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Grant Analysis

Purpose & Target

This grant aims to expand, improve, or transform the utility of mammalian cancer and tumor models specifically for translational research. The core objective is to ensure these models are robust representations of human biology, appropriate for testing clinically important questions, and provide reliable information that ultimately benefits patients. It targets research organizations of various types and sizes, including higher education institutions, nonprofits, for-profit organizations (including small businesses), and various government entities, both within the U.S. and internationally. This is a SECTOR-SPECIFIC grant, focusing exclusively on oncology and cancer translational science. Key filtering criteria include the explicit focus on translational research using mammalian cancer models, and importantly, the grant is 'Clinical Trial Not Allowed', meaning applications proposing clinical trials will not be considered. Purely mechanistic research or the development of models for non-clinical research are also explicitly excluded. This is a recurring grant opportunity, as it is a reissue of a previous funding announcement, with multiple application deadlines extending through 2026.

Financial Structure

Funding Amounts

Maximum Grant Amount: Application budgets are limited to $499,000 direct costs per year.
Overall Budget: The total budget available for this funding opportunity across all awards is not specified.
Minimum Grant Amount: A minimum grant amount per application is not specified.
Currency: All financial amounts are in USD (United States Dollar), as this is a U.S. government grant from NIH.

Co-financing and Matching Funds

No Cost Sharing Required: This funding opportunity explicitly states that cost sharing is not required, meaning applicants do not need to contribute their own funds or secure matching funds from other sources as a condition of the grant.

Eligible and Ineligible Costs

Eligible Costs: Funds cover direct costs associated with the proposed research project, up to the annual limit. All costs must adhere to the principles outlined in the NIH Grants Policy Statement. Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Ineligible Costs: While not exhaustively listed, costs associated with activities explicitly excluded from the grant's scope are implicitly ineligible. This includes costs for clinical trials, purely mechanistic, non-clinical cancer research, or the development of new mammalian models for non-clinical research.

Payment Schedule and Mechanisms

Payment Mechanisms: Funds are typically provided through standard NIH grant disbursement mechanisms. A Notice of Award (NoA) authorizes the release of funds.

Financial Reporting and Audit Requirements

Reporting: Recipients are required to submit an annual Research Performance Progress Report (RPPR) and financial statements. Upon project closeout, a final RPPR, an invention statement, and expenditure data (Federal Financial Report) are required.
Audit Requirements: As a federal award, recipients are subject to audit requirements as per 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.

Financial Guarantees

Not Specified: No explicit financial guarantees or security requirements are mentioned in the provided documentation.

Eligibility Requirements

Eligible Organizations This grant welcomes a broad range of organization types:

Higher Education Institutions: This includes both public/state-controlled and private institutions.
Nonprofits: Both those with 501(c)(3) IRS status and those without.
For-Profit Organizations: This category explicitly includes both 'Small Businesses' and other for-profit entities.
Local Governments: Such as State, County, City or Township, Special District Governments, and Indian/Native American Tribal Governments (both Federally Recognized and Other).
Federal Governments: Eligible Agencies of the Federal Government and U.S. Territories or Possessions.
Other: 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, and Regional Organizations.
Foreign Organizations: Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are explicitly eligible to apply.

Specific Qualifications and Registrations To be eligible, applicants must complete and maintain several critical registrations before submitting their application. These registrations can take 6 weeks or more, so starting early is advised:

System for Award Management (SAM): Must have and maintain an active registration, which requires annual renewal.
Unique Entity Identifier (UEI): Issued as part of the SAM.gov registration process. The same UEI must be used for all registrations and on the grant application.
eRA Commons: Organizations must register with eRA Commons and identify at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account. PD/PIs must also have their own eRA Commons account affiliated with the organization.
Grants.gov: Must have an active SAM registration to complete Grants.gov registration.
NCAGE Code: Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code to register in SAM.

Research Scope Requirements

No Clinical Trials: Applications proposing clinical trials are not allowed and will not be accepted. The grant is specifically for 'Clinical Trial Not Allowed' research.
Exclusions: The following types of activities are outside the scope and will not be reviewed:
- Mechanistic, non-clinical cancer research that uses mammalian models.
- Development of a new mammalian model or models for non-clinical research.

Cost Sharing

No Cost Sharing Required: This funding opportunity does not require cost sharing.

Application Process

Application Deadlines and Timeline This grant opportunity has multiple application deadlines through 2026. Applicants should note the distinction between 'New' applications and 'Renewal/Resubmission/Revision' applications.

New Application Due Dates:
- February 05, 2025
- June 05, 2025
- October 05, 2025
- February 05, 2026
- June 05, 2026 (latest new application deadline)
Renewal / Resubmission / Revision Due Dates:
- March 05, 2025
- July 05, 2025
- November 05, 2025
- March 05, 2026
- July 05, 2026 (latest overall application deadline)

All applications are due by 5:00 PM local time of the applicant organization. Applicants are strongly encouraged to submit early to allow time for corrections. Grant Duration

The maximum project period allowed is 5 years.

Required Documentation and Materials Applicants must follow the detailed instructions in the NIH 'Research (R) Instructions in the How to Apply - Application Guide' and any program-specific instructions in this NOFO. Key forms and sections include:

SF424(R&R) Forms: Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile.
Budget Forms: R&R or Modular Budget, R&R Subaward Budget (if applicable).
PHS 398 Forms: Cover Page Supplement, Research Plan.
Research Plan Components: This is critical and must include specific sections:
- Resource Sharing Plan
- Data Management and Sharing Plan: Mandatory for all projects generating scientific data, regardless of the requested direct costs.
PHS Human Subjects and Clinical Trials Information: If human subjects are involved, a study record or delayed onset study record must be included.
PHS Assignment Request Form
Appendix: Only limited materials are allowed, primarily blank questionnaires or surveys. No publications or other materials should be included in the Appendix.

Application Procedure and Submission Applications must be submitted electronically through one of the following systems:

NIH ASSIST system (online preparation, submission, and tracking).
Institutional System-to-System (S2S) solution (check with your institution).
Grants.gov Workspace (prepare and submit, track in eRA Commons).

It is mandatory to complete all required registrations (SAM, UEI, eRA Commons, Grants.gov) before the application due date. Failure to do so is not a valid reason for late submission. All PD(s)/PI(s) must include their eRA Commons ID. Review Process and Selection Criteria

Applications undergo scientific and technical merit evaluation by a Scientific Review Group (SRG) convened by the Center for Scientific Review (CSR).
Following peer review, applications receive a second level of review by the appropriate national Advisory Council or Board.
Funding Decisions are based on:
- Scientific and technical merit (as determined by peer review).
- Availability of funds.
- Relevance of the proposed project to NCI program priorities.
Only applications deemed to have the highest scientific and technical merit (generally the top half) will proceed to discussion and receive an overall impact score.

Types of Support Offered This grant provides monetary funding (financial assistance). Additionally, engagement with the Oncology Models Forum (OMF) community is encouraged, which can provide indirect support through mentorship, networking, and access to resources like collaborative tools and opportunities. Reporting and Post-Award Obligations

Annual Reporting: Recipients must submit a Research Performance Progress Report (RPPR) and financial statements annually.
Closeout Reports: A final RPPR, an invention statement, and expenditure data are required for award closeout.
Compliance: Adherence to all terms and conditions of the NIH Grants Policy Statement and applicable federal regulations throughout the award period.

Evaluation Period For the latest application deadline of July 05, 2026:

Scientific Merit Review: November 2026
Advisory Council Review: January 2027
Earliest Start Date: April 2027

Evaluation Criteria

Applications will be evaluated based on their scientific and technical merit through a rigorous peer review system. Reviewers will provide an overall impact score reflecting their assessment of the project's likelihood to exert a sustained, powerful influence on the research field. Scored Review Criteria These three factors will receive a separate criterion score and are central to the scientific merit assessment:

Importance of the Research (Significance and Innovation): Reviewers will assess the project's significance to the field of translational cancer research and the level of innovation it brings. This includes whether the project proposes novel approaches to overcome translational deficiencies, define new uses, or advance standard practices for models.
Rigor and Feasibility (Approach): This assesses the soundness of the research design, methodology, and the feasibility of achieving the proposed objectives. It will consider how robust and well-designed the experimental plan is.
Expertise and Resources (Investigator(s) and Environment): The qualifications and experience of the project's investigators (Program Director(s)/Principal Investigator(s)) and the adequacy of the proposed research environment and resources will be evaluated.

Additional Review Criteria These items are considered in determining the overall impact score but do not receive separate criterion scores:

Protections for Human Subjects: If human subjects are involved, the adequacy of their protection will be reviewed.
Vertebrate Animals: If vertebrate animals are used, the justification and ethical treatment will be assessed.
Biohazards: If the research involves specific hazardous materials or procedures, the proposed protection measures for personnel and the environment will be evaluated.
Resubmissions/Revisions: Previous review outcomes and proposed changes/expansions will be considered.

Additional Review Considerations These items are considered but do not impact the overall impact score:

Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring the validity of these resources.
Budget and Period of Support: Assessment of whether the requested budget and project duration are justified and reasonable in relation to the proposed research.

Impact Expectations Projects are expected to lead to outcomes that improve oncology practice, inform clinical trials, identify biomarkers, and address significant unmet translational needs, such as developing new metastasis models or refining immunotherapeutic strategies. The ultimate aim is to provide reliable information for patient benefit. Competitive Advantage Factors Successful applications will demonstrate high scientific and technical merit, particularly in significance and innovation, with a rigorous approach and a highly qualified team. Aligning with NCI's program priorities for translational research and proactively engaging with the Oncology Models Forum (OMF) community can also be beneficial.

Compliance & Special Requirements

Regulatory Compliance Grant recipients must adhere to a comprehensive set of federal regulations and policies:

Uniform Administrative Requirements: Compliance with 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
NIH Grants Policy Statement: All awards are subject to the terms and conditions outlined in the NIH Grants Policy Statement.
Public Health Service Act: Awards are made under the authority of Sections 301 and 405 of the Public Health Service Act.
Federal Regulations: Compliance with 42 CFR Part 52.
Nondiscrimination Laws: Recipients must comply with all applicable nondiscrimination laws, as agreed upon during SAM.gov registration, and submit an Assurance of Compliance (HHS-690).
Mandatory Disclosure: Recipients must disclose any information related to violations of federal criminal law involving fraud, bribery, or gratuity that could affect the federal award (2 CFR 200.113).

Data Protection and Privacy

Data Management and Sharing Plan: If your research generates scientific data, a Data Management and Sharing Plan is mandatory and must comply with the 2023 NIH Policy for Data Management and Sharing. This plan must be implemented as described once approved.
Human Subjects Protections: If the project involves human subjects, compliance with relevant protections is critical, including obtaining Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval.

Environmental and Ethical Standards

Biohazards: If the proposed research includes biohazards, the application must evaluate and propose adequate protection for research personnel and the environment.
Ethical Standards: Adherence to ethical standards in research, particularly concerning human subjects and vertebrate animals, is required.

Intellectual Property Policies While specific IP policies are not detailed in this NOFO, they will be subject to the general NIH Grants Policy Statement. An invention statement is required for closeout of the award. Risk Management NIH reviews an applicant's federal award history in SAM.gov to ensure sound business practices. Plans for managing biohazards should also be included. Unique Aspects and Strategic Opportunities

Focus on Translational Research: This grant is highly specialized, specifically targeting translational applications of mammalian models in cancer research, as opposed to purely mechanistic studies or model development for non-clinical use. This distinction is critical for eligibility.
Engagement with Oncology Models Forum (OMF): A unique requirement is the expectation for applicants to attend the Oncology Models Forum Annual Meeting, and encouragement to participate in OMF workshops and webinars. This fosters collaboration, knowledge exchange, and access to a dedicated community, offering a significant strategic advantage and networking opportunity.
Clinical Trial Exclusion: The explicit exclusion of clinical trials means applicants must carefully design their projects to remain within the defined 'translational research' scope, without moving into clinical intervention or patient-facing trials. This clarity helps focus on the specific research type NCI is seeking.

Potential Challenges

The strict differentiation between translational research versus mechanistic/non-clinical research or clinical trials requires careful proposal crafting to ensure responsiveness.
The comprehensive list of required registrations (SAM, UEI, eRA Commons, Grants.gov) can be time-consuming and must be completed well in advance of the application deadline.

Cross-cutting Considerations

Data Sharing: Mandatory data management and sharing plans emphasize the importance of open science and data reuse.
International Collaboration: The eligibility of foreign organizations and foreign components highlights the global nature of cancer research and encourages international partnerships.

Grant Details