I 
119TH CONGRESS 
1ST SESSION H. R. 3491 
To amend the Public Health Service Act to authorize the Secretary of Health 
and Human Services to carry out a program of research, training, 
and investigation related to Down syndrome, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 19, 2025 
Ms. DEGETTE (for herself, Mr. HUDSON, Ms. DELAURO, Mr. COLE, Ms. 
NORTON, and Mr. STAUBER) introduced the following bill; which was re-
ferred to the Committee on Energy and Commerce 
A BILL 
To amend the Public Health Service Act to authorize the 
Secretary of Health and Human Services to carry out 
a program of research, training, and investigation related 
to Down syndrome, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘DeOndra Dixon IN-
CLUDE Project Act of 2025’’. 
VerDate Sep 11 2014 
02:20 May 22, 2025
Jkt 059200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H3491.IH
H3491
kjohnson on DSK7ZCZBW3PROD with $$_JOB
SEC. 2. DEONDRA DIXON INCLUDE PROJECT. 
Part B of title IV of the Public Health Service Act 
(42 U.S.C. 284 et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 409K. DOWN SYNDROME RESEARCH. 
‘‘(a) IN GENERAL.—The Director of NIH shall carry 
out a program of research, training, and investigation re-
lated to Down syndrome to be known as the ‘INvestigation 
of Co-occurring conditions across the Lifespan to Under-
stand Down syndromE Project’ or the ‘INCLUDE 
Project’. 
‘‘(b) PROGRAM ELEMENTS.—The program under 
subsection (a) shall include— 
‘‘(1) high-risk, high-reward research on the ef-
fects of trisomy 21 on human development and 
health; 
‘‘(2) promoting research for participants with 
Down syndrome across the lifespan, including cohort 
studies to facilitate improved understanding of 
Down syndrome and co-occurring conditions and de-
velopment of new interventions; 
‘‘(3) expanding the number of clinical trials 
that are inclusive of, or expressly for, participants 
with Down syndrome, including novel biomedical and 
pharmacological interventions and other therapies 
VerDate Sep 11 2014 
02:20 May 22, 2025
Jkt 059200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H3491.IH
H3491
kjohnson on DSK7ZCZBW3PROD with $$_JOB
designed to promote or enhance activities of daily 
living; 
‘‘(4) research on the biological mechanisms in 
individuals with Down syndrome pertaining to struc-
tural, functional, and behavioral anomalies and dys-
function as well as stunted growth; 
‘‘(5) supporting research to improve diagnosis 
and treatment of conditions co-occurring with Down 
syndrome, including the identification of biomarkers 
related to risk factors, diagnosis, and clinical re-
search and therapeutics; 
‘‘(6) research on the causes of increased preva-
lence, and concurrent treatment, of co-occurring con-
ditions, such as Alzheimer’s disease and related de-
mentias and autoimmunity, in individuals with Down 
syndrome; and 
‘‘(7) research, training, and investigation on im-
proving the quality of life of individuals with Down 
syndrome and their families. 
‘‘(c) COORDINATION; PRIORITIZING NONDUPLICA-
TIVE RESEARCH.—The Director of NIH shall ensure 
that— 
‘‘(1) the programs and activities of the insti-
tutes and centers of the National Institutes of 
Health relating to Down syndrome and co-occurring 
VerDate Sep 11 2014 
02:20 May 22, 2025
Jkt 059200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H3491.IH
H3491
kjohnson on DSK7ZCZBW3PROD with $$_JOB
conditions are coordinated, including through the 
Office of the Director of NIH and priority-setting 
reviews conducted pursuant to section 402(b)(3); 
and 
‘‘(2) such institutes and centers, prioritize, as 
appropriate, Down syndrome research that does not 
duplicate existing research activities of the National 
Institutes of Health. 
‘‘(d) CONSULTATION
WITH
STAKEHOLDERS.—In 
carrying out activities under this section, the Director of 
NIH shall, as appropriate and to the maximum extent fea-
sible, consult with relevant stakeholders, including patient 
advocates, to ensure that such activities take into consid-
eration the needs of individuals with Down syndrome. 
‘‘(e) BIENNIAL REPORTS TO CONGRESS.— 
‘‘(1) IN GENERAL.—The Director of NIH shall 
submit, on a biennial basis, to the Committee on 
Energy and Commerce and the Subcommittee on 
Labor, Health and Human Services, Education, and 
Related Agencies of the Committee on Appropria-
tions of the House of Representatives and the Com-
mittee on Health, Education, Labor, and Pensions 
and the Subcommittee on Labor, Health and 
Human Services, Education, and Related Agencies 
of the Committee on Appropriations of the Senate, 
VerDate Sep 11 2014 
02:20 May 22, 2025
Jkt 059200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H3491.IH
H3491
kjohnson on DSK7ZCZBW3PROD with $$_JOB
a report that catalogs the research conducted or 
supported under this section. 
‘‘(2) CONTENTS.—Each report under para-
graph (1) shall include— 
‘‘(A) identification of the institute or cen-
ter involved; 
‘‘(B) a statement of whether the research 
is or was being carried out directly by such in-
stitute or center or by multiple institutes and 
centers; and 
‘‘(C) identification of any resulting real- 
world evidence that is or may be used for clin-
ical research and medical care for patients with 
Down syndrome.’’. 
Æ 
VerDate Sep 11 2014 
02:20 May 22, 2025
Jkt 059200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6301
E:\BILLS\H3491.IH
H3491
kjohnson on DSK7ZCZBW3PROD with $$_JOB