Notice Of Intent for research, development, testing and evaluation to establish safety and toxicology data in a large animal model and initial safety and efficacy data in an injured human using patients presented to an Urban, Level 1 Trauma Center

The U.S Army Medical Research Acquisition Activity (USAMRAA) in support of the United States Special Operations Command (USSOCOM), intends to modify a Firm-Fixed Price (FFP), Sole Source Award with James Cook University, 1 Angus Smith Drive, Townsville, QLD, 4811, Australia, in accordance with statute 10 U.S.C. 2304(c)(1) as implemented under authority FAR 6.302-1, Only One Responsible Source and No Other Supplies or Service Will Satisfy Agency Requirements. The Period of Performance for this proposed action is for a period of 24 months. This proposed contract action will provide a follow-on effort for the research, development, testing and evaluation required to establish safety and toxicology data in a large animal model and initial safety and efficacy data in an injured human using patients presented to an Urban, Level-1 Trauma Center. This research continues the study of small-volume resuscitation therapy utilizing 3% NACI with Adenosine, Lidocaine and MG2+ (ALM) solution that offers the healthcare provider a small-volume, intravenously infusible fluid that improves cardiac function and hemodynamics in a hemorrhaging patient compared to current available treatments. The continued development of a small-volume fluid that can offer cardiac and hemodynamic stability while a patient is being transported to definitive care would revolutionize prolonged field care in combat situations as well as in the civilian realm. This follow-on effort has two aims. The first aim includes utilizing data produced in the current contract to study the safety and toxicology of efficacious dosing under the large animal model in preparation to move to pre-clinical human trials. The second aim utilizes the data obtained in the current contract and data obtained in the first aim to conduct initial safety and efficacy research in injured humans to demonstrate both safety of ALM in this patient population as well as a clear clinical benefit based on a range of parameters including: survival, amount of blood product administered, and time of return to hemodynamic normalcy. James Cook University is the current research entity which has performed all of the research under this effort. The North American Industry Classification System (NAICS) for this requirement is 541712 and the size standard is 1,000 employees. THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE QUOTES and a written solicitation will not be issued. This announcement constitutes the only notice by the Government; however any interested business that believes it can meet the requirement must respond in writing in the form of a capability statement. Responses must include supporting evidence that is clear and concise which articulates the ability to comply with the requirement outlined above. A request for documentation will not be considered an affirmative response. This Notice of Intent is not a request for competitive quotes. Information received will be considered solely for the purpose to determine whether a competitive procurement is in the best interest of the Government. A determination by the Government not to compete this procurement on a full and open competitive basis will be made based on the responses received. Determination is solely within the discretion of the Government. If no written responses are received by the date listed below, which reflects fifteen (15) days after the publication of this notice, the proposed action will be awarded without further remark. Interested business concerns must identify their capability in writing to the below e-mail address no later than 5:00 PM EST, 24 August 2018. All questions and responses concerning this notice shall be emailed to Ronnie Sanford, Contract Specialist at Ronald.s.sanford2.civ@mail.mil.