Title: ARPA–H Act
Policy area: Health

Summary:
Advanced Research Project Authority for Health Act or the ARPA-H Act
This bill establishes within the National Institutes of Health (NIH) the Advanced Research Projects Authority for Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects. The bill also establishes an interagency advisory committee to inform the authority's activities.
The authority director shall be appointed by the President and report to the NIH director. The authority director must, among other duties, designate personnel to serve as program managers who select projects to support, make recommendations about terminating or continuing projects, and otherwise administer authority programs.
The authority may use a variety of mechanisms to support the research projects, including grants, contracts, and prize competitions. To receive funding, an applicant must demonstrate sufficient, unsuccessful attempts to secure private funding for its project and other criteria. Furthermore, the authority's budget is separate from the NIH budget.
In addition, the authority must (1) develop and periodically update a strategic plan, (2) annually report on its activities, and (3) seek to contract with the National Academies of Sciences, Engineering, and Medicine to evaluate the authority's performance.
The Food and Drug Administration (FDA) may meet with the authority and other federal partners to discuss actions to facilitate the development of medical projects and products prioritized by the authority. The authority must reimburse the FDA for the costs associated with supporting authority activities.
The bill also requires the Government Accountability Office to report on issues related to the authority's hiring and staffing.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3819 Introduced in Senate (IS)]

<DOC>






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.''.
                                 <all>