Notice of Intent to Sole Source for Commercial Purchases Under SAT

The Food and Drug Administration intends to issue a Firm-Fixed Price Purchase Order for a Distek Dissolution System and Autosampler Instrument with accessories. The required system must meet all requirements in the attached Statement of Work, including utilizing syringe pumps and syringe filters, and being equipped with interchangeable shafts. The autosampler must utilize syringe filters and have USB and ethernet connections for data retrieval and archival requirements. The system will be used to support dissolution testing of extended-release dosage forms at the Irvine Medical Products Laboratory. • The system must meet all requirements in the attached Statement of Work. • The system must utilize syringe pumps and syringe filters. • The system must be equipped with interchangeable shafts. • The autosampler must utilize syringe filters. • The system must have USB and ethernet connections for data retrieval and archival requirements.