The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the development of regulated therapeutic and diagnostic solutions for patients affected by opioid and/or stimulants use disorders (OUD/StUD). The current drug crisis surrounding OUD/StUD is a significant issue, with over 100,000 overdose deaths reported in a one-year period. The goal of this solicitation is to offer new medical products that can monitor, diagnose, and treat patients suffering from these disorders. The solicitation is open to small business companies that have developed or are developing FDA-regulated products for different indications and are interested in demonstrating their potential application in the OUD/StUD space. The research and development activities may fall into two areas: pharmacotherapeutics (small molecules and biologics) and medical therapeutic and diagnostic devices, including software as a medical device. The proposed projects should aim to address the needs of patients suffering from OUD/StUD and may include activities such as target identification, lead optimization, preclinical studies, formulation development, and clinical trials. The funding for these projects will be provided through the Small Business Innovation Research (SBIR) program, with Phase I and Phase II funding available. The application due dates are August 15, 2023, February 14, 2024, August 13, 2024, and February 14, 2025. For more information and to apply, interested parties can visit the grants.gov website or the solicitation agency URL provided.