Notice of Intent to Sole Source FRESENIUS 2008K2 HEMODIALYSIS SYSTEMS to FRESENIUS MEDICAL CARE HOLDINGS INC.

The Naval Medical Logistics Command, Fort Detrick, MD intends to negotiate on a sole source basis (IAW FAR 13) with Fresenius Medical Care Holdings Inc, 920 Winter Street, Waltham, MA 02451-1521, as the only responsible source that can provide Fresenius 2008K2 Systems and CRRT EPROM w/purchase of New 2008K2. These systems are compatible to their hemodialysis systems and stock of consumables already in place. The systems shall include all instruments necessary for completing all hemodialysis procedures. Not only does National Naval Medical Center (NNMC) Bethesda have Fresenius hemodialysis systems, but Walter Reed Army Medical Center (WRAMC) will be bringing over a number of systems to the new joint facility. Any variation will produce unsuccessful outcomes. 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 American Industry Classification System (NAICS) 339112 with a Small Business Size Standard of 500 employees. 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 within 15 days after publication of this synopsis will be considered by the Government. 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 normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Regulatory Requirements: The system and all of the 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. Capability statements shall be submitted by email only as a MS Word or Adobe PDF attachment to Christina Boyd-Brown christina.boyd-brown@med.navy.mil. Statements are due by 4:00pm (EST) 04 December 2009. No phone calls accepted.