform. This waiver is in the 

interest of allowing greater transparency 

and opportunities for public 

participation, in addition to 

convenience for advisory committee 

members, speakers, and guest speakers. 

The conditions for issuance of a waiver 

under 21 CFR 10.19 are met. 

Dated: January 30, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–02229 Filed 2–2–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Small Health 

Care Provider Quality Improvement 

Program, OMB No. 0915–0387— 

Extension 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than April 5, 2024. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N39, 5600 Fishers 

Lane, Rockville, Maryland 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at (301) 443–3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

Small Health Care Provider Quality 

Improvement Program, OMB No. 0915– 

0387—Extension. 

Abstract: This program is authorized 

by the Public Health Service Act, 

section 330A(g) (42 U.S.C. 254c(g)). This 

authority permits the Federal Office of 

Rural Health Policy (FORHP) to award 

Small Health Care Provider Quality 

Improvement grants that expand access 

to, coordinate, and improve the quality 

of basic health care services, and 

enhance the delivery of health care, in 

rural areas. Specifically, FORHP may 

award grants to provide for the planning 

and implementation of Small Health 

Care Provider Quality Improvement 

activities, including activities related to 

increasing care coordination, enhancing 

chronic disease management, and 

improving patient health outcomes. 

The purpose of the Small Health Care 

Provider Quality Improvement Grant 

Program is to provide support to rural 

primary care providers for 

implementation of quality improvement 

activities. The goal of the program is to 

promote the development of an 

evidence-based culture and delivery of 

coordinated care in the primary care 

setting. Additional objectives of the 

program include improved health 

outcomes for patients, enhanced chronic 

disease management, and better 

engagement of patients and their 

caregivers. Organizations participating 

in the program are required to use an 

evidence-based quality improvement 

model, perform tests of change focused 

on improvement, and use health 

information technology (HIT) to collect 

and report data. HIT may include an 

electronic patient registry or an 

electronic health record and is a critical 

component for improving quality and 

patient outcomes. With HIT it is 

possible to generate timely and 

meaningful data, which helps providers 

track and plan care. HRSA collects 

information from grant recipients that 

participate in this program using an 

OMB-approved set of performance 

measures and seeks to extend its 

approved information collection. 

Need and Proposed Use of the 

Information: For this program, 

performance measures were drafted to 

provide data to the program and to 

enable HRSA to provide aggregate 

program data required by Congress 

under the Government Performance and 

Results Act of 1993. These measures 

cover the principal topic areas of 

interest to FORHP, including: (1) access 

to care, (2) population demographics, (3) 

staffing, (4) consortium/network, (5) 

sustainability, and (6) project specific 

domains. All measures will speak to 

FORHP’s progress toward meeting the 

goals set. FORHP collects this 

information to quantify the impact of 

grant funding on access to health care, 

quality of services, and improvement of 

health outcomes. FORHP uses the data 

for program improvement and grantees 

use the data for performance tracking. 

No changes are proposed from the 

current data collection effort, but 

FORHP estimates fewer respondents to 

align with the current cohort of 

grantees. 

Likely Respondents: The respondents 

would be the grant recipients (program 

grantees, not patients who receive 

health care services) of the Small Health 

Care Provider Quality Improvement 

Program grants. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 


lotter on DSK11XQN23PROD with NOTICES1