NEI Small Business Innovation Research (SBIR) Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U44)
National Eye Institute (NEI), National Institutes of Health (NIH)
Up to $1,000,000 per year, total project cost not exceeding $2,000,000
Maximum duration of three years
Support SBCs in conducting early-stage clinical trials focused on screening, diagnosing, preventing, or treating vision disorders.
Mission of NEI is to eliminate vision loss and improve quality of life through vision research.
Small business concerns (SBCs)
Individuals with vision disorders
Federal funding from the National Institutes of Health (NIH)
Cooperative agreement mechanism
Recurring funding opportunity
Small business concerns (SBCs) organized for profit
Must meet the NIH definition of a clinical trial
Evidence of FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) application submission required
Must be based in the United States
Must have not more than 500 employees
Not specified
Clinical trials for vision disorders
Completion of clinical trials with safety and efficacy data
Commercialization plan required
Expertise in conducting clinical trials
Safety monitoring and oversight required
Up to $1,000,000 per year, total project cost not exceeding $2,000,000
Costs related to the conduct of clinical trials are eligible
Applications due by 5:00 PM local time of applicant organization
Maximum duration of three years
Must comply with FDA regulations for IND/IDE
Clinical protocol, commercialization plan, data management plans
Scientific merit and alignment with NEI mission