Inactive

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 f... 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 with a twelve (12) month base year to Rees Scientific Corporation, Trenton, NJ 08638 on a sole source basis to provide validation, calibration and preventative maintenance service to the existing Rees environmental monitoring system located in the Center for Cellular Engineering (CCE) at the NIH Clinical Center (CC). The CCE operates several current Good Manufacturing Practices (cGMP) facilities which are utilized to manufacture cellular therapies for patients enrolled on Clinical Trials at the NIH. The In order to be compliant with 21CFR 211.67 (Current Good Manufacturing Practice for Finished Pharmaceuticals, Subpart Equipment Maintenance and Cleaning), a service contract is required for the system that monitors the environmental conditions within facilities used to manufacture cell therapies, as well as the performance of all critical equipment used in manufacturing and storage of cell therapies. A Rees Scientific environmental monitoring system is installed in the 3T, 2J and T10B facilities operated by the CCE to meet this requirement. Due to the criticality of this system, only fully GMP/GDP trained technicians, certified and trained on the Rees system, are allowed to service the inputs and software used in the aforementioned facilities. Rees is the approved qualified vendor by the Quality Assurance group for the CCE as well as the Clinical Center for environmental monitoring services and service contracts for the GMP cellular therapy production facilities at the NIH CC. The software and hardware are proprietary to Rees Scientific Corporation and the company is the sole provider of the requested 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 Kerry-Ann Chisholm, Contract Specialist, kerry-ann.chisholm@nih.gov by the due date and time marked in this notice.