Botulinum Neurotoxin Standards for Immoassay Development

The Centers for Disease Control and Prevention (CDC), National Center for Zoonotic, Vector-Borne, and Enteric Diseases (NCZVED)/Division of Foodborne, Bacterial and Mycotic Diseases (DFBMD) intends to procure botulinum neurotoxin standards for immoassay development on a sole source basis from Metabiologics Inc., Madison, Wisconsin 53719. The North American Industry Classification System (NAICS) code for this requirement is 325411, Medicinal and Botanical Manufacturing, and the Small Business Standard Size is 750 employees. The Government intends to procure from only one source under the authority of FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. The National Botulism Laboratory Preparedness Team (NBLPT) requires purified dichain and complex toxins to perform quality control and performance evaluations of the Botulinum Toxin ELISA. NBLPT has performed previous quality control and performance evaluations with toxins procured from Metabiologics Inc and it would be impossible to properly compare performance evaluation results from lot to lot if toxins from another source were used. In addition, NBLPT will be developing a novel in vitro antitoxin potency assay in which antitoxin binding to toxin coated plates is measured. Metabiologics is the only vendor identified that produces such plates. This is not a request for competitive proposals, nor is a solicitation available. Any firm that believes it can furnish the items described above is encouraged to give written notification to the Contract Specialist within 15 days of the date of this synopsis. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the above requirements. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this proposed action, based on responses to this notice, is solely within the discretion of the Government.