Grants8 | The most comprehensive grants search on the web

Grant Analysis

Purpose & Target

GRANT PURPOSE AND TARGET: - Single, clear statement of grant's core objective: To support Small Business Concerns (SBCs) in conducting investigator-initiated exploratory clinical trials related to neurological disorders, focusing on Phase 1 and 2 studies to generate data for future clinical development and commercialization. - Explicit identification of target recipient type and size: United States SMEs (Small Business Concerns) with not more than 500 employees. - MUST state if grant is 'SECTOR-SPECIFIC' or 'SECTOR-AGNOSTIC': SECTOR-SPECIFIC - Geographic scope and any location requirements: - United States based organizations. - Clinical trials may involve single or multi-site (up to three clinical sites) within the US. - Foreign components (e.g., specific activities, collaborations) may be allowed if thoroughly justified, but foreign institutions are not eligible to apply. - Key filtering criteria for initial grant screening: - Must be a US Small Business Concern (SBC). - Must propose an exploratory clinical trial (Phase 1 or 2) in neurological disorders. - Must not be for definitive efficacy trials (e.g., Phase 3). - Must not involve more than three clinical sites. - Grant frequency and program context: - Recurring funding opportunity (multiple application deadlines until September 2026). - Part of the NIH Small Business Innovation Research (SBIR) program, designed to bridge the funding gap (Valley of Death) for regulated product development.

Financial Structure

FINANCIAL STRUCTURE: - Budget Range and Limitations: - Phase I awards: Up to $295,924 in total funding support (direct costs, indirect costs, fee) normally. - Phase I awards (exception): Up to $700,000 total costs, with no more than $500,000 total costs in any single year. (Contact program officials before submitting exceeding normal caps). - Phase II awards: Up to $1,972,828 in total funding support normally. - Phase II awards (exception): Up to $3,000,000 total costs, with no more than $1,500,000 total costs in any single year. (Contact program officials before submitting exceeding normal caps). - Eligible and Ineligible Costs: - Budget should be reasonable and appropriate for the research project. - Applicants should budget for services of a Medical Safety Monitor. - Costs for biospecimen banking (via BioSEND protocols) are generally borne by the recipients, not included as a component of the NINDS Biomarkers Repository award. - Travel expenses of Data and Safety Monitoring Board (DSMB) members and meeting room rental are handled by NINDS, not the applicant's budget. - Matching Fund Requirements and Percentages: - No cost sharing is required as defined in the NIH Grants Policy Statement. - However, applicants are strongly encouraged to secure independent third-party investor funds as part of their Fundraising Plan. - For companies working in small markets (rare disease, Humanitarian Use Device, young pediatric population, complex research tools): Expected to secure independent third-party funding equal to or greater than one-third of the NINDS funds requested. - For all other projects: Expected to secure independent third-party funding equal to or greater than the total amount of the NINDS funds requested. - Co-financing Requirements: - Contributions from sources other than NIH (third parties) must be detailed in the budget justification but do not constitute formal 'cost-sharing'. - Financial Reporting Requirements: - Research Performance Progress Report (RPPR) annually. - Federal Financial Report (FFR) as required. - Final Invention Statement and Certification (HHS 568). - Annual Invention Utilization Reports. - Financial Guarantees Required: Not explicitly stated as a separate guarantee, but securing third-party investor funds is a strong expectation for commercialization. - Indirect Cost Policies: Indirect costs are included within the stated total funding support caps.

Eligibility Requirements

ELIGIBILITY REQUIREMENTS: Organizational Eligibility

Organization Type:
Must be a Small Business Concern (SBC) as defined by the U.S. Small Business Administration (SBA).
Must be organized for profit.
Must have a place of business located in the United States and primarily operate within the U.S. or make a significant contribution to the U.S. economy.
Legal forms: Individual proprietorship, partnership, limited liability company (LLC), corporation, joint venture, association, trust, or cooperative.
For joint ventures, there must be less than 50% participation by foreign business entities.
Ownership: Must be more than 50% directly owned and controlled by U.S. citizens/permanent resident aliens, other U.S.-owned business concerns, Indian tribes, Alaska Native Corporations (ANCs), Native Hawaiian Organizations (NHOs), or a combination.
Alternatively, may be more than 50% owned by multiple venture capital operating companies (VCOCs), hedge funds, or private equity firms (no single firm may own more than 50% unless it also qualifies as an SBC).
Employee Count:
Must have, including its affiliates, not more than 500 employees.
Previous Award Performance (Benchmarks, if applicable):
Phase I to Phase II Transition Rate: For SBCs with >20 Phase I awards in the past 5 fiscal years (excluding most recent), must meet or exceed a 0.25 transition rate (0.5 for >50 Phase I awards) or be ineligible for one year.
Phase II to Commercialization Benchmark: For SBCs with >15 Phase II awards in the past 10 fiscal years (excluding two most recent), must show average of at least $100,000 (or 0.15 patents) in revenues/investments per Phase II award, or be ineligible for one year. (Increases to $250,000 for >50 Phase II awards, and $450,000 for >100 Phase II awards).

Geographic Requirements

Must be a United States entity.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components (activities conducted outside the U.S.) may be allowed if thoroughly justified and necessary.

Registration & Compliance

Required Registrations (must be active and completed prior to application submission):
System for Award Management (SAM) with annual renewal.
Unique Entity Identifier (UEI) (issued via SAM.gov).
SBA Company Registry.
eRA Commons (organization and PD/PI accounts).
Principal Investigator (PD/PI) Requirements:
Primary employment of PD/PI must be with the SBC at time of award and during project conduct (for SBIR).
For projects with multiple PDs/PIs, at least one must meet the primary employment requirement.
Must have an eRA Commons account.
Must commit a minimum of 10% effort to the project.
Must have documented experience in clinical trials and the disease area, including timely submission of primary publications from previous trials.

Project Specific Requirements

Clinical Trial Required: Only applications proposing a clinical trial are accepted.
Regulatory Readiness: For studies requiring IND/IDE, applicants must provide documentation of FDA approval (e.g., 'may proceed' email/letter, full approval letter), exemption, or detailed plan for addressing a hold/conditions.
Site Limitation: Clinical trials must be single-site or multi-site with up to three clinical sites.
Scope Exclusions: Applications are not responsive if their primary aim is:
To establish or confirm definitive efficacy (e.g., Phase 3 clinical trials, Pivotal device trials).
To estimate intervention effect size for power calculations of future efficacy trials.
To discover biomarkers.
To conduct preclinical activities to support IND/IDE followed by clinical trial activities, without demonstrated FDA approval/exemption.
To conduct ancillary studies (research undertaken to address scientific questions relevant to the parent study requiring access to data/records from the parent study, and/or involving collection of additional data, specimens, or records).

Application Process

APPLICATION PRACTICAL INFORMATION: Application Timeline and Deadlines

Open Date (Earliest Submission Date): December 05, 2023
Application Due Dates (latest listed): September 05, 2026, by 5:00 PM local time of applicant organization.
Letter of Intent (LOI) Due Date(s): 30 days prior to the application due date (encouraged, but not required or binding).
Expiration Date of NOFO: September 06, 2026.
Review and Award Cycles:
Scientific Merit Review: Typically 2-3 months after due date.
Advisory Council Review: Typically 2-3 months after Scientific Review.
Earliest Start Date: Typically 2-3 months after Advisory Council Review.

Required Documentation and Materials

Application Package: Must be accessed and submitted electronically via NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
Standard Forms: SF424(R&R) forms (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile Expanded, R&R Budget, R&R Subaward Budget, PHS 398 Cover Page Supplement, PHS 398 Research Plan, PHS Human Subjects and Clinical Trials Information, PHS Assignment Request Form).
SBIR Application Certification: Required for SBCs majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms.
Fundraising Plan Documentation: (For Phase II, Direct to Phase II, or Fast-Track applications; optional, but strongly encouraged for all) Include documents related to third-party investors' commitment (e.g., term sheets, redacted bank statements, letters of support with specific dollar figures/ranges). File name: 'Third-Party Investors'.
Regulatory Plan Documentation: Mandatory. Describe regulatory pathway, timeline for FDA approval, and include evidence of contact/approval from appropriate regulatory authority (e.g., FDA 'may proceed' email, IDE approval letter, exemption letter, or Non-Significant Risk documentation from IRB for non-regulated interventions). Applications without this will be withdrawn.
Community Engagement and Research Inclusion (CERI) Plan: Mandatory (maximum 2 pages). Describe community engagement strategies, community partners (if applicable), partnership development, strategy for incorporating input, and success evaluation metrics.
Letters of Support: Required for subcontracts, service agreements, collaborating industry partners, CTSA resource utilization. Encouraged from patient organizations and third-party investors (documenting financial commitment).
Resource Sharing Plans: As per SF424(R&R) Application Guide.
Data Management and Sharing Plan: Mandatory for all applicants. Describe methods for data collection, quality control, confidentiality, privacy, dataset locking, and sharing (noting SBIR/STTR data rights retention for up to 20 years).
Commercialization Plan: (For Fast-track and Phase II only) Address company's approach to recruiting diverse employees, intellectual property protection (IP landscape, constraints, future plans), and a detailed Finance Plan (Fundraising Plan) for securing independent third-party investor funds.
Appendix: Phase I SBIR/STTR Appendix materials are not permitted. Only limited items as described in the SF424(R&R) Application Guide are allowed for other small business applications.

Submission Process

Applications must be submitted electronically through Grants.gov. Applicants must track their application status in eRA Commons.
Errors must be corrected, and a changed/corrected application submitted before the due date and time.
Applicants are responsible for viewing their application in eRA Commons before the due date to ensure accurate and successful submission.

Project Implementation Timeline and Reporting

Project Period: Up to 2 years for Phase I, and up to 3 years for Phase II.
Study Timeline: Applicants must provide a detailed timeline with achievable milestones including:
Completion of start-up activities (protocol finalization, site contracting, ClinicalTrials.gov registration, regulatory approvals).
Earliest possible enrollment date.
Enrollment of 25%, 50%, 75%, and 100% of targeted sample size.
Completion of all study data collection.
Completion of primary and secondary endpoint data analyses.
Completion of final study report.
Publication of primary study results.
Reporting of results in ClinicalTrials.gov.
Submission of final public use dataset to NINDS.
Reporting Obligations:
Research Performance Progress Report (RPPR) annually.
Final RPPR, Final Invention Statement and Certification, and Annual Invention Utilization Reports within 120 days of the end of the grant budget period.
Reporting of information about first-tier subawards to the Federal Subaward Reporting System (FSRS) for subawards over the threshold.
Semiannual disclosures regarding civil, criminal, and administrative proceedings in SAM if cumulative federal awards >$10,000,000.

Evaluation Criteria

EVALUATION CRITERIA: Reviewers will provide an overall impact score based on the likelihood of the project to exert a sustained, powerful influence on the research field(s). The following scored criteria are assessed: Significance

Addresses important problem, critical barrier, or unmet need.
Rigor of prior research supporting the project (discuss limitations if data does not meet rigor guidelines).
Improvement to scientific knowledge, technical capability, or clinical practice if aims achieved.
Commercial potential of the product/service.
For Phase II/Fast-Track: Strength of commercialization plan, market opportunity, and customer need.
Convincing evidence of 'equipoise' (medical/patient communities view the question as important and the study as acceptable).
Essentiality of the proposed exploratory trial to inform subsequent clinical development steps.

Investigator(s)

Appropriateness of PD(s)/PI(s), collaborators, and researchers to the project.
Sufficiency of effort dedicated to project.
Experience and training of PD(s)/PI(s) and their accomplishments.
For collaborative/multi-PD/PI projects: Complementary expertise, appropriate leadership/governance/organizational structure.
For later stages: Team's expertise in commercializing the technology/service/product.
Ability to organize, manage, and implement the clinical trial and meet milestones/timelines.
Expertise in study coordination, data management, and statistics.
For multicenter trials: Appropriateness of organizational structure, identification of potential center investigators and coordinating center staff.

Innovation

Innovative approach to addressing a problem, barrier, or unmet need.
Potential to challenge/shift current paradigms.
Significant advantages over existing/developing approaches, methodologies, instrumentation, or interventions.
For Phase II/Fast-Track: Reasonable plan to create a temporal barrier against competitors (e.g., IP protection).
Advantage offered by proposed technology/product over existing/developing solutions for the same indication.
Design/research plan includes innovative elements enhancing sensitivity, information potential, or scientific/clinical advancement.

Approach

Research aims appropriate for current development stage and necessary to advance product/service.
Well-reasoned strategy, methodology, and analyses to accomplish specific aims.
Plans to address weaknesses in rigor of prior supporting research.
Strategies to ensure robust and unbiased approach.
Consideration of potential problems, alternative strategies, and benchmarks for success.
For Phase I: Ability to establish feasibility and manage risky aspects; clear, measurable Phase II milestones.
For Fast-Track: Clear, measurable Phase II milestones; significant advancement toward commercialization.
For Phase II: Demonstrated progress in Phase I, feasibility, and solid foundation for Phase II.
Outline of specific plans for clinical development beyond this exploratory trial.
Appropriateness of go/no-go criteria for subsequent efficacy trials (for later-stage exploratory trials).
Evidence of patient group involvement in study design and recruitment.
Leveraging existing NIH tools and resources (e.g., research networks).
For renewal applications: Appropriateness of trial administration, recruitment progress, and likelihood of achieving aims.
Consideration of NINDS Common Data Elements.
Adequacy of study design for primary/secondary outcomes.
Justification for study design based on prior rigorous research.
Adequacy of power and interpretability of results.
Appropriateness of study populations, intervention arms, and trial duration.
Plans for recruitment, retention, handling dropouts, and monitoring accrual.
Consideration of randomization, masking, controls, and inclusion/exclusion criteria.
Plans to standardize and assure quality of protocol adherence and data collection.
Adequate procedures for data management and quality control.
Plan to complete data analysis within award period.

Environment

Contribution of scientific and business environment to success and commercialization.
Adequacy of SBC support, equipment, and physical resources.
Benefit from unique features of scientific environment, subject populations, or collaborative arrangements.
For Phase I: Appropriate business expertise/resources identified for project aims and commercialization.
For Phase II/Fast-Track: Access to business experts/resources for project aims and commercialization.
Ability to address regulatory issues (internal staff or consultants).
Appropriateness of administrative, data coordinating, enrollment, and laboratory/testing centers.
Adequacy of ability to conduct trial at proposed sites.
Evidence of individual site/center ability for multi-sites (enrollment, protocol adherence, data handling, organizational structure).

Additional Review Criteria (not scored, but considered): - Study Timeline: Detail, feasibility, justification, incorporation of efficiencies, discussion of challenges/solutions. - Intellectual Property (IP): Strength of IP portfolio/position, reasonable strategy to protect IP, IP sharing/management in multi-PD/PI/institution cases. - Fundraising Plan: Ability to establish relationships with third-party investors and secure substantial independent third-party funds. Detail and corroborating documentation (e.g., term sheet). Demonstrated value-added contribution of third-party funds. - Commercialization (Phase II and Fast-Track Only): Market opportunity, understanding barriers, strategies to address barriers, post-SBIR development/commercialization milestones, funding plan, suitability of management team, strategy for product adoption/revenue generation. - Protections for Human Subjects: Justification for human subject involvement, adequacy of protection against risks, potential benefits, importance of knowledge, data and safety monitoring. For exempt research, justification for exemption, human subjects involvement, and material sources. - Inclusion of Women, Racial and Ethnic Minorities, and Individuals Across the Lifespan: Justification for inclusion/exclusion based on scientific goals and research strategy, plans for inclusion. Consideration of participant diversity in recruitment/retention. - Vertebrate Animals: Description of procedures, justification for animal use, interventions to minimize discomfort, justification for euthanasia method. - Biohazards: Assessment of potential hazards, adequacy of proposed protection.

Compliance & Special Requirements

COMPLIANCE AND SPECIAL REQUIREMENTS: Regulatory Compliance

FDA Compliance: Studies requiring an Investigational New Drug (IND) or Investigational Device Exemption (IDE) must demonstrate appropriate FDA approval or exemption. Required documentation (e.g., 'may proceed' letter, approval letter, exemption letter) is critical for review.
IRB Approval: Institutional Review Board (IRB) approval is required prior to funding. Single IRB use is required for multisite clinical trials per NIH policy and the revised Common Rule (45 CFR 46.114).
Data Protection and Privacy: Compliance with the NIH Policy for Data Management and Sharing. Applicants must describe plans for data collection, quality control, confidentiality, privacy, dataset locking, and sharing. SBIR/STTR recipients retain rights to generated data for up to 20 years after the award date.
Environmental Compliance: Not specifically detailed, but general federal environmental regulations apply.
Ethical Standards: Adherence to ethical standards for human subjects research, including protection against risks, and appropriate inclusion/exclusion criteria for participants.
Accessibility and Inclusion: Ensure meaningful access for individuals with limited English proficiency and persons with disabilities. Compliance with federal civil rights laws prohibiting discrimination based on race, color, national origin, age, sex, and disability.
Industry-Specific Regulatory Compliance: Specific requirements related to drugs, biologics, devices, or diagnostics as applicable to the intervention being studied.

Risk Management and Security

Data and Safety Monitoring: Must describe a Data and Safety Monitoring Plan (DSMP) in accordance with NINDS guidelines. Medical Safety Monitor required; budget for their services.
Clinical Site Monitoring: A Clinical Site Monitoring Plan is required, detailing how site adherence to protocol and consenting will be ensured, responsible parties, frequency, and deficiency handling.
Foreign Relationships Disclosure: Applicants must disclose all funded and unfunded relationships with foreign countries for owners and 'covered individuals' (senior key personnel) using the Required Disclosures of Foreign Affiliations or Relationships to Foreign Countries form. Failure to comply can lead to denial or termination of awards.
Security Risk Assessment: NIH will assess security risks related to foreign involvement, including malign foreign talent recruitment programs or business entities/affiliations in 'foreign countries of concern'. Risks identified will be addressed prior to award, and unresolved risks may lead to award denial or repayment of funds.

Intellectual Property (IP)

Applicants should consult technology transfer officials for IP strategy.
Must describe the IP landscape of their investigational product, known constraints, and future filing plans.
If IP is not owned by the SBC, a letter from the IP owner must confirm no limitations impeding study goals.

Special Considerations

Focus on Exploratory Trials: This NOFO specifically targets Phase 1 and Phase 2 exploratory clinical trials, not definitive efficacy trials (Phase 3). Applications proposing Phase 3 or larger multi-site trials (beyond 3 sites) are non-responsive and should seek other NIH funding mechanisms (e.g., NINDS Efficacy Clinical Trials NOFO, or NINDS clinical trial networks like NeuroNEXT, StrokeNet).
Community Engagement: Mandatory Community Engagement and Research Inclusion (CERI) Plan to ensure patient and community input in study design, execution, and dissemination, especially for health disparity populations.
Fundraising Expectation: A significant expectation for all projects, and a required benchmark for funding consideration, is the plan and demonstrated ability to secure independent third-party investor funds to support commercialization post-grant.
Rigor and Transparency: Strong emphasis on robust study design, rigorous preliminary data, minimization of bias, and transparent reporting of methods, analyses, and results across all aspects of the research.

Grant Details