Federal Register / Vol. 89, No. 30 / Tuesday, February 13, 2024 / Notices 10083 

Initiatives, Office of the Chief Operating 

Officer, CDC, pursuant to Public Law 

92–463. The grant applications and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable material, and 

personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Disease, 

Disability, and Injury Prevention and 

Control Special Emphasis Panel (SEP)— 

SIP24–008, Managing Epilepsy Well 

Network (MEW). 

Date: May 9, 2024. 

Time: 10 a.m.–6 p.m., EDT. 

Place: Teleconference/Web 

Conference. 

Agenda: To review and evaluate grant 

applications. 

For Further Information Contact: 

Catherine Barrett, Ph.D., Scientific 

Review Officer, National Center for 

Chronic Disease Prevention and Health 

Promotion, Centers for Disease Control 

and Prevention, 4770 Buford Highway, 

Mailstop S106–3, Atlanta, Georgia 

30341–3717. Telephone: (404) 718– 

7664; Email: CBarrett@cdc.gov. 

The Director, Office of Strategic 

Business Initiatives, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Office of Strategic Business 

Initiatives, Office of the Chief Operating 

Officer, Centers for Disease Control and 

Prevention. 

[FR Doc. 2024–02882 Filed 2–12–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Notice of Closed Meeting 

Pursuant to 5 U.S.C. 1009(d), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended, and the Determination of 

the Director, Office of Strategic Business 

Initiatives, Office of the Chief Operating 

Officer, CDC, pursuant to Public Law 

92–463. The grant applications and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable material, and 

personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Disease, 

Disability, and Injury Prevention and 

Control Special Emphasis Panel (SEP)— 

SIP24–003, Cancer Prevention and 

Control Research Network (CPCRN). 

Date: May 1, 2024. 

Time: 10 a.m.–6 p.m., EDT. 

Place: Teleconference/Web 

Conference. 

Agenda: To review and evaluate grant 

applications. 

For Further Information Contact: 

Natalie Brown, M.P.H., Scientific 

Review Officer, National Center for 

Chronic Disease Prevention and Health 

Promotion, Centers for Disease Control 

and Prevention, 4770 Buford Highway, 

Mailstop S106–3, Atlanta, Georgia 

30341–3717. Telephone: (404) 639– 

4601; Email: NBrown3@cdc.gov. 

The Director, Office of Strategic 

Business Initiatives, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Office of Strategic Business 

Initiatives, Office of the Chief Operating 

Officer, Centers for Disease Control and 

Prevention. 

[FR Doc. 2024–02878 Filed 2–12–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for Office of Management 

and Budget (OMB) Review; Social 

Services Block Grant Post-Expenditure 

Report, Pre-Expenditure Report, and 

Intended Use Plan (OMB #0970–0234) 

AGENCY: Office of Community Services, 

Administration for Children and 

Families, Department of Health and 

Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Administration for 

Children and Families’ (ACF) Office of 

Community Services (OCS) is requesting 

from OMB a three-year extension of the 

Social Services Block Grant (SSBG) 

Post-Expenditure Report, PreExpenditure Report, and Intended Use 

Plan (OMB #0970–0234). OCS is 

proposing to make minor editorial 

modifications to some column titles in 

the Pre- and Post-Expenditure Reports, 

for clarification. 

DATES: Comments are due within 30 

days of publication. OMB must decide 

about 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 full 

consideration if OMB receives it within 

30 days of this 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. Identify all emailed 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: On an annual basis, 

states and territories are required to 

submit the following reports: (1) An 

Intended Use Plan that provides data 

and narrative descriptions related to the 

state’s SSBG program. The Intended Use 

Plan includes details about the delivery 

of SSBG services and the state agency 

administering the SSBG Program. ACF 

is proposing to expand the currently 

approved information collection to 

include the collection of states’ 

Intended Use Plans with a model 

format. Recipients are required to 

submit their Pre-Expenditure Report no 

less than 30 days prior to the start of the 

period covered by the report. (2) A PreExpenditure Report demonstrates the 

state’s anticipated allocation of SSBG 

funding among the 29 pre-defined SSBG 

service categories. Historically, states 

have submitted this report using the 

Post-Expenditure Report Form, and the 

associated burden is included in the 

currently approved information 

collection. Recipients are required to 

submit their Intended Use Plan no less 

than 30 days prior to the start of the 

period covered by the report, together 

with the Pre-Expenditure Report. (3) A 

Post-Expenditure Report details the 

state’s actual use of SSBG funding 

among each of the 29 service categories. 


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10084 Federal Register / Vol. 89, No. 30 / Tuesday, February 13, 2024 / Notices 

Recipients are required to submit their 

Post-Expenditure Report within 6 

months of the end of the period covered 

by the report. 

The law governing the programs at 

Title XX of the Social Security Act [42 

U.S.C. 1397c] mandates states and 

territories submit to the federal 

administering office an Intended Use 

Plan and Pre-Expenditure report. These 

materials are to detail the planned use 

of funds. At the end of the fiscal year, 

the law also requires states to provide 

the federal agency with a reconciliation 

of the actual use of grant funds in the 

Post-Expenditure Report [42 U.S.C. 

1397e]. 

The forms and model plans support 

the states and territories in meeting the 

statutory requirement and provide a 

consistent set of tools for information 

collection on the grants’ use for each 

state, as well as grant wide. The state 

and territory reports are congregated 

and analyzed and, in turn, comprise the 

SSBG Annual Report. The data informs 

the program’s performance and 

efficiency measures for program impact 

and efficacy. OCS is proposing to make 

minor editorial modifications to some 

column titles in the Pre- and PostExpenditure Reports, for clarification. 

Respondents: Agencies that 

administer the SSBG at the state or 

territory level, including the 50 states; 

the District of Columbia; the 

Commonwealth of Puerto Rico; 

Massachusetts Commission for the 

Blind (M–CFB); and the territories of 

American Samoa, Guam, the U.S. Virgin 

Islands, and the Commonwealth of 

Northern Mariana Islands. 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual 

burden 

hours 

Pre-Expenditure Report Form ......................................................................... 57 1 2 114 

Intended Use Plan ........................................................................................... 57 1 40 2,280 

Post-Expenditure Reporting Form ................................................................... 57 1 110 6,270 

Estimated Total Annual Burden Hours: .................................................... ........................ ........................ ........................ 8,664 

Authority: 42 U.S.C. 1397–1397e. 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–02851 Filed 2–12–24; 8:45 am] 

BILLING CODE 4184–24–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2001–D–0219] 

Use of Data Monitoring Committees in 

Clinical Trials; Draft Guidance for 

Industry; Availability; Agency 

Information Collection Activities; 

Proposed Collection; Comment 

Request 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Use of 

Data Monitoring Committees in Clinical 

Trials.’’ This guidance is intended to 

assist sponsors of clinical trials in 

determining when a data monitoring 

committee (DMC) (also known as a data 

and safety monitoring board (DSMB), a 

data and safety monitoring committee 

(DSMC), or an independent data 

monitoring committee (IDMC)) would 

be useful for trial monitoring and what 

procedures and practices should be 

considered to guide their operation. 

When finalized, this guidance will 

supersede the final guidance for clinical 

trial sponsors entitled ‘‘Establishment 

and Operation of Clinical Trial Data 

Monitoring Committees,’’ issued in 

March 2006. This draft guidance is not 

final nor is it in effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by April 15, 2024 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

Submit electronic or written comments 

on the proposed collection of 

information in the draft guidance by 

April 15, 2024. 

ADDRESSES: You may submit comments 

on any guidance 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– 

2001–D–0219 for ‘‘Use of Data 

Monitoring Committees in Clinical 

Trials.’’ 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 


lotter on DSK11XQN23PROD with NOTICES1