H.R. 3491: DeOndra Dixon INCLUDE Project Act of 2025
Sponsor
Diana DeGette
Democrat · CO-1
Down syndrome research gets a permanent NIH home
Why it matters
Every 2 years, NIH would have to show Congress what Down syndrome research it is actually funding and what evidence it is producing. H.R. 3491 turns the INCLUDE Project into a standing federal program and pushes research beyond childhood to daily living, Alzheimer’s, dementia, and autoimmunity.
H.R. 3491 would write the NIH INCLUDE Project into federal law, making Down syndrome research a permanent named program instead of an initiative that depends on agency priorities.
The bill tells NIH to study Down syndrome across the full lifespan. That includes basic science on trisomy 21, cohort studies that follow people over time, and more clinical trials that include people with Down syndrome or are designed specifically for them.
It also points NIH toward the health issues families often worry about most: co-occurring conditions, biomarkers, diagnosis, treatment, and quality of life. The bill specifically names Alzheimer’s disease, related dementias, and autoimmunity, and it allows research on therapies that help with activities of daily living.
Just as important, NIH would have to coordinate this work across its institutes instead of leaving it fragmented. The agency would be told to prioritize research that does not duplicate what NIH is already doing and to consult patient advocates and other stakeholders when setting priorities.
Congress would then get a report every 2 years showing which NIH institutes did the work, whether they collaborated, and what real-world evidence came out of it. That does not guarantee new funding, but it does create a clearer paper trail for whether this research is actually happening.
Bill Progress
Latest Action · Jul 21, 2026
Passed the House, received in Senate
H.R. 3491 Bill Summary
What H.R. 3491 actually does.
Down syndrome research becomes a standing NIH program
H.R. 3491 formally establishes the INCLUDE Project at NIH as an ongoing program for research, training, and investigation related to Down syndrome.
Research follows people across their whole lives
NIH would be directed to support studies across the lifespan, including cohort research designed to improve understanding of Down syndrome and related conditions over time.
More clinical trials can be built for Down syndrome patients
The bill supports expanding clinical trials that include people with Down syndrome or are expressly designed for them, including biomedical, drug, and daily-living therapies.
Alzheimer’s, dementia, and autoimmunity are explicitly included
The research agenda specifically covers co-occurring conditions, including Alzheimer’s disease, related dementias, and autoimmunity, along with diagnosis, treatment, and biomarker work.
NIH has to coordinate instead of duplicating work
NIH would have to coordinate Down syndrome research through the Director's office and prioritize projects that do not duplicate existing NIH research activities.
Congress gets a recurring scorecard
Every 2 years, NIH would have to report to key House and Senate health and appropriations committees on what research was done, which institutes were involved, and what real-world evidence resulted.
Who benefits from H.R. 3491?
People with Down syndrome
They are the focus of the bill's clinical trials, diagnosis, treatment, biomarker, and co-occurring-condition research — including studies that follow health needs from childhood through aging.
Families caring for someone with Down syndrome
The bill includes research on quality of life and therapies that support activities of daily living, reflecting the practical questions families face outside a lab.
Doctors and researchers who need better evidence
More coordinated NIH studies and biennial reporting could make it easier to see which institutes are producing usable data for clinical care and where research gaps remain.
Patient advocates
NIH would be expected to consult stakeholders, including patient advocates, when carrying out the program, giving advocates a formal opening to shape research priorities.
Who is affected by H.R. 3491?
National Institutes of Health
NIH would have to run the INCLUDE Project as a formal program, coordinate work across institutes, consult stakeholders, and send Congress a report every 2 years.
NIH institutes and centers
Institutes working on Down syndrome and related conditions would face more coordination and more visibility because reports must identify who did the research and whether multiple institutes worked together.
Congressional health and spending committees
Key House and Senate committees would receive regular reports that let lawmakers track whether NIH is producing distinct, usable Down syndrome research.
Researchers seeking NIH support
Projects that add something new may have an advantage because the bill tells NIH to prioritize nonduplicative research.
What Congress Is Saying
H.R. 3491 has come up 12 times in the Congressional Record so far.
H.R. 3491 also appeared in 1 more House floor reference and 7 routine cosponsor filings.
HR3491 Legislative Journey
Committee Action
Jul 21, 2026
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
House: Vote: 4649-4650
Jul 20, 2026
On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4649-4650)
House: Committee Action
Jul 2, 2026
Reported by the Committee on Energy and Commerce. H. Rept. 119-722.
House: Vote: 46-0
May 21, 2026
Ordered to be Reported by the Yeas and Nays: 46 - 0.
House: Committee Action
May 19, 2025
Referred to the House Committee on Energy and Commerce.
About the Sponsor
Diana DeGette
Democrat, Colorado's 1st congressional district · 29 years in Congress
Committees: Energy and Commerce
View full profile →
Cosponsors (18)
This bill has 18 cosponsors: 12 Democrats, 6 Republicans, reflecting bipartisan support. Cosponsors represent 11 states: Colorado, Connecticut, District of Columbia, and 8 more.
Richard Hudson
Republican · NC
Rosa DeLauro
Democrat · CT
Tom Cole
Republican · OK
Eleanor Norton
Democrat · DC
Pete Stauber
Republican · MN
Paul Tonko
Democrat · NY
Brittany Pettersen
Democrat · CO
Angie Craig
Democrat · MN
Jason Crow
Democrat · CO
Joe Neguse
Democrat · CO
Mark Pocan
Democrat · WI
Ann Wagner
Republican · MO
Committee Sponsors
Health, Education, Labor, and Pensions Committee
0 of 23 committee members cosponsored
No committee members have cosponsored this bill
Energy and Commerce Committee
2 of 54 committee members cosponsored
33 Democrats across these committees haven't cosponsored yet. Mobilize their constituents
H.R. 3491 Quick Facts
- Committee
- Health, Education, Labor, and Pensions
- Chamber
- House
- Policy
- Health
- Introduced
- May 19, 2025
Passed the House, received in Senate
Jul 21, 2026
Official Sources
Official bill status, text, actions, and summaries for the DeOndra Dixon INCLUDE Project Act of 2025.
Official NIH overview of the INCLUDE Project that H.R. 3491 would write into federal law as a standing program.
Official NIH explainer on clinical trials, relevant because the bill seeks to expand trials inclusive of or expressly for people with Down syndrome.
Official government-hosted text of the Public Health Service Act, which H.R. 3491 would amend by adding new section 409K.
H.R. 3491 Common Questions
What does H.R. 3491 actually do?
It makes the NIH INCLUDE Project a formal federal program for Down syndrome research, training, and investigation instead of leaving it as an internal initiative.
Does H.R. 3491 cover adults with Down syndrome or just children?
Adults too. The bill tells NIH to support research across the lifespan, including long-term cohort studies and work on aging-related conditions.
Would this bill expand clinical trials for people with Down syndrome?
Yes. H.R. 3491 supports more clinical trials that include people with Down syndrome or are designed specifically for them.
Does the bill include Alzheimer's and dementia research?
Yes. It specifically includes research on co-occurring conditions such as Alzheimer's disease and related dementias in people with Down syndrome.
Does H.R. 3491 mention autoimmunity?
Yes. The bill explicitly includes research on the increased prevalence of autoimmunity in people with Down syndrome and possible treatment approaches.
Would NIH have to listen to patient advocates under H.R. 3491?
Yes, as much as feasible. The bill says NIH should consult relevant stakeholders, including patient advocates, when carrying out the program.
Does H.R. 3491 provide new funding for Down syndrome research?
Not directly. The bill sets up the program in law, but it does not include a specific dollar amount for funding.
How often would NIH have to report to Congress?
Every 2 years. Those reports must show which NIH institutes did the research, whether they worked together, and what real-world evidence came from it.
Based on H.R. 3491 bill text
H.R. 3491 Bill Text
“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.”
Source: U.S. Government Publishing Office
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