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Grant Analysis

Purpose & Target

This grant supports basic research into the biological and genetic causes and mechanisms of cancer health disparities.
It targets investigators and organizations engaged in early-stage exploratory projects, pilot studies, and feasibility studies.
This grant is SECTOR-SPECIFIC for cancer research and health disparities.
The geographic scope includes organizations within the US and Non-U.S. Entities (Foreign Organizations).
Key filtering criteria: Focus on basic research, cancer health disparities, no clinical trials allowed, and specific inclusion of race/ethnicity variables.
This is a recurring grant opportunity, reissued to align with agency priorities.

Financial Structure

The combined direct costs for the two-year project period may not exceed $275,000.
No more than $200,000 may be requested in any single year.
This NOFO does not require cost sharing.
Pre-award costs are allowable as described in the NIH Grants Policy Statement.
Recipients are required to submit Research Performance Progress Reports (RPPR) annually and financial statements (Federal Financial Report) for closeout.
All NIH awards are subject to the terms and conditions, cost principles, and audit requirements described in the NIH Grants Policy Statement and 2 CFR Part 200.

Eligibility Requirements

Eligible Organizations

Higher Education Institutions: Public/State Controlled, Private.
Nonprofits: Both with and without 501(c)(3) IRS Status.
For-Profit Organizations: Small Businesses and other For-Profit Organizations.
Local Governments: State, County, City or Township, Special District, Indian/Native American Tribal (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, Non-domestic (non-U.S.) Entities (Foreign Organizations).

Specific Qualifications & Registrations

Applicants must complete and maintain active registrations in: System for Award Management (SAM), Unique Entity Identifier (UEI), eRA Commons, and Grants.gov.
Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code in addition to SAM.
Principal Investigators (PD/PIs) must have an eRA Commons account and affiliate with the applicant organization.
Registrations can take 6+ weeks and must be completed prior to application submission.

Geographic Requirements

Open to organizations based in the US.
Non-domestic (non-U.S.) Entities (Foreign Organizations) are explicitly eligible to apply and receive funding.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible.
Foreign components, as defined by NIH, are allowed.

Exclusions

Studies that do not propose cancer health disparity research are non-responsive.
Studies investigating age and/or sex disparities in the absence of race/ethnicity variables are not solicited.
Behavioral, social, environmental, or community/population-based studies that do not incorporate biological mechanisms in their specific aims are non-responsive.
Long-term projects or projects designed to increase knowledge in a well-established area are not suited for the R21 mechanism.
Projects of limited cost or scope that use widely accepted approaches and methods within well-established fields are not suited for this R21 mechanism.

Application Process

Application Process & Submission

Applications must be submitted electronically via NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
Required registrations (SAM, UEI, eRA Commons, Grants.gov) must be completed before submission.
All applications are due by 5:00 PM local time of the applicant organization.
Applicants are encouraged to apply early to allow time for corrections.

Key Dates & Deadlines

Open Date (Earliest Submission Date): January 16, 2025
Latest Application Due Date (for New applications): October 16, 2027
Latest Application Due Date (for Renewal / Resubmission / Revision): November 16, 2027, by 5:00 PM local time.
Expiration Date: November 17, 2027
If a submission date falls on a weekend or Federal holiday, the deadline is automatically extended to the next business day.

Required Documentation & Materials

SF424(R&R) forms (Cover, 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, including:
- Research Strategy (clearly describing Importance of Research, Rigor & Feasibility, Expertise & Resources)
- 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 are involved)
PHS Assignment Request Form
Only limited Appendix materials are allowed (e.g., blank questionnaires, blank surveys); no publications or other materials.

Project Implementation & Reporting

The total project period may not exceed 2 years.
Research Performance Progress Reports (RPPR) are required annually.
A final RPPR, invention statement, and expenditure data (Federal Financial Report) are required for award closeout.
NIH will review and measure performance based on details and outcomes shared in RPPRs.

Post-Award Requirements

Recipient institutions must ensure that protocols are reviewed by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC) for human subjects research.
Recipients must comply with all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
Awards are subject to terms and conditions described in the NIH Grants Policy Statement and 2 CFR Part 200.

Evaluation Criteria

Overall Impact

Reviewers assess the likelihood of 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 the proposed research advances understanding of biological mechanisms contributing to cancer health disparities in underrepresented and/or underserved populations.
- Whether the project breaks new ground, extends previous discoveries, or develops novel techniques/methodologies.
Factor 2. Rigor and Feasibility (Approach):
- Whether the approach is appropriate to evaluate how biology may influence risk, incidence, and/or progression of cancer in underrepresented and underserved populations.
- The rigor of the experimental design and methodology.
Factor 3. Expertise and Resources (Investigator(s) and Environment):
- Whether the investigator(s) possess demonstrated background, training, and expertise for the proposed work.
- For multidisciplinary teams, the quality of the leadership plan and how collective expertise contributes to project success.
- Whether institutional resources are appropriate for successful execution of the work.

Additional Review Criteria (Not scored, but considered for overall impact)

Protections for Human Subjects: Justification for involvement, adequacy of protection, potential benefits, importance of knowledge gained, data and safety monitoring (if applicable).
Vertebrate Animals: Justification for use, appropriateness of species, interventions to minimize discomfort, justification for euthanasia method (if applicable).
Biohazards: Assessment of significant hazards and proposed protection measures.
Resubmissions: Evaluation of the full application as newly presented.

Additional Review Considerations (Not scored, but considered for overall impact)

Authentication of Key Biological and/or Chemical Resources: Evaluation of plans for validating resources.
Budget and Period of Support: Evaluation of whether the budget and requested duration are justified and reasonable relative to the proposed research.

Compliance & Special Requirements

Regulatory Compliance

Awards are made under the authority of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.
Recipients must comply with all applicable nondiscrimination laws, as agreed upon during SAM.gov registration.
For activities involving health IT, recipients must use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if applicable.
Mandatory disclosure of violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award (2 CFR 200.113).

Data Protection & Cybersecurity

A Data Management and Sharing Plan is required for all projects that generate scientific data.
If recipients, subrecipients, or third-party entities have ongoing access to HHS systems or handle PII/PHI from HHS, they must develop plans and procedures modeled after the NIST Cybersecurity framework.

Ethical & Research Standards

Compliance with ethical standards for research involving human subjects (45 CFR Part 46) and vertebrate animals is required.
Research must be basic research focusing on biological/genetic causes and mechanisms of cancer health disparities.
Explicitly, studies investigating age or sex disparities without race/ethnicity variables are not solicited.
Behavioral, social, environmental, or community-based studies must incorporate biological mechanisms to be responsive.

Special Considerations

This grant utilizes the R21 (Exploratory/Developmental Research Grant) mechanism, intended for high-risk, high-reward early-stage exploratory projects that may lead to breakthroughs or novel techniques.
Clinical trials are NOT allowed for this funding opportunity.
The NOFO aims to aid and facilitate the growth of a nationwide cohort of scientists in cancer health disparities research and support early-stage exploratory projects that can lead to future in-depth mechanistic studies (like R01 projects).

Grant Details