Notice of Intent to Sole Source_CFSAN-2024-123137.pdf

Notice of Intent to Sole Source

The U.S. Food & Drug Administration (FDA) intends to issue a sole-source commercial product purchase order to BIOMERIEUX INC located at 515 S Colorow DR Salt Lake City, Utah 84108-1248.

An award is anticipated to be made using Simplified Acquisition Procedures and under the authority of Federal Acquisition Regulation (FAR) Part 13.106-1(b)(1)(i) wherein the circumstances of the proposed contract action deem only one source reasonably available.

The FDA requires the purchase a Bacterial Identification and Monitoring System for the FDA’s Office of Applied Research and Safety Assessment (OARSA) to support the Center for Food Safety and Applied Nutrition (CFSAN) efforts to develop protocols for detecting foodborne pathogens in food and environmental samples, such as Shiga toxin-producing E. coli, Salmonella, and food-borne parasites (Cyclospora cayentanensis). BIOMERIEUX INC has been identified as the only manufacturer of a microbial identification system that has the shortest hands-on time (with about 40-50% fewer steps than other identified systems) and the most advanced technology to provide the fastest Identification of microbes; the system includes an Advanced Expert System (AES) that analyzes minimal inhibitory concentration (MIC) patterns and detects phenotypes for most organisms tested. With its ability to provide accurate fingerprint recognition of bacterial resistance mechanisms and phenotypes, the AES is a critical component of the required system and only available through BIOMERIEUX INC’s proprietary technology.

This notice is not a request for competitive quotations. However, any party that believes it can meet this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement.

Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed award based upon responses to this notice is solely within the discretion of the Government.

It is anticipated that an award will be issued to BIOMERIEUX INC within approximately fifteen (15) days after the response date of this notice unless the Government determines that any other entity has the capability to meet this requirement.

Response Date: 05/07/2024 at 5:00 p.m. ET. Please email responses to Contracting Officer Benjamin Dorgan at benjamin.dorgan@fda.hhs.gov. No phone calls will be accepted.

mailto:benjamin.dorgan@fda.hhs.gov