Notice of Intent to Sole Source.pdf

Notice of Intent to Sole Source

Subject: Fixed Price (FFP) Purchase Order Type for the procurement of an xMAP Reagents-Food Allergen Detection Assay Kit-non-Denatured-Sole Source as a Sole Source acquisition to Radix BioSolutions, Ltd, under Request for Quote RFQ-FDA-2021-1243272

Notice of Intent to Sole Source to: Radix BioSolutions, Ltd.

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 Radix BioSolutions, Ltd., located at:

Radix BioSolutions, Ltd. 111 Cooperative Way, Suite 120 Georgetown, Texas 78626 Phone: 512-869- 8000 Fax: 512-868-9040 Email: kgo @radixbiosolutions.com Attn: Dr. Kerry Oliver.

FDA requires an xMAP Reagents-Food Allergen Detection Assay Kit-non-Denatured.

In late 2013 the FDA issued a contract (HHSF223201310201C) to Radix BioSolutions (Georgetown, TX) for the development of a multiplex assay to support enforcement of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) and the Gluten-Free Regulation 2013. The xMAP Food Allergen Detection Assay developed by Radix BioSolutions was a single laboratory validated and its performance with various foods characterized as prelude to conducting MLV. This project specifically requires xMAP Buffered Detergent Food Allergen Detection Assay test kits. These kits are a unique product developed by Radix BioSolutions under FDA Contract # HHSF223201310201C and single laboratory validated per FDA Contract # HHSF223201510071A. The unique properties of these test kits were also extensively characterized in studies conducted by the FDA as published in the scientific literature (Anal Bioanal Chem. 2015, 407:4195-206; J Agric Food Chem. 2016, 64:1202- 1211) and in multiple international presentations. Substitution of the test kits is not acceptable.

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 Radix BioSolutions 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 06/10/2021. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov mailto:Emmanuel.mbah@fda.hhs.gov