SAM #FDA-SSN-133612

FDA Seeks Preventive Maintenance and Repair for Dionex and ECLIPSE ORBITRAP LC/MS Systems

This opportunity involves post-warranty preventive maintenance and repair services for specialized laboratory equipment at the FDA White Oak Campus: - Government Buyer: - U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) - On behalf of Center for Biologics Evaluation and Research (CBER) and Office of Vaccines Research and Review (OVRR) - OEMs and Vendors: - Dionex (manufacturer of the Ultimate 3000 NCS-3500RS NANO UHPLC system) - ECLIPSE ORBITRAP (manufacturer of the ETD Mass Spectrometer) - Products/Services Requested: - Preventive maintenance and repair services for: - Dionex Ultimate 3000 NCS-3500RS NANO UHPLC system - ECLIPSE ORBITRAP ETD Mass Spectrometer - Services must include: - Scheduled preventive maintenance - Unlimited corrective maintenance/repairs - Use of OEM-certified replacement parts - Access to OEM technical updates - Unlimited technical support - Detailed service records and reports - Unique/Notable Requirements: - All work must be performed by OEM-trained and certified service engineers - All parts and procedures must meet OEM specifications - Service must be provided at the FDA/CBER White Oak Campus, Building 52-72, room G310, Silver Spring, MD - Period of performance is one base year with two option years

Description

MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), is issuing this source sought announcement on behalf of the Center for Biologics Evaluation and Research (CBER). The purpose is to determine if there are existing small business sources capable of providing Post-warranty Preventive Maintenance and Repair Services on a liquid chromatography mass spectrometry (LC/MS) system. Vendors who are not small businesses, especially those who can offer domestic products, are also encouraged to submit a capability statement. This statement should include company information and demonstrate the ability to meet all minimum requirements listed below, including the country of manufacture of the products offered. If your firm qualifies as a small business under North American Industry Classification System (NAICS) Code 811210 - Electronic and Precision Equipment Repair and Maintenance, with a Small Business Size Standard of $34 million, and you believe your firm can provide the described supplies/services, please email Warren.Dutter@fda.hhs.gov. Background: The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) / Office of Vaccines Research and Review (OVRR), requires Post-warranty Preventive Maintenance and Repair Services for a liquid chromatography mass spectrometry (LC/MS) system, including a Dionex Ultimate 3000 NCS-3500RS NANO UHPLC system (SN: 8170238) interfaced with an ECLIPSE ORBITRAP ETD Mass Spectrometer (SN: FSN40119). This instrumentation is used by the FDA to investigate glycoconjugate-based vaccine antigen structures via mass spectrometry. A service agreement will ensure accurate experimental results, operational continuity, and protection of the government’s investment. This requirement covers one base year and two option years. The LC/MS system is currently operational but not under a service contract. System Components: Dionex Ultimate 3000 NCS-3500RS NANO UHPLC system (SN: 8170238) ECLIPSE ORBITRAP ETD Mass Spectrometer (SN: FSN40119) Preventive Maintenance and Repair Service Minimum Performance Requirements: The Contractor shall provide one (1) scheduled on-site preventive maintenance visit per year, including parts. The Contractor shall provide unlimited on-site corrective maintenance/repairs within 3 business days of a service call, where issues cannot be resolved remotely after 2 business days. Activities shall be performed by OEM-trained and certified service engineers, following OEM specifications, manuals, and service bulletins, using OEM-certified parts. The service plan shall include access to OEM technical developments, repair bulletins, and unlimited software, firmware, and application updates. The Contractor shall provide OEM-certified replacement parts. Technical support (via phone and email) shall be available Monday through Friday, 8:00 AM – 5:00 PM Eastern Time. All pricing shall be inclusive of labor, travel, parts, components, and subassemblies. Deliverables: Service Records and Reports The Contractor shall provide, after each service call (including warranty work), a field service report detailing equipment information, reason for service, work performed, tools used, technician contact info, on-site hours, and parts replaced. Additionally, a summary report shall be submitted to the FDA COR and Contract Specialist, covering all maintenance and repair activities. Place of Performance: US FDA/CBER, White Oak Campus Building 52-72, Room G310 10903 New Hampshire Avenue Silver Spring, MD 20993 Period(s) of Performance: Base Year: 07/01/2026 – 06/30/2027 Option Year 1: 07/01/2027 – 06/30/2028 Option Year 2: 07/01/2028 – 06/30/2029 Responses to this Sources Sought must demonstrate that the respondent is regularly engaged in selling similar services. While the target audience is small business vendors capable of supplying U.S. services, all interested parties may respond. At a minimum, responses should include: Business name, bio, UEI number, address, website, size status (e.g., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact, mailing address (if different), phone, and email. Provide this information again if responding on behalf of another firm. Past performance within the last 3 years, including sale date, description, dollar value, client info, and manufacturer details (including UEI and size status) if different from respondent. Descriptive literature, brochures, or marketing materials detailing the preventive maintenance services offered for the system. Technical information demonstrating the services meet the technical requirements. Identification of any relevant Best in Class (BIC) contracts or other government-wide contracts. GSA Schedule contract(s) and applicable SINs. If a large business, information on subcontracting opportunities for small businesses. Standard warranty and payment terms. Place of manufacture or service performance, and any other info relevant to Buy American and Made in America requirements. Pricing information (informational only). Note that the Government is not responsible for locating additional information. Interested contractors must submit capability statements via email to Warren Dutter at warren.dutter@fda.hhs.gov by April 13, 2026, at 1:00 PM Central Time. Reference: FDA-SSN-133612. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or pay for responses. The Government may use the information provided for any necessary purpose. Responses should be complete and detailed enough to demonstrate qualifications. Weblinks will not be opened or viewed. The Government is under no obligation to acknowledge receipt or provide feedback. A pre-solicitation synopsis and solicitation may be published later, but responses to this notice are not considered adequate responses to a solicitation. Confidentiality and Proprietary Information: No proprietary, classified, confidential, or sensitive information should be included. The Government reserves the right to use any non-proprietary technical information in future solicitations. Additional Notes: If the requirements seem restrictive, please submit comments. While this is not a request for quotes, pricing information would be helpful. This is a market survey for written information only; no solicitation or contract will result from this announcement. No costs incurred in responding will be reimbursed. No phone inquiries about RFQ packages or solicitations will be accepted. To protect procurement integrity, technical contact details will not be provided.

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