Down Syndrome Clinical Cohort Coordinating Center (DS-4C) for the INCLUDE Project (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) (U54 Clinical Trial Not Allowed) | RFA OD 24 005

Opportunity Information: Apply for RFA OD 24 005

The National Institutes of Health (NIH) is soliciting applications for a Down Syndrome Clinical Cohort Coordinating Center (DS-4C) under the NIH INCLUDE Project (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE). The overall purpose of INCLUDE is to improve health and quality of life for people with Down syndrome by strengthening research infrastructure and enabling deeper, lifespan-oriented study of conditions that commonly co-occur with Down syndrome. This particular funding opportunity focuses on creating a central coordinating hub that can organize, align, and accelerate a new Down Syndrome Cohort Development Program (DS-CDP), rather than directly running clinical trials; the mechanism is explicitly labeled “Clinical Trial Not Allowed.”

The award uses a U54 cooperative agreement mechanism, which typically means the NIH expects substantial involvement with the funded center beyond standard grant oversight. In practical terms, DS-4C is meant to function as the backbone for a broader cohort-building effort: it will handle overall coordination, communications, and outreach; support the development of new cohorts of individuals with Down syndrome; and curate the metadata generated from those cohorts so the resulting datasets are findable, usable, and consistent across sites. The emphasis on metadata curation signals that NIH is prioritizing harmonization and future reuse, so that data coming from multiple cohorts and institutions can be combined or compared without each project reinventing standards or documentation.

This NOFO is positioned within a larger, interconnected program structure. A companion funding opportunity (RFA-OD-23-052) supports the Cohort Research Sites that will do on-the-ground cohort recruitment and data collection. Another related NOFO (RFA-OD-23-054) supports a Federated Biobanking Resource, indicating that biological specimens and related data are expected to be managed in a coordinated way across the INCLUDE ecosystem. The DS-4C coordinating center is therefore expected to work across these components, helping ensure that cohort sites and the biobanking resource operate with aligned practices, shared definitions, and compatible data/metadata standards, while also keeping the overall program moving toward INCLUDE-wide goals.

A notable application requirement is the Plan for Enhancing Diverse Perspectives (PEDP). The PEDP is not optional: it is assessed during scientific and technical peer review, and applications that do not include a PEDP are considered incomplete and will be withdrawn. This requirement highlights NIH’s intent to strengthen the breadth of perspectives involved in the work and, by extension, to improve how well cohorts represent the real-world diversity of individuals with Down syndrome and their families. Applicants are encouraged to use NIH’s PEDP guidance materials and follow the instructions carefully, suggesting that the plan should be concrete and integrated into the center’s management, staffing, engagement, and operational approach rather than treated as a generic statement.

Eligibility is broad and includes many common U.S. applicant types such as state, county, and city governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other eligible entities. The NOFO also explicitly calls out additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, and U.S. territories or possessions, reflecting a clear interest in expanding participation across institution types and communities.

The geographic rules are specific: non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply as the applicant organization. However, non-domestic components of U.S. organizations are eligible, and foreign components (as NIH defines them in its Grants Policy Statement) are allowed. This means a U.S.-based applicant may include certain international elements or collaborations if structured appropriately, but the prime awardee must be domestic.

Key administrative details included in the source data are: Funding Opportunity Number RFA-OD-24-005; agency NIH; funding instrument cooperative agreement; and an original closing date of January 26, 2024. The opportunity is listed under multiple CFDA numbers (93.172, 93.233, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.865, 93.866), reflecting NIH’s multi-institute involvement and the cross-cutting nature of Down syndrome research across conditions and lifespan stages. The award ceiling and expected number of awards were not specified in the provided listing, which typically means applicants should rely on the full NOFO text and NIH communications for budget expectations and program scale.

Taken together, this funding opportunity is best understood as an infrastructure and coordination award designed to make multiple new Down syndrome cohorts possible, consistent, and useful to the wider research community. The DS-4C is expected to provide program-level leadership in cohort development support, stakeholder outreach, and rigorous metadata stewardship so that data emerging from the DS-CDP can be integrated, discovered, and leveraged for future scientific questions aimed at improving care and outcomes for people with Down syndrome.

• The National Institutes of Health in the food and nutrition, health, income security and social services sector is offering a public funding opportunity titled "Down Syndrome Clinical Cohort Coordinating Center (DS-4C) for the INCLUDE Project (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) (U54 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): 93.172, 93.233, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.865, 93.866.
• This funding opportunity was created on 2023-10-19.
• Applicants must submit their applications by 2024-01-26. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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.

Apply for RFA OD 24 005

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