WIRELESS BIOPSY DELIVERY SYSTEM

THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE QUOTES. The Defense Health Agency Contracting Activity (DHACA), Western Markets Contracting Division (WMCD), on behalf of Naval Medical Center San Diego (NMCSD), intends to negotiate and award a firm fixed price contract in accordance with Federal Acquisition Regulation (FAR) 13.106-1(b)(1)(i), only one source being available to meet the Government's needs, to: Merit Medical Systems Inc 1600 W Merit Pkwy South Jordan, UT 84095 The anticipated award will be made under the statutory authority permitting other than Full and Open Competition, FAR 13.501(a), Sole Source Acquisitions. Anticipated delivery date is 31 July 2023. The North American Industry Classification System (NAICS) code for this requirement is 339113- Surgical Appliance and Supplies Manufacturing; the business standard is 800 Employees. Product Service Code (PSC) 6515 Medical and Surgical Instruments, Equipment and Supplies. The object of this sole source award is to provide for a new Firm Fixed Priced Supplies and Material contract to provide for a Wireless Biopsy Delivery System with the ability to meet the following conditions: A non-ferromagnetic wire-free localization technology that is cleared for long-term placement in breast and soft tissues. The placement of the wire-free localization device cannot impede or impair MRI studies should they be warranted. For these reasons, we require a radio detecting and ranging (RADAR) localization system. Based on the market research and approved justification and approval memorandum, Merit Medical Systems is the only source that can meet the Government's minimum requirements. This notice of intent is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes a letter validating authorization to provide OEM preventive maintenance and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to provide the required services for NMCSD. Capability statements shall not exceed 3 (8.5 x 11) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source purchase order. Submit capability statements no later than 10:00 AM Pacific Daylight Time, 7 June 2023. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: kenneth.d.harmon.civ@health.mil. The email subject line shall state, - HT9410-23-N-0048, Wireless Biopsy Device at Naval Medical Center San Diego. NO TELEPHONE REQUESTS/OFFERS WILL BE HONORED