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
95220 Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Notices 

cellular-gene-therapy-products/ 

approved-cellular-and-gene-therapyproducts. 

Dated: November 26, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–28206 Filed 11–29–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5253] 

Anesthetic and Analgesic Drug 

Products Advisory Committee; Notice 

of Meeting; Establishment of a Public 

Docket; Request for Comments— 

Biologics License Application 761393 

for Condoliase Injection 

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 Anesthetic and Analgesic 

Drug Products 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 

January 10, 2025, from 9 a.m. to 4:30 

p.m. Eastern Time. 

ADDRESSES: The public may attend the 

meeting at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

The public will also have the option to 

participate, and the advisory committee 

meeting will be heard, viewed, 

captioned, and recorded through an 

online teleconferencing and/or video 

conferencing platform. 

Answers to commonly asked 

questions about FDA advisory 

committee meetings, including 

information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2024–N–5253. 

The docket will close on January 9, 

2025. 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 January 9, 2025. 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 

December 26, 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 canceled, 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 

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–5253 for ‘‘Anesthetic and 

Analgesic Drug Products Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments—Biologics 

License Application (BLA) 761393 for 

Condoliase Injection.’’ 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: 

LaToya Bonner, Center for Drug 

Evaluation and Research, Food and 


ddrumheller on DSK120RN23PROD with NOTICES1