Notice of Intent to Sole Source.pdf

Notice of Intent to Sole Source

Subject: Fixed Price (FFP) Purchase Order Type for the procurement of a QIAcuity Digital PCR System as a Sole Source acquisition to Qiagen LLC, under Request for Quote RFQ-FDA-CFSAN- 2022-111986-1253985

Notice of Intent to Sole Source to: Life Technologies Corporation.

Pursuant to the authority of 41 USC 3304(a)(1), as implemented by Federal Acquisition Regulation (FAR) Subpart 6.302-1, (there is only one responsible source, and no other supplies or services will satisfy agency requirements). The Food and Drug Administration (FDA) intends to award a Sole Source Fixed Price (FFP) Purchase Order Type to Qiagen LLC., located at:

19300 Germantown Road Germantown, MD 20874-1415

US Orders: 800-426-8157 Fax: 800-718-2056

FDA requires a QIAcuity Digital PCR System-Sole. The QIAcuity digital PCR {dPCR) instrument by QIAGEN is based on a unique nanoplate microfluidic technology and is designed to perform fully automated nucleic acid absolute quantification across life science research. The requested instrument has 5 channels on one plate for multiplexed target detection, as well as a barcode scanner to identify the nanoplate ID, which is scanned by the barcode reader that is integrated inside the instrument. The Qiagen QIAcuity instrument has multiple models that adjust to different sample sizes, making it suitable for the different work performed at the Office of Applied Research and Safety Assessment (OARSA), based on the pathogen and sample experimental designs. Also, this instrument does not require separate acquisition of software and data (other comparable instruments require in software and data acquisition separately). Software and data acquisition (if not done automatically) can interfere with some lab analyses when or if the software’s gets new or continuous updates.

The QIAcuity digital PCR {dPCR) instrument by QIAGEN, combines user-friendly workflow for reaction set-up and rapid, walk-away automated performance of the entire digital PCR process consisting of partitioning, amplification and imaging for maximum operator convenience. Sample, target and fluorophore information can be easily imported using sample input templated using QIAcuity dPCR Software Suite, whereas each of the nanoplate ID is identified by scanning its barcode by the barcode reader integrated inside the instrument. Monitoring the process and instrument status from remote is available with the QIAcuity dPCR Software Suite in case instrument and Software are located in the same local network.

QIAGEN certifies, that it is the only supplier of the following QIAcuity digital PCR instruments and that all instruments and related instrument/service bundles are solely distributed by QIAGEN subsidiaries and official QIAGEN distributors, with no thirty party re-sellers.

The associated NAICS Code is: 334516-Analytical Laboratory Instrument Manufacturing.

This notice is not a request for competitive proposals. However, any party that believes it is capable of meeting this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.

It is anticipated that an award will be issued to Qiagen LLC., within approximately fifteen (15) days after the date of this notice unless the Government determines that any other organization has the capacity to meet this requirement.

Response Date: 12:00 p.m. EST 04/23/2022. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov mailto:Emmanuel.mbah@fda.hhs.gov