Advanced Research Projects Agency for Health (ARPA-H): Congressional Action and Selected Policy Issues

Advanced Research Projects Agency for Health (ARPA-H): Congressional Action and Selected Policy Issues

Advanced Research Projects Agency for Health August 12, 2022
(ARPA-H): Congressional Action and Selected
Kavya Sekar
Policy Issues
Analyst in Health Policy

Through FY2022 appropriations (P.L. 117-103), Congress provided $1 billion to the Department
Marcy E. Gallo
of Health and Human Services (HHS) to establish the Advanced Research Projects Agency for
Analyst in Science and
Health (ARPA-H). The law provided funding to a new ARPA-H account at HHS, available until
Technology Policy
September 30, 2024, and allowed the HHS Secretary to place the new agency anywhere within

the department within 30 days of enactment. On March 30, 2022, HHS Secretary Xavier Becerra
submitted a notice to the appropriations committees that ARPA-H is to reside within the National

Institutes of Health (NIH), while the ARPA-H Director is to report directly to the HHS Secretary.
The Biden Administration originally proposed ARPA-H as part of the President’s FY2022 budget request for the NIH. The
budget request sought $6.5 billion for ARPA-H over three years to “drive transformational health research innovation and
speed medical breakthroughs by tackling ambitious challenges requiring large-scale, sustained, and cross-sector
coordination.” As proposed by the Biden Administration, the initial focus of ARPA-H would have included building
platforms and capabilities to try to deliver cures for diseases such as cancer, Alzheimer’s disease, and diabetes.
Absent additional legislation, the FY2022 appropriation gives HHS considerable flexibility to design and structure the new
agency. As proposed by the Biden Administration, ARPA-H is modelled after other “ARPAs,” especially the Defense
Advanced Research Projects Agency (DARPA) and the Advanced Research Projects Agency-Energy (ARPA-E). The
“ARPA model” involves an organizational structure designed to be flat and nimble, staffed by tenure-limited program
managers with a high degree of autonomy to select and fund research projects using a milestone-based contract approach. In
contrast, NIH relies predominantly on the scientific peer review process to award most of its funding. Some evidence
suggests that this investigator-driven and consensus-based process is less likely to fund transformative or “high-risk, high-
reward” projects. Supporters of the proposal argue that high-risk, high-reward biomedical research may lead to health
breakthroughs on a faster timeline and is critical to ensuring U.S. competitiveness and addressing societal challenges.
Several bills are being considered in the 117th Congress that would codify and further delineate ARPA-H’s goals, structure,
placement, activities, and authorities. A Senate proposal, S. 3819, was incorporated into the PREVENT Pandemics Act (S.
3799), in an amendment in the nature of a substitute, and ordered to be reported by the Senate Committee on Health,
Education, Labor, and Pensions (HELP) on March 15, 2022. Meanwhile, the Advanced Research Projects Agency for Health
Act (H.R. 5585) passed the House on June 22, 2022. As Congress continues its deliberations on ARPA-H, several policy
debates remain. Such debates include (1) where to place ARPA-H within the federal government and how to facilitate its
independence and autonomy, (2) what the appropriate goals are for ARPA-H and how to prevent its activities and programs
from duplicating the efforts of other federal agencies and the private sector, and (3) what the appropriate current and future
appropriations levels are for ARPA-H.

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Contents
Introduction ..................................................................................................................................... 1
Overview of the Biden Administration’s ARPA-H Proposal .................................................... 2
White House Listening Sessions for ARPA-H .................................................................... 4
Executive Action ................................................................................................................. 4
Congressional Action ................................................................................................................ 6
Appropriations .................................................................................................................... 6
Authorizations ..................................................................................................................... 7
Selected Policy Issues ..................................................................................................................... 8
Independence and Autonomy .................................................................................................... 8
Defining Goals and Preventing Duplication ........................................................................... 10
Funding ................................................................................................................................... 12

Tables

Table A-1. Comparison of Key Provisions in ARPA-H Authorization Legislation ....................... 13

Appendixes
Appendix. Comparison of Key Provisions in ARPA-H Authorization Legislation ....................... 13

Contacts
Author Information ........................................................................................................................ 27

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Introduction
The federal government has long invested in biomedical science through the National Institutes of
Health (NIH). This investment has been credited with contributing to advances in treating disease
and providing medical care, increasing life expectancy, and preventing millions of deaths. For
much of its history, NIH has focused in large part on supporting basic research: research that
explores the fundamental mechanisms of biology and behavior. Such research facilitates scientific
knowledge that informs medical advances. Traditionally, the private sector, such as the
biopharmaceutical industry, has largely taken on the role of supporting research and development
(R&D) activities aimed at bringing new technologies and products to market, such as
pharmaceutical drugs.1
In recent years, legislation such as the 21st Century Cures Act (P.L. 114-255) and the provisions
establishing the National Center for Advancing Translational Sciences (NCATS)2 have expanded
NIH’s role in biomedical innovation, that is, research efforts aimed at driving new paradigms and
potentially breakthrough science and technologies.3 The Biden Administration continued this
trend by proposing a new Advanced Research Projects Agency for Health (ARPA-H) at NIH in its
FY2022 budget request.4
In March 2022, Congress adopted the ARPA-H proposal in the Consolidated Appropriations Act,
2022 (P.L. 117-103), which provided $1 billion to a new Department of Health and Human
Services (HHS) account to establish ARPA-H (in Division H, Labor, HHS, Education, and
Related Agencies Appropriations Act, LHHS). Both chambers are considering bills that would
codify ARPA-H and define its goals, scope, placement, activities, and authorities (e.g., H.R. 5585
and S. 3819). Subsequently, S. 3819 was incorporated into the PREVENT Pandemics Act (S.
3799) as amended and ordered to be reported by the Senate Committee on Health, Education,
Labor, and Pensions (HELP) on March 15, 2022. The House passed H.R. 5585 on June 22, 2022.
The ARPA-H proposal responds to concerns by some in the scientific and patient advocacy
communities that traditional funding processes are too risk averse—supporting incremental
advances over high-risk, high-reward, or potentially transformative research.5 Support for high-
risk, high-reward research is considered an important element in developing breakthrough
technologies that address societal challenges, including health-related challenges, and in

1 For more information on NIH and the process of pharmaceutical drug development, see CRS Report R41705, The
National Institutes of Health (NIH): Background and Congressional Issues, by Judith A. Johnson and Kavya Sekar;
and CRS Infographic IG10013, The Pharmaceutical Drug Development Process, by Agata Bodie and Kavya Sekar.
2 NCATS was established by the Consolidated Appropriations Act, 2012 (P.L. 112-74).
3 The NIH defines innovation as “something new or improved, including research for (1) development of new
technologies, (2) refinement of existing technologies, or (3) development of new applications for existing
technologies.” NIH peer review criteria also uses the following criteria to evaluate innovation in a research proposal:
“Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel
theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or
methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a
refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or
interventions proposed?” See https://grants.nih.gov/grants/peer/critiques/rpg.htm.
4 White House, Office of Science and Technology Policy, “Advanced Research Projects Agency for Health (ARPA-
H),” https://www.whitehouse.gov/ostp/advanced-research-projects-agency-for-health-arpa-h/.
5 For example, see Suzanne Wright Foundation, “HARPA: Health Advanced Research Projects Agency,”
https://www.harpa.org/; and Bhaven N. Sampat, and Robert Cook-Deegan, “An ARPA for Health Research?,” Milbank
Quarterly, https://www.milbank.org/quarterly/opinions/an-arpa-for-health-research/.
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maintaining the economic competitiveness of the United States.6 In addition, the recent rapid
development of safe and effective Coronavirus Disease 2019 (COVID-19) vaccines based on
novel technologies such as messenger RNA (mRNA), built partly upon investments by the
Defense Advanced Research Projects Agency (DARPA), has spurred increased interest in the
usefulness and value of the “ARPA model” or other innovative approaches for biomedical
research in general.7
This report provides an overview of ARPA-H as proposed by the Biden Administration, outlines
congressional action as of the date of the report, and discusses selected policy issues still under
debate as Congress considers legislation that would explicitly authorize ARPA-H. The Appendix
provides a side-by-side comparison of key provisions in the legislative proposals that would
codify ARPA-H.
Overview of the Biden Administration’s ARPA-H Proposal
The Biden Administration laid out its vision for the proposed ARPA-H in NIH’s FY2022 budget
request. Administration officials also published an ARPA-H concept paper and an article in
Science magazine, authored by then-NIH Director Francis Collins, then-director of the White
House Office of Science and Technology Policy (OSTP) Eric Lander, and others, both of which
laid out a more detailed vision and justification for the proposed agency.8 According to the
proposal, ARPA-H would be modeled after the Defense Advanced Research Projects Agency
(DARPA), which is part of the Department of Defense (DOD), and would contain several “ARPA
model” characteristics, including a flat organizational structure designed to be nimble and staffed
by tenure-limited program managers with a high degree of autonomy to select and fund projects
using a milestone-based contract approach.9 NIH, in contrast, generally funds most of its research
through the scientific peer review process—a committee-based review process to evaluate
scientific investigator-driven research proposals for funding.10 Some data suggests that this
investigator-driven and consensus-based process may not adequately fund “high-risk, high-
reward” projects,11 a term often associated with projects that have high potential for meeting

6 Organization for Economic Cooperation and Development (OECD), Effective Policies to Foster High-Risk/High-
Reward Research, OECD Science, Technology, and Industry Policy Papers, No. 112, May 2021, https://read.oecd.org/
10.1787/06913b3b-en?format=pdf.
7 CRS Insight IN11446, DARPA’s Pandemic-Related Programs, by Marcy E. Gallo; and Chiara Franzoni, Paula
Stephan, and Reinhilde Veugelers, “Funding Risky Research,” National Bureau of Economic Research Working Paper,
June 2021.
8 NIH, Congressional Justification: FY2022, May 28, 2021, https://officeofbudget.od.nih.gov/pdfs/FY22/br/
2022%20CJ%20Overview%20Volume%20May%2028.pdf, pp. 1-11; White House, Advanced Research Project
Agency for Health (ARPA-H): Concept Paper, https://www.whitehouse.gov/wp-content/uploads/2021/06/ARPA-H-
Concept-Paper.pdf; NIH, “Lander, Collins Set Forth a Vision for ARPA-H,” press release, June 22, 2021,
https://www.nih.gov/news-events/news-releases/lander-collins-set-forth-vision-arpa-h; and Francis S. Collins et al.,
“ARPA-H: Accelerating Biomedical Breakthroughs,” Science, vol. 373, no. 6551 (July 9, 2021).
9 For more information on DARPA, see CRS Report R45088, Defense Advanced Research Projects Agency: Overview
and Issues for Congress, by Marcy E. Gallo.
10 See “Peer Review Process for Extramural Funding” in CRS Report R41705, The National Institutes of Health (NIH):
Background and Congressional Issues, by Judith A. Johnson and Kavya Sekar.
11 Chiara Franzoni, Paula Stephan, and Reinhilde Veugelers, “Funding Risky Research,” National Bureau of Economic
Research Working Paper, June 2021; Mikko Packalen and Jay Bhattacharya, “NIH Funding and the Pursuit of Edge
Science,” Proceedings of the National Academy of Sciences, vol. 117, no. 22 (June 2, 2020), pp. 12011-12016; and
Pierre Azoulay, Erica Fuchs, and Anna Goldstein, “Funding Breakthrough Research: Promises and Challenges of the
‘ARPA Model,’” National Bureau of Economic Research, June 2018.
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fundamental scientific or technological challenges, involve a high degree of novelty and/or
multidisciplinary approaches, but also have a higher risk of failure than other projects.12
The FY2022 budget request included $6.5 billion for ARPA-H “to make pivotal investments in
breakthrough technologies and broadly applicable platforms, capabilities, resources, and solutions
that have the potential to transform important areas of medicine and health for the benefit of all
patients and that cannot readily be accomplished through traditional research or commercial
activity.”13 According to the proposal, ARPA-H is to “build platforms and capabilities to deliver
cures for cancer, Alzheimer’s disease, diabetes, and other diseases.”14 Additionally, the
Administration has provided a list of potential ARPA-H projects, including the development of
accurate, wearable, blood pressure technology; the preparation of mRNA vaccines against
common forms of cancer; drug or gene therapy delivery systems that can target any organ, tissue,
or cell type; and platforms to reduce health disparities in maternal morbidity and mortality,
among others.15
Funding was requested for a period of three years to “allow for both scale-up in FY2022 and
redeployment of resources in the next two years if projects fail to meet performance milestones.”
The vast majority of funding would support extramural research (i.e., research conducted outside
the federal government), with a smaller amount of funding reserved for staffing and
administrative functions. Unlike NIH Institutes and Centers (ICs), the proposed ARPA-H would
not have its own intramural research program (i.e., research conducted at NIH facilities).16
The FY2022 budget request described the types of challenges ARPA-H would seek to address
through its investments, including:
 Support for complex research and development that requires large-scale,
sustained, cross-sector coordination;
 The creation of new capabilities (e.g., technologies, data resources, disease
models);
 Support for high-risk exploration that could establish entirely new paradigms;
and
 The commercialization of biomedical innovations using financial incentives and
other mechanisms.17
Most ARPA-H awards would support industry, universities, and nonprofit research institutions
and may involve some agreements with other federal agencies. While the proposed agency
structure would be “operationally distinct” from NIH ICs, ARPA-H would still coordinate
research and activities with NIH ICs and other Department of Health and Human Services (HHS)
agencies (e.g., the Food and Drug Administration [FDA]).

12 For a discussion of definitions of “high-risk, high-reward research,” see pages 11-13 of Organization for Economic
Cooperation and Development (OECD), Effective Policies to Foster High-Risk/High-Reward Research, OECD
Science, Technology, and Industry Policy Papers, No. 112, May 2021, https://read.oecd.org/10.1787/06913b3b-en?
format=pdf.
13 White House, Advanced Research Project Agency for Health (ARPA-H): Concept Paper.
14 NIH, Congressional Justification: FY2022, pp. 10-11.
15 NIH, Congressional Justification: FY2022, pp. 10-11; and White House, Advanced Research Project Agency for
Health (ARPA-H): Concept Paper.
16 NIH, Congressional Justification: FY2022, pp. 10-11.
17 NIH, Congressional Justification: FY2022, pp. 10-11.
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White House Listening Sessions for ARPA-H
In July and August 2021, OSTP and NIH held 15 listening sessions on the proposed ARPA-H
with thousands of biomedical stakeholders. In September 2021, OSTP and NIH summarized
participant recommendations, which emphasized the following:18
 A focus on technologies, rather than specific diseases: Stakeholders
emphasized that ARPA-H should focus on developing technologies that could
have applications across a wide range of diseases, rather than focus on specific
diseases. Stakeholders also noted specific types of technologies for the new
agency to support, such as data-sharing platforms, diagnostics platforms,
artificial intelligence and machine learning algorithms, and wearables and digital
technologies.
 Embracing equity and diversity as a cornerstone of the mission: Stakeholders
suggested that equity and diversity considerations should be incorporated into all
aspects of ARPA-H, from staffing to project selection and execution. Some also
suggested that ARPA-H should prioritize programs that take a holistic approach
that considers health in the context of broader environmental, cultural, economic
and social factors.
 Coordination and collaboration: Participants emphasized the need to partner
and consult with diverse private, academic, and public sector entities.
Stakeholders advised that ARPA-H should avoid areas that are well-funded by
NIH or the private sector, and should pursue projects that are complementary to
currently funded efforts. They also emphasized a need for mechanisms to support
commercialization of ARPA-H-supported technologies and programs through
collaboration with FDA and the Centers for Medicare & Medicaid Services
(CMS).
Executive Action
The Consolidated Appropriations Act, 2022 (P.L. 117-103), gave the HHS Secretary the ability to
transfer ARPA-H to any HHS agency or office, including NIH, within 30 days of enactment. It
required the Secretary to notify Congress at least 15 days in advance of such a transfer. On March
30, 2022, HHS Secretary Becerra submitted a notice to the appropriations committees that ARPA-
H would reside within NIH, with the ARPA-H Director reporting directly to the HHS Secretary.19
On May 25, 2022, HHS Secretary Becerra announced the formal establishment of ARPA-H
within NIH and named Dr. Adam H. Russell as the acting interim director for the agency.20 In
addition, an organizational structure for ARPA-H was published in the Federal Register on May
27, 2022. As outlined in the federal notice, ARPA-H will be composed of 14 offices, as follows:
 Acquisition and Contracting Office: Advises the ARPA-H Director and staff on
acquisition and contract and grant financial advisory services.

18 White House Office of Science and Technology Policy and NIH, Listening Sessions for ARPA-H: Summary Report,
https://www.whitehouse.gov/wp-content/uploads/2021/09/093021-ARPA-H-Listening-Session-Summary_Final.pdf.
19 Lev Facher, “Biden’s High-Stakes Biomedical Science Agency ARPA-H Will Be Part of the NIH—But There’s a
Twist,” STAT, March 31, 2022.
20 Department of Health and Human Services, “HHS Secretary Becerra Establishes ARPA-H within NIH, Names
Adam H. Russell, D.Phil. Acting Deputy Director,” press release, May 25, 2022,
https://www.hhs.gov/about/news/2022/05/25/hhs-secretary-becerra-establishes-arpa-h-within-nih-names-adam-h-
russell-phil-acting-deputy-director.html.
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 Comptroller's Office: 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.
 Engagement and Communications Office: 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.
 Legislative and Governmental Affairs Office: 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.
 Strategic Resources Office: Advises the ARPA-H Director and staff on all
phases of ARPA-H-wide administration and management.
 Treatment Innovation Office: Furthers development of novel and innovative
therapeutics or other interventions to manage, treat, or cure diseases and
conditions.
 Health Equity, Dissemination, and Implementation Office: Advances
programs that concentrate on promoting health equity, access to care, and ethical
aspects of science and technology development.
 Health Promotion and Disease Detection Office: Advances approaches,
interventions, and technologies that further the overall health and wellness of
Americans and prevent diseases.
 Health Resources and Policies Office: 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.
 Systems Technology Office: Focuses on those systems that impact health—from
physiologic systems (e.g., immune) to the health care system and everything in
between.
 Equity and Inclusion Office: Coordinates, facilitates, and supports programs to
ensure equity, diversity, and inclusion in all aspects of ARPA-H’s work.
 Strategic Planning, Evaluation, and Analytics Office: Oversees ARPA-H-wide
planning, evaluation, and analysis/analytic activities.
 Innovation and Entrepreneurship Office: Inspires innovation and creativity
throughout ARPA-H, including stimulating the culture of innovation, ideation,
and dynamic thinking and leveraging design research and design thinking.21

21 National Institutes of Health, “Establishment of the Advanced Research Projects Agency for Health,” 87 Federal
Register 32174-32176, May 27, 2022.
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Congressional Action
Appropriations
FY2022
Enacted: On March 15, 2022, the Consolidated Appropriations Act, 2022 (P.L. 117-103) was
signed into law. It provided $1 billion in appropriations to a new account at HHS for ARPA-H,
with funding available until September 30, 2024.22 Unlike earlier ARPA-H appropriations
proposals, the law did not condition the availability of funds on enactment of legislation
specifically establishing ARPA-H. Thus, this legislation does not preclude the Administration
from moving forward with establishing ARPA-H and provides for the following implementation
activities:
 presidential appointment of the ARPA-H Director;
 hiring and appointment flexibilities;
 the ability to make awards as grants, contracts, cooperative agreement, and other
transactions;23
 exemption from NIH scientific peer review requirements; and
 the ability of the HHS Secretary to transfer ARPA-H to any HHS agency or
office, including NIH, within 30 days of enactment. (The HHS Secretary’s
response is noted in the text box above).
The explanatory statement accompanying the law does not provide further details on Congress’s
policy intentions for ARPA-H.24 The report accompanying the House FY2022 LHHS
appropriations bill (H.Rept. 117-96; incorporated by reference) “encourages NIH to collaborate
with DARPA to develop the foundational policies, procedures, and staff training for ARPA–H
employees.”25
FY2023
Request: Announced on March 28, 2022, President Biden’s FY2023 budget request for NIH
proposes $5 billion for ARPA-H in an NIH account, with funding available until September 30,
2025.26 The FY2023 request reiterates the same vision for ARPA-H as in the FY2022 request, and
notes that “opportunities or obstacles identified by the Cancer Moonshot may become candidates
for the new approach to transformational change offered by ARPA-H.” The Beau Biden Cancer

22 Title II, Division H of Consolidated Appropriations Act, 2022 (P.L. 117-103).
23 The law cites the definition of “other transaction” in Public Health Service Act (PHSA) Section 319L(a)(3), which
means “transactions, other than procurement contracts, grants, and cooperative agreements.” For further information on
OT authorities, see CRS Report R45521, Department of Defense Use of Other Transaction Authority: Background,
Analysis, and Issues for Congress, by Heidi M. Peters.
24 See U.S. Congress, House Committee on Rules, Division H- LHHS Appropriations 2022, Explanatory Statement,
committee print, 117th Cong., 1st sess., p. 119.
25 As directed in the Explanatory Statement cited in footnote 23 (page 1), “Unless otherwise noted, the language set
forth in H.Rept. 117-96 carries the same weight as language included in this explanatory statement and should be
complied with unless specifically addressed to the contrary in this explanatory statement.”
26 NIH, Congressional Justification: FY2023, March 28, 2022, https://officeofbudget.od.nih.gov/pdfs/FY23/br/
Overview%20of%20FY%202023%20Presidents%20Budget.pdf, p. 33.
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Moonshot is another one of President Biden’s major policy priorities related to biomedical
research.27
House: On July 5, 2022, the House Appropriations Committee reported an FY2023
appropriations bill (H.R. 8295) that would provide $2.75 billion, available until September 30,
2025, to an ARPA-H account under the Office of the Secretary—$1.75 billion above the FY2022-
enacted level. Additionally, the report (H.Rept. 117-403) accompanying the bill states:
The Committee strongly supports the mission of ARPA–H to drive transformational
innovation in health research. The Committee believes that given its focus on supporting
high-risk, high reward projects and distinct approach to selecting and managing research
projects, establishing ARPA–H as a separate entity within HHS will maximize the
likelihood of the agency’s success.
Senate: On July 28, 2022, the Senate Appropriations Committee Majority Chair Patrick Leahy
released draft Senate appropriations bills.28 The draft LHHS bill would provide $1 billion,
available through September 30, 2025, to an ARPA-H account under NIH.29 This amount would
be the same funding level as FY2022-enacted and $1.75 billion less than in the House-reported
bill. Additionally, the draft report accompanying the bill states:30
Following the decision by the Secretary to transfer ARPA-H to NIH in May, funding is
provided to ARPA–H as a standalone agency within NIH. However, the Committee
believes ARPA–H will require a very different culture and mission than NIH’s other 27
Institutes and Centers. To foster the development of an entrepreneurial culture, the
Committee expects ARPA–H to be physically located away from the main NIH campus.
The Committee expects NIH to conduct a transparent and competitive process for a
location site.
Authorizations
House:
On June 22, 2022, the House passed the Advanced Research Projects Agency-Health Act (H.R.
5585), with amendments to the bill previously reported by the House Committee on Energy and
Commerce on June 13, 2022 (H.Rept. 117-365). This standalone bill, introduced by House
Energy and Commerce Health Subcommittee Chair Representative Eshoo, would authorize and
establish ARPA-H within HHS.
Two other bills to authorize ARPA-H were previously introduced in the House. Representatives
Diana DeGette and Fred Upton introduced the Cures 2.0 Act (H.R. 6000) on November 17, 2021.
Section 501 of this bill would authorize ARPA-H and establish it within NIH (see “Independence
and Autonomy” for more on placement within the federal government). An early version of the
Build Back Better Act (H.R. 5376) budget reconciliation measure, reported in the House on
September 27, 2021, included authorization language and funding of $3 billion for ARPA-H. The

27 NIH, Congressional Justification: FY2023, pp. 4-13.
28 Senate Committee on Appropriations, “Chairman Leahy Releases Fiscal Year 2023 Senate Appropriations Bills,”
press release, July 28, 2022, https://www.appropriations.senate.gov/news/majority/breaking-chairman-leahy-releases-
fiscal-year-2023-senate-appropriations-bills.
29 U.S. Congress, Senate Committee on Appropriations, FY2023 LHHS Appropriations, committee print, 117th Cong.,
2nd sess., July 28, 2022, https://www.appropriations.senate.gov/imo/media/doc/LHHSFY2023.PDF.
30 U.S. Congress, Senate Committee on Appropriations, Subcommittee on Labor, Health and Human Services, and
Education, and Related Agencies, Explanatory Statement for FY2023 LHHS Appropriations Bill, committee print,
117th Cong., 2nd sess., July 2022, https://www.appropriations.senate.gov/imo/media/doc/LHHSFY23REPT.pdf.
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House-passed version on November 19, 2021, however, did not include ARPA-H related
language.
Senate: On March 10, 2022, Senators Patty Murray and Richard Burr, the chair and ranking
member of the Senate Health, Education, Labor, and Pensions (HELP) Committee (the committee
of jurisdiction for NIH), introduced S. 3819, the Advanced Research Project Authority for Health
Act, which would establish ARPA-H within NIH. This bill was incorporated as Section 331 of S.
3799, the PREVENT Pandemics Act in an amendment in the nature of a substitute, which was
ordered to be reported by the Senate HELP Committee on March 15, 2022.
Table A-1 provides a detailed side-by-side comparison of ARPA-H legislative proposals in the
House (H.R. 5585) and Senate (S. 3799, as amended).
Selected Policy Issues
The bills that would establish ARPA-H are generally similar; however, some key differences and
policy questions remain. The following sections describe select policies under debate and
potential issues for congressional consideration.
Independence and Autonomy
Independence at the agency level to shape a distinct mission and culture along with autonomy of
program managers to select and fund projects are viewed as key components of the ARPA
model.31 Stakeholders, the Biden Administration, and Members of Congress have debated where
to place ARPA-H within the federal government, particularly whether to house the new entity
within NIH or as a separate agency under HHS (NIH’s parent department). As noted, HHS
Secretary Becerra has decided that ARPA-H is to reside within NIH, while the ARPA-H Director
is to report directly to the HHS Secretary. Congress could still decide to change ARPA-H’s
placement through legislation. Aside from placement, Congress is also debating further options of
ensuring ARPA-H’s independence and autonomy.
The Biden Administration originally proposed placing ARPA-H within NIH, arguing that “the
goals of ARPA-H fall squarely within NIH’s mission” and that placing ARPA-H within NIH
would promote scientific collaboration and help avoid duplication across programs.32 On the
other hand, some stakeholders see NIH’s culture as relatively conventional and risk-averse and
question whether NIH’s leadership and culture could affect ARPA-H’s ability to succeed in
research for transformational innovation.33 Such stakeholders support placing ARPA-H outside of
NIH to ensure independence and autonomy. For example, in a recent hearing before the House
Committee on Energy and Commerce, Keith Yamamoto, Vice Chancellor for Science Policy and
Strategy at the University of California San Francisco, stated the following regarding housing
ARPA-H outside of NIH:
The main force of that argument is that the mission and goals of ARPA-H are different.
NIH is a masterful agency at discovery of new knowledge, but does not actually extend to
being able to develop applications for that new knowledge. And the route for being able to

31 Azoulay et al., “Funding Breakthrough Research: Promises and Challenges of the ‘ARPA Model,’” pp. 9-10.
32 Collins et al., “ARPA-H: Accelerating Biomedical Breakthroughs.”
33 Sarah Omermohle, “Skeptics Question If Biden’s New Science Agency Is a Breakthrough or More Bureaucracy,”
Politico, July 5, 2021; Jacqueline Alemany, “Biden Has Proposed a New Agency to Turbocharge Medical Treatments.
But There’s a Fight over Where It Should Live,” Washington Post, June 23, 2021.
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do that has already been cast and demonstrated extremely well in DARPA and ARPA-E.
And so, I think that’s the reason that it should be outside. Setting up that new culture and
operating model within the culture and operating model of NIH, as successful as it is, right,
would be challenging at best.34
In the same hearing before the House Committee on Energy and Commerce, Esther Krofah,
Executive Director of FasterCures and Center for Public Health at the Milken Institute, stated,
“we do not see a reason ARPA-H could not be situated within NIH and still accomplish its
mission, including advantages to having easy access to other NIH infrastructure, personnel,
programs, and expertise.”35
There is precedent for innovative biomedical science efforts both at NIH and at other HHS units.
NIH has supported projects such as the Human Genome Project; the Common Fund for cross-
cutting and milestone-driven innovative projects; NCATS, which focuses on innovation in
medical product development; and, more recently, the Rapid Acceleration of Diagnostics program
to boost innovation for COVID-19 diagnostics.36 The HHS Office of Science and Medicine under
the Assistant Secretary for Health has managed InnovationX, which includes several public-
private partnerships aimed at accelerating innovation, including for kidney disease and Lyme
disease.37 Additionally, the Biomedical Advanced Research and Development Authority
(BARDA) at HHS under the Assistant Secretary for Preparedness and Response engages in
efforts to develop medical countermeasures to address public health emergencies.38 Regardless of
where the new agency is placed, it would likely need to consult with NIH programs, HHS
programs such as BARDA, as well as biomedical programs at DOD to promote collaboration and
avoid duplication.
The authorizing bills under consideration in the House (H.R. 5585) and Senate (S. 3799, as
amended) differ in ARPA-H’s placement. H.R. 5585 would establish ARPA-H as an independent
entity within HHS while S. 3799 (as amended) would establish ARPA-H as an agency under NIH.
Additionally, the authorizing bills include provisions that seek to ensure the independence and
autonomy of ARPA-H. Specifically, H.R. 5585 would prohibit another federal agency or
department from requiring that an ARPA-H official submit legislative recommendations,
testimony, or comments on legislation to any officer or agency for approval prior to submission to
Congress if such recommendations, testimony, or comments are those of the Director or such
officer, and do not necessarily reflect the views of the President or another agency. The provisions
related to independence in S. 3799 (as amended) would (1) prohibit ARPA-H from being located
on the NIH campus and in close proximity to the National Capital Region and (2) prohibit the
ARPA-H Director from appointing personnel to the agency who were employed by NIH three
years prior to such appointment. Additionally, all of the authorizing bills would require that any
budget request for the agency be separate and distinct from either HHS or NIH (see
“Appropriations” below for additional discussion).

34 U.S. Congress, House Committee on Energy and Commerce, Subcommittee on Health, ARPA-H: The Next Frontier
of Biomedical Research, 117th Cong., 2nd sess., February 8, 2022.
35 U.S. Congress, House Committee on Energy and Commerce, Subcommittee on Health, ARPA-H: The Next Frontier
of Biomedical Research, 117th Cong., 2nd sess., February 8, 2022.
36 White House, Advanced Research Project Agency for Health (ARPA-H): Concept Paper, p. 4.
37 HHS, “InnovationX,” https://www.hhs.gov/ash/osm/innovationx/index.html.
38 HHS Office of the Assistant Secretary for Preparedness and Response, “Biomedical Advanced Research and
Development Authority,” https://phe.gov/about/barda/Pages/default.aspx.
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Some have argued that ARPA-H’s founding director would play a crucial role in developing a
unique culture that guides the agency to success.39 For example, the report accompanying the
House FY2022 LHHS appropriations bill (H.Rept. 117-96) “strongly encourages NIH to recruit
an ARPA-H Director with extraordinary technical and leadership skills, who has a proven track-
record in innovation and partnership-building.”40 Both of the proposals would require the ARPA-
H Director to be appointed by the President (consistent with enacted appropriations), though they
differ in whether the Director would report to the NIH Director or the HHS Secretary. The
proposals also specify different appointment terms. H.R. 5585 would authorize a five-year
appointment term for the ARPA-H Director while S. 3799 (as amended) would authorize a four-
year term. Both bills would allow for one consecutive term. Both of the proposals similarly
specify that the Director have qualifications to manage advanced biomedical research programs,
with some slight differences.
Defining Goals and Preventing Duplication
Existing ARPAs address their mandate to advance high-risk, high-reward research and
technologies by seeking to fill what is called the white space, a perceived gap or opportunity in
the technology landscape.41 The Biden Administration has argued that the current ecosystem of
biomedical R&D—with curiosity-driven research funded by NIH and the public sector and
commercialization-driven R&D funded largely by industry—is adequate for most biomedical
innovation but leaves certain critical gaps that ARPA-H could fill. Specifically, project ideas that
the Administration asserts are left unfunded by the current system include those that (1) are high
risk and/or require significant funding, (2) involve complex coordination among multiple parties,
(3) have a focus that is too applied for academia, and (4) have a scope that “is so broad that no
company can realize the full economic benefit.”42 Some empirical research supports these claims:
recent economic analyses provide some evidence that both the pharmaceutical industry and NIH
underinvest in high-risk R&D.43
The ARPA-H bills (H.R. 5585 and S. 3799, as amended) define overall agency goals similarly,
with some variations (see Table A-1). Both of the bills emphasize breakthrough biomedical
technologies and innovation in ARPA-H’s proposed statutory goals. Neither of the bills establish
ARPA-H to focus on specific diseases or areas of research. A main difference in ARPA-H goals
between the bills is that H.R. 5585 explicitly names ensuring U.S. global leadership in science
and innovation, especially with respect to global health threats, as an overall goal.

39 Jocelyn Kaiser, “The U.S. Just Created a Big New Biomedical Research Agency. But Questions Remain,” Science,
March 15, 2022, https://www.science.org/content/article/u-s-just-created-big-new-biomedical-research-agency-
questions-remain.
40 Omermohle, “Skeptics Question If Biden’s New Science Agency Is a Breakthrough or More Bureaucracy;” Sampat
and Cook-Deegan, “An ARPA for Health Research?”; and U.S. Congress, House Committee on Appropriations,
Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, Report to Accompany H.R.
4502, 117th Cong., 1st sess., July 19, 2021, pp. 165-166.
41 National Academies of Sciences, Engineering, and Medicine, An Assessment of ARPA-E (Washington, DC: The
National Academies Press, 2017), p. 95; and Azoulay et al., “Funding Breakthrough Research: Promises and
Challenges of the ‘ARPA Model.’”
42 Collins et al., “ARPA-H: Accelerating Biomedical Breakthroughs.”
43 Joshua L. Krieger, Danielle Li, and Dimitris Papanikolaou, “Missing Novelty in Drug Development,” National
Bureau of Economic Research, vol. 35, no. 2 (2022), pp. 636-679; Chiara Franzoni, Paula Stephan, and Reinhilde
Veugelers, “Funding Risky Research,” National Bureau of Economic Research Working Paper, June 2021; and Mikko
Packalen and Jay Bhattacharya, “NIH Funding and the Pursuit of Edge Science,” Proceedings of the National Academy
of Sciences, vol. 117, no. 22 (June 2, 2020), pp. 12011-12016.
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Some have expressed concern about the potentially broad scope of ARPA-H.44 Both of the
authorizing bills would require ARPA-H to develop and submit to Congress a strategic plan for
the new agency and submit annual reports to Congress that detail current, proposed, and planned
ARPA-H projects.
Some have expressed concern that ARPA-H could duplicate existing medical and health research
efforts across the federal government.45 Myriad federal agencies support medical and health
research, not only NIH—the largest supporter of such research—but also DOD, the Department
of Veterans Affairs (VA), and other agencies within HHS.46 The authorizing bills address
considerations related to aligning ARPA-H efforts with those of other federal agencies, as shown
in the sections on “Coordination and Cooperation” and “Advisory Committees” in the Appendix.
For example, S. 3799 (as amended) and H.R. 5585 would both require the establishment of an
interagency advisory committee tasked with avoiding duplication and improving the coordination
of ARRPA-H’s efforts with other federal agencies. H.R. 5585 would also require the Government
Accountability Office to conduct an independent review of HHS’s research portfolio every three
years to assess the degree of unnecessary duplication and make recommendations regarding any
potential reorganization, consolidation, or termination of duplicative program and projects.
Additionally, other federal agencies would play a critical role in commercialization of
implementation of ARPA-H technologies or innovations—for example, FDA would regulate
many ARPA-H-supported medical products. Both bills would require ARPA-H to coordinate with
the FDA to expedite and facilitate the transformation and development of ARPA-H activities into
medical products and solutions for patients. Federal health care programs, such as the Centers for
Medicare & Medicaid Services (CMS) and the VA, could end up implementing or paying for
ARPA-H supported innovations. H.R. 5585 would require ARPA-H to share timely information
with CMS for coverage decisions. Both bills also provide for follow-on production or
procurement and demonstration programs, as shown in the section on “Other Transactions,
Follow-on Production, Technology Transfer, and Procurement and Demonstration” in Table A-1.
There is also concern about duplicating commercial or philanthropic research efforts. Both bills
direct ARPA-H to prioritize investments in areas that are underfunded by the public and private
sector, and to facilitate public-private partnerships. S. 3799 (as amended) includes provisions that
are aimed at preventing ARPA-H funding from crowding out private sector investment. For
example, S. 3799 (as amended) would require the ARPA-H Director to ensure that ARPA-H does
not provide funding for a research program or project unless the applicant demonstrates that it has
made sufficient unsuccessful attempts to secure private financing, and that there is a lack of
significant private support for the program or project.
Another ARPA agency, the Advanced Research Projects Agency-Energy (ARPA-E) faced similar
concerns regarding potential duplication; however, a recent study by the U.S. Government
Accountability Office found that “ARPA-E has practices in place to help manage overlap and

44 See, for example, Jeff Tollefson, “The Rise of ‘ARPA-Everything’ and What It Means for Science,” Nature, July 8,
2021, https://www.nature.com/articles/d41586-021-01878-z; and Bhaven N. Sampat and Robert Cook-Deegan, “An
ARPA for Health Research?,” Milbank Quarterly, https://www.milbank.org/quarterly/opinions/an-arpa-for-health-
research/.
45 U.S. Congress, House Committee on Energy and Commerce, Subcommittee on Health, ARPA-H: The Next Frontier
of Biomedical Research, 117th Cong., 2nd sess., February 8, 2022.
46 Research!America, U.S. Investments in Medical and Health Research and Development, 2019,
https://www.researchamerica.org/sites/default/files/Publications/InvestmentReport2019_Fnl.pdf.
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duplication during its program development cycle.”47 Congress may consider whether to identify
any best practices from ARPA-E that could be applied to ARPA-H program development.
Funding
The Consolidated Appropriations Act, 2022 (P.L. 117-103) provided ARPA-H with $1 billion in
funding available until September 30, 2024. This is in contrast with the $6.5 billion in initial
funding proposed by the Biden Administration for the same period.48 It is also lower than the
authorized amounts in H.R. 5585. H.R. 5585 would authorize $500 million for each of FY2023
through FY2027. S. 3799 (as amended) does not specify an authorization level and instead would
authorize “such sums as may be necessary” for FY2023 through FY2027. In comparison, DARPA
is funded at $3.9 billion for FY2022, ARPA-E has FY2022 funding of $450 million, and fewer
than half of NIH ICs have an annual budget that exceeds $1 billion (11 out of 25 accounts).49
Taking a wider view, total U.S. investments in health and medical research (both public and
private) were estimated at $194.175 billion in 2018.50
Stakeholders have debated the appropriate initial funding level for ARPA-H. Given that ARPA-H
is an untested new agency, some argue that it should start small and grow over time depending on
its success.51 However, in the context of the ARPA model, there is a risk of providing too little
funding. Insufficient funding is seen by some as one of the reasons another agency modeled after
DARPA, the Homeland Security Advanced Research Projects Agency (HSARPA), has not been
viewed as a success.52 In addition, biomedical research—especially medical product R&D—tends
to be expensive relative to some other areas of technology R&D.53 Also, given the long lag time
that generally exists between R&D activities and a commercially viable product or service, as
well as the focus on high-risk projects, it can be difficult to determine the appropriate ARPA-H
funding level in the short term.
In an effort to separate ARPA-H funding from other NIH programs, S. 3799 (as amended) would
provide that ARPA-H’s budget be separate from other NIH budget requests. (As an independent
agency, the ARPA-H established by H.R. 5585 would likely have a separate budget request).
Members of Congress also have considered whether and how to leverage private funding—such
as from industry or philanthropy—to help support ARPA-H’s efforts. Currently, NIH structures
many of its medical product development and biomedical innovation programs as public-private
partnerships. Both bills would direct ARPA-H to partner with a range of public and private
entities. In addition, S. 3799 (as amended) would direct the ARPA-H Director, as a part of the
Director’s duties, to prioritize investments in areas that require public-private partnerships.

47 U.S. Government Accountability Office, Advanced Research Projects Agency-Energy: Agency Has Practices for
Avoiding Duplication and Involving Stakeholders in the Development of Research Programs, GAO-22-104775,
February 3, 2022, p. 1, https://www.gao.gov/assets/gao-22-104775.pdf.
48 NIH, Congressional Justification: FY2022, pp. 10-11.
49 See CRS Report R46869, Federal Research and Development (R&D) Funding: FY2022, coordinated by John F.
Sargent Jr.
50 Research!America, “U.S. Investments in Medical and Health Research and Development: 2013-2018,” Fall 2019,
https://www.researchamerica.org/sites/default/files/Publications/InvestmentReport2019_Fnl.pdf.
51 See, for example, Tollefson, “The Rise of ‘ARPA-Everything’ and What It Means for Science.”
52 For example, see Nate Bruggeman and Ben Rohrbaugh, “Closing Critical Gaps that Hinder Homeland Security
Technology Innovation,” Belfer Center, Harvard Kennedy School, April 2020, p. 3, https://www.belfercenter.org/sites/
default/files/files/publication/HSP%20paper%20series%205-2.pdf.
53 GAO, Drug Industry: Profits, Research and Development Spending, and Merger and Acquisition Deals, GAO-18-
40, November 2017, pp. 28-37.
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Appendix. Comparison of Key Provisions in ARPA-
H Authorization Legislation
Table A-1 provides a side-by-side comparison of the two bills under consideration that would
authorize ARPA-H in the 117th Congress. In the House, H.R. 5585 was passed on June 22, 2022.
In the Senate, the PREVENT Pandemics Act (S. 3799, as amended), which incorporates the
previously introduced Advanced Research Project Authority for Health Act (S. 3819) as Section
331, was ordered to be reported by the Senate HELP Committee on March 15, 2022.
H.R. 5585 is used as a comparator bill, as it was first introduced. The provisions are not presented
in the order they appear in the comparator bill, but rather are grouped categorically to facilitate
topical comparison of the proposals. Provision references are included in brackets. In some
instances, similar language is used in different categorical sections of the bills; such instances are
noted throughout the table.
Table A-1. Comparison of Key Provisions in ARPA-H Authorization Legislation
Advanced Research Projects
Advanced Research Projects Agency-
Authority for Health Act
Provision(s)
Health Act (H.R. 5585)
(Section 331 of S. 3799, as amended)
Authorization
Would amend Public Health Service Act
Would amend the PHSA, Title IV to add at
(PHSA), Title IV (National Research
the end “Subpart 3—Advanced Research
Institutes) to add at the end “Part J—
Projects Authority for Health,” which
Advanced Research Projects Agency-
includes one section, Section 483:
Health,” which includes one section, Section
Advanced Research Projects Authority for
499A: Advanced Research Projects Agency-
Health.
Health.

[H.R. 5585 §2]
[S.3799 §331]
Placement in
Placement: Would establish ARPA-H
Placement: Would establish ARPA-H
Federal
within the Department of Health and Human within NIH.
Government and Services (HHS) and, not later than 180 days
[Proposed PHSA §483(b)]
Organizational
after enactment, require the transfer of all
Structure
existing functions, personnel, missions,

activities, authorities, and funds of APRA-H
Organizational Structure: No similar
within NIH to the ARPA-H established by
provisions.
the bil .
[Proposed PHSA §499A(a)(1)]

Organizational Structure: Would
require ARPA-H to be organized to include
an Office of the Director; no more than six
program offices; and such special project
office as the Director may establish.
[Proposed PHSA §499A(a)(2)(A)].

Would also require that no fewer than two-
thirds of the program offices be exclusively
dedicated to research and development.
[Proposed PHSA §499A(a)(2)(B)].
Goals/Purpose
The stated goals of ARPA-H would be to:
The stated purpose of ARPA-H would be

to (key differences from H.R. 5585

foster the development of new,
breakthrough capabilities, technologies,
italicized):
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Advanced Research Projects
Advanced Research Projects Agency-
Authority for Health Act
Provision(s)
Health Act (H.R. 5585)
(Section 331 of S. 3799, as amended)
systems, and platforms to accelerate

support high-impact, cutting-edge
innovations in health and medicine that
research in biomedicine and broadly
are not being met by federal programs
applicable breakthrough technologies
or private entities;
that have the potential to significantly

revolutionize detection, diagnosis,
transform and advance areas of
mitigation, prevention, treatment and
biomedical science and medicine in a
curing of serious diseases and medical
manner that cannot readily be
conditions through the development of
accomplished through traditional
transformative health technologies;
biomedical research or commercial
activity; and

promote high-risk, high-reward
innovation for the development and

overcome long-term and significant
translation of transformative health
technological and scientific barriers to
technologies; and
advancing such technologies in order
to improve the prevention, diagnosis,

contribute to ensuring the United
mitigation, treatment, and cure of
States maintains global leadership in
health conditions.
science and innovation; the highest
quality of life and health for its citizens;
[Proposed PHSA §483(b)]
and an aggressive agenda for innovation
to address global health threats that
place U.S. citizens at risk.
[Proposed PHSA §499A(b)(1)]
Methods
Methods of the agency would include:
No similar category of provisions.

Comparable language in “Goals” and

discovering, identifying, and promoting
revolutionary advances in health
“Duties of the Director” sections.
sciences;


translating scientific discoveries into
transformative health technologies;

providing resources and support to
create platform capabilities that draw
on multiple disciplines;

using researchers in a wide range of
disciplines, including the life sciences,
the physical sciences, engineering, and
the computational sciences;

delivering advanced proofs of concept
that demonstrate clinically meaningful
advances;

developing new capabilities, advanced
computational tools, predictive models,
or analytical techniques to identify
potential targets and technological
strategies for early disease detection
and intervention;

accelerating transformational
technological advances in areas with
limited technical certainty; and

prioritizing investments based on such
considerations as scientific opportunity
and uniqueness of fit to the strategies
and operating practices of ARPA-H; the
effect on disease burden, including
unmet patient need, quality and
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Advanced Research Projects
Advanced Research Projects Agency-
Authority for Health Act
Provision(s)
Health Act (H.R. 5585)
(Section 331 of S. 3799, as amended)
disparity gaps, and the potential to
preempt progression of serious disease;
and the effect of the fiscal liability of the
federal government with respect to
health care and the ability to reduce the
cost of care through innovation.
[Proposed PHSA §499A(b)(2)]
ARPA-H
The ARPA-H Director position would be
The ARPA-H Director position would be
Director
established as fol ows:
established as fol ows (key differences from
Position

H.R. 5855 italicized):
Appointment: Appointed by the President.
Reports to the Secretary of HHS.
Appointment: Appointed by the
[Proposed PHSA §499A(c)(1), (3)]
President. Reports to NIH Director.

[Proposed PHSA §483(c)(1)]
Term: Five years. May be reappointed for

one consecutive term.
Term: Four years. May be reappointed for
[Proposed PHSA §499A(c)(5)]
up to one consecutive term at the discretion
of the President.

[Proposed PHSA §483(c)(3)]
Qualifications: An individual who, by
reason of professional background and

experience, is qualified to manage: (1)
Qualifications: Individual who, by
research and advanced development
professional background and experience, is
programs; and (2) large-scale, high-risk
qualified to advise the Secretary on, and
initiatives with respect to health research
manage research programs that advance
and technology development across multiple
the purposes of ARPA-H in, promoting
sectors, including generating transformative
biomedical and novel technology
health technologies and improving health
innovation, and who has demonstrated
outcomes for patients.
ability to identify and develop partnerships
[Proposed PHSA §499A(c)(2)]
to address strategic needs in meeting such
purposes.

[Proposed PHSA §483(c)(2)]
Autonomy Regarding
Recommendations and Testimony: No

U.S. officer or agency has authority to
Autonomy: No comparable provision.
require the Director of ARPA-H or any
other ARPA-H officer to submit legislative
recommendations, testimony, or comments
on legislation to any officer or agency for
approval prior to submission to Congress if
such materials include a statement indicating
that the views expressed are those of such
officer and do not reflect the views of the
President or another agency.
[Proposed PHSA §499A(c)(6)]
Duties and
Duties:
Duties: (grouped for comparison):
Authorities of

Approve and terminate the projects and Similar to H.R. 5585
the Director
programs of ARPA-H;

Approve all new programs within

Set research and development priorities
ARPA-H and terminate any program
with respect to ARPA-H goals and
within ARPA-H that is not achieving
manage the budget of ARPA-H;
its goals;
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Advanced Research Projects
Advanced Research Projects Agency-
Authority for Health Act
Provision(s)
Health Act (H.R. 5585)
(Section 331 of S. 3799, as amended)

Develop funding criteria and assess the

Establish strategic goals, objectives,
success of programs through the
and priorities for ARPA-H pursuant to
establishment of technical milestones;
ARPA-H’s purposes;

Advance ARPA-H goals through

Establish criteria for funding and
consideration of the advice of the
assessing the success of programs
ARPA-H Interagency Advisory
through the establishment of technical
Committee;
milestones; and

Solicit data, as needed, from NIH and

Facilitate coordination between HHS
other relevant entities;
and its agencies, and other relevant

federal departments and agencies.

Coordinate with the Director of NIH
to ensure that the programs of ARPA-H Different from H.R. 5585
build on and are informed by scientific

Ensure that applications for funding
research supported by NIH (see
disclose current and previous
“Cooperation and Coordination” below
research and development efforts,
for other relevant provisions);
including any scientific or technical

Coordinate with the heads of federal
barriers encountered in the course of
agencies and, to the extent practicable,
such efforts or challenges in securing
ensure that the activities of ARPA-H
funding;
supplement (and do not supplant) the

Support transformative, translational,
efforts of other federal agencies (see
applied, and advanced research in
“Cooperation and Coordination” below
areas of biomedical science to address
for other relevant provisions); and
specific technical or scientific

Ensure that ARPA-H does not provide
questions by (1) prioritizing
funding for a project unless the
investments based on scientific
program manager determines that the
potential and impact on the field of
project meets ARPA-H goals.
biomedicine, especial y in areas that
[Proposed PHSA §499A(c)(4)]
require public-private partnerships; (2)
translating scientific discoveries and

cutting-edge innovation into
Authorities:
technological advancements; (3)

Delegate authorities, except the
encouraging opportunities to develop
appointment of the Deputy Director;
broadly applicable technologies using a
multi-disciplinary approach; and (4)
[Proposed PHSA §499A(c)(7)]
making investments in high-risk, high-

Appoint a Deputy Director to serve as
reward research that may have
the first assistant to the office; and
application for medicine and health
[Proposed PHSA §499A(c)(8)]
(H.R. 5585 includes similar language in
“Methods” category);

Waive Paperwork Reduction Act

Encourage strategic col aboration and
requirements with respect to ARPA-H
partnerships with a broad range of
methods (subsection (b)(2)).
entities, including academia, industry,
[Proposed PHSA §499A(d)]
and non-profit organizations (H.R.

5585 lists partnering with other
entities in “Program Managers”
category); and

Ensure that the United States
maintains global leadership in
researching and developing health
technologies (H.R. 5585 includes
similar language in the “Goals”
category).
[Proposed PHSA §483(c)(4)]

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Advanced Research Projects
Advanced Research Projects Agency-
Authority for Health Act
Provision(s)
Health Act (H.R. 5585)
(Section 331 of S. 3799, as amended)
Authorities: No additional authorities
specified.

Funding Awards
The ARPA-H Director would be authorized
The ARPA-H Director would be
to make awards in the form of grants,
authorized to make awards in the form of
contracts (including multi-year contracts),
grants, contracts (including multi-year
cooperative agreements, prizes, and other
contracts), cooperative agreements, prizes,
transactions.
and other transactions. Defines “other

transactions” to mean “transactions, other
than procurement contracts, grants, and
Grants and cooperative agreements awarded cooperative agreements.” (by reference to
would be subject to the uniform
PHSA §319L(a)(3) in the Proposed PHSA
administrative requirements, cost principles,
§483(a)(3)).
and audit requirements for federal awards
under part 200 of Title 2, Code of Federal
[Proposed PHSA §483(e)(1)]
Regulations. Total line-item and itemized

facilities and administrative costs would be
Would allow the ARPA-H Director to use
required to be made publicly available and
authorities and processes under the
published in a machine-readable format.
Stevenson-Wydler Technology Innovation

Act of 1980 (15 U.S.C. §3719) for prize
Contracts awarded would be subject to
competitions (H.R. 5585 references the
Federal Acquisition Regulation.
Stevenson-Wydler definition for “prize” in
the Definitions section).

[Proposed PHSA §483(e)(3)]
Funded research would not be subject to
NIH peer review or advisory council review

or approval.
Funded research would not be subject to
[Proposed PHSA §499A(h)]
NIH peer review or advisory council
review or approval.

[Proposed PHSA §483(e)(5)]
In accordance with existing federal
requirements as specified, the ARPA-H

Director would be required to only award
Would require the ARPA-H Director to
new awards to recipients who do not have
ensure that ARPA-H does not provide
more than three ongoing ARPA-H awards.
funding for a research program or project
[Proposed PHSA §499A(o)(4)]
unless the applicant demonstrates that it
has made sufficient unsuccessful attempts

to secure private financing, and that there
Domestic Prioritization: In making
is a lack of significant private support for
awards, the ARPA-H Director would be
the program or project. In addition, the
required to prioritize domestic recipients
ARPA-H Director would be required to
conducting research on transformative
ensure that the program or project is in
health technology in the United States. As
the best interests of the United States and
appropriate and practicable, the Director
has the potential to significantly transform
would be required to ensure that
and advance biomedicine.
nondomestic recipients are conducting
[Proposed PHSA §483(f)(2)]
research in col aboration with a domestic
recipient.

Domestic Prioritization: No similar
provisions. (Note: May fol ow NIH policy
The ARPA-H Director would not be allowed for foreign award eligibility, see NIH,
to make awards to nondomestic recipients
“Who is Eligible?”
organized under the laws of Russia, Iran,
https://grants.nih.gov/grants/who-is-
North Korea, China or other countries as
eligible.htm).
determined to be a covered foreign country

Congressional Research Service

17

ARPA-H: Congressional Action and Selected Policy Issues

Advanced Research Projects
Advanced Research Projects Agency-
Authority for Health Act
Provision(s)
Health Act (H.R. 5585)
(Section 331 of S. 3799, as amended)
under section 119C of the National Security
Act of 1947.
[Proposed PHSA §499A(o)]
Other
ARPA-H Director would be authorized to
The ARPA-H Director would be
Transactions,
award other transactions.
authorized to enter into other
Follow-on
[Proposed PHSA §499A(h)(1)(E)]
transactions.
Production,
[Proposed PHSA §483(e)(1)]
Technology

Transfer, and
Follow-On Production Award

Procurement
Authority: An “other transaction” entered
To the maximum extent practicable,
and
into may provide for the award of a fol ow-
competitive procedures would be required
Demonstration
on production contract or transaction,
when entering into other transactions to
either to the participants in the transaction
carry out projects.
by ARPA-H or another federal agency. For
Would authorize other transaction
the purposes of this authority, “other
authorities to be exercised for a project if
transaction” would include all individual
the project manager submits a proposal to
subprojects awarded under the transaction
the ARPA-H Director for each use of such
to a consortium of United States industry
authority before conducting or supporting
and academic institutions.
a project, including why other transaction
A fol ow-on production contract may be
authority is essential to project success.
awarded without the use of competitive
The project manager must receive approval
procedures (as defined in federal
from the ARPA-H Director before using
requirements) if (1) competitive procedures
other transaction authority, and then must
were used for the selection of parties for
report to the Director on project activities
participation in the other transaction; and (2) for each fiscal year in which the project
the participants in the other transaction
manager used the authority.
successful y completed the project provided
[Proposed PHSA §483(e)(2)]
for in the transaction.

As a precondition, the ARPA-H Director
would be allowed to award a fol ow-on
Procurement and Demonstration:
production contract or transaction when the The ARPA-H Director would have
Director determines that the individual
authority to seek opportunities to partner
project or subproject as a part of a
with procurement programs of other
consortium is successful y completed by the
federal agencies to demonstrate
participants. However, the award may not
technologies resulting from ARPA-H
be made contingent on successful
activities.
completion of all activities within a
[Proposed PHSA §483(e)(4)]
consortium. Contracts and other

transactions under this authority may be
Technology Transfer Office: No
awarded pursuant to existing federal
comparable provisions.
procurement law or under such procedures,
terms, and conditions as the Director may

establish by regulation.
[Proposed PHSA §499(s)]

Technology Transfer Office: The ARPA-
H Director would be allowed to establish an
Office of Technology Transfer to facilitate
the transfer of federally-owned or federally-
originated technology to recipients of an
ARPA-H award (other than federal
government entities).
[Proposed PHSA §499(r)]
Congressional Research Service

18

ARPA-H: Congressional Action and Selected Policy Issues

Advanced Research Projects
Advanced Research Projects Agency-
Authority for Health Act
Provision(s)
Health Act (H.R. 5585)
(Section 331 of S. 3799, as amended)
Confidentiality
The fol owing types of information col ected
Would provide that nothing in the new
and Protection
by ARPA-H from award recipients would be
ARPA-H PHSA section is to be construed
of Information
considered commercial and financial
as authorizing disclosure of trade secrets
information from a person, which is not
or other privileged or confidential
subject to disclosure under the Freedom of
information under FOIA or other laws.
Information Act (FOIA; 5 U.S.C. §552(b)(4)):
[Proposed PHSA §483(j)(1)]

Plans for commercialization of

technologies developed under the
award, including business plans,
technology-to-market plans, market
studies, and cost and performance
models;

Investments provided to an awardee
from third parties, including amounts
and the percentage of ownership of the
awardee provided in return for the
investments;

Additional financial support that the
awardee (1) plans to invest or has
invested in the technology developed
under the award, or (2) is seeking from
third parties; and

Revenue from the licensing or sale of
new products or services resulting from
research conducted under the award.
[Proposed PHSA §499(e)]
Facilities
The ARPA-H Director would have the
The ARPA-H Director would have the
authority to:
authority to (key differences from H.R.

5855 italicized):

Acquire (by purchase, lease,
condemnation, or otherwise),

Acquire (by purchase, lease,
construct, improve, repair, operate, and
condemnation, or otherwise),
maintain such real and personal
construct, improve, repair, operate,
property as are necessary; and
and maintain such real and personal

property as are necessary; and

Lease any nonexcess real property and
related personal property under the

Lease an interest in property for not
jurisdiction of ARPA-H.
more than 20 years, notwithstanding
The Director would be required to deposit
Section 1341(a)(1) of title 31, United
amounts received for a lease into the ARPA-
States Code.
H account as discretionary offsetting
[Proposed PHSA §483(h)(1)]
col ections, and such amounts would be

available to the extent, and in the amounts
provided in advance appropriations acts, to
Would require that ARPA-H, including its
cover ARPA-H costs for the lease and for
headquarters, not be located near the
maintenance and other property
National Capital Region and not on any part
improvements as specified.
of the NIH campus. Would require the
ARPA-H Director to consider
[Proposed PHSA §499A(i)]
characteristics of the intended location and
Would require that ARPA-H, including its
the extent to which such location would
headquarters, not be located on any part of
facilitate advancement of ARPA-H’s
the existing NIH campus. Would require the
purposes.
ARPA-H Director to consider characteristics [Proposed PHSA §483(h)(2)]
of the intended location and the extent to

Congressional Research Service

19

ARPA-H: Congressional Action and Selected Policy Issues

Advanced Research Projects
Advanced Research Projects Agency-
Authority for Health Act
Provision(s)
Health Act (H.R. 5585)
(Section 331 of S. 3799, as amended)
which such location would facilitate
advancement of ARPA-H’s purposes.
[Proposed PHSA §499A (i)(4)]
Personnel
Would grant the ARPA-H Director the
Similar to H.R. 5585:
Authorities
authority to waive certain civil service
Would grant the ARPA-H Director the
personnel requirements in making and
authority to waive certain civil service
rescinding scientific, medical, and
personnel requirements in making and
professional personnel appointments.
rescinding scientific, medical, and
Would grant the ARPA-H Director the
professional personnel appointments.
ability to use existing hiring authorities
[Proposed PHSA §483(d)(4)(A)]
granted to the Secretary of HHS to hire
administrative, financial, contracts, legislative

affairs, information technology, ethics, and
In making personnel or staff appointments,
communications staff as necessary.
the ARPA-H Director would be authorized
The ARPA-H Director would also be
to consider as appropriate factors such
directed to make efforts to recruit and
factors as populations that are traditionally
retain a diverse workforce, including
underrepresented in the biomedical
individuals underrepresented in science and
research enterprise.
medicine and racial and ethnic minorities (as
[Proposed PHSA §483(d)(3)(B)]
long as such efforts comply with applicable

federal civil rights law).
The ARPA-H Director would be
The ARPA-H Director would also be
authorized to contract with private
authorized to contract with private entities
recruiting firms for hiring of qualified
in hiring qualified personnel.
technical staff.
Would allow the ARPA-H Director to use
[Proposed PHSA §483(d)(4)(D)]
the Intergovernmental Personnel Act to staff

ARPA-H with employees from other federal
agencies, state and local governments, Indian
Different from H.R. 5585
tribes and tribal organizations, institutions of
Would require the ARPA-H Director to
higher education, and other organizations.
ensure that personnel appointed to staff or
Would al ow the ARPA-H Director to
support ARPA-H are individuals who, at
accept detailees from other federal agencies
the time of appointment and for three
for a period of up to three years.
years prior to such appointment, were not
employed by NIH.
[Proposed PHSA §499A(j)]
[Proposed PHSA §483 (d)(4)(E)(i)]

The ARPA-H Director would be
authorized to appoint no more than 120
personnel under the agency’s hiring
authority. The ARPA-H Director would be
required to notify Congress if he/she
determines that additional personnel are
required.
[Proposed PHSA §483 (d)(4)(E)(i )]
Program
Recruitment: Would require the ARPA-H
Recruitment: In designating program
Managers
Director to recruit program managers with
managers, the ARPA-H Director would be
expertise in a wide range of disciplines,
required to consider individuals with
including life sciences, physical sciences,
demonstrated scientific expertise and
engineering, and computational sciences.
management skil s required to advance
[Proposed PHSA §499A(j)(3)(C)]
ARPA-H and who represent a diverse set
of professional experiences or

backgrounds, including experience in
Term: Three years. May serve two terms.
Congressional Research Service

20

ARPA-H: Congressional Action and Selected Policy Issues

Advanced Research Projects
Advanced Research Projects Agency-
Authority for Health Act
Provision(s)
Health Act (H.R. 5585)
(Section 331 of S. 3799, as amended)

academia, industry, government, nonprofit
Duties:
organizations, or other sectors.

[Proposed PHSA §483(d)(3)(A)]

Establish research and development
goals for programs, including timelines

and milestones, in consultation with the
Term: Three years. May serve two terms.
Director, and make such goals publicly
available;
[Proposed PHSA §483(d)(C)]


Col aborate with experts from NIH and
other federal agencies and experts in
Duties (grouped for comparison):
relevant scientific fields to identify
Similar to H.R. 5585
research and development gaps and

Establish research and development
opportunities;
goals for the programs in consultation

Convene workshops and meetings, as
with the Director, including timelines
needed, with entities such as patients,
and milestones, and make such goals
patient advocacy groups, practitioners,
available to the public;
professional societies, and other

Communicate with leaders in the
stakeholders to solicit input on
health care and biomedical research
programs and goals;
and development fields, from both the

Manage applications and proposals for
public and private sectors,
making grants, cooperative agreements,
representatives of patient
contracts, prizes and other transaction
organizations, institutions of higher
awards for advanced research that may
education, and nonprofit organizations
show particular promise, especial y in
to identify areas of need and scientific
areas in which the federal government
opportunity with the potential to
and the private sector may not have
transform biomedicine.
undertaken sufficient research;

Select the projects to be supported

Issue funding opportunity
under the program after considering:
announcements using uniform
(1) the novelty and scientific and
administrative processes;
technical merit of the proposed

project; (2) the demonstrated

Select, on the basis of merit, each of the
projects to be supported under a
capabilities of the applicants; (3)
program carried out by ARPA-H, taking
potential future commercial
into consideration the scientific and
applications as proposed; (4) the
technical merit of the proposed
degree to which the project addresses
projects; the capabilities of the
a scientific or technical question and
applicants to successful y carry out the
has the potential to transform
proposed project; the unmet needs or
biomedicine; and (5) other criteria as
ability to improve outcomes within
established by the ARPA-H Director;
patient populations; future commercial

Encourage research col aborations,
applications of the project or feasibility
including by identifying and supporting
of partnering with one or more
applicable public-private partnerships;
commercial entities; the potential for
and
interdisciplinarity of the approach of the  Recommend program restructuring,
project; and such other criteria as are
expansion, or termination of research
established by the ARPA-H Director;
projects or whole projects, as
and
necessary.

Conduct project reviews within 18

months of funding awards to identify
milestones and monitor progress of
Different from H.R. 5585
such milestones with respect to each

Provide project oversight and
project and prior to the disbursement
management of strategic initiatives to
of new funds;
advance the purpose of the program.

Congressional Research Service

21

ARPA-H: Congressional Action and Selected Policy Issues

Advanced Research Projects
Advanced Research Projects Agency-
Authority for Health Act
Provision(s)
Health Act (H.R. 5585)
(Section 331 of S. 3799, as amended)

Provide recommendations to the
[Proposed PHSA §483(d)(2)(B)]
ARPA-H Director with respect to
advancing the goals of the agency;

Cultivate opportunities for the
commercial application or community
use of successful projects, including
through the establishment of
partnerships between or among
awardees;

Identify innovative cost-sharing
arrangements for ARPA-H projects;

Provide recommendations to expand,
restructure, or terminate research
partnerships or projects; and

Ensure that animal studies meet
requirements in the Public Health
Service Policy on Humane Care and
Use of Laboratory Animals, and
applications apply statistical modeling
approaches and appropriately justify
animal sample sizes to meet project
goals.
[Proposed PHSA §499A(k)]
Coordination
Would require the ARPA-H Director to
Would require the ARPA-H Director to
and Cooperation share timely and relevant information with
ensure, to the maximum extent
the Administrator of the Centers for
practicable, that ARPA-H activities are
Medicare & Medicaid Services (CMS) that
coordinated with and do not duplicate
may help to expedite determinations of
efforts of: (1) other HHS programs,
coverage of transformative health
including NIH and the Biomedical
technologies developed by ARPA-H.
Advanced Research and Development
[Proposed PHSA §499A(f)]
Authority (BARDA) programs, and (2)
other relevant efforts or research operated

or overseen by other federal departments
Would authorize the HHS Secretary,
and agencies.
through the Commissioner of Food and
[Proposed PHSA §483(f)(1)]
Drugs and in consultation with the ARPA-H
Director, to take actions to facilitate the

translation of transformative health
Would authorize the FDA to meet with
technologies into solutions for patients and
ARPA-H and appropriate federal partners
to expedite the development of drugs,
such as BARDA at appropriate intervals to
devices, and biological products, including
discuss the development status and actions
through:
that may be taken to facilitate the

development of medical products and

Helping to ensure that drug, device, or
biological product development
projects that are of highest priority for
programs gather the nonclinical and
ARPA-H. Would require the ARPA-H
clinical data necessary to advancing the
Director to reimburse FDA for FDA
development of such products and to
activities conducted under the authority of
obtaining their approval, licensure, or
the section.
clearance by the U.S. Food and Drug
[Proposed PHSA §483(f)(4)]
Administration (FDA);


Expediting review of investigational new

drug applications, review of

investigational device exemptions, and
review of applications for approval
Congressional Research Service

22

ARPA-H: Congressional Action and Selected Policy Issues

Advanced Research Projects
Advanced Research Projects Agency-
Authority for Health Act
Provision(s)
Health Act (H.R. 5585)
(Section 331 of S. 3799, as amended)
licensure, and clearance of drugs,
devices, or biological products; and

Meeting at appropriate intervals with
the ARPA-H Director and any member
of the ARPA-H Interagency Research
Council to discuss the development
status of drugs, devices, or biological
products that the highest priorities to
the ARPA-H Director, unless
determined the meetings are not
necessary.
The authority is not to be construed as
limiting FDA’s authority with respect to
drugs, devices, or biological products.
The ARPA-H Director may reimburse FDA
for related expenditures.
[Proposed PHSA §499A(g)]
Advisory
Advisory Committee: Would require the
Advisory Committee: Would establish
Committee
ARPA-H Director to establish an interagency an ARPA-H Interagency Advisory
advisory committee—the ARPA-H
Committee to coordinate efforts and
Interagency Research Council—tasked with
provide advice and assistance on specific
advising the Director, including by making
program or project tasks and the overall
recommendations on research priorities that direction of ARPA-H. Members would
would provide the greatest return on
include the heads of the fol owing agencies
investment with respect to improving human or their designees: NIH, CDC, FDA, ASPR,
health, avoiding duplication of efforts in the
HHS Office of the Assistant Secretary of
federal government, and improving
Health, DARPA, the DOE Office of
coordination with other federal agencies;
Science, NSF, and any other agency with
and identifying and developing strategies to
subject matter expertise that the ARPA-H
address regulatory, reimbursement, and
Director determines appropriate. The
market barriers to commercialization or
Federal Advisory Committee Act (5 U.S.C.
adoption of transformative health
App.) would not apply to this committee. The
technologies, including technologies intended Committee would be advisory in nature
to preempt serious disease. Members could
only.
include (1) the heads of several HHS
[Proposed PHSA §483(g)]
operating divisions or their designees,
including NIH, FDA, CMS, BARDA, the

Centers for Disease Control and Prevention
Other Advice: Would also authorize the
(CDC), the National Center for Advancing
ARPA-H Director to seek input from
Translational Sciences [part of NIH], the
PCAST; representatives of professional or
Agency for Healthcare Research and Quality, scientific organizations with expertise in
the Office of Minority Health, the Assistant
technology under consideration or
Secretary for Preparedness and Response
development by ARPA-H; and
(ASPR), the Health Resources and Services
representatives of patient organizations,
Administration; (2) the Director of Office of
public health, innovators, and other public
Science and Technology Policy; (3) Director
and private entities.
of DARPA; (4) the Director of the National
[Proposed PHSA §483(f)(3)]
Science Foundation (NSF); (5) the Director
of the Office of Science of the Department
of Energy (DOE); (6) Director of the
Advanced Research Projects Agency-Energy
(ARPA-E); and (7) representatives of any
federal agency with subject matter expertise
Congressional Research Service

23

ARPA-H: Congressional Action and Selected Policy Issues

Advanced Research Projects
Advanced Research Projects Agency-
Authority for Health Act
Provision(s)
Health Act (H.R. 5585)
(Section 331 of S. 3799, as amended)
as determined by the ARPA-H Director. The
Council would be advisory in nature only.
The council would be required to meet one
year after enactment, then, during
subsequent fiscal years, the Director would
convene the committee as needed. The
Council may function through established or
ad-hoc committees, task forces, or
interagency groups to share information on
health innovations funded by ARPA-H and
receive input on areas of particular promise
for ARPA-H projects.
[Proposed PHSA §499A(q)]
Other Advice: Would also authorize the
ARPA-H Director to consult with the
President’s Committee of Advisors on
Science and Technology (PCAST); peers in
the scientific community, including academia
and industry; an existing advisory committee
providing advice to the HHS Secretary or
head of other HHS operating division; the
new interagency research council (above);
and any other entity the Director may deem
appropriate.
[Proposed PHSA §499A(p)]
Annual Report
Annual Report: Beginning not later than
Annual Report: As part of the annual
and Strategic
one year after the date of the enactment,
budget request submitted for each fiscal
Plan
and each fiscal year thereafter, the ARPA-H
year, the ARPA-H Director would be
Director would be required to submit a
required to provide Congress a report
report to Congress on the actions
describing:
undertaken, and results generated, by ARPA-
(1) Projects supported by ARPA-H during
H, including:
the previous fiscal year including the stage
(1) A description of projects supported by
of development and details as to whether
ARPA-H in the previous fiscal year and
the project is meeting its milestones;
whether such projects are meeting the goals
(2) Projects supported by ARPA-H during
developed by the Director;
the previous fiscal year that were
(2) A description of projects terminated in
terminated and the reasons for
the previous fiscal year, and the reason for
termination;
such termination;
(3) Projects supported by ARPA-H during
(3) A description of projects starting in the
the previous fiscal year that examine topics
next fiscal year, as available;
and technologies related to other activities
(4) Activities conducted in coordination with funded by HHS, including an analysis of
other federal agencies;
whether in supporting such projects, the
ARPA-H Director is in compliance with
(5) An analysis of the extent of coordination
relevant requirements; and
with NIH and CMS, including successes and
barriers with respect to achieving the goals
(4) Current, proposed, and planned
of the agency.
projects to be carried out.
(6) A description of the demographic
[Proposed PHSA §483(k)(1)]
diversity (including racial and gender) if

available of direct recipients and performers
Strategic Plan: Not later than 180 days
in funded projects and of the ARPA-H
after the appointment of the first ARPA-H
workforce; and
Director, and every four years thereafter, the
ARPA-H Director would be required to
Congressional Research Service

24

ARPA-H: Congressional Action and Selected Policy Issues

Advanced Research Projects
Advanced Research Projects Agency-
Authority for Health Act
Provision(s)
Health Act (H.R. 5585)
(Section 331 of S. 3799, as amended)
(7) Disclosure by the reward recipient of
submit to Congress a plan describing the
whether the principal investigators named on strategic plan that ARPA-H wil use to
the award participate in foreign talent
guide future investments over the fol owing
programs, including the provision of copies
four fiscal years. Every two years after
of all grants, contracts, or other agreements
initial submission, the ARPA-H Director
or supporting documentation related to such would be required to submit a
programs as a condition of receipt of federal
supplemental strategic plan that details any
biomedical research funds.
changes. Requirements for NIH Institute
[Proposed PHSA §499A(l)(1)]
and Center strategic plans would not apply
to ARPA-H.
Strategic Plan: Not later than one year
[Proposed PHSA §483(k)(2)]
after the date of the enactment, and every
three years thereafter, the ARPA-H

Director would be required to provide

Congress a strategic plan describing how

ARPA-H wil carry out investments each
fiscal year in the next three-year period.
[Proposed PHSA §499A(m)]
Evaluation and
Evaluation by the National Academies
NASEM Evaluation: Not later than three
Performance
of Sciences, Engineering, and Medicine
years after enactment, the ARPA-H Director
Measurement
(NASEM): Not later than five years after
would be required to enter into a contract
the date of enactment, the Secretary of HHS
with NASEM for an evaluation of ARPA-H,
would be required to enter into an
including the goals and purposes of ARPA-
agreement with NASEM to study and
H and the degree to which ARPA-H
evaluate whether ARPA-H has met its goals.
activities support and align with such goals
NASEM would be required to submit the
and purposes. The evaluation may include
results of the evaluation to Congress and the (1) recommendations to improve ARPA-H,
Secretary of HHS.
which may include lessons learned from
[Proposed PHSA §499A(l)(2)]
other advanced research and development
agencies or authorities in HHS or
elsewhere in the federal government; (2)
lessons learned from ARPA-H’s
establishment and their applicability to
other HHS programs, and (3) an analysis of
whether ARPA-H projects were duplicative
of other research programs supported by
HHS or other federal agencies. NASEM
would be required to submit the evaluation
to Congress and make it publicly available.
[Proposed PHSA §483(l)]

Performance Measures Framework:
Would require the ARPA-H Director, in
consultation with the advisory committee,
to develop a performance measures
framework for ARPA-H programs and
projects in order to facilitate evaluation
required under subsection (m), including
data needed to perform such evaluation as
consistent with the NASEM evaluation.
[Note: There appears to be drafting error
as subsection (m) is an authorization of
appropriations.]
[Proposed PHSA §483(g)(5)]
Congressional Research Service

25

ARPA-H: Congressional Action and Selected Policy Issues

Advanced Research Projects
Advanced Research Projects Agency-
Authority for Health Act
Provision(s)
Health Act (H.R. 5585)
(Section 331 of S. 3799, as amended)

Other Reports
Independent Review: Not later than one
Report on Personnel: The ARPA-H
year after enactment and every three years
Director would be required to maintain
thereafter, the Government Accountability
records regarding the use of ARPA-H
Office (GAO) would conduct an
personnel authorities, including the number
independent review of the research portfolio of positions fil ed with such authorities,
of HHS, including ARPA-H, NIH, FDA, and
types of appointments, demographic
BARDA, to assess the degree of unnecessary information, and other specified
duplication of existing federal programs and
information. Not later than one year after
projects; and to make recommendations
enactment and annually thereafter, the
regarding any potential reorganization,
Director would be required to submit a
consolidation, or termination of such
report to specified congressional
program and projects.
committees on the total number of
[Proposed PHSA §499A(n)]
appointments fil ed and how the positions
relate to ARPA-H’s purposes.
[Proposed PHSA §483(d)(4)(B)-(C)]

GAO Report on Personnel: Not later
than two years after enactment, GAO
would be required to report to Congress
on the use of ARPA-H personnel
authorities, including on the number of
positions, the types of appointments, how
the positions relate to ARPA-H’s mission,
how the appointments were made, sources
used for identifying candidates, and
aggregate demographic information. Would
also require GAO to report on any
challenges, limitations, or gaps related to
the use of personnel authorities, and any
related recommendations.
[Proposed PHSA §483(d)(4)(F)]

Confidentiality Clarification and
Reporting: Beginning not later than one
year after the date of enactment, and each
fiscal year thereafter, the ARPA-H
Director would be required to submit a
report to Congress on the number of
times the Secretary has used the authority
to withhold information from disclosure
and the nature of any request for
information that was denied.
[Proposed PHSA §483(j)]
Funding
Would authorize to be appropriated $500
Would authorize the appropriation of such
mil ion for each of FY2023 through FY2027
sums as may be necessary for each of
to remain available until expended.
FY2023 through FY2027.
[Proposed PHSA §499A(v)(1)]
[Proposed PHSA §483(m)]

Would authorize the use of not more than
15 percent of the amounts made available to
Would provide that any budget request for
ARPA-H for any fiscal year for administrative ARPA-H be separate from other NIH
expenses to operate ARPA-H.
budget requests.
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ARPA-H: Congressional Action and Selected Policy Issues

Advanced Research Projects
Advanced Research Projects Agency-
Authority for Health Act
Provision(s)
Health Act (H.R. 5585)
(Section 331 of S. 3799, as amended)
[Proposed PHSA §499A(v)(2)]
[Proposed PHSA §483(n)]

Definitions
Advanced Proofs of Concept: data, a
No definitions for these terms, although
prototype, or other experimental evidence
definitions provided for other specified
that may precede the development of
terms as noted elsewhere.
transformative health technologies and
[Proposed PHSA 483(a)]
demonstrates the feasibility of a new
concept.

Transformative Health Technology: a
drug, biological product, intervention,
platform, tool, or device that should be
prioritized to detect, diagnose, mitigate,
prevent, cure, or treat a serious disease or
medical condition for which there are unmet
needs; and for which significant scientific
uncertainty and regulatory risk exist, or
incentives in the commercial market are
unlikely to result in the adequate or timely
development of such drug, biological
product, intervention, platform, tool, or
device.
Also references existing terms in statute for
“biologic product,” “drug,” “device,” “federal
acquisition regulation,” “federal agency,” and
“prize.”
[Proposed PHSA §499A(u)]
Source: CRS analysis of H.R. 5585, as passed by the House on June 22, 2022, at Congress.gov and text of the
amendment in the nature of a substitute to S. 3799 at
https://www.help.senate.gov/imo/media/doc/PREVENT%20Pandemics%20Managers.pdf.
Notes: H.R. 5585 serves as the baseline for comparison.

Author Information

Kavya Sekar
Marcy E. Gallo
Analyst in Health Policy
Analyst in Science and Technology Policy

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ARPA-H: Congressional Action and Selected Policy Issues

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Congressional Research Service
R47074 · VERSION 3 · UPDATED
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