Questions-Responses.docx
DOCX document 75 KB Posted
- Attached to
- Investigating Associations Between Acute Abuse Liability Outcomes and Switching Behavior
- Solicitation number
- 75F40126R00031
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This is a Questions and Responses document for FDA solicitation 75F40126R00031 regarding a research study on electronic nicotine delivery systems (ENDS) and their association with combustible cigarette use reduction. The document addresses four key inquiries from potential offerors regarding study design and contract parameters.
The FDA clarified that while multiple abuse liability outcome measures are specified in the RFP—including plasma nicotine pharmacokinetics, pharmacodynamic effects, subjective effects, demand, progressive-ratio self-administration, and use topography—all outcomes should be evaluated in exploratory analyses, with contractors permitted to narrow primary outcomes to a subset they deem most important, such as nicotine Cmax, subjective measures like liking and satisfaction, demand intensity, progressive ratio breakpoint, and ad libitum puff counts. Remote ambulatory phase execution with virtual check-ins and shipped biomarker specimens is potentially acceptable provided detailed methodology and compliance assurance measures are submitted. The FDA mandated that offerors must propose a four-year period of performance as specified in the RFP, with work expected to be completed within this timeframe, though early completion is not objectionable. The anticipated award date is on or about September 2026. This solicitation is issued by the Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services.
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| File | Type | Posted |
|---|---|---|
| Solicitation 75F40126R00031.pdf |
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Question/Responses for 75F40126R00031 Question #1: The RFP states that the primary aim of the study is to determine whether acute abuse liability outcomes associated with use of the study ENDS are associated with subsequent reductions in combustible cigarette (CC) use during the ambulatory phase. Given the broad range of abuse liability outcomes specified in the RFP (e.g., plasma nicotine pharmacokinetics, pharmacodynamic effects, subjective effects, demand, progressive-ratio self-administration, and use topography), does FDA have greater interest in any specific outcome measure or outcome domain as the primary predictor? This information would help inform sample size determination and the proposed statistical analysis plan.
Response: Because all the listed outcomes could be submitted for tobacco-product application review, we would like all outcomes evaluated at least in exploratory analyses. For the purposes of sample size determination, the primary outcomes could be narrowed down to a subset of domain outcomes that The Contractor considers most important, such as nicotine Cmax for plasma nicotine pharmacokinetics; “liking,” “satisfaction,” or withdrawal alleviation for subjective effects; demand intensity for hypothetical purchasing tasks; progressive ratio breakpoint; and/or number of ad libitum puffs for puff topography.
Question #2: Would it be acceptable for the ambulatory phase to be conducted remotely, with study check-in visits completed virtually and biomarker specimens collected remotely and shipped to a central laboratory or storage facility for analysis? This approach may reduce participant burden and has been successfully implemented in similar studies.
Response: This approach might be acceptable if sufficient details on the recommended approach and methods used to ensure participant compliance with all outcome assessments, including biomarker submission, are provided.
Question #3: The RFP specifies a four-year period of performance. If the proposed study can be completed in a shorter timeframe while meeting all study objectives and deliverable requirements, would FDA consider a proposed period of performance of less than four years acceptable?
Response: No. Offerors shall propose a four-year period of performance as specified in the RFP. The Government anticipates that all contract requirements will be completed within the four-year period of performance. Completion of all required work prior to the end of the period of performance would not, in itself, be unacceptable; however, offerors shall base their proposals on the four-year period of performance specified in the solicitation.
Question #4: Is there an anticipated award date or estimated start date for the period of performance? Comment by Crisp, Camille: I will respond Response: The anticipated award date is on or about September 2026.
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