This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation and a written solicitation will not be issued. “Brand Name or Equal product only”. The following FAR Clause applies: Clause 52.211-6 - Brand Name or Equal (AUG 1999) This requirement is “Subject to the Availability of Funds” The Following FAR Clause applies: AVAILABILITY OF FUNDS (52.232-18) (APR 1984) This synopsis, NAICS code 334516, identified as REQ 1241778 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. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the beta.sam.gov website for the release of any amendments to this solicitation. Hard copies will only be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. Purchase of One (1) Antibiotic Zone Reader and 1,500 Flat Face Peni Cylinders “Brand Name or Equal” Background The Food and Drug Administration (FDA), Pacific Southwest Medical Products Laboratory (PSMPL) conducts a range of microbiological analyses on medical products to determine if they meet United States Pharmacopeia (USP} and other regulatory requirements. The laboratory requires an instrument capable of reading and measuring the zones of clearance for antibiotic potency testing and 1,500 flat face peni cylinders to perform USP Chapter 81 testing. Purpose/Objective The instrument and peni cylinders are required in order to perform antibiotic potency testing on pharmaceutical products in accordance with USP Chapter 81. Requirements I. The contractor shall provide a Trinity V3 Antibiotic Potency Zone Reader or equivalent, including all necessary supplies, equipment, components, adapters, software, power supply, plates; accessories, etc. to seamlessly install, set-up, and test. The antibiotic zone reader instrument shall meet or exceed the following requirements: • Equipped with a high-resolution digital camera capable of reading zones of clearing on agar surfaces in accordance with USP Chapter 81, refer to Attachment A. • Includes an integrated computer processing unit and software capable of recording the diameters for the zone of clearing and performing the calculations required by USP Chapter 81 such as plate corrections, relative standard deviation, and percent relative standard deviation, compute standard curve data, linear regression analysis and a determination of potency and % label claim for the unknown sample. • Included software must be capable of generating an analytical report displaying standard curve data such as correlation coefficient, slope, y intercept, plate readings and corrected values, and final determination of unknown sample potency. • Includes integrated computer touch screen measuring at least 22". • Instrument must be compatible with 120V electrical outlets. • Include inside delivery and validation documentation for installation qualification, operational qualification and performance qualification of the instrument. II. The contractor shall provide 1,500 flat face peni cylinders must meet or exceed the following specifications • Comprised of stainless steel • Dimensions: Inner diameter: 6mm+/-1mm; Outer diameter: 8mm+/-1mm and Length: 10mm+/-1mm. Trade and Service Specifications 1. The instruments must be a newly manufactured unit, not used and refurbished or previously used for demonstration. 2. Contractor is responsible for a turn-key solution to meet the requirements, purpose and objectives listed herein. 3. The entire system must be warranted for parts and labor for a minimum of 12 months from the date of formal government acceptance. The vendor must also be capable_ of servicing the instrument through the covered warranty period. The system must include at least a one (1) year warranty and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, factory-certified replacement parts, engineer labor and travel costs. Any equipment repair and maintenance work shall be performed by an OEM-trained engineer. This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) access to all current OEM factory parts, not build-to-order parts. The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in repairs must be guaranteed, factory-tested, OEM quality parts. 4. Instrument operators shall have access during the warranty period to a technical representative call center at no additional charge, for technical assistance and trouble-shooting, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument. 5. All standard information on the equipment, including but not limited to User Manuals, Operation and Maintenance (O&M) Manuals, Safety Data Sheets (SOS), troubleshooting guides, and any other applicable documentation, shall be provided upon installation of the system. Deliverables or Delivery Schedule One (1) Antibiotic Zone Reader and a quantity of 1,500 Flat Face Peni Cylinders meeting the requirements stated above shall be deliver within 90 calendar days from award date. Delivery will be accepted during regular business hours (Monday-Friday) during the times of 8:00 AM - 4:00 PM Pacific Time. Inspection and Acceptance Upon arrival, the shipping container will be inspected for damage. If significant damage is observed, such as a hole going through the container and packing to reach the. enclosure itself, it will be rejected. Place of Performance Ship to: POC: To be determined at time of award FDA/PSMPL 19701 Fairchild. Irvine, CA 92612 Period of Performance Total Contract Period of Performance is One Year which includes the Systems Warranty period. The Government will award a contract resulting from this solicitation to the responsible quoter as a fixed‐price contract on the lowest price technically acceptable (LPTA) evaluation method. Award will be made on the basis of the lowest evaluated price meeting or exceeding the non‐cost factor (technical conformance to the requirements of the solicitation). The Quoter’s initial quotation shall contain the Quoter’s best terms from a price standpoint. Failure to demonstrate meeting any of the requirements will result in a rating of technically unacceptable and will not be considered for award. FAR provisions can be found on the following website: http://Acquisition.gov The following provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors-Commercial Items; 52.225-2 Buy American Certificate; 52.212-4 Contract Terms and Conditions-Commercial Items; 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items including subparagraphs: 52.222-3, Convict Labor 52.222-19, Child Labor-Cooperation with Authorities and Remedies 52.222-21, Prohibition of Segregated Facilities 52.222-26, Equal Opportunity 52.222-36, Affirmative Action for Workers with Disabilities 52.222-50, Combating Trafficking in Persons 52.225-1, Buy American Act--Supplies 52.225-13, Restrictions on Certain Foreign Purchases 52.232-33, Payment by Electronic Fund Transfer-Central Contractor Registration. In order to facilitate the award process, ALL quotes shall include a statement regarding the terms and conditions herein. Additionally, all quotes shall include price (s); FOB point; a poc (name and telephone number); a statement from the offeror verifying that they are Registered in SAM under NAICS code; ___delivery date (delivery date is of the utmost importance); business size; and payment terms. Delivery shall be to FDA. FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email to
[email protected] and be received by 5:00 PM (1700) on May 29 2021 to the attention of Mary Rose A. Nicol,
[email protected] . Offerors shall ensure the RFQ number is visible in the header of the email. ALL QUESTIONS REGARDING THIS SYNOPSIS/SOLICIATION MUST BE SUBMITTED IN WRITING NO LATER THAN 5:00 PM (1630) EST ON June 2, 2021. FAX QUOTES SHALL NOT BE ACCEPTED.