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Grant Analysis

Purpose & Target

This funding opportunity, PAR-25-118, from the National Cancer Institute (NCI) aims to support fundamental, mechanistic research into how diet and lipid metabolism are linked to tumor growth and progression. The grant seeks to bridge the fields of nutrition and molecular metabolism, and to stimulate research and tool development in this complex area, especially concerning how lipids connect diet with cancer biology. This is a SECTOR-SPECIFIC grant, focusing specifically on cancer research and nutrition science. It targets a wide range of U.S.-based organizations, from academic institutions to for-profit businesses, involved in biomedical research.

Financial Structure

Award Amount and Limitations

The grant supports projects with direct costs not exceeding $275,000 for the entire two-year project period.
No more than $200,000 may be requested in any single year.

Cost Sharing

No cost sharing is required for this funding opportunity. This means you do not need to provide matching funds from other sources.

Eligible and Ineligible Costs

The grant specifies 'direct costs' for the project. Specific eligible and ineligible cost categories are not detailed within this document but are governed by the general NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Payment and Reporting

This is a Cooperative Agreement, meaning funding will be disbursed with substantial involvement and coordination from NIH/NCI staff.
Recipients will be required to submit annual Research Performance Progress Reports (RPPR) and financial statements as part of the ongoing reporting obligations.

Eligibility Requirements

Who Can Apply This grant is open to a very broad range of organizations based in the United States. If you are an organization or institution, you are likely eligible, provided you are registered with the necessary U.S. government systems. Specifically, the following types of organizations can apply:

Higher Education Institutions: Both public and private universities and colleges.
Nonprofits: This includes both 501(c)(3) IRS status and other types of nonprofit organizations.
For-Profit Organizations: Both 'Small Businesses' and larger 'For-Profit Organizations'.
Government Entities: This covers local, state, county, city, township, special district, and Indian/Native American Tribal Governments (both federally recognized and others), as well as eligible agencies of the Federal Government and U.S. Territories or Possessions.
Other: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, and Regional Organizations.

Geographic Location

Applicants must be U.S.-based organizations. Foreign (non-U.S.) entities are not eligible to apply directly for funding.
However, 'foreign components' (meaning parts of the research conducted abroad) are allowed if they are part of an eligible U.S. organization.

What Kind of Projects are Not Allowed

Clinical trials are strictly forbidden. This grant supports basic and mechanistic research, not studies involving human clinical trials.
Applications that do not propose fundamental, mechanistic investigations or lack appropriate nutrition expertise will be considered non-responsive.
Applications including more than one figure or one-half page of unpublished preliminary data will not be reviewed. If you have substantial preliminary data, you are encouraged to apply for the related U01 funding opportunity instead.

Key Requirements for All Applicants

Registration: Your organization must complete and maintain active registrations with several U.S. government systems before submitting an application. This includes:
- System for Award Management (SAM): Requires annual renewal.
- Unique Entity Identifier (UEI): Issued through SAM.gov.
- eRA Commons: Requires at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
- Grants.gov.
Individual Qualifications: The Program Director(s)/Principal Investigator(s) (PD/PIs) must have an eRA Commons account and the skills, knowledge, and resources to conduct the proposed research.
No Cost Sharing: This grant does not require any matching funds or cost sharing from the applicant organization.
Multiple Applications: Your organization can submit more than one application, but each must be scientifically distinct. The NIH will not accept duplicate or highly overlapping applications.
Expertise: Due to the transdisciplinary nature, inclusion of significant co-Investigators or using the multi-PD/PI option is strongly encouraged. This ensures formal training and expertise in both nutrition sciences and cancer research. While not strictly required for a single PD/PI, demonstrable combined expertise is expected.

Application Process

Key Dates and Deadlines

Open Date (Earliest Submission): January 14, 2025
Letter of Intent Due Dates (encouraged, but not required or binding):
- Approximately 30 days prior to the application due date.
Application Due Dates (5:00 PM local time of applicant organization):
- February 14, 2025 (for new, renewal, resubmission, revision applications)
- October 23, 2025 (for new, renewal, resubmission, revision applications) - This is the latest deadline.
Earliest Project Start Dates:
- December 2025 (for applications due February 2025)
- July 2026 (for applications due October 2025)
Expiration Date of Funding Opportunity: October 24, 2025

Application Procedure and Submission

Electronic Submission Only: Applications must be submitted electronically through one of the following platforms:
- NIH ASSIST system (preferred for preparing, submitting, and tracking applications).
- Institutional system-to-system (S2S) solution (check with your institution).
- Grants.gov Workspace.
No Paper Applications will be accepted.
Timely Submission: Applicants are strongly encouraged to submit early to allow time for correcting any errors before the deadline. Applications that miss the due date and time will be considered late.
Tracking: After submission, applicants must track the status of their application in the eRA Commons.

Required Documentation and Materials Applicants must follow the instructions in the 'Research (R) Instructions in the How to Apply - Application Guide' unless explicitly stated otherwise in this funding opportunity. Key components include:

SF424(R&R) Forms: Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile.
R&R or Modular Budget: Submit detailed budget information.
PHS 398 Cover Page Supplement.
PHS 398 Research Plan: This is a critical section, requiring specific sub-sections:
- Significance: Clearly describe how proposed studies link diet to tumor growth/progression and how dietary variables causally affect lipid metabolism-mediated tumor growth.
- Innovation: Explain how the experiments will uncover new connections between diet and lipid metabolism (tumor-specific or cell non-autonomous factors).
- Approach: Provide detailed descriptions, especially for diet composition. Explain how the approach identifies molecular mechanisms and considers systemic/stromal factors. Preliminary data is not required but limited submission (one figure, half page) is allowed.
Resource Sharing Plan: Required for all applications.
Data Management and Sharing Plan: Required for all applications that generate scientific data.
Appendix: Only limited materials allowed (e.g., blank questionnaires, blank surveys). No publications or other materials.
PHS Human Subjects and Clinical Trials Information: Required if human subjects are involved.
PHS Assignment Request Form.

Application Assistance

eRA Service Desk: For system-related questions (ASSIST, eRA Commons, errors, warnings, submission issues). Available Monday-Friday, 7 a.m. to 8 p.m. ET (closed on federal holidays). Toll-free: 1-866-504-9552 (Press 1 for eRA Commons or ASSIST), Phone: 301-402-7469 (Press 1 for eRA Commons or ASSIST).
General Grants Information: For questions on application instructions, processes, and NIH grant resources. Email: [email protected] (preferred), Phone: 301-480-7075.
Grants.gov Customer Support: For registration and Workspace questions. Contact Center: 800-518-4726, Email: [email protected].
Scientific/Research Contact(s): For questions on project responsiveness.
- For tumor cell autonomous mechanisms: Kristine Willis, Ph.D. (301-792-1338, [email protected])
- For tumor cell non-autonomous mechanisms: Natalia Mercer, Ph.D. (240-276-6220, [email protected])

Evaluation Criteria

The applications for this grant will be evaluated based on their scientific and technical merit through a peer review system. The primary goal is to identify projects with the potential for a sustained, powerful influence on the research field. Scored Review Criteria Reviewers will provide an 'overall impact score' and separate scores for the first two factors:

Factor 1. Importance of the Research (Significance and Innovation):
- How well does the proposed research link dietary variables to tumor growth and/or progression?
- Does it clearly describe how dietary variables are proposed to causally influence lipid metabolism-mediated tumor growth and progression?
- How innovative are the proposed experiments? Do they have the potential to reveal previously unknown connections between diet and lipid metabolism within tumors, or via systemic factors/non-cancerous cells in the tumor microenvironment?
Factor 2. Rigor and Feasibility (Approach):
- Are the proposed methods sound and well-defined?
- If diets are used, are their compositions precisely detailed?
- Does the approach clearly explain how it will identify or deepen understanding of cellular/molecular mechanisms through which diet influences lipid metabolism to affect tumor growth/progression?
- Does it consider systemic, stromal, and/or microenvironmental factors on tumor metabolism where applicable?
- While preliminary data isn't required, if provided (limited to one figure/half page), it will be evaluated. Applicants can also provide underlying logic/rationale instead.
- Are major challenges summarized, and alternative approaches described?
Factor 3. Expertise and Resources (Investigator(s) and Environment):
- Do the investigators (PD/PIs, co-Investigators) possess the necessary expertise and formal training in both nutrition sciences and cancer research?
- Is the research environment appropriate and does it offer the resources needed for the proposed work?
- Does the application encourage the appropriate use of diverse scientific environments and resources for an integrative approach to cancer research?

Additional Review Considerations (Not Scored, but Impact Overall Score) Reviewers will also consider:

Protections for Human Subjects: If human subjects are involved, are adequate protections in place?
Vertebrate Animals: If live vertebrate animals are used, is their use justified, and are measures in place to minimize discomfort?
Biohazards: Are potential biohazards adequately addressed with protection measures?
Authentication of Key Biological and/or Chemical Resources: Are plans proposed to ensure the validity of these resources?
Budget and Period of Support: Is the requested budget reasonable and justified in relation to the proposed research and project period?

Program Priorities

Mechanistic Research: The grant prioritizes fundamental research that addresses knowledge gaps in the connection between diet, nutrition, and lipid metabolism related to cancer.
Dietary Manipulations: Studies investigating high-fat and ketogenic diets are of particular interest, as are mechanistic studies of dietary changes that affect cancer cell metabolism without causing weight gain.
Health Disparities: Applications that examine how these topics contribute to health disparities are especially welcome and encouraged.
Collaboration: Active participation in NCI-organized working groups and collaboration among awardees to share data and expertise is expected.

Compliance & Special Requirements

Regulatory and Policy Compliance

NIH Grants Policy Statement: All awards are subject to the comprehensive policies and terms outlined in the NIH Grants Policy Statement.
Federal Regulations: Compliance with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards) and 42 CFR Part 52 applies.
Non-discrimination: Recipients must comply with all applicable non-discrimination laws and submit an Assurance of Compliance (HHS-690).
Federal Statutes: Adherence to all federal statutes and regulations relevant to federal financial assistance, including public policy requirements and mandates, is mandatory.
Mandatory Disclosure: Recipients or subrecipients must disclose any violations of federal criminal law (fraud, bribery, gratuity) affecting the federal award.

Data Management and Sharing

Data Management and Sharing Plan (DMSP): All applicants planning research that generates scientific data are required to submit a DMSP. This plan must be implemented upon approval.
Data Public Availability: Awardees are expected to deposit data in appropriate publicly available databases in a timely manner. Models, software, and other tools developed should also be made publicly available according to NIH and NCI policies.

Ethical and Research Standards

Human Subjects and Vertebrate Animals: If your project involves human subjects or vertebrate animals, specific review and approval procedures apply to ensure ethical treatment and compliance with guidelines.
Biohazards: If the research includes biohazardous materials or procedures, adequate protection measures must be proposed.

Intellectual Property

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

Unique Aspects of a Cooperative Agreement (UH2) This grant is a Cooperative Agreement, meaning there will be substantial Federal scientific or programmatic involvement from the National Cancer Institute (NCI). This is a partnership approach where:

Recipient's Primary Role: You, as the recipient, maintain the dominant role and primary responsibility for the overall project, including scientific progress, data analysis, reporting, and dissemination of results.
NCI's Substantial Involvement: NCI program staff (acting as project scientists) will be actively involved. Their responsibilities include:
- Monitoring technical direction and approving experimental changes.
- Assisting in avoiding duplication of efforts.
- Facilitating collaborative research among recipients.
- Serving as a resource on NCI/NIH programs, resources, and infrastructures.
- Evaluating and promoting best practices.
- Monitoring operations and recommending project directions.
- Organizing annual meetings, workshops, and working groups.
Joint Responsibilities: Close coordination between recipients and NIH staff is expected for establishing and developing collaborative arrangements, including identifying new research directions.

Collaboration and Dissemination Expectations

Awardees are expected to collaborate actively, share data and expertise, and participate in NCI-organized working groups.
Results must be presented at a virtual annual meeting open to the scientific community.

Grant Details