Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices 83023 

Dated: September 27, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–23637 Filed 10–11–24; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–0026] 

Issuance of Priority Review Voucher; 

Rare Pediatric Disease Product; 

AQNEURSA (Levacetylleucine) 

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 AQNEURSA 

(levacetylleucine), approved on 

September 24, 2024, manufactured by 

IntraBio Inc., meets the criteria for 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 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 AQNEURSA (levacetylleucine), 

manufactured by IntraBio Inc., meets 

the criteria for a priority review 

voucher. AQNEURSA (levacetylleucine) 

is indicated for the treatment of 

neurological manifestations of 

Niemann-Pick disease type C in adults 

and pediatric patients weighing ≥15 kg. 

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 AQNEURSA 

(levacetylleucine), go to the ‘‘Drugs@

FDA’’ website at http://

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

daf/. 

Dated: October 8, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–23712 Filed 10–11–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Statement of Organization, Functions, 

and Delegations of Authority 

This notice amends Part R of the 

Statement of Organization, Functions, 

and Delegations of Authority of the 

Department of Health and Human 

Services (HHS), Health Resources and 

Services Administration (HRSA) (60 FR 

56605, as amended November 6, 1995; 

as last amended at 89 FR 19832 dated 

March 20, 2024) to reorganize sections 

of the Maternal and Child Health 

Bureau (MCHB). 

This reorganization updates and/or 

realigns functions, including 

delegations of authority for MCHB (RM). 

Chapter RM—Maternal and Child 

Health Bureau (RM) 

Section RM.10 Organization 

Establish the Office of Strategy, 

Innovation, and External Affairs and the 

Division of Women’s Health. 

Following this realignment, MCHB 

includes the following components: 

• Office of the Associate 

Administrator (RM), 

• Office of Policy and Planning 

(RMA), 

• Office of Strategy, Innovation, and 

External Affairs (RMB), 

• Office of Operations and 

Management (RM1), 

• Division of Services for Children 

with Special Health Needs (RM2), 

• Division of Child, Adolescent, and 

Family (RM3), 

• Division of Maternal and Child 

Health Workforce Development (RM4), 

• Division of Healthy Start and 

Perinatal Services (RM5), 

• Division of State and Community 

Health (RM6), 

• Division of Home Visiting and Early 

Childhood Systems (RM8), 

• Office of Epidemiology and 

Research (RM9), and 

• Division of Women’s Health (RMC). 

Section RM.20 Function 

Update the functional statements for 

the Office of the Associate 

Administrator, Office of Policy and 

Planning, Division of Healthy Start and 

Perinatal Services, and Division of 

Home Visiting and Early Childhood 

Systems and add the functional 

statement for the Office of Strategy, 

Innovation, and External Affairs and 

Division of Women’s Health: 

Office of the Associate Administrator 

(RM) 

The Office of the Associate 

Administrator provides national 

leadership and policy direction for 

MCHB programs. These programs are 

designed to improve the health of 

women of childbearing age, infants, 

children, adolescents and their families, 

children with special health needs, and 

persons with hemophilia. Specifically, 

the Office: (1) coordinates the planning, 

development, implementation, and 

evaluation of MCHB’s programs and 

activities; (2) facilitates effective, 

collaborative relationships with other 

health and related programs; (3) 

establishes program mission, goals, 

objectives, and policy with broad 

Administration guidelines; (4) arranges 

and provides technical assistance to 

ensure that grantees meet program 

expectations; (5) serves as principal 

contact point across HRSA, HHS, and 

other agencies on matters concerning 

the health status of America’s mothers 

and children; and (6) provides 

information and reports on MCHB’s 

programs to Congress, other federal 

agencies, the public, and other 

stakeholders. 

Office of Policy and Planning (RMA) 

The Office of Policy and Planning 

serves as MCHB’s focal point for the 

development of MCHB policy and 

program planning. Specifically, the 

Office: (1) supports the Office of the 

Associate Administrator in identifying, 

planning, and implementing policy and 

program priorities across MCHB; (2) 

advises and assists in the development, 

coordination, and management of 

program and policy documents and 

responses to departmental and HRSA 

initiatives; and (3) coordinates with 

other components within HRSA, HHS, 

federal agencies, state and local 

governments, and other public and 

private organizations on issues affecting 

MCHB programs and policies. 

Office of Strategy, Innovation, and 

External Affairs (RMB) 

The Office of Strategy, Innovation, 

and External Affairs serves as MCHB’s 

focal point for strategic planning, 


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