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), in acquiring preventative maintenance, corrective/remedial maintenance repair service agreement on a Sony SH800 Cell Sorter and a Sony SA-3800 Cell Spectral Analyzer to maintain the functionality of the equipment.to study cellular responses to Clostridium difficile and Commensal Bacteria. The FDA is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of providing services of a small business manufacturer or producer for the items described herein. 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 811219-Other Electronic and Precision Equipment Repair and Maintenance; Small Business Size Standard is $22 million. The FDA/NCTR/ requires preventative maintenance, corrective/remedial maintenance repair service agreement on a Sony SH800 Cell Sorter (Serial Number: 1760005) and a Sony SA-3800 Cell Spectral Analyzer (Serial Number: 1990004) to maintain the functionality of the equipment to study cellular responses to Candida albicans infection and drug-delivery nanoparticles. Both instruments have delicate fluidic and laser optical systems in them that require periodic cleaning and alignment and replacement of expendable parts, such as tubing and filters. Both instruments are currently under a maintenance contract until September 2020, from Sony Biotechnology Inc. CLIN#1- Base Year (09/02/2020 thru 09/01/2021) Preventative and Corrective/remedial maintenance repair service agreement: Sony SH800 Cell Sorter (Serial Number: 1760005) and Sony SA-3800 Cell Spectral (Serial Number: 1990004) Quantity: 12 Unit: Months Unit Price: ____ GSA Contract Number_____ (if applicable) Period of Performance (Base Year): 09/02/2020 thru 09/01/2021 FOB Point Destination: All on-site corrective/remedial maintenance, service/repair visits shall be at 3900 NCTR Road, Jefferson, AR 72079. The contractor shall be required to meet the following performance requirements: 1. Minimum of one (1) planned preventative maintenance visit for all units each contract period. All costs for labor, travel, and parts required for preventative maintenance shall be included. 2. Unlimited phone and email support during the contractor's normal operating hours. Initial response within 8 business hours of contact for assistance (e.g., telephone-based, email-based, website-based, etc.) 3. 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 the instrument. 4. Unlimited on-site corrective/remedial maintenance, service/repair visits which again includes all labor, parts, and travel costs. Provide on-site service response within three business days of notification if issue cannot be corrected remotely within 8 hours from call for service. 5. Absolute adherence to and conformity with Original Equipment Manufacturer (OEM) specifications, manuals, bulletins, latest technical developments, PM procedures, application updates using OEM replacement parts, components, subassemblies etc. in performing all preventative maintenance and repair services. 6. Performance by formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc. 7. System software and firmware updates required for reliability improvements and correction of any defects; 8. 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 Specialist 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. 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 of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following: • Business name, DUNS 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, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. • Three (3) years of past performance information for the manufacture, and/or sale and support in which the offeror has provided same or substantially similar products and used for same or near-same applications as set forth herein. 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, 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. • 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; 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 on or before November 30, 2019 by 12:00 hours (Central Time in Jefferson, Arkansas). Reference FDA-SSN-1222036 and information regarding this source for sought, please contact email address
[email protected]. Notice of Intent Responses to this source 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 FedBizOpps. 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).