Inactive

Title MVE 1536P-190F Cryofreezers and Kryo750Plus controlled rate freezers for Cellular Engineering cGMP Facility Product Service Code: 6630 NAICS Code: 541714 Place of Performance: Bethesda, MD 20892... Title MVE 1536P-190F Cryofreezers and Kryo750Plus controlled rate freezers for Cellular Engineering cGMP Facility Product Service Code: 6630 NAICS Code: 541714 Place of Performance: Bethesda, MD 20892 USA POTS: 23-006764 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 Cryo Associates Incorporation Gaithersburg, Maryland 20879 on a sole source basis to provide two (2) MVE 1536P-190F Cryofreezers and one (1) Kryo750Plus controlled rate freezers to the Center for Cellular Engineering (CCE) at the NIH Clinical Center (CC). This equipment is used to cryopreserve and store starting material and intermediates used in the manufacture of cell based and gene therapies as well as the final product for treatment. This equipment is used in CCE’s other manufacturing facilities. There is a need for harmonization of equipment to reduce the cost of maintenance, spare parts and training on these pieces of equipment. Additionally, in order to replace this equipment with alternate devices the FDA requires demonstration of comparability which will require extensive qualification and validation activities that will be costly in time and resources and will introduce delays to patient treatments, potentially compromising clinical outcome, which in turn, may compromise the ability to evaluate the clinical products in trials. The proposed vendor, Cryo Associates Incorporation, is the only vendor that provides these freezers. 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 electronically to the attention of Shasheshe Goolsby, Contract Specialist, shasheshe.goolsby@nih.gov by May 14, 2023 4:00PM EST.