Grants8 | The most comprehensive grants search on the web

Grant Analysis

Purpose & Target

The core objective of this grant is to solicit exploratory research projects focused on the early-stage development of highly innovative technologies. These technologies must offer novel molecular or cellular analysis capabilities for basic, clinical, or epidemiological cancer research, emphasizing new capabilities with a high degree of technical innovation for targeting, probing, or assessing molecular and cellular features of cancer biology.

Target recipient type and size: Open to a wide range of organizations including higher education institutions, non-profits, for-profit businesses (including small businesses), and various government entities. No specific size limits mentioned.
This is a SECTOR-SPECIFIC grant, focused on cancer research and technology development.
Geographic scope: Worldwide. Applicants can be based in the U.S. or non-U.S. entities (foreign organizations).
Key filtering criteria: Projects must involve early-stage, highly innovative technology development for cancer biology, must not involve clinical trials, and must not be hypothesis-driven research using existing technologies. Emphasis on technical feasibility not yet established.
Grant frequency and program context: This is a reissue (RFA-CA-24-008), indicating it's a recurring opportunity within the broader NCI-sponsored Innovative Molecular Analysis Technologies (IMAT) Program. It specifically uses the R61 mechanism for exploratory/developmental projects at their inception or idea-based phase.

Financial Structure

Total funding available: NCI intends to fund approximately $4,200,000 for fiscal year 2026.
Estimated number of awards: 17.
Award budget limit: $150,000 per year (direct costs).
Total project period limit: Not to exceed 3 years.
Maximum individual award amount: Up to $450,000 over three years ($150,000 direct costs per year x 3 years).
Currency: USD.
Matching fund requirements: Not required.
Modular budget is expected unless the applicant is a Foreign Organization.
Pre-award costs are allowable as described in the NIH Grants Policy Statement.

Eligibility Requirements

Organizational Type and Structure

Eligible organization types include: Higher Education Institutions (Public/State Controlled, Private), Nonprofits (501(c)(3) IRS Status, without 501(c)(3) IRS Status), For-Profit Organizations (Small Businesses, Other than Small Businesses), Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal - Federally Recognized and Other), Federal Governments (Eligible Agencies of the Federal Government, U.S. Territory or Possession), and 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 explicitly eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible.

Geographic and Regulatory Requirements

Applicants can be based in the U.S. or any foreign country.
Required Registrations (prior to application submission, can take 6+ weeks):
System for Award Management (SAM) with active annual renewal.
NATO Commercial and Government Entity (NCAGE) Code for foreign organizations.
Unique Entity Identifier (UEI) (issued via SAM.gov registration).
eRA Commons registration for the organization and for all Program Directors/Principal Investigators (PD/PIs). Multiple PD/PIs are allowed.
Grants.gov registration (requires active SAM registration).

Project Specific Exclusions

Projects proposing clinical trials are not allowed.
Projects focused on the application of existing technologies where novelty is in the biological or clinical target/question (i.e., traditional biological-hypothesis driven research) are not responsive.
Projects involving existing technologies not yet demonstrated for cancer-relevant application must involve significant additional technical modifications/development or a significant question of feasibility to qualify for the R61 mechanism.
Non-responsive projects also include:
Instrumentation for whole-body or in vivo imaging.
Biomarker discovery or biomarker validation.
Development of drugs or therapies.
Development of probes or tagging agents for specific target molecules (unless generalizable with broad targeting/application).
Projects focused primarily on software/informatics solutions, database development, data mining, statistical tools, and computational/mathematical modeling (limited software/computational efforts for new devices/methods are acceptable).
Applications lacking appropriate quantitative performance measures.

Application Process

Application Deadlines and Submission

Application Due Dates:
April 04, 2025 (New, Renewal/Resubmission/Revision)
October 03, 2025 (New, Renewal/Resubmission/Revision)
All applications are due by 5:00 PM local time of the applicant organization.
No late applications will be accepted.
Letter of Intent Due Date: 30 days prior to the application due date (not required, but encouraged).
Submission platform: Applications must be submitted electronically through Grants.gov using one of three options:
NIH ASSIST system.
Institutional system-to-system (S2S) solution.
Grants.gov Workspace.
Applicants are encouraged to submit early to allow time for error corrections.

Required Documentation and Materials

Follow instructions in the Research (R) Instructions in the 'How to Apply - Application Guide', supplemented by specific NOFO instructions.
Specific page limitation: The 'Research Strategy' section is limited to 6 pages.
Key components of the application:
SF424(R&R) forms (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile).
R&R or Modular Budget (modular expected unless foreign organization).
R&R Subaward Budget (if applicable).
PHS 398 Cover Page Supplement.
PHS 398 Research Plan, including:
- 'Specific Aims' with a sub-section 'Statement of Potential Impact' addressing new capability, impact, and how limitations of current technologies are overcome.
- 'Research Strategy' addressing: Importance of Research (new/improved technical capabilities, potential impact, unmet technical need, health disparities mitigation), Rigor and Feasibility (technical approach, anticipated difficulties, workarounds).
- Dedicated sub-section 'Performance Measures' within Research Strategy: Must be quantitative, scientifically justified, and clearly defined (e.g., detection limit, sensitivity, throughput).
Resource Sharing Plan.
Data Management and Sharing Plan (required for all applications generating scientific data).
Appendix: Only limited materials allowed; no publications or other material (except blank questionnaires/surveys).
PHS Human Subjects and Clinical Trials Information form (if applicable, though clinical trials are not allowed).
PHS Assignment Request Form.

Review and Selection Process

Applications evaluated for scientific/technical merit by Scientific Review Group convened by NCI.
Written critiques provided for all applications.
Selection process: Only applications with highest scientific/technical merit (generally top half) will be discussed.
Appeals of initial peer review will not be accepted.
Funding decisions consider: scientific/technical merit, availability of funds, relevance to program priorities.

Post-Award Requirements

Recipients are required to attend an annual meeting (2-3 days) of funded investigators.
Reporting:
Annual Research Performance Progress Report (RPPR).
Annual financial statements.
Final RPPR, invention statement, and expenditure data for closeout.
Compliance with NIH Grants Policy Statement and specific terms outlined in the Notice of Award.

Evaluation Criteria

Overall Impact

Reviewers will assess the likelihood of the project to exert a sustained, powerful influence on the research field, considering the following scored criteria and additional criteria.

Scored Review Criteria

Factor 1: Importance of the Research (Significance and Innovation)
Novelty: New or improved technical capabilities; potential for substantial improvements or qualitatively new capabilities over current approaches.
Transformative Potential: Beyond incremental improvements, potential to transform research in laboratory, epidemiology, and/or clinical settings.
Impact: Potential impact on cancer research or clinical care; explanation of why potential impact outweighs risks.
Unmet Need: Addresses an unmet technical need from the research community.
Health Disparities: Plans to address or mitigate potential creation/exacerbation of cancer health disparities, and integration of affected populations or data from them.
Factor 2: Rigor and Feasibility (Approach)
Technical Approach: Description of the approach, anticipated difficulties, and possible workarounds.
Study Design: Rigorous study design with a verifiable approach, based on well-defined performance measures.
Factor 3: Expertise and Resources (Investigator(s) and Environment)

Additional Review Criteria (Not scored, but considered for Overall Impact)

Performance Measures
Appropriateness: How well proposed measures determine if aims are accomplished and key risk factors are addressed.
Quantifiability: Measures are quantitative, feasible, and scientifically justified.
Proof-of-Concept: If achieved, would establish proof-of-concept for future developmental efforts.
Usefulness: Would meeting performance capabilities create a useful tool for the research community.
Example metrics: sensitivity, specificity, throughput, resolution, price point, etc.
Protections for Human Subjects (if applicable).
Vertebrate Animals (if applicable).
Biohazards (if applicable).
Authentication of Key Biological and/or Chemical Resources.
Budget and Period of Support: Justification and reasonableness in relation to proposed research.

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.
Compliance with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
Recipients must comply with all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
Projects involving health IT must use systems meeting standards in 45 CFR part 170, Subpart B, and if for eligible clinicians, certified under the ONC Health IT Certification Program.

Data Protection and Ethical Standards

Data Management and Sharing Plan: Required for all applicants planning research that generates scientific data.
Cybersecurity: Recipients with access to HHS systems or PII/PHI must develop plans modeled after the NIST Cybersecurity framework.
Human Subjects/Ethical Review:
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval required for protocols involving human subjects.
Protections for human subjects and vertebrate animals will be considered during review.

Mandatory Disclosures

Recipients must disclose any information related to violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award.

Special Considerations

Focus on high technical innovation and high potential impact, even with a high level of risk.
Projects must be focused on developing generally applicable technologies to advance cancer research, not on pursuing specific biological discoveries with tools.
Applicants are encouraged to describe how their proposed technology will address or mitigate cancer health disparities.
Projects may enable cancer research or clinical control in low-resource settings (e.g., practicality of use, limited infrastructure, affordability).
An annual meeting of all funded investigators is required.

Grant Details