THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT, IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE. The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) has issued this sources sought announcement on behalf of the Office of Regulatory Affairs (ORA) in order to determine if there are existing sources capable of providing Brand Name or equal Biomerieux Vitek Immunodiagnostic Assay System (VIDAS) Salmonella, Listeria and QCV (Quality Control Verification) kits. If your firm is considered a source under North American Industry Classification System (NAICS) code 325413, In-Vitro Diagnostic Substance Manufacturing, and you believe that your firm would be able to provide the FDA with the products described below, please submit an email to
contact@example.gov. The company must identify whether or not it is a Small Business and demonstrate how it can meet all of the minimum performance requirements. Background The 10 FDA/ORA field laboratories currently perform over 120,000 individual analyses for the presence of pathogens in food. Isolates from these samples are identified and confirmed as pathogens using the VIDAS instrument manufactured by BioMerieux. ORA requires Salmonella, Listeria and QCV kits for continued analysis. Minimum Performance Requirements: - Test kits must be compatible with existing VIDAS instrumentation. - Test kits must be ready-to-use Solid Phase Receptacle (SPR) coated with antibodies against Salmonella, and Listeria specific antigens - Assay strips must contain 10 wells, be foil-sealed and labeled o Labels must contain a barcode that identifies assay code, kit lot number and expiration date o Strip Well 1 must be empty for sample, control or standard introduction and have perforated foil for ease of sample introduction o Strip well 2 must contain 400 uL of prewash solution o Strip wells 3-5 and 7-9 must contain 600 uL of wash buffer o Strip well 6 must contain 400 uL of conjugate o Strip well 10 must contain a cuvette with substrate in which a flourometric reading can be performed - Kits must contain: o Assay standard and controls containing purified and inactivated organism specific antigen + preservative + protein stabilizer o Assay positive controls o Assay specific confidence interval o Assay negative control containing TRIS with buffered saline and tween, pH 7.6 o Specification sheet containing the factory master calibration data required for test calibration on the instrument used for pathogen detection - Kits must allow assay interpretation using existing VIDAS automated readers and store all pertinent lot and reagent information within the reader Responses to this sources sought shall demonstrate that the respondent is regularly engaged in the sale of same or substantially similar supplies. All interested parties may respond. At a minimum, responses shall include the following: - Business name and bio, DUNS number, business address, business website, business size (if Small Business or not and status if Small Business (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. - Past Performance information for the manufacturer and/or sale of same or substantially similar supplies to include date of sale, description, dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent. - Descriptive literature, brochures, marketing material, etc. detailing the nature of the supplies the responding firm is regularly engaged in manufacturing and/or selling. - If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested. If a large business, provide if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non?proprietary technical information in any resultant solicitation(s). Interested Contractors must respond with capability statements via email to
contact@example.gov on or before July 10, 2015 by 3:00pm EST. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre?solicitation synopsis and solicitation may be published in FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation.
