Notice Of Intent to Sole Source for Harmonic Scalpel Generator Units

DEPARTMENT OF THE NAVY NAVAL MEDICAL LOGISTICS COMMAND NOTICE OF INTENT The Naval Medical Logistics Command intends to negotiate on a sole source basis IAW FAR 13 with Ethicon US LLC, 4545 Creek Rd., ML#3, Cincinnati, OH 45242, as the only responsible source that can provide Harmonic Scalpel Generator Units and accessories to be used in the main operatory areas for surgical procedures aboard the USNS Comfort and the USNS Mercy. The USNS Mercy T-AH 19 has a critical need for two (2) harmonic generators, two (2) carts, two (2) generator connectors, two (2) Enseal connectors, four (4) hand pieces and two (2) footswitches with cables. USNS Comfort T-AH 20 has a critical need for two (2) harmonic generators, two (2) carts, two (2) generator connectors, two (2) Enseal connectors, twelve (12) hand pieces, one (1) 5MM shear and one (1) 9CM shear. Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. Regulatory Requirements: The system and all its components shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America; even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements. This acquisition is being conducted under simplified acquisition procedures IAW FAR 13. There are no set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 339112 with a small business size standard of 500. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government solely for the purpose of determining whether or not to conduct a competitive procurement. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Submit capability statements via email (using PDF, MS Word, Excel attachments) to Christina Boyd-Brown at Christina.BoydBrown.civ@mail.mil. Statements are due no later than 08:00 A.M. Eastern Time (ET) on 22 August 2016. No phone calls accepted.