Validation Center for Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) (U54 Clinical Trials Not Allowed)

Closed Posted

Opportunity number
RFA-RM-27-014
Agency
Applications due
Award size
Up to $2,000,000

Opportunity facts

Assistance listings
Funding instrument
Cooperative Agreement
Category
  • Health
Eligible applicants
  • Special District Governments
  • Other
  • Small Businesses
  • Independent School Districts
  • 501(c)(3) Nonprofits
  • Public or Indian Housing Auth.
  • For Profit Organizations
  • Tribal Governments (Federally Recognized)
  • State Governments
  • Non-501(c)(3) Nonprofits
  • Higher Education Inst. (Public)
  • Higher Education Inst. (Private)
  • County Governments
  • Tribal Organizations (Not Federally Recognized)
  • City/Township Governments
Points of contact

Opportunity details come from Grants.gov. Updated .

About this opportunity

The National Institutes of Health Common Fund, with other NIH Institutes and Centers, intends to publish a Notice of Funding Opportunity to solicit applications for a Validation Center under the Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) program by October 2, 2026. This is a single-award cooperative agreement with an expected award of approximately $2.7 million in FY2027. Applications are due September 2, 2026, with an earliest start date of October 2, 2026.

Eligible applicants include higher education institutions (public and private), nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations, state and local governments, tribal governments and organizations, and special district governments. Foreign organizations, non-domestic entities, and foreign components of U.S. organizations are not eligible.

The first-year budget is capped at $2 million in direct costs, with a maximum of $3.2 million annually in years two through five. The project period runs up to five years. This award mechanism signals substantial NIH programmatic involvement throughout the grant period.

The Validation Center will serve as an independent hub for third-party verification, validation, interoperability, and uncertainty quantification of AI-enabled, image-based, multimodal Clinical Decision Support tools developed by the PRIMED-AI Consortium. Applications must establish three cores: a Validation Core for independent AI tool validation and reproducibility assessment; a Translation Core to develop sustainable tools for regulatory clinical translation support; and a Fast-track Core to fund sub-projects addressing unmet clinical and data science needs. For years two through five, the Fast-track Core must reserve $1.5 million annually in restricted funds for collaborations with other consortium members, with at least 75 percent directed to external collaborators.

Applications must use multi-PD/PI structure with at least 2 person-months commitment from one PI and 1 person-month from others, plus a dedicated project manager with 6 person-months minimum. Applicants must develop a coordination plan with other PRIMED-AI award recipients, establish continuous sequestration and annotation of independent validation data, implement standardized evaluation protocols, and develop technical validation guidelines for regulatory interaction.

The program utilizes the U54 activity code and falls under CFDA 93.310 (Trans-NIH Research Support).

Synopsis

The overarching goal of this notice of funding opportunity (NOFO) and its companion opportunities is to establish the Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) Program to support development of innovative, reliable, cost-effective, and sustainable multimodal AI-based clinical decision support (CDS) tools. PRIMED-AI CDS tools are based on the integration of clinical imaging with other types of multimodal health data to enhance care for patients with a wide range of health conditions. The PRIMED-AI Program seeks to catalyze the adoption of AI-based CDS tools into clinical workflows to enable novel personalized medicine strategies that address significant health challenges. The purpose of this NOFO is to solicit applications for the creation of a Validation Center to serve as a dedicated hub for the comprehensive evaluation and characterization of AI-enabled, image-based, multimodal CDS tools developed by the PRIMED-AI Consortium, to ensure these tools are reliable, reproducible, and generalizable. The Validation Center will focus on verification, validation, interoperability, and uncertainty quantification to comprehensively characterize performance of the CDS tools developed by the program. The core functions of the Validation Center will involve the systematic validation of PRIMED-AI Consortium deliverables, including those emerging from award recipients under the Playbook, Data-to-Model Academic-Industrial Partnerships, and Model-to-Clinic NOFOs.

Eligibility

Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International Collaborations:Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Files

File Type Posted
PKG00293510.pdf PDF
RFA-RM-27-014-Full-Announcement.html HTML file

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