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Grant Analysis

Purpose & Target

This grant, part of the 'Innovation Grants to Nurture Initial Translational Efforts (IGNITE)' suite, aims to accelerate the development of new treatments for neurological or neuromuscular disorders. It specifically funds early-stage translational research focused on developing in vitro, ex vivo, or in vivo assays and conducting iterative screening to identify and characterize potential therapeutic agents. This is a SECTOR-SPECIFIC grant, exclusively targeting the healthcare/biotechnology sector, specifically in neuroscience and drug discovery. Eligible applicants are diverse, ranging from academic institutions and non-profits to small and large for-profit organizations, and various government entities. Key filtering criteria for initial screening: Your project must focus on neurological or neuromuscular disorders, involve assay development and therapeutic agent identification through screening, and explicitly not propose clinical trials or late-stage therapeutic optimization. The geographic scope is US and international. The grant is offered through a recurring program with multiple application deadlines each year, indicating ongoing commitment to this research area.

Financial Structure

This grant provides financial support with specific limitations and policies:

Budget Limitations: The direct costs for the project cannot exceed $499,000 in any one year. The cumulative direct costs for the entire three-year project period may not exceed $750,000.
Eligible Costs: Pre-award costs are allowable, provided they comply with the NIH Grants Policy Statement.
Ineligible Costs: While not explicitly listed, costs for activities outside the defined scope of this NOFO (e.g., clinical trials, therapeutic optimization) would be considered ineligible.
Matching Fund Requirements: No matching funds or cost-sharing are required for this grant opportunity.
Financial Reporting Requirements: Recipients are required to submit a Research Performance Progress Report (RPPR) annually and provide financial statements as per NIH policy. A final RPPR, invention statement, and expenditure data are required for award closeout.
Indirect Cost Policies: Not explicitly detailed in this NOFO, but standard NIH policies regarding indirect costs will apply as described in the NIH Grants Policy Statement.

Eligibility Requirements

To be eligible for this grant, organizations must meet specific criteria:

Eligible Organization Types: A very broad range of organization types can apply, including:
- Higher Education Institutions (Public/State Controlled, Private)
- Nonprofits (both 501(c)(3) IRS status and other)
- For-Profit Organizations (including 'Small Businesses' and other for-profit entities, though 'small business' is not defined by specific employee count in the grant documents)
- Local Governments (State, County, City, Township, Special District, and various Indian/Native American Tribal Governments)
- Federal Government (Eligible Agencies, U.S. Territory or Possession)
- Other: Independent School Districts, Public Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, and Regional Organizations.
Geographic Requirements: Organizations based in the United States are eligible. Additionally, Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply, meaning organizations from outside the U.S. can also receive funding.
Required Registrations: All applicant organizations must complete and maintain active registrations before applying. This process can take 6 weeks or more, so plan accordingly:
- System for Award Management (SAM): Requires annual renewal.
- NATO Commercial and Government Entity (NCAGE) Code: Required for foreign organizations, in lieu of a CAGE code.
- Unique Entity Identifier (UEI): Issued through the SAM.gov registration process.
- eRA Commons: Requires organizations to identify at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
- Grants.gov: Requires active SAM registration.
Program Director/Principal Investigator (PD/PI): Any individual with the necessary skills and resources can serve as a PD/PI. They must have an eRA Commons account affiliated with the applicant organization.
Cost Sharing: No cost sharing is required for this funding opportunity.
Number of Applications: Applicant organizations may submit more than one application, provided each is scientifically distinct. However, the NIH will not accept duplicate or highly overlapping applications that are under review simultaneously.

Exclusion Criteria/Non-Responsive Activities: * Clinical trials are not allowed. Projects proposing any clinical trial will not be accepted. * The grant does not support later-stage activities such as medicinal chemistry optimization, SAR studies, IND enabling studies, manufacturing for clinical use, or development of clinical bioassays. * It also does not support certain basic science activities like establishing proof of concept for a biological target (except limited target deconvolution following phenotypic screening), studies of disease mechanism, or development of assays/probes for basic research. * Projects focused on in vivo proof of concept efficacy studies in mammalian models, pharmacodynamic biomarkers, diagnostic/monitoring/predictive/prognostic biomarkers, device development, device/drug combinations, surgical procedures, diagnostics, rehabilitation strategies, or entirely in silico projects are not responsive to this grant.

Application Process

Applying for this grant involves a structured process with multiple opportunities:

Application Deadlines: There are several recurring application due dates, all by 5:00 PM local time of the applicant organization. The latest listed deadline is October 20, 2027.
- February 18, 2025
- June 18, 2025
- October 20, 2025
- February 18, 2026
- June 18, 2026
- October 20, 2026
- February 18, 2027
- June 18, 2027
- October 20, 2027 Applicants are encouraged to apply early to allow time for error correction.
Submission Format and Platform: Applications must be submitted electronically using either the NIH ASSIST system, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
Pre-Application Requirements: It is strongly encouraged for applicants to contact NINDS Scientific/Research Staff to discuss potential projects before submission to ensure alignment with the NOFO and include critical elements like milestones.
Required Documentation and Materials: A comprehensive application package is required, including:
- Standard SF424(R&R) forms (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, Budget, Subaward Budget).
- PHS 398 Research Plan: Must clearly demarcate R61 Phase Specific Aims and R33 Phase Specific Aims. The Research Strategy should address rigor, transparency, assay validation plan, innovation, a detailed timeline with specific milestones, and a therapeutic discovery plan.
- Other Attachment #1: Milestones (required, 1-page limit): This is critical. It must contain quantitative go/no-go milestones for the R61/R33 transition. Applications missing this will be withdrawn.
- Other Attachment #2: Intellectual Property (IP) (required, 1-page limit): Outline your IP strategy, discuss the IP landscape, known constraints, future filing plans, and IP management for multi-institutional projects.
- Resource Sharing Plan and Data Management and Sharing Plan (required for all applications generating scientific data).
- PHS Human Subjects and Clinical Trials Information (if applicable, clinical trials are not allowed, but human subjects research may be).
- PHS Assignment Request Form.
- Appendix: Only blank questionnaires or surveys are allowed.
Project Implementation Timeline: The total project period cannot exceed three years. The R61 (exploratory/developmental) phase can last a maximum of two years, and the R33 (screening/characterization) phase can also last a maximum of two years. The two phases cannot overlap in time.
Reporting Obligations: Annual Research Performance Progress Reports (RPPR) are required, along with financial statements. A final RPPR and invention statement are required at closeout.
Application Assistance Availability: Contact the eRA Service Desk for technical issues, Grants.gov Customer Support for registration, or NIH General Grants Information for application instructions. NINDS Scientific/Research Staff are available for scientific questions.

Evaluation Criteria

Applications are rigorously evaluated for their scientific and technical merit based on several key factors:

Overall Impact: Reviewers assess the likelihood of the project making a sustained, powerful influence on the research field.
Factor 1: Importance of the Research (Scored)
- Significance: Does the project address an important gap, solve a critical problem, or offer a valuable conceptual/technical advance? Is the rationale strong and based on rigorous background data? Specifically, does a successful therapeutic represent a significant improvement over existing options, and do applicants understand the target patient population?
- Innovation: Does the proposed work apply novel concepts, methods, or technologies, or use existing ones in novel ways? Reviewers will consider the novelty of the target, modality, and/or approach to therapy development.
Factor 2: Rigor and Feasibility (Scored)
- Approach: Can the project produce unbiased, reproducible, and robust data? Are experimental designs rigorous, controls appropriate, and sample sizes justified? Are plans for analysis, interpretation, and reporting strong? Consideration is given to whether proposed assays will be robust, reproducible, and have appropriate throughput, and if screening funnels and hit prioritization plans are clear.
- Feasibility: Is the proposed approach sound and achievable within the given timeframe? For less certain but high-potential studies, is the uncertainty balanced by potential major advances?
- Milestones and Timeline: This is critical. Reviewers evaluate the robustness and clarity of the quantitative go/no-go milestones for transitioning from the R61 to the R33 phase. Milestones must be specific enough to allow clear decision-making and reflect the success of the R61 phase, ensuring the R33 phase is feasible and worthwhile. The overall project timeline must be realistic and efficient.
Factor 3: Expertise and Resources (Scored)
- Investigator(s): Do the lead researchers have the necessary background, training, and expertise for the proposed work, including knowledge of the biological target and therapy development process? For multiple PDs/PIs, the quality of the leadership plan is assessed.
- Environment: Are the institutional resources (facilities, equipment) adequate for successful execution of the project?
Additional Review Criteria (Not scored separately, but contribute to overall impact)
- Protections for Human Subjects: If applicable, justification for involvement, protection from risks, potential benefits, importance of knowledge, and data/safety monitoring.
- Vertebrate Animals: If applicable, justification for use, interventions to minimize discomfort, and euthanasia methods.
- Biohazards: Assessment of hazardous materials/procedures and proposed protections.
Additional Review Considerations (Not scored, but considered)
- Intellectual Property (IP) Strategy: Evaluation of outlined constraints, strength of IP portfolio, and plans for IP protection and sharing (if multiple investigators/institutions).
- Authentication of Key Biological and/or Chemical Resources: Plans for ensuring validity of resources.
- Budget and Period of Support: Justification and reasonableness of the requested budget and project duration.

Compliance & Special Requirements

Compliance and specific requirements are crucial for this grant:

Regulatory Compliance: All awards are subject to the NIH Grants Policy Statement, the Public Health Service Act (Sections 301 and 405), Federal Regulations 42 CFR Part 52, and 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
Ethical Standards and Permits: If your research involves human subjects, Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is mandatory. For vertebrate animals, specific guidelines for their involvement must be followed. Biohazard considerations must also be addressed.
Data Protection and Sharing: Compliance with the 2023 NIH Policy for Data Management and Sharing is required. All applications generating scientific data must include a Data Management and Sharing Plan.
Intellectual Property (IP) Policies: A one-page IP strategy document is a mandatory attachment. It must detail the IP landscape, any known constraints (e.g., existing patents, agreements), and future IP filing plans. For multi-institutional applications, a clear plan for IP sharing and management is necessary. Note that exceptions to the NIH data sharing policy may exist due to IP considerations.
Mandatory Disclosures: Recipients must disclose any violations of federal criminal law involving fraud, bribery, or gratuity that could affect the federal award.
Unique Phased Award Structure: This grant utilizes an R61/R33 Phased Innovation Award mechanism. The R61 phase supports preparatory activities, and the R33 phase supports screening efforts. Transition from R61 to R33 is contingent on successful completion of proposed, quantitative go/no-go milestones. These milestones are strictly evaluated and must be clearly defined in your application.
Emphasis on Rigor and Transparency: Applicants must demonstrate adherence to NIH guidance for rigor and transparency in experimental design. This includes minimizing bias, ensuring reproducibility, justifying sample sizes, appropriate controls, and transparent reporting of methods and results.
Strategic Alignment: Projects should show how knowledge gained will support future therapeutic discovery efforts beyond the grant period, potentially leading to early clinical trials. Collaborations with experts in drug development, clinicians, and biostatisticians are encouraged.

Grant Details