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

Changes from April 15, 2022 to August 12, 2022

This page shows textual changes in the document between the two versions indicated in the dates above. Textual matter removed in the later version is indicated with ~~red strikethrough~~ and textual matter added in the later version is indicated with blue.

Advanced Research Projects Agency for Health ~~April 15~~August 12, 2022 , 2022
(ARPA-H): Congressional Action and Selected
Kavya Sekar
Policy Issues
Analyst in Health Policy Analyst in Health Policy

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

the department within 30 days of enactment. On March 30, 2022, HHS Secretary Xavier Becerra 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 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. 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 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 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 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 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 platforms and capabilities to try to deliver cures for diseases such as cancer, Alzheimer’s disease, cancer, Alzheimer’s disease, ~~diabetes, and other diseases.~~
and diabetes. Absent additional legislation, the FY2022 appropriation gives HHS considerable flexibility to design and structure the new 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 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 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 “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 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 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 suggests that this investigator-driven and consensus-based process is less likely to fund transformative or “high-risk, high-high-risk, high-~~reward~~reward” projects. projects.
Supporters of the proposal argue that high-risk, high-reward biomedical research may lead to health breakthroughs on a faster 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. timeline and is critical to ensuring U.S. competitiveness and addressing societal challenges.
Several bills Several bills ~~introduced~~are being considered in the 117th Congress in the 117th Congress that would codify and further delineate ARPA-H’s goals, structure, placement, would codify and further delineate ARPA-H’s goals, structure, placement,
activities, and authorities. activities, and authorities. ~~These include H.R. 5585 and H.R. 6000 introduced in the House and S. 3819 introduced in the~~
~~Senate. Subsequently~~A Senate proposal, S. 3819, S. 3819, was incorporated into the PREVENT Pandemics Act (S. 3799), in an amendment in the nature 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 of a substitute, and ordered to be reported by the Senate Committee on Health, Education, Labor, and Pensions (HELP) on
~~March 15, 2022.~~ March 15, 2022. Meanwhile, the Advanced Research Projects Agency for Health Act (H.R. 5585) passed the House on June 22, 2022. As Congress continues its deliberations on ARPA-H, several policy debates remain. Such debates include 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 (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 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. agencies and the private sector, and (3) what the appropriate current and future appropriations levels are for ARPA-H.

Congressional Research Service Congressional Research Service

ARPA-H: Congressional Action and Selected Policy Issues

Introduction
The federal government has long invested in biomedical science through the National Institutes of 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 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 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 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 explores the fundamental mechanisms of biology and behavior. Such research facilitates scientific
knowledge that informs medical advances. Traditionally, the private sector, such as the 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 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 (R&D) activities aimed at bringing new technologies and products to market, such as
pharmaceutical drugs.1 pharmaceutical drugs.1
In recent years, legislation such as the 21st Century Cures Act (P.L. 114-255) and the provisions 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 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 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 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 trend by proposing a new Advanced Research Projects Agency for Health (ARPA-H) at NIH in its
FY2022 budget request.4FY2022 budget request.4 In March 2022, Congress adopted the ARPA-H proposal in the In March 2022, Congress adopted the ARPA-H proposal in the
Consolidated Appropriations Act, 2022 (P.L. 117-103), which Consolidated Appropriations Act, 2022 (P.L. 117-103), which ~~provides~~provided $1 billion to a new $1 billion to a new
Department of Health and Human Services (HHS) account to establish ARPA-HDepartment of Health and Human Services (HHS) account to establish ARPA-H~~. In addition,~~
~~several bills have been introduced~~ (in Division H, Labor, HHS, Education, and Related Agencies Appropriations Act, LHHS). Both chambers are considering bills that would codify ARPA-H and define its goals, scope, that would codify ARPA-H and define its goals, scope,
placement, activities, and authorities (e.g., H.R. 5585placement, activities, and authorities (e.g., H.R. 5585~~, H.R. 6000,~~ and S. 3819). Subsequently, S. and S. 3819). Subsequently, S.
3819 was incorporated into the PREVENT Pandemics Act (S. 3799) as amended and ordered to 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 be reported by the Senate Committee on Health, Education, Labor, and Pensions (HELP) on
March 15, 2022. March 15, 2022.
The House passed H.R. 5585 on June 22, 2022. The ARPA-H proposal responds to concerns by some in the scientific and patient advocacy 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 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-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 risk, high-reward research is considered an important element in developing breakthrough
technologies that address societal challenges, including health-related challenges, and in 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, 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; , by Judith A. Johnson and Kavya Sekar;
and CRS Infographic IG10013, and CRS Infographic IG10013, The Pharmaceutical Drug Development Process, by Agata Bodie and Kavya Sekar. , by Agata Bodie and Kavya Sekar.
2 NCATS was established by the Consolidated Appropriations Act, 2012 (P.L. 112-74). 2 NCATS was established by the Consolidated Appropriations Act, 2012 (P.L. 112-74).
3 The NIH defines 3 The NIH defines innovation as “something new or improved, including research for (1) development of new 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, (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: 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 “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 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 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 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. 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-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/. 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,” 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?,” 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/. , 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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link to page link to page 1516 ARPA-H: Congressional Action and Selected Policy Issues

maintaining the economic competitiveness of the United States.6 In addition, the recent rapid development of safe and effective Coronavirus Disease 2019 (COVID-19) vaccines based on development of safe and effective Coronavirus Disease 2019 (COVID-19) vaccines based on
novel technologies such as novel technologies such as ~~mRNA~~messenger RNA (mRNA), built partly upon investments by the Defense Advanced , built partly upon investments by the Defense Advanced
Research Projects Agency (DARPA), has spurred increased interest in the usefulness and value of 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 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 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 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. Thedebate 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 provides a side-by-side comparison of key provisions in the legislative proposals that would
~~authorize~~codify ARPA-H. 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 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 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 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 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 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 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 (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 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 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 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 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 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-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 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~~

6 Organization for Economic Cooperation and Development (OECD), Effective Policies to Foster High-Risk/High-Reward Research, OECD Science, Technology, and Industry Policy Papers, No. 112, May 2021, https://read.oecd.org/10.1787/06913b3b-en?format=pdf. 10.1787/06913b3b-en?format=pdf.
7 CRS Insight IN11446, 7 CRS Insight IN11446, DARPA’s Pandemic-Related Programs, by Marcy E. Gallo; and Chiara Franzoni, Paula , by Marcy E. Gallo; and Chiara Franzoni, Paula
Stephan, and Reinhilde Veugelers, “Funding Risky Research,” National Bureau of Economic Research Working Paper, Stephan, and Reinhilde Veugelers, “Funding Risky Research,” National Bureau of Economic Research Working Paper,
June 2021. June 2021.
8 NIH, 8 NIH, Congressional Justification: FY2022, May 28, 2021, https://officeofbudget.od.nih.gov/pdfs/FY22/br/, May 28, 2021, https://officeofbudget.od.nih.gov/pdfs/FY22/br/
2022%20CJ%20Overview%20Volume%20May%2028.pdf, pp. 1-11; White House, 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-, 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, 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., 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,” “ARPA-H: Accelerating Biomedical Breakthroughs,” Science, vol. 373, no. 6551 (July 9, 2021). , vol. 373, no. 6551 (July 9, 2021).
9 For more information on DARPA, see CRS Report R45088, 9 For more information on DARPA, see CRS Report R45088, Defense Advanced Research Projects Agency: Overview
and Issues for Congress, by Marcy E. Gallo. , by Marcy E. Gallo.
10 See “Peer Review Process for Extramural Funding” in CRS Report R41705, 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. , by Judith A. Johnson and Kavya Sekar.
11 Chiara Franzoni, Paula Stephan, and Reinhilde Veugelers, “Funding Risky Research,” 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 , June 2021; Mikko Packalen and Jay Bhattacharya, “NIH Funding and the Pursuit of Edge
Science,” Science,” Proceedings of the National Academy of Sciences, vol. 117, no. 22 (June 2, 2020), pp. 12011-12016; and , 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 Pierre Azoulay, Erica Fuchs, and Anna Goldstein, “Funding Breakthrough Research: Promises and Challenges of the
‘ARPA Model,’” ‘ARPA Model,’” National Bureau of Economic Research, June 2018. , 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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Congressional Research Service 2 ARPA-H: Congressional Action and Selected Policy Issues fundamental scientific or technological challenges, involve a high degree of novelty and/or multidisciplinary approaches, but also have a higher risk of failure than other projects.12 The FY2022 budget request included $6.5 billion for ARPA-H “to make pivotal investments in 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 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 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 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 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 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 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 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, 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, or cell type; and platforms to reduce health disparities in maternal morbidity and mortality,
among others.15 among others.15
Funding was requested for a period of three years to “allow for both scale-up in FY2022 and 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.” 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 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 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 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 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 The FY2022 budget request described the types of challenges ARPA-H would seek to address
through its investments, including: through its investments, including:
 Support for complex research and development that requires large-scale,  Support for complex research and development that requires large-scale, sustained, cross-sustained, cross-
sector coordination; sector coordination;
 The creation of new capabilities (e.g., technologies, data resources, disease  The creation of new capabilities (e.g., technologies, data resources, disease models); models);
 Support for high-risk exploration that could establish entirely new paradigms;  Support for high-risk exploration that could establish entirely new paradigms; and and
 The commercialization of biomedical innovations using financial incentives and  The commercialization of biomedical innovations using financial incentives and ~~other~~
other mechanisms.17 mechanisms.17
Most ARPA-H awards would support industry, universities, and nonprofit research institutions 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 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 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) research and activities with NIH ICs and other Department of Health and Human Services (HHS)
agencies (e.g., the Food and Drug Administration [FDA]). 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~~

12 For a discussion of definitions of “high-risk, high-reward research,” see pages 11-13 of Organization for Economic Cooperation and Development (OECD), Effective Policies to Foster High-Risk/High-Reward Research, OECD Science, Technology, and Industry Policy Papers, No. 112, May 2021, https://read.oecd.org/10.1787/06913b3b-en?format=pdf. format=pdf.
13 White House, 13 White House, Advanced Research Project Agency for Health (ARPA-H): Concept Paper. .
14 NIH, 14 NIH, Congressional Justification: FY2022, pp. 10-11. , pp. 10-11.
15 NIH, 15 NIH, Congressional Justification: FY2022, pp. 10-11; and White House, , pp. 10-11; and White House, Advanced Research Project Agency for
Health (ARPA-H): Concept Paper. .
16 NIH, 16 NIH, Congressional Justification: FY2022, pp. 10-11. , pp. 10-11.
17 NIH, 17 NIH, Congressional Justification: FY2022, pp. 10-11. , 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~~ Congressional Research Service 3 ARPA-H: Congressional Action and Selected Policy Issues
White House Listening Sessions for ARPA-H
In July and August 2021, OSTP and NIH held 15 listening sessions on the proposed 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 with thousands of biomedical stakeholders. In September 2021, OSTP and NIH summarized
participant recommendations, which emphasized the following:participant recommendations, which emphasized the following:2018
  A focus on technologies, rather than specific diseases: Stakeholders : Stakeholders
emphasized that ARPA-H should focus on developing technologies that could emphasized that ARPA-H should focus on developing technologies that could
have applications across a wide range of diseases, rather than focus on specific have applications across a wide range of diseases, rather than focus on specific
diseases. Stakeholders also noted specific types of technologies for the new diseases. Stakeholders also noted specific types of technologies for the new
agency to support, such as data-sharing platforms, diagnostics platforms, agency to support, such as data-sharing platforms, diagnostics platforms,
artificial intelligence and machine learning algorithms, and wearables and digital artificial intelligence and machine learning algorithms, and wearables and digital
technologies. technologies.
  Embracing equity and diversity as a cornerstone of the mission: Stakeholders Stakeholders
suggested that equity and diversity considerations should be incorporated into all suggested that equity and diversity considerations should be incorporated into all
aspects of ARPA-H, from staffing to project selection and execution. Some also 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 suggested that ARPA-H should prioritize programs that take a holistic approach
that considers health in the context of broader environmental, cultural, economic that considers health in the context of broader environmental, cultural, economic
and social factors. and social factors.
  Coordination and collaboration: Participants emphasized the need to partner and consult with diverse private, academic, and public sector entities. Stakeholders advised that ARPA-H should Stakeholders advised that ARPA-H should
avoid areas that are well-funded by NIH or the private sector, and should pursue 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 projects that are complementary to currently funded efforts. They also
emphasized a need for mechanisms to support commercialization of ARPA-H-emphasized a need for mechanisms to support commercialization of ARPA-H-
supported technologies and programs through collaboration with FDA and the supported technologies and programs through collaboration with FDA and the
Centers for Medicare Centers for Medicare ~~and~~& Medicaid Services Medicaid Services (CMS). Executive Action The Consolidated Appropriations Act, 2022 (P.L. 117-103), gave the HHS Secretary the ability to transfer ARPA-H to any HHS agency or office, including NIH, within 30 days of enactment. It required the Secretary to notify Congress at least 15 days in advance of such a transfer. On March 30, 2022, HHS Secretary Becerra submitted a notice to the appropriations committees that ARPA-H would reside within NIH, with the ARPA-H Director reporting directly to the HHS Secretary.19 On May 25, 2022, HHS Secretary Becerra announced the formal establishment of ARPA-H within NIH and named Dr. Adam H. Russell as the acting interim director for the agency.20 In addition, an organizational structure for ARPA-H was published in the Federal Register on May 27, 2022. As outlined in the federal notice, ARPA-H will be composed of 14 offices, as follows:  Acquisition and Contracting Office: Advises the ARPA-H Director and staff on acquisition and contract and grant financial advisory services. 18 White House Office of Science and Technology Policy and NIH, Listening Sessions for ARPA-H: Summary Report, https://www.whitehouse.gov/wp-content/uploads/2021/09/093021-ARPA-H-Listening-Session-Summary_Final.pdf. 19 Lev Facher, “Biden’s High-Stakes Biomedical Science Agency ARPA-H Will Be Part of the NIH—But There’s a Twist,” STAT, March 31, 2022. 20 Department of Health and Human Services, “HHS Secretary Becerra Establishes ARPA-H within NIH, Names Adam H. Russell, D.Phil. Acting Deputy Director,” press release, May 25, 2022, https://www.hhs.gov/about/news/2022/05/25/hhs-secretary-becerra-establishes-arpa-h-within-nih-names-adam-h-russell-phil-acting-deputy-director.html. Congressional Research Service 4 ARPA-H: Congressional Action and Selected Policy Issues  Comptroller's Office: Directs ARPA-H-wide budget policy, planning, analysis, formulation, and presentation, in collaboration with HHS Office of the Assistant Secretary for Financial Resources and NIH Office of Budget.  Engagement and Communications Office: Plans and directs activities to communicate information about ARPA-H programs and accomplishments to the general public, scientific community, patients and patient groups, professional societies and organizations, and public advocacy groups.  Legislative and Governmental Affairs Office: Advises the ARPA-H Director and staff on the full range of legislative and intragovernmental issues, and provides leadership and direction for ARPA-H legislative analysis, development, and liaison.  Strategic Resources Office: Advises the ARPA-H Director and staff on all phases of ARPA-H-wide administration and management.  Treatment Innovation Office: Furthers development of novel and innovative therapeutics or other interventions to manage, treat, or cure diseases and conditions.  Health Equity, Dissemination, and Implementation Office: Advances programs that concentrate on promoting health equity, access to care, and ethical aspects of science and technology development.  Health Promotion and Disease Detection Office: Advances approaches, interventions, and technologies that further the overall health and wellness of Americans and prevent diseases.  Health Resources and Policies Office: Advances progress in confronting challenges to the overall ecosystem of biomedical and health research, whether they be processes, policies, or models, to enable acceleration of advances.  Systems Technology Office: Focuses on those systems that impact health—from physiologic systems (e.g., immune) to the health care system and everything in between.  Equity and Inclusion Office: Coordinates, facilitates, and supports programs to ensure equity, diversity, and inclusion in all aspects of ARPA-H’s work.  Strategic Planning, Evaluation, and Analytics Office: Oversees ARPA-H-wide planning, evaluation, and analysis/analytic activities.  Innovation and Entrepreneurship Office: Inspires innovation and creativity throughout ARPA-H, including stimulating the culture of innovation, ideation, and dynamic thinking and leveraging design research and design thinking.21 21 National Institutes of Health, “Establishment of the Advanced Research Projects Agency for Health,” 87 Federal Register 32174-32176, May 27, 2022. Congressional Research Service 5 ARPA-H: Congressional Action and Selected Policy Issues ~~(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~~
Congressional Action Appropriations FY2022 Enacted: On March 15, 2022, the Consolidated Appropriations Act, 2022 (P.L. 117-103) was signed into On March 15, 2022, the Consolidated Appropriations Act, 2022 (P.L. 117-103) was signed into
law. It law. It ~~provides~~provided $1 billion in appropriations to a new account at HHS for ARPA-H, with funding $1 billion in appropriations to a new account at HHS for ARPA-H, with funding
available until September 30, 2024.available until September 30, 2024.2122 Unlike earlier ARPA-H appropriations proposals, the law Unlike earlier ARPA-H appropriations proposals, the law
~~does~~did not condition the availability of funds on enactment of legislation specifically establishing 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 ARPA-H. Thus, this legislation does not preclude the Administration from moving forward with
establishing ARPA-H and provides for the following implementation activities: establishing ARPA-H and provides for the following implementation activities:
 presidential appointment of the ARPA-H Director;  presidential appointment of the ARPA-H Director;
 hiring and appointment flexibilities;  hiring and appointment flexibilities;
 the ability to make awards as grants, contracts, cooperative agreement, and other  the ability to make awards as grants, contracts, cooperative agreement, and other
transactions; transactions;2223
 exemption from NIH scientific peer review requirements; and  exemption from NIH scientific peer review requirements; and
 the ability of the HHS Secretary to transfer ARPA-H to any HHS agency or  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 office, including NIH, within 30 days of enactment. (The HHS Secretary’s
response is noted in the text box above). response is noted in the text box above).
The explanatory statement accompanying the law does not provide further details on Congress’s The explanatory statement accompanying the law does not provide further details on Congress’s
policy intentions for ARPA-H.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).~~
2224 The report accompanying the House FY2022 LHHS appropriations bill (H.Rept. 117-96; incorporated by reference) “encourages NIH to collaborate with DARPA to develop the foundational policies, procedures, and staff training for ARPA–H employees.”25 FY2023 Request: Announced on March 28, 2022, President Biden’s FY2023 budget request for NIH proposes $5 billion for ARPA-H in an NIH account, with funding available until September 30, 2025.26 The FY2023 request reiterates the same vision for ARPA-H as in the FY2022 request, and notes that “opportunities or obstacles identified by the Cancer Moonshot may become candidates for the new approach to transformational change offered by ARPA-H.” The Beau Biden Cancer 22 Title II, Division H of Consolidated Appropriations Act, 2022 (P.L. 117-103). 23 The law cites the definition of “other transaction” in Public Health Service Act (PHSA) Section 319L(a)(3), which 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 means “transactions, other than procurement contracts, grants, and cooperative agreements.” For further information on
OT authorities, see CRS Report R45521, OT authorities, see CRS Report R45521, Department of Defense Use of Other Transaction Authority: Background,
Analysis, and Issues for Congress, by Heidi M. Peters. , by Heidi M. Peters.
2324 See U.S. Congress, House Committee on Rules, See U.S. Congress, House Committee on Rules, Division H- LHHS Appropriations 2022, Explanatory Statement, ,
committee print, 117th Cong., 1st sess., p. 119. 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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~~link to page 15~~ ~~ARPA-H: Congressional Action and Selected Policy Issues~~

~~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–~~25 As directed in the Explanatory Statement cited in footnote 23 (page 1), “Unless otherwise noted, the language set forth in H.Rept. 117-96 carries the same weight as language included in this explanatory statement and should be complied with unless specifically addressed to the contrary in this explanatory statement.” 26 NIH, Congressional Justification: FY2023, March 28, 2022, https://officeofbudget.od.nih.gov/pdfs/FY23/br/Overview%20of%20FY%202023%20Presidents%20Budget.pdf, p. 33. Congressional Research Service 6 link to page 11 link to page 11 ARPA-H: Congressional Action and Selected Policy Issues Moonshot is another one of President Biden’s major policy priorities related to biomedical research.27 House: On July 5, 2022, the House Appropriations Committee reported an FY2023 appropriations bill (H.R. 8295) that would provide $2.75 billion, available until September 30, 2025, to an ARPA-H account under the Office of the Secretary—$1.75 billion above the FY2022-enacted level. Additionally, the report (H.Rept. 117-403) accompanying the bill states: The Committee strongly supports the mission of ARPA–H to drive transformational innovation in health research. The Committee believes that given its focus on supporting high-risk, high reward projects and distinct approach to selecting and managing research projects, establishing ARPA–H as a separate entity within HHS will maximize the likelihood of the agency’s success. Senate: On July 28, 2022, the Senate Appropriations Committee Majority Chair Patrick Leahy released draft Senate appropriations bills.28 The draft LHHS bill would provide $1 billion, available through September 30, 2025, to an ARPA-H account under NIH.29 This amount would be the same funding level as FY2022-enacted and $1.75 billion less than in the House-reported bill. Additionally, the draft report accompanying the bill states:30 Following the decision by the Secretary to transfer ARPA-H to NIH in May, funding is provided to ARPA–H as a standalone agency within NIH. However, the Committee believes ARPA–H will require a very different culture and mission than NIH’s other 27 Institutes and Centers. To foster the development of an entrepreneurial culture, the Committee expects ARPA–H to be physically located away from the main NIH campus. The Committee expects NIH to conduct a transparent and competitive process for a location site. Authorizations House: On June 22, 2022, the House passed the Advanced Research Projects Agency-Health Act (H.R. Health Act (H.R. 5585), with amendments to the bill previously reported by the House Committee on Energy and Commerce on June 13, 2022 (H.Rept. 117-365)~~5585) on October 15, 2021~~. This . This
~~standalone bill~~standalone bill, introduced by House Energy and Commerce Health Subcommittee Chair Representative Eshoo, would authorize and establish ARPA-H within HHS. would authorize and establish ARPA-H within HHS. Two other bills to authorize ARPA-H were previously introduced in the House. Representatives Diana Representatives Diana
DeGette and Fred Upton introduced the Cures 2.0 Act (H.R. 6000) on November 17, 2021. 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 Section 501 of this bill would authorize ARPA-H and establish it within NIH (see “Independence
and Autonomy”and Autonomy” for more on placement within the federal government). An early version of the Build Back Better Act (H.R. 5376) budget reconciliation measure, reported in the House on September 27, 2021, included authorization language and funding of $3 billion for ARPA-H. The 27 NIH, Congressional Justification: FY2023, pp. 4-13. 28 Senate Committee on Appropriations, “Chairman Leahy Releases Fiscal Year 2023 Senate Appropriations Bills,” press release, July 28, 2022, https://www.appropriations.senate.gov/news/majority/breaking-chairman-leahy-releases-fiscal-year-2023-senate-appropriations-bills. 29 U.S. Congress, Senate Committee on Appropriations, FY2023 LHHS Appropriations, committee print, 117th Cong., 2nd sess., July 28, 2022, https://www.appropriations.senate.gov/imo/media/doc/LHHSFY2023.PDF. 30 U.S. Congress, Senate Committee on Appropriations, Subcommittee on Labor, Health and Human Services, and Education, and Related Agencies, Explanatory Statement for FY2023 LHHS Appropriations Bill, committee print, 117th Cong., 2nd sess., July 2022, https://www.appropriations.senate.gov/imo/media/doc/LHHSFY23REPT.pdf. Congressional Research Service 7 link to page 16 ARPA-H: Congressional Action and Selected Policy Issues House-passed version on November 19, 2021, however, did not include ARPA-H related language. ~~for more on placement within the federal government).~~
Senate: On March 10, 2022, Senators Patty Murray and Richard Burr, the chair and ranking 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 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 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. 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 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. 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 provides a detailed side-by-side comparison of ARPA-H legislative proposals in the
House (H.R. 5585House (H.R. 5585 ~~and H.R. 6000~~) and Senate (S. 3799, as amended). ) and Senate (S. 3799, as amended).
Selected Policy Issues
The bills that would establish ARPA-H are generally similar; however, some key differences and 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 policy questions remain. The following sections describe select policies under debate and
potential issues for congressional consideration. potential issues for congressional consideration.
Independence and Autonomy
Independence at the agency level to shape a distinct mission and culture along with autonomy of 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 program managers to select and fund projects are viewed as key components of the ARPA
model.model.2631 Stakeholders, the Biden Administration, and Members of Congress have debated where 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 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 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 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 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 placement through legislation. Aside from placement, Congress is also debating further options of
ensuring ARPA-H’s independence and autonomyensuring ARPA-H’s independence and autonomy. ~~as discussed below.~~
The Biden Administration originally proposed placing ARPA-H within NIH, arguing that “the 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 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.would promote scientific collaboration and help avoid duplication across programs.2732 On the On the
other hand, some stakeholders see NIH’s culture as relatively conventional and risk-averse and 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 question whether NIH’s leadership and culture could affect ARPA-H’s ability to succeed in
research for transformational innovation.research for transformational innovation.2833 Such stakeholders support placing ARPA-H outside of Such stakeholders support placing ARPA-H outside of
NIH to ensure independence and autonomy. For example, in a recent hearing before the House 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 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 Strategy at the University of California San Francisco, stated the following regarding housing
ARPA-H outside of NIH: ARPA-H outside of NIH:
The main force of that argument is that the mission and goals of ARPA-H are different. 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 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 being able to develop applications for that new knowledge. And the route for being able to
31 Azoulay et al., “Funding Breakthrough Research: Promises and Challenges of the ‘ARPA Model,’” pp. 9-10. 32 Collins et al., “ARPA-H: Accelerating Biomedical Breakthroughs.” 33 Sarah Omermohle, “Skeptics Question If Biden’s New Science Agency Is a Breakthrough or More Bureaucracy,” Politico, July 5, 2021; Jacqueline Alemany, “Biden Has Proposed a New Agency to Turbocharge Medical Treatments. But There’s a Fight over Where It Should Live,” Washington Post, June 23, 2021. Congressional Research Service 8 link to page 9 ARPA-H: Congressional Action and Selected Policy Issues do that has already been cast and demonstrated extremely well in DARPA and ARPA-E. 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 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, operating model within the culture and operating model of NIH, as successful as it is, right,
would be challenging at best.would be challenging at best.2934
In the same hearing before the House Committee on Energy and Commerce, Esther Krofah, 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, 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 “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, mission, including advantages to having easy access to other NIH infrastructure, personnel,
programs, and expertise.”programs, and expertise.”3035
There is precedent for innovative biomedical science efforts both at NIH and at other HHS units. 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-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 cutting and milestone-driven innovative projects; NCATS, which focuses on innovation in
medical product development; and, more recently, the Rapid Acceleration of Diagnostics program medical product development; and, more recently, the Rapid Acceleration of Diagnostics program
to boost innovation for COVID-19 diagnostics.to boost innovation for COVID-19 diagnostics.3136 The HHS Office of Science and Medicine under The HHS Office of Science and Medicine under
the Assistant Secretary for Health has managed InnovationX, which includes several public-the Assistant Secretary for Health has managed InnovationX, which includes several public-
private partnerships aimed at accelerating innovation, including for kidney disease and Lyme private partnerships aimed at accelerating innovation, including for kidney disease and Lyme
disease.disease.3237 Additionally, the Biomedical Advanced Research and Development Authority Additionally, the Biomedical Advanced Research and Development Authority
(BARDA) at HHS under the Assistant Secretary for Preparedness and Response engages in (BARDA) at HHS under the Assistant Secretary for Preparedness and Response engages in
efforts to develop medical countermeasures to address public health emergencies.efforts to develop medical countermeasures to address public health emergencies.3338 Regardless of where the new agency is placed, it would likely need to consult with NIH programs, HHS programs such as BARDA, as well as biomedical programs at DOD to promote ~~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. collaboration and avoid duplication.
The authorizing bills The authorizing bills under consideration in the House (H.R. 5585in the House (H.R. 5585 ~~and H.R. 6000~~) and Senate (S. 3799, as amended) ) and Senate (S. 3799, as amended)
differ in ARPA-H’s placement. H.R. 5585 would establish ARPA-H as an independent entity differ in ARPA-H’s placement. H.R. 5585 would establish ARPA-H as an independent entity
within HHS while within HHS while ~~H.R. 6000 and S. 3799,~~ S. 3799 (as amendedas amended,) would establish ARPA-H as an agency would establish ARPA-H as an agency
under NIH. under NIH.
Additionally, the authorizing bills include provisions that seek to ensure the independence and 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 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, 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 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 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 officer, and do not necessarily reflect the views of the President or another agency. The provisions
related to independence in S. 3799related to independence in S. 3799~~: (1~~ (as amended) would ) would (1) prohibit ARPA-H from being located on the NIH prohibit ARPA-H from being located on the NIH
campus and in close proximity to the National Capital Region and (2) campus and in close proximity to the National Capital Region and (2) ~~would~~ prohibit the ARPA-prohibit the ARPA-
H Director from appointing personnel to the agency who were employed by NIH three years prior 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 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”request for the agency be separate and distinct from either HHS or NIH (see “Appropriations”
below for additional discussion). 34 U.S. Congress, House Committee on Energy and Commerce, Subcommittee on Health, ARPA-H: The Next Frontier of Biomedical Research, 117th Cong., 2nd sess., February 8, 2022. 35 U.S. Congress, House Committee on Energy and Commerce, Subcommittee on Health, ARPA-H: The Next Frontier of Biomedical Research, 117th Cong., 2nd sess., February 8, 2022. 36 White House, Advanced Research Project Agency for Health (ARPA-H): Concept Paper, p. 4. 37 HHS, “InnovationX,” https://www.hhs.gov/ash/osm/innovationx/index.html. 38 HHS Office of the Assistant Secretary for Preparedness and Response, “Biomedical Advanced Research and Development Authority,” https://phe.gov/about/barda/Pages/default.aspx. Congressional Research Service 9 link to page 16 ARPA-H: Congressional Action and Selected Policy Issues ~~below for additional discussion).~~
Some have argued that ARPA-H’s founding director would play a crucial role in developing a 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.unique culture that guides the agency to success.3439 For example, the report accompanying the For example, the report accompanying the
House FY2022 LHHS appropriations bill (H.Rept. 117-96) “strongly encourages NIH to recruit 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-an ARPA-H Director with extraordinary technical and leadership skills, who has a proven track-
record in innovation and partnership-building.”record in innovation and partnership-building.”~~35 All~~40 Both of the proposals would require the ARPA- of the proposals would require the ARPA-H H
Director to be appointed by the President (consistent with enacted appropriations), though they 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 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 proposals also specify different appointment terms. H.R. 5585 ~~and H.R. 6000~~ would authorize a would authorize a
five-year appointment term for the ARPA-H Director while S. 3799five-year appointment term for the ARPA-H Director while S. 3799, (as amendedas amended,) would authorize would authorize
a four-year term. a four-year term. ~~All~~Both bills would allow for one consecutive term. bills would allow for one consecutive term. ~~All~~Both of the proposals similarly of the proposals similarly
specify that the Director have qualifications to manage advanced biomedical research programs, specify that the Director have qualifications to manage advanced biomedical research programs,
with some slight differences. with some slight differences.
Defining Goals and Preventing Duplication
Existing ARPAs address their mandate to advance Existing ARPAs address their mandate to advance ~~the development and application of~~ high-risk, high-risk,
high-reward research and technologies by seeking to fill what is called the high-reward research and technologies by seeking to fill what is called the white space, a , a
perceived gap or opportunity in the technology landscape.perceived gap or opportunity in the technology landscape.3641 The Biden Administration has argued The Biden Administration has argued
that the current ecosystem of biomedical R&D—with curiosity-driven research funded by NIH 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 and the public sector and commercialization-driven R&D funded largely by industry—is

34adequate for most biomedical innovation but leaves certain critical gaps that ARPA-H could fill. Specifically, project ideas that the Administration asserts are left unfunded by the current system include those that (1) are high risk and/or require significant funding, (2) involve complex coordination among multiple parties, (3) have a focus that is too applied for academia, and (4) have a scope that “is so broad that no company can realize the full economic benefit.”42 Some empirical research supports these claims: recent economic analyses provide some evidence that both the pharmaceutical industry and NIH underinvest in high-risk R&D.43 The ARPA-H bills (H.R. 5585 and S. 3799, as amended) define overall agency goals similarly, with some variations (see Table A-1). Both of the bills emphasize breakthrough biomedical technologies and innovation in ARPA-H’s proposed statutory goals. Neither of the bills establish ARPA-H to focus on specific diseases or areas of research. A main difference in ARPA-H goals between the bills is that H.R. 5585 explicitly names ensuring U.S. global leadership in science and innovation, especially with respect to global health threats, as an overall goal. 39 Jocelyn Kaiser, “The U.S. Just Created a Big New Biomedical Research Agency. But Questions Remain,” 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-March 15, 2022, https://www.science.org/content/article/u-s-just-created-big-new-biomedical-research-agency-
questions-remain. questions-remain.
3540 Omermohle, “Skeptics Question If Biden’s New Science Agency Is a Breakthrough or More Bureaucracy;” Sampat 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, 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, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, Report to Accompany H.R. H.R.
4502, 117th Cong., 1st sess., July 19, 2021, pp. 165-166. 4502, 117th Cong., 1st sess., July 19, 2021, pp. 165-166.
3641 National Academies of Sciences, Engineering, and Medicine, National Academies of Sciences, Engineering, and Medicine, An Assessment of ARPA-E (Washington, DC: The (Washington, DC: The
National Academies Press, 2017), p. 95; and Azoulay et al., “Funding Breakthrough Research: Promises and National Academies Press, 2017), p. 95; and Azoulay et al., “Funding Breakthrough Research: Promises and
Challenges of the ‘ARPA Model.’” Challenges of the ‘ARPA Model.’”
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~~link to page 15 link to page 15~~ ~~ARPA-H: Congressional Action and Selected Policy Issues~~

~~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~~42 Collins et al., “ARPA-H: Accelerating Biomedical Breakthroughs.” 43 Joshua L. Krieger, Danielle Li, and Dimitris Papanikolaou, “Missing Novelty in Drug Development,” National Bureau of Economic Research, vol. 35, no. 2 (2022), pp. 636-679; Chiara Franzoni, Paula Stephan, and Reinhilde Veugelers, “Funding Risky Research,” National Bureau of Economic Research Working Paper, June 2021; and Mikko Packalen and Jay Bhattacharya, “NIH Funding and the Pursuit of Edge Science,” Proceedings of the National Academy of Sciences, vol. 117, no. 22 (June 2, 2020), pp. 12011-12016. Congressional Research Service 10 link to page 16 link to page 16 ARPA-H: Congressional Action and Selected Policy Issues Some have expressed concern about the potentially broad scope of ARPA-H.44 Both of the of the
authorizing bills would require ARPA-H to develop and submit to Congress a strategic plan for 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 the new agency and submit annual reports to Congress that detail current, proposed, and planned
ARPA-H projects. ARPA-H projects.
Some have expressed concern that ARPA-H could duplicate existing medical and health research Some have expressed concern that ARPA-H could duplicate existing medical and health research
efforts across the federal government.efforts across the federal government.4045 Myriad federal agencies support medical and health Myriad federal agencies support medical and health
research, not only NIH—the largest supporter of such research—but also DOD, the Department research, not only NIH—the largest supporter of such research—but also DOD, the Department
of Veterans Affairs (VA), and other agencies within HHS.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.~~46 The The
authorizing bills address considerations related to aligning ARPA-H efforts with those of other 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 “federal agencies, as shown in the sections on “Coordination and Cooperation” and “~~Advice~~Advisory Committees” in ” in
tthe Appendix. For example~~For example~~, S. 3799, S. 3799, (as amendedas amended,) and H.R. 5585 would both require the and H.R. 5585 would both require the
establishment of an interagency advisory committee tasked with avoiding duplication and establishment of an interagency advisory committee tasked with avoiding duplication and
improving the coordination improving the coordination of ARRPA-H’s efforts with other federal agencies. H.R. 5585 would also require the Government Accountability Office to conduct an independent review of HHS’s research portfolio every three years to assess the degree of unnecessary duplication and make recommendations regarding any potential reorganization, consolidation, or termination of duplicative program and projects. Additionally, other federal agencies would play a critical role in commercialization of implementation of ARPA-H technologies or innovations—for example, FDA would regulate many ARPA-H-supported medical products. Both bills would require ARPA-H to coordinate with the FDA to expedite and facilitate the transformation and development of ARPA-H activities into medical products and solutions for patients. Federal health care programs, such as the Centers for Medicare & Medicaid Services (CMS) and the VA, could end up implementing or paying for ARPA-H supported innovations. H.R. 5585 would require ARPA-H to share timely information with CMS for coverage decisions. Both bills also provide for follow-on production or procurement and demonstration programs, as shown in the section on “Other Transactions, Follow-on Production, Technology Transfer, and Procurement and Demonstration” in Table A-1. There is also concern about duplicating commercial or philanthropic research efforts. Both bills direct ARPA-H to prioritize investments in areas that are underfunded by the public and private sector, and to facilitate public-private partnerships. S. 3799 (as amended)~~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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~~ARPA-H: Congressional Action and Selected Policy Issues~~

~~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 includes provisions that are aimed at preventing ARPA-H funding from crowding out
private sector investment. For example, S. 3799private sector investment. For example, S. 3799, (as amendedas amended,) would require the ARPA-H would require the ARPA-H
Director to ensure that ARPA-H does not provide funding for a research program or project unless 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 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. financing, and that there is a lack of significant private support for the program or project.
Another Another ARPA agency, the Advanced Research Projects Agency-Energy (ARPA-E) faced similar agency, the Advanced Research Projects Agency-Energy (ARPA-E) faced similar
concerns regarding potential duplication; however, a recent study by the U.S. Government 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 Accountability Office found that “ARPA-E has practices in place to help manage overlap and
44 See, for example, Jeff Tollefson, “The Rise of ‘ARPA-Everything’ and What It Means for Science,” Nature, July 8, 2021, https://www.nature.com/articles/d41586-021-01878-z; and Bhaven N. Sampat and Robert Cook-Deegan, “An ARPA for Health Research?,” Milbank Quarterly, https://www.milbank.org/quarterly/opinions/an-arpa-for-health-research/. 45 U.S. Congress, House Committee on Energy and Commerce, Subcommittee on Health, ARPA-H: The Next Frontier of Biomedical Research, 117th Cong., 2nd sess., February 8, 2022. 46 Research!America, U.S. Investments in Medical and Health Research and Development, 2019, https://www.researchamerica.org/sites/default/files/Publications/InvestmentReport2019_Fnl.pdf. Congressional Research Service 11 ARPA-H: Congressional Action and Selected Policy Issues duplication during its program development cycle.”47~~duplication during its program development cycle.”42~~ Congress may consider whether to identify Congress may consider whether to identify
any best practices from ARPA-E that could be applied to ARPA-H program development. 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) The Consolidated Appropriations Act, 2022 (P.L. 117-103) ~~provides~~provided ARPA-H with $1 billion in ARPA-H with $1 billion in
funding available until September 30, 2024. This is in contrast with the $6.5 billion in initial 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.funding proposed by the Biden Administration for the same period.4348 It is also lower than the It is also lower than the
authorized amountsauthorized amounts ~~included~~ in H.R. 5585 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,~~. H.R. 5585 would authorize $500 million for each of FY2023 through FY2027. S. 3799 (as amended) does not does not
specify an authorization level and instead would authorize “such sums as may be necessary” for 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 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 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).exceeds $1 billion (11 out of 25 accounts).4449 Taking a wider view, total U.S. investments in health and medical research (both public and private) were estimated at $194.175 billion in 2018.50
Stakeholders have debated the appropriate initial funding level for ARPA-H. Given that ARPA-H 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 is an untested new agency, some argue that it should start small and grow over time depending on
its success.its success.4551 However, in the context of the ARPA model, there is a risk of providing too little 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 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 DARPA, the Homeland Security Advanced Research Projects Agency (HSARPA), has not been
viewed as a success.viewed as a success.4652 In addition, biomedical research—especially medical product R&D—tends In addition, biomedical research—especially medical product R&D—tends
to be expensive relative to some other areas of technology R&D.to be expensive relative to some other areas of technology R&D.4753 Also, given the long lag time Also, given the long lag time
that generally exists between R&D activities and a commercially viable product or service, 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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~~ARPA-H: Congressional Action and Selected Policy Issues~~

as well as the focus on high-risk projects, it can be difficult to determine the appropriate ARPA-H funding level in the short term. In an effort to separate ARPA-H funding from other NIH programs, 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~~S. 3799 (as amended) would provide that ARPA-H’s budget be separate from other NIH budget requests. (As an independent agency, the ARPA-H established by H.R. 5585 would likely have a separate budget request). ~~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 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 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 many of its medical product development and biomedical innovation programs as public-private
partnerships. partnerships. ~~All three~~Both bills would direct ARPA-H to partner with a range of public and private bills would direct ARPA-H to partner with a range of public and private
entities. In addition, S. 3799entities. In addition, S. 3799, (as amendedas amended,) would direct the ARPA-H Director, as a part of the would direct the ARPA-H Director, as a part of the
Director’s duties, to prioritize investments in areas that require public-private partnerships. 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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~~link to page 15~~47 U.S. Government Accountability Office, Advanced Research Projects Agency-Energy: Agency Has Practices for Avoiding Duplication and Involving Stakeholders in the Development of Research Programs, GAO-22-104775, February 3, 2022, p. 1, https://www.gao.gov/assets/gao-22-104775.pdf. 48 NIH, Congressional Justification: FY2022, pp. 10-11. 49 See CRS Report R46869, Federal Research and Development (R&D) Funding: FY2022, coordinated by John F. Sargent Jr. 50 Research!America, “U.S. Investments in Medical and Health Research and Development: 2013-2018,” Fall 2019, https://www.researchamerica.org/sites/default/files/Publications/InvestmentReport2019_Fnl.pdf. 51 See, for example, Tollefson, “The Rise of ‘ARPA-Everything’ and What It Means for Science.” 52 For example, see Nate Bruggeman and Ben Rohrbaugh, “Closing Critical Gaps that Hinder Homeland Security Technology Innovation,” Belfer Center, Harvard Kennedy School, April 2020, p. 3, https://www.belfercenter.org/sites/default/files/files/publication/HSP%20paper%20series%205-2.pdf. 53 GAO, Drug Industry: Profits, Research and Development Spending, and Merger and Acquisition Deals, GAO-18-40, November 2017, pp. 28-37. Congressional Research Service 12 link to page 16 ARPA-H: Congressional Action and Selected Policy Issues

Appendix. Comparison of Key Provisions in ARPA-
H Authorization Legislation
Table A-1 provides a side-by-side comparison of the provides a side-by-side comparison of the ~~three bills~~ two bills under consideration that would authorize ARPA-H in that would authorize ARPA-H in
the 117th Congress. In the House, H.R. 5585 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~~ was passed on June 22, 2022. In the Senate, the PREVENT Pandemics Act (S. In the Senate, the PREVENT Pandemics Act (S.
3799, as amended), which incorporates the previously introduced Advanced Research Project 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 Authority for Health Act (S. 3819) as Section 331, was ordered to be reported by the Senate
HELP Committee on March 15, 2022. 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 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 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 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 instances, similar language is used in different categorical sections of the bills; such instances are
noted throughout the table. noted throughout the table.
Table A-1. Comparison of Key Provisions in ~~APRA~~ARPA-H Authorization Legislation
Advanced Research
Projects Advanced Research ~~Project~~
~~Project~~ Projects Agency- Authority for Health Act Provision(s) Health Act (H.R. 5585) (Section 331 of ~~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~~Would amend Public Health Service Public Health Service
~~Standalone provision. Does~~
~~Amends~~Act Would amend the PHSA the PHSA, Title IV Title IV
to add at ~~Act~~ (PHSA)(PHSA), Title IV (National Research the end “Subpart 3—Advanced Research Institutes) to add at the end “Part J— ~~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~~ Projects Authority for Health,” which Advanced Research Projects Agency- includes one section, Section 483: Health,” which includes one section, Section Advanced Research Projects Authority for 499A: Advanced Research Projects Agency- Health. Health. [H.R. 5585 §2] [S.3799 §331] Placement in Placement: ]
~~Placement in~~
Would establish ARPA-H Would establish ARPA-H
~~Would direct the Secretary~~
Placement: Would establish ARPA-H Federal within the Department of Health and Human within NIH. Government and Services (HHS) and, not later than 180 days [Proposed PHSA §483(b)] Organizational after enactment, require the transfer of all Structure existing functions, personnel, missions, activities, authorities, and funds of APRA-H Organizational Structure: No similar within NIH to the ARPA-H established by provisions. the bil . [Proposed PHSA §499A(a)(1)] Organizational Structure: Would require ARPA-H to be organized to include an Office of the Director; no more than six program offices; and such special project office as the Director may establish. [Proposed PHSA §499A(a)(2)(A)]. Would also require that no fewer than two-thirds of the program offices be exclusively dedicated to research and development. [Proposed PHSA §499A(a)(2)(B)]. Goals/Purpose~~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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~~Activities~~
~~Activities~~and significant translation of transformative health technological and scientific barriers to technologies; and advancing such technologies in order to improve the prevention, diagnosis,  contribute to ensuring the United mitigation, treatment, and cure of States maintains global leadership in health conditions. science and innovation; the highest quality of life and health for its citizens; [Proposed PHSA §483(b)] and an aggressive agenda for innovation to address global health threats that place U.S. citizens at risk. [Proposed PHSA §499A(b)(1)] Methods Methods of the agency would include: No similar category of provisions.  Comparable language in “Goals” and discovering, identifying, ~~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 and promoting
revolutionary advances in revolutionary advances in
~~italicized~~):health “Duties of the Director” sections. sciences;  translating scientific discoveries into transformative health technologies;  providing resources and support to create platform capabilities that draw on multiple disciplines;  using researchers in a wide range of disciplines, including the life sciences, the physical sciences, engineering, and the computational sciences;  delivering advanced proofs of concept that demonstrate clinically meaningful advances;  developing new capabilities, advanced computational tools, predictive models, or analytical techniques to identify potential targets and technological strategies for early disease detection and intervention;  accelerating transformational technological advances in areas with limited technical certainty; and  prioritizing investments based on such considerations as scientific opportunity and uniqueness of fit to the
~~“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 strategies and operating practices of ARPA-H; the effect on disease burden, including unmet patient need, quality and Congressional Research Service 14 ARPA-H: Congressional Action and Selected Policy Issues Advanced Research Projects Advanced Research Projects Agency- Authority for Health Act Provision(s) Health Act (H.R. 5585) (Section 331 of S. 3799, as amended) disparity gaps, and the potential to preempt progression of serious disease; and the effect of the fiscal liability of the federal government with respect to health care and the ability to reduce the cost of care through innovation. [Proposed PHSA §499A(b)(2)] ~~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)]~~
~~Congressional Research Service~~

14

~~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)~~
~~ARPA-H~~
~~The ARPA-H Director position~~
~~The ARPA-H Director~~ARPA-H The ARPA-H Director position would be The ARPA-H Director position would be Director established as fol ows:
~~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 established as fol ows (key
~~differences from H.R. 5855~~
~~differences from H.R. 5855~~
Appointment: Appointed by
italicized):
italicized):
~~the President.~~ differences from Position H.R. 5855 italicized): Appointment: Appointed by the President. Reports to the Reports to the
Secretary of HHS.Secretary of HHS.

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

[ [~~H.R. 6000 §501(c)(1)]~~
~~[Proposed PHSA~~
Proposed PHSA §483(c)(1)] Term: Five years. May be Five years. May be

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

years. May be reappointed for [Proposed PHSA §499A(c)(5)] [Proposed PHSA §499A(c)(5)]
up to one consecutive term 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~~

discretion of the President. [Proposed PHSA §483(c)(3)] Qualifications: An individual who, by reason of professional background and experience, is qualified to manage: (1) Qualifications: Individual who, by research and advanced development professional background and experience, is programs; and (2) large-scale, high-risk qualified to ~~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~~
advise the Secretary on, and initiatives with respect to health research manage research programs that advance and technology development across multiple the purposes of ARPA-H in, promoting sectors, including generating transformative biomedical and novel technology health technologies and improving health innovation, and who has demonstrated outcomes for patients. ability to identify and develop partnerships [Proposed PHSA §499A(c)(2)] to address strategic needs in meeting such purposes. [Proposed PHSA §483(c)(2)] Autonomy Regarding Recommendations and Testimony: No ~~Testimony:~~ ~~No U.S. officer or~~
Autonomy: No
~~demonstrated ability to~~
~~agency has authority to require~~
U.S. officer or agency has authority to Autonomy: No comparable provision.comparable provision. require
~~identify and develop~~
the Director of ARPA-H or the Director of ARPA-H or
~~partnerships to address~~
any other ARPA-H officer to submit legislative recommendations, testimony, ~~other ARPA-H officer to~~
~~strategic needs in meeting~~
~~submit legislative~~
~~such purposes.~~
~~recommendations, testimony,~~
~~[Proposed PHSA~~
or comments on legislation to or comments on legislation to
~~§483(c)(2)]~~
any officer or agency for any officer or agency for
approval prior to submission to approval prior to submission to

Congress if Congress if such materials include a statement indicating ~~such materials~~
Autonomy: No
~~include a statement indicating~~
~~comparable provision.~~
that the views expressed are that the views expressed are
those of such officer and do not those of such officer and do not
reflect the views of the reflect the views of the
President or another agency. President or another agency.
[Proposed PHSA §499A(c)(6)] [Proposed PHSA §499A(c)(6)]
~~Congressional Research Service~~

15

~~ARPA-H: Congressional Action and Selected Policy Issues~~

~~Duties of the~~Duties and
Duties:
Duties: (grouped for comparison): Authorities of  Approve and terminate the projects and Similar to H.R. 5585 the Director programs of ARPA-H;  Approve all new programs within  Set research and development priorities ARPA-H and terminate any program with respect to ARPA-H goals and within ARPA-H that is not achieving manage the budget of ARPA-H; its goals; Congressional Research Service 15 ARPA-H: Congressional Action and Selected Policy Issues Advanced Research Projects Advanced Research Projects Agency- Authority for Health Act Provision(s) Health Act (H.R. 5585) (Section 331 of S. 3799, as amended)  Develop funding criteria and assess the  Establish strategic goals, objectives, success of programs through the and priorities for ARPA-H pursuant to establishment of technical milestones; ARPA-H’s purposes;  Advance ARPA-H goals through  Establish criteria for funding and consideration of the advice of the assessing ~~(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,~~
the success of programs ARPA-H Interagency Advisory through the establishment of technical Committee; milestones; and  Solicit data, as needed, from NIH and  Facilitate coordination between HHS other relevant entities; and its agencies, and other relevant  federal departments and agencies. Coordinate with the ~~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 Director of NIH to ensure
~~“Personnel Authorities”~~that the programs of ARPA-H Different from H.R. 5585 build on and are informed by scientific  Ensure that applications for funding research supported by NIH (see disclose current and previous “Cooperation and Coordination” below research and development efforts, for other relevant provisions); including any scientific or technical  Coordinate with the heads of federal barriers encountered in the course of agencies and, to the extent practicable, such efforts or challenges in securing ensure that the activities of ARPA-H funding; supplement (and do not supplant) the  Support transformative, translational ~~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 , efforts of other federal agencies (see applied, and advanced research in “Cooperation and Coordination” below areas of biomedical science to address for other relevant provisions); and ~~areas of biomedical~~
~~“Cooperation and~~

~~science to address~~
~~Coordination” below for~~

specific technical or specific technical or
scientific  Ensure that ARPA-H does not provide questions by (1) prioritizing funding for a project unless the investments based on scientific program manager determines that the ~~other relevant provisions).~~
~~scientific questions by~~
~~[Proposed PHSA §499A(c)(4)]~~
~~(1) prioritizing~~

~~investments based on~~
~~scientific~~ potential and potential and
impact on the field of impact on the field of
project meets ARPA-H goals. biomedicine, especial y biomedicine, especial y
in areas that in areas that [Proposed PHSA §499A(c)(4)] require require
public-private public-private
partnerships; (2) partnerships; (2)
translating scientific translating scientific
discoveries and discoveries and
cutting-edge innovation into Authorities: technological advancements; (3)  Delegate authorities, except the encouraging opportunities to develop appointment of the Deputy Director; broadly applicable technologies using a multi-disciplinary approach; and (4) [Proposed PHSA §499A(c)(7)] making investments in high-risk, high-  Appoint a Deputy Director to serve as reward research that may have the first assistant to the office; and application for medicine and health [Proposed PHSA §499A(c)(8)] (H.R. 5585 includes similar language in “Methods” category);  Waive Paperwork Reduction Act ~~cutting-edge~~
~~Congressional Research Service~~

16

ARPA-H: Congressional Action and Selected Policy Issues

Advanced Research
Projects Advanced Research ~~Project~~
~~Project~~ Projects Agency- Authority for
Health Act Provision(s) ~~Agency—~~Health Act (H.R.
5585) ( Section ~~501 of Cures Act~~
~~Health Act (Sec. 331 of~~
~~Provision(s)~~
~~5585)~~
~~2.0 (H.R. 6000)~~
~~S. 3799, as amended)~~331 of S. 3799, as amended) Authorities: No additional authorities specified.
Funding Awards
The ARPA-H Director would The ARPA-H Director would
~~The ARPA-H Director~~be authorized The ARPA-H Director would be to make awards in the form of grants, authorized to make awards in the form of contracts (including multi-year contracts), grants, contracts (including multi-year cooperative agreements, prizes, and other contracts), cooperative agreements, prizes, transactions. and other transactions. Defines “other transactions” to mean “transactions, other than procurement contracts, grants, and Grants and cooperative agreements awarded cooperative agreements.” (by reference to would be subject to the uniform PHSA §319L(a)(3) in the Proposed PHSA administrative requirements, cost principles, §483(a)(3)). and audit requirements for federal awards under part 200 of Title 2, Code of Federal [Proposed PHSA §483(e)(1)] Regulations. Total line-item and itemized facilities and administrative costs would be Would allow the ARPA-H Director to use required to be made publicly available and authorities and processes under the published in a machine-readable format. Stevenson-Wydler Technology Innovation Act of 1980 (15 U.S.C. §3719) for prize Contracts awarded would be subject to competitions (H.R. 5585 references the Federal Acquisition Regulation. Stevenson-Wydler definition for “prize” in the Definitions section). [Proposed PHSA §483(e)(3)] Funded research would not be subject to NIH peer review or advisory council review or approval. Funded research would not be subject to [Proposed PHSA §499A(h)] NIH peer review or advisory council review or approval.
~~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~~
[Proposed PHSA §483(e)(5)] In accordance with existing federal requirements as specified, the ARPA-H Director would be required to only award Would require the ARPA-H Director to new awards to recipients who do not have ensure that ARPA-H does not provide more than three ongoing ARPA-H awards. funding for a research program or project [Proposed PHSA §499A(o)(4)] unless the applicant demonstrates ~~the applicant demonstrates~~
~~maintain, enhance, or~~
that it that it has made sufficient unsuccessful attempts to secure private financing, and that there Domestic Prioritization: In making is a lack of significant private support for awards, the ARPA-H Director would be ~~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.~~

the program or project. In addition, the required to prioritize domestic recipients ~~In addition, the~~ ARPA-H ARPA-H
Director would be required Director would be required
to to conducting research on transformative ensure that the program ensure that the program
or project is in or project is in health technology in the United States. As the best the best
interests of the United interests of the United
~~States and~~ States and appropriate and practicable, the Director has the potential has the potential
to significantly transform to significantly transform
~~and advance biomedicine.~~
would be required to ensure that and advance biomedicine. nondomestic recipients are conducting [Proposed PHSA [Proposed PHSA
§483(f)(2)] §483(f)(2)]

~~Congressional Research Service~~

18 research in col aboration with a domestic recipient. Domestic Prioritization: No similar provisions. (Note: May fol ow NIH policy The ARPA-H Director would not be allowed for foreign award eligibility, see NIH, to make awards to nondomestic recipients “Who is Eligible?” organized under the laws of Russia, Iran, https://grants.nih.gov/grants/who-is- North Korea, China or other countries as eligible.htm). determined to be a covered foreign country Congressional Research Service 17

ARPA-H: Congressional Action and Selected Policy Issues

Advanced Research
Projects Advanced Research ~~Project~~
~~Project~~ Projects Agency- Authority for
Health Act Provision(s) ~~Agency—~~Health Act (H.R.
5585) ( Section ~~501 of Cures Act~~
~~Health Act (Sec. 331 of~~
~~Provision(s)~~
~~5585)~~
~~2.0 (H.R. 6000)~~
~~S. 3799, as amended)~~
~~Cooperative~~331 of S. 3799, as amended) under section 119C of the National Security Act of 1947. [Proposed PHSA §499A(o)] Other ARPA-H Director would be authorized to The ARPA-H Director would be Transactions, award other transactions. authorized to enter into other Follow-on [Proposed PHSA §499A(h)(1)(E)] transactions. Production, [Proposed PHSA §483(e)(1)] Technology Transfer, and Follow-On Production Award Procurement Authority: An “other transaction” entered To the maximum extent practicable, and into may provide for the award of a fol ow- competitive procedures would be required Demonstration on production contract or transaction, when entering into other transactions to either to the participants in the transaction carry out projects. by ARPA-H or another federal agency. For Would authorize other transaction the purposes of this authority, “other authorities to be exercised for a project if transaction” would include all individual
~~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~~

the project manager submits a proposal to submits a proposal to ~~the~~

~~Such agreements are~~
~~used only when the use~~
subprojects awarded under the transaction the ARPA-H Director for each use of such to a consortium of United States industry authority ~~ARPA-H Director for each~~
~~of standard contracts~~
~~use of such authority~~
~~or grants is not feasible~~
~~before conducting or~~
~~or appropriate; and~~
~~supporting~~ before conducting or supporting and academic institutions. a project, 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~~ including why other transaction A fol ow-on production contract may be authority is essential to project success. awarded without the use of competitive The project manager must receive approval procedures (as defined in federal from the ARPA-H Director before using requirements) if (1) competitive procedures other transaction ~~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~~ authority, and then must were used for the selection of parties for report to the Director on project activities participation in the other transaction; and (2) for each fiscal year in which the project the participants in the other transaction manager used the authority. successful y completed the project provided [Proposed PHSA §483(e)(2)] for in the transaction. As a precondition, the ARPA-H Director would be allowed to award a fol ow-on Procurement and Demonstration: production contract or transaction when the The ARPA-H Director would have Director determines that the individual authority to seek opportunities to partner project or subproject as a part of a with procurement programs of other consortium is successful y completed by the federal agencies to demonstrate participants. However, the award may not technologies resulting from ARPA-H be made contingent on successful activities. completion of all activities within a ~~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)]~~
~~Congressional Research Service~~

19

ARPA-H: Congressional Action and Selected Policy Issues

Advanced Research
Projects Advanced Research ~~Project~~
~~Project~~ Projects Agency- Authority for Health Act Provision(s) Health Act (H.R. 5585) (Section 331 of S. 3799, as amended) Confidentiality The fol owing types of information col ected Would provide that nothing in the new and Protection by ARPA-H from award recipients would be ARPA-H PHSA section is to be construed of Information considered commercial and financial as authorizing disclosure of trade secrets information from a person, which is not or other privileged or confidential subject to disclosure under the Freedom of information under FOIA or other laws. Information Act (FOIA; 5 U.S.C. §552(b)(4)): [Proposed PHSA §483(j)(1)]  Plans for commercialization of technologies developed under the award, including business plans, technology-to-market plans, market studies, and cost and performance models;  Investments provided to an awardee from third parties, including amounts and the percentage of ownership of the awardee provided in return for the investments;  Additional financial support that the awardee (1) plans to invest or has invested in the technology developed under the award, or (2) is seeking from third parties; and  Revenue from the licensing or sale of new products or services resulting from research conducted under the award. [Proposed PHSA §499(e)] Facilities The ARPA-H Director would have the The ARPA-H Director would have the authority to: authority to (key differences from H.R.  5855 italicized): Acquire (by purchase, lease, condemnation, or otherwise),  Acquire (by purchase, lease, construct, improve, repair, operate, and condemnation, or otherwise), maintain such real and personal construct, improve, repair, operate, property as are necessary; and and maintain such real and personal  property as are necessary; and Lease any nonexcess real property and related personal property under the  Lease an interest in property for not jurisdiction of ARPA-H. more than 20 years, notwithstanding The Director would be required to deposit Section 1341(a)(1) of title 31, United amounts received for a lease into the ARPA- States Code. H account as discretionary offsetting [Proposed PHSA §483(h)(1)] col ections, and such amounts would be available to the extent, and in the amounts provided in advance appropriations acts, to Would require that ARPA-H, including its cover ARPA-H costs for the lease and for headquarters, not be located near the maintenance and other property National Capital Region and not on any part improvements as specified. of the NIH campus. Would require the ARPA-H Director to consider [Proposed PHSA §499A(i)] characteristics of the intended location and Would require that ARPA-H, including its the extent to which such location would headquarters, not be located on any part of facilitate advancement of ARPA-H’s the existing NIH campus. Would require the purposes. ARPA-H Director to consider characteristics [Proposed PHSA §483(h)(2)] of the intended location and the extent to Congressional Research Service 19 ARPA-H: Congressional Action and Selected Policy Issues Advanced Research Projects Advanced Research Projects Agency- Authority for Health Act Provision(s) Health Act (H.R. 5585) (Section 331 of S. 3799, as amended) which such location would facilitate advancement of ARPA-H’s purposes. [Proposed PHSA §499A (i)(4)] Personnel Would grant the~~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)~~
~~Other~~
~~The ARPA-H Director would~~
~~Does not specify other~~
~~Does not specify other~~
~~Authorities of~~
~~have the authority to:~~
~~ARPA-H Director~~
~~ARPA-H Director~~
~~the Director~~

~~authorities.~~
~~authorities.~~

~~Partner with public and~~
~~private entities as specified~~
~~(H.R. 6000 lists partnering~~
~~with a broad range of~~
~~institutions in the~~
~~“activities” category; S.~~
~~3799 lists partnering with a~~
~~broad range of institutions~~
~~as an “ARPA-H Director~~
~~duties” category);~~
~~[Proposed PHSA~~
~~§499A(e)]~~

~~Delegate authorities,~~
~~except the appointment of~~
~~the Deputy Director;~~
~~[Proposed PHSA~~
~~§499A(c)(7)]~~

~~Appoint a Deputy~~
~~Director to serve as acting~~
~~ARPA-H Director in the~~
~~absence of the Director;~~
~~and~~
~~[Proposed PHSA~~
~~§499A(c)(8)]~~

~~Waive Paperwork~~
~~Reduction Act~~
~~requirements with respect~~
~~to activities under (c)(3)(F)~~
~~(NOTE: appears to be~~
~~drafting error as~~
~~referenced provision does~~
~~not exist).~~
~~[Proposed PHSA~~
~~§499A(d)]~~
~~Congressional Research Service~~

21

~~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~~ ARPA-H Director the Similar to H.R. 5585: Authorities authority to waive certain civil service Would grant the ARPA-H Director the personnel requirements in making and authority to waive certain civil service rescinding scientific, medical, and personnel requirements in making and professional personnel appointments. rescinding scientific, medical, and Would grant the ARPA-H Director the professional personnel appointments. ability to use existing hiring authorities [Proposed PHSA §483(d)(4)(A)] granted to the Secretary of HHS to hire administrative, financial, contracts, legislative affairs, information technology, ethics, and In making personnel or staff appointments, communications staff as necessary. the ARPA-H Director would be authorized The ARPA-H Director would also be to consider as appropriate factors such directed to make efforts to recruit and factors as populations that are traditionally retain a diverse workforce, including underrepresented in the biomedical individuals underrepresented in science and research enterprise. medicine and racial and ethnic minorities (as [Proposed PHSA §483(d)(3)(B)] long as such efforts comply with applicable federal civil rights law). The ARPA-H Director would be The ARPA-H Director would also be authorized to contract with private authorized to contract with private entities recruiting firms for hiring of qualified in hiring qualified personnel. technical staff. Would allow the ARPA-H Director to use ~~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 [Proposed PHSA
§483(d)(§483(d)(~~3)(A~~4)(D)] the Intergovernmental Personnel Act to staff ARPA-H with employees from other federal agencies, state and local governments, Indian Different from H.R. 5585 tribes and tribal organizations, institutions of Would require the ARPA-H Director to higher education, and other organizations. ensure that personnel appointed to staff or Would al ow the ARPA-H Director to support ARPA-H are individuals who, at accept detailees from other federal agencies the time of appointment and for three for a period of up to three years. )]

~~Would require the ARPA-~~
~~H Director to ensure that~~
~~personnel appointed to~~
~~staff or support ARPA-H~~
~~Congressional Research Service~~

22

~~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~~
(d)(4)(E)(i )] Program Recruitment: Would require the ARPA-H Recruitment: In designating program Managers Director to recruit program managers with managers, the ARPA-H Director would be expertise in a wide range of disciplines, required to consider individuals with including life sciences, physical sciences, demonstrated scientific expertise and engineering, and computational sciences. management skil s required to advance [Proposed PHSA §499A(j)(3)(C)] ARPA-H and who represent a diverse set of professional experiences or backgrounds, including experience in Term: Three years. May serve two terms. Congressional Research Service 20 ARPA-H: Congressional Action and Selected Policy Issues Advanced Research Projects Advanced Research Projects Agency- Authority for Health Act Provision(s) Health Act (H.R. 5585) (Section 331 of S. 3799, as amended) academia, industry, government, nonprofit Duties: organizations, or other sectors.  [Proposed PHSA §483(d)(3)(A)] Establish research and development goals for programs, including timelines and milestones, in consultation with the Term: Three years. May serve two terms. Director, and make such goals publicly available; [Proposed PHSA §483(d)(C)]  Col aborate with experts from NIH and other federal agencies and experts in Duties (grouped for comparison): relevant scientific fields to identify Similar to H.R. 5585 research and development gaps and  Establish research and development opportunities; goals for the programs in consultation  Convene workshops and meetings, as with the Director, including timelines needed, with entities such as patients, and milestones, and make such goals patient advocacy groups, practitioners, available to the public; professional societies, and other  Communicate with leaders in the stakeholders to solicit input on health care and biomedical research programs and goals; and development fields, from both the  Manage applications and proposals for public and private sectors, making grants, cooperative agreements, representatives of patient contracts, prizes and other transaction organizations, institutions of higher awards for advanced research that may education, and nonprofit organizations show particular promise, especial y in to identify areas of need and scientific areas in which the federal government opportunity with the potential to and the private sector may not have transform biomedicine. undertaken sufficient research;  Select the projects to be supported  Issue funding opportunity under the program after considering: announcements using uniform (1) the novelty and scientific and administrative processes; technical merit of the proposed  project; (2) the demonstrated Select, on the basis of merit, each of the projects to be supported under a capabilities of the applicants; (3) program carried out by ARPA-H, taking potential future commercial into consideration the scientific and applications as proposed; (4) the technical merit of the proposed degree to which the project addresses projects; the capabilities of the a scientific or technical question and applicants to successful y carry out the has the potential to transform proposed project; the unmet needs or biomedicine; and (5) other criteria as ability to improve outcomes within established by the ARPA-H Director; patient populations; future commercial  Encourage research col aborations, applications of the project or feasibility including by identifying and supporting of partnering with one or more applicable public-private partnerships; commercial entities; the potential for and interdisciplinarity of the approach of the  Recommend program restructuring, project; and such other criteria as are expansion, or termination of research established by the ARPA-H Director; ~~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~~
~~Congressional Research Service~~

24projects or whole projects, as and necessary.  Conduct project reviews within 18 months of funding awards to identify milestones and monitor progress of Different from H.R. 5585 such milestones with respect to each  Provide project oversight and project and prior to the disbursement management of strategic initiatives to of new funds; advance the purpose of the program. Congressional Research Service 21

~~ARPA-H: Congressional Action and Selected Policy Issues~~

~~Advanced Research~~
~~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~~ Would require the ARPA-H Director to and Cooperation share timely and relevant information with ensure, to the maximum extent the Administrator of the Centers for~~the Administrator of~~
~~coordination between~~
practicable, that ARPA-H practicable, that ARPA-H
~~the Centers for Medicare &~~
~~ARPA-H and: (1) the heads~~
~~activities are coordinated~~
activities are Medicare & Medicaid Services (CMS) Medicaid Services (CMS) to
~~of the research, public~~
that coordinated with and do not duplicate with and do not duplicate
~~expedite the development,~~
~~health, and regulatory~~may help to expedite determinations of
efforts of: (1) other HHS 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~~ programs, coverage of transformative health including NIH and the Biomedical technologies developed by ARPA-H. Advanced Research and Development [Proposed PHSA §499A(f)] Authority (BARDA) programs, and (2) other relevant efforts or research operated or overseen by other federal departments Would authorize the HHS Secretary, and agencies. through the Commissioner of Food and [Proposed PHSA §483(f)(1)] Drugs and in consultation with the ARPA-H Director, to take actions to facilitate the translation of transformative health Would authorize the FDA to meet with technologies into solutions for patients and ARPA-H and appropriate federal partners to expedite the development of drugs, such as BARDA at appropriate intervals to devices, and biological products, including discuss the development status and actions through: that may be taken to facilitate the  development of medical products and Helping to ensure that drug, device, or biological product development projects that are of highest priority for programs gather the nonclinical and ARPA-H. Would require the ARPA-H clinical data necessary to advancing the Director to reimburse FDA for FDA development of such products and to activities conducted under the authority of obtaining their approval, licensure, or the section. clearance by the U.S. Food and Drug [Proposed PHSA §483(f)(4)] Administration (FDA);  Expediting review of investigational new drug applications, review of investigational device exemptions, and review of applications for approval Congressional Research Service 22 ARPA-H: Congressional Action and Selected Policy Issues Advanced Research Projects Advanced Research Projects Agency- Authority for Health Act Provision(s) Health Act (H.R. 5585) (Section 331 of S. 3799, as amended) licensure, and clearance of drugs, devices, or biological products; and  Meeting at appropriate intervals with the ARPA-H Director and any member of the ARPA-H Interagency Research Council to discuss the development status of drugs, devices, or biological products that the highest priorities to the ARPA-H Director, unless determined the meetings are not necessary. The authority is not to be construed as limiting FDA’s authority with respect to drugs, devices, or biological products. The ARPA-H Director may reimburse FDA for related expenditures. [Proposed PHSA §499A(g)] Advisory Advisory Committee: Would require the Advisory Committee: Would establish Committee ARPA-H ~~limiting FDA’s~~

~~authorities for medical~~
~~product review and~~
~~approval.~~
~~[H.R. 6000 §501(k)]~~
~~Congressional Research Service~~

26

~~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~~Director to establish an interagency an ARPA-H ~~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~~
Interagency Advisory advisory committee—the ARPA-H Committee to coordinate efforts and Interagency Research Council—tasked with provide advice and assistance on specific advising the Director, including by making program or project tasks and the overall recommendations on research priorities that direction of ARPA-H. Members would would provide the greatest return on include the heads of the fol owing agencies investment with respect to improving human or their designees: NIH, CDC, FDA, ASPR, health, avoiding duplication of efforts in the HHS Office of the Assistant Secretary of federal government, and improving Health, DARPA, the DOE Office of coordination with other federal agencies; Science, NSF, and any other agency with and identifying and developing strategies to subject matter expertise that the ARPA-H address regulatory, reimbursement, and Director determines appropriate. The market barriers to commercialization or Federal Advisory Committee Act (5 U.S.C. adoption of transformative health App.) would not apply to this committee. The technologies, including technologies intended Committee would be advisory in nature to preempt serious disease. Members could only. include (1) the heads of several HHS [Proposed PHSA §483(g)] operating divisions or their designees, including NIH, FDA, CMS, BARDA, the Centers for Disease Control and Prevention Other Advice: Would also authorize the (CDC), the National Center for Advancing ARPA-H Director to seek input from Translational Sciences [part of NIH], the PCAST; representatives of professional or Agency for Healthcare Research and Quality, scientific organizations with expertise in the Office of Minority Health, the Assistant technology under consideration or Secretary for Preparedness and Response development by ARPA-H; and (ASPR), the Health Resources and Services representatives of patient organizations, Administration; (2) the Director of Office of public health, innovators, and other public Science and Technology Policy; (3) Director and private entities. ~~and Technology Policy; (3)~~
~~organization with expertise~~
~~apply to this committee.~~
~~Director of DARPA; (4) the~~
~~in specific processes or~~of DARPA; (4) the Director of the National
[Proposed PHSA §483( [Proposed PHSA §483(~~g)]~~
f)(3)] Science Foundation (NSF); (5) the Director Director of the Office of Science of the Department of Energy (DOE); (6) Director of the Advanced Research Projects Agency-Energy (ARPA-E); and (7) representatives of any federal agency with subject matter expertise Congressional Research Service 23 ARPA-H: Congressional Action and Selected Policy Issues Advanced Research Projects Advanced Research Projects Agency- Authority for Health Act Provision(s) Health Act (H.R. 5585) (Section 331 of S. 3799, as amended) as determined by the ARPA-H Director. The Council would be advisory in nature only. The council would be required to meet one year after enactment, then, during subsequent fiscal years, the Director would convene the committee as needed. The Council may function through established or ad-hoc committees, task forces, or interagency groups to share information on health innovations funded by ARPA-H and receive input on areas of particular promise for ARPA-H projects. [Proposed PHSA §499A(q)] ~~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~~
Other Advice: Would also authorize the authorize the ARPA-H Director to consult with the President’s Committee of ~~ARPA-H Director~~
~~patient organizations, public~~
~~to seek advice from the~~
~~health, innovators, and~~
~~President’s Committee of~~
~~other public and private~~
Advisors on Advisors on Science and Technology (PCAST); peers in the scientific community, including academia and industry; an existing advisory committee providing advice to the HHS Secretary or head of other HHS operating division; the new interagency research council (above); and any other entity the Director may deem appropriate. [Proposed PHSA §499A(p)] Annual Report Annual Report: Beginning not later than Annual Report: As part of the annual and Strategic ~~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)]~~
~~Congressional Research Service~~

27

~~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~~
one year after the date of the enactment, date of the enactment, ~~and each~~ budget request submitted for each fiscal submitted for each fiscal
~~request submitted for~~Plan and each ~~each~~
fiscal year thereafter, the fiscal year thereafter, the
~~year, the ARPA-H Director~~
~~fiscal~~ ARPA-H year, the ARPA-H year, the ARPA-H
~~ARPA-H~~ Director would be Director would be
~~would be required to~~
Director would be required Director would be required
~~required~~ to submit a to submit a ~~report~~ required to to
provide Congress a report provide Congress a report
report to ~~to provide Congress a~~
Congress on the actions Congress on the actions
describing: describing:
~~report describing:~~
undertaken, and results undertaken, and results
~~(1) Projects supported by~~
generated, by ARPA- (1) Projects supported by (1) Projects supported by
~~generated, by ARPA-H,~~
~~ARPA-H during the previous ARPA-H during the~~
~~including~~
~~fiscal year,~~ARPA-H during H, including: the previous fiscal year including the stage ~~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~~ (1) A description of projects supported by of development and details as to whether ARPA-H in the previous fiscal year and the project is meeting its milestones; whether such projects are meeting the goals (2) Projects supported by ARPA-H during developed by the Director; the previous fiscal year that were (2) A description of projects terminated in terminated and the reasons for the previous fiscal year, and the reason for termination; such termination; (3) Projects supported by ARPA-H during (3) A description of projects starting in the the previous fiscal year that examine topics next fiscal year, as available; and technologies related to other activities (4) Activities conducted in coordination with funded by HHS, including an analysis of other federal agencies; whether in supporting such projects, the ARPA-H Director is in compliance with (5
~~(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~~) An analysis of the extent of coordination relevant requirements; and with NIH and CMS, including successes and barriers with respect to achieving the goals (4) Current, proposed, and planned of the agency. projects to be carried out. (6) A description of the demographic [Proposed PHSA §483(k)(1)] diversity (including racial and gender) if available of direct recipients and performers Strategic Plan: Not later than 180 days in funded projects and of the ARPA-H after the appointment of the first ARPA-H workforce; and Director, and every four ~~, and every four~~
~~over the fol owing three~~
years thereafter, the years thereafter, the ARPA-H Director would be required to Congressional Research Service 24 ARPA-H: Congressional Action and Selected Policy Issues Advanced Research Projects Advanced Research Projects Agency- Authority for Health Act Provision(s) Health Act (H.R. 5585) (Section 331 of S. 3799, as amended) (7) Disclosure by the reward recipient of ~~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~~ submit to Congress a plan describing the whether the principal investigators named on strategic plan strategic plan
that ARPA-H wil use to that ARPA-H wil use to
the award participate in foreign talent guide future investments guide future investments
over the fol owing over the fol owing programs, including the provision of copies four four
fiscal years. Every two years fiscal years. Every two years
~~after~~ after of all grants, contracts, or other agreements initial submission, the initial submission, the
ARPA-H Director ARPA-H Director or supporting documentation related to such would be would be
required to submit a required to submit a
programs as a condition of receipt of federal supplemental strategic plan supplemental strategic plan
that details any that details any biomedical research funds. changes. changes.
Requirements for NIH Requirements for NIH
~~Institute~~ Institute [Proposed PHSA §499A(l)(1)] and Center ~~and Center~~
strategic plans would not strategic plans would not
apply apply to ARPA-H. Strategic Plan: Not later than one year [Proposed PHSA §483(k)(2)] after the date of the enactment, and every three years thereafter, the ARPA-H Director would be required to provide Congress a strategic plan describing how ARPA-H wil carry out investments each fiscal year in the next three-year period. [Proposed PHSA §499A(m~~to ARPA-H.~~
~~Congressional Research Service~~

28

ARPA-H: Congressional Action and Selected Policy Issues

Advanced Research
Projects Advanced Research ~~Project~~
~~Project~~ Projects Agency- Authority for Health Act Provision(s) Health Act (H.R. 5585) (Section 331 of S. 3799, as amended) Other Reports Independent Review: Not later than one Report on Personnel: The ARPA-H year after enactment and every three years Director would be required to maintain thereafter, the Government Accountability records regarding the use of ARPA-H Office (GAO) would conduct an personnel authorities, including the number independent review of the research portfolio of positions fil ed with such authorities, of HHS, including ARPA-H, NIH, FDA, and types of appointments, demographic BARDA, to assess the degree of unnecessary information, and other specified duplication of existing federal programs and ~~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,~~
information. Not later than one year after later than one year after
~~including a general~~
~~enactment and annually~~
~~description of the~~
~~thereafter, the Director~~
~~cooperative agreement or~~
projects; and to make recommendations enactment and annually thereafter, the regarding any potential reorganization, Director would be required to submit a consolidation, or termination of such report to specified congressional program and projects. committees on the total number of [Proposed PHSA §499A(n)] appointments fil ed and ~~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 how the positions relate to ARPA-H’s purposes. [Proposed PHSA §483(d)(4)(B)-(C)] ~~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 Not later than
two years after enactment, two years after enactment,
~~Government Accountability~~
~~Office (GAO)~~ GAO would be would be
required to report to required to report to
Congress Congress on the on use of ARPA-use of ARPA-
H personnel authorities, H personnel authorities,
including on the number of including on the number of
positions, the types of positions, the types of
appointments, how the appointments, how the
positions relate to ARPA-positions relate to ARPA-
H’s mission, how the H’s mission, how the
appointments were made, appointments were made,
sources used for identifying sources used for identifying
candidates, and aggregate candidates, and aggregate
demographic information. demographic information.
Would also require GAO Would also require GAO
to report on any challenges, to report on any challenges,
~~limitations, or gaps related~~
~~Congressional Research Service~~

30

ARPA-H: Congressional Action and Selected Policy Issues

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