Preventive Maintenance and Repair Service Agreement for two Zeiss Merlin Field Emission Gun Scanning Electron Microscope (FEG SEM) and a Gatan 3View serial block face sectioning device

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 Preventive Maintenance and Repair Service Agreement for two Zeiss Merlin Field Emission Gun Scanning Electron Microscope (FEG SEM) and a Gatan 3View serial block face sectioning device. The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required supplies. 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 Background The National Center for Toxicological Research (NCTR) Nanotechnology Core facility needs instruments that require a yearly maintenance contract to ensure reliability for the support of research. This request is for the new service and maintenance contract for specific services on the below instruments. Objectives To provide best possible service/maintenance/repair contracts to the following instruments: Zeiss Merlin Field Emission Gun Scanning Electron Microscope (FEG SEM), Serial Number: MRL 40-6054; Zeiss Merlin Field Emission Gun Scanning Electron Microscope (FEG SEM), Serial Number: MRL 40-4265; Gatan 3View serial block face sectioning device, Serial Number: 3V033M SBFSEM. (Note: This instrument is paired with the Zeiss FEG SEM, Serial Number: MRL 40-4265). Scope The FDA Nanotechnology Core Facility (Nanocore) utilizes multiple types of equipment for the characterization of nanomaterials and biological and clinical samples. This solicitation is for a service contract covering the following ZEISS/GATAN instruments: Zeiss Merlin Field Emission Gun Scanning Electron Microscope (FEG-SEM), Serial Number: MRL 40-6054 Zeiss Merlin Field Emission Gun Scanning Electron Microscope (FEG-SEM), Serial Number: MRL 40-4265 Gatan 3View Serial Block Face Sectioning Device, Serial Number: 3V033M (Note: This instrument is paired with the Zeiss FEG-SEM, Serial Number: MRL 40-4265) These instruments require a yearly service contract to ensure operational reliability in support of ongoing research. These instruments, along with their subcomponents, require, at a minimum One (1) year of complete, all-inclusive, preventive maintenance and repair service coverage for MRL 40-6054. And One (1) year of the highest-tiered service coverage available for the combined MRL 40-4265 and 3V033M instruments. All services provided under this contract shall meet the minimum technical requirements set forth below. Requirements Minimum Preventative and Corrective Maintenance Requirements: Zeiss Merlin MRL 40-6054 Base Year performance requirements. The Zeiss Merlin MRL 40-6054 must have the most comprehensive, highest-tiered, all-inclusive service coverage offered by the vendor. Repairs to the MRL 40-6054 taking longer than 30 calendar days from the time a documented service call is initiated will result in the excess days being added to the end of the period of performance, effectively extending the contract by that amount. In cases of reasonable and documented unforeseen circumstances, the Government may, at its discretion, agree to extend the 30-day repair deadline. To expedite repairs and minimize potential impacts on scientific research, the contractor shall ensure timely access to qualified field engineers and/or technicians who shall be authorized to conduct site visits, authorize and obtain required parts and perform necessary repairs without unnecessary administrative delays, including delays related to internal purchase order processing or subcontractor authorization requirements. Corrective/remedial repair site visits shall occur within 3 5 business days of a service call being initiated, for issues that cannot be resolved remotely via telephone or internet. Coverage shall include one (1) Field Emission Gun (FEG) tip change-out per the first contract year. All maintenance and repair activities shall be performed by formally trained and OEM-certified technicians and/or engineers to ensure the equipment meets original manufacturer specifications. All repairs and PM services shall be performed in accordance with OEM specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc. PM service shall include a minimum of one (1) on-site visit per contract year for routine instrument calibration and certification. The contractor shall provide the FDA Contracting Officer's Representative (COR), Technical Representative (TR), and system operator personnel with access to the manufacturer's technical call center, which shall be staffed by senior engineers to provide a high level of troubleshooting expertise for the instrument. Technical support (e.g., telephone, email, web-based, etc.) shall be available Monday through Friday, excluding Federal Holidays, during normal business hours Eastern Time, and the contractor shall begin working toward a resolution within 24 hours of the initial request for assistance. Coverage shall include OEM technical bulletins, repair procedures, and unlimited software, firmware, and application updates All costs for labor, travel, and parts required for preventative maintenance and repairs shall be included. Performance requirements: Zeiss Merlin MRL 40-4265, including the Gatan Serial Block Face microtome (Ser. No. 3V033M) The contract must include all available service coverage for the Zeiss Merlin MRL 40-4265, including the Gatan Serial Block Face microtome (Ser. No. 3V033M) attached to that instrument. The service agreement for the Zeiss Merlin MRL 40-4265 and Gatan 3View shall not be subject to the 30-calendar-day repair deadline or associated contract extension provision specified above for the MRL 40-6054. All maintenance and repair activities shall be performed by formally trained and OEM-certified technicians and/or engineers to ensure the equipment meets original manufacturer specifications. All repairs and PM services shall be performed in accordance with OEM specifications, manuals, and service bulletins, using OEM replacement parts when available, components, subassemblies, etc. PM service shall include a minimum of one (1) on-site visit per contract year for routine instrument calibration and certification. consumable parts required to complete the PM will be purchased by the government. The contractor shall provide the FDA Contracting Officer's Representative (COR), Technical Representative (TR), and system operator personnel with access to the manufacturer's technical call center, which shall be staffed by senior engineers to provide a high level of troubleshooting expertise for the instrument. Technical support (e.g., telephone, email, web-based, etc.) shall be available Monday through Friday, excluding Federal Holidays, during normal business hours Eastern Time, and the contractor shall begin working toward a resolution within 24 hours of the initial request for assistance. Coverage shall include OEM technical bulletins, repair procedures, and unlimited software, firmware, and application updates. Coverage shall include one (1) Field Emission Gun (FEG) tip change-out per Merlin SEM per contract year. Repairs: All costs for labor and travel required for repairs shall be included. Parts paid by the Government. Option Years 1-3: Zeiss Merlin MRL 40-6054 and Zeiss Merlin MRL 40-4265, including the Gatan Serial Block Face microtome (Ser. No. 3V033M) performance requirements Starting October 1, 2027, Carl Zeiss Microscopy will no longer be able to guarantee the availability of replacement parts for the microscope. The service agreement for the Zeiss Merlin MRL 40-6054 shall no longer be subject to the 30-calendar-day repair deadline or associated contract extension provision specified above. To expedite repairs and minimize potential impacts on scientific research, the contractor shall ensure timely access to qualified field engineers and/or technicians which shall be authorized to conduct site visits, obtain required parts and perform necessary repairs without unnecessary administrative delays, including delays related to internal purchase order processing or subcontractor authorization requirements. Corrective/remedial repair site visits shall occur within 3 5 business days of a service call being initiated, for issues that cannot be resolved remotely via telephone or internet. All maintenance and repair activities shall be performed by formally trained and OEM-certified technicians and/or engineers to ensure the equipment meets original manufacturer specifications. All…