H. R. 2617—1312 
CHAPTER 4—ADVANCED RESEARCH PROJECTS 
AGENCY–HEALTH 
SEC. 2331. ADVANCED RESEARCH PROJECTS AGENCY–HEALTH. 
(a) IN GENERAL.—Title IV of the Public Health Service Act 
is amended by adding at the end the following: 
‘‘PART J—ADVANCED RESEARCH PROJECTS 
AGENCY–HEALTH. 
‘‘SEC. 499A. ADVANCED RESEARCH PROJECTS AGENCY–HEALTH. 
‘‘(a) ESTABLISHMENT.— 
‘‘(1) IN GENERAL.—There is established within the National 
Institutes of Health the Advanced Research Projects Agency– 
Health (referred to in this section as ‘ARPA–H’). Not later 
than 180 days after the date of enactment of this section, 
the Secretary shall transfer all functions, personnel, missions, 
activities, authorities, and funds of the Advanced Research 
Projects Agency for Health as in existence on the date of enact-
ment of this section, to ARPA–H established by the preceding 
sentence. 
‘‘(2) ORGANIZATION.— 
‘‘(A) IN GENERAL.—There shall be within ARPA–H— 
‘‘(i) an Office of the Director; 
‘‘(ii) not more than 8 program offices; and 
‘‘(iii) such special project offices as the Director 
may establish. 
‘‘(B) REQUIREMENT.—Not fewer than two-thirds of the 
program offices of ARPA–H shall be exclusively dedicated 
to supporting research and development activities, con-
sistent with the goals and functions described in subsection 
(b). 
‘‘(C) NOTIFICATION.—The Director shall submit a 
notification to the Committee on Health, Education, Labor, 
and Pensions and the Committee on Appropriations of the 
Senate and the Committee on Energy and Commerce and 
the Committee on Appropriations of the House of Rep-
resentatives if the Director determines that additional pro-
gram offices are required to carry out this section. 
‘‘(3) EXEMPTION FROM CERTAIN POLICIES OF NIH.— 
‘‘(A) IN GENERAL.—Except as otherwise provided for 
in this section, and subject to subparagraph (B), in estab-
lishing ARPA–H pursuant to paragraph (1), the Secretary 
may exempt ARPA–H from policies and requirements of 
the National Institutes of Health that are in effect on 
the day before the date of enactment of this section as 
necessary and appropriate to ensure ARPA–H can most 
effectively achieve the goals described in subsection (b)(1). 
‘‘(B) NOTICE.—Not later than 90 days after the date 
of enactment of this section, the Secretary shall publish 
a notice in the Federal Register describing the specific 
policies and requirements of the National Institutes of 
Health from which the Secretary intends to exempt ARPA– 
H, including a rationale for such exemptions. 
‘‘(b) GOALS AND FUNCTIONS.— 
‘‘(1) GOALS.—The goals of ARPA–H shall be to—
H. R. 2617—1313 
‘‘(A) foster the development of novel, breakthrough, 
and broadly applicable capabilities and technologies to 
accelerate transformative innovation in biomedical science 
and medicine in a manner that cannot be readily accom-
plished through traditional Federal biomedical research 
and development programs or commercial activity; 
‘‘(B) revolutionize the detection, diagnosis, mitigation, 
prevention, treatment, and cure of diseases and health 
conditions by overcoming long-term and significant techno-
logical and scientific barriers to developing transformative 
health technologies; 
‘‘(C) promote high-risk, high-reward innovation to 
enable the advancement of transformative health tech-
nologies; and 
‘‘(D) contribute to ensuring the United States— 
‘‘(i) pursues initiatives that aim to maintain global 
leadership in science and innovation; and 
‘‘(ii) improves the health and wellbeing of its citi-
zens by supporting the advancement of biomedical 
science and innovation. 
‘‘(2) FUNCTIONS.—ARPA–H shall achieve the goals specified 
in paragraph (1) by addressing specific scientific or technical 
questions 
by 
involving 
high-impact 
transformative, 
translational, applied, and advanced research in relevant areas 
of science, by supporting— 
‘‘(A) discovery, identification, and promotion of revolu-
tionary advancements in science; 
‘‘(B) translation of scientific discoveries into trans-
formative health technologies with potential application 
for biomedical science and medicine; 
‘‘(C) creation of platform capabilities that draw on mul-
tiple disciplines; 
‘‘(D) delivery of proofs of concept that demonstrate 
meaningful advances with potential clinical application; 
‘‘(E) development of new capabilities and methods to 
identify potential targets and technological strategies for 
early disease detection and intervention, such as advanced 
computational tools and predictive models; and 
‘‘(F) acceleration of transformational health techno-
logical advances in areas with limited technical certainty. 
‘‘(c) DIRECTOR.— 
‘‘(1) IN GENERAL.—The President shall appoint a director 
of ARPA–H (in this section referred to as the ‘Director’). 
‘‘(2) QUALIFICATIONS.—The Director shall be an individual 
who, by reason of professional background and experience— 
‘‘(A) is especially qualified to advise the Secretary on, 
and manage— 
‘‘(i) research and development programs; and 
‘‘(ii) large-scale, high-risk initiatives with respect 
to health research and technology development across 
multiple sectors, including identifying and supporting 
potentially transformative health technologies; and 
‘‘(B) has a demonstrated ability to identify and develop 
partnerships to address strategic needs in meeting the 
goals described in subsection (b)(1). 
‘‘(3) REPORTING.—The Director shall report to the Secretary 
of Health and Human Services.
H. R. 2617—1314 
‘‘(4) DUTIES.—The duties of the Director shall include the 
following: 
‘‘(A) Establish strategic goals, objectives, and priorities 
for ARPA–H to advance the goals described in subsection 
(b)(1). 
‘‘(B) Approve the projects and programs of ARPA–H 
and restructure, expand, or terminate any project or pro-
gram within ARPA–H that is not achieving its goals. 
‘‘(C) Develop funding criteria and assess the success 
of programs through the establishment of technical mile-
stones. 
‘‘(D) Request that applications for funding disclose cur-
rent and previous research and development efforts related 
to such applications, as appropriate, and identify any chal-
lenges associated with such efforts, including any scientific 
or technical barriers encountered in the course of such 
efforts or challenges in securing sources of funding, as 
applicable. 
‘‘(E) Coordinate with the heads of relevant Federal 
departments and agencies to facilitate sharing of data and 
information, as applicable and appropriate, and ensure that 
research supported by ARPA–H is informed by and supple-
ments, not supplants, the activities of such departments 
and agencies and is free of unnecessary duplication of 
effort. 
‘‘(F) Ensure ARPA–H does not provide funding for a 
project unless the program manager determines that the 
project aligns with the goals described in subsection (b)(1). 
‘‘(G) Prioritize investments based on considerations 
such as— 
‘‘(i) scientific opportunity and potential impact, 
especially in areas that fit within the strategies and 
operating practices of ARPA–H and require public- 
private partnerships to effectively advance research 
and development activities; and 
‘‘(ii) the potential applications that an innovation 
may have to address areas of currently unmet need 
in medicine and health, including health disparities 
and the potential to prevent progression to serious 
disease. 
‘‘(H) Encourage strategic collaboration and partner-
ships with a broad range of entities, which may include 
institutions of higher education, minority-serving institu-
tions (defined, for the purposes of this section, as institu-
tions and programs described in section 326(e)(1) of the 
Higher Education Act of 1965 and institutions described 
in section 371(a) of such Act), industry, nonprofit organiza-
tions, Federally funded research and development centers, 
or consortia of such entities. 
‘‘(5) 
TERM.—Notwithstanding 
section 
405(a)(2), 
the 
Director— 
‘‘(A) shall be appointed for a 4-year term; and 
‘‘(B) may be reappointed for 1 consecutive 4-year term. 
‘‘(6) AUTONOMY OF AGENCY REGARDING RECOMMENDATIONS 
AND
TESTIMONY.—No office or agency of the United States 
shall have authority to require the Director to submit legislative 
recommendations, or testimony or comments on legislation, to
H. R. 2617—1315 
any officer or agency of the United States for approval, com-
ments, or review prior to the submission of such recommenda-
tions, testimony or comments to Congress, if such recommenda-
tions, testimony, or comments to Congress include a statement 
indicating that the views expressed therein are those of the 
Director and do not necessarily reflect the views of the Presi-
dent or another Federal department, agency, or office. 
‘‘(7) DEPUTY
DIRECTOR.—The Director shall appoint a 
Deputy Director to serve as the principal assistant to the 
Director. 
‘‘(8) NONAPPLICATION OF CERTAIN PROVISION.—The restric-
tions contained in section 202 of the Departments of Labor, 
Health and Human Services, and Education, and Related Agen-
cies Appropriations Act, 1993 (Public Law 102–394; 42 U.S.C. 
238f note) related to consultants and individual scientists 
appointed for limited periods of time shall not apply to the 
Director appointed under this subsection. 
‘‘(d) APPLICATION OF CERTAIN FLEXIBILITIES.—The flexibilities 
provided to the National Institutes of Health under section 301(g) 
shall apply to ARPA–H with respect to the functions described 
in subsection (b)(2). 
‘‘(e) PROTECTION OF INFORMATION.— 
‘‘(1) NO AUTHORIZATION FOR DISCLOSURE.—Nothing in this 
section shall be construed as authorizing the Director to disclose 
any information that is a trade secret or other privileged or 
confidential information subject to section 552(b)(4) of title 5, 
United States Code, or section 1905 of title 18, United States 
Code. 
‘‘(2) REPORTING.—If there have been requests under section 
522 of title 5, United States Code, or the Secretary has used 
such authority to withhold information within the preceding 
year, not later than 1 year after the date of enactment of 
this section, and annually thereafter, the Director shall report 
to the Committee on Health, Education, Labor, and Pensions 
of the Senate and the Committee on Energy and Commerce 
of the House of Representatives on— 
‘‘(A) the number of instances in which the Secretary 
has used the authority under this subsection to withhold 
information from disclosure; and 
‘‘(B) the nature of any request under section 552 of 
title 5, United States Code, or section 1905 of title 18, 
United States Code, that was denied using such authority. 
‘‘(3) CLARIFICATION.—The protections for trade secrets or 
other privileged or confidential information described in para-
graph (1) shall not be construed to limit the availability or 
disclosure of information necessary to inform and facilitate 
the evaluation required under subsection (k)(2). Any such 
information made available to members of the National Acad-
emies of Sciences, Engineering, and Medicine (referred to in 
this section as the ‘National Academies’) for such evaluation 
shall be kept confidential by such members and shall not be 
used for any purposes other than informing and facilitating 
the evaluation required under subsection (k)(2). 
‘‘(f) COOPERATION WITH
THE FOOD
AND DRUG ADMINISTRA-
TION.—