NIH Advanced Development and Validation of Emerging Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed)

NIH Advanced Development and Validation of Emerging Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed) is sponsored by National Institutes of Health (NIH). This program supports the advanced development and validation of emerging technologies that have the potential to significantly impact basic and clinical cancer research.

Expired RFA-CA-25-004: Advanced Development and Validation of Emerging Biospecimen Science Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. 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 Advanced Development and Validation of Emerging Biospecimen Science Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed) R33 Exploratory/Developmental Grants Phase II.

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 Phase 1 Exploratory/Developmental Grant Exploratory/Developmental Grants Phase II Phase 1 Exploratory/Developmental Grant See Section III.

3. Additional Information on Eligibility . Assistance Listing Number(s) Funding Opportunity Purpose Through this Notice of Funding Opportunity (NOFO), National Cancer Institute (NCI) solicits grant applications proposing exploratory research projects focused on further development and validation of emerging technologies that improve the quality and handling of samples used for cancer research or clinical care.

Through this NOFO, NCI will support the development of tools, devices, assays, and associated methods for the collection, handling, processing, preservation, or storage of cancer-relevant biospecimens and their derivatives.

This includes tools with new capabilities to preserve or protect sample integrity, or establish verification criteria for quality assessment/quality control and address issues related to pre-analytical degradation of targeted analytes.

Through this NOFO, NCI solicits R33 applications where major feasibility gaps for the technology or methodology have been overcome, as demonstrated with supportive preliminary data, but still require further development and rigorous validation to encourage adoption by the research community.

These technologies are expected to accelerate and/or enhance research in cancer biology, early detection and screening, clinical diagnosis, treatment, or epidemiology, or address issues associated with cancer health disparities.

Projects proposing to use existing technologies where the novelty resides in the application of the technology or the biological or clinical question being pursued, and not the technical capabilities being developed, are not appropriate for this NOFO and will not be reviewed. This funding opportunity is part of a broader NCI-sponsored Innovative Molecular Analysis Technologies (IMAT) Program .

Funding Opportunity Goal(s) The goals of this NOFO are: to identify cancer risks and risk reduction strategies, to identify factors that cause cancer in humans, and to discover and develop mechanisms for cancer prevention and preventive interventions in humans; to improve screening and early detection strategies and to develop accurate diagnostic techniques and methods for predicting the course of disease in cancer patients; to develop the means to cure as many cancer patients as possible and to control the disease in those patients who are not cured; to provide fundamental information on the cause and nature of cancer in people; to reduce cancer risk, incidence, morbidity, and mortality and enhance quality of life in cancer survivors.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due 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. No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

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.

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) solicits grant applications proposing exploratory research projects focused on further development and validation of emerging technologies that improve the quality and handling of samples used for cancer research or clinical care.

Proposed projects should offer new tools, devices, instrumentation, assays, and associated methods to improve the collection, handling, processing, preservation, or storage of biological samples and their derivatives. This includes tools that maximize or interrogate the quality of samples under diverse conditions and tools to address issues related to pre-analytical degradation of targeted analytes.

These technologies are expected to accelerate and/or enhance research in cancer biology, early detection, screening, clinical diagnosis, treatment, epidemiology, or address issues associated with cancer health disparities. This NOFO utilizes the R33 mechanism which is suitable for projects where proof-of-principle of the proposed technology or methodology has been demonstrated and supportive preliminary data are available.

Projects proposed in response to this NOFO may involve further development of a novel technology to address an need in cancer research or clinical care and must include a rigorous validation strategy to establish repeatable, reliable performance of the technology in a cancer-relevant biological context of use.

Projects proposing to apply existing technologies where the novelty resides in the application of the technology or the biological or clinical question being pursued, and not the technical capabilities being developed, are not appropriate for this NOFO and will not be reviewed. This funding opportunity is part of a broader NCI-sponsored Innovative Molecular Analysis Technologies (IMAT) Program.

Since its inception in 1998, the IMAT Program has focused on stimulating and accelerating the development, validation, maturation, and dissemination of the most novel and highly innovative technologies in support of cancer research and medicine.

Together with the NCI's other technology-focused programs, the IMAT program continues to support the development of tools and methods that enable cancer researchers to make new discoveries, enhance our understanding of cancer etiology and proliferation, improve detection capabilities, develop diagnostic methods and treatment strategies, conduct population-scale studies, address and reduce disparities in clinical care, and assist in clinical decision-making.

The current issuance of the IMAT Program consists of four separate NOFOs that cover the following two areas: Molecular and Cellular Analysis Technology Development for Cancer Research is intended to support the development of technologies with novel measurement, probing, or targeting of cancer-relevant targets at the molecular or cellular level which may in turn accelerate basic, epidemiologic, or clinical cancer research.

RFA-CA-25-001 (R61): Supports an early-stage feasibility study (inception through preliminary development) to demonstrate the core functional capabilities of the proposed technology. RFA-CA-25-002 (R33): Supports the advanced development and robust validation of the technology following completion of the initial phase of development.

Cancer-relevant Biospecimen Science Technologies is centered on the development and validation of novel technologies to improve and reduce variability in the collection, processing, handling, preservation, or isolation of cancer-relevant biospecimens and their derivatives, including tools to assess their quality and biological integrity. .

RFA-CA-25-003 (R61): Supports an early-stage feasibility study (inception through preliminary development) to demonstrate the core functional capabilities of the proposed technology. RFA-CA-25-004 ( this NOFO, R33 ): Supports the advanced development and robust validation of the technology following completion of the initial phase of development.

Additional information about the IMAT Program and its individual NOFOs can be found on the IMAT website .

Specific Research Objectives and Scope of this NOFO The proposed projects must be focused on the advanced development, optimization, and validation of emerging biospecimen science-relevant technologies and methodologies that either improve the quality or handling of biospecimens and/or samples derived from biospecimens to increase their utility in cancer research and/or clinical care.

The proposed technology should address unmet needs in basic, preventative, diagnostic, translational, epidemiological, health disparities, and/or clinical cancer research or have broad potential use in cancer research.

In addition, all projects proposed in response to this NOFO must involve all the following general attributes: Advanced development, optimization, or validation of a novel tool with potential for substantial improvements over current approaches and/or add qualitatively new research capabilities.

New or imrpoved technical capabilities that are potentially transformative to research in a laboratory, epidemiology, and/or a clinical setting, beyond providing incremental improvements to existing capabilities. Rigorous study design with a verifiable approach, based on well-defined, performance measures (see below for a description of performance measures). For details on addressing these requirements, see Section IV.

Application and Submission Information . Responsive Technologies and Scientific Scope Responsive technologies include relevant techniques, tools, devices, assays, and associated methods.

These technologies must focus on offering improved capabilities for collection, handling, preserving and/or preparing cancer biospecimens for basic or clinical research purposes with a focus on improving or assessing the integrity of targeted molecular and/or cellular features.

The proposed project must clearly be focused on the development of generally applicable technologies to advance cancer research, NOT on pursuing specific discoveries with these tools. Applicants are encouraged to consider how their technologies may impact cancer health disparities and address how new or exacerbated disparities will be mitigated. Technology development projects in any area of cancer-relevant research are encouraged.

General areas of interest include, but are not limited to, the following: Novel technologies to benchmark or otherwise assess the biological integrity of classes of molecular analytes (e.g.protein complexes, non-coding RNA, classes of epigenetic lesions, etc); Novel technologies and techniques to provide high-quality preservation of specific classes of molecules, subcellular components, whole cells or bulk tissue; New tools that would allow researchers to leverage samples collected from routine clinical practice for cancer prevention research; New methods, tools, and procedures to improve the preparation of biospecimens for downstream molecular analysis (e.g., genomic or RNA sequencing, mass spectrometry-based protein profiling or metabolite analysis, etc.); Methods or platforms to improve the quality and relevance of patient-derived models; Technologies that can allow for rigorous and/or expeditious collection and/or processing of various relevant types of biospecimens (including at-home sample collection) while ensuring sufficiently high quality to facilitate epidemiological cancer research in patients and cancer survivors; Technologies or tools to collect relevant biological specimens or overcome various barriers in research on the incidence, prevalence, mortality, and burden of cancer among members of underserved populations; and Technologies to enable cancer research or clinical care in low-resource settings, including locations with limited clinical or laboratory infrastructure, use in non-traditional healthcare settings, and affordability.

Applications must include quantitative performance measures. Performance measures are a means of judging the success of the project and technical function of the new technology (device, assay, etc.). Performance measures should be well-described, quantifiable, and scientifically justified.

Critical components for proposed measures include the numerically described target of performance as well as the means by which it will be assessed. For additional details on this requirement, see Section IV. Application and Submission Information .

The following aspects/characteristics remain outside the scope of the IMAT Program and this NOFO. Applications proposing projects with any of the following characteristics will not be reviewed: Pursuit of a biological or clinical hypothesis for which the novelty of the project resides in the biological or clinical question ( i. e .

, traditional biological-hypothesis driven research) and NOT in the novel technical capability being developed; Use of existing technologies (for which a proof-of-concept has already been demonstrated in a cancer-relevant biological system) that may be ready for advanced development and validation without substantial further developmental efforts; Instrumentation for whole-body or in vivo imaging; Inclusion of clinical trials or toxicology studies beyond those required to demonstrate the capabilities of the technology; Biomarker discovery or biomarker validation; Development of probes or tagging agents for specific target molecules (though generalizable contrast agents or probes with broad targeting capabilities or broad potential application are allowed); Development of drugs or therapies; Projects focused primarily on software/informatics solutions, database development, data mining, statistical tools, and computational/mathematical modeling with the exception of projects which include limited amounts of software development or computational efforts as might be needed to support the proposed development of new devices or methods; and/or Additionally, applications lacking appropriate quantitative performance measures, as determined by NCI program staff, will not be reviewed.

As there are several unique application requirements for this NOFO, applicants must address the requested items outlined for the Research Plan in Section IV. 2. Application and Submission Information .

IMPORTANT NOTE : Researchers uncertain as to whether their intended technology development project meets the requirements of this NOFO are encouraged to contact the Scientific/Research Contact listed below.

Alternative Opportunities Related IMAT NOFO: Applicants proposing projects that still involve a critical question as to the overall feasibility of the approach should consider applying to the companion NOFO ( RFA-CA-25-003 ), which uses the R61 mechanism.

NOTE: Applications proposing to use new technologies for hypothesis-driven research or merge complementary technologies without a substantial requirement for further development or a clear need for analytical validation are beyond the scope of the IMAT program solicitations altogether.

An annual meeting of all investigators funded through this program will be held to share progress and research insights that may lead to further progress in the development of technologies for cancer research and clinical care for cancer patients. All investigators supported through this NOFO are required to attend this meeting each year, lasting 2-3 days, unless otherwise notified by NCI program officials. 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. 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 NCI intends to fund an estimate of 2 awards, corresponding to a total of $900,000, for fiscal year 2026. Future year amounts will depend on annual appropriations.

Application budgets are limited to $300,000 per year (in direct costs). The total project period request may not exceed 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. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: Center for Strategic Scientific Initiatives National Cancer Institute (NCI) 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: Include a brief subsection "Statement of Potential Impact" on the expected potential of the proposed technology to transform cancer research or clinical practice. The following questions should be addressed with this statement: What is the new capability provided by the proposed technology?

How may it be expected to be highly impactful on biomedical research and medicine? How will the proposed technology overcome limitations of currently available technologies or alternative approaches to enable cancer research?

Research Strategy: Applicants may organize their research strategy as desired, but must address the following required aspects: Importance of the Research Describe the new or improved technical capabilities that will be advanced and validated.

The project must focus on the further development of an emerging technology beyond the early-stage proof of concept demonstration and engage a rigorous validation of the novel capability in a cancer-relevant biological context of use.

The technology must offer substantial improvements over currently available approaches to address an unmet need in basic, preventative, diagnostic, translational, epidemiological and/or clinical cancer research. Applications should provide appropriate background/preliminary data to justify that the technology has passed the pilot developmental stage and shows promise.

Applications based on work supported by a prior IMAT R21 or R61 award must describe the extent to which the aims of the prior IMAT award have been achieved. For applications not based on work supported by a prior IMAT award, an equivalent level of evidence should be provided. Describe the potential impact of the proposed tool on cancer research or clinical care.

Applicants are encouraged to explain the significance of the proposed work and describe the unmet technical need from the research community that will be addressed by the technology, as well as its anticipated use in laboratory research and/or clinical settings. There should be a description of how the project may impact health disparities and how any new or exacerbated cancer disparities will be addressed or mitigated.

Describe the technical approach , including the steps to evaluate and rigorously validate the proposed technology within the context of its intended use, anticipated difficulties, and possible workarounds. Quantitative performance measures. There must be a dedicated subsection within Research Strategy labeled "Performance Measures."

Performance measures are an objective measure of the target performance capabilities and must include the numerically described target of performance as well as the means by which it will be assessed. Performance measures are specific to the technology being developed. They should be carefully selected and precisely defined.

Whenever appropriate, present the proposed measures in the context of current technologies to substantiate the anticipated transformative potential. Performance measures should appropriately address any key risk factors for the project. They are a means of demonstrating successful validation of the technology.

Performance measures may be a measure of sensitivity, specificity, throughput, resolution, a price point, or any other measure or test to demonstrate progress towards the aims. They must be well-described, quantifiable, and scientifically justified.

An example of a properly described performance measure could be achieving improved recovery of spike-in molecular additives from whole blodd with X efficiency (+/- Y) under conditions a, b, and c, over a concentration range from p to q. See Section V. Application Review Information for information on review criteria related to performance measures.

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