Advanced Research Projects Agency for Health April 15, 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 creates a new ARPA-H account at HHS, with funding available until
Technology Policy
September 30, 2024, and allows 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 cancer, Alzheimer’s disease, diabetes, and other diseases.
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 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 introduced in the 117th Congress would codify and further delineate ARPA-H’s goals, structure, placement,
activities, and authorities. These include H.R. 5585 and H.R. 6000 introduced in the House and S. 3819 introduced in the
Senate. Subsequently, 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. 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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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 provides $1 billion to a new
Department of Health and Human Services (HHS) account to establish ARPA-H. In addition,
several bills have been introduced that would codify ARPA-H and define its goals, scope,
placement, activities, and authorities (e.g., H.R. 5585, H.R. 6000, 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 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
maintaining the economic competitiveness of the United States.6 In addition, the recent rapid

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/.
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/
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development of safe and effective Coronavirus Disease 2019 (COVID-19) vaccines based on
novel technologies such as 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
authorize 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
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

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.
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?
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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]).
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, 2025.18 The
FY2023 request reiterates the same vision for ARPA-H as in the FY2022 request, and also notes

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.
18 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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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
Moonshot is another one of President Biden’s major policy priorities related to biomedical
research.19
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:20
 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: 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 and Medicaid Services (CMS). Participants also
emphasized the need to partner and consult with diverse private, academic, and
public sector entities.

19 NIH, Congressional Justification: FY2023, pp. 4-13.
20 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.
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HHS ARPA-H Placement Decision
As discussed below, 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. In addition, the
Secretary was required 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 is to reside within NIH,
while the ARPA-H Director is to report directly to the HHS Secretary.
See Lev Facher, “Biden’s High-Stakes Biomedical Science Agency ARPA-H Wil Be Part of the NIH—But There’s a
Twist,” STAT, March 31, 2022.
Congressional Action
Appropriations
On March 15, 2022, the Consolidated Appropriations Act, 2022 (P.L. 117-103) was signed into
law. It provides $1 billion in appropriations to a new account at HHS for ARPA-H, with funding
available until September 30, 2024.21 Unlike earlier ARPA-H appropriations proposals, the law
does 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;22
 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.23
Earlier appropriations proposals included higher funding levels for ARPA-H, but conditioned
funding on authorizing legislation. However, these proposals were not enacted. The Consolidated
Appropriations Act, 2022 (H.R. 4502),24 which passed the House on July 29, 2021, would have
provided $3 billion for ARPA-H in a new account at NIH available until September 30, 2024,
with the condition that funds would be available only if legislation specifically establishing
ARPA-H were enacted into law. Separately, the Senate-introduced Departments of Labor, Health

21 Title II, Division H of Consolidated Appropriations Act, 2022 (P.L. 117-103).
22 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.
23 See U.S. Congress, House Committee on Rules, Division H- LHHS Appropriations 2022, Explanatory Statement,
committee print, 117th Cong., 1st sess., p. 119.
24 H.R. 4502 contains the text of seven regular appropriations bills reported by the House Appropriations Committee:
H.R. 4502 (Labor-HHS-Education) (Div. A), H.R. 4356 (Agriculture) (Div. B), H.R. 4549 (Energy-Water) (Div. C),
H.R. 4345 (Financial Services) (Div. D), H.R. 4372 (Interior) (Div. E), H.R. 4355 (Military Construction and Veterans
Affairs) (Div. F), and H.R. 4550 (Transportation-HUD) (Div. G).
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and Human Services, and Education, and Related Agencies Appropriations Act, 2022 (S. 3062)
would have provided $2.4 billion for ARPA-H available through September 30, 2024, also with
the condition that funds would be available only if legislation specifically establishing ARPA-H
were enacted into law.25
Authorizations
House: 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 House-passed version on November 19, 2021, however,
did not include ARPA-H related language.
Two other bills to authorize ARPA-H have been introduced in the House. Representative Anna
Eshoo, chair of the House Energy and Commerce (E&C) Health Subcommittee, introduced the
Advanced Research Project Agency–Health Act (H.R. 5585) on October 15, 2021. This
standalone bill would authorize and establish ARPA-H within HHS. 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).
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 H.R. 6000) 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.26 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

25 The text of the Senate majority draft Labor-HHS-Education bill and accompanying committee report is linked to the
press release “Chairman Leahy Releases Remaining Nine Senate Appropriations Bills,” October 18, 2021,
https://www.appropriations.senate.gov/news/majority/chairman-leahy-releases-remaining-nine-senate-appropriations-
bills. See also “Shelby: Democrats’ Partisan Bills Threaten FY22 Appropriations Process,” October 18, 2021,
https://www.appropriations.senate.gov/news/shelby-democrats-partisan-bills-threaten-fy22-appropriations-process.
26 Azoulay et al., “Funding Breakthrough Research: Promises and Challenges of the ‘ARPA Model,’” pp. 9-10.
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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 as discussed below.
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.27 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.28 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
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.29
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.”30
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.31 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.32 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.33 Regardless of
where the new agency is placed, it would likely need to consult with NIH programs, HHS

27 Collins et al., “ARPA-H: Accelerating Biomedical Breakthroughs.”
28 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.
29 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.
30 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.
31 White House, Advanced Research Project Agency for Health (ARPA-H): Concept Paper, p. 4.
32 HHS, “InnovationX,” https://www.hhs.gov/ash/osm/innovationx/index.html.
33 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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programs such as BARDA, as well as biomedical programs at DOD and FDA to promote
collaboration and avoid duplication.
The authorizing bills in the House (H.R. 5585 and H.R. 6000) 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 H.R. 6000 and 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: (1) would prohibit ARPA-H from being located on the NIH
campus and in close proximity to the National Capital Region and (2) would 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).
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.34 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.”35 All 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 and H.R. 6000 would authorize a
five-year appointment term for the ARPA-H Director while S. 3799, as amended, would authorize
a four-year term. All bills would allow for one consecutive term. All 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 the development and application of 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.36 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

34 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.
35 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.
36 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.’”
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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.”37 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.38
The ARPA-H bills (H.R. 5585, H.R. 6000, and S. 3799, as amended) define overall agency goals
similarly, with some variations (see Table A-1). All the bills emphasize breakthrough biomedical
technologies and innovation in ARPA-H’s proposed statutory goals. None of the bills establish
ARPA-H to focus on specific diseases or areas of research. Differences in ARPA-H goals among
the bills include that H.R. 5585 names ensuring U.S. global leadership as an overall goal; that
H.R. 6000 mentions reducing the human and economic cost of disease; and that S. 3799, as
amended, focuses on advancements that cannot be readily accomplished through traditional
commercial or research activity.
Some have expressed concern about the potentially broad scope of ARPA-H.39 All 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.40 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.41 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.
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. 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 “Advice” 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. In addition, all
three bills would require ARPA-H to coordinate with the FDA to expedite and facilitate the

37 Collins et al., “ARPA-H: Accelerating Biomedical Breakthroughs.”
38 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.
39 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/.
40 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.
41 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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transformation and development of ARPA-H activities into medical products and solutions for
patients.
There is also concern about duplicating commercial or philanthropic research efforts. 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
duplication during its program development cycle.”42 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) provides 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.43 It is also lower than the
authorized amounts included in H.R. 5585 and H.R. 6000. H.R. 5585 would authorize $3 billion
for ARPA-H, and H.R. 6000 would authorize appropriations at the Administration-requested level
of $6.5 billion—both with funding available until expended. 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).44
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.45 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.46 In addition, biomedical research—especially medical product R&D—tends
to be expensive relative to some other areas of technology R&D.47 Also, given the long lag time
that generally exists between R&D activities and a commercially viable product or service,
measuring the contribution of R&D to end the product can be difficult.

42 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.
43 NIH, Congressional Justification: FY2022, pp. 10-11.
44 See CRS Report R46869, Federal Research and Development (R&D) Funding: FY2022, coordinated by John F.
Sargent Jr.
45 See, for example, Tollefson, “The Rise of ‘ARPA-Everything’ and What It Means for Science.”
46 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.
47 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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In an effort to separate ARPA-H funding from other NIH programs, all three bills would require a
separate ARPA-H budget request from other NIH or HHS budget requests. H.R. 5585 would
additionally create a new fund for financing ARPA-H. Both H.R. 5585 and H.R. 6000 would
allow for submission of a budget directly to Congress, similar to existing NIH “professional
judgment budgets” or “bypass budgets.” Existing NIH professional judgment budgets—submitted
directly from NIH to Congress for certain research areas—estimate funding needs based solely on
scientific priorities and opportunities rather than through the traditional budget development
process that weighs other policy objectives and funding priorities.48
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. All three 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.

48 For other NIH professional judgment budgets, see National Cancer Institute, “NCI Professional Judgment Budget,
President’s Budget and Appropriations,” https://www.cancer.gov/about-nci/budget/fact-book/historical-trends/bypass-
appropriations; National Institute on Aging, “Bypass Budget Proposal Archive,” https://www.nia.nih.gov/about/bypass-
budget-proposal-archive; and NIH Office of AIDS Research, “NIH HIV Research Budget,” https://www.oar.nih.gov/
hiv-policy-and-research/budget. For context, see CRS Report R47019, The Executive Budget Process: An Overview, by
Dominick A. Fiorentino and Taylor N. Riccard.
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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 three bills that would authorize ARPA-H in
the 117th Congress. In the House, H.R. 5585 and H.R. 6000 have been introduced and were
discussed in a hearing on March 17, 2022.49 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 APRA-H Authorization Legislation
Advanced Research
Advanced Research Project
Project Authority for
Agency—Health Act (H.R.
Section 501 of Cures Act
Health Act (Sec. 331 of
Provision(s)
5585)
2.0 (H.R. 6000)
S. 3799, as amended)
Authorization
Amends Public Health Service
Standalone provision. Does
Amends the PHSA Title IV
Act (PHSA) Title IV (National
not amend the PHSA.
to add new “Subpart 3—
Research Institutes) to add new [H.R. 6000 §501(a)]
Advanced Research
“Part J—Advanced Research
Projects Authority for
Projects Agency-Health” at the
Health” to include one
end with two sections: (1)
section, Section 483:
Section 499A: Advanced
Advanced Research
Research Projects Agency-
Projects Authority for
Health and (2) Section 499B:
Health.
Health Advanced Research and
[S. 3819 §2]
Development Fund.
[H.R. 5585 §2]
Placement in
Would establish ARPA-H
Would direct the Secretary
Would establish ARPA-H
Federal
within the Department of
of HHS to establish ARPA-H within NIH.
Government
Health and Human Services
within the National
[Proposed PHSA §483(b)]
(HHS).
Institutes of Health (NIH).
[Proposed PHSA §499A(a)]
[H.R. 6000 §501(a)]

49 U.S. Congress, House Committee on Energy and Commerce, Subcommittee on Health, The Future of Medicine:
Legislation to Encourage Innovation and Improve Oversight, 117th Cong., 1st sess., March 17, 2022.
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Advanced Research
Advanced Research Project
Project Authority for
Agency—Health Act (H.R.
Section 501 of Cures Act
Health Act (Sec. 331 of
Provision(s)
5585)
2.0 (H.R. 6000)
S. 3799, as amended)
Goals
The stated goals of ARPA-H
The stated goals of ARPA-H
The stated purpose of
would be to:
would be to deliver
ARPA-H would be to (key

breakthrough capabilities
differences from H.R. 5585

foster the development of
new, breakthrough
through technologies,
italicized):
capabilities, technologies,
systems, and platforms that

support high-impact,
systems, and platforms to
(key differences from H.R.
cutting-edge research
accelerate innovations in
5585 italicized):
in biomedicine and
health and medicine;

accelerate the
broadly applicable

discovery and
breakthrough

revolutionize diagnosis,
mitigation, prevention, and
application of
technologies that have
treatment of diseases
transformational
the potential to
through the development
innovations in health
significantly transform
of transformative health
and medical product
and advance areas of
technologies and high-need
development; and
biomedical science and
cures;

medicine in a manner

reduce the human and
that cannot readily be

economic cost of disease.

promote high-risk, high-
accomplished through
reward innovation to
[H.R. 6000 §501(b)(1)]
traditional biomedical
develop high-need cures
research or commercial
(H.R. 6000 includes similar
activity; and
language in the ARPA-H
activities category); and

overcome long-term
and significant

ensure the United States
technological and
maintains global leadership
scientific barriers to
in science and innovation,
advancing such
and the highest quality of
technologies in order
life and health for its
to improve the
citizens.
prevention, diagnosis,
[Proposed PHSA
mitigation, treatment,
§499A(b)(1)]
and cure of health
conditions.
[Proposed PHSA §483(b)]
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Activities
Activities of the agency would
Activities of the agency
No similar category of
(“Means”)
include:
would include (grouped for
provisions. Comparable

comparison; key differences
language in “Goals” and

identifying and promoting
revolutionary advances in
italicized):
“Duties of the Director”
health sciences;
Similar to H.R. 5585:
sections.


accelerating

identifying and
transformational
promoting
technological advances in
revolutionary advances
areas with limited funding
in biomedical and health
or technical certainty;
research that enable

new paradigms in

prioritizing investments
based on such
health;
considerations as scientific

accelerating
opportunity and
transformational health
uniqueness of fit to the
advances in areas that
strategies and operating
the relevant industries by
practices of ARPA-H; the
themselves are not likely
effect on disease burden,
to undertake because of
including unmet patient need
technical, financial, or
and the fiscal liability of
other uncertainty; and
the federal government

prioritizing project
with respect to health
investments based on
care; and potential
scientific opportunity
opportunities to advance
and uniqueness of fit to
health equity;
ARPA-H strategies and

translating scientific
operating practice,
discoveries into
together with the
technological innovations
prospective impact on
and high-need cures;
disease burden

(regardless of disease

providing resources and
support to create platform
prevalence), both human
capabilities that draw on
and fiscal, including the
multiple disciplines; and
health care fiscal liability
of the federal

delivering advanced proofs
government.
of concept that
demonstrate clinically
Different from H.R. 5585:
meaningful advances.

promoting high-risk,
[Proposed PHSA
high-reward innovation
§499A(b)(2)]
(H.R. 5585 includes
similar language as an
ARPA-H goal); and

partnering with, and
providing funding to, a
broad range of
institutions, including
universities, national
laboratories, public
sector organizations,
private companies,
nonprofit organizations,
and foreign institutions.
(H.R. 5585 lists
partnering with a broad
range of institutions as
an ARPA-H Director
authority.)
[H.R. 6000 §501(b)(2)]
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Advanced Research
Advanced Research Project
Project Authority for
Agency—Health Act (H.R.
Section 501 of Cures Act
Health Act (Sec. 331 of
Provision(s)
5585)
2.0 (H.R. 6000)
S. 3799, as amended)
ARPA-H
The ARPA-H Director position
The ARPA-H Director
The ARPA-H Director
Director Position would be established as fol ows: position would be
position would be

established as fol ows (key
established as fol ows (key
differences from H.R. 5855
differences from H.R. 5855
Appointment: Appointed by
italicized):
italicized):
the President. Reports to the
Secretary of HHS.

[Proposed PHSA §499A(c)(1),
Appointment: Appointed
Appointment: Appointed
(3)]
by the President.
by the President. Reports to
NIH Director.

[H.R. 6000 §501(c)(1)]
[Proposed PHSA
Term: Five years. May be

§483(c)(1)]
reappointed for one
Term: Five years. May be
consecutive term.
reappointed for one

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

[H.R. 6000 §501(c)(2)]
consecutive term at the
Qualifications: By
discretion of the President.
professional background and

[Proposed PHSA
experience is qualified to
Qualifications: By
§483(c)(3)]
manage: (1) research and
professional background and
advanced development
experience, is qualified to

programs; and (2) large-scale,
advise the Secretary on, and
Qualifications: By
high-risk initiatives with respect
manage research programs
professional background
to health research across
addressing, matters
and experience, is qualified
multiple sectors, including
pertaining to long-term and
to advise the Secretary on,
generating high-need cures.
high-risk barriers to the
and manage research
[Proposed PHSA §499A(c)(2)]
development of health
programs that advance the
innovation.
purposes of ARPA-H in,

[H.R. 6000 §501(c)(2)]
promoting biomedical and
Autonomy Regarding
novel technology
Recommendations and

innovation, and who has
Testimony: No U.S. officer or
Autonomy: No
demonstrated ability to
agency has authority to require
comparable provision.
identify and develop
the Director of ARPA-H or
partnerships to address
other ARPA-H officer to
strategic needs in meeting
submit legislative
such purposes.
recommendations, testimony,
[Proposed PHSA
or comments on legislation to
§483(c)(2)]
any officer or agency for
approval prior to submission to

Congress if such materials
Autonomy: No
include a statement indicating
comparable provision.
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)]
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Duties of the
Duties:
Duties (grouped for
Duties: (grouped for
Director

comparison):
comparison):

Set research and
development priorities
Similar to H.R. 5585:
Similar to H.R. 5585
with respect to ARPA-H

Set national research

Establish strategic
goals and manage the
priorities to advance
goals, objectives, and
budget of ARPA-H;
the mission of the
priorities for ARPA-H

Advance ARPA-H goals
agency as informed by a
pursuant to ARPA-H’s
through consideration of
multi-sectoral board of
purposes;
the advice of the ARPA-H
advisors;

Approve all new
Interagency Advisory

Approve all new
programs within
Committee;
programs within ARPA-
ARPA-H and

Approve and terminate
H;
terminate any program
the projects and programs

within ARPA-H that is

Have final funding
of ARPA-H;
authority to initiate and
not achieving its goals;

Develop funding criteria
terminate program

Establish criteria for
and assess the success of
funding; and
funding and assessing
programs through the

the success of

Establish criteria for
establishment of technical
funding and assessing
programs through the
milestones;
the success of
establishment of

technical milestones;

Solicit data, as needed,
programs through the
from NIH and other
establishment of
and
relevant federal agencies,
technical milestones;

Facilitate coordination
private entities, academia,
Different from H.R. 5585:
between HHS and its
nonprofit organizations,
agencies, and other
and international

Appoint the personnel
relevant federal
organizations;
necessary to
departments and
successful y execute the

agencies.

Coordinate with the
goals of ARPA-H (see
Director of NIH to ensure
“Personnel Authorities” Different from H.R. 5585
that the programs of
below for other

Ensure that
ARPA-H build on and are
relevant provisions);
applications for funding
informed by scientific
and
disclose current and
research supported by
previous research and
NIH (see “Cooperation

Designate employees to
development efforts,
and Coordination” below
serve as program
including any scientific
for other relevant
managers for each of
or technical barriers
provisions); and
the programs
established pursuant to
encountered in the

Coordinate with the heads
the responsibilities
course of such efforts
of federal agencies and, to
established for ARPA-H
or challenges in
the extent practicable,
(see “Program
securing funding.;
ensure that the activities
Managers” below for

Support
of ARPA-H supplement
other relevant
transformative,
(and do not supplant) the
provisions).
translational, applied,
efforts of other federal
and advanced research
agencies (see
[H.R. 6000 §501(c)(3)]
in areas of biomedical
“Cooperation and

science to address
Coordination” below for

specific technical or
other relevant provisions).
scientific questions by
[Proposed PHSA §499A(c)(4)]
(1) prioritizing

investments based on
scientific potential and
impact on the field of
biomedicine, especial y
in areas that require
public-private
partnerships; (2)
translating scientific
discoveries and
cutting-edge
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Advanced Research
Advanced Research Project
Project Authority for
Agency—Health Act (H.R.
Section 501 of Cures Act
Health Act (Sec. 331 of
Provision(s)
5585)
2.0 (H.R. 6000)
S. 3799, as amended)
Funding Awards
The ARPA-H Director would
The ARPA-H Director
The ARPA-H Director
be authorized to make awards
would be authorized to
would be authorized to
in the form of grants, contracts, make awards in the form of
make awards in the form of
including multi-year contracts,
grants, contracts, including
grants, contracts, including
cooperative agreements, prizes,
multi-year contracts,
multi-year contracts,
and other transactions.
cooperative agreements,
cooperative agreements,

prizes, and other
prizes, and other
transactions. Funded
transactions. Defines
Contracts awarded would be
research would not be
“other transactions” to
subject to Federal Acquisition
subject to NIH peer review
mean “transactions, other
Regulations (48 C.F.R. Chapter
or advisory council review
than procurement
1), but not to regulations in 48
or approval.
contracts, grants, and
C.F.R. Chapter 3.
[H.R. 6000 §501(i)]
cooperative agreements.”
[Proposed PHSA §499A(g)]
(by reference to PHSA
Specified information
§319L(a)(3) in the Proposed
col ected from award
PHSA §483(a)(3)])
recipients would be
[Proposed PHSA
exempted from Freedom of
§483(e)(1)]
Information Act disclosures
(FOIA), including

commercialization plans,
Funded research would not
market studies, and
be subject to NIH peer
investments provided to the
review or advisory council
awardee from third parties,
review or approval.
among others.
[Proposed PHSA
[H.R. 6000 §501(j)]
§483(e)(5)]

The ARPA-H Director
Would require the ARPA-
would have authority to
H Director to ensure that
execute contracts developed ARPA-H does not provide
by in-house program
funding for a research
managers who select
program or project unless
external performers, and
the applicant demonstrates
maintain, enhance, or
that it has made sufficient
terminate projects based on
unsuccessful attempts to
performance against explicit
secure private financing,
milestones.
and that there is a lack of
[H.R. 6000 §501(c)(2)(B)]
significant private support
for the program or project.

In addition, the ARPA-H
Director would be required
to ensure that the program
or project is in the best
interests of the United
States and has the potential
to significantly transform
and advance biomedicine.
[Proposed PHSA
§483(f)(2)]

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Advanced Research
Advanced Research Project
Project Authority for
Agency—Health Act (H.R.
Section 501 of Cures Act
Health Act (Sec. 331 of
Provision(s)
5585)
2.0 (H.R. 6000)
S. 3799, as amended)
Cooperative
ARPA-H Director would be
When entering into
To the maximum extent
Agreements and
authorized to award other
cooperative agreements and
practicable, competitive
Other
transactions or prototype
other transactions, the
procedures would be
Transactions
projects that are directly
ARPA-H Director would be
required when entering
relevant to enhancing ARPA-H
required to ensure that:
into other transactions to
goals.

carry out projects.

Federal funds under the
[Proposed PHSA §499A(g)(5)]
agreement do not
Authorizes other
exceed the total
transaction authorities to
amount provided by
be exercised for a project if
other parties;
the project manager

submits a proposal to the

Such agreements are
used only when the use
ARPA-H Director for each
of standard contracts
use of such authority
or grants is not feasible
before conducting or
or appropriate; and
supporting a project,
including why other

To the maximum
transaction authority is
extent practicable, such
essential to project success.
agreements do not
The project manager must
duplicate research
receive approval from the
being conducted under
ARPA-H Director before
existing HHS and other
using other transaction
federal programs.
authority, and then must
In addition, cooperative
report to the Director on
agreements and other
project activities for each
transactions would be
fiscal year in which the
authorized to include a
project manager used the
clause that requires
authority.
payments to ARPA-H (or
[Proposed PHSA
any other federal entity) as a §483(e)(2)]
condition for receiving
support under such
agreement. Authorizes
payments to be credited to a
Treasury account
established for support of
advanced research projects
provided for in cooperative
agreements and other
transactions.
[H.R. 6000 §501(i)(1)-(4)]
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ARPA-H: Congressional Action and Selected Policy Issues

Personnel
Would grant the ARPA-H
Similar to H.R. 5585 (key
Similar to H.R. 5585:
Authorities
Director the authority to waive
differences italicized):
Would grant the ARPA-H
certain civil service personnel
Would grant the ARPA-H
Director the authority to
requirements with regard to:
Director the authority to
waive certain civil service

Personnel hired under
waive certain civil service
personnel requirements in
PHSA Section 207(f);
personnel requirements with making and rescinding

regard to:
scientific, medical, and

Additional appointments of
scientific, medical, and

professional personnel

Personnel hired under
professional personnel;
PHSA Section 207(f);
appointments.
and

[Proposed PHSA

Additional

§483(d)(4)(A)]

Appointments to positions
appointments of
of administration or
scientific, medical, and

management of ARPA-H.
professional personnel
In making personnel or staff
Such authorities are in addition
(would place a limitation
appointments, the ARPA-H
to existing hiring authorities
each year on additional
Director would be
granted to the Secretary of
payments an employee
authorized to consider as
HHS.
could receive under such
appropriate factors such
appointment to the lesser
The ARPA-H Director would
factors as populations that
of $25,000 or the
also be directed to make efforts
are traditionally
amount equal to 25% of
to recruit and retain a diverse
underrepresented in the
the employee’s annual
workforce, including individuals
biomedical research
rate of basic pay); and
underrepresented in science
enterprise.
and medicine and racial and

Appointments to
[Proposed PHSA
ethnic minorities.
positions of
§483(d)(3)(B)]
administration or
The ARPA-H Director would

management of ARPA-
also be authorized to contract
H.
The ARPA-H Director
with private entities in
would be authorized to
appointing qualified personnel.
Would allow the ARPA-H
contract with private
Director to use all
Would provide the ARPA-H
recruiting firms for hiring of
authorities in existence on
Director with the authority to
qualified technical staff.
the date of enactment that
use the Intergovernmental
are provided to the
[Proposed PHSA
Personnel Act to staff ARPA-H
Secretary of HHS to hire
§483(d)(4)(D)]
with employees from other
administrative, financial,

federal agencies, state and local
information technology staff,
governments, Indian tribes and
Different from H.R. 5585
and any other staff the ARPA-
tribal organizations, institutions
H Director determines are
In designating program
of higher education, and other
necessary.
managers, the ARPA-H
organizations.
Director would be required
Would also authorize the
[Proposed PHSA §499A(i)]
to consider individuals with
ARPA-H Director to recruit
demonstrated scientific
and retain a diverse
expertise and management
workforce, including
skil s required to advance
individuals underrepresented ARPA-H and who
in science and medicine and
represent a diverse set of
racial and ethnic minorities.
professional experiences or
[H.R. 6000 §501(d)]
backgrounds, including

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

Would require the ARPA-
H Director to ensure that
personnel appointed to
staff or support ARPA-H
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ARPA-H: Congressional Action and Selected Policy Issues

Program
Term: Three years. May serve
Term:
Term: Three years. May
Managers
two terms.
Three years. May serve two
serve two terms.
Duties:
terms.
[Proposed PHSA

Duties (grouped for
§483(d)(C)]

Establish research and
development goals for
comparison):
Duties (grouped for
programs in accordance
Similar to H.R. 5585:
comparison):
with guidance from the

Define the research and Similar to H.R. 5585
Director;
development goals and

Establish research and

Select, on the basis of
milestones of the
development goals for
merit, each of the projects
program involved, in
the programs in
to be supported under a
line with guidance from
consultation with the
program carried out by
the ARPA-H Director;
Director, including
ARPA-H, taking into

Select, on the basis of
timelines and
consideration the novelty
merit and need, each of
milestones, and make
and scientific and technical
the projects to be
such goals available to
merit of the proposed
supported under the
the public;
projects; the
program involved after
demonstrated capabilities

Select the projects to
considering the novelty
of the applicants to
be supported under
and scientific and
successful y carry out the
the program after
technical merit of the
proposed project; the
considering: (1) the
proposed projects; the
unmet needs within
novelty and scientific
demonstrated
patient populations; the
and technical merit of
capabilities of the
consideration by the
the proposed project;
applicants to
applicant of future
(2) the demonstrated
successful y carry out
commercial applications of
capabilities of the
the proposed project;
the project, including the
applicants; (3)
the consideration by
feasibility of partnering
potential future
the applicant of future
with one or more
commercial
commercial applications
commercial entities; and
applications as
of the project; or the
such other criteria as are
proposed; (4) the
unmet need within
established by the
degree to which the
patient populations;
Director of ARPA-H;
project addresses a

Track progress and
scientific or technical

Identify milestones and
course-correct projects
question and has the
monitor progress of such
when needed; and
potential to transform
milestones with respect to
biomedicine; and (5)
each project;

Recommend, as
necessary, the
other criteria as

Provide recommendations
restructuring or
established by the
to the Director of ARPA-
termination of projects
ARPA-H Director;
H with respect to
supported by ARPA-H.

Encourage research
advancing the goals of the
col aborations,
agency;
[H.R. 6000 §501(e)]
including by identifying

Provide recommendations
and supporting
to expand, restructure, or
applicable public-
terminate research
private partnerships;
partnerships or projects;

Recommend program

Col aborate with experts
restructuring,
from NIH and other
expansion, or
federal agencies and
termination of
experts in relevant
research projects or
scientific fields to identify
whole projects, as
research and development
necessary; and
opportunities;

Communicate with

Convene workshops, as
leaders in the health
needed, with relevant
care and biomedical
federal agencies,
research and
institutions of higher
development fields,
education, nonprofit
from both the public
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ARPA-H: Congressional Action and Selected Policy Issues

Advanced Research
Advanced Research Project
Project Authority for
Agency—Health Act (H.R.
Section 501 of Cures Act
Health Act (Sec. 331 of
Provision(s)
5585)
2.0 (H.R. 6000)
S. 3799, as amended)
Coordination and Would require the ARPA-H
Would require the ARPA-H
Would require the ARPA-
Cooperation
Director to coordinate with
Director to ensure effective,
H Director to ensure, to
the Commissioner of Food and
early, and frequent
the maximum extent
Drugs and the Administrator of
coordination between
practicable, that ARPA-H
the Centers for Medicare &
ARPA-H and: (1) the heads
activities are coordinated
Medicaid Services (CMS) to
of the research, public
with and do not duplicate
expedite the development,
health, and regulatory
efforts of: (1) other HHS
application, coverage, and
agencies of HHS, including
programs, including NIH
implementation of high-need
NIH, the Food and Drug
and BARDA programs, and
cures.
Administration (FDA), CMS,
(2) other relevant efforts or
[Proposed PHSA §499A(f)]
the Centers for Disease
research operated or
Control and Prevention
overseen by other federal

(CDC), and the Assistant
departments and agencies.

Secretary for Preparedness
[Proposed PHSA
and Response; (2) the
§483(f)(1)]
Director of the National
Science Foundation; and (3)

the Director of the Office of The ARPA-H Director
Science of the Department
would have authority to
of Energy.
seek opportunities to
[H.R. 6000 §501(g)(1)]
partner with procurement
programs of other federal
The ARPA-H Director
agencies to demonstrate
would also be required to
technologies resulting from
coordinate among the ful
ARPA-H activities.
set of advanced research
[Proposed PHSA
projects agencies, including
§483(e)(4)]
the Defense Advanced
Research Projects Agency,

the Advanced Research
Would authorize the FDA
Projects Agency-Energy, and
to meet with ARPA-H and
others that may be
appropriate federal
established.
partners such as BARDA at
[H.R. 6000 §501(g)(2)]
appropriate intervals to
discuss the development
Would authorize the
status and actions that may
Secretary of HHS, acting
be taken to facilitate the
through the FDA and in
development of medical
consultation with ARPA-H,
products and projects that
to take actions to facilitate
are of highest priority for
the transformation of
ARPA-H. Would require
biomedical breakthroughs
the ARPA-H Director to
into tangible solutions for
reimburse FDA for FDA
patients and expedite the
activities conducted under
development and review of
the authority of the section.
medical products. The
[Proposed PHSA
ARPA-H Director must
§483(f)(4)]
reimburse the FDA for
related expenditures. This

authorization is not to be

construed as limiting FDA’s

authorities for medical
product review and
approval.
[H.R. 6000 §501(k)]
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ARPA-H: Congressional Action and Selected Policy Issues

Advice
Advisory Committee:
Advisory Committee
Advisory Committee:
Would require the ARPA-H
Consultation: Would
Would establish an ARPA-
Director to establish an
authorize the ARPA-H
H Interagency Advisory
interagency advisory committee Director to seek advice on
Committee to coordinate
tasked with advising the
any aspect of the agency
efforts and provide advice
Director, including by making
from any advisory
and assistance on specific
recommendations on research
committee that, as of the
program or project tasks
priorities that would provide
date of enactment, provides
and the overall direction of
the greatest return on
advice to the Secretary of
ARPA-H. Members are to
investment with respect to
HHS (or any head of a
include the heads of the
improving human health,
research, public health, or
fol owing agencies or their
avoiding duplication of efforts in regulatory agency of HHS),
designees: NIH, CDC, FDA,
the federal government, and
as well as an advisory
HHS Office of the Assistant
improving coordination with
committee established on or Secretary for Preparedness
other federal agencies; and
after enactment to support
and Response, HHS Office
identifying and developing
the programs of ARPA-H.
of the Assistant Secretary
strategies to address market
[H.R. 6000 §501(h)(1)]
of Health, DARPA, the
barriers to commercialization
DOE Office of Science,
or adoption of high-need cures.
Other Advice: Would also
NSF, and any other agency
Members could include (1) the
authorize the ARPA-H
with subject matter
heads of several HHS operating
Director to seek advice and
expertise that the ARPA-H
divisions or their designees,
review from the President’s
Director determines
including NIH, FDA, CMS,
Committee of Advisors on
appropriate. The Federal
CDC, and BARDA; (2) the
Science and Technology; any
Advisory Committee Act (5
Director of Office of Science
professional or scientific
U.S.C. App.) would not
and Technology Policy; (3)
organization with expertise
apply to this committee.
Director of DARPA; (4) the
in specific processes or
[Proposed PHSA §483(g)]
Director of the National
technologies under
Science Foundation (NSF); (5)
development by ARPA-H;

the Director of the Office of
and representatives of
Other Advice: Would
Science of the Department of
patient communities.
also authorize the ARPA-H
Energy (DOE), and (6)
[H.R. 6000 §501(h)(2)]
Director to seek input
representatives of any federal
from the President’s
agency with subject matter
Council of Advisors on
expertise as determined by the
Science and Technology;
ARPA-H Director. The Federal
representatives of
Advisory Committee Act (5
professional or scientific
U.S.C. App.) would not apply to
organizations with
this committee.
expertise in technology
[Proposed PHSA §499A(n)]
under consideration or
development by ARPA-H;
Other Advice: Would also
and representatives of
authorize the ARPA-H Director
patient organizations, public
to seek advice from the
health, innovators, and
President’s Committee of
other public and private
Advisors on Science and
entities.
Technology; peers in the
[Proposed PHSA
scientific community, including
§483(f)(3)]
academia and industry; experts
in other federal agencies; any
professional or scientific
organization with expertise in
technologies under
development by ARPA-H or a
relevant scientific discipline; and
representatives of patient
communities.
[Proposed PHSA §499A(m)]
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ARPA-H: Congressional Action and Selected Policy Issues

Annual Report
Annual Report: Beginning not Annual Report: As part of
Annual Report: As part
and Strategic
later than one year after the
the annual budget request
of the annual budget
Plan
date of the enactment, and each submitted for each fiscal
request submitted for each
fiscal year thereafter, the
year, the ARPA-H Director
fiscal year, the ARPA-H
ARPA-H Director would be
would be required to
Director would be required
required to submit a report to
provide Congress a report
to provide Congress a
Congress on the actions
describing:
report describing:
undertaken, and results
(1) Projects supported by
(1) Projects supported by
generated, by ARPA-H,
ARPA-H during the previous ARPA-H during the
including
fiscal year, including the
previous fiscal year
(1) A description of projects
transition of project
including the stage of
supported by ARPA-H in the
outcomes to clinical
development and details as
previous fiscal year and
practice; the impact on
to whether the project is
whether such projects are
clinical outcome; and the
meeting its milestones.
meeting the goals developed by
creation of biomedical
(2) Projects supported by
the Director;
capabilities;
ARPA-H during the
(2) A description of projects
(2) Successes and barriers to previous fiscal year that
terminated in the previous fiscal scientific interchanges;
were terminated and the
year, and the reason for such
(3) Rapid knowledge
reasons for termination.
termination;
transfer;
(3) Projects supported by
(3) A description of projects
(4) Resource optimization;
ARPA-H during the
starting in the next fiscal year,
and
previous fiscal year that
as available; activities conducted
examine topics and
in coordination with other
(5) Heightened investment
technologies related to
federal agencies; and
impact among col aborators. other activities funded by
(4) An analysis of the extent of
[H.R. 6000 §501(f)(2)]
HHS, including an analysis
coordination with NIH, FDA,
Strategic Vision: Not later of whether in supporting
and CMS, including successes
than 180 days after
such projects, the ARPA-H
and barriers with respect to
enactment, the ARPA-H
Director is in compliance
achieving the goals of the
Director would be required
with relevant requirements.
agency.
to provide Congress with a
(4) Current, proposed, and
[Proposed PHSA §499A(k)(1)]
report describing the
planned projects to be
strategic vision that ARPA-H carried out.
Strategic Plan: Not later than wil use to guide the choices [Proposed PHSA
one year after the date of the
for future health investments §483(k)(1)]
enactment, and every four
over the fol owing three
years thereafter, the ARPA-H

fiscal years beginning on or
Director would be required to
after the date of enactment.
Strategic Plan: Not later
provide Congress a strategic
than 180 days after the
plan describing how ARPA-H
[H.R. 6000 §501(f)(1)]
appointment of the first
wil carry out investments each

ARPA-H Director, and
fiscal year in the next four-year
every four years thereafter,
period.
the ARPA-H Director
[Proposed PHSA §499A(l)]
would be required to
submit to Congress a plan

describing the strategic plan
that ARPA-H wil use to
guide future investments
over the fol owing four
fiscal years. Every two years
after initial submission, the
ARPA-H Director would be
required to submit a
supplemental strategic plan
that details any changes.
Requirements for NIH
Institute and Center
strategic plans would not
apply to ARPA-H.
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ARPA-H: Congressional Action and Selected Policy Issues

Advanced Research
Advanced Research Project
Project Authority for
Agency—Health Act (H.R.
Section 501 of Cures Act
Health Act (Sec. 331 of
Provision(s)
5585)
2.0 (H.R. 6000)
S. 3799, as amended)
consistent with the NASEM
evaluation. [NOTE:
Appears to be drafting
error as subsection (m) is
an authorization of
appropriations.]
[Proposed PHSA
§483(g)(5)]

Other Reports
No additional reports.
Report on Cooperative
Report on Personnel:
Agreements and Other
The ARPA-H Director
Transactions: Not later
would be required to
than 90 days after the end of maintain records regarding
each fiscal year, the ARPA-H the use of ARPA-H
Director would be required
personnel authorities,
to submit a report to
including the number of
Congress on all cooperative
positions fil ed with such
agreements and other
authorities, types of
transactions entered into
appointments, demographic
during such fiscal year. The
information, and other
report would be required to
specified information. Not
detail specific information,
later than one year after
including a general
enactment and annually
description of the
thereafter, the Director
cooperative agreement or
would be required to
other transaction and the
submit a report to specified
reasons for not using a
congressional committees
contract or grant to provide
on the total number of
support for such advanced
appointments fil ed and
research, and the amount of
how the positions relate to
payments received by the
ARPA-H’s purposes.
federal government, among
[Proposed PHSA
other things.
§483(d)(4)(B)-(C)]
[H.R. 6000 §501(f)(3)]

GAO Report on
Personnel: Not later than
two years after enactment,
Government Accountability
Office (GAO) would be
required to report to
Congress on 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
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ARPA-H: Congressional Action and Selected Policy Issues

Advanced Research
Advanced Research Project
Project Authority for
Agency—Health Act (H.R.
Section 501 of Cures Act
Health Act (Sec. 331 of
Provision(s)
5585)
2.0 (H.R. 6000)
S. 3799, as amended)
Funding
Would require the
Would authorize the
Would authorize the
establishment of the Health
appropriation of $6.5 bil ion
appropriation of such sums
Advanced Research and
to ARPA-H in FY2022 to
as may be necessary for
Development Fund in the
remain available until
each of FY2023 through
Treasury to be administered by
expended.
FY2027.
the ARPA-H Director. Would
[H.R. 6000 §501(l)(1)]
[Proposed PHSA §483(m)]
authorize the appropriation of
$3 bil ion to the fund in FY2022 Would require that the

to remain available until
budget of ARPA-H be a
Would provide that any
expended.
separate line item in the
budget request for ARPA-H
[Proposed PHSA §499B(a),
annual budget request
be separate from other
(c)(1)]
submitted by the President
NIH budget requests.
to Congress and that ARPA-
[Proposed PHSA §483(n)]
Would require that the annual
H have the authority to
budget request for ARPA-H be
submit its annual budget

separate from the rest of the
request directly to Congress
budget for HHS and that the
concurrently with its
ARPA-H Director prepare and
submission to the Office of
submit directly to the
Management and Budget.
President, for review and
[H.R. 6000 §501(l)(2)]
transmittal to Congress, an
annual budget for ARPA-H after Also specifically establishes
reasonable opportunity for
an account for other
comment (but without change)
transactions and cooperative
by the Secretary of HHS.
agreements; see
[Proposed PHSA §499B(b)]
“Cooperative Agreements
and Other Transactions.”
Would require that
[H.R. 6000 §501(i)(7)]
appropriations to the Fund be
separate and distinct from
other appropriations for HHS.
Would require for each fiscal
year beginning with FY2022
that discretionary new budget
authority provided in an
appropriations act for ARPA-H
be made available for that fiscal
year and include advance
discretionary new budget
authority that first becomes
available for the first fiscal year
fol owing the budget year.
[Proposed PHSA §499B(c)]
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ARPA-H: Congressional Action and Selected Policy Issues

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