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Grant Analysis

Purpose & Target

This grant aims to support US small businesses in bridging the "Valley of Death" funding gap for neurological disease treatments, tools, and diagnostics. It targets small businesses that have previously received an NIH SBIR or STTR Phase II award, allowing them to pursue advanced clinical trials (Phase 1 or 2) or develop complex research tools towards commercialization. This is a SECTOR-SPECIFIC grant focused on neurological disorders and related medical biotechnology. Geographic scope is limited to the United States for eligible small business concerns, though project activities may include foreign components. Key filtering criteria include prior NIH SBIR/STTR Phase II funding, status as a US Small Business Concern, and focus on clinical trials or research tools for neurological conditions. This is a recurring grant opportunity with multiple application due dates until April 2027, reissued from a previous program.

Financial Structure

Budget Range:
- Normal maximum per award: $2,045,816 (total funding support including direct, indirect costs, and fee).
- NINDS generally does not fund applications greater than $3,000,000 total funding support per award.
- Maximum annual total cost per award: $1,500,000.
Eligible Costs:
- Must budget for a Medical Safety Monitor.
- If a Data and Safety Monitoring Board (DSMB) is appointed by NINDS, budget for travel expenses for up to 6 investigator team members to attend an annual one-day, in-person meeting.
- Allowable pre-award costs as described in the NIH Grants Policy Statement.
Ineligible Costs:
- Costs for collection of biospecimens are explicitly not included as a component of the NINDS Biomarkers Repository award.
Matching Fund/Co-financing Expectations:
- Strongly encouraged to secure independent third-party funding.
- For projects targeting small markets (rare disease, Humanitarian Use Device, young pediatric population, neuroscience research tools): Expected independent third-party funding equal to or greater than one-third (33.33%) of the NINDS funds requested.
- For all other projects: Expected independent third-party funding equal to or greater than the NINDS funds requested (100%).
- These third-party funds are not considered cost-sharing as defined by NIH but must be detailed in the budget justification.
Financial Guarantees:
- Documentation of support from third-party investors is required (e.g., term sheets, redacted bank statements, or letters of support with specific dollar figures/ranges).
- For public companies issuing stock as part of fundraising, a letter of commitment from the Chairman of the Board of Directors specifying capital amount, dedication to project, and value-added contribution.
Financial Reporting:
- Annual Research Performance Progress Report (RPPR).
- Financial statements as required by NIH Grants Policy Statement.
- Final RPPR, Final Invention Statement and Certification, Annual Invention Utilization Reports, Federal Financial Report (FFR), SBIR.gov reports.

Eligibility Requirements

Eligible Organization Type

United States Small Business Concerns (SBCs):
- Must be organized for profit.
- Must have a place of business located in the United States and operate primarily within the US or make a significant contribution to the US economy.
- Must be in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust, or cooperative.
- If a joint venture, must have less than 50% participation by foreign business entities.
- Ownership requirements:
  - More than 50% directly owned and controlled by one or more US citizens or permanent resident aliens, OR
  - More than 50% owned by multiple venture capital operating companies, hedge funds, or private equity firms (no single entity owning more than 50% unless it qualifies as an SBC itself).
Employee Count:
- Must have, including its affiliates, not more than 500 employees.

Prior Funding Requirements

Must be a previous NIH SBIR or STTR Phase II award recipient.
Must submit a Phase IIB application within the first six due dates following the expiration of the Phase II budget period.

Performance Benchmarks (for Phase I and II awardees, if applicable)

Phase I to Phase II Transition Rate:
- For companies with >20 Phase I awards (past 5 fiscal years, excluding most recent): must meet/exceed 0.25 transition rate. Failure means 1-year ineligibility for Phase I, Fast-Track, or Direct Phase II.
- For companies with >50 Phase I awards (past 5 fiscal years, excluding most recent) for application deadlines on or after April 5, 2023: must meet/exceed 0.5 transition rate. Failure means not eligible for >20 total Phase I and II awards for 1 year.
Phase II to Commercialization Benchmark:
- For companies with >15 Phase II awards (past 10 fiscal years, excluding two most recent): must show avg. $100,000 in revenues/investments per Phase II award OR 0.15 patents per Phase II award. Failure means 1-year ineligibility for New Phase I, Fast-track, or Direct Phase II.
- For companies with >50 Phase II awards (past 10 fiscal years, excluding two most recent) for application deadlines on or after April 5, 2023: must show avg. $250,000 aggregated sales/investment per Phase II award. Failure means not eligible for >20 total Phase I and II awards for 1 year.
- For companies with >100 Phase II awards (past 10 fiscal years, excluding two most recent) for application deadlines on or after April 5, 2023: must show avg. $450,000 aggregated sales/investment per Phase II award. Failure means not eligible for >20 total Phase I and II awards for 1 year.

Geographic Restrictions

Foreign Organizations (non-U.S.): Not eligible to apply.
Non-domestic components of U.S. Organizations: Not eligible to apply.
Foreign components within the project may be allowed, but scrutinized for security risks.

Principal Investigator (PD/PI) Requirements

Primary employment of the PD/PI must be with the small business concern at the time of award and during the project's conduct.
Each PD/PI must commit a minimum of 10% effort to the project.
Must have experience in the conduct of clinical trials and expertise in the disease area, including timely submission of primary publications.

Exclusion Criteria

Applications for Phase 3 trials where the primary aim is to establish or confirm definitive efficacy are non-responsive.
Trials where the primary objective is to estimate intervention effect size for power calculations of future efficacy trials are non-responsive.
Multi-site clinical trials with more than three clinical sites are non-responsive.
Preclinical activities to support IND/IDE followed by clinical trial activities supported by this IND/IDE are non-responsive.
Ancillary studies (requiring data/records from parent study or additional data/specimens/records) are not permitted.

Application Process

Application Deadlines and Submission

Latest Application Due Date: 2027-04-05 17:00:00, by 5:00 PM local time of the applicant organization.
Subsequent application due dates are in September, January, and April of each year until the expiration date.
Open Date (Earliest Submission Date): August 05, 2024.
Letter of Intent (LOI) Due Date: 30 days prior to the specific application due date (not required, but encouraged).
Submission Platform: Electronic submission via NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
Error Correction: Applicants are encouraged to submit early to allow time to correct errors before the due date. Corrected applications must be resubmitted by the deadline.

Required Registrations (Must be completed before submission)

System for Award Management (SAM): Active registration required, renewed at least annually.
Unique Entity Identifier (UEI): Issued through SAM.gov registration.
SBA Company Registry: Required, proof of registration must be attached to application.
eRA Commons: Requires at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account. Takes up to 2 weeks.
Grants.gov: Requires active SAM registration.

Required Documentation and Materials

SBIR Application Certification: For majority Venture Capital Operating Company (VCOC)-owned SBCs.
Fundraising Plan Documentation: Includes term sheets, redacted bank statements, or other appropriate documents showing third-party investor commitment. Must be collated in one PDF file named 'Third-Party Investors'.
Regulatory Plan Documentation (for clinical trials): Describes regulatory pathway, timeline for approval, and evidence of FDA contact (e.g., 'may proceed' letters, IDE/IND approval status, exemption proof).
Community Engagement and Research Inclusion (CERI) Plan (for patient populations): Max 2 pages, detailing communities of interest, community partners, partnership development, input incorporation strategy, and success metrics.
PHS 398 Research Plan:
- Research Strategy: Scientific rationale, preliminary data, current status of therapeutics.
- Significance and Biological Relevance: Importance of trial, risks/benefits, how results advance product.
- Preliminary Studies: Major findings from previous preclinical/clinical studies, including prior SBIR/STTR Phase II outcomes.
- Approach: Potential biases/challenges, go/no-go criteria, stakeholder evidence.
Letters of Support:
- For subcontracts/service agreements.
- For collaborating industry partners.
- From CTSA program officers (if utilizing CTSA resources).
- For third-party financial support (signed by authorized individuals).
- From patient organizations (encouraged).
Resource Sharing Plans.
Data Management and Sharing Plan.
Commercialization Plan: Detailed sections on value, company, market, IP protection, Finance Plan (including detailed fundraising plan), Statement of Need, and SBIR/STTR Commercialization History.
PHS Human Subjects and Clinical Trials Information form: Including study population characteristics, recruitment/retention plan, study timeline, protection/monitoring plans, and protocol synopsis.

Post-Award Requirements

ClinicalTrials.gov: Registration and results reporting for all clinical trials.
IRB/IEC Approval: Required prior to funding and for all major changes.
Investigational New Drug (IND)/Investigational Device Exemption (IDE): Required for clinical research involving regulated interventions.
Reporting: Annual Research Performance Progress Reports (RPPR), financial statements, final reports (Final RPPR, Final Invention Statement, FFR).
SAM.gov/FSRS: Reporting first-tier subawards and executive compensation. Maintaining currency of information regarding civil/criminal/administrative proceedings.
Foreign Relationships Reporting: Updated Disclosure Form for changes in relationships with foreign countries of concern. Regular annual updates via RPPRs.

Evaluation Criteria

Reviewers will assess applications based on "Overall Impact" and scored criteria, with additional considerations. Overall Impact

Assesses the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved.

Scored Review Criteria (Given separate scores)

Significance:
- Importance of the proposed clinical trial.
- Discussion of risks and benefits.
- How results (positive or negative) will advance product development.
- Why the proposed trial is necessary to inform subsequent efficacy trial design.
Investigator(s):
- Experience of PD(s)/PI(s) and other Senior/Key Personnel in clinical trial conduct and disease area.
- Documented timely submission of primary publications from previous trials.
Innovation:
- Encouragement of innovative and efficient study designs (e.g., adaptive dose-finding, futility designs, Bayesian designs for devices).
- Preference for utilizing digital/mobile/sensor technologies and web-based systems for data collection.
Approach:
- Soundness of scientific rationale and preliminary data (including preclinical/clinical studies and rigor guidelines).
- Clear go/no-go criteria for later-stage exploratory studies.
- Evidence that relevant stakeholders have equipoise and view the study as important/acceptable.
- Discussion of potential biases/challenges and how addressed.
Environment:
- Adequacy of resources (institutional support, equipment, facilities, personnel).
- Suitability of clinical sites and patient populations.

Additional Review Criteria (Considered but not separately scored)

Study Timeline:
- Achievability of proposed milestones for each project stage (startup, enrollment, data collection, analyses, reporting, publication).
Commercialization Plan:
- Value of the SBIR/STTR project, expected outcomes, and impact.
- Company profile.
- Market, customer, and competition analysis.
- Intellectual property (IP) protection strategy, including constraints and future filing plans.
- Detailed Finance Plan for securing independent third-party investor funds (type, source, amount, schedule).
- Clear Statement of Need for government funding to accelerate commercialization.
- SBIR/STTR Commercialization History.
Protections for Human Subjects:
- Adequacy of plans for human subjects protection.
- Data and Safety Monitoring Plan (DSMP).
- Clinical Site Monitoring Plan.
Inclusion of Women, Minorities, and Individuals Across the Lifespan:
- Adequacy of plans for inclusion and recruitment (site selection, community engagement, language access).
Other: Vertebrate Animals, Biohazards, Resubmissions, Phase IIB Competing Renewals, Revisions will also be reviewed as applicable.

Additional Review Considerations (Considered but not scored and do not influence overall impact)

Applications with Foreign Components: Justification and necessity for work outside the US.
Resource Sharing Plans: Reasonableness of plans or rationale for not sharing.
Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity.
Budget and Period of Support: Justification and reasonableness relative to proposed research.

Compliance & Special Requirements

Regulatory Compliance

Human Subjects Research:
- Institutional Review Board (IRB) Approval: Required prior to funding.
- Regulatory Approvals: Other necessary approvals (e.g., Recombinant DNA Advisory Committee) required prior to funding.
- FDA Compliance: For clinical trials involving FDA-regulated products (drugs, biologics, devices), required documentation of FDA interaction and status (e.g., 'may proceed' letters for IND, full approval for IDE, or exemption proof).
- Single IRB: For multisite clinical trials, compliance with NIH policy and 45CFR46.114 (Common Rule) is required.
Clinical Trial Registration: Mandatory registration and results reporting on ClinicalTrials.gov.

Data and Intellectual Property

Data Management and Sharing Plan: Required for all applicants. SBIR/STTR recipients may retain data rights for up to 20 years after the award date.
Intellectual Property (IP): Applicants should describe the IP landscape surrounding their product and any constraints. Clarification on how IP will be shared/managed in multi-institution/multi-PD/PI applications.

Foreign Affiliations and Security

Disclosure of Foreign Relationships: Required for all owners and "covered individuals" (senior key personnel) through the "Required Disclosures of Foreign Affiliations or Relationships to Foreign Countries" form.
Security Risk Assessment: NIH, CDC, and FDA assess security risks related to foreign involvement, particularly with "countries of concern" (e.g., People's Republic of China).
- Risk factors include: malign foreign talent recruitment programs, business entity/parent/subsidiary in countries of concern, foreign affiliation with research institutions in countries of concern.
- Such involvement may lead to denial or termination of award if it interferes with activities, creates duplication, presents conflicts of interest, was undisclosed, violates law/terms, or poses national security risk.
- Recipients are required to monitor and update disclosures post-award. Material misstatements or changes posing security risks can lead to award termination and repayment of funds.

Ethical and Inclusivity Standards

Ethical Standards: Compliance with ethical standards for human biomedical and behavioral intervention studies.
Inclusion: Study design and recruitment plans must ensure the inclusion of women, minorities, and individuals across the lifespan. Considerations for patients with limited English proficiency are expected.
Community Engagement: Required Community Engagement and Research Inclusion (CERI) Plan for research on patient populations, demonstrating strategies for community involvement from planning to findings communication.

Other Special Considerations

Focus on "Valley of Death": Explicitly addresses the funding gap between Phase II and commercialization, making strong third-party investment crucial.
NINDS Consultation: Applicants are strongly encouraged to consult with NINDS Scientific/Research staff early in the application planning process.
Leveraging Resources: Encouraged to utilize existing NINDS resources (e.g., BioSEND, Human Cell and Data Repository), NIH resources (CTSA, NeuroQOL, NIH Toolbox, PROMIS, CDEs), and partner with advocacy groups, foundations, academic institutions.
Medical Safety Monitoring: Budgeting for independent Medical Safety Monitor services is required.

Grant Details