Core Objective: To encourage revision applications from currently funded NCI R01 research projects to incorporate novel NCI-supported technologies, thereby expanding upon original research questions and accelerating progress in cancer research.
Target Recipient Type and Size: Currently funded NCI R01 research projects, which can originate from a wide range of organizations including Higher Education Institutions, Nonprofits, For-Profit Organizations (including Small Businesses), Local Governments, Federal Governments, and other entities. Organizational size is not specified by employee count.
Designation: SECTOR-SPECIFIC
Geographic Scope: Worldwide, as non-U.S. entities (foreign organizations) are eligible to apply.
Key Filtering Criteria: Applicants must be existing NCI R01 awardees with at least one year remaining on their parent grant. The proposed revision must integrate a new technical approach or device developed through the NCI Innovative Molecular Analysis Technologies (IMAT) program and not be commercially available or developed by the parent R01's PI.
Grant Frequency and Program Context: This is a reissue of a previous funding opportunity (RFA-CA-24-012), indicating a recurring nature within the NCI IMAT program, which aims to promote interdisciplinary collaboration in developing innovative tools for cancer research.
Financial Structure
Total estimated funding for the call: $700,000 for Fiscal Year 2026.
Number of anticipated awards: 3.
Application budgets may not exceed $150,000 in direct costs per year.
Project period: Up to 2 years, not to exceed the remaining number of years on the parent grant. This means a single award could be up to $300,000 over two years.
This NOFO does not require cost sharing as defined by NIH Grants Policy Statement.
Pre-award costs are allowable as described in the NIH Grants Policy Statement Section 7.9.1.
Financial reporting requirements include annual Research Performance Progress Reports (RPPR) and financial statements. A final RPPR, invention statement, and expenditure data are required for closeout.
For-Profit Organizations (Small Businesses, Other For-Profit)
Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal (Federally Recognized and 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))
Non-domestic (non-U.S.) Entities and non-domestic components of U.S. Organizations are eligible to apply.
Required Registrations: Applicant organizations must complete and maintain active registrations in:
System for Award Management (SAM) - requires renewal at least annually.
Unique Entity Identifier (UEI) - issued as part of SAM.gov registration.
eRA Commons - for organizational and PD/PI accounts.
Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code to register in SAM.
Project and Funding Status
Must be a currently funded hypothesis-driven NCI R01 research project.
The parent award must have at least one year left at the estimated time of the revision award (excluding periods of no-cost extension).
Funds cannot be requested beyond the end date of the parent award.
Technology Requirements
The application must propose to incorporate a new technical approach or device developed through support from the NCI Innovative Molecular Analysis Technologies (IMAT) program.
Non-responsive Projects: Applications will be considered non-responsive if they propose to:
Incorporate technology platforms that are commercially available to the research community.
Incorporate technologies that were not developed through the support of the NCI IMAT program.
Use technologies that were developed by a Principal Investigator (PI) on the parent R01.
Seek support during a period of no-cost extension of the parent grant.
Individual Requirements
Program Directors/Principal Investigators (PD/PIs) must have an eRA Commons account.
Application Process
Application Timeline and Deadlines
Open Date (Earliest Submission Date): March 04, 2025
Application Due Date (latest): October 03, 2025 by 5:00 PM local time of applicant organization.
Letter of Intent Due Date(s): 30 days prior to the application due date (optional, but encouraged).
Scientific Merit Review: February 2026 (for applications submitted by Oct 3, 2025).
Advisory Council Review: May 2026 (for applications submitted by Oct 3, 2025).
Earliest Start Date: July 2026 (for applications submitted by Oct 3, 2025).
No late applications will be accepted.
If a submission date falls on a weekend or federal holiday, the deadline is automatically extended to the next business day.
Application Submission Process
Applications must be submitted electronically through either:
Requires completion and maintenance of active registrations in SAM, UEI, eRA Commons, and Grants.govprior to submitting the application. Obtaining these registrations can take 6 weeks or more.
Program Directors/Principal Investigators (PD/PIs) must have an eRA Commons account.
Applicants are strongly encouraged to submit applications early to allow time for correction of any errors.
Applications will be evaluated for completeness, compliance, and responsiveness; incomplete, non-compliant, or non-responsive applications will not be reviewed.
Required Documentation and Content
Applicants must follow the instructions in the Research (R) Instructions in the 'How to Apply - Application Guide' as well as program-specific instructions outlined in this NOFO.
Letter of Intent (Optional): If submitted, it should include the descriptive title of proposed activity, PD/PI name(s) and contact info, names of other key personnel, participating institution(s), and the funding opportunity number and title.
Page Limitations: Adhere to the 'Table of Page Limits'. The Research Strategy section is specifically limited to 6 pages.
PHS 398 Research Plan: Specific additional instructions include:
Introduction: One-page limit. Describe the nature of the revision, its influence on the current grant's specific aims, research design, and methods. Include sufficient information on the original grant and technology needs. If a resubmission, address prior review comments.
Specific Aims: List specific objectives, expected to add one or more separate aims. Address overall impact on cancer research.
Research Strategy: Must identify the IMAT-supported technology being incorporated and evidence supporting its readiness for independent validation. Describe the nature of collaboration with IMAT technology developers (if applicable). Include 'Importance of Research' and 'Rigor and Feasibility' subsections. Explain how the proposed project advances cancer research and independently validates the new technology.
Resource Sharing Plan: Required.
Data Management and Sharing Plan: Required for all applications, regardless of direct costs requested.
Appendix: Only limited materials allowed (e.g., blank questionnaires); no publications or other similar materials.
PHS Human Subjects and Clinical Trials Information: Required if human subjects research, clinical research, or NIH-defined clinical trials are involved.
Post-Award Requirements
Recipients are required to submit an annual Research Performance Progress Report (RPPR) and financial statements.
A final RPPR, invention statement, and expenditure data are required for closeout of the award.
Evaluation Criteria
Overall Impact
Reviewers will provide an overall impact score reflecting the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved.
Scored Review Criteria
Factor 1: Importance of the Research (Significance and Innovation): Assesses the project's potential to advance cancer research and the novelty of the approach.
Factor 2: Rigor and Feasibility (Approach): Evaluates the soundness of the scientific approach and the practicality of the proposed work.
Factor 3: Expertise and Resources (Investigator(s) and Environment): Considers the qualifications and experience of the research team and the suitability of the research environment.
Additional Review Criteria (Considered, but not Scored)
Protections for Human Subjects (if applicable).
Vertebrate Animals (if applicable).
Biohazards (if applicable).
Revisions: The appropriateness of the proposed expansion of the scope of the project will be evaluated.
Additional Review Considerations (Not Scored, Not Part of Overall Impact Score)
Authentication of Key Biological and/or Chemical Resources.
Budget and Period of Support: Evaluation of whether the budget and requested period are justified and reasonable in relation to the proposed research.
Selection Criteria
Scientific and technical merit of the proposed project (as determined by peer review).
Availability of funds.
Relevance of the proposed project to program priorities.
Compliance & Special Requirements
Regulatory Compliance
All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Recipients must comply with applicable non-discrimination laws and submit an Assurance of Compliance (HHS-690).
Compliance with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards) is required.
Federal statutes and regulations relevant to federal financial assistance, including those in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
Mandatory disclosure of violations of federal criminal law involving fraud, bribery, or gratuity violations (2 CFR 200.113, NIH Grants Policy Statement Section 4.1.35).
Data and IT Requirements
Data Management and Sharing: Recipients must comply with the 2023 NIH Policy for Data Management and Sharing. The approved Data Management and Sharing Plan must be implemented.
Health IT Standards: If the award involves implementing, acquiring, or upgrading health IT, it must meet standards and implementation specifications adopted in 45 CFR part 170, Subpart B, and be certified under the ONC Health IT Certification Program (if applicable).
Cybersecurity: For recipients with ongoing access to HHS information or operational technology systems that process Personal Identifiable Information (PII) or Personal Health Information (PHI), plans and procedures modeled after the NIST Cybersecurity framework are required.
Human Subject and Clinical Trial Specifics (if applicable)
ClinicalTrials.gov Registration: If the award provides for one or more clinical trials, the responsible party must register and submit results information on ClinicalTrials.gov.
IRB/IEC Approval: All protocols must be reviewed by the institution's Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Data and Safety Monitoring: Oversight and monitoring are required for all NIH-supported human biomedical and behavioral intervention studies.
IND/IDE Requirements: Clinical research involving investigational therapeutics, vaccines, or devices must be performed under an FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE).
Intellectual Property
No specific IP policies are detailed beyond general NIH grants policy, implying standard federal regulations apply.
Other Specific Requirements and Considerations
This funding opportunity exclusively targets revision applications from existing NCI R01 awardees, not new grant applications.
The incorporated technology must have been developed specifically through the NCI IMAT program.
The project should provide corroborative data to enhance the rigor of new findings and offer independent validation of the emerging technology for the broader cancer research community.
Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.
NIH will review an applicant's federal award history in SAM.gov to ensure sound business practices prior to making an award.
Grant Details
cancer research
oncology
biomedical research
health technology
molecular analysis
cellular analysis
innovative tools
technology development
technology validation
research collaboration
NCI
NIH
R01
IMAT
clinical trials
diagnostics
therapeutics
prevention
early detection
treatment strategies
risk reduction
clinical care
health disparities
biospecimen science
grants
funding
usa
Revision Applications for Incorporation of Novel NCI-Supported Technology to Accelerate Cancer Research (R01 Clinical Trial Optional)
RFA-CA-25-005
National Cancer Institute (NCI) - Innovative Molecular Analysis Technologies (IMAT) program
Grants8