Cellular Combat Wound Initiative clinical trials.

The Department of the Interior, National Business Center, Acquisition Services Directorate (AQD), on behalf of the Naval Medical Research Center (NMRC), intends to solicit and negotiate with only one source under the authority of 6.302 and award on a sole source basis to Stemnion, Inc, for continued clinical testing of the Cellular Combat Wound Initiative. The resulting award action will be accomplished in accordance with FAR 6.302-1 "Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements." The sole source commercial contract resulting from this action will have Stemnion Inc. pursue the "Cellular Combat Wound Initiative" over an 18 month period of performance from approximately November 24, 2010 to May 24, 2012. The sole source is necessary, because Stemnion has researched and developed novel burn and wound therapies. This acquisition will fund a series of pre-clinical trial efforts as well as FDA human clinical trials with final deliverables consisting of a report on trial outcomes. Stemnion's novel cellular wound healing technology will accelerate and improve healing a variety of combat-related injuries and their associated chronic wounds. Stemnion's proprietary therapies decrease tissue loss, obtain more rapid wound closure, and decrease scarring. Applications include burn wounds, eye injuries, and therapies designed to strengthen the suture sites for abdominal surgery patients. It is expected that the benefits of therapies developed to care for wounded servicemen and women will be immediately applicable to civilian patients across a broad spectrum of needs that range from burn victims to adults afflicted with the slow-healing wounds typical of Type II diabetes. This synopsis of proposed contract action is being prepared in accordance with FAR 5.201, 5.203, 6.302-1, and 6.305 and is neither a request for proposal nor a request for information. However, the Government will consider all responses received within 5 days after date of publication of this synopsis. Firms wishing to challenge the sole source must submit an interest letter and capability statements that demonstrates your firm's ability to provide an equivalent supply and service as described above. Interested parties must provide a rationale as to why they should be considered. Respond to the below points of contact no later than November 22, 2010, by 2:00 pm Eastern Time and reference D11PS18761 in your correspondence. Neither Acquisition Services nor NMRC will reimburse for any costs connected with providing the capability information. Firms must be registered in the Central Contractor Registration Database (CCR - www.ccr.gov), and Online Representations and Certifications Application (ORCA-https://orca.bpn.gov/) prior to the award of any contract or agreement. Firms must register on a one-time basis and annually confirm accuracy and completeness of registration information. If you have any questions, please direct your inquires to the points of contact below. NAICS Code is 325412 - Pharmaceutical Preparation Manufacturing Points of Contact:All inquiries must be addressed by e-mail to the Acquisition Services Directorate care of Contracting Officer Tamia A. True ([email protected]) with a copy to Contract Specialist Brian C. Baker ([email protected]). Responses to this notice must be submitted in writing, via e-mail, no later than November 22, 2010, 2:00 pm, Eastern Time. Interested sources may identify their interest and capability to respond to the requirement. Response to this notice is not required.