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Grant Analysis

Purpose & Target

This grant supports the advanced development and rigorous validation of emerging biospecimen science technologies for cancer research and clinical care. It targets research organizations capable of demonstrating proof-of-principle for novel tools, devices, assays, and methods that improve the quality and handling of biological samples. The grant is SECTOR-SPECIFIC, focusing exclusively on cancer research and related clinical applications. - Geographic Scope: Primarily U.S. organizations, but foreign (non-U.S.) entities are also eligible to apply. - Key Filtering Criteria: Focus on technology development/validation, R33 mechanism (advanced development), 'Clinical Trial Not Allowed'. - Grant Frequency: Recurring, as it's a reissue (RFA-CA-24-011) and part of the broader, ongoing NCI-sponsored Innovative Molecular Analysis Technologies (IMAT) Program.

Financial Structure

Budget Range: Up to $300,000 direct costs per year.
Total Project Budget Limit: Max $900,000 direct costs over the total project period.
Project Period: May not exceed 3 years.
Funding Available: NCI intends to fund an estimate of 2 awards, corresponding to a total of $900,000 for fiscal year 2026 (for the overall program, not per award).
Eligible Costs: Direct costs up to the stated limits.
Matching Fund Requirements: Not required.
Co-financing Requirements: Not required.
Indirect Cost Policies: Follow NIH Grants Policy Statement guidelines (not explicitly detailed in provided text).
Financial Reporting Requirements: Recipients must submit annual Research Performance Progress Reports (RPPR) and financial statements as required by the NIH Grants Policy Statement.

Eligibility Requirements

Organizational Eligibility

Eligible Organization Types:
Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (501(c)(3) IRS Status, or without 501(c)(3) IRS Status)
For-Profit Organizations (Small Businesses, Other For-Profit)
Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal Governments (Federally Recognized or Other))
Federal Governments (Eligible Agencies of the Federal Government, U.S. Territory or Possession)
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, Regional Organizations, Non-domestic (non-U.S.) Entities (Foreign Organizations).
Organizational Structure Preferences: No explicit structure preferences, but allows for applications with multiple Program Directors/Principal Investigators (PDs/PIs).

Technical Expertise and Infrastructure Requirements

Projects must demonstrate that major feasibility gaps for the technology/methodology have been overcome with supportive preliminary data (proof-of-principle).
Proposed technologies must offer substantial improvements over current approaches and/or add qualitatively new research capabilities.
Rigorous validation strategy required to establish repeatable, reliable performance in a cancer-relevant biological context.
Projects focused primarily on software/informatics solutions, database development, data mining, statistical tools, and computational/mathematical modeling are generally non-responsive, unless as limited support for new device/method development.

Geographic and Regulatory Requirements

Geographic Eligibility: Organizations from the U.S. are eligible. Foreign (non-U.S.) entities are also eligible to apply.
Required Registrations:
System for Award Management (SAM) with active registration (annual renewal required). Foreign organizations need an NCAGE code for SAM.
Unique Entity Identifier (UEI) obtained through SAM.gov.
eRA Commons account for the organization (Signing Official and PD/PI accounts required).
Grants.gov registration.

Exclusion Criteria and Disqualifying Factors

Clinical Trial Status: 'Clinical Trial Not Allowed'. Applications proposing clinical trials will not be accepted.
Projects where novelty resides in applying existing technology or pursuing a biological/clinical question, rather than developing new technical capabilities.
Projects involving instrumentation for whole-body or in vivo imaging as the primary focus.
Biomarker discovery or biomarker validation as the primary focus.
Development of drugs or therapies.
Projects lacking appropriate quantitative performance measures.

Application Process

Application Timeline and Deadlines

Open Date (Earliest Submission Date): March 04, 2025
Application Due Dates:
April 04, 2025 (for July 2025 review, Oct 2025 council, Dec 2025 earliest start)
October 03, 2025 (for Feb 2026 review, May 2026 council, July 2026 earliest start)
Latest Submission Deadline: October 03, 2025 by 5:00 PM local time of applicant organization.
Letter of Intent Due Date: 30 days prior to the application due date (not required, but encouraged).
Expiration Date: October 04, 2025 (grant program closes)
No late applications will be accepted.

Application Procedure and Submission

Applications must be submitted electronically via Grants.gov using either the NIH ASSIST system, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
Applicants are encouraged to submit early to allow time for corrections.
All required registrations (SAM, UEI, eRA Commons, Grants.gov) must be completed before submission.
PD(s)/PI(s) must have an eRA Commons account and include their ID in the application.

Required Documentation and Materials

Follow instructions in the Research (R) Instructions of the 'How to Apply - Application Guide', along with program-specific instructions in this NOFO.
PHS 398 Research Plan:
Specific Aims: Must include a brief 'Statement of Potential Impact' subsection explaining new capability, potential impact on biomedical research, and how it overcomes current limitations.
Research Strategy: Must address: 'Importance of the Research' (new/improved technical capabilities, preliminary data, potential impact, health disparities) and 'Rigor and Feasibility' (technical approach, anticipated difficulties, and a dedicated 'Performance Measures' subsection with quantitative, scientifically justified measures).
Resource Sharing Plan: Required.
Data Management and Sharing Plan: Required for all applications generating scientific data.
Appendix: Only limited materials allowed (e.g., blank questionnaires/surveys). Publications are not allowed.
PHS Human Subjects and Clinical Trials Information: Required if human subjects research is involved (clinical trials are not allowed).

Progress Tracking and Reporting

Annual Research Performance Progress Reports (RPPR) are required.
Financial statements as required by NIH Grants Policy Statement.
A final RPPR, invention statement, and expenditure data are required for closeout.

Support Offered

Funding: Financial assistance in the form of a grant.

Evaluation Criteria

Overall Impact

Reviewers assess the likelihood of the project to exert a sustained, powerful influence on the research field.

Scored Review Criteria (receive separate factor scores)

Factor 1. Importance of the Research (Significance and Innovation):
How the new or improved technical capabilities will be advanced and validated.
Evidence that the technology has moved beyond pilot developmental stage with preliminary data.
Potential impact of the proposed tool on cancer research or clinical care.
How the project addresses unmet technical needs and enables new research.
Impact on health disparities and mitigation of any new/exacerbated disparities.
Factor 2. Rigor and Feasibility (Approach):
Soundness of the technical approach for evaluation and rigorous validation.
Identification of anticipated difficulties and workarounds.
Presence of a dedicated subsection for 'Performance Measures' that are objective, quantitative, and scientifically justified.
Performance measures should define numerically described targets and assessment means (e.g., sensitivity, specificity, throughput, resolution, price point).
Whether meeting performance measures would establish a useful tool for the research community.
Factor 3. Expertise and Resources (Investigator(s) and Environment):
Competence and experience of the PD(s)/PI(s) and other key personnel.
Adequacy of the institutional environment and available resources.

Additional Review Criteria (no scores, but considered for overall impact)

Protections for Human Subjects (if applicable).
Vertebrate Animals (if applicable).
Biohazards (if applicable).
Authenticity of Key Biological and/or Chemical Resources.

Additional Review Considerations (no scores, no impact on overall impact score)

Budget and Period of Support: Justification and reasonableness of the budget and requested project period.

Compliance & Special Requirements

Regulatory Compliance

General Compliance: All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Non-discrimination: Recipients must comply with all applicable non-discrimination laws and submit an Assurance of Compliance (HHS-690).
Federal Regulations: Compliance with all federal statutes and regulations relevant to federal financial assistance (e.g., 2 CFR Part 200).

Data Protection and Privacy

Data Management and Sharing: Required for all research generating scientific data; plan must be implemented as described upon approval.
Health IT: If award funding involves implementing, acquiring, or upgrading health IT, recipients must use health IT that meets specified standards (45 CFR part 170, Subpart B) and ONC Health IT Certification Program requirements.
Cybersecurity: Recipients with consistent access to HHS systems or PII/PHI must develop plans and procedures modeled after the NIST Cybersecurity framework.

Ethical Standards

Human Subjects: If involving human subjects research (non-clinical trial), recipient institutions must ensure protocols are reviewed by their IRB or IEC.
Mandatory Disclosure: Recipients must disclose information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award.

Unique Aspects and Requirements

Annual Meeting: All investigators funded through this NOFO are required to attend an annual 2-3 day meeting to share progress and research insights.
Non-Responsive Projects: Clearly defined types of projects that are out of scope (e.g., hypothesis-driven research, clinical trials, biomarker discovery, drug/therapy development, whole-body imaging, most software-only projects).
Contact Encouraged: Researchers uncertain about meeting requirements are encouraged to contact the Scientific/Research Contact before applying.

Grant Details