SPECIAL NOTICE
65 -- Food allergen detection kits
- Notice Date
- 8/28/2018
- 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
- 1199538
- 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 food allergen detection kits to Radix BioSolutions, Ltd., 111 Cooperative Way, Suite 120, Georgetown, Texas 78626. 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 FDA has been mandated to enforce the Food Allergen Labeling Consumer Protection Act of 2004 (FALCPA) and develop and enforce the Gluten-free Regulation of 2013. To support enforcement of these Laws and Regulations, the Office of Regulatory Science commissioned and help develop a multiplex assay for the simultaneous detection of food allergens and gluten, xMAP Food Allergen Detection Assay (xMAP FADA). The xMAP FADA was developed as a result of a competitive award issued to Radix BioSolutions of Georgetown, TX. Since, development of the xMAP FADA, the FDA has conducted single-laboratory validation, extensive in-house research peer-reviewed scientific publications (below) and approximately 10 presentations], and multi-laboratory validation in conjunction with the Canadian Government, USDA-FSIS, private industry, and all ORA laboratories involved in food allergen and gluten testing. The kits being ordered under are to evaluate the xMAP FADA with dietary supplements as prelude to establishing its performance utility with this class of products. Radix is only one manufacturer of the xMAP FADA and the use of intermediary distributors jeopardizes the performance (e.g., reliability) of the test kits. 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/1199538/listing.html)
- Record
- SN05060780-W 20180830/180828231814-faabb91b945690e3bde373f8dff5c648 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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