Federal Register / Vol. 88, No. 185 / Tuesday, September 26, 2023 / Notices 66007 

Name of grant recipient that has funds to be returned for reallotment 

Preliminary 

amount 

available for 

reallotment 1

Seneca Nation of Indians .................................................................................................................................................................... 20,244 

South Puget Intertribal Planning Agency ............................................................................................................................................ 739 

Spirit Lake Nation ................................................................................................................................................................................ 287,077 

Standing Rock Sioux Tribe .................................................................................................................................................................. 396,242 

Thlopthlocco Tribal Town .................................................................................................................................................................... 9,446 

Turtle Mountain Band of Chippewa Indians ........................................................................................................................................ 2,376,042 

United Keetoowah Band of Cherokee Indians .................................................................................................................................... 272,128 

Ute Indian Tribe ................................................................................................................................................................................... 1,672 

Yankton Sioux Tribe ............................................................................................................................................................................ 244,986 

Total .............................................................................................................................................................................................. 21,985,238 

1Preliminary funds for reallotment consist of the funds in excess of LIHEAP’s 10 percent carryover cap that (1) 73 recipients indicated on the 

FFRs or reported on the CRRs as unobligated; or (2) amounted to 100 percent of regular funds or IIJA funds for the 3 recipients that failed to 

submit the associated FFRs and their CRRs. 

If funds are reallotted, then grant 

recipients may use them for any 

purpose authorized under LIHEAP and 

must add these funds to their total 

LIHEAP funds payable for FFY 2023 for 

purposes of calculating statutory caps 

on administrative costs, carryover, 

Assurance 16 activities, and 

weatherization assistance. 

Additionally, all recipients of these 

funds must (1) ensure that they are 

included in the amounts on Lines 1.1 of 

their FFY 2023 CRRs; (2) reconcile these 

funds, to the extent that they received 

them, on a separate FFR; and (3) record, 

on their FFY 2023 Household Reports, 

households that receive benefits at least 

partly from these funds. State recipients 

must also ensure that these funds are 

included in the Grantee Survey sections 

of their FFY 2023 LIHEAP Performance 

Data Forms. 

Statutory Authority: 42 U.S.C. 

8626(b). 

Karen D. Shields, 

Senior Grants Policy Specialist, Office of 

Grants Policy, Office of Administration. 

[FR Doc. 2023–20788 Filed 9–25–23; 8:45 am] 

BILLING CODE 4184–80–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for Office of Management 

and Budget Review; Title V State 

Sexual Risk Avoidance Education 

(Office of Management and Budget 

#0970–0551) 

AGENCY: Family and Youth Services 

Bureau, Administration for Children 

and Families, United States Department 

of Health and Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Family and Youth 

Services Bureau (FYSB) within the 

Administration on Children, Youth and 

Families (ACYF) is accepting mandatory 

formula grant applications and State 

plans from States and Territories for the 

development of and implementation for 

Title V State Sexual Risk Avoidance 

Education (SRAE) Program. The Title V 

State SRAE Notice of Funding 

Opportunity (NOFO) sets forth the 

application requirements for recipients. 

This request is to extend Office of 

Management and Budget (OMB) 

approval of the request for information. 

No changes are proposed. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

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 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. Identify all emailed 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: The Title 

V SRAE Program has mandatory, 

formula allotments for State and 

Territories to apply. The application 

process is for States and Territories to 

submit and for ACYF/FYSB to collect an 

application, State plan, and semi-annual 

performance progress reports. 

Purpose and Use of the Information 

Collection 

The application and State plans will 

offer information about the proposed 

State project and it will be used as the 

primary basis to determine whether or 

not the project meets the minimum 

requirements of the NOFO for the grant 

award. 

The Performance Progress Reports are 

collected semi-annually and will inform 

the monitoring of the grantees’ program 

design, program evaluation, 

management improvement, service 

quality and compliance with agreed 

upon goals. ACYF/FYSB will use the 

information to assure effective service 

delivery for program participants. 

Finally, the data from this collection 

will be used to report outcomes and 

efficiencies and will provide valuable 

information to policy makers and key 

stakeholders in the development of 

program and research efforts. 

Respondents: Thirty-eight States and 

nine Territories, to include, District of 

Columbia, Puerto Rico, Virgin Islands, 

Guam, American Samoa, Northern 

Mariana Islands, the Federated States of 

Micronesia, the Marshall Islands, and 

Palau. 


lotter on DSK11XQN23PROD with NOTICES1
66008 Federal Register / Vol. 88, No. 185 / Tuesday, September 26, 2023 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument Total number 

of respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual 

burden hours 

Applications ...................................................................................................... 47 1 24 1,128

State Plans ...................................................................................................... 47 1 40 1,880 

Performance Progress Reports ....................................................................... 47 2 16 1,504 

Estimated Total Annual Burden 

Hours: 4,512. 

Authority: Section 510 of the Social 

Security Act (42 U.S.C. 710), as 

amended by section 50502 of the 

Bipartisan Budget Act of 2018 (Pub. L. 

115–123) and extended by Division CC, 

title III, section 303 of the Consolidated 

Appropriations Act, 2022 (Pub. L. 117– 

103). 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2023–20758 Filed 9–25–23; 8:45 am] 

BILLING CODE 4184–83–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–0001] 

Advancing the Development of 

Pediatric Therapeutics on Drug Dosing 

in Pediatric Patients With Renal 

Impairment; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

workshop entitled ‘‘Advancing the 

Development of Pediatric Therapeutics 

(ADEPT 8) on Drug Dosing in Pediatric 

Patients With Renal Impairment.’’ The 

purpose of the public workshop is to 

discuss the current landscape of drug 

dosing in pediatric patients with renal 

impairment, understand the gaps in 

knowledge, and consider innovative 

approaches to improve the current 

paradigm for dosing in pediatric 

patients with renal impairment. 

DATES: The public workshop will be 

held on November 30, 2023, and 

December 1, 2023, from 9 a.m. to 5 p.m. 

eastern time each day. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public workshop will 

be held at the FDA White Oak Campus 

Great Room and online. Entrance for the 

registered public workshop participants 

(non-FDA employees) is through 

Building 1 where routine security check 

procedures will be performed. For 

parking and security information, please 

refer to https://www.fda.gov/about-fda/ 

visitor-information. 

FOR FURTHER INFORMATION CONTACT: Julie 

Levin, Office of New Drugs Public 

Meeting Support, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 6481, Silver Spring, 

MD 20993–0002, 202–567–7565, 

ONDPublicMTGSupport@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The pharmacokinetics of drugs 

excreted by the kidneys may be altered 

by renal (kidney) impairment, requiring 

dosing adjustments. However, the 

majority of drugs that are predominantly 

renally excreted and have dosage 

recommendations for adults with renal 

impairment lack dose adjustment 

recommendations for pediatric patients 

with renal impairment. This is largely 

due to the lack of generation of 

pharmacokinetic data in pediatric 

patients with renal impairment, which 

is attributable to both the ethical and the 

practical limitations of conducting 

dedicated renal impairment studies in 

pediatric patients, as well as the 

exclusion of pediatric patients with 

renal impairment from most clinical 

efficacy and safety studies. For drugs 

that are renally cleared, exposures can 

be impacted by both the maturation of 

kidney function and the renal 

impairment due to kidney disease. 

II. Topics for Discussion at the Public 

Workshop 

The main objective of the ‘‘Advancing 

the Development of Pediatric 

Therapeutics (ADEPT 8) on Drug Dosing 

in Pediatric Patients With Renal 

Impairment’’ workshop is to discuss 

current approaches to classifying renal 

impairment in the pediatric population, 

identify data gaps, and explore 

scientifically supported approaches and 

methods for providing information on 

dosing adjustment. The workshop will 

specifically focus on measurements of 

renal function, extrapolation of adult 

data, and approaches to generating 

clinical trial data to assess the impact of 

renal impairment on the 

pharmacokinetics of drugs in pediatric 

patients. In addition, the workshop will 

allow for an open dialogue around the 

use of these approaches among 

regulators, industry, academia, and 

patient organizations. 

III. Participating in the Public 

Workshop 

Registration: To register for the public 

workshop, please visit the following 

website: https://www.eventbrite.com/e/ 

adept-8-pediatric-renal-impairmentworkshop-tickets-687423571407. Please 

provide complete contact information 

for each attendee, including name, title, 

affiliation, address, email, and 

telephone. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Persons interested in 

attending this public workshop must 

register by November 15, 2023, 11:59 

p.m. Eastern Time. Early registration is 

recommended because seating is 

limited; therefore, FDA may limit the 

number of participants from each 

organization. Registrants will receive 

confirmation when they have been 

accepted. 

If you need special accommodations 

due to a disability, please contact Julie 

Levin at ONDPublicMTGSupport@

fda.hhs.gov no later than November 15, 

2023. 

Streaming Webcast of the Public 

Workshop: This public workshop will 

also be via Zoom. A link will be 

provided via email to registered 

participants. If you have never attended 

a Zoom event before, test your internet 

connection by joining a test meeting at 

https://zoom.us/test. FDA has verified 

the website addresses in this document, 

as of the date this document is 

published in the Federal Register, but 

websites are subject to change over time. 

Transcripts: Please be advised that 

when 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. 


lotter on DSK11XQN23PROD with NOTICES1