Attachment 1 Human Skin Homograft Response Tables.xlsx
XLSX spreadsheet 28 KB Posted
- Solicitation number
- BARDA-2020-Allograft-Skin-Thermal-Burn-(01B)
About this file
This document contains an attachment and information regarding a Request for Information from the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response seeking capabilities information from suppliers of human skin allografts for burn injuries. The attachment includes tables requesting details on suppliers' average annual skin allograft recovery and inventory, donor testing and clearance times, manufacturing surge capacity, processing and storage facilities, distribution volumes, and critical shipping supplies. Product information tables request each supplier's indication for use, sterility assurance level, whether the allograft is meshed or non-meshed including available mesh ratios, shelf life and storage conditions. Suppliers are asked to provide responses using the provided tables by the specified solicitation number.
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| File | Type | Posted |
|---|---|---|
| Allograft_Skin_Thermal_Burn_2020_OTSBSSN_01B.pdf |
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Capabilities Information Sources Sought Notice Human Skin Homograft for Burn Injuries
Attachment 1 (Tab 1) for SBSSN No.: BARDA-2020-Thermal Burn (01A) OTSBSSN No.: BARDA-2020-Thermal Burn (01B)
| BARDA-2020-Thermal Burn Capabilities Information | ||
| Field | Example | Response |
| Product Name | TRUESKINSTM | |
| Average Amount of Skin Allograft Recovered Annually (cm2/year) | 90,000 | |
| Average Annual Inventory of Human Skin Allograft (cm2/year) | 50,000 | |
| Tissue Donor Medical Testing Clearance Duration (days) | 30 | |
| Amount of recovered Skin Allograft rejected annually (medically not cleared) (cm2/year) | 20,000 | |
| Manufacturing Surge Capacity Available (Y/N) | Y | |
| How many processing rooms are available on a routine bases? | 10 | |
| How many processing rooms are used during routine operations? | 3 | |
| Average Skin Allograft Distribution Annually (cm2/year) | 50,000 | |
| Number of Burn Centers Supplied | 3 | |
| Number of ABA Verified Burn Centers Supplied | 2 | |
| Total Inventory Capacity (cm2) | 200,000 | |
| If using cryopreservation, how many freezers are on-hand for product referenced in Table 1? | 8 | |
| How many freezers are being used for product referenced in Table 1? | 2 | |
| Critical supplies needed to ship product? | Dry Ice | |
| Y | N |
Product Information Sources Sought Notice Human Skin Homograft for Burn Injuries
Attachment 1 (Tab 2) for SBSSN No.: BARDA-2020-Thermal Burn (01A) OTSBSSN No.: BARDA-2020-Thermal Burn (01B)
| BARDA-2020-Thermal Burn Product Information | ||
| Field | Example | Response |
| Product Name | TRUESKINSTM | |
| Indication for use | ||
| Sterility Assurance Level | 1.00E-06 | |
| Meshed / Non-Meshed? | Non-Meshed/Meshed | |
| Meshed Ratio(s) | 1:5/2:1 | |
| Shelf-life (years) | 5 | |
| Storage Conditions | Cryopreservation -80° C | |
| Product Preparation Direction | Thaw rapidly in warm saline solution <2 minutes | |
| Additional Items Needed for product(s) use | Staples (provided) for holding dressing in place/secondary dressing | |
| Price per cm2 ($) | $2.00 | |
| Non-Meshed | Meshed | Non-Meshed/Meshed |
File details come from the government source that posted it. Updated .