[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]


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  Federal Register / Vol. 89, No. 56 / Thursday, March 21, 2024 / 
Presidential Documents  

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                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 1993 (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.

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                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.

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                    (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;

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(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