U.S.C. 285e–4(a)) is amended by inserting ‘‘, in-
cluding senior researchers who are members of a mi-
nority group’’ before the period at the end of the 
first sentence. 
(c) INCENTIVES TO INCREASE DIVERSITY IN ALZ-
HEIMER’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 addi-
tion 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 Alz-
heimer’s disease with clinical trial sites established in 
areas with a higher concentration of minority groups, in-
cluding rural areas if practicable. 
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‘‘(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 re-
search with clinical trial sites in areas described in sub-
paragraph (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 pro-
vided for the conduct or support of such clinical research, 
the Director of the Institute shall provide additional fund-
ing 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 col-
lected by the Bureau of the Census; and 
‘‘(ii) may also consider— 
‘‘(I) data from the Centers for Medicare & 
Medicaid Services on the incidence of Alz-
heimer’s disease in the United States by region; 
and 
‘‘(II) such other data as the Director de-
termines appropriate. 
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‘‘(4) In order to facilitate the participation of mem-
bers 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 methodolo-
gies; and 
‘‘(B) encourage the use of remote health tech-
nologies, including telehealth, remote patient moni-
toring, and mobile technologies, that reduce or elimi-
nate barriers to participation of members of minor-
ity groups in such clinical research. 
‘‘(5)(A) Clinical research on Alzheimer’s disease con-
ducted or supported under this subpart shall ensure that 
such research includes outreach activities designed to in-
crease 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 
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‘‘(II) a description of the plan to conduct such 
outreach. 
‘‘(ii) The Director of the Institute shall encourage ap-
plicants for, and recipients of, grants under this subpart 
to conduct clinical research on Alzheimer’s disease to en-
gage with community-based organizations to increase par-
ticipation 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 mean-
ing 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 Di-
rector of the Institute shall take such actions as are nec-
essary to ensure that clinical research on Alzheimer’s dis-
ease conducted or supported under this subpart is de-
signed 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.— 
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‘‘(A) IN
GENERAL.—An examination of 
each exclusion criterion to determine if the cri-
terion 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 nec-
essary 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 cri-
terion as narrowly as possible to avoid un-
necessary limits to the population of the 
clinical study. 
‘‘(2) REQUIREMENT
FOR
STRONG
JUSTIFICA-
TION 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— 
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‘‘(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 STRATE-
GIES
TO
INCREASE
PARTICIPATION
OF
UNDERREP-
RESENTED
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 Popu-
lations and in consultation with the Division of Extra-
mural Activities, the Director of the Institute shall support 
resource information and technical assistance to grantees 
under section 445 (relating to Alzheimer’s disease cen-
ters), other grantees, and prospective grantees, designed 
to increase the participation of minority populations in 
clinical research on Alzheimer’s disease conducted or sup-
ported under this subpart. 
‘‘(2) The resource information and technical assist-
ance provided under paragraph (1) shall include the main-
tenance 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 
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under this subpart and other researchers in the develop-
ment of the clinical research designed to increase the par-
ticipation of minority populations in such clinical re-
search.’’. 
(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 Re-
search, 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 Alz-
heimer’s disease conducted during the preceding year: 
‘‘(A) The number of participants who are mem-
bers of a minority group in such clinical trials. 
‘‘(B) The number of such clinical trials for 
which incentives under subsection (d)(3) were made 
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available, the nature of such incentives, the amount 
of increased funding (if any) made available for re-
search on Alzheimer’s disease, and the training pro-
vided 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 mi-
nority 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, includ-
ing through posting on the appropriate website of the De-
partment 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 
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Services $60,000,000 to carry out the amendments made 
by this section, to remain available until expended. 
Æ 
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