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Grant Analysis

Purpose & Target

The core objective of this grant is to support the advanced development and rigorous validation of novel molecular and cellular analysis technologies for cancer research. - It targets organizations (academic, non-profit, for-profit, governmental) capable of conducting high-level research. - This is a SECTOR-SPECIFIC grant, focused exclusively on cancer research and related technology development. - Geographic scope includes the U.S. and Non-domestic (non-U.S.) Entities. - Key filtering criteria: Focus on technology development (not hypothesis-driven biology), preliminary data showing feasibility, and the potential for transformative impact on cancer research. - This is a recurring grant opportunity, being a reissue within the long-standing Innovative Molecular Analysis Technologies (IMAT) Program.

Financial Structure

Total funding available: $4,300,000 for fiscal year 2026 (for an estimated 10 awards).
Maximum grant amount per award: Application budgets are limited to $300,000 per year (in direct costs).
Project period: Up to 3 years.
Currency: USD.
Matching funds/cost sharing: Not required; the NOFO explicitly states it 'does not require cost sharing'.
Eligible costs: Direct costs are specified up to the annual limit. Pre-award costs are allowable as described in the NIH Grants Policy Statement Section 7.9.1.
Ineligible costs: Not detailed, but projects with clinical trials or toxicology studies beyond demonstrating technology capabilities, biomarker discovery/validation, drug/therapy development, or primarily software/informatics solutions are non-responsive and will not be reviewed.
Financial reporting: Annual Research Performance Progress Reports (RPPR) and financial statements are required. A final RPPR and expenditure data are required for closeout.

Eligibility Requirements

Organizational Type & Legal Structure

Eligible: Higher Education Institutions (Public/State Controlled, Private), Nonprofits (with/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 - Federally Recognized and Other), Federal Governments (Eligible Agencies, U.S. Territory or Possession), and Other (Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based/Community-based Organizations, Regional Organizations, Non-domestic (non-U.S.) Entities (Foreign Organizations)).

Geographic Requirements

Open to organizations based in the U.S. and Non-domestic (non-U.S.) Entities. Foreign components of U.S. organizations are allowed.

Technical & Capacity Requirements

Projects must have overcome major feasibility gaps, as demonstrated by supportive preliminary data.
Applicants should provide background/preliminary data equivalent to work supported by a prior IMAT R21 or R61 award, showing the technology has passed the pilot developmental stage.
Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must have the skills, knowledge, and resources necessary to carry out the proposed research.

Registration & Compliance

Must complete and maintain active registrations in System for Award Management (SAM) (including Unique Entity Identifier - UEI).
Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) code to register in SAM.
Must register with eRA Commons (requiring at least one Signing Official and one PD/PI account).
Must register with Grants.gov.
All registrations must be completed prior to application submission; this process can take 6 weeks or more.

Application Process

Application Process & Submission

Submission Deadlines:
- April 04, 2025, by 5:00 PM local time of applicant organization.
- October 03, 2025, by 5:00 PM local time of applicant organization (latest deadline).
No late applications will be accepted.
Open Date (Earliest Submission): March 04, 2025.
Letter of Intent: Optional, but encouraged 30 days prior to the application due date.
Submission Method: Electronic only, via NIH ASSIST system, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.

Required Documentation & Materials

Standard SF424(R&R) forms and PHS 398 forms (Cover Page Supplement, Research Plan, Human Subjects and Clinical Trials Information, Assignment Request Form).
A 'Statement of Potential Impact' within the Specific Aims of the Research Plan.
A dedicated 'Performance Measures' subsection within the Research Strategy, detailing quantitative, scientifically justified measures.
Resource Sharing Plan (if applicable).
Data Management and Sharing Plan (required for all applications regardless of direct costs).
Limited Appendix materials allowed: Only blank questionnaires or blank surveys. No publications or other material.

Project Implementation & Reporting

Grant Duration: Total project period may not exceed 3 years.
Earliest Start Dates: December 2025 (for April submissions) or July 2026 (for October submissions).
Reporting Obligations:
- Annual Research Performance Progress Report (RPPR).
- Annual financial statements.
- Final RPPR and Federal Financial Report for closeout.
Meeting Requirement: All funded investigators are required to attend an annual 2-3 day meeting to share progress and insights, unless otherwise notified by NCI program officials.

Evaluation Criteria

Overall Impact

Reviewers will assess the likelihood of the project to exert a sustained, powerful influence on the research field(s) involved.

Scored Review Criteria

Importance of the Research (Significance and Innovation): Evaluation of new or improved technical capabilities, substantial improvements over current approaches, addressing unmet needs in cancer research, and potential transformative impact.
Rigor and Feasibility (Approach): Assessment of the technical approach, validation strategy, anticipated difficulties, and workarounds. Emphasis on rigorous study design and reliable performance.
Expertise and Resources (Investigator(s) and Environment): Evaluation of the qualifications of the PD(s)/PI(s) and key personnel, and the adequacy of the research environment.

Additional Review Criteria (Not Scored, but Impact Overall Score)

Performance Measures: Appropriateness of proposed quantitative performance measures to determine if aims are accomplished, if key risk factors are addressed, and if the technology's validated performance would establish a useful tool.
Protections for Human Subjects (if applicable).
Vertebrate Animals (if applicable).
Biohazards (if applicable).
Authentication of Key Biological and/or Chemical Resources.
Justification and reasonableness of the budget and requested period of support.

Compliance & Special Requirements

Regulatory & Legal Compliance

Adherence to U.S. federal regulations including 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards), Public Health Service Act (42 USC 241 and 284), and Federal Regulations 42 CFR Part 52.
Compliance with all applicable nondiscrimination laws; recipients must submit an Assurance of Compliance (HHS-690).
Mandatory disclosure of any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award.

Data Management & Security

Required compliance with the 2023 NIH Policy for Data Management and Sharing.
For projects involving health IT, use health IT that meets standards in 45 CFR part 170, Subpart B, and if applicable for clinical settings, health IT certified under the ONC Health IT Certification Program.
For handling Personal Identifiable Information (PII) or Personal Health Information (PHI), recipients must develop plans and procedures modeled after the NIST Cybersecurity framework.

Ethical & Research Standards

Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is required for human subjects research.
Projects must clearly focus on technology development for cancer research, not on pursuing specific biological or clinical hypotheses with existing tools.

Unique Aspects & Strategic Opportunities

This R33 mechanism specifically targets advanced development and robust validation of technologies where major feasibility gaps have been overcome, requiring strong preliminary data.
Applications must include quantitative performance measures that are well-described, quantifiable, and scientifically justified to demonstrate technical progress and success.
Potential for substantial improvements over current approaches and/or adding qualitatively new, transformative research capabilities is highly valued.
Encouraged to address or mitigate cancer health disparities and propose technologies enabling research or clinical control in low-resource settings (e.g., limited infrastructure, non-traditional healthcare, affordability).

Grant Details