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Grant Analysis

Purpose & Target

The core objective of this grant is to encourage in-depth phenotyping and hypothesis-driven research using specific IMPC-generated knockout mouse strains. The focus is on strains exhibiting embryonic or perinatal lethality or subviability, serving as models for human diseases like structural birth defects, fertility issues, and placental defects. - Single, clear statement of grant's core objective: To facilitate comprehensive study of IMPC-generated knockout mouse strains that are embryonically or perinatally lethal, or subviable, to advance understanding of gene function in human health and disease. - Explicit identification of target recipient type and size: Research institutions of all sizes, including universities, non-profits, for-profit organizations (small and large businesses), and various government entities. - MUST state if grant is 'SECTOR-SPECIFIC' or 'SECTOR-AGNOSTIC': This grant is SECTOR-SPECIFIC. - Geographic scope and any location requirements: Global scope; open to U.S. and non-U.S. (foreign) organizations and components of U.S. organizations. - Key filtering criteria for initial grant screening: Must involve IMPC/KOMP2-generated knockout mouse strains. Clinical trials are explicitly not allowed. Research should focus on developmental biology, genetics, and mechanisms of lethality or subviability. - Grant frequency and program context: This is a reissue (re-evaluation/update of PAR-23-074) of an existing funding opportunity, indicating it is a recurring program. It is part of the ongoing NIH Knockout Mouse Phenotyping Program (KOMP2) and the broader International Mouse Phenotyping Consortium (IMPC) initiative.

Financial Structure

Funding Instrument: Grant, a financial assistance mechanism providing money or property.
Award Budget: Direct costs of up to $499,999.0 per year may be requested. The maximum project period is 5 years.
Currency: USD.
Cost Sharing: Not required, implying a 100.0% funding rate of eligible costs.
Eligible Costs: Generally, costs associated with the proposed research activities, as allowable under NIH Grants Policy Statement. Funds can be included for deposition of phenotypic data to a public database.
Ineligible Costs: Costs related to activities that constitute a clinical trial, as clinical trials are not allowed.
Pre-award Costs: Allowable only as described in NIH Grants Policy Statement Section 7.9.1.
Financial Reporting: Annual Research Performance Progress Report (RPPR) and financial statements are required. A final RPPR and expenditure data are required for award closeout.
Audit Requirements: Awards are subject to 2 CFR Part 200, which includes audit requirements for Federal awards. NIH reviews an applicant's federal award history in SAM.gov.

Eligibility Requirements

Organization Type

Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (with or without 501(c)(3) IRS Status, other than institutions of higher education)
For-Profit Organizations (Small Businesses, Other than Small Businesses)
Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal Governments - 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) are eligible to apply.

Geographic Location

U.S. organizations are eligible.
Non-U.S. (foreign) entities and non-U.S. components of U.S. organizations are eligible to apply.

Technical Expertise & Infrastructure

Applicants must have the skills, knowledge, and resources necessary to carry out the proposed research.

Regulatory Requirements

All applicant organizations must complete and maintain active registrations prior to submission:
- System for Award Management (SAM), renewed at least annually. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code to register in SAM.
- Unique Entity Identifier (UEI), issued via SAM.gov.
- eRA Commons, with at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
- Grants.gov (requires active SAM registration).
All PD(s)/PI(s) must have an eRA Commons account.

Clinical Trial Status

Applications proposing clinical trials are Not Allowed.

Application Limits

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
Duplicate or highly overlapping applications under review at the same time will not be accepted.

Cost Sharing

Cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms is not required.

Application Process

Application Submission Dates

Open Date (Earliest Submission Date): May 05, 2025.
Application Due Dates:
- New applications: June 05, 2025 and October 05, 2025.
- Renewal/Resubmission/Revision applications: July 05, 2025 and November 05, 2025 (latest).
All applications are due by 5:00 PM local time of the applicant organization.
Expiration Date: January 08, 2026.

Application Platforms

Applications must be submitted electronically through one of the following:
- NIH ASSIST system.
- An institutional system-to-system (S2S) solution.
- Grants.gov Workspace.

Required Documentation and Materials

Applicants must follow instructions in the Research (R) Instructions in the How to Apply - Application Guide and specific instructions in this NOFO.
Key forms/components include: SF424(R&R) series (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, PHS Human Subjects and Clinical Trials Information (if human subjects are involved), and PHS Assignment Request Form.
Research Strategy: Must clearly justify the chosen research approach (non-hypothesis-driven secondary screening, hypothesis-driven research, or a combination) and how KOMP2/IMPC resources will be utilized.
Letters of Support: Encouraged for demonstrating commitment to depositing phenotypic data to a public database. Related costs can be included in the budget.
Resource Sharing Plan: Required for all applications. Must adhere to instructions provided in the Application Guide. NICHD expects sharing of biospecimens, tools, workflows, and pipelines consistent with open-source practices.
Data Management and Sharing Plan: Required for all research generating scientific data, regardless of direct costs requested.
Appendix: Limited to blank questionnaires or blank surveys. No publications or other materials are allowed.

Pre-Application Requirements

Letter of Intent (LOI): Although not required or binding, applicants are encouraged to submit an LOI 30 days prior to the application due date. It should include the proposed activity's descriptive title, PD(s)/PI(s) contact information, names of other key personnel, participating institution(s), and the funding opportunity number/title.

Progress Tracking and Post-Award Requirements

Applicants are responsible for tracking their application status in the eRA Commons.
Annual Reporting: Recipients must submit annual Research Performance Progress Reports (RPPR) and financial statements.
Award Closeout: A final RPPR, an invention statement, and the expenditure data portion of the Federal Financial Report are required.
Compliance: Recipients must comply with all terms and conditions of the award, including review by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC) for protocols involving human subjects.
Mandatory Disclosure: Recipients must disclose any violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award.

Application Assistance

eRA Service Desk: For system questions (ASSIST, eRA Commons, application errors). Phone: 301-402-7469 or 866-504-9552. Online help is the preferred method.
General Grants Information: For questions on application instructions, processes, and NIH grant resources. Email: [email protected], Phone: 301-480-7075.
Grants.gov Customer Support: For Grants.gov registration and Workspace issues. Phone: 800-518-4726, Email: [email protected].

Evaluation Criteria

Overall Impact

Reviewers will assess the likelihood for 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): Evaluation of the significance and innovation of the proposed project, including its potential to advance scientific knowledge and its novelty.
Factor 2. Rigor and Feasibility (Approach): Assessment of the overall strategy, methodology, and analyses planned for the research, including measures to ensure rigor and reproducibility.
Factor 3. Expertise and Resources (Investigator(s) and Environment): Evaluation of the qualifications, experience, and leadership of the Program Director(s)/Principal Investigator(s) and the adequacy of the institutional environment and resources.

Additional Review Criteria (Considered but not scored)

Protections for Human Subjects: If applicable, evaluation of plans for protecting human participants involved in the research.
Vertebrate Animals: If applicable, assessment of the justification for animal use, appropriateness of species, and interventions to minimize discomfort and pain.
Biohazards: Evaluation of potential hazards to research personnel or the environment and proposed protection measures.
Resubmissions: Evaluation of the revised application.
Renewals: Assessment of the progress made in the prior funding period.
Revisions: Evaluation of the appropriateness of expanding the project's scope.

Additional Review Considerations (Considered but not scored)

Authentication of Key Biological and/or Chemical Resources: Review of plans for ensuring the validity of these resources.
Budget and Period of Support: Evaluation of the justification and reasonableness of the budget and requested project duration.

Programmatic Priorities / Research Interests of Participating Institutes

NICHD: Interest in evaluating embryonic lethal, perinatal lethal, and subviable KO strains with structural/other defects in embryonic development (e.g., gastrulation, organogenesis, multi-organ systems; limb, neural, cardiovascular, musculoskeletal, urogenital, digestive, respiratory). Also, links between fertility and co- morbid conditions in subviable strains, and defects in trophoblast/placental development leading to embryonic lethality.
NIDCR: Support for research in dental, oral, and craniofacial biology, including craniofacial development, neural crest migration, mineralized tissues, and salivary gland function.
ORWH: Interest in supporting biomedical research that considers sex influences and includes adequate plans for collecting and reporting sex-specific data (Sex as a Biological Variable - SABV) to understand its influence on health and disease.

Data Management and Sharing Plan

Compliance with the 2023 NIH Policy for Data Management and Sharing is required and will be considered during peer review and award decisions.

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.
Compliance with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards) is required.
Recipients must comply with all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
Adherence to all federal statutes and regulations relevant to federal financial assistance, including Public Policy Requirements, Objectives, and other Appropriation Mandates.
Protocols involving human subjects must be reviewed and approved by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC).

Data Protection and Sharing

Mandatory compliance with the 2023 NIH Policy for Data Management and Sharing for research that generates scientific data. An approved Data Management and Sharing Plan must be implemented.
NICHD expects that biospecimens resulting from funded research will be shared with the wider scientific community.
Tools, workflows, and pipelines created or used with grant support should be shared, aligning with open-source practices and NIH Best Practices for Software Sharing.

Ethical Standards

Projects involving vertebrate animals must adhere to specific criteria for humane treatment, justification of use, and minimization of discomfort.
Research involving human subjects must ensure adequate protections.
Mandatory disclosure of federal criminal law violations (fraud, bribery, gratuity) potentially affecting the federal award.

Research-Specific Requirements

Proposed research must primarily utilize IMPC-generated knockout mouse strains that exhibit embryonic or perinatal lethality or subviability.
Three main research approaches are supported: non-hypothesis-driven secondary/tertiary screening, a combination of screening and hypothesis-driven research, or strictly hypothesis-driven research.
Research interests of participating NIH Institutes (NICHD, NIDCR, ORWH) guide relevance, including structural birth defects, fertility, placental defects, craniofacial biology, and the consideration of Sex as a Biological Variable (SABV).

Risk Management

Applicants must address potential biohazards in their proposed research and describe adequate protection measures for personnel and the environment.

Reporting and Audit Expectations

Continuous adherence to all reporting requirements, including annual Research Performance Progress Reports (RPPRs) and financial statements.
NIH may review an applicant's federal award history in SAM.gov to assess sound business practices and integrity prior to making an award.

Intellectual Property

An invention statement is required for award closeout, implying compliance with federal intellectual property regulations for grant-funded discoveries.

Grant Details