MARKET RESEARCH PURPOSES ONLY - NOT A REQUEST FOR PROPOSAL OR SOLICITATION This is a Sources Sought notice to determine the availability of Small Businesses capable of supplying the preventive maintenance services for the instrument system 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 811219 - Other Electronic and Precision Equipment Repair and Maintenance, Small Business Size Standard – $22 million. Requirement and Background The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER), Division of Bacterial, Parasitic and Allergenic Products, Laboratory of Vaccine Structure is responsible for evaluating the importance of glycosylation of viral and bacterial antigens as well as pathogen-host carbohydrate dependent interactions. Polysaccharide and other glycoconjugate based vaccines and their components are analyzed using a Thermo Scientific LTQ XL mass spectrometer (S/N: LTQ20968). This instrument is used to identify structural components of these molecular entities such as, but not limited to, monosaccharide composition, glycan sequence and substituents. These structural data are required to better define the chemical identity of vaccine components, vaccine candidates and associated glycoconjugates in vaccine research and regulation duties at CBER. The current requirement is for a base period and one option year of preventive maintenance. The system is currently covered under an existing agreement through 9/29/2022. Minimum Technical Requirements are as follows for a base period and one option year of preventive maintenance and repair service for Thermo Scientific LTQ XL mass spectrometer system, S/N: LTQ20968: *Shall include one (1) planned on-site preventive maintenance visit for routine preventive maintenance; *Shall include unlimited on-site repair services by factory-trained and certified engineers within 2-3 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 7:00 AM - 5:00 PM Eastern (Prevailing) Time; *All maintenance and repair service activities shall be performed by formally trained and certified technicians and/or engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.; *XCalibur 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 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: 9/30/2022 through 9/29/2023 Option Year 1: 9/30/2023 through 9/29/2024 Delivery Address: U.S. Food and Drug Administration Center for Biologics Evaluation and Research Bldg. 52/72 Room G430 10903 New Hampshire Avenue 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. Provide this same information again if responding with the capability of providing virus stocks offered by another firm; Descriptive literature, brochures, marketing material, etc. detailing the preventive maintenance and repair services which the responding firm is regularly engaged in providing identical or similar LTQ XL mass spectrometers. 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 DUNS number 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. If applicable, respondent shall provide place (country) of product/service manufacture or performance and any other applicable information to enable review and analysis pertaining 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 April 28, 2022, 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).