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Grant Analysis

Purpose & Target

Core Objective: This grant aims to support the development and testing of multi-level and/or multi-domain intervention research to effectively reduce disparities in liver diseases and liver cancer among populations experiencing health disparities in the United States and its territories.
Target Recipient Type: Primarily research institutions, non-profits, governmental agencies, and for-profit organizations capable of conducting public health and biomedical research.
Target Recipient Size: Not specified, open to a wide range of organizational sizes.
SECTOR-SPECIFIC: This grant is sector-specific, focusing on Healthcare, Public Health, and Biomedical Research.
Geographic Scope: United States (U.S.) and its territories.
Key Filtering Criteria: Focus on health disparities, intervention research, U.S. populations, and liver diseases/cancer. Clinical trials are optional.
Grant Frequency: This is a recurring funding opportunity with multiple application due dates until January 2028, indicating it's part of an ongoing program.

Financial Structure

Funding Instrument: Grant (financial assistance).
Award Budget: Application budgets are not limited but must reflect the actual needs of the proposed project.
For projects targeting the National Cancer Institute (NCI) and requesting $500,000 or more in direct costs in any single year (excluding consortium F&A), a Scientific/Research Contact must be contacted at least 6 weeks before submission. Note: NCI will not consider proposals greater than $500,000 for direct costs in any year.
Maximum Project Period: 5 years.
Cost Sharing: Not required.
Pre-award Costs: Allowable as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.
Financial Reporting: Annual Research Performance Progress Reports (RPPR) and financial statements are required. A final RPPR, invention statement, and expenditure data are required for closeout.

Eligibility Requirements

Organizational Types

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
Nonprofits with 501(c)(3) IRS Status (other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (other than Institutions of Higher Education)
Small Businesses
For-Profit Organizations (other than Small Businesses)
State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government
U.S. Territory or Possession
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

Geographic Requirements

Applicant organizations must be based in the U.S.
Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. organizations are not eligible to apply.
Foreign components (activities conducted outside the U.S. by a U.S. applicant) are allowed.

Registration Requirements

Applicants must complete and maintain an active System for Award Management (SAM) registration, renewed at least annually. This includes obtaining a Commercial and Government Entity (CAGE) Code or NATO Commercial and Government Entity (NCAGE) Code.
A Unique Entity Identifier (UEI) issued as part of the SAM.gov registration process is required and must be used consistently across all registrations and the application.
Organizations must register with eRA Commons, identifying at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
Grants.gov registration is required and depends on an active SAM registration.
Registration processes can take 6 weeks or more; applicants should start early.

Principal Investigator (PD/PI) Requirements

Any individual with the necessary skills, knowledge, and resources may serve as PD(s)/PI(s).
All PD(s)/PI(s) must have an eRA Commons account affiliated with the applicant organization.
For multiple PDs/PIs, the NIH Multiple Program Director/Principal Investigator Policy applies.

Application Limitations

Organizations may submit more than one application, provided each is scientifically distinct.
Duplicate or highly overlapping applications are not accepted under review simultaneously.

Cost Sharing

Cost sharing is not required for this funding opportunity.

Clinical Trials

Applications may propose or not propose clinical trial(s); both options are accepted.

Application Process

Application Submission

Application packages are accessed through NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
Applications must be submitted electronically via Grants.gov.
Applicants must track their application status in eRA Commons.
Applications are due by 5:00 PM local time of the applicant organization on the specified due date.
If a submission date falls on a weekend or federal holiday, the deadline is automatically extended to the next business day.
Applicants are encouraged to submit early to allow time for correcting any errors.
Applications that are incomplete, non-compliant, non-responsive, or submitted late may not be reviewed.

Key Dates

Open Date (Earliest Submission Date): January 05, 2025.
Expiration Date: January 08, 2028.
Letter of Intent Due Date: Not Applicable.
Application Due Dates: This grant has recurring due dates for new applications on February 05, June 05, and October 05 of 2025, 2026, and 2027. For renewal/resubmission/revision applications, the dates are March 05, July 05, and November 05 of 2025, 2026, and 2027. The latest possible submission deadline is November 05, 2027.

Required Documentation and Materials

All instructions in the 'How to Apply - Application Guide' must be followed, with specific additions outlined in the NOFO.
Adhere to all page limitations specified in the 'How to Apply - Application Guide' and 'Table of Page Limits'.
Specific forms include: SF424(R&R) 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, Research Plan; Resource Sharing Plan; Other Plan(s) (including a Data Management and Sharing Plan); Appendix (limited to blank questionnaires/surveys, no publications or other material); PHS Human Subjects and Clinical Trials Information; PHS Assignment Request Form.
The Research Plan must detail how the project advances interventions, addresses health outcomes, focuses on health disparity populations, includes a conceptual model (multiple socio-ecological levels/domains), employs a multidisciplinary approach, considers marginalized identities, and engages communities/partners. If foreign components are included for NIMHD, their contribution to U.S. minority health/disparity reduction must be described.
All applications must include a Data Management and Sharing Plan.

Pre-application Requirements

Organizations 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 prior to application submission. (Specific note: NCI will not consider proposals greater than $500,000 direct costs).
All required organizational registrations (SAM, UEI, eRA Commons, Grants.gov) must be completed before submission, which can take a significant amount of time.
All Program Directors/Principal Investigators must have a valid eRA Commons ID.

Post-award Requirements

Recipients are required to submit an annual Research Performance Progress Report (RPPR) and financial statements.
A final RPPR, invention statement, and expenditure data are required for award closeout.
Clinical trials must be registered and results reported on ClinicalTrials.gov.
Protocols involving human subjects require Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval.
Data and Safety Monitoring is required for human biomedical and behavioral intervention studies.
Clinical research involving investigational therapeutics/devices may require FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE).

Evaluation Criteria

Overall Impact

Reviewers will provide an overall impact score reflecting the likelihood of the project to exert a sustained, powerful influence on the research field(s) involved.

Scored Review Criteria

Importance of the Research: Evaluates the significance and innovation of the proposed project.
Rigor and Feasibility: Assesses the soundness of the proposed approach and its practicality.
Expertise and Resources: Considers the qualifications of the investigator(s) and the adequacy of the research environment and available resources.

Additional Review Criteria (Considered for overall impact, but not separately scored)

Protections for Human Subjects: Adequacy of plans for human subjects involved in the research.
Vertebrate Animals: Evaluation of procedures involving animals, justifications for their use, measures to minimize discomfort, and justification for euthanasia methods if applicable.
Biohazards: Assessment of hazardous materials or procedures and proposed protection measures.
Resubmissions: Evaluation of the resubmitted application in its entirety.
Renewals: Evaluation of the progress made during the previous funding period (if applicable).

Additional Review Considerations (No scores, not for overall impact score)

Authentication of Key Biological and/or Chemical Resources: Review of plans for identifying and ensuring the validity of key biological and chemical resources.
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.

Selection Process

Funding decisions will consider:
- Scientific and technical merit of the proposed project, as determined by peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.

Compliance & Special Requirements

Regulatory Compliance

Awards are subject to 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
All NIH grants are subject to the terms and conditions outlined in the NIH Grants Policy Statement.
Recipients must comply with all applicable nondiscrimination laws, as agreed upon during SAM.gov registration, and must submit an Assurance of Compliance (HHS-690).
Compliance with all federal statutes and regulations relevant to federal financial assistance, including those in NIH Grants Policy Statement Section 4 Public Policy Requirements, is mandatory.

Data Management & Sharing

Recipients must adhere to the 2023 NIH Policy for Data Management and Sharing, and implement their approved Data Management and Sharing Plan.

Mandatory Disclosure

Recipients and subrecipients must disclose any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations that could affect the federal award, in accordance with 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Health IT & Cybersecurity

If funding involves implementing, acquiring, or upgrading health IT, recipients must use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B.
For eligible clinicians in ambulatory settings or hospitals, health IT must be certified under the ONC Health IT Certification Program.
Entities with ongoing access to HHS information/operational technology systems or handling Personal Identifiable Information (PII)/Personal Health Information (PHI) obtained from HHS must develop cybersecurity plans and procedures modeled after the NIST Cybersecurity framework.

Project Design & Scope Expectations

Projects should involve multi-level and/or multi-domain interventions to address liver disease and liver cancer disparities.
Interventions should extend beyond individual-level health behavior modification to interpersonal and community levels.
Holistic research considering contextual factors (NIMHD Research Framework) is encouraged.
Tailored interventions in diverse settings (e.g., clinics, schools, community centers, workplaces) are encouraged.
Projects should focus on U.S. studies, include relevant clinical factors, and may incorporate environmental measurements and personal/intergenerational histories.
Interventions should aim to change modifiable factors of incidence/progression, not just increase awareness/screening.
Projects addressing co-infections (e.g., HIV) and chronic disease comorbidities (e.g., obesity, diabetes, substance use disorders) are of interest.
Multidisciplinary expertise and appropriate intervention study designs (e.g., randomized trials) are strongly encouraged.
Assessment of Social Determinants of Health (SDOH) using PhenX Toolkit measures is encouraged.
Health information technology applications and social media elements may be included.
Interest in 'natural experiments' where health disparities are assessed based on variation in exposures/outcomes.
Particular interest in interventions addressing early onset of liver disease risk factors.
Projects must be community-engaged, involving shared leadership and collaboration with community organizations, clinicians, public health groups, etc.
Culturally and environmentally appropriate interventions are encouraged.

NCI Specific Research Interests

Intervention research focusing on environmental exposures and liver cancer disparities.
Research on interventions to reduce health disparities in liver cancer beyond HBV/HCV (non-viral factors).
Multi-level and/or multi-domain Social Determinants of Health interventions related to liver cancer disparities.
Intervention research promoting cancer control across screening, prevention, treatment, management, and survivorship for liver cancer.

Foreign Components

Foreign components are allowed but must demonstrate how they contribute to improving minority health and/or reducing health disparities in the United States.

Intergovernmental Review

This funding opportunity is not subject to intergovernmental review (E.O. 12372).

Grant Details