Attachment No. 3 - Questions & Answers.docx

DOCX document 18 KB Posted

Attached to
Analysis of Constituents of Leachate from ENDS Components
Solicitation number
FDA-RFP-1241927B
Issued by

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.

View the file

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 PDF
Sol_Doc_.doc DOC document

On GovTribe

Work with this file

  • Download the original file
  • Contacts named in this file
  • Similar government files
  • Ask GovTribe AI about this file

Text version

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

File details come from the government source that posted it. Updated .