[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

[[Page 32175]]

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

[[Page 32176]]

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