Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment (R01 - Clinical Trial Optional)

Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment (R01 - Clinical Trial Optional) is sponsored by National Cancer Institute (NCI). Encourages partnerships between academic institutions and industry to translate technologies for diagnosis and treatment into clinical applications.

PAR-25-337: Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment (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 for Translation of Technologies for Diagnosis and Treatment (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 The purpose of this Notice of Funding Opportunity (NOFO) Announcement 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, diagnosis, treatment, and/or monitoring of disease status. This NOFO defines "innovation" as likelihood to deliver a new capability to end users. This NOFO will support clinical trials that test functionality or validate performance in the chosen setting.

This NOFO is not intended to support clinical trials that lack translation as the primary motivation. Applications that propose phase III clinical trials iare not sought by and will not be supported through this NOFO. This NOFO does not propose to support commercial production or basic research projects.

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. This NOFO will also support research that aims to cure as many cancer patients as possible and to control the disease in those patients who are not cured.

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 The purpose of this Notice of Funding Opportunity (NOFO) Announcement 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, diagnosis, treatment, and/or monitoring of disease status.

Examples of possible advances may include, but are not limited to: Commercially supported systems; Quality assurance, quality control; Management of reproducibility, error propagation; Validation, Correlation studies; Calibration, software applications; Integrative bioinformatics; Consensus or standard usage across different commercial platforms or sites; Extensions to low resource settings, or underserved populations; Machine learning, artificial intelligence; Automated predictive analysis; Analytical and clinical validation using clinical samples, and correlation studies; and Cancer control studies in population science, among other advances.

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.

This NOFO will support clinical trials that test functionality or validate performance in the chosen setting. This NOFO is not intended to support clinical trials that lack translation as the primary motivation. Applications that propose phase III clinical trials are not sought by and will not be supported through this NOFO.

This NOFO does not propose to support commercial production or basic research projects. 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 knowhow 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, or cancer control; 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 knowhow 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.

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; wearable devices and biosensors to monitor lifestyle factors and cancer-relevant exposures; and population scale dissemination tools 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.

Applications that propose phase III clinical trials are not responsive to this NOFO. Investigator-initiated phase III cancer-related medical/oncologic intervention and/or investigational imaging clinical trials as specified in the NCI policy for R01 and P01 activity codes found in Notice NOT-CA-13-012 are not responsive to this NOFO.

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

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 budgets are limited to $499,000 (direct costs) per year. 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 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 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 : Without duplicating information in the biosketches, 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. 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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200. 113 and NIH Grants Policy Statement Section 4.

1. 35 . Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and