SOLICITATION NOTICE
65 -- Notice of Intent to Award a Sole Source Contract for MIoBS ELISA Test Kits
- Notice Date
- 5/23/2017
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- 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
- FDA-SS-1183853
- Archive Date
- 6/20/2017
- Point of Contact
- Lisa K. Yaw, Phone: 2404024018
- E-Mail Address
-
lisa.yaw@fda.hhs.gov
(lisa.yaw@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Notice of Intent to Award a Sole Source Contract for MIoBS ELISA Test Kits The Food and Drug Administration intends to make a sole source award for MIoBS ELISA Test Kits in the amount of $38,920. The award will be made to: Crystal Chem, Inc. 1536 Brook Drive, Suite A Downers Grove, IL 60515 In accordance with FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. The FDA requires test kits in support of method development for the detection of undeclared food allergens and gluten. These test kits are unique in their sensitivity (0.3 μg/mL), specificity, and reliability as demonstrated in multi-laboratory validations. In addition, the FDA has recognized the uniqueness of these test kits in the Gluten-free Regulation published in the Federal Registry, as official methods required for the analysis of regulatory samples, required for use in FDA field assignments. The methods currently being employed by the FDA for regulatory enforcement involve the use of analyte specific ELISA technology to detect seven of the eight major food allergens; namely, egg, gluten/wheat, milk, peanut, tree nut (almond, hazelnut, and walnut), crustacean shellfish, and soy protein. The most sensitive of these methods are those developed by MIoBS (Morinaga Institutes of Biological Sciences, Inc.) with limits of detection (LOD values) of 0.4 g/mL. These MIoBS ELISA Test Kits have been demonstrated to be reliable in multi-laboratory validation studies besides required for the analysis of regulatory samples are used to visualize proteins in Western Blots and was cited in a proposed regulation for fermented and hydrolyzed gluten published in the Federal Register. Substitute ELISA test kits are not acceptable due to the unique features of the MIoBS ELISA test kits. The NAICS code for this action is 325413. This procurement is made under the authority of FAR 6.302- Only one responsible source and no other supplies or services will satisfy agency requirements. This is a notice of intent to issue an award on a sole source basis. This notice of intent is not a solicitation for competitive proposals. Any other firms desiring consideration must fully identify their interest and capability to provide this item to: Lisa Yaw Contracts Specialist Lisa.Yaw@fda.hhs.gov 240-402-4018 A determination by the government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. The projected award date is on or about June 5, 2017.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS-1183853/listing.html)
- Place of Performance
- Address: 5100 Paint Branch Parkway, College Park MD, 20740-3835, USA, College Park, Maryland, 20740, United States
- Zip Code: 20740
- Zip Code: 20740
- Record
- SN04518311-W 20170525/170523234730-a3beffe3064da14de6f94b1f19ae0489 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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