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42 U.S.C. § 237a — Health and Human Services Office on

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42 U.S.C. § 237a — Health and Human Services Office on

Page 109 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 237a 1 So in original. Probably should be ‘‘lifespans;’’. Subsec. (a)(1). Pub. L. 114–255, § 3071(a)(2)(A), sub- stituted ‘‘Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service (in this section referred to as the ‘Service’), not to exceed 2,000 members, the purpose of which is to recruit and retain outstanding and qualified scientific and technical ex- perts in the fields of biomedical research, clinical re- search evaluation, and biomedical product assessment’’ for ‘‘Silvio O. Conte Senior Biomedical Research Serv- ice, not to exceed 500 members’’. Subsec. (a)(2). Pub. L. 114–255, § 3071(a)(2)(B), amended par. (2) generally. Prior to amendment, par. (2) read as follows: ‘‘The authority established in paragraph (1) re- garding the number of members in the Silvio O. Conte Senior Biomedical Research Service is in addition to any authority established regarding the number of members in the commissioned Regular Corps, in the Reserve Corps, and in the Senior Executive Service. Such paragraph may not be construed to require that the number of members in the commissioned Regular Corps, in the Reserve Corps, or in the Senior Executive Service be reduced to offset the number of members serving in the Silvio O. Conte Senior Biomedical Re- search Service (in this section referred to as the ‘Serv- ice’).’’ Subsec. (a)(3). Pub. L. 114–255, § 3071(a)(2)(C), added par. (3). Subsec. (b). Pub. L. 114–255, § 3071(a)(3)(A), substituted ‘‘, clinical research evaluation, or biomedical product assessment’’ for ‘‘or clinical research evaluation’’ in in- troductory provisions. Subsec. (b)(1). Pub. L. 114–255, § 3071(a)(3)(B), inserted ‘‘or a doctoral or master’s level degree in engineerin

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Page 109 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 237a 1 So in original. Probably should be ‘‘lifespans;’’. Subsec. (a)(1). Pub. L. 114–255, § 3071(a)(2)(A), sub- stituted ‘‘Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service (in this section referred to as the ‘Service’), not to exceed 2,000 members, the purpose of which is to recruit and retain outstanding and qualified scientific and technical ex- perts in the fields of biomedical research, clinical re- search evaluation, and biomedical product assessment’’ for ‘‘Silvio O. Conte Senior Biomedical Research Serv- ice, not to exceed 500 members’’. Subsec. (a)(2). Pub. L. 114–255, § 3071(a)(2)(B), amended par. (2) generally. Prior to amendment, par. (2) read as follows: ‘‘The authority established in paragraph (1) re- garding the number of members in the Silvio O. Conte Senior Biomedical Research Service is in addition to any authority established regarding the number of members in the commissioned Regular Corps, in the Reserve Corps, and in the Senior Executive Service. Such paragraph may not be construed to require that the number of members in the commissioned Regular Corps, in the Reserve Corps, or in the Senior Executive Service be reduced to offset the number of members serving in the Silvio O. Conte Senior Biomedical Re- search Service (in this section referred to as the ‘Serv- ice’).’’ Subsec. (a)(3). Pub. L. 114–255, § 3071(a)(2)(C), added par. (3). Subsec. (b). Pub. L. 114–255, § 3071(a)(3)(A), substituted ‘‘, clinical research evaluation, or biomedical product assessment’’ for ‘‘or clinical research evaluation’’ in in- troductory provisions. Subsec. (b)(1). Pub. L. 114–255, § 3071(a)(3)(B), inserted ‘‘or a doctoral or master’s level degree in engineering, bioinformatics, or a related or emerging field,’’ after ‘‘related field,’’. Subsec. (d)(2). Pub. L. 114–255, § 3071(a)(4), substituted ‘‘and shall not exceed the amount of annual compensa- tion (excluding expenses) specified in section 102 of title 3’’ for ‘‘and shall not exceed the rate payable for level I of the Executive Schedule unless approved by the President under section 5377(d)(2) of title 5’’. Subsecs. (e) to (g). Pub. L. 114–255, § 3071(a)(5), (6), re- designated subsecs. (f) and (g) as (e) and (f), respec- tively, and struck out former subsec. (e). Prior to amendment, text of subsec. (e) read as follows: ‘‘The Secretary may, upon the request of a member who— ‘‘(1) performed service in the employ of an institu- tion of higher education immediately prior to his ap- pointment as a member of the Service, and ‘‘(2) retains the right to continue to make contribu- tions to the retirement system of such institution, ‘‘contribute an amount not to exceed 10 percent per annum of the member’s basic pay to such institution’s retirement system on behalf of such member. A mem- ber who requests that such contribution be made shall not be covered by, or earn service credit under, any re- tirement system established for employees of the United States under title 5, but such service shall be creditable for determining years of service under sec- tion 6303(a) of such title.’’ 1993—Pub. L. 103–43, § 2001(b), substituted ‘‘Silvio O. Conte Senior Biomedical Research Service’’ for ‘‘Senior Biomedical Research Service’’ in section catchline. Subsec. (a). Pub. L. 103–43, § 2001(a), amended subsec. (a) generally. Prior to amendment, subsec. (a) read as follows: ‘‘There shall be in the Public Health Service a Senior Biomedical Research Service (hereinafter in this section referred to as the ‘Service’), not to exceed 350 members at any time.’’ Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective on the 90th day following Nov. 5, 1990, see section 529 [title III, § 304(c)] of Pub. L. 101–509, set out as an Effective Date of 1990 Amendment note under section 212 of this title. § 237a. Health and Human Services Office on Women’s Health (a) Establishment of Office There is established within the Office of the Secretary, an Office on Women’s Health (re- ferred to in this section as the ‘‘Office’’). The Of- fice shall be headed by a Deputy Assistant Sec- retary for Women’s Health who may report to the Secretary. (b) Duties The Secretary, acting through the Office, with respect to the health concerns of women, shall— (1) establish short-range and long-range goals and objectives within the Department of Health and Human Services and, as relevant and appropriate, coordinate with other appro- priate offices on activities within the Depart- ment that relate to disease prevention, health promotion, service delivery, research, and pub- lic and health care professional education, for issues of particular concern to women throughout their lifespan; 1 (2) provide expert advice and consultation to the Secretary concerning scientific, legal, eth- ical, and policy issues relating to women’s health; (3) monitor the Department of Health and Human Services’ offices, agencies, and re- gional activities regarding women’s health and identify needs regarding the coordination of activities, including intramural and extra- mural multidisciplinary activities; (4) establish a Department of Health and Human Services Coordinating Committee on Women’s Health, which shall be chaired by the Deputy Assistant Secretary for Women’s Health and composed of senior level represent- atives from each of the agencies and offices of the Department of Health and Human Serv- ices; (5) establish a National Women’s Health In- formation Center to— (A) facilitate the exchange of information regarding matters relating to health infor- mation, health promotion, preventive health services, research advances, and education in the appropriate use of health care; (B) facilitate access to such information; (C) assist in the analysis of issues and problems relating to the matters described in this paragraph; and (D) provide technical assistance with re- spect to the exchange of information (in- cluding facilitating the development of ma- terials for such technical assistance); (6) coordinate efforts to promote women’s health programs and policies with the private sector; and (7) through publications and any other means appropriate, provide for the exchange of information between the Office and recipients of grants, contracts, and agreements under subsection (c), and between the Office and health professionals and the general public. (c) Grants and contracts regarding duties (1) Authority In carrying out subsection (b), the Secretary may make grants to, and enter into coopera- Page 110 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 237a tive agreements, contracts, and interagency agreements with, public and private entities, agencies, and organizations. (2) Evaluation and dissemination The Secretary shall directly or through con- tracts with public and private entities, agen- cies, and organizations, provide for evalua- tions of projects carried out with financial as- sistance provided under paragraph (1) and for the dissemination of information developed as a result of such projects. (d) Reports Not later than 1 year after March 23, 2010, and every second year thereafter, the Secretary shall prepare and submit to the appropriate committees of Congress a report describing the activities carried out under this section during the period for which the report is being pre- pared. (e) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014. (July 1, 1944, ch. 373, title II, § 229, as added Pub. L. 111–148, title III, § 3509(a)(1), Mar. 23, 2010, 124 Stat. 531.) Statutory Notes and Related Subsidiaries CONSTRUCTION Pub. L. 111–148, title III, § 3509(j), Mar. 23, 2010, 124 Stat. 537, provided that: ‘‘Nothing in this section [en- acting 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] (or the amendments made by this section) shall be construed to limit the authority of the Secretary of Health and Human Services with respect to women’s health, or with respect to activities carried out through the Department of Health and Human Services on the date of enactment of this section [Mar. 23, 2010].’’ TRANSFER OF FUNCTIONS Pub. L. 111–148, title III, § 3509(a)(2), Mar. 23, 2010, 124 Stat. 533, provided that: ‘‘There are transferred to the Office on Women’s Health (established under section 229 of the Public Health Service Act [42 U.S.C. 237a], as added by this section), all functions exercised by the Office on Women’s Health of the Public Health Service prior to the date of enactment of this section [Mar. 23, 2010], including all personnel and compensation author- ity, all delegation and assignment authority, and all remaining appropriations. All orders, determinations, rules, regulations, permits, agreements, grants, con- tracts, certificates, licenses, registrations, privileges, and other administrative actions that— ‘‘(A) have been issued, made, granted, or allowed to become effective by the President, any Federal agen- cy or official thereof, or by a court of competent ju- risdiction, in the performance of functions trans- ferred under this paragraph; and ‘‘(B) are in effect at the time this section takes ef- fect, or were final before the date of enactment of this section and are to become effective on or after such date, shall continue in effect according to their terms until modified, terminated, superseded, set aside, or revoked in accordance with law by the President, the Secretary, or other authorized official, a court of competent juris- diction, or by operation of law.’’ INFORMATION AND AWARENESS ON EATING DISORDERS Pub. L. 114–255, div. B, title XIII, § 13005, Dec. 13, 2016, 130 Stat. 1286, provided that: ‘‘(a) INFORMATION.—The Secretary of Health and Human Services, acting through the Director of the Of- fice on Women’s Health, may— ‘‘(1) update information, related fact sheets, and re- source lists related to eating disorders that are avail- able on the public Internet website of the National Women’s Health Information Center sponsored by the Office on Women’s Health, to include— ‘‘(A) updated findings and current research re- lated to eating disorders, as appropriate; and ‘‘(B) information about eating disorders, includ- ing information related to males and females; ‘‘(2) incorporate, as appropriate, and in coordina- tion with the Secretary of Education, information from publicly available resources into appropriate obesity prevention programs developed by the Office on Women’s Health; and ‘‘(3) make publicly available (through a public Internet website or other method) information, re- lated fact sheets, and resource lists, as updated under paragraph (1), and the information incorporated into appropriate obesity prevention programs under para- graph (2). ‘‘(b) AWARENESS.—The Secretary of Health and Human Services may advance public awareness on— ‘‘(1) the types of eating disorders; ‘‘(2) the seriousness of eating disorders, including prevalence, comorbidities, and physical and mental health consequences; ‘‘(3) methods to identify, intervene, refer for treat- ment, and prevent behaviors that may lead to the de- velopment of eating disorders; ‘‘(4) discrimination and bullying based on body size; ‘‘(5) the effects of media on self-esteem and body image; and ‘‘(6) the signs and symptoms of eating disorders.’’ NO NEW REGULATORY AUTHORITY Pub. L. 111–148, title III, § 3509(h), Mar. 23, 2010, 124 Stat. 537, provided that: ‘‘Nothing in this section [en- acting 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 author- ity.’’ LIMITATION ON TERMINATION 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 (in- cluding the Office of Research on Women’s Health of the National Institutes of Health) or Federal appoint- ive 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 ex- istence 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 resolu- tion of approval.’’ Executive Documents EX. ORD. NO. 14120. ADVANCING WOMEN’S HEALTH RESEARCH AND INNOVATION Ex. Ord. No. 14120, Mar. 18, 2024, 89 F.R. 20095, pro- vided: 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: Page 111 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 237a SECTION 1. Policy. My Administration is committed to getting women the answers they need about their health. For far too long, scientific and biomedical re- search 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 promi- nent 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) [see Tables for classification] 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 re- search. In 2016, the Congress built on these require- ments in the 21st Century Cures Act (Public Law 114–255) [see Tables for classification], which directed the NIH to further its pursuit of women’s health re- search, including by strengthening clinical trial inclu- sion 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 invest- ments in biomedical research have supported break- throughs in women’s health. Through the discovery of genetic factors that increase the risk of breast cancer and innovations in mammography, we have trans- formed our approach to prevention, early detection, and treatment, and have improved outcomes for women facing a breast cancer diagnosis. We have improved ac- cess 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 identi- fied some of the most characteristic symptoms of heart attack in women, which are different from those in men—discoveries that have helped deliver faster treat- ment to women when every second counts. This is what we can achieve when we invest in women’s health re- search. 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 in- cludes a wide array of executive departments and agen- cies (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 Govern- ment to advance women’s health, including through in- vestments in innovation and improved coordination within and across agencies. We are also mobilizing leaders across a wide range of sectors, including indus- try, philanthropy, and the medical and research com- munities, to improve women’s health. 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, evi- dence-based health care and to improve health out- comes 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 re- searchers and scientists answer today’s most pressing questions related to women’s health. Investing in inno- vation in women’s health is an investment in the fu- ture 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 pre- vent, diagnose, and treat health conditions in women. SEC. 2. Definitions. For purposes of this order: (a) The term ‘‘women’s health research’’ means re- search aimed at expanding knowledge of women’s health across their lifespans, which includes the study and analysis of conditions specific to women, condi- tions that disproportionately impact women, and con- ditions 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) [set out below], to advance women’s health research. (c) The term ‘‘agency Members of the Initiative’’ re- fers to the Secretary of Defense, the Secretary of Agri- culture, the Secretary of Health and Human Services, the Secretary of Veterans Affairs, the Administrator of the Environmental Protection Agency, and the Direc- tor 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 Mem- bers 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, feder- ally funded research and other Federal funding oppor- tunities. Agency Members of the Initiative shall con- sider issuing new guidance, application materials, re- porting requirements, and research dissemination strategies to advance the study of women’s health, in- cluding to: (i) require applicants for Federal research funding, as appropriate, to explain how their proposed study de- signs will consider and advance our knowledge of wom- en’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 med- ical conditions that may affect women differently or disproportionately; (iii) improve accountability for grant recipients, in- cluding, as appropriate, by requiring regular reporting on their implementation of, and compliance with, re- search and data standards related to women’s health, including compliance with recruitment milestones; and (iv) improve the recruitment, enrollment, and reten- tion of women in clinical trials, including, as appro- priate, by reducing barriers through technological and data sciences advances. (b) Within 30 days of the date of this order [Mar. 18, 2024], the Chair of the Initiative and the Director of the NIH Office of Research on Women’s Health, in consulta- tion 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. (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 Initia- tive shall report to the President on the status of im- plementation 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 re- search across fields and areas of expertise; Page 112 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 237a (ii) addressing health disparities and inequities af- fecting women, including those related to race, eth- nicity, age, socioeconomic status, disability, and expo- sure to environmental factors and contaminants that can directly affect health; and (iii) supporting the translation of research advance- ments 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 fund- ing opportunity and through better facilitating poten- tial grant applicants’ access to information about fund- ing 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, chal- lenges, prizes, and other mechanisms to spur innova- tion 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 Pro- grams; (iii) support the role of small businesses and entre- preneurs in advancing innovation in women’s health re- search, including through Small Business Innovation Research Programs and Small Business Technology Transfer Programs; and (iv) invest in translational science to convert re- search 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) [15 U.S.C. 9401 note], the Secretary of Health and Human Services, in consultation with the Director of the Na- tional Science Foundation, shall consider the opportu- nities for and challenges that affect women’s health re- search in the responsible deployment and use of artifi- cial 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 evi- dence-based research agenda that will guide Federal and private sector investments in menopause-related research; (ii) evaluate evidence-based interventions and strate- gies to improve women’s experiences in the menopausal and perimenopausal periods, including the delivery of treatments for women experiencing menopause in clin- ical 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 en- sure that the public has evidence-based information about menopause, including menopause-related re- search 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 im- proved 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 collabora- tion 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 pri- ority areas within women’s health as identified by the Initiative, as follows: (a) Within 90 days of the date of this order, the Direc- tors 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 need- ed 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 wom- en’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 re- search 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 recommenda- tions 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 Presi- dent 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 de- partment or agency, or the head thereof; or (ii) the functions of the Director of the Office of Man- agement and Budget relating to budgetary, administra- tive, or legislative proposals. (b) This order shall be implemented consistent with applicable law and subject to the availability of appro- priations. (c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforce- able 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. J.R. BIDEN, JR. WHITE HOUSE INITIATIVE ON WOMEN’S HEALTH RESEARCH Memorandum of President of the United States, Nov. 13, 2023, 88 F.R. 80085, provided: Memorandum for the Heads of Executive Depart- ments 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 re- search 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, under- investing 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’ eco- nomic security. By contrast, increasing investments in Page 113 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 237a women’s health research can yield broad societal gains, including lower health care costs and a more produc- tive and inclusive workforce. To address pervasive gaps in our knowledge of wom- en’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, re- search. We can—and must—increase our efforts to invest in research that maximizes our ability to prevent, diag- nose, 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, devel- oping 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 Ini- tiative shall consist of the heads of the following exec- utive 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 Administra- tion; (xvii) the Substance Abuse and Mental Health Serv- ices Administration; (xviii) the Agency for Healthcare Research and Qual- ity; (xix) the Advanced Research Projects Agency for Health; (xx) the National Institutes of Health Office of Re- search 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 with- in 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 wom- en’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 advi- sory 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 iden- tify opportunities for additional investments that could catalyze significant progress in addressing wom- en’s health needs; (ii) setting Initiative-wide priorities to help guide strategic Federal research investments; (iii) improving coordination among agencies and of- fices pursuing women’s health research, including by better integrating research efforts and facilitating interdisciplinary research; (iv) developing policy recommendations to better en- sure that the health needs of women are considered, as- sessed, and reported for Federal research and data col- lection 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, in- cluding those related to race, ethnicity, age, socio- economic status, disability, and exposure to environ- mental factors and contaminants that can directly af- fect health; (vi) developing recommendations to support the translation of research advancements into practical benefits for patients and providers; (vii) identifying opportunities to develop public-pri- vate partnerships and to increase coordination of Fed- eral efforts with the private and philanthropic sectors in order to drive innovation; (viii) engaging the scientific and research commu- nities, including by helping promote the publication and dissemination of actionable research and data on women’s health and by making Federal datasets avail- able to support research; (ix) assessing opportunities to recruit, train, and sup- port 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 memo- randum and applicable law, the Initiative may gather relevant information from external stakeholders, in- cluding Federal, State, local, Tribal, and territorial government officials; researchers and academics; wom- en’s health organizations; philanthropic leaders; indus- try stakeholders; and other entities and persons that may assist the Initiative in accomplishing the objec- tives 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 imple- menting this memorandum at least twice each year. SEC. 6. General Provisions. (a) Nothing in this memo- randum shall be construed to impair or otherwise af- fect: (i) the authority granted by law to an executive de- partment or agency, or the head thereof; or (ii) the functions of the Director of the Office of Man- agement and Budget relating to budgetary, administra- tive, or legislative proposals. (b) This memorandum shall be implemented con- sistent with applicable law and subject to the avail- ability of appropriations. (c) This memorandum is not intended to, and does not, create any right or benefit, substantive or proce- Page 114 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 238 dural, 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. J.R. BIDEN, JR. PART B—MISCELLANEOUS PROVISIONS Editorial Notes CODIFICATION This part was classified to subchapter XXV (§ 300aaa et seq.) of this chapter prior to its renumbering by Pub. L. 103–43, title XX, § 2010(a)(1)–(3), June 10, 1993, 107 Stat. 213. § 238. Gifts for benefit of Service (a) Acceptance by Secretary The Secretary of Health and Human Services is authorized to accept on behalf of the United States gifts made unconditionally by will or otherwise for the benefit of the Service or for the carrying out of any of its functions. Condi- tional gifts may be so accepted if recommended by the Surgeon General, and the principal of and income from any such conditional gift shall be held, invested, reinvested, and used in accord- ance with its conditions, but no gift shall be ac- cepted which is conditioned upon any expendi- ture not to be met therefrom or from the income thereof unless such expenditure has been ap- proved by Act of Congress. (b) Depository of funds; availability for expendi- ture Any unconditional gift of money accepted pur- suant to the authority granted in subsection (a) of this section, the net proceeds from the liq- uidation (pursuant to subsection (c) or sub- section (d) of this section) of any other property so accepted, and the proceeds of insurance on any such gift property not used for its restora- tion, shall be deposited in the Treasury of the United States and are hereby appropriated and shall be held in trust by the Secretary of the Treasury for the benefit of the Service, and he may invest and reinvest such funds in interest- bearing obligations of the United States or in obligations guaranteed as to both principal and interest by the United States. Such gifts and the income from such investments shall be available for expenditure in the operation of the Service and the performance of its functions, subject to the same examination and audit as is provided for appropriations made for the Service by Con- gress. (c) Evidences of unconditional gifts of intangible property The evidences of any unconditional gift of in- tangible personal property, other than money, accepted pursuant to the authority granted in subsection (a) of this section shall be deposited with the Secretary of the Treasury and he, in his discretion, may hold them, or liquidate them except that they shall be liquidated upon the re- quest of the Secretary of Health and Human Services, whenever necessary to meet payments required in the operation of the Service or the performance of its functions. The proceeds and income from any such property held by the Sec- retary of the Treasury shall be available for ex- penditure as is provided in subsection (b) of this section. (d) Real property or tangible personal property The Secretary of Health and Human Services shall hold any real property or any tangible per- sonal property accepted unconditionally pursu- ant to the authority granted in subsection (a) of this section and he shall permit such property to be used for the operation of the Service and the performance of its functions or he may lease or hire such property, and may insure such prop- erty, and deposit the income thereof with the Secretary of the Treasury to be available for ex- penditure as provided in subsection (b) of this section: Provided, That the income from any such real property or tangible personal property shall be available for expenditure in the discre- tion of the Secretary of Health and Human Serv- ices for the maintenance, preservation, or repair and insurance of such property and that any proceeds from insurance may be used to restore the property insured. Any such property when not required for the operation of the Service or the performance of its functions may be liq- uidated by the Secretary of Health and Human Services, and the proceeds thereof deposited with the Secretary of the Treasury, whenever in his judgment the purposes of the gifts will be served thereby. (July 1, 1944, ch. 373, title II, § 231, formerly title V, § 501, 58 Stat. 709; July 3, 1946, ch. 538, § 10, 60 Stat. 425; June 16, 1948, ch. 481, § 6(b), 62 Stat. 469; 1953 Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Pub. L. 90–574, title V, § 503(b), Oct. 15, 1968, 82 Stat. 1012; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695; renum- bered title XXI, § 2101, Pub. L. 98–24, § 2(a)(1), Apr. 26, 1983, 97 Stat. 176; renumbered title XXIII, § 2301, Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100 Stat. 3755; renumbered title XXV, § 2501, Pub. L. 100–607, title II, § 201(1), (2), Nov. 4, 1988, 102 Stat. 3062; renumbered title XXVI, § 2601, Pub. L. 100–690, title II, § 2620(a), Nov. 18, 1988, 102 Stat. 4244; renumbered title XXVII, § 2701, Pub. L. 101–381, title I, § 101(1), (2), Aug. 18, 1990, 104 Stat. 576; renumbered title II, § 231, Pub. L. 103–43, title XX, § 2010(a)(1)–(3), June 10, 1993, 107 Stat. 213.) Editorial Notes CODIFICATION Section was formerly classified to section 300aaa of this title prior to renumbering by Pub. L. 103–43, to sec- tion 300cc of this title prior to renumbering by Pub. L. 100–607, to section 300aa of this title prior to renum- bering by Pub. L. 99–660, and to section 219 of this title prior to renumbering by Pub. L. 98–24. AMENDMENTS 1968—Subsec. (e). Pub. L. 90–574 struck out subsec. (e) which provided for acknowledgment of donations of $50,000 or more in aid of research by the establishment of suitable memorials within the National Institutes of Health and the National Institute of Mental Health. 1948—Subsec. (e). Act June 16, 1948, substituted ‘‘Na- tional Institutes of Health’’ for ‘‘National Institute of Health’’.

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Federal law — U.S. Code and appendices · legal_authorities

15 U.S.C. § 9401 — Veterans’ health initiative

**(a) Purposes** The purposes of this section are to advance Department of Energy expertise in artificial intelligence and high-performance computing in order to improve health outcomes for veteran populations by— (1) supporting basic research through the application of artificial intelligence, high-performance computing, modeling and simulation, machine learning, and large-scale data analytics to identify and solve outcome-defined challenges in the health sciences; (2) maximizing the impact of the Department of Veterans Affairs’ health and genomics data housed at the National Laboratories, as well as data from other sources, on science, innovation, and health care outcomes through the use and advancement of artificial intelligence and high-performance computing capabilities of the Department; (3) promoting collaborative research through the establishment of partnerships to improve data sharing between Federal agencies, National Laboratories, institutions of higher education, and nonprofit institutions; (4) establishing multiple scientific computing user facilities to house and provision available data to foster transformational outcomes; and (5) driving the development of technology to improve artificial intelligence, high-performance computing, and networking relevant to mission applications of the Department, including modeling, simulation, machine learning, and advanced data analytics. **(b) Veterans health research and development** (1) **In general** — The Secretary of Energy (in this section referred to as the “Secretary”) shall establish and carry out a research program in artificial intelligence and high-performance computing, focused on the development of tools to solve large-scale data analytics and management challenges associated with veteran’s healt

Source: Supplied U.S. Code snapshot — release unconfirmed · 15 U.S.C. § 9401

Stored review status: release_metadata_unconfirmed. The source passage cites 15 U.S.C. § 9401. This identifies an authority to review, not proof of applicability.

Federal law — U.S. Code and appendices · legal_authorities

15 U.S.C. § 9401 — Definitions

Page 2569 TITLE 15—COMMERCE AND TRADE § 9401 of Pub. L. 116–283, div. A, Jan. 1, 2021, 134 Stat. 3497, which is classified principally to this chapter. For com- plete classification of subtitle E to the Code, see Ta- bles. § 9306. Rule of construction Nothing in this chapter shall be construed to alter or amend any State law or action with re- gard to sustainable chemistry, as defined by the State. (Pub. L. 116–283, div. A, title II, § 266, Jan. 1, 2021, 134 Stat. 3502.) Editorial Notes REFERENCES IN TEXT This chapter, referred to in text, was in the original ‘‘this subtitle’’, meaning subtitle E (§§ 261–267) of title II of Pub. L. 116–283, div. A, Jan. 1, 2021, 134 Stat. 3497, which is classified principally to this chapter. For com- plete classification of subtitle E to the Code, see Ta- bles. CHAPTER 119—NATIONAL ARTIFICIAL INTELLIGENCE INITIATIVE Sec. 9401. Definitions. SUBCHAPTER I—NATIONAL ARTIFICIAL INTELLIGENCE INITIATIVE 9411. National Artificial Intelligence Initiative. 9412. National Artificial Intelligence Initiative Of- fice. 9413. Coordination by Interagency Committee. 9414. National Artificial Intelligence Advisory Committee. 9415. National AI Research Resource Task Force. SUBCHAPTER II—NATIONAL ARTIFICIAL INTELLIGENCE RESEARCH INSTITUTES 9431. National Artificial Intelligence Research In- stitutes. SUBCHAPTER III—DEPARTMENT OF COMMERCE ARTIFICIAL INTELLIGENCE ACTIVITIES 9441. Stakeholder outreach. 9442. National Oceanic and Atmospheric Adminis- tration Artificial Intelligence Center. SUBCHAPTER IV—NATIONAL SCIENCE FOUNDA- TION ARTIFICIAL INTELLIGENCE ACTIVITIES 9451. Artificial intelligence research and edu- cation. SUBCHAPTER V—DEPARTMENT OF ENERGY ARTIFICIAL INTELLIGENCE RESEARCH PROGRAM 9461. Depart

Source: Supplied 2024 U.S. Code historical extraction · 15 U.S.C. § 9401

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 237a — Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service

**(a) Creation; number of members** (1) There shall be in the Public Health Service a Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service (in this section referred to as the “Service”), not to exceed 2,000 members, the purpose of which is to recruit and retain outstanding and qualified scientific and technical experts in the fields of biomedical research, clinical research evaluation, and biomedical product assessment. (2) The authority established in paragraph (1) may not be construed to require the Secretary to reduce the number of employees serving under any other employment system in order to offset the number of members serving in the Service. (3) The Secretary shall assign experts under this section to agencies within the Department of Health and Human Services taking into account the need for the expertise of such expert. **(b) Appointments; qualifications; provisions inapplicable to members** The Service shall be appointed by the Secretary without regard to the provisions of title 5 regarding appointment, and shall consist of individuals outstanding in the field of biomedical research, clinical research evaluation, or biomedical product assessment. No individual may be appointed to the Service unless such individual (1) has earned a doctoral level degree in biomedicine or a related field, or a doctoral or master’s level degree in engineering, bioinformatics, or a related or emerging field, and (2) meets the qualification standards prescribed by the Office of Personnel Management for appointment to a position at GS–15 of the General Schedule. Notwithstanding any previous applicability to an individual who is a member of the Service, the provisions of subchapter I of chapter 35 (relating to retention preference), chapter 43 (re

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 237a

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