Statement of Organization, Functions, and Delegations of Authority, 83023-83024 [2024-23783]
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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
83024
Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices
communications, external engagement,
and program development. Specifically,
the Office works closely with the Office
of the Associate Administrator to
develop strategic plans, facilitate
program alignment, and support special
initiatives.
khammond on DSKJM1Z7X2PROD with NOTICES
Division of Healthy Start and Perinatal
Services (RM5)
The Division of Healthy Start and
Perinatal Services provides national
leadership in planning, directing,
coordinating, monitoring, and
evaluating national programs focused on
maternal, infant, family, and women’s
health for targeted populations,
especially for those at high-risk for poor
health and health outcomes.
Specifically, the Division: (1)
administers local, state, and national
programs on perinatal and women’s
health, with an emphasis on infant
mortality reduction and eliminating
disparities in infant, maternal, and
women’s health outcomes before and
after pregnancy; (2) develops policy and
provides technical assistance, national
resource development and
dissemination, and workforce
development to address national trends
in maternal, infant, family, and
women’s health status and gaps in
evidence-based healthcare services for
these populations as well as Division
programs; (3) administers funds and
other resources for grants, contracts, and
cooperative agreements; (4) coordinates
with MCHB, agency, departmental, and
intradepartmental initiatives in
promoting the Division’s program
objectives and the mission of MCHB; (5)
coordinates the Advisory Committee on
Infant and Maternal Mortality; (6) liaises
with public, private, professional, and
non-governmental organizations for
Division programs; (7) disseminates
information on Division programs to
local, state, and national audiences; (8)
participates in strategic and policy
planning, health services research and
evaluation, regulatory activities, and
fiscal strategic planning, administration,
and analysis relating to Division
programs; and (9) provides technical
assistance and support to central and
regional office staff of MCHB, HRSA,
HHS, and other federal agencies.
Division of Home Visiting and Early
Childhood Systems (RM8)
The Division of Home Visiting and
Early Childhood Systems plans,
develops, implements, oversees,
monitors, and evaluates national
programs, including the Maternal,
Infant, and Early Childhood Home
Visiting Program and a portfolio of early
childhood systems programs.
VerDate Sep<11>2014
16:35 Oct 11, 2024
Jkt 265001
Specifically, the Division: (1) provides
leadership and coordination of federal,
regional, state, local, and nongovernmental efforts to promote the
health and well-being of pregnant
women, infants, young children and
their families; (2) develops, analyzes,
and/or disseminates policies, standards,
guidelines, research, and evaluation
information for the various Division
programs; (3) establishes and maintains
cooperative relationships within HRSA,
with other federal agencies, and with
other relevant public and private
organizations to implement programs to
improve maternal and child health
outcomes, develop and improve
comprehensive coordinated early
childhood systems, conduct research
and evaluation, and advance
educational and training programs for
the early childhood workforce; (4)
administers and manages a program of
interagency agreements, cooperative
agreements, grants, and contracts that
will enhance service delivery and
systems building; and (5) provides
technical assistance and engagement to
state and local health personnel, other
federal agencies, and other stakeholders
on maternal health, early childhood
health and development, and
comprehensive and coordinated systems
of care.
Division of Women’s Health (RMC)
The Division of Women’s Health
provides national leadership in policy,
planning, programming, outreach, and
education to improve the health,
wellness, and safety of women across
the lifespan. Specifically the Division:
(1) provides leadership, technical
assistance, and support to improve
health outcomes for women; (2) engages
with health professionals and other
stakeholders to identify and disseminate
the latest evidence and best practices in
women’s health; (3) establishes shortrange and long-range goals, plans, leads,
and administers activities that improve
women’s health; (4) enhances the health
care infrastructure and service delivery
system by supporting innovative
programs throughout the lifespan for
women as well as for children and
families; and (5) works to improve
prevention, early identification,
treatment, and referral for health
services for women and their families.
Section RM.30 Delegation of
Authority
All delegations of authority and redelegations of authority made to
officials and employees of affected
organizational components will
continue in them or their successors
pending further redelegation, if allowed,
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
provided they are consistent with this
reorganization.
This reorganization is effective upon
date of signature.
(Authority: 44 U.S.C. 3101)
Carole Johnson,
Administrator.
[FR Doc. 2024–23783 Filed 10–11–24; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Findings of research
misconduct have been made against
Bret Rutherford, M.D. (Respondent),
who was formerly a Research
Psychiatrist, New York State Psychiatric
Institute (NYSPI). Respondent engaged
in research misconduct in research
supported by U.S. Public Health Service
(PHS) funds, specifically National
Institute of Mental Health (NIMH),
National Institutes of Health (NIH),
grants R01 MH102293 and R61/R33
MH110029. The administrative actions,
including debarment for a period of
three (3) years followed by supervision
for a period of three (3) years, were
implemented beginning on September
27, 2024, and are detailed below.
FOR FURTHER INFORMATION CONTACT:
Sheila Garrity, JD, MPH, MBA, Director,
Office of Research Integrity, 1101
Wootton Parkway, Suite 240, Rockville,
MD 20852, (240) 453–8200.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that the Office of Research
Integrity (ORI) has taken final action in
the following case:
Bret Rutherford, M.D., New York State
Psychiatric Institute (NYSPI): Based on
the report of an investigation conducted
by NYSPI and additional analysis
conducted by ORI in its oversight
review, ORI found that Dr. Bret
Rutherford (Respondent), former
Research Psychiatrist, NYSPI, engaged
in research misconduct in research
supported by PHS funds, specifically,
NIMH, NIH, grants R01 MH102293 and
R61/R33 MH110029.
ORI found that Respondent engaged
in research misconduct by recklessly
falsely reporting that all human research
subjects met the inclusion/exclusion
criteria for late-life depression studies in
five (5) published papers, thus affecting
the reported clinical research methods
and results including demographics,
SUMMARY:
E:\FR\FM\15OCN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 199 (Tuesday, October 15, 2024)]
[Notices]
[Pages 83023-83024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23783]
-----------------------------------------------------------------------
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,
[[Page 83024]]
communications, external engagement, and program development.
Specifically, the Office works closely with the Office of the Associate
Administrator to develop strategic plans, facilitate program alignment,
and support special initiatives.
Division of Healthy Start and Perinatal Services (RM5)
The Division of Healthy Start and Perinatal Services provides
national leadership in planning, directing, coordinating, monitoring,
and evaluating national programs focused on maternal, infant, family,
and women's health for targeted populations, especially for those at
high-risk for poor health and health outcomes. Specifically, the
Division: (1) administers local, state, and national programs on
perinatal and women's health, with an emphasis on infant mortality
reduction and eliminating disparities in infant, maternal, and women's
health outcomes before and after pregnancy; (2) develops policy and
provides technical assistance, national resource development and
dissemination, and workforce development to address national trends in
maternal, infant, family, and women's health status and gaps in
evidence-based healthcare services for these populations as well as
Division programs; (3) administers funds and other resources for
grants, contracts, and cooperative agreements; (4) coordinates with
MCHB, agency, departmental, and intradepartmental initiatives in
promoting the Division's program objectives and the mission of MCHB;
(5) coordinates the Advisory Committee on Infant and Maternal
Mortality; (6) liaises with public, private, professional, and non-
governmental organizations for Division programs; (7) disseminates
information on Division programs to local, state, and national
audiences; (8) participates in strategic and policy planning, health
services research and evaluation, regulatory activities, and fiscal
strategic planning, administration, and analysis relating to Division
programs; and (9) provides technical assistance and support to central
and regional office staff of MCHB, HRSA, HHS, and other federal
agencies.
Division of Home Visiting and Early Childhood Systems (RM8)
The Division of Home Visiting and Early Childhood Systems plans,
develops, implements, oversees, monitors, and evaluates national
programs, including the Maternal, Infant, and Early Childhood Home
Visiting Program and a portfolio of early childhood systems programs.
Specifically, the Division: (1) provides leadership and coordination of
federal, regional, state, local, and non-governmental efforts to
promote the health and well-being of pregnant women, infants, young
children and their families; (2) develops, analyzes, and/or
disseminates policies, standards, guidelines, research, and evaluation
information for the various Division programs; (3) establishes and
maintains cooperative relationships within HRSA, with other federal
agencies, and with other relevant public and private organizations to
implement programs to improve maternal and child health outcomes,
develop and improve comprehensive coordinated early childhood systems,
conduct research and evaluation, and advance educational and training
programs for the early childhood workforce; (4) administers and manages
a program of interagency agreements, cooperative agreements, grants,
and contracts that will enhance service delivery and systems building;
and (5) provides technical assistance and engagement to state and local
health personnel, other federal agencies, and other stakeholders on
maternal health, early childhood health and development, and
comprehensive and coordinated systems of care.
Division of Women's Health (RMC)
The Division of Women's Health provides national leadership in
policy, planning, programming, outreach, and education to improve the
health, wellness, and safety of women across the lifespan. Specifically
the Division: (1) provides leadership, technical assistance, and
support to improve health outcomes for women; (2) engages with health
professionals and other stakeholders to identify and disseminate the
latest evidence and best practices in women's health; (3) establishes
short-range and long-range goals, plans, leads, and administers
activities that improve women's health; (4) enhances the health care
infrastructure and service delivery system by supporting innovative
programs throughout the lifespan for women as well as for children and
families; and (5) works to improve prevention, early identification,
treatment, and referral for health services for women and their
families.
Section RM.30 Delegation of Authority
All delegations of authority and re-delegations of authority made
to officials and employees of affected organizational components will
continue in them or their successors pending further redelegation, if
allowed, provided they are consistent with this reorganization.
This reorganization is effective upon date of signature.
(Authority: 44 U.S.C. 3101)
Carole Johnson,
Administrator.
[FR Doc. 2024-23783 Filed 10-11-24; 8:45 am]
BILLING CODE 4165-15-P
