Advanced Research Projects Agency for Health (ARPA-H): Potential Questions for Consideration

September 8, 2021 – September 23, 2021 R46901

Advanced Research Projects Agency for Health September 23, 2021
(ARPA-H): Potential Questions for
Kavya Sekar
Consideration
Analyst in Health Policy

The National Institutes of Health (NIH), an agency in the Department of Health and Human
Marcy E. Gallo
Services (HHS), proposed the creation of an Advanced Research Projects Agency for Health
Analyst in Science and
(ARPA-H) as part of President Biden’s FY2022 budget request. The budget request seeks $6.5
Technology Policy
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.” The initial focus of ARPA-H would include building platforms

and capabilities to try to deliver cures for cancer, Alzheimer’s disease, diabetes, and other
diseases.
ARPA-H would follow the model of other “ARPAs,” especially the Defense Advanced Research Projects Agency (DARPA)
and the Advanced Research Projects Agency-Energy (ARPA-E), including an organizational structure designed to be flat and
nimble, tenure-limited program managers with a high degree of autonomy to select and fund projects, and a miles tone-based
contract approach. In contrast, NIH relies predominantly on the scientific peer review process to award most of its funding.
Some data 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 research is critical to ensuring U.S. competitiveness and
addressing societal challenges.
On July 29, 2021, the House passed the Consolidated Appropriations Act, 2022 (H.R. 4502), which would provide $3 billion
over three years for ARPA-H in a new account at NIH. The funds would be available only if legislation specifically
establishing ARPA-H is enacted into law. Separately, a House Energy and Commerce Committee print, transmitted to the
House Committee on Budget on September 15, 2021, proposes establishment and funding of ARPA-H at HHS, with funding
of $3 billion available until expended. This provision is a part of legislative recommendations responding to the
reconciliation directives in the FY2022 budget resolution (S.Con.Res. 14). The Senate has not yet introduced or considered
regular appropriations or other legislation related to ARPA-H. As Congress continues its deliberations on whether and how to
enact and fund the ARPA-H proposal, it may consider a number of questions discussed in this report, including
 Should Congress establish ARPA-H?
 What might ARPA-H focus on?
 How would ARPA-H compare to other NIH programs and biomedical research efforts?
 How would ARPA-H compare to other “ARPAs”?
 Should ARPA-H be part of NIH?
 What legislative authorities may ARPA-H require or warrant?
 How might ARPA-H be evaluated?
 What would be the appropriate funding level 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 mil ions of deaths. For
much of its history, NIH has focused largely on supporting basic research: research that explores
the fundamental mechanisms of biology and behavior. Such research facilitates scientific
knowledge that informs medical advances. Traditional y, 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
potential y breakthrough science and technologies.3 The Biden Administration continues this
trend by proposing a new Advanced Research Projects Agency for Health (ARPA-H) at NIH in its
FY2022 budget request.
This report identifies policy questions relevant to congressional considerations of whether—and,
if so, how—to establish a new ARPA-H entity. The report does not explicitly address alternative
options to accomplishing the goals of the ARPA-H proposal, which might include expanding
upon existing efforts instead of establishing a new ARPA-H or the consolidation of existing
related programs into a new entity.
Overview of Proposed ARPA-H
While the current publicly available information on the proposal lacks specifics, the Biden
Administration has laid out its vision for the proposed ARPA-H in NIH’s FY2022 budget request,
in addition to a concept paper and an article published in Science magazine by NIH Director
Francis Collins, the director of the White House Office of Science and Technology Policy Eric
Lander, and others.4 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

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; and CRS Infographic IG10013, The
Pharm aceutical Drug Developm ent Process.
2 NCAT S was established by the Consolidated Appropriations Act, 2012 (P.L. 112-74).
3 T he 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 applica tions 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 NIH, Congressional Justification: FY2022, May 28, 2021, pp. 10-11, https://officeofbudget.od.nih.gov/pdfs/FY22/br/
2022%20CJ%20Overview%20Volume%20May%2028.pdf ; 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).
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(DOD), and would contain several DARPA model characteristics, including a flat organizational
structure designed to be nimble, tenure-limited program managers with a high degree of
autonomy to select and fund projects, and a milestone-based contract approach.5 NIH, in contrast,
general y 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.6
Some data suggests that this investigator-driven and consensus-based process may not adequately
fund “high-risk, high-reward” projects,7 a term often associated with projects that have high
potential for meeting fundamental scientific or technological chal enges and that involve a high
degree of novelty and/or multidisciplinary approaches that may not be favored by traditional
scientific funding models.8
The 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 potential y transformative research.9 Support for high-risk, high-reward
research is considered an important element in developing breakthrough technologies that address
societal chal enges, including health-related chal enges, and in maintaining the economic
competitiveness of the United States.10 In addition, the recent rapid development of safe and
effective Coronavirus Disease 2019 (COVID-19) vaccines based on novel technologies such as
mRNA, driven partly by DARPA investments, has spurred some to consider the usefulness and
value of the DARPA model or other innovative approaches for biomedical research in general.11
The budget request includes $6.5 bil ion 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 al
patients and that cannot readily be accomplished through traditional research or commercial
activity.”12 According to the proposal, ARPA-H is to “build platforms and capabilities to deliver
cures for cancer, Alzheimer’s disease, diabetes, and other diseases.”13 Additional y, 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,

5 For more information on DARPA, see CRS Report R45088, Defense Advanced Research Projects Agency: Overview
and Issues for Congress.
6 See “Peer Review Process for Extramural Funding” in CRS Report R41705, The National Institutes of Health (NIH):
Background and Congressional Issues.
7 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.
8 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, T echnology, and Industry Policy Papers, No. 112, May 2021, https://read.oecd.org/10.1787/06913b3b-en?
format=pdf.
9 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/.
10 OECD, Effective Policies to Foster High-Risk/High-Reward Research.
11 CRS Insight IN11446, DARPA’s Pandemic-Related Programs; and Franzoni, Stephan, and Veugelers, “Funding
Risky Research.”
12 White House, Advanced Research Project Agency for Health (ARPA-H): Concept Paper.
13 NIH, Congressional Justification: FY2022, pp. 10-11.
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or cel type; and platforms to reduce health disparities in maternal morbidity and mortality,
among others.14
Funding is requested for a period of three years to “al ow 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 smal er 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).15
The FY2022 budget request describes the types of chal enges 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.16
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 “operational y distinct” from NIH ICs, ARPA-H would stil 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]).
Congressional Action
The Consolidated Appropriations Act, 2022 (H.R. 4502),17 which passed the House on July 29,
2021, would provide $3 bil ion 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 specifical y
establishing ARPA-H is enacted into law. Separately, a House Energy and Commerce Committee
print, transmitted to the House Committee on Budget on September 15, 2021, would provide $3
bil ion available until expended to establish and fund ARPA-H (in Subtitle J, Part 3, Section
31031). This provision is a part of legislative recommendations responding to the reconciliation
directives in the FY2022 budget resolution (S.Con.Res. 14).18 The provision would establish

14 NIH, Congressional Justification: FY2022, pp. 10-11; and White House, Advanced Research Project Agency for
Health (ARPA-H): Concept Paper.
15 NIH, Congressional Justification: FY2022, pp. 10-11.
16 NIH, Congressional Justification: FY2022, pp. 10-11.
17 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 (T ransportation-HUD) (Div. G).
18 Specifically, the relevant provision is included in Subtitle J, “ “Budget Reconciliation Legislative Recommendat ions
Relating to Public Health,” as amended, in Part 3, Section 31031, “Funding for Advanced Research Projects Agency
for Health,” see “Amendment in the Nature of a Substitute to the Committee Print for Subtitle J,”
https://docs.house.gov/meetings/IF/IF00/20210913/114039/BILLS-117-J-P000034-Amdt -1.pdf. T hese legislative
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ARPA-H within HHS, and does not specify where ARPA-H would be placed in the department.
The provision also includes a number of responsibilities and directives tied to the ARPA-H
funding, including those related to research priorities and funding awards, coordination with other
agencies, hiring for program managers and other staff, and exemptions from scientific peer
review requirements, among others. If both bil s were enacted into law, ARPA-H would receive
total funding of $6 bil ion. In addition, two representatives have circulated a discussion draft that
would authorize an ARPA-H, among other provisions.19
The Senate has not yet introduced its FY2022 Departments of Labor, Health and Human
Services, and Education, and Related Agencies (LHHS) Appropriations legislation (i.e., the
annual appropriations bil that provides most of NIH’s funding) or other legislation that would
establish or fund ARPA-H.
Potential Questions for Consideration
The following sections address key policy questions that Congress might consider when
determining whether and how to enact and fund the ARPA-H proposal. Throughout, the report
references Biden Administration ARPA-H proposal documents as wel as the House E&C
committee print legislative recommendations to establish ARPA-H and places these proposals in
light of broader policy questions and considerations.
Should Congress Establish ARPA-H?
According to the Biden Administration, “through bold, ambitious ideas and approaches, ARPA-H
can help shape the future of health and medicine in the U.S. by transforming the seemingly
impossible into reality.”20 While the establishment of ARPA-H is one option for supporting high-
risk, high-reward research, there are other research funding mechanisms that may be used to
foster high-risk, high-reward research. For example, according to a study by the Organization for
Economic Cooperation and Development (OECD), high-risk, high-reward research can be
supported through
 Funding mechanisms specifical y designed to support high-risk, high-reward
research as a primary goal (e.g., DARPA; ARPA-E; NIH’s High-Risk, High-
Reward Research Program);
 Funding mechanisms that have high-risk, high-reward research as their primary
mission within a broader set of objectives (e.g., National Science Foundation’s
(NSF’s) Research Advanced by Interdisciplinary Science and Engineering
program);

recommendations were transmitted to the Ho use Committee on Budget during a committee mark -up on Wednesday,
September 15, 2021; see U.S. Congress, House Committee on Energy and Commerce, Full Com m ittee Hybrid Markup,
117th Cong., September 15, 2021,
https://energycommerce.house.gov/sites/democrats.energycommerce.house.gov/files/documents/FC%20Markup%2 0A
ction%20Sheet%202021.09.13-15.pdf.
19 Congresswoman Diana DeGette, “DeGette, Upton Unveil Bipartisan Legislation to Create Biden’s New Advanced
Research Agency to Cure Cancer,” press release, June 22, 2021, https://degette.house.gov/media-center/press-releases/
CURES2.
20 White House, Advanced Research Project Agency for Health (ARPA-H): Concept Paper, p. 7.
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 Funding mechanisms in which supporting high-risk, high-reward research is a
secondary goal or an important consideration in the proposal evaluation process
(e.g., NSF’s Early Grants for Exploratory Research program); and
 Funding mechanisms geared toward supporting scientific research with multiple
possible goals including advancing scientific knowledge, achieving economic
outcomes, or advancing societal outcomes, although there are no clear criteria for
fostering high-risk, high-reward research.21
Additional y, the OECD identified people-based awards, scientific prize competitions, and
internal or institution funding as mechanisms for fostering high-risk, high-reward research.22
Congress might consider the use or expansion of other funding mechanisms to support high-risk,
high-reward biomedical research in lieu of establishing ARPA-H. Congress might also seek to
support other innovative models for financing biomedical innovation, either as an alternative to or
in conjunction with the ARPA-H proposal. For example, the Long-term Opportunities for
Advancing New Studies for Biomedical Research Act (H.R. 3437) would create a federal y
backed loan program to support research and clinical trials for therapies that would address unmet
medical needs.
What Might ARPA-H Focus On?
According to the NIH FY2022 budget request, ARPA-H would “build platforms and capabilities
to deliver cures for cancer, Alzheimer’s disease, diabetes, and other diseases … collapse barriers
and speed the development, application, and implementation of urgently needed health
breakthroughs.”23 Additional y, the Administration provided an il ustrative list of potential ARPA-
H projects, including the development of mRNA vaccines that target common forms of cancer,
inexpensive and accurate wearable sensors to monitor blood sugar, and platforms to reduce
maternal morbidity and mortality disparities, among others.24 The legislative language in the
House E&C committee print for establishing ARPA-H and its objectives is very similar to the
language used in Biden Administration proposal documents.25
For comparison, the Advanced Research Projects Agency-Energy (ARPA-E) within the
Department of Energy addresses its mandate to advance high-risk, high-reward energy
technologies by seeking to fil what it cal s the white space, a perceived gap or opportunity in the
energy technology landscape. Specifical y, ARPA-E provides funding for “technological
approaches that are truly novel or greatly underexplored … [or] to fil gaps left in other research
or funding programs.”26 As proposed, ARPA-H may focus on the white space in the biomedical
research landscape. This role for an ARPA-H is consistent with the view among some scholars

21 OECD, Effective Policies to Foster High-Risk/High-Reward Research.
22 OECD, Effective Policies to Foster High-Risk/High-Reward Research.
23 NIH, Overview of FY2022 President’s Budget, May 2021, p. 10, https://officeofbudget.od.nih.gov/pdfs/FY22/br/
2022%20CJ%20Overview%20Volume%20May%2028.pdf .
24 White House, Advanced Research Project Agency for Health (ARPA-H): Concept Paper, p. 5.
25 Specifically the committee print establishes ARPA-H “for purposes of making pivotal investments in breakthrough
technologies and broadly applicable plat forms, capabilities, resources, and solutions that have the potential to transform
important areas of medicine and health for the benefit of all individuals and that cannot readily be accomplished
through traditional biomedical research or commercial activity.” T his is very similar to language in White House,
Advanced Research Project Agency for Health (ARPA-H): Concept Paper.
26 National Academies of Sciences, Engineering, and Medicine, An Assessment of ARPA-E (Washington, DC: T he
National Academies Press, 2017), p. 95.
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that the DARPA model is best suited to fund projects that occupy a productive middle ground
between basic and applied research and focus on unexplored potential breakthrough
technologies.27
Identifying the white space would be the responsibility of ARPA-H program managers who,
similar to DARPA and ARPA-E program managers, would have more autonomy in the
decisionmaking process than is typical of other federal agencies that fund R&D. ARPA-H’s
potential mandate is broad—perhaps purposeful y so—to provide the proposed agency with
maximum flexibility in the projects and problems it may seek to address.
Some stakeholders have expressed concern about the potential y broad scope of ARPA-H.28
Given the flexibility and open-endedness provided by the “ARPA model,” Congress and the
public might benefit from additional public information about processes and principles ARPA-H
would use to create programs and to select and fund projects.
According to the Biden Administration, “to determine which risks should be taken and to evaluate
proposed programs and projects, ARPA-H should adopt an approach similar to DARPA’s
‘Heilmeier Catechism,’ a set of principles that assesses the chal enge, approach, relevance, risk,
duration, and metrics of success.”29
Congress might consider requiring ARPA-H to make the principles used to select and fund
projects publicly available. Additional y, Congress might consider requiring ARPA-H to make its
strategic priorities public and solicit stakeholder input on the development of such priorities.
ARPA-H’s priorities could potential y fluctuate over both the short and long term; however, they
could serve as an important signal to researchers and the private sector.
How Would ARPA-H Compare to Other NIH Programs and
Biomedical Research Efforts? What Gap Could It Fill?
The Biden Administration argues that the current ecosystem of biomedical R&D—with curiosity-
driven research funded by NIH30 and the public sector and with for-profit and commercialization-
driven R&D funded largely by industry—is adequate for most biomedical innovation but leaves
certain critical gaps that ARPA-H could fil .31 Specifical y, project ideas that the Administration
asserts are left unfunded by the current system include those that (1) are either 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

27 Azoulay, Fuchs, and Goldstein, “Funding Breakthrough Research.”
28 Jeff T ollefson, “T he Rise of ‘ARPA-Everything’ and What It Means for Science,” Nature, July 8, 2021,
https://www.nature.com/articles/d41586-021-01878-z.
29 White House, Advanced Research Project Agency for Health (ARPA-H): Concept Paper, p. 7.
30 NIH issues three types of funding opportunity announcements (FOAs): parent announcements, which are broad
FOAs allowing applicants to submit an investigator-initiated application for a specific activity code; program
announcements, which are FOAs issued by one or more ICs to highlight areas of scient ific interest; and Requests for
Applications, which are FOAs issued by one or more ICs to highlight well-defined areas of scientific interest to
accomplish specific program objectives. For more information see, NIH, “Understanding Funding Opportunities,”
https://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/understand-funding-
opportunities.htm.
31 Collins et al., “ARPA-H: Accelerating Biomedical Breakthroughs.”
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realize the full economic benefit.”32 The Science article asserts that ARPA-H would pursue “use-
driven” ideas in comparison to NIH’s typical “curiosity-driven” approach.33
As mentioned above, a key consideration for establishing ARPA-H is how to ensure that the new
agency would concentrate its efforts on identifying “white space” in the biomedical research
landscape. While no entity within NIH, or in the U.S. biomedical research enterprise at large,
follows an exact DARPA model, NIH does have some existing programs aimed at fostering
biomedical innovation. These include the Common Fund for cross-cutting and milestone-driven
innovative projects; the National Center for Advancing Translational Sciences (NCATS), which
focuses on innovation in medical product development; and several NIH-wide programs, such as
the Accelerating Medicines Partnership, a public-private partnership aimed at transforming the
processes for developing new diagnostics and treatments.34 Certain stakeholders have argued that
some existing efforts—particularly NCATS—have not been funded wel enough to achieve their
intended goals.35 This suggests that ARPA-H may not be necessary if existing efforts saw
increased funding. However, the Biden Administration asserts that ARPA-H would be distinct
from these existing programs, although it acknowledges some potential overlap (especial y with a
certain NCATS program) and the need for coordination to avoid duplication.36 The House E&C
committee print language would require the ARPA-H Director to “ensure to the maximum extent
practicable” that the projects and activities of ARPA-H are coordinated with and do not duplicate
research conducted or supported by HHS.37
Congress may also consider requiring an independent entity such as NIH’s Scientific
Management Review Board (SMRB),38 the Government Accountability Office (GAO), or the
National Academy of Medicine to conduct a review of al NIH programs to assess the degree of
potential overlap with the proposed ARPA-H and the need for consolidation or termination of
existing programs. Such a review could also identify lessons learned or best practices from
NCATS or the Common Fund that could serve as a guide for ARPA-H.
Further, philanthropic funders play a significant role in U.S. biomedical R&D.39 Some of these
entities are engaged in activities that would overlap with the proposed activities of ARPA-H.
Examples include the nonprofit Chan Zuckerberg Initiative, which focuses on funding biomedical
science efforts that address unmet health needs and barriers to success, including support for
translation of new technologies,40 and the Bil and Melinda Gates Foundation, which funds

32 Collins et al., “ARPA-H: Accelerating Biomedical Breakthroughs.”
33 Collins et al., “ARPA-H: Accelerating Biomedical Breakthroughs.”
34 NIH, “About the Common Fund,” June 17, 2021, https://commonfund.nih.gov/about; NCAT S, “About NCAT S,”
https://ncats.nih.gov/about; and NIH, “ Accelerating Medicines Partnership,” https://www.nih.gov/research-training/
accelerating-medicines-partnership-amp.
35 Jocelyn Kaiser, “Seven Years Later, NIH Center T hat Aims to Speed Drugs to Market Faces Challenges,” Science,
September 25, 2019.
36 White House, Advanced Research Project Agency for Health (ARPA-H): Concept Paper, p. 6.
37 House E&C Committee Print for “Subtitle J—Public Health,” as amended, p. 26.
38 T he SMRB is a federal advisory committee created by the NIH Reform Act of 2006 ( P.L. 109-482) that advises NIH
on its organizational structure, including its use of authorities to reorganize NIH institutes, centers, and offices. See
SMRB, “Charter,” https://smrb.od.nih.gov/charter.html.
39 Research!America, U.S. Investments in Medical and Health Research and Development: 2013-2018, 2019,
https://www.researchamerica.org/sites/default/files/Publications/InvestmentReport2019_Fnl.pdf.
40 NIH also supports translational research. For example, see the Edward R. Roybal Centers for T ranslational Research
in the Behavioral and Social Sciences of Aging at https://www.nia.nih.gov/research/dbsr/edward-r-roybal-centers-
translational-research-behavioral-and-social-sciences-aging.
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vaccine platform technologies.41 These are both directed at similar types of projects that the
proposed ARPA-H may support. Congress and the Administration might consider both how to
differentiate ARPA-H from existing NIH programs and private sector initiatives as wel as how
ARPA-H could interact with these programs and initiatives. DARPA, for instance, plays a role as
a convener among relevant players in industry, academia, and the government.
How Would ARPA-H Compare to Other “ARPAs”?
According to the Biden Administration:
Although DARPA is an excellent inspiration for ARPA -H, it is not a perfect model for
biomedical and health research. It serves the needs of a single customer, the DOD, and its
mission is focused on national security. Its projects typically involve engineered systems.
By contrast, health breakthroughs (i) interact with biological systems that are much more
complex and more poorly understood than engineered systems, requiring close coupling to
a vast body of biomedical knowledge and experience; (ii) interact with a complex wo rld of
many customers and users —including patients, hospitals, physicians, biopharma
companies and payers; (iii) interact in complex ways with human behavior and social
factors; and (iv) require navigating a complex regulatory landscape. ARPA -H can learn
from DARPA, but will need to pioneer new approaches.42
As noted earlier, the Biden Administration mentions a range of technologies and projects that the
new agency could support—such as new research tools and technologies (e.g., data platforms),
new drugs or treatments (e.g., mRNA vaccines for cancer), and innovative health care programs
and practices (e.g., virtual midwife programs to reduce maternal morbidity and mortality). While
ARPA-H may provide the initial support for such technologies and platforms, they would likely
be made available for research, commercial, or clinical use through different mechanisms. Some
of the proposed ARPA-H technologies, such as research technologies, may be made available
through open-source platforms or licensing. Others that contribute to the development of new
medical products may transition to industry for further financing and development. Innovative
health care programs and practices may transition to another federal health agency, private
organization, or be adopted as common practice throughout the health care industry.
According to a Biden Administration official, ARPA-H could provide incentives for industry
adoption of ARPA-H-funded innovations, or it could partner with other federal agencies such as
FDA to lower regulatory hurdles in getting such innovations to the marketplace.43 Some federal
agencies (e.g., the Department of Veterans Affairs) could become customers for ARPA-H-funded
innovations.
The House E&C committee print includes language that would direct the ARPA-H Director to
facilitate the translation of scientific discoveries into innovations, including by collaborating with
FDA on the development of medical products; the language would also require that medical
product development programs gather data necessary for FDA approval.44
Given the complexity of the health care industry as wel as unique regulatory considerations,
Congress might further consider if it were to establish an ARPA-H whether to explicitly authorize

41 Chan Zuckerberg Initiative, “Science Programs,” https://chanzuckerberg.com/science/programs-resources/ and Bill
and Melinda Gates Foundation, “Vaccine Development and Surveillance,” https://www.gatesfoundation.org/our-work/
programs/global-health/vaccine-development-and-surveillance.
42 White House, Advanced Research Project Agency for Health (ARPA-H): Concept Paper, p. 3.
43 Beth Wang, “ARPA-H Would Work with Industry, FDA, CMS to Bring Products to Market,” Inside Health Policy,
July 26, 2021, https://insidehealthpolicy.com/daily-news/arpa-h-would-work-industry-fda-cms-bring-products-market .
44 House E&C Committee Print for “Subtitle J—Public Health,” as amended, p. 26.
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a program within ARPA-H that would facilitate commercialization and implementation. ARPA-E,
for example, has a Technology-to-Market Program specifical y focused on this concern that offers
services and support to ARPA-E awardees in the development and execution of a
commercialization plan. ARPA-H could establish a similar program to aid in the transition of
technologies and programs it supports to industry or into practice, perhaps in coordination with
the FDA and the Centers for Medicare and Medicaid Services. Congress might also consider
whether to require ARPA-H to incorporate considerations of equitable access to, and the
affordability of, new medical products into its funding criteria or commercialization programs
and how to balance these criteria with ensuring private sector investment in and uptake of ARPA-
H supported innovations. In addition, Congress might consider how ARPA-H may interact or
engage with other federal agencies in the pursuit of health breakthroughs and the development of
programs, policies, and activities that go beyond R&D funding (i.e., early adoption of innovative
products and services).
Should ARPA-H Be Part of NIH?
The Biden Administration has argued that “the goals of ARPA-H fal squarely within NIH’s
mission” and that placing ARPA-H within NIH wil promote scientific collaboration and help
avoid duplication across programs.45 While House-passed LHHS appropriations would fund
ARPA-H in a new account at NIH, the House E&C committee print language would establish
ARPA-H under HHS without specifying its placement in the department. The placement of
ARPA-H―whether to house the new entity within NIH or as a separate agency under HHS
(NIH’s parent department)―is a key debate among stakeholders and Members of Congress. The
debate stems, in part, from a perception among some stakeholders that NIH’s culture is relatively
conventional and risk-averse. Some question if NIH’s leadership and culture could affect ARPA-
H’s ability to succeed in research for transformational innovation.46 Such stakeholders support
placing ARPA-H outside of NIH to ensure independence and autonomy. Additional y, there is
concern among other stakeholders that ARPA-H could crowd out funding for other NIH ICs in
future NIH budget and appropriations considerations.47
There is past precedent for innovative biomedical science efforts both within NIH and at the HHS
Secretarial level. At NIH, in addition to Common Fund and NCATS, NIH has supported projects
such as the Human Genome Project and, more recently, the Rapid Acceleration of Diagnostics
program to boost innovation for COVID-19 diagnostics.48 At HHS, the Office of the Chief
Technology Officer has managed several public-private partnerships aimed at accelerating
innovation, including for kidney disease and Lyme disease.49 Additional y, the Biomedical
Advanced Research and Development Authority (BARDA) under the Assistant Secretary for
Preparedness and Response engages in efforts to drive innovation for medical countermeasures to
address public health emergencies.50

45 Collins et al., “ARPA-H: Accelerating Biomedical Breakthroughs.”
46 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 T urbocharge Medical T reatments.
But T here’s a Fight over Where It Should Live,” Washington Post, June 23, 2021.
47 See, for example, American Society for Biochemistry and Molecular Biology (ASBMB), “ASBMB Responds to
Proposal for New Health Research Agency,” ASBMB Today, July 27, 2021.
48 White House, Advanced Research Project Agency for Health (ARPA-H): Concept Paper, p. 4.
49 HHS Office of the Chief T echnology Officer, “Innovation and Partnerships,” May 15, 2020.
50 HHS Office of the Assistant Secretary for Preparedness and Response, “ Biomedical Advanced Research and
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If ARPA-H were to be established, its ability to succeed could depend more on its statutory and
programmatic design and its leadership than its placement within the federal government.
Congress could develop ARPA-H legislation in a way that gives ARPA-H leadership
independence to act and formulate strategies, regardless of where the new agency is housed. No
matter where the new agency could be placed, it would likely need to consult with programs both
within and outside of NIH to promote collaboration and avoid duplication—including DOD,
BARDA, and FDA, among others. 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; the report
accompanying the House FY2022 LHHS appropriations bil (H.Rept. 117-96) “strongly
encourages NIH to recruit an ARPA-H Director with extraordinary technical and leadership skil s,
who has a proven track-record in innovation and partnership-building.”51 The House E&C
committee print language would direct HHS to hire a Director to head ARPA-H for a term of no
more than five years (subject to one renewal period).52 Some have also suggested facilitating
independence by housing ARPA-H in a different location than NIH’s main campus in Bethesda,
MD; NIH Director Francis Collins has publicly stated that this possibility is “on the table.”53
What Legislative Authorities May ARPA-H Require or Warrant?
As noted earlier, the Consolidated Appropriations Act, 2022 (H.R. 4502), passed by the House on
July 29, 2021, would provide funding for ARPA-H only if legislation specifical y authorizing the
establishment of ARPA-H were enacted into law. While the House E&C committee print
language would provide authorization for the new ARPA-H and its activities, the scope of its
provisions must be in compliance with the rules governing budget reconciliation measures.54
Therefore, even if the E&C committee print language for ARPA-H were enacted into law,
Congress may consider additional legislation to further specify and/or expand ARPA-H’s
authorities.
Such legislation may include flexibilities in hiring personnel and in the mechanisms used to
acquire goods and services (e.g., contracts for R&D) that many view as key aspects of the DARPA
model. Specifical y, the Biden Administration is requesting the authority to directly hire scientific
and technical experts from outside the federal government (i.e., academia, industry, and think
tanks) for limited-term appointments (three to five years). It is requesting that such hiring
authority exempt the agency from complying with traditional civilian personnel requirements,
thereby al owing it to streamline its hiring process and increase the level of compensation it could
offer.55 The ability of ARPA-H to recruit and retain scientific and technical experts could be
critical to the success of ARPA-H given the prominent role of program managers in determining

Development Authority,” https://phe.gov/about/barda/Pages/default.aspx.
51 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 Accom pany H.R.
4502, 117th Cong., 1st sess., July 19, 2021, pp. 165-166.
52 House E&C Committee Print for “Subtitle J—Public Health,” as amended, p. 25.
53 An earlier version of the House FY2022 LHHS Appropriations report also recommended that “ ARPA-H be housed
outside of NIH’s main campus in Bethesda, MD,” but this language was removed in the final report version. See Lev
Facher, “NIH’s Francis Collins: For Biden’s New Research Agency to Succeed, It Should Prepare for Some Projects to
Fail,” STAT News, July 15, 2021.
54 For more information, see CRS Report RL30862, The Budget Reconciliation Process: The Senate’s “Byrd Rule.”
55 White House, “ Advanced Research Projects Agency for Health (ARPA-H) Fact Sheet,”
https://www.whitehouse.gov/wp-content/uploads/2021/06/ARPA-H-Fact-Sheet.pdf.
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the direction and success of the proposed agency. NIH already has some special hiring authorities,
including an amended hiring authority (Public Health Service Act Section 228)56 in the 21st
Century Cures Act (P.L. 114-255) that expanded HHS’s ability to hire qualified scientific and
technical experts in the biomedical sciences. According to GAO, as of May 2020, HHS had not
yet used these authorities.57 Despite the hiring authorities provided by P.L. 114-255, ARPA-H
may require additional hiring flexibilities for its program managers. The House E&C committee
print language would direct the ARPA-H Director to hire and appoint personnel, including
program managers for terms of no more than three years with specified responsibilities, and
compensate personnel at a rate determined by the ARPA-H Director.
The Biden Administration is also requesting other transactions authority (OT authority) for
ARPA-H. An OT authority is an acquisition mechanism that does not fit into any of the traditional
mechanisms used by the federal government for acquiring goods or services—contracts, grants,
or cooperative agreements. OT authority is general y viewed as giving federal agencies additional
flexibility to develop agreements tailored to the needs of the project and its participants, who do
not have to comply with the government’s procurement regulations. Only those agencies that
have been provided OT authority by Congress may engage in other transactions. General y, the
reason for creating OT authority is that the government needs to obtain leading-edge R&D or
prototypes from commercial sources that are unwil ing or unable to navigate the government’s
procurement regulations. Some analysts raise concerns over potential risks associated with the
use of OT agreements (OTAs), including diminished oversight and exemption from laws and
regulations designed to protect government and taxpayer interests.58 Congress has provided NIH
currently with several OT authorities, though many are specific to individual ICs.59 The House
E&C committee print language would al ow ARPA-H to award funding as OTAs, and references
NIH’s existing OT authority in Public Health Service Act 402(n).60
OT authority may prove controversial in the context of medical products; the intel ectual property
rights to inventions under an OTA are usual y negotiable.61 A common justification for using
OTAs is that some companies may seek greater intel ectual property protections than are available
under traditional federal funding mechanisms when deciding to work with ARPA-H.62 In recent
years, there has been increased interest in ensuring that medical products discovered with federal
support are affordable, including by having the federal government exercise some of its
intel ectual property rights to inventions developed with federal support.63 With these rights

56 42 U.S.C. §237.
57 GAO, Biomedical Research: HHS Has Not Yet Used New Authorities to Improve Recruit and Retention of Scientists,
May 8, 2020, https://www.gao.gov/assets/710/707051.pdf. For NIH’s hiring authorities, see NIH Office of Human
Resources, “Pay at NIH,” https://hr.nih.gov/benefits/pay/pay-nih.
58 Scott Amey, “Other T ransactions: Do the Rewards Outweigh the Risks?,” Project on Government Oversight, March
15, 2019, https://www.pogo.org/report/2019/03/other-transactions-do-the-rewards-outweigh-the-risks/.
59 For more information on other transactions, see GAO, Federal Acquisitions: Use of ‘Other Transaction’ Agreements
Lim ited and Mostly for Research and Developm ent Activities, GAO-16-209, January 7, 2016.
60 42 U.S.C. §282(n). Specifically, that language allows NIH to engage in other transactions with respect to projects
that carry out “ high impact cutting-edge research that fosters scientific creativity and increases fundamental biological
understanding leading to the prevention, diagnosis, or treatment of diseases and disorders, or research urgently required
to respond to a public health threat” (among other project types).
61 For more information see, CRS Legal Sidebar LSB10422, COVID-19 Medical Countermeasures: Intellectual
Property and Affordability.
62 GAO, Federal Acquisitions.
63 See National Academies of Science, Medicine, and Engineering, “T he Role of NIH in Drug Development Innovation
and Its Impact on Patient Access: Proceedings of a Workshop,” 2019, http://nationalacademies.org/hmd/Reports/2019/
role-of-NIH-in-drug-development -innovation-and-its-impact-on-patient-access-proceedings.aspx; and Alfred B.
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potential y waived in OTAs, there may be some concern about the government’s ability to ensure
that products developed with ARPA-H support are available and affordable commercial y.64
Additional y, the Biden Administration is requesting that ARPA-H
 receive multiyear budget authority (i.e., funding that is available for obligation
for a fixed period in excess of one fiscal year);
 be exempt from using the traditional peer review process required by NIH ICs;
and
 be explicitly granted the authority to conduct prize competitions.65
The House E&C committee print language would provide ARPA-H with al of the above listed
legislative authorities requested by the Biden Administration.
How Might ARPA-H Be Evaluated?
It is unclear how the Administration would measure the success of ARPA-H. Measuring the
impact of R&D investments can be difficult. For example, there is general y a long lag time
between R&D activities and the availability of a commercial product or service. It can also be
difficult to quantify spillover effects (i.e., R&D knowledge applied to an area that differs from the
original intent) and to understand the degree to which a specific R&D project contributed to the
development of a product or innovation. The identification and measurement of noneconomic or
societal impacts such as health outcomes can be chal enging. Moreover, given the focus on high-
risk projects, a portion of ARPA-H projects would be expected to fail. Despite such chal enges,
evaluation and impact assessment support decisionmaking by providing insight into the
efficiency, effectiveness, and relevance of policies and programs.66
Congress might consider requiring an independent evaluation of ARPA-H, as it has for ARPA-E.
In the America Creating Opportunities to Meaningfully Promote Excel ence in Technology,
Education, and Science Act of 2007 (P.L. 110-69), Congress required the Secretary of Energy to
enter into an agreement with the National Academies of Sciences, Engineering, and Medicine
(NASEM) to conduct an evaluation of how wel ARPA-E was achieving its goals and statutory
mission. In 2017, NASEM released a study that provided both an operational assessment and a
technical evaluation of ARPA-E. Specifical y, the operational assessment appraised the
appropriateness and effectiveness of ARPA-E’s structure in positioning it to achieve its mission
and goals, while the technical evaluation described the most significant accomplishments or
impacts of ARPA-E as of 2017, and considered how wel ARPA-E’s activities supported the
agency’s goals (i.e., whether ARPA-E programs/awards were truly focused on transformational
energy technologies).67
An initial assessment of ARPA-H could focus on the operational aspects of the proposed agency,
in addition to determining if APRA-H is actual y fil ing a gap in biomedical innovation (i.e.,
supporting R&D that would not be funded or supported by other mechanisms). The evaluation
could also focus on shorter-term performance measures such as publications, patenting, or private

Engelberg and Aaron S. Kesselheim, “Use the Bayh-Dole Act to Lower Drug Prices for Government Healthcare
Programs,” Nature Medicine, vol. 22, no. 576 (June 7, 2016).
64 Sampat and Cook-Deegan, “An ARPA for Health Research?”
65 For more information on prize competitions, see CRS Report R45271, Federal Prize Competitions.
66 OECD, “Evaluation and Impact Assessment of ST I Policies,” in OECD Science, Technology and Innovation Outlook
2016 (Paris: OECD Publishing, 2016), p. 1, https://doi.org/10.1787/sti_in_outlook-2016-13-en.
67 NASEM, An Assessment of ARPA-E, pp. 16-17.
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investments in technologies original y supported by ARPA-H. A subsequent evaluation or
evaluations could focus more on the economic and societal impacts of ARPA-H funding. To
facilitate such evaluation, Congress might consider requiring ARPA-H to develop a framework
for the collection of data and other information that would al ow for robust assessment. Congress
could also require periodic or annual reports from ARPA-H that describe the projects being
supported and how such activities are advancing biomedical R&D and the mission of the
proposed agency to create breakthrough health technologies.
What Would Be the Appropriate Funding Level for ARPA-H?
The Biden Administration proposed an initial funding level of $6.5 bil ion for the new agency.68
However, the House has passed LHHS appropriations legislation (H.R. 4502) that would fund
ARPA-H at $3 bil ion, and the House E&C committee print recommends a funding level of $3
bil ion. Al proposals would provide funding for multiple years.69 For reference, DARPA has an
annual budget of $3.5 bil ion, ARPA-E has a FY2021 funding level of $425 mil ion, and fewer
than half of NIH ICs have an annual budget that exceeds $1 bil ion (11 out of 25 accounts).70
Biomedical research—especial y medical product R&D activities—tends to be expensive relative
to some other areas of technology R&D, which may explain a relatively higher funding level for
ARPA-H.71 Given that ARPA-H is an untested new agency, some argue that it should start smal
and grow over time depending on its success.72 If future budget resolutions were to impose more
stringent discretionary spending limits, Congress could face difficult future choices in al ocating
limited funds among ARPA-H, NIH IC accounts, and other discretionary health programs.73
Starting with higher baseline funding for ARPA-H could make such choices even more
chal enging.
Congress might also consider whether and how to leverage private sector 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 facilitated by the Foundation for the NIH,74 which could play a similar role in
financing ARPA-H programs.

68 NIH, Congressional Justification: FY2022, pp. 10-11.
69 Specifically, the Biden Administration requested funding for ARPA-H available until September 30, 2024; see NIH,
FY22022 Congressional Justification, p. 34. House-passed LHHS appropriations (H.R. 4502) would appropriate
funding to ARPA-H available until September 30, 2024. T he E&C committee print would provide appropriations until
expended.
70 See CRS Report R46869, Federal Research and Development (R&D) Funding: FY2022 ; and CRS Report R45088,
Defense Advanced Research Projects Agency: Overview and Issues for Congress.
71 GAO, Drug Industry: Profits, Research and Development Spending, and Merger and Acquisition Deals, GAO-18-
40, November 2017, pp. 28-37.
72 T ollefson, “The Rise of ‘ARPA-Everything’ and What It Means for Science.”
73 For an overview of the annual budget resolution process, see CRS In Focus IF10647, The Budget Resolution and the
Budget Control Act’s Discretionary Spending Limits.
74 See “Public-Private Partnerships” in CRS Report R41705, The National Institutes of Health (NIH): Background and
Congressional Issues; and CRS Report R46109, Agency-Related Nonprofit Research Foundations and Corporations.
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Author Information

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

Disclaimer
This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan
shared staff to congressional committees and Members of Congress. It operates solely at the behest of and
under the direction of Congress. Information in a CRS Report should n ot be relied upon for purposes other
than public understanding of information that has been provided by CRS to Members of Congress in
connection with CRS’s institutional role. CRS Reports, as a work of the United States Government, are not
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