Sec. 501. Advanced Research Projects Agency for Health

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The Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall establish the Advanced Research Projects Agency for Health (to be referred to in this Act as ARPA–H ) to transform and improve important areas of medicine and health for the well-being of all individuals in the United States. The goals of ARPA–H shall be to deliver breakthrough capabilities through technologies, systems, and platforms that— accelerate the discovery and application of transformational innovations in health and medical product development; and reduce the human and economic cost of disease.

ARPA–H may achieve the established goals under paragraph (1), including by any of the following means: Promoting high-risk, high-reward innovation. Identifying and promoting revolutionary advances in biomedical and health research that enable new paradigms in health. Accelerating transformational health advances in areas that the relevant industries by themselves are not likely to undertake because of technical, financial, or other uncertainty. Prioritizing project investments based on scientific opportunity and uniqueness of fit to ARPA–H strategies and operating practice, together with the prospective impact on disease burden (regardless of disease prevalence), both human and fiscal, including the health care fiscal liability of the Federal government.

Partnering with, and providing funding to, a broad range of institutions, including universities, national laboratories, public sector organizations, private companies, nonprofit organizations, and foreign institutions. ARPA–H shall be headed by a Director, who shall be appointed by and serve at the pleasure of the President (referred to in this section as the Director of ARPA–H ). The Director of ARPA–H shall— be an individual who, by reason of professional background and experience, is qualified to advise the Secretary on, and manage research programs addressing, matters pertaining to long-term and high-risk barriers to the development of health innovation; have authority to execute contracts developed by in-house program managers who select external performers, and maintain, enhance or terminate projects based on performance against explicit milestones; and have a time-limited appointment of 5 years with the opportunity, at the discretion of the President, of one extension.

The duties of the Director of ARPA–H shall be to— set national research priorities to advance the mission of the agency as informed by a multi-sectoral board of advisors; approve all new programs within ARPA–H; have final funding authority to initiate and terminate program funding; establish criteria for funding and assessing the success of programs through the establishment of technical milestones; appoint the personnel necessary, consistent with subsection (d), to successfully execute the goals of ARPA–H; and designate employees to serve as program managers to carry out the duties described in subsection

(e)for each of the programs established pursuant to the responsibilities established for ARPA–H. The Director of ARPA–H is authorized to— 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 lease an interest in property for not more than 20 years, notwithstanding section 1341(a)(1) of title 31, United States Code. The Director of ARPA–H may— make appointments to positions of administration or management of ARPA–H without regard to any provision in title 5, United States Code, governing appointments under the civil service laws and fix the compensation of such positions at a rate not to exceed the amount of annual compensation (excluding expenses) specified in section 102 of title 3, United States Code, notwithstanding section 202 of Department of Health and Human Services Appropriations Act, 1993 ( Public Law 102–394 ); hire personnel under section 207(f) of the Public Health Service Act ( 42 U.S.C. 209(f) ) and establish governing criteria to recruit, appoint, and compensate personnel under this section notwithstanding section 202 of Department of Health and Human Services Appropriations Act, 1993 ( Public Law 102–394 ) or any provision of title 5, United States Code, governing the rates of pay or classification of employees in the Executive branch; make additional appointments of scientific, medical, and professional personnel under this section without regard to any provision in title 5, United States Code, governing appointments under the civil service laws and 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, notwithstanding section 202 of Department of Health and Human Services Appropriations Act, 1993 ( Public Law 102–394 ) or any provision of title 5, United States Code, governing the rates of pay or classification of employees in the Executive branch; and recruit and retain a diverse workforce, including individuals underrepresented in science and medicine and racial and ethnic minorities. The Director of ARPA–H may use all authorities in existence on the date of enactment of this Act that are provided to the Secretary to hire administrative, financial, information technology staff, and any other staff the Director of ARPA–H determines are necessary to carry out this section. Except as provided in subparagraph (B), the service of an employee under an appointment under paragraph (1)(A) in the position of a program manager may not exceed 3 years. The Director of ARPA–H may, in the case of a particular employee, extend the period to which service is limited under subparagraph

(A)by up to 3 years if the Director determines that such action is necessary to promote the efficiency of ARPA–H. The total amount of the additional payments paid to an employee under paragraph (1)(C) for any 12-month period may not exceed the least of the following amounts: $25,000. The amount equal to 25 percent of the employee's annual rate of basic pay. The amount of the limitation that is applicable for a calendar year under section 5307(a)(1) of title 5, United States Code. An employee designated as a program manager pursuant to subsection (c)(3)(F) shall— define the research and development goals and milestones of the program involved, in line with guidance from the Director; track progress and course-correct projects when needed; recommend, as necessary, the restructuring or termination of projects supported by ARPA–H; and select, on the basis of merit and need, each of the projects to be supported under the program involved after considering— the novelty and scientific and technical merit of the proposed projects; the demonstrated capabilities of the applicants to successfully carry out the proposed project; the consideration by the applicant of future commercial applications of the project; or the unmet need within patient populations. Not later than 180 days after the date of the enactment of this Act, the Director of ARPA–H shall provide to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate a report describing the strategic vision that ARPA–H will use to guide the choices of ARPA–H for future health investments over the following 3 fiscal years beginning on or after the date of the enactment of this Act. As part of the annual budget request submitted for each fiscal year, the Director of ARPA–H shall provide to the congressional committees specified in paragraph

(1)a report describing— projects supported by ARPA–H during the previous fiscal year, including— the transition of projects’ outcomes to clinical practice; the impact on clinical outcome; and the creation of biomedical capabilities; and successes and barriers to scientific interchanges; rapid knowledge transfer; resource optimization; and heightened investment impact among collaborators. Not later than 90 days after the end of each fiscal year, the Director of ARPA–H shall submit to the congressional committees specified in paragraph

(1)a report on all cooperative agreements and other transactions (other than contracts and grants) entered into under this subsection during such fiscal year. The report shall contain, with respect to such cooperative agreement and transaction, the following: A general description of the cooperative agreement or other transaction (as the case may be), including the innovations for which advanced research is provided for under such agreement or transaction. The potential clinical and, if any, commercial utility of such innovations. The reasons for not using a contract or grant to provide support for such advanced research. The amount of the payments, if any, referred to in subsection (i)(2) that were received by the Federal Government in connection with such cooperative agreement or other transaction during the fiscal year covered by the report. The amount of the payments reported under subparagraph (D), if any, that were credited to the account established under subsection (i)(7). The Director of ARPA–H shall ensure effective, early, and frequent coordination between ARPA–H and the heads of the research, public health, and regulatory agencies of the Department of Health and Human Services, including— the Director of the National Institutes of Health; the Commissioner of Food and Drugs; the Administrator of the Centers for Medicare & Medicaid Services; the Director of the Centers for Disease Control and Prevention; and the Assistant Secretary for Preparedness and Response. The Director of the National Science Foundation. The Director of the Office of Science of the Department of Energy. The Director shall also coordinate among the full set of advanced research project agencies including— the Defense Advanced Research Project Agency; the Advanced Research Project Agency-Energy; and others as they may be established. The Director of ARPA–H may seek advice on any aspect of ARPA–H from— any advisory committee that, as of the date of the enactment of this Act, is providing advice to the Secretary of Health and Human Services (or any head of a research, public health, or regulatory agency of the Department of Health and Human Services); and an advisory committee established on or after such date of the enactment to support the programs of ARPA–H and to provide advice and assistance on— specific program tasks; or overall direction of ARPA–H. In addition to the advisory committees specified in paragraph (1), the Director of ARPA–H may seek advice and review from— the President’s Committee of Advisors on Science and Technology; any professional or scientific organization with expertise in specific processes or technologies under development by ARPA–H; and representatives of patient communities. The Director of ARPA–H, in carrying out advanced research projects through ARPA–H, may enter into grants, contracts, cooperative agreements, cash prizes, and other transactions (as defined in section 319L(a) of the Public Health Service Act (42 U.S.C. 247d–7e(a))) with any person, any agency or instrumentality of the United States, any unit of State or local government, and any other entity institutions, including universities, national laboratories, public sector organizations, private companies, nonprofit organizations, and foreign institutions. The Director of ARPA–H shall ensure that, in entering into cooperative agreements and other transactions under paragraph (1)— to the extent the Director of ARPA–H determines practicable, the Federal funds provided under the cooperative agreement or other transaction do not exceed the total amount provided by other parties to the cooperative agreement or other transaction; and the authority under paragraph

(1)is used only when the use of standard contracts or grants is not feasible or appropriate. Cooperative agreements and other transactions entered into by the Director of ARPA–H under paragraph

(1)may include a clause that requires a person or other entity to make payments to ARPA–H (or any other department or agency of the Federal Government) as a condition for receiving support under the agreement or other transaction. The Director of ARPA–H shall ensure that to the maximum extent practicable, a cooperative agreement or other transaction under this section does not provide for research that duplicates research being conducted under existing programs carried out by the Department of Health and Human Services, the Department of Defense, or other Federal Government entities. The amount of any payment received by the Federal Government pursuant to a requirement imposed under paragraph

(1)may be credited, to the extent authorized by the Director of ARPA–H, to the account established under paragraph (7). Amounts so credited shall be merged with other funds in the account and shall be available for the same purposes and the same period for which other funds in such account are available. The Director of ARPA–H may enter into a multi-year contract if— 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; the Director determines that a multiyear contract will serve the best interests of the Federal Government in carrying out this section; and the contract includes a provision 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. A provision referred to in subparagraph (A)(iii) shall provide that funds available for paying termination costs shall remain available for that purpose until the costs associated with termination of the contract are paid. The authority provided under paragraph

(1)may be exercised without regard to section 3324 of title 31, United States Code. There is hereby established on the books of the Treasury an account for support of advanced research projects provided for in cooperative agreements and other transactions entered into under paragraph (1). Funds in such account shall be available for the payment of such support. The Director of ARPA–H may carry out prize competitions in accordance with section 24 of the Stevenson-Wydler Technology Innovation Act of 1980 ( 15 U.S.C. 3719 )) in support of the goals specified in subsection (b). Research funded pursuant to this section shall not be subject to— advisory council approval under section 405(b)(2) of the Public Health Service Act ( 42 U.S.C. 284(b)(2) ); advisory council review under section 406(a)(3)(A)(ii) of such Act ( 42 U.S.C. 284a(a)(3)(A)(ii) ); or the peer review requirements under section 492 of such Act ( 42 U.S.C. 284(b)(2) , 289a). The information specified in paragraph

(2)shall be exempt from disclosure under section 552 of title 5, United States Code (commonly referred to as the Freedom of Information Act). The information specified in this paragraph is information collected by ARPA–H from recipients of financial assistance awards, including the following: Plans for commercialization of technologies developed under the award, including business plans, technology-to-market plans, market studies, and cost and performance models. Investments provided to an awardee from third parties (such as venture capital firms, hedge funds, and private equity firms), including the amounts and the percentage of ownership of the awardee provided in return for the investments. The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs and in consultation with the Director of ARPA–H, may take actions to facilitate transformation of biomedical breakthroughs into tangible solutions for patients and to expedite development of medical products, including through any of the following means: Helping to ensure that medical product development programs, in as efficient a manner as possible, gather the nonclinical and clinical data necessary to advancing the development of such products and to obtaining their approval, licensure, or clearance, as applicable, by the Food and Drug Administration under sections 505, 510(k), and 515 of such Act ( 21 U.S.C. 355 , 360(k), 360) and section 351 of the Public Health Service Act ( 42 U.S.C. 262 ). Expediting review of investigational new drug applications under section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ), review of investigational device exemptions under section 520(g) of such Act ( 21 U.S.C. 360j(g) ), and review of applications for approval, licensure, and clearance of medical products under sections 505, 510(k), and 515 of such Act ( 21 U.S.C. 355 , 360(k), 360) and section 351 of the Public Health Service Act ( 42 U.S.C. 262 ). Meeting at appropriate intervals with the Director of ARPA–H and any other appropriate medical product development partners, such as the Director of the Biomedical Advanced Research and Development Authority to discuss the development status of medical products and projects that are the highest priorities to ARPA–H, unless the Director of ARPA–H and the Commissioner of Food and Drugs determine that any such meetings are not necessary. The authority specified in paragraph

(1)shall not be construed as limiting the authority of the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs with respect to the review and approval, clearance, authorization for emergency use, or licensure of a medical product under the Federal Food, Drug and Cosmetic Act ( 21 U.S.C. 321 et seq. ) or section 351 of the Public Health Service Act ( 42 U.S.C. 262 ). Utilizing interagency agreements or other appropriate resource allocation mechanisms available, the Director of ARPA–H, using funds made available to ARPA–H, shall reimburse the Food and Drug Administration for expenditures made by the Food and Drug Administration for activities carried out under this section that have been identified by the Commissioner of Food and Drugs and the Director of ARPA–H as being carried out by the Food and Drug Administration. In this section, the term medical product means a drug (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 )), a device (as defined in such section 201), or a biological product (as defined in section 351 of the Public Health Service Act ( 42 U.S.C. 262 )). There is authorized to be appropriated to carry out this section $6,500,000,000 for fiscal year 2022, to remain available until expended. The budget of ARPA–H shall be a separate line item in the annual budget request submitted by the President to the Congress. ARPA–H shall have the authority to submit its annual budget request directly to Congress concurrently with its submission to the Office of Management and Budget.

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