The U.S. Food and Drug Administration (FDA) intends to negotiate and award on a sole source basis to Waters Corporation (Waters) under the authority 41 U.S.C. 1903, as set forth in FAR 13.501(a)(1)(ii). This acquisition is in support of the FDA’s Office of Regulatory Affairs. FDA intends to procure from Waters the Empower 3 Enterprise system, user and instrument licenses that will support the San Juan laboratory to continue routine sample analysis and reporting. The system will enhance the capability for individual licenses with user and administrative roles, multiple instrument control, data collection, processing and reporting, and streamlined audit trails and project/data backup. The laboratory currently utilizes the Empower 3 Workgroup system to screen and analyze samples. The upgrade to the Empower 3 Enterprise system will increase the number of users, their capabilities and instrument licenses. Waters is the only manufacturer and supplier of the Empower 3 Enterprise system. There are no other resellers that can provide this software, supplies and maintenance services. The Contractor shall provide the Enterprise system, user and instrument licenses to support the laboratory. The period of performance for this system is one (1) year. This notice of intent is not a request for competitive quotations. However, any firm that believes it can meet these requirements may submit a written response via email to Alicia Baltimore at the email address below by noon on August 17, 2020. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the above requirement. Information received will be considered; however, a determination by the Government not to compete the proposed acquisition based on responses to this notice is solely within the discretion of the Government. If no responses are received, the FDA will proceed with the sole source award to Waters Technologies Corporation, 34 Maple Street, Milford, MA 01757-3696. The anticipated award date of this purchase order is on or about August 24, 2020. If you have any questions regarding this announcement, please contact Alicia Baltimore via email at
[email protected] .