I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

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

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

6 ‘‘ENACT Act of 2021’’. 


kjohnson on DSK79L0C42PROD with BILLS
2 

•HR 3085 IH

1 SEC. 2. INCENTIVES, IMPROVEMENTS, AND OUTREACH TO 

2 INCREASE DIVERSITY IN ALZHEIMER’S DIS3 EASE RESEARCH. 

4 (a) IMPROVING ACCESS FOR AND OUTREACH TO

5 UNDERREPRESENTED POPULATIONS.— 

6 (1) EXPANDING ACCESS TO ALZHEIMER’S RE7 SEARCH CENTERS.— 

8 (A) IN GENERAL.—Section 445(a)(1) of 

9 the Public Health Service Act (42 U.S.C. 285e– 

10 2(a)(1)) is amended— 

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

12 the Institute may’’ and inserting the fol13 lowing: 

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

15 ‘‘(A) may’’; 

16 (ii) by striking ‘‘disease.’’ and insert17 ing ‘‘disease; and’’; and 

18 (iii) by adding at the end the fol19 lowing: 

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

21 into cooperative agreements and make grants to 

22 public or private nonprofit entities under this sub23 section for the planning, establishment, and oper24 ation of new such centers that are located in areas 

25 with a higher concentration of minority groups (as 

26 determined under section 444(d)(3)(D)), such as enVerDate Sep 11 2014 04:15 Jun 10, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3085.IH H3085

kjohnson on DSK79L0C42PROD with BILLS
3 

•HR 3085 IH

1 tities that are historically Black colleges and univer2 sities, Hispanic-serving institutions, Tribal colleges 

3 and universities, or centers of excellence for other 

4 minority populations.’’. 

5 (B) USE OF FUNDING FOR CLINICS TO OP6 ERATE CLINICAL TRIALS.—Section 445(b) of 

7 the Public Health Service Act (42 U.S.C. 285e– 

8 2(b)) is amended by adding at the end the fol9 lowing: 

10 ‘‘(3) Federal payments made under a cooperative 

11 agreement or grant under subsection (a) from funds made 

12 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 and 

17 rural populations and other underserved populations; 

18 and 

19 ‘‘(B) to operate clinical trials’’. 

20 (2) OUTREACH.— 

21 (A) ALZHEIMER’S DISEASE CENTERS.— 

22 Section 445(b) of the Public Health Service Act 

23 (42 U.S.C. 285e–2(b)), as amended by para24 graph (1)(B), is further amended by adding at 

25 the end the following new paragraph: 


kjohnson on DSK79L0C42PROD with BILLS
4 

•HR 3085 IH

1 ‘‘(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 

7 shall include— 

8 ‘‘(A) using established mechanisms to encour9 age members of minority groups to participate in 

10 clinical trials on Alzheimer’s disease; 

11 ‘‘(B) expanding education efforts to make mem12 bers of minority groups aware of ongoing clinical 

13 trials; 

14 ‘‘(C) working with trial sponsors to increase the 

15 number of recruitment events for members of minor16 ity groups; 

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

18 and local physician professional organizations, espe19 cially for members of such organizations who are 

20 primary care physicians or physicians who specialize 

21 in dementia, to increase awareness of clinical re22 search opportunities for members of minority 

23 groups; and 


kjohnson on DSK79L0C42PROD with BILLS
5 

•HR 3085 IH

1 ‘‘(E) using community-based participatory re2 search methodologies to engage with minority popu3 lations.’’. 

4 (B) RESOURCE CENTERS FOR MINORITY

5 AGING RESEARCH.—Section 444(c) of the Pub6 lic Health Service Act (42 U.S.C. 285e–1(c)) is 

7 amended— 

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

9 ‘‘(c)(1)’’ ; and 

10 (ii) by adding at the end the following 

11 new paragraph: 

12 ‘‘(2) The Director, acting through the Resource Cen13 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 dis17 ease carried out or supported under this subpart.’’. 

18 (b) INCENTIVES TO INCREASE DIVERSITY IN ALZ19 HEIMER’S DISEASE RESEARCH THROUGH PRINCIPAL IN20 VESTIGATORS AND RESEARCHERS FROM UNDERREP21 RESENTED POPULATIONS.— 

22 (1) ALZHEIMER’S CLINICAL RESEARCH AND

23 TRAINING AWARDS.—Section 445I of the Public 

24 Health Service Act (42 U.S.C. 285e–10a) is amendVerDate Sep 11 2014 04:15 Jun 10, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3085.IH H3085

kjohnson on DSK79L0C42PROD with BILLS
6 

•HR 3085 IH

1 ed by adding at the end the following new sub2 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 enhance 

7 diversity in the conduct or support of clinical re8 search on Alzheimer’s disease under this subpart by 

9 encouraging the participation of individuals from 

10 groups 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 FOR PRINCIPAL INVESTIGA15 TORS.—The Director of the Institute shall provide 

16 training for principal investigators who are members 

17 of a minority group with respect to skills for— 

18 ‘‘(A) the design and conduct of clinical re19 search and clinical protocols; 

20 ‘‘(B) applying for grants for clinical re21 search; and 

22 ‘‘(C) such other areas as the Director de23 termines to be appropriate.’’. 

24 (2) SENIOR RESEARCHER AWARDS.—Section 

25 445B(a) of the Public Health Service Act (42 


kjohnson on DSK79L0C42PROD with BILLS
7 

•HR 3085 IH

1 U.S.C. 285e–4(a)) is amended by inserting ‘‘, in2 cluding senior researchers who are members of a mi3 nority group’’ before the period at the end of the 

4 first sentence. 

5 (c) INCENTIVES TO INCREASE DIVERSITY IN ALZ6 HEIMER’S DISEASE RESEARCH THROUGH TRIAL SITES.— 

7 Section 444(d) of the Public Health Service Act (42 

8 U.S.C. 285e–1(d)) is amended— 

9 (1) by striking ‘‘(d)’’ and inserting ‘‘(d)(1)’’ ; 

10 and 

11 (2) by adding at the end the following new 

12 paragraphs: 

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 Institute 

17 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 

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


kjohnson on DSK79L0C42PROD with BILLS
8 

•HR 3085 IH

1 ‘‘(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 pro9 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— 

16 ‘‘(i) shall consider the most recent data col17 lected by the Bureau of the Census; and 

18 ‘‘(ii) may also consider— 

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

20 Medicaid Services on the incidence of Alz21 heimer’s disease in the United States by region; 

22 and 

23 ‘‘(II) such other data as the Director de24 termines appropriate. 


kjohnson on DSK79L0C42PROD with BILLS
9 

•HR 3085 IH

1 ‘‘(4) In order to facilitate the participation of mem2 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 

6 community-based participatory research methodolo7 gies; and 

8 ‘‘(B) encourage the use of remote health tech9 nologies, including telehealth, remote patient moni10 toring, and mobile technologies, that reduce or elimi11 nate barriers to participation of members of minor12 ity groups in such clinical research. 

13 ‘‘(5)(A) Clinical research on Alzheimer’s disease con14 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 such 

21 grant— 

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

23 of minority populations with respect to participation 

24 in such clinical research; and 


kjohnson on DSK79L0C42PROD with BILLS
10 

•HR 3085 IH

1 ‘‘(II) a description of the plan to conduct such 

2 outreach. 

3 ‘‘(ii) The Director of the Institute shall encourage ap4 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: 

9 ‘‘(A) The term ‘clinical research’ includes a 

10 clinical trial. 

11 ‘‘(B) The term ‘minority group’ has the mean12 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 Di18 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 patient 

23 population. Such actions may include the following: 

24 ‘‘(1) EXAMINATION OF CRITERIA.— 


kjohnson on DSK79L0C42PROD with BILLS
11 

•HR 3085 IH

1 ‘‘(A) IN GENERAL.—An examination of 

2 each exclusion criterion to determine if the cri3 terion is necessary to ensure the safety of trial 

4 participants or to achieve the study objectives. 

5 ‘‘(B) MODIFICATION OF CRITERIA.—In the 

6 case of an exclusion criterion that is not nec7 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; or 

11 ‘‘(ii) encouraging tailoring the cri12 terion as narrowly as possible to avoid un13 necessary limits to the population of the 

14 clinical study. 

15 ‘‘(2) REQUIREMENT FOR STRONG JUSTIFICA16 TION FOR EXCLUSION.—A review of each exclusion 

17 criterion to ensure that populations are included in 

18 clinical trials, such as older adults, individuals with 

19 a mild form of disease, individuals at the extremes 

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

21 strong clinical or scientific justification to exclude 

22 them. 

23 ‘‘(3) USE OF ADAPTIVE DESIGN.—Encouraging 

24 the use of an adaptive clinical trial design that— 


kjohnson on DSK79L0C42PROD with BILLS
12 

•HR 3085 IH

1 ‘‘(A) starts with a defined population 

2 where there are concerns about safety; and 

3 ‘‘(B) may expand to a broader population 

4 based on initial data from the trial and external 

5 data.’’. 

6 (e) RESOURCE CENTER FOR SUCCESSFUL STRATE7 GIES TO INCREASE PARTICIPATION OF UNDERREP8 RESENTED POPULATIONS IN 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 Popu13 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 assist22 ance provided under paragraph (1) shall include the main23 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 


kjohnson on DSK79L0C42PROD with BILLS
13 

•HR 3085 IH

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 ‘‘(A) The number of participants who are mem23 bers of a minority group in such clinical trials. 

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

25 which incentives under subsection (d)(3) were made 


kjohnson on DSK79L0C42PROD with BILLS
14 

•HR 3085 IH

1 available, the nature of such incentives, the amount 

2 of increased funding (if any) made available for re3 search on Alzheimer’s disease, and the training pro4 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 for 

8 which the principal investigator is a member of a mi9 nority group. 

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

11 which a significant percentage of researchers are 

12 members of a minority group. 

13 ‘‘(E) Modifications to patient eligibility criteria 

14 in clinical trial designs under section 445I(e). 

15 ‘‘(F) Outreach and education efforts conducted 

16 under section 445(b)(3). 

17 ‘‘(3) The Director of the Institute shall make each 

18 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 to 

23 be appropriated to the Secretary of Health and Human 


kjohnson on DSK79L0C42PROD with BILLS
15 

•HR 3085 IH

1 Services $60,000,000 to carry out the amendments made 

2 by this section, to remain available until expended. 

Æ 


kjohnson on DSK79L0C42PROD with BILLS