Modification to Contract 75D30123C16444 (GMP Manufacturing of CDC FluSC2 Multiplex EUA Kit)

The Centers for Disease Control and Prevention intends to award a sole source firm fixed price modification to Biosearch Technologies, Inc. (2199 S McDowell Boulevard EXT, Petaluma, CA 94954). Contract 75D30123C16444 was awarded to Biosearch Technologies under the authority of FAR 6.301-1, - Only one responsible source and no other supplies or services will satisfy agency requirements. This contract provides for the manufacture of quantity 1,020 vials of oligonucleotide primers and probes per ISO 13485 utilizing Good Manufacturing Practices (GMP) as defined under 21 CFR 820. The required delivery date is 25 September 2023. CDC requires a modification to this contract to produce a second lot equating to 1,020 vials of the same oligonucleotide primers and probes per ISO 13485 utilizing Good Manufacturing Practices (GMP) as defined under 21 CFR 820. The estimated delivery date for this additional lot is 5 months from modification execution. Biosearch Technologies is the only source that can manufacture oligonucleotide primers and probes with specific internal BHQnova quencher design that is needed for the diagnostic FluSC2 Multiplex assay which is approved for Emergency Use Authorization (EUA) by the FDA in GMP ISO 13485 quality level. FDA will not allow any substitution of already approved essential materials that make up the assay which has been approved for EUA. Other sources can manufacture the FDA approved FluSC2 Multiplex assay, but that FDA approved assay does not provide for the specific internal BHQnova quencher design required under this acquisition. To date, CDC has not identified another company who has the capability to manufacture the probes with internal BHQnova quencher with the requisite quality and production capacity. This contract action (modification) is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302-1 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 proposals; however, all proposals/responses received within fifteen (15) days of the issuance of this notice will be considered by the Government. A determination by the Government to compete this proposed contract action (modification) based upon the 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 Mark Draluck at syq1@cdc.gov by 5:00 P.M. EST., 1 June 2023.