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 King Fisher APEX96 Deep Well Instrument for DNA Lysate Prep as a Sole Source acquisition to Life Technologies Corporation, under Request for Quote RFQ-FDA-2021-1243355.

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 Life Technologies Corporation., located at:

3175 Staley Road Grand Island New York 14072 USA Fax No.: 1-800-331-2286 USA To Order: 1-800-955-6288 USA www.thermofisher.com.

Email: NA1nstrument0rders@thermofisher.com or Fax it to 877-680-2537.

FDA requires King Fisher APEX96 Deep Well Instrument for DNA Lysate Prep. FDA used the MagMAX Express96 instrument to prepare DNA from 1,000 μl sample in 96 wells format using protocols in the laboratory that have been validated with Applied Biosystems™ MagMAX™ kits and reagents. FDA uses the MagMAX Express96 instrument to prepare DNA from 1,000 μl sample in 96 wells format using protocols in the laboratory that have been validated with Applied Biosystems™ MagMAX™ kits and reagents. While the King Fisher Flex96DW is the updated version of the MagMAX Express96, the KingFisher Apex 96DW is the upgraded version, being able to store the samples at 4°C after processing, thus limiting DNA degradation in the samples, and with internal UV lights to decontaminate the instrument between sets of samples. Therefore, FDA wants to acquire the King Fisher Apex 96DW. The broken MagMax Express96 will be traded in with the King Fisher Apex 96DW. In addition, protocols in the laboratory have been validated with Applied Biosystems™ MagMAX™ kits and reagents so FDA is seeking for an instrument to process up to 1,000 µl sample in 96 wells format.

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 Life Technologies Corporation 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 06/20/2021. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov mailto:Emmanuel.mbah@fda.hhs.gov