MODIFICATION
A -- Flow cytometry pathogen-specific reagents for detection of Vibrio spp., Staphylococcus aureus, and Campylobacter spp. in food - Solicitation 1
- Notice Date
- 6/5/2009
- 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 Field Finance & Acquisition Services, HFT-320, 3900 NCTR Road, Jefferson, Arkansas, 72079-9502
- ZIP Code
- 72079-9502
- Solicitation Number
- FDA-09-223-SOL-00048
- Archive Date
- 7/21/2009
- Point of Contact
- Nicholas E Sartain, Phone: 870-543-7370
- E-Mail Address
-
nick.sartain@fda.hhs.gov
(nick.sartain@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Solicitation The project consists of developing three novel flow cytometric reagents for detecting pathogenic bacterial agents in food. The targeted agents are Campylobacter spp.; Staphylococcus aureus, and Vibrio spp. This procurement will be open to all sources. The applicable North American Industry Classification System (NAICS) code is 541711-Research and Development in Biotechnology and the Small Business Size Standard is 500 employees. The period of performance is 365 calendar days after notice of award for product development. The IDIQ portion period of performance will be 365 calendar days after successful product development. The resulting contract will be a firm-fixed price type. The anticipated release date of the RFP is on or about June 5, 2009. The solicitation will be available for download on FedBizOpps website when the RFP is issued. Scope of Work Independently and not as an agent of the government, the contractor shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things necessary for or incident to the performance of the work set forth herein. The contractor shall develop three novel flow cytyometric reagents for detecting pathogenic bacterial agents in food. The targeted agents are Campylobacter spp., Staphylococcus aureus, and Vibrio spp. These reagents must fluoresce under 488 nm excitation and produce a strong signal in a typical cytometric FL1 channel (525nm) but not significantly in FL2 or FL3 regions. The finished product shall also include additional modifiers that eliminate or significantly reduce assay-confounding auto-fluorescence from the food particles. The finished product of each reagent that can cytometrically detect and count each of the three target pathogens while meeting relevant inclusivity, exclusivity, competitive, linearity, and quantitative detection limit criteria, as well as the capacity to exclude food matrix signal interference for food products with which each target pathogen is commonly associated (e.g. - Campylobacter in pork, Vibrio in seafood, Staphylococcus in raw milk). Acceptable detection of a single CFU can be achieved by a four hour culture in TSB under agent-optimal incubation conditions from a 100 level inoculation followed by 5 uM filtration or other minimal sample preparation, <15 minute incubation followed by flow cytometric detection in 250 L of the TSB. Linear dynamic range should be 4 logs or greater. The "Competitive" criterion means that the target organism is correctly detected and counted in up to a 106 excess of a typical non-pathogenic bacterial food contaminant. Inclusivity and exclusivity specifications vary with each agent but mean: • for inclusivity, successful detection of those pathogenic species and strains of each target that are typically found in the US human food supply. • for exclusivity, lack of signal from non-target bacterial organisms commonly found in the same foods as the target. Schedule of Items Item No. Description 01- Development of Campylobacter spp. reagent as specified. 02- Development of Vibrio spp. reagent as specified. 03- Development of Staphylococcus aureus reagent as specified. This is a level of effort term item in accordance with FAR 16.207. After successful product development there will be an IDIQ portion to the contract. The government will require delivery for the reagents to multiple locations, on multiple dates over a one year period. IDIQ 01 Campylobacter spp. reagent as specified. Minimum quantity 750 IDIQ 02 Vibrio spp. reagent as specified. Minimum quantity 600 IDIQ 03 Staphylococcus aureus reagent as specified. Minimum quantity 600 The solicitation will be awarded based on best value (FAR 15.101-1); therefore, proposals will be evaluated on technical merit, cost effectiveness and past performance. Competitive formal source selection procedures will be used in accordance with FAR 15.3. Technical/management and past performance when combined are approximately equal in importance to cost or price in determining the best overall value to the Government. 1-Technical/Management Criteria: a. Product sample to demonstrate successful product development. This shall be accomplished by one of two methods. ---weight 40% (1) by providing a workable sample of each product development reagent that can cytometrically detect and count each of the three target pathogens while meeting relevant inclusivity, exclusivity, competitive, linearity, and quantitative detection limit criteria, as well as the capacity to exclude food matrix signal interference for food products with which each target pathogen is commonly associated (e.g. - Campylobacter in pork, Vibrio in seafood, Staphylococcus in raw milk); or (2) show the technical capability to develop such products, by providing a workable reagent that can cytometrically detect within four hours one cell of a typical food-borne gram negative or gram positive bacterium in two of the following food matrices. 1. a leafy green vegetable. 2. hamburger 3. peanut butter 4. chili peppers. b. Demonstrate ability and understanding of the Scope of Work.---Weight 30% (i) Technical approach and work plan to accomplish the development of the target bacteria reagents. (ii) Offeror/management commitment in development of novel reagents for food analysis by flow cytometry. c. Demonstrate technical experience of projects of similar size, scope and complexity.-Weight 30% (i) The proposed staffing plan and the qualifications and experience of proposed personnel will be evaluated for relevancy to the work to be performed. (ii) Prior Corporate experience performed during the last 3 years will be evaluated for relevancy - the degree to which the prior projects are similar in size, scope and complexity. 2-Past Performance a. How well the offeror has performed on previous projects of similar size, scope and complexity. (i) Projects that have been completed in the last 3 years. Offerors will be evaluated on how well they have performed on previous projects of similar size, scope, and complexity. Projects must have been completed in the last 3 years. The Government's evaluation of the offeror's past performance shall be a subjective assessment based upon information supplied by the offeror in response to this solicitation. The Government may also utilize information, which may be available from a variety of other public and private sources that have useful and relevant information. This criterion will include, but is not necessarily limited to, factors such as: • Quality of Service • Timeliness of Performance • Price Control • Business Relations - The Past Performance Factor evaluation will assess the relevance and breadth of the Offeror's experience and the quality of the Offeror's past performance at satisfying its customers. The Government is seeking to determine whether the Offeror consistently delivers quality services in a timely and cost effective manner. Only recent experience within the last three (3) years will be considered in this evaluation. Offerors without a record of relevant past performance or for whom information on past performance is not available may not be evaluated favorably or unfavorably on past performance and shall be rated neutral on Factor 2 - Past Performance. Offerors will be ranked based on the responses to the past performance questionnaires received from their references, as well as information obtained from any other sources. Offerors past performance will be assigned a pass rating, neutral rating or a fail rating based on the past performance scores. 3-Price
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA-09-223-SOL-00048/listing.html)
- Place of Performance
- Address: 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN01837876-W 20090607/090605235915-809804eb629ce0cadbb9988ea693aadb (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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