[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