Notice of Intent to Sole Source XCR Diagnostics, Inc.

The Centers for Disease Control and Prevention’s Department of National Center of Emerging and Zoonotic Infectious Diseases intends to award a sole source firm-fixed price purchase order to XCR Diagnostics, Inc., for primers and probes and positive controls for the Laboratory Response Network Clostridium botulinum polymerase chain reaction assay. XCR Diagnostics’ products have been subjected to a thorough internal and external validation and changing to a new manufacturer would necessitate repeating a lengthy validation to ensure future results are in concordance with expectations for assay performance. It is therefore essential that we continue to order primers and probes and positive controls for this assay from the same manufacturer. No other products meet the specifications required because some of the oligonucleotide components of the PCR assays are proprietary and cannot be reproduced or substituted by another vendor. This contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b) and 41 U.S.C. 3304(a)(1). Interested persons may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive quotations; however, all quotations/responses received within ten (10) days of the issuance of this notice will be considered by the Government. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Any quotation/response should be emailed to the Contract Specialist at [email protected] by 13:00 EST 09 April 2021.