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Grant Analysis

Purpose & Target

This grant, part of the 'Innovation Grants to Nurture Initial Translational Efforts (IGNITE) Program', aims to foster the development and validation of animal models and human/animal tissue ex vivo systems. These models must accurately reflect the characteristics of specific neurological or neuromuscular disorders to significantly improve their relevance for future neurotherapeutic discovery. The grant is SECTOR-SPECIFIC, focusing exclusively on the healthcare and biomedical research sectors, particularly neuroscience and drug discovery. It targets a wide range of organizations involved in research, including academic institutions, non-profits, for-profits (including small businesses), and various government entities in the U.S. and internationally. The key filtering criteria are the grant's explicit focus on model development and validation for neurological/neuromuscular diseases, with clinical trials not allowed. It also requires a phased approach (R61/R33) with clear milestones. This is a recurring funding opportunity with multiple application cycles available until October 2027, reissuing a previous call.

Financial Structure

This funding opportunity provides a 'Grant', which is a financial assistance mechanism to carry out an approved project.

Budget Limitations:
- Direct costs for your project cannot exceed $499,000 in any single year.
- The cumulative direct costs for the entire three-year project period cannot exceed $750,000.
Cost Sharing: This grant does not require cost sharing or matching funds.
Eligible and Ineligible Costs: While not exhaustively itemized, typical research-related costs are generally eligible. Applications proposing therapeutic screening/identification, efficacy/safety evaluation of agents, basic disease mechanism studies, biomarker discovery/development, or device development are explicitly stated as 'not responsive' and thus, costs associated with these activities would be ineligible.
Financial Reporting: 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 project closeout.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Eligibility Requirements

To be eligible for this grant, your organization must fall into one of the following categories:

Higher Education Institutions: This includes both public/state-controlled and private institutions.
Nonprofits: Both 501(c)(3) IRS status and other non-profits are eligible.
For-Profit Organizations: This encompasses both 'Small Businesses' and other 'For-Profit Organizations'.
Government Entities: Local governments (State, County, City, Special District, Indian/Native American Tribal) and eligible agencies of the Federal Government are included.
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, and Non-domestic (non-U.S.) Entities (Foreign Organizations) are also eligible.

Specific Qualifications and Certifications:

Your organization must complete and maintain active registrations with the System for Award Management (SAM), including obtaining a Unique Entity Identifier (UEI). Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code in lieu of a CAGE code.
You must also register with eRA Commons and ensure your Program Director(s)/Principal Investigator(s) have eRA Commons accounts affiliated with your organization.
Applications must not propose clinical trials.
Applications must explicitly propose activities for both an R61 phase and an R33 phase, with a clear distinction between them (they cannot overlap in time). Missing either phase will result in administrative withdrawal.
Quantitative go/no-go milestones are a mandatory attachment. Failure to include this document will result in administrative withdrawal.

Geographic Location Requirements:

Organizations based in the United States are eligible.
Non-domestic (non-U.S.) Entities (Foreign Organizations) are also eligible to apply.

Application Process

Application Deadlines and Timeline This grant has multiple application due dates, with the latest application deadline being October 20, 2027, by 5:00 PM local time of the applicant organization. It is strongly advised to submit applications early to allow time for corrections. For applications submitted by the latest deadline, the evaluation and award timeline is as follows:

Scientific Merit Review: March 2028
Advisory Council Review: May 2028
Earliest Start Date: July 2028

Application Procedure and Submission You must submit your application electronically through one of the following methods:

NIH ASSIST system
An institutional system-to-system (S2S) solution
Grants.gov Workspace

All required registrations (SAM, UEI, eRA Commons) must be completed before submission, which can take six weeks or more. Required Documentation and Materials In addition to standard forms (SF424(R&R) series, PHS 398 series), specific critical documents include:

Milestones Document (Required Attachment): A one-page limit document detailing quantitative go/no-go milestones for the transition from the R61 to the R33 phase. This document is mandatory, and applications without it will be administratively withdrawn.
Specific Aims Section: Must clearly delineate activities for both the R61 Phase Specific Aims and R33 Phase Specific Aims with separate headers.
Research Strategy Section: This extensive section must cover:
- Rationale and Unmet Need: Justify the translational relevance and novelty of your model, addressing its advantages over existing alternatives.
- Value for Future Drug Discovery/Development: Explain how your model will be used in the drug discovery and development process.
- Approach: Provide a detailed plan for producing the model, ensuring feasibility and applicability, and conducting thorough internal and external validation studies. This includes addressing rigor (e.g., controls, sample size, blinding, randomization) and reproducibility.
- Timeline: A clear and feasible timeline for specific aims and progression between the R61 and R33 phases, considering factors like animal breeding and aging.
Letters of Support: Highly encouraged from clinical collaborators outlining their roles and responsibilities. If collaborating with a private entity, a letter from a high official addressing agreements on agents, data sharing, and licensing is required.
Resource Sharing Plan: Required documentation outlining how research resources will be shared.
Data Management and Sharing Plan: Mandatory for all applications that generate scientific data.

Grant Duration The total project period for the combined R61/R33 application cannot exceed three years. Within this, neither the R61 phase nor the R33 phase can exceed two years individually (e.g., 1-year R61 + 2-year R33, or 2-year R61 + 1-year R33 are permissible combinations). Reporting Obligations Throughout the grant period, annual Research Performance Progress Reports (RPPR) and financial statements are required. A final RPPR, invention statement, and expenditure data are needed for closeout.

Evaluation Criteria

Applications are rigorously evaluated based on several key factors: Overall Impact Reviewers will assess the likelihood of your project having a sustained and powerful influence on the research field. A strong application doesn't need to excel in every category, but should demonstrate potential for significant scientific impact. Factor 1: Importance of the Research (Significance and Innovation)

Significance: How important is your proposed research? Does it address a critical gap in knowledge, solve a major problem, or offer a valuable technical advancement? The scientific background, whether from prior literature or preliminary data, must justify the study.
Innovation: Does your work apply novel concepts, methods, or technologies? Or does it use existing ones in new ways to enhance the project's impact? Note that even if your project isn't groundbreaking in its approach, it can still be highly important.
Specific to this Grant: Reviewers will specifically look at:
- The model's potential to translate to human disease.
- The appropriateness of any matched control models.
- The feasibility of the model being widely used by the scientific community.
- The unmet need for your proposed model within the defined clinical disease area and its role in the drug discovery process.
- Your understanding of the field and how your proposed model fits into it.

Factor 2: Rigor and Feasibility (Approach)

Rigor: Will your proposed studies produce unbiased, reproducible, and robust data? This includes evaluating the experimental design, controls, sample size justification, and plans for analysis and reporting. Plans to address biological variables (like sex or age) are also important.
Feasibility: Is your approach sound and achievable within the proposed timelines? For studies with higher uncertainty, the potential for major advancements will be weighed. Plans for internal, construct, face, and, if possible, predictive validation are crucial.
Specific to this Grant: Key considerations include:
- The feasibility of completing the R61 activities within the allotted time and the entire project within the three-year limit, considering model generation, breeding, aging, and validation steps.
- The detailed plans for internal and external validation, including comparisons to human disease, etiology, and the use of clinically validated therapeutics (if available).
- The robustness and clarity of your quantitative go/no-go milestones. These milestones are critical for the transition from the R61 to the R33 phase.
- The realism and efficiency of your overall project timeline.

Factor 3: Expertise and Resources (Investigator(s) and Environment)

Investigator(s): Do the key personnel have the necessary background, training, and expertise (e.g., in pharmacology, experimental design, statistical analysis) to conduct the research? For applications with multiple Principal Investigators, the quality of the leadership plan is assessed.
Environment: Are the institutional resources sufficient for successful project execution?
Specific to this Grant: Reviewers will assess:
- Whether investigators have knowledge and experience with the biological target and disease biology needed to produce and validate the model.
- If appropriate effort is dedicated to the project.
- The formation of collaborations with clinicians and drug development experts to ensure the project's relevance to new therapeutic development. Letters of support from clinical collaborators are highly encouraged, outlining their roles and responsibilities in the collaboration.

Compliance & Special Requirements

Regulatory Compliance All awards are subject to the comprehensive NIH Grants Policy Statement and 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards). Recipients must adhere to all applicable non-discrimination laws and relevant federal statutes and regulations. Data Protection and Privacy A Data Management and Sharing Plan is required for all applications involving the generation of scientific data. This plan outlines how data will be managed and shared, and its implementation is mandatory upon approval. Ethical Standards Projects involving human subjects or vertebrate animals must demonstrate adherence to strict ethical guidelines, including justifications for their involvement, protection against risks, and appropriate procedures for care and use. Evaluation also considers potential biohazards and proposed protective measures. Risk Management Applications are expected to demonstrate rigorous study design and transparent reporting to minimize bias, ensure reproducibility, and allow for accurate interpretation of results. This includes detailed plans for experimental design, controls, sample size justification, and statistical methods. Unique Aspects and Strategic Opportunities This grant utilizes a unique R61/R33 phased innovation award mechanism. The R61 phase supports initial development and internal validation, while the R33 phase supports scaling and external validation. Progress from R61 to R33 is strictly contingent on the successful completion of pre-defined, quantitative go/no-go milestones. Key exclusions from this NOFO include:

Studies involving therapeutic agent screening or efficacy/safety evaluation.
Basic science studies focused on disease mechanisms (unless directly for face/construct validation based on accepted hypotheses).
Development of diagnostic, monitoring, predictive, or prognostic biomarkers.
Development of devices, device/drug combinations, surgical procedures, or rehabilitation strategies.

Strategic Alignment: Applicants are strongly encouraged to form multidisciplinary teams that include academic experts, industry professionals, biostatisticians, and particularly clinicians with an understanding of human conditions and therapeutic development. Such collaborations can significantly enhance the translational relevance and impact of the proposed model.

Grant Details