A--Notice of Intent to Issue a Sole Source Solicitation/Contract for the Validation of Manufacturing Processes, Warehousing and Delivery of Cryopreserved Platelets (CPP) Product to Support Efforts to Obtain FDA Licensure

The U.S. Army Medical Research Acquisition Activity (USAMRAA) intends to issue a Cost Plus Fixed Fee Contract to a single source under the authority of FAR 6.302-1(a)(2)(iii), Only One Responsible Source and No Other Supplies or Services will Satisfy Agency Requirements, on or about 1 APR 2013 to Clinical Research Management (CRM). The period of performance is 5 years. USAMRAA intends to award this requirement as a sole source to CRM since the services are follow-on from a current contract award and awarding to another source would cause unacceptable delays/gaps in service during the time required to issue a new competitive contract. This requirement is for direct support of US Army product development efforts to license Cryopreserved Platelets (CPP) with the Food and Drug Administration (FDA) for management of severe hemorrhage from wounding. The Government's ultimate goal is to establish a validated current Good Manufacturing Practices (cGMP) process for CPP that meets regulatory requirements for FDA licensure and that can ultimately be transferred to military or other blood banks for manufacture of CPP for battlefield use. The specific purpose of this proposed contract, is the continuation of development of CPP by CRM at Dartmouth-Hitchcock Medical Center (DHMC) that includes ongoing long-term storage/stability studies, characterization of CPP physical structure and function relevant to FDA requirements, evaluation of a new DMSO bag and closed fill system, conduct of process validation studies, support for submission of a Biologics License Application (BLA), and supply of clinical trial material. As a sole-source logical follow-on to ongoing work by CRM at DHMC, this contracting action will enable the CPP Program to continue development without incurring significant schedule delays and duplicative costs as they relate to the establishment and qualification of a cGMP manufacturing facility. The CPP Program is scheduled to begin a Phase 1, low-dose escalation study in August 2013. CRM is the only known source capable of rendering the required services to deliver clinical trial material prior to the study start as no other contractor is currently developing a CPP product. The North American Industry Classification System (NAICS) code for this requirement is 541711 with the size standard of 500 employees. This notice of intent is not a request for proposals or quotes; however, all responsible sources may submit a quotation and technical capabilities, which, if received within fifteen calendar days of publication of this notice, shall be considered by USAMRAA. All responses must be submitted to the Government point of contact Shannyn M. Scassero at contact@example.gov. A determination by the Government not to open the requirement to competition based upon the responses to this notice is solely within the discretion of the Government.