022421_FBO Post_ 2021 Skin Allograft PBS - Pre-solicitation Notice.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

Assistant Secretary for Preparedness & Response Washington, D.C. 20201

SYSTEM FOR AWARD MANAGEMENT

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 human cadaveric skin allograft for the treatment of deep-partial and full thickness burn wounds.

General Information

Document Type: Pre-Solicitation Notice

Posted Date: February 24, 2021 Solicitation Number: RFP# 75A50121R00018

Classification Code: C – Supplies and Equipment

NAICS Code:

62 – Health Care and Social Assistance / 621991 – Blood and Organ Banks

Synopsis

Treatment and care for burn injuries is labor intensive and influenced by the unique properties of each case, with complicating factors that include patient age, pre-existing health conditions, as well as burn wound size, depth and location. The challenges of providing definitive burn care significantly increase when delivering treatment after a mass casualty event in a resource strained environment. To mitigate some of these challenges, BARDA has collaboratively worked with the burn care community to identify areas in the delivery of care and improvements to treatment procedures. Two major areas where enhanced medical countermeasures (MCM) can provide a meaningful difference are in the triage of patients’ initial care and in a definitive burn care setting.

The objective of this solicitation is to build a reliable infrastructure for an established MCM within the definitive care paradigm that would provide burn care treatment and aid the recovery of patients during a mass casualty.

This solicitation will focus on the procurement of human cadaveric skin allograft (hereafter termed, ‘allograft’, (aka homograft)). Allograft has been widely used for over 70 years, dating back to WWII, in the management of burn injuries to provide temporary coverage. Under this acquisition, the US Government plans to establish a vendor-managed inventory (VMI) system to support a robust supply chain for allograft. Ensuring MCM supply would address product access to end-users, one of the key challenges in the delivery of care. In combination with other efforts, this treatment will enhance the overall capacity of burn care specialists to rapidly and effectively temporize and provide cover for burn wound injuries in the event of a medical countermeasure (MCI) with many burn victims.

Discussions with the professional burn community and market research data indicate a range of products are available for temporary cover of deep dermal and full thickness burn injuries, which ultimately need permanent skin through autografting. Human skin allograft remains the gold standard for temporary wound cover and is a reliable product of choice among surgeons in the burn community. During severe medical emergencies and mass casualties where delivery of care is imperative, a large and reliable supply of a range of MCMs is critical.

While newer MCMs under development for similar indications might be technologically innovative and considered an advanced generational leap in treatment, all new products take time for market integration through experiential use. These factors lead to a delay in wide overall adoption to supplant legacy MCMs like allograft. This serves as a primary rationale for establishing a robust supply chain of human skin allograft for the burn community. Allograft availability is essential to address MCM resources until such time that newer next generational skin products are both developed and incorporated into mainstream burn care. For the US Government, it provides a foundational preparedness on which newer products would gain eventual, consistent utility and adoption with the end-user community.

A qualified Offeror capable of meeting the procurement of allograft shall have significant volume of products as would be specified in the solicitation and supply over one or more contract options. In addition, the offeror should be capable to handle the logistics to maintain, ship, and ensure delivery of large quantities of allograft to qualified burn centers in a public emergency scenario.

In order to meet these objectives, Offerors would need to fulfill the following Mandatory Criteria for their proposals to be considered responsive:

1) Only human cadaveric skin allograft are covered. No other types of products, sources irrespective of their similarity or claimed equivalence in form, function or market data are entertained under this solicitation.

2) A qualified Offeror is an American Association of Tissue Banks (AATB) accredited tissue bank having a well-established supply-chain with verifiable, federally recognized Organ Procurement Organizations and existing business relationships with burn centers. Evidence of meeting this qualification would be required.

3) Qualified Offeror(s) shall have a demonstrable and established inventory management system for storing the procured allograft. A qualified Offeror is required to provide a statement to this effect. Under vendor managed inventory (VMI) an Offeror is required to routinely rotate and sustainably replenish product inventory as part of their commercial trade, such that the procured product is not lost due to expiry.

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. Furthermore, the Biomedical Advanced Research and Development Authority (BARDA) Division of Contracts Management and Acquisition (CMA) is not seeking proposals at this time and will not accept unsolicited proposals.

It is anticipated that an RFP may be available electronically through the beta.SAM.gov website under Contract Opportunities in March 2021 for 30 days with proposals being due in April 2021. Once any RFP is posted, we encourage all responsible sources, particularly small businesses, to submit a proposal, which will be considered by the agency. It is the Offeror's responsibility to monitor this internet site (https://beta.sam.gov) for the release of this 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 calls will be accepted. No facsimile transmissions will be accepted.

It is anticipated that a contract with both cost reimbursement and firm-fixed price aspects will be awarded in or around July - September 2021. The anticipated period of performance for any resultant contract(s) will be for a total of 60 months and up to 120 months, if all Option periods are exercised. 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.beta.sam.gov.

Contracting Office Address:

Office of the Assistant Secretary for Preparedness & Response (ASPR) Department of Health and Human Services 200 C St. SW Washington, District of Columbia 20024 United States

Points of Contact:

Jill Johnson BARDA Contracting Officer jill.johnson@hhs.gov

Sabrina McIntyre BARDA Contract Specialist sabrina.mcintyre@hhs.gov

Narayan Iyer, PhD BARDA/CBRN Burn Branch Chief narayan.iyer@hhs.gov