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Grant Analysis

Purpose & Target

The core objective of this grant is to encourage revision applications from currently funded NCI U01 research projects. The goal is to expand existing cancer research by incorporating novel technical approaches or devices developed through the NCI Innovative Molecular Analysis Technologies (IMAT) program. This aims to independently validate and accelerate the adoption of these emerging technologies for broader cancer research applications. - Target recipients: Currently funded NCI U01 research projects. - Recipient size: Not specified (broad range of eligible organization types). - SECTOR-SPECIFIC: Cancer Research. - Geographic scope: US-based and non-US entities (Foreign Organizations) are eligible. - Key filtering criteria: Must be an existing NCI U01 awardee with at least one year remaining on the parent award; must integrate NCI IMAT-supported technology. - Grant frequency: Recurring (reissue of a previous funding opportunity). - Program context: Part of the NCI IMAT program, fostering interdisciplinary collaboration in developing tools and methods for cancer research.

Financial Structure

This grant provides financial support as a cooperative agreement, with specific budget limitations. - Total estimated funding available: $700,000 for fiscal year 2026 across an estimated 3 awards. - Maximum direct costs per year: $150,000. - Project period: Up to 2 years, not exceeding the remaining number of years on the parent award. - Cost sharing: Not required. - Indirect cost policies: Modular budgets are expected for domestic organizations, unless submitted by a foreign organization. - Financial reporting: Recipients must submit annual Research Performance Progress Reports (RPPR) and financial statements. A final RPPR, invention statement, and expenditure data are required for award closeout.

Eligibility Requirements

To be eligible for this grant, your organization must meet specific criteria related to its current funding status and the technology you propose to incorporate. Organizational Eligibility

Must be a currently funded NCI U01 research project.
The parent U01 project must have at least one year left at the estimated time of the revision award (excluding no-cost extensions).
Applicants cannot request funds beyond the end date of the parent award.
Eligible Organization Types:
- Higher Education Institutions (Public/State Controlled, Private)
- Nonprofits (with or without 501(c)(3) IRS Status)
- For-Profit Organizations (Small Businesses, Other For-Profits)
- Local Governments (State, County, City/Township, Special District)
- Indian/Native American Tribal Governments (Federally Recognized, Other)
- Federal Governments (Eligible Agencies, U.S. Territory or Possession)
- Other: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations.
- Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible.
- Non-domestic (non-U.S.) components of U.S. Organizations are eligible.
- Foreign components, as defined by NIH Grants Policy Statement, are allowed.

Technical Requirements

The proposed technical approach or device must have been developed through support from the NCI IMAT program.
The technology must be ready for independent validation.

Registration Requirements

Applicant organizations must complete and maintain active registrations with:
- System for Award Management (SAM) (requires annual renewal).
- NATO Commercial and Government Entity (NCAGE) Code (for foreign organizations).
- Unique Entity Identifier (UEI) (issued via SAM.gov).
- eRA Commons (organization and PD(s)/PI(s) accounts).
- Grants.gov (requires active SAM registration).
PD(s)/PI(s) must have an eRA Commons account affiliated with the applicant organization.

Exclusion Criteria (Non-Responsive Projects)

Applications seeking to incorporate technology platforms that are commercially available to the research community.
Applications proposing to incorporate technologies that were not developed through the support of the NCI IMAT program.
Applications proposing to use technologies that were developed by a PI on the parent U01.
Applications seeking support during periods of no cost extension of the parent award.

Application Process

The application process for this grant involves specific forms, content requirements, and strict deadlines. Application Submission

Submission Deadline (Latest): October 03, 2025, by 5:00 PM local time of the applicant organization.
Applicants are encouraged to apply early to correct any errors.
No late applications will be accepted.
Submission Methods: Applications must be submitted electronically via:
- NIH ASSIST system.
- An institutional system-to-system (S2S) solution.
- Grants.gov Workspace.

Pre-Application Requirements

Letter of Intent (Optional but encouraged): Due 30 days prior to the application due date. Includes descriptive title, PD(s)/PI(s) contact info, key personnel, institutions, and funding opportunity number.
Registrations: All required organizational and individual registrations (SAM, UEI, NCAGE for foreign, eRA Commons, Grants.gov) must be completed prior to application submission. This can take 6+ weeks.

Required Documentation and Materials

Application Package: Accessed through ASSIST, Grants.gov Workspace, or institutional S2S solution.
Standard Forms (Follow 'How to Apply - Application Guide' instructions, unless specified otherwise in NOFO):
- SF424(R&R) Cover
- SF424(R&R) Project/Performance Site Locations
- SF424(R&R) Other Project Information
- SF424(R&R) Senior/Key Person Profile (must include PI from parent award)
- R&R or Modular Budget
- R&R Subaward Budget
- PHS 398 Cover Page Supplement
- PHS Human Subjects and Clinical Trials Information (if applicable)
- PHS Assignment Request Form
NOFO-Specific Content:
- Introduction to Application (1 page limit): Describe the nature of the revision, its influence on parent study, and information about the original grant. For resubmissions, include response to prior review.
- Specific Aims: List objectives of proposed research in context of parent award. Revision is expected to add one or more separate aims. Must address overall impact on cancer research.
- Research Strategy (6-page limit):
  - Must identify the IMAT-supported technology being incorporated and evidence of its readiness for independent validation.
  - If original developers are collaborating, describe their participation and leveraged strengths.
  - Include subsections 'Importance of Research' and 'Rigor and Feasibility'.
  - Describe current tools and their shortcomings.
  - Detail advantages of the IMAT-supported technology.
  - Briefly describe how the project validates the new technology for the cancer research community.
- Resource Sharing Plan: Required.
- Data Management and Sharing Plan: Required for all applications generating scientific data.
- Appendix: Limited to blank questionnaires or blank surveys (no publications or other material).

Post-Award Reporting and Compliance

Annual Reporting: Research Performance Progress Report (RPPR) and financial statements.
Closeout: Final RPPR, invention statement, and expenditure data are required.
NIH Grants Policy Statement: All awards are subject to its terms and conditions.

Application Assistance

eRA Service Desk: For system questions (ASSIST, eRA Commons, errors, post-submission issues).
General Grants Information: For application instructions, processes, and NIH grant resources.
Grants.gov Customer Support: For Grants.gov registration and Workspace.

Evaluation Criteria

Applications will be evaluated for their scientific and technical merit by peer review. The primary goal is to assess the potential for the project to significantly influence the research field. Overall Impact

Reviewers will provide an overall impact score reflecting the likelihood of the project to exert a sustained, powerful influence on the research field(s).

Scored Review Criteria (Factors 1 and 2 receive separate scores)

Factor 1. Importance of the Research (Significance and Innovation): Evaluates how significant and innovative the proposed expansion is.
Factor 2. Rigor and Feasibility (Approach): Assesses the soundness of the scientific approach and the project's feasibility.
Factor 3. Expertise and Resources (Investigator(s) and Environment): Reviews the qualifications of the research team and the suitability of the research environment.

Additional Review Criteria (Considered but not scored)

Protections for Human Subjects: If applicable, evaluates plans for human subject protection.
Vertebrate Animals: If applicable, evaluates plans concerning vertebrate animals.
Biohazards: If applicable, evaluates plans for managing biohazards.
Resubmissions: For resubmitted revision applications, the full application is evaluated.
Revisions: Evaluates the appropriateness of the proposed expansion of the scope of the parent project.

Additional Review Considerations (Considered but not scored)

Authentication of Key Biological and/or Chemical Resources: Evaluation of plans to identify and ensure the validity of these resources.
Budget and Period of Support: Assessment of whether the requested budget and project duration are justified and reasonable for the proposed research.

Compliance & Special Requirements

Compliance with federal regulations and specific NIH policies is mandatory for all awards under this funding opportunity. Regulatory and Administrative Compliance

Adherence to the NIH Grants Policy Statement.
Compliance with 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
Nondiscrimination laws: Recipients must follow all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
Federal statutes and regulations relevant to federal financial assistance, including public policy requirements.
NIH may terminate awards for non-compliance (2 CFR Part 200.340, NIH Grants Policy Statement Section 8.5.2).

Data and Information Requirements

Data Management and Sharing Plan: Required for all projects generating scientific data and must be implemented as approved.
Health IT Standards: If the award involves health IT, recipients must use systems meeting 45 CFR part 170, Subpart B standards. For clinical settings, ONC Health IT Certified Program technology must be used if available.
Cybersecurity: Recipients with access to HHS systems or handling PII/PHI must develop plans modeled after the NIST Cybersecurity framework.

Human Subjects and Clinical Trial Specifics

Human Subjects Research: If involved, applicants must follow instructions for the PHS Human Subjects and Clinical Trials Information form.
Clinical Trials:
- Optional for this NOFO.
- If conducting clinical trials, responsible parties must register and submit results on ClinicalTrials.gov.
- Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is required for all protocols.
- Data and Safety Monitoring requirements apply to human biomedical and behavioral intervention studies.
- Projects involving investigational therapeutics/devices require FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE).

Intellectual Property

Recipients are required to submit an invention statement for award closeout.

Cooperative Agreement Terms

This is a Cooperative Agreement (U01), implying substantial Federal scientific or programmatic involvement from NIH staff.
NIH staff will assist, guide, coordinate, or participate in project activities.
The recipient retains the dominant role and prime responsibility for the project, with specific tasks shared with NIH as defined.

Grant Details