Do Laboratory Prescribed and Ad Libitum Use Sessions Represent Real-World ENDS Use?
Closed Solicitation Posted
- Solicitation number
- 75F40125R00096
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541380 Testing Laboratories and Services
- PSC
- Q301 Reference Laboratory Testing
- Place of performance
- Rockville, Maryland 20852, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Food and Drug Administration's Center for Tobacco Products is seeking a contractor to conduct a comprehensive clinical research study examining Electronic Nicotine Delivery Systems (ENDS) use patterns through solicitation 75F40125R00096. The study aims to determine whether laboratory-based ENDS use sessions accurately represent real-world usage by recruiting both experienced and inexperienced ENDS users for a multi-stage research project involving a 14-day ambulatory phase followed by two laboratory sessions. The research will include detailed monitoring of product use, nicotine pharmacokinetics, and behavioral data collection, comparing prescribed and ad libitum ENDS use patterns while examining how factors like nicotine concentration and user experience influence usage behavior. Evaluation will be based on technical understanding, past performance, staffing plan, key personnel, and pricing, with technical factors weighted as significantly more important than price. Proposals are due by August 25, 2025, at 2:00 PM Eastern Time.
This procurement does not include any set-aside designations and will be awarded as a hybrid firm-fixed price and time-and-material contract arrangement. The performance period spans four years from September 1, 2025 to August 31, 2029, providing substantial duration for the comprehensive research study. The study will utilize a closed-ENDS device with two different nicotine concentrations and incorporate topography monitoring systems for precise data collection. Work will be performed in Rockville, MD, positioning the contractor near the FDA's operational headquarters. No incumbent contractors or specific award values are mentioned in the available documentation, though the multi-year timeline and complex research requirements suggest this represents a significant contract opportunity in the testing laboratories and services sector.
Notice text
See Attached Combined Synopsis/Solicitation for 75F40125R00096.
Files
| File | Type | Posted |
|---|---|---|
| Solicitation 75F40125R00096.pdf |
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