II 118th CONGRESS 2d Session S. 5278 IN THE SENATE OF THE UNITED STATES September 25, 2024 Mr. Booker introduced the following bill; which was read twice and referred to the Committee on Foreign Relations A BILL To provide additional authorities for the leadership of the United States Agency for International Development in health technology innovation for global health in low-resource settings, and for other purposes.

1. Short titles; table of contents (a) Short titles This Act may be cited as the Supporting Innovative Global Health Technologies Act of 2024 or the SIGHT Act . (b) Table of contents The table of contents for this Act is as follows: Sec. 1. Short titles; table of contents. Sec. 2. Findings. Sec. 3. Statement of policy. Sec. 4. Definitions. Sec. 5. Chief Innovation Officer for Health. Sec. 6. Global Health Research and Development Advisory Council. Sec. 7. Global Health Research and Development program area activities and budget. Sec. 8. Grant program for expanded use of global health research and development. Sec. 9. Strategy and reports. 2. Findings Congress finds the following: (1) The United States Agency for International Development has— (A) a unique role in the research and development of health technologies for global health that complements the work of other departments and agencies of the United States Government; and (B) both an advantage and a unique mandate for the development of health technologies to be used in low-resource settings. (2) It is in the national interest of the United States to build greater country capacity for research and development of new health technologies to be used in low- and middle-income countries. (3) Investments by the United States Government in global health research and development should be coordinated with, and leverage investments from, partner country governments, other government donors, and the private sector. (4) Human immunodeficiency virus (HIV), tuberculosis (TB), malaria, neglected tropical diseases, emerging infectious diseases (such as COVID–19, Ebola, and Zika), and many other health conditions (such as complications in pregnancy) have a disproportionate public health burden in low- and middle-income countries. (5) Health technologies that were developed for use in high-income countries often cannot be implemented in low-resource settings in low- and middle-income countries or require adaptation to be effective. (6) Due to poverty or low incidence, many neglected tropical diseases and emerging infectious diseases either lack or have limited commercial markets to drive health technology innovation. (7) Achieving the ambitious goals set through initiatives such as the President's Emergency Plan for AIDS Relief (commonly referred to as PEPFAR) and the President’s Malaria Initiative (commonly referred to as PMI ) will not be possible without the development and scale-up of new health technologies designed for use in low-resource settings, which are needed to address both long-standing endemic diseases and prepare for potential pandemic threats. (8) Public funding has proven highly successful at incentivizing the development of health technologies for global health that are high-impact, accessible, and cost-saving. (9) COVID–19 has demonstrated the importance of global access to health technologies designed for low-resource settings. (10) Support for the development of accessible health technologies for low-resource settings can have reciprocal value and produce tools that reduce health care costs, improve public health, and strengthen health security for the United States. (11) For decades, USAID has been a catalyst in the global health innovation ecosystem. While other Federal departments and agencies, including the National Institutes of Health, the Centers for Disease Control and Prevention, and the Department of Defense, provide support for global health technologies, USAID is the only Federal agency that provides broad support for the late-stage development of new health technologies to combat neglected tropical diseases, emerging infectious diseases, and other health conditions for low-resource settings. (12) While the need for new tools to tackle disease threats has grown in recent years, investments by USAID in research and development have shrunk as a proportion of its overall global health spending and have been squeezed by stagnant budgets and growing needs. (13) Innovation at USAID is primarily supported from siloed disease- and population-specific appropriations accounts, resulting in the limitation of its ability to seek shared value across health sectors or health threats. (14) USAID is compelled to prioritize support for immediate program needs with imperfect tools at the expense of support for technologies that can improve clinical effectiveness, increase access to care, save costs, and build capacity and ownership by partner countries. 3. Statement of policy It is the policy of the United States that— (1) research and development for new health technologies— (A) is essential for the success of the global health programs of the United States Government; and (B) provides for the improved effectiveness, cost-effectiveness, and sustainability of such programs; and (2) funding and other support for global health research and development under this Act shall be additional and complementary to, and may not replace, displace, or otherwise compromise, funding otherwise provided for— (A) existing and ongoing global health research and development of the United States Government; or (B) activities relating to the implementation of the global health programs of the United States Government. 4. Definitions In this Act: (1) Administrator The term Administrator means the Administrator of the United States Agency for International Development. (2) Appropriate congressional committees The term appropriate congressional committees means— (A) the Committee on Foreign Relations of the Senate ; and (B) the Committee on Foreign Affairs of the House of Representatives . (3) Global health The term global health includes efforts to combat and prepare for— (A) neglected tropical diseases; (B) emerging infectious diseases; (C) antimicrobial resistance; and (D) any other condition that may not be easily treated, diagnosed, or prevented in low-resource settings. (4) Global health research and development The term global health research and development includes an activity, or the support for such an activity, related to research, development, testing, evaluation, deployment, or implementation of any new health technology. (5) Health technology The term health technology — (A) means a vaccine, therapeutic, diagnostic, device, or other tool designed, modified, or adapted for use in low-resource settings to improve global health; and (B) includes personal protective equipment and insecticide so used. (6) Low-resource setting The term low-resource setting means a location with limited or inconsistent access to running water, electricity, refrigeration, supply chains, lab services, medical equipment, trained health care personnel, or other resources important for global health. (7) USAID The term USAID means the United States Agency for International Development. 5. Chief Innovation Officer for Health (a) Establishment There is established, within the USAID Bureau for Global Health, the position of Chief Innovation Officer for Health, which shall be classified at the level of Deputy Assistant Administrator or equivalent. (b) Appointment The Administrator shall appoint the Chief Innovation Officer for Health from among such individuals as the Administrator determines have— (1) relevant experience within private sector industry; and (2) an expert understanding of health finance and the research, development, testing, evaluation, deployment, and implementation of new health technology. (c) Relationship to Assistant Administrator for Global Health The Chief Innovation Officer for Health shall— (1) serve as the principal advisor to the USAID Assistant Administrator for Global Health regarding global health research and development necessary to meet the requirements of the United States Government and the governments of partner countries for improving global health; and (2) report directly to the USAID Assistant Administrator for Global Health. (d) Duties The Chief Innovation Officer for Health shall— (1) ensure cross-sector, USAID-wide cooperation, support, and programming for global health research and development— (A) to increase the effectiveness of USAID international development programs; and (B) to support the foreign policy and development goals of the United States Government; (2) draw on the expertise of other Federal departments and agencies and of nongovernmental organizations (including affected communities and institutions in low- or middle-income countries, businesses, health and science research organizations, and institutions of higher education) that pursue global health-related research and development to identify the most pressing requirements for the development of health technologies that will improve global health and USAID programs relating to global health; (3) leverage research and investments by other USAID components, other Federal departments and agencies, and nongovernmental organizations (including businesses, health and science research organizations, institutions of higher education, and governments or other institutions of partner countries) to support the research and development of new health technologies by the Chief Innovation Officer for Health; (4) administer the processes for awarding grants, entering into partnerships, and jointly establishing other arrangements to support global health research and development (including by administering the grant program required under section 8); and (5) serve as the Chairperson of the Global Health Research and Development Advisory Council established pursuant to section 6. (e) Authorities The USAID Assistant Administrator for Global Health shall take such steps as may be necessary to ensure that the Chief Innovation Officer for Health has sufficient authority within the Bureau for Global Health to carry out the duties described in subsection (d). 6. Global Health Research and Development Advisory Council (a) Establishment The Administrator shall establish an advisory council, which shall be known as the Global Health Research and Development Advisory Council (referred to in this section as the Council ). (b) Membership The Council shall be composed of— (1) the USAID Chief Innovation Officer for Health, who shall serve as the Chair of the Council (referred to in this section as the Chair ); (2) not more than 8 additional members, who shall be appointed by the Administrator from among individuals who— (A) have been recommended for such appointment by the Chair; and (B) are scientists or other experts with experience in global health research and development through or on behalf of— (i) USAID; (ii) any other Federal department or agency; (iii) affected communities in low- or middle-income countries; or (iv) nongovernmental organizations, including nonprofit organizations, businesses, and institutes of higher education. (c) Terms (1) In general Each member of the Council other than the Chair shall be appointed for a 6-year term. (2) Vacancies Any member appointed to fill a vacancy occurring before the expiration of the term for which the predecessor of the member was appointed shall be appointed only for the remainder of such term. A vacancy in the Council shall be filled in the manner in which the original appointment was made. (d) Compensation (1) Prohibition of compensation of Federal employees Except as provided in paragraph (2), members of the Council who are full-time officers or employees of the United States may not receive additional pay, allowances, or benefits by reason of their service on the Council. (2) Travel expenses Each member of the Council shall receive travel expenses, including per diem in lieu of subsistence, in accordance with applicable provisions under subchapter I of chapter 57 of title 5, United States Code. (e) Meetings The Council shall meet at the call of the Chair. (f) Duties The Council shall be responsible for advising the Administrator regarding USAID priorities and objectives with respect to global health research and development, including by providing such advice on an individual member basis or as a collective Council, as the Chair may direct. (g) Nonapplicability of Federal Advisory Committee Act Chapter 10 of title 5, United States Code (commonly referred to as the Federal Advisory Committee Act ), shall not apply to the Council. 7. Global Health Research and Development program area activities and budget (a) In general The Administrator shall carry out global health research and development activities with respect to new health technologies with the potential to advance the effectiveness and sustainability of USAID global health programs, including the potential to advance— (1) health technologies with characteristics identified or otherwise prioritized by affected communities and partner countries; (2) health technologies with characteristics that facilitate introduction and access of the respective technology to ensure use by those in need; and (3) support for capacity-building within partner countries and the transition by such countries to greater country-level ownership, responsibility, and decision-making with respect to global health. (b) Budget Not later than 90 days after the date of the enactment of this Act, the Administrator shall— (1) establish a single, separate budget line for the activities described in subsection (a), under which funds made available to the Administrator to carry out such activities shall be categorized; and (2) include information regarding amounts expended and requested to be expended under such budget line in the budget justification materials submitted in support of the budget of the President for each fiscal year beginning on or after the date on which such budget line is established. 8. Grant program for expanded use of global health research and development (a) Grant program The Administrator, acting through the Chief Innovation Officer for Health appointed pursuant to section 5, shall carry out a grant program under which the Administrator may award competitive grants to nongovernmental organizations that the Administrator determines to be eligible. (b) Use of amounts Grant amounts awarded pursuant to this section may only be used— (1) to develop new health technologies designed for use in low-resource settings to improve global health; (2) to evaluate and improve the implementation, production, and scale-up of health technologies in low-resource settings in partner countries; and (3) to invest in the research capacity of institutions in low- and middle-income partner countries to lead and contribute to the development of health technologies. (c) Conditions on grant award The Administrator may not award a grant to an entity under this section unless— (1) such entity submits to the Administrator a proposal demonstrating sufficient technical standards, as determined by the Administrator, for any of the purposes listed in paragraphs (1) through (3) of subsection (b) for which the entity intends to use such grant amounts; (2) the entity agrees, as a condition of receiving such grant, to report not less frequently than annually to the Administrator regarding the use of such grant amounts during the grant period; and (3) the Administrator certifies to the appropriate congressional committees that such award is in compliance with section 3(2). (d) Additional nature of authority The authority to award grants under this section is in addition to, and not in lieu of, any other authority of the Administrator, including any such authority under part I or II of the Foreign Assistance Act of 1961 ( 22 U.S.C. 2151 et seq. ). 9. Strategy and reports (a) Report on progress Not later than 180 days after the date of the enactment of this Act, and before submitting the budget justification materials in support of the budget of the President for the first fiscal year beginning after the date of the enactment of this Act, the Administrator shall submit to the appropriate congressional committees, and publish on a publicly available USAID website, a report containing— (1) a detailed description of the status of the Global Health Research and Development Advisory Council established pursuant to section 6; (2) recommendations by the Global Health Research and Development Advisory Council; (3) solicitations for grant awards authorized under section 8; (4) a comprehensive accounting of awards and objectives to be included within the annual report to Congress on the USAID health-related research and development strategy required under the Department of State, Foreign Operations, and Related Programs Appropriations Act for the relevant fiscal year (or by a report accompanying such Act from the Committee on Appropriations of the Senate or the Committee on Appropriations of the House of Representatives ); (5) a detailed description of how planned investments by USAID in the activities described in section 7(a) align with USAID's multiyear strategy titled Global Health Research and Development Strategy 2023–2028 and developed pursuant to section 7019(e) of division K of the Consolidated Appropriations Act, 2022 ( Public Law 117–103 ); and (6) a detailed description of how investments made by USAID in such activities advance the other USAID health-related programming goals. (b) Annual reports Not later than 1 year after the date of the enactment of this Act, and annually thereafter for the following 5 years as part of the annual report referred to in subsection (a)(4), the Administrator shall submit to the appropriate congressional committees, and publish on a publicly available USAID website, a report containing, with respect to the fiscal year covered by the report— (1) information on any grants awarded, or other assistance provided, by the Administrator during such year pursuant to this Act or any other relevant provision of law for the support of global health research and development in support of USAID programs; (2) the primary, secondary, and tertiary purposes of— (A) any such grants awarded; and (B) any investments in the activities described in section 7(a) made or proposed by the Administrator during such year; (3) a summary of the consultations with communities and researchers based in partner countries regarding any such investments; (4) a description of the outcomes and status of the activities described in section 7(a) that were carried out or otherwise supported by the Administrator during such fiscal year; (5) the identification of any amounts obligated or expended during such year by the Administrator from any appropriations account to support global health research and development, presented both as a summary and in a table that is disaggregated by health area, type of research or development activity, and appropriations account; and (6) a description of relevant objectives and expected outcomes for the subsequent fiscal year.