BWIT Presolicitation Notice 06302023.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES

Administration for Strategic Preparedness & Response Washington, D.C. 20201

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: Project BioShield Procurement of Burn Wound Imaging Technology

General Information Document Type: Pre-Solicitation Notice Solicitation Number: 75A50123R00002 Product Service Code: AN13 – Health R&D Services; Health Care Services;

Experimental Development NAICS Code: 541714 – Research and Development in Biotechnology

(except Nanobiotechnology)

Synopsis

Treatment and care for burn injuries is both resource and labor intensive. The national capacity for burn care is typically limited, which presents a significant challenge to address a sudden surge in patients after a burn mass casualty incident. For example, the current standard of care for these assessments largely relies on visual clinical judgement based on the experience of the care providers. Studies have shown that even trained burn specialists have only modest 70% accuracy in their visual clinical judgement while the frontline emergency physicians, though relatively broadly trained but inexperienced in burn care, function with just 50% accuracy in their capability. Effective use of valuable resources and management of surgical burden relies on the ability to properly triage burn patients who need timely surgical care or discharge.

A systemic capability to deliver burn care based on early, accurate assessment of burn size with clinical guidance on prognosis of burn wound healing largely does not exist. Building these two important capabilities within the national burn care treatment paradigm is expected to be transformational and have cascading effects in delivery of care across the burn care continuum.

Furthermore, these capabilities would improve the delivery of care via reduction in unnecessary transfers and better management of limited burn care resources.

In order to address these unmet needs, 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 this 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.

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.

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. Updates to the details provided could arise based on information and insight gained in the interim. Furthermore, BARDA is not at this time seeking proposals, and will not accept unsolicited proposals.

The Government intends to issue a Request for Proposals on or about July 15, 2023, through the Sam.gov website. Proposals will be due 45 calendar following release of the RFP. Once an RFP is posted, we encourage all responsible sources that meet the mandatory criteria detailed above, to submit a proposal which will be considered by BARDA. It is the Offeror's responsibility to monitor this internet site (www.sam.gov) for the release of the 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.

Any contract awarded from the RFP solicitation will have both cost-plus-fixed-fee and firm-fixed-price line items and will be awarded in or around September 2023. The anticipated period of performance for any resultant contract(s) will be up to 84 months with an initial base period of 36 months. Additional details and requirements will be described in the solicitation. Furthermore, all respondents must be registered in the Systems for Award Management: https://www.sam.gov.

Contracting Office Address:

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

Points of Contact:

Kevin Dean BARDA Contract Specialist Kevin.Dean1@hhs.gov

Jonathan Gonzalez BARDA Contracting Officer Jonathan.Gonzalez@hhs.gov

Julio Barrera-Oro, Ph.D.

Health Scientist, Division of CBRN Countermeasures Julio.Barrera-Oro@hhs.gov https://sam.gov/content/home https://www.sam.gov/ https://www.sam.gov/ mailto:Jill.Johnson@hhs.gov mailto:Mark.Albrecht@hhs.gov mailto:Jonathan.Gonzalez@hhs.gov mailto:Mark.Albrecht@hhs.gov mailto:Jonathan.Gonzalez@hhs.gov mailto:Julio.Barrera-oro@hhs.gov