Notice of Intent to Sole Source.pdf

Notice of Intent to Sole Source

Subject: Fixed Price (FFP) Purchase Order Type for the Procurement for On-Going Work on Allergens Detection, to be Sole Sourced to Crystal Chem, Inc., under RFQ-FDA-2021-1243276-ELISA Kit Procurement for On-Going Work on Allergens Detection.

Notice of Intent to Sole Source to: Crystal Chem, Inc.

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) Type purchase order to Crystal Chem, Inc., located at:

Crystal Chem, Inc.

1536 Brook Dr # A, Downers Grove, IL 60515 Tel 630-889-9003 Fax 630-889-9021 http://www.crystalchem.com ATTN: Ms Hema Shah

FDA has a requirement for the procurement of ELISA Kit Procurement for On-Going Work on Allergens Detection, to be Sole Sourced to Crystal Chem, Inc., under RFQ-FDA-2021-1243276. Market research was conducted through Internet searches, and communication with manufacturers. Crystal Chem, Inc., was identifies as the only responsible source because they are the only manufacturer of the items, which are being requested and the manufacturer does not authorize third party providers. CFSAN is required to acquire a total of 28 MIoBS ELISA test kits. On a quarterly basis, the FDA will place orders for up to 7 MIoBS ELISA Test Kits.

The project for which this contract is being issued, requires MIoBS ELISA test kits. These test kits are unique in their sensitivity (0.3 µg/mL), specificity, and reliability as demonstrated in multi-laboratory validations (J Food Hyg Soc Japan 2004, 45:120; J AOAC Intl 2006, 89:1600; J AOAC Intl 2007, 90:427). In addition, the FDA has recognized the uniqueness of these test kits in the Gluten-free Regulation published in the Federal Registry ([Federal Register Aug 5, 2013, 78:47154-47179, Doc.

2013–18813), as official methods required for the analysis of regulatory samples (CMS or Sample # 57152, 116472, 123641, 136851, etc), required for use in FDA field assignments (DFPG Assignment No.: 14-14, ORA concurrence number is 2014041501; DFPG Assignment No.: 15-13), and cited in several scientific papers published by the FDA (J Food Prot 2015, 78:1167; J Food Prot 2015, 78:1237;

J Ag Food Chem 2015, 63:10525) The exclusive distributor of MIoBS ELISA test kits in the U.S. is Crystal Chem Inc. (Downers Grove, IL). Substitute ELISA test kits are not acceptable due to the unique features of the MIoBS ELISA test kits.

The associated NAICS Code is: 325413-In-Vitro Diagnostic Substance Manufacturing.

Template http://www.crystalchem.com/

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 Crystal Chem, Inc.., 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 08/25/2021. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov mailto:Emmanuel.mbah@fda.hhs.gov