Inactive

Title Endosafe® NexGen-PTS devices with 2 Zebra ZQ320 US printer kits and two PTS IQ/OQ/PQ qualification kits for the Center for Cellular Engineering cGMP Facility Product Service Code: 6550 NAICS Cod... Title Endosafe® NexGen-PTS devices with 2 Zebra ZQ320 US printer kits and two PTS IQ/OQ/PQ qualification kits for the Center for Cellular Engineering cGMP Facility Product Service Code: 6550 NAICS Code: 334516 Place of Performance: Bethesda, MD 20892 USA POTS: 23-006040 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) intends to award a fixed price contract to Charles River Laboratories, Inc. on a sole source basis to provide two Endosafe® NexGen-PTS devices with two Zebra ZQ320 US printer kits and two IQ/OQ/PQ Qualification Kits to the Department of Transfusion Medicine (DTM), Center for Cellular Engineering (CCE) at the NIH Clinical Center (CC). The purpose of this requirement is to acquire the equipment needed for the activation of the new Center for Cellular Engineering Current Good Manufacturing Practices (cGMP) Facility. The equipment needed are two Endosafe® NexGen-PTS devices with 2 Zebra ZQ320 US printer kits and two IQ/OQ/PQ qualification kits. These Endosafe® NexGen-PTS devices will be used to confirm that cellular therapies manufactured by CCE are free from endotoxin and can be used in the treatment of patients enrolled on clinical trials at the Clinical Center of the NIH. Charles River Laboratories, Inc. is the only source that provides the Endosafe® NexGen-PTS devices that are approved by the FDA as well as meets the needs specified in the code of federal regulations. 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 Shasheshe Goolsby, Contract Specialist, shasheshe.goolsby@nih.gov by May 5, 10:00AM EST.