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###### Department of Health and Human Services

###### National Institutes of Health

# AGENCY:

National Institutes of Health, HHS.

# ACTION:

Notice.

# 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                           ( print 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                           ( print 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