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Grant Analysis

Purpose & Target

This grant, the NEI Small Business Innovation Research (SBIR) Cooperative Agreement (U44), aims to support early-stage clinical trials with greater than minimal risk that evaluate interventions for vision disorders. - Single, clear statement of grant's core objective: To fund investigator-initiated clinical trials by small businesses focused on screening, diagnosing, preventing, or treating vision disorders, leading to commercialization. - Explicit identification of target recipient type and size: Small Business Concerns (SBCs) with not more than 500 employees. - MUST state if grant is 'SECTOR-SPECIFIC' or 'SECTOR-AGNOSTIC': SECTOR-SPECIFIC (Healthcare: Vision Research). - Geographic scope and any location requirements: United States-based organizations; all research and development activities must be performed within the United States and its territories. - Key filtering criteria for initial grant screening: Must be a US-based SBC, proposing an early-stage clinical trial (Phase I/II) for vision disorders that is greater than minimal risk, with a strong commercialization plan. - Grant frequency and program context: This is a recurring funding opportunity under the NIH SBIR program, offering multiple application deadlines annually. It uses the U44 cooperative agreement mechanism, designed for early-stage clinical trials with substantial NIH involvement, distinct from other NIH clinical trial mechanisms.

Financial Structure

Award Budget: NEI permits Phase II or IIB budget requests up to $1,000,000** (total costs) per year.
Total Project Period Costs: The total costs for the entire project period should not exceed $2,000,000** total costs.
Currency: USD.
Minimum Grant Amount: Not specified.
Maximum Grant Amount: 2000000.0 (for the entire project).
Funding Rate: Not specified as a percentage.
Cost Sharing: Not required.
Co-financing: Not explicitly required, but if co-funding or in-kind support is planned from non-NIH sources, letters of commitment (e.g., type, amount, and source of support) are required.
Eligible Costs: Activities related to the conduct, completion, and analysis of a clinical trial, including training of study personnel, enrollment and recruitment, investigational product costs, data collection/management/quality control, laboratory work, data analyses, study management and oversight, establishment of committees, preparation of final study reports, regulatory activities, and site monitoring.
Ineligible Costs: Phase I applications are not permitted. Applications proposing projects beyond a three-year project period are non-responsive.
Indirect Cost Policies: Not detailed in the provided text but implied to follow SBIR/STTR regulations.
Financial Guarantees: Not explicitly required from applicants.
Payment Schedule: Not explicitly detailed.

Eligibility Requirements

Organizational Type & Legal Structure

Must be a Small Business Concern (SBC).
Organized for profit, with a place of business located in the United States.
Legal forms include individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust, or cooperative.
If a joint venture, there must be less than 50 percent participation by foreign business entities.
Ownership: Must be more than 50% directly owned and controlled by one or more individuals (US citizens or permanent residents), other business concerns (each >50% owned by US citizens/permanent residents), an Indian tribe, ANC or NHO (or wholly owned entity), or any combination of these; OR more than 50% owned by multiple venture capital operating companies, hedge funds, or private equity firms (no single one owning >50% unless it's an SBC itself).

Organizational Size

Has, including its affiliates, not more than 500 employees.

Geographic Location

Place of business located in the United States.
Operates primarily within the United States or makes a significant contribution to the US economy.
All research and development activities must be performed within the United States (defined as the 50 States, territories and possessions of the United States, the Commonwealth of Puerto Rico, the Federated States of Micronesia, the Republic of Palau, the Republic of the Marshall Islands, and the District of Columbia).
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic components of U.S. Organizations are not eligible to apply (though foreign components as defined by NIH GPS may be allowed).

Technical & Project-Specific Qualifications

Proposal must implement investigator-initiated, early-stage clinical trials with greater than minimal risk (typically Phase I or II trials).
Proposed study must evaluate interventions aimed at screening, diagnosing, preventing, or treating vision disorders.
Must meet the NIH definition of a clinical trial.
Must include strong preliminary and/or pre-clinical data.
Must have a well-described Commercialization Plan.
If seeking a Phase II or IIB award, must have received an eligible predicate award (e.g., pre-clinical studies, planning activities).
An application without an eligible predicate award must be submitted as a Direct to Phase II application.
If the proposed clinical trial involves an unapproved drug or device, evidence of an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) application submission to the FDA (or evidence of exemption) is required at the time of application submission.
Clinical trial planning activities should be completed prior to application submission, and investigators must be ready to implement the proposed trial at the time of award.

Compliance & Registration

Must complete and maintain active registration with System for Award Management (SAM).
Must have a Unique Entity Identifier (UEI) issued as part of SAM.gov registration.
Must register with SBA Company Registry.
Must register with eRA Commons (organization, Signing Official, and Program Director/Principal Investigator accounts).
Must register with Grants.gov.

Performance Benchmarks (for companies with prior SBIR/STTR awards)

For SBIR and STTR Phase I applicants that have received more than 20 Phase I awards over the past 5 fiscal years (excluding most recent), must meet or exceed a Phase I to Phase II Transition Rate of 0.25.
For SBIR and STTR Phase I applicants that have received more than 50 Phase I awards over the past 5 fiscal years (excluding most recent), must meet or exceed a Phase I to Phase II Transition Rate of 0.5.
For companies that have received more than 15 Phase II awards from all agencies over the past 10 fiscal years (excluding two most recently completed fiscal years), must show an average of at least $100,000 in revenues and/or investments per Phase II award or at least 0.15 patents per Phase II award.
For companies that have received more than 50 Phase II awards over the past 10 fiscal years (excluding two most recently completed fiscal years), must show an average of at least $250,000 of aggregated sales and investment per Phase II award.
For companies that have received more than 100 Phase II awards over the past 10 fiscal years (excluding two most recently completed fiscal years), must show an average of at least $450,000 of aggregated sales and investment per Phase II award.

Personnel Requirements

The primary employment of the Program Director/Principal Investigator (PD/PI) must be with the small business concern at the time of award and during the conduct of the proposed project. For projects with multiple PDs/PIs, at least one must meet this requirement.

Application Process

Application Submission Process

Application forms must be accessed through NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
All applications are due by 5:00 PM local time of the applicant organization.
Applicants are encouraged to submit early to allow time for error correction.
If a submission date falls on a weekend or Federal holiday, the deadline is automatically extended to the next business day.
Applications that are incomplete, non-compliant, or non-responsive will be withdrawn without review.
Post-submission materials: A 1-2 page document providing an update on the clinical trial (e.g., sites recruited, FDA approvals, personnel recruitment) may be submitted up to 30 days prior to the review meeting.

Key Dates (Latest Applicable Deadlines)

Letter of Intent Due Date: May 27, 2026
Application Due Date (for new/renewal/resubmission): September 23, 2026
Scientific Merit Review: January 2027 (for Sep 2026 due date)
Advisory Council Review: March 2027 (for Sep 2026 due date)
Earliest Start Date: July 2027 (for Sep 2026 due date)
Expiration Date for the NOFO: January 08, 2027

Required Documentation and Materials

SBIR Application Certification: Required for SBCs majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms (file name: 'SBIR Application VCOC Certification.pdf').
Clinical Protocol: A full clinical protocol must be included (file name: 'ClinicalProtocol.pdf').
Manual of Procedures (MOP): Optional, can be submitted (file name: 'MOP.pdf').
Interventional Agent(s) or Device(s) Availability: Documentation from the FDA (e.g., 'may proceed' email/letter for IND, full approval for IDE, or exemption letter) is required if applicable (file name: 'FDADocumentation.pdf').
Data Management, Quality Assurance and Monitoring Plans: Details on data entry, management, storage, security, personnel training, safety monitoring (including DSMC activities), and quality control (file name: 'DataManagement.pdf').
NEI Involvement Statement: A statement acknowledging and agreeing to NEI staff post-award involvement in conducting clinical research studies and describing plans to accommodate this involvement.
Milestones: A 1-2 page maximum attachment detailing scheduled project events and goals (file name: 'MilestonePlan.pdf').
Gantt Chart: A 1-page maximum project timeline including major tasks and estimated start/completion dates (file name: 'Gantt.pdf').
Long-term Care Plan for Patients: A 3-page maximum attachment describing anticipated care needs of participants after the trial ends, related to their trial participation (file name: 'Long-term Care.pdf').
Letters of Support: Required to document access to or commitment of critical resources, including consortium/site participants, cores, laboratories, pharmacies, data management resources, or other collaborators. Letters of commitment are also needed for co-funding or in-kind support from non-NIH sources.
Commercialization Plan: Must include: Statement of Need, SBIR/STTR Commercialization History, Project Management Plan, Regulatory Plan (if applicable, with evidence of FDA interaction), and Fundraising Plan.
Data Management and Sharing Plan (DMS Plan): Required in the Other Plan(s) section, addressing data management and sharing activities for scientific data.
Informed Consent Form(s) and, if applicable, Assent Form(s): To be included in the Appendix.

Project Implementation and Reporting Obligations

Grant duration: Up to three years maximum for Phase II.
Regular Reporting: Recipients are required to submit the Research Performance Progress Report (RPPR) annually and Federal Financial Reports (FFR).
Final Reports: Final RPPR, Final Invention Statement and Certification (HHS 568), and Annual Invention Utilization Reports are due within 120 days of the end of the grant budget period.
ClinicalTrials.gov: Registration and submission of results information are required.
Milestones: Progress toward delineated milestones must be documented and reported.
Data Sharing: Compliance with the NIH Data Management and Sharing Policy is required, and the approved DMS Plan must be implemented.
Publications: Expected to publish and publicly disseminate results, data, and other products, including the ClinicalTrials.gov 'NCT number' in all trial publications.

Evaluation Criteria

Overall Impact

Reviewers will provide an overall impact score based on the assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved.

Scored Review Criteria (each given a separate score)

Significance: Evaluates the importance of the problem, the need for the trial, the potential impact of the results, and how well the clinical trial will test the proposed hypothesis(es).
Investigator(s): Assesses the qualifications, experience, and leadership of the PD/PI(s) and the appropriateness of the team for the proposed project.
Innovation: While a clinical trial application may include study design, methods, and intervention that are not inherently innovative, this criterion considers whether the project addresses important questions or unmet needs within the field.
Approach: Evaluates the soundness of the research design, methodology, and proposed clinical protocol. This includes the feasibility of the approach, the readiness for implementation at the time of award, and contingency plans for anticipated impediments. It also considers the plans for implementing Good Clinical Practices (GCP), Good Clinical Laboratory Practices (GCLP), and Good Manufacturing Practices (GMP) as appropriate.
Environment: Examines the scientific and business environment, access to necessary resources, and how the company will obtain appropriate business resources, including relevant intellectual property, to facilitate commercialization.

Additional Review Criteria (no separate scores, considered for overall impact)

Study Timeline: Review of the appropriateness and feasibility of the proposed project period, timeline, and milestones, including progress toward stated objectives.
Protections for Human Subjects: Adequacy of plans for human subjects protection and adherence to ethical standards.
Biohazards: Adequacy of plans for handling biohazards, if applicable.
Resubmissions/Renewals: For resubmitted or renewed applications, the appropriateness of the responses to criticisms and comments from the previous review.
Budget and Period of Support: Assessment of whether the requested budget and project period are realistic and justified in relation to the proposed work.

Additional Review Considerations (no scores, do not influence overall impact score)

Applications with Foreign Components: Consideration of potential security risks related to foreign affiliations or ties with foreign countries of concern, as assessed by the HHS Due Diligence Program. This includes connections to malign foreign talent recruitment programs, business entities/subsidiaries in foreign countries of concern, or affiliations with research institutions in foreign countries of concern. A finding of foreign involvement does not necessarily disqualify an applicant but will be reviewed against specific risk criteria.

Compliance & Special Requirements

Regulatory Compliance

Projects must meet the NIH definition of a clinical trial.
Compliance with FDA regulations for investigational new drugs (IND) or investigational device exemptions (IDE) is mandatory, including requirements under 21 CFR 312.
Adherence to Good Clinical Practices (GCP), Good Clinical Laboratory Practices (GCLP), and Good Manufacturing Practices (GMP), as appropriate, is required.
ClinicalTrials.gov registration and timely results reporting are legally required for applicable clinical trials.
All human subjects protocols must receive approval from an Institutional Review Board (IRB) or Independent Ethics Committee (IEC).

Ethical Standards

A Data Monitoring and Safety Committee (DSMC) is required for this mechanism, operating under an approved Charter. The DSMC is responsible for safeguarding trial participant interests, assessing safety and efficacy, and monitoring overall conduct.
The PD/PI must ensure that responses to safety or oversight monitoring recommendations are formally reviewed and approved by the medical monitor or DSMC quorum.

Data Protection and Intellectual Property

A Data Management and Sharing Plan (DMS Plan) must be included and implemented in compliance with the NIH DMS Policy.
Recipients will retain custody of and primary rights to the data and software developed under these awards, subject to Government rights of access.
SBIR and STTR recipients may retain the rights to data generated for up to 20 years after the award date.

Foreign Relationships and Security Risks

Applicants are required to disclose all funded and unfunded relationships with foreign countries for all owners and 'covered individuals' (senior key personnel).
NIH will assess potential security risks, including involvement in a malign foreign talent recruitment program, having a business entity/subsidiary in the People's Republic of China or another foreign country of concern, or foreign affiliations with research institutions in such countries.
Failure to submit required foreign disclosure forms during the Just-in-Time (JIT) process will result in non-consideration for funding.
Post-award, recipients must monitor and report any changes to foreign relationships; non-compliance or identified security risks may lead to award termination or requirement to repay funds.

Cooperative Agreement Specifics (Substantial NIH Involvement)

This is a Cooperative Agreement, meaning there will be substantial Federal scientific or programmatic involvement from NEI staff throughout the project.
NEI program staff will assist, guide, coordinate, or participate in project activities, including monitoring progress, managing adverse events, participating in DSMC meetings, and assisting with publication review.
While NIH is substantially involved, the recipient retains the dominant role and prime responsibility for the project.
NEI reserves the right to curtail, withhold, or terminate support for reasons such as inadequate progress toward milestones, major protocol breaches, ethical issues, or unapproved substantive changes to the protocol.

Other Requirements

A robust Commercialization Plan is a key application component, outlining strategies to bring the product/technology to market using non-SBIR funds.
Projects must be milestone-driven, with clear, scheduled events signifying completion of major project stages.
All research and development activities must be performed within the United States and its territories.
Any support or involvement from industry or other third parties (beyond licensing IP) requires notification and concurrence by NEI.
Appropriate acknowledgment of NEI/NIH support is required in all publications and presentations.

Grant Details