The Government intends to solicit and negotiate with only one source. This notice is issued for informational purposes only and not a request for competitive proposals. A determination to compete this procurement based on a response to this notice is solely within the discretion of the government.

A sole source determination was based on the following: The A-40 flow cytometer, made by Litmus Rapid-B, is the current instrument being used in the laboratory. It has approved protocols/standard operating procedures (SOP) in place when used for FDA enforcement and outbreak response. This instrument requires validation in order to carry out that critical function. Part of the validation process requires the demonstration that the methods work for detecting and enumerating target bacteria in food on multiple instruments. This means that multiple instruments must get the same results from the same assays they perform. The assays that will be used are for: salmonella, listeria and E. coli 0157, all important to the health security of the American people. Litmus has developed the specific reagents for these particular assays. The reagents and the flow cytometer must work in tandem as a part of the validation process. Any other flow cytometer will not provide the required analysis capabilities or compatibility. Litmus Rapid-B is the only manufacturer of the A-40 flow cytometer instrument. No other instruments can be used because they would not give equivalent results nor maintain the consistency of results already in place.

The proposed award is for products under the associated North American Industry Classification System (NAICS) Code is- 334516-Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees.

 Scheduled item(s) include:

1. A-40 Flow Cytometer system and components.

FOB Destination: FDA/NCTR, 3900 NCTR Road, Jefferson, AR 72079-9502.

All responsible sources may submit a response, which shall be considered by the agency, if received no later than 15 days from the date of this announcement. Responses must be sent to the attention of Nick Sartain, National Center for Toxicological Research, U.S. Food and Drug Administration, 3900 NCTR Road, Jefferson, AR 72079-9502, faxed to (870) 543-7990, or email [email protected].