H.R. 3491

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3491 Reported in House (RH)]

<DOC>

Union Calendar No. 627
119th CONGRESS
2d Session
H. R. 3491

[Report No. 119-722]

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 
referred to the Committee on Energy and Commerce

July 2, 2026

Additional sponsors: Mr. Tonko, Ms. Pettersen, Ms. Craig, Mr. Crow, Mr. 
Neguse, Mr. Pocan, Mrs. Wagner, Ms. Ross, Mr. Kustoff, Mr. Subramanyam, 
Mr. Nadler, Mr. Walkinshaw, and Mr. Wittman

July 2, 2026

Committed to the Committee of the Whole House on the State of the Union 
and ordered to be printed

_______________________________________________________________________

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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ``DeOndra Dixon INCLUDE Project Act of 
2025''.

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 related to Down syndrome to be 
known as the `INvestigation of Co-occurring conditions across the 
Lifespan to Understand 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 effects 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 development 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 designed to promote or 
enhance activities of daily living;
``(4) research on the biological mechanisms in individuals 
with Down syndrome pertaining to structural, functional, and 
behavioral anomalies and dysfunction 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 research and therapeutics;
``(6) research on the causes of increased prevalence, and 
concurrent treatment, of co-occurring conditions, such as 
Alzheimer's disease and related dementias and autoimmunity, in 
individuals with Down syndrome; and
``(7) research, training, and investigation on improving 
the quality of life of individuals with Down syndrome and their 
families.
``(c) Coordination; Prioritizing Nonduplicative Research.--The 
Director of NIH shall ensure that--
``(1) the programs and activities of the institutes and 
centers of the National Institutes of Health relating to Down 
syndrome and co-occurring 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 feasible, consult with relevant stakeholders, 
including patient advocates, to ensure that such activities take into 
consideration 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 Appropriations of the 
House of Representatives and the Committee 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, a report that 
catalogs the research conducted or supported under this 
section.
``(2) Contents.--Each report under paragraph (1) shall 
include--
``(A) identification of the institute or center 
involved;
``(B) a statement of whether the research is or was 
being carried out directly by such institute or center 
or by multiple institutes and centers; and
``(C) identification of any resulting real-world 
evidence that is or may be used for clinical research 
and medical care for patients with Down syndrome.''.
Union Calendar No. 627

119th CONGRESS

2d Session

H. R. 3491

[Report No. 119-722]

_______________________________________________________________________

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.

_______________________________________________________________________

July 2, 2026

Committed to the Committee of the Whole House on the State of the Union 
and ordered to be printed