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Grant Analysis

Purpose & Target

Core Objective: This grant aims to support extramural research focused on investigating and mitigating challenges in clinical assay development and validation. The primary goal is to address preanalytical variability in various biospecimens (e.g., tumor tissue biopsies, liquid biopsies, bodily fluids) to achieve evidence-based standardization of biopsy handling practices.
Target Recipient Type and Size: Eligible applicants include a wide range of organizations from higher education institutions and non-profits to for-profit businesses (small and large), and various governmental entities. There are no explicit organizational size limitations, but applicants must demonstrate capacity for multidisciplinary research.
SECTOR-SPECIFIC: This grant is specifically focused on the HEALTHCARE sector, particularly in the area of cancer research, diagnostics, and biospecimen science.
Geographic Scope: The grant is open to both domestic (U.S.) and non-domestic (non-U.S.) entities, making it a global opportunity for eligible organizations.
Key Filtering Criteria: Ideal applicants will be conducting research on preanalytical variability, not developing new technologies or undertaking biomarker discovery. Projects must relate to clinical assay development and validation, and clearly demonstrate relevance to cancer clinical problems.
Grant Frequency and Program Context: This is a recurring funding opportunity, listed as a reissue of PAR-22-049, with multiple application deadlines extending through September 2027. It uses a Cooperative Agreement (U01) activity code, signifying substantial programmatic involvement from the National Institutes of Health (NIH).

Financial Structure

Award Budget: Application budgets are limited to $250,000 direct costs per year.
Total Funding Available: The total number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications; a specific overall budget for the call is not stated.
Cost Sharing: This Notice of Funding Opportunity (NOFO) does not require cost sharing.
Eligible Costs: All awards are subject to the terms and conditions and cost principles described in the NIH Grants Policy Statement. Pre-award costs are allowable as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.
Financial Reporting Requirements: Recipients must submit the Research Performance Progress Report (RPPR) annually. Financial statements are required for closeout, including the expenditure data portion of the Federal Financial Report.

Eligibility Requirements

Eligible Organization Types

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 For-Profit Organizations (Other than Small Businesses).
Local Governments: State, County, City or Township, Special District, and Indian/Native American Tribal Governments (Federally Recognized and Other).
Federal Governments: Eligible Agencies of the Federal Government and 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) are eligible to apply, including non-domestic components of U.S. Organizations. Foreign components are allowed.

Required Registrations and Certifications

Applicant organizations must complete and maintain active registrations in:
- System for Award Management (SAM), requiring annual renewal.
- Unique Entity Identifier (UEI), issued via SAM.gov.
- NATO Commercial and Government Entity (NCAGE) Code for foreign organizations.
- eRA Commons, with at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
- Grants.gov (requires active SAM registration).
Program Directors/Principal Investigators (PD/PIs) must have an eRA Commons account and affiliate it with the applicant organization.

Scope Limitations and Exclusions

Clinical Trial Not Allowed: This funding opportunity specifically excludes applications that propose clinical trials.
Non-responsive Applications (will not be funded):
- Technology development projects for novel biospecimen fixatives/technologies (these are supported by the NCI Innovative Molecular Analysis Technologies (IMAT) program).
- Biomarker discovery projects.
- Projects related to early detection biomarker assays.
- Projects related to global cancer genomic/proteomic studies.

Organizational Structure and Capacity

Applications should demonstrate the ability to perform preanalytical, analytical, and clinical validation of assays.
Proposed research should be conducted by a 'collaborative, interdisciplinary network' of 'multidisciplinary scientific teams' (e.g., pathologists, oncologists, radiologists, molecular biologists, statisticians).
Applicant organizations may submit more than one application, provided each is scientifically distinct.

Application Process

Application Timeline and Deadlines

Latest Application Due Date: September 10, 2027, by 5:00 PM local time of the applicant organization. There are multiple earlier due dates as well.
Letter of Intent (LOI) Due Date: Encouraged 30 days prior to the application due date (not binding).
Earliest Start Date: For applications due Sept 10, 2027, the earliest start date is July 2028.

Application Procedure and Submission

Submission Platforms: Applications must be submitted electronically through one of the following:
- NIH ASSIST system.
- Institutional system-to-system (S2S) solution.
- Grants.gov Workspace.
Required Documentation:
- SF424(R&R) Cover and associated forms (Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, R&R or Modular Budget, R&R Subaward Budget).
- PHS 398 Cover Page Supplement.
- PHS 398 Research Plan: Must include Specific Aims (with relevance to NOFO objectives), a detailed Research Strategy (Overview, Study Design with statistical justification).
- Resource Sharing Plan.
- Data Management and Sharing Plan (required for all applications, regardless of direct costs).
- PHS Human Subjects and Clinical Trials Information form (if human subjects involved).
Page Limitations: All page limitations specified in the How to Apply-Application Guide and Table of Page Limits must be followed.
Submission Guidance: Applicants are strongly encouraged to submit early to allow time for corrections. Applications must comply with all instructions in the Application Guide and the NOFO; non-compliant applications may be delayed or not accepted.

Grant Duration and Reporting

Grant Duration: The maximum project period for an award is 5 years.
Reporting Obligations:
- Annual Research Performance Progress Report (RPPR).
- Final RPPR, invention statement, and expenditure data for closeout.
- Quarterly updates on human subject and accrual reports (for recipients).

Application Assistance

eRA Service Desk: For system questions (ASSIST, eRA Commons, errors, warnings), call 301-402-7469 or 866-504-9552 (Toll Free), or submit a web ticket.
General Grants Information (NIH): For application instructions and processes, email [email protected] or call 301-480-7075.
Grants.gov Customer Support: For registration and Workspace issues, call 800-518-4726 or email [email protected].
Scientific/Research Contacts: Several NCI contacts are listed for scientific inquiries.
Financial/Grants Management Contact: One NCI contact is listed for financial inquiries.

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 These factors contribute to the overall impact score and receive separate factor scores: - Factor 1. Importance of the Research (Significance and Innovation): - Potential to substantially improve the reliability of specific, clinically relevant biomarker assays. - Potential to improve understanding of how biopsy collection, processing, and storage procedures affect analytical performance for current and emerging clinical biomarkers. - Clear definition of the study's context and biomarkers in current clinical trials. - Significance of the proposed studies and the unmet clinical need addressed. - Evidence suggesting proposed preanalytical factors are problematic for biomarker assays and that improvement strategies can be identified. - How results will advance and contribute to expediting clinical biomarker assay development through evidence-based standardization. - Factor 2. Rigor and Feasibility (Approach): - Clear objectives and unambiguous scientific goals/hypotheses. - Assessment of analytical performance characteristics (specificity, sensitivity, precision) in the context of specific preanalytical conditions. - How results contribute new knowledge in biospecimen science and advance clinical biomarker assay development. - Statistical justification for the study design (specimen numbers, biomarker evaluations, statistical power, precision, probability of effect detection). - Focus on biospecimen preanalytical variability in small tumor tissue and liquid biopsies. - How the proposed biomarker assay(s) will advance/improve a significant cancer clinical problem and help patient diagnosis, prognosis, or treatment. - Factor 3. Expertise and Resources (Investigator(s) and Environment): - Ability of the applicant's team to perform preanalytical, analytical, and clinical validation of assays. - Multidisciplinary scientific teams (e.g., pathologists, oncologists, radiologists, molecular biologists, statisticians) with expertise in clinical medicine, biospecimen procurement, biology, technology platforms, experimental design, and analysis. Additional Review Criteria (Considered, but not scored)

Protections for Human Subjects: Appropriateness of proposed protections.
Vertebrate Animals: Appropriateness of proposed use.
Biohazards: Management plans.
Resubmissions, Renewals, Revisions: Appropriateness of the proposed expansion of the scope of the project, as applicable.

Additional Review Considerations (Considered, but not scored)

Authentication of Key Biological and/or Chemical Resources: Validity of plans for identifying and ensuring resource validity.
Budget and Period of Support: Justification and reasonableness in relation to the proposed research.

Compliance & Special Requirements

Regulatory Compliance

Adherence to all provisions of the NIH Grants Policy Statement, 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards), and other HHS, PHS, and NIH grant administration policies.
Compliance with all applicable nondiscrimination laws, requiring submission of an Assurance of Compliance (HHS-690).
Recipients must ensure protocols involving human subjects are reviewed by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).

Data Protection and Management

Data Management and Sharing Plan: Required for all applications, consistent with the 2023 NIH Policy for Data Management and Sharing. Recipients must implement the approved plan.
Cybersecurity: Recipients handling HHS-owned information or sensitive data (PII/PHI) must develop plans and procedures modeled after the NIST Cybersecurity framework.

Intellectual Property

Recipients retain custody of and primary rights to data, technologies, and software developed under the awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

Industry-Specific Compliance

Health IT: If funding involves implementing, acquiring, or upgrading health IT, it must meet standards and implementation specifications adopted in 45 CFR part 170, Subpart B. If for eligible clinicians in ambulatory settings or hospitals, use health IT certified under the ONC Health IT Certification Program.

Unique Aspects and Collaboration

Cooperative Agreement (U01): This mechanism signifies 'substantial Federal scientific or programmatic involvement' from NIH. NIH staff (Project Scientists) will assist, guide, coordinate, and participate in project activities, acting in a partnership role, not a dominant one. Recipients retain primary responsibility for the project.
Steering Committee: A Steering Committee will be formed, including PIs, NCI Project Scientist(s), and other scientific experts (potentially FDA and NIST scientists, and a patient advocate). This committee will establish policies and procedures for collaborative projects, set research priorities, and contribute to evidence-based best practices.
Multidisciplinary Teams: The NOFO emphasizes the need for multidisciplinary teams to address complex biospecimen science challenges effectively.

Risk Management

The core research objective is to identify and mitigate preanalytical variability, which directly relates to managing risks in clinical assay development and reproducibility.

Exclusions and Non-responsive Research

As stated in eligibility, projects constituting clinical trials are explicitly not allowed. Also excluded are technology development for novel fixatives, biomarker discovery, early detection biomarker assays, or global cancer genomic/proteomic studies.

Grant Details