MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA) is conducting market research to support a National Center for Toxicological Research (NCTR), Division of Genetic and Molecular Toxicology (DGMT), requirement for a preventive maintenance agreement for a Vitrocell 24/48 in vitro exposure system. This is a Sources Sought Notice to determine the availability and capability of small businesses in providing annual preventive maintenance service for a Vitrocell 24/48 in vitro exposure system Though the target audience is small businesses or small businesses capable of supplying the services of a small business, all interested parties may respond. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposals or Request for Quotation, nor is it an indication the Government will contract for the items contained herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a small business set-aside is possible for the required services. To protect the procedural integrity of any future procurement, if any, that may arise from this announcement, information regarding the technical point of contact will not be provided and no appointments or other types of arrangements for presentations shall be made. The appropriate NAICS code for this acquisition is 811219 - Other Electronic and Precision Equipment Repair and Maintenance; Small Business Size Standard is $22.0 million. If your firm is considered a small business under this NAICS Code, and believe you are capable of providing the FDA with the supplies and/or services described below, you are encouraged to submit a capability statement subject to the requirements listed below to Tim Walbert at
[email protected]. Requirement and Background The FDA’s NCTR DGMT requires an annual preventive maintenance agreement for its Vitrocell 24/48 in vitro exposure instrument system. This system is heavily used, specifically for a current study designed to evaluate the toxicity of ortho-phthaldehyde aerosols in human air-liquid-interface (ALI) airway tissue models. The unique properties of aerosols and delivery of test articles from them requires the sophisticated, specialized instrumentation provided by the Vitrocell exposure system. Thus, it is imperative that this instrument be maintained on an annual basis. The requirement is for a base period and two one-year option periods of on-site preventive maintenance. The instrument is not covered under an existing agreement. Initial period of performance is anticipated to be 6/1/2022 through 5/31/2023. Minimum Technical Requirements are as follows for a base year and two (2) option years of preventive maintenance service for a Vitrocell 24/48 in vitro exposure system: *One (1) planned on-site preventive maintenance visit per contract year, to include the following services: disassembly, cleaning, and re-assembly of exposure top and dilution systems; cleaning of all components; change-out of O-rings, tubing, and filters; tightness test of system; *Initial visit for the base year shall be performed within 90 days of contract award; *Access by the FDA Technical Representative (TR) and system operator personnel to the manufacturer’s call center for technical assistance, which is staffed by qualified Vitrocell technicians or engineers; * Remote service support for Vitrocell Monitor software, firmware, and application updates as required; *Unlimited access to e-mail and telephone support; *All maintenance activities shall be performed by formally trained and certified technicians and/or engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins; *All preventive maintenance pricing shall be inclusive of labor, travel, and accommodations. 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 Year: 6/1/2022 through 5/31/2023; Option Year 1: 6/1/2023 through 5/31/2024; Option Year 2: 6/1/2024 through 5/31/2025; Delivery/Service Address: U.S. Food and Drug Administration National Center for Toxicological Research Bldg. 14, Lab 1026 3900 NCTR Road Jefferson, AR 72079-9501 Responses to this Sources Sought notice shall unequivocally demonstrate the respondent is currently engaged in providing the preventive maintenance services described herein and meeting the 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 these services offered by another firm; Descriptive literature, brochures, marketing material, etc. detailing the preventive maintenance services which the responding firm is regularly engaged in providing, including services for Vitrocell 24/48 in vitro exposure systems. Capability statements must provide sufficient information that unequivocally demonstrates that the technical requirements and delivery time identified above for each contract year 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 services for Vitrocell 24/48 in vitro exposure systems. 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 UEI number and size status) if not the respondent; 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; Respondent shall provide origin (country) of service 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; 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. Interested parties shall respond with Capability Statements by e-mail only, by 2:00 pm (Central Daylight Time - Local Prevailing Time in Jefferson, Arkansas) on Friday, April 22, to Tim Walbert, Contract Specialist, at the following address:
[email protected]. Please include the following in the Subject Line of the e-mail: 75F40122R1251886. 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 provide the products or services described herein. 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 solicitation may be published at SAM.gov/Contract 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).