Inactive

This document has been amended as of 7/6/2021. Amended text is indicated in bold underlined text. SOURCES SOUGHT NOTICE # FDA_SSN_1242780 for preventive maintenance-repair service for Siemens Inveon P... This document has been amended as of 7/6/2021. Amended text is indicated in bold underlined text. SOURCES SOUGHT NOTICE # FDA_SSN_1242780 for preventive maintenance-repair service for Siemens Inveon PET-CT scanner Posted Date: July 1, 2021 Response Date: July 16, 2021 by no later than 2:00 pm CDT Classification: 6640 – Laboratory Equipment and Supplies NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing 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 instrument system described below. 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; the applicable Small Business Size Standard is $22 million. Requirement and Background The Division of Neurotoxicology functions within the U. S. Food and Drug Administration (FDA) National Center for Toxicological Research in Jefferson, Arkansas, and focuses on increasing our understanding of the processes associated with neurotoxic outcomes – harmful effects associated with the brain and nervous system. The Division uses a broad range of research approaches to capitalize on the expertise of personnel in diverse areas of neuroscience and other scientific disciplines. The Division continues to expand its capabilities in the area of bio-imaging and has added microPET (positron emission tomography), CT (computer tomography) and MRI (magnetic resonance imaging) instruments along with trained personnel. These innovative imaging technologies give researchers a unique way to monitor brain and nervous-system activity with minimal discomfort to the study subject. To this end, it is of paramount importance to maintain these sophisticated instrument systems for optimal operating conditions and accuracy. Currently, the Division of Neurotoxicology requires a preventive maintenance (PM) and repair service agreement for its Siemens Inveon Multimodality PET-CT scanner, Model: 400-455747, Serial Number: 7050. The required agreement is for a base year, two 12-month option years, and a third partial (8/30/2024 through 12/31/2024) of PM and support. The instrument is currently covered through 8/29/2021. Minimum Technical Requirements The preventive maintenance and repair service agreement shall meet/include the following minimum technical requirements: *Shall cover PET detector, CT detector, CT x-ray source, and all associated IT components and software; *Shall include a minimum of one (1) planned on-site preventive maintenance visit for routine certification and calibration per contract year; *Shall include unlimited on-site corrective/remedial maintenance/repair visits which includes parts, labor, and travel; *Shall provide a response time within 3-5 business days after receipt of service call if issue cannot be corrected remotely within 8 hours from call for service; *Shall provide 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; * Shall include software, firmware, and application updates as required by the OEM; *Priority access to technical support (e-mail and telephone) Mondays - Fridays (excluding Federal Holidays) between the hours of 8:00 AM - 6:00 PM Eastern Time; *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, using OEM replacement parts, components, subassemblies, etc.; *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, 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. Periods of Performance Base Year: 8/30/2021 through 8/29/2022 Option Year 1: 8/30/2022 through 8/29/2023 Option Year 2: 8/30/2023 through 8/29/2024 Option Year 3: 8/30/2024 through 12/31/2024 (partial)* *Service will not be available after 12/31/2024 due to end of life-cycle for instrument system Delivery/Service Address: U.S. Food and Drug Administration National Center for Toxicological Research 3900 NCTR Road Jefferson, AR 72079 Responses to this Sources Sought notice shall unequivocally demonstrate the respondent is currently engaged in providing the required preventive maintenance and repair service agreement meeting the technical requirements set forth above. Although the target audience is small businesses or small businesses capable of providing these systems 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, 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 again if responding with the capability of providing an instrument offered by another firm; Descriptive literature, brochures, marketing material, etc. detailing the instrument and equipment (to include consumables) which the responding firm is regularly engaged in providing; Information on available service/maintenance plans for the identified equipment; 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 if subcontracting opportunities 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, as described above, in person, by e-mail, fax, mail or other delivery method before 2:00 pm (Central Daylight Time - Local Prevailing Time in Jefferson, Arkansas) on July 16, 2021 to timothy.walbert@fda.hhs.gov. Reference the following on the outside packaging: FDA_SSN_1242780. 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 Federal Business 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).