Limited Competition: Continued Development of INCLUDE (Investigation of Co-occurring Conditions across the Lifespan to Understand Down syndromE) Project Data Coordinating Center (U2C Clinical Trial Not Allowed)

Background
The National Institutes of Health (NIH) is issuing this limited competition Notice of Funding Opportunity (NOFO) to solicit continued participation as the Data Coordinating Center for the INCLUDE Project, which investigates co-occurring conditions across the lifespan to understand Down syndrome.

The mission of the NIH, particularly through the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), is to ensure that every person is born healthy and wanted, and that all children have the opportunity to achieve their full potential for healthy and productive lives. This initiative aims to address significant health challenges faced by individuals with Down syndrome, who often experience a range of co-occurring conditions that impact their quality of life.

Grant Details
The recipient funded by this NOFO will be responsible for three broad responsibilities:
1) Constructing a Data Hub Core that integrates and shares INCLUDE Project data through a web-based data portal, data repository services, integrated cloud analysis platforms, and associated infrastructure;
2) Serving as a Data Management Core (DMC) that coordinates the collection, processing, harmonization, and sharing of phenotypic, genomic, and other -omics data generated from Down syndrome cohorts;
3) Developing and managing an Administrative and Outreach Core (AOC) that oversees administrative logistics and outreach activities.

The AOC will facilitate communication between stakeholders, organize training sessions on using the Data Hub, maintain a registry of investigators participating in the INCLUDE program, and create newsletters to disseminate information about DCC activities. The DMC will also support a centralized Virtual Biorepository resource for coordinating biospecimen repositories relevant to Down syndrome research.

Eligibility Requirements
Only current recipients funded under RFA-OD-20-007 are eligible to apply. Non-domestic entities are not eligible to apply. Individuals from diverse backgrounds are encouraged to apply.

Period of Performance
The maximum project period is 5 years.

Grant Value
$6 million total costs in FY 2025 to fund one award; application budgets are limited to up to $6 million total costs per year.