Non-Surgical Debridement Products for Definitive Care of Burn Injuries

Update Small Business Subcontracting Plan link and add template. Update 7/8/2015: AN AMENDMENT AND RESPONSES TO QUESTIONS ARE NOW POSTED FOR THIS SOLICITATION Update 6/26/2015: This is a solicitation notice. Please see attached document. Synopsis In mass casualty incidents, especially one resulting from the detonation of an improvised nuclear device (IND), thermal burn injuries are one of the significant public health consequences. This threat to national security has been recognized in a material threat determination (MTD) issued by the Department of Homeland Security (DHS). Several types of burns may be expected due to the release of an immense amount of thermal energy and the resulting secondary fires. Some victims are likely to suffer burns and trauma, along with radiation exposure as well. Mitigating burn injuries in a mass casualty incident requires a two-staged strategy, termed - Field Care' and - Definitive Care'. Field Care occurs at the site of injury to provide initial treatment for burn wounds. Victims may also require treatment for trauma, including monitoring of their vital signs for airway, breathing, and circulation. For victims of substantial burns, fluid replenishment is particularly important to prevent other complications. Consequently, during field care, the initial treatment goals focus on stabilizing patients by immediately addressing trauma and providing clean, anti-infective protective cover for burn injuries followed by fluid replenishment and pain medication. Upon triage, patients are transferred to medical centers specialized for burn injuries where personnel and products become accessible to initiate long-term - Definitive Care' in a more controlled environment. Deployment of Non-Surgical Debridement Products would increase the treatment capacity for burn patients particularly during public health emergencies by providing easier and/or more rapid ways to remove necrotic burn tissue versus current surgical procedures. This would reduce resource burdens associated with surgical procedures (materials, operating rooms, specialized medical personnel, etc.) and enable more patients to receive definitive closure for burn wounds within the clinically required time frames. Such products should provide equivalent or better healing times and functional outcomes versus surgical procedures. BARDA is seeking to fund late-stage development and procurement of non-surgical debridement products that can enhance the capacity to provide definitive care for thermal burn injuries. This will reduce the dependence on surgical debridement while still achieving equivalent goals as the standard of care practice. Candidate products are expected to reduce the amount of surgical excision procedures and may also demonstrate other desirable attributes, such as but not limited to, better resource utilization, reduction in burden on the surgical operating rooms, and aid prioritize delivery of burn care without compromise in the healing time for wound closure and quality of functional outcome. Overall, it would increase the ability of medical responders to provide definitive care for more patients during a public health emergency than the current standard of care. All candidate products are expected to be in late-stage development (in active clinical Phase II or beyond) with supporting data for a commercial indication for burn care and able to be accessed in sufficient quantities to enable an effective emergency response. Pre-Solicitation Notice Objective This Pre-solicitation Notice is issued pursuant to FAR Subpart 5.2. It does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. This Pre-solicitation Notice does not commit the Government to contract for any supply or service whatsoever. Furthermore, AMCG is not at this time seeking proposals, and will not accept unsolicited proposals. It is anticipated that an RFP may be available electronically through the FedBizOpps website in June 2015 for 30 days with proposals being due in July 2015. Once any RFP is posted we encourage all responsible sources, particularly small businesses, to submit a proposal which will be considered by the agency. It is the Offeror's responsibility to monitor this internet site (www.fbo.gov) for the release of this solicitation as well as any amendments. Potential Offerors will be responsible for downloading their own copy of the solicitation and any amendments via this website. No collect calls will be accepted. No facsimile transmissions will be accepted. It is anticipated that 1-2 cost reimbursement/firm-fixed price contract awards may be awarded in September 2015. The anticipated period of performance for any resultant contracts will be for a total of 60 months. Additional details and requirements will be described in the solicitation. Furthermore, all respondents must be registered in the System for Award Management (SAM) https://www.sam.gov. Contracting Office Address: Office of the Assistant Secretary for Preparedness & Response (ASPR) Department of Health and Human Services 200 C St. SW Washington, District of Columbia 20024 United States Point of Contact: Matthew Rose Contracting Officer Matthew.Rose@hhs.gov Phone: 202-205-2901