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 the National Center for Toxicological Research (NCTR) requirement for a preventative maintenance contract on a Vitrocell 24/48 exposure modules. The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required services. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort. The associated North American Industry Classification System (NAICS) Code is- 811210 – Electronic and Precision Equipment Repair and Maintenance; the applicable Small Business Size Standard is $34 million. Statement of Work The Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), has a collaborative research project with the Center for Tobacco Products (CTP) which requires highly specialized 24/48 exposure modules. The collaborative research project is to conduct toxicity evaluation of whole smoke generated from a variety of tobacco products using smoking regimens in airway in vitro tissue models (project No. E07788.01). Such collaborative work will generate scientific evidence that supports the regulatory mission of CTP using the toxicology expertise and facilities at NCTR. These specialized 24/48 exposure modules are used to expose cells to whole smoke aerosols generated by a smoking machine. The exposure modules are a crucial component in this study and a service contract with annual PM on the modules is critical for the success of this project. Study design for in vitro smoke exposure at the air-liquid-interface to better mimic the human exposure and puffing pattern, NCTR proposes to expose airway air-liquid-interface cultures to diluted whole smoke in an intermittent manner. Up to five cigarettes for each dose will be smoked one at a time. Concentrated smoke from one cigarette will be delivered to a dilution system interfaced with Vitrocell® Exposure Modules and diluted with clean air, and then will be drawn to the air-liquid interface of the cultures by a vacuum pump. In this way, cells will be exposed to various dilutions of whole cigarette smoke produced once every 60 s (for the ISO smoking protocol) or 30 s (for CI machine smoking regimen), with up to 5 cigarette-equivalents of smoke being used to expose cultures for each run. Preliminary dose-range finding studies will expose the cultures to 9%, 20%, and 34% of whole cigarette smoke using the smoking protocols mentioned above every day for 5 days. Changes in cytotoxicity, tissue integrity, cilia beating frequency, mucin secretion, and cytokine secretion will be measured after 1, 3, and 5 exposures. The test doses and treatment durations will be further adjusted based on the responses measured with these endpoints. Should changes in the frequency of smoke delivered to the cells be deemed necessary, the smoking machine will be programmed to smoke more than 1 cigarette at the same dose at a time, resulting in higher rates of smoke delivery. On-site Preventative Maintenance Performance requirements on a Vitrocell 24/48 Exposure system (ENDS) electronic nicotine delivery system, serial number: VC 24/48 160320: -The contractor shall provide one (1) scheduled on-site planned preventive maintenance visit per year. The consumables required for PM visit shall be included in the contract. All costs for labor, travel, and parts required for preventative maintenance shall be included. -The maintenance and repair activities shall be performed by the service engineers who are trained and certified, and the service provider should follow the Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc. -The contractor shall include unlimited software and firmware updates during the entire coverage period(s). -The contractor shall include unlimited technical support (via phone and email) on software and hardware related issues and trouble-shooting capabilities, Monday through Friday (excluding Federal Holidays). - Access by the FDA Technical Representative (TR) and system operator personnel to the manufacturer’s call center for technical assistance including software, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument. - Priority response for repairs if the problem can’t be resolved remotely within 5 days. Cost for travel, labor and parts are not included but subject to a bilateral modification under the contract. Modification must be issued prior to travel. - Deliverables: Service Records and Reports The Contractor shall, commensurate with the completion of each service call or preventative maintenance visit, provide the end-user of the equipment and the Contracting Officer 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. Place of Performance NCTR 3900 NCTR Road, Jefferson, AR, 72079. Period of Performance Base Period: July 15, 2025 through July 14, 2026 Option Year 1: July 15, 2026 through July 14, 2027 Option Year 2: July 15, 2027 through July 14, 2028 Option Year 3: July 15, 2028 through July 14, 2029 Option Year 4: July 15, 2029 through July 14, 2030 FOB Point Destination. All items shall include shipping and handling to the destination identified herein. Alternative solutions will be considered insofar as any such alternate system and/or system components meet the minimum intended use of the system and brand name or equal technical requirements. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product/service of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following: Business name, SAM Unique Entity ID 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 if responding to provide a product manufactured by another firm); Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, ISO certifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. Three (3) years of past performance service information, if not the manufacturer of the equipment identified herein, where the respondent has provided same or substantially similar service solutions on the same or near-same brand name equipment. 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 ID number and size status) if not the respondent. The offeror’s capability to initiate service on-site within the time specified above. Offeror shall provide estimated historical on-site response time from the initial call for service until a service technician was on-site for the brand name and model of instrument in this solicitation or a standard target time for onsite performance from initiation of service call. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement. If applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on. Capability and understanding of accessibility testing and customization to conform with the applicable Section 508 standards identified herein. Provide information if the respondent has an Accessibility Conformance Report (ACR) for the products offered for the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC). Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment. If a large business, identify the subcontracting opportunities that would 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; and 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. The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before May 30, 2025 by 13:00 hours (Central Time in Jefferson, Arkansas) to
[email protected]. Reference NCTR-2025-129403. 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 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).