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Grant Analysis

Purpose & Target

The core objective of this grant is to support the continued operation, maintenance, and enhancement of mature bioinformatics resources. These resources must be crucial for the research community utilizing animal models of embryonic developmental processes, with an emphasis on wide dissemination and interoperability. - Target recipient type and size: Organizations such as Higher Education Institutions, Nonprofits, For-Profit Organizations, and various Government entities that currently maintain established, mature bioinformatics resources. Organizational size is not defined by employee count, but implies entities with significant scientific and technical capacity. - SECTOR-SPECIFIC: This grant is sector-specific, focusing on bioinformatics resources within biomedical research, particularly developmental biology and congenital anomalies. - Geographic scope and any location requirements: The lead applicant organization must be based in the United States. While foreign components (e.g., international collaborators) are allowed within a U.S. organization's application, non-U.S. entities are not eligible to apply as the primary applicant. - Key filtering criteria for initial grant screening: The project must involve a mature, existing bioinformatics resource, not initial research and development or proof-of-concept. It must pertain to animal models of embryonic developmental processes, human/animal development, or structural congenital anomalies. Clinical trials are not allowed. - Grant frequency and program context: This is a recurring grant opportunity, being a reissue of a previous program (PAR-20-126). It is part of the National Institutes of Health's (NIH) ongoing efforts to support critical bioinformatics infrastructure for large-scale biological data.

Financial Structure

Budget range: Requested direct costs are expected to range from $500,000 to $1,750,000 per year.
Maximum annual direct costs: Requested direct costs cannot exceed $1,750,000 per year.
Currency: The currency for funding is USD (United States Dollar), as this is a U.S. government grant.
Matching funds/Cost sharing: Cost sharing is not required for this Notice of Funding Opportunity (NOFO).
Indirect cost policies: Standard NIH grants policies, as described in the NIH Grants Policy Statement, apply.
Eligible costs: Costs must reflect the actual needs of the proposed project, covering expenses related to the operation, maintenance, dissemination, development, enhancement, user training, services, data storage, and curation of bioinformatics resources.
Ineligible costs: Pre-award costs are only allowable as described in NIH Grants Policy Statement Section 7.9.1. Projects specifically for initial development or proof-of-concept are not funded under this grant.

Eligibility Requirements

Organization Type and Legal Structure

Eligible: Higher Education Institutions (Public/State Controlled, Private), Nonprofits (with/without 501(c)(3) IRS Status), For-Profit Organizations (Small Businesses, Other For-Profit), Local Governments (State, County, City/Township, Special District, Indian/Native American Tribal Governments - Federally Recognized and Other), Eligible Agencies of the Federal Government, 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 Location

Applicant organization must be U.S. based.
Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components are allowed within a U.S. organization's application.

Resource Maturity and Focus

Resources must be sufficiently mature to have verifiable support from and utility for users within the developmental biology research community.
Resources must have a demonstrable national and international impact.
Not intended to support: Research and development for proof of concept, initial development of a tool or resource, or projects that utilize a tool already supported through these grants.
Not for tools or resources that duplicate activities of the National Library of Medicine or existing resources supported by other Institutes of the National Institutes of Health.

Technical and Project Scope

Projects must not propose clinical trials.
Resources must be of demonstrable value toward advancing research utilizing animal model systems in biomedical sciences.
Resources must be of particular importance to those seeking to understand the biological basis of human and animal development and the etiology of structural congenital anomalies.
Resources must operate according to FAIR Data principles (Findable, Accessible, Interoperable, and Reusable).

Registration Requirements

Applicant organizations must complete and maintain active registrations with: System for Award Management (SAM), Unique Entity Identifier (UEI), eRA Commons, and Grants.gov. Registration can take 6 weeks or more.
Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code to register in SAM.
Program Directors/Principal Investigators (PD(s)/PI(s)) must have an eRA Commons account.

Application Process

Application Submission

Application Deadlines: Applications are due by 5:00 PM local time of the applicant organization on the following dates:
- January 25, 2025
- May 25, 2025
- September 25, 2025
- January 25, 2026
- May 25, 2026
- September 25, 2026
- January 25, 2027
- May 25, 2027
- September 25, 2027 (This is the latest listed deadline)
Submission Method: Electronic submission is mandatory, using either the NIH ASSIST system or an institutional system-to-system (S2S) solution, submitted via Grants.gov. Applicants must then track the status of their application in the eRA Commons.
Required Registrations (prior to submission): Applicant organizations must complete and maintain active registrations with the System for Award Management (SAM), Unique Entity Identifier (UEI), eRA Commons, and Grants.gov. These registrations can take 6 weeks or more.
Program Directors/Principal Investigators (PD(s)/PI(s)) must also have an eRA Commons account.
Letter of Intent (LOI): Submission of an LOI is encouraged but not required or binding. It should be submitted 30 days prior to the application due date and include: descriptive title, PD(s)/PI(s) contact information, names of other key personnel, participating institutions, and the funding opportunity number and title.

Required Documentation and Materials

Application Package: Must be accessed through ASSIST or an institutional S2S solution.
Instructions: Applicants must strictly follow the Multi-Project (M) Instructions in the 'How to Apply - Application Guide' and any program-specific instructions in this NOFO.
Components: Applications must include an 'Overall' component and may include specific sub-components for 'Administrative Core', 'Curation', 'Technical Development', 'Computation', and 'Dissemination'.
Required Forms/Sections: SF424(R&R) Cover, PHS 398 Cover Page Supplement, Research & Related Other Project Information, Project/Performance Site Locations, Research and Related Senior/Key Person Profile, Component-specific Budgets, PHS 398 Research Plan (including Introduction, Specific Aims, and Research Strategy), Letters of Support, Resource Sharing Plan, Data Management and Sharing Plan, and a limited Appendix.
Page Limitations: Specific page limits apply to various components (e.g., Overall Research Strategy is 12 pages, Curation Research Strategy is 12 pages).

Project Implementation & Reporting

Project Period: The maximum project period allowed is 5 years.
Reporting: Recipients are required to submit an annual Research Performance Progress Report (RPPR) and annual financial statements.
Closeout: A final RPPR, an invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of the award.

Application Support

eRA Service Desk: For questions regarding ASSIST, eRA Commons, application errors, and post-submission issues.
General Grants Information: For questions about application instructions, processes, and NIH grant resources.
Grants.gov Customer Support: For registration and Workspace inquiries.
Scientific/Research Contact: Kathryn Stein, PhD (NICHD) is available for inquiries concerning the funding opportunity and programmatic objectives.
Peer Review Contact: Joanna Kubler-Kielb, PhD (NICHD).
Financial/Grants Management Contact: Bonnie Jackson (NICHD).

Evaluation Criteria

Overall Impact (Scored Criteria)

Significance: Assesses if the Resource Program addresses an important problem or critical barrier; rigor of supporting prior research; how scientific knowledge/technical capability will improve; and how concepts/methods/technologies will change.
Investigator(s): Evaluates if PD(s)/PI(s), collaborators, and other researchers are well-suited (experience, training, accomplishments). For multi-PD/PI, assesses complementary expertise, leadership approach, and organizational structure.
Innovation: Determines if the application challenges current research paradigms; novelty of theoretical concepts, approaches, methodologies, instrumentation, or interventions; or proposes refinement/improvement/new application of existing concepts.
Approach: Reviews the overall strategy, methodology, and analyses for reasoning and appropriateness; plans to address prior research weaknesses; robust and unbiased approach; consideration of problems, alternatives, and benchmarks; and adequate plans for relevant biological variables (e.g., sex) and human subjects protection/inclusion.
Environment: Assesses if the scientific environment contributes to success; adequacy of institutional support, equipment, and physical resources; and benefit from unique features or collaborations.

Additional Review Criteria (Not Separately Scored)

Resource Value: Is the proposed resource program of significant and demonstrable value for advancing biomedical research using animal model systems, particularly for human/animal development and/or birth defects?
Maturity & Utility: Is the resource sufficiently mature with verifiable support and utility within the relevant research communities?
Cost-Effectiveness & Quality: Is the Resource Program cost-effective, and are appropriate quality control measures in place?
Data Principles: Does the application appropriately support and enable FAIR data principles?
Data Standards: Does the application make use of appropriate community data standards?
Interoperability: Does the resource program include an overall strategy for integration and interoperability with other NIH resources, such as the Alliance of Genome Resources?
Human Subjects: If applicable, justification for involvement and proposed protections against research risks.
Inclusion: If human subjects are involved, evaluation of plans for inclusion (or exclusion) of individuals based on sex, race, ethnicity, and age.
Vertebrate Animals: If applicable, assessment of proposed procedures, justification for species, and interventions to limit discomfort.
Biohazards: Determination of adequate protection if materials or procedures are potentially hazardous.

Post-Application Review

Resubmissions: Evaluation considers responses to comments from previous scientific review and changes made.
Renewals: Progress made in the last funding period is considered.
Revisions: Appropriateness of proposed scope expansion; adequacy of responses to comments for previously non-recommended investigations.

Compliance & Special Requirements

Regulatory Compliance

Federal Laws: Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act, as amended.
Federal Regulations: Projects must comply with Federal Regulations 42 CFR Part 52 and 2 CFR Part 200 ('Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards').
Nondiscrimination: Recipients must comply with all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690) when registering in SAM.gov.

Data and Intellectual Property

Data Management and Sharing: Recipients are required to adhere to the 2023 NIH Policy for Data Management and Sharing. A Data Management and Sharing Plan must be submitted and, upon approval, implemented as described.
FAIR Data Principles: Resources developed or maintained under this grant must operate according to the FAIR Data principles (Findable, Accessible, Interoperable, and Reusable).
Resource Sharing: Portals, tools, workflows, and pipelines created or used with grant support are expected to be well-documented and shared with the wider scientific community in a timely manner.
Open-Source Software: Plans to share open-source software, including source code, use cases, and system design documentation, should be specified 'where possible'. If commercial or proprietary resources are used, a justification must be provided, along with a description of how data transparency and interoperability will be maintained.

Ethical Standards and Oversight

Human Subjects: If human subjects are involved, plans must address protection from research risks and the inclusion (or exclusion) of individuals based on sex, race, ethnicity, and age, consistent with federal regulations (45 CFR Part 46). Grantee institutions must ensure protocols are reviewed by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Vertebrate Animals: If live vertebrate animals are involved, applications must provide a complete description of procedures, justification for species, and interventions to limit discomfort.
Biohazards: Reviewers will assess whether proposed materials or procedures are potentially hazardous and if adequate protection is proposed.

Financial and Reporting Compliance

Mandatory Disclosure: Recipients must disclose any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations that could affect the federal award.
Post Submission Materials: Applicants are required to follow NIH policy regarding post-submission materials.

Strategic Alignment and Unique Considerations

Maturity Requirement: This grant is specifically for the continued operation, maintenance, and enhancement of existing, mature bioinformatics resources, not for early-stage development or proof-of-concept studies.
Interoperability: A strong emphasis is placed on ensuring that the funded resources are integrable and interoperable with other NIH resources, such as the Alliance of Genome Resources, through mechanisms like Application Program Interfaces (APIs).
Not a Clinical Trial: This funding opportunity explicitly states 'Clinical Trial Not Allowed'. Applications proposing clinical trials will not be accepted.
Consultant Encouragement: Applicants are strongly encouraged to consult with the Scientific/Research Contact (Kathryn Stein, PhD) at NICHD to ensure their proposed project aligns with the objectives and programmatic interests of this NOFO.

Grant Details