The Centers for Disease Control & Prevention (CDC) intends to solicit and negotiate a sole source contract with Biosearch Technologies, Inc. 2199 S McDowell Boulevard, Petaluma, CA 94954. This notice is provided in accordance with FAR 5.203(a). The CDC, Office for Laboratory Systems and Response (OLSR), as part of national preparedness, supplies PCR kits to the Laboratory Response Network (LRN) network. This nationwide program is comprised of over 100 LRN laboratories that have the capability to detect potential biothreat and emerging infectious disease agents. LRN reagents are used by state and local public health, FDA, USDA, EPA, DOD, and neighboring international laboratories. The LRN’s purpose is the detection, analysis, and reporting of biothreat agents and biological agents causing any emergency public health problem. Because of the rapid and successful growth of the LRN, the amount of reagents required to supply and sustain the member laboratories to conduct testing has increased. If we are unable to purchase these proprietary reagents, the Government’s ability to respond to a biothreat or emerging infectious disease will be severely impaired. Failure to procure these will compromise response capability of agencies such as the EPA, USDA, FBI, DHS, and others depending on LRN capacity to accomplish their own preparedness and response missions. This LRN requirement currently includes production of up to thirty-three different PCR kit types. Manufacturer shall meet the minimal quality standards defined by FDA in 21 CFR820 for the production of in vitro diagnostic devices. The Contractor shall perform the following Technical Requirements: a. Ensure by documentation that primer and probe sequences remain confidential and proprietary information and as the exclusive and secure property of the Government. b. Assure by documentation that primer and probe sequence information never leaves the manufacturing facility, is never shared with a third party, and that the information remains secure within the Contractor’s facility. c. Provide all raw materials and labor to produce kits. d. Provide packaging materials and pay shipping to the Government. e. Produce and submit pilot batches of 6 kits for each kit type. Pilots will be evaluated within three (3) weeks at CDC. f. Supply completed batch (the order quantity) after pilot approval and receipt of authorization to ship. Delivery schedule will be identified on individual delivery orders. g. Allow all lots to be Quality Control (QC) tested/inspected by the Government prior to acceptance and payment. h. Package and ship finished goods in compliance with Government requirements and/or shipping/packaging instructions. The primer and probe kits are vital tools used in high-security laboratories authorized by the Centers for Disease Control and Prevention (CDC), such as Laboratory Response Network (LRN) and Biowatch laboratories, for the detection of potential bioterrorism agents. These kits must adhere to the Quality Systems Regulations (QSR) of the Food and Drug Administration (FDA) for real-time PCR primer and probe kits. They are specifically designed to identify bioterrorism agents such as Y. pestis, B. anthracis, Variola, F. tularensis, Burkholderia, Brucella species, and others. Each kit is required to contain one or more unique signatures, utilize probes with Black Hole Quencher technology, and be manufactured in accordance with QSR requirements. The authority permitting other than full and open competition is FAR 13.501. Biosearch Technologies, Inc. is the only entity capable of completing this requirement because they are the sole licensed and authorized supplier for producing BHQ probes for clinical applications. All responsible sources may submit a capability statement, proposal, or quotation to Matthew Nelson, Contract Specialist, at
[email protected], which shall be considered by the agency. The deadline for submissions is November 7, 2024, at 3:30 PM EST. The Government will review any/all information submitted to determine if other responsible sources exist that could provide this requirement. Information received in response to this announcement will be used solely for the purpose of determining whether to conduct a competitive procurement.