The Food and Drug Administration (FDA) is conducting a market survey to assess the availability and potential technical capability of small businesses as defined by NAICS code 325413 to provide gram negative kits, gram positive kits, bacillus cards, and yeast cards for the Vitek® instrument at the FDA Northeast Food and Feed Laboratory. The Gram Negative kits, Gram Positive kits, Bacillus Cards, and Yeast cards are utilized by the Northeast Food and Feed Laboratory (NFFL) to identify microorganisms recovered from products regulated by the Food and Drug Administration (FDA). Products tested in the laboratory include, import foods and domestic products collected during establishment inspections of food processing facilities. These kits are an essential need to ensure that pathogens records are correctly identified in an accurate and timely manner. The kits must work flawlessly in the government owned Vitek instrument. The Laboratory has two Biomerieux VITEK 2 COMPACT instruments in service for which kits of test cards are needed to run the instrument to obtain results on confirming bacterial genus and species. Additionally, the majority of the methods employed by the Laboratory require the use of confirmation by VITEK 2 COMPACT in order to finalize results on regulatory samples of foods and cosmetics. The instrument is a VITEK® 2 COMPACT, manufactured by Biomerieux, serial numbers are #5083805 and #5147117. The Vitek instrument utilized in the laboratory is a data base driven system that requires specific test kits for identification of; yeast and mold, gram negative bacteria, gram positive bacteria and anaerobic microorganisms. The Vitek instrumentation utilized in the laboratory accurately identifies pure cultural isolates to genus and species providing a probability in percentage depending on the microorganism and card utilized for identification. Minimum Technical Requirements: Kits shall have an expiration date of at least six (6) months beyond their delivery dates Kits shall work seamlessly in the existing FDA-owned Vitek Instrument (VITEK® 2 COMPACT, manufactured by Biomerieux, serial numbers are #5083805 and #5147117) Shipments to the lab shall be of the same lot number These kits must be capable of testing pure culture to confirm the genus and species of enteric Gram-negative bacteria, Gram-positive bacteria, yeasts and bacillus isolates Deliverables Gram Positive Kits - 4 boxes/Bi-Month - 1st Day of the Month Beginning August 1, 2020 Gram Negative Kits - 6 Boxes/Bi-Month - 1st Day of the Month Beginning August 1, 2020 Yeast Cards - 1 boxes/Bi-Month - 1st Day of the Month Beginning August 1, 2020 Bacillus Cards - 1 Boxes/Bi-Month - 1st Day of the Month Beginning August 1, 2020 Inspection and Acceptance The COR will perform inspection and acceptance of reagents and services to be provided. The Project Officer – to be determined upon contract award - is the authorized representative of the Contracting Officer. The Government will accept goods, reports and services only if they conform to all terms and conditions of the SOW, and satisfy the performance standards developed under this SOW. The Government will reject non-conforming products and services. The Contractor shall correct any deficiencies within two 2 business days of when the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the Contractor shall immediately notify the COR of the reason for the delay and provide a proposed corrective action plan within 1 day via email. Shipping Destination Food and Drug Administration, Northeast Food and Feed Laboratory 158-15 Liberty Avenue Jamaica, NY 11433-1034 The delivery or services must be during regular business hours (Monday-Friday) during the times of 8:00 AM – 4:00 PM, excluding holidays. Period of Performance The Period of Performance is as follows: July 26, 2020 – July 25, 2021 Option Year 1 – July 26, 2021 – July 25, 2022 Option Year 2 – July 26, 2022 – July 25, 2023 Option Year 3 – July 26, 2023 – July 25, 2024 Option Year 4 – July 26, 2024 – July 25, 2025 The information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Respondents shall specify and document that their NAICS code is 325413 and provide proof of their business size. This is a request for information and shall not be construed as a solicitation or obligation on the part of the FDA for any future solicitation. Telephone inquiries will not be accepted. All interested parties shall submit their capability statements via email to be received by June 29, 2020, at 1:00 p.m Eastern Time, to the Contracting Office Address: Food and Drug Administration, Michael Gemmill, Contract Specialist,
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