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Title: GTX and ATX Electroporation Systems Preventative Maintenance Service Product Service Code: J066 NAICS Code: 811210-Electronic and Precision Equipment Repair and Maintenance Place of Performance... Title: GTX and ATX Electroporation Systems Preventative Maintenance Service Product Service Code: J066 NAICS Code: 811210-Electronic and Precision Equipment Repair and Maintenance Place of Performance: Bethesda, MD 20892 POTS: 23-007610 Description: This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested. The National Institutes of Health (NIH), Clinical Center, Purchasing and Contract Office on behalf of the Department of Transfusion Medicine/Center for Clinical Engineering intends to award a fixed price contract to MaxCyte located in Rockville, MD 20850 on a sole source basis to provide GTX and ATX Electroporation System Preventative Maintenance and Calibration Services (Serial Numbers 194 and 266) for a base period. The Department of Transfusion Medicine/Center for Clinical Engineering has a requirement for annual calibration services and preventative maintenance services on government owned Electroporation Systems. The Center for Cellular Engineering manufactures cell-based therapies for patients who either have no, or have exhausted all other standard treatment options. The manufacturing operations are regulated by the Current Good Manufacturing Practices (cGMPs) as mandated by the Food and Drug Administration (FDA) in 21CFR 210, 211, 600 and 1271. The FDA mandates that critical equipment used in the manufacturing, processing and testing of drug product must be maintained in a controlled manner (21 CFR 211.63, 21 CFR 211.67). The only known sole capable of performing these services is the original equipment manufacturer, MaxCyte. MaxCyte has trained and qualified technicians to perform preventative maintenance, software upgrades, and annual calibration services. The highly specialized equipment is proprietary in nature. If an unauthorized third-party service provider performs work on the GTX and ATX Electroporation Systems, it will void the manufacturer’s warranty. Therefore, MaxCyte, the original equipment manufacturer is the known source capable of performing the required services. This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. Interested parties may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government. Comments to this announcement, referencing this posting number, may be submitted to the CC, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Sheri Eiri Contract Specialist, sheri.eiri@nih.gov by the due date and time marked in this notice.