Pre-Solicitation Notice - Burn Wound Imaging Technology   4

Background
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.

Work Details
The USG seeks BWIT devices that meet the following mandatory criteria: 1. Evidence of completed preliminary clinical studies with evaluation in both emergency department and burn centers. Satisfactory evidence with summary data that the proposed system has the capability to provide guidance to the care providers.
2. Evidence of system performance in adults and pediatric population. Satisfactory evidence to be provided could include data in both populations.
3. Evidence of discussion with FDA with guidance established for a regulatory strategy. Satisfactory evidence shall include a summary of FDA meeting minutes.

Period of Performance
The anticipated period of performance for any resultant contract(s) will be up to 84 months with an initial base period of 36 months.

Place of Performance
Contracting Office Address: Administration for Preparedness & Response (ASPR), Department of Health and Human Services, 400 7th SW, Washington, District of Columbia 20024, United States