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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6424 Introduced in House (IH)]

<DOC>

118th CONGRESS
  1st Session
                                H. R. 6424

  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.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                           November 15, 2023

Mr. Fitzpatrick (for himself, Ms. Houlahan, and Ms. Salazar) introduced 
  the following bill; which was referred to the Committee on Foreign 
                                Affairs

_______________________________________________________________________

                                 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.

    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 ``Supporting Innovative Global Health 
Technologies Act of 2023'' or the ``SIGHT Act''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) The United States Agency for International Development 
        has 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, 
        having both an advantage and unique mandate for development of 
        health technologies for use 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 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, tuberculosis, 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 to 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, the United States Agency for 
        International Development 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, the 
        United States Agency for International Development is the only 
        Federal agency that provides broad support for the late-stage 
        development of new health technologies to combat neglected 
        tropical diseases and emerging infectious diseases and other 
        health conditions for low-resource settings specifically.
            (12) While the need for new tools to tackle disease threats 
        has grown, in recent years, investments by the United States 
        Agency for International Development in research and 
        development have shrunk as a proportion of its overall global 
        health spending, squeezed by both stagnant budgets and growing 
        needs.
            (13) Innovation at the United States Agency for 
        International Development 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) The United States Agency for International Development 
        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.

SEC. 3. STATEMENT OF POLICY.

    It is the policy of the United States that--
            (1) research and development for new health technologies is 
        essential for the success of the global health programs of the 
        United States Government, by providing 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 existing and ongoing 
        global health research and development of the United States 
        Government or activities relating to the implementation of the 
        global health programs of the United States Government.

SEC. 4. CHIEF INNOVATION OFFICER FOR HEALTH.

    (a) Establishment.--There is established within the Bureau for 
Global Health of the Agency the position of Chief Innovation Officer 
for Health. Such position is 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 relevant experience within private sector 
industry and an expert understanding of health finance and of 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 Assistant 
        Administrator for Global Health on 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 Assistant Administrator for 
        Global Health.
    (d) Duties.--The Chief Innovation Officer for Health shall be 
responsible for the following:
            (1) Ensuring cross-sector, Agency-wide cooperation, 
        support, and programming for global health research and 
        development, for the purpose of increasing the effectiveness of 
        international development programs of the Agency and supporting 
        the foreign policy and development goals of the United States 
        Government.
            (2) Drawing on the expertise of other departments and 
        agencies of the United States Government 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 to improve global health and 
        programs of the Agency relating to global health.
            (3) Leveraging research and investments by other elements 
        of the Agency, other departments and agencies of the United 
        States Government, 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 of Health.
            (4) Administering the processes for the award of grants, 
        entry into partnerships, and joint establishment of other 
        arrangements, to support global health research and development 
        (including by administering the grant program under section 7).
            (5) Serving as the Chairperson of the Global Health 
        Research and Development Advisory Council established under 
        section 5.
    (e) Authorities.--The 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 under subsection (d).

SEC. 5. GLOBAL HEALTH RESEARCH AND DEVELOPMENT ADVISORY COUNCIL.

    (a) Establishment.--The Administrator shall establish an advisory 
council to be known as the ``Global Health Research and Development 
Advisory Council'' (in this section referred to as the ``Council'').
    (b) Membership.--The Council shall be composed of the following:
            (1) The Chief Innovation Officer for Health of the Agency 
        under section 4, who shall serve as the Chairperson of the 
        Council (in this section referred to as the ``Chairperson'').
            (2) Not more than 8 other members appointed by the 
        Administrator from among individuals--
                    (A) recommended for such appointment by the 
                Chairperson; and
                    (B) who are scientists or other experts with 
                experience in global health research and development 
                through or on behalf of--
                            (i) the Agency;
                            (ii) any other department or agency of the 
                        United States Government;
                            (iii) affected communities in low- or 
                        middle-income countries; and
                            (iv) nongovernmental organizations, 
                        including nonprofit organizations, businesses, 
                        and institutes of higher education.
    (c) Terms.--
            (1) In general.--Each member other than the Chairperson 
        shall be appointed for a term of 6 years.
            (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 that 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 
Chairperson.
    (f) Duties.--The Council shall be responsible for advising the 
Administrator regarding the priorities and objectives for the Agency 
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 Chairperson may direct.
    (g) Nonapplicability of Federal Advisory Committee Act.--Chapter 10 
of title 5, United States Code, shall not apply to the Council.

SEC. 6. 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 the global health programs of the Agency, 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.--The Administrator shall--
            (1) not later than 90 days after the date of the enactment 
        of this Act, establish a single, separate budget line for the 
        activities under subsection (a), under which funds authorized 
        to be appropriated or otherwise made available to the 
        Administrator for the purpose of carrying 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 any fiscal year beginning on or after the 
        date of such establishment.

SEC. 7. GRANT PROGRAM FOR EXPANDED USE OF GLOBAL HEALTH RESEARCH AND 
              DEVELOPMENT.

    (a) Grant Program.--The Administrator, acting through the Chief 
Innovation Officer for Health under section 4, shall carry out a grant 
program under which the Administrator may award grants on a competitive 
basis to nongovernmental organizations that are determined eligible by 
the Administrator.
    (b) Use of Amounts.--Grant amounts awarded under this section may 
only be used for the following purposes:
            (1) Developing new health technologies designed for use in 
        low-resource settings to improve global health.
            (2) Evaluating and improving the implementation, 
        production, and scale-up of health technologies in low-resource 
        settings in partner countries.
            (3) Investing 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) the 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 such award, to 
        report to the Administrator regarding the use of such grant 
        amounts on a basis that is not less frequent than annually for 
        the duration of the grant period; and
            (3) the Administrator certifies to the appropriate 
        congressional committees that such award is in compliance with 
        section 3(2) of this Act.
    (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.).

SEC. 8. STRATEGY AND REPORTS.

    (a) Report on Progress.--Not later than 180 days after the date of 
the enactment of this Act, and prior to the submission of the budget 
justification materials in support of the budget of the President for 
the first fiscal year following the date of the enactment of this Act, 
the Administrator shall submit to the appropriate congressional 
committees, and publish on a publicly available website of the Agency, 
a report that contains the following:
            (1) A detailed description of the status of the Global 
        Health Research and Development Advisory Council under section 
        5.
            (2) Recommendations by such Global Health Research and 
        Development Advisory Council.
            (3) Solicitations for grant awards under section 7.
            (4) Comprehensive accounting of awards and objectives to be 
        included within the annual report to Congress on the health-
        related research and development strategy of the Agency 
        required pursuant to the Department of State, Foreign 
        Operations, and Related Programs Appropriations Act (or the 
        report accompanying such appropriations bill reported by the 
        Committees on Appropriations of the House or Representatives or 
        Senate) for the respective fiscal year.
            (5) A detailed description of how the planned investments 
        by the Agency in the activities under section 6(a) align with 
        the multiyear strategy of the Agency 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).
            (6) A detailed description of how investments made by the 
        Agency in such activities advance the other health-related 
        programming goals of the Agency.
    (b) Annual Reports.--Not later than 1 year after the date of the 
enactment of this Act, and annually thereafter for the next 5 years as 
part of the annual report specified in subsection (a)(4), the 
Administrator shall submit to the appropriate congressional committees, 
and publish on a publicly available website of the Agency, a report 
that contains, with respect to the year covered by the report, the 
following:
            (1) Information on any grants awarded, or other assistance 
        provided, by the Administrator during such year pursuant to an 
        authority under this Act or any other relevant provision of law 
        for the support of global health research and development in 
        support of programs of the Agency.
            (2) The primary, secondary, and tertiary purposes of--
                    (A) any such grants awarded; and
                    (B) any investments in the activities under section 
                6(a) made or proposed by the Administrator during such 
                year.
            (3) A summary of how affected communities and researchers 
        based in partner countries have been consulted with respect to 
        any such investments.
            (4) A description of the outcomes and status of the 
        activities under section 6(a) carried out or otherwise 
        supported by the Administrator during such year.
            (5) An identification of any amounts obligated or expended 
        during such year by the Administrator, from any appropriations 
        account, to support global health research and development. 
        Such information shall be presented both as a summary and in a 
        table delineated by--
                    (A) health area;
                    (B) type of research or development activity; and
                    (C) appropriations account.
            (6) A description of relevant objectives and expected 
        outcomes for the subsequent year.

SEC. 9. DEFINITIONS.

    In this Act:
            (1) Administrator.--The term ``Administrator'' means the 
        Administrator for the United States Agency for International 
        Development.
            (2) Agency.--The term ``Agency'' means the United States 
        Agency for International Development.
            (3) Appropriate congressional committees.--The term 
        ``appropriate congressional committees'' means--
                    (A) the Committee on Foreign Affairs of the House 
                of Representatives; and
                    (B) the Committee on Foreign Relations of the 
                Senate.
            (4) 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.
            (5) 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.
            (6) 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.
            (7) 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.
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