Intent to Award a Sole Source Contract for RAPID'L. mono agar plates

The Food and Drug Administration intends to make a sole source award to Bio-Rad Laboratories for RAPID'L.mono agar plates to ensure the rapid identification and enumeration of Listeria monocytogenes in outbreak-related foods in accordance with FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

The Division of Microbiology in the Office of Regulatory Science has recently investigated the Blue Bell ice cream linked to a multi-state listeriosis outbreak of Listeria monocytogenes. It was determined that the ice cream linked to a listeriosis outbreak had very low level of L. monocytogenes. This finding has triggered many scientific and policy discussions on the control of this important pathogen, especially in foods that do not support its growth. ORS has demonstrated that the most appropriate selective media to enumerate Listeria monocytogenes in ice cream and derived products is RAPID'L.mono by inhibiting the typical background flora found in dairy products. Among other selective media evaluated, only RAPID'L.mono provided the most efficient suppression of the background microorganisms present in ice-cream.
RAPID'L.mono agar is a validated agar by both FDA and ISO for the isolation of L. monocytogenes in select food matrices. FDA has performed extensive validation work and established that the use the RAPID'L.mono agar manufactured by Bio-Rad to analyze ice cream and milk shakes is critical. This selective media may only be purchased through Bio-Rad, the sole licensee of this product, and no other entity is authorized to sell or distribute this product.

Alternative products are not acceptable and counter to achieving the rapid identification and enumeration of Listeria monocytogenes in outbreak-related foods, which will greatly enhance the Agency's ability to investigate and trace back foodborne outbreak events in a timely manner.

The period of performance will be for one year. The NAICS code for this action is 325998. This procurement is made under the authority of FAR 6.302- Only one responsible source and no other supplies or services will satisfy agency requirements.

This is a notice of intent to issue this solicitation on a sole source basis. This notice of intent is not a solicitation for competitive proposals. Any other firms desiring consideration must fully identify their interest and capability to provide this item. A determination by the government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. The projected award date is on or about June 1, 2016.