Inactive

Title (3) Nucleocounter NC-200 devices with IOPQ kits for the Cellular Engineering Current Good Manufacturing Practices (cGMP) Facility Product Service Code: 6640 NAICS Code: 423450 Place of Performan... Title (3) Nucleocounter NC-200 devices with IOPQ kits for the Cellular Engineering Current Good Manufacturing Practices (cGMP) Facility Product Service Code: 6640 NAICS Code: 423450 Place of Performance: Bethesda, MD 20892 USA POTS: 23-006102 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 ChemoMetec Incorporation Bohemia, New York on a sole source basis to provide three (3) Nucleocounter NC-200 devices with IOPQ kits for the cGMP facility at the NIH Clinical Center (CC). The purpose of this requirement is to acquire the equipment needed for the activation of the new cGMP Facility. This equipment is used to quantify cell numbers. The FDA requires cell numbers to be quantified to calculate the appropriate dosage of cell therapies. Inaccurate quantitation of cell therapy doses has the potential to expose patients to inadequate cell therapy if the dose is too low, or to the risk of side effects such as cytokine storm if the dose is too high. The Nucleocounter NC-200 is a device that is widely used in cell therapy and is provided with an appropriate IQ/OQ/PQ package by the vendor, which meets the expectation of the FDA. The proposed vendor is the only manufacturer of this device. 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 Office of Purchasing and Contracts electronically to the attention of Shasheshe Goolsby, Contract Specialist, shasheshe.goolsby@nih.gov by May 19, 2023 8:00AM EST.