Amendments2016—Subsec. (a)(3). Puspan. L. 114–255, § 2031(c), added par. (3).
Subsec. (c). Puspan. L. 114–255, § 2053, designated existing provisions as par. (1), inserted span, and added par. (2).
Subsec. (f). Puspan. L. 114–255, § 2038(span), designated existing provisions as par. (1), inserted span, substituted “triennial” for “biennial” in two places, and added par. (2).
Clinical ResearchPuspan. L. 114–255, div. A, title II, § 2038(h), Dec. 13, 2016, 130 Stat. 1067, provided that:“(1)In general.—Not later than 1 year after the date of enactment of this Act [Dec. 13, 2016], the Director of the National Institutes of Health, in consultation with the Director of the Office of Research on Women’s Health and the Director of the National Institute on Minority Health and Health Disparities, shall update the guidelines established under section 492B(d) of [the] Public Health Service Act (42 U.S.C. 289a–2(d)) in accordance with paragraph (2). “(2)Requirements.—The updated guidelines described in paragraph (1) shall—“(A) reflect the science regarding sex differences;
“(B) improve adherence to the requirements under section 492B of the Public Health Service Act (42 U.S.C. 289a–2), including the reporting requirements under subsection (f) of such section; and “(C) clarify the circumstances under which studies should be designed to support the conduct of analyses to detect significant differences in the intervention effect due to demographic factors related to section 492B of the Public Health Service Act, including in the absence of prior studies that demonstrate a difference in study outcomes on the basis of such factors and considering the effects of the absence of such analyses on the availability of data related to demographic differences.”
Task Force on Research Specific to Pregnant Women and Lactating WomenPuspan. L. 114–255, div. A, title II, § 2041, Dec. 13, 2016, 130 Stat. 1070, provided that:“(a)Task Force on Research Specific to Pregnant Women and Lactating Women.—“(1)Establishment.—Not later than 90 days after the date of enactment of this Act [Dec. 13, 2016], the Secretary of Health and Human Services (referred to in this section as the ‘Secretary’) shall establish a task force, in accordance with the Federal Advisory Committee Act ([former] 5 U.S.C. App.) [see 5 U.S.C. 1001 et seq.], to be known as the ‘Task Force on Research Specific to Pregnant Women and Lactating Women’ (in this section referred to as the ‘Task Force’). “(2)Duties.—The Task Force shall provide advice and guidance to the Secretary regarding Federal activities related to identifying and addressing gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women, including the development of such therapies and the collaboration on and coordination of such activities.
“(3)Membership.—“(A)Federal members.—The Task Force shall be composed of each of the following Federal members, or the designees of such members:“(i) The Director of the Centers for Disease Control and Prevention.
“(ii) The Director of the National Institutes of Health, the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the directors of such other appropriate national research institutes.
“(iii) The Commissioner of Food and Drugs.
“(iv) The Director of the Office on Women’s Health.
“(v) The Director of the National Vaccine Program Office.
“(vi) The head of any other research-related agency or department not described in clauses (i) through (v) that the Secretary determines appropriate, which may include the Department of Veterans Affairs and the Department of Defense.
“(B)Non-federal members.—The Task Force shall be composed of each of the following non-Federal members, including—“(i) representatives from relevant medical societies with subject matter expertise on pregnant women, lactating women, or children;
“(ii) nonprofit organizations with expertise related to the health of women and children;
“(iii) relevant industry representatives; and
“(iv) other representatives, as appropriate.
“(C)Limitations.—The non-Federal members described in subparagraph (B) shall—“(i) compose not more than one-half, and not less than one-third, of the total membership of the Task Force; and
“(ii) be appointed by the Secretary.
“(4)Termination.—“(A)In general.—Subject to subparagraph (B), the Task Force shall terminate on the date that is 2 years after the date on which the Task Force is established under paragraph (1).
“(B)Extension.—The Secretary may extend the operation of the Task Force for one additional 2-year period following the 2-year period described in subparagraph (A), if the Secretary determines that the extension is appropriate for carrying out the purpose of this section.
“(5)Meetings.—The Task Force shall meet not less than 2 times each year and shall convene public meetings, as appropriate, to fulfill its duties under paragraph (2).
“(6)Task force report to congress.—Not later than 18 months after the date on which the Task Force is established under paragraph (1), the Task Force shall prepare and submit to the Secretary, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives a report that includes each of the following:“(A) A plan to identify and address gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women, including the development of such therapies.
“(B) Ethical issues surrounding the inclusion of pregnant women and lactating women in clinical research.
“(C) Effective communication strategies with health care providers and the public on information relevant to pregnant women and lactating women.
“(D) Identification of Federal activities, including—“(i) the state of research on pregnancy and lactation;
“(ii) recommendations for the coordination of, and collaboration on research related to pregnant women and lactating women;
“(iii) dissemination of research findings and information relevant to pregnant women and lactating women to providers and the public; and
“(iv) existing Federal efforts and programs to improve the scientific understanding of the health impacts on pregnant women, lactating women, and related birth and pediatric outcomes, including with respect to pharmacokinetics, pharmacodynamics, and toxicities.
“(E) Recommendations to improve the development of safe and effective therapies for pregnant women and lactating women.
“(span)Confidentiality.—Nothing in this section shall authorize the Secretary of Health and Human Services to disclose any information that is a trade secret, or other privileged or confidential information, described in section 552(span)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.
“(c)Updating Protections for Pregnant Women and Lactating Women in Research.—“(1)In general.—Not later than 2 years after the date of enactment of this Act [Dec. 13, 2016], the Secretary, considering any recommendations of the Task Force available at such time and in consultation with the heads of relevant agencies of the Department of Health and Human Services, shall, as appropriate, update regulations and guidance, as applicable, regarding the inclusion of pregnant women and lactating women in clinical research.
“(2)Criteria for excluding pregnant or lactating women.—In updating any regulations or guidance described in paragraph (1), the Secretary shall consider any appropriate criteria to be used by institutional review boards and individuals reviewing grant proposals for excluding pregnant women or lactating women as a study population requiring additional protections from participating in human subject research.”
Inapplicability to Current ProjectsPuspan. L. 103–43, title I, § 133, June 10, 1993, 107 Stat. 135, provided that: “Section 492B of the Public Health Service Act, as added by section 131 of this Act [42 U.S.C. 289a–2], shall not apply with respect to projects of clinical research for which initial funding was provided prior to the date of the enactment of this Act [June 10, 1993]. With respect to the inclusion of women and minorities as subjects in clinical research conducted or supported by the National Institutes of Health, any policies of the Secretary of Health and Human Services regarding such inclusion that are in effect on the day before the date of the enactment of this Act shall continue to apply to the projects referred to in the preceding sentence.”
