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SAMDAILY.US - ISSUE OF APRIL 28, 2023 SAM #7822
MODIFICATION

65 -- GMP Manufacturing of CDC FluSC2 Multiplex EUA Kit

Notice Date
4/26/2023 12:16:14 PM
 
Notice Type
Justification
 
NAICS
325413 — In-Vitro Diagnostic Substance Manufacturing
 
Contracting Office
CDC OFFICE OF ACQUISITION SERVICES ATLANTA GA 30333 USA
 
ZIP Code
30333
 
Solicitation Number
75D30123C16444
 
Archive Date
05/26/2023
 
Point of Contact
Mark Draluck, Phone: 7704880938, Devin Barich
 
E-Mail Address
syq1@cdc.gov, uca9@cdc.gov
(syq1@cdc.gov, uca9@cdc.gov)
 
Award Number
75D30123C16444
 
Award Date
04/26/2023
 
Description
CDC awarded contract number 75D30123C16444 to Biosearch Technologies, Inc., 2199 S McDowell Boulevard EXT, Petaluma, CA 94954, on 26 April 2023, in the amount of $399,993.00. This notice makes available a Justification and Approval for Other than Full and Open Competition (J&A) that applies to this contract. This contract was issued under the authority of FAR 6.302-1, 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.� In accordance with the attached J&A, 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. The attached J&A is being made available within 14 days of contract award in accordance with FAR 6.305(a) and will remain active for 30 days in accordance with FAR 6.305(d)(3).�
 
Web Link
SAM.gov Permalink
(https://sam.gov/opp/a71d247741944ec1b3c3cda9c9183401/view)
 
Place of Performance
Address: Petaluma, CA 94954, USA
Zip Code: 94954
Country: USA
 
Record
SN06662682-F 20230428/230426230104 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

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