No official summary available for this bill.
[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.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Foreign Affairs.
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