95218 Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Notices 

and Affordable Care Act, Public Law 

111–148, enacted on March 23, 2010, 

and the Health Care and Education 

Reconciliation Act, Public Law 111– 

152, enacted on March 30, 2010 

collectively, ‘‘Affordable Care Act’’, 

expanded access to health insurance for 

individuals and employees of small 

businesses through the establishment of 

new Affordable Insurance Exchanges 

(Exchanges), including the Small 

Business Health Options Program 

(SHOP). Beginning January 1, 2014, the 

Exchanges became operational. The 

Exchanges enhance competition in the 

health insurance market, expand access 

to affordable health insurance for 

millions of Americans, and provide 

consumers with a place to easily 

compare and shop for health insurance 

coverage. 

States can choose to establish and 

operate a State-based Exchange (SBE) or 

a State-based Exchange on the Federal 

Platform (SBE–FP). States electing to 

operate as an SBE–FP rely on the 

Federal Healthcare.gov platform to carry 

out eligibility and enrollment functions. 

For states that do not elect to operate 

either an SBE or SBE–FP, the Secretary 

of the U.S. Department of Health and 

Human Services (HHS) will establish 

and operate a Federally-facilitated 

Exchange (FFE) in those states. Form 

Number: CMS–10371 (OMB control 

number: 0938–1119; Frequency: 

Occasionally; Affected Public: State, 

Local or Tribal Government; Number of 

Respondents: 23; Total Annual 

Responses: 343; Total Annual Hours: 

7,317. (For policy questions regarding 

this collection contact Tiffany Y. 

Animashaun at Tiffany.Animashaun@

cms.hhs.gov). 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–28083 Filed 11–29–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Low Income Home Energy 

Assistance Program (LIHEAP) 

Performance Data Form (Office of 

Management and Budget #0970–0449) 

AGENCY: Office of Community Services, 

Administration for Children and 

Families, U.S. Department of Health and 

Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Administration for 

Children and Families (ACF) Office of 

Community Services (OCS) within the 

U.S. Department of Health and Human 

Services (HHS) is requesting an 

extension without change to the current 

version of the Low Income Home Energy 

Assistance Program (LIHEAP) 

Performance Measures (Office of 

Management and Budget (OMB) #0970– 

0449) for use through June 30,2025, and 

for approval of a revised version to use 

beginning July 1, 2025. 

DATES: Comments due January 31, 2025. 

In compliance with the requirements of 

the Paperwork Reduction Act of 1995, 

ACF is soliciting public comment on the 

specific aspects of the information 

collection described above. 

ADDRESSES: You can obtain copies of the 

proposed collection of information and 

submit comments by emailing 

infocollection@acf.hhs.gov. Identify all 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: OCS administers LIHEAP at 

the Federal level. The LIHEAP 

Performance Data Form (LPDF) is an 

annual report in response to section 

2610(b) of the Low-Income Home 

Energy Assistance Act of 1981 (42 

U.S.C. 8629(b)(2))(LIHEAP statute), 

which requires the Secretary of HHS to 

submit, no later than June 30 of each 

Federal fiscal year, a report to Congress 

on LIHEAP for the prior Federal fiscal 

year. The completeness, accuracy, 

consistency, and timeliness of responses 

to data collections are needed for HHS 

to do the following: 

• Provide reliable and complete fiscal 

and household data to Congress in the 

Department’s LIHEAP Report to 

Congress for the Federal fiscal year; and 

• Respond to questions from the 

Congress, Department, OMB, White 

House, and other interested parties in a 

timely manner; and 

• Report LIHEAP performance results 

as part of the Administration’s annual 

Congressional Justification. 

In response to the 2010 Government 

Accountability Office (GAO) report, Low 

Income Home Energy Assistance 

Program—Greater Fraud Prevention 

Controls are Needed (GAO–10–621), 

and in consideration of the 

recommendations issued by the LIHEAP 

Performance Measures Implementation 

Work Group, OCS required the 

collection and reporting of these 

performance measures by State LIHEAP 

grant recipients, including the District 

of Columbia. The original LPDF was 

approved by OMB in November 2014 

and has been in use since. The LPDF 

provides for the collection of data on 

State grant recipients’ sources and uses 

of LIHEAP funds, including average 

benefit amounts, as well as data for the 

following performance measures: 

1. The benefit targeting index for high 

burden households receiving LIHEAP 

fuel assistance; 

2. The burden reduction targeting 

index for high burden households 

receiving LIHEAP fuel assistance; 

3. The number of households where 

LIHEAP prevented a potential home 

energy crisis; and 

4. The number of households where 

LIHEAP benefits restored home energy. 

All State LIHEAP grant recipients, 

including the District of Columbia, are 

required to complete the LPDF on an 

annual basis through ACF’s web-based 

data collection and reporting system, 

the Online Data Collection, which is 

available at the GrantSolutions 

homepage (https://

home.grantsolutions.gov/home). The 

reporting requirements will be 

described through the LIHEAP Forms 

and Funding Applications page (https:// 

www.acf.hhs.gov/ocs/form/liheapforms-and-funding-applications) of 

ACF’s website. 

This request will (1) continue 

approval to collect information using 

the currently approved version of the 

LPDF through June 30, 2025; and (2) 

incorporate changes to the LPDF 

designed to collect performance data on 

the impacts of supplemental Federal 

LIHEAP funds and to improve form 

fields and language. The changes 

proposed would go into effect in July 

2025 and consist of (1) changing the 

name of Module 1 of the form from 

‘‘Grantee Survey’’ to ‘‘Grant Recipient 

Survey’’; (2) adding an item for 

reporting carryover of Residential 

Energy Assistance Challenge (REACH) 

funds to the following FY; (3) adding an 

item for reporting non-administrative 

information technology enhancements; 

(4) removing maximum income cutoffs 

from funding uses; (5) replacement of 

sources and uses of Coronavirus Aid, 

Relief, and Economic Security Act 

(CARES Act) funds and American 

Rescue Plan Act of 2021 (ARPA) funds 

with the Infrastructure Investment and 

Jobs Act (IIJA) funds; and (6) minor 

wording and structural changes. 

Module 1 Grant Recipient Survey 

Module 1 of the LPDF will continue 

to require the following data from each 

State for the Federal fiscal year: 

• Grant recipient information. 

• Sources and uses of LIHEAP funds, 

by funding type. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Notices 95219 

• Average LIHEAP household

benefits, by funding type. 

Modules 2, 2A, and 2B Required 

LIHEAP Performance Measures 

Modules 2, 2A, and 2B of the LPDF 

will continue to require the following 

data from each State for the Federal 

fiscal year: 

• Grant recipient information;

• Energy burden targeting;

• Restoration of home energy service;

and 

• Prevention of loss of home energy.

Modules 2, 2A, and 2B require

reporting on households that received 

benefits from, respectively, nonsupplemental funds, CARES Act funds, 

and ARPA funds. 

Module 3 LIHEAP Performance 

Measures (Optional Reporting) 

Module 3 of the LIHEAP LPDF will 

continue to voluntarily collect the 

following additional information from 

each interested grant recipient for the 

Federal fiscal year: 

• Average annual energy usage;

• Unduplicated number of

households using supplemental heating 

fuel and air conditioning; 

• Unduplicated number of

households that had restoration of home 

energy service, and 

• Unduplicated number of

households that had prevention of loss 

of home energy. 

LIHEAP grant recipients will be able 

to compare their own results to the 

results for other States, as well as to 

regional and national results, through 

the Data Warehouse of the LIHEAP 

Performance Management website as 

they manage their programs. 

Respondents 

State governments, including the 

District of Columbia; the largest five 

electricity and natural gas vendors by 

State; the largest ten fuel oil and 

propane vendors by State; and State 

sub-grant recipients. 

ANNUAL BURDEN ESTIMATES

LIHEAP performance data form Total number 

of respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual burden 

hours 

State Grant Recipients—Module I ................................................................... 51 1 30 1,530 

State Grant Recipients—Modules II and III ..................................................... 51 1 158.6 8,088.6 

Sub-Grant Recipients (in States with sub-grant recipient managed systems)—Modules II and III ............................................................................. 100 1 6.3 630 

Energy Vendors (largest 5 electric, 5 natural gas, 10 fuel oil, and 10 propane vendors per State-average)—Modules II and III ................................ 1,530 1 8.5 13,005 

Estimated Total Annual Burden 

Hours: 23,253.6. 

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. 

Authority: 42 U.S.C. 8629(b); 42 

U.S.C. 8624(b); 42 U.S.C. 8623(c). 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–28152 Filed 11–29–24; 8:45 am] 

BILLING CODE 4184–80–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–1636] 

Issuance of Priority Review Voucher; 

Rare Pediatric Disease Product; 

KEBILIDI (eladocagene exuparvovectneq) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a rare pediatric disease 

product application. The Federal Food, 

Drug, and Cosmetic Act (FD&C Act) 

authorizes FDA to award priority review 

vouchers to sponsors of approved rare 

pediatric disease product applications 

that meet certain criteria. FDA is 

required to publish notice of the award 

of the priority review voucher. FDA has 

determined that KEBILIDI (eladocagene 

exuparvovec-tneq), approved on 

November 13, 2024, manufactured by 

PTC Therapeutics Inc., meets the 

criteria for a priority review voucher. 

FOR FURTHER INFORMATION CONTACT: 

Myrna Hanna, 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: FDA is 

announcing the issuance of a priority 

review voucher to the sponsor of an 

approved rare pediatric disease product 

application. Under section 529 of the 

FD&C Act (21 U.S.C. 360ff), FDA will 

award priority review vouchers to 

sponsors of approved rare pediatric 

disease product applications that meet 

certain criteria. FDA has determined 

that KEBILIDI (eladocagene 

exuparvovec-tneq), manufactured by 

PTC Therapeutics Inc., meets the 

criteria for a priority review voucher. 

KEBILIDI (eladocagene exuparvovectneq) is indicated for treatment of adult 

and pediatric patients with aromatic Lamino acid decarboxylase deficiency. 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go to https://www.fda.gov/industry/ 

developing-products-rare-diseasesconditions/rare-pediatric-disease-rpddesignation-and-voucher-programs. For 

further information about KEBILIDI 

(eladocagene exuparvovec-tneq), go to 

the Center for Biologics Evaluation and 

Research’s Approved Cellular and Gene 

Therapy Products website at https://

www.fda.gov/vaccines-blood-biologics/ 


ddrumheller on DSK120RN23PROD with NOTICES1