Attachment No. 3 - Questions & Answers.docx
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- Solicitation number
- FDA-RFP-1241927B
About this file
This document contains questions and answers regarding Amendment #2 to solicitation FDA-RFP-1241927B. The solicitation seeks a contractor to conduct laboratory analysis to characterize and quantify chemical constituents of leachate from discarded electronic nicotine delivery system, or ENDS, components collected without direct interaction with users. Acceptable collection methods include gathering discarded components from public areas like streets, schools, and malls. While direct collection is preferred, an alternative approach of purchasing unused products and exposing them to simulated environmental conditions in a smoking machine would also be considered. The questions provide clarification on the agency's openness to alternative collection methods involving purchased rather than discarded products.
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Other files
| File | Type | Posted |
|---|---|---|
| Sol_Doc_Amend No.3.doc | DOC document | |
| Sol_Doc_Amend No.3.doc | DOC document | |
| Sol_Doc_Amend No.2.doc | DOC document | |
| Sol_Doc_Amend No.1.doc | DOC document | |
| Attachment No. 2 - HHS Class Deviation 2020-20.docx | DOCX document | |
| Attachment No. 1 - FAR Class Deviation 2020-05.pdf | ||
| Sol_Doc_.doc | DOC document |
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Attachment 3 – Questions & Answers
FDA-RFP-1241927B – Amendment # 2 Analysis of Constituents of Leachate from ENDS Components
Questions & Answers
| Q1. | Regarding Task 6 “ENDS Component Collection”, does FDA require the contractor to obtain these components that have actually been used by the end users, or would FDA also be open to the contractor purchasing the components from a retailer and then using our smoking machine to consume the products before testing? |
| A1. | Yes. The contractor is expected to collect the ENDS components that have been littered by ENDS users without any interaction with the individual users. Therefore, the collection could be from streets, around schools, around malls, etc. where people throw the remainder of the product after it is used (littering). However, part of the evaluation of the proposal will be based on the contractor’s plan for collection of the components. If the contractor buys the products, smokes it in a machine, and exposes the different parts to different environmental conditions that mimic the real environment, then that will be ideal situation. |
End of Question & Answers
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