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[Federal Register Volume 89, Number 250 (Tuesday, December 31, 2024)]
[Notices]
[Pages 107149-107150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31364]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

Statement of Organization, Functions, and Delegations of 
Authority

AGENCY: Advanced Research Projects Agency for Health, Department of 
Health and Human Services.

ACTION: Notice.

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SUMMARY: This document announces that the Establishment of the Advanced 
Research Projects Agency for Health (ARPA-H) is being amended to 
reflect a revised organizational structure for ARPA-H that aligns with 
current statutory requirements. See 42 U.S.C. 290c(a)(2).

SUPPLEMENTARY INFORMATION: The Establishment of the Advanced Research 
Projects Agency for Health (ARPA-H) (May 24, 2022, at 87 FR 32174) 
should now read as follows:

Section I. Mission

    The mission of ARPA-H is to (1) expand technical possibilities for 
the future of health, (2) forge a resilient health ecosystem to ensure 
optimal well-being for all, (3) drive scalable solutions to improve 
health care access and affordability, (4) build proactive health 
capacity to keep people from becoming patients, (5) foster data-driven 
innovation across the health ecosystem, and (6) increase the 
probability of successful transition.

Section II. Organization

    ARPA-H consists of the following offices and personnel:

The ARPA-H Office of the Director

    The ARPA-H Office of the Director (Director's Office (DIRO)) is 
comprised of:

1. The ARPA-H Director
2. Deputy Director
3. Chief of Staff
4. Such other staff as necessary to support the Office of the Director.

    The ARPA-H Director is appointed by the President (42 U.S.C. 290c 
(1)) and reports directly to the Secretary of Health and Human 
Services. 42 U.S.C. 290c (3). The Secretary has delegated all 
determinations regarding ARPA-H programs and operations to be in the 
sole authority and discretion of the Director. Consistent with 42 
U.S.C. 290c(c)(4)(B), this includes all decisions regarding the 
approval, termination and funding of all ARPA-H projects and programs.
    DIRO's functions and responsibilities are as follows: (1) Oversee 
the creation of agency technical strategy, program approval, 
prioritization and implementation (2) Lead all aspects of internal 
Director's Office operations, including ongoing management of the 
agency's communications, legislative, governmental, legal, 
international, and mission office activities (3) Serve as the primary 
liaison for all Executive and Legislative functions of the 
organization, and fulfills principal level duties across HHS, including 
engagement with the Secretary and counselors (4) Serve as the primary 
liaison to Technical Staff, including program managers and their teams, 
and the Director's Advisory staff to ensure consistent and effective 
coordination and communication.

The Health Science Futures Office

    The Health Science Futures Office (HSFO) is comprised of:

1. Director
2. Deputy Director
3. Such other staff as necessary to support the HSF Director.

    The HSFO's functions and responsibilities are as follows: (1) 
Remove scientific and technological limitations that stymie our 
nation's progress toward new solutions for the health care of the 
future. (2) Cultivate novel, agile tools that will facilitate 
revolutionary advances in medical care. (3) Leverage the latest 
scientific breakthroughs and invests in the development of platforms 
and technologies that do not yet exist. (4) Propose agency-sponsored 
research programs to the ARPA-H Director, ensuring they align with 
strategic objectives.

The Resilient Systems Office

    The Resilient Systems Office (RSO) is comprised of is comprised of:

1. Director
2. Deputy Director
3. Such other staff as necessary to support the RSO
    RSO's mission and responsibilities are as follows: (1) Drive 
advances in health systems to improve their resilience, robustness, and 
interoperability, as well as their ability to adapt to unforeseen 
events, such as cyber-attacks, hospital closures, staffing shortages, 
emerging pathogens, and natural disasters. (2) Improve the continuity 
of care during regional and national emergencies, provides time savings 
to healthcare workforces, enhances quality of care across geographies, 
improves the robustness of clinical artificial intelligence (AI) 
applications, makes it easier for patients and clinicians to make 
informed decisions, and reduces gaps between advanced research and 
clinical care (3) Develop, implement, and manage novel, innovative 
scientific and technical programs aimed at improving health outcomes. 
(4) Propose agency-sponsored research programs to the ARPA-H Director, 
ensuring they align with strategic objectives.

The Scalable Solutions Office

    The Scalable Solutions Office (SSO) is comprised of:

1. Director
2. Deputy Director
3. Such other staff as necessary to support the SSO.

    SSO's functions and responsibilities are as follows: (1) Aim to 
improve health care access and affordability for all Americans by 
working with partners to streamline manufacturing processes, optimize 
distribution networks, and develop innovative delivery methods to bring 
critical health technologies and treatments to underserved communities 
and remote areas. (2) Focus on advancing research and development to 
create scalable health solutions, expanding the reach of proven 
technologies, and accelerating their integration into the healthcare 
system.

[[Page 107150]]

(3) Develop, implement, and manage novel, innovative scientific and 
technical programs to democratize access to life-saving innovations and 
reduce disparities in health outcomes across the United States. (4) 
Propose agency-sponsored research programs to the ARPA-H Director, 
ensuring they align with strategic objectives.

The Proactive Health Office

    The Proactive Health Office (PHO) is comprised of:

1. Director
2. Deputy Director
3. Such other staff as necessary to support the PHO.

    PHO's functions and responsibilities are as follows: (1) Improve 
personal health and wellness to reduce the likelihood that people will 
become patients. (2) Establish preventative programs that create new 
capabilities to identify and characterize disease risk, reduce 
comorbidities, and promote treatments and behaviors to address 
challenges to Americans' health, whether those are viral, bacterial, 
physical, psychological, or caused by the natural aging process. (3) 
Develop, implement, and manage novel, innovative scientific and 
technical programs aimed at improving health outcomes. (4) Propose 
agency-sponsored research programs to the ARPA-H Director, ensuring 
they align with strategic objectives.

The Project Accelerator Transition Innovation Office

    The Project Accelerator Transition Innovation Office (PATIO) is 
comprised of:

1. Director
2. Deputy Director
3. Such other staff as necessary to support the PATIO.

    PATIO's missions and responsibilities are as follows: (1) Increase 
the probability that solutions thrive independently after they 
transition from ARPA-H. (2) Provide a wide variety of services to 
Program Managers (PMs) and ARPA-H performers throughout the entire 
program lifecycle. (3) Provide a tailored, full-suite of 
entrepreneurial and tech-to-market services to ARPA-H program managers 
and performers, including access to C-suite level talent to advise on 
various topics: clinical, business, user adoption, manufacturing, 
landscape analysis, and regulatory matters. (4) Manage ARPA-H's Small 
Business Innovation Research (SBIR). (5) Ensure capabilities are 
primarily designed for user experience. Provide Minimum Viable Product 
(MVP) and market-testing experimentation to uncover insights into 
customer desirability, access, and trust. (6) Maintain ARPANET-H, 
including the Investor Catalyst and Customer Experience Hub and Spoke 
Network to create a Nationwide Health Innovation Network for ARPA-H to 
help performers bring their ideas to market. (7) Develop a unique 
portfolio to address challenging problems related to health for 
fostering revolutionary advances and paradigm shifts. (8) Propose 
agency-sponsored research programs to the ARPA-H Director, ensuring 
they align with strategic objectives.

The Office of Operations

    The Office of Operations (OO) is comprised of:

1. Director
2. Deputy Director
3. Such other staff as necessary to support the OO.

    OO's functions and responsibilities are as follows: (1) Advise the 
ARPA-H Director and staff on the planning, development, and 
implementation of agency Business Operation services. (2) Lead all 
aspects of internal business operations, including ongoing management 
of the agency's financial and budget activities, human capital, 
contracting and acquisitions, and other administrative and operational 
activities including but not limited to travel and training. (3) 
Oversee the creation of relevant business operations Standard Operating 
Procedures (SOPs), develops tracking and reporting processes and tools, 
provides high-level input to inform legal and financial risk, and 
develops systems that support administrative processes within the 
agency. (4) Oversee the Agency's security related procedures and 
programs including research security risk and supply chain risk 
management. (5) Manage ARPA-H's regional footprint and associated 
infrastructure across hub locations, including facilities and space 
management. (6) Oversee management of ARPA-H's official records 
management in collaboration with Office of Information Technology and 
Data Innovation.

The Office of Information Technology and Data Innovation

    The Office of Information Technology and Data Innovation (ITDI) is 
comprised of:

1. The Chief Technology Officer
2. The Chief Information Officer
3. The Chief Information and Security Officer
4. The Chief Data Officer
5. Such other staff as necessary to support the ITDI Office.

    ITDI's functions and responsibilities are as follows: (1) Advise 
the ARPA-H Director, staff, and programs on every aspect of Information 
Technology (IT) and Data modernization, governance, and allocation of 
relevant technology and communication resources to drive the agency's 
mission. (2) Support the research, development, launch, and maintenance 
of tools to support data governance, innovation, and analytics across 
the agency, including data needs for program development. (3) Lead 
development of agency-wide IT, AI/ML, Technology Infrastructure, Cloud 
Computing, Networking, End User Computing, Cybersecurity, Technology 
Compliance, Telecommunications, and Responsible use of Technology 
Policy. (4) Develop and implement enterprise solutions to enable lean 
and agile business operations and collaboration. (5) Leads agency 
efforts to ensure user and data privacy and security management across 
all platforms and services. (6) Liaise with HHS and across the U.S. 
government to ensure compliance and consistency with U.S. government 
policy impacting IT tools and services, as well as data storage and 
analysis. (7) Conduct life cycle investment planning and monitoring as 
needed to support the areas listed above.

Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2024-31364 Filed 12-26-24; 11:15 am]
BILLING CODE 4140-01-P
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