PURPOSE The Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), is issuing this Sources Sought Notice (SSN) to collect information of specific product and service suppliers supporting the mission. Information collected from this SSN serves as market research whereby BARDA could partner with one or more organizations to achieve the preparedness goals set forth by the U.S. Government (USG). The information collected in response to this SSN is intended to strengthen BARDA’s understanding of the current and future marketplace. This notice seeks information from Other than Small Businesses (OTSB) and Small Businesses (SB) regarding their qualifications, experience, and capabilities. BARDA’s mission is primarily to build national preparedness by developing a broad range of medical countermeasures (MCM) that mitigate various threats as elaborated in the sections below. Under this SSN, BARDA is specifically seeking information on FDA approved autograft sparing technologies or those that may be approved in the next 5 years that could reduce the amount of donor skin required to treat full thickness burns and skin defects to reduce patient morbidity and mortality. The technologies sought are expected to function in burn and trauma centers. Autograft sparing technologies that are well-integrated in routine healthcare settings inherently build national preparedness and the capability to apply these tools during mass casualties involving burn injuries. (See Objective section below for details). Based on the unmet needs in both burn and trauma care, BARDA is seeking technologies with both of the following capabilities: (1) To treat thermal burn wounds and full-thickness skin defects (resulting from burns or traumatic injuries) in both adults and pediatrics, AND (2) To reduce the amount of donor skin required for treatment FDA approved technology products should already have or have high potential to integrate within the current US healthcare settings (Trauma/Burn Centers), market data on statistics or performance and adoption in routine care use. If the product has not yet received FDA approval, data supporting these goals would be useful. BACKGROUND Within the Chemical, Biological, Radiological, and Nuclear (CBRN) Medical Countermeasures Division of BARDA, the Burn and Blast MCM program has a responsibility to build comprehensive national preparedness for the management of burns and blast trauma caused by nuclear detonation, whether accidental or intentional. Since 2013, the Burn and Blast program has been systematically executing the strategic priority to develop effective medical countermeasures (MCMs) across the entire care continuum for burn and blast trauma. Multiple products for the management of initial and definitive care burns and blast trauma injuries are already in development under Advanced Research and Development or Project BioShield (PBS) contracts. In this SSN, we outline the objective as well as the performance characteristics and functional rationale for the products in routine care and in burn mass casualty. OBJECTIVE: Autograft sparing technology to improve patient outcomes A large burn mass casualty incident could quickly overwhelm the US healthcare infrastructure. Severe burn injuries (especially, >10% TBSA) typically require highly specialized care for effective delivery of resource-intensive therapies including surgeries. Nationally, this capability is critically limited at multiple levels and would challenge timely access and treatment of those injured even in a relatively small incident. This makes it imperative to leverage technology that reduces the amount of donor skin required for full thickness and large deep partial thickness burns. Reducing the required amount of donor skin for delivery of definitive care has the potential to greatly improve the patient’s quality of life while reducing hospital length of stay and the need for reconstructive surgery. Under this SSN, BARDA is seeking information from product developers autograft sparing devices that reduce the amount of donor skin required to treat full thickness wounds from burns and trauma in children and adults. FDA cleared technologies will be prioritized. Developers must include performance data from burn centers and from emergency departments. For FDA approved products, please include commercial sales data demonstrating results for market penetration and adoption in commercial use at various burn and trauma centers. PRODUCT USE SETTINGS BARDA is seeking information which justifies the use of autograft sparing MCMs that can be used in multiple use case settings such as emergency rooms, outpatient settings or definitive care at any appropriate trauma or burn centers. The device will be capable of safely and effectively reducing the amount of donor skin required to treat full thickness wounds. DEVELOPMENT STATUS Under this SSN, BARDA is seeking information on FDA approved autograft sparing devices and / or those technologies under advanced development likely to be approved by the FDA within the next five years. It is recommended that product developers provide their regulatory strategy and previous interactions with FDA as part of the narrative submission. Information such as clinical performance data in adult and pediatric populations should be included. A strategy for commercialization and expansion within the US health care system should be also included. A statement of the product raw material sourcing and supply chain should be included, and US-based manufacturing is preferred. Responses shall be sent electronically to
[email protected]. Responses are due no later than July 31 by 3PM US EDT .