In the nature of a substitute.

This amendment, proposed by Mr. Hickenlooper and Mr. Moran, aims to change the bill S. 1838 by striking everything after the enacting clause and inserting new text to create the DeOndra Dixon INCLUDE Project Act of 2026.

The purpose of this amendment is to add a section to the Public Health Service Act that requires the Director of the NIH to run a program of research, training, and investigation regarding Down syndrome, known as the INCLUDE Project.

Program Goals

The amendment specifies that the program will focus on:

• High-risk, high-reward research on how trisomy 21 affects human health and development.
• Promoting research and cohort studies for participants with Down syndrome across their lifespan to understand the condition and co-occurring conditions.
• Increasing clinical trials for participants with Down syndrome, including therapies and interventions to enhance daily living.
• Researching biological mechanisms related to dysfunction, behavioral anomalies, structural anomalies, and stunted growth.
• Improving the diagnosis and treatment of co-occurring conditions, including finding related biomarkers.
• Researching the causes and treatment of co-occurring conditions like autoimmunity and Alzheimer's disease and related dementias.
• Research and training to improve the quality of life for families and individuals with Down syndrome.

Accountability and Coordination

To keep the program efficient and responsive, the amendment requires the Director of the NIH to:

• Coordinate activities across NIH institutes and centers to ensure research does not duplicate existing activities.
• Consult with stakeholders and patient advocates to consider the needs of people with Down syndrome.
• Submit reports every two years to specific House and Senate committees. These reports must identify the centers involved, whether the research was direct or shared, and any real-world evidence that can be used for medical care and clinical research.