The United States Army Medical Research Acquisition Activity (USAMRAA) intends to issue a Firm-Fixed-Price sole source Research and Development (R&D) contract under the authority of FAR 6.302-1 (a)(2)(iii)(A) - Only one responsible source and no other supplies will satisfy agency requirements, on or about 06 September 2013 to BioQuiddity Incorporated, 185 Berry Street, Suite 160 San Francisco, CA 94107-1756 on behalf of the sponsor agency 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. The purpose of this effort is to develop and test a non-electrical infusion pump that intravenously dispenses pain killers and anesthesia to patients in the field in route to higher echelons of care. The pre-filled, non-electric, and ready-to-use infusion system will be subjected to bioequivalence studies followed by a clinical evaluation to demonstrate the product's safety and efficacy. This acquisition will allow the Contractor to complete final product manufacturing verification and validation, final product toxicity and sterility testing, and performance testing of the final combination of products. The infusion system will be subject to a bioequivalence study for human factors and clinical evaluation of the final product making the infusion kits acceptable to the U.S. Food and Drug Administration (FDA). This requirement is a follow-on research project for the continued development and testing of a non-electrical infusion pump to aid in the delivery of treatment of patients in the field. The intent of the effort is to decrease the probability of medication errors, reduce the probability of hospital acquired infections, as well as decrease logistical and process related costs. On-going research and development studies with BioQuiddity 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, 03 September 2013. 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. Please submit all questions and concerns via e-mail to Christopher Sult at
[email protected]. Telephone inquiries will not be accepted.