The Department of Health and Human Services, through the National Institutes of Health (NIH), invites applications for the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44). This funding opportunity aims to support small business concerns (SBCs) in conducting investigator-initiated clinical trials aligned with the NIAID research mission. Focused on high-impact, hypothesis-driven studies, it encourages high-risk clinical trials with unique features, such as non-routine interventions. Key dates include an open submission date starting April 12, 2024, with a final application due date of January 14, 2027. Eligible organizations are U.S.-based SBCs that meet specific ownership criteria and have fewer than 500 employees. The maximum award for Phase II is $1 million per year for three years, contingent upon NIH appropriations and application quality. The proposal process requires detailed planning of the clinical trial, with milestones and comprehensive regulatory compliance included. Submission is exclusively electronic via Grants.gov, and prior consultation with NIAID staff is encouraged to ensure alignment with agency goals. This funding initiative seeks to advance clinical research capabilities, particularly concerning infectious diseases, immunology, and related health challenges.