Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to stimulate efforts to translate scientific discoveries and engineering developments into methods or tools that address problems in basic research to understand disease, or in applied research to assess risk, detect, prevent, diagnose, treat, and/or manage disease. The rationale is to deliver new capabilities to meet evolving requirements for technologies and methods relevant to the advance of research and delivery of care in pre-clinical, clinical and non-clinical settings, domestic or foreign, for conditions and diseases within the missions of participating institutes.

PAR-25-338: Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment (R01 - Clinical Trial Not Allowed)

Posted Date: December 31, 2024 Open Date (Earliest Submission Date): January 05, 2025 Expiration Date: January 08, 2028

Participating Organization(s):

• National Institutes of Health (NIH)

Components of Participating Organizations:

• National Cancer Institute (NCI)
• National Eye Institute (NEI)
• National Institute of Dental and Craniofacial Research (NIDCR)
• Office of Research on Women's Health (ORWH)

Part 1. Overview Information

Funding Opportunity Title: Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment (R01 - Clinical Trial Not Allowed)

Activity Code: R01 Research Project Grant

Announcement Type: Reissue of PAR-21-166

Related Notices:

• March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.
• January 10, 2025 - Notice of Correction to PAR-25-338 Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment (R01 - Clinical Trial Not Allowed). See Notice NOT-CA-25-032.
• April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084.
• August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
• August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.

Funding Opportunity Number (FON): PAR-25-338

Companion Funding Opportunity: PAR-25-337, R01 Research Project

Assistance Listing Number(s): 93.394, 93.395, 93.313, 93.121, 93.867

Funding Opportunity Purpose: The purpose of this Notice of Funding Opportunity (NOFO) is to stimulate efforts to translate scientific discoveries and engineering developments into methods or tools that address problems in basic research to understand disease, or in applied research to assess risk, detect, prevent, diagnose, treat, and/or manage disease. The rationale is to deliver new capabilities to meet evolving requirements for technologies and methods relevant to the advance of research and delivery of care in pre-clinical, clinical and non-clinical settings, domestic or foreign, for conditions and diseases within the missions of participating institutes.

This NOFO specifies a partnership structure that is expected to help bridge gaps in knowledge and experience by engaging the strengths of academic, industrial, and other investigators. The partners on each application should establish an inter-disciplinary, multi-institutional research team to work in strategic alliance to implement a coherent strategy to develop and translate a solution to their chosen problem. They are expected to plan, design, and validate that the solution will be suitable for end users. Each partnership should include at least one academic and one industrial organization. Each partnership should plan to transition a technology, method, assay, device, and/or system from a demonstration of possibility to a status useful in the chosen setting. Funding may be requested to enhance, adapt, optimize, validate, and otherwise translate technologies that address problems in biology, pathology, risk assessment, detection, diagnosis, treatment, and/or monitoring of disease status.

This NOFO defines "innovation" as likelihood to deliver a new capability to end users.

Funding Opportunity Goal(s): The overall goals of this NOFO are to improve screening and early detection strategies and to develop accurate diagnostic techniques and methods for predicting the course of disease in cancer patients.

Key Dates:

Application Due Dates, Review and Award Cycles:

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.

Required Application Instructions: It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

• Use the NIH ASSIST system to prepare, submit and track your application online.
• Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
• Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose: The purpose of this Notice of Funding Opportunity Announcement (NOFO) is to stimulate efforts to translate scientific discoveries and engineering developments into methods or tools that address problems in basic research to understand disease, or in applied research to assess risk, detect, prevent, diagnose, treat, and/or manage disease. The rationale is to deliver new capabilities to meet evolving requirements for technologies and methods relevant to the advance of research and delivery of care in pre-clinical, clinical and non-clinical settings, domestic or foreign, for conditions and diseases within the missions of participating institutes.

This NOFO specifies a partnership structure that is expected to help bridge gaps in knowledge and experience by engaging the strengths of academic, industrial, and other investigators. The partners on each application should establish an inter-disciplinary, multi-institutional research team to work in strategic alliance to implement a coherent strategy to develop and translate a solution to their chosen problem. They are expected to plan, design, and validate that the solution will be suitable for end users. Each partnership should include at least one academic and one industrial organization. Each partnership should plan to transition a technology, method, assay, device, and/or system from a demonstration of possibility to a status useful in the chosen setting. Funding may be requested to enhance, adapt, optimize, validate, and otherwise translate technologies that address problems in biology, pathology, risk assessment, detection, diagnosis, treatment, and/or monitoring of disease status.

Examples of possible advances may include, but are not limited to:

• Affordability
• Commercially supported systems
• Next-generation systems
• Quality assurance, quality control
• Management of reproducibility, error propagation
• Validation, Correlation studies
• Quantification methods
• Research resources
• Calibration, software applications
• Integrative bioinformatics
• Consensus or standard usage across different commercial platforms or sites
• Extensions to low resource settings, or underserved populations
• Knowledge-based systems
• Machine learning, artificial intelligence
• Automated predictive analysis
• Analytical and clinical validation using clinical samples, and correlation studies

This NOFO defines innovation as likelihood to deliver a new capability to end users. This definition of innovation is deliberately broad to accommodate a wide range of projects and their problems in need of solutions. For example, objectives may include adaptations of existing or new technologies or methods affordable for use in any setting, including those with low resources or underserved populations.

Background and Research Objectives: The rationale of this NOFO is to deliver new capabilities to meet evolving requirements for technologies and methods relevant to the advance of research and delivery of care in pre-clinical, clinical and non-clinical settings, domestic or foreign. This NOFO specifies a partnership structure expected to help bridge gaps in investigator knowledge and experience by engaging the strengths of academic, industrial, and other investigators. They are expected to plan, design, and solve a problem, and validate it as suitable for end users.

Key parties are expected to participate from the beginning. The academic-industrial partnership may include any number of participants and organizations necessary to assemble a critical mass of expertise and know-how for effective execution. The level of participation is expected to vary among the partners as necessary to reach the specific translational research goals proposed. The strategic alliance is expected to combine research strengths, laboratory, and other resources unique to each group to advance the translational research goal. Industrial involvement from the beginning is expected to facilitate more efficient transfer of intellectual property to the commercial setting. For example, it is likely final outcomes would improve if the investigators chose from the start to adopt industry's focus on manufacturability and reliability. For clinically oriented projects, routine use of good laboratory practices (GLP) and good manufacturing practices (GMP) would reduce risk and raise the likelihood of meeting FDA standards and consumer expectations. Commercialization of the proposed technologies would be the usual goal, but is not necessarily the only path to sustainable dissemination that is a critical objective of this NOFO. This NOFO will support work up to the point of pre-commercial production, but specifically does not support commercial production.

Technology translation to solve a target problem may focus on clinical research, clinical care delivery, or non-clinical research. Technological improvements may focus on reproducibility, reliability, rapidity, ease of use, or affordability.

Partnerships of academics and their affiliated start-up technology companies are allowable so long as financial conflicts of interests will be managed in compliance with Department of Health and Human Services and National Institutes of Health policy as described in 42 CFR part 50. The level of participation and budget details are expected to vary among the partners as necessary to achieve the specific aims proposed. The investigators have the discretion to set effort levels and apportion budget according to the timing and other project requirements at each research step.

Each academic-industrial partnership is encouraged to solve its targeted problem within the funding period. This NOFO will support the placement of copies of prototypes in multiple research sites for study and validation of performance.

Possible technologies designed to address a targeted problem as defined in this NOFO include, but are not limited to, the following:

• Development, integration and validation of new molecular diagnosis, imaging or spectroscopy systems, technologies, methods, assays, or devices, related component technologies, molecular diagnostic technology, image processing methods, and development of informatics tools; for example, non-stain molecular contrast methods for pathology slide microscopy, such as molecular bond vibrational spectroscopic imaging maps.
• Implementation of research methods on one version or multiple manufacturer's versions of commercial platforms, where appropriate.
• Harmonization of data collection and data analysis across single and/or different commercial platforms to reduce the sources of uncertainty in use of biomarkers or other research areas as required for multi-site preclinical or clinical investigations; these efforts may include development of open computer platforms and open source software tools.
• Development of shared resources, data archives, and other approaches intended to facilitate consensus methods for optimization and validation of emerging technologies and methods; it is understood that many commercial entities develop open source tools to support validation of technologies and such applications are encouraged.

Applications appropriate for this NOFO require the following attributes:

• Contain research partnerships formed by academic and industrial investigators, and any other participants to assure the group has a critical mass of essential skills and know-how to perform the translational aims proposed.
• Propose to enhance, adapt, optimize, validate, and otherwise translate a technology, method, assay, device, or system for diagnosis, imaging or spectroscopy for (a) current commercially supported system, (b) next-generation system, (c) quality assurance and quality control, (d) validation and correlation studies, (e) quantitative methods, (f) related research resource, or (g) other possibilities.
• Propose to mitigate or solve a targeted problem in risk assessment, detection, diagnosis, staging, treatment, and/or treatment monitoring.
• Propose to accomplish substantial progress toward delivery of their translated product as a new capability for use by end users in pre-clinical, clinical research or clinical care.
• Propose to develop or adapt a technology for a low resource setting or underserved population.

IC-Specific Interests:

National Cancer Institute (NCI): The NCI leads, conducts, and supports cancer research across the nation to advance scientific knowledge and help all people live longer, healthier lives. As the leader of the cancer research enterprise, collectively known as the National Cancer Program, and the largest funder of cancer research in the world, NCI manages a broad range of research, training, and information dissemination activities that reach across the entire country, meeting the needs of all demographics rich and poor, urban and rural, and all racial/ethnic populations.

Examples of technologies that are of interest to NCI include, but are not limited to:

• For tissue ex vivo or in vivo imaging and integration for detection/diagnosis/prognosis.
• For measuring immune health status, immune processes (e.g., immunocompetence, resilience, immune surveillance) or for evaluating functional capacity of cancer-relevant immune cells, neoantigen presenting or binding immune cells, or durability of natural anti-tumor immune response.
• For primary and secondary lymphoid organ function tests.
• To monitor immunotoxicity, cancer associated opportunistic infections, cytokine release syndrome, and cancer treatment-related adverse events.
• Point-of-care or point-of-need tools for predicting cancer risk, detection, diagnosis, prognosis, or minimal residual disease, and affordable technologies for rural cancer care.
• Next-generation non-invasive or minimally invasive diagnostics platforms e.g., liquid biopsy-based multiomic analysis platforms.
• For producing next generation cancer therapeutics, including nanobody-based diagnostics, theragnostics or therapeutics; in vivo editing; in vitro and in vivo engineering of immune cells for immunotherapy, or immune modulation.
• DL/ML/AI based models/foundation models that integrate one or more data types.
• For analysis of exposures, including environmental and chemical exposures, and cancer-relevant microbiome and virome; host-microbiome interactions, and tools for gene-environment interaction.
• Tools for cancer care coordination; and wearable devices and biosensors to monitor lifestyle factors and cancer-relevant exposures; and population scale dissemination tools.

National Eye Institute (NEI): The mission of the National Eye Institute (NEI) is to eliminate vision loss and improve quality of life through vision research. The NEI invites applications for research that aligns with our strategic plan. The NEI is interested in stimulating translation of novel diagnostics, scientific discoveries, and therapies to treat diseases and disorders of the visual system, especially blinding eye diseases such as glaucoma, age-related macular degeneration, retinitis pigmentosa and other conditions of the visual nervous system. Each project must have a well-defined endpoint, achievable within a five-year time frame, for developing a diagnostic or treatment for a specific disease or disorder of the visual system. Investigators are strongly encouraged to contact NEI scientific/research contact prior to submission, to ensure this is the correct NOFO for their proposed research.

The National Eye Institute (NEI) strongly encourages applicants to use common formats for files and metadata standards when incorporating ocular imaging in their research proposals (see NOT-EY-24-006). This applies to both clinical and nonclinical research applications submitted in response to NOFOs where NEI is the issuing or participating organization. It is anticipated the widespread adoption of standardized imaging formats will significantly advance the field by 1) simplifying streamlined digital workflows; 2) enhancing interoperability of large datasets; and 3) developing extensive and comprehensive training sets for artificial intelligence driven research. By promoting these standards, the NEI goal is to create an environment where data can be seamlessly integrated and analyzed across different studies, thereby, amplifying the overall impact of vision research.

Office of Research on Women’s Health (ORWH): ORWH is part of the Office of the Director, NIH, and works with the 27 NIH Institutes and Centers to co-fund women’s health-related applications and research projects that have received an award from one of the participating NIH Institutes and Centers (ICs) listed in the announcement. Applications seeking ORWH co-funding should ensure that the proposed work is aligned with at least one goal and objective outlined in the 2024 – 2028 NIH-Wide Strategic Plan for Research on the Health of Women (https://www.nih.gov/women/strategicplan). ORWH is particularly interested in applications focused on diseases and health conditions that predominantly affect women, present and progress differently in women, or are female-specific.

Non-Responsive Projects: This NOFO is not intended to support commercial production, basic research projects or clinical studies that lack translation as their primary motivation. Therefore, this NOFO does not support basic research projects that do not emphasize translational processes of adaptation, optimization, and validation for a targeted research or clinical problem. An application proposing a biological research problem as its essence, (where the technology and methods have already been adapted, optimized, validated and established) is not responsive to this NOFO.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument: Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed:

• New
• Renewal
• Resubmission
• Revision

The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial? Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards: The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget: Application budgets are limited to $499,000 (direct costs) per year.

Award Project Period: The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants:

Eligible Organizations:

• Higher Education Institutions (Public/State Controlled, Private)
• Nonprofits Other Than Institutions of Higher Education (with 501(c)(3) IRS Status, without 501(c)(3) IRS Status)
• For-Profit Organizations (Small Businesses, Other than Small Businesses)
• Local Governments (State, County, City or Township, Special District)
• Indian/Native American Tribal Governments (Federally Recognized, Other than Federally Recognized)
• Federal Governments (Eligible Agencies of the Federal Government)
• 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)
• Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.
• Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
• Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations:

Applicant Organizations: Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the 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 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.
• NATO Commercial and Government Entity (NCAGE) Code: Foreign organizations must obtain an 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.

Eligible Individuals (Program Director/Principal Investigator): Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply-Application Guide.

2. Cost Sharing: This NOFO does not require cost sharing as defined in the 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. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations: All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission: The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

• SF424(R&R) Cover: All instructions in the How to Apply - Application Guide must be followed.
• SF424(R&R) Project/Performance Site Locations: 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.
• SF424(R&R) Senior/Key Person Profile: All instructions in the How to Apply- Application Guide must be followed.
• R&R or Modular Budget: All instructions in the How to Apply- Application Guide must be followed.
• 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:
  • Specific Aims: The application should clearly describe what capability will be achieved by successful completion of the proposed work. Performance targets, error estimates, statistical requirements, and a timeline with metrics should be provided.
  • Research Strategy: All applications submitted for this NOFO should include a description of the strategic alliances planned by the investigators and their institutions to ensure the range of expertise will be sufficient to complete the goals proposed. In addition, the following should be specifically addressed:
    • Importance of the Research (Significance and Innovation):
      • Background and Significance: The application should clearly state a biomedical related problem, its importance, and the potential benefits gained via proposed mitigation or solution.
      • Innovation: For this announcement, innovation guidelines for NIH grants are modified to include innovation defined as the likelihood to deliver a new capability to end-users.
    • Rigor and Feasibility (Approach): Provide a detailed, rational plan for translation of the new method or technology that addresses a biomedical related problem. Indicate why it is ready to be translated. Provide preliminary data that support the study plan, feasibility, and approach to validation. For context, include a description of expected user groups and their environments.
    • Expertise and Resources (Investigator(s) and Environment):
      • Key personnel: Describe in detail the role(s) of key investigators. Applications for methods or technologies with proposed clinical applications should include physicians with clinical expertise in the relevant area to help ensure focus on clinical needs and clinical utility.
      • Governance and organization structure outline: The arrangements for collaborations must allow administration of the joint effort as a single project. Describe the overall organization, major tasks each partnering organization will complete, and contributions each partner will bring to the effort. Describe the extent an award under this NOFO could advance the product or service far enough to attract sufficient, independent third-party financing and/or strategic partnerships in carrying out full commercialization. Include details on shared leadership, administration, cost sharing (if any), conflict resolution, as well as technical, pre-clinical and clinical responsibilities, as appropriate.
• 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:
  • All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
• 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.
• Foreign Organizations: Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply- Application Guide.

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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Mandatory Disclosure: Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector General Grant Self Disclosure Program at [email protected]

Post Submission Materials: Applicants are required to follow the instructions for post-submission materials, as described 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.

For this particular announcement, note the following:

• "Innovation" is defined as likelihood to deliver a new capability to end-users.
• An application with an objective to solve a non-clinical problem does not need to show any potential for direct clinical translation.

Overall Impact: Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Scored Review Criteria: Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score.

• Factor 1. Importance of the Research (Significance and Innovation):

  • Significance: Evaluate the importance of the proposed research in the context of current scientific challenges and opportunities, either for advancing knowledge within the field, or more broadly. Assess whether the application addresses an important gap in knowledge in the field, would solve a critical problem, or create a valuable conceptual or technical advance. Evaluate the rationale for undertaking the study, the rigor of the scientific background for the work (e.g., prior literature and/or preliminary data) and whether the scientific background justifies the proposed study.
  • Innovation: Evaluate the extent to which innovation influences the importance of undertaking the proposed research. Note that while technical or conceptual innovation can influence the importance of the proposed research, a project that is not applying novel concepts or approaches may be of critical importance for the field. Evaluate whether the proposed work applies novel concepts, methods or technologies or uses existing concepts, methods, technologies in novel ways, to enhance the overall impact of the project.
    • Specific to this NOFO:
      • Evaluate whether the application addresses a solution likely to mitigate an important problem in non-clinical, pre-clinical, or clinical research, or clinical care delivery.
      • Evaluate whether the application presents a path likely to deliver an emerging or new capability to end users.

• Factor 2. Rigor and Feasibility (Approach):

  • Approach: Evaluate the scientific quality of the proposed work. Evaluate the likelihood that compelling, reproducible findings will result (rigor) and assess whether the proposed studies can be done well and within the timeframes proposed (feasibility).
    • Rigor: Evaluate the potential to produce unbiased, reproducible, robust data. Evaluate the rigor of experimental design and whether appropriate controls are in place. Evaluate whether the sample size is sufficient and well-justified. Assess the quality of the plans for analysis, interpretation, and reporting of results. Evaluate whether the investigators presented adequate plans to address relevant biological variables, such as sex or age, in the design, analysis, and reporting. For applications involving human subjects or vertebrate animals, also evaluate: the rigor of the intervention or study manipulation (if applicable to the study design); whether outcome variables are justified; whether the results will be generalizable or, in the case of a rare disease/special group, relevant to the particular subgroup; whether the sample is appropriate and sufficiently diverse to address the proposed question(s). For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research. Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science.
    • Feasibility: Evaluate whether the proposed approach is sound and achievable, including plans to address problems or new challenges that emerge in the work. For proposed studies in which feasibility may be less certain, evaluate whether the uncertainty is balanced by the potential for major advances. For applications involving human subjects, including clinical trials, evaluate the adequacy and feasibility of the plan to recruit and retain a study population that appropriately models the target population. Additionally, evaluate the likelihood of successfully achieving the proposed enrollment based on age, race, ethnicity, and sex. For clinical trial applications, evaluate whether the study timeline and milestones are feasible.

• Factor 3. Expertise and Resources (Investigator(s) and Environment):

  • Investigator(s): Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.
  • Environment: Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.
    • Specific to this NOFO:
      • Evaluate whether the proposed partnerships have sufficient complementary expertise to negotiate the steps necessary to execute the proposed translational research.
      • Evaluate whether the partners could work together effectively and apply a sufficient range of expertise and knowledge to complete the proposed translational project.
      • Evaluate whether the partners' strategic alliance provides resources and environment likely to achieve the project goals of solving or mitigating the stated problem.
      • Evaluate whether the governance and organizational structure is likely to support a good outcome.

Additional Review Criteria: As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.

• Protections for Human Subjects: For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, 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, 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.
• Vertebrate Animals: When the proposed research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
• Biohazards: When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.
• Resubmissions: As applicable, evaluate the full application as now presented.
• Renewals: As applicable, evaluate the progress made in the last funding period.
• Revisions: As applicable, evaluate the appropriateness of the proposed expansion of the scope of the project.

Additional Review Considerations: 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.

• Authentication of Key Biological and/or Chemical Resources: For projects involving key biological and/or chemical resources, evaluate the brief plans proposed for identifying and ensuring the validity of those resources.
• Budget and Period of Support: Evaluate whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process: Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR), in accordance with NIH peer review policy and procedures, 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.

Applications will be assigned on the basis of established PHS referral guidelines 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 appropriate national Advisory Council or Board. 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.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.
• 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.
• Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. NIH may terminate awards under certain circumstances. See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support.

Successful recipients under this NOFO agree that:

• Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity. Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.
• Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.
• 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.
  • Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information.

Cooperative Agreement Terms and Conditions of Award: Not Applicable

3. Data Management and Sharing: Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

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.

Annual Research Performance Progress Reports on grants funded under this FOA: In Section B, Accomplishments, subsection B.2. What was accomplished under the Goals, include specific accomplishments that may indicate translational progress. For example, cite publications, patents (awarded, maintained, licensed, pending), FDA or other regulatory agency approvals (investigational, marketing), clinical trials (planned, underway, completed), products (devices, agents, therapies, techniques, protocols, analytics), or any other candidate metric of translational progress toward dissemination and delivery to end users.

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.

Section VII. Agency Contacts

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

Application Submission Contacts:

• 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)
  • Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
  • Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
• General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
  • Email: [email protected] (preferred method of contact)
  • Telephone: 301-480-7075
• Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
  • Contact Center Telephone: 800-518-4726
  • Email: [email protected]

Scientific/Research Contact(s):

• Miguel R. Ossandon, Ph.D. (he/him/his)
  • National Cancer Institute (NCI)
  • Telephone: 240-276-5714
  • Email: [email protected]
• Darrell Tata, Ph.D.
  • National Cancer Institute (NCI)
  • Telephone: 240-781-3315
  • Email: [email protected]
• Rao L. Divi, Ph.D.
  • National Cancer Institute, NIH
  • Phone: (240) 276 6913
  • Email: [email protected]
• Benjamin Philip Johns, PhD
  • ORWH - Office of Research on Women's Health
  • Phone: 301-435-1681
  • E-mail: [email protected]
• Zhong Chen, M.D., Ph.D.
  • National Institute of Dental and Craniofacial Research (NIDCR)
  • Telephone: 301-529-7083
  • Email: [email protected]
• Tony Douglas Gover
  • NEI - NATIONAL EYE INSTITUTE
  • Phone: 301-529-7370
  • E-mail: [email protected]

Peer Review Contact(s):

• Dr Lambratu Rahman Sesay
  • Center for Scientific Review (CSR)
  • Telephone: 301-905-8294
  • Email: [email protected]

Financial/Grants Management Contact(s):

• Shane Woodward
  • National Cancer Institute (NCI)
  • Telephone: 240-276-6303
  • Email: [email protected]
• Gabriel Hidalgo
  • National Institute of Dental and Craniofacial Research (NIDCR)
  • Phone: 301-827-4630
  • E-mail: [email protected]
• Karen Robinson Smith
  • NEI - NATIONAL EYE INSTITUTE
  • Phone: 301-435-8178
  • E-mail: [email protected]

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.

Authority and Regulations: 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.

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