Pre Solicitation Notice 75A50125R00007.docx

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

PRESOLICITATION NOTICE

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION MAY BE ISSUED ON A LATER DATE.

Title:

BARDA Procurement of Enzymatic Debridement Products for Treatments of Deep and Full-Thickness Severe Burn Injuries

General Information:

Synopsis

This acquisition is for procuring a national preparedness stockpile against large burn mass casualty incidences (BCMI). Surgical Debridement is the current standard of care for removing dead skin tissue (eschar) from severe burn injuries as the required first step in definitive care. Discussions with the professional burn community and market research data indicates that products that more selectively debride necrotic burned skin earlier in patient care can reduce resource burden and improve patient outcomes. Such products should be compatible with current procedures to allow easy integration so they can also be used during mass casualty scenarios involving significantly high numbers of burn patients by enabling debridement at the patient bedside to free up operating room time.

Currently, BARDA contracts a Vendor Managed Inventory (VMI) for procurement of enzymatic debridement product using Project BioShield (PBS) funding. This contract expires in September 2025. To maintain preparedness and response to mass burn disasters, PBS support beyond FY25 is needed to continue to procure an enzymatic debridement product. BARDA seeks to procure and establish a deployable cache of product (Preparedness Inventory) managed by the product’s vendor in coordination with their commercial (Planned) inventory. This system would establish a vendor-managed inventory (VMI) as a collaborative access-maintenance model of product to maintain ready and rotate through commercial sales to prevent expiry and waste. The contractor will ensure all product is within expiry and report total inventory numbers to BARDA monthly. In return, BARDA pays for this monthly maintenance and the right to access and deploy this VMI cache in the event of a national emergency. This system allows for cost-effective national preparedness by preventing the need to replace expiring product. In addition, it is critical the USG invest in next generation debridement products that are more cost effective, sustainable, and capable to addressing national health threat needs. Towards those goals, PBS funding will additionally support the development of a more effective, room temperature stable formulation, enhanced efficacy and explore the potential for its use on blast trauma wounds for additional preparedness capability and return on investment.

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.

Any contract(s) 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 2025. The anticipated period of performance for any resultant contract(s) will be up to 120 months with an initial base period of 120 months. Additional details and requirements will be described in the solicitation.

Furthermore, all respondents must be registered in the System for Award Management (SAM):

https://www.sam.gov.

Contracting Office Address:

Administration for Strategic Preparedness and Response (ASPR) Department of Health and Human Services 200 C St. SW Washington, District of Columbia 20024 United States

Points of Contact:

Yifan Yang BARDA Contracting Officer Yifan.Yang@hhs.gov

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

Veronica Stroud BARDA Contracting Specialist Veronica.Stroud@hhs.gov

Julio Barrera-Or0 BARDA Project Officer/ Contracting Officer’s Representative julio.barrera-oro@hhs.gov image1.png