UPDATE 7/8/2015: AN AMENDMENT, RESPONSES TO QUESTIONS, AND A WORD VERSION OF THIS SOLICITATION IS NOW POSTED. UPDATE 6/26/2015: THIS IS A SOLICITATION NOTICE. PLEASE SEE ATTACHMENT. FEDERAL BUSINESS OPPORTUNITIES PRESOLICITATION NOTICE THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION MAY BE ISSUED ON A LATER DATE. Title: Cell-Based Skin Substitutes for Definitive Care of Burn Injuries General Information Document Type: Pre-Solicitation Notice Posted Date: May 18, 2015 Solicitation Number: RFP# 15-100-SOL-00018 Classification Code: A - Research & Development NAICS Code: 541 -- Professional, Scientific, and Technical Services/541711 -- Research and Development in Biotechnology 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. Many 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. Cell-based skin substitutes requiring a single surgical application (in lieu of autografting) would increase treatment capacity to provide definitive wound closure to burn injuries. The use of skin substitutes particularly during public health emergencies could potentially reduce the time, labor, and resource burdens associated with standard of care. This would free up resources to enable treatment for more patients. Highly desirable skin substitutes are those which are fully resorbable, facilitate definitive wound closure of partial thickness and even full thickness burn wounds, and require no additional surgical procedures after placement on the excised burn wound. BARDA is seeking to fund late-stage development and procurement of cell-based skin substitutes that can enhance the capacity to provide definitive care for thermal burn injuries. A key potentially desirable attribute of cell-based skin substitutes may be to reduce or eliminate the need for autografting and thereby increase the efficiency of burn care by promoting faster burn wound healing and recovery. 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 treatment of deep partial and/or full thickness skin burn injuries. Products are to be procured in sufficient quantities at the discretion of the USG to enable an effective emergency response either upon FDA approval or under other authorities available under Project BioShield as appropriate. 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 a 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
