Allograft_Skin_Thermal_Burn_2020_OTSBSSN_01B.pdf

Other Than Small Business Sources Sought Notice

OTSBSSN No.: BARDA-2020-Thermal Burn (01B) Human Skin Homograft for Burn Injuries

I. INTRODUCTION

The purpose of this Other Than Small Business Sources Sought Notice (01B) is to seek declarations of technical capabilities, data, and materials from qualified other than small business concerns relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. The proposed NAICS for this proposed requirement is 541714.

Please note that a Small Business Sources Sought Notice (01A) has also been posted regarding this possible requirement, and is intended solely for prospective Offerors that are considered to be a Small Business. Prospective Offerors shall respond to the appropriate notice relative to their business size standard.

THIS IS STRICTLY FOR MARKET RESEARCH.

II. AUTHORITY

The Office of Contracts Management Acquisition (CMA) issues this Other Than Small Business Sources Sought Notice (OTSBSSN) 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.

III. ACRONYM

“AATB” means American Association of Tissue Banks “ASPR” means Assistant Secretary for Preparedness and Response “BARDA” means Office of the Biomedical Advanced Research and Development Authority within the U.S. Department of Health and Human Services “CBRN” means Chemical, Biological, Radiological, and Nuclear “CMA” means Contracts Management and Acquisition “CONOPs” means Concepts of Operations “cGXP” means any of cGMP, current Good Manufacturing Practices; cGLP, current Good Laboratory Practices; cGTP, current Good Tissue Practices; or cGCP, current Good Clinical Practices “FAR” means Federal Acquisition Regulation “FDA” means the U.S. Food and Drug Administration “FDP” means Final Drug Product “FTSG” means Full-Thickness Skin Graft “HHS” means the U.S. Department of Health and Human Services “IND” means Improvised Nuclear Device “Licensed” means approved for use by a regulatory authority, “MCI” means Mass Casualty Incident “MCM” means Medical Countermeasure “Notice” means this Sources Sought Notice “PEP” means Post Exposure Prophylaxis “PHEMCE” means the Public Health Emergency Medical Countermeasures Enterprise “RFI” means Request for Information “SAL” means sterility assurance level “SNS” means Strategic National Stockpile

“STSG” means Split-Thickness Skin Graft “SSN” means Sources Sought Notice “TBSA” Total Body Surface Area “USG” means United States Government “VMI” means Vendor Managed Inventory

IV. DEFINITIONS

“Autograft” - a tissue or organ that is transplanted from one part to another part of the same body.

“Allograft” - a homograft between allogeneic individuals.

“Allogeneic” - involving, derived from, or being individuals of the same species that are sufficiently unalike genetically to interact antigenically (i.e. genetically not identical).

“Homograft” - a graft of tissue taken from a donor of the same species as the recipient. In this notice, the term homograft and allograft are considered the same.

“Offeror” – any organization responsible for processing and distributing human skin allograft for burn wounds responding to this Notice and meeting the criteria being requested.

“Tissue Bank”- repository for human tissue intended for clinical or research purposes.

V. PURPOSE

The Office of the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) intends to use responses to this Other Than Small Business Sources Sought Notice (OTSBSSN) for planning potential future acquisitions. BARDA seeks pertinent marketplace data on availabilities and capabilities for procuring, stockpiling, and investing in human skin homograft for the treatment of burn and trauma injuries resulting from mass casualty incidents.

BARDA seeks information on availabilities, capabilities, and other pertinent marketplace data to support a vendor managed inventory for this product. This information is intended to strengthen BARDA’s understanding of the current and future marketplace and enhance its ability to obtain quality services economically, and to efficiently and lawfully establish potential vendor source files and listings. BARDA will not award any contracts under this Notice.

VI. BACKGROUND

Certain natural disasters and large-scale acts of terrorism have the potential to inflict a wide range of thermal burn injuries on a large number of victims. The extent of such mass casualties and damage to the local infrastructure depends on many factors. Preparation and planning for optimal deployment and use of burn medical countermeasures (MCM) is essential to limiting the morbidity and mortality from such mass casualty incidents. A range of new burn MCMs are under development for use in a definitive care settings that have the potential to minimize the consequences of deep dermal burn injuries. However, many technologies are still in clinical development and are not available for use or to build burn care preparedness in the short term. Products such as human skin allograft are well established as a treatment in burn care and part of the traditional interventions used in the operating room. In patients with deep dermal burn injuries over a large total body surface area (TBSA), skin allografts remain a product of choice among many burn surgeons as a first line of treatment to provide reliable temporary burn wound coverage.

BARDA seeks to understand the preparedness efforts that can be introduced to minimize the disruptive effects of product shortages in the supply chain following a mass casualty incident (MCI). This effort includes maintenance of product stockpiles and reinforcing supply chains during steady state operations that may contribute to minimizing these impacts, including, but not limited to the following:

Tissue bank affiliation with procurement organizations, verified burn centers, national associations, and other tissue banks.

The human skin homograft supply chain and its vulnerabilities, dependencies, and opportunities for improvement within the United States.

Recovery and processing of human skin homograft surge capacity (i.e. what is the time constraint from donor skin recovery to processing and medical clearance?) Understanding this constraint—how much human skin homograph can be supplied in a specified time frame without disturbing routine operations?

Continuity of operations and response capabilities of tissue banks practicing skin banking (i.e.

those organizations that process and distribute human skin allograft for burn wounds termed Offeror, for the intent of this Notice) to provide human skin allografts in response to a public health emergency or a National Emergency Declaration.

Tissue bank product commercial labeling, inventory identification and tracking systems.

Tissue bank managed supply chain logistics and critical supplies supporting operations.

Market share and the amount of human skin allograft used for routine burn care.

Based on the information gathered from this notice, BARDA may consider developing strategies for building a preparedness level that may require maintaining an inventory of human skin homografts for the treatment of burn and trauma injuries resulting from mass casualties. Therefore, BARDA is interested in strategies to:

Ensure the resilience of the supply chain for human skin allograft with the intent of securing inventories for emergency distribution.

Increase product levels to support a stockpile requirement or surge capacity using a VMI.

Encourage partnerships and collaboration among tissue banks for the coordination and maintenance of a VMI.

Improve product stock rotation, tracking and logistics technologies for vendor-managed material and/or adopt other strategies that enable more sustainable supply chain management.

Extend product shelf life, and/or expedite product delivery to definitive care locations.

VII. PROJECT REQUIREMENTS

This Notice is restricted to human skin allograft (homograft) products indicated for temporary wound cover during routine burn care in a clinical setting. Human skin allograft procurement, processing, storage and packaging should be performed using aseptic techniques appropriate for a sterile surgical environment as set by the AATB Standards for Tissue Banking. Human skin allografts typically used for temporary coverage of epithelial surface wounds (e.g. due to full or partial-thickness burns) are the only subject of interest in this Notice.

This Notice is for a product to serve all members of the U.S. population who would be in need in an MCI to include at–risk individuals. Products with limited or no applicability for use in at-risk populations are not desirable. Products that only address the needs of one portion of the populations considered to be at-risk and lack general applicability do not meet the scope of this Notice.

BARDA seeks to identify suppliers of processed human skin homograft used in a definitive care setting for treatment of burn injuries to provide temporary burn wound cover.

These products should be:

o In a sustainable commercial production and operating with an established supply chain and vendor managed inventory.

o Recovered, processed, stored and distributed in compliance with current FDA, AATB and other regulatory requirements.

o Indicated for wound coverage for both partial and full-thickness burn injuries o Sterilized at a sterility assurance level (SAL) of at least SAL 10-3 with a shelf life of at least 3 years.

o Available within 24-48 hours upon request for use nationwide in any burn center or location by a qualified burn surgeon.

Based on the information gathered from this notice, BARDA may consider developing strategies for building a preparedness level that may require maintaining an inventory of human skin homografts for the treatment of burn and trauma injuries resulting from mass casualties. Therefore, BARDA is interested in strategies to:

Ensure the resilience of the supply chain for human skin allograft with the intent of securing inventories for emergency distribution.

Increase product levels to support a stockpile requirement or surge capacity using a VMI.

Encourage partnerships and collaboration among tissue banks for the coordination and maintenance of a VMI.

Improve product stock rotation, tracking and logistics technologies for vendor-managed material and/or adopt other strategies that enable more sustainable supply chain management.

Extend product shelf life, and/or expedite product delivery to definitive care locations.

VIII. CAPABILITY STATEMENT/INFORMATION SOUGHT

Respondents are asked to provide only the most pertinent information, data, and materials necessary to adequately convey a declaration of capability in line with this notice. Respondents must submit separate Business and Technical Representation, and both shall each not exceed 10 single sided pages (including all attachments, charts, etc.). Content contained in excess of the stated limit per section will not be reviewed. Respondents are asked to state in their capability statement, whether they are responding to the Small Business Sources Sought Notice or the Other Than Small Business Sources Sought Notice.

1. Business Representations Respondents shall make business representations to ASPR/BARDA in the following order:

a) Business Information Provide potential respondent name, principal place of business, DUNS number, taxpayer identification number, number of employees, annual revenue of company, point of contact, and email address.

b) NAICS Codes Provide your applicable NAICS Code.

c) Compliance Statement Provide a statement assuring compliance with all applicable laws and this notice.

d) Capability Statement Provide relevant business information on capability, prior experience, and business interests to provide the type of product(s) specified under Section VII, above.

2. Technical Representations Respondents shall submit the technical representations to ASPR/BARDA in the order listed below as separate sections. (Note: sections not relevant to the respondent may be left without information by marking it ‘NA/Reserved,’ to maintain the section numbering).

a) Response Specification In response to this notice, clearly describe the capability and experience that meets the requirements specified in Section VII. Additionally, provide the information requested in Table 1.

Capabilities Information below in the attached Excel Workbook (Tab 1).

Table 1. Capabilities Information

b) Technical Information:

All sponsors responding to this notice are required to provide the information on their products and capabilities by providing a short narrative describing experience with human skin tissue recovery, procurement operations, non-proprietary processing practices, storage, maintenance and shipping.

In addition, provide the information requested in Table 2. Product Information below in the attached Excel Workbook (Tab 2).

Table 2. Product Information

c) Surge Capacity and Supporting Information:

In accordance with the current manufacturing capacity of the product closest to the size configuration (400 to 600 cm2), specify recent data on annual sales and inventory turnover. Please project the maximum feasible increase in production that would be achievable without additional investment in manufacturing infrastructure. Please consider the following example as a way to communicate your organization’s surge capacity:

Routine Operations (annual capacity): 25,000 units of 400 cm2 skin allograft Optimum Production Level (the number of units beyond which production causes fixed and variable costs to increase): 35,000 units per year Months to build routine inventory: 6 months Shipping Cost: list all ancillary needs: average shipments to a burn center

Surge: (~ two times the optimum production level (x2)) = surge Ramp up time (i.e. time required to reach surge capacity while maintaining the current supply to users): (surge / production time) – (routine production time) = ramp up time Surge cost: (incremental costs to achieve surge) = surge costs Bulk Shipment Cost: list additional ancillary needs and calculate costs for shipment configuration for products in bulk (surge amounts) to end users.

In support of the above information, please provide the following:

i. Outline the specific time required for achieving the surge capacity, approximate start-up costs, and resources.

ii. Also outline other limitations and factors that would affect achieving the projected surge capacity.

iii. Identify potential solutions or options that would mitigate major risk factors to expanding routine operational capacity to the surge capacity.

d) Inventory Management:

Provide information on established inventory management practices if the USG were to procure product and require the manufacturer (vendor) to manage the inventory termed vendor managed inventory (VMI). Consistent with the data provided above, please specify the approximate product turnover (rotation) due to regular commercial sales. Provide estimates on a range of product volume over which the inventory could be maintained with sufficient rotation to reduce expiration related waste. Please provide information on computer system/software in use for management of inventory.

Please specify if it would be applicable for use in a VMI as outlined above. What tracking and logistics software are used for shipping and product tracing?

e) Supply Chain Management:

Describe the critical elements in the product supply chain leading to the inventory at the present time in a steady-state routine care environment. Any emergency or MCI has the potential to cause losses in manufacturing capacity and/or impact facility operations. This may result in shortages and disruptions in the delivery of a product to places of critical need. Please specify the organization’s operation plans to ensure robustness in the supply chain to foster redundancy to ensure access to the product. Please specify if the organizational willingness to partner with other tissue banks to accomplish such critical task with or without teaming agreements. What are some of the ways your organization already partners with other tissue banks to improve the existing supply chain and fair market competition?

Please provide or address:

i) The existing supply chain system regarding skin tissue banking.

ii) The Offeror’s existing customer base, partnerships with organ procurement organizations, and compliance with federal and AATB regulations.

iii) Availability and willingness of the Offeror to share information on business continuity operations. This includes current plans to ensure product availability and delivery logistics with other organizations in the industry.

iv) Willingness of the Offeror to introduce and collaborate on improvements to the supply chain towards improving redundancy and resilience in a public health emergency with other tissue banking organizations.

f) Shelf-life and Storage Conditions:

Provide any information including the required storage conditions, maximum tested shelf life for the product, special packaging, and any data showing a technological advancement in shelf life extension beyond industry standards.

NARRATIVE SECTIONS:

1. Product Name: As marketed or published. Provide the product insert included in the package.

(Note: Do not include any product brochures and promotional marketing material).

2. Clearly specify any contraindications associated with the product. This includes contraindications related to type of injury, patient populations or specific medical conditions.

Please specify if there are any other special considerations or concerns regarding the use of the product. If none, please indicate ‘none.’

3. Provide a list of the top three (3) selling/ordered allograft products for burn wounds offered.

Please include the sales volume for each of the three (3) product size configurations sold in the last year and their respective attributes, type (meshed/unmeshed), and size in cm2 etc.

4. Describe all items needed to ensure the product availability for its intended purpose at a burn center such as dry ice, other supplies for packing and shipping. Please also identify if specific materials and supplies are recommended for proper use of the product at a burn center (for example thawing solution).

5. Include a short description of the formats of packaging configurations (for example, number of items per case, case dimensions, etc.).

6. Current Manufacturing Capacity: Provide a summary of manufacturing achievements, average completed manufacturing runs, and manufacturing capacity.

3. Other Information ASPR/BARDA encourages all respondents to submit currently available marketing or extant information, or to notify ASPR/BARDA of the publicly available location; thereof to the maximum extent consistent with this notice’s requirements and limitations.

Respondents shall mark confidential, privileged, proprietary, trade-secret, copyrighted information, data, and materials with appropriate restrictive legends. 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, and ASPR/BARDA assumes no liability for the disclosure, use, or reproduction of the information, data, and materials.

4. Response Format, Transmission, and Closing Date Respondents shall provide declarations of capability and all information, data, and materials in Microsoft Office ®, or Adobe® Acrobat® format, and furnish responses electronically (via email) to Sabrina.McIntyre@hhs.gov for receipt by 4:00 P.M. ET on June 30, 2020. Any questions, comments, or concerns regarding this notice shall be written and transmitted via email to Sabrina.McIntyre@hhs.gov.

IX. DISCLAIMER AND IMPORTANT NOTES

This notice does not obligate the Government to award a contract or otherwise pay for information provided in response. The 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 Government to determine the organization’s qualifications to perform the work. Respondents are advised that the 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 beta.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.

X. CONFIDENTIALITY:

Respondents shall mark confidential, privileged, proprietary, trade-secret, copyrighted information, data, and materials with appropriate restrictive legends. 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, and ASPR/BARDA assumes no liability for the disclosure, use, or reproduction of the information, data, and materials. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.

Attachment(s)

Attachment 1 Human Skin Homograft Response Tables.xlsx