The Centers for Disease Control and Prevention (CDC), National Center for Immunization and Respiratory Diseases (NCIRD), Influenza Division (ID) intends to publish a solicitation seeking vendors capable of manufacturing research use only (RUO) and in vitro diagnostic (IVD) quality dual-labeled hydrolysis oligonucleotide probes, using alternate quenching chemistries, for use with CDC influenza real-time RT-PCR assays. Development and manufacture of IVD tests in accordance with FDA regulations requires compliance with Title 21 of the Code of Federal Regulations (CFR).

The mission of the ID is the prevention of illness, suffering, and death from influenza in the United States and around the world. NCIRD/ID monitors and investigates influenza viruses that are the causative agent of influenza disease in humans. Surveillance and diagnosis of influenza can be supported by the use of in vitro diagnostic (IVD) tests that detect the presence of influenza viruses in clinical specimens and virus culture.

The CDC Influenza Division has developed numerous IVD tests that specifically detect known, circulating influenza viruses in humans and identify potentially new influenza viruses that emerge from avian and other animal sources. The ID has obtained FDA clearance for IVD diagnostic assays validated with oligonucleotide probes that contain specific chemistries.

The Government will perform formal on-site inspection of vendor facility during the manufacturing of sample probes. The purpose of the inspection is to confirm that proposing offerors meet or exceed FDA requirements for manufacture of IVD quality reagents in accordance with Good Manufacturing Practices (GMP) Quality System (QS) regulations. Compliance with GMP-QS regulations is an absolute vendor requirement for consideration of an award.

Vendors who have been determined to meet FDA requirements for manufacture of IVD quality reagents will be requested to produce three (3) small manufacturing lots of oligonucleotide primers and for inspection and acceptance or rejection by the government. The purpose of this evaluation to verify that the manufacturer's product can consistently meet the CDC's design specification, operate functionally within the CDC test system, and adhere to the CDC's quality process requirements and timeline.

Vendors found capable of manufacturing the required products IAW agency specifications will be eligible for award of an indefinite delivery-indefinite quantities (IDIQ) contract for production of future agency requirements. Anticipated award date is currently on or about 20 Sep 2013.

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