[Federal Register Volume 87, Number 103 (Friday, May 27, 2022)]
[Notices]
[Pages 32174-32176]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-11519]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Establishment of the Advanced Research Projects Agency for Health
AGENCY: National Institutes of Health, Department of Health and Human
Services.
ACTION: Notice.
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SUMMARY: The National Institutes of Health (NIH) has modified its
structure. This notice announces the establishment of the Advanced
Research Projects Agency for Health (or ARPA-H).
DATES: This reorganization was approved by the Secretary of Health and
Human Services and takes effect May 24, 2022.
SUPPLEMENTARY INFORMATION: Part N, National Institutes of Health, of
the Statement of Organization, Functions, and Delegations of Authority
for the Department of Health and Human Services (HHS) (May 27, 1975 at
40 FR 22859, as amended most recently on November 3, 2004 at 69 FR
64081, and redesignated from Part HN as Part N on November 9, 1995 at
60 FR 56605, is amended as set forth below to implement ARPA-H.
Section N, Organization and Functions is amended as follows:
(1) Under Grants Management Branch (NW83, formerly HNW83) insert
the following:
Advanced Research Projects Agency for Health (NY, formerly HNY).
(1) Provides leadership for high-risk, high-reward biomedical and
health research to speed application and implementation of health
breakthroughs equitably. (2) Creates, supports, and manages programs to
catalyze the development of transformative, evidenced-based, use-driven
capabilities, platforms, and technologies in a range of biomedical and
health research areas. (3) Facilitates partnerships and collaboration
among government, academia, industry, and other sectors to accelerate
the translation of innovation into meaningful and measurable benefits
for the nation. (4) Converts use-driven research into tangible,
sustainable solutions for patients.
Acquisition and Contracting Office (NY2, formerly HNY2). (1)
Advises the ARPA-H Director and staff on acquisition and contract and
grant financial advisory services. (2) Develops/implements ARPA-H
policies, provides oversight, and manages the operational components in
the areas of acquisition and contracts management, including other
transactions. (3) Manages and conducts a comprehensive program of all
research and development contracting, non-research and development
contracting, ARPA-H support contracting, and commercial item
acquisitions using simplified acquisition procedures, GSA Federal
Supply Schedule acquisitions and simplified acquisitions. (4) Provides
advice and assistance regarding all phases of the acquisition cycle
from planning to closeout with the purpose of accomplishing all
acquisitions needed for the scientific mission and all related
acquisitions required by its customers.
Comptroller's Office (NY3, formerly HNY3). (1) Directs ARPA-H-wide
budget policy, planning, analysis, formulation, and presentation, in
collaboration with HHS Office of the Assistant Secretary for Financial
Resources and NIH Office of Budget. (2) Manages the ARPA-H appropriated
budget, including reprogramming and coordination of the use of the
Director's Discretionary Fund and transfer authority. (3) Advises the
ARPA-H Director and staff and provides leadership and direction for
budgetary matters and financial management activities. (4) Develops
policies and instructions for central services budget preparation and
presentation. (5) Administers allocation of funds and manages a system
of fund and budgetary controls. (6) Provides an ARPA-H manpower
resource control system designed to allocate resources. (7) Provides,
develops, and maintains an ARPA-H Management Account
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Structure. (8) Directs planning and implementation of ARPA-H fiscal
systems and procedures, in coordination with NIH and/or HHS fiscal
systems and procedures, and provides accounting services to all ARPA-H
components. (9) Supports the Office of Acquisition and Contracting
(OAC) in the development of policies and procedures pertaining to
grants and contracts.
Engagement and Communications Office (NY4, formerly HNY4). (1)
Plans and directs activities to communicate information about ARPA-H
programs and accomplishments to the general public, scientific
community, patients and patient groups, professional societies and
organizations, and public advocacy groups. (2) Advises the Director of
ARPA-H on effective communications strategies. (3) Represents the
Director of ARPA-H in relations with media, scientific publications,
and other public stakeholder groups. (4) Coordinates communications
policy, strategy, and activities, including Freedom of Information Act
requests, with the NIH Office of Communications and Public Liaison. (5)
Leads internal and external engagement activities and outreach efforts
to develop, build, and improve ARPA-H relationships with stakeholders.
(6) Develops and implements initiatives to collect feedback and gain
support of ARPA-H research initiatives. (7) Collaborates with the ARPA-
H Office of Legislative and Congressional Affairs on a range of
external advocacy initiatives in furtherance of ARPA-H's mission. (8)
Creates and publishes public and agency information resources including
regular publications in a variety of formats. (9) Fosters participation
in and promotion of ARPA-H activities. (10) Maintains resources for
ARPA-H special events, recruitment initiatives and other public-facing
activities.
Legislative and Governmental Affairs Office (NY5, formerly HNY5).
(1) Advises the ARPA-H Director and staff on the full range of
legislative and intragovernmental issues, and provides leadership and
direction for ARPA-H legislative analysis, development, and liaison.
(2) Identifies, analyzes, and reports on legislative developments
relevant to ARPA-H programs and activities and the national biomedical
and health research effort. (3) Monitors new legislative proposals and
their progress through the legislative process, including changes in
the statutory base of ARPA-H activities, and develops and coordinates
technical assistance. (4) Assesses, monitors, and manages the ARPA-H
relationship with the ARPA-H Congressional Authorizing and
Appropriations Committees, as well as other agencies across the federal
government, and takes necessary action to facilitate improvements in
these relationships. (5) Provides coordination on ARPA-H legislative
matters with the NIH, HHS, Congress, Federal Agencies, and other non-
Federal national and international organizations. (6) Coordinates the
preparation of testimony or statements for ARPA-H leadership before
congressional committees or other groups. (7) Develops responses to
Congressional requests, develops responses to report language, and
special reports, staff documents, or other materials concerning ARPA-H
interests, activities, and relationships.
Strategic Resources Office (NY6, formerly HNY6). (1) Advises the
ARPA-H Director and staff on all phases of ARPA-H-wide administration
and management. (2) Provides leadership and direction to all aspects of
ARPA-H management. (3) Oversees the management of functions in the
areas of personnel management, management policy, management
assessment, and logistics management, IT support, safety, space and
facility management, property, support services, and security
operations. (4) Coordinates with and serves as a liaison to the
relevant NIH offices to provide a high-level of service to ARPA-H
staff.
Treatment Innovation Office (NY7, formerly HNY7). (1) Furthers
development of novel and innovative therapeutics or other interventions
to manage, treat, or cure diseases and conditions. (2) Advises the
ARPA-H Director on matters concerning ARPA-H-sponsored research
activities related to disease or condition management therapies. (3)
Responds to requests for information on highly technical matters and
matters of public policy related to therapeutics and treatment
interventions.
Health Equity, Dissemination, and Implementation Office (NY8,
formerly HNY8). (1) Advances programs that concentrate on promoting
health equity, access to care, and ethical aspects of science and
technology development. (2) Undertakes projects and initiatives to
address and lessen health disparities and inequities in biomedical and
health research within the United States and abroad. (3) Advises the
ARPA-H Director on matters concerning ARPA-H-sponsored research
activities related to health equity, inclusion, recruitment,
enrollment, and retention, access to care, and ethical aspects of
science and technology development, as well dissemination and
implementation of those research advances into real-world settings and
clinical practice. (4) Responds to requests for information on highly
technical matters and matters of scientific and public policy related
to health equity, inclusion, recruitment, enrollment, and retention,
access to care, and ethical aspects of science and technology
development, as well dissemination and implementation of those research
advances into real-world settings and clinical practice.
Health Data Office (NY9, formerly HNY9). (1) Focuses on thoughtful
approaches to revolutionizing how scientific and health data and
information technology are collected, organized, integrated, and used.
(2) Develops strategies to assemble interdisciplinary teams to fuse
mathematical approaches and biomedical research creating massive
datasets that are carefully annotated, made widely available, allow for
integration across programs, and are sensitive to issues of subject
consent, personal privacy, and unintended biases that are crucial for
addressing the most significant biomedical problems faced by society.
(3) Advises the ARPA-H Director on matters concerning ARPA-H-sponsored
research activities related to health data and information technology.
(4) Responds to requests for information on highly technical matters
and matters of scientific and public policy related to health data and
information technology.
Health Promotion and Disease Detection Office (NYA, formerly HNYA).
(1) Advances approaches, interventions, and technologies that further
the overall health and wellness of Americans and prevent diseases. (2)
Promotes innovation in tools, technologies, processes, or other
approaches that enhance early detection of diseases. (3) Advises the
ARPA-H Director on matters concerning ARPA-H-sponsored research
activities related to health promotion and disease detection. (4)
Responds to requests for information on highly technical matters and
matters of public policy related to health promotion and disease
detection.
Health Resources and Policies Office (NYB, formerly HNYB). (1)
Advances progress in confronting challenges to the overall ecosystem of
biomedical and health research, whether they be processes, policies, or
models, to enable acceleration of advances. (2) Applies scientific and
engineering principles to solve challenges that delay the delivery of
technologies, interventions, or other approaches to the patient. (3)
Advises the ARPA-H Director on matters concerning ARPA-H-sponsored
research activities related to health resources and policy. (4)
Responds to
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requests for information on highly technical matters and matters of
scientific and public policy related to health resources and policy.
Systems Technology Office (NYC, formerly HNYC). (1) Focuses on
those systems that impact health--from physiologic systems (e.g.,
immune) to the healthcare system and everything in between. (2) Speeds
progress in the integration of systems, including and especially
technological approaches to doing so. (3) Advises the ARPA-H Director
on matters concerning ARPA-H-sponsored research activities related to
health systems technology. (4) Responds to requests for information on
highly technical matters and matters of scientific and public policy
related to health systems technology.
Equity and Inclusion Office (NYD, formerly HNYD). (1) Coordinates,
facilitates, and supports programs to ensure equity, diversity, and
inclusion in all aspects of ARPA-H's work. (2) Provides strategic and
programmatic leadership for ARPA-H's efforts to reduce health
disparities and foster health equity in biomedical research. (3)
Evaluates ARPA-H's progress towards achieving greater diversity and
health equity in biomedical and health research. (4) Promotes ARPA-H
efforts to build a diverse cohort of collaborators, staff, performers,
and others.
Strategic Planning, Evaluation, and Analytics Office (NYE, formerly
HNYE). (1) Oversees ARPA-H-wide planning, evaluation, and analysis/
analytic activities. (2) Advises ARPA-H leadership and staff on all
aspects of strategic planning, reporting, and operational effectiveness
for ARPA-H activities. (3) Provides leadership and guidance to ARPA-H's
business community in the development and oversight of a strategic
administrative management plan, goals, organizational effectiveness and
business analytics. (4) Oversees the development of analytic and
evaluation strategies to drive greater efficiency and effectiveness in
administrative and programmatic operations.
Innovation and Entrepreneurship Office (NYF, formerly HNYF). (1)
Inspires innovation and creativity throughout ARPA-H, including
stimulating the culture of innovation, ideation, and dynamic thinking
and leveraging design research and design thinking. (2) Promotes
practical strategies to provide resources for programs and projects to
incorporate and implement transition principles to inform innovation in
overall ARPA-H commercialization strategies. (3) Serves as the ARPA-H
focal point for the management of all Small Business Innovation
Research (SBIR) and Small Business Technology Transfer (STTR) Program
activities, and implementation of pertinent legislation, rules and
regulations and associated matters related to the SBIR/STTR Program.
(4) Proposes and implements innovative strategies to promote the
commercialization of innovative high impact technologies including
research tools, medical devices, and therapeutics throughout the
program development and management lifecycle. (5) Assesses the
commercial potential of ARPA-H technology priorities and provides
guidance on how best to structure programs, projects, and goals for
successful transition.
Delegations of Authority: 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.
Dated: May 24, 2022.
Xavier Becerra,
Secretary, U.S. Department of Health and Human Services.
[FR Doc. 2022-11519 Filed 5-25-22; 4:15 pm]
BILLING CODE 4140-01-P