MARKET RESEARCH PURPOSES ONLY - NOT A REQUEST FOR PROPOSAL OR SOLICITATION This is a Sources Sought notice to determine the availability of SAM.gov-registered small businesses capable of supplying the preventive maintenance and repair services for the instrument system(s) described herein. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposal, Request for Quotation, or an indication the Government intends to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a small business set-aside is possible. The appropriate NAICS code for the acquisition is 811210 - Electronic and Precision Equipment Repair and Maintenance, Small Business Size Standard – $30 million. Requirement The U.S. Food and Drug Administration (FDA) Office of Acquisitions and Grants Services (OAGS) presents this Sources Sought Notice (SSN) on behalf of the Center for Biologics Evaluation and Research (CBER) to identify existing small businesses capable of providing preventive maintenance and repair services for a Thermo Electron nano-UHPLC Orbitrap Fusion Lumos ETD mass spectrometer system, Serial Number: FSN20419, configured to include the following components: Thermo Electron nano-UHPLC Orbitrap Fusion Lumos ETD mass spectrometer system, Serial Number: FSN20419; Dionex Ultimate 3000 NCS-3500RS Nano LC system, Serial Number: 8134209; Dionex WPS-3000TPL RS Autosampler, Serial Number: 8135195. The Government requires a base year and two (2) option years of these services to commence upon expiration of an existing agreement on 3/16/2023. If your firm is considered a small business source under North American Industry Classification System (NAICS) 811210–Electronic and Precision Equipment Repair and Maintenance, Small Business Size Standard of $30 Million, and believe that your firm is capable of providing these services, please submit a capability statement by e-mail to
[email protected]. by the date and time specified above, providing all information as required below. Background The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Division of Bacterial, Parasitic and Allergenic Products (DBPAP) functions within the Office of Vaccine Research and Review (OVRR), whose mission is to protect and enhance public health by assuring the availability of safe and effective vaccines, allergenic extracts, and other related products. In pursuit of this mission, allergenic extract preparations are used for the diagnosis and treatment of allergic diseases such as asthma. In the United States, FDA’s CBER regulates over 1,200 allergenic products licensed for clinical use. Of this total, only 19 are standardized for potency; CBER has a long-standing mission to expand this list because standardization substantially improves product safety and efficacy by providing consistent allergen protein measurement in extract preparations. Current standardization approaches involve a combination of measuring biological potency and total allergenic activity using skin testing and immunochemical based ELISA assays. It is now widely recognized that these techniques are inadequate to sufficiently address the complexity of allergenic products. However, new, sophisticated technologies based on nano-UHPLC-high resolution mass spectrometry (known as LC/MS) offer unique, cutting-edge capabilities to improve and expand this list of standardized products. A critical tool utilized in this DBPAP research is a Thermo Electron Lumos Orbitrap Fusion ETD Mass Spectrometer which provides the necessary high resolution and accurate mass to meet our research requirements for extract standardization. This instrument system is currently covered under a preventive maintenance-repair service agreement through 3/16/2023; accordingly, DBPAP requires a follow-on agreement to ensure proper functioning of the system for the foreseeable future. The required agreement consists of a base year and two (2) option years of service. Minimum Technical Requirements are as follows for a Thermo Electron nano-UHPLC Orbitrap Fusion Lumos ETD mass spectrometer system, Serial Number: FSN20419, configured to include the following components: Thermo Electron nano-UHPLC Orbitrap Fusion Lumos ETD mass spectrometer system, Serial Number: FSN20419; Dionex Ultimate 3000 NCS-3500RS Nano LC system, Serial Number: 8134209; Dionex WPS-3000TPL RS Autosampler, Serial Number: 8135195. *Shall include one (1) planned on-site preventive maintenance visit for each covered instrument for routine preventive maintenance; *On-site response time of 3 business days from receipt of FDA service request (repairs only); *Shall include unlimited on-site repair services by factory-trained and certified engineers within 3-5 days of reported problem; *Access by the FDA Technical Representative (TR) and system operator personnel to the manufacturer’s call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting a particular instrument or piece of lab equipment; *Priority access to technical support (e-mail and telephone) Mondays - Fridays (excluding Federal Holidays) between the hours of 8:00 AM - 5:00 PM Eastern (Prevailing) Time; *All maintenance and repair service activities shall be performed by factory-trained and certified technicians and/or engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.; *Software upgrades, firmware, and hardware updates as required by the OEM; *All preventive maintenance and repair service pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc. Service Records and Reports *The Contractor shall, commensurate with the completion of each preventive maintenance or repair service visit (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, a detailed description of the work performed, the test instruments or other equipment used to perform the service, the name(s) and contact information of the technician who performed the 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 Technical Point of Contact (TPOC) and Contract Specialist, summarizing all maintenance activities (including warranty work) each time service is performed. Preventive maintenance and/or repair service shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or opm.gov. Federal Holidays are as follows: New Year’s Day Martin Luther King, Jr.’s Birthday Washington’s Birthday Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day Contract Type: Commercial Item-Firm Fixed Price Period(s) of Performance (Estimated): Base Period: 3/16/2023 through 3/15/2024 Option Year 1: 3/16/2024 through 3/15/2025 Option Year 2: 3/16/2025 through 3/15/2026 Delivery Address: U.S. Food and Drug Administration CBER-OVRR-DBPAP Bldg. 52/72, Room 3328 Silver Spring, MD 20993-0002 Responses to this Sources Sought notice shall unequivocally demonstrate the respondent is currently engaged in providing the onsite preventive maintenance and repair services as described herein and meeting all technical requirements set forth above. Although the target audience for this Notice are small businesses or small businesses capable of providing these stocks from another small business, all interested parties may respond. At a minimum, responses in the form of a Capability Statement shall include the following: Business name and bio, SAM Unique Entity Identifier (UEI), 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; Descriptive literature, brochures, marketing material, etc. detailing the preventive maintenance and repair services which the responding firm is regularly engaged in providing for systems identical or similar to a Thermo Electron nano-UHPLC Orbitrap Fusion Lumos ETD mass spectrometer system, Serial Number: FSN20419, configured to include the following additional components: Dionex Ultimate 3000 NCS-3500RS Nano LC system, Serial Number: 8134209; Dionex WPS-3000TPL RS Autosampler, Serial Number: 8135195. Capability statements must provide sufficient information that unequivocally demonstrates that the technical requirements and delivery time identified above can be met; Provide recent (within the last three (3) years) and relevant past performance information for the manufacture and/or sale in which the offeror has provided same or substantially similar preventive maintenance and repair services. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of 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 SAM Unique Entity Identifier (UEI) and size status) if not the respondent; If applicable, standard commercial warranty and payment terms; If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SIN’s that are applicable to this potential requirement are also requested; If a large business, provide documentation of any subcontracting opportunities which exist for small business concerns; 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; Respondent shall advise if the services required is currently available on a “Best in Class” or other Government-wide or HHS-wide contract. Respondent shall provide country (or countries) of origin for the products and/or services offered in response to this solicitation, and shall include any other applicable information to enable review and analysis pursuant to the requirements under the Buy American Act and requirements relating to Executive Order 14005 - Ensuring the Future is Made in All of America by All of America’s Workers, in the event that a nonavailability waiver request (submitted through the Made in America Office (MIAO) Digital Waiver Portal) is required. Interested parties shall respond with Capability Statements as described above by e-mail only, before 2:00 pm (Central Daylight Time - Local Prevailing Time in Jefferson, Arkansas) on February 13, 2023, to Tim Walbert, Contract Specialist, at the following address:
[email protected]. Notice of Intent Responses to this Sources Sought announcement will assist the Government in determining whether or not 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/or combined synopsis-solicitation may be published on SAM/Federal Contract Opportunities (formerly FBO) at https://sam.gov/content/opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality and Proprietary Information 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).