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#1254703 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. Background: The U.S. FDA, San Juan Laboratory in the Office of Regulatory Science, Office of Medical Products, Tobacco, and Specialty Laboratory Operations is a Pharma Specialty Laboratory. Many Pharmacopeial articles either are hydrates or contain water in adsorbed form. As a result, the determination of the water content is important in demonstrating compliance with the Pharmacopeial standards. The San Juan Laboratory performs titrimetric water determinations as a part of routine regulatory sample analyses. The San Juan Laboratory needs to replace an obsolete Karl Fischer that is more than 10 years in use. Objectives: To acquire a “Brand Name or Equal Karl Fischer Titrator with an Automated Autosampler” to replace a manual Karl Fischer Titrator that is obsolete in the market and starting to show chemical and mechanical wear. The Karl Fischer Titrator with an Automated Autosampler that has the capability of determining the water content in up to fifty samples unattended, improving the reproducibility and integrity of the sample results and saving analytical time. The automated system is a closed system, improving safety, eliminating contact with solvents. New technology minimizes solvent and energy consumption, reduces analytical time, reduces operating costs, and produces electronic reports and records. Scope/Requirements/Deliverables: The Contractor shall provide all resources necessary to accomplish the tasks and deliverables described in this Statement of Work (SOW). The Contractor shall provide a “Brand Name or Equal Karl Fischer Titrator with Automated Autosampler” and the additional components, accessories, and services to meet the requirements below. Salient Performance Characteristics: “The Brand Name or Equal Karl Fisher Titrator and Automated Autosampler” which shall meet or exceed the following specifications: Karl Fischer Titrator (KFT) Professional Function License that includes: Liquid handling Measure U/T/pH/Conc Calibration Endpoint titration without conditioning Monotonic equivalence point titration Dynamic equivalence point titration Parallel dosing Parallel titration Dosing module with additional burette Sample robot module with two sample rack plates 16 x 120 mL Equipped with main lift and at minimum, one gripper Built in magnetic stirring functionality 2-channel peristaltic pump: rinsing and aspiration pump Shall include 32 PTFE magnetic stir bars (16 mm) Shall include a minimum of 32 brown glass 120 mL sample titration beakers Shall include 32 lids with seals for 120 mL sample beakers for volumetric Karl Fischer Titration Shall include at least two connection tubing, minimum 150 cm, with light protection, kink protection and attached connection fittings Shall include a double fixed cable Pt-wire electrode for KFT and the adapter cable socket connectable to the analog measuring module Shall include an analog measuring module for the connection of analog electrodes Shall include an autosampler titration head for KFT Shall include a lid tray for sample robot Shall include a centering adapter for 120 mL sample beakers Shall include 2 MDL connector cables Shall include 2 network cables Shall include 43-65 mm gripper fingers Shall include intelligent 10 mL cylinder unit with dosing tubing and anti-diffusion tip. Shall include instrument controller (computer) with, at minimum: Windows 10 – 64 bit or better OS Processor i5 or better Microsoft Home and Business 8 GB of RAM 500 GB Hard Drive or better 1 GB Ethernet port DVD RW Drive 22” monitor or better Mouse and keyboard USB to Ethernet adapter for PC 4-port VPN GB Ethernet router Cable USB (OTG) Mini B PI-USB All required connection and power cables Shall include current Karl Fischer and Autosampler software and instrument licenses and current instrument firmware Shall include inside delivery Shall dispose all shipping materials including pallets, carton, plastics, wood, etc. and removal from the facility premises. Shall include installation Shall include start up and verification of installation and operation Shall include inside delivery Shall include training for 5 – 7 users Shall include training for 2 administrators Trade and Service Specs: Equipment shall be newly manufactured, not used, refurbished, or previously used for demonstration. The contractor shall provide a minimum of a one-year manufacturing warranty for all manufactured equipment and parts. The warranty shall be included with the equipment and not separately priced. The warranty 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 original equipment manufacturer (OEM) trained engineer. The service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in PM and repairs must be guaranteed, factory-tested, OEM quality parts. FDA shall have access to a technical representative call center, Monday through Friday, at no additional charge, for technical assistance and troubleshooting. The contractor shall ensure that the call center is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument. The contractor shall provide training and validation of the instrument at the time of installation. The contractor shall ensure complete training for 5-7 users and 2 administrators. The contractor shall provide Installation/Operation Qualification (IQ/OQ) certification. The qualification and verification report shall include the standard operating procedures and the allowed manufacturer limits for the instrument. A copy of the calibration report and the qualification and verification report(s) shall be reviewed and approved by the COR. The contractor shall provide installation to include inside delivery, disposing pallets, boxes, and any associated garbage, and unpacking the equipment and inventory of parts with a lab representative. Inside delivery and shipping charges shall be included. Documentation Requirements: Installation/Operation Qualification Documentation Instrument Manuals Training certificate for users and administrators Training certification for trainers Repair Service and Documentation: The Contractor shall repair or replace any part or parts under the warranty that prove to be defective at no additional charge to the Government. For repairs that fall under the warranty, the Contractor shall plan for the fastest delivery for parts and will schedule service upon receipt of parts within 72 business hours (3 days) upon COR approval. All replacement parts shall be from the original manufacturer and will be installed to the original manufacturers’ specifications. At the completion of any warranty service and contracted services, the contractor shall provide a written service report to the SJNL COR and/or COR designee. This report shall clearly indicate the date of the service, the type of service performed the model and serial number(s) of the equipment serviced, the name of the field service technician, a brief description of the service performed and copy of the calibration certificate of any reference material used. Deliverable Table/Period of Performance: Deliverable Quantity Due Date Karl Fischer, automated autosampler, and accessories 1 Within 6-8 weeks after date of award Installation and Operation Qualification 1 Within 6-8 weeks after date of award Installation and Operation Qualification Documentation. 1 Within 6-8 weeks after date of award Training (5 - 7 users, 2 administrators) and completion certificates for users 1 Within 6-8 weeks after date of award Instrument Manuals 1 Within 6-8 weeks after date of award Inside Building Delivery with Same Day unpacking and transport to operation location. 1 Same Day of Delivery Disposition of Shipping Materials 1 Same Day of Delivery Inspection and Acceptance: The COR and/or COR designee will perform inspection and acceptance of equipment, installation, and services to be provided. The COR and/or COR designee – to be determined upon contract award. A final inspection and acceptance of all work performed, reports and other deliverables will be performed by the COR and/or COR designee to ensure the services/products provided meet the requirements of the Statement of Work (SOW), and the Contractor shall make changes as requested during the inspection and acceptance process. Inspection and acceptance will occur at the place of performance and take place within five (5) business days of task being completed. The Government will provide written notification of acceptance or rejection within five (5) business days. Inspection will include review of the deliverables to ensure adequacy. 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 fifteen (15) business days of when the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this period, the Contractor shall immediately notify the COR of the reason for the delay and provide a proposed corrective action plan within five (5) business days. Place of Performance: Food and Drug Administration, 466 Fernandez Juncos Avenue, San Juan, PR 00901-3223 Unless, otherwise specified, the Contractor shall perform work Monday through Friday (excluding Federal Holidays) between the hours of 8:00 a.m. and 4:30 p.m. EST. Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day. Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) due to inclement weather. Contracting Officer Authority The Contracting Officer (CO) is the sole person authorized to make or approve any changes in any of the requirements of this order and notwithstanding any provisions contained elsewhere in the order, the said authority remains solely with the CO. In the event the Contractor makes any changes at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in the delivery order terms and conditions, including price. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the order and modify any term or condition of the order. The CO is the only individual who can legally obligate Government funds. The Contracting Officer’s Representative (COR) or Project Officer is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the order price, terms or conditions. The COR/Project Officer is responsible for the technical aspects of the project and serves as technical liaison with the contractor and is responsible for the final inspection and acceptance, and such other responsibilities as may be specified in the order. Contract Type Firm-Fixed-Price (FFP). Government Contacts Contracting Officer: (CO): Office of Acquisitions Grants and Services Mary Rose A. Nicol, CO Phone: 240-402-7606 Email:
[email protected] Contracting Office Representative (COR): TBD Government Holidays January (New Year’s Day) September (Labor Day) January (Martin Luther King Day) October (Columbus Day) February (President’s Day) November (Veterans Day) May (Memorial Day) November (Thanksgiving Day) July (Independence Day) December (Christmas Day) Vendor must call the COR at least 48 hours prior to delivery. Unless otherwise specified, deliveries shall be made inside to the Delivery Point specified above, Monday through Friday (excluding Federal Holidays see below between the hours of 8:00 a.m. and 4:00 p.m. in accordance with the delivery location time zone (Atlantic Standard Time). Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day. Delivery must be inside the laboratory facility. The San Juan Laboratory has no equipment to assist transporting the equipment form the delivery truck to inside the building. The contractor is responsible for planning and transporting the equipment to inside the building. The laboratory does not have a holding area; therefore, the contractor is responsible for removing packaging materials and presenting the equipment to the operation site the same day of the inside delivery . Period of Performance: The period of performance shall be 12- month from the date of award which includes a 12- month warranty period . The Instrument isnto be inside delivered no later than 6-8 weeks after date of award. SALIENT CHARACTERISTICS All the following are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated by the Government. **Offerors shall address each of the salient characteristics in order to be considered.** BASIS OF AWARD 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.gov under NAICS code; 334516 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 quotes must be submitted via email to
[email protected] and be received by 5:00 PM (1700) on May 8, 2022 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 (1700) EST May 2, 2022. FAX QUOTES SHALL NOT BE ACCEPTED.