R--U.S. Food and Drug Administration (FDA) submission and clearance of the Portable Neuromodulation Stimulator (PoNS ).

The United States Army Medical Research Acquisition Activity (USAMRAA) intends to issue a cost-sharing cost-reimbursement 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 02 March 2015 to the NeuroHabilitation Corporation, 208 Palmer Alley, Newtown, PA 18940 on behalf of the United States Army Medical Materiel Agency (USAMMA). The North American Industrial Classification System (NAICS) code for this acquisition is 334510 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 Portable Neuromodulation Stimulator (PoNS ) v4.0 device. The contractor shall provide Subject Matter Expertise (SME) in the execution of a pivotal trial and applications training to support the PoNSTM product development. This includes the development of the clinical protocol to support the de novo 510(k) marketing clearance application. This is a new contract for support services based on the continual collaboration to advance the PoNSTM device through FDA approval to assist physical therapy in the treatment of soldiers and others with balance and gait disorder. The intent of the effort is to improve physical rehabilitation by utilizing the PoNSTM device with Cranial Nerve Non-invasive Neuromodulation (CN-NINM) training as an advanced level of physical therapy. By obtaining FDA approval for the PoNSTM device, the device can be made available to help patients to recover normal movement control and improve their quality of life. 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, 27 December 2014. 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.