Omics Phenotypes Related to Down Syndrome for the INCLUDE Project (X01 Clinical Trial Not Allowed) | PAR 24 081

Opportunity Information: Apply for PAR 24 081

The NIH opportunity titled "Omics Phenotypes Related to Down Syndrome for the INCLUDE Project (X01 Clinical Trial Not Allowed)" (PAR-24-081) is designed to help researchers generate large, integrated datasets that connect genomic and other omics measurements to clinical and phenotypic information in people with Down syndrome. It sits under the NIH INCLUDE Project (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE), which is building shared resources to better understand why certain health conditions co-occur with Down syndrome over the lifespan and what molecular pathways may be driving those outcomes. The overall goal is discovery: producing well-annotated, high-volume omics data that can be combined across studies and reused by the wider research community to accelerate insights into mechanisms, biomarkers, and future therapeutic directions.

A key feature of this NOFO is that it is an X01 resource-access mechanism rather than a typical grant that provides direct research dollars to the applicant. In practical terms, applicants are not asking NIH for money to run the assays themselves. Instead, they are applying for access to INCLUDE-supported resources and infrastructure to perform large-scale omics generation on samples they already have (or can justify as appropriate for the project). Because of that structure, the expected value to successful applicants is the production of costly, standardized, large-scale data types through the INCLUDE Project system, with the resulting data becoming part of a broader Down syndrome data ecosystem.

The NOFO encourages proposals that perform omics assays on existing biospecimens collected from individuals with Down syndrome and appropriate control participants. It supports a wide range of omics modalities when scientifically justified, including whole genome sequencing (both short-read and long-read approaches), exome sequencing, epigenomic profiling, and transcriptome sequencing. It also allows for proteomics and metabolomics, along with single-cell methods such as single-cell RNA sequencing and ATAC sequencing. This breadth is meant to enable integrated, multi-layered views of biology, for example linking DNA variation to gene expression changes, epigenetic regulation, cell-type specific programs, protein abundance, and metabolite shifts that may be relevant to co-occurring conditions in Down syndrome.

Another major emphasis is improving representation. The NOFO specifically encourages applicants to propose cohorts that include underrepresented racial and ethnic groups, or to strengthen the diversity of existing collections by increasing racial and ethnic representation. This reflects a broader NIH priority to ensure that foundational datasets do not disproportionately reflect a narrow subset of the population, and that downstream discoveries and potential clinical applications are more likely to generalize across communities.

Data sharing is central to the program. The omics outputs, along with associated clinical and phenotypic data, will be deposited into an INCLUDE Project controlled-access database. That means the data are intended for broad research use, but with governance and access controls appropriate for sensitive human data. The expectation is that the community will be able to query, combine, and reanalyze these datasets, improving reproducibility and enabling cross-cohort comparisons that would be difficult for any single lab to assemble on its own.

Administrative details from the source information include that the sponsoring agency is the National Institutes of Health, the opportunity category is discretionary, and the funding instrument type is listed as a grant under an X01 mechanism with clinical trials not allowed. The CFDA numbers associated with the opportunity include 93.121, 93.172, 93.173, and 93.865. The original closing date is March 13, 2026. While an award ceiling and expected awards count are not specified in the provided listing, that is consistent with the idea that the primary "award" is access to centralized resources rather than a conventional budgeted research grant.

Eligibility is broad and spans many organization types, including state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; 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) and small businesses; and other entities. The NOFO also highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, faith-based or community-based organizations, certain tribal governments that are not federally recognized, regional organizations, US territories or possessions, eligible federal agencies, and even non-US (foreign) organizations. This wide eligibility aligns with the program's interest in reaching diverse cohorts and leveraging existing biospecimen collections wherever they are located, as long as the proposed work is well-justified and fits the INCLUDE data-sharing framework.

Overall, this opportunity is best understood as a way to plug valuable Down syndrome biospecimen collections into a national-scale omics generation and sharing pipeline. Successful projects will contribute standardized, high-dimensional datasets linked to clinical and phenotypic context, expanding the INCLUDE Project resource and enabling many downstream studies aimed at understanding the molecular mechanisms behind co-occurring health conditions in Down syndrome across the lifespan.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Omics Phenotypes Related to Down Syndrome for the INCLUDE Project (X01 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): 93.121, 93.172, 93.173, 93.865.
• This funding opportunity was created on 2023-12-05.
• Applicants must submit their applications by 2026-03-13. (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.

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