Intent to Sole Source Good Manufacturing Practices (GMP) Influenza A Primer Kits
Closed Pre-Solicitation Posted
- Solicitation number
- 75D301-26-Q-78825
- Agency
-
CDC Office of Acquisition Services
Centers for Disease Control and Prevention, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 325413 In-Vitro Diagnostic Substance Manufacturing
- Place of performance
- Petaluma, California 94954, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Centers for Disease Control and Prevention (CDC), specifically the National Center for Immunization and Respiratory Diseases Influenza Division, intends to award a sole source, firm fixed price purchase order to procure Good Manufacturing Practices (GMP) Influenza A Primer Kits. These oligonucleotide reagents must meet GMP quality standards as defined under 21 CFR 820 and will be manufactured using a validated process to support the CDC's genomic surveillance of influenza viruses through multi-segment reverse transcription polymerase chain reaction (M-RTPCR) testing. The primary objective is to establish a contract that provides specifically designed oligonucleotide primers capable of amplifying all eight gene segments of Influenza A viruses in a single-step reaction. While this notice indicates an intent to sole source to Biosearch Technologies Inc., firms believing they can meet the requirement are encouraged to submit a written capability statement to contract specialist Dawnnia Daley at xwf5@cdc.gov by February 9, 2026, at 5:00 p.m. ET to be considered. No competitive solicitation will be posted on SAM.gov; however, the government will remain open to alternative sources through this capability statement process prior to award.
This procurement carries no set-aside designation and is currently directed toward Biosearch Technologies Inc., located at 2199 S McDowell Boulevard EXT, Petaluma, CA, 94954, as the identified sole source contractor. The notice does not specify the contract award value, budget range, or quantity of primer kits required, leaving these details to be determined during negotiations with the selected contractor. The procurement falls under NAICS code 325413 (In-Vitro Diagnostic Substance Manufacturing) and PSC code 6550 (In Vitro Diagnostic Substances, Reagents, Test Kits and Sets), reflecting the specialized nature of the diagnostic reagent manufacturing involved. The pre-solicitation notice was posted on January 26, 2026, with a deadline of February 9, 2026, for firms to express interest through written capability statements.
Notice text
The Center for Disease Control and Prevention (CDC), National Center for Immunization and Respiratory Diseases Influenza Division (NCIRD/ID), intends to award a sole source, firm fixed price purchase order in accordance with FAR 13.101(b), soliciting from a single source, to Biosearch Technologies Inc., Address: 2199 S McDowell Boulevard EXT, Petaluma, CA, 94954, for Good Manufacturing Practices (GMP) Influenza A Primer Kits. The purpose of this acquisition is to establish a contract to meet the current requirements for specifically designed oligonucleotide reagents of GMP quality level as defined under 21 CFR 820. The Contractor will manufacture oligonucleotide primers using their validated process. The NAICS code for this procurement is 325413, In-Virtro Diagnostic Substance Manufacturing.
The Influenza Division of the Centers for Disease Control and Prevention (CDC) monitors and investigates influenza viruses that are the causative agents of influenza disease in humans. Genomic surveillance of influenza can be supported by Research Use Only (RUO) tests that amplify influenza viruses in clinical specimens and virus culture, and use this amplified material for genomic sequencing. The Influenza Division has created a method of amplifying all eight gene segments of Influenza A viruses in a one-step multi-segment reverse transcription polymerase chain reaction (M-RTPCR) reaction.
As a result of this notice, no competitive solicitation will be posted on SAM.gov. The government will issue and negotiate only one solicitation to Biosearch Technologies Inc. However, firms that believe they can meet this requirement are encouraged to identify themselves and give written notice by providing a capability statement to the contract specialist, Dawnnia Daley, at xwf5@cdc.gov by February 9, 2026, at 5:00 p.m. ET. The contract specialist will not respond to verbal requests. All requests must be in writing.
A determination by the government not to take this proposed action will be based on responses to this notice and is solely within the discretion of the contracting officer. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Inquiries shall reference the solicitation number, 75D301-26-Q-78825, on the subject line and be sent to Dawnnia Daley by email at xwf5@cdc.gov.
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