I

117TH CONGRESS
1ST SESSION

H. R. 3085

To amend the Public Health Service Act to improve the diversity ofparticipants 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 BILLTo amend the Public Health Service Act to improve thediversity of participants in research on Alzheimer’s disease, and for other purposes.
1

Be it enacted by the Senate and House of Representa-

2 tives of the United States of America in Congress assembled,
3

SECTION 1. SHORT TITLE.

4This Act may be cited as the ‘‘Equity in Neuroscience

5 and Alzheimer’s Clinical Trials Act of 2021’’ or the

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6 ‘‘ENACT Act of 2021’’.

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SEC. 2. INCENTIVES, IMPROVEMENTS, AND OUTREACH TO

2

INCREASE DIVERSITY IN ALZHEIMER’S DIS-

3

EASE RESEARCH.

4(a) IMPROVING ACCESS FOR AND OUTREACH TO

5 UNDERREPRESENTED POPULATIONS.—67(1) EXPANDING ACCESS TO ALZHEIMER’S RESEARCH CENTERS.—

8(A) IN GENERAL.—Section 445(a)(1) of

9the Public Health Service Act (42 U.S.C. 285e–102(a)(1)) is amended—

11(i) by striking ‘‘(a)(1) The Director of

12

the Institute may’’ and inserting the fol-13

lowing:14‘‘(a)(1) The Director of the Institute—

15‘‘(A) may’’;16(ii) by striking ‘‘disease.’’ and insert-17

ing ‘‘disease; and’’; and18(iii) by adding at the end the fol-

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19

lowing:20‘‘(B) beginning January 1, 2022, shall enter

21

into cooperative agreements and make grants to22

public or private nonprofit entities under this sub-23

section for the planning, establishment, and oper-

24

ation of new such centers that are located in areas

25with a higher concentration of minority groups (as26determined under section 444(d)(3)(D)), such as en•HR 3085 IH

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tities that are historically Black colleges and univer-2

sities, Hispanic-serving institutions, Tribal colleges3

and universities, or centers of excellence for other4

minority populations.’’.

5(B) USE OF FUNDING FOR CLINICS TO OP-

6

ERATE CLINICAL TRIALS.—Section

7

the Public Health Service Act (42 U.S.C. 285e–82(b)) is amended by adding at the end the fol-9

lowing:10445(b) of‘‘(3) Federal payments made under a cooperative

11 agreement or grant under subsection (a) from funds made12 available under section 2(g) of the ENACT Act of 2021
13 shall, with respect to Alzheimer’s disease, be used in part
14 to establish and operate diagnostic and treatment clinics
15 designed—
16‘‘(A) to meet the special needs of minority and17rural populations and other underserved populations;

18

and

19

‘‘(B) to operate clinical trials’’.

20(2) OUTREACH.—

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21(A) ALZHEIMER’SDISEASECENTERS.—

22

Section 445(b) of the Public Health Service Act

23(42 U.S.C. 285e–2(b)), as amended by para-

24

graph (1)(B), is further amended by adding at

25

the end the following new paragraph:•HR 3085 IH
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‘‘(4) Federal payments made under a cooperative

2 agreement or grant under subsection (a) shall be used to
3 establish engagement centers to carry out public outreach,
4 education efforts, and dissemination of information for
5 members of minority groups about clinical trial participa6 tion. Activities funded pursuant to the preceding sentence

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7 shall include—
8‘‘(A) using established mechanisms to encour-9

age members of minority groups to participate in

10

clinical trials on Alzheimer’s disease;11‘‘(B) expanding education efforts to make mem-12

bers of minority groups aware of ongoing clinical

13

trials;14‘‘(C) working with trial sponsors to increase the15number of recruitment events for members of minor-

16

ity groups;

17‘‘(D) conducting outreach to national, State,18

and local physician professional organizations, espe-

19

cially for members of such organizations who are20

primary care physicians or physicians who specialize

21

in dementia, to increase awareness of clinical re-22

search opportunities for members of minority

23

groups; and•HR 3085 IH
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‘‘(E) using community-based participatory re-2

search methodologies to engage with minority popu-

3

lations.’’.

4(B) RESOURCE CENTERS FOR MINORITY

5

AGING RESEARCH.—Section 444(c) of the Pub-6

lic Health Service Act (42 U.S.C. 285e–1(c)) is7

amended—8(i) by striking ‘‘(c)’’ and inserting

9‘‘(c)(1)’’ ; and10(ii) by adding at the end the following

11

new paragraph:12‘‘(2) The Director, acting through the Resource Cen-

13 ters for Minority Aging Research of the Institute, shall
14 carry out public outreach, education efforts, and dissemi15 nation of information for members of minority groups
16 about participation in clinical research on Alzheimer’s dis-kjohnson on DSK79L0C42PROD with BILLS

17 ease carried out or supported under this subpart.’’.
18(b) INCENTIVES TO INCREASE DIVERSITY IN ALZ-

19

HEIMER’S DISEASE RESEARCH THROUGH PRINCIPAL IN-

20

VESTIGATORS

21

RESENTED POPULATIONS.—

22(1) ALZHEIMER’SAND

RESEARCHERS FROM UNDERREP-

CLINICALRESEARCH

23

TRAINING

24

Health Service Act (42 U.S.C. 285e–10a) is amend-

AWARDS.—Section

445I of the Public•HR 3085 IH
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AND

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ed by adding at the end the following new sub-2

section:3‘‘(d) ENHANCING THE PARTICIPATION OF PRINCIPAL

4 INVESTIGATORS AND RESEARCHERS WHO ARE MEMBERS
5

OF UNDERREPRESENTED POPULATIONS.—

6‘‘(1) IN GENERAL.—The Director shall enhance7

diversity in the conduct or support of clinical re-8

search on Alzheimer’s disease under this subpart by

9

encouraging the participation of individuals from

10groups that are underrepresented in the biomedical,

11

clinical, behavioral, and social sciences as principal

12

investigators of such clinical research, as researchers

13

for such clinical research, or both.

14‘‘(2) TRAINING

PRINCIPALINVESTIGA-

15

TORS.—The Director of the Institute shall provide

16

training for principal investigators who are members

17of a minority group with respect to skills for—

18‘‘(A) the design and conduct of clinical re-19

search and clinical protocols;

20‘‘(B) applying for grants for clinical re-21

search; and22

kjohnson on DSK79L0C42PROD with BILLSFOR‘‘(C) such other areas as the Director de-23

termines to be appropriate.’’.

24(2) SENIOR

25

RESEARCHER

AWARDS.—Section

445B(a) of the Public Health Service Act (42•HR 3085 IH
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U.S.C. 285e–4(a)) is amended by inserting ‘‘, in-2

cluding senior researchers who are members of a mi-

3

nority group’’ before the period at the end of the4

first sentence.

5(c) INCENTIVES TO INCREASE DIVERSITY IN ALZ-

6

HEIMER’S DISEASE RESEARCH THROUGH TRIAL SITES.—

7 Section 444(d) of the Public Health Service Act (428 U.S.C. 285e–1(d)) is amended—
910(1) by striking ‘‘(d)’’ and inserting ‘‘(d)(1)’’ ;and11(2) by adding at the end the following new

12paragraphs:

13‘‘(2) In conducting or supporting clinical research on

14 Alzheimer’s disease for purposes of this subpart, in addi15 tion to requirements otherwise imposed under this title,
16 including under section 492B, the Director of the Institute17 shall increase the participation of members of minority
18 groups in such clinical research through one or more of
19 the activities described in paragraph (3).
20‘‘(3)(A) The Director of the Institute shall provide

21 incentives for the support of clinical research on Alz22 heimer’s disease with clinical trial sites established in

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23 areas with a higher concentration of minority groups, in24 cluding rural areas if practicable.

•HR 3085 IH
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‘‘(B) In determining whether to conduct or support

2 clinical research on Alzheimer’s disease, the Director of
3 the Institute shall encourage the conduct of clinical re4 search with clinical trial sites in areas described in sub5 paragraph (A) as a higher-level priority criterion among
6 the criteria established to evaluate whether to conduct or
7 support clinical research.
8‘‘(C) In determining the amount of funding to be pro-

9 vided for the conduct or support of such clinical research,
10 the Director of the Institute shall provide additional fund11 ing for the conduct of such clinical research with clinical
12 trial sites in areas described in subparagraph (A).
13‘‘(D) In determining whether an area is an area with

14 a higher concentration of minority groups, the Director
15 of the Institute—1617‘‘(i) shall consider the most recent data collected by the Bureau of the Census; and18‘‘(ii) may also consider—

19‘‘(I) data from the Centers for Medicare &20

Medicaid Services on the incidence of Alz-21

heimer’s disease in the United States by region;

22

and

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23‘‘(II) such other data as the Director de-24

termines appropriate.

•HR 3085 IH
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‘‘(4) In order to facilitate the participation of mem-

2 bers of minority groups in clinical research supported
3 under this subpart, in addition to activities described in
4 paragraph (3), the Director of the Institute shall—
5‘‘(A) ensure that such clinical research uses

6community-based participatory research methodolo-7gies; and

8‘‘(B) encourage the use of remote health tech-9

nologies, including telehealth, remote patient moni-10

toring, and mobile technologies, that reduce or elimi-

11

nate barriers to participation of members of minor-

12

ity groups in such clinical research.

13‘‘(5)(A) Clinical research on Alzheimer’s disease con-

14 ducted or supported under this subpart shall ensure that
15 such research includes outreach activities designed to in16 crease the participation of members of minority groups in
17 such research.
18‘‘(B)(i) Each applicant for a grant under this subpart

19 for clinical research on Alzheimer’s disease shall submit
20 to the Director of the Institute in the application for suchkjohnson on DSK79L0C42PROD with BILLS

21 grant—
22‘‘(I) a budget for outreach activities to members

23of minority populations with respect to participation24

in such clinical research; and•HR 3085 IH
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‘‘(II) a description of the plan to conduct such2

outreach.

3‘‘(ii) The Director of the Institute shall encourage ap-

4 plicants for, and recipients of, grants under this subpart
5 to conduct clinical research on Alzheimer’s disease to en6 gage with community-based organizations to increase par7 ticipation of minority populations in such research.
8‘‘(6) For purposes of this subpart:

910‘‘(A) The term ‘clinical research’ includes aclinical trial.

11‘‘(B) The term ‘minority group’ has the mean-

12

ing given such term by reason of section 492B(g).’’.

13(d) PARTICIPANT ELIGIBILITY CRITERIA.—Section

14 445I of the Public Health Service Act (42 U.S.C. 285e–
15 10a), as amended by subsection (b)(1), is further amended
16 by adding at the end the following new subsection:17‘‘(e) PARTICIPANT ELIGIBILITY CRITERIA.—The Di-

18 rector of the Institute shall take such actions as are nec19 essary to ensure that clinical research on Alzheimer’s dis20 ease conducted or supported under this subpart is de21 signed with eligibility criteria that ensure the clinical trial
22 population reflects the diversity of the prospective patientkjohnson on DSK79L0C42PROD with BILLS

23 population. Such actions may include the following:
24‘‘(1) EXAMINATION OF CRITERIA.—•HR 3085 IH
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‘‘(A) INexamination of2each exclusion criterion to determine if the cri-

3

terion is necessary to ensure the safety of trial

4

participants or to achieve the study objectives.

5‘‘(B) MODIFICATION OF CRITERIA.—In the6case of an exclusion criterion that is not nec-

7

essary to ensure the safety of trial participants

8

or to achieve the study objectives—

9‘‘(i) encouraging the modification or

10

elimination of the criterion; or11‘‘(ii) encouraging tailoring the cri-

12

terion as narrowly as possible to avoid un-

13

necessary limits to the population of the14

clinical study.

15‘‘(2) REQUIREMENT FOR STRONG JUSTIFICA-

16

TION FOR EXCLUSION.—A review of each exclusion

17

criterion to ensure that populations are included in18

clinical trials, such as older adults, individuals with19

a mild form of disease, individuals at the extremes

20of the weight range, or children, unless there is a21

strong clinical or scientific justification to exclude

22

them.

23
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24‘‘(3) USE OF ADAPTIVE DESIGN.—Encouraging
the use of an adaptive clinical trial design that—•HR 3085 IH
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‘‘(A) starts with a defined population2

where there are concerns about safety; and3‘‘(B) may expand to a broader population

4

based on initial data from the trial and external

5data.’’.

6(e) RESOURCE CENTER FOR SUCCESSFUL STRATE-

7

GIES

8

RESENTEDTO

INCREASE PARTICIPATIONPOPULATIONSINOFUNDERREP-ALZHEIMER’S DISEASE

9 CLINICAL RESEARCH.—Section 444 of the Public Health
10 Service Act (42 U.S.C. 285e–1) is amended by adding at
11 the end the following new subsection:12‘‘(e)(1) Acting through the Office of Special Popu-

13 lations and in consultation with the Division of Extra14 mural Activities, the Director of the Institute shall support
15 resource information and technical assistance to grantees
16 under section 445 (relating to Alzheimer’s disease cen17 ters), other grantees, and prospective grantees, designed
18 to increase the participation of minority populations in
19 clinical research on Alzheimer’s disease conducted or sup20 ported under this subpart.
21‘‘(2) The resource information and technical assist-

22 ance provided under paragraph (1) shall include the main-

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23 tenance of a central resource library in order to collect,
24 prepare, analyze, and disseminate information relating to
25 strategies and best practices used by recipients of grants•HR 3085 IH
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1 under this subpart and other researchers in the develop2 ment of the clinical research designed to increase the par3 ticipation of minority populations in such clinical re4 search.’’.
5(f) ANNUAL REPORTS.—Section 444 of the Public

6 Health Service Act (42 U.S.C. 285e–1), as amended by
7 subsection (e), is further amended by adding at the end
8 the following new subsection:
9‘‘(f)(1)(A) The Director of the Institute shall submit

10 annual reports to the Congress on the impact of the
11 amendments made to this subpart by the ENACT Act of
12 2021.
13‘‘(B) The Secretary shall transmit a copy of each

14 such report to the Advisory Council on Alzheimer’s Re15 search, Care, and Services established under section 2(e)16 of the National Alzheimer’s Project Act (Public Law 111–
17 375).
18‘‘(2) In each report under paragraph (1), the Director

19 of the Institute shall include information and data on the
20 following matters with respect to clinical trials on Alz21 heimer’s disease conducted during the preceding year:
22

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23‘‘(A) The number of participants who are members of a minority group in such clinical trials.

24‘‘(B) The number of such clinical trials for25

which incentives under subsection (d)(3) were made•HR 3085 IH
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available, the nature of such incentives, the amount2

of increased funding (if any) made available for re-3

search on Alzheimer’s disease, and the training pro-4

vided to principal investigators who are members of

5

a minority group and the amount of funding (if any)

6

for such training.

7‘‘(C) The number of such clinical trials for8

which the principal investigator is a member of a mi-

9

nority group.

10‘‘(D) The number of such clinical trials for11

which a significant percentage of researchers are12

members of a minority group.

1314‘‘(E) Modifications to patient eligibility criteria
in clinical trial designs under section 445I(e).

15‘‘(F) Outreach and education efforts conducted16

under section 445(b)(3).

17‘‘(3) The Director of the Institute shall make each18 report under paragraph (1) available to the public, includ19 ing through posting on the appropriate website of the De20 partment of Health and Human Services.’’.
21(g) AUTHORIZATION OF APPROPRIATIONS.—For each

22 of fiscal years 2022 through 2026, there is authorized tokjohnson on DSK79L0C42PROD with BILLS

23 be appropriated to the Secretary of Health and Human•HR 3085 IH
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1 Services $60,000,000 to carry out the amendments made2 by this section, to remain available until expended.

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