NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement

NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement is sponsored by National Institutes of Health (NIH). Solicits applications for observational or biomarker validation studies requiring prospective collection or continued analysis of data/biospecimens to advance knowledge in dental, oral, and craniofacial health.

PAR-25-239: NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 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 Institute of Dental and Craniofacial Research ( NIDCR ) Funding Opportunity Title NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed) U01 Research Project – Cooperative Agreements Notices of Special Interest associated with this funding opportunity 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 Part 2 Section III. 3.

Additional Information on Eligibility. Assistance Listing Number(s) Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) will support, through the cooperative agreement mechanism, investigator-initiated observational studies or biomarker validation studies that require prospective collection of data/biospecimens or continued analysis of data/biospecimens.

Funding Opportunity Goal(s) NIDCR extramural research provides research funds to support basic, translational, and clinical research in dental, oral, and craniofacial health and disease through grants, cooperative agreements, and contracts that support scientists working in institutions throughout the United States and internationally.

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 This Notice of Funding Opportunity (NOFO) will support, through the cooperative agreement mechanism, investigator-initiated observational studies or biomarker validation studies that require prospective collection of data/biospecimens or continued analysis of data/biospecimens collected as part of a previous NIDCR cooperative agreement.

NIDCR is committed to identifying effective preventive, diagnostic and treatment approaches for dental, oral and craniofacial diseases and disorders. Improving health through the generation of high-quality data from adequately-powered, well-executed clinical studies is a high priority for NIDCR.

Various types of well-designed clinical studies involving the prospective collection of data and/or biospecimens have the potential to generate robust data and contribute to the knowledge base to improve oral health. Longitudinal studies allow for prospective assessment of risk factors (exposures) and their relation to disease development. Also, disease and standard-of-care treatment outcomes can be observed and measured systematically.

A biomarker analytic and/or clinical validation study is designed to validate a strong candidate biomarker measure(s) or endpoint(s) for which robust preliminary data exist that support utility in diagnosis, prognosis, monitoring, and/or prediction of response to treatment.

Rigorous scientific inquiry in genetics, gene expression, gene regulatory pathways, gene-environment interactions, metabolism, or disease/treatment mechanisms through -omics analyses require large numbers of study participants from whom biospecimens are collected in a standardized manner. Biospecimen analyses can include epi/genomic, epi/transcriptomic, protein, cellular, metabolomic, imaging, and physiologic endpoints.

Continued analysis of potential targets in preclinical models may contribute to knowledge gaps in the pathophysiology of disease and/or pathways for treatment. Because prospective observational and biomarker analytic and clinical validation studies are resource intensive, NIDCR anticipates funding only those studies of highest priority and mission relevance.

Aspects of studies that are of key interest to NIDCR include the appropriateness of the design to answer the study question, rigor in exposure and outcome assessment, evidence that an appropriate study population can be enrolled quickly and be retained, selection of appropriate methodologies for biospecimen collection, storage and analysis, and involvement of collaborators with expertise in the design, implementation and analysis of large observational studies, such as experienced statisticians and data managers.

For applications proposing prospective collection of data and/or biospecimens, we strongly encourage that the investigative team include a data coordinating center. Investigators considering preparing and applying are strongly encouraged to consult with NIDCR Scientific/Research staff prior to beginning the application process to determine NIDCR interest in the concept that would be proposed in the application.

Prospective observational studies: Study designs considered appropriate to this NOFO would be epidemiologic studies of disease prevalence or incidence, cohort studies prospectively ascertaining risk factors for disease development, cohort studies that provide longitudinal follow-up of treatment outcomes, case-control studies with longitudinal follow-up, and large cross-sectional studies or case-control studies evaluating genomic changes, gene-environment interactions, or disease/treatment mechanisms through -omics, cellular, and imaging analyses.

Research studies may be proposed for long-term follow-up of clinical trial participants after a preventive or therapeutic intervention, and the initial trial has ended. The additional follow-up could be used to assess long-term adverse events, sustained effects of the intervention, or to collect additional data that could potentially create combined cohorts to uncover new knowledge.

Biomarker validation studies: This NOFO will promote advanced analytic and/or clinical validation of strong candidate biomarkers and endpoints for diagnostic or prognostic utility to demonstrate that biomarker or endpoint change is reliably correlated with pathophysiology, clinical outcome, therapeutic target engagement or treatment response.

It is assumed that a candidate biomarker has been identified and assay technology or method of detection has been developed. Specifically, it is expected that the initial discovery of the biomarker or assay will have been performed on a pre-existing set of human biospecimens with the same disease or condition as that in the proposed validation application.

This biomarker validation NOFO will support analytic validation studies that establish the accuracy, precision, sensitivity, specificity, reportable range of test results for the test system, reference intervals (normal values) with controls and calibrators; establish the desired magnitude and reliability of the association between the biomarker or endpoint and disease pathophysiology, clinical outcome, target engagement or treatment response; and demonstrate test reproducibility and harmonization of assays or equipment across testing sites.

This NOFO will also support clinical validation studies that validate the proposed biomarkers in a new, independent cohort to estimate the prevalence of the marker within patients for the intended clinical use; establish that the biomarker or endpoint acceptably identifies, measures, or predicts response for the disease or condition of interest; and establish an appropriate cut-off or threshold for a biomarker assay for the intended clinical context.

This NOFO will not support the biomarker and endpoint Discovery Phase, which may include initial identification, development of detection technology, and preliminary validation studies, such as initial analytic validation of the detection method along with studies designed to correlate modulation of the biomarker or endpoint with disease pathology, target engagement, or treatment response.

These applications will be considered non-responsive and will not proceed to review.

Examples of studies that might be supported by this NOFO include, but are not limited to: Applications of multi-center observational cohort studies assessing preventive and risk factors for development or progression of dental, oral or craniofacial diseases (e.g., dental caries, periodontal disease, head and neck cancer, orofacial pain conditions, oral sequelae of systemic conditions); Applications of observational cohort studies assessing treatment outcomes for oral diseases or conditions (e.g., periodontal disease, Sjögren's syndrome, craniofacial anomalies, orofacial pain conditions); Research to study oral health outcomes in medically complex patients, such as those with oral sequelae of systemic treatments or conditions; Research to establish the natural history of oral infections and their persistence (e.g., oral HPV infection); Research to study the effectiveness of standard of care periodontal therapy for those with type 1 or type 2 diabetes and factors that predict response to therapy; Observational cohort or cross-sectional studies developing or establishing algorithms for tailoring or targeting behavioral or social interventions for individuals, groups, communities, or settings in which further assessment is justified; Development of predictive tools for optimizing disease prevention and treatment.

Applications that leverage existing biospecimens, data and/or epidemiologic cohorts to further promote high quality data sharing, consistent with the NIH Data Management and Sharing (DMS) Policy, and generation of additional multidimensional using new analytic methods and technologies.

Applications of cross-sectional or cohort studies collecting and analyzing biospecimens through -omics to assess risk for or treatment responses to dental, oral, and/or craniofacial diseases including craniosynostosis and orofacial clefting; Applications of cross-sectional or cohort studies collecting and analyzing biospecimens to assess mechanisms of dental, oral, and/or craniofacial diseases or treatment pathways through analyses of -omics data such as genomics, epigenomics, transcriptomics, epitranscriptomics, proteomics, metabolomics, or metagenomics; Applications of cohort studies assessing associations of psychosocial and behavioral factors with -omics changes (including epigenetic modifications to the human genome and/or oral microbiome alterations) and impact of the associations upon oral diseases and conditions; Applications of cohort studies that analyze interaction of the human genome and oral microbiome in response to environmental stimuli and impact of the interaction on oral diseases and conditions; Applications proposing analysis of complex codependencies that include oncogene addiction, tumor-suppressor hypersensitivity and metabolic dependencies in oral cancer and the identification of combinations of targets which could be exploited for therapeutic interventions; Applications of analytic validation using biospecimens appropriate for the clinical context of the intended use to establish analytic metrics and harmonization of assays for the biomarker(s) of interest; Applications of clinical validation of biomarker(s) through prospective collection, with the goal of establishing robust correlations between biomarker and dental, oral or craniofacial disease detection or therapeutic response.

This NOFO will not support studies that meet the NIH Definition of a Clinical Trial . Investigators proposing clinical trials must use NIDCR NOFOs soliciting applications for clinical trials . The proposed clinical study must meet all applicable NIH and Office of Human Research Protections (OHRP) policy requirements.

Awardees are required to comply with NIDCR Clinical Terms of Award . After NIDCR approval of the final clinical research protocol and associated documents, clinical sites will complete study staff training and other site initiation activities prior to study subject recruitment.

The materials contained in the U01 application should be sufficient to demonstrate readiness to complete site initiation requirements in a timely manner, once the study documents are approved. Investigators considering smaller prospective observational studies should consider submitting a NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) application or an application in response to other appropriate NOFOs.

Investigators are strongly encouraged to consult with NIDCR Scientific/Research staff prior to beginning the application process regarding the suitability of this NOFO for their particular study. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

See Section VI. 2 for additional information about the substantial involvement for this NOFO. 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. 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 not limited but need to reflect the actual needs of the proposed project. A project duration of up to five years may be requested.

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 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) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are 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.

Other Attachments: The information provided here will be considered by reviewers and is meant to supplement, not duplicate, information provided in the Research Plan or the Study Record: PHS Human Subjects and Clinical Trials Information form. The application must contain a Quality Management Plan and Clinical Data Management Plan , according to the instructions below. 1.

Quality Management Plan . The purpose of the Quality Management Plan is to establish standard processes for all study-related activities, to assess and document adherence to all clinical study procedures, and to ensure the quality of data collection procedures. Describe plans to standardize study processes, train study staff, and monitor adherence to the clinical protocol.

Describe the methods and systems for data collection (e.g., Case Report Forms/CRFs), including timely data entry, and review to ensure accurate and consistent data collection. 2. Clinical Data Management Plan .

The purpose of the Clinical Data Management Plan is to establish validated systems and controls to ensure the integrity of the clinical research data being collected for the proposed study. Describe the methods and systems for data verification and data validation. Describe the frequency of data verification, data query process, and any planned mitigation strategies in the event of data system noncompliance.

Describe methods and systems to ensure data confidentiality and subject privacy. If the proposed study involves prospective data collection, the application must also contain a Schedule of Events , according to the instructions below. Provide a schematic, table, or text description of the protocol-specified schedule of events for an individual study participant.

It should capture each study visit/assessment time point and planned activity(ies) for each time point. 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.

A detailed budget with budget justifications must be included for the entire study and data analysis period. If parts of the costs of the study are to be borne by sources other than NIH, these contributions must be presented in detail in the budget justification. These outsource costs do not constitute cost sharing as defined in the current NIH Grants Policy Statement and should not be presented as part of the requested budget.

All instructions in the How to Apply-Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: The significance and biological relevance of the proposed study must be stated clearly.

It should be supported by the following: Provide a clear statement of the question(s) that the study will address and its importance. Describe the scientific rationale and clinical need (if applicable) for the study, including an assessment of previous preclinical and/or clinical studies and their quality.

Describe the potential for the study results to impact knowledge, clinical practice or health care policy For biomarker validation studies, provide supporting data to demonstrate that the candidate biomarker identifies, measures or predicts the disease or condition of interest.

For biomarker validation studies, describe the current status of initial analytic validation and preliminary analytic performance of the biomarker(s) in human specimens within the intended clinical context. Address the feasibility of recruiting participants who are eligible for the proposed research.

For an application proposing a multi-site study, applicants are expected to provide evidence that each recruiting center has access to sufficient study participants who meet the eligibility criteria. Provide a concise snapshot of the planned clinical study. It is expected to: Clearly state the study objectives.

Describe and provide rationale for the study design, including study groups and number of sites. Specify the primary and important secondary outcome measures that align with each objective, provide justification for their selection, and describe how they will be collected and the criteria for measuring them.

Describe the study population, including the sample size, pertinent demographic information, required health status or disease condition, and geographic location. Explain why the study population is an appropriate group to address the study objectives. Do not duplicate information described in section 2 (Study Population Characteristics) of the Study Record: PHS Human Subjects and Clinical Trials Information .

Provide a statistical analysis plan, including power calculations, data analysis approaches, and plans for handling missing data. Discuss potential biases or challenges in the proposed study and how they will be minimized and/or addressed.

For biomarker analytic validation studies, describe the plans to evaluate performance of the biomarker assay(s) (e.g. accuracy, precision, sensitivity, specificity, reportable range of test results, reference intervals (normal values) with controls and calibrators, reproducibility, and magnitude and reliability of the association between biomarker and outcome).

For biomarker clinical validation studies, describe the number of study participants/biospecimens needed to test prevalence of the marker and associate assay results with a pre-specified clinical outcome within the intended clinical context of use and establish the threshold or cut-off for the assay. For studies involving genomic or -omics analyses, provide the plan for biospecimen analysis.

Letters of Support: Letters of support from clinical partners, research collaborators, or other groups the investigators propose to work with should 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 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.

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. The Data Management and Sharing Plan attachment is in addition to, and separate from, the Clinical Data Management Plan attachment. 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. Section 2 - Study Population Characteristics 2.

5 Recruitment and Retention Plan If applicable, describe plans and strategies for participant recruitment/enrollment, including outreach activities and pre-study assessments of the ability of participating sites to recruit the proposed target number of participants.

Describe approaches to be used for retention and follow-up of enrolled participants and address any anticipated changes in the composition of the study population over the course of the study. Provide a timeline for implementing and completing the study, including the estimated time to: a) open study to enrollment; b) complete data collection; and c) complete final data analysis. Section 3 - Protection and Monitoring Plans 3.

5 Overall Structure of the Study Team For studies that include multiple sites and/or a separate data coordinating center or laboratory, describe the organizational structure and communication plans for the study. Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

PHS Assignment Request Form All instructions in the How to Apply- Application Guide must be followed. 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