Inactive

The Office of the Biomedical Advanced Research and Development Authority (BARDA), within the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Se... The Office of the Biomedical Advanced Research and Development Authority (BARDA), within the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) intends to use Project BioShield (PBS) to support development of a novel burn wound imaging technology (BWIT). This technology is envisioned as a non-invasive imaging device to rapidly assess the wound size and severity and assist emergency physicians on triage decisions to more specialized burn centers. It would also be designed to provide information useful for clinical decision by burn care specialists on the wound areas in need of interventional treatment to achieve definitive healing. Furthermore, adoption will be expanded through placement of these devices into both initial and definitive burn care settings with end-user training. Under the proposed RFP, BARDA will support advanced development of such imaging devices, manufacturing capability as well as execution of pivotal clinical studies to achieve FDA approval and product procurement for placement in routine burn care settings to build mass casualty preparedness. Questions are due on August 1, 2023. Proposals are due on September 1, 2023. Attached to this SAM Notice are the following: 1. Request for Proposals (Solicitation) 2. SF33 3. Budget Template Spreadsheet

Inactive

The Office of the Biomedical Advanced Research and Development Authority (BARDA), within the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Se... The Office of the Biomedical Advanced Research and Development Authority (BARDA), within the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) intends to use Project BioShield (PBS) to support development of a novel burn wound imaging technology (BWIT). This technology is envisioned as a non-invasive imaging device to rapidly assess the wound size and severity and assist emergency physicians on triage decisions to more specialized burn centers. It would also be designed to provide information useful for clinical decision by burn care specialists on the wound areas in need of interventional treatment to achieve definitive healing. Furthermore, adoption will be expanded through placement of these devices into both initial and definitive burn care settings with end-user training. Under the proposed RFP, BARDA will support advanced development of such imaging devices, manufacturing capability as well as execution of pivotal clinical studies to achieve FDA approval and product procurement for placement in routine burn care settings to build mass casualty preparedness. PLEASE SEE ATTACHED PRESOLICITATION NOTICE FOR FULL DESCRIPTION.