The proposed bill establishes the "Rhode Island Biotechnology Regulatory Sandbox Act," which creates a regulatory sandbox program within the Department of Business Regulation (DBR). This program allows biotechnology companies, research institutions, and other entities to obtain limited access to the market to test innovative biotechnology products or services without obtaining a license or other state authorization that might otherwise be required.

The bill includes definitions of key terms such as "applicable agency," "applicant," "consumer," "department," "innovation," "innovative biotechnology product or service," "regulatory sandbox," and "sandbox participant." It outlines the application process for participants, which includes submitting a nonrefundable application fee, demonstrating jurisdiction in the state, and providing relevant information about the innovative product or service to be tested.

Participants may receive temporary exemptions from state laws or regulations identified in their application, with certain prohibitions in place, including those related to human genetic modification and environmental protection laws. The sandbox period is capped at 24 months, with an option for renewal based on further review. Participants are required to submit quarterly progress reports detailing compliance, risks, and findings.

Before providing a product or service to consumers, sandbox participants must disclose specific information, including the nature of the testing and potential risks. The bill also mandates that participants retain records and report any failures of the product or service during the testing period.

At least 30 days before the end of the sandbox period, participants must notify the DBR of their intent to exit the sandbox or seek an extension. The department may grant an extension for up to 12 months for the purpose of obtaining a license or other authorization. The act aims to foster innovation in the biotechnology sector while ensuring consumer protection and regulatory compliance.