Title: ENACT Act of 2021
Policy area: Health

Summary:
Equity in Neuroscience and Alzheimer's Clinical Trials Act of 2021 or the ENACT Act of 2021
This bill sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimer's disease and related dementias.
Specifically, the National Institute on Aging (NIA) must establish and provide technical assistance to Alzheimer's research centers located in areas with higher concentrations of minority groups. These centers must
Additionally, the NIA must disseminate information to members of minority populations about participating in clinical trials and take other actions to enhance diversity with respect to the Alzheimer's research that it conducts or supports.
The bill also directs the NIA to increase diversity among Alzheimer's researchers by encouraging the participation of individuals who are from groups that are underrepresented in clinical, behavioral, and social sciences.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3085 Introduced in House (IH)]

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117th CONGRESS
  1st Session
                                H. R. 3085

  To amend the Public Health Service Act to improve the diversity of 
    participants in research on Alzheimer's disease, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 11, 2021

Ms. Blunt Rochester (for herself, Ms. Herrera Beutler, Mr. Curtis, Mr. 
  Smith of New Jersey, and Ms. Waters) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
  To amend the Public Health Service Act to improve the diversity of 
    participants in research on Alzheimer's disease, 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 ``Equity in Neuroscience and 
Alzheimer's Clinical Trials Act of 2021'' or the ``ENACT Act of 2021''.

SEC. 2. INCENTIVES, IMPROVEMENTS, AND OUTREACH TO INCREASE DIVERSITY IN 
              ALZHEIMER'S DISEASE RESEARCH.

    (a) Improving Access for and Outreach to Underrepresented 
Populations.--
            (1) Expanding access to alzheimer's research centers.--
                    (A) In general.--Section 445(a)(1) of the Public 
                Health Service Act (42 U.S.C. 285e-2(a)(1)) is 
                amended--
                            (i) by striking ``(a)(1) The Director of 
                        the Institute may'' and inserting the 
                        following:
    ``(a)(1) The Director of the Institute--
            ``(A) may'';
                            (ii) by striking ``disease.'' and inserting 
                        ``disease; and''; and
                            (iii) by adding at the end the following:
            ``(B) beginning January 1, 2022, shall enter into 
        cooperative agreements and make grants to public or private 
        nonprofit entities under this subsection for the planning, 
        establishment, and operation of new such centers that are 
        located in areas with a higher concentration of minority groups 
        (as determined under section 444(d)(3)(D)), such as entities 
        that are historically Black colleges and universities, 
        Hispanic-serving institutions, Tribal colleges and 
        universities, or centers of excellence for other minority 
        populations.''.
                    (B) Use of funding for clinics to operate clinical 
                trials.--Section 445(b) of the Public Health Service 
                Act (42 U.S.C. 285e-2(b)) is amended by adding at the 
                end the following:
    ``(3) Federal payments made under a cooperative agreement or grant 
under subsection (a) from funds made available under section 2(g) of 
the ENACT Act of 2021 shall, with respect to Alzheimer's disease, be 
used in part to establish and operate diagnostic and treatment clinics 
designed--
            ``(A) to meet the special needs of minority and rural 
        populations and other underserved populations; and
            ``(B) to operate clinical trials''.
            (2) Outreach.--
                    (A) Alzheimer's disease centers.--Section 445(b) of 
                the Public Health Service Act (42 U.S.C. 285e-2(b)), as 
                amended by paragraph (1)(B), is further amended by 
                adding at the end the following new paragraph:
    ``(4) Federal payments made under a cooperative agreement or grant 
under subsection (a) shall be used to establish engagement centers to 
carry out public outreach, education efforts, and dissemination of 
information for members of minority groups about clinical trial 
participation. Activities funded pursuant to the preceding sentence 
shall include--
            ``(A) using established mechanisms to encourage members of 
        minority groups to participate in clinical trials on 
        Alzheimer's disease;
            ``(B) expanding education efforts to make members of 
        minority groups aware of ongoing clinical trials;
            ``(C) working with trial sponsors to increase the number of 
        recruitment events for members of minority groups;
            ``(D) conducting outreach to national, State, and local 
        physician professional organizations, especially for members of 
        such organizations who are primary care physicians or 
        physicians who specialize in dementia, to increase awareness of 
        clinical research opportunities for members of minority groups; 
        and
            ``(E) using community-based participatory research 
        methodologies to engage with minority populations.''.
                    (B) Resource centers for minority aging research.--
                Section 444(c) of the Public Health Service Act (42 
                U.S.C. 285e-1(c)) is amended--
                            (i) by striking ``(c)'' and inserting 
                        ``(c)(1)'' ; and
                            (ii) by adding at the end the following new 
                        paragraph:
    ``(2) The Director, acting through the Resource Centers for 
Minority Aging Research of the Institute, shall carry out public 
outreach, education efforts, and dissemination of information for 
members of minority groups about participation in clinical research on 
Alzheimer's disease carried out or supported under this subpart.''.
    (b) Incentives to Increase Diversity in Alzheimer's Disease 
Research Through Principal Investigators and Researchers From 
Underrepresented Populations.--
            (1) Alzheimer's clinical research and training awards.--
        Section 445I of the Public Health Service Act (42 U.S.C. 285e-
        10a) is amended by adding at the end the following new 
        subsection:
    ``(d) Enhancing the Participation of Principal Investigators and 
Researchers Who Are Members of Underrepresented Populations.--
            ``(1) In general.--The Director shall enhance diversity in 
        the conduct or support of clinical research on Alzheimer's 
        disease under this subpart by encouraging the participation of 
        individuals from groups that are underrepresented in the 
        biomedical, clinical, behavioral, and social sciences as 
        principal investigators of such clinical research, as 
        researchers for such clinical research, or both.
            ``(2) Training for principal investigators.--The Director 
        of the Institute shall provide training for principal 
        investigators who are members of a minority group with respect 
        to skills for--
                    ``(A) the design and conduct of clinical research 
                and clinical protocols;
                    ``(B) applying for grants for clinical research; 
                and
                    ``(C) such other areas as the Director determines 
                to be appropriate.''.
            (2) Senior researcher awards.--Section 445B(a) of the 
        Public Health Service Act (42 U.S.C. 285e-4(a)) is amended by 
        inserting ``, including senior researchers who are members of a 
        minority group'' before the period at the end of the first 
        sentence.
    (c) Incentives to Increase Diversity in Alzheimer's Disease 
Research Through Trial Sites.--Section 444(d) of the Public Health 
Service Act (42 U.S.C. 285e-1(d)) is amended--
            (1) by striking ``(d)'' and inserting ``(d)(1)'' ; and
            (2) by adding at the end the following new paragraphs:
    ``(2) In conducting or supporting clinical research on Alzheimer's 
disease for purposes of this subpart, in addition to requirements 
otherwise imposed under this title, including under section 492B, the 
Director of the Institute shall increase the participation of members 
of minority groups in such clinical research through one or more of the 
activities described in paragraph (3).
    ``(3)(A) The Director of the Institute shall provide incentives for 
the support of clinical research on Alzheimer's disease with clinical 
trial sites established in areas with a higher concentration of 
minority groups, including rural areas if practicable.
    ``(B) In determining whether to conduct or support clinical 
research on Alzheimer's disease, the Director of the Institute shall 
encourage the conduct of clinical research with clinical trial sites in 
areas described in subparagraph (A) as a higher-level priority 
criterion among the criteria established to evaluate whether to conduct 
or support clinical research.
    ``(C) In determining the amount of funding to be provided for the 
conduct or support of such clinical research, the Director of the 
Institute shall provide additional funding for the conduct of such 
clinical research with clinical trial sites in areas described in 
subparagraph (A).
    ``(D) In determining whether an area is an area with a higher 
concentration of minority groups, the Director of the Institute--
            ``(i) shall consider the most recent data collected by the 
        Bureau of the Census; and
            ``(ii) may also consider--
                    ``(I) data from the Centers for Medicare & Medicaid 
                Services on the incidence of Alzheimer's disease in the 
                United States by region; and
                    ``(II) such other data as the Director determines 
                appropriate.
    ``(4) In order to facilitate the participation of members of 
minority groups in clinical research supported under this subpart, in 
addition to activities described in paragraph (3), the Director of the 
Institute shall--
            ``(A) ensure that such clinical research uses community-
        based participatory research methodologies; and
            ``(B) encourage the use of remote health technologies, 
        including telehealth, remote patient monitoring, and mobile 
        technologies, that reduce or eliminate barriers to 
        participation of members of minority groups in such clinical 
        research.
    ``(5)(A) Clinical research on Alzheimer's disease conducted or 
supported under this subpart shall ensure that such research includes 
outreach activities designed to increase the participation of members 
of minority groups in such research.
    ``(B)(i) Each applicant for a grant under this subpart for clinical 
research on Alzheimer's disease shall submit to the Director of the 
Institute in the application for such grant--
            ``(I) a budget for outreach activities to members of 
        minority populations with respect to participation in such 
        clinical research; and
            ``(II) a description of the plan to conduct such outreach.
    ``(ii) The Director of the Institute shall encourage applicants 
for, and recipients of, grants under this subpart to conduct clinical 
research on Alzheimer's disease to engage with community-based 
organizations to increase participation of minority populations in such 
research.
    ``(6) For purposes of this subpart:
            ``(A) The term `clinical research' includes a clinical 
        trial.
            ``(B) The term `minority group' has the meaning given such 
        term by reason of section 492B(g).''.
    (d) Participant Eligibility Criteria.--Section 445I of the Public 
Health Service Act (42 U.S.C. 285e-10a), as amended by subsection 
(b)(1), is further amended by adding at the end the following new 
subsection:
    ``(e) Participant Eligibility Criteria.--The Director of the 
Institute shall take such actions as are necessary to ensure that 
clinical research on Alzheimer's disease conducted or supported under 
this subpart is designed with eligibility criteria that ensure the 
clinical trial population reflects the diversity of the prospective 
patient population. Such actions may include the following:
            ``(1) Examination of criteria.--
                    ``(A) In general.--An examination of each exclusion 
                criterion to determine if the criterion is necessary to 
                ensure the safety of trial participants or to achieve 
                the study objectives.
                    ``(B) Modification of criteria.--In the case of an 
                exclusion criterion that is not necessary to ensure the 
                safety of trial participants or to achieve the study 
                objectives--
                            ``(i) encouraging the modification or 
                        elimination of the criterion; or
                            ``(ii) encouraging tailoring the criterion 
                        as narrowly as possible to avoid unnecessary 
                        limits to the population of the clinical study.
            ``(2) Requirement for strong justification for exclusion.--
        A review of each exclusion criterion to ensure that populations 
        are included in clinical trials, such as older adults, 
        individuals with a mild form of disease, individuals at the 
        extremes of the weight range, or children, unless there is a 
        strong clinical or scientific justification to exclude them.
            ``(3) Use of adaptive design.--Encouraging the use of an 
        adaptive clinical trial design that--
                    ``(A) starts with a defined population where there 
                are concerns about safety; and
                    ``(B) may expand to a broader population based on 
                initial data from the trial and external data.''.
    (e) Resource Center for Successful Strategies to Increase 
Participation of Underrepresented Populations in Alzheimer's Disease 
Clinical Research.--Section 444 of the Public Health Service Act (42 
U.S.C. 285e-1) is amended by adding at the end the following new 
subsection:
    ``(e)(1) Acting through the Office of Special Populations and in 
consultation with the Division of Extramural Activities, the Director 
of the Institute shall support resource information and technical 
assistance to grantees under section 445 (relating to Alzheimer's 
disease centers), other grantees, and prospective grantees, designed to 
increase the participation of minority populations in clinical research 
on Alzheimer's disease conducted or supported under this subpart.
    ``(2) The resource information and technical assistance provided 
under paragraph (1) shall include the maintenance of a central resource 
library in order to collect, prepare, analyze, and disseminate 
information relating to strategies and best practices used by 
recipients of grants under this subpart and other researchers in the 
development of the clinical research designed to increase the 
participation of minority populations in such clinical research.''.
    (f) Annual Reports.--Section 444 of the Public Health Service Act 
(42 U.S.C. 285e-1), as amended by subsection (e), is further amended by 
adding at the end the following new subsection:
    ``(f)(1)(A) The Director of the Institute shall submit annual 
reports to the Congress on the impact of the amendments made to this 
subpart by the ENACT Act of 2021.
    ``(B) The Secretary shall transmit a copy of each such report to 
the Advisory Council on Alzheimer's Research, Care, and Services 
established under section 2(e) of the National Alzheimer's Project Act 
(Public Law 111-375).
    ``(2) In each report under paragraph (1), the Director of the 
Institute shall include information and data on the following matters 
with respect to clinical trials on Alzheimer's disease conducted during 
the preceding year:
            ``(A) The number of participants who are members of a 
        minority group in such clinical trials.
            ``(B) The number of such clinical trials for which 
        incentives under subsection (d)(3) were made available, the 
        nature of such incentives, the amount of increased funding (if 
        any) made available for research on Alzheimer's disease, and 
        the training provided to principal investigators who are 
        members of a minority group and the amount of funding (if any) 
        for such training.
            ``(C) The number of such clinical trials for which the 
        principal investigator is a member of a minority group.
            ``(D) The number of such clinical trials for which a 
        significant percentage of researchers are members of a minority 
        group.
            ``(E) Modifications to patient eligibility criteria in 
        clinical trial designs under section 445I(e).
            ``(F) Outreach and education efforts conducted under 
        section 445(b)(3).
    ``(3) The Director of the Institute shall make each report under 
paragraph (1) available to the public, including through posting on the 
appropriate website of the Department of Health and Human Services.''.
    (g) Authorization of Appropriations.--For each of fiscal years 2022 
through 2026, there is authorized to be appropriated to the Secretary 
of Health and Human Services $60,000,000 to carry out the amendments 
made by this section, to remain available until expended.
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