Logistics Center (RFA-RM-27-015)

Logistics Center (RFA-RM-27-015) is sponsored by National Institutes of Health (NIH) Common Fund. This funding opportunity, under the PRIMED-AI program, is for a Logistics Center to coordinate program activities and provide administrative, evaluation, and outreach support.

RFA-RM-27-015: Logistics Center for Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) (U24 Clinical Trials Not Allowed) 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) U24 Resource-Related Research Projects – Cooperative Agreements Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON) Companion Funding Opportunity Research Project (Cooperative Agreements) Phase 1 Exploratory/Developmental Cooperative Agreement/Exploratory/Developmental Cooperative Agreement Phase II Phase 1 Exploratory/Developmental Cooperative Agreement/Exploratory/Developmental Cooperative Agreement Phase II Specialized Center (Cooperative Agreements) See Part 2, Section III. 3.

Additional Information on Eligibility.

Assistance Listing Number(s) 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.

Open Date (Earliest Submission Date) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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). 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. Part 1. Overview Information 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 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.

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: 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.

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.

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 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 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. 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. 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.

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 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or Possession 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 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. 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. 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 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. 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. All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the How to Apply - Application Guide must be followed. 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 All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

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. All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 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