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Grant Analysis

Purpose & Target

Single, clear statement of grant's core objective: To facilitate genomic research by supporting the development and distribution of high-value genomic resources for broad use by the research community.
Explicit identification of target recipient type and size: Open to a wide range of organization types including higher education, non-profits, for-profits (including small businesses), and various government entities.
MUST state if grant is 'SECTOR-SPECIFIC' or 'SECTOR-AGNOSTIC': SECTOR-SPECIFIC
Geographic scope and any location requirements: Global eligibility, open to U.S. and non-U.S. entities (Foreign Institutions).
Key filtering criteria for initial grant screening:
- Project must focus on creating or maintaining broadly applicable genomic resources (e.g., analysis tools, data standards, data production, sample collections).
- Projects supporting only specific diseases or biological questions are not appropriate.
- Clinical trials are not allowed.
- Must demonstrate broad community need and utility.
Grant frequency and program context: Recurring funding opportunity with multiple application due dates until January 2026. Part of the National Institutes of Health (NIH) grant programs, specifically a cooperative agreement (U24) involving substantial federal programmatic involvement.

Financial Structure

Budget: Application budgets are not limited but must reflect the actual needs of the proposed project.
Maximum project period: 5 years.
No cost sharing is required.
Direct costs of $500,000 or more in any single year (excluding consortium F&A) require contacting a Scientific/Research Contact at least 6 weeks prior to submission.
An applied research component to improve resource development methods may be included, up to 10% of the award costs.
Awards are subject to terms and conditions described in the NIH Grants Policy Statement and Federalwide Research Terms and Conditions.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Financial reporting requirements include submission of the Research Performance Progress Report (RPPR) annually and Federal Financial Report for closeout.
Recipients of applicable NIH grants and cooperative agreements are required to report first-tier subawards over the threshold to the Federal Subaward Reporting System (FSRS).
Recipients with cumulative active Federal grants/contracts exceeding $10,000,000 must report and maintain current information in SAM regarding civil, criminal, and administrative proceedings.

Eligibility Requirements

Organization Type

Eligible organizations include:
- Higher Education Institutions (Public/State Controlled, Private)
- Nonprofits (with/without 501(c)(3) IRS Status)
- For-Profit Organizations (Small Businesses, Other than Small Businesses)
- Local Governments (State, County, City or Township, Special District, Federally Recognized/Other Indian/Native American Tribal Governments)
- 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 Institutions) and non-U.S. components of U.S. Organizations are eligible to apply.

Registrations

Applicant organizations must complete and maintain active registration with System for Award Management (SAM), which requires renewal at least annually.
Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code for SAM registration.
A Unique Entity Identifier (UEI) is issued as part of the SAM.gov registration process and must be used for all registrations and on the grant application.
Organizations must register with eRA Commons and identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account.
Applicants must have an active SAM registration to complete Grants.gov registration.
All required registrations must be completed prior to application submission and can take 6 weeks or more.

Individual (PD/PI) Qualifications

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as PD(s)/PI(s) is invited to apply.
All PD(s)/PI(s) must have an eRA Commons account.

Exclusion Criteria

Applications proposing clinical trials are not allowed.
Duplicate or highly overlapping applications under review at the same time are not accepted.
Resources that support only specific diseases or biological questions (e.g., human development or mechanisms of mutation) are not appropriate for this funding opportunity.

Application Process

Key Dates and Deadlines

Open Date (Earliest Submission Date): April 25, 2023.
Letter of Intent Due Date(s): 60 days prior to the application due date (optional, not binding).
Application Due Dates (New/Renewal/Resubmission/Revision, as allowed):
- September 25, 2024
- January 25, 2025
- September 25, 2025
- January 25, 2026 (Latest date for this FOA)
All applications are due by 5:00 PM local time of the applicant organization.
Expiration Date of FOA: January 26, 2026.
Review Cycle for January 25, 2026 submission:
- Scientific Merit Review: March 2026
- Advisory Council Review: May 2026
- Earliest Start Date: July 2026

Application Submission

Electronic submission is required via ASSIST, Grants.gov Workspace, or an institutional system-to-system solution. Paper applications are not accepted.
Applicants are encouraged to apply early to allow time for correcting errors.
Failure to complete required registrations in advance of a due date is not a valid reason for a late submission.
Applicants are responsible for viewing their application in eRA Commons before the due date to ensure accurate and successful submission.
For requests of $500,000 or more in direct costs in any year, applicants must contact a Scientific/Research Contact at least 6 weeks before submitting the application.

Required Documentation and Content

Applicants must strictly follow the Research (R) Instructions in the SF424 (R&R) Application Guide and any program-specific instructions within this FOA.
The Letter of Intent (optional) should include: descriptive title, PD(s)/PI(s) contact information, names of other key personnel, participating institution(s), and the FOA number and title.
The Research Strategy section is limited to 30 pages.
Within the Research Strategy, applications must address the following:
- Community Need: Explain the rationale, describe potential/current user communities, provide usage metrics, and demonstrate broad utility.
- Genomic Community Resource Production Plan: Describe the resource and its production, include quarterly milestones, plans for efficiency gains, proposed technologies, quality control procedures, and plans for updates. An optional applied research component (up to 10% of costs) can be included.
- Governance Plan: Describe the administrative structure, staff expertise, roles, conflict resolution. Include plans for a Scientific Advisory Board (SAB) (required for $500,000+ direct costs, optional for smaller; meets annually). Discuss plans for obtaining additional support and how the resource will integrate/coordinate with others.
- Dissemination and Outreach Plan: Detail how data, software, or biological materials will be disseminated (including infrastructure), how user feedback will be incorporated, and how awareness and user support will be provided.
Resource Sharing Plan: Must specifically address protocol and reagent sharing, and software sharing.
Data Management and Sharing Plan: Required for all applications. Must describe data types, deposition locations/timeline, broad consent for human subjects data, and adherence to FAIR (Findable, Accessible, Interoperable, and Reusable) guidelines.
Appendix: Only limited materials are allowed (e.g., blank questionnaires/surveys); no publications or other materials are permitted.
Human Subjects and Clinical Trials Information: If applicable, follow specific instructions for this form.

Evaluation Criteria

Overall Impact

Reviewers assess the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved.

Scored Review Criteria

Significance:
- Does the project address the needs of the broad genomics research community?
- Is the scope of activities appropriate and will it bring unique advantages/capabilities?
- Are dissemination, outreach, and user support strategies appropriate and maximizing significance?
- Are coordination and integration activities with other resources appropriate to maximize utility?
Investigator(s):
- Are the PD(s)/PI(s) and personnel well-suited, with experience in research and community resource management?
- Do they demonstrate experience coordinating collaborative research?
- For multi-PD/PI projects, are expertise and skills complementary, and are leadership, governance, and conflict resolution plans appropriate?
Innovation:
- Does the application propose novel organizational concepts or management strategies?
- Are concepts/strategies novel to one type of research program or broadly applicable?
- Is a refinement, improvement, or new application of concepts/strategies proposed?
Approach:
- Are the overall strategy, operational plan, and organizational structure well-reasoned?
- Will investigators promote robust and unbiased scientific approaches among users?
- Are potential problems, alternative strategies, and benchmarks for success presented?
- Is feasibility established and risks managed for early-stage resources?
- Are milestones and timelines clear, reasonable, and appropriate?
- Are plans adequate for considering relevant biological variables (e.g., sex)?
Environment:
- Will the institutional environment contribute to success in serving the genomics community?
- Are institutional support, equipment, and physical resources adequate?
- Does the project benefit from unique features of the institutional environment, infrastructure, or personnel?
- Are resources available for electronic information handling?

Additional Review Criteria (not separately scored, but contribute to overall impact)

Protections for Human Subjects: Justification, protection against risks, benefits, importance of knowledge, data/safety monitoring.
Inclusion of Women, Minorities, and Individuals Across the Lifespan: Justification for inclusion/exclusion based on sex, race, ethnicity, and age.
Vertebrate Animals: Description of procedures, justification for use, minimization of discomfort, euthanasia methods.
Biohazards: Assessment of potential hazards and proposed protections.
Resubmissions: Evaluation of responses to previous comments and changes made.
Renewals: Consideration of progress made in the last funding period.
Revisions: Appropriateness of the proposed expansion of project scope.

Additional Review Considerations (not scored, but reviewed)

Applications from Foreign Organizations: Assessment of special opportunities for furthering research through unique talent, resources, populations, or environmental conditions.
Resource Sharing Plans: Reasonableness of sharing plans (e.g., model organisms) or rationale for not sharing.
Authentication of Key Biological and/or Chemical Resources: Comment on plans for validity.
Budget and Period of Support: Consideration of whether the budget and requested period are justified and reasonable.

Funding Decisions will also consider:

Relevance of the proposed project to program priorities and to a broad range of diseases and research questions.
Compliance with broad data, software, and resource sharing policies.
Cost effectiveness of the methods for resource production and maintenance.

Compliance & Special Requirements

Regulatory Compliance

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement, Federalwide Research Terms and Conditions, and relevant CFR parts (e.g., 45 CFR Part 75, 2 CFR Part 200).
Recipients must comply with Federal civil rights laws that prohibit discrimination (based on race, color, national origin, age, sex, disability), including ensuring meaningful access for persons with Limited English Proficiency and effective communication with persons with disabilities.
Compliance with Federal conscience laws and religious non-discrimination laws is required.
Awardees must ensure a safe and respectful work environment, free from sexual harassment.
Recipients are subject to Federal Awardee Performance and Integrity Information System (FAPIIS) requirements for awards over $10,000,000 cumulative value, requiring reporting on civil, criminal, and administrative proceedings.

Data and Resource Sharing

The NIH Policy for Data Management and Sharing is effective for this FOA (due dates on or after January 25, 2023).
Protocols and reagents produced must be broadly available, distributed at minimal cost, and without undue intellectual property constraints.
Software developed must be freely available to biomedical researchers and educators, permit dissemination and commercialization of enhanced versions, be transferable, and allow modification of source code and free sharing of modifications. NIH will have unrestricted access and use of the software, including the right to transfer it to other resource projects.
Data, metadata, and technical protocols must be deposited into existing, publicly available data repositories that are easily accessible and machine-readable.
Data and information produced or distributed by the resource must follow FAIR (Findable, Accessible, Interoperable, and Reusable) guidelines.
NIH will have unrestricted access and use of the data, including the right to transfer it. Awardees must grant other resources the ability to use and redistribute data without restriction (unless limited by consent requirements).

Ethical Standards

Applications are for 'Clinical Trial Not Allowed' projects.
Recipient institutions must ensure that protocols involving human subjects are reviewed by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Adherence to policies regarding sharing of genomic and other data, data access, standardized formats, timely publication, and intellectual property established by NIH and NHGRI.

Cooperative Agreement (U24) Specifics

This is a cooperative agreement, meaning there will be substantial Federal scientific or programmatic involvement from NIH staff (e.g., liaison, coordination, advice, assessment of progress, potential co-authorship).
Awardees retain the dominant role and prime responsibility for determining research approaches, designing protocols, setting milestones, releasing resources, and preparing publications.
A Dispute Resolution Panel can be convened for disagreements on scientific or programmatic matters between award recipients and NHGRI.

Grant Details