Safety and Pharmacokinetics of Riluzole in Patients with Traumatic Acute Spinal Cord Injury

Intent to Award Sole Source Safety and Pharmacokinetics of Riluzole in Patients with Traumatic Acute Spinal Cord Injury The United States Army Medical Research Acquisitions Activity (USAMRAA), on behalf of the U.S. Army Medical Material Development Activity (USAMMDA), is issuing a Notice of Intent to Award a Sole Source contract. This is not a request for proposals. This notice does not represent a commitment by the government to pay for cost incurred in preparation and submission of data in response to this announcement. This is a Notice of Intent to Award a Sole Source contract to Methodist Hospital, in conjunction with the Christopher and Dana Reeve Foundation , Houston Texas, utilizing Joint Warfighter Medical Research Program (JWMRP) in accordance with FAR 6.302-1(a)(2), only one responsible source and no other supplies or services will satisfy agency requirements. As directed by Congress in the FY2015 Omnibus; Consolidated and Further Continuing Appropriations Act, Public Law 113-235 pages 271-272, $50M "shall be used to augment and accelerate high priority Department of Defense (DoD) and Service medical requirements and to continue prior year initiatives that are close to achieving their objectives and yielding a benefit to military medicine. The funds shall not be used for new projects or for basic research." For this reason, the undersigned determined that the cited statutory authority permitting other than full and open competition is supported and required. This Bill essentially limits the competition to contractor's that have existing Congressional Special Interest Research Projects (contracts or assistance agreements) and have a military relevance. The Bill also states that funds shall be awarded at the discretion of the Secretary of Defense following a review of medical research and development gaps. The strategy in executing the JWMRP was to find highly valued research efforts on a research grant or contract that could meet critical service requirements and that were not being continued through other appropriations. Based on a comparative analysis by the scientific and programmatic reviewers from USAMRMC, approximately 27 JWMRP research projects were selected for a continuation of the previous effort. (Contracts and Assistance Agreements.) The U.S. Army Medical Research and Materiel Command of the Department of Defense (DOD) has worked with North American Clinical Trials Network (NACTN) since 2006 via contracts W81XWH-07-1-0361 and W81XWH-10-2-0042 and through a new contract, W81XWH-13-2-0040, issued in May 2013. Methodist Hospital, in conjunction with the Christopher and Dana Reeve Foundation proposes to implement a Phase 2/3 randomized, double blind, controlled clinical trial of the neuroprotective drug riluzole for acute SCI. The projected outcome is a significant improvement in motor score when patients with acute SCI are treated with riluzole. The purpose and objective of the study are to further assess safety and efficacy of riluzolein acute SCI based on preclinical studies that argue for the larger study. This trial will test the hypotheses that patients with American Spinal Cord Injury Association (ASIA) B and SCI's C will realize significant improvement in motor outcome when treated acutely with riluzole and that a therapeutic level of plasma concentration of riluzole can be determined to validate a neuroprotective effect. This notice of intent is for information purposes only. The action will be awarded without further notice. The Point of Contact (POC) for this action is contact@example.gov.