RFA-RM-27-015-Full-Announcement.html
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- Opportunity number
- RFA-RM-27-015
About this file
This is a Notice of Funding Opportunity (NOFO) for the Logistics Center for Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) Program issued by the National Institutes of Health (NIH) Common Fund. The NOFO solicits applications for a U24 Cooperative Agreement to establish an administrative hub supporting the broader PRIMED-AI initiative, which aims to develop AI-based clinical decision support tools integrating clinical imaging with multimodal health data. The Logistics Center must comprise three integrated cores—Administration, Evaluation, and Outreach—responsible for managing steering committee meetings, advisory boards, workshops, data and resource sharing infrastructure, and a web portal showcasing PRIMED-AI-developed tools. The FON is RFA-RM-27-015, with companion funding opportunities under U01 (RFA-RM-27-011), UG3/UH3 (RFA-RM-27-012 and -013), and U54 (RFA-RM-27-014) mechanisms.
The application deadline is September 2, 2026, with an earliest start date of October 2, 2026. One award is anticipated with approximately $750,000 committed for FY2027, with budgets capped at $575,000 direct costs for year one and $2,500,000 direct costs annually for years two through five. The maximum project period is five years. Applicants must submit applications electronically through ASSIST, Grants.gov Workspace, or institutional system-to-system solutions; all required registrations (SAM, UEI, eRA Commons, Grants.gov) must be completed prior to submission. Multi-PD/PI applications are required, with one PD/PI committing at least two person-months annually and others devoting at least one person-month each. Eligible applicants include higher education institutions, nonprofits with 501(c)(3) status, for-profit organizations, government entities, and faith-based organizations; foreign organizations are not eligible. Applications will be peer-reviewed by a Scientific Review Group and then by the National Institute of Biomedical Imaging and Bioengineering Advisory Council, with scoring based on significance, investigator qualifications, innovation, approach, and environment. Restricted funding allocations of $2.5 million annually for years two through five must support $1 million in collaborative teaming projects and $1.5 million in innovative curricula development, both requiring NIH Steering Committee approval.
RFA-RM-27-015-Full-Announcement.html
Text of this file
Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)
National Institutes of Health (NIH)
Components of Participating Organizations
Office of Strategic Coordination (Common Fund)
This Notice of Funding Opportunity (NOFO) is developed as a Common Fund Initiative (https://commonfund.nih.gov/) through the Office of the NIH Director, Office of Strategic Coordination (https://commonfund.nih.gov/). All NIH Institutes and Centers participate in Common Fund initiatives. The NOFO will be administered by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) on behalf of the NIH.
Note: Not all NIH Institutes, Centers, and Offices (ICOs) participate in Announcements. Applicants should carefully note which ICOs participate in this announcement and view their respective areas of research interest at the ICO-Specific Scientific Interests website. ICOs that do not participate in this announcement will not consider applications for funding.
Funding Opportunity Title
Logistics Center for Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) (U24 Clinical Trials Not Allowed)
Activity Code
U24 Resource-Related Research Projects – Cooperative Agreements
Announcement Type
New
Related Notices
Check for any recent Notices of NIH Policy Changes that may impact application requirements.
Funding Opportunity Number (FON)
RFA-RM-27-015
Companion Funding Opportunity
RFA-RM-27-011
, U01 Research Project (Cooperative Agreements)
RFA-RM-27-012
UG3/
UH3
Phase 1 Exploratory/Developmental Cooperative Agreement/Exploratory/Developmental Cooperative Agreement Phase II
RFA-RM-27-013
UG3/
UH3
Phase 1 Exploratory/Developmental Cooperative Agreement/Exploratory/Developmental Cooperative Agreement Phase II
RFA-RM-27-014
, U54 Specialized Center (Cooperative Agreements)
Number of Applications
See Part 2, Section III. 3. Additional Information on Eligibility.
Assistance Listing Number(s)
93.310
Funding Opportunity Purpose
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 create a Logistics Center for the PRIMED-AI Program to facilitate and coordinate PRIMED-AI activities to maximize impact for the PRIMED-AI community. Within the Logistics Center, three integrated Cores will serve the functions of Administration, Evaluation, and Outreach for the PRIMED-AI Consortium. It is expected that the Logistics Center will work closely with other PRIMED-AI consortium members to collect, curate and disseminate information regarding tools developed by the PRIMED-AI award recipients, and will facilitate widespread access and awareness across the relevant scientific, patient, and clinical communities.
Funding Opportunity Goal(s)
The Office of Strategic Coordination (Common Fund) supports research and other projects that will accelerate fundamental biomedical discovery and translation of that knowledge into effective prevention strategies and new treatments.
Key Dates
Posted Date
June 30, 2026
Open Date (Earliest Submission Date)
September 02, 2026
| Application Due Dates |
| Review and Award Cycles |
| New |
| Renewal / Resubmission / Revision (as allowed) |
| AIDS - New/Renewal/Resubmission/Revision, as allowed |
| Scientific Merit Review |
| Advisory Council Review |
| Earliest Start Date |
October 02, 2026
Not Applicable
Not Applicable
| March 2027 | |
| May 2027 |
July 2027
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
No late applications will be accepted for this Notice of Funding Opportunity (NOFO).
Expiration Date
October 03, 2026
Due Dates for E.O. 12372
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
| There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity. | |
| Use the NIH ASSIST system to prepare, submit and track your application online. | |
| Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability. | |
| Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application. |
Table of Contents
Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Purpose The Logistics Center will provide the administrative infrastructure necessary to facilitate and coordinate PRIMED-AI activities to maximize the impact of the PRIMED-AI Program. Within the Logistics Center, three integrated Cores will serve the functions of Administration, Evaluation, and Outreach. The Logistics Center is responsible for management of steering committee (SC) meetings, advisory boards, workshops, community interfaces, outreach, and coordination of teaming activities in consultation with NIH PRIMED-AI staff. In addition to these functions, the Logistics Center will work closely with the Validation Center to maintain strong communication and cross-pollination across the PRIMED-AI Consortium. Finally, the Logistics Center is expected to develop and manage a PRIMED-AI web portal to showcase tools developed as a result of the PRIMED-AI Consortium. It is expected that the Logistics Center will work closely with other PRIMED-AI award recipients to collect, curate and disseminate information regarding tools developed in the PRIMED-AI projects, and will facilitate wide-spread access and awareness.
Background Clinical imaging plays a pivotal role in diagnosis, treatment, and assessment of health outcomes; however, it is often utilized in isolation from other types of data during the development of artificial intelligence (AI)-based clinical decision support (CDS) tools. Current AI applications typically leverage a single imaging modality from radiological or ophthalmological sources. Because health is shaped by a variety of interconnected factors–clinical, biological, genetic, environmental and social–the Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) Program seeks to integrate clinical imaging with relevant, complementary multimodal data (MMD). The overarching goal of the PRIMED-AI Program is to catalyze the development and adoption of innovative AI-based CDS tools into clinical workflows. The PRIMED-AI Program initiatives collectively aim to tackle complex clinical challenges by fostering cross-disciplinary collaboration to create innovative, reliable, cost-effective, and sustainable AI solutions that enable precision medicine strategies.
Prior to applying, applicants are encouraged to check the PRIMED-AI Program website for updates to relevant FAQs and informational webinars, and are also encouraged to read all companion NOFOs to ensure they are aware of the goals and responsibilities of all PRIMED-AI award recipients, including methods PRIMED-AI intends to utilize to address error mitigation and technical management. Familiarity with the companion NOFOs may better inform proposed Logistics Center interconnections with other aspects of the PRIMED-AI Program.
Key Terms used in PRIMED-AI Program (listed alphabetically):
| Clinical decision support (CDS) tool. A type of software, computational model, or digital system that is incorporated into clinical workflows to assist in determining a course of action related to patient care. |
| Clinical imaging. Any FDA-approved imaging modality used in patient care, including radiologic (e.g., radiographic, computed tomographic, magnetic resonance, molecular, radionuclide imaging), ophthalmologic (e.g., Optical Coherence Tomography), endoscopic, and dermatologic imaging, and video. Clinical imaging of human participants is intended to be the anchor data type that multimodal data are integrated within the PRIMED-AI Program, which will form the basis for AI algorithm development and testing of CDS tools. |
| DICOM standard. Digital Imaging and Communications in Medicine (DICOM) standard, the most widely used by the community to address interoperability challenge, is strongly encouraged but not required. Inclusion of non-DICOM standard clinical imaging must include a plan to develop standards in conjunction with the PRIMED-AI community if none currently exist. |
| Harmonization. The process of bringing together data from different sources and ensuring that it is consistent, comparable, and compatible. This involves standardizing data formats, structures, and definitions so that data from various sources can be integrated and analyzed together effectively. |
| Interoperability. The ability for AI models and associated data and metadata to be understood and work across different AI platforms and have the potential to be used consistently across different health systems. |
| Multimodal data (MMD). Representing different types of data and information from multiple sources that may include multiple clinical imaging modalities and non-imaging health data (e.g., electronic health records, EEG, EKG, laboratory test results (-omics), wearable sensor data, medical reports). Multiscale data are encouraged; however, microscopy-based imaging of biospecimens ex vivo (e.g., digital pathology) cannot represent the sole imaging data type. Although non-human imaging and/or MMD data may have assisted in development of an AI-model, overt representation and reliance on data derived from non-human sources for CDS tool development, testing, and validation will be given low programmatic priority. |
| Playbook. A collection of actionable guidelines, standardized protocols, and/or standardized operating procedures for the reliable and effective development and deployment of multimodal clinical decision support tools. The Playbook is a collection of frameworks. |
| Precision Medicine. Sometimes called personalized medicine or individualized medicine, refers to a healthcare approach that uses information based on a patient's individual characteristics such as health measures, genotype, phenotype, environment, and lifestyle information to guide, tailor, and optimize decisions related to their medical care and management. |
| PRIMED-AI Consortium. The consortium constitutes members of PRIMED-AI excluding NIH program staff. PRIMED-AI Program is an umbrella term encompassing the consortium, NIH staff, and overall programmatic objectives. |
| Uncertainty Quantification. Measuring or quantifying the impact of uncertainties in complex systems, including quantifying the confidence in outcomes predicted by multimodal AI models. |
| Validation. Validation exists on a continuum in the PRIMED-AI Program. Analytical or technical validation is based on the evaluation of algorithmic performance and the ability of a multimodal AI model to make accurate predictions. Initially, a model or algorithm can meet expected performance on retrospective and/or entirely new clinical datasets within the confines of a specific hospital or healthcare system. It is useful locally (internally) but is not yet applicable (generalizable) to the wider real-world population. Subsequently, for clinical validation, a model or algorithm can be tested (externally) on new wider real-world population datasets to predict a meaningful outcome and meet regulatory criteria for the claimed use case. The PRIMED-AI Program anticipates validation of projects along this continuum as outlined in the NOFOs. |
| Verification. The process by which data integrity and construction of models is assessed for appropriateness within the context of use or intended purpose. |
Key Requirements of the Logistics Center Specifically, the Logistics Center must include the following Core components tasked as follows:
Administrative Core:
Provide logistical and administrative assistance in arranging PRIMED-AI Steering Committee (SC) and working group meetings, conference calls, workshops, and in-person annual consortium meetings;
Prepare documents, develop policies, and provide recordkeeping for the PRIMED-AI Consortium;
In coordination with the Validation Center, work towards developing and implementing standard procedures for data and metadata collection, storage and sharing, as well as facilitating the Validation Center's subproject management;
Through the use of restricted funds as detailed in Section IV below, support research teaming projects in consultation with NIH PRIMED-AI staff that address critical needs in the PRIMED-AI Program pipeline (e.g., underutilized data, robustness, CDS tool user interfaces) that arise as the Program matures;
Through the use of restricted funds, support development of innovative curricula and outreach activities to facilitate communication between physicians, data scientists, and patients on topics in the PRIMED-AI space in consultation with NIH staff.
Evaluation Core:
Develop and manage an external advisory group to provide feedback on the spectrum of issues from data science to clinical uses and implications of multimodal AI CDS tools and resources developed by the Consortium;
Provide timely reports to NIH staff as needed on activities and progress made by the PRIMED-AI Consortium, maintain and make accessible to NIH and the PRIMED-AI Consortium all significant related documents, including policies, guidelines, records, assets, publications, and meeting minutes generated by the various PRIMED-AI Program committees, topical working groups, and consultants.
Outreach Core:
Implement a PRIMED-AI Consortium-wide data and resource sharing infrastructure via development of a web portal that ensures sustainable sharing and coordination between PRIMED-AI members;
| Interact with other governmental AI-infrastructure efforts as appropriate (e.g. Genesis Mission). |
| Promote clinical AI adoption and innovation through interaction with the healthcare and AI community. |
In addition to the above, the Logistics Center will be responsible for the development of a PRIMED-AI Consortium consensus policy document, to include policies associated with (1) data sharing, security, privacy, ethics and usage, (2) data sequestration and AI-readiness, (3) error mitigation and technical management of tools developed in the PRIMED-AI Consortium, (4) subproject lifecycle management, (5) data and model interoperability, (6) opportunities for collaborations and stakeholder engagement, and (7) operational guidelines, among others. These policies will apply to all award recipients and external groups who wish to utilize PRIMED-AI resources.
Because of the expertise needed to manage the Logistics Center and the collaborative nature of this Center, a multiple PD/PI (multi-PI) application is required.
See Section VIII. Other Information for award authorities and regulations.
Section II. Award Information
Funding Instrument
Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.
Application Types Allowed
New
The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Clinical Trial?
Not Allowed: Only accepting applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.
Need help determining whether you are doing a clinical trial?
Funds Available and Anticipated Number of Awards
The NIH Common Fund intends to commit approximately $750,000 in FY2027. One award is anticipated, contingent upon availability of funds and receipt of a sufficient number of meritorious applications.
Award Budget
Application budgets are limited to $575,000 direct costs for the first year and up to $2,500,000 direct costs per year for the remaining four years of the project. Requested budgets need to reflect the actual needs of the proposed project.
Award Project Period
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations
| Higher Education Institutions - Includes all types | |
| Public/State Controlled Institutions of Higher Education | |
| Private Institutions of Higher Education |
Nonprofits Other Than Institutions of Higher Education
| Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) |
| Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) |
For-Profit Organizations
| Small Businesses |
| For-Profit Organizations (Other than Small Businesses) |
Local Governments
| State Governments |
| County Governments |
| City or Township Governments |
| Special District Governments |
| Indian/Native American Tribal Governments (Federally Recognized) |
| Indian/Native American Tribal Governments (Other than Federally Recognized) |
| Federal Governments | |
| U.S. Territory or Possession |
Other
Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations
Foreign Organizations/Foreign Collaborations
Non-domestic (non-U.S.) Entities (Foreign Organizations) 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.
Required Registrations
Applicant Organizations Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
| eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. |
| Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration. |
Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.
Eligible Individuals (Program Director/Principal Investigator)
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.
Effective management will require a significant commitment by the Program Director(s)/Principal Investigator(s). A multi-PD/PI application is required - one PD/PI is expected to commit at least 2 person months annually and the other(s) should devote at least 1 person month each.
2. Cost Sharing This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.
3. Additional Information on Eligibility Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
| A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. |
| A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. |
| An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications). |
Section IV. Application and Submission Information
1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
2. Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Page Limitations All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.
Instructions for Application Submission
The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.
SF424(R&R) Cover All instructions in the How to Apply - Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
SF424(R&R) Other Project Information
Other Attachments:
Milestones, Timelines and Progress Reporting Plan – (3-page limit) Applicants must define a clear set of goals for the proposed Logistics Center and semi-annual milestones with metrics that will document progress towards the achievement of the ultimate goals of the PRIMED-AI Program. The filename "Milestones Timelines and Progress Reporting Plan.pdf" should be used for this attachment. This plan must include a Gantt chart of proposed timelines and milestones, as well as a detailed list of all milestones with associated details. Applicants will include plans for critically evaluating and revising these milestones on a regular basis. The number and duration of milestones will depend on the project being proposed, so applicants should include these items for every year, as appropriate. Applicants must describe how they will prioritize their activities to ensure that the main goals of the PRIMED-AI Program will be achieved. Milestones may be revised at the time of the award. Milestones must address all aspects of the plans submitted as part of the research strategy, including a timeline for Consortium consensus policy development, expected milestones for distribution of restricted funds, and proposed plans for reporting progress to the NIH.
SF424(R&R) Senior/Key Person Profile
R&R Budget
Restricted Funds for Collaborative PRIMED-AI Consortium activities For award years 2-5, budgets must contain $2,500,000 each year to fund collaborations with other PRIMED-AI Program members and/or external entities to:
Approximately $1,000,000 of restricted funds per year must be utilized to address collaboration and teaming needs (e.g., underutilized data, robustness, CDS tool user interfaces) that arise as the Program matures. It is intended that these collaborations will be established with at least one PRIMED-AI member and can include new members (e.g., academic, industry, clinical) who may contribute unique expertise and varied perspectives. At least 75% of restricted funds must go to selected collaborators and/or non-Logistics Center award recipients. Under "Other Expenses" category, enter the corresponding amount of direct costs as "Collaboration Restricted Fund."
Approximately $1,500,000 of restricted funds per year must be utilized to develop and deliver innovative curricula to facilitate communication between physicians, data scientists, and patients on topics in the PRIMED-AI space. Innovative projects will be sought to enrich communication and trust-building towards the translation and use of PRIMED-AI CDS tools. For example, materials may be developed to address behavioral (professional and societal) barriers to adoption of PRIMED-AI CDS tools. Groups who receive these funds in collaboration with the Logistics Center will also work collaboratively with the Validation Center to focus on topics related to error mitigation and technical management pertinent to PRIMED-AI goals. At least 50% of restricted funds must go to selected collaborators and/or non-Logistics Center award recipients. Under "Other Expenses" category, enter the corresponding amount of direct costs as "Outreach Restricted Fund."
Proposals for utilization of restricted funds must be approved by the PRIMED-AI SC and submitted to the NIH PO of record starting in the first quarter starting year two of the Logistics Center award and continuing first quarter of each year thereafter. The NIH PRIMED-AI working group will determine if the proposals are appropriate (ie within scope of the PRIMED-AI Program) and release funds after being approved for use on the proposed projects.
The Logistics Center may propose adjustments to the allocation amounts listed above based on shifting programmatic needs - these adjustments must be thoroughly justified by the Center PIs and approved by NIH staff. All these funds are restricted and require NIH prior approval for use. If the NIH PRIMED-AI Working Group, via the Steering Committee, deems such collaborations scientifically unwarranted or out of scope, the restricted budget may be re-allocated to the primary project or other PRIMED-AI award recipients on a yearly basis. A prior approval request is required to re-allocate these funds to other studies.
MPI and Logistics Center staff requirements Effective management will require a significant commitment by the Program Director(s)/Principal Investigator(s). A multi-PD/PI application is required - one PD/PI is expected to commit at least 2 person months annually and the other(s) should devote at least 1 person month each.
The Logistics Center is responsible for managing in person meetings and regular conference calls. Budgets should reflect costs associated with managing and hosting these meetings, both in person and virtual. Applicants should also request funds for 2-6 group members to attend annual in person meetings, Program-led tutorials, and open innovation meetings, as appropriate.
The Logistics Center should budget at least 6 person months for a dedicated project manager/director (PM/PD) for the project with the appropriate scientific expertise and project management responsibilities, who would support the PI(s) with project management. The PM/PD will be the primary liaison with the PRIMED-AI Program and Steering Committee.
R&R Subaward Budget
PHS 398 Cover Page Supplement
PHS 398 Research Plan All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Research Strategy Due to the PRIMED-AI Program's significant focus on imaging data, it is expected that the proposed Logistics Center team members will have significant experience with imaging, and/or will include imaging data experts.
As part of the research strategy, applicants are required to submit the following:
| Administration Plan – Applicants must describe the plans for the Administration Core that will manage and integrate PRIMED-AI activities, including who will oversee the day-to-day activities (e.g., a project manager if not the PD/PI) and how the management structure will support achievement of the proposed goals and milestones. The applicants must indicate their experience with managing large consortia, programs and/or collaborations, to include examples from previous successful large-scale collaborations. Useful elements of this description include the organization of the proposed projects, its management structure, personnel and leadership structure, plan and structure to develop Consortium consensus policy documents, and oversight mechanisms for evaluating progress towards milestones. The plan should also cover activities related to restricted funds, including but not limited to needs assessment, solicitation development, reviewing, awarding, and managing sub-project awards. The plan must also describe how the various units of the Consortium will be integrated, and how collaborations or subcontracts, if proposed, will be managed. This plan must also include an outline of expected annual meetings and coordination meetings planned for the award period, to include a plan for a Playbook award recipients "Best Practices" Showcase approximately halfway through the award period. | |
| Evaluation Core and External Advisory Plan – The Logistics Center must include an outline for a proposed Evaluation Core to oversee critical evaluation of the progress of the PRIMED-AI Program. The Logistics Center is required to submit a joint report with the Validation Center outlining a proposed sustainability plan beginning in year three of the award period. External advisor group will include recruitment of relevant public stakeholders not associated with the PRIMED-AI Program to provide input and advice on Program direction. This external advisory group will serve the purpose of providing the PRIMED-AI members with feedback on clinical uses and implications of multimodal AI tools and resources developed by the Consortium, and should include patient groups, clinical users, software developers, AI experts, and other relevant stakeholders. It is expected that evaluation of the PRIMED-AI resources will be accomplished through "case studies", that utilize PRIMED-AI tools in relevant real-world environments to show efficacy and applicability of tools - inclusion of end users, impacted groups, regulatory bodies (i.e. FDA, ONC) and/or key stakeholders must be a substantial component of the external advisory group plan. This committee is intended to be independent of External Program Consultants recruited by NIH to provide advice to the NIH and is intended to provide external input to the PRIMED-AI members directly. | |
| Outreach Core Plan – The PRIMED-AI Program is intended to have a national impact and provide leadership for the integration of clinical imaging and multimodal data for the development of clinical decision support tools that enable precision medicine strategies. Applicants must describe a plan and allocate sufficient resources to develop an Outreach Core that will provide outreach to the scientific, patient, and clinical communities (and any other relevant communities). The applicants must indicate their experience with setting up large centers and/or collaborations, to include examples from previous successful large-scale collaborations. This description must include a section dedicated to explaining how the Consortium will facilitate partnerships with external groups, including but not limited to patient advocacy, industry, and clinical groups, in the context of the PRIMED-AI Program. As a component of this description, the application must include a plan for the establishment of a "community review board" that incorporates feedback from potential users and partners to ensure PRIMED-AI research is relevant, ethical, and addresses the needs of the intended community. Finally, this plan must include proposed efforts to educate the community on tools developed by the Consortium and to promote effective methods for developing validated multimodal AI tools for use in the clinic. Examples of outreach include presentations, short courses, or symposia offered independently or in conjunction with scientific meetings attended by the user community; web-based tutorials; detailed walkthroughs; and user manuals and training guides that describe the features of the Consortium resources. | |
| PRIMED-AI Web Portal Development Plan – The Logistics Center, through the Outreach Core, will lead the development of a web portal for the PRIMED-AI Program that will function as a resource for the public to access resources developed by the PRIMED-AI Consortium. The portal will be the central platform and landing page enabling users to discover information pertaining to the PRIMED-AI Program and its ongoing activities, tools and resources, training, and outreach materials. This web portal must enable broad use of PRIMED-AI resources, to include outreach resources, any PRIMED-AI developed curricula, frameworks and SOPs, and validated tools developed by the PRIMED-AI award recipients. Applicants must provide a web portal development plan that includes: | Description of the User Interface Portal (UIP) that will facilitate user-friendly querying, retrieval and reporting of tools developed by the PRIMED-AI award recipients; |
| Backend design format for simplified upload of tools and/or data, to include frameworks from the Playbook award recipients, developed by the PRIMED-AI award recipients; | |
| Description of how the portal will be evaluated by collecting system metrics and feedback from external users and how such information will be used to improve the portal; | |
| The recipient will be responsible for Information Security of the created portal. Specifically, recipient-hosted information systems should maintain relevant security controls). Describe the plans for how this will be achieved. |
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed.
Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.
No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.
PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:
If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.
PHS Assignment Request Form
3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
4. Submission Dates and Times Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide.
5. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review.
6. Funding Restrictions All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.
7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Mandatory Disclosure
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.
Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy
Any instructions provided here are in addition to the instructions in the policy.
Section V. Application Review Information
1. Criteria Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Overall Impact
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the proposed Logistics Center address the needs of the PRIMED-AI Consortium that it will coordinate? Is the scope of activities proposed for the Logistics Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the PRIMED-AI Consortium?
| Specific to this NOFO: | |
| To what extent will the proposed Logistics Center effectively coordinate the overall performance of the PRIMED-AI Consortium, promote collaborations, interdisciplinary science, and communication between PRIMED-AI and external investigators, and enable the dissemination of resources to the broader community? |
Investigator(s)
Are the PD(s)/PI(s) and other personnel well suited to their roles in the Logistics Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing AI-focused research? Do the investigators demonstrate significant experience with coordinating collaborative technology or clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Logistics Center? Does the applicant have experience overseeing selection and management of subawards, if needed?
| Specific to this NOFO: | |
| To what extent does the proposed team's track record indicate that they are capable of acting as a facilitator and organizer of a large Logistics Center or equivalent? | |
| To what extent does the proposed team's track record indicate their experience in developing and maintaining collaborations across clinicians, industry, patient advocacy groups, and other relevant stakeholders in the imaging and multimodal AI field, as well as in overseeing critical evaluation of progress of a large research consortium/program? | |
| To what extent does the proposed team's track record indicate they are capable of supporting and facilitating policy and governance discussions in large HHS-funded consortia or multisite research? | |
| To what extent does the proposed team's track record or demonstrated expertise indicate they will be able to properly and efficiently perform needs assessment, solicitation development, and sub-project life cycle management? |
Innovation
Does the application propose novel organizational concepts, management strategies, or instrumentation that is important to coordinating the Primed AI Consortium that the Logistics Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?
| Specific to this NOFO: | |
| To what extent does the application address the current trends and challenges in supporting and coordinating development of innovative, reliable, and cost-effective multimodal AI-based clinical decision support tools? | |
| To what extent does the application leverage novel collaboration and communication strategies for timely coordination across multiple sites and research programs, as well as external stakeholder engagement and outreach efforts? | |
| To what extent will the plan promote clinical AI adoption and innovation? |
Approach
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the Primed AI Consortium the Logistics Center will serve? Will the investigators promote strategies to ensure a robust scientific approach across the Primed AI Consortium, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? Does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the Primed AI Consortium? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?
| Specific to this NOFO: | |
| To what extent will the proposed Center perform outreach, with regards to making connections with the patient community and caregivers, for feedback on Program deliverables? | |
| To what extent does the proposed external advisory group plan allow in depth external evaluation of the PRIMED-AI Program?. | |
| To what extent does the proposed web portal development plan allow for the development of an efficient and easy to use web portal to house PRIMED-AI resources? | |
| Is the management plan well-described and to what extent is it commensurate with the level of complexity required for a PRIMED-AI Center? |
Environment
Will the institutional…
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