Notice2025-00080
Statement of Organization, Functions, and Delegations of Authority
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 7, 2025
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The National Institutes of Health (NIH) All of Us Research Program has modified their organizational structure. The new organizational structure was approved by the Secretary of Health and Human Services on December 19, 2024.
Full Text
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<title>Federal Register, Volume 90 Issue 4 (Tuesday, January 7, 2025)</title>
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[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1179-1181]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-00080]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Statement of Organization, Functions, and Delegations of
Authority
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The National Institutes of Health (NIH) All of Us Research
Program has modified their organizational structure. The new
organizational structure was approved by the Secretary of Health and
Human Services on December 19, 2024.
FOR FURTHER INFORMATION CONTACT: Tara A. Schwetz, Director, Division of
Program Coordination, Planning, and Strategic Initiatives (DPCPSI);
9000 Rockville Pike, Bethesda, MD 20892; 301-402-9852.
SUPPLEMENTARY INFORMATION: Part N, National Institutes of Health (NIH),
of the Statement of Organization, Functions, and Delegations of
Authority for the Department of Health and Human Services (HHS) (42
U.S.C. 281(c); section 401(c) of the Public Health Service Act, as
amended) is amended as set forth below to reflect the reorganization of
the National Institute of Health, Office of the Director, by abolishing
(1) the All of Us Research Program in the NIH Office of the Director,
(2) establishing the All of Us Research Program within the Division of
Program Coordination, Planning and Strategic Initiatives (DPCPSI), (3)
establish the Environmental Influences on Child Health Outcomes Program
Office (EHCO), and (4) the revised functional statement of DPCPSI.
Section N-B, Organization and Functions, under the heading National
Institute of Health (N, formerly HN), Office of the Director (NA,
formerly HNA) is amended as follows:
(1) In the Office of the Director (NA, formerly HNA) remove the
following:
All of Us Research Program Office (NAK, formerly HNAK). (1)
Oversees the design, development, implementation, and evaluation of the
All of Us Research Program Office, the largest and most diverse
research cohort of its kind, to foster a new era of medicine in which
researchers, providers, and patients work together to develop
individualized care by supporting research into the complex factors
promoting health and treatment to cure disease.
Office of the Chief Executive Officer (NAK1, formerly HNAK1). (1)
Provides leadership for the All of Us Research Program; (2) manages and
directs executive-level activities and functions; (3) provides policy
guidance and overall operational coordination for the organizational
units within the All of Us Research Program; (4) supports and
coordinates research projects through Other Transaction (OT) Authority,
research grants, contracts, and other mechanisms; (5) initiates,
develops, manages, and maintains collaborative relationships and
partnerships with other Federal and non-Federal organizations,
academia, industry, participants, and patients; and (6) provides
leadership and oversight to the All of Us Research Program Consortium.
Division of Cohort Development (NAK3, formerly HNAK3). (1) Oversees
planning, implementation, and evaluation of all cohort development
activities, including the enrollment and retention of diverse
participants activities for the All of Us Research Program; (2)
provides oversight for the biospecimen collection enterprise, including
tissue accrual, biospecimen quality and distribution, data generation
and analysis, in coordination with the NIH and other Federal partners;
(3) oversees a collaborative and integrated network of awardees
including health care provider organizations, a direct volunteer
network, and a biobank; and
[[Page 1180]]
(4) assesses risk management issues, such as onsite inspections,
providing reports and recommendations as needed.
Division of Technology and Platform Development (NAK4, formerly
HNAK4). (1) Oversees the development, operations and management of
participant and researcher facing platforms and tools; (2) provides
strategic insight for innovative approaches and methods for
computational dynamic modeling and complexity theory; (3) advises,
plans and directs the continuous modernization of infrastructure to
ensure data integrity, security, connectivity and operability across
the Program platform; (4) facilitates the development of state-of-the-
art data collection, data systems and structures to ensure rapid,
reliable, interoperable, scalable and secure systems responsive to
research; (5) provides leadership, management, and oversight of the
Information Systems Security (JSS) activities and ensures consistency
with legislation, regulations, and NIH and other Federal policies,
including the Federal Information Security Management Act (FISMA),
Federal Managers Financial Integrity Act (FMFIA), and the PMI Privacy
and Trust Principles, and PMI Data Security Policy Principles and
Framework.
Division of Communications (NAK5, formerly HNAK5). (1) Advances the
public face of the All of Us Research Program by providing leadership,
direction, and implementation for communications policies, plans, and
products in support of the program's mission and priorities; (2)
oversees media plans and website development and implementation for the
program and its consortium; and (3) develops content for a variety of
communications resources.
Division of Engagement and Outreach (NAK6, formerly HNAK6). (1)
Provides strategic direction for outreach and engagement with
stakeholders including participants, communities, health care
providers, and researchers; (2) implements and evaluates ongoing
outreach and engagement efforts to refine the program's approach and
identify new needs; (3) implements novel approaches for long-term
engagement of diverse populations; and (4) collaborates and coordinates
the sharing of participant feedback and perspectives throughout the All
of Us Research Program and with the broader research community.
Division of User Experience (NAK7, formerly HNAK7). (1) Provides
strategic direction for outreach and engagement with stakeholders
including participants, communities, health care providers, and
researchers; (2) implements and evaluates ongoing outreach and
engagement efforts to refine the program's approach and identify new
needs; (3) implements novel approaches for long-term engagement of
diverse populations; and (4) collaborates and coordinates the sharing
of participant feedback and perspectives throughout the All of Us
Research Program and with the broader research community.
(2) In the Division of Program Coordination, Planning, and
Strategic Initiatives (NAW, formerly HNAW) insert the following:
All of Us Research Program Office (NAWK, formerly HNAWK). (1)
Oversees the design, development, implementation, and evaluation of the
All of Us Research Program Office, the largest and most diverse
research cohort of its kind, to foster a new era of medicine in which
researchers, providers, and patients work together to develop
individualized care by supporting research into the complex factors
promoting health and treatment to cure disease.
Office of the Chief Executive Officer (NAWK1, formerly HNAWK1). (1)
Provides leadership for the All of Us Research Program; (2) manages and
directs executive-level activities and functions; (3) provides policy
guidance and overall operational coordination for the organizational
units within the All of Us Research Program; (4) supports and
coordinates research projects through Other Transaction (OT) Authority,
research grants, contracts, and other mechanisms; (5) initiates,
develops, manages, and maintains collaborative relationships and
partnerships with other Federal and non-Federal organizations,
academia, industry, participants, and patients; and (6) provides
leadership and oversight to the All of Us Research Program Consortium.
Division of Medical and Scientific Research (NAWK2, formerly
HNAWK2). (1) Provides clinical and scientific direction for the complex
and highly varied activities related to the All of Us Research Program;
(2) serves as the medical liaison to Institute/Center leadership within
the NIH and to the partnering health care provider organizations that
are part of the All of Us Research Program Consortium; (3) oversees the
administration of clinical projects supported by the All of Us Research
Program; (4) oversees the development and delivery of genomics
information; and (5) supports the advancement of regulatory science in
the precision medicine era.
Division of Cohort Development (NAWK3, formerly HNAWK3). (1)
Oversees planning, implementation, and evaluation of all cohort
development activities, including the enrollment and retention of
diverse participants activities for the All of Us Research Program; (2)
provides oversight for the biospecimen collection enterprise, including
tissue accrual, biospecimen quality and distribution, data generation
and analysis, in coordination with the NIH and other Federal partners;
(3) oversees a collaborative and integrated network of awardees
including health care provider organizations, a direct volunteer
network, and a biobank; and (4) assesses risk management issues, such
as onsite inspections, providing reports and recommendations as needed.
Division of Technology and Platform Development (NAWK4, formerly
HNAWK4). (1) Oversees the development, operations and management of
participant and researcher facing platforms and tools; (2) provides
strategic insight for innovative approaches and methods for
computational dynamic modeling and complexity theory; (3) advises,
plans and directs the continuous modernization of infrastructure to
ensure data integrity, security, connectivity and operability across
the Program platform; (4) facilitates the development of state-of-the-
art data collection, data systems and structures to ensure rapid,
reliable, interoperable, scalable and secure systems responsive to
research; (5) provides leadership, management, and oversight of the
Information Systems Security (JSS) activities and ensures consistency
with legislation, regulations, and NIH and other Federal policies,
including the Federal Information Security Management Act (FISMA),
Federal Managers Financial Integrity Act (FMFIA), and the PMI Privacy
and Trust Principles, and PMI Data Security Policy Principles and
Framework.
Division of Communications (NAWK5, formerly HNAWK5). (1) Advances
the public face of the All of Us Research Program by providing
leadership, direction, and implementation for communications policies,
plans, and products in support of the program's mission and priorities;
(2) oversees media plans and website development and implementation for
the program and its consortium; and (3) develops content for a variety
of communications resources.
Division of Engagement and Outreach (NAWK6, formerly HNAWK6). (1)
Provides strategic direction for outreach and engagement with
stakeholders
[[Page 1181]]
including participants, communities, health care providers, and
researchers; (2) implements and evaluates ongoing outreach and
engagement efforts to refine the program's approach and identify new
needs; (3) implements novel approaches for long-term engagement of
diverse populations; and (4) collaborates and coordinates the sharing
of participant feedback and perspectives throughout the All of Us
Research Program and with the broader research community.
(3) In the Division of Program Coordination, Planning, and
Strategic Initiatives (NAW, formerly HNAW) insert the following:
Environmental Influences on Child Health Outcome (NAWL, formerly
HNAWL). (1) Provides scientific leadership for initiatives to catalyze
observational and interventional research to enhance the health of
children for generations to come; (2) provides support for longitudinal
observational research and a Pediatric Clinical Trials Network for
interventional research; (3) facilitates work of grantees to implement
innovative paradigms for research and provides programmatic oversight,
scientific guidance, organizational infrastructure, and resources to
grantees; and (4) engages with external and internal partners to
facilitate bidirectional communication about research gaps and to
disseminate findings.
(4) In the Division of Program Coordination, Planning, and
Strategic Initiatives (NAW, formerly HNAW) revise the functions as
follows:
Division of Program Coordination, Planning, and Strategic
Initiatives (NAW, formerly HNAW). (1) Identifies and reports on
research that represents important areas of emerging scientific
opportunities, rising public health challenges, or knowledge gaps that
deserve special emphasis and would benefit from conducting or
supporting additional research that involves collaboration between two
or more Institutes and Centers (ICs), or would otherwise benefit from
strategic coordination and planning; (2) coordinates research and
activities related to AIDS, behavioral and social sciences, women's
health, disease prevention, research infrastructure, sexual and gender
minorities, tribal health, data science, dietary supplements,
nutrition, and the All of Us Research and Environmental influences on
Child Health Outcomes (ECHO) programs, and INvestigation of Co-
occurring conditions across the Lifespan to Understand Down syndromE
(INCLUDE) project; (3) uses resources (databases, analytic tools, and
methodologies) and develops specifications for new resources, when
needed, to conduct assessments based on NIH and other databases in
support of portfolio analyses and priority setting in scientific areas
of interest across NIH; (4) serves as a resource for portfolio
management at the programmatic level; (5) ensures that NIH addresses
important areas of emerging scientific opportunities and public health
challenges effectively; and (6) plans, conducts, and coordinates NIH-
wide planning and evaluation activities and reporting such as that
required by the Government Performance and Results Act (GPRA).
Delegations of Authority Statement: All delegations and
redelegations of authority to officers and employees of NIH that were
in effect immediately prior to the effective date of this amendment and
are consistent with this amendment shall continue in effect, pending
further redelegation.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2025-00080 Filed 1-3-25; 11:15 am]
BILLING CODE 4140-01-P
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