SOURCES SOUGHT
B -- Test to Detect /Distinguish Sulfas and Antibiotics in Kidney or other Tissue
- Notice Date
- 4/3/2007
- Notice Type
- Sources Sought
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Agriculture, Food Safety and Inspection Service, Acquisitions and Agreements Section, 5601 Sunnyside Avenue, Mail drop 5230, Beltsville, MD, 20705, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- FSIS-13-B-07
- Response Due
- 5/4/2007
- Archive Date
- 5/19/2007
- Description
- Request for Information/Sources Sought Synopsis. The Food Safety and Inspection Service (FSIS), a public health regulatory agency of the U.S. Department of Agricultural (USDA), protects consumers by ensuring that meat, poultry, and egg products are safe, wholesome, and accurately labeled. The FSIS Midwestern Laboratory located at 4300 Goodfellow Blvd, Bldg 105-D, St. Louis, MO, performs regulatory testing for veterinary drug residues in animal tissues from livestock and poultry. This testing includes screening and confirming drug residues of the antimicrobial classes including, but not limited to, the sulfonamide group and classes of antibiotics such as tetracyclines, beta-lactams, aminoglycosides, and macrolides. These drugs are either banned or have limited use in food animals. The USDA, FSIS is seeking sources capable of providing the agency with a test(s), ideally a single test that is capable of detecting/distinguishing sulfas and antibiotics at the tolerance level in meat and poultry kidney and/ or other tissue. The test will be used to detect controlled or banned residues in food animal tissues as provided under the code of Federal Regulations Title 21 Parts 530 and 556, Title 40 and the Federal Meat Inspections Act, the Poultry Products Inspection Act and the Egg Products Inspection Act. The current test developed by FSIS is the Bioassay for the Detection, Identification, and Quantitation of Antimicrobial Residues in Meat and Poultry Products. The bioassay is a seven plate agar diffusion assay that can detect and quantitate a range of antibioitic residues in kidney. The bioassay test is capable of detecting beta- lactams, aminoglycosides, macrolides, and tetracyclines. While the bioassay is a good screen, it has certain limitations. The test is not reliable for the quantitation of certain drugs when used in combination, namely, when penicillin G occurs with other beta-lactams, and when neomycin occurs with other aminoglycosides. Tolerances for drugs in these classes may be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=556. A copy of the current bioassay method is located in Attachment 1 to this Request for Information/Sources Sought Synopsis. In the solicitation respondents will be asked to supply the FSIS with an automated test system to screen for antimicrobial residue classes in tissues, tissue extracts, blood and/or urine. FSIS will prefer one test, preferably something similar to a protein chip that screens and identifies the specific residue antimicrobial classes; sulfonamides, tetracyclines, beta-lactams, aminoglycosides, fluoroquinolones, cephalasporins, phenicols, macrolides, and other antimicrobials. The test must differentiate each of these drug classes when present in food animal tissue. The test system must have the capability to perform multi-analyte testing on single individual samples. The test system must have the ability to detect down to the part-per-billion (ppb) level for select drugs. The test system will be validated for use with the tissue matrices used for FSIS regulatory testing, which are currently liver, kidney and muscle tissues or tissue extracts from cattle, swine, poultry and egg products. In the solicitation respondents will also be asked to provide information on blood and urine tests. Test system validation results will need to be provided to FSIS. Where applicable, the validation data must include sensitivity, specificity, limits of detection, limits of quantitation, ruggedness and method uncertainty. The test must be on a scientifically recognized platform such as a 96-well plate or biochip format and be fully automated for ease of use. The test system must be such that one person can analyze 25-50 samples within 4 to 6 hours. Furthermore, the solicitation will require respondents to generate or submit data on a range of drugs from each compound class. Respondents will submit a description of the protocol used to determine the limits of detection, which should reflect tests run in an appropriate matrix (not water or buffer). The solicitation will ask respondents to describe the method used to determine the limits of detection, and the limits of detection for each drug or antimicrobial class tested. Limit of detection data on fluoroquinolones (enrofloxacin and danofloxacin), chloramphenicol, and florfenicol will also need to be submitted. A complete description of the procedure, along with estimated times required per analysis, will be required. This calendar year, FSIS will have run approximately 5,500 kidney bioassay tests. This number does not include liver and muscle tissues which are partially bioassayed if the kidney is positive. Due to the number of samples analyzed, FSIS requires the system and equipment to be user friendly and durable. Although, FSIS cannot identify how many kidney bioassay tests will be needed in the future, approximately 5,500 should be used as a guide if price estimates are requested. In consideration of the description of testing outlined in this sources sought synopsis, if you are a source capable of providing such a test please respond to this synopsis with your company information, business size, and a brief summary of applicable capabilities. Although other NAICS Codes may be considered, the anticipated code associated with this notice is 325414 and the size standard is 500 employees. This notice is NOT a request for proposals and the Government does NOT intend to pay for information submitted. Respondents will not be notified of the results of the evaluation of the information they provide. No contract award will be made on the basis of responses received; however, the information will be used in FSIS?s assessment of capable sources. Responses should be postmarked by 3:00pm EST on May 4, 2007. Mail three copies of your response to: USDA, FSIS, OM, ASD, AAS Attn: Crandall Watson 5601 Sunnyside Ave., 2-L188C, Maildrop 5230 Beltsville, MD 20705. Faxed responses are not permitted. Questions concerning this announcement may be submitted by 3:00pm EST on April 4, 2007 via email only to Crandall.Watson@fsis.usda.gov, no telephone inquires will be honored. AUTOMATIC NOTIFICATION: By registering to receive notification on posted synopses, you will be automatically notified via email of any changes to the project. To register, select Vendor Notification Service and follow the steps. [END OF TEXT]
- Record
- SN01264878-W 20070405/070403220155 (fbodaily.com)
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