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Grant Analysis

Purpose & Target

This grant aims to support the early-stage development of highly innovative technologies that improve the quality and handling of biological samples used in cancer research or clinical care.
It targets organizations with novel technical ideas for biospecimen science.
This is a SECTOR-SPECIFIC grant.
Geographic scope: Organizations worldwide are eligible to apply.
Key filtering criteria: Focus on early-stage, high-risk, high-impact technology development, specifically for biospecimen science in cancer. Clinical trials are not allowed.
Grant frequency: This is a reissue, indicating a recurring program with specific annual application cycles.

Financial Structure

Application budgets are limited to $150,000 per year in direct costs.
The total project period may not exceed 3 years, implying a maximum total award of $450,000.
Currency: USD.
No cost sharing is required.
A modular budget is expected for domestic applicants. Foreign organizations will use an R&R budget.
Pre-award costs are allowable as described in the NIH Grants Policy Statement.
Financial reporting required annually (Federal Financial Report portion) and upon closeout.

Eligibility Requirements

Eligible Organization Types

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
Nonprofits with 501(c)(3) IRS Status
Nonprofits without 501(c)(3) IRS Status
Small Businesses
For-Profit Organizations (Other than Small Businesses)
State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government
U.S. Territory or Possession
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)

Required Registrations

Applicant organizations must complete and maintain active registrations for:
- System for Award Management (SAM)
- NATO Commercial and Government Entity (NCAGE) Code (for foreign organizations)
- Unique Entity Identifier (UEI)
- eRA Commons (organization and PD/PI accounts)
- Grants.gov
All registrations must be completed prior to application submission.

Individual Eligibility

Any individual(s) with the skills, knowledge, and resources to carry out the proposed research can be a Program Director/Principal Investigator (PD/PI).
All PD(s)/PI(s) must have an eRA Commons account affiliated with the applicant organization.

Project Stage

Projects must be at their inception, conceptual, or idea-based phase.
Technical feasibility of the proposed technology should not yet be established.
Preliminary data are not required, but accepted if available.

Exclusion Criteria

Projects where the novelty resides solely in the biological or clinical question, not in the technical capability.
Use of existing technologies ready for validation without substantial further developmental efforts.
Instrumentation for whole-body or in vivo imaging.
Inclusion of clinical trials or toxicology studies beyond those needed to demonstrate technology capabilities.
Biomarker discovery or biomarker validation.
Development of probes or tagging agents for specific target molecules (generalizable probes are allowed).
Development of drugs or therapies.
Projects primarily focused on software/informatics solutions, database development, data mining, statistical tools, or computational/mathematical modeling, unless limited and directly supporting new device/method development.
Applications lacking quantitative performance measures.

Application Process

Application Process Timeline

Open Date (Earliest Submission): March 04, 2025
Letter of Intent Due Date: 30 days prior to the application due date (encouraged, not binding).
Application Due Dates:
- April 04, 2025, 5:00 PM local time of applicant organization.
- October 03, 2025, 5:00 PM local time of applicant organization.
Expiration Date for NOFO: October 04, 2025 (latest possible submission).
Earliest Start Date (for April 2025 submissions): December 2025
Earliest Start Date (for October 2025 submissions): July 2026
Review and Award Cycles:
- April 2025 submissions: Scientific Merit Review (July 2025), Advisory Council Review (October 2025).
- October 2025 submissions: Scientific Merit Review (February 2026), Advisory Council Review (May 2026).

Required Documentation & Materials

SF424(R&R) forms (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile).
Budget: R&R or Modular Budget (modular expected for domestic, R&R for foreign).
PHS 398 Cover Page Supplement.
PHS 398 Research Plan:
- Specific Aims: Must include a 'Statement of Potential Impact' subsection.
- Research Strategy: Must include subsections on 'Importance of Research', 'Rigor and Feasibility', and a dedicated 'Performance Measures' subsection.
Resource Sharing Plan.
Data Management and Sharing Plan (required regardless of direct costs).
Appendix: Limited materials allowed.
PHS Human Subjects and Clinical Trials Information (if applicable).
PHS Assignment Request Form.

Submission

Applications must be submitted electronically through Grants.gov.
Applicants must track status in eRA Commons.
No late applications will be accepted.

Post-Award Requirements

Annual Research Performance Progress Report (RPPR).
Annual financial statements (Federal Financial Report portion).
Final RPPR, invention statement, and expenditure data for closeout.
Required attendance at an annual meeting of funded investigators (2-3 days).

Evaluation Criteria

Overall Impact

Reviewers provide an overall impact score reflecting the likelihood of the project to exert a sustained, powerful influence on the research field.
An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Scored Review Criteria

Factor 1: Importance of the Research (Significance and Innovation)
- Assessment of new or improved technical capabilities.
- Focus on initial development and demonstration of highly novel technologies.
- Potential for substantial improvement over current approaches or addressing an unmet need in cancer research.
- High technical innovation, even with relatively high risk.
- Potential impact on cancer research or clinical care.
- Significance of the proposed work and how potential impact outweighs risks.
- Description of unmet technical need and anticipated use.
- Impact on health disparities and how new/exacerbated disparities will be addressed or mitigated.
Factor 2: Rigor and Feasibility (Approach)
- Assessment of the technical approach, including anticipated difficulties and workarounds.
- Quantitative Performance Measures: Evaluation of how appropriate, quantitative, and feasible the performance measures are to determine if aims are accomplished and key risks addressed.
  - Measures must be quantifiable and scientifically justified.
  - Assessment of whether achieving these measures establishes a useful tool for the research community.
  - Measures should define numerically described targets and the means of assessment.
  - Should address key risk factors for the project.
Factor 3: Expertise and Resources (Investigator(s) and Environment)
- Evaluation of the qualifications and experience of the PD(s)/PI(s) and other key personnel.
- Assessment of the institutional environment and resources available for the proposed research.

Additional Review Considerations (not scored, but influence overall impact)

Protections for Human Subjects: If applicable.
Vertebrate Animals: If applicable.
Biohazards: If applicable.
Resubmissions: Evaluation of the full application as presented.
Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity of resources.
Budget and Period of Support: Justification and reasonableness of the budget in relation to proposed research.

Compliance & Special Requirements

Regulatory Compliance

Compliance with NIH Grants Policy Statement and 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
Adherence to all applicable non-discrimination laws and submission of an Assurance of Compliance (HHS-690).
Compliance with federal statutes and regulations for federal financial assistance.

Data & Technology Standards

Data Management and Sharing: Required to comply with the NIH Policy for Data Management and Sharing.
Data Protection: For projects involving PII/PHI obtained from HHS, recipients must develop plans modeled after the NIST Cybersecurity framework.
Health IT: If award funding involves health IT implementation, acquisition, or upgrade, recipients must use health IT meeting standards in 45 CFR part 170, Subpart B, and if applicable, certified under the ONC Health IT Certification Program.

Project Specific Requirements

Clinical Trial Not Allowed: This NOFO specifically excludes applications proposing clinical trials.
Innovation: Projects must propose the early-stage development of highly innovative technologies and offer novel capabilities or substantial improvements.
Risk Tolerance: The grant supports high-risk projects, but applicants must justify how potential impact outweighs risks.
Quantitative Performance Measures: Applications must include clearly defined, quantifiable, and scientifically justified performance measures within the Research Strategy section. Applications lacking these will not be reviewed.
Biospecimen Focus: The technology must specifically focus on improving the quality or handling of biospecimen samples for cancer research/clinical care.
Annual Meeting: Investigators funded through this NOFO are required to attend an annual 2-3 day meeting.

Grant Details