Statement of Organization, Functions, and Delegations of Authority, 107149-107150 [2024-31364]
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Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Notices
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Dated: December 23, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–31363 Filed 12–30–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Statement of Organization, Functions,
and Delegations of Authority
Advanced Research Projects
Agency for Health, Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
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:
khammond on DSK9W7S144PROD with NOTICES
SUMMARY:
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
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107149
ARPA–H consists of the following
offices and personnel:
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 ARPA–H Office of the Director
The Resilient Systems Office
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 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.
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
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
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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.
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31DEN1
107150
Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Notices
(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.
khammond on DSK9W7S144PROD with NOTICES
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
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Jkt 265001
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.
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases;
E:\FR\FM\31DEN1.SGM
31DEN1
]]>Agencies
[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.
-----------------------------------------------------------------------
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
