[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 2745 Introduced in Senate (IS)]

<DOC>






114th CONGRESS
  2d Session
                                S. 2745

  To amend the Public Health Service Act to promote the inclusion of 
        minorities in clinical research, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 5, 2016

   Ms. Collins (for herself, Ms. Warren, Mr. Kirk, Ms. Baldwin, Mr. 
 Alexander, and Mrs. Murray) introduced the following bill; which was 
 read twice and referred to the Committee on Health, Education, Labor, 
                              and Pensions

_______________________________________________________________________

                                 A BILL


 
  To amend the Public Health Service Act to promote the inclusion of 
        minorities in clinical research, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Advancing NIH Strategic Planning and 
Representation in Medical Research Act''.

SEC. 2. NIH STRATEGIC PLAN.

    (a) Strategic Plan.--Section 402 of the Public Health Service Act 
(42 U.S.C. 282) is amended--
            (1) in subsection (b)(5), by inserting before the semicolon 
        the following: ``, and through the development, implementation, 
        and updating of the strategic plan developed under subsection 
        (m)''; and
            (2) by adding at the end the following:
    ``(m) NIH Strategic Plan.--
            ``(1) In general.--Not later than 2 years after the date of 
        enactment of the Advancing NIH Strategic Planning and 
        Representation in Medical Research Act, and once every 6 years 
        thereafter, the Director of NIH, in consultation with the 
        directors of the national research institutes and national 
        centers, shall develop and submit to the appropriate committees 
        of Congress and post on the Internet website of the National 
        Institutes of Health, a 6-year coordinated strategy (to be 
        known as the `NIH Strategic Plan') to provide direction to the 
        biomedical research investments made by the National Institutes 
        of Health, to facilitate collaboration across the institutes 
        and centers, to leverage scientific opportunity, and to advance 
        biomedicine.
            ``(2) Requirements.--The strategy under paragraph (1) 
        shall--
                    ``(A) identify strategic research priorities and 
                objectives across biomedical research, including--
                            ``(i) an assessment of the state of 
                        biomedical and behavioral research, including 
                        areas of opportunity with respect to basic, 
                        clinical, and translational research;
                            ``(ii) priorities and objectives to advance 
                        the treatment, cure, and prevention of health 
                        conditions;
                            ``(iii) emerging scientific opportunities, 
                        rising public health challenges, and scientific 
                        knowledge gaps; and
                            ``(iv) the identification of near-, 
                        mid-, and long-term scientific needs;
                    ``(B) consider, in carrying out subparagraph (A)--
                            ``(i) disease burden in the United States;
                            ``(ii) rare diseases and conditions;
                            ``(iii) biological, social, and other 
                        determinants of health that contribute to 
                        health disparities; and
                            ``(iv) other factors the Director of NIH 
                        determines appropriate;
                    ``(C) include multi-institute priorities, including 
                coordination of research among institutes and centers;
                    ``(D) include strategic priorities for funding 
                research through the Common Fund, in accordance with 
                section 402A(c)(1)(C);
                    ``(E) address the agency's proposed and ongoing 
                activities related to training and the biomedical 
                workforce; and
                    ``(F) describe opportunities for collaboration with 
                other agencies and departments, as appropriate.
            ``(3) Use of plans.--Strategic plans developed and updated 
        by the national research institutes and national centers of the 
        National Institutes of Health shall be prepared regularly and 
        in such a manner that such plans will be informed by the 
        strategic plans developed and updated under this subsection.''.
    (b) Conforming Amendment.--Section 402A(c)(1)(C) of the Public 
Health Service Act (42 U.S.C. 282a(c)(1)(C)) is amended by striking 
``Not later than June 1, 2007, and every 2 years thereafter,'' and 
inserting ``As part of the NIH Strategic Plan required under section 
402(m),''.

SEC. 3. COLLABORATION TO ENHANCE DIVERSITY IN CLINICAL RESEARCH.

    Section 402(b) of the Public Health Service Act (42 U.S.C. 282(b)) 
is amended--
            (1) by amending paragraph (4) to read as follows:
            ``(4) shall assemble accurate data to be used to assess 
        research priorities, including--
                    ``(A) information to better evaluate scientific 
                opportunity, public health burdens, and progress in 
                reducing health disparities; and
                    ``(B) data on study populations of clinical 
                research, funded by or conducted at each national 
                research institute and national center, which--
                            ``(i) specifies the inclusion of--
                                    ``(I) women;
                                    ``(II) members of minority groups;
                                    ``(III) relevant age categories; 
                                and
                                    ``(IV) other demographic variables 
                                determined to be necessary by the 
                                Director of NIH;
                            ``(ii) is disaggregated by research area, 
                        condition, and disease categories; and
                            ``(iii) is to be made publicly available on 
                        the Internet website of the National Institutes 
                        of Health;''; and
            (2) in paragraph (8)--
                    (A) in subparagraph (A), by striking ``and'' at the 
                end; and
                    (B) by adding at the end the following:
                    ``(C) foster collaboration between clinical 
                research projects funded by the respective national 
                research institutes and national centers that--
                            ``(i) conduct research involving human 
                        subjects; and
                            ``(ii) collect similar data; and
                    ``(D) encourage the collaboration described in 
                subparagraph (C) to--
                            ``(i) allow for an increase in the number 
                        of subjects studied; and
                            ``(ii) utilize diverse study populations, 
                        with special consideration to biological, 
                        social, and other determinants of health that 
                        contribute to health disparities;''.

SEC. 4. PROMOTING INCLUSION IN CLINICAL RESEARCH.

    (a) Strategic Plan.--Section 492B(a) of the Public Health Service 
Act (42 U.S.C. 289a-2(a)) is amended by adding at the end the 
following:
            ``(3) Strategic planning.--
                    ``(A) In general.--The directors of the national 
                institutes and national centers shall consult at least 
                once annually with the Director of the National 
                Institute on Minority Health and Health Disparities and 
                the Director of the Office of Research on Women's 
                Health regarding objectives of the national institutes 
                and national centers to ensure that future activities 
                by such institutes and centers take into account women 
                and minorities and are focused on reducing health 
                disparities.
                    ``(B) Strategic plans.--Any strategic plan issued 
                by a national institute or national center shall 
                include details on the objectives described in 
                subparagraph (A).''.
    (b) Clarification of Requirements.--Section 492B(c) of the Public 
Health Service Act (42 U.S.C. 289a-2(c)) is amended--
            (1) by striking ``In the case'' and inserting the 
        following:
            ``(1) In general.--In the case''; and
            (2) by adding at the end the following:
            ``(2) Reporting requirements.--For any new and competing 
        project of clinical research subject to the requirements under 
        this section that receives a grant award 1 year after the date 
        of enactment of the Advancing NIH Strategic Planning and 
        Representation in Medical Research Act, or any date thereafter, 
        for which a valid analysis is provided under paragraph (1)--
                    ``(A) and which is an applicable clinical trial as 
                defined in section 402(j), the entity conducting such 
                clinical research shall submit the results of such 
                valid analysis to the clinical trial registry data bank 
                expanded under section 402(j)(3), and the Director of 
                NIH shall, as appropriate, consider whether such entity 
                has complied with the reporting requirement described 
                in this subparagraph in awarding any future grant to 
                such entity, including pursuant to section 
                402(j)(5)(A)(ii) when applicable; and
                    ``(B) the Director of NIH shall encourage the 
                reporting of the results of such valid analysis 
                described in paragraph (1) through any additional means 
                determined appropriate by the Director.''.
    (c) Reporting.--Section 492B(f) of the Public Health Service Act 
(42 U.S.C. 289a-2(f)) is amended--
            (1) by striking ``biennial'' each place such term appears 
        and inserting ``triennial'' in each such place;
            (2) by striking ``The advisory council'' and inserting the 
        following:
            ``(1) In general.--The advisory council''; and
            (3) by adding at the end the following:
            ``(2) Contents.--Each triennial report prepared by an 
        advisory council of each national research institute as 
        described in paragraph (1) shall include each of the following:
                    ``(A) The number of women included as subjects, and 
                the proportion of subjects that are women, in any 
                project of clinical research conducted during the 
                applicable reporting period, disaggregated by 
                categories of research area, condition, or disease, and 
                accounting for single-sex studies.
                    ``(B) The number of members of minority groups 
                included as subjects, and the proportion of subjects 
                that are members of minority groups, in any project of 
                clinical research conducted during the applicable 
                reporting period, disaggregated by categories of 
                research area, condition, or disease and accounting for 
                single-race and single-ethnicity studies.
                    ``(C) For the applicable reporting period, the 
                number of projects of clinical research that include 
                women and members of minority groups and that--
                            ``(i) have been completed during such 
                        reporting period; and
                            ``(ii) are being carried out during such 
                        reporting period and have not been completed.
                    ``(D) The number of studies completed during the 
                applicable reporting period for which reporting has 
                been submitted in accordance with subsection 
                (c)(2)(A).''.
    (d) 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''.

SEC. 5. IMPROVING RESEARCH RELATED TO SEXUAL AND GENDER MINORITY 
              POPULATIONS.

    (a) In General.--Part A of title IV of the Public Health Service 
Act (42 U.S.C. 281 et seq.) is amended by adding at the end the 
following:

``SEC. 404M. RESEARCH RELATED TO SEXUAL AND GENDER MINORITY 
              POPULATIONS.

    ``The Director of NIH shall, as appropriate, encourage efforts to 
improve research related to the health of sexual and gender minority 
populations, including by--
            ``(1) facilitating increased participation of sexual and 
        gender minority populations in clinical research supported by 
        the National Institutes of Health, and reporting on such 
        participation, as applicable;
            ``(2) facilitating the development of valid and reliable 
        methods for research relevant to sexual and gender minority 
        populations; and
            ``(3) addressing methodological challenges.''.
    (b) Reporting.--
            (1) In general.--The Secretary, in collaboration with the 
        Director of the National Institutes of Health, shall as 
        appropriate--
                    (A) continue to support research for the 
                development of appropriate measures related to 
                reporting health information about sexual and gender 
                minority populations; and
                    (B) not later than 2 years after the date of 
                enactment of this Act, disseminate and make public such 
                measures.
            (2) National academy of medicine recommendations.--In 
        developing the measures described in paragraph (1)(A), the 
        Secretary shall take into account recommendations made by the 
        National Academy of Medicine.

SEC. 6. IMPROVING COORDINATION RELATED TO MINORITY HEALTH AND HEALTH 
              DISPARITIES.

    Section 464z-3 of the Public Health Service Act (42 U.S.C. 285t) is 
amended--
            (1) by redesignating subsection (h), relating to 
        interagency coordination, that follows subsection (j) as 
        subsection (k); and
            (2) in subsection (k) (as so redesignated)--
                    (A) in the heading, by striking ``Interagency'' and 
                inserting ``Intra-NIH'';
                    (B) by striking ``as the primary Federal 
                officials'' and inserting ``as the primary Federal 
                official'';
                    (C) by inserting a comma after ``review'';
                    (D) by striking ``Institutes and Centers of the 
                National Institutes of Health'' and inserting 
                ``national research institutes and national centers''; 
                and
                    (E) by adding at the end the following: ``The 
                Director of the Institute may foster partnerships 
                between the national research institutes and national 
                centers and may encourage the funding of collaborative 
                research projects to achieve the goals of the National 
                Institutes of Health that are related to minority 
                health and health disparities.''.

SEC. 7. ENHANCING THE RIGOR AND REPRODUCIBILITY OF SCIENTIFIC RESEARCH.

    (a) Establishment.--Not later than 1 year after the date of 
enactment of this Act, the Secretary of Health and Human Services, 
acting through the Director of the National Institutes of Health, shall 
convene a working group under the Advisory Committee to the Director of 
the National Institutes of Health, appointed under section 222 of the 
Public Health Service Act (42 U.S.C. 217a), to develop and issue 
recommendations for a formal policy, which may incorporate or be 
informed by relevant existing and ongoing activities, to enhance rigor 
and reproducibility of scientific research funded by the National 
Institutes of Health.
    (b) Considerations.--In developing and issuing the recommendations 
under subsection (a), the working group established under such 
subsection shall consider, as appropriate--
            (1) preclinical experiment design, including analysis of 
        sex as a biological variable;
            (2) clinical experiment design, including--
                    (A) the diversity of populations studied for 
                clinical research, with respect to biological, social, 
                and other determinants of health that contribute to 
                health disparities;
                    (B) the circumstances under which summary 
                information regarding biological, social, and other 
                factors that contribute to health disparities should be 
                reported; and
                    (C) the circumstances under which clinical studies, 
                including clinical trials, should conduct an analysis 
                of the data collected during the study on the basis of 
                biological, social, and other factors that contribute 
                to health disparities;
            (3) applicable levels of rigor in statistical methods, 
        methodology, and analysis;
            (4) data and information sharing in accordance with 
        applicable privacy laws and regulations; and
            (5) any other matter determined relevant by the working 
        group.
    (c) Policies.--Not later than 18 months after the date of enactment 
of this Act, the Director of the National Institutes of Health shall 
consider the recommendations developed by the working group under 
subsection (a) and develop or update policies as appropriate.
    (d) Report.--Not later than 2 years after the date of enactment of 
this Act, the Director of the National Institutes of Health, acting 
through the working group established under subsection (a), shall issue 
a report to the Secretary of Health and Human Services, the Committee 
on Health, Education, Labor, and Pensions of the Senate, and the 
Committee on Energy and Commerce of the House of Representatives 
regarding recommendations developed under such subsection and any 
subsequent policy changes implemented, to enhance rigor and 
reproducibility in scientific research funded by the National 
Institutes of Health.
    (e) 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(b)(4) of title 5, United States Code, or 
section 1905 of title 18, United States Code.

SEC. 8. TASK FORCE ON RESEARCH SPECIFIC TO PREGNANT WOMEN AND LACTATING 
              WOMEN.

    (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, 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 (5 U.S.C. App.), 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 designee of such member:
                            (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.
    (b) 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(b)(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, 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.

SEC. 9. WOMEN AND MINORITIES IN RESEARCH.

    (a) Basic Research.--
            (1) Developing policies.--Not later than 2 years after the 
        date of enactment of this Act, the Director of the National 
        Institutes of Health (referred to in this section as the 
        ``Director of NIH''), taking into consideration the findings of 
        the working group established under section 7, shall develop 
        policies for projects of basic research funded by National 
        Institutes of Health to assess--
                    (A) relevant biological variables including sex, as 
                appropriate; and
                    (B) how differences between male and female cells, 
                tissues, or animals may be examined and analyzed.
            (2) Revising policies.--The Director of NIH may update or 
        revise the policies developed under paragraph (1) as 
        appropriate.
            (3) Consultation and outreach.--In developing, updating, or 
        revising the policies under this section, the Director of NIH--
                    (A) shall consult with--
                            (i) the Office of Research on Women's 
                        Health;
                            (ii) the Office of Laboratory Animal 
                        Welfare; and
                            (iii) appropriate members of the scientific 
                        and academic communities; and
                    (B) shall conduct outreach to solicit feedback from 
                members of the scientific and academic communities on 
                the influence of sex as a variable in basic research, 
                including feedback on when it is appropriate for 
                projects of basic research involving cells, tissues, or 
                animals to include both male and female cells, tissues, 
                or animals.
            (4) Additional requirements.--The Director of NIH shall--
                    (A) ensure that projects of basic research funded 
                by the National Institutes of Health are conducted in 
                accordance with the policies developed, updated, or 
                revised under this section, as applicable; and
                    (B) encourage that the results of such research, 
                when published or reported, be disaggregated as 
                appropriate with respect to the analysis of any sex 
                differences.
    (b) Clinical Research.--
            (1) In general.--Not later than 1 year after the date of 
        enactment of this Act, the Director of NIH, 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 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.
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