N62645-15-C-4009: Research Involving Cerebral Perfusion Pressure in Support of the Naval Medical Research Center, Silver Spring MD

Sources Sought Notice The Naval Medical Logistics Command (NMLC) is seeking sources to perform a research and development (R&D) project in support of the Naval Medical Research Center (NMRC), Silver Spring, MD. The research project will extend the existing capability of physicians to treat patients with life threatening traumatic brain injury (TBI) and possibly increase the threshold for the safe cerebral perfusion pressure. The University of Miami is the only entity to have conducted the prior, Office of Naval Research funded effort. This project is for an already approved FDA drug which has not yet been approved for the treatment of TBI or cerebral perfusion pressure. The objective of the project is to pursue a new Food and Drug Administration (FDA) indication that will support the treatment of Marines and Sailors wounded in the field. The estimated period of performance of the project is 36 months. If capable sources are not identified through this notice, then NMLC intends to award a sole source contract under the authority of FAR 6.302-1 to Kenneth G. Proctor, University of Miami Miller School of Medicine; Daughtry Department of Surgery; 1800 NW 10th Ave Ryder Trauma Center Miami, FL 33136 for the performance of the described requirement. The research group at the University of Miami conducted the prior clinical study at a major trauma hospital and has the data to support advancement of this research effort into clinical practice. This project is an extension of an Office of Naval Research sponsored grant that has been conducted for the past 5 years. Over the course of five years, the University of Miami completed a prospective, open-label, randomized controlled non-inferiority clinical trial (Clinical Trial Identifier NCT00795366). In addition, the University of Miami also initiated a retrospective data analysis in non-randomized patient records. The purpose of this effort is to complete the review of both the prospective and retrospective data collection to support the FDA application. This sources sought notice is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 1 (8.5 x 11 inch) page using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information will not be considered as an affirmative response. 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 or to proceed with a sole source contract. Capability statements are due by 5:00 PM Eastern Time, 24 December, 2014. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: Ronald.Sanford@med.navy.mil.