MODIFICATION
66 -- Food Allergen Multiplex Assay
- Notice Date
- 12/27/2012
- Notice Type
- Modification/Amendment
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA-SS-1113543
- Point of Contact
- Christopher R. McGucken, Phone: 3018277161
- E-Mail Address
-
christopher.mcgucken@fda.hhs.gov
(christopher.mcgucken@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Food and Drug Administration (FDA) Food Allergen Multiplex Assay The Food and Drug Administration (FDA) of the U.S. Department of Health and Human services (DHHS) is conducting a market survey to seek potential sources from qualified small business firms under North American Industry Classification (NAICS) Code 541711 (Research and Development in Biotechnology) for food allergen detection from food samples. An antibody-based technology that has shown a high level of reliability with sensitivities comparable to or better than ELISAs is xMAP technology. This bead-based technology has been demonstrated to be reliable in the detection of various proteinaceous toxins in foods (Garber et al. 2010) with a throughput exceeding ELISA test kits since each analytical sample can be simultaneously screened for multiple analytes and subjected to a confirmatory test process. Further, by employing antibodies used in ELISA test kits and dipsticks, the properties of the antibodies are already known. This eliminates some of the evaluative processes necessary before a method can be adopted and makes the method compatible with other methods currently being employed by the food industry and contract labs. The instrumentation for xMAP technology, the Bio-Plex (Bio-Rad Laboratories, CA, USA) or Luminex 100/200 System (Luminex Corp., TX, USA) is currently available to most FDA field labs. The objectives for the FDA’s Food Allergen Muliplex Assay are as follows: Establish a commercial product line for the detection and confirmation of the presence in food of egg, gluten/wheat, milk, peanut, crustacean shellfish, soy, or tree nut (e.g., almond, hazelnut, walnut, Brazil nut, cashew, coconut, macadamia, pistachio) allergens to support the regulatory enforcement of the Food Allergen Consumer Protection Act of 2004 (FALCPA) and the Gluten-Free regulation currently under review by FDA senior management; The FDA is looking for qualified firms willing and capable of assembling these assays to achieve these objectives. Minimum qualifications include: Demonstrated evidence of experience employing X-MAP validated methods in application to food allergens. -or- Demonstrated evidence of experience employing ELISA antibodies in relation to the testing for food allergens. Note: While a qualified contractor does not have to have prior experience in both of the above areas, it is expected that subcontracting will be utilized in the assembly of the assays. Interested SMALL BUSINESS ONLY should submit their capability statements )no more than 10 pages in length to: Christopher R. McGucken, Contract Specialist, Food and Drug Administration, Office of Acquisitions and Grant Services, 5630 Fishers Lane, Rockville, MD 20851 or Christopher.Mcgucken@fda.hhs.gov, no later than 12pm (noon) EST on January 14 th, 2013. Generic capability statements will be considered non-responsive. Capability statements must be tailored to this request and identify the source’s capabilities to complete this requirement including information on key staff experience and education, and a description of corporate experience with similar projects.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA-SS-1113543/listing.html)
- Record
- SN02956218-W 20121229/121227234103-cd560bf8beadf0cc89dd775882dca66e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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