SSN BARDA-CBRN-06102024 FY25 PBS_Autograft Sparing.pdf

Sources Sought Notice (SSN)

Autograft Sparing Devices for Burn and Trauma

SSN Number: BARDA-CBRN-06102024

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.

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 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.

CAPABILITY STATEMENT/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 (and not more than two) 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 (in line with the objective defined in the SSN).

b. Product use data supporting autograft sparing/reduction in donor site size.

c. Ease of use and justification for use in routine burn care and especially in the context of a mass casualty incident.

d. Summary information on FDA approval or relevant guidance from the most recent FDA meeting regarding the product’s regulatory path towards approval for treatment of thermal burn wounds and full-thickness skin defects, if available.

e. Brief description of regulatory pathway status and summary of results of a pilot or pivotal study completed to support efficacy for improved healing in full thickness burns and skin defects

f. Description of product development and regulatory activities still needed to achieve FDA clearance, if applicable

g. Other potential uses of the same device in routine medical care and the stage of development for these other indications.

h. Company’s strategy and investments in other medical care market segments that may make the product sustainable.

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, manufacturing and supply chain management of product including key product components, and risk mitigation strategies.

c. Relevant information about the product manufacturing capacity (current state in line with supporting commercial projections) and spare capacity that would allow for stockpile via a vendor managed inventory (VMI); and capacity to scale up levels to meet increased demands either for stockpiling or increase commercial sales.

d. Market list price and typical commercial service operations for management of the components (if applicable) as well as experience in maintaining a VMI.

e. Organizational experience in working with governmental agencies including federal, state, and local agencies.

f. Sources of investments (outside of USG investments, if any) that offer the company financial stability and capability to build broader markets for other investments.

4. Respondents must complete the product information table in Appendix 1 of this SSN.

5. Respondents may mark the information as confidential, privileged, proprietary, trade-secret, copyrighted information, data, and materials with appropriate restrictive legends, as appropriate.

ASPR/BARDA will presume that any unmarked information, data, and materials were furnished with an “unlimited rights” license, as FAR subpart 27.4 defines that term. ASPR/BARDA assumes no liability for the disclosure, use, or reproduction of the information, data, and materials.

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 Richard.hall@hhs.gov. Responses are due no later than July 31 by

3PM US EDT.

THIS INFORMATION IS REQUESTED FOR INFORMATION GATHERING PURPOSES ONLY.

Posting Date: June 10, 2024 mailto:Richard.hall@hhs.gov

APPENDIX 1:

Product Company Latest Regulatory Activity

Stage of Development (POC, pilot, pivotal)

Intended Use (include clinical usage environments, populations indicated)

Capabilities (donor skin ratio/improved healing time)

Other Indication(s) & Stage of Development

Cost per unit

Shelf Life Manufacturing Status (GMP) Capacity (annual commercial projections and spare capacity for VMI/surge or scale up capacity)

Small Business – Yes/No