Centers for Precision Disease Modeling (U54) (Clinical Trials Not Allowed) | PAR 24 305

Opportunity Information: Apply for PAR 24 305

The Centers for Precision Disease Modeling (U54) opportunity (PAR-24-305) is an NIH cooperative agreement designed to build and advance multi-disciplinary Centers that can translate findings from human genomics and personalized medicine into more predictive, precision animal models for preclinical research. The core idea is to close the gap between human genetic variation discovered in patients and the experimental systems used to test biology and potential interventions, by combining cutting-edge animal genomics, gene editing, and related technologies (including the creation of interspecies somatic hybrids where scientifically justified). These Centers are meant to function as national resources that not only run a set of focused research projects but also provide broadly useful model development and testing capabilities to the wider biomedical community.

A central requirement is that each Center establishes a clear, community-facing process for nominating unique human genomic variants for testing. In practice, this means building an intake and prioritization workflow that lets outside researchers propose variants of interest (for example, variants suspected to cause disease or modify disease risk), then moving selected variants through a cost-effective, high-throughput animal model pipeline. After confirming that the intended gene editing worked as expected, the Center is expected to carry out rigorous functional studies and deep phenotyping to determine what the variant does biologically and whether it drives disease-relevant traits. The emphasis is on comprehensive assays and phenotyping analyses that can meaningfully evaluate causality, mechanisms, and translational relevance, rather than simple confirmation that an edit exists.

Another major mission is resource creation, distribution, and service to the field. The Centers are expected to generate precision animal model resources and make them available to the broader research community, along with associated services and know-how. This includes establishing pipelines that support preclinical scientific discovery, robust disease modeling, and the development or testing of interventions grounded in these innovative models. Although each Center will likely focus its internal efforts on a limited number of targeted projects (to ensure depth and quality), it is expected to maintain flexible, multifaceted research and operational capabilities that can be adapted over time to support a wide range of diseases and variant types as community needs evolve.

This NOFO uses the U54 cooperative agreement mechanism, which typically indicates substantial NIH involvement in the program’s stewardship and coordination compared with a standard grant. Clinical trials are not allowed under this funding opportunity, so the work should remain in the preclinical and mechanistic space: model generation, validation, phenotyping, functional genomics, and translationally relevant preclinical studies, rather than interventional studies in human participants.

Eligibility is broad across U.S.-based organizations and governmental entities. Eligible applicants include state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other tribal organizations; public housing authorities/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3), excluding higher education where noted); for-profit organizations (other than small businesses); and small businesses. The NOFO also explicitly calls out additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, HBCUs, Tribally Controlled Colleges and Universities, eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. At the same time, it clearly excludes foreign participation as applicants or components: non-U.S. entities may not apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as NIH defines them) are not allowed.

Key administrative details from the posting include the NIH as the sponsoring agency, the health research activity category, CFDA number 93.351, and an original application closing date of 2024-12-15. The award ceiling and expected number of awards are not specified in the provided listing, so applicants would need to consult the full NOFO text for budget expectations, project period limits, and any programmatic caps or recommended funding levels.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Centers for Precision Disease Modeling (U54) (Clinical Trials Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.351.
• This funding opportunity was created on 2024-10-04.
• Applicants must submit their applications by 2024-12-15. (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 PAR 24 305

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