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Grant Analysis

Purpose & Target

This grant aims to support basic, mechanistic research into the biological and genetic causes of cancer health disparities. It seeks to fund innovative studies that investigate these biological/genetic contributors, develop new methodologies and models, and utilize secondary data analyses.

Target recipients: Investigators and scientists with expertise in basic research related to cancer health disparities.
SECTOR-SPECIFIC: Healthcare, specifically cancer research.
Geographic scope: Nationwide (US) and international (Non-U.S. Entities are eligible to apply).
Key filtering criteria: Focus on basic mechanistic research, exclude clinical trials, must address cancer health disparities tied to race/ethnicity.
Grant frequency: Recurring, with multiple application deadlines through October 2027. This is a reissue of a previous funding opportunity (PAR-24-277).

Financial Structure

Application budgets are not limited, but must reflect the actual needs of the proposed project.
There are no specific minimum or maximum funding amounts stated per award.
This funding opportunity does not require cost sharing or co-financing.
Applicants requesting $500,000 or more in direct costs in any single year (excluding consortium F&A) must contact a Scientific/Research Contact at least 6 weeks before submitting their application.
Financial reporting requires annual Research Performance Progress Reports (RPPR) and financial statements.
A final RPPR, invention statement, and expenditure data are required for closeout.
All awards are subject to terms, conditions, and cost principles described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1.

Eligibility Requirements

Eligible Organizations

Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (with or 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 Governments - Federally Recognized or 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) are eligible to apply.

Required Registrations

Applicant organizations must complete and maintain active registrations in:
System for Award Management (SAM) - requires annual renewal.
NATO Commercial and Government Entity (NCAGE) Code (for foreign organizations, in lieu of CAGE).
Unique Entity Identifier (UEI) - issued as part of SAM.gov registration.
eRA Commons - register once UEI is established; requires at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
Grants.gov - requires active SAM registration.
All registrations must be completed prior to application submission; can take 6+ weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources to carry out the proposed research.
All PD(s)/PI(s) must have an eRA Commons account and associate it with the applicant organization.

Exclusion Criteria

Applications proposing clinical trials are NOT allowed.
Studies that do not propose cancer health disparity research are non-responsive.
Studies investigating age and/or sex disparities without race/ethnicity variables are non-responsive.
Behavioral, social, environmental, or community/population-based studies that do not incorporate biological mechanisms in their specific aims are non-responsive.
Strictly hypothesis-generating, exploratory, and correlative studies are discouraged.
Duplicate or highly overlapping applications under review at the same time are not accepted.

Application Process

Application Deadlines and Submission

Applications are accepted multiple times per year with specific due dates:
New applications: February 05, June 05, October 05 (of 2025, 2026, 2027).
Renewal/Resubmission/Revision applications: March 05, July 05, November 05 (of 2025, 2026, 2027).
All applications are due by 5:00 PM local time of the applicant organization.
Applicants are strongly encouraged to apply early to allow time for corrections.
The latest submission deadline is November 05, 2027.

Submission Process

Applications must be submitted electronically via Grants.gov.
Utilize one of these platforms:
NIH ASSIST system (online preparation, submission, tracking).
Institutional system-to-system (S2S) solution.
Grants.gov Workspace.
After submission, track application status in eRA Commons.
Errors found during submission must be corrected, and a changed/corrected application submitted by the due date.

Required Documentation and Materials

Follow instructions in the Research (R) Instructions in the How to Apply - Application Guide and program-specific instructions in this NOFO.
Standard application forms (SF424(R&R) series, PHS 398 series) are required.
Research Strategy: Must clearly describe:
Significance: How the research advances understanding of biological mechanisms in cancer health disparities.
Approach: How the approach evaluates biology's influence on cancer risk/incidence/progression.
Investigator(s) and Environment: How the team's expertise suits the research.
Resource Sharing Plan: Required.
Data Management and Sharing Plan: Required for research generating scientific data.
PHS Human Subjects and Clinical Trials Information form: Required if human subjects are involved (clinical trials are NOT allowed for this grant, but human subjects research may be).
Appendix: Only limited materials allowed (e.g., blank questionnaires/surveys; no publications).

Review and Award Timeline

Scientific Merit Review occurs approximately in March or July or November (for new applications) / July or November or March (for renewal/resubmission/revision).
Advisory Council Review occurs approximately in May or January or October.
Earliest Start Date can be July, April, or December.
For the latest submission on November 5, 2027, the Scientific Merit Review is March 2028, Advisory Council Review is May 2028, and Earliest Start Date is July 2028.

Post-Award Requirements

Recipients must comply with all terms and conditions of the award, NIH Grants Policy Statement, and federal regulations.
Annual Research Performance Progress Reports (RPPR) and financial statements are required.
A final RPPR, invention statement, and expenditure data are required for award closeout.
NIH will monitor performance based on details and outcomes shared in the RPPR.

Evaluation Criteria

Applications are evaluated for scientific and technical merit through NIH's peer review system, considering the likelihood of the project to exert a sustained, powerful influence on the research field. Scored Review Criteria Reviewers will provide an overall impact score and separate factor scores for the first two factors: - Factor 1. Importance of the Research (Significance and Innovation): - How the proposed research may advance understanding of biological mechanisms contributing to cancer health disparities in underrepresented and/or underserved populations. - Factor 2. Rigor and Feasibility (Approach): - How the approach is appropriate to evaluate how biology may influence risk, incidence, and/or progression of cancer in underrepresented and underserved populations. - This includes the development and testing of new methodologies, models, and secondary data analyses. - Factor 3. Expertise and Resources (Investigator(s) and Environment): - How the investigative team is well-suited to study biological mechanisms of cancer health disparities. - For multidisciplinary teams, how collective expertise complements and contributes to project success. Additional Review Criteria (not scored but considered for overall impact)

Protections for Human Subjects: Evaluate justification for involvement, proposed protections against risks, potential benefits, importance of knowledge gained, and data/safety monitoring (if applicable).
Vertebrate Animals: Evaluate proposed procedures, justification for use, interventions to minimize discomfort, and justification for euthanasia method (if applicable).
Biohazards: Evaluate specific materials/procedures for hazards to personnel/environment and proposed protections.
Resubmissions/Renewals/Revisions: Progress made, appropriateness of expansion, as applicable.

Additional Review Considerations (not scored but considered for overall impact)

Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity of resources.
Budget and Period of Support: Justification and reasonableness of budget and requested project period in relation to the proposed research.

Selection Criteria

Scientific and technical merit determined by peer review.
Availability of funds.
Relevance of the proposed project to program priorities (NCI's DCB, DCP, and CCHE interests).

Compliance & Special Requirements

Regulatory Compliance

Adherence to the NIH Grants Policy Statement, including terms and conditions.
Compliance with 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
Compliance with applicable nondiscrimination laws, requiring submission of an Assurance of Compliance (HHS-690).
Compliance with all federal statutes and regulations relevant to federal financial assistance.

Data Protection and Privacy

Required compliance with the 2023 NIH Policy for Data Management and Sharing, including implementation of an approved Data Management and Sharing Plan.
For health IT activities, use health IT that meets adopted standards (45 CFR part 170, Subpart B) and is certified under the ONC Health IT Certification Program (if applicable).
Compliance with Cybersecurity Act of 2015: Recipients with ongoing access to HHS systems/data must develop plans modeled after the NIST Cybersecurity framework to protect HHS systems and data.

Ethical and Scientific Standards

Strong emphasis on ethical standards for research involving human subjects (45 CFR Part 46) and vertebrate animals.
Proposed research must be basic, mechanistic and focused on biological/genetic causes of cancer health disparities. Immediate clinical translational potential is NOT required.

Special Considerations

Project Focus: Specifically targets biological mechanisms of cancer health disparities, emphasizing ancestral/racial/ethnic factors. Projects focusing only on age or sex disparities are not responsive.
Research Design: Encourages comparative research designs between at least two populations, with one or more being underserved. Also encourages the use of biospecimens, patient-derived models, and datasets from diverse racial/ethnic/underserved groups.
Technical Innovation: Encourages development and testing of new methodologies, models (e.g., 3D cellular, organoids, xenografts), and computational approaches to understand disparities.
Risk: Projects that are strictly hypothesis-generating, exploratory, and correlative studies are discouraged, indicating a preference for well-defined, mechanistic research with a clear approach.
Strategic Opportunity: This NOFO aims to foster a national cohort of scientists specializing in basic cancer health disparities research, expanding available resources and tools for the field.
Mandatory Disclosure: Recipients must disclose violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award.

Grant Details