Opportunity Information: Apply for RFA RM 27 014
The NIH is offering a single cooperative agreement (U54; clinical trials not allowed) to create a PRIMED-AI Validation Center, a centralized hub that will independently and systematically evaluate AI-enabled clinical decision support (CDS) tools that combine clinical imaging with other kinds of health data (multimodal data). This opportunity sits inside a broader NIH initiative called the Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) Program, which is designed to speed the development and real-world adoption of reliable, affordable, and sustainable AI-based CDS tools that can fit into clinical workflows and support more personalized care across many diseases and care settings. The big idea is that imaging (radiology, pathology, and other image-based signals) becomes more clinically powerful when interpreted alongside complementary data sources such as electronic health record information, laboratory values, demographics, genomics or other -omics, physiologic signals, and similar modalities, and the program aims to turn that combined signal into decision support clinicians can actually trust and use.
The Validation Center is meant to function as the program’s quality and trust backbone. Rather than building new models as the main output, this center is expected to provide comprehensive evaluation and characterization of models and related deliverables produced across the PRIMED-AI Consortium. In practical terms, it is responsible for establishing and running rigorous methods to determine whether PRIMED-AI tools are reliable, reproducible, and generalizable across different datasets, institutions, equipment, workflows, and patient subgroups. The NOFO emphasizes four technical focus areas for this work: verification (checking the tool is implemented correctly and behaves as intended), validation (measuring performance for the intended use and population), interoperability (ensuring the tool can work with varied data systems, formats, and clinical IT environments), and uncertainty quantification (making sure the tool can communicate confidence, limitations, and risk of error in ways that support safe decision-making). Collectively, these functions are intended to reduce the gap between promising AI prototypes and tools that can be responsibly integrated into patient care.
A key point is that the Validation Center is not operating in isolation; it is explicitly designed to validate PRIMED-AI Consortium deliverables, including outputs from related PRIMED-AI awards such as the Playbook activities, Data-to-Model Academic-Industrial Partnerships, and Model-to-Clinic efforts. That framing signals that the center will likely need strong coordination capacity: common evaluation protocols, shared benchmarking infrastructure, consistent reporting, and the ability to engage many external development teams while maintaining independence and methodological rigor. Because the award mechanism is a cooperative agreement, the NIH will generally expect substantial programmatic involvement and coordination, meaning the center will likely participate in structured consortium governance and shared planning rather than operating as a stand-alone research project.
From an administrative standpoint, the opportunity is identified as RFA-RM-27-014 under NIH (CFDA 93.310), categorized as discretionary funding in the health area. NIH anticipates making one award, with an annual or project cap listed as an award ceiling of $2,000,000 (as stated in the source data). The original application due date is October 2, 2026, and the funding instrument is a U54 cooperative agreement with clinical trials not allowed, which generally means the proposed work should focus on evaluation, benchmarking, validation science, and related infrastructure rather than interventional studies that meet NIH’s definition of a clinical trial.
Eligibility is broad across U.S.-based organizational types, including state, county, and local governments; special districts; independent school districts; public and private institutions of higher education; 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 (including small businesses and other than small businesses); and other eligible entities as described in the NOFO’s eligibility section. At the same time, the NOFO is explicit that non-U.S. entities cannot apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as NIH defines them) are not allowed, which effectively confines the work and supported activities to domestic organizations and domestic components.
Overall, this grant is best understood as NIH funding for an independent validation and characterization engine for multimodal, imaging-centered AI decision support. The center’s success will be judged less by producing a single algorithm and more by whether it can provide trustworthy, standardized, and actionable evidence about how PRIMED-AI tools perform, where they break, how portable they are, what uncertainty they carry, and what is needed to make them usable across real-world clinical environments.Apply for RFA RM 27 014
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Validation Center for Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) (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): 93.310.
- This funding opportunity was created on 2026-06-30.
- Applicants must submit their applications by 2026-10-02. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $2,000,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- 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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Frequently Asked Questions (FAQs): NIH PRIMED-AI Validation Center (U54)
What is this funding opportunity?
This NIH opportunity funds a single cooperative agreement (U54; clinical trials not allowed) to establish a PRIMED-AI Validation Center. The center is intended to serve as a centralized, independent hub that systematically evaluates AI-enabled clinical decision support (CDS) tools that combine clinical imaging with other health data (multimodal data).
What is the PRIMED-AI Program, and how does this award fit into it?
The Validation Center sits within the broader NIH initiative called the Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) Program. PRIMED-AI is designed to accelerate development and real-world adoption of reliable, affordable, and sustainable AI-based CDS tools that fit clinical workflows and support more personalized care across diseases and care settings. The Validation Center functions as the program's quality and trust backbone by evaluating tools developed across the PRIMED-AI Consortium.
What kinds of AI tools will the Validation Center evaluate?
The center will evaluate AI-enabled CDS tools that use clinical imaging (such as radiology, pathology, and other image-based signals) alongside complementary data sources. Examples of complementary modalities mentioned include electronic health record information, laboratory values, demographics, genomics or other -omics, physiologic signals, and similar health data types.
Is the main goal to build new AI models?
No. The Validation Center is not primarily intended to build new models as the main output. Instead, it is expected to provide comprehensive evaluation and characterization of models and related deliverables produced across the PRIMED-AI Consortium.
What does NIH mean by "independent" evaluation in this context?
Based on the description provided, the Validation Center is intended to act as a centralized hub that independently and systematically evaluates PRIMED-AI tools. The emphasis is on maintaining methodological rigor while engaging multiple external development teams across the consortium.
What are the main technical focus areas NIH emphasizes for the Validation Center?
The NOFO highlights four technical focus areas for the Validation Center's work: verification, validation, interoperability, and uncertainty quantification. Together, these areas are intended to strengthen confidence that tools are reliable and safe to integrate into patient care.
What is "verification" in the context of validating AI clinical decision support tools?
Verification refers to checking that the tool is implemented correctly and behaves as intended. In other words, it is about confirming the system works as designed from an implementation and functional behavior standpoint.
What is "validation" in the context of this opportunity?
Validation refers to measuring performance for the intended use and population. The goal is to determine how well a tool performs for the specific clinical context it is meant to support.
What does "interoperability" mean for PRIMED-AI tools?
Interoperability focuses on whether a tool can work with varied data systems, formats, and clinical IT environments. The aim is to ensure tools can function across different technical and institutional settings rather than being limited to one site or one data pipeline.
What is "uncertainty quantification," and why is it important here?
Uncertainty quantification is about ensuring a tool can communicate confidence, limitations, and risk of error in ways that support safe decision-making. This includes conveying where predictions may be less reliable and what limitations may apply.
What problem is the Validation Center supposed to solve?
The center is intended to reduce the gap between promising AI prototypes and tools that can be responsibly integrated into patient care. It does this by producing trustworthy, standardized evidence about performance, reproducibility, generalizability, portability across environments, and uncertainty characteristics.
Who will the Validation Center be validating tools for?
The Validation Center is designed to validate PRIMED-AI Consortium deliverables, including outputs from related PRIMED-AI awards such as Playbook activities, Data-to-Model Academic-Industrial Partnerships, and Model-to-Clinic efforts.
How does the cooperative agreement (U54) structure affect how the work will be conducted?
Because this is a cooperative agreement, NIH generally expects substantial programmatic involvement and coordination. The center will likely participate in structured consortium governance and shared planning rather than operating as a stand-alone project.
Does this opportunity allow clinical trials?
No. The funding mechanism is a U54 cooperative agreement with clinical trials not allowed. The proposed work should therefore focus on evaluation, benchmarking, validation science, and supporting infrastructure rather than interventional studies that meet NIH's definition of a clinical trial.
How many awards does NIH expect to make under this opportunity?
NIH anticipates making one award for this opportunity.
What is the maximum funding level mentioned for this award?
The source information lists an award ceiling of $2,000,000 (annual or project cap as presented in the source data).
What is the opportunity number and NIH reference information?
The opportunity is identified as RFA-RM-27-014 under NIH, with CFDA 93.310.
When is the application due?
The original application due date listed is October 2, 2026.
What kinds of organizations are eligible to apply?
Eligibility is broad across U.S.-based organizational types, including: state, county, and local governments; special districts; independent school districts; public and private institutions of higher education; 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 (including small businesses and other than small businesses); and other eligible entities as described in the NOFO's eligibility section.
Are non-U.S. organizations eligible to apply?
No. The NOFO is explicit that non-U.S. entities cannot apply.
Can a U.S. organization include a non-U.S. component or foreign component in the project?
No. The information provided states that non-U.S. components of U.S. organizations are not eligible and that foreign components (as NIH defines them) are not allowed.
What types of data and environments must the Validation Center consider in evaluation?
The center is expected to determine whether PRIMED-AI tools are reliable, reproducible, and generalizable across different datasets, institutions, equipment, workflows, and patient subgroups.
What does "generalizable" mean in the way this opportunity describes it?
In the provided description, generalizable means the tools should maintain appropriate performance across diverse datasets and real-world variation, including differences across institutions, equipment, workflows, and patient subgroups.
What practical capabilities will the Validation Center likely need to operate effectively?
The description indicates the center will likely need strong coordination capacity, including the ability to establish common evaluation protocols, shared benchmarking infrastructure, consistent reporting, and effective engagement with multiple external development teams while preserving independence and rigor.
How will success be judged for this Validation Center?
Success is expected to be judged less by producing a single algorithm and more by whether the center can provide trustworthy, standardized, and actionable evidence about how PRIMED-AI tools perform, where they fail, how portable they are, what uncertainty they carry, and what is needed to make them usable across real-world clinical environments.
What is the overarching "big idea" behind PRIMED-AI tools?
The program is built on the idea that imaging becomes more clinically powerful when interpreted alongside complementary health data (multimodal data). The goal is to translate that combined signal into clinical decision support that clinicians can trust and use within real clinical workflows.
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