“Dynabeads Streptavidin M-280

The Centers for Disease Control and Prevention (CDC), Deputy Director for Non-Infectious Diseases (DDNID) National Center for Environmental Health (NCEH) intends to award a sole source firm-fixed price contract in the purchasing of 3 bottles of 100mL each of “Dynabeads Streptavidin M-280 used to isolate botulinum neurotoxin from clinical samples to Thermo Fisher Scientific, 168 Third Avenue, Waltham, MA 02451. All data obtained to date over the past 8 years has been obtained with these beads and to change the type of beads would invalidate experiments and data. We cannot be certain of the performance of other types of beads in our studies; we must have continuity of experiments and experimental data. This product meets our required quality specifications and allows us to remain compliant with CLIA regulations and CDC policies as we are using these beads to report results from clinical samples under a CLIA regulated method. ThermoFisher Scientific is the only manufacturer and vendor of Dynabeads. Dynabeads have a uniform spherical shape with highly defined and consistent product characteristics. This yields levels of reproducibility which are unmatched by other beads. This allows for highly reproducible results, yielding data which meets the division’s tight standards for reproducibility. The beads are indeed very uniform, with a coefficient of variation of less than 3%. In addition to yielding reproducible results, this also allows for a reduction in non-specific binding. Because we use these beads to isolate botulinum neurotoxin from highly complex matrices (like stool) the reduction in non-specific binding allows for a lower limit of detection of the neurotoxin. Additionally, the batch-to-batch reproducibility is less than 5%, meaning that each batch produced. The statutory authority for this sole source acquisition is U.S.C. 2304 (c) (1) in accordance with FAR Part 6.302-1 only one responsible source and no other supplies or services will satisfy the agency requirements. The NAICS code for this procurement is 324199 All Other Basic Organic Chemical Manufacturing, size standard 1250. No solicitation will be posted. This notice of intent is not a request for quote. A determination by the government not to compete the proposed purchase order based upon responses to this notice is solely within the discretion of the Contracting Officer. Interested parties who believe they possess the capability to satisfy this requirement should submit a capability statement demonstrating their ability to meet the requirement. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. All responses should be emailed to Mr. Philip Robinson at [email protected] using solicitation number 75D 301-20-Q-71280 in the subject line no later than 12:00 PM Eastern Standard Time, April 3, 2020.