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Grant Analysis

Purpose & Target

Core Objective: To facilitate well-planned clinical trials across the cancer prevention and control spectrum by supporting studies that acquire critical data to complete the protocol of a full-scale multi-center Phase II or later phase trial.
Target Recipient Type and Size: Open to a wide range of organizations including higher education institutions, nonprofits (both 501(c)(3) and others), for-profit organizations (including small businesses), local and federal governments, and non-domestic (foreign) entities. There are no explicit size restrictions, focusing on organizational capacity for clinical research planning.
SECTOR-SPECIFIC: This grant is SECTOR-SPECIFIC, focusing exclusively on cancer prevention and control clinical trials and related research activities.
Geographic Scope: Worldwide, as non-domestic (non-U.S.) entities are eligible to apply.
Key Filtering Criteria: The grant is for planning activities for future clinical trials, not for conducting full trials or early-stage mechanistic research. Applicants must have preliminary efficacy or effectiveness data for the future intervention already in existence. Proposals must include a detailed milestone plan and a description of the future clinical trial.
Grant Frequency and Program Context: This is a recurring funding opportunity with multiple application due dates extending through October 2027, reissued from a previous program (PAR-22-174). It is a U34 Planning Cooperative Agreement, intended to fill a gap in the NCI's funding mechanisms by supporting preparatory studies for robust clinical trials.

Financial Structure

Award Type: Cooperative Agreement (U34).
Min/Max Funding: Applications are limited to $225,000 in direct costs per year. The maximum direct costs over the 3-year project period are:
$450,000 without a clinical trial.
$600,000 with a pilot/feasibility clinical trial.
Currency: USD.
Funding Rate: The grant covers eligible direct costs up to the specified limits; no specific funding rate percentage is provided, but it's full coverage of approved direct costs within limits.
Matching Funds/Co-financing: Cost sharing is not required.
Eligible Costs: Pre-award costs are allowable as described in the NIH Grants Policy Statement.
Financial Reporting: Recipients are required to submit annual financial statements and a final Federal Financial Report.

Eligibility Requirements

Organizational Eligibility

Eligible Organization Types:
Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (501(c)(3) IRS Status and others)
For-Profit Organizations (Small Businesses, Other For-Profit)
Local Governments (State, County, City, Township, Indian/Native American Tribal - Federally Recognized and Other)
Federal Governments (Eligible Agencies, U.S. Territory or Possession)
Other: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations, Non-domestic (non-U.S.) Entities (Foreign Organizations).
Geographic Location Requirements: Open to domestic (U.S.) and non-domestic (non-U.S.) entities, including foreign organizations and foreign components of U.S. organizations.

Registration Requirements

Applicant Organizations: Must complete and maintain active registrations prior to application submission.
System for Award Management (SAM.gov): Requires annual renewal. Includes assignment of a Unique Entity Identifier (UEI).
NATO Commercial and Government Entity (NCAGE) Code: Required for foreign organizations to register in SAM.
eRA Commons: Requires registration for the organization and at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI).
Grants.gov: Requires active SAM registration.
Program Directors/Principal Investigators (PD/PIs): Must have an eRA Commons account, affiliated with the applicant organization.

Project Specific Eligibility

Project Scope: Must propose studies for the acquisition of data critical to completing the protocol of a full-scale multi-center Phase II or later phase clinical trial.
Preliminary Data: Preliminary efficacy or effectiveness data to justify the future intervention trial must exist at the time of application.
Required Documents: Applications must include a detailed Milestone Plan and a Future Clinical Trial Description.

Exclusion Criteria

Non-Responsive Applications: Applications will not be reviewed if they are:
First-in-human studies.
Only propose to write a protocol or manual, develop infrastructure, or implement an already fully designed trial.
Include purely mechanistic work or animal studies.
Lack a milestone plan or a future clinical trial description.
For an intervention without preliminary efficacy or effectiveness data.

Application Process

Application Submission

Application Deadlines: Multiple cycles are available, with the latest application due date being October 25, 2027, by 5:00 PM local time of the applicant organization. If a due date falls on a weekend or federal holiday, the deadline is automatically extended to the next business day.
Letter of Intent: Although not required or binding, it is encouraged and due 30 days prior to the application due date.
Submission Platforms: Applications must be submitted electronically through the NIH ASSIST system, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
Submission Process: Applicants are encouraged to submit early to allow time for correcting any errors identified during the submission process.

Required Documentation and Materials Applicants must follow the instructions in the Research (R) Instructions of the 'How to Apply - Application Guide', supplemented by this NOFO's specific instructions: - SF424(R&R) Forms: Includes Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, R&R or Modular Budget, and R&R Subaward Budget (if applicable). - Milestone Plan: A separate attachment (filename 'Milestone Plan.pdf', max 2 pages) detailing necessary planning activities, timelines, and measurable, realistic milestones. - Future Clinical Trial Description: A separate attachment (filename 'Future Clinical Trial Description.pdf', max 3 pages) providing context for the future clinical trial, distinct from any pilot/feasibility trial during the U34 period. - PHS 398 Forms: Includes Cover Page Supplement and Research Plan. - Research Plan: Must address both planning activities and the future trial, covering significance, detailed future trial design (e.g., objectives, population, endpoints, sample size), statistical methods, pilot/feasibility trial metrics, potential problems, stakeholder engagement, and organization/management. - Letters of Support: Required for planning activities, consortium/site participants, and any co-funding or in-kind support. - Resource Sharing Plan: Required for all applications. - Data Management and Sharing Plan: Required for all applications that generate scientific data. - Appendix: Limited to blank questionnaires or blank surveys. - PHS Human Subjects and Clinical Trials Information: Required if human subjects are involved, including a Recruitment and Retention Plan, Study Timeline (for the planning study), and Statistical Design and Power (for the planning study). - PHS Assignment Request Form. Post-Award Requirements

Annual Reporting: Recipients are required to submit a Research Performance Progress Report (RPPR) annually.
Project Closeout: A final RPPR, an invention statement, and the expenditure data portion of the Federal Financial Report are required for award closeout.
Milestone Achievement: Future year funding is contingent upon the satisfactory achievement of performance milestones.

Evaluation Criteria

The evaluation process assesses the scientific and technical merit of applications, with an overall impact score reflecting the likelihood of the project's sustained influence on the research field. Scored Review Criteria Reviewers assign separate criterion scores for these factors, which contribute to the overall impact score: - Importance of the Research (Significance and Innovation): Evaluation of the importance of the problem being studied, the need for the future trial, and the potential impact of its results. - Rigor and Feasibility (Approach): Assessment of the soundness of the proposed planning activities, including sufficient detail of the future clinical trial, statistical methods, pilot/feasibility trial metrics, potential problems, alternative strategies, and benchmarks for success. - Expertise and Resources (Investigator(s) and Environment): Evaluation of the skills, knowledge, and resources of the PD(s)/PI(s) and the adequacy of the institutional and collaborative environment to conduct the proposed planning activities. Additional Review Considerations (not scored, but influence overall impact)

Milestone Plan: Reviewers evaluate if proposed milestones are appropriate, measurable, realistic, and feasible for the planning work, including specific milestones for network requirements.
Letters of Support: Assessment of letters from key leaders, investigators, and stakeholders to ensure sufficient engagement, effort, resources, and space for the proposed planning activities.
Study Timeline: For planning studies involving clinical trials, reviewers assess the detailed, feasible, and justified timeline, including start-up activities, anticipated enrollment rates, and follow-up. Consideration is given to efficiency, use of existing resources, and contingency plans for challenges.
Inclusion of Women, Minorities, and Individuals Across the Lifespan: For human subjects research, plans for inclusion (or justification for exclusion) are evaluated for scientific goals and research strategy.
Authentication of Key Biological and/or Chemical Resources: For projects involving these resources, proposed plans for validity are considered.
Budget and Period of Support: Evaluation of whether the requested budget and project duration are fully justified and reasonable in relation to the proposed research.

Compliance & Special Requirements

Regulatory Compliance

Federal Regulations: All awards are subject to the NIH Grants Policy Statement, 2 CFR Part 200 (Uniform Administrative Requirements), and relevant sections of the Public Health Service Act (42 USC 241 and 284), 42 CFR Part 52, and other applicable federal statutes.
Nondiscrimination: Recipients must comply with all applicable nondiscrimination laws, demonstrated by registering in SAM.gov and submitting an Assurance of Compliance (HHS-690).
Mandatory Disclosures: Recipients must disclose information related to violations of federal criminal law involving fraud, bribery, or gratuity that could affect the federal award.

Clinical Trial and Human Subjects Requirements

ClinicalTrials.gov Registration: If an award involves applicable clinical trials, the 'responsible party' must register and submit results information on ClinicalTrials.gov. NIH expects registration and reporting for all trials.
IRB/IEC Approval: Recipient institutions must ensure all protocols are reviewed and approved by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Data and Safety Monitoring: All NIH-supported human biomedical and behavioral intervention studies require oversight and monitoring to ensure participant safety and data integrity.
Investigational New Drug (IND)/Investigational Device Exemption (IDE): Compliance with FDA requirements for clinical research involving investigational products.

Data Management and Intellectual Property

Data Management and Sharing Plan: Required for all applications generating scientific data and must be implemented as approved.
Data Rights: Recipients retain custody of and primary rights to data and software developed under these awards, subject to Government rights of access consistent with DHHS, PHS, and NIH policies.

Cooperative Agreement Specifics

Substantial NIH Programmatic Involvement: Unlike standard grants, this cooperative agreement involves significant NIH staff participation (e.g., Project Scientists, Program Official) in project activities, including ensuring scope alignment, scientific guidance, managing issues, facilitating collaborations, negotiating milestone compliance, and reviewing regulatory compliance.
Recipient Responsibility: While NIH has substantial involvement, the recipient retains the dominant role and prime responsibility for the project.
Network Compliance: Recipients must comply with the guidelines and standard operating procedures of the network through which future trials will be conducted.
Dispute Resolution: A specific dispute resolution procedure is in place for scientific or programmatic disagreements between recipients and NIH within the award's scope.

Performance and Accountability

Milestone Contingency: Future year support is contingent on satisfactory achievement of negotiated performance milestones. Underperformance may lead to remedial plans, increased monitoring, or other actions, including budget reduction or award withholding.

Grant Details