Issuance of Priority Review Voucher; Rare Pediatric Disease Product; AQNEURSA (Levacetylleucine), 83023 [2024-23712]
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Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices
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
Dated: October 8, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
Food and Drug Administration
[FR Doc. 2024–23712 Filed 10–11–24; 8:45 am]
BILLING CODE 4164–01–P
[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.
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
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about AQNEURSA
(levacetylleucine), go to the ‘‘Drugs@
FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
VerDate Sep<11>2014
16:35 Oct 11, 2024
Jkt 265001
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).
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
83023
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,
E:\FR\FM\15OCN1.SGM
15OCN1
]]>Agencies
[Federal Register Volume 89, Number 199 (Tuesday, October 15, 2024)]
[Notices]
[Page 83023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23712]
-----------------------------------------------------------------------
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/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further
information about AQNEURSA (levacetylleucine), go to the ``Drugs@FDA''
website at https://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
