Academic-Industrial Partnerships (AIP) to Translate and Validate In Vivo Imaging Systems

Academic-Industrial Partnerships (AIP) to Translate and Validate In Vivo Imaging Systems is sponsored by NIH. Supports partnerships between academia and industry to translate and validate in vivo imaging systems, including AI-based technologies.

PAR-25-079: Academic-Industrial Partnerships (AIP) to Translate and Validate In Vivo Imaging Systems (R01 Clinical Trial Optional) 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. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Cancer Institute ( NCI ) Funding Opportunity Title Academic-Industrial Partnerships (AIP) to Translate and Validate In Vivo Imaging Systems (R01 Clinical Trial Optional) R01 Research Project Grant 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. 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) Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to stimulate translation of scientific discoveries and engineering developments in imaging, data science and/or spectroscopic technologies into methods or tools that address contemporary problems in understanding the fundamental biology, potential risk of development, diagnosis, or treatment of cancer.

A distinguishing feature of each application to this NOFO will be formation of an academic-industrial partnership: a strategic alliance of academic and industrial investigators who work together as partners to identify and translate a technological solution for mitigation of a cancer (or other disease-related) problem.

In this sense, the NOFO acts more as a funding mechanism for driving translational research in imaging than for a specific scientific or clinical research area. These partnerships are expected to solidify pre-existing collaborations or establish new ones that would drive the field of imaging, as a whole, further than if they had not been formed. This NOFO defines innovation as the likelihood to deliver a new capability to end users.

This funding announcement will support clinical trials that test functionality or validate performance in the chosen setting. However, this NOFO is not intended to support commercial production, basic research projects, or clinical trials that lack translation as the primary motivation. Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk.

Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

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. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II.

Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V.

Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII.

Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to stimulate translation of scientific discoveries and engineering developments in imaging / quantifiable imaging, data science and/or spectroscopic technologies into tools or methods that address contemporary problems in understanding the fundamental biology, potential risk of development, diagnosis, and/or treatment for cancer A characteristic feature of each application submitted in response to this NOFO will be the formation of an academic-industrial partnership: a strategic alliance of academic and industrial investigators who work together as partners to identify and translate a novel technological solution towards detection /diagnosis or treatment of cancers.

In this sense, the NOFO acts more as funding mechanism for driving translational research in imaging more than for a specific scientific or clinical research area. The partnerships formed between academia and industries are expected to solidify pre-existing collaborations or establish new ones that would drive the field of imaging, as a whole, further than if they had not been formed.

The goals for proposed technologies are imaging applications in clinical trials, clinical research, non-clinical research, and/or patient care. Among other possibilities, they may include pre-clinical imaging investigations or investigations that combine patient specimens and pre-clinical methods, or optimizations of methods across different commercial platforms, and sites.

Further possibilities include expansion of research in new directions by emphasizing areas involving (i) surgical imaging technologies which can help identify and improve cancer margin location with reduced costs, and broaden availability to the community, (ii) development and validation of cancer activatable agents and other novel probes to enhance image detection of exceptionally small tumor colonies, (iii) development and validation of algorithms for improved imaging detection, diagnosis, and measurement of treatment response, (iv) leveraging machine learning algorithms or the development of novel ones to aid in quantifiable image analysis, segmentation, integration of large data sets or other to evolve the clinical utility of ‘artificial intelligence for diagnostic imaging.

This NOFO specifies a partnership structure intended to help translate imaging, data science-focused, and spectroscopic technologies through a combination of complementary knowledge and experience, and common strengths found across academic and industrial investigators.

This inter-disciplinary/-sector approach would allow these teams to work together to plan, design, and engineer the efficient transition of a new method or technology from a working prototype to a status suitable for careful validation.

One example of benefit to this partnership structure could be from bringing the rigor in the biomedical industry’s use of good laboratory practices (GLP) and good manufacturing practices (GMP) to the academic setting, which could later facilitate the more efficient transfer of academic intellectual property to the commercial setting.

Another example of benefit to this partnership structure could be from bringing academic novelty to the commercial sector, which could facilitate less risk in the commercial setting. The rationale for this NOFO is to address the rapidly evolving requirements needed to move advanced imaging technologies or methods into pre-clinical, clinical, and non-clinical research settings.

This NOFO is designed to stimulate academic-industrial partnerships to overcome translational research barriers up to the point of pre-commercial production but specifically, this NOFO does not support commercial production. Specific Research Objectives and Scope This announcement applies to discoveries and engineering development results that have demonstrated the feasibility and are ready to be optimized and validated.

The applicants are expected to identify and address a problem in cancer. The focus is on the translation of imaging and spectroscopy systems and methods that represent advances with promise for addressing unmet needs in cancer.

These can be found in areas such as clinical research, cancer prevention, biology, development, screening, earlier detection, diagnosis, therapy monitoring, risk assessment for individuals or populations, and cancer outcomes.

Academic-Industrial Partnership (AIP) and Translational Research The grant application for the academic-industrial partnership should present a well-organized translational research strategy for the proposed technology or method, aiming to tackle a specific objective related to cancer detection and/or treatment. Technology translation may focus on clinical research, clinical care delivery, or non-clinical research.

Furthermore, imaging and imaging-related technology for non-human cancer research is supportable by this funding opportunity whether or not it appears to have future prospects of direct clinical use. Translational efforts are expected to enhance, adapt, optimize, validate, and transition a prior, currently existing, or next-generation prototype technology or method.

Overall objectives may be for clinical research, clinical care delivery, or non-clinical research.

The focus within these objectives may include, but are not limited to: Quantifiable imaging tools and methods; Multimodal imaging platforms or spectroscopic tool(s); Imaging platforms for anatomical, molecular, functional, or metabolic analysis; Image-guided interventions; Development and validation of imaging technologies applied during cancer surgery which can help identify and improve cancer margin location with reduced costs, and broaden availability to the community; Development and validation of fast and accurate intraoperative techniques to improve pathological analysis of cancer tissue in near-real time during surgery; Development and validation of cancer activatable agents and other novel probes to enhance image detection of exceptionally small tumor colonies; Development and validation of imaging tools to improve analysis, acquisition, lesion visualization, navigation guidance, or measurement of treatment response; and Integration of modern computational or informatics methods ( e.g., machine learning/vision to ‘Machine/Artificial Intelligence’, integrated bioinformatics, predictive analytics, etc.) into preclinical and clinical imaging methods to enhance/optimize utility for detection, diagnosis, or treatment monitoring.

Technological improvements may focus on reproducibility, reliability, speed, ease of use, and/or affordability.

The improvements may also include but are not limited to: Calibration and software applications; Quality control procedures and parameters; Management of reproducibility and error propagation; Methods for prospectively annotating imaging data to be ‘Artificial Intelligence’ ready and subsequent validation; Validation and correlation studies; Optimizations across different commercial imaging platforms and/or sites; and Use in high, middle, or low resource settings.

The intent of this NOFO is to encourage investigators to assemble a team with strengths and resources sufficient to achieve the proposed translational goals. Therefore, a pre-requisite application feature is the formation of a team that includes at least one academic investigator and one investigator from an industrial organization among key team members.

The level of participation and budget details should reflect levels necessary to achieve the specific aims proposed and may vary relative to these aims. Investigator partnerships have the discretion to set effort levels and apportion budget according to the timing and other project requirements at each research step.

Innovation, at its conception, grows as it gains the functionality and readiness to deliver a new capability to end-users. For this announcement, innovation is defined as the likelihood to deliver a new capability to end-users. Non-Responsive Applications The following types of studies are not responsive to this NOFO.

Applications proposing such studies will be considered non-responsive and will not be reviewed. This NOFO is not intended to support Clinical studies that lack translation as their primary motivation; and Application without academic-industrial partnership. See Section VIII.

Other Information for award authorities and regulations. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. Section II.

Award Information 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 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.

Optional: Accepting applications that either propose or do not propose clinical trial(s). Need help determining whether you are doing a clinical trial? 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.

Application budget is limited to less than $500,000 direct cost per year and must reflect the actual needs of the proposed project. The maximum project period is 5 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign 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. 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 time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

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. 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 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. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

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

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: Specific Aims: The application should clearly describe the capabilities to be achieved through 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 in response to this NOFO should include a description of the strategic alliances planned by the investigators and their institutions to ensure that the range of expertise will be sufficient to complete the goals proposed.

In addition, the following should be specifically addressed : 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 what 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.

Background and Significance: The application should clearly state a cancer related problem, its importance, and the potential benefits gained via proposed mitigation or solution. Approach: Provide a detailed, rational plan for translation of the new method or technology that addresses a cancer 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. 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.

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.

Note: This announcement is not intended to support commercial production, basic research projects or clinical studies that lack translation as their primary motivation. 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.

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.

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 (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. 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. All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form .

Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply Application Guide. See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the NCI, NIH. Applications that are incomplete, non-compliant and or non-responsive 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 [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 Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following 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.

Reviewers will evaluate 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 criterion score. Factor 1.

Importance of the Research (Significance and Innovation) 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. 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 address a technical solution likely to mitigate an important problem in non-clinical, pre-clinical, clinical research, or clinical care delivery. Evaluate whether the application present a path likely to deliver an emerging or new capability to end-users.

If the application focuses on preclinical studies to support its translational path, evaluate whether the rationale, relative to its successful outcome, for enabling an emerging or new capability to end-users is reasonable. Factor 2. Rigor and Feasibility (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). 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