§ 287d. Office of Research on Women’s Health

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1944

   National Institutes of Health Revitalization Act of 1993

   Pub. L. 103–43 title I § 141(a)(3) · 107 Stat. 122

   Enacted · 42 U.S.C. § 287d

   July 1, 1944, ch. 373, title IV, § 486, as added Pub. L. 103–43, title I, § 141(a)(3), June 10, 1993, 107 Stat. 136

   Source evidence

   Code source credit
   July 1, 1944, ch. 373, title IV, § 486, as added Pub. L. 103–43, title I, § 141(a)(3), June 10, 1993, 107 Stat. 136

   Enacted provision · exact public law section
   (3) by inserting after part E the following part: “Part F— Research on Women’s Health “SEC. 486. OFFICE OF RESEARCH ON WOMEN’S HEALTH. “(a) Establishment.— There is established within the Office of the Director of NIH an office to be known as the Office of Research on Women’s Health (in this part referred to as the ‘Office’). The Office shall be headed by a director, who shall be appointed by the Director of NIH. “(b) Purpose.— The Director of the Office shall— “(1) identify projects of research on women’s health that should be conducted or supported by the national research institutes; “(2) identify multidisciplinary research relating to research on women’s health that should be so conducted or supported; “(3) carry out paragraphs (1) and (2) with respect to the aging process in women, with priority given to menopause; “(4) promote coordination and collaboration among entities conducting research identified under any of paragraphs (1) through (3); “(5) encourage the conduct of such research by entities receiving funds from the national research institutes; “(6) recommend an agenda for conducting and supporting such research; “(7) promote the sufficient allocation of the resources of the national research institutes for conducting and supporting such research; “(8) assist in the administration of section 492B with respect to the inclusion of women as subjects in clinical research; and “(9) prepare the report required in section 486B. “(c) Coordinating Committee.— “(1) In carrying out subsection (b), the Director of the Office shall establish a committee to be known as the Coordinating Committee on Research on Women’s Health (in this subsection referred to as the ‘Coordinating Committee’). “(2) The Coordinating Committee shall be composed of the Directors of the national research institutes (or the designees of the Directors). “(3) The Director of the Office shall serve as the chair of the Coordinating Committee. “(4) With respect to research on women’s health, the Coordinating Committee shall assist the Director of the Office in— “(A) identifying the need for such research, and making an estimate each fiscal year of the funds needed to adequately support the research; “(B) identifying needs regarding the coordination of research activities, including intramural and extramural multidisciplinary activities; “(C) supporting the development of methodologies to determine the circumstances in which obtaining data specific to women (including data relating to the age of women and the membership of women in ethnic or racial groups) is an appropriate function of clinical trials of treatments and therapies; “(D) supporting the development and expansion of clinical trials of treatments and therapies for which obtaining such data has been determined to be an appropriate function; and “(E) encouraging the national research institutes to conduct and support such research, including such clinical trials. “(d) Advisory Committee.— “(1) In carrying out subsection (b), the Director of the Office shall establish an advisory committee to be known as the Advisory Committee on Research on Women’s Health (in this subsection referred to as the ‘Advisory Committee’). “(2) The Advisory Committee shall be composed of no fewer than 12, and not more than 18 individuals, who are not officers or employees of the Federal Government. The Director of the Office shall make appointments to the Advisory Committee from among physicians, practitioners, scientists, and other health professionals, whose clinical practice, research specialization, or professional expertise includes a significant focus on research on women’s health. A majority of the members of the Advisory Committee shall be women. “(3) The Director of the Office shall serve as the chair of the Advisory Committee. “(4) The Advisory Committee shall— “(A) advise the Director of the Office on appropriate research activities to be undertaken by the national research institutes with respect to— “(i) research on women’s health; “(ii) research on gender differences in clinical drug trials, including responses to pharmacological drugs; “(iii) research on gender differences in disease etiology, course, and treatment; “(iv) research on obstetrical and gynecological health conditions, diseases, and treatments; and “(v) research on women’s health conditions which require a multidisciplinary approach; “(B) report to the Director of the Office on such research; “(C) provide recommendations to such Director regarding activities of the Office (including recommendations on the development of the methodologies described in subsection (c)(4)(C) and recommendations on priorities in carrying out research described in subparagraph (A)); and “(D) assist in monitoring compliance with section 492B regarding the inclusion of women in clinical research. “(5) (A) The Advisory Committee shall prepare a biennial report describing the activities of the Committee, including findings made by the Committee regarding— “(i) compliance with section 492B; “(ii) the extent of expenditures made for research on women’s health by the agencies of the National Institutes of Health; and “(iii) the level of funding needed for such research. “(B) The report required in subparagraph (A) shall be submitted to the Director of NIH for inclusion in the report required in section 403. “(e) Representation of Women Among Researchers.— The Secretary, acting through the Assistant Secretary for Personnel and in collaboration with the Director of the Office, shall determine the extent to which women are represented among senior physicians and scientists of the national research institutes and among physicians and scientists conducting research with funds provided by such institutes, and as appropriate, carry out activities to increase the extent of such representation. “(f) Definitions.— For purposes of this part: “(1) The term ‘women’s health conditions’, with respect to women of all age, ethnic, and racial groups, means all diseases, disorders, and conditions (including with respect to mental health)— “(A) unique to, more serious, or more prevalent in women; “(B) for which the factors of medical risk or types of medical intervention are different for women, or for which it is unknown whether such factors or types are different for women; or “(C) with respect to which there has been insufficient clinical research involving women as subjects or insufficient clinical data on women. “(2) The term ‘research on women’s health’ means research on women’s health conditions, including research on preventing such conditions. “SEC. 486A. NATIONAL DATA SYSTEM AND CLEARINGHOUSE ON RESEARCH ON WOMEN’S HEALTH. “(a) Data System.— “(1) The Director of NIH, in consultation with the Director of the Office and the Director of the National Library of Medicine, shall establish a data system for the collection, storage, analysis, retrieval, and dissemination of information regarding research on women’s health that is conducted or supported Public information. by the national research institutes. Information from the data system shall be available through information systems available to health care professionals and providers, researchers, and members of the public. “(2) The data system established under paragraph (1) shall include a registry of clinical trials of experimental treatments that have been developed for research on women’s health. Such registry shall include information on subject eligibility criteria, sex, age, ethnicity or race, and the location of the trial site or sites. Principal investigators of such clinical trials shall provide this information to the registry within 30 days after it is available. Once a trial has been completed, the principal investigator shall provide the registry with information pertaining to the results, including potential toxicities or adverse effects associated with the experimental treatment or treatments evaluated. “(b) Clearinghouse.— The Director of NIH, in consultation with the Director of the Office and with the National Library of Medicine, shall establish, maintain, and operate a program to provide information on research and prevention activities of the national research institutes that relate to research on women’s health. “SEC. 486B. BIENNIAL REPORT. “(a) In General.— With respect to research on women’s health, the Director of the Office shall, not later than February 1, 1994, and biennially thereafter, prepare a report— “(1) describing and evaluating the progress made during the preceding 2 fiscal years in research and treatment conducted or supported by the National Institutes of Health; “(2) describing and analyzing the professional status of women physicians and scientists of such Institutes, including the identification of problems and barriers regarding advancements; “(3) summarizing and analyzing expenditures made by the agencies of such Institutes (and by such Office) during the preceding 2 fiscal years; and “(4) making such recommendations for legislative and administrative initiatives as the Director of the Office determines to be appropriate. “(b) Inclusion in Biennial Report of Director of NIH.— The Director of the Office shall submit each report prepared under subsection (a) to the Director of NIH for inclusion in the report submitted to the President and the Congress under section 403.”.

2. 1998

   Women’s Health Research and Prevention Amendments of 1998

   Pub. L. 105–340 title I § 106 · 112 Stat. 3191

   Substituted · 42 U.S.C. § 287d(d)(2)

   Pub. L. 105–340 substituted “NIH” for “the Office”

   Source evidence

   Code amendment note
   Subsec. (d)(2). Pub. L. 105–340 substituted “NIH” for “the Office”.

   Enacted provision · exact public law section
   SEC. 106. OFFICE OF RESEARCH ON WOMEN’S HEALTH. Section 486(d)(2) of the Public Health Service Act (42 U.S.C. 287d(d)(2)) is amended by striking “Director of the Office” and inserting “Director of NIH”.

3. 2010

   Patient Protection and Affordable Care Act

   Pub. L. 111–148 title III § 3509(c) · 124 Stat. 119

   Inserted · 42 U.S.C. § 287d(a)

   Pub. L. 111–148 inserted “and who shall report directly to the Director” before period at end

   Source evidence

   Code amendment note
   Subsec. (a). Pub. L. 111–148 inserted “and who shall report directly to the Director” before period at end.

   Enacted provision · exact public law section
   (c) Office of Women’s Health Research.— Section 486(a) of the Public Health Service Act (42 U.S.C. 287d(a)) is amended by inserting “and who shall report directly to the Director” before the period at the end thereof.

4. 2016

   21st Century Cures Act

   Pub. L. 114–255 div. A title II § 2038(c) · 130 Stat. 1033

   Substituted · 42 U.S.C. § 287d(c)(2)

   Pub. L. 114–255 substituted “senior-level staff designees” for “designees”

   Source evidence

   Code amendment note
   Subsec. (c)(2). Pub. L. 114–255 substituted “senior-level staff designees” for “designees”.

   Enacted provision · exact public law section
   (c) Coordination.— Section 486(c)(2) of the Public Health Service Act (42 U.S.C. 287d(c)(2)) is amended by striking “designees” and inserting “senior-level staff designees”.

5. 2022

   Legislative Branch Appropriations Act, 2022

   Pub. L. 117–103 div. P title I § 141(d) · 136 Stat. 49

   Inserted · 42 U.S.C. § 287d(d)(4)(A)(iv)

   Pub. L. 117–103 inserted “, including preventable maternal mortality and severe maternal morbidity” before “; and”

   Source evidence

   Code amendment note
   Subsec. (d)(4)(A)(iv). Pub. L. 117–103 inserted “, including preventable maternal mortality and severe maternal morbidity” before “; and”.

   Enacted provision · exact public law section
   Sec. 141. gifts (a) Revising Authorities of Librarian to Accept Gifts.— The first undesignated paragraph of section 4 of the Act entitled “An Act to create a Library of Congress Trust Fund Board, and for other purposes”, approved March 3, 1925 (2 U.S.C. 160), is amended— (1) in the first sentence— (A) by striking “and” before “(3) gifts or bequests of money for immediate disbursement”; and (B) by striking the period at the end and inserting the following: “; and (4) gifts or bequests of securities or other personal property.”; (2) in the second sentence, by inserting “of money” after “bequests”; (3) in the third sentence, by striking “enter them” and inserting “enter the gift, bequest, or proceeds”; and (4) by inserting after the second sentence the following new sentence: “In the case of a gift of securities, the Librarian shall sell the gift and provide the donor with such acknowledgment as needed for the donor to substantiate the gift.”. (b) Effective Date.— The amendments made by this section shall apply with respect to fiscal year 2022 and each succeeding fiscal year.

5 of 5 references resolved to an enrolled provision