PRIMED-AI: Validation Center (U54 Clinical Trial Not Allowed)

The PRIMED-AI: Validation Center (U54 Clinical Trial Not Allowed) grant opportunity, under the purview of the National Institutes of Health (NIH) Common Fund and other NIH Institutes and Centers (ICs), is a forthcoming funding initiative aimed at supporting precision medicine. The NIH Common Fund is known for spearheading cross-cutting programs that enable collaborative, transdisciplinary research across the NIH and the broader scientific community. This particular program, known as Precision Medicine with Artificial Intelligence - Integrating Imaging with Multimodal Data (PRIMED-AI), seeks to fund a specialized Validation Center. This center will function as a central entity responsible for verifying, validating, and characterizing the performance and reliability of AI-based clinical decision support (CDS) tools that integrate imaging with other health data types. The primary objective of the PRIMED-AI Validation Center is to act as an independent hub for rigorous third-party validation of deliverables developed under the broader PRIMED-AI program. These deliverables are AI-enabled, image-based multimodal CDS tools designed to enhance personalized healthcare decision-making for individuals with chronic or other significant health conditions. The Validation Center will carry out systematic retesting, harmonization, and uncertainty quantification of these tools, thereby enhancing confidence in their safety, efficacy, and generalizability. The funding mechanism for this opportunity is the U54 cooperative agreement, which is used by NIH to support complex, large-scale, multidisciplinary projects. This opportunity does not permit clinical trials. Rather, it emphasizes the technical and computational rigor needed to validate AI algorithms and systems in healthcare. Applicants are expected to possess deep expertise in the validation of AI models, including knowledge of failure modes and mechanisms for quantifying confidence in AI-generated predictions. The intention of this pre-solicitation notice is to allow adequate time for potential applicants to form collaborations, gather necessary resources, and develop competitive applications. The final Notice of Funding Opportunity (NOFO) is expected to be published on April 1, 2026. The projected application due date is June 1, 2026, with awards anticipated by March 1, 2027. The same date is also expected to serve as the project start date. As this is a forecasted opportunity, no applications are being solicited at this time. However, the NIH encourages interested parties to begin preparatory activities, particularly those aligned with the required technical expertise in AI validation. No pre-application concept papers or letters of intent are specified at this stage. Eligible applicants include a wide range of entities such as public and private institutions of higher education, nonprofits with 501(c)(3) status (excluding IHEs), tribal organizations and governments, county governments, independent school districts, public housing authorities, small businesses, and for-profit organizations that are not small businesses. There is no cost-sharing or matching requirement for this opportunity. For further inquiries, interested applicants are advised to contact Dr. Sahana N. Kukke at the NIH Common Fund via phone at 301-402-3756 or email at [email protected]. The assistance listing number associated with this opportunity is 93.310, and the estimated total program funding is $3.9 million. Detailed application instructions and program requirements will be provided in the full NOFO upon its release.