Pub. L. 114–255, div. B, title XIII, § 13005, Dec. 13, 2016, 130 Stat. 1286, provided that:

Pub. L. 111–148, title III, § 3509(h), Mar. 23, 2010, 124 Stat. 537, provided that: “Nothing in this section [enacting this section, sections 242s, 299b–24a, and 914 of this title and section 399b of Title 21, Food and Drugs, amending sections 287d, 290aa, 299b–25, and 299b–26 of this title, and enacting provisions set out as notes under this section] and the amendments made by this section may be construed as establishing regulatory authority or modifying any existing regulatory authority.”

Pub. L. 111–148, title III, § 3509(i), Mar. 23, 2010, 124 Stat. 537, provided that: “Notwithstanding any other provision of law, a Federal office of women’s health (including the Office of Research on Women’s Health of the National Institutes of Health) or Federal appointive position with primary responsibility over women’s health issues (including the Associate Administrator for Women’s Services under the Substance Abuse and Mental Health Services Administration) that is in existence on the date of enactment of this section [Mar. 23, 2010] shall not be terminated, reorganized, or have any of it’s [sic] powers or duties transferred unless such termination, reorganization, or transfer is approved by Congress through the adoption of a concurrent resolution of approval.”

Memorandum of President of the United States, Nov. 13, 2023, 88 F.R. 80085, provided:

Memorandum for the Heads of Executive Departments and Agencies

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. Women make up half of the United States population, but for too long, a lack of timely research and data on women’s health has left health care providers without important tools to diagnose and treat millions of women with debilitating conditions, including cardiovascular disease, Alzheimer’s disease, autoimmune disorders, mental health conditions, and conditions specific to women such as endometriosis and fibroids.

Beyond the immediate health consequences, underinvesting in women’s health research can decrease women’s well-being and quality of life, hold women back in the workplace, and affect their families’ economic security. By contrast, increasing investments in women’s health research can yield broad societal gains, including lower health care costs and a more productive and inclusive workforce.

To address pervasive gaps in our knowledge of women’s health, we must accelerate research on the unique health needs of women across their lifespans. Research gaps are especially acute for diseases and conditions that are more prevalent among women and for health conditions associated with women’s midlife and later years, including perimenopause and menopause. Gaps are often even more significant for those who have been historically underrepresented in, or excluded from, research.

We can—and must—increase our efforts to invest in research that maximizes our ability to prevent, diagnose, and treat health conditions in women across the United States. Meaningful progress requires robust, dedicated research infrastructure—including a strong, diverse research workforce—and investment within and beyond the Federal Government. We all have a part to play in galvanizing women’s health research, developing innovative and cutting-edge interventions that promote women’s health, and ensuring that women across the United States have access to high-quality health care.

Accordingly, I hereby direct the following actions:

Sec. 2. Establishment. There is established, within the Office of the First Lady, a White House Initiative on Women’s Health Research (Initiative).

Sec. 3. Membership. (a) The Initiative shall be led by a Chair designated by the President who shall hold a dual role in the Office of the First Lady and on the staff of the White House Gender Policy Council.

(b) In addition to the Chair, the members of the Initiative shall consist of the heads of the following executive departments and agencies (agencies) and offices, or their designees:

(i) the Office of the Vice President;

(ii) the Department of Defense;

(iii) the Department of Agriculture;

(iv) the Department of Health and Human Services;

(v) the Department of Veterans Affairs;

(vi) the Environmental Protection Agency;

(vii) the Office of Management and Budget;

(viii) the Domestic Policy Council;

(ix) the Office of Science and Technology Policy;

(x) the National Science Foundation;

(xi) the National Institutes of Health;

(xii) the Food and Drug Administration;

(xiii) the Centers for Disease Control and Prevention;

(xiv) the Indian Health Service;

(xv) the Centers for Medicare and Medicaid Services;

(xvi) the Health Resources and Services Administration;

(xvii) the Substance Abuse and Mental Health Services Administration;

(xviii) the Agency for Healthcare Research and Quality;

(xix) the Advanced Research Projects Agency for Health;

(xx) the National Institutes of Health Office of Research on Women’s Health; and

(xxi) the heads of such other agencies and offices as the Chair may, from time to time, designate.

(c) The Department of Health and Human Services shall provide funding and administrative support as may be necessary for the performance and functions of the Initiative, to the extent permitted by law and within existing appropriations.

(d) At the direction of the Chair, the Initiative may establish subgroups consisting exclusively of Initiative members or their designees, as appropriate, including to coordinate across agency offices dedicated to women’s health.

Sec. 4. Mission and Functions. (a) The mission of the Initiative is to advance women’s health research in the United States. The functions of the Initiative are advisory only and shall include, consistent with applicable law, the following actions with the goal of advancing women’s health research:

(i) assessing the Federal research landscape to identify opportunities for additional investments that could catalyze significant progress in addressing women’s health needs;

(ii) setting Initiative-wide priorities to help guide strategic Federal research investments;

(iii) improving coordination among agencies and offices pursuing women’s health research, including by better integrating research efforts and facilitating interdisciplinary research;

(iv) developing policy recommendations to better ensure that the health needs of women are considered, assessed, and reported for Federal research and data collection efforts, where feasible and in accordance with current research and data collection and analysis guidelines;

(v) forming targeted recommendations to address 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;

(vi) developing recommendations to support the translation of research advancements into practical benefits for patients and providers;

(vii) identifying opportunities to develop public-private partnerships and to increase coordination of Federal efforts with the private and philanthropic sectors in order to drive innovation;

(viii) engaging the scientific and research communities, including by helping promote the publication and dissemination of actionable research and data on women’s health and by making Federal datasets available to support research;

(ix) assessing opportunities to recruit, train, and support women pursuing health and biomedical research careers to help strengthen and diversify the research workforce; and

(x) identifying ways to increase public awareness of the need for greater investment in and attention to women’s health research, as well as women’s health outcomes.

(b) Consistent with the objectives of this memorandum and applicable law, the Initiative may gather relevant information from external stakeholders, including Federal, State, local, Tribal, and territorial government officials; researchers and academics; women’s health organizations; philanthropic leaders; industry stakeholders; and other entities and persons that may assist the Initiative in accomplishing the objectives of this memorandum.

Sec. 5. Recommendations to the President. (a) Within 45 days of the date of this memorandum [Nov. 13, 2023], the members of the Initiative or their designees shall provide recommendations to the President, through the Chair, on concrete actions that agencies and offices can take to advance women’s health research.

(b) The heads of agencies and offices participating in the Initiative shall assist and provide information to the Chair, consistent with applicable law, as may be necessary to carry out the functions of the Initiative. Each participating agency and office shall bear its own expense for participating in the Initiative.

(c) The heads of agencies and offices participating in the Initiative, or their designees, shall inform the President, through the Chair, on progress implementing this memorandum at least twice each year.

Sec. 6. General Provisions. (a) Nothing in this memorandum 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 memorandum shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) This memorandum 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.

(d) The Secretary of Health and Human Services is authorized and directed to publish this memorandum in the Federal Register.