A02 Attachment 1-Final.docx

This document is an Attachment 1 - Questions for Vendors to a Request for Information (RFI) for a fast-acting chemical sterilant. The RFI is seeking information from vendors on their ability to provide a chemical sterilant that can quickly sterilize surgical tools and medical equipment through immersion, preferably within 10 minutes, without requiring electrical power or large volumes of liquid. The chemical sterilant must have the required approvals from the FDA and EPA, be available commercially, and be usable for multiple rounds of sterilization after activation. The agency is interested in understanding the potential for an FDA-cleared chemical sterilant that can sterilize within 10 minutes, as well as the ability to provide the product in a concentrated form to reduce logistical burdens. The attachment includes 10 specific questions for vendors to respond to regarding the capabilities of their chemical sterilant products.