PRIMED-AI: Multi-use Framework Playbooks (UG3 Clinical Trial Not Allowed)

The PRIMED-AI: Multi-use Framework Playbooks opportunity, formally listed as NOT-RM-25-020, is a forecasted grant initiative from the National Institutes of Health (NIH), under the U.S. Department of Health and Human Services. Specifically, it is a program coordinated by the NIH Common Fund in collaboration with other NIH Institutes and Centers. The Common Fund supports cross-cutting programs that address emerging scientific opportunities and pressing health challenges that cannot be adequately addressed by any single NIH Institute or Center alone. This opportunity falls under the Trans-NIH Research Support funding category and uses the UG3 activity code, which is designed for early-phase exploratory or developmental cooperative agreements. The central objective of the PRIMED-AI program is to promote the development of artificial intelligence (AI) tools that integrate clinical imaging with other types of multimodal health data. These tools are intended to support precision medicine approaches, particularly for individuals with chronic or complex health conditions. The Playbook initiative within this program focuses on supporting discrete pilot projects that produce guidance frameworks—or “playbooks”—to ensure responsible, effective, and ethical development and deployment of PRIMED-AI technologies. These playbooks are expected to address critical areas such as data ontology and linkage, model transparency and governance, error mitigation strategies, and regulatory readiness including potential pathways for FDA approval. The funding mechanism will be structured as a cooperative agreement, and clinical trials are not allowed under this announcement. The total estimated program funding is $650,000. Details on award ceilings, award floors, or the number of awards expected are not specified in the forecast and require further clarification once the final Notice of Funding Opportunity (NOFO) is released. There is no cost sharing or matching requirement. Eligible applicants include a wide range of entities such as federally recognized Native American tribal governments, state and county governments, public housing authorities, independent school districts, public and private institutions of higher education, for-profit and nonprofit organizations, and small businesses. Additional tribal organizations, even if not federally recognized, may also apply. This breadth of eligibility supports the collaborative and interdisciplinary nature of the research focus, and applicants with strong expertise in AI-driven imaging integration and multimodal data harmonization are particularly encouraged to prepare for this opportunity. As a forecasted opportunity, the grant is not yet open for application submissions. The NIH anticipates posting the official NOFO on July 1, 2025, with full applications due by November 1, 2025. Selected projects are expected to be awarded by September 1, 2026, with the same date targeted for project initiation. Although applications are not currently being accepted, the forecast aims to give interested applicants ample time to build collaborations, align projects with NIH priorities, and prepare strong, responsive proposals once the NOFO is live. For questions or additional details, interested parties may contact Dr. Sahana N. Kukke at the NIH Office of the Director/Common Fund. She can be reached by phone at 301-402-3756 or via email at ODPRIMED-AI@od.nih.gov. This early engagement notice allows potential applicants to begin conceptualizing and planning projects well in advance, positioning them to respond effectively when the opportunity is officially announced.

The notice encourages early collaboration and preparation, particularly among teams with expertise in AI and multimodal data integration.