SOLICITATION NOTICE
68 -- Bacteriological Media
- Notice Date
- 4/21/2010
- 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, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- F1071071
- Archive Date
- 5/21/2010
- Point of Contact
- William T. Lee, Phone: 3014435863, Doreen Williams, Phone: 301827-3366
- E-Mail Address
-
william.lee@fda.hhs.gov, doreen.williams@fda.hhs.gov
(william.lee@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-39. This solicitation is issued as a Request for Proposal (RFQ). This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 325413, is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following specifications, under the simplified acquisition procedures. This solicitation is posted Full and Open for all qualified businesses and will be awarded as a Firm Fixed Price Purchase Order. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. The Office of Regulatory Affairs (ORA) has requested the purchase of the following items: Brand Name or Equal ( Biomeriux, Inc.) 001: B8460, Lactose Broth in 500 ml Boston Round Bottles (101 mm x 225 mm glass); 12 Bottles per box, (120) EA. 002: 303050, Tetrathionate Broth with Brilliant Green, 10 ml Tubes (16 mm x 125 mm glass); 100 Tubes per box, (32) EA. 003: 42073, Rappaport Vassiliadis (RV) Medium, 10 ml Tubes (16 mm x 125 mm glass); 20 Tubes per box, (160) EA. 004: T8080, M Broth, 10 ml Tubes (16mm x 125 mm glass); 20 Tubes per box, (320) EA. The Detroit District High Throughput Microbiology Laboratory (HTML), Office of Regulatory Affairs (ORA), U.S. Food and Drug Administration (FDA) requires 720 liters of Lactose Broth, 32 liters of Rappaport Vassiliadis Medium, 32 liters of Tetrathionate Broth and 64 liters of M broth as an approximate one month supply of bacteriological media for the processing of environmental microbiological samples received from FDA field investigations. The majority of these investigations will determine the presence of and the potential for Salmonella adulteration of the U.S. food supply. The Detroit HTML will be receiving up to 600 environmental samples per day, four days per week, through 2010 as part of its defined work plan. These investigative samples will be collected chiefly from food processing firms, and Detroit HTML will receive and process samples from FDA ORA District Offices across the nation. The environmental samples will be analyzed for Salmonella, and regulatory actions could result, based on Detroit HTML analysis. All environmental samples received from field investigations will require enrichment (18 - 24 h), selective enrichment (18 - 24 h), and post-enrichment incubations (6 - 8 h) using the bacteriological media described above and as defined by official AOAC and FDA Bacteriological Analytical Manual methods. Under normal operating conditions, sample initiation will occur four days per week (Tuesday through Friday) with the Detroit HTML processing a maximum of 1,800 environmental samples during a 24 hour period. During emergency operations, the processing of environmental samples will occur seven days per week with media requirements also being increased. A dependable supplier/vendor with the ability to provide the required custom volumes of bacteriological media to the Detroit HTML under these emergency operations is necessary. The consistent supply of sterile bacteriological media in a timely fashion is essential to the Detroit HTML efforts to protect the U.S. food supply from Salmonella adulteration and thereby the American consumer from the threat of Salmonella poisoning. The on-time delivery of the above described microbiological media will allow the Detroit HTML to respond to emergencies in a timely, efficient and safe manner. The sterile, prepared media for Salmonella analyses of FDA investigative samples, must include Lactose Broth, Rappaport Vassiliadis Medium, Tetrathionate Broth with Brilliant Green and M Broth. The media must be validated and quality controlled to perform optimally in Biomerieux's VIDAS Salmonella detection system. The media must be provided sterile with a certificate of sterility, and in glass vessels of 500 ml for Lactose Broth, and 10 ml for RV, Tetrathionate and M Broths. These media will be essential for the proper analysis of environmental microbiological samples received from FDA field investigations. Once received, these official investigative FDA samples will be subject to AOAC approved methods of analysis that are further defined by the FDA's Bacteriological Analytical Manual. Under normal operating conditions, sample initiation will occur four days per week (Tuesday through Friday). Detroit HTML will be processing a maximum of 1,800 environmental sub-samples during a 24 hour period. During emergency operations, the laboratory will be operating 24 hours per day seven days per week. Thus bacteriological media may need to be supplied at a higher rate, than is specified, and the manufacturer/supplier should have the flexibility to increase this supply upon short but reasonable notice.. FOB: Destination DELIVERY SCHEDULE: 30 days after award EVALUATION AND AWARD: The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor "Meeting the Technical Requirements"; 2) Relevant Experience, 3) Price. Meeting the Technical Requirements is significantly more important than Relevant and price. The FDA intends to make an award immediately after the response of this notice. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures. CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to: william.lee@fda.hhs.gov no later than April 26, 2010, 4:30 p.m. EST. No phone calls will be accepted. QUOTATIONS DUE: All quotations are due, via email to: william.lee@fda.hhs.gov, no later than May 6, 2010, 4:30 p.m. EST. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.211-6, FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. FAR 52.217-9.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/F1071071/listing.html)
- Place of Performance
- Address: ORA, 300 River Place, Suite 5900, Detroit, Michigan, 48207, United States
- Zip Code: 48207
- Zip Code: 48207
- Record
- SN02127842-W 20100423/100421234516-e8ad1325543b5e83fae392a49e16ed49 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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