H.R. 3491 – DeOndra Dixon INCLUDE Project Act of 2025

AI-Generated Summary

Updated July 24, 2026 at 3:52 AM UTC

The DeOndra Dixon INCLUDE Project Act of 2025 amends the Public Health Service Act to establish a dedicated NIH program for Down syndrome research, called the INCLUDE Project. The law directs the NIH to fund a broad range of studies—from basic science on trisomy 21 to clinical trials and quality‑of‑life initiatives—while coordinating efforts across institutes and consulting with patient advocates. It also requires regular reporting to Congress on the program’s activities and outcomes.

Key Provisions

Creates the “INCLUDE Project,” a National Institutes of Health (NIH) program focused on research, training, and investigation of Down syndrome.
Funds high‑risk, high‑reward studies on how trisomy 21 affects development and health, and supports cohort studies that follow people with Down syndrome across their lives.
Expands clinical trials that include or target participants with Down syndrome, testing new biomedical, pharmacological, and therapeutic approaches to improve daily functioning.
Supports research into the biological mechanisms behind structural, functional, behavioral, and growth differences in people with Down syndrome.
Funds work to improve diagnosis and treatment of conditions that often co‑occur with Down syndrome, such as Alzheimer’s disease, dementia, and autoimmune disorders, including the search for biomarkers.
Promotes research, training, and initiatives aimed at enhancing the quality of life for individuals with Down syndrome and their families.
Requires NIH to coordinate Down‑syndrome research across its institutes, avoid duplicate efforts, and prioritize non‑duplicative projects.
Mandates consultation with stakeholders, including patient advocates, to ensure research addresses the needs of the Down‑syndrome community.
Requires NIH to submit biennial reports to relevant congressional committees detailing the research conducted, the institutes involved, and any real‑world evidence generated.

Legislative Activity

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12 earlier actions

SenateIntro Referral Latest Action

Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

July 21, 2026

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HouseIntro Referral

Introduced in House

May 19, 2025

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

May 19, 2025

HouseCommittee

Committee Consideration and Mark-up Session Held

Energy and Commerce Committee

May 21, 2026

HouseCommittee

Ordered to be Reported by the Yeas and Nays: 46 - 0.

Energy and Commerce Committee

May 21, 2026

HouseCommittee

Reported by the Committee on Energy and Commerce. H. Rept. 119-722.

Energy and Commerce Committee

July 2, 2026

HouseCalendars

Placed on the Union Calendar, Calendar No. 627.

July 2, 2026

HouseFloor

Mr. Guthrie moved to suspend the rules and pass the bill.

July 20, 2026 • 3:57 PM

HouseFloor

Considered under suspension of the rules. (consideration: CR H4649-4651)

July 20, 2026 • 3:57 PM

HouseFloor

DEBATE - The House proceeded with forty minutes of debate on H.R. 3491.

July 20, 2026 • 3:57 PM

HouseFloor

Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4649-4650)

July 20, 2026 • 4:04 PM

HouseFloor

On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4649-4650)

July 20, 2026 • 4:04 PM

HouseFloor

Motion to reconsider laid on the table Agreed to without objection.

July 20, 2026 • 4:04 PM

SenateIntro Referral

Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

July 21, 2026

Floor Debate

4 members

What members said about H.R. 3491 on the floor

2 Republicans2 Democrats

Rep. Diana DeGetteD-CO-1 · Jul 20, 2026

Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, my bill with Representative Hudson, the DeOndra Dixon INCLUDE Project Act, codifies the renaissance in Down syndrome research at…

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, my bill with Representative Hudson, the DeOndra Dixon INCLUDE Project Act, codifies the renaissance in Down syndrome research at NIH that was kicked off when the INCLUDE Project began in 2018. This bill sustains and encourages this critical research.

After being left behind by NIH for nearly 20 years, the Down syndrome community is finally seeing research advancements that will extend and improve their lives. What we learn from this research will not only help us better understand Down syndrome but also heart disease, Alzheimer's, cancer, and many co-occurring conditions.

I am so proud that much of this work is happening right in my home district of Denver, Colorado. The Crnic Institute for Down syndrome on the Anschutz Medical Campus leads more than 200 scientists at the largest Down syndrome research facility in the world. They see incredible breakthroughs every day.

This type of innovation puts science first and benefits not only individuals living with Down syndrome and their families but every single one of us because we are learning more and more about disease biology and just why some conditions work differently in people with Down syndrome.

It is why the bill passed the House last Congress with unanimous support. I am so happy that I was able to work for many years with my friend, the former chair of the Energy and Commerce Committee, Cathy McMorris Rodgers, on this bill in the last Congress. I know it is a labor of love and deeply personal for her family and every family that has been touched by Down syndrome.

It has been an honor to also work with my constituent, Michelle Sie Whitten, the president of the Quincy Jones Exceptional Advocacy Award, a driving force for this bill, and a fierce advocate for her daughter and everyone with Down syndrome. It has also been an honor to work with my friend and colleague Representative Hudson, whose dedication to the Down syndrome community has been essential to push this bill closer to the finish line. I simply could not have had a better partner on this issue.

The INCLUDE Project Act will ensure that critical Down syndrome research continues to advance. This year, it must finally be enacted into law.

I urge my colleagues to join Representative Hudson and me to support the bill, and I reserve the balance of my time.

Mr. Speaker, I yield 2 minutes to the distinguished gentleman from New York (Mr. Tonko), another great advocate for this bill.

Mr. Speaker, I yield back the balance of my time.

Rep. Gabe EvansR-CO-8 · Jul 20, 2026

Speaker, I rise today in strong support of the Deondra Dixon INCLUDE Project Act of 2025. I was incredibly proud to support this bill as it made it's way through the legislative process in the Energy…

Rep. Paul TonkoD-NY-20 · Jul 20, 2026

Mr. Speaker, I thank my colleague from Colorado for yielding. I rise in strong support of the DeOndra Dixon INCLUDE Project Act and applaud my colleagues, Representative Diana DeGette and Richard…

Rep. Brett GuthrieR-KY-2 · Jul 20, 2026

Mr. Speaker, I move to suspend the rules and pass the bill (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…

Bill Text

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Referred in SenateIssued July 21, 2026

IIB

119th CONGRESS

2d Session

H. R. 3491

IN THE SENATE OF THE UNITED STATES

July 21, 2026

Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions

AN ACT

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.

1.

Short title

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

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:

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.

.

Passed the House of Representatives July 20, 2026.

Kevin F. McCumber,

Clerk.