SPECIAL NOTICE
68 -- Bacteriological Media
- Notice Date
- 4/7/2010
- 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, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1071071
- Archive Date
- 4/29/2010
- Point of Contact
- William T. Lee, Phone: 3014435863, Doreen Williams,
- 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
- Document Type: Sources Sought Release Date: April 7, 2010 Response Date: April 14, 2010 at 4:30pm, EST via e-mail to Contract Specialist: William Lee at William.Lee@FDA.HHS.GOV Contracting Office Address: Food and Drug Administration 5630 Fisher Lane Rockville, Maryland 20857 Description: Sterile Prepared Bacteriological Media This is a Sources Sought to determine the availability and capability of small business (including certified 8(a), Small Disadvantage businesses, HUB Zone businesses; veteran-owned small businesses, and women-owned small businesses. This notice is being posted for fact finding and planning purposes only and shall not be construed as an Invitation for Bid, a Request for Proposal, Solicitation, Request for Quotes, or an indication the Government will contract for the items or services herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. The Government does not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this source sought. Any response received will not be used as a proposal. The FDA anticipates using a Firm Fixed Price Purchase Order. The NAICS code is 325413. The Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), Division of Acquisition Operations (DAO) is seeking to identify sources with capabilities and prior experience to provide a one month supply of Bacteriological Media: Brand Name or Equal (Biomerieux, 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. Part A. Capability and Technical Experience - Interested parties should submit capability statement describing adequate training and experience in scientific and technical appropriateness in reference to the potential work to be conducted in Part B. Size of Business - Please provide your business size (including certified 8(a), Small Disadvantage businesses, HUB Zone businesses; veteran-owned small businesses, and women-owned small businesses) and submit copies of any documentation such as letters of certifications to indicate the firm status. Part C. Organizational Conflict of Interest (OCI) - If any; provide disclosure of business activities of your company, your affiliates, and your team members and affiliates of your team members which create either a conflict of interest or the appearance of a conflict of interest in the performance of the possible work on evaluation listed above. Part D. Small Business - Describe your ability to meet the requirements in accordance with 52.219.14 - Limitation of Subcontracting. Responses shall adhere to the following: 1. Reference the Sources Sought number when submitting Capability Statement. 2. The capability statement shall be no more than five (5) pages in length. 3. The marketing materials shall not be included. 4. The capability statement shall be e-mailed to the attention of the Contract Specialist listed above. FDA makes no implied or in fact contract by issuing this Sources Sought document. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Material that requires a non-disclosure agreement or that may be business sensitive will not be accepted. Please note that responses to this notice will not be returned.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1071071/listing.html)
- Place of Performance
- Address: 300 River Place, Suite 5900, Detroit, Michigan, 48207, United States
- Zip Code: 48207
- Zip Code: 48207
- Record
- SN02114803-W 20100409/100407234750-4bfce78f8734b1a65cf321cce0b4316f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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