This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR 12.6 as supplemented with FAR 13 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-06. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION. A SEPARATE SOLICITATION DOCUMENT ( I.E. STANDARD FORM ) WILL NOT BE ISSUED. The solicitation number for this acquisition is RFQ-FDA-75F40121Q00105 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation: 334516 Analytical Laboratory Instrument Manufacturing. The Small Business Size Standard is 1,000 employees. This is an unrestricted full and open competition RFQ. Simplified acquisition procedures will be utilized. The U. S Food & Drug Administration (FDA), Office of Acquisitions and Grant Services (OAGS) requires custom prepared 96-well plates in accordance with the specifications identified herein. Inquires Offerors must submit all questions concerning this solicitation in writing electronically to
[email protected]. Questions must be received no later than August 9, 2021 1:00 p.m. Eastern Standard Time (EST). Any responses to questions will be made in writing, without identification of the questioner, and will be included in an amendment to the solicitation. Even if provided in other form, only the question responses included in the amendment to the solicitation will govern performance of the contract. BACKGROUND INFORMATION The mission statement for FDA’s Center for Veterinary Medicine (CVM) reads, “Protecting Human and Animal Health.” To achieve this broad mission, CVM: Makes sure an animal drug is safe and effective before approving it. The center approves animal drugs for companion (pet) animals, such as dogs, cats, and horses; and for food-producing animals, such as cattle, pigs, chickens, and even honey bees. If the drug is for a food-producing animal, before approving it, the center also makes sure that food products made from treated animals—meat, milk, eggs, and honey—are safe for people to eat; Monitors the safety and effectiveness of animal drugs on the market; Makes sure animal food—which includes animal feed, pet food, and pet treats—is safe, made under sanitary conditions, and properly labeled; Makes sure a food additive used in animal food is safe and effective before approving it; Conducts research that helps the center ensure the safety of animal drugs, animal food, and food products made from animals; and Helps make more animal drugs legally available for minor species, such as fish, hamsters, and parrots; and for minor (infrequent and limited) uses in a major species, such as cattle, turkeys, and dogs. To fulfill its mission, CVM’s Office of Research, Vet-LIRN requires two formats of custom prepared dehydrated 96-well plates filled with various concentrations of specified antibiotics in each well; identified below as Format #1 and Format #2. Format #1 plates are required to perform antimicrobial susceptibility testing on fish (aquaculture) isolates collected as a part of Vet-LIRN antimicrobial resistance (AMR) surveillance. Format #2 plates are required to perform antimicrobial susceptibility testing on aquatic bacterial (aquaculture) isolates collected from cultured fish and shellfish in order to generate interpretive criteria for antimicrobial resistance (AMR) surveillance. Note: Reference attachment titled, "RFQ 75F40121Q00105," for complete combined synopsis/solicitation.