R--U.S. Food and Drug Administration (FDA) submission and clearance of the Arsenal Medical, Inc. Wound Stasis System (WSS) medical device.

The United States Army Medical Research Acquisition Activity (USAMRAA) intends to issue a Firm Fixed-Price sole source contract under the authority of FAR 6.302-1 (a) (2) (ii) - Only One Responsible Source and No Other Services will Satisfy Agency Requirements, on or about 07 August 2015 to the Arsenal Medical Incorporated, 480 Arsenal Street, Watertown, MA 02472 on behalf of the United States Army Medical Materiel Agency (USAMMA). The North American Industrial Classification System (NAICS) code for this acquisition is 541711 and the size standard is 500 employees. The purpose of this effort is to obtain the U.S. Food and Drug Administration (FDA) submission and clearance of the Arsenal Medical, Inc. Wound Stasis System (WSS) medical device. The Contractor shall provide Subject Matter Expertise (SME) in the execution of the pivotal trial and applications training to support the Arsenal Medical, Inc. WSS medical device product development. This includes the development of the clinical protocols, Quality System Regulation (QSR) - compliant representative test articles for the study, and training material for users on the Arsenal Medical, Inc. WSS medical device. This is a new contract for support services based on the continual collaboration to advance the Arsenal Medical, Inc. WSS device through FDA approval for a treatment for intracavitary, noncompressible hemorrhage. The intent of the effort is to fulfill the current capability to effectively minimize, mitigate, and prevent injury and personal impact to the service member utilizing the Arsenal Medical, Inc. WSS medical device with point-of-injury therapies. By obtaining FDA approval for the Arsenal Medical, Inc. WSS medical device, the device can be made available to the military and civilian population to help save lives and prevent deaths. On-going support and development is essential to the Government's mission and needs, thereby precluding consideration of another entity. Interested contractors may identify their interest and bona fide capability to fulfill the requirement. This notice of intent is not a request for competitive proposals. Interested parties who believe they can meet this requirement shall submit information about their capabilities no later than 4:00 PM EST, 15 May 2015. All information shall be furnished at no cost or obligation to the Government. No solicitation will be made available. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this proposed solicitation based upon responses to this notice is solely within the discretion of the Government. Telephone inquiries will not be accepted.