Advancing Women's Health Research and Innovation
| Published date | 21 March 2024 |
| Record Number | 2024-06123 |
| Citation | 89 FR 20095 |
| Court | Executive Office Of The President |
| Section | Presidential Documents |
Federal Register, Volume 89 Issue 56 (Thursday, March 21, 2024)
[Federal Register Volume 89, Number 56 (Thursday, March 21, 2024)]
[Presidential Documents]
[Pages 20095-20099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06123] Presidential Documents
Federal Register / Vol. 89, No. 56 / Thursday, March 21, 2024 /
Presidential Documents
[[Page 20095]]
Executive Order 14120 of March 18, 2024
Advancing Women's Health Research and Innovation
By the authority vested in me as President by the
Constitution and the laws of the United States of
America, it is hereby ordered as follows:
Section 1. Policy. My Administration is committed to
getting women the answers they need about their health.
For far too long, scientific and biomedical research
excluded women and undervalued the study of women's
health. The resulting research gaps mean that we know
far too little about women's health across women's
lifespans, and those gaps are even more prominent for
women of color, older women, and women with
disabilities.
The notion of including women in clinical trials used
to be revolutionary--which means many diagnostics and
treatments were developed without women in mind and
thus failed to account for women's health. Over 30
years ago, the Congress passed the landmark National
Institutes of Health Revitalization Act of 11993 (Public
Law 103-43) to direct the National Institutes of Health
(NIH), the largest public funder of biomedical research
in the world, to include women and people of color in
NIH-funded clinical research. In 2016, the Congress
built on these requirements in the 21st Century Cures
Act (Public Law 114-255), which directed the NIH to
further its pursuit of women's health research,
including by strengthening clinical trial inclusion and
data analysis, developing research and data standards
to advance the study of women's health, and improving
NIH-wide coordination on women's health research.
These policies led to significant increases in women's
participation in clinical trials, and ongoing
investments in biomedical research have supported
breakthroughs in women's health. Through the discovery
of genetic factors that increase the risk of breast
cancer and innovations in mammography, we have
transformed our approach to prevention, early
detection, and treatment, and have improved outcomes
for women facing a breast cancer diagnosis. We have
improved access to life-saving treatments for women
with severe heart failure by ensuring that the devices
they need are the right size for a woman's body. We
have also identified some of the most characteristic
symptoms of heart attack in women, which are different
from those in men--discoveries that have helped deliver
faster treatment to women when every second counts.
This is what we can achieve when we invest in women's
health research.
It is time, once again, to pioneer the next generation
of discoveries in women's health. My Administration
seeks to fundamentally change how we approach and fund
women's health research in the United States. That is
why I established the first-ever White House Initiative
on Women's Health Research (Initiative)--which is
within the Office of the First Lady and includes a wide
array of executive departments and agencies (agencies)
and White House offices--to accelerate research that
will provide the tools we need to prevent, diagnose,
and treat conditions that affect women uniquely,
disproportionately, or differently.
Together with the First Lady's tireless efforts, the
Initiative is already galvanizing the Federal
Government to advance women's health, including through
investments in innovation and improved coordination
within and across agencies. We are also mobilizing
leaders across a wide range of sectors, including
industry, philanthropy, and the medical and research
communities, to improve women's health.
[[Page 20096]]
It is the policy of my Administration to advance
women's health research, close health disparities, and
ensure that the gains we make in research laboratories
are translated into real-world clinical benefits for
women. It is also the policy of my Administration to
ensure that women have access to high-quality,
evidence-based health care and to improve health
outcomes for women across their lifespans and
throughout the country.
I will continue to call on the Congress to provide the
transformative investments necessary to help our
researchers and scientists answer today's most pressing
questions related to women's health. Investing in
innovation in women's health is an investment in the
future of American families and the economy. At the
same time, agencies must use their existing authorities
to advance and integrate women's health across the
Federal research portfolio, close research gaps, and
make investments that maximize our ability to prevent,
diagnose, and treat health conditions in women.
Sec. 2. Definitions. For purposes of this order:
(a) The term ``women's health research'' means
research aimed at expanding knowledge of women's health
across their lifespans, which includes the study and
analysis of conditions specific to women, conditions
that disproportionately impact women, and conditions
that affect women differently.
(b) The term ``White House Initiative on Women's
Health Research'' means the interagency, advisory body
established by the Presidential Memorandum of November
13, 2023 (White House Initiative on Women's Health
Research), to advance women's health research.
(c) The term ``agency Members of the Initiative''
refers to the Secretary of Defense, the Secretary of
Agriculture, the Secretary of Health and Human
Services, the Secretary of Veterans Affairs, the
Administrator of the Environmental Protection Agency,
and the Director of the National Science Foundation.
Sec. 3. Further Integrating Women's Health Research in
Federal Research Programs. (a) Building on research and
data standards issued by the NIH in 2016, agency
Members of the Initiative shall consider actions to
develop or strengthen research and data standards that
enhance the study of women's health across all
relevant, federally funded research and other Federal
funding opportunities. Agency Members of the Initiative
shall consider issuing new guidance, application
materials, reporting requirements, and research
dissemination strategies to advance the study of
women's health, including to:
(i) require applicants for Federal research funding, as appropriate, to
explain how their proposed study designs will consider and advance our
knowledge of women's health, including through the adoption of standard
application language;
(ii) consider women's health, as appropriate, during the evaluation of
research proposals that address medical conditions that may affect women
differently or disproportionately;
(iii) improve accountability for grant recipients, including, as
appropriate, by requiring regular reporting on their implementation of, and
compliance with, research and data standards related to women's health,
including compliance with recruitment milestones; and
(iv) improve the recruitment, enrollment, and retention of women in
clinical trials, including, as appropriate, by reducing barriers through
technological and data sciences advances.
(b) Within 30 days of the date of this order, the
Chair of the Initiative and the Director of the NIH
Office of Research on Women's Health, in consultation
with the Director of the Office of Management and
Budget (OMB), shall establish and co-chair a subgroup
of the Initiative to promote interagency alignment and
consistency in the development of agency research and
data standards to enhance the study of women's health.
[[Page 20097]]
(c) Within 90 days of the date of this order,
agency Members of the Initiative shall report to the
Chair of the Initiative on actions taken to strengthen
research and data standards to enhance the study and
analysis of women's health and related conditions.
(d) Within 180 days of the date of this order and
on an annual basis thereafter, agency Members of the
Initiative shall report to the President on the status
of implementation of research and data standards.
Sec. 4. Prioritizing Federal Investments in Women's
Health Research. (a) Agency Members of the Initiative
shall identify and, as appropriate and consistent with
applicable law, prioritize grantmaking and other awards
to advance women's health research, with an emphasis
on:
(i) promoting collaborative, interdisciplinary research across fields and
areas of expertise;
(ii) addressing health disparities and inequities affecting women,
including those related to race, ethnicity, age, socioeconomic status,
disability, and exposure to environmental factors and contaminants that can
directly affect health; and
(iii) supporting the translation of research advancements into improved
health outcomes.
(b) Agency Members of the Initiative shall take
steps to promote the availability of federally funded
research and other Federal funding opportunities to
advance women's health, including through the
development and inclusion of standard language related
to women's health, as appropriate, in all relevant
notices of funding opportunity and through better
facilitating potential grant applicants' access to
information about funding opportunities related to
women's health research.
(c) To advance innovation, commercialization, and
risk mitigation, agency Members of the Initiative
shall:
(i) identify and, as appropriate and consistent with applicable law, seek
ways to use innovation funds, challenges, prizes, and other mechanisms to
spur innovation in women's health;
(ii) invest in innovation to accelerate women's health research, including
through or in collaboration with the Advanced Research Projects Agency for
Health and the Congressionally Directed Medical Research Programs;
(iii) support the role of small businesses and entrepreneurs in advancing
innovation in women's health research, including through Small Business
Innovation Research Programs and Small Business Technology Transfer
Programs; and
(iv) invest in translational science to convert research findings and
discoveries into treatments and interventions that improve women's health
outcomes and reduce health disparities, including through the Department of
Agriculture National Institute of Food and Agriculture research programs.
(d) In implementing section 8(b) of Executive Order
14110 of October 30, 2023 (Safe, Secure, and
Trustworthy Development and Use of Artificial
Intelligence), the Secretary of Health and Human
Services, in consultation with the Director of the
National Science Foundation, shall consider the
opportunities for and challenges that affect women's
health research in the responsible deployment and use
of artificial intelligence (AI) and AI-enabled
technologies in the health and human services sector.
Sec. 5. Galvanizing Research on Women's Midlife Health.
(a) Within 90 days of the date of this order, to
address research gaps in understanding women's health
and diseases and conditions associated with women's
midlife and later years, the Secretary of Health and
Human Services shall:
(i) launch a comprehensive assessment of the current state of the science
on menopause to develop an evidence-based research agenda that will guide
Federal and private sector investments in menopause-related research;
[[Page 20098]]
(ii) evaluate evidence-based interventions and strategies to improve
women's experiences in the menopausal and perimenopausal periods, including
the delivery of treatments for women experiencing menopause in clinical
care settings;
(iii) consider developing new common data elements and survey tools to
expand the ethical and equitable collection of data on issues related to
women's midlife health; and
(iv) develop new comprehensive resources to help ensure that the public has
evidence-based information about menopause, including menopause-related
research initiatives, findings, and symptom-prevention and treatment
options.
(b) The Secretary of Defense and the Secretary of
Veterans Affairs shall evaluate the needs of women
service members and veterans related to midlife health
and shall develop recommendations to support improved
treatment and targeted research of midlife health
issues, including menopausal symptoms.
Sec. 6. Assessing Unmet Needs to Support Women's Health
Research. The Director of OMB and the Assistant to the
President and Director of the Gender Policy Council
(Directors) shall lead an effort, in collaboration with
the Initiative, to identify current gaps in Federal
funding for women's health research and shall submit
recommendations to the President describing the
additional funding and programming necessary to
catalyze research on women's health, including in
priority areas within women's health as identified by
the Initiative, as follows:
(a) Within 90 days of the date of this order, the
Directors shall, in consultation with the Initiative,
develop guidance for assessing additional funding that
agencies need to close research gaps in women's health.
(b) Within 180 days of the date of this order,
Members of the Initiative shall consult the guidance
described in subsection (a) of this section and shall
each submit a report to the Directors that identifies
the funding needed to catalyze research on women's
health.
(c) Based on the reports described in subsection
(b) of this section, the Directors shall develop and
submit recommendations to the President on steps the
Federal Government should take to catalyze research on
women's health. These recommendations shall identify
any statutory, regulatory, budgetary, or other changes
that may be necessary to ensure that Federal laws,
policies, practices, and programs support women's
health research more effectively.
(d) Following the submission of the recommendations
described in subsection (c) of this section, each
Member of the Initiative shall report annually to the
Directors on progress made in response to those
recommendations and to improve the study of women's
health. The Director of OMB shall provide a summary of
Members' progress and any new recommendations to the
President on an annual basis, consult with each Member
on their women's health research funding needs during
the annual budget process, and calculate Federal
funding for women's health research on an annual basis.
Sec. 7. General Provisions. (a) Nothing in this order
shall be construed to impair or otherwise affect:
(i) the authority granted by law to an executive department or agency, or
the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget
relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with
applicable law and subject to the availability of
appropriations.
[[Page 20099]]
(c) This order is not intended to, and does not,
create any right or benefit, substantive or procedural,
enforceable at law or in equity by any party against
the United States, its departments, agencies, or
entities, its officers, employees, or agents, or any
other person.
(Presidential Sig.)
THE WHITE HOUSE,
March 18, 2024.
[FR Doc. 2024-06123
Filed 3-20-24; 8:45 am]
Billing code 3395-F4-P
