This opportunity is closed.The response deadline was Sep 1, 2022.

HEALTH AND HUMAN SERVICES, DEPARTMENT OF / FOOD AND DRUG ADMINISTRATION / FDA OFFICE OF ACQ GRANT SVCS / FOOD AND DRUG ADMINISTRATION

xMAP Buffered-Detergent Food Allergen Detection Assay kits - NOTICE OF INTENT TO AWARD SOLE SOURCE

FDA-22-1255639ContractSpecial NoticeSAM.gov

Quick Facts

NAICS

325998

Set-Aside

Full & Open

Description

NOTICE OF INTENT TO AWARD SOLE SOURCE Project Title: xMAP Buffered-Detergent Food Allergen Detection Assay kits Announcement No: FDA-22-1255639 The Government hereby submits a notice of intent to award a sole source contract to RADIX BIOSOLUTIONS LLC for xMAP Buffered-Detergent Food Allergen Detection Assay kits. The total estimated value is less than $150K. This sole source contracting action a notice pursuant to FAR 5.203(a) for the requirement based on the application of FAR 6.302-1. This hereby constitutes a synopsis of this requirement. This is an award under NAICS 325998. RADIX BIOSOLUTIONS LLC. is the contractor who developed the initial multiplex assay (under contract HHSF223201310201C) 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 single-laboratory validated and its performance with various foods characterized as prelude to conducting a multi-laboratory validation. Responses to this notice shall demonstrate clear and convincing evidence that competition would be advantageous to the Government, would not be cost or time prohibitive, and would not hinder the mission objective of the FDA. The determination not to compete this proposed contract action solely within the discretion of the Government. Information received will normally be considered for the purposes of determining whether to conduct a competitive procurement. The Government will not be responsible for any costs incurred by responding to this notice. This is NOT a request for quotes or proposals. Questions or comments to this Notice of Intent should be directed to Contract Specialist, Elena Tatarov, at [email protected] (via email only) and within 7 days of the notice of intent posting date. Please indicate in the subject line of your email: Notice of Intent Questions Submission – FDA-22-1255639.