SPECIAL NOTICE
66 -- Notice of Intent to Award a Sole Source Contract for ELISA MIoBS Kits - FDA-SS-1165316
- Notice Date
- 4/27/2016
- Notice Type
- Special Notice
- 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-1165316
- Archive Date
- 5/26/2016
- Point of Contact
- Lisa K. Yaw, Phone: (240) 402-4018
- E-Mail Address
-
lisa.yaw@fda.hhs.gov
(lisa.yaw@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Notice of Intent to Award a Sole Source Contract for ELISA MIoBS Kits The Food and Drug Administration intends to make a sole source award to Crystal Chem, Inc. for ELISA MIoBS Kits to support its regulatory mission in accordance with FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. Food and Drug Administration, CFSAN has a requirement for ELISA MIoBS test kits in support of the Division of Bioanalytical Chemistry's (DBC) regulatory enforcement of the Food Allergen Consumer Protection Act of 2004 (FALCPA) and the Gluten-Free Regulation issued by the FDA on August 5, 2013. The detection of undeclared food allergens and gluten are necessary for the regulatory enforcement of the Food Allergen Consumer Protection Act of 2004 (FALCPA) and the Gluten-Free Regulation issued by the FDA on August 5, 2013. The FDA issued a final rule that established a regulatory definition of the term "gluten-free" and uniform conditions for its voluntary use in the labeling of packaged foods. Defining the term "gluten-free" will help consumers with celiac disease know what the term means when it is on a food or supplement package. 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. Current research to enhance FDA analytical methods in support of regulatory actions requires the availability and purchase of MIoBS ELISA Test Kits. The ELISA MIoBS kits are required for R&D in support of regulatory actions by the FDA, therefore it is critical that the test kits are those stipulated for use by the FDA and demonstrated to meet established needs of reliability and performance. As such, this contract specifically refers to, and requires ELISA test kits manufactured by MIoBS (Morinaga Institutes of Biological Sciences, Inc.) whose exclusive U.S. distributor is Crystal Chem, Inc. Alternative products or non-MIoBS recognized suppliers for the U.S. are not acceptable and counter to achieving the stipulated goals of the project as the regulation written and enforced by the FDA stipulates the use of MIoBS ELISA Test Kits. The period of performance will be for one base period plus two optional years. 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 this solicitation 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. 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 May 20, 2016.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS-1165316/listing.html)
- Place of Performance
- Address: 5100 Paint Branch Parkway, College Park, Maryland, 20740, United States
- Zip Code: 20740
- Zip Code: 20740
- Record
- SN04097900-W 20160429/160427235103-c4b02f040fd19505ca7d965dc0dc2a4f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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