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Grant Analysis

Purpose & Target

Core Objective: Validate molecular/cellular/imaging markers and their assays for cancer detection, diagnosis, prognosis, monitoring, prediction of response/resistance to treatment, and for cancer prevention/control, specifically for use in NCI-supported clinical trials/studies.
Target Recipient Type: Investigator-initiated research from Higher Education Institutions, Non-profits, For-Profit Organizations (including Small Businesses), Local Governments, Federal Governments, and other specified organizations.
Target Recipient Size: Not explicitly defined by size, but by expertise and capacity for multidisciplinary collaboration.
Designation: SECTOR-SPECIFIC
Geographic Scope: U.S. organizations only; foreign components allowed in projects but not as lead applicants.
Key Filtering Criteria: Focus on cancer; assay validation (not discovery or clinical trial); existing assays that work on human samples; U.S. applicant.
Grant Frequency: Recurring (reissue of PAR-23-313), with multiple application due dates until October 2026.
Program Context: This opportunity addresses the need for analytically and clinically validated assays for NCI-supported cancer treatment, control, or prevention trials, with substantial NCI scientific involvement through a cooperative agreement.

Financial Structure

Award Budget (Direct Costs):
- UH2 phase: up to $275,000 for the entire 2-year phase, with no more than $200,000 requested in any one year.
- UH3 phase: up to $250,000 per year for up to 3 years.
Total potential direct costs: Up to $1,025,000 (UH2 max $275,000 + UH3 max $250,000 * 3 years).
Currency: USD
Matching Fund Requirement: None.
Co-financing Requirement: None.
Eligible Costs: 'Direct costs' (as defined by NIH Grants Policy Statement) are eligible.
Ineligible Costs: Not explicitly detailed beyond the scope exclusions (e.g., clinical trials, early-stage technology development).
Payment Mechanisms: Not detailed, but implies periodic disbursements based on cooperative agreement and annual reporting.
Financial Reporting: Annual 'Research Performance Progress Report (RPPR)' and financial statements are required. A final RPPR, invention statement, and expenditure data are required for closeout.
Audit Requirements: Subject to '2 CFR Part 200', Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
Indirect Cost Policies: Not explicitly stated, but standard NIH Grants Policy Statement practices for indirect costs would apply.
Financial Guarantees: None specified.

Eligibility Requirements

Organizational Type & Legal Structure

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/Township, Special District, Indian/Native American Tribal (Federally Recognized, Other than Federally Recognized))
Federal Governments (Eligible Agencies of the Federal Government, U.S. Territory or Possession)
Other Organizations (Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations)

Geographic Requirements

Applicant organization must be a U.S. entity.
Non-domestic (non-U.S.) Entities are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed within a U.S. lead application.

Capacity & Experience

Applicants must have 'working assay(s) using human specimens'.
Must propose projects focused on validation of assays, not early-stage technology development or biomarker discovery.
Team must include a clinical investigator, clinical laboratory staff, and a statistician.
Clinical laboratory staff should be aware of 'Good Laboratory Practices (GLP)' or 'ISO 17025' standards; if assays are for medical decision-making, they must be performed in 'CLIA-certified laboratories'.

Registration & Compliance

Must complete and maintain active registration with 'System for Award Management (SAM)' (requires annual renewal).
Must have a 'Unique Entity Identifier (UEI)'.
Must register with 'eRA Commons' and have at least one 'Signing Official (SO)' and one 'Program Director/Principal Investigator (PD/PI)' account.
Must register with 'Grants.gov'.
All PD/PIs must have an 'eRA Commons' account.

Exclusion Criteria

Applications proposing to support clinical trials are non-responsive.
Applications proposing early-stage development of technologies/assays are non-responsive.
Applications with assays not demonstrated to work on human samples are non-responsive.
Projects focused on technology development for assays or biomarker discovery (e.g., Innovative Molecular Analysis Technologies Program (IMAT) or Early Detection Research Network (EDRN) scope) are non-responsive.

Application Process

Application Deadlines & Timeline

Latest Application Due Date: October 14, 2026 by 5:00 PM local time of applicant organization. Other due dates include February 14, 2025; June 11, 2025; October 15, 2025; February 13, 2026; June 10, 2026.
Expiration Date of NOFO: October 15, 2026.
Earliest Start Date: Varies by application due date, ranging from December 2025 (for Feb 2025 due date) to July 2027 (for Oct 2026 due date).
Project Period: Initial UH2 phase must not exceed 2 years; second UH3 phase must not exceed 3 years. Total project period up to 5 years.
Review Process Timeline: Scientific Merit Review typically occurs approximately 5 months after the application due date, followed by Advisory Council Review approximately 7 months after the application due date.

Submission Process & Materials

Application Package Access: Must be accessed through the 'NIH ASSIST system', 'Grants.gov Workspace', or an institutional 'system-to-system (S2S) solution'.
Required Registrations (prior to submission): 'System for Award Management (SAM)' (including 'Unique Entity Identifier (UEI)'), 'eRA Commons', and 'Grants.gov'. These registrations can take 6 weeks or more.
Required Forms: Standard 'SF424(R&R)' forms (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 Human Subjects and Clinical Trials Information' (if applicable), and 'PHS Assignment Request Form'.
Required Content in Research Plan:
- 'Specific Aims': Clearly state overall goals and separate Specific Aims for the UH2 and UH3 phases.
- 'Research Strategy': Must include 'Background and Significance', 'Preliminary Data', and 'Approach' (divided into UH2 Analytical Validation Phase and UH3 Clinical Validation Phase).
- 'Milestones and Timeline': A detailed timeline (Gantt chart) with clear, quantitative, objective criteria for 'go/no-go' decision points for both phases, especially for transition from UH2 to UH3.
Additional Plans: 'Resource Sharing Plan' and a 'Data Management and Sharing Plan' are required.
Appendix: Only limited materials are allowed, specifically blank questionnaires or blank surveys. No publications or other material may be included.
Submission Tracking: Applicants are responsible for tracking their application status in 'eRA Commons' and correcting any errors prior to the due date.

Support & Assistance

'eRA Service Desk': Provides assistance with system questions (ASSIST, eRA Commons, application errors). Toll-free: 1-866-504-9552 (Press 1), Phone: 301-402-7469 (Press 1).
'General Grants Information': For questions on application instructions and processes. Email: [email protected], Phone: 301-480-7075.
'Grants.gov Customer Support': For registration and Workspace assistance. Phone: 800-518-4726.
Specific 'Scientific/Research Contacts' at NCI are available for inquiries related to different research areas (response/resistance, companion diagnostics, screening/early detection, epidemiology/population science).
'Peer Review Contact' and 'Financial/Grants Management Contact' information is also provided.

Post-Award & Reporting

Annual 'Research Performance Progress Report (RPPR)' and financial statements are required.
A final RPPR, invention statement, and expenditure data are necessary for grant closeout.
Recipient institutions must ensure that protocols are reviewed and approved by their 'Institutional Review Board (IRB)' or 'Independent Ethics Committee (IEC)'.

Evaluation Criteria

Overall Impact

Reviewers will assess the likelihood for the project to exert a sustained, powerful influence on the research field(s).
The potential of the proposed project to validate or harmonize assays/markers for a specific cancer-related clinical context is essential and a main factor in assessing overall merit.

Scored Review Criteria

Factor 1: Importance of the Research (Significance and Innovation): Evaluates the significance of the cancer-related problem addressed, biologic/discovery rationale for the marker(s), potential for affecting the intended clinical context (treatment, prevention, control), and appropriateness of specimen type and assay use.
Factor 2: Rigor and Feasibility (Approach): Assesses the clarity and comprehensiveness of the plan for analytical validation (including accuracy, precision, sensitivity, specificity, reportable range, reference intervals, standardization, quality control), plan for obtaining well-annotated human specimens, evaluation of marker stability, addressed regulatory issues, and the clinical validation plan (including clinical endpoint definition, association of assay results with endpoint, statistical power analysis, and additional optimization). Also evaluates the presence of well-defined, quantitative milestones and a detailed timeline (Gantt chart) for both UH2 and UH3 phases, including the transition between phases.
Factor 3: Expertise and Resources (Investigator(s) and Environment): Reviews the qualifications and experience of the multidisciplinary team (clinical investigator, clinical laboratory staff, statistician, and commercial developer if applicable) and the adequacy of facilities and resources for analytical and clinical validation.

Additional Review Criteria (Considered, but not scored)

Protections for Human Subjects: Justification for involvement, proposed protections, potential benefits, importance of knowledge, data and safety monitoring, and justification for exemption if applicable.
Vertebrate Animals: Justification for animal use versus alternatives, appropriateness of species, interventions to minimize discomfort, and justification for euthanasia method.
Biohazards: Assessment of hazardous materials/procedures and proposed protections.
Resubmissions: Evaluation of the full application as presented.
Renewals: Evaluation of progress made in the last funding period (Not Applicable for this NOFO).

Additional Review Considerations (Considered, but not scored)

Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring the validity of these resources.
Budget and Period of Support: Evaluation of whether the budget and requested period are fully justified and reasonable in relation to the proposed research.

Compliance & Special Requirements

Regulatory & Ethical Compliance

'Human Subjects': Research involving human subjects must comply with '45 CFR Part 46', and recipient institutions must ensure protocols are reviewed by their 'Institutional Review Board (IRB)' or 'Independent Ethics Committee (IEC)'.
'Clinical Laboratory Standards': Assays used for medical decision-making need to be performed in 'CLIA-certified laboratories'. Assays for testing postulates or mechanisms should conform to 'GLP' (Good Laboratory Practices) or 'ISO 17025' standards. Clinical laboratory staff should be aware of 'Westgard rules'.
'FDA Requirements': Applicants must address potential regulatory requirements, including the need for an 'Investigational Device Exemption (IDE)' from the FDA for assays integrated into clinical trials.
'Data Protection & Sharing': Recipients are required to adhere to the '2023 NIH Policy for Data Management and Sharing' and submit a comprehensive 'Data Management and Sharing Plan'.
'Mandatory Disclosures': Recipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity that could affect the federal award.
'Federal Regulations': All awards are subject to '2 CFR Part 200' (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards) and the 'NIH Grants Policy Statement'.

Unique Programmatic Aspects (Cooperative Agreement)

'Substantial Federal Involvement': This is a 'Cooperative Agreement', meaning NIH/NCI staff ('Project Scientist') will have substantial programmatic involvement beyond normal stewardship, assisting and guiding project activities.
'Recipient Responsibility': While NIH is involved, recipients retain the primary responsibility for defining overall research objectives, experimental approaches, designing protocols, setting milestones, and ensuring scientific rigor and compliance.
'Joint Responsibility': A 'Steering Committee', composed of recipient representatives and NCI Project Scientists, will facilitate communication, coordination, and shared advice among funded projects.
'Intellectual Property': Recipients retain custody and primary rights to data and software developed under these awards, subject to Government rights of access.
'Project Progression': Transition from the UH2 phase (analytical validation) to the UH3 phase (clinical validation) is contingent upon meeting proposed milestones and NCI administrative review. NCI reserves the right to terminate or curtail any individual award, including the UH3 phase, if insufficient progress towards milestones is observed.

Strategic & Contextual Information

'Project Focus': This NOFO is specifically intended for the validation of assays to the point where they can be integrated into future clinical trials/studies as investigational assays; it does not support the conduct of clinical trials themselves.
'Technology Readiness': Applicants must have 'existing assays' that work on human samples. Technologies used should be already in use or soon to be approved for clinical laboratories; this is not a technology development NOFO.
'Imaging Definition': In the context of this NOFO, 'imaging' refers to in vitro modalities (e.g., microscopy), and specifically excludes clinical radiology (e.g., PET or MRI).
'Commercialization': Plans for collaboration with a commercial partner who can support the distribution and commercialization of the assays are encouraged but not required, contributing to the assay's sustainability.

Grant Details