MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Division of Biological Standards and Quality Control (DBSQC) requires one (1) base year of Post-warranty Preventive Maintenance and Repair service agreement for a Thermo Fisher Liquid Chromatography-Mass Spectrometry (LC-MS) system, plus an additional four (4) option years of Post-warranty Preventive Maintenance, and Repair service. The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the services described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort: The associated North American Industry Classification System (NAICS) Code is 811219 - Other Electronic and Precision Equipment Repair and Maintenance; Small Business Size Standard is $22 million. The LC/MS System includes the following: Thermo Fisher Fusion Orbitrap ETD mass spectrometer (SN:FSN10307) Dionex HPLC system: UltiMate 3000 binary RSLnano pump, SN: 8092526 UltiMate 3000 LPG-3400RS, SN: 8092496 Instrument controlling computer and software programs (Xcalibur and DCMSlink for Xcalibur) The system currently covered under a preventive maintenance and repair service agreement until 3/04/2022, contract HHSF223201710041A. Minimum Performance Requirements: The Contractor shall provide unlimited on-site preventive maintenance repairs on the HPLC and Mass Spectrometer, which includes all parts, labor and travel for any preventive maintenance. The repairs shall be completed within 3 business days of call for service where problems cannot be resolved remotely after 2 business days All Preventative Maintenance (PM) and repair activities shall be performed by formally trained and certified technicians/engineers. Engineers must be certified by Thermo Fisher Scientific, familiar with Dionex nano HPLC system and Thermo’s Fusion Orbitrap ETD mass spectrometer. Vendors are expected to have past or current service experiences with the Orbitrap Fusion mass spectrometer and DionexHPLC with a nano pump and an auto-sampler. All repair and services shall be performed following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins using OEM replacement parts, components subassemblies, etc. iii) All parts must be OEM certified. The Contractor shall maintain the computer controlling the instrument and provide software program updates and notification without charges. Pricing for all repair and PM services shall be inclusive of labor, travel, replacement parts, components, subassemblies etc. Shall include unlimited technical support (e.g., telephone-based, emails-based, website-base, etc.), Mondays – Fridays (excluding Federal Holidays) between the hours of 7:00 AM – 5:00 PM Eastern Time. Service Records and Reports - the Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended, and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA COR and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed. Period of Performance: Base Year: 03/05/2022 to 03/04/2023 Option Year 1: 03/05/2023 to 03/04/2024 Option Year 2: 03/05/2024 to 03/04/2025 Option Year 3: 03/05/2025 to 03/04/2026 Option Year 4: 03/05/2026 to 03/04/2027 Place of Performance: FDA/CBER Building 52/72, Room 1106 10903 New Hampshire Avenue Silver Spring, MD 20993. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered product/services meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying services of a small business, all interested parties may respond. At a minimum, responses shall include the following: Business name, DUNS number, business address, business website, business size status (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 (Provide this same information if responding to provide a product manufactured by another firm); Sufficient descriptive literature that unequivocally demonstrates that offered service can meet the above requirements. All descriptive material necessary for the government to determine whether the service offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. Past Performance information shall include recent (within the last 3 years) and relevant (prior experience information for the same or substantially similar Preventive Maintenance and Repair service agreement. For each past performance reference include the date of service, description of service provided and the manufacturer name and model of the equipment serviced, 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 company (to include DUNS number and size status) if not the respondent. Documentation, if not the manufacturer of the equipment identified herein, of technical competency on the operation and repair of the brand name equipment. Such documentation should include certification from the original equipment manufacturer or other training certificates within the past calendar year. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement. Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment. If a large business, identify the subcontracting opportunities that would exist for small business concerns; Standard commercial warranty and payment terms; and Though this is not a request for quote, informational pricing is encouraged. The government is not responsible for locating or securing any information, not identified in the response. The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before November 8, 2021 by 1:00 PM (Central Time in Jefferson, Arkansas) to
[email protected], Reference: FDA-SSN-1249580. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures. Disclaimer and Important Notes 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 SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation. 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).