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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 [www.gpo.gov]
[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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