76844 Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

[CFDA Number: 93.568] 

Proposed Reallotment of Fiscal Year 

2023 Funds for the Low Income Home 

Energy Assistance Program 

AGENCY: Office of Community Services 

(OCS), Administration for Children and 

Families (ACF), Department of Health 

and Human Services (HHS). 

ACTION: Notice for public comment. 

SUMMARY: The ACF, OCS, Division of 

Energy Assistance announces a 

preliminary determination that funds 

from the federal fiscal year 2023 (FY23) 

Low Income Home Energy Assistance 

Program (LIHEAP) are available for 

reallotment to states, territories, tribes, 

and tribal organizations that received 

FY24 direct LIHEAP awards. The 

purpose of this award is to redistribute 

FY23 annual LIHEAP funds that 

recipients were unable to obligate or 

carry over to FY24. No sub-recipients of 

these recipients or other entities may 

apply for these funds. 

DATES: Comments are due by: October 

21, 2024. 

ADDRESSES: Comments may be 

submitted to: Peter Edelman, Program 

Analyst, Office of Community Services, 

Administration for Children and 

Families, 330 C Street SW, 5th Floor; 

Mail Room 5425; Washington, DC 20201 

or via email: peter.edelman@

acf.hhs.gov. Comments may also be 

faxed to 202–401–5661. 

FOR FURTHER INFORMATION CONTACT: 

Akm Rahman, Program Operations 

Branch Chief, Division of Energy 

Assistance, Office of Community 

Services, 330 C Street SW, 5th Floor; 

Mail Room 5425; Washington, DC 

20201. Telephone: 202–401–5306; 

email: Akm.Rahman@acf.hhs.gov. 

SUPPLEMENTARY INFORMATION: After 

receiving Federal Financial Reports 

(FFRs), Carryover and Reallotment 

Reports (CRRs), and fourth-quarter 

Quarterly Reports (QRs) from FY23 

LIHEAP recipients, ACF has determined 

that $18,363,980 in FY23 LIHEAP funds 

may be available for reallotment for 

FY24. This determination was based on 

the reports of 75 recipients and the total 

obligations of 4 recipients. LIHEAP 

recipients submitted the FY23 CRRs to 

OCS, as required by regulations 

applicable to LIHEAP at 45 CFR 

96.81(b). 

The LIHEAP statute allows recipients 

who have funds unobligated at the end 

of the FY for which they are awarded to 

request that they be allowed to carry 

over up to 10 percent of their full-year 

allotments to the next FY (42 U.S.C. 

8626(b)(2)). Funds in excess of this 

amount must be returned to the U.S. 

Department of Health and Human 

Services and are subject to reallotment 

under 42 U.S.C. 8626(b)(1). 

In accordance with 42 U.S.C. 

8626(b)(3), ACF notified each of the 79 

recipients that reported or, in the 

absence of reporting, had potentially 

$18,363,980 of unobligated funds above 

their carryover caps. In these notices, 

ACF told each recipient about the 

amount that, according to the recipients’ 

reports, it needed to return for deobligation and redistribution to FY24 

recipients as part of the reallotment. It 

also gave each recipient 30 calendar 

days to provide comments directly to 

ACF. 

All LIHEAP recipients that receive a 

portion of these funds will be notified 

of the final reallotment amount 

redistributed to them for FY24. This 

decision will also be published in the 

Federal Register and in a Dear 

Colleague Letter that is posted to ACF’s 

website under LIHEAP Dear Colleague 

Letters. 

The FY23 LIHEAP funds that ACF 

preliminarily expects to become 

available for reallotment determination 

come from the following recipients in 

the following amounts: 

Name of recipient that has funds to be returned for reallotment 

Preliminary 

amount 

available for 

reallotment 1

Alaska .......................................................................................................................................................................................... $4,917,545 

Idaho ............................................................................................................................................................................................ 4,896,940 

Michigan ....................................................................................................................................................................................... 55,139 

Commonwealth of the Northern Mariana Islands ........................................................................................................................ 47,429 

Absentee Shawnee Tribe of Indians of Oklahoma ..................................................................................................................... 14,595 

Alabama-Quassarte Tribal Town ................................................................................................................................................. 18,204 

Aniak Traditional Council ............................................................................................................................................................. 49,847 

Berry Creek Rancheria ................................................................................................................................................................ 11,727 

Big Valley Band of Pomo Indians ................................................................................................................................................ 3,150 

Bishop Paiute Tribe ..................................................................................................................................................................... 17,447 

Blackfeet Tribe ............................................................................................................................................................................. 66,242 

Catawba Indian Nation ................................................................................................................................................................ 14,656 

Cheyenne and Arapaho Tribes ................................................................................................................................................... 7,692 

Choctaw Nation of Oklahoma ...................................................................................................................................................... 80,195 

Chuathbaluk Traditional Council .................................................................................................................................................. 34,383 

Cocopah Indian Tribe .................................................................................................................................................................. 20,605 

Coeur d’Alene Tribe ..................................................................................................................................................................... 18,278 

Comanche Nation ........................................................................................................................................................................ 4,726 

Confederated Salish and Kootenai Tribes .................................................................................................................................. 360,718 

Confederated Tribes of Siletz Indians of Oregon ........................................................................................................................ 42,360 

Confederated Tribes of the Grand Ronde Community of Oregon .............................................................................................. 15,524 

Cow Creek Band of Umpqua Tribe of Indians ............................................................................................................................ 511 

Dena’Nena’Henash—Tanana Chiefs Conference ....................................................................................................................... 26,018 

Eastern Shoshone Tribe .............................................................................................................................................................. 135,825 

Fort Peck Assiniboine and Sioux Tribes ..................................................................................................................................... 584,537 

Gila River Indian Community ....................................................................................................................................................... 73,461 

Hoh Tribe ..................................................................................................................................................................................... 2,212 

Hoopa Valley Tribe ...................................................................................................................................................................... 12,878 

Hopland Band of Pomo Indians .................................................................................................................................................. 2,852 

Houlton Band of Maliseet Indians ............................................................................................................................................... 201,488 

Indian Township Tribal Government ........................................................................................................................................... 528,130 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices 76845 

Name of recipient that has funds to be returned for reallotment 

Preliminary 

amount 

available for 

reallotment 1

Inter-Tribal Council of MI, Inc ...................................................................................................................................................... 129,655 

Jicarilla Apache Nation ................................................................................................................................................................ 42,275 

Karuk Tribe .................................................................................................................................................................................. 1,746 

Kaw Nation .................................................................................................................................................................................. 5,017 

Kiowa Tribe of Oklahoma ............................................................................................................................................................ 89,127 

Little River Band of Ottawa Indians ............................................................................................................................................. 10,074 

Lower Elwha Klallam Tribe .......................................................................................................................................................... 7,986 

Lummi Nation ............................................................................................................................................................................... 19,363 

Makah Tribe ................................................................................................................................................................................. 25,257 

Mashpee Wampanoag Tribe ....................................................................................................................................................... 171,286 

Mi’kmaq Nation ............................................................................................................................................................................ 44,858 

Mississippi Band of Choctaw Indians .......................................................................................................................................... 8,426 

Modoc Nation ............................................................................................................................................................................... 1,426 

Muckleshoot Indian Tribe ............................................................................................................................................................ 1,110 

Navajo Nation .............................................................................................................................................................................. 800,838 

Nooksack Indian Tribe ................................................................................................................................................................. 36,196 

Northern Arapaho Tribe ............................................................................................................................................................... 19,950 

Northern California Indian Development Council, Inc ................................................................................................................. 846 

Northern Cheyenne Tribe ............................................................................................................................................................ 25,583 

Oglala Sioux Tribe ....................................................................................................................................................................... 28,490 

Orutsararmiut Native Council ...................................................................................................................................................... 276,283 

Otoe-Missouria Tribe of Indians .................................................................................................................................................. 6,087 

Paiute Indian Tribe of Utah ......................................................................................................................................................... 140,249 

Pawnee Nation of Oklahoma ....................................................................................................................................................... 6,740 

Pleasant Point Tribal Government .............................................................................................................................................. 50,685 

Poarch Band of Creek Indians .................................................................................................................................................... 146,887 

Pueblo of Jemez .......................................................................................................................................................................... 12,562 

Pueblo of Zuni ............................................................................................................................................................................. 28,337 

Quapaw Nation ............................................................................................................................................................................ 22,161 

Quileute Tribe .............................................................................................................................................................................. 69,502 

Quinault Indian Nation ................................................................................................................................................................. 17,503 

Riverside-San Bernardino County Indian Health, Inc ................................................................................................................. 6,645 

Sac and Fox Nation of Oklahoma ............................................................................................................................................... 6,573 

Samish Indian Nation .................................................................................................................................................................. 14,590 

San Carlos Apache Tribe ............................................................................................................................................................ 8,904 

Sault Ste. Marie Tribe of Chippewa Indians ............................................................................................................................... 1,064 

Sitka Tribe of Alaska ................................................................................................................................................................... 53,222 

Spirit Lake Nation ........................................................................................................................................................................ 101,127 

Spokane Tribe of Indians ............................................................................................................................................................ 23,773 

Standing Rock Sioux Tribe .......................................................................................................................................................... 2,896,833 

Swinomish Indian Tribal Community ........................................................................................................................................... 39,631 

The Delaware Tribe of Indians .................................................................................................................................................... 4,501 

The Klamath Tribes ..................................................................................................................................................................... 162,427 

Tonkawa Tribe of Oklahoma ....................................................................................................................................................... 3,374 

Turtle Mountain Band of Chippewa Indians ................................................................................................................................ 69,032 

United Cherokee Ani-Yun-Wiya Nation ....................................................................................................................................... 55,932 

Ute Indian Tribe ........................................................................................................................................................................... 8,647 

Yankton Sioux Tribe .................................................................................................................................................................... 395,886 

Total ...................................................................................................................................................................................... 18,363,980 

1Preliminary funds for reallotment consist of the funds in excess of LIHEAP’s 10 percent carryover cap that (1) 75 recipients indicated on the 

FFRs or reported on the CRRs or QRs as unobligated; or (2) amounted to 100 percent of regular funds or IIJA funds for the 4 recipients that 

failed to submit the associated FFRs and their CRRs or QRs. 

If funds are reallotted, then they will 

be allocated in accordance with 42 

U.S.C. 8623 and must be treated by 

LIHEAP recipients that receive them as 

funds appropriated for FY24. As FY24 

funds, they will be subject to all 

requirements of the LIHEAP statute, 

including 42 U.S.C. 8626(b)(2), which 

requires that a recipient obligate at least 

90 percent of its total block grant 

allocation for a fiscal year by the end of 

the fiscal year for which the funds are 

appropriated; that is, by September 30, 

2024. Furthermore, recipients that 

receive these funds may use these funds 

for any purpose authorized under 

LIHEAP and must add them to their 

total LIHEAP funds payable for FY24 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 these funds 

are included in the amounts on Lines 

1.1 of their FY24 CRRs; (2) reconcile 

these funds, to the extent that they 

received them, on their corresponding 

FFRs; and (3) record, on their FY24 

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 

FY24 LIHEAP Performance Data Forms. 


lotter on DSK11XQN23PROD with NOTICES1
76846 Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices 

1The FD&C Act includes a sunset of authority to 

award rare pediatric disease priority review 

vouchers. Section 529(b)(5) of the FD&C Act 

provides that after September 30, 2024, FDA may 

not award any rare pediatric disease priority review 

vouchers unless a rare pediatric disease product 

application: (1) is for a drug that, not later than 

September 30, 2024, is designated under section 

529(d) of the Act as a drug for a rare pediatric 

disease, and (2) is, not later than September 30, 

2026, approved under section 505(b)(1) of the FD&C 

Act or section 351(a) of the PHS Act. This limit of 

FDA’s authority to award rare pediatric disease 

vouchers does not affect the ability to use rare 

pediatric disease priority review vouchers issued by 

FDA. 

2Although under section 565A(g) of the FD&C 

Act, material threat MCM priority review vouchers 

may not be awarded after October 1, 2023, this 

‘‘sunset’’ of authority to award vouchers does not 

affect the ability to use material threat MCM 

priority review vouchers that have already been 

issued. 

3 Information regarding the tropical disease 

priority review voucher program is available at: 

https://www.fda.gov/regulatory-information/searchfda-guidance-documents/tropical-disease-priorityreview-vouchers. 

4 Information regarding the rare pediatric disease 

priority review voucher program is available at: 

https://www.fda.gov/Drugs/Development

ApprovalProcess/DevelopmentResources/ 

ucm375479.htm. 

5 Information regarding the material threat MCM 

priority review voucher program is available at: 

https://www.fda.gov/emergency-preparedness-andresponse/mcm-legal-regulatory-and-policyframework/21st-century-cures-act-mcm-relatedcures-provisions. 

Statutory Authority: 42 U.S.C. 

8626(b). 

Anthony Petruccelli, 

Senior Grants Policy Specialist, Office of 

Grants Policy, Office of Administration. 

[FR Doc. 2024–21390 Filed 9–18–24; 8:45 am] 

BILLING CODE 4184–80–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4246] 

Fee Rate for Using a Priority Review 

Voucher in Fiscal Year 2025 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the fee rate for using a 

priority review voucher for fiscal year 

(FY) 2025. The Federal Food, Drug, and 

Cosmetic Act (FD&C Act), as amended, 

authorizes FDA to determine and collect 

priority review user fees for certain 

applications for review of human drug 

or biological products when those 

applications use a tropical disease, rare 

pediatric disease, or material threat 

medical countermeasure (MCM) priority 

review voucher. These vouchers are 

awarded to the sponsors of tropical 

disease, rare pediatric disease, or 

material threat MCM product 

applications, respectively, that meet the 

requirements of the FD&C Act, upon 

FDA approval of such applications. The 

amount of the fee for using a priority 

review voucher is determined each 

fiscal year, based on the difference 

between the average cost incurred by 

FDA to review a human drug 

application designated as priority 

review in the previous fiscal year, and 

the average cost incurred in the review 

of an application that is not subject to 

priority review in the previous fiscal 

year. This notice establishes the FY 

2025 priority review fee rate applicable 

to submission of eligible applications 

for review of human drug or biological 

products using a rare pediatric disease, 

material threat MCM, or tropical disease 

priority review voucher and outlines the 

payment procedures for such fees. 

DATES: This rate is effective on October 

1, 2024, and will remain in effect 

through September 30, 2025. 

FOR FURTHER INFORMATION CONTACT: 

Olufunmilayo Ariyo, Office of Financial 

Management, Food and Drug 

Administration, 4041 Powder Mill Rd., 

6th Floor, Beltsville, MD 20705–4304, 

240–402–4989; or the User Fees Support 

Staff at OO-OFBAP-OFM-UFSSGovernment@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Establishment of the Tropical Disease 

Priority Review Voucher 

Section 1102 of the Food and Drug 

Administration Amendments Act of 

2007 (Pub. L. 110–85) added section 524 

to the FD&C Act (21 U.S.C. 360n). In 

section 524 of the FD&C Act, Congress 

encouraged development of new human 

drug and biological products for 

prevention and treatment of tropical 

diseases by offering additional 

incentives for obtaining FDA approval 

of such products. Under section 524 of 

the FD&C Act, the sponsor of an eligible 

human drug application for a tropical 

disease (as defined in section 524(a)(3) 

of the FD&C Act) shall receive a priority 

review voucher upon approval of the 

tropical disease product application (as 

defined in section 524(a)(4) of the FD&C 

Act). 

B. Establishment of the Rare Pediatric 

Disease Priority Review Voucher 

Section 908 of the Food and Drug 

Administration Safety and Innovation 

Act (Pub. L. 112–144) added section 529 

of the FD&C Act (21 U.S.C. 360ff). In 

section 529 of the FD&C Act, Congress 

encouraged development of new human 

drugs and biological products for 

prevention and treatment of certain rare 

pediatric diseases by offering additional 

incentives for obtaining FDA approval 

of such products. Under section 529 of 

the FD&C Act, the sponsor of an eligible 

human drug for a rare pediatric disease 

(as defined in section 529(a)(3)) shall 

receive a priority review voucher upon 

approval of the rare pediatric disease 

product application (as defined in 

section 529(a)(4) of the FD&C Act).1

C. Establishment of the Material Threat 

MCM Priority Review Voucher 

Section 3086 of the 21st Century 

Cures Act (Pub. L. 114–255) added 

section 565A to the FD&C Act (21 U.S.C. 

360bbb–4a). In section 565A of the 

FD&C Act, Congress encouraged 

development of material threat MCMs 

by offering additional incentives for 

obtaining FDA approval of such 

products. Under section 565A of the 

FD&C Act, the sponsor of an eligible 

material threat MCM application (as 

defined in section 565A(a)(4)) shall 

receive a priority review voucher upon 

approval of the material threat MCM 

application.2

D. Transferability of the Priority Review 

Voucher 

The recipient of a priority review 

voucher may either use the voucher for 

a future human drug application 

submitted to FDA under section 

505(b)(1) of the FD&C Act (21 U.S.C. 

355(b)(1)) (or section 351(a)) of the 

Public Health Service Act (PHS Act) (42 

U.S.C. 262(a)), or transfer (including by 

sale) the voucher to another party. The 

voucher may be transferred repeatedly 

until it ultimately is used for a human 

drug application submitted to FDA 

under section 505(b)(1) of the FD&C Act 

or section 351(a) of the PHS Act. As 

further described below, a priority 

review is a review conducted with a 

Prescription Drug User Fee Act 

(PDUFA) goal date of 6 months after the 

receipt or filing date, depending on the 

type of application. Information 

regarding review goals for FY 2025 is 

available at: https://www.fda.gov/ 

media/151712/download. 

The sponsor that uses a priority 

review voucher is entitled to a priority 

review of its eligible human drug 

application, but must pay FDA a 

priority review user fee in addition to 

any other fee required by PDUFA. FDA 

published information on its website 

about how the priority review voucher 

program operates.345

This notice establishes the FY 2025 

priority review fee rate for use of 


lotter on DSK11XQN23PROD with NOTICES1