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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