SPECIAL NOTICE
65 -- MIoBS Test kits
- Notice Date
- 8/28/2018
- Notice Type
- Special Notice
- NAICS
- 334513
— Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- 1199416
- Archive Date
- 9/10/2018
- Point of Contact
- SUSAN BECHTEL, Phone: 3013481921
- E-Mail Address
-
SUSAN.BECHTEL@FDA.HHS.GOV
(SUSAN.BECHTEL@FDA.HHS.GOV)
- Small Business Set-Aside
- N/A
- Description
- The Food and Drug Administration (FDA) intends to award a Sole Source firm-fixed price purchase order for a MIoBS ELISA Test Kits with Chrystal Chem Inc., 955 Busse Road, Elk Grove Village, IL 60007. In accordance with FAR part 6.302-1, the contractor is the only responsible source who can provide the required supplies needed to satisfy the agencies requirements. 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 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) Please email responses to Susan Bechtel at susan.bechtel@fda.hhs.gov by September 9, 2018
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1199416/listing.html)
- Record
- SN05060826-W 20180830/180828231826-954896599a9f82811d06910aa0068754 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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