Part 1. Overview Information

Key Dates

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).

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.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. 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.
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

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

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

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. 

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.

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.

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

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.

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

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

R&R Budget

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:

1. 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."

2. 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

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.

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:

1. 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.
2. 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.
3. 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.
4. 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:
   1. 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;
   2. 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;
   3. 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;
   4. 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

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

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

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

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. 

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.

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).

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.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by CSR, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Requests for reconsideration of initial peer review will not be accepted for applications submitted in response to this NOFO. 

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Institute of Biomedical Imaging and Bioengineering Advisory Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant's federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant's integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 "Federal awarding agency review of risk posed by applicants."  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient's business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy." 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Cybersecurity plans and procedures must at minimum include the following:

• Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
  • Identify:
    • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
  • Protect:
    • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
    • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
    • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
    • Regularly backup sensitive data and test backups.
  • Detect:
    • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
  • Respond:
    • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
    • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • Recover:
    • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on  MAT/MOUD.

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this Program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below. 

Roles and Responsibilities:

NIH PRIMED-AI Working Group (WG): Consists of NIH programmatic staff from multiple Institutes and Centers of the NIH. This group will be primarily responsible for the stewardship of the PRIMED-AI Program and will participate as non-voting members in the committees.   

External Program Consultants (EPCs):  External Program Consultants provide critical scientific and managerial insights and recommendations to NIH staff. These recommendations might be relayed to the awardees at the discretion of the NIH.  EPC are invited to attend annual meetings and other key events to have awareness of progress and provide feedback to NIH staff in their consulting capacity. 

Steering Committee (SC):  The SC includes funded contact PIs and NIH PRIMED-AI Program staff to jointly provide scientific input and coordination for the PRIMED-AI Program. It is expected that most of the decisions on the activities of the SC will be reached by consensus. If a vote is needed, each project PD/PI (or Contact PI in the case of multi-PI projects) will have one vote. NIH staff will be non-voting members of the SC. When a vote is required, at least 60% of the votes must be affirmative for approval. The SC may establish working groups as needed, which will include representatives from the PRIMED-AI Consortium, the NIH, and possibly other experts.  

PRIMED-AI Consortium: The PRIMED-AI Consortium will be made up of all PRIMED-AI award recipients. The organizational structure is meant to enable the overall goals of the PRIMED-AI Program.   

The PD(s)/PI(s) will have the primary responsibility for: 

• Leading the project as a whole, and agreeing to accept close assistance, advice, coordination, and collaborate with the NIH PRIMED-AI Program Staff and other award recipients.
• Planning, direction, and execution of the proposed project will be solely that of the PD(s)/PI(s). They will determine experimental approaches, design protocols, set project milestones and conduct experiments.
• Participating in group activities, including the SC to share design and analysis techniques and promote comparability across studies wherever possible.
• Ensuring active participation of partner sites and collaborators in group activities, if applicable.
• Implementing consensus SC recommendations for designing, implementing, evaluating, and disseminating PRIMED-AI Consortium modeling research projects, as appropriate and feasible. 
• Agreeing to abide by any policies -- including those regarding intellectual property, data and software release, publication of PRIMED-AI Consortium papers, quality control metrics, standardization, metadata requirements, and public copyright licensing -- that are recommended and consented to by the PRIMED-AI SC and approved by the NIH PRIMED-AI WG, as well as applicable NIH policies, laws, and regulations. Providing information to the NIH Program Official and Project Scientist concerning progress and activities on a regular basis in an agreed upon format, no less than monthly. Attending and participating in SC meetings and accepting and implementing the consensus guidelines and procedures, as appropriate.

Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. 

Award recipients must work collaboratively with all members of the PRIMED-AI Consortium to develop and provide usage statistics and quantitative metrics for data and resources for the purposes of programmatic evaluation and continuous improvement. In carrying out stewardship of this NOFO, the PRIMED-AI Program staff may use these metrics to assess effectiveness and communicate the impact of the Program. 

NIH Staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The Program Official (PO) is an NIH staff member who will provide programmatic oversight and stewardship of the projects, including review of pre-award and award documents/requirements, review of progress reports and budgets, and any other programmatic issues that may arise. The PO will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the Notice of Award. The PO will make the final determination on the negotiated milestones and will also make the final determination on whether the milestones are met. The PO has the option to recommend, following consultation with the NIH PRIMED-AI Program staff, the withholding or reduction of support from any project that substantially fails to achieve its goals according to the milestones agreed to at the time of the award.  

The Project Scientist (PS) is a NIH staff member who will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination. However, the role of NIH staff will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus of the PRIMED-AI Consortium and that NIH staff will be given the opportunity to offer input to this process, as a non-voting member.   

The NIH PS will have the following substantial involvement:

• Participating with the other SC members in the group process of setting research priorities, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted. The PS may facilitate the group process and not direct it.
• Serving as a liaison, helping to coordinate activities among and for the award recipients, including acting as a liaison to the NIH, and as an information resource for the award recipients about other research activities. The PS will coordinate the efforts of the Program with other groups conducting similar studies.
• Attending all SC meetings as a non-voting member and assisting in developing operating guidelines, quality control procedures, and consistent policies for dealing with situations that require coordinated action. The PS will be responsible for working with the PD/PIs in facilitating logistical aspects of the Program.
• Reporting periodically on the progress of the Program to the NIH PRIMED-AI Program staff and leadership.
• Serving as a liaison between the SC and the external advisory groups.
• Providing oversight and advice in the management and technical performance of the award projects.
• Facilitation of sharing and dissemination of the data and related resources developed in the course of the PRIMED-AI Program to the scientific community at large.  

The NIH may enlist additional scientific experts as necessary from within the NIH, or other government agencies, whose function will be to advise the PD(s)/PI(s) in carrying out the goals and aims of the approved studies. 

The NIH reserves the right to curtail or phase out the award in the event of (1) a substantial shortfall in accomplishing the management goals and responsibilities as stated in the reviewed application, (2) failure to meet procedures and milestones, and/or (3) substantive changes in the management of award(s) that are not in keeping with the objectives of the NOFO. 

Areas of Joint Responsibilities:

Consistent with achieving the goals of the PRIMED-AI Program, the NIH requires all award recipients to collaborate effectively with each other to maximize the chances of overall success of the entire Program.  Close interaction among the participating investigators will be required, as well as significant involvement from the NIH. The award recipients and designated NIH Staff will participate in the annual PRIMED-AI Consortium meeting and scheduled conference calls and share information on data resources, methodologies, analytical tools, as well as preliminary developments. PDs/PIs, key personnel and pre- and post-doctoral trainees are eligible to attend these meetings. EPCs will attend the annual meetings, as well as other relevant NIH staff.   

PRIMED-AI Program Evaluation:

Award recipients must work collaboratively with all members of the PRIMED-AI Consortium to develop and provide usage statistics and quantitative metrics for data and resources for the purposes of programmatic evaluation and continuous improvement. In carrying out stewardship of this NOFO, the NIH or its Institutes and Centers may request information essential to an evaluation of the effectiveness of the PRIMED-AI Program from the award recipients. Award recipients may be contacted during and after the completion of this award for periodic updates on information helpful in evaluating the impact of the program. 

Conflict of Interest Management Plan:

The Conflict of Interest Management Strategy for Cooperative Agreements includes several approaches. Decision-making authority on budgetary and funding actions, grants management actions, and management of clinical and regulatory activities and intellectual property issues is assigned to staff of the IC managing the awards. The responsibility for final decision-making may reside with senior NIH management and leadership, separate organizational components and/or oversight committees. It is anticipated that the Project Scientist will refrain from activities that rise to a level of involvement that results in conflicts of interest, for example, co-publication. Should the extent and nature of staff involvement evolve to the level where conflicts of interest arise, NIH will carefully re-evaluate the alignment of duties among Program staff and implement specific strategies to manage the conflicts of interest. 

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the SC chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the recipients. This special dispute resolution procedure does not alter the recipients' right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.  

3. Data Management and Sharing

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. 

Sharing scientific data accelerates biomedical research discovery, in part, by enabling validation and ensuring reproducibility of research results, providing accessibility to high-value datasets, and promoting data reuse for future research studies. PRIMED-AI applicants must provide a Data Management and Sharing Plan. Applicants are encouraged to review the following resources supporting the Data Management and Sharing Plan:

• Artificial Intelligence in Research: Policy Considerations and Guidance: https://osp.od.nih.gov/policies/artificial-intelligence/
• NOT-OD-25-081: Protecting Human Genomic Data when Developing Generative Artificial Intelligence Tools and Applications
• Checklist to evaluate the suitability of data for record linkage: https://github.com/NIH-NICHD-Ecosystem/E2_Record-Linkage-Implementation-Checklist/tree/main

Incumbent upon being a Common Fund award recipient, engagement with the Common Fund Data Ecosystem (CFDE) is required for dissemination of PRIMED-AI assets and resources. This may include the sharing of software, CDS tools, AI models, and other related resources with managers of the CFDE infrastructure for the purpose of increasing distribution and integrating with other Common Fund data resources.

1. Metadata and asset ingest into the CFDE Data Resource Portal: The Logistics Center will use the submission tool to submit new metadata and assets to the portal.
2. Logistics Center will facilitate preparation of PRIMED-AI metadata and assets for CFDE reuse efforts. For this program, add CDS tools, and AI models and include APIs, and API documentation.
3. Logistics Center will gather metrics around the usage of the PRIMED-AI web portal. They must also work with the CFDE Evaluation team from the Integration and Coordination Core (ICC) to gather recommended metrics and use automated software and processes to streamline data collection.
4. Active Participation in CFDE:
   1. Participate in CFDE Steering Committee (monthly)
   2. Participate in relevant working groups (monthly / quarterly)
   3. Attend CFDE webinar series (monthly)
   4. Attend CFDE-program meetings (bi-annually)
   5. Present at public CFDE webinar series (annually)
   6. Interact with the CFDE Centers and provide input on Center products (as needed)
   7. Provide information about education and outreach opportunities (as needed)
   8. Participate in Centers coordinated activities (e.g., providing workflows to CFDE Cloud Workspace, participate in a training or data reuse session with the CFDE Training Center) 

Intellectual Property (IP) Rights

The successful development of multi-modal AI models and the integration of imaging and multimodal data sets on the PRIMED-AI AIP projects are anticipated to require either substantial investment and support by private sector industries, and/or may involve collaborations with other organizations such as academic, other government agencies, and/or non-profit research institutions not directly involved in the PRIMED-AI program. NIH recognizes that intellectual property rights are likely to play an important role in achieving the goals of this program.

To this end, all award recipients shall understand and acknowledge the following:

• The award recipient is solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials needed for the award recipient to perform the project.
• Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the recipient any proprietary rights, including intellectual property rights, or any materials needed by the recipient to perform the project.
• The award recipient is required to report to the U.S. Government all inventions made in the performance of the project, as specified by 35 U.S.C. Sect. 202 (Bayh-Dole Act).
• The award recipient acknowledges the applicability of 35 U.S.C. 200 et. seq. (Bayh-Dole Act) and the resulting US Government rights that apply to any agreements resulting from this NOFO.
• Recipients will have primary rights to the data and resources developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH regulations and policies, including 2 CFR § 200.315.
• The Recipient will declare any relevant Intellectual Property, pre-existing or otherwise, that was not made with the NIH funds, during the application process.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Award recipients must work collaboratively with all members of the PRIMED-AI Program to develop and provide usage statistics and quantitative metrics for data and resources for the purposes of programmatic evaluation and continuous improvement. In carrying out stewardship of this NOFO, the PRIMED-AI Program staff may use these metrics to assess effectiveness and communicate the impact of the Program.Enter text here.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk - Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

Common Fund PRIMED-AI Program

Email: ODPRIMED-AI@od.nih.gov

Center for Scientific Review (CSR) 

Email: NOFOReviewContact@csr.nih.gov

Email: nibibchiefgrantsmanagementofficer@nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.