Bill > H6243

This bill establishes the Rhode Island Biotechnology Regulatory Sandbox Program within the Department of Business Regulation (DBR), which creates a structured framework for innovative biotechnology companies to test new products and services with limited regulatory requirements. The program allows qualified applicants to obtain temporary market access without standard licensing, providing they meet strict application criteria, including demonstrating technological innovation, consumer benefits, and potential risks. Participants must disclose comprehensive information to consumers about the experimental nature of their products, and are required to submit quarterly reports detailing their progress, compliance, and any potential issues. The sandbox has a maximum testing period of 24 months, with a possible 12-month extension, during which participants receive targeted regulatory relief while still maintaining consumer protections. Applicants must undergo rigorous screening by the DBR and relevant state agencies, and will be evaluated based on factors like their technological expertise, financial stability, and potential consumer impact. At the end of the testing period, participants must either seek full authorization, discontinue their product, or arrange for ongoing duties to be fulfilled. The bill also mandates that the DBR provide an annual report to the general assembly evaluating the program's effectiveness and recommending potential regulatory reforms, ensuring transparency and continuous improvement of the biotechnology innovation ecosystem.

Business and Industry

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