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 and who shall report directly to the Director.

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 289a–2 of this title with respect to the inclusion of women as subjects in clinical research; and

(9) prepare the report required in section 287d–2 of this title.

With respect to research on women’s health, the Coordinating Committee shall assist the Director of the Office in—

(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 senior-level staff designees of the Directors).

(3) The Director of the Office shall serve as the chair of the Coordinating Committee.

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.

The Advisory Committee shall—

(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 NIH 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.

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 289a–2 of this title regarding the inclusion of women in clinical research.

The Advisory Committee shall prepare a biennial report describing the activities of the Committee, including findings made by the Committee regarding—

(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 289a–2 of this title; (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 283 of this title.

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.

For purposes of this part:

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.

(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; amended Pub. L. 105–340, title I, § 106, Oct. 31, 1998, 112 Stat. 3193; Pub. L. 111–148, title III, § 3509(c), Mar. 23, 2010, 124 Stat. 534; Pub. L. 114–255, div. A, title II, § 2038(c), Dec. 13, 2016, 130 Stat. 1065.)