Inactive

Title: Terumo COBE® 2991 Cell Processor and Terumo Elutra Cell Separation System Preventative Maintenance Services NAICS Code: 811210 - Electronic and Precision Equipment Repair and Maintenance- (Smal... Title: Terumo COBE® 2991 Cell Processor and Terumo Elutra Cell Separation System Preventative Maintenance Services NAICS Code: 811210 - Electronic and Precision Equipment Repair and Maintenance- (Small Business Size Standard-$34M Average Annual Receipts) FSC/PSC: J066- Maintenance/repair/rebuild Of Equipment- Instruments and Laboratory Equipment Place of Performance: National Institutes of Health Clinical Center 10 Center Drive Building 10, Room TBD Bethesda, MD 20892 POTS: 24-005746 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, Office of Purchasing and Contracts (OPC), on behalf of the Center for Cellular Engineering (CCE) intends to award a firm-fixed price sole source purchase order to Terumo Blood and Cell Technologies, Inc., located in Lakewood, Colorado 80215-4440 to provide instrumentation preventative maintenance services. Terumo BCT, Inc. is the sole manufacturer and sole supplier of its proprietary instruments and associated supplies and the only source to perform preventative maintenance services on the Terumo COBE® 2991 Cell Processor and Terumo Elutra Cell Separation Systems Preventative Maintenance Services. Terumo BCT does not have any third-party authorized service providers and therefore the only capable source of performing these services. The Center for Cellular Engineering manufactures cell-based therapies for patients who either 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 FDA in 21 CFR 210, 211, 600 and 1271. The Food and Drug Administration mandates that critical equipment used in the manufacturing, processing, and testing of drug product must be maintained in a controlled manner to ensure proper operation these critical devices (21 CFR 211.63, 21 CFR 211.67). 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 on the email subject ine, may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Sheri Eiri Contract Specialist by email at sheri.eiri@nih.gov by the due date, and time marked in this notice March 14, 2024 by 12:00 pm Noon EST.