Select Foreign Animal Disease Diagnostics Products

Sources Sought for Select Foreign Animal Disease Diagnostics Products ***This notice has been extended for 60 days*** The availability of accurate and validated veterinary diagnostic tests is crucial to the success of containing any animal disease outbreak. Such tests need to demonstrate consistent, reproducible, and reliable results over a range of animal species and sample types. Diagnostic tests are essential to verify the health status of animals and facilitate the safe movement of live animals and their commodities through both domestic and international commerce. USDA seeks information for Foreign Animal Disease (FAD) diagnostics products for the following select FADs: Foot and Mouth Disease (FMD), African Swine Fever (ASF), and Classical Swine Fever (CSF). USDA intends to use this information to augment our database of available and near market solutions for these select FADs. Information gathered through the sources sought notice will be analyzed to determine whether it would be appropriate and feasible to include test kits and their components in the National Animal Vaccine and Veterinary Countermeasures Bank (NAVVCB). The purpose of this Sources Sought Notice is to obtain an indication of interest and to obtain capability information from those interested sources. THERE IS NO DEFINED REQUIREMENT AT THIS TIME. THIS IS PRELIMINARY MARKET RESEARCH. This is not a solicitation. The applicable North American Industry Classification System (NAICS) code assigned to this effort is 325413 with a small business size standard of 1,250 employees. Information is sought on types of diagnostic products for FMD, ASF, and CSF including but not limited to: agent-specific PCR kits; serological assays for detection and monitoring as well as DIVA (differentiate infected from vaccinated animals) diagnostics; point-of-care diagnostics (pen-side); and other novel approaches to FAD diagnostics for these select livestock diseases. USDA requests manufacturers, wholesalers, and suppliers furnish the following information in response to this sources sought notice: Name and type of kit or reagent Whether it is licensed or permitted for use in the United States by CVB Physical address of the production site of the manufacturer (not just the distributor) Both technical and marketing points of contact and relevant information Information on data storage and control options for point-of-care assays Technical requirements of the kits (what type(s) of laboratory instrumentation is it adapted to be used) Sensitivity and specificity data of a diagnostic test (if applicable and known) and any experimental data supporting this claim, i.e., Se/Sp data by target species and the types of specimens tested (e.g. blood, mucus, feces, etc.) Any data that the manufacturer may possess or is aware of to support the use of aggregate sampling (e.g. pooling of swabs or serum; oral fluids testing) with their diagnostic assay The shelf-life of the finished kits Where possible, the shelf-life of the individual components of the kit Whether there is physical space and technical oversight for storage of kits or bulk reagents/components The routine production capacity and timing in production in units/week or units/quarter The surge capacity (the excess capacity above the routine demands) in units/week or units/quarter Any information deemed proprietary in nature should be specifically identified as such. Any information marked as proprietary will be protected from unauthorized disclosure. This information is intended to be stored in a government owned database. Future contracts for database maintenance or further market research may make information not otherwise marked proprietary, available outside of government. Please provide information in pdf format. Please submit all responses electronically to the Contracting Officer Bob Zeglin at [email protected] with the subject line “12639520SSFAD”