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 Center for Biologics Evaluation and Research (CBER) in order to determine if there are existing small business sources capable of providing Preventive Maintenance and Repair Services for a Hamamatsu NDP NanoZoomer slide scanning system (S/N: 000104). If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 811219 - Other Electronic and Precision Equipment Repair and Maintenance; Small Business Size Standard is $22 million and believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to
[email protected]. The vendor should include information about the company and demonstrate that it can meet all of the minimum performance requirements. Background: The FDA/CBER/ Microscopy and Imaging core facility requires Preventive Maintenance and Repair Services for a Hamamatsu NDP NanoZoomer slide scanning system. The service shall cover the entire Hamamatsu NDP NanoZoomer system, including microscope and objective lens, stages and slide holders and cassette, any robotics-related parts and accessories, as well as light and fluorescent light sources, focusing module, cubes, filters, cables, cameras, time delay integration sensors, fluorescent module, software, and any system-related accessories and instrument computer workstation. Minimum Performance Requirements: The Contractor shall provide two (2) scheduled on-site planned preventive maintenance visits per year to inspect/maintain Hamamatsu NDP NanoZoomer system including objective lens, stages, filters, cubes, sensors, robotics-related parts, slide holders and cassette, focusing modules, cables, cameras, light sources, and any system related accessories, instrument control computer workstation including fluorescent module. The Contractor shall provide unlimited On-Site Corrective Maintenance/Repairs within 3 business days of call for service where problems cannot be resolved remotely after 2 business days. All Preventive Maintenance and repairs shall be performed on-site by formally trained and certified technicians/service engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc. The Contractor shall include software updates and training /support when available. The Contractor shall provide factory-certified replacement parts. The Contractor shall include unlimited technical support (via phone and email) on software and hardware and troubleshooting with the equipment issues, Monday through Friday (excluding Federal Holidays) 8:00 AM – 5:00 PM Eastern Time. The contractor must provide scheduled and Emergency services between the hours of 8:00 AM – 5:00 PM Monday through Friday (excluding Federal Holidays) Eastern Time. All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc for the system. The contractor shall provide the loaner parts and/or instrument until repair is finished without limitation of loaner time, within five business days of original on-site repair attempt. The contractor shall provide all shipping arrangements inclusive of packaging without extra cost if repairs are to be made to any instrument component off-site from the instrument location. 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 (7/13/2022-7/12/2023) Option Year 1 (7/13/2023-7/12/2024) Option Year 2 (7/13/2024-7/12/2025) Option Year 3 (7/13/2025-7/12/2026) Delivery Location: FDA/CBER 10903 New Hampshire Ave. Silver Spring, MD 20993 Though the target audience is small business vendors or small businesses capable of supplying a U.S. service of a small business vendor or producer all interested parties may respond. At a minimum, responses shall include the following: Business name and bio, unique entity identification (UEI) 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 again if responding to provide a service offered by another firm. Past Performance information for the manufacturer and/or sale of same or substantially similar product and service or similar brand instruments 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 UEI number and size status) if not the respondent. Descriptive literature, brochures, marketing material, etc. detailing the nature of the product and service the responding firm is regularly engaged in manufacturing and/or selling. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered services meet the technical requirements identified above. The offeror shall advise if the product and/or service is on a Best in Class contract. If applicable, the offeror shall clearly identify where the offered product is made. 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. Standard commercial warranty and payment terms. Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed. Informational pricing is desired. The Government is not responsible for locating or securing any information, not identified in the response. Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before May 13, 2022 by 1:00 PM Central Time at the Food and Drug Administration, Field Operations Branch, FDA | OO | OFBA | OAGS | DAP, Attn: Warren Dutter, email
[email protected]. Reference: FDA-SSN-112280. 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). Additional Notes: If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.