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) | RFA OD 25 002

Opportunity Information: Apply for RFA OD 25 002

The National Institutes of Health (NIH) is offering a limited-competition cooperative agreement to support the continued operation and development of the INCLUDE Project Data Coordinating Center (DCC) under the INCLUDE initiative, which stands for INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE. The central purpose of this opportunity is to keep a dedicated coordinating hub in place that can manage, harmonize, and accelerate research data efforts tied to understanding Down syndrome and the health conditions that often occur alongside it across the full lifespan. The award mechanism is a U2C cooperative agreement (Clinical Trial Not Allowed), which typically means NIH expects substantial scientific and/or programmatic involvement with the awardee during the project period, and the scope is not intended to include independent clinical trials as part of the funded activities.

This funding opportunity is explicitly limited competition, meaning it is not broadly open to all potential applicants despite the wide list of organization types that NIH generally recognizes as eligible. In practical terms, only current recipients funded under the prior announcement RFA-OD-20-007 are eligible to apply for this continuation. While the notice lists many organization categories that can be eligible applicants in NIH programs (including state, local, and tribal governments; public and private institutions of higher education; nonprofit and for-profit entities; small businesses; and certain community-based organizations), the controlling eligibility condition is that the applicant must already be funded under the earlier RFA-OD-20-007 award for this DCC effort. The notice also clarifies limits related to foreign involvement: non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply, but foreign components (as defined by the NIH Grants Policy Statement) are allowed. In other words, the prime applicant organization must be U.S.-based and eligible under the limited-competition requirement, yet the project can still include certain foreign components when justified and compliant with NIH policy.

The opportunity is identified as RFA-OD-25-002 and is categorized as discretionary funding. It uses the cooperative agreement funding instrument, reflecting an expectation of close coordination with NIH. The activity area is listed under Health, Income Security and Social Services, and the associated CFDA (Assistance Listing) numbers span multiple NIH research support and disease-area listings (93.233, 93.837, 93.838, 93.839, 93.840, 93.865), signaling that this coordinating center work sits at the intersection of data infrastructure, multi-institute collaboration, and health research programs. The application deadline (original closing date) is 2024-12-12, and the opportunity was created on 2024-11-05.

From a functional standpoint, a project Data Coordinating Center in a large NIH initiative like INCLUDE generally serves as the backbone for multi-study collaboration. While the notice text provided is brief, the intent is clear: the DCC is expected to continue supporting the INCLUDE research ecosystem by organizing and standardizing data across participating projects, enabling secure data sharing, improving data quality and interoperability, and helping ensure that data generated across studies can be combined or compared in meaningful ways. This type of center often provides governance support (for example, data use procedures and coordination across working groups), develops common data elements or harmonization strategies, supports analytic and reporting infrastructure, and maintains platforms that allow researchers to find, access, and use data appropriately. The overarching emphasis is on understanding co-occurring conditions in people with Down syndrome over time, which requires longitudinal thinking, careful data stewardship, and coordination across diverse study designs and participant populations.

The award ceiling listed is $6,000,000, which indicates the scale NIH anticipates for the coordinating center responsibilities, though the final budget and scope would be shaped by NIH priorities and the cooperative agreement negotiations. The notice lists “ExpectedAwards:” but does not provide a number in the supplied text; for many DCC continuations, NIH often anticipates a small number of awards (sometimes a single award) consistent with the concept of one central coordinating center, but applicants would need to rely on the full NOFO for any definitive statement.

In summary, this NOFO is a continuation opportunity designed to keep the INCLUDE Data Coordinating Center operating and evolving, with NIH remaining actively involved through the cooperative agreement structure. It is limited to current awardees under the predecessor announcement, excludes foreign organizations as applicants while allowing foreign components, and sets a high-level budget ceiling appropriate for a major, cross-project data infrastructure and coordination role supporting Down syndrome research across the lifespan.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "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)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.837, 93.838, 93.839, 93.840, 93.865.
• This funding opportunity was created on 2024-11-05.
• Applicants must submit their applications by 2024-12-12. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $6,000,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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