The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR Part 13.501(a)). The proposed source is Edwards Lifesciences of 1 Edwards Way, Irvine, CA 92614. Naval Medical Center San Diego (NMCSD) has a requirement for biological heart valves, both mitral and aortic, as well as mechanical annuloplasty rings; these items are specifically available only via physician prescription. These valves include bovine tissue aortic and mitral valves, mitral annuloplasty rings, and tricuspid annuloplasty rings. The bioprosthetic heart valves shall be treated with an anticalcification treatment with at least 10 years of clinical follow-up data. The requirement is also for inventory and shelf-life based stock rotation to replace these products at no cost to the government prior to the stamped expiration date on all unused products.

The unit 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.

There are not 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. 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.

If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Brian Miller at [email protected]. In addition, challenges can be faxed to 301-619-1132 Attn: Brian Miller, Reference solicitation number N0025913RCD0034. Email challenges are preferred. Closing date for challenges is no later than 10:00 AM. ET on 7 August 2013. No phone calls will be accepted.

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