National Institutes of Health (NIH)
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.
U54 Specialized Center- Cooperative Agreements
See Section III. 3. Additional Information on Eligibility.
The overarching goal of this notice of funding opportunity (NOFO) and its companion opportunities is to establish the Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) Program to support development of innovative, reliable, cost-effective, and sustainable multimodal AI-based clinical decision support (CDS) tools. PRIMED-AI CDS tools are based on the integration of clinical imaging with other types of multimodal health data to enhance care for patients with a wide range of health conditions. The PRIMED-AI Program seeks to catalyze the adoption of AI-based CDS tools into clinical workflows to enable novel personalized medicine strategies that address significant health challenges.
The purpose of this NOFO is to solicit applications for the creation of a Validation Center to serve as a dedicated hub for the comprehensive evaluation and characterization of AI-enabled, image-based, multimodal CDS tools developed by the PRIMED-AI Consortium, to ensure these tools are reliable, reproducible, and generalizable. The Validation Center will focus on verification, validation, interoperability, and uncertainty quantification to comprehensively characterize performance of the CDS tools developed by the program. The core functions of the Validation Center will involve the systematic validation of PRIMED-AI Consortium deliverables, including those emerging from award recipients under the Playbook, Data-to-Model Academic-Industrial Partnerships, and Model-to-Clinic NOFOs.
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.
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| October 02, 2026 | Not Applicable | Not Applicable | March 2027 | May 2027 | July 2027 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the 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.
The Validation Center (VC) will serve as a dedicated hub for the comprehensive evaluation and characterization of AI-enabled, image-based, multimodal Clinical Decision Support (CDS) tools developed by the PRIMED-AI Consortium, to ensure these tools are reliable, reproducible and generalizable.
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 Validation Center interconnections with other aspects of the PRIMED-AI Program. Detailed definitions for key terms used in the PRIMED-AI program can be found on the PRIMED-AI website mentioned above.
The organizational structure of the Validation Center must include three main Cores, 1) a Validation Core; 2) Translation Core to establish sustainable tool(s) in support of AI model clinical translation; and 3) Fast-track Core, addressing identified unmet needs.
Validation Core - Independent validation of PRIMED-AI CDS tools. The Validation Center will function as a hub for independent, rigorous AI tool validation - focused on the overall reproducibility of AI models developed by the PRIMED-AI Program, including those developed under the companion NOFOs. The Validation Center supports PRIMED-AI generated tools in relation to the patient care continuum. The Validation Center will focus on verification, validation, interoperability, and uncertainty quantification to comprehensively characterize performance of the CDS tools developed by the PRIMED-AI Consortium. These validated resources and evaluation findings will be made available through a publicly accessible, centralized PRIMED-AI web portal managed by the Logistics Center in consultation with the model developers.
Translation Core - Sustainable tools for regulatory clinical translation support. Through the development of a validation pipeline, the Validation Center will also be expected to develop a tool (or tools) that will allow users to benchmark and evaluate models in various clinical environments (e.g. accuracy, monitor drift). Ideally, the tool(s) should promote sustainability after the end of the Program and have the ability to be utilized by the broader research community. This could take the form of, but not limited to, an Independent Test Assessment Program (https://www.nibib.nih.gov/programs/radx-innovation-funnel), modular performance assessment tools and/or metrics/protocols. While not required, the applicants should also work towards having these tools be MDDT–eligible (Medical Device Development Tools - https://www.fda.gov/medical-devices/medical-device-development-tools-mddt). This could also include integration with other AI-enabled science efforts, including the Genesis Mission.
Fast-track Core – funding support for unmet clinical and data science needs. The Validation Center will develop a fast-track process that addresses unmet clinical needs in PRIMED-AI relevant areas. The fast-track process requirements include network ideation activities, development of solicitations, and evaluation of proposals in consultation with the Steering Committee and NIH PRIMED-AI Program staff. The Fast-track Core will support modular software tool development sub-projects and/or other identified needs. This will create opportunities to expand the PRIMED-AI community, bring in new collaborations, and address existing relevant gaps. It is anticipated that the Validation Center would manage no more than ten (10) sub-projects per year. The first round of sub-project awards is to be made in Year Two of the grant project period.
MPI and Validation Center staff requirements - 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 PRIMED-AI Program will have regular conference calls and meetings. Applicants should request funds for 2-6 group members to attend annual meetings, Consortium-led tutorials, and open innovation meetings, as appropriate. The Validation 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.
Specifically, the Validation Center will perform the following cross-cutting tasks:
Develop a coordination plan consistent with achieving the goals of this Program incorporating all PRIMED-AI Consortium award recipients.
Continuously sequester and annotate multimodal data for validation and benchmarking purposes, independent of data utilized by PRIMED-AI award recipients to train models. Benchmark data sets will be made public through the PRIMED-AI web portal in collaboration with the Logistic Center.
Implement and execute standardized, rigorous protocols for the benchmarking, evaluation and risk assessment of CDS tools developed by PRIMED-AI award recipients.
Develop technical validation guidelines for the PRIMED-AI Consortium proposed interaction with regulatory bodies (e.g. FDA, ONC) to facilitate that validation plans are consistent with relevant regulations.
Develop best practices on how the Validation Center's processes will remain transparent , reproducible , and sustainable.
See Section VIII. Other Information for award authorities and regulations.
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.
The OER Glossary and the How to Apply - Application Guide provides 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.
The NIH Common Fund intends to commit approximately $2,700,000 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 $2,000,000 direct costs for the first year and up to $3,200,000 direct costs 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.
Higher Education Institutions - Includes all types
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
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.
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 his/her 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 Section 1.2- Definitions of Terms.
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:
The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.
It is critical that applicants follow the Multi-Project (M) 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) and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.
| Component | Component Type for Submission | Page Limit | Required/Optional | Minimum | Maximum |
|---|---|---|---|---|---|
| Overall | Overall | 12 | Required | 1 | 1 |
| Validation Core | Core | 12 | Required | 1 | 1 |
| Translation Core | Core | 12 | Required | 1 | 1 |
| Fast-track Core | Core | 12 | Required | 1 | 1 |
The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.
When preparing the application, use Component Type 'Overall'.
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.
Complete entire form.
Follow standard instructions.
Follow standard instructions.
Enter primary site only.
A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.
Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.
A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.
The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.
A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.
Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.
Research Strategy:
As part of the research strategy, applicants are required to structure the Validation Center to include three main Cores as described in the Part 2, Section 1: 1) a Validation Core; 2) Translation Core; and 3) Fast-track Core.
The Validation Center should address the following cross-cutting plans:
Coordination Plan with PRIMED-AI Consortium Award Recipients – The Validation Center will develop a coordination plan for interactions with (1) the Logistics Center, to include plans for ensuring timely validation of resources for inclusion in the PRIMED-AI Web Portal, and jointly develop a sustainability plan beyond the PRIMED-AI Program support period; (2) the Playbook award recipients, to ensure that frameworks developed by the Playbook award recipients are incorporated into the validation process, (3) Data-to-Model AIP, and Model-to-Clinic award recipients, to implement and execute standardized, rigorous protocols for the initial and ongoing evaluation of CDS tools.
Milestones and Progress – Applicants must define semi-annual milestones with metrics that will document progress towards the achievement of the ultimate goals of the PRIMED-AI Program. The milestone and progress section should address the three main cores of the Validation Center, in an easily identifiable and attributable way (e.g. Gantt chart). Applicants should include plans for critically evaluating and revising these milestones on a regular basis, in consultation with NIH program staff.
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, with the following additional instructions:
Applicants should indicate their willingness to abide by all data deposition, quality control metrics, standardization, metadata requirements, data and software release, and public copyright license policies developed by the PRIMED-AI Consortium and approved by NIH staff. Prior to funding, NIH Program Staff may negotiate modifications to the Sharing Plan with the applicant.
Other Plan(s):
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.
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.
All instructions in the How to Apply- Application Guide must be followed.
When preparing your application, use Component Type 'Core.'
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Validation Core)
Complete only the following fields:
Research & Related Other Project Information (Validation Core)
Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.
Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Project /Performance Site Location(s) (Validation Core)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Validation Core)
Budget (Validation Core)
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Validation Core)
Specific Aims: State concisely the goals of the Validation Core. Include a succinct summary of the core and its relevant experience to the stated objectives of this solicitation.
Research Strategy: This section should provide a clear description of the plan, timeline, and milestones to implement the proposed Validation Core activities, including but not limited to:
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, with the following modification:
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Evaluation and Validation Plan - The Center must implement and execute standardized, rigorous protocols for the initial and ongoing evaluation of CDS tools developed by PRIMED-AI award recipients (D2M-AIP and M2C). This requires establishing and maintaining high-quality, representative benchmark datasets to assess validity, generalizability, fit-for-purpose, and performance stability over time or across deployment contexts. This plan must include a proposed "model card" protocol or similar. Components of model cards may include, but are not limited to, context of model use including provenance, uncertainty quantification, datasets used for model training, relevant patient populations, limits of predictive accuracy, code documentation, etc.
The applicants must include in the plan an explanation of how the validation pathway will remain transparent, reproducible, and sustainable.
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.
PHS Human Subjects and Clinical Trials Information (Validation Core)
When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.
When preparing your application, use Component Type 'Core.'
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Translation Core)
Complete only the following fields:
Research & Related Other Project Information (Translation Core)
Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.
Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Project /Performance Site Location(s) (Translation Core)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Translation Core)
Budget (Translation Core)
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Translation Core)
Specific Aims: State concisely the goals of the Translation Core. Include a succinct summary of the core and its relevant experience to the stated objectives of this solicitation.
Research Strategy: This section should provide a clear description of the plan, timeline, and milestones to implement the proposed Translation Core activities, including but not limited to:
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, with the following modification:
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.
PHS Human Subjects and Clinical Trials Information (Translation Core)
When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.
When preparing your application, use Component Type 'Core.'
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Fast-track Core)
Complete only the following fields:
Research & Related Other Project Information (Fast-track Core)
Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.
Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Project /Performance Site Location(s) (Fast-track Core)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Fast-track Core)
Budget (Fast-track Core)
Budget forms appropriate for the specific component will be included in the application package.
Restricted Funds for Collaborative PRIMED-AI Consortium activities - For award years 2-5, budgets must contain $1,500,000 each year to fund collaborations with other PRIMED-AI Consortium members and/or collaborators external to PRIMED-AI to:
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Fast-track Core)
Specific Aims: State concisely the goals of the Fast-track Core. Include a succinct summary of the core and its relevant experience to the stated objectives of this solicitation.
Research Strategy: This section should provide a clear description of the plan, timeline and milestones to implement the proposed Fast-track Core activities, including but not limited to: [SK2]
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, with the following modification:
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.
PHS Human Subjects and Clinical Trials Information (Fast-track Core)
When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.
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
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) using ASSIST or other electronic submission systems. 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 How to Apply- Application Guide.
This initiative is not subject to intergovernmental review.
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.
Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.
For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.
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) and component Project Leads 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.
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 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.
Applicants are required to follow the instructions for post-submission materials, as described in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to 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.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Specific to this NOFO:
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific to this NOFO:
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:
1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific to this NOFO:
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Specific to this NOFO:
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.
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
This NOFO only accepts applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medicine Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions (as applicable), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals (as applicable), the committee will consider the progress made in the last funding period.
For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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.
Not Applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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 (NIBIB) Advisory Council. The following will be considered in making funding decisions:
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.
After the peer review of the application is completed, the PD/PI will be able to access their 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.
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 organizations 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.
The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
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:
Cybersecurity plans and procedures must at minimum include the following:
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.
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. To address particular issues, 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:
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.
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.
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.
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.
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 assessment/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.
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.
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.
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. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.
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:
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.
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:
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.
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
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.