The "Rhode Island Biotechnology Regulatory Sandbox Act" establishes a new regulatory framework within the Department of Business Regulation (DBR) for biotechnology companies to test innovative products and services with limited exemptions from certain state regulations. This new chapter, Chapter 167 in Title 42 of the General Laws, includes definitions for key terms such as "applicable agency," "applicant," and "sandbox participant." The bill outlines an application process for companies wishing to participate, requiring them to demonstrate qualifications, disclose any criminal convictions, and provide detailed information about their innovations. Notably, applicants with serious criminal convictions related to theft, fraud, or dishonesty are prohibited from participation, ensuring that only qualified entities can engage in testing.
The bill also mandates that the DBR inform applicants of their application status within ninety days and allows for a maximum sandbox testing period of twenty-four months, with the possibility of renewal. Participants must disclose essential information about their products to consumers, maintain records, and report on their activities, including any product failures. The department has the authority to deny applications and remove participants for violations, emphasizing transparency and accountability. Additionally, participants are required to continue fulfilling their ongoing duties after exiting the sandbox and may request extensions for their testing period, with quarterly reporting on their efforts to obtain necessary licenses. The act will take effect upon passage.