ENACT Act of 2021

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 dis- ease, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Equity in Neuroscience 4 and Alzheimer’s Clinical Trials Act of 2021’’ or the 5 ‘‘ENACT Act of 2021’’. 6 VerDate Sep 11 2014 04:15 Jun 10, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3085.IH H3085 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 3085 IH SEC. 2. INCENTIVES, IMPROVEMENTS, AND OUTREACH TO 1 INCREASE DIVERSITY IN ALZHEIMER’S DIS- 2 EASE RESEARCH. 3 (a) IMPROVING ACCESS FOR AND OUTREACH TO 4 UNDERREPRESENTED POPULATIONS.— 5 (1) EXPANDING ACCESS TO ALZHEIMER’S RE- 6 SEARCH CENTERS.— 7 (A) IN GENERAL.—Section 445(a)(1) of 8 the Public Health Service Act (42 U.S.C. 285e– 9 2(a)(1)) is amended— 10 (i) by striking ‘‘(a)(1) The Director of 11 the Institute may’’ and inserting the fol- 12 lowing: 13 ‘‘(a)(1) The Director of the Institute— 14 ‘‘(A) may’’; 15 (ii) by striking ‘‘disease.’’ and insert- 16 ing ‘‘disease; and’’; and 17 (iii) by adding at the end the fol- 18 lowing: 19 ‘‘(B) beginning January 1, 2022, shall enter 20 into cooperative agreements and make grants to 21 public or private nonprofit entities under this sub- 22 section for the planning, establishment, and oper- 23 ation of new such centers that are located in areas 24 with a higher concentration of minority groups (as 25 determined under section 444(d)(3)(D)), such as en- 26 VerDate 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 tities that are historically Black colleges and univer- 1 sities, Hispanic-serving institutions, Tribal colleges 2 and universities, or centers of excellence for other 3 minority populations.’’. 4 (B) USE OF FUNDING FOR CLINICS TO OP- 5 ERATE CLINICAL TRIALS.—Section 445(b) of 6 the Public Health Service Act (42 U.S.C. 285e– 7 2(b)) is amended by adding at the end the fol- 8 lowing: 9 ‘‘(3) Federal payments made under a cooperative 10 agreement or grant under subsection (a) from funds made 11 available under section 2(g) of the ENACT Act of 2021 12 shall, with respect to Alzheimer’s disease, be used in part 13 to establish and operate diagnostic and treatment clinics 14 designed— 15 ‘‘(A) to meet the special needs of minority and 16 rural populations and other underserved populations; 17 and 18 ‘‘(B) to operate clinical trials’’. 19 (2) OUTREACH.— 20 (A) ALZHEIMER’S DISEASE CENTERS.— 21 Section 445(b) of the Public Health Service Act 22 (42 U.S.C. 285e–2(b)), as amended by para- 23 graph (1)(B), is further amended by adding at 24 the end the following new paragraph: 25 VerDate Sep 11 2014 04:15 Jun 10, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3085.IH H3085 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 3085 IH ‘‘(4) Federal payments made under a cooperative 1 agreement or grant under subsection (a) shall be used to 2 establish engagement centers to carry out public outreach, 3 education efforts, and dissemination of information for 4 members of minority groups about clinical trial participa- 5 tion. Activities funded pursuant to the preceding sentence 6 shall include— 7 ‘‘(A) using established mechanisms to encour- 8 age members of minority groups to participate in 9 clinical trials on Alzheimer’s disease; 10 ‘‘(B) expanding education efforts to make mem- 11 bers of minority groups aware of ongoing clinical 12 trials; 13 ‘‘(C) working with trial sponsors to increase the 14 number of recruitment events for members of minor- 15 ity groups; 16 ‘‘(D) conducting outreach to national, State, 17 and local physician professional organizations, espe- 18 cially for members of such organizations who are 19 primary care physicians or physicians who specialize 20 in dementia, to increase awareness of clinical re- 21 search opportunities for members of minority 22 groups; and 23 VerDate Sep 11 2014 04:15 Jun 10, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3085.IH H3085 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 3085 IH ‘‘(E) using community-based participatory re- 1 search methodologies to engage with minority popu- 2 lations.’’. 3 (B) RESOURCE CENTERS FOR MINORITY 4 AGING RESEARCH.—Section 444(c) of the Pub- 5 lic Health Service Act (42 U.S.C. 285e–1(c)) is 6 amended— 7 (i) by striking ‘‘(c)’’ and inserting 8 ‘‘(c)(1)’’ ; and 9 (ii) by adding at the end the following 10 new paragraph: 11 ‘‘(2) The Director, acting through the Resource Cen- 12 ters for Minority Aging Research of the Institute, shall 13 carry out public outreach, education efforts, and dissemi- 14 nation of information for members of minority groups 15 about participation in clinical research on Alzheimer’s dis- 16 ease carried out or supported under this subpart.’’. 17 (b) INCENTIVES TO INCREASE DIVERSITY IN ALZ- 18 HEIMER’S DISEASE RESEARCH THROUGH PRINCIPAL IN- 19 VESTIGATORS AND RESEARCHERS FROM UNDERREP- 20 RESENTED POPULATIONS.— 21 (1) ALZHEIMER’S CLINICAL RESEARCH AND 22 TRAINING AWARDS.—Section 445I of the Public 23 Health Service Act (42 U.S.C. 285e–10a) is amend- 24 VerDate 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 ed by adding at the end the following new sub- 1 section: 2 ‘‘(d) ENHANCING THE PARTICIPATION OF PRINCIPAL 3 INVESTIGATORS AND RESEARCHERS WHO ARE MEMBERS 4 OF UNDERREPRESENTED POPULATIONS.— 5 ‘‘(1) IN GENERAL.—The Director shall enhance 6 diversity in the conduct or support of clinical re- 7 search on Alzheimer’s disease under this subpart by 8 encouraging the participation of individuals from 9 groups that are underrepresented in the biomedical, 10 clinical, behavioral, and social sciences as principal 11 investigators of such clinical research, as researchers 12 for such clinical research, or both. 13 ‘‘(2) TRAINING FOR PRINCIPAL INVESTIGA- 14 TORS.—The Director of the Institute shall provide 15 training for principal investigators who are members 16 of a minority group with respect to skills for— 17 ‘‘(A) the design and conduct of clinical re- 18 search and clinical protocols; 19 ‘‘(B) applying for grants for clinical re- 20 search; and 21 ‘‘(C) such other areas as the Director de- 22 termines to be appropriate.’’. 23 (2) SENIOR RESEARCHER AWARDS.—Section 24 445B(a) of the Public Health Service Act (42 25 VerDate Sep 11 2014 04:15 Jun 10, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3085.IH H3085 kjohnson on DSK79L0C42PROD with BILLS 7 •HR 3085 IH U.S.C. 285e–4(a)) is amended by inserting ‘‘, in- 1 cluding senior researchers who are members of a mi- 2 nority group’’ before the period at the end of the 3 first sentence. 4 (c) INCENTIVES TO INCREASE DIVERSITY IN ALZ- 5 HEIMER’S DISEASE RESEARCH THROUGH TRIAL SITES.— 6 Section 444(d) of the Public Health Service Act (42 7 U.S.C. 285e–1(d)) is amended— 8 (1) by striking ‘‘(d)’’ and inserting ‘‘(d)(1)’’ ; 9 and 10 (2) by adding at the end the following new 11 paragraphs: 12 ‘‘(2) In conducting or supporting clinical research on 13 Alzheimer’s disease for purposes of this subpart, in addi- 14 tion to requirements otherwise imposed under this title, 15 including under section 492B, the Director of the Institute 16 shall increase the participation of members of minority 17 groups in such clinical research through one or more of 18 the activities described in paragraph (3). 19 ‘‘(3)(A) The Director of the Institute shall provide 20 incentives for the support of clinical research on Alz- 21 heimer’s disease with clinical trial sites established in 22 areas with a higher concentration of minority groups, in- 23 cluding rural areas if practicable. 24 VerDate Sep 11 2014 04:15 Jun 10, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3085.IH H3085 kjohnson on DSK79L0C42PROD with BILLS 8 •HR 3085 IH ‘‘(B) In determining whether to conduct or support 1 clinical research on Alzheimer’s disease, the Director of 2 the Institute shall encourage the conduct of clinical re- 3 search with clinical trial sites in areas described in sub- 4 paragraph (A) as a higher-level priority criterion among 5 the criteria established to evaluate whether to conduct or 6 support clinical research. 7 ‘‘(C) In determining the amount of funding to be pro- 8 vided for the conduct or support of such clinical research, 9 the Director of the Institute shall provide additional fund- 10 ing for the conduct of such clinical research with clinical 11 trial sites in areas described in subparagraph (A). 12 ‘‘(D) In determining whether an area is an area with 13 a higher concentration of minority groups, the Director 14 of the Institute— 15 ‘‘(i) shall consider the most recent data col- 16 lected by the Bureau of the Census; and 17 ‘‘(ii) may also consider— 18 ‘‘(I) data from the Centers for Medicare & 19 Medicaid Services on the incidence of Alz- 20 heimer’s disease in the United States by region; 21 and 22 ‘‘(II) such other data as the Director de- 23 termines appropriate. 24 VerDate Sep 11 2014 04:15 Jun 10, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H3085.IH H3085 kjohnson on DSK79L0C42PROD with BILLS 9 •HR 3085 IH ‘‘(4) In order to facilitate the participation of mem- 1 bers of minority groups in clinical research supported 2 under this subpart, in addition to activities described in 3 paragraph (3), the Director of the Institute shall— 4 ‘‘(A) ensure that such clinical research uses 5 community-based participatory research methodolo- 6 gies; and 7 ‘‘(B) encourage the use of remote health tech- 8 nologies, including telehealth, remote patient moni- 9 toring, and mobile technologies, that reduce or elimi- 10 nate barriers to participation of members of minor- 11 ity groups in such clinical research. 12 ‘‘(5)(A) Clinical research on Alzheimer’s disease con- 13 ducted or supported under this subpart shall ensure that 14 such research includes outreach activities designed to in- 15 crease the participation of members of minority groups in 16 such research. 17 ‘‘(B)(i) Each applicant for a grant under this subpart 18 for clinical research on Alzheimer’s disease shall submit 19 to the Director of the Institute in the application for such 20 grant— 21 ‘‘(I) a budget for outreach activities to members 22 of minority populations with respect to participation 23 in such clinical research; and 24 VerDate Sep 11 2014 04:15 Jun 10, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H3085.IH H3085 kjohnson on DSK79L0C42PROD with BILLS 10 •HR 3085 IH ‘‘(II) a description of the plan to conduct such 1 outreach. 2 ‘‘(ii) The Director of the Institute shall encourage ap- 3 plicants for, and recipients of, grants under this subpart 4 to conduct clinical research on Alzheimer’s disease to en- 5 gage with community-based organizations to increase par- 6 ticipation of minority populations in such research. 7 ‘‘(6) For purposes of this subpart: 8 ‘‘(A) The term ‘clinical research’ includes a 9 clinical trial. 10 ‘‘(B) The term ‘minority group’ has the mean- 11 ing given such term by reason of section 492B(g).’’. 12 (d) PARTICIPANT ELIGIBILITY CRITERIA.—Section 13 445I of the Public Health Service Act (42 U.S.C. 285e– 14 10a), as amended by subsection (b)(1), is further amended 15 by adding at the end the following new subsection: 16 ‘‘(e) PARTICIPANT ELIGIBILITY CRITERIA.—The Di- 17 rector of the Institute shall take such actions as are nec- 18 essary to ensure that clinical research on Alzheimer’s dis- 19 ease conducted or supported under this subpart is de- 20 signed with eligibility criteria that ensure the clinical trial 21 population reflects the diversity of the prospective patient 22 population. Such actions may include the following: 23 ‘‘(1) EXAMINATION OF CRITERIA.— 24 VerDate Sep 11 2014 04:15 Jun 10, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H3085.IH H3085 kjohnson on DSK79L0C42PROD with BILLS 11 •HR 3085 IH ‘‘(A) IN GENERAL.—An examination of 1 each exclusion criterion to determine if the cri- 2 terion is necessary to ensure the safety of trial 3 participants or to achieve the study objectives. 4 ‘‘(B) MODIFICATION OF CRITERIA.—In the 5 case of an exclusion criterion that is not nec- 6 essary to ensure the safety of trial participants 7 or to achieve the study objectives— 8 ‘‘(i) encouraging the modification or 9 elimination of the criterion; or 10 ‘‘(ii) encouraging tailoring the cri- 11 terion as narrowly as possible to avoid un- 12 necessary limits to the population of the 13 clinical study. 14 ‘‘(2) REQUIREMENT FOR STRONG JUSTIFICA- 15 TION FOR EXCLUSION.—A review of each exclusion 16 criterion to ensure that populations are included in 17 clinical trials, such as older adults, individuals with 18 a mild form of disease, individuals at the extremes 19 of the weight range, or children, unless there is a 20 strong clinical or scientific justification to exclude 21 them. 22 ‘‘(3) USE OF ADAPTIVE DESIGN.—Encouraging 23 the use of an adaptive clinical trial design that— 24 VerDate Sep 11 2014 04:15 Jun 10, 2021 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H3085.IH H3085 kjohnson on DSK79L0C42PROD with BILLS 12 •HR 3085 IH ‘‘(A) starts with a defined population 1 where there are concerns about safety; and 2 ‘‘(B) may expand to a broader population 3 based on initial data from the trial and external 4 data.’’. 5 (e) RESOURCE CENTER FOR SUCCESSFUL STRATE- 6 GIES TO INCREASE PARTICIPATION OF UNDERREP- 7 RESENTED POPULATIONS IN ALZHEIMER’S DISEASE 8 CLINICAL RESEARCH.—Section 444 of the Public Health 9 Service Act (42 U.S.C. 285e–1) is amended by adding at 10 the end the following new subsection: 11 ‘‘(e)(1) Acting through the Office of Special Popu- 12 lations and in consultation with the Division of Extra- 13 mural Activities, the Director of the Institute shall support 14 resource information and technical assistance to grantees 15 under section 445 (relating to Alzheimer’s disease cen- 16 ters), other grantees, and prospective grantees, designed 17 to increase the participation of minority populations in 18 clinical r [Text truncated for display. 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