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Grant Details

https://www.grants.gov/search-results-detail/356717

Grant Analysis

Purpose & Target

  • Core Objective: To accelerate the adoption and validation of molecular/cellular/imaging markers and assays for cancer detection, diagnosis, prognosis, monitoring, and prediction of response or resistance to treatment, as well as markers for cancer prevention and control. This grant is for clinical validation of established assays, not early-stage technology development or conduct of clinical trials.
  • Target Recipient Type and Size: Broad range of organizations including higher education, nonprofits, for-profit entities (small and other businesses), and various government entities. No specific size limitations beyond general organizational capacity.
  • SECTOR-SPECIFIC: Healthcare/Cancer Research
  • Geographic Scope: United States-based organizations. Foreign organizations are not eligible to apply, but foreign components of U.S. organizations are allowed.
  • Key Filtering Criteria: Applicant must have an assay(s) whose performance has been analytically validated in specimens similar to those for the intended clinical use. The project must not propose early-stage technology development or clinical trials.
  • Grant Frequency and Program Context: This is a reissuance of a previous funding opportunity (PAR-23-314), indicating it is a recurring program. It uses the UH3 Exploratory/Developmental Cooperative Agreement Phase II mechanism, which implies substantial Federal scientific or programmatic involvement post-award.

Financial Structure

  • Award Budget: Direct costs are limited to $250,000 per year.
  • Maximum Project Period: 3 years.
  • No specific total budget for the funding opportunity is provided, only per-award limits.
  • Cost Sharing: This NOFO does not require cost sharing.
  • Eligible Costs: All NIH awards are subject to the terms and conditions, cost principles outlined in the NIH Grants Policy Statement.
  • Ineligible Costs: Pre-award costs are only allowable as described in the NIH Grants Policy Statement Section 7.9.1.
  • Payment Mechanisms: Funds may be requested from the designated HHS payment system or office upon receipt of a Notice of Award (NoA).
  • Financial Reporting: Recipients are required to submit financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting, and a final Federal Financial Report for closeout.

Eligibility Requirements

Eligible Organizations
  • Higher Education Institutions: Public/State Controlled and Private Institutions of Higher Education
  • Nonprofits: With or without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • For-Profit Organizations: Small Businesses and Other For-Profit Organizations
  • Local Governments: State, County, City or Township, Special District, Indian/Native American Tribal Governments (Federally Recognized and 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.
Geographic Requirements
  • Primary Applicant: Must be a U.S. organization.
  • Foreign Organizations: Not eligible to apply.
  • Foreign Components: Allowed, as defined in the NIH Grants Policy Statement.
Assay Requirements
  • Existing Assay: Applicant must have an assay(s) that has been analytically validated within its intended clinical context of use. The assay(s) must be suitable for performing in a clinical trial/study after conversion to a clinical assay.
  • Clinical Laboratory: Assays intended for medical decision-making need to be performed in CLIA-certified laboratories. Assays for hypothesis/mechanism testing should conform to GLP or ISO 17025 standards.
Exclusions (Non-Responsive Applications - Will Not Be Reviewed)
  • Projects that propose to support clinical trials.
  • Applications that propose early-stage development of technologies/assay(s).
  • Applications with assay(s) where performance has not been analytically validated in specimens similar to those for the intended clinical use.
  • Projects focused on technology development for assays or biomarker discovery (e.g., those covered by IMAT or EDRN programs).

Application Process

Application Deadlines and Submission
  • Open Date (Earliest Submission Date): January 14, 2025
  • Application Due Dates (Latest): October 14, 2026 (5:00 PM local time of applicant organization).
  • All applications are due by 5:00 PM local time of applicant organization.
  • Submission Options: NIH ASSIST system, institutional system-to-system (S2S) solution, or Grants.gov Workspace.
  • Early submission is encouraged to allow time for corrections.
  • System Issues: Follow 'Dealing with System Issues' guidance if issues threaten on-time submission.
Required Registrations (Must be completed prior to application submission)
  • Applicant Organizations:
  • System for Award Management (SAM) active registration (requires annual renewal).
  • NATO Commercial and Government Entity (NCAGE) Code (for foreign organizations, though foreign organizations are ineligible to apply as primary applicants).
  • Unique Entity Identifier (UEI) (issued via SAM.gov registration).
  • eRA Commons registration (requires at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account).
  • Grants.gov registration (requires active SAM registration).
  • Program Directors/Principal Investigators (PD(s)/PI(s)):
  • Must have an eRA Commons account, affiliated with the applicant organization.
  • If PD/PI is also SO, two distinct eRA Commons accounts are needed.
Required Documentation and Materials
  • SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, R&R Budget, R&R Subaward Budget.
  • PHS 398 Cover Page Supplement.
  • PHS 398 Research Plan: Must include Specific Aims, Research Strategy (Background and Significance, Preliminary Data, Clinical Validation Phase Plan).
  • Resource Sharing Plan.
  • Data Management and Sharing Plan (required for all applications, regardless of direct costs).
  • Appendix: Limited materials allowed (e.g., blank questionnaires/surveys; no publications).
  • PHS Human Subjects and Clinical Trials Information (if applicable).
  • PHS Assignment Request Form.
Application Content Requirements
  • Research Strategy Sub-Sections:
  • Background and Significance: Define specific cancer-related problem, biologic/discovery rationale, potential impact.
  • Preliminary Data: Current state of assay development, analytical performance with human specimens, analytical validation metrics.
  • Clinical Validation Phase Plan: Optimization of analytical validation, definition of clinical endpoint, plan to accrue specimens, statistical power analysis, plan for clinical validation, plan to address regulatory requirements, identification of pitfalls/alternatives, metrics for UH3 phase.
Team Composition (Investigative Team should include)
  • Clinical Investigator: Defines clinical context, oversees assay incorporation into trials.
  • Clinical Laboratory Staff: Performs assay translation into clinical assays; needs awareness of GLP/ISO 17025 or CLIA-certification.
  • Statistician: Familiar with marker studies, especially for power calculations in UH3 phase.
  • Commercial Developer: Encouraged but not required for collaboration on distribution/commercialization.
Post-Award Requirements and Compliance
  • Annual Research Performance Progress Report (RPPR) and financial statements.
  • Final RPPR, invention statement, and expenditure data for closeout.
  • Data Management and Sharing Plan: Recipients must implement the approved plan.
  • Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval required for human subjects research.
  • Compliance with federal-wide and HHS-specific policy requirements (e.g., 2 CFR Part 200, NIH Grants Policy Statement).
  • Mandatory Disclosure: Report violations of federal criminal law (fraud, bribery, gratuity) affecting federal award.

Evaluation Criteria

Overall Impact
  • Reviewers will assess 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):
  • How well the project addresses a specific cancer-related problem.
  • Biological or discovery research rationale for the marker(s) and its importance.
  • Potential of the proposed marker(s) and assay(s) to affect the intended clinical context in treatment trials, prevention studies, or cancer control studies.
  • Factor 2. Rigor and Feasibility (Approach):
  • Current state of development of assays and their use in preclinical development.
  • Demonstrated analytical performance of assays with human specimens, including reagents, technologies, and specimen types.
  • Analytical validation metrics (Accuracy, Precision, Analytical sensitivity, Analytical specificity, Reportable range, Reference intervals, Standardization, Quality control).
  • Plan for additional optimization of analytical validation.
  • Plan to accrue specimens for clinical validation, including identification of clinical trial/study for specimens, documentation of availability, and pre-approvals.
  • Statistical power analysis for specimen numbers.
  • Plan for clinical validation within the intended clinical context.
  • Plan to address regulatory requirements for clinical trial/study integration.
  • Identification of potential pitfalls and alternative approaches.
  • Metrics for clinical validation to be achieved during the UH3 phase.
  • Factor 3. Expertise and Resources (Investigator(s) and Environment):
  • Multidisciplinary team composition, including Clinical Investigator(s), Clinical Laboratory Staff, and Statistician.
  • Expertise of clinical laboratory staff in GLP/ISO 17025 standards or CLIA-certification (as applicable).
  • Involvement of a statistician familiar with marker studies.
  • Resources available to perform the proposed work.
Additional Review Considerations (Not Scored, but Impact Overall Score)
  • Protections for Human Subjects.
  • Vertebrate Animals: Justifications for use, alternative models, interventions to minimize discomfort, euthanasia methods.
  • Biohazards: Evaluation of hazards and proposed protections.
  • Resubmissions/Renewals/Revisions: Evaluation of progress or proposed scope changes.
Additional Review Items (Not Scored, Do Not Impact Overall Score)
  • Authentication of Key Biological and/or Chemical Resources.
  • Budget and Period of Support: Justification and reasonableness relative to proposed research.
Funding Decisions Considerations
  • Scientific and technical merit (peer review).
  • Availability of funds.
  • Relevance to program priorities.

Compliance & Special Requirements

Regulatory Compliance
  • Assays for medical decision-making: Need to be performed in CLIA-certified laboratories.
  • Assays for hypothesis/mechanism testing: Should conform to GLP or ISO 17025 standards.
  • Required Registrations: SAM, UEI, eRA Commons, Grants.gov must be active.
  • IRB/IEC Approval: Required for protocols involving human subjects.
Data Protection and Sharing
  • Data Management and Sharing Plan: Required for all applications that generate scientific data, regardless of requested direct costs. Plan must be implemented as described upon approval.
Ethical Standards
  • Protections for Human Subjects: Evaluated during review.
  • Vertebrate Animals: Evaluation of procedures, justifications, and minimization of discomfort/pain.
Intellectual Property Policies
  • Recipients will retain custody of and primary rights to data and software developed, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
Risk Management and Security
  • Not explicitly detailed beyond general federal compliance, but implicitly addressed through compliance with GLP/ISO standards for laboratory work.
Unique Aspects / Cooperative Agreement
  • Funding Instrument: Cooperative Agreement (UH3 mechanism), indicating substantial Federal scientific or programmatic involvement by NIH staff during the project.
  • NIH Role: To support and stimulate recipient activities through partnership; not to assume direction or prime responsibility.
  • Recipient's Primary Responsibility:
  • Defining research objectives/approaches.
  • Determining experimental approaches, designing protocols, setting milestones.
  • Overseeing multidisciplinary teams.
  • Ensuring compliance with regulations (e.g., human subjects).
  • Adhering to NIH policies (IP, data release).
  • Submitting periodic updates/reports.
  • Participating in Steering Committee and regular teleconferences.
  • Attending annual Steering Committee meetings.
  • NIH Substantial Involvement (NCI Project Scientist(s)):
  • Providing input on experimental/clinical approaches, protocol design.
  • Advising on scientific, analytical, and clinical issues.
  • Assisting with regulatory and compliance issues.
  • Monitoring progress towards milestones.
  • Tracking participant accrual for clinical testing.
  • Stimulating interactions among recipients.
  • Contributing to publications if appropriate.
  • Joint Responsibility: Steering Committee (non-voting organizational body) for communication, coordination, and shared advice.
  • Dispute Resolution: Specific procedure outlined for disagreements between recipients and NIH.
Industry-Specific Compliance
  • Assays intended for medical decision-making must comply with CLIA certification standards.
  • Assays for research purposes should conform to GLP or ISO 17025 standards.

Grant Details

cancer biomarkers assays validation clinical studies molecular markers cellular markers imaging markers diagnosis prognosis treatment response pharmacodynamic markers toxicity markers oncology prevention cancer control laboratory science biotechnology research and development nih nci cooperative agreement uh3 analytical validation clinical validation medical research public health
Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed)
PAR-25-075
National Cancer Institute (NCI) / National Institutes of Health (NIH)
UNIVERSITY NGO SME ENTERPRISE PUBLIC OTHER
US
HEALTHCARE TECHNOLOGY OTHER
DEVELOPMENT EARLY_MARKET
OTHER
SDG3
FUNDING RESEARCH_DEVELOPMENT CAPACITY_BUILDING OPERATIONAL_SUPPORT
250000.00
250000.00
250000.00
USD
100.00
Oct. 14, 2026, 5 p.m.
March 2027 - May 2027