DeOndra Dixon INCLUDE Project Act of 2025
- Bill Number
- H.R. 3491
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2026-07-02: Placed on the Union Calendar, Calendar No. 627.
- Last Updated
- 2026-07-09T23:08:39Z
AI-Generated Summary
Purpose The legislation authorizes the Director of the National Institutes of Health (NIH) to establish and carry out a dedicated program of research, training, and investigation focused on Down syndrome, known as the INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project. It amends the Public Health Service Act to formalize this effort.
Key Provisions
- Creates a new Section 409K in Part B of Title IV of the Public Health Service Act (42 U.S.C. 284 et seq.).
- Requires the program to include: high-risk research on trisomy 21 effects; lifespan cohort studies on Down syndrome and co-occurring conditions; expanded clinical trials inclusive of individuals with Down syndrome; studies on biological mechanisms, biomarkers, and co-occurring conditions like Alzheimer's disease and autoimmunity; and efforts to improve quality of life.
- Mandates coordination among NIH institutes and centers to avoid duplicative research and prioritize non-duplicative projects.
- Requires consultation with stakeholders, including patient advocates, to align activities with the needs of individuals with Down syndrome.
- Directs biennial reports to specified congressional committees detailing research conducted, involved institutes, and any resulting real-world evidence for clinical use.
Significant Changes to Existing Law This bill introduces a new statutory section explicitly directing NIH to implement the INCLUDE Project, expanding on the agency's general research authority under the Public Health Service Act by specifying program elements, coordination requirements, and reporting obligations tailored to Down syndrome.
Potential Impacts
- On government agencies: Directs NIH resources and priorities toward Down syndrome research, potentially influencing funding allocations and institute activities.
- On citizens: Aims to support improved diagnosis, treatments, and quality-of-life outcomes for individuals with Down syndrome and their families through expanded research and clinical trials.
- No direct effects on international relations are outlined.
Main Stakeholders Affected
- Individuals with Down syndrome and their families.
- Patient advocacy groups.
- NIH institutes and centers.
- Congressional committees overseeing health appropriations and policy.
Notable Legal, Constitutional, or Political Implications The bill represents a standard exercise of Congress's authority to direct federal research programs through amendments to existing public health statutes. It contains no provisions raising constitutional concerns and reflects bipartisan sponsorship.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (18)
Rep. Hudson, Richard [R-NC-9], Rep. DeLauro, Rosa L. [D-CT-3], Rep. Cole, Tom [R-OK-4], Del. Norton, Eleanor Holmes [D-DC-At Large], Rep. Stauber, Pete [R-MN-8], Rep. Tonko, Paul [D-NY-20], Rep. Pettersen, Brittany [D-CO-7], Rep. Craig, Angie [D-MN-2], Rep. Crow, Jason [D-CO-6], Rep. Neguse, Joe [D-CO-2], Rep. Pocan, Mark [D-WI-2], Rep. Wagner, Ann [R-MO-2], Rep. Ross, Deborah K. [D-NC-2], Rep. Kustoff, David [R-TN-8], Rep. Subramanyam, Suhas [D-VA-10], Rep. Nadler, Jerrold [D-NY-12], Rep. Walkinshaw, James R. [D-VA-11], Rep. Wittman, Robert J. [R-VA-1]
Recent Actions
- 2026-07-02: Placed on the Union Calendar, Calendar No. 627.
- 2026-07-02: Reported by the Committee on Energy and Commerce. H. Rept. 119-722.
- 2026-07-02: Reported by the Committee on Energy and Commerce. H. Rept. 119-722.
- 2026-05-21: Ordered to be Reported by the Yeas and Nays: 46 - 0.
- 2026-05-21: Committee Consideration and Mark-up Session Held
- 2025-05-19: Referred to the House Committee on Energy and Commerce.
- 2025-05-19: Introduced in House
- 2025-05-19: Introduced in House
Bill Versions
- DeOndra Dixon INCLUDE Project Act of 2025 — issued 2025-05-19 — PDF (5 pages)
- DeOndra Dixon INCLUDE Project Act of 2025 — issued 2026-07-02 — PDF (8 pages)