Notice of Intent to Sole Source for Commercial Purchases Under SAT

The Food and Drug Administration (FDA) has issued a Notice of Intent to award a sole-source, firm-fixed-price purchase order to Distek, Inc. for one Distek Dissolution System and Autosampler Instrument with accessories. The equipment will support dissolution testing of extended-release dosage forms at the Irvine Medical Products Laboratory in Irvine, California. Market research indicates that Distek, Inc. is the only source capable of meeting the government's specific technical requirements. These include a system utilizing syringe pumps and syringe filters, interchangeable shafts for paddles or baskets, an autosampler that uses syringe filters rather than plate filters for rapid switching, and USB/ethernet connections to support data retrieval and archival in compliance with ISO 17025 accreditation standards. Although this notice does not constitute a competitive solicitation, interested parties who believe they can satisfy the requirements may submit a capability statement. Submissions must include technical documentation demonstrating compliance with the Statement of Work and must be received via email by July 20, 2026, at 2:00 PM Eastern Time. The FDA will use these responses solely to determine whether a competitive procurement is warranted. Delivery of the system is required within 60 days of contract award.