The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the NEI Small Business Innovation Research (SBIR) Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U44-Clinical Trial Required). This solicitation is focused on supporting small business concerns (SBCs) that propose to implement investigator-initiated clinical trials related to the research mission of the NEI. The technology or research being solicited is early-stage clinical trials with greater than minimal risk that investigate the safety and/or efficacy of screening, diagnostic, preventative, or therapeutic interventions for eye diseases or disorders. The typical applications of this technology include evaluating and optimizing interventions, selecting the best interventions or dosing regimens, determining optimal outcome measures, establishing proof-of-principle, and collecting information on utility. The project duration is three years, and the funding specifics can be found on the grants.gov website.