Federal Register / Vol. 90, No. 6 / Friday, January 10, 2025 / Notices 2005 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Chyana Woodyard, who is 

the Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Chyana Woodyard, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2025–00385 Filed 1–8–25; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10069] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

the necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions, 

the accuracy of the estimated burden, 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected, and the use of automated 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

DATES: Comments must be received by 

March 11, 2025. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number: ll, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, please access the CMS PRA 

website by copying and pasting the 

following web address into your web 

browser: https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing 

FOR FURTHER INFORMATION CONTACT: 

William N. Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS 10069 Rural Community Hospital 

Demonstration Program Application 

Under the PRA (44 U.S.C. 3501– 

3520), Federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

The term ‘‘collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires Federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collections 

1. Type of Information Collection 

Request: Reinstatement of a previously 

approved collection; Title of 

Information Collection: Rural 

Community Hospital Demonstration 

Program Application; Use: CMS is 

requesting the information collection 

request previously approved under 

OMB control number 0938–0880, the 

Medicare Waiver Demonstration/Model 

Application, be reinstated. The approval 

lapsed due to an administrative 

oversight. 

The Centers for Medicare & Medicaid 

Services (CMS) has operated the 

statutory Rural Community Hospital 

(RCH) Demonstration since 2004. The 

authorizing statute instructed CMS to 

test cost-based payment for Medicare 

inpatient services for rural hospitals 

with fewer than 51 beds that are not 

eligible to be Critical Access Hospitals 

(CAH). 

The RCH Demonstration Program was 

initially authorized by section 410A of 

the Medicare Modernization Act (MMA) 

of 2003. Following the initial 5-year 

authorization, the demonstration has 

been extended 3 times, each time for an 

additional 5 years—first, by Sections 

3123 and 10313 of the Affordable Care 

Act; then by section 15003 of the 21st 

Century Cures Act; and by section 128 

of the Consolidated Appropriations Act 

of 2021. Currently, the demonstration 

has 20 participants out of a maximum 

of 30 hospitals, and it is scheduled to 

end in 2028. 

For previous authorizations, CMS has 

issued a Request for Applications (RFA) 

to solicit applications for the 

demonstration program. For the last 

solicitation, in 2017, CMS received 51 

applications for 13 open spaces. CMS is 

planning on a new RFA to fill the ten 

spaces that are currently open. 

Per the RFA, applications are 

requested in identical format, regardless 

of the specific goals and projects of the 

individual applicants. The standardized 

application format is not controversial, 

and it will reduce burden on applicants 

and reviewers. Responses are strictly 

voluntary. The standard format will 

enable CMS to select proposals that 

meet CMS objectives and show the best 

potential for success. 

The RFA will ask interested hospitals 

to provide a problem statement, 

strategies for ongoing financial viability, 

goals for participation in the 

demonstration, and plans for 

collaboration with other providers in 

the area. Applications will be submitted 

in the user-friendly format outlined in 

the Medicare Waiver Demonstration/ 

Model Application. 


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2006 Federal Register / Vol. 90, No. 6 / Friday, January 10, 2025 / Notices 

A panel of evaluators will be 

assembled and utilize a standardized 

rubric to score the submitted proposals 

and identify hospitals with the highest 

scores. Results will be used to guide the 

future of the Medicare and Medicaid 

programs and to inform reform 

initiatives. Form Number: CMS–10069 

(OMB control number: 0938–0880); 

Frequency: Once; Affected Public: 

Business or other for-profits and Notfor-profit institutions; Number of 

Respondents: 30; Total Annual 

Responses: 30; Total Annual Hours: 

2,400. (For policy questions regarding 

this collection contact Alexis Lilly at 

410–786–3501). 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2025–00399 Filed 1–8–25; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Amendment of the Statement of 

Organizations, Functions and 

Delegation of Authority 

AGENCY: Office of Refugee Resettlement, 

Administration for Children and 

Families, Department of Health and 

Human Services. 

ACTION: Notice of amendment. 

SUMMARY: The Administration for 

Children and Families (ACF) is 

amending the Statement of 

Organization, Functions and Delegation 

of Authority (‘‘Statement’’) issued in the 

Federal Register on April 28, 2009. The 

Statement delegated specific provisions 

of the William Wilberforce Trafficking 

Victims Protection Reauthorization Act 

of 2008, Public Law 110–457, section 

235 from the Assistant Secretary for 

Children and Families to the Director of 

the Office of Refugee Resettlement. This 

amendment modifies the Statement to 

authorize the Director of the Office of 

Refugee Resettlement to redelegate the 

listed authorities contained within the 

Statement. 

DATES: This amendment of the April 28, 

2009, Statement of Organization, 

Functions and Delegation of Authority 

is effective on date of signature. 

FOR FURTHER INFORMATION CONTACT: 

Toby Biswas, Director of Policy, 

Division of Unaccompanied Children 

Policy, Unaccompanied Children 

Bureau, Office of Refugee Resettlement, 

Administration for Children and 

Families, Department of Health and 

Human Services, Washington, DC, (202) 

205–4440 or UCPolicyRegulatoryAffairs@acf.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

The first paragraph of the Statement 

of Organization, Functions and 

Delegation of Authority issued in the 

Federal Register on April 28, 2009 (74 

FR 19232) currently reads as follows: ‘‘Notice is hereby given that I delegate 

to the Director of the Office of Refugee 

Resettlement the following authority 

delegated to the Assistant Secretary for 

Children and Families by the Secretary 

of the Department of Health and Human 

Services (HHS) under the William 

Wilberforce Trafficking Victims 

Protection Reauthorization Act of 2008, 

Public Law 110–457, section 235.’’ 

This paragraph is amended to read as 

follows: 

‘‘Notice is hereby given that I have 

delegated to the Director of the Office of 

Refugee Resettlement, with authority to 

re-delegate, the following authority 

delegated to the Assistant Secretary for 

Children and Families by the Secretary 

of the Department of Health and Human 

Services (HHS) under the William 

Wilberforce Trafficking Victims 

Protection Reauthorization Act of 2008, 

Public Law 110–457, section 235.’’ 

The intention of this amendment is to 

provide notice to the public of the 

Assistant Secretary’s delegation of 

authority provided in subsequent 

portions of the notice, as well as the 

authority to redelegate the listed 

authorities. 

All other provisions of the Statement 

of Organization, Functions and 

Delegation of Authority issued in the 

Federal Register on April 28, 2009 (74 

FR 19232) will remain unchanged. 

Meg Sullivan, 

Principal Deputy Assistant Secretary for the 

Administration for Children and Families, 

performing the delegable duties of the 

Assistant Secretary for Children and Families. 

[FR Doc. 2025–00262 Filed 1–8–25; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1262] 

Notice of Approval of Product Under 

Voucher: Rare Pediatric Disease 

Priority Review Voucher; ALYFTREK 

(vanzacaftor, tezacaftor, and 

deutivacaftor) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of approval of a product 

redeeming a priority review voucher. 

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 issuance of priority 

review vouchers as well as the approval 

of products redeeming a priority review 

voucher. FDA has determined that the 

application for ALYFTREK (vanzacaftor, 

tezacaftor, and deutivacaftor), approved 

December 20, 2024, meets the criteria 

for redeeming a priority review voucher. 

FOR FURTHER INFORMATION CONTACT: 

Cathryn Lee, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–1394. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the approval of a product 

redeeming a rare pediatric disease 

priority review voucher. Under section 

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

FDA will report the issuance of rare 

pediatric disease priority review 

vouchers and the approval of products 

for which a voucher was redeemed. 

FDA has determined that the 

application for ALYFTREK (vanzacaftor, 

tezacaftor, and deutivacaftor) tablets 

meets the redemption criteria. 

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/ForIndustry/ 

DevelopingProductsforRareDiseases

Conditions/RarePediatricDiseasePriority

VoucherProgram/default.htm. For 

further information about ALYFTREK 

(vanzacaftor, tezacaftor, and 

deutivacaftor), go to the ‘‘Drugs@FDA’’ 

website at https://

www.accessdata.fda.gov/scripts/cder/ 

daf/. 

Dated: January 3, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–00341 Filed 1–8–25; 8:45 am] 

BILLING CODE 4164–01–P 


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