Early-Stage Innovative Technology Development for Basic and Clinical Cancer Research (R61 Clinical Trial Not Allowed) (RFA-CA-27-001)

Early-Stage Innovative Technology Development for Basic and Clinical Cancer Research (R61 Clinical Trial Not Allowed) (RFA-CA-27-001) is sponsored by National Cancer Institute (NCI). This Notice of Funding Opportunity (NOFO) solicits R61 applications for early-stage projects proposing proof-of-concept/pilot studies to test the technical feasibility of innovative technologies offering new capabilities for the molecular or cellular characterization of cancer o…

RFA-CA-27-001: Early-Stage Innovative Technology Development for Basic and Clinical Cancer Research (R61 Clinical Trial Not Allowed) 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 ) Note: Not all NIH Institutes, Centers, and Offices (ICOs) participate in Announcements.

Applicants should carefully note which ICOs participate in this announcement and view their respective areas of research interest at the ICO-Specific Scientific Interests website . ICOs that do not participate in this announcement will not consider applications for funding.

Funding Opportunity Title Early-Stage Innovative Technology Development for Basic and Clinical Cancer Research (R61 Clinical Trial Not Allowed) R61 Phase 1 Exploratory/Developmental Grant Check for any recent Notices of NIH Policy Changes that may impact application requirements. Funding Opportunity Number (FON) Companion Funding Opportunity Exploratory/Developmental Grants Phase II 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) solicits grant applications proposing to develop innovative technologies offering new capabilities for the molecular or cellular characterization of cancer or for improved handling and quality control of biospecimens for basic, clinical, or epidemiological cancer research.

The NOFO solicits R61 applications for early-stage projects proposing proof-of-concept/pilot studies to test the technical feasibility of the proposed method, tool, assay, platform, or instrument. Technologies proposed for development may have potential for widespread applicability but must be focused for this program on cancer-relevant use cases.

Projects proposing to apply or use existing technologies for hypothesis-driven research where the novelty resides in the biological or clinical target/question being pursued are not responsive to this solicitation 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 improve screening and early detection strategies and to develop accurate diagnostic techniques and methods for predicting the course of disease in cancer patients. 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. 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.

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. Use Grants. gov 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) solicits grant applications proposing exploratory research projects focused on the inception and early-stage development of highly innovative technologies with new or improved capabilities for targeting, probing, or assessing molecular and cellular features of cancer biology or for handling or performing quality control of biospecimens for basic or clinical cancer research.

This NOFO is meant to support highly innovative projects with high potential impact in a cancer-relevant field, even if they involve some level of risk of failure. Technologies proposed for development may have the potential for widespread applicability but for this program, projects must focus on improving cancer-relevant technical capabilities. This NOFO utilizes the R61 award mechanism for exploratory/developmental projects.

The R61 mechanism is suitable for projects that are at their inception, conceptual, or idea-based phase. In this phase, the technical feasibility of the proposed technology or methodology should not yet have been established. Preliminary data are not required but are accepted if available.

If preliminary data are sufficient to suggest the feasibility of the approach is established, then consideration should be given to submitting to the companion R33 NOFO (RFA-CA-27-002).

Applications involving further improvements to an existing technology that has not yet been demonstrated for the proposed cancer-relevant application(s) are also within the scope of this NOFO but must involve significant additional technical modifications/development for the proposed cancer-relevant context of use, or some significant question of feasibility exists for achieving the proposed technical performance.

A clear description of the feasibility risk for the proposed advancement of that technology must be included in the application to justify the use of the R61 mechanism. Applicants are encouraged to reach out to the Scientific/Research Contact below with any questions. 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, and assist in clinical decision-making.

The current issuance of the IMAT Program consists of two separate NOFOs that cover the following two stages of development: RFA-CA-27-001 (this NOFO, R61): Early-stage mechanism. Supports feasibility studies (concept through preliminary development) to develop and demonstrate the core functional capabilities of the proposed technology. RFA-CA-27-002 (R33): Advanced stage of development.

Supports improvements, optimization, and technical validation of the technology following completion of the proof-of-concept stage 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 early-stage development and proof-of-concept of an innovative molecular or cellular analysis technology or tool for biospecimen handling/quality control.

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

New or improved technical capabilities that are potentially transformative to cancer research in laboratory, epidemiology, and/or clinical settings, beyond 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 novel materials, platforms, assays, instrumentation, devices, and associated methods. These technologies may be intended for use in vitro , in situ, and/or in vivo (with some exceptions listed below), and may target the needs of basic, diagnostic, translational, epidemiological, and/or clinical cancer research.

This program specifically supports new molecular/cellular analysis technologies (e.g. sequencing approaches, proteomics methods, imaging technologies, immuno oncology tools, biomarker detection assays, etc.) as well as novel biospecimen science tools (e.g. new approaches for the collection, isolation, handling, storage, or quality assessment of cancer biospecimens including tissue, blood, cultured cells, model systems, etc.).

The proposed projects must clearly be focused on the development of generally applicable technologies to advance cancer research, NOT on pursuing specific discoveries with these tools. Applications focused on using technologies for hypothesis-driven research and not on building new technical capabilities will be considered nonresponsive and will not be reviewed .

Technology development projects in any area of cancer-related research are encouraged.

General areas of interest include, but are not limited to, the following: Novel technologies to distinguish, assess, and/or monitor cancer stages and progression or cancer-associated immunity (both for point of care and for remote monitoring of patients outside a clinical setting); Novel technologies that may aid the elucidation of basic mechanisms underlying cancer initiation and progression; New sample collection or analysis methods or tools to improve early cancer detection, screening and/or cancer risk assessment; Technologies that can facilitate and/or enhance analysis or preservation of samples for use in cancer epidemiology and population science studies ( e.

g .

, at-home sample collection, tools to monitor and analyze the impact of environmental factors or physical activity, tools to enable population-scale genomics or survival cancer research); Technologies to facilitate/accelerate the processes of drug discovery or development of generic approaches to improve drug delivery; 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.); Technologies to newly enable cancer research or clinical control in low-resource settings, which may include practicality-of-use in 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 proposed 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 technical 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; Creation of probes or tagging agents for specific target molecules using established methods (though development of novel generalizable methods for creating or designing probes/tags 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 (including machine learning models); Applications lacking appropriate performance measures to test progress towards the aims and characterize or benchmark the target performance of the new tool or method (must include the numerical target, e.g. not just propose to measure sensitivity, but state a target sensitivity of X uM).

As there are several unique review considerations for this NOFO, applicants must address the requested items outlined for the Research Plan in Section IV. 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 are beyond questions of technical feasibility, but still require further development and validation should consider applying to the companion NOFO ( RFA-CA-27-002 ), which uses the R33 mechanism. Further development encompasses optimization and scaling of the technology or merging with complementary technologies to improve the overall functionality.

NOTE : Applications proposing to use novel technologies for hypothesis-driven research or merge complementary technologies without a substantial requirement for further development or a clear need for technical/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: This NOFO only accepts applications that do not propose clinical trials.

Note: Applications may propose activities involving human subjects that are not deemed clinical trials. Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards NCI intends to commit a total of $5,100,000, in fiscal year 2027 to fund an estimated 20 awards.

Future year amounts will depend on annual appropriations. Application budgets are limited to $150,000 per year (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 - Includes all types 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) Foreign Organizations/International Collaborations 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. NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts.

All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16. 8 Collaborative International Research Awards .

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding.

This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components , funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

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. Foreign organizations must obtain a NATO Commercial and Government Entity (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.

All PD(s)/PI(s) must be registered with ORCID . The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help .

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 (in this NOFO, in a policy notice , or other notice from NIH Guide for Grants and Contracts ). 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. For this specific NOFO, the Research Strategy section is limited to 6 pages.

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.

For this specific NOFO, a modular budget is expected unless the applicant is a Foreign Organization. Travel: Applicants may include travel support for an investigator from their research team to attend the IMAT Program annual meeting. The meeting location varies each year and is held at an IMAT investigator institution site in the U.S. or at NIH's facilities in Maryland.

All investigators supported through this NOFO must attend this meeting annually. 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 sub-section "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 technical capability provided by the proposed technology?

How may it be expected to be highly impactful for biomedical research and medicine? If applicable, 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: Describe the new or improved technical capabilities that are proposed to be developed. The project must be focused on the initial development and proof-of-concept demonstration of a highly novel technology in a biologically relevant system.

The proposed technology must offer novel technical capabilities or substantial improvement over currently available approaches to address an unmet need in a field of cancer research. This NOFO is meant to support projects with high technical innovation, even if they come with a relatively high level of risk. 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 why potential impact outweighs risks. Describe the unmet technical need from the research community that will be addressed by the technology and its anticipated use in laboratory research and/or clinical settings. Describe the technical approach , including steps to develop the proposed technology.

A clear description of the feasibility risk for the proposed advancement of the technology should be included in the application to justify the use of the R61 mechanism, as well as how this risk can be mitigated by identifying anticipated difficulties and describing possible workarounds. Quantitative Performance Measures There must be a dedicated subsection within the Research Strategy labeled "Performance Measures."

Performance measures are an objective measure of the target performance capabilities and must include the numerically described target as well as the means by which it will be assessed ( e.g. , we aim to achieve a detection of X uM with a p-value <0.

05; we'll know we are successful when we achieve accurate quantification across a dynamic range of X to Y copies per mL of sample; we expect to reduce assay time from X days to Y hours; our go/no-go criteria for this step is a sensitivity of at least X% and specificity of at least Y%). Performance measures are specific to the technology being proposed. 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 judging the success of the R61 project and for demonstrating that key feasibility gaps have been overcome, thereby justifying support for further developmental efforts ( e.g. , under a future R33 project). For some steps in development of the tool, it may be sufficient to define a single performance measure. For others, multiple performance measures may be more appropriate.

Example performance measures include a measure of sensitivity, specificity, throughput, resolution, cost, reproducibility, dynamic range, limit of detection, sample recovery, or any other measure or test to demonstrate progress towards the aims. They must be well-described, quantifiable, and scientifically justified. See Section V.

Application Review Information for information on review criteria related to performance measures. An application that lacks performance measures that include the numerically described target of performance will not be reviewed . 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: A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page . The DMS Plan must address the elements in the structured format.

Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. 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