[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3819 Introduced in Senate (IS)]
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117th CONGRESS
2d Session
S. 3819
To establish an Advanced Research Projects Authority for Health within
the National Institutes of Health.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 10 (legislative day, March 7), 2022
Mrs. Murray (for herself and Mr. Burr) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To establish an Advanced Research Projects Authority for Health within
the National Institutes of Health.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Advanced Research Project Authority
for Health Act'' or the ``ARPA-H Act''.
SEC. 2. ADVANCED RESEARCH PROJECTS AUTHORITY FOR HEALTH.
Part E of title IV of the Public Health Service Act (42 U.S.C. 287
et seq.) is amended by inserting after subpart 2 of such part the
following:
``Subpart 3--Advanced Research Projects Authority for Health
``SEC. 483. ADVANCED RESEARCH PROJECTS AUTHORITY FOR HEALTH.
``(a) Definitions.--In this section:
``(1) ARPA-H.--The term `ARPA-H' means the Advanced
Research Projects Authority for Health established under
subsection (b).
``(2) Director.--The term `Director' means the Director of
ARPA-H appointed under subsection (c).
``(3) Other transactions.--The term `other transactions'
has the meaning given such term in section 319L(a)(3).
``(b) Establishment of the Advanced Research Projects Authority for
Health.--There is established within the National Institutes of Health
the Advanced Research Projects Authority for Health, for purposes of--
``(1) supporting high-impact, cutting-edge research in
biomedicine and broadly applicable breakthrough technologies
that have the potential to significantly transform and advance
areas of biomedical science and medicine in a manner that
cannot readily be accomplished through traditional biomedical
research or commercial activity; and
``(2) overcoming long-term and significant technological
and scientific barriers to advancing such technologies in order
to improve the prevention, diagnosis, mitigation, treatment,
and cure of health conditions.
``(c) Director.--
``(1) In general.--ARPA-H shall be headed by a Director,
who shall be appointed by the President. The Director shall
report to the Director of NIH.
``(2) Qualifications.--The Director shall be an individual
who, by reason of professional background and experience, is
especially qualified to advise the Secretary on, and manage,
research programs that advance the purposes of ARPA-H in
promoting biomedical and novel technology innovation pursuant
to this section, and who has a demonstrated ability to identify
and develop partnerships to address strategic needs in meeting
such purposes.
``(3) Appointment.--Notwithstanding section 405(a)(2), the
Director shall be appointed for a period of 4 years. The
President may extend the term of a Director for a period of up
to 4 additional years.
``(4) Duties.--The Director shall--
``(A) establish strategic goals, objectives, and
priorities for ARPA-H, pursuant to the purposes of
ARPA-H described in subsection (b);
``(B) approve all new programs within ARPA-H and
terminate any program within ARPA-H that is not
achieving its goals;
``(C) establish criteria for funding and assessing
the success of programs through the establishment of
technical milestones;
``(D) ensure that applications for funding disclose
current and previous research and development efforts,
and identify any challenges 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 and
appropriate, in pursuit of the technology area for
which funding is requested;
``(E) facilitate coordination between the
Department of Health and Human Services, relevant
agencies within such Department, and other relevant
Federal departments and agencies, with respect to
research supported by ARPA-H;
``(F) support transformative, translational,
applied, and advanced research in areas of biomedical
science to address specific technical or scientific
questions by--
``(i) prioritizing investments based on
scientific potential and impact on the field of
biomedicine, as described in subsection (b),
especially in areas that require public-private
partnerships in order to effectively advance
research and development activities;
``(ii) translating scientific discoveries
and cutting-edge innovation into technological
advancements;
``(iii) encouraging opportunities to
develop broadly applicable technologies, using
a multi-disciplinary approach; and
``(iv) making investments in high-risk,
high-reward research related to broadly
applicable technologies, capabilities, and
platforms that may have an application for
medicine and health;
``(G) encourage strategic collaboration and
partnerships with a broad range of entities, including
institutions of higher education, industry, nonprofit
organizations, or consortia of such entities, which may
include federally funded research and development
centers; and
``(H) ensure that the United States maintains
global leadership in researching and developing health
technologies.
``(d) Personnel.--
``(1) In general.--The Director shall establish and
maintain within ARPA-H a staff with appropriate qualifications
and expertise to enable ARPA-H to carry out the
responsibilities under this section.
``(2) Program managers.--
``(A) In general.--The Director shall designate
employees to serve as program managers for the programs
established or supported pursuant to subsection (c)(4).
``(B) Responsibilities.--A program manager shall--
``(i) establish, in consultation with the
Director, research and development goals for
the program, including timelines and
milestones, and make such goals available to
the public;
``(ii) provide project oversight and
management of strategic initiatives to advance
the purpose of the program;
``(iii) encourage research collaborations,
including by identifying and supporting
applicable public-private partnerships;
``(iv) select the projects to be supported
under the program after considering--
``(I) the novelty, scientific, and
technical merit of the proposed
projects;
``(II) the demonstrated
capabilities of the applicants to
successfully carry out the proposed
project and achieve designated
milestones within the applicable
timeline;
``(III) the potential future
commercial applications of the project
proposed by the applicant;
``(IV) the degree to which the
project addresses a scientific or
technical question pursuant to
subsection (c)(4)(F) and has the
potential to transform biomedicine, as
described in subsection (b); and
``(V) other criteria as established
by the Director;
``(v) recommend program restructure,
expansion, or termination of research projects
or whole projects, as necessary and
appropriate; and
``(vi) communicate with leaders in the
health care and biomedical research and
development fields, including from both the
public and private sectors, representatives of
patient organizations, institutions of higher
education, and nonprofit organizations, to
identify areas of need and scientific
opportunity with the potential to transform
biomedicine as described in subsection (b).
``(C) Term.--The term of a program manager shall be
not more than 3 years, and, at the discretion of the
Director, may be renewed for one additional period of
up to 3 years.
``(3) Considerations.--The Director--
``(A) in designating employees to serve as program
managers under paragraph (1), shall consider, as
appropriate, individuals with demonstrated scientific
expertise and management skills required to advance the
purposes of ARPA-H, and who represent a diverse set of
professional experiences or backgrounds, including
individuals with experience in academia, industry,
government, nonprofit organizations, or other sectors;
and
``(B) in making appointments of personnel to staff
or support ARPA-H, may consider other factors, as
appropriate, such as populations that are traditionally
underrepresented in the biomedical research enterprise.
``(4) Hiring.--
``(A) In general.--The Director may--
``(i) make or rescind appointments of
scientific, medical, and professional
personnel, without regard to any provision of
title 5, United States Code governing
appointments under the civil service laws and
notwithstanding section 202 of the Department
of Health and Human Services Appropriations
Act, 1993 (Public Law 102-394); and
``(ii) fix the compensation of such
personnel at a rate to be determined by the
Director, up to the amount of annual
compensation (excluding expenses) specified in
section 102 of title 3, United States Code.
``(B) Reporting.--The Director shall establish and
maintain records regarding the use of the authority
under subparagraph (A)(i), including--
``(i) the number of positions filled
through such authority;
``(ii) the types of appointments of such
positions;
``(iii) the titles, occupational series,
and grades of such positions;
``(iv) the number of positions publicly
noticed to be filled under such authority;
``(v) the number of qualified applicants
who apply for such positions;
``(vi) the qualification criteria for such
positions; and
``(vii) the demographic information of
individuals appointed to such positions.
``(C) Reports to congress.--Not later than one year
after the date of enactment of the Advanced Research
Project Authority for Health Act, and annually
thereafter for each fiscal year in which such authority
is used, the Director shall submit to the Committee on
Health, Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the House
of Representatives a report describing the total number
of appointments filled under this subsection within the
fiscal year and how the positions relate to the
purposes of ARPA-H.
``(D) Private recruiting firms.--The Director may
contract with private recruiting firms for the hiring
of qualified technical staff to carry out this section.
``(E) Clarifications.--
``(i) Previous positions.--The Director
shall ensure that the personnel who are
appointed to staff or support ARPA-H are
individuals who, at the time of appointment and
for 3 years prior to such appointment, were not
employed by the National Institutes of Health.
``(ii) Number of personnel.--The Director
may appoint not more than 120 personnel under
this section. The Director shall submit a
notification to Congress if the Director
determines that additional personnel are
required to carry out this section.
``(F) GAO report.--Not later than 2 years after the
date of enactment of the Advanced Research Project
Authority for Health Act, the Comptroller General of
the United States shall submit to the Committee on
Health, Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the House
of Representatives a report on the use of the authority
provided under subparagraph (A)(i). Such report shall,
in a manner that protects personal privacy, to the
extent required by applicable Federal and State privacy
law, at a minimum, include information on--
``(i) the number of positions publicly
noticed and filled under the authority under
this subsection;
``(ii) the occupational series, grades, and
types of appointments of such positions;
``(iii) how such positions related to
advancing the purposes of ARPA-H;
``(iv) how the Director made appointment
decisions under this subsection;
``(v) sources used to identify candidates
for filling such positions;
``(vi) the number of individuals appointed;
``(vii) aggregated demographic information
related to individuals appointed; and
``(viii) any challenges, limitations, or
gaps related to the use of the authority under
this subsection and any related recommendations
to address such challenges, limitations, or
gaps.
``(e) Funding Awards.--
``(1) In general.--In carrying out this section, the
Director may award grants, contracts, cooperative agreements,
cash prizes, and enter into other transactions, as described in
paragraph (2).
``(2) Other transactions.--
``(A) Limitations on entering into other
transactions.--
``(i) In general.--To the maximum extent
practicable, competitive procedures shall be
used when entering into other transactions to
carry out projects under this section.
``(B) Written determinations required.--The
authority of this paragraph may be exercised for a
project if the project manager--
``(i) submits a proposal to the Director
for each individual use of such authority
before conducting or supporting a project,
including why the use of such authority is
essential to promoting the success of the
project;
``(ii) receives approval for the use of
such authority from the Director; and
``(iii) for each year in which the program
manager has used such authority in accordance
with this paragraph, submits a report to the
Director on the activities of the program
relating to such project.
``(3) Prize competitions.--The Director may utilize the
authorities and processes established under section 24 of the
Stevenson-Wydler Technology Innovation Act of 1980 (15 U.S.C.
3719) to support prize competitions, in accordance with this
section.
``(4) Federal demonstration of technologies.--The Director
may seek opportunities to partner with procurement programs of
Federal agencies to demonstrate technologies resulting from
activities funded through ARPA-H.
``(5) Clarifications.--Research supported by this section
shall not be subject to the requirements of section
406(a)(3)(A)(ii) or 492.
``(f) Coordination, Collaboration, Nonduplication, and
Consultation.--
``(1) Coordination.--To the maximum extent practicable, the
Director shall ensure that the activities of ARPA-H are
coordinated with, and do not duplicate the efforts of--
``(A) other programs within, or research conducted
or supported by, the Department of Health and Human
Services, including the National Institutes of Health
and the Biomedical Advanced Research and Development
Authority; and
``(B) other relevant efforts or research and
development programs operated or overseen by other
departments, agencies, or offices of the Federal
Government.
``(2) Funding determinations.--The Director shall ensure
that ARPA-H does not provide funding for a research program or
project unless the applicant for such funding demonstrates
that--
``(A)(i) such applicant has made sufficient
unsuccessful attempts to secure private financing, and
that there is a lack of significant private support for
the program or project; or
``(ii) such program or project is in the best
interests of the United States; and
``(B) such program or project has the potential to
significantly transform and advance the field of
biomedicine, as described in subsection (b).
``(3) Consultation.--In carrying out this section, the
Director may seek input from--
``(A) the President's Council of Advisors on
Science and Technology;
``(B) representatives of professional or scientific
organizations with expertise in specific technologies
under consideration or development by ARPA-H; and
``(C) representatives of patient organizations,
public health, innovators, and other public and private
entities.
``(4) Enhanced collaboration and communication.--
``(A) In general.--In order to facilitate enhanced
collaboration and communication with respect to the
most current priorities of ARPA-H, the Food and Drug
Administration may meet with ARPA-H and any other
appropriate Federal partners, such as the Biomedical
Advanced Research and Development Authority, at
appropriate intervals, to discuss the development
status, and actions that may be taken to facilitate the
development, of medical products and projects that are
the highest priorities to ARPA-H.
``(B) Relation to otherwise authorized activities
of the food and drug administration.--Utilizing
interagency agreements or other appropriate resource
allocation mechanisms available, the Director shall
reimburse the Food and Drug Administration, as
appropriate, for activities identified by the
Commissioner of Food and Drugs and the Director as
being conducted by the Food and Drug Administration
under the authority of this section, using funds made
available to ARPA-H.
``(g) Advisory Committee.--
``(1) In general.--There is established an ARPA-H
Interagency Advisory Committee (referred to in this subsection
as the `Advisory Committee') to coordinate efforts and provide
advice and assistance on specific program or project tasks and
the overall direction of ARPA-H.
``(2) Members.--The Advisory Committee established under
paragraph (1) shall consist of the heads of the following
agencies or their designees:
``(A) The National Institutes of Health.
``(B) The Centers for Disease Control and
Prevention.
``(C) The Food and Drug Administration.
``(D) The Office of the Assistant Secretary for
Preparedness and Response.
``(E) The Office of the Assistant Secretary of
Health.
``(F) The Defense Advanced Research Projects
Agency.
``(G) The Office of Science of the Department of
Energy.
``(H) The National Science Foundation.
``(I) Any other agency with subject matter
expertise that the Director of ARPA-H determines
appropriate to advance programs or projects under this
section.
``(3) Nonapplicability of faca.--The Federal Advisory
Committee Act (5 U.S.C. App.) shall not apply to the Advisory
Committee.
``(4) Advisory nature.--The functions of the Advisory
Committee shall be advisory in nature, and nothing in this
subsection shall be construed as granting such Committee
authority over the activities authorized under this section.
``(5) Performance measures framework.--The Director, in
consultation with the Advisory Committee, shall develop a
performance measures framework for programs or projects
supported by ARPA-H in order to inform and facilitate the
evaluation required under subsection (m), including
identification of any data needed to perform such evaluation,
consistent with subsection (l).
``(h) Facilities.--
``(1) Authorities.--The Director is authorized to--
``(A) acquire (by purchase, lease, condemnation or
otherwise), construct, improve, repair, operate, and
maintain such real and personal property as are
necessary to carry out this section; and
``(B) lease an interest in property for not more
than 20 years, notwithstanding section 1341(a)(1) of
title 31, United States Code.
``(2) Locations.--
``(A) In general.--ARPA-H, including its
headquarters, shall not be located, including
headquartered, inside of, or in close proximity to, the
National Capital region, and shall not be located on
any part of the National Institutes of Health campuses.
``(B) Considerations.--In determining the location
of facilities, the Director shall consider the
characteristics of the intended location and the extent
to which such location will facilitate advancement of
the ARPA-H purposes pursuant to subsection (b).
``(i) Rule of Construction.--The authorities granted by this
section--
``(1) are in addition to existing authorities granted to
the Secretary; and
``(2) shall not be construed to modify or supersede any
existing authorities.
``(j) Protection of Information.--
``(1) In general.--Nothing in this section shall be
construed as authorizing the Secretary 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.--One year after the date of enactment of
the Advanced Research Project Authority for Health Act, 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.
``(k) Reports and Strategic Plans.--
``(1) Annual report.--As part of the annual budget request
submitted for each fiscal year, the Director shall provide 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 Representatives a report that describes--
``(A) projects supported by ARPA-H during the
previous fiscal year, and, with respect to each such
project, the stage of development and details as to
whether the project is meeting project milestones;
``(B) projects supported by ARPA-H in the previous
fiscal year that were terminated, and the reasons for
termination;
``(C) projects supported by ARPA-H during the
previous fiscal year that examine topics and
technologies closely related to other activities funded
by the Department of Health and Human Services,
including an analysis of whether in supporting such
projects, the Director is in compliance with the
requirements of this section; and
``(D) current, proposed, and planned projects to be
carried out.
``(2) Strategic plan.--Not later than 180 days after the
appointment of the first Director pursuant to subsection (c),
and every 4 years thereafter, the Director shall provide 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 Representatives a plan describing the strategic plan
that ARPA-H will use to guide future investments over the
following 4 fiscal years. Every 2 years after the date of
submission of the initial plan, the Director shall submit a
supplemental strategic plan that details any changes to such
strategic vision, as appropriate. The requirements regarding
individual institute and center strategic plans under section
402(m), including paragraph (3) of such subsection, shall not
apply to ARPA-H.
``(l) National Academies of Sciences, Engineering, and Medicine
Evaluation.--
``(1) In general.--Not later than 3 years after the date of
enactment of the Advanced Research Project Authority for Health
Act, the Director shall seek to enter into a contract with the
National Academies of Sciences, Engineering, and Medicine under
which the National Academies conducts an evaluation of ARPA-H
regarding the goals and purposes of ARPA-H and the degree to
which the activities of ARPA-H support, and align with, such
goals and purposes.
``(2) Inclusions.--The evaluation under paragraph (1) may
include--
``(A) recommendations on how to improve upon the
operation of, and projects carried out by, ARPA-H,
which may include lessons learned from other advanced
research and development agencies or authorities within
the Department of Health and Human Services and in
other departments, agencies, or offices of the Federal
Government;
``(B) a description of lessons learned from the
establishment and operation of ARPA-H, and the manner
in which those lessons may apply to the operation of
other programs of the Department of Health and Human
Services; and
``(C) an analysis of whether any projects supported
by ARPA-H were duplicative of other research programs
supported by the Department of Health and Human
Services or other another relevant Federal department
or agency.
``(3) Availability.--Upon completion of the evaluation, the
evaluation shall be submitted by the Director 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
Representatives and made publicly available.
``(m) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated such sums as may be necessary
for each of fiscal years 2023 through 2027.
``(n) Additional Budget Clarification.--Any budget request for
ARPA-H shall be separate from the other budget requests of the National
Institutes of Health.''.
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