Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01, Clinical Trial Not Allowed) is sponsored by National Cancer Institute (NCI), National Institutes of Health (NIH). This funding opportunity supports the validation of assays developed from existing NIH R01 projects to accelerate their clinical use.

This could include mass spectrometry-based assays for secreted protein biomarkers that have shown promise in earlier research.

PAR-24-304: Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed) 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 Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed) 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) encourages revision applications (formerly called "competing revisions") from currently funded NCI R01 research projects.

The applicants should propose projects that are expected to accelerate the pace of translation of NCI-supported methods/assays/technologies (referred to as "assays") to the clinic.

Specifically, the focus of applications submitted in response to this NOFO should be on the adaption and clinical validation of molecular/cellular/imaging markers (referred to as "markers" or "biomarkers") for cancer detection, diagnosis, prognosis, monitoring, and prediction of response in treatment, as well as markers for cancer prevention and control.

Applications may support the acquisition of well-annotated specimens from NCI-supported or other clinical trials or observational cohorts/consortia for the purpose of clinical validation of the assay. Research projects proposed in response to this NOFO encourage multidisciplinary interaction among scientific investigators, assay developers, clinicians, statisticians, and clinical laboratory staff.

Clinical laboratory scientist(s) and statistical experts are highly encouraged to comprise integral parts of the application. This NOFO is not intended to support early-stage development of technology or the conduct of clinical trials, but rather the adaption and validation of assays to the point where they could be integrated into clinical trials as investigational assays/tools/devices.

Open Date (Earliest Submission Date) 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) encourages revision applications (formerly called "competing revisions") from currently funded NCI R01 research projects.

The applicants should propose projects that are expected to accelerate the pace of translation of NCI-supported methods/assays/technologies (referred to as "assays") to the clinic.

Specifically, the focus of applications submitted in response to this NOFO should be on the adaption and clinical validation of molecular/cellular/imaging markers (referred to as "markers" or "biomarkers") for cancer detection, diagnosis, prognosis, monitoring, and prediction of response in treatment, as well as markers for cancer prevention and control.

Applications may support acquisition of well-annotated specimens from NCI-supported or other clinical trials or observational cohorts/consortia for the purpose of clinical validation of the assay. Research projects proposed in response to this NOFO encourage multidisciplinary interaction among scientific investigators, assay developers, clinicians, statisticians, and clinical laboratory staff.

Clinical laboratory scientist(s) and statistical experts are highly encouraged to comprise integral parts of the application. This NOFO is not intended to support early-stage development of technology or the conduct of clinical trials, but rather the adaption and validation of assays to the point where they could be integrated into clinical trials as investigational assays/tools/devices.

Molecular markers and tissue imaging markers are increasingly being integrated into clinical trials as enrichment or stratification markers for the identification of target patient populations in the development of new drugs or treatment regimens.

They are also co-developed as treatment response markers for therapies (i.e. companion diagnostics), where positive findings from large clinical trials can provide the level of evidence needed to support their clinical use. Many of these tissue imaging or molecular markers and assays are developed by investigators in academic institutions or small biotechnology companies through research funded by research project grants.

Such markers may be suitable for assessing risk of developing cancer or risk of recurrence relevant for cancer prevention or cancer control. However, most investigators may not appreciate the rigors of marker validation and/or may not have the expertise to navigate the regulations that clinical laboratory assays need to meet.

Additionally, marker and assay validation applications that do not include mechanistic, hypothesis-driven studies may not fare well during grant application reviews. These factors can hamper innovation, where many new biomarkers might be continuously discovered and developed early on but do not successfully advance and often fall to the wayside during later stages of development.

Despite the need to incorporate these markers into clinical trials, many assays are not adequately validated and not ready for use on patients even as investigational assays/tools/devices.

This NOFO will allow the investigators to advance the development of assays that they have begun working on with their existing research project (R01) awards without having to formulate the validation study into an application for a new, independent research project grant.

This NOFO will utilize the NIH Research Project Grant (R01) mechanism and targets currently funded NCI R01 projects with at least two years left at the estimated time of award. Applicants cannot request funds beyond the end date of the parent award.

Specific Research Objectives Applications in response to this NOFO should propose to clinically validate an existing assay using human specimens in a clinical laboratory into a molecular assay that can be used in a clinical trial for the detection, diagnosis, treatment, prevention, or control of cancer.

However, projects that improve standardization or harmonization of assay performance among laboratories are also highly encouraged, and these types of projects may involve continued efforts in assay optimization and ensuring concordance of assay results from different laboratories.

Therefore, these types of applications may be viewed as exceptions to the requirement that analytical validation should have been completed by the time revision applications are submitted. The primary elements for achieving the research objectives are as follows. Existing assay : an assay that has been reduced to practice in human tissues.

An assay from discovery research or based on the scientific investigator's R01 project should have essentially completed analytical validation (as described below in the "Assay Prerequisites" section). The clinical use of the assay for a specific disease should be clearly stated and defined.

Clinical laboratory : a laboratory that provides assay results that either assist in medical decision-making or test postulates pertaining to cancer treatments, or prevention or cancer control interventions. Assays that support medical decision-making need to be performed in Clinical Laboratory Improvement Act of 1968 (CLIA)-certified laboratories.

Assays to test postulates should conform to Good Laboratory Practice (GLP) or ISO 17025 standards in order to assure that the data generated by the assay are of sufficient quality as to be useful in clinical trials and justify sample collection.

Molecular diagnostic : a biomarker measured in a validated assay that is associated with a clinical endpoint in a pre-defined clinical context that yields usable information about a diagnosis, prognosis, or response to clinical intervention for treatment, prevention, or control of cancer. The project should focus on assays that are likely to be used in treatment, prevention, or cancer control trials.

There does not need to be a commitment to a particular clinical trial. However, the applicants are expected to have access to samples that are appropriate for the clinical context of the intended use of the assays. The project should use technologies already in use or soon to be approved for use in clinical laboratories since this is not a technology development NOFO.

Applications to improve inter-laboratory standardization or harmonization of assays among different laboratories for use in clinical trials are appropriate for this NOFO and are highly encouraged. Clinical laboratory assays are deemed to be "harmonized" when the results are independent of the specific assay procedure/protocol and where and when the assay is performed.

If a commutable reference material is available and the unit of measurement for the analyte has been standardized, the assays can be harmonized by requiring that all procedures be directly or indirectly calibrated to the primary reference material using the standardized unit of measure.

This would require a multicenter study to evaluate the performance of the assay protocols, including the limit of detection, limit of quantification as applicable, linearity of the assay across the measuring range, precision, and reproducibility (inter- and intra-assay variability).

Assay Prerequisites and Preliminary Data: The applicant should have an assay that was derived from discovery or early technology development research supported by an R01 grant. The assay may be a multiplex assay or a classifier but should be converted to a clinical assay that can be performed in a clinical trial.

The assay should have either been completed or be near the end of analytical validation with fine-tuning of cut-offs or thresholds for a positive assay result left for clinical validation. Preliminary data should define the current status of the assay and analytical performance characteristics, as well as justify support for optimization and usability of a clinical trial.

It is expected that the following metrics will have been achieved during the analytical validation of the assay performed on human specimens : analytic accuracy, precision, sensitivity, reportable range of test results for the test system, reference intervals (normal values) with controls and calibrators, and reproducibility.

Objectives for Clinical Validation Project : The objectives for the clinical validation study should include the following.

Determination of the sensitivity and specificity of the assay with respect to a defined clinical endpoint within the described clinical context of use; Estimation of the prevalence of the marker within subjects or patients for the intended clinical use; Establishment of an appropriate cut-off or threshold for the assay using appropriate statistical analysis; Demonstration of the association of the assay result with a clinical endpoint (e.g. survival, response, disease presence or absence) in samples from patients that have been treated or exposed to a uniform intervention or observation for treatment, prevention or cancer control trials.

The applications proposed for this NOFO will necessitate multi-disciplinary interaction and collaboration among scientific investigators, clinicians, statisticians, and clinical laboratory scientists and staff. Therefore, in addition to the PD/PI, the Project Team should include the following participants.

Clinical Investigator : Investigator(s) who define the intended clinical context of use for the marker and its assay and will oversee their incorporation into a potential clinical trial. The clinical investigator is likely to be an oncologist(s) who treats patients but may be a translational scientist. Clinical Laboratory Staff : Staff who will perform the translation of the assay into a clinical assay.

The staff may work in a CLIA-certified clinical laboratory but do not need to if the assay is not intended to be used for medical decision-making. In that case, the assay is likely to be for hypothesis or mechanism of action testing and the clinical laboratory staff and their laboratory need to be aware of Good Laboratory Practices and/or ISO 17025 standards and perform to that level of quality.

The clinical laboratory staff also needs to be aware of the Westgard rules . Statistician : A statistician familiar with the needs of biomarker studies should be part of the team and perform analyses such as power calculations for assessing the use of the assay and its biomarker within the intended clinical context.

Commercial Developer (optional): While not necessary for all projects, successful assays will need to be distributed and supported. Therefore, collaboration with a commercial partner who will support the distribution and commercialization of the assay is encouraged, but not required.

Non-responsive Applications The following types of activities remain outside the scope of this NOFO, and applications proposing them are non-responsive to this NOFO and will not be reviewed. This NOFO is not meant to support clinical trials but rather the laboratory work and analyses to get assays to the point where their clinical utility could be assessed in other trials.

Note that in the context of this NOFO “imaging” refers to in vitro imaging modalities such as microscopy but not clinical radiology (e.g. MRI or PET). Other projects that are not appropriate for this NOFO include technology development, such as those covered by the Innovation Molecular Analysis Technologies Program (IMAT) or projects for the Early Detection Research Network (EDRN) at the NCI.

IMPORTANT NOTE : Researchers uncertain whether their intended project meets the requirements of this NOFO are encouraged to contact the Scientific/Research Contact listed below. 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 Revision applications to active NIH R01 recipients.

Resubmission (only of Revision applications originally submitted to this NOFO) 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. Not Allowed: Only accepting applications that do not propose clinical trials.

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 $150,000 in direct costs in any single year.

The parent grant must be active when the application is submitted. There must be a minimum two years of support remaining on the parent award (not to include a no cost extension) at the estimated time of award. If a no-cost extension is needed on the parent grant, it must be in place before the revision application is submitted.

The maximum project period is 3 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: Research Strategy: The Research Strategy should be organized into sections as identified below. 1.

Background and Significance : The importance of the markers and assays should be well justified for developing into a clinical test. Define the cancer problem to be addressed, including the marker and its assay and how they fit the intended clinical context in which they will be used. Provide the biologic or discovery research rationale for the marker and its importance.

Outline the potential of the proposed marker/assay for affecting the intended clinical context in diagnosis, treatment, prevention, or cancer control trials. 2.

Preliminary Data : Describe the current status of analytical validation of the assay in human specimens within the intended clinical context, including the current reagents, technologies, and types of specimens that the assay will use (e.g., fresh frozen or formalin-fixed tissue, serum or plasma).

Applications should have completed analytical validation of the assay in human biospecimens and not just in cell lines by the time they submit their revision application, so that they can focus on clinical validation rather than analytical validation. An exception would be applications that strive to improve assay performance by inter-laboratory standardization or harmonization among different clinical laboratories. 3.

Approach: Include plans for additional optimization of analytical validation that should primarily be limited to establishing thresholds or cut-offs for assay; plans to accrue specimens to perform clinical validation of assay including identification of the clinical resource or trial that will provide specimens; documentation of appropriate availability and pre-approvals to get specimens (i.e., documentation that the repository holder has identified and confirmed availability of specimens and that there is an appropriate process to get the specimens with reasonable certainty); plan for integration of clinical laboratory staff and statisticians into the project; provision of statistical power analysis that defines the number of specimens needed; plan for clinical validation of the assay within the intended clinical context of use; plans to address the regulatory requirements needed to get assay into clinical trial(s); identification of potential pitfalls and alternative approaches to overcome obstacles to clinical validation of the assay; plans to address other regulatory issues as applicable such as control of intellectual property and evaluation of significant risk of the assay within the clinical context of a clinical trial; and plans for collaboration with commercial entities to support the assay if it is successful.

Letters of Support : Letters of support must be included. 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