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This document is a Questions and Answers (Q&A) report related to Solicitation 75F40124R00126 entitled "Investigating the Impact of Non-tobacco Nicotine Enantiomeric Ratio on ENDS Abuse Liability" issued by the Food and Drug Administration (FDA) Office of Acquisition and Grant Services.

The Q&A report addresses a question regarding whether the contractor can subcontract with a European-based partner to conduct a portion of the laboratory work. The FDA's response indicates that more details are needed, such as the location of the services and the subcontractor's relationship with foreign entities, as this may be subject to FAR Part 25 and the applicable contract clauses. The report also advises that revised proposals will be accepted up to Friday, August 9, 2024 at 2:00 PM due to the posting of this Q&A.

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August 7, 2024

Questions and Answers (Q&A) Report

FDA Solicitation 75F40124R00126 entitled “Investigating the Impact of Non-tobacco Nicotine Enantiomeric Ratio on ENDS Abuse Liability.”

As a result of the posting of this Q&A report, all Offerors are advised, revised proposals will be accepted up to Friday, August 9, 2024, 2:00 PM.

Question:

“Can you confirm that we can subcontract with a European-based partner to conduct a portion of the Laboratory.”

Response:

“At this time, we cannot confirm. Specifically, more details regarding the subcontractor is needed. This will include additional information regarding where the services will be performed (e.g., within the US or in a foreign country/territory) and the subcontractor’s relationship with other foreign entities, as examples.

Please refer to FAR Part 25 and the applicable clauses incorporated in the solicitation at Paragraph 7.3 52.212-5, entitled, “Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services (May 2024)”.”

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