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42 U.S.C. § 290c — Advanced Research Projects Agency–Health
Federal law — U.S. Code and appendices · legal_authorities
**(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 December 29, 2022, the Secretary shall transfer all functions, personnel, missions, activities, authorities, and funds of the Advanced Research Projects Agency for Health as in existence on December 29, 2022, 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, consistent 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 Representatives if the Director determines that additional program 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 establishing 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 December 29, 2022, as necessary and appropriate to ensure ARPA–H can most effectively achieve the goals described in subsection (b)(1).
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Source location: Title 42, Chapter 6A, § 290c; chapter-6a-public-health-service.md
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**(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 December 29, 2022, the Secretary shall transfer all functions, personnel, missions, activities, authorities, and funds of the Advanced Research Projects Agency for Health as in existence on December 29, 2022, 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, consistent 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 Representatives if the Director determines that additional program 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 establishing 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 December 29, 2022, 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 December 29, 2022, 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—
(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 accomplished 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 technological and scientific barriers to developing transformative health technologies;
(C) promote high-risk, high-reward innovation to enable the advancement of transformative health technologies; 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 citizens 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 revolutionary advancements in science;
(B) translation of scientific discoveries into transformative health technologies with potential application for biomedical science and medicine;
(C) creation of platform capabilities that draw on multiple 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 technological 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.
(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 program within ARPA–H that is not achieving its goals.
(C) Develop funding criteria and assess the success of programs through the establishment of technical milestones.
(D) Request that applications for funding disclose current and previous research and development efforts related to such applications, as appropriate, 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.
(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 supplements, 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 partnerships with a broad range of entities, which may include institutions of higher education, minority-serving institutions (defined, for the purposes of this section, as institutions and programs described in [section 1063b(e)(1) of title 20](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title20-section1063b/e/1&num=0&edition=prelim) and institutions described in [section 1067q(a) of title 20](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title20-section1067q/a&num=0&edition=prelim)), industry, nonprofit organizations, Federally funded research and development centers, or consortia of such entities.
(5) **Term** — Notwithstanding [section 284(a)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section284/a/2&num=0&edition=prelim), 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 any officer or agency of the United States for approval, comments, or review prior to the submission of such recommendations, testimony or comments to Congress, if such recommendations, 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 President 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 restrictions contained in section 202 of the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 1993 (Public Law 102–394; [42 U.S.C. 238f](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section238f&num=0&edition=prelim) 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 241(g) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section241/g&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552/b/4&num=0&edition=prelim) or [section 1905 of title 18](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1905&num=0&edition=prelim).
(2) **Reporting** — If there have been requests under section 522 11 So in original. Probably should be “section 552”. of title 5 or the Secretary has used such authority to withhold information within the preceding year, not later than 1 year after December 29, 2022, 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552&num=0&edition=prelim) or [section 1905 of title 18](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1905&num=0&edition=prelim) that was denied using such authority.
(3) **Clarification** — The protections for trade secrets or other privileged or confidential information described in paragraph (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 Academies 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 Administration**
(1) **In general** — In order to facilitate the 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 Federal partners 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.
(2) **Reimbursement** — Utilizing interagency agreements or other appropriate resource allocation mechanisms available, the Director shall reimburse, using funds made available to ARPA–H, 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 subsection.
**(g) Awards**
(1) **In general** — In carrying out this section, the Director may—
(A) award grants and cooperative agreements, which shall include requirements to publicly report indirect facilities and administrative costs, broken out by fixed capital costs, administrative overhead, and labor costs;
(B) award contracts, which may include multi-year contracts subject to [section 3903 of title 41](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section3903&num=0&edition=prelim);
(C) award cash prizes, utilizing the authorities and processes established under [section 3719 of title 15](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section3719&num=0&edition=prelim); and
(D) enter into other transactions, as defined by [section 247d–7e(a)(3) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d–7e/a/3&num=0&edition=prelim), subject to paragraph (2).
(2) **Limitations on entering into other transactions**
(A) *Use of competitive procedures* — To the maximum extent practicable, competitive procedures shall be used when entering into other transactions under this section.
(B) *Written determination required* — The authority of paragraph (1)(D) may be exercised for a project if the program manager—
(i) submits a request to the Director for each individual use of such authority before conducting or supporting a program, including an explanation of 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 related to such project.
(3) **Exemptions from certain requirements** — Research funded by ARPA–H shall not be subject to the requirements of [section 284a(a)(3)(A)(ii) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section284a/a/3/A/ii&num=0&edition=prelim) or [section 289a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section289a&num=0&edition=prelim).
**(h) Facilities authority**
(1) **In general** — The Director is authorized, for administrative purposes, 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section1341/a/1&num=0&edition=prelim).
(2) **Locations**
(A) *In general* — ARPA–H, including its headquarters, shall not be located on any part of the existing National Institutes of Health campuses.
(B) *Number of locations* — ARPA–H shall have offices or facilities in not less than 3 geographic areas.
(C) *Considerations* — In determining the location of each office or facility, the Director shall make a fair and open consideration of—
(i) the characteristics of the intended location; and
(ii) the extent to which such location will facilitate advancement of the goals and functions specified in subsection (b).
**(i) Personnel**
(1) **In general** — The Director may—
(A) appoint and remove scientific, engineering, medical, and professional personnel, which may include temporary or term-limited appointments as determined by the Director to fulfill the mission of ARPA–H, without regard to any provision in title 5 governing appointments and removals under the civil service laws;
(B) notwithstanding any other provision of law, including any requirement with respect to General Schedule pay rates under subchapter III of chapter 53 of title 5, fix the base pay 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title3-section102&num=0&edition=prelim); and
(C) contract with private recruiting firms for assistance in identifying highly qualified candidates for technical positions needed to carry out this section.
(2) **Support staff** — The Director may use authorities in existence on December 29, 2022, that are provided to the Secretary to hire administrative, financial, clerical, and other staff necessary to carry out functions that support the goals and functions described in subsection (b).
(3) **Number of personnel** — The Director may appoint not more than 210 personnel under this section. 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 Representatives if the Director determines that additional personnel are required to carry out this section.
(4) **Clarification on previous positions**
(A) *In general* — Except as provided in subparagraph (B), 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. The Director may grant an exemption only for individuals who are uniquely qualified, by way of professional background and expertise, to advance the goals and functions specified in subsection (b).
(B) *Nonapplication of provision* — The restriction provided under subparagraph (A) shall not apply to any individuals who are employed by ARPA–H on December 29, 2022.
(5) **Additional considerations** — In appointing personnel under this subsection, the Director—
(A) may contract with private entities for the purposes of recruitment services;
(B) shall make efforts to recruit a diverse workforce, including individuals underrepresented in science, engineering, and medicine, including racial and ethnic minorities, provided such efforts do not conflict with applicable Federal civil rights law, and individuals with a variety of professional experiences or backgrounds; and
(C) shall recruit program managers with demonstrated expertise in a wide range of scientific disciplines and management skills.
(6) **Use of Intergovernmental Personnel Act** — To the extent needed to carry out the authorities under paragraph (1) and the goals and functions specified in subsection (b), the Director may utilize hiring authorities under sections 3371 through 3376 of title 5.
(7) **Authority to accept Federal detailees** — The Director may accept officers or employees of the United States or members of the uniformed service on a detail from an element of the Federal Government, on a reimbursable or a nonreimbursable basis, as jointly agreed to by the heads of the receiving and detailing elements, for a period not to exceed 3 years.
**(j) Program managers**
(1) **In general** — The Director shall appoint program managers for 3-year terms (and may reappoint such program managers for 1 additional consecutive 3-year term) for the programs carried out by ARPA–H.
(2) **Duties** — A program manager shall—
(A) establish, in consultation with the Director, research and development goals for programs, including timelines and milestones, and make such goals available to the public;
(B) manage applications and proposals, through the appropriate officials, for making awards as described in subsection (g) for activities consistent with the goals and functions described in subsection (b);
(C) issue funding opportunity announcements, using uniform administrative processes, as appropriate;
(D) select, on the basis of merit, each of the projects to be supported under a program carried out by ARPA–H, and taking into consideration—
(i) the scientific, technical merit, and novelty of the proposed project;
(ii) the ability of the applicant to successfully carry out the proposed project;
(iii) the potential future commercial applications of the project proposed by the applicant, including whether such applications may have the potential to address areas of currently unmet need within biomedicine and improve health outcomes;
(iv) the degree to which the proposed project has the potential to transform biomedicine and addresses a scientific or technical question pursuant to subsection (b);
(v) the potential for the project to take an interdisciplinary approach; and
(vi) such other criteria as established by the Director;
(E) provide project oversight and management of strategic initiatives to advance the program, including by conducting project reviews not later than 18 months after the date of funding awards to identify and monitor progress of milestones with respect to each project and prior to disbursement of additional funds;
(F) provide recommendations to the Director with respect to advancing the goals and functions specified in subsection (b);
(G) encourage research collaborations and cultivate opportunities for the application or utilization of successful projects, including through identifying and supporting applicable public-private partnerships or partnerships between or among award recipients;
(H) provide recommendations to the Director to establish, expand, restructure, or terminate partnerships or projects; and
(I) communicate and collaborate with leaders and experts within the health care and biomedical research and development fields, including from both the public and private sectors and, as necessary, through the convening of workshops and meetings, to identify research and development gaps and opportunities and solicit stakeholder input on programs and goals.
**(k) Reports and evaluation**
(1) **Annual report**
(A) *In general* — Beginning not later than 1 year after December 29, 2022, as part of the annual budget request submitted for each fiscal year, the Director shall submit a report on the actions undertaken, and the results generated, by ARPA–H, including—
(i) a description of projects supported by ARPA–H in the previous fiscal year and whether such projects are meeting the goals developed by the Director pursuant to subsection (c)(4)(A);
(ii) a description of projects terminated in the previous fiscal year, and the reason for such termination;
(iii) a description of planned programs starting in the next fiscal year, pending the availability of funding;
(iv) activities conducted in coordination with other Federal departments and agencies;
(v) a description of any successes with, or barriers to, coordinating with other Federal departments and agencies to achieve the goals and functions under subsection (b);
(vi) aggregated demographic information, if available, of direct recipients and performers in funded projects and of the ARPA–H workforce (consistent with the reporting requirements under paragraph (3)); and
(vii) a summary of award recipient compliance with [section 242v of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section242v&num=0&edition=prelim).
(B) *Submission to Congress* — The report under subparagraph (A) shall be submitted to—
(i) the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives; and
(ii) the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate.
(2) **Evaluation**
(A) *In general* — Not later than 5 years after December 29, 2022, the Director shall seek to enter into an agreement with the National Academies under which the National Academies conducts an evaluation of whether ARPA–H is meeting the goals and functions specified in subsection (b).
(B) *Submission of results* — The agreement entered into under subparagraph (A) shall require the National Academies to submit the evaluation conducted under such agreement to the Director, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives, and make the report publicly available.
(3) **Reporting related to ARPA–H personnel**
(A) *In general* — The Director shall establish and maintain records regarding the use of the authority under subsection (i)(1)(A), 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.
(B) *Reports to Congress* — Not later than 2 years after December 29, 2022, 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 subsection (i) within the fiscal year and how the positions relate to the goals and functions of ARPA–H.
(C) *GAO report* — Not later than 2 years after December 29, 2022, 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 subsection (i)(1)(A). 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 subsection (i);
(ii) the occupational series, grades, and types of appointments of such positions;
(iii) how such positions related to advancing the goals and functions of ARPA–H;
(iv) how the Director made appointment decisions under subsection (i);
(v) a summary of sources used to identify candidates for filling such positions, as applicable;
(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 subsection (i) and any related recommendations to address such challenges, limitations, or gaps.
**(l) Strategic plan** Not later than 1 year after December 29, 2022, and every 3 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 strategic plan describing how ARPA–H will carry out investments each fiscal year in the following 3-year period. The requirements regarding individual institute and center strategic plans under [section 282(m) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section282/m&num=0&edition=prelim), including paragraph (3) of such subsection, shall not apply to ARPA–H.
**(m) Independent review** Not later than 1 year after December 29, 2022, and every 4 years thereafter, the Comptroller General of the United States shall conduct, and 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, an independent review of the biomedical research and development portfolio of the Department of Health and Human Services, including ARPA–H, the National Institutes of Health, the Food and Drug Administration, and the Biomedical Advanced Research and Development Authority—
(1) to assess the degree of any potential duplication of existing Federal programs and projects; and
(2) to make any recommendations regarding any potential reorganization, consolidation, or termination of such programs and projects.
**(n) Prioritization**
(1) **In general** — The Director shall—
(A) prioritize awarding grants, cooperative agreements, contracts, prizes, and other transaction awards to entities that will conduct funded work in the United States;
(B) as appropriate and practicable, encourage nondomestic recipients of any grants, cooperative agreements, contracts, prizes, and other transactions under this section to collaborate with a domestic entity;
(C) not make awards under this section to nondomestic entities organized under the laws of a covered foreign country (as defined in [section 3059 of title 50](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title50-section3059&num=0&edition=prelim)); and
(D) in accordance with the requirements of chapter 33 of title 41 and the Federal Acquisition Regulation, not make awards under this section to entities that have more than 3 ongoing concurrent awards under this section.
(2) **Clarification** — In making an award under this section, the Director may waive the requirements of subparagraphs (A), (B), and (D) of paragraph (1) if such requirements cannot reasonably be met, and the proposed project has the potential to advance the goals described in subsection (b)(1). The Director shall provide notice to Congress not later than 30 days after waiving such requirements.
**(o) Additional consultation** In carrying out this section, the Director may consult with—
(1) the President’s Council of Advisors on Science and Technology;
(2) representatives of professional or scientific organizations, including academia and industry, with expertise in specific technologies under consideration or development by ARPA–H;
(3) an existing advisory committee providing advice to the Secretary or the head of any operating or staff division of the Department;
(4) the advisory committee established under subsection (p); and
(5) any other entity the Director may deem appropriate.
**(p) 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 or office 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.) 22 See References in Text note below. 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**
(A) *In general* — 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 (k)(2), including identification of any data needed to perform such evaluation,
(B) *Availability of performance measures* — The Director shall provide to the National Academies such performance measures and data necessary to perform the evaluation required under subsection (k)(2).
**(q) Rule of construction** The authorities under this section, with respect to the Director, are additional authorities that do not supersede or modify any existing authorities.
**(r) Transformative health technology defined** In this section, the term “transformative health technology” means a novel, broadly applicable capability or technology—
(1) that has potential to revolutionize the detection, diagnosis, mitigation, prevention, cure, or treatment of a disease or health condition that can cause severe health outcomes and which is an area of currently unmet need; and
(2) for which—
(A) significant scientific or technical challenges exist; or
(B) incentives in the commercial market are unlikely to result in the adequate or timely development of such capability or technology.
**(s) Authorization of appropriations** To carry out this section, there is authorized to be appropriated $500,000,000 for each of the fiscal years 2024 through 2028, to remain available until expended.
**(t) Additional budget clarification** Any budget request for ARPA–H shall propose a separate appropriation from the other accounts of the National Institutes of Health.
Cross-references
Connections may be documented source relationships, shared citations or nearby passages. Each explains its basis; a connection alone does not establish applicability to your situation.
Federal law — U.S. Code and appendices · legal_authorities
The President shall receive in full for his services during the term for which he shall have been elected compensation in the aggregate amount of $400,000 a year, to be paid monthly, and in addition an expense allowance of $50,000 to assist in defraying expenses relating to or resulting from the discharge of his official duties. Any unused amount of such expense allowance shall revert to the Treasury pursuant to [section 1552 of title 31](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section1552&num=0&edition=prelim), United States Code. No amount of such expense allowance shall be included in the gross income of the President. He shall be entitled also to the use of the furniture and other effects belonging to the United States and kept in the Executive Residence at the White House.
Source: Supplied U.S. Code snapshot — release unconfirmed · 3 U.S.C. § 102
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Definitions** In this section:
(1) **Agency** — The term “agency” means a Federal agency.
(2) **Director** — The term “Director” means the Director of the Office of Science and Technology Policy.
(3) **Federal agency** — The term “Federal agency” has the meaning given under [section 3703 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section3703&num=0&edition=prelim), except that term shall not include any agency of the legislative branch of the Federal Government.
(4) **Head of an agency** — The term “head of an agency” means the head of a Federal agency.
**(b) In general** Each head of an agency, or the heads of multiple agencies in cooperation, may carry out a program to award prizes competitively to stimulate innovation that has the potential to advance the mission of the respective agency.
**(c) Prize competitions** For purposes of this section, a prize competition may be 1 or more of the following types of activities:
(1) A point solution prize that rewards and spurs the development of solutions for a particular, well-defined problem.
(2) An exposition prize competition that helps identify and promote a broad range of ideas and practices that may not otherwise attract attention, facilitating further development of the idea or practice by third parties.
(3) Participation prize competitions that create value during and after the competition by encouraging contestants to change their behavior or develop new skills that may have beneficial effects during and after the competition.
(4) Such other types of prize competitions as each head of an agency considers appropriate to stimulate innovation that has the potential to advance the mission of the respective agency.
**(d) Topics** In selecting topics for prize compet
Source: Supplied U.S. Code snapshot — release unconfirmed · 15 U.S.C. § 3719
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** The Secretary shall, acting through the Director of NIH, establish a nonprofit corporation to be known as the Foundation for the National Institutes of Health (hereafter in this section referred to as the “Foundation”). The Foundation shall not be an agency or instrumentality of the United States Government.
**(b) Purpose of Foundation** The purpose of the Foundation shall be to support the National Institutes of Health in its mission (including collection of funds for pediatric pharmacologic research), and to advance collaboration with biomedical researchers from universities, industry, and nonprofit organizations.
**(c) Certain activities of Foundation**
(1) **In general** — In carrying out subsection (b), the Foundation may solicit and accept gifts, grants, and other donations, establish accounts, and invest and expend funds in support of the following activities with respect to the purpose described in such subsection:
(A) A program to provide and administer endowed positions that are associated with the research program of the National Institutes of Health. Such endowments may be expended for the compensation of individuals holding the positions, for staff, equipment, quarters, travel, and other expenditures that are appropriate in supporting the endowed positions.
(B) A program to provide and administer fellowships and grants to research personnel in order to work and study in association with the National Institutes of Health. Such fellowships and grants may include stipends, travel, health insurance benefits and other appropriate expenses. The recipients of fellowships shall be selected by the donors and the Foundation upon the recommendation of the National Institutes of Health employees in the laboratory where the fellow would serve
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 290b
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Applications for biomedical and behavioral research grants, cooperative agreements, and contracts; regulations**
(1) The Secretary, acting through the Director of NIH, shall by regulation require appropriate technical and scientific peer review of—
(A) applications made for grants and cooperative agreements under this chapter for biomedical and behavioral research; and
(B) applications made for biomedical and behavioral research and development contracts to be administered through the National Institutes of Health.
(2) Regulations promulgated under paragraph (1) shall require that the review of applications made for grants, contracts, and cooperative agreements required by the regulations be conducted—
(A) to the extent practical, in a manner consistent with the system for technical and scientific peer review applicable on November 20, 1985, to grants under this chapter for biomedical and behavioral research, and
(B) to the extent practical, by technical and scientific peer review groups performing such review on or before November 20, 1985,
and shall authorize such review to be conducted by groups appointed under sections 282(b)(16) and 284(c)(3) of this title.
**(b) Periodic review of research at National Institutes of Health** The Director of NIH shall establish procedures for periodic technical and scientific peer review of research at the National Institutes of Health. Such procedures shall require that—
(1) the reviewing entity be provided a written description of the research to be reviewed, and
(2) the reviewing entity provide the advisory council of the national research institute involved with such description and the results of the review by the entity,
and shall authorize such review to be conducted by groups appointed under sections
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 289a
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Intramural research**
(1) **In general** — Not later than 60 days after December 29, 2022, the Secretary of Health and Human Services (referred to in sections 242v to 242v–3 of this title as the “Secretary”) shall prohibit personnel of the National Institutes of Health engaged in intramural research from participation in foreign talent recruitment programs.
(2) **Exemption** — Paragraph (1) shall not apply to participation in international conferences or other international exchanges, partnerships, or programs, for which such participation has been approved by the National Institutes of Health. In such circumstances, the National Institutes of Health shall ensure appropriate training is provided to the participant on how to respond to overtures from individuals associated with foreign talent recruitment programs.
**(b) Extramural research** The Secretary shall require disclosure of participation in foreign talent recruitment programs, including the provision of copies of all grants, contracts, or other agreements related to such programs, and other supporting documentation related to such programs, as a condition of receipt of Federal extramural biomedical research funding awarded through the Department of Health and Human Services.
**(c) Consistency** The Secretary shall ensure that the policies developed, updated, or issued pursuant to subsections (a) and (b) are, to the greatest extent practicable, consistent with the requirements of subtitle D of title VI of division B of Public Law 117–167 ([42 U.S.C. 19231](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section19231&num=0&edition=prelim) et seq.) related to foreign talent recruitment programs.
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 242v
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Definition.—** In this section, a multiyear contract is a contract for the purchase of property or services for more than one, but not more than 5, program years.
**(b) Authority To Enter Into Contract.—** An executive agency may enter into a multiyear contract for the acquisition of property or services if—
(1) funds are available and obligated for the contract, for the full period of the contract or for the first fiscal year in which the contract is in effect, and for the estimated costs associated with a necessary termination of the contract; and
(2) the executive agency determines that—
(A) the need for the property or services is reasonably firm and continuing over the period of the contract; and
(B) a multiyear contract will serve the best interests of the Federal Government by encouraging full and open competition or promoting economy in administration, performance, and operation of the agency’s programs.
**(c) Termination Clause.—** A multiyear contract entered into under the authority of this section shall include a clause that provides that the contract shall be terminated if funds are not made available for the continuation of the contract in a fiscal year covered by the contract. Funds available for paying termination costs shall remain available for that purpose until the costs associated with termination of the contract are paid.
**(d) Cancellation Ceiling Notice.—** Before a contract described in subsection (b) that contains a clause setting forth a cancellation ceiling in excess of $10,000,000 may be awarded, the executive agency shall give written notification of the proposed contract and of the proposed cancellation ceiling for that contract to Congress. The contract may not be awarded until the end of the 30-day period beginning on th
Source: Supplied U.S. Code snapshot — release unconfirmed · 41 U.S.C. § 3903
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Federal law — U.S. Code and appendices · legal_authorities
Whoever, being an officer or employee of the United States or of any department or agency thereof, any person acting on behalf of the Federal Housing Finance Agency, or agent of the Department of Justice as defined in the Antitrust Civil Process Act ([15 U.S.C. 1311–131](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1311–131&num=0&edition=prelim)4), or being an employee of a private sector organization who is or was assigned to an agency under chapter 37 of title 5, publishes, divulges, discloses, or makes known in any manner or to any extent not authorized by law any information coming to him in the course of his employment or official duties or by reason of any examination or investigation made by, or return, report or record made to or filed with, such department or agency or officer or employee thereof, which information concerns or relates to the trade secrets, processes, operations, style of work, or apparatus, or to the identity, confidential statistical data, amount or source of any income, profits, losses, or expenditures of any person, firm, partnership, corporation, or association; or permits any income return or copy thereof or any book containing any abstract or particulars thereof to be seen or examined by any person except as provided by law; shall be fined under this title, or imprisoned not more than one year, or both; and shall be removed from office or employment.
Source: Supplied U.S. Code snapshot — release unconfirmed · 18 U.S.C. § 1905
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Federal law — U.S. Code and appendices · legal_authorities
For the purpose of any reorganization under [section 203 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section203&num=0&edition=prelim), the Secretary, with the approval of the Director of the Office of Management and Budget, is authorized to make such transfers of funds between appropriations as may be necessary for the continuance of transferred functions.
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 238f
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Federal law — U.S. Code and appendices · legal_authorities
**(a)** Each agency shall make available to the public information as follows:
(1) Each agency shall separately state and currently publish in the Federal Register for the guidance of the public—
(A) descriptions of its central and field organization and the established places at which, the employees (and in the case of a uniformed service, the members) from whom, and the methods whereby, the public may obtain information, make submittals or requests, or obtain decisions;
(B) statements of the general course and method by which its functions are channeled and determined, including the nature and requirements of all formal and informal procedures available;
(C) rules of procedure, descriptions of forms available or the places at which forms may be obtained, and instructions as to the scope and contents of all papers, reports, or examinations;
(D) substantive rules of general applicability adopted as authorized by law, and statements of general policy or interpretations of general applicability formulated and adopted by the agency; and
(E) each amendment, revision, or repeal of the foregoing.
Except to the extent that a person has actual and timely notice of the terms thereof, a person may not in any manner be required to resort to, or be adversely affected by, a matter required to be published in the Federal Register and not so published. For the purpose of this paragraph, matter reasonably available to the class of persons affected thereby is deemed published in the Federal Register when incorporated by reference therein with the approval of the Director of the Federal Register.
(2) Each agency, in accordance with published rules, shall make available for public inspection in an electronic format—
(A) final opinions, including concurring and dissen
Source: Supplied U.S. Code snapshot — release unconfirmed · 5 U.S.C. § 552
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Federal law — U.S. Code and appendices · legal_authorities
The Executive departments are:
Source: Supplied U.S. Code snapshot — release unconfirmed · 5 U.S.C. § 101
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