Cleared to Post_FY25 Debridement MCM_SSN 1106 2024 (002).pdf

Sources Sought Notice (SSN) Enzymatic Debridement Products for Severe Burns

SSN No.: BARDA-CBRN-11122024-VES

TYPE: Sources Sought Notice

PRODUCT SERVICE CODE: AN13

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 on 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) which mitigate medical consequences from various threats. Under this SSN, BARDA is specifically seeking information on FDA approved, enzymatic debridement products for non-surgical removal of necrotic eschar tissue from severe burns or those that may be approved in the next 2 years. The technologies sought are expected to function in U.S. burn centers. Burn debridement products that can be well-integrated into routine burn care settings inherently build national preparedness by creating the capability to use these tools during mass casualties involving burn injuries. (See Objective section below for details).

AUTHORITY

The Office of Contracts, Management and Acquisition (CMA) issues this Sources Sought Notice (SSN) on behalf of the Biomedical Advanced Research and Development Authority (BARDA) pursuant to FAR paragraphs 5.205(c), 15.201(e) and FAR parts 10, 19. Information collected in response to this SSN will enhance BARDA’s ability to establish potential vendor source files and listings and lawfully execute the preparedness mission efficiently and lawfully.

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 and make available effective medical countermeasures (MCMs) across the entire care continuum for burn and blast trauma. Multiple products for the management of initial and definitive care of burns have been developed under Advanced Research and Development or Project BioShield (PBS) contracts. In this SSN, we outline our objective to better understand the commercial availability of once such product in routine care for burn mass casualty preparedness.

OBJECTIVE: Enzymatic debridement for non-surgical removal of necrotic tissue from severe burns.

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 time and surgical burden to debride necrotic tissue from partial and full thickness burns as the first critical treatment step in definitive care.

Reducing the time to eschar removal in a more selective way than the current standard of care by surgery with bladed instruments 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/distributors of medical products that enzymatically remove necrotic tissue (eschar) from partial and full thickness burns in both children and adults. Responders to this SSN must include performance data from U.S. burn centers. For FDA approved products, please include commercial sales data (including future projections) as an indication of market penetration and adoption into commercial use. Please also include information that clearly describes the strategy and infrastructure requirements for integrating the enzymatic debridement product into routine burn care settings.

BARDA is seeking information on the commercial availability of products with the following capabilities:

1. Selectively removes necrotic skin from severe thermal burns of both partial and full thickness in both adults and pediatrics.

2. Functions in non-surgical settings (e.g., patient bedside) to achieve complete debridement.

3. Achieves complete debridement within 24 hours as per approved indication to enable the next step in burn care.

4. The priority of this SSN is to seek information is regarding FDA approved products. Information on products still in advanced development with the potential for FDA approval within two years may be provided as supported by data and communications with the FDA.

5. Potential to support a vendor-managed inventory (VMI) of product for emergency distribution in response to a mass burn casualty incident. This inventory must rotate into commercial sales when not used for emergency response to prevent expiry and waste.

SUBMISSION INSTRUCTIONS:

1. Respondents must submit separate narratives covering technical and business-related information, each not exceeding 5 pages (total 10 pages)

2. The technical narrative shall cover only the most pertinent information, such as performance data, use-case settings, capability of the product and the company to adequately meet the objective and purpose described. If there are multiple product/combinations available, we recommend that you ideally select only one product for which information is provided in your narrative. The narrative may include figures, schematics, diagrams, and photographs as needed within the page limit.

Please ensure the narrative covers the following:

a. A clear description of the product’s intended use, functionality, and use case setting for enzymatic debridement of partial and full thickness thermal burn wounds (in line with the objectives defined above).

b. Product use data supporting enzymatic debridement for complete eschar removal as indicated.

c. Ease of use and justification for use in routine burn care and potential value for use in a mass casualty incident.

d. Relevant information about the product manufacturing / warehousing / distribution capacity in line with commercial projections, excess / spare capacity that would allow for stockpile via a vendor managed inventory (VMI); future capacity for scale up to meet increased commercial demands. Provide a description of the organization system to ensure product rotation in a VMI through commercial sales to prevent product expiry and waste (e.g., inventory tracking systems).

e. If product is not manufactured in US, current/future summary plans to onshore capacity, and information on timeline, process, and risk mitigation.

f. For products still in advanced development to achieve FDA approval, provide a summary of status and timeline for product development and regulatory activities.

3. The business narrative shall cover company information, including capability to supply the product.

This includes the following:

a. Company mission and description of the business information (registered as small business/NAICS code), including locations, management, and employees.

b. Organizational capability across the US for management of product manufacturing, supply chain, warehousing, inventory management, distribution, and risk mitigation strategies.

c. If serving as a commercial distributor, commercial distribution rights, limitations, and risk mitigation of supply chain.

d. Provide current market list price. To the extent possible provide future market projections.

e. Summarize any plans and strategy to increase product penetration into the U.S. burn care market.

4. While the data is treated as confidential and will not be disclosed publicly, please do not include proprietary information in response to this SSN.

DISCLAIMER AND IMPORTANT NOTES

This notice is issued solely for information and planning purposes and does not obligate the US Government to award a contract. No entitlement to payment of direct or indirect costs or charges by the US Government will arise because of the submission of the requested information. No reimbursement will be made for any costs associated with providing information in response to this announcement and any follow up information requests. The US Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the US Government to determine the organization’s qualifications to perform the work. Respondents are advised that the US Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published on SAM.gov under Contract Opportunities in accordance with FAR part 5. However, responses to this notice will not be considered adequate responses to a solicitation.

Responses shall be sent electronically to veronica.stroud@hhs.gov. Responses are due no later than December 2 by 3PM US EST.

THIS INFORMATION IS REQUESTED FOR INFORMATION GATHERING PURPOSES ONLY.

mailto:veronica.stroud@hhs.gov

HHS BARDA POCs:

Julio Barrera-Oro julio.barrera-oro@hhs.gov Yifan Yang Yifan.Yang@hhs.gov Veronica Stroud veronica.stroud@hhs.gov

Posting Date: November 12, 2024 mailto:julio.barrera-oro@hhs.gov mailto:Yifan.Yang@hhs.gov mailto:veronica.stroud@hhs.gov