Investigating the impact of non-tobacco nicotine enantiomeric ratio on ends abuse liability
Active Definitive Contract Awarded Last action
- Contract number
- 75F40124C00103
- Awardee
-
The Fox Foundation Inc. UEI WQEZGN77P6G3
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Obligated
- $3,408,203
Award facts
- Opportunity
-
- Investigating the Impact of Non-tobacco Nicotine Enantiomeric Ratio on ENDS Abuse Liability Solicitation · 75F40124R00126 · Posted Jun 20, 2024
- Contract value 100% obligated
- $3,408,203.00 Current and potential, with all options
- Completion date 71% complete
- Current and potential, with all options
- Contracting staff
- NAICS code
- 541690 Other Scientific and Technical Consulting Services
- Set-aside
- No set-aside
- Competition
- Competed under SAP · 1 offer Simplified Acquisition
- Pricing
- Firm Fixed Price
- Place of performance
- Tampa, FL 33611, USA
- Legislative mandates
-
- Employment Eligibility Verification (E-Verify) FAR subpart 22.18
- Service Contract Inventory FAR subpart 4.17
Award details come from SAM.gov/FPDS.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Other Administrative Action | $0 | |
| Other Administrative Action | $0 | |
| Other Administrative Action | $0 | |
| Original award | $3,408,203 |
About this award
The Food and Drug Administration (FDA) awarded a $3.4M firm fixed-price contract to The Fox Foundation Inc. on September 24, 2024, to conduct a clinical laboratory study investigating the abuse liability of electronic nicotine delivery systems (ENDS) formulated with non-tobacco nicotine (NTN) compared to tobacco-derived nicotine (TDN). The three-year contract, which extends through September 2027, requires The Fox Foundation to execute a randomized, double-blinded, within-subjects crossover study evaluating nicotine exposure, subjective effects, and user behavior across e-liquids with varying enantiomeric ratios of S- and R-nicotine. The work will be performed in Tampa, Florida, and includes chemical characterization of e-liquids, collection of serial blood samples, and comprehensive assessment of pharmacodynamic and subjective measures. This is a civilian acquisition with no set-aside designation.
The solicitation reflects the FDA's regulatory interest in understanding how nicotine formulation and composition affect the potential for abuse of ENDS products, supporting the agency's public health mission regarding novel tobacco and nicotine products. Chemical and behavioral characterization of different nicotine enantiomeric ratios will provide scientific evidence to inform FDA policy and regulatory decisions. The contract was awarded under NAICS code 541690 (Other Scientific and Technical Consulting Services) and utilized firm fixed-price terms, indicating well-defined scope and deliverables for this clinical research effort.
Quick answers
Who was awarded contract 75F40124C00103?
75F40124C00103 was awarded to The Fox Foundation Inc. by Food and Drug Administration (Department of Health and Human Services) on September 24, 2024.
How much is contract 75F40124C00103 worth?
The government has obligated $3,408,203 on 75F40124C00103.
Was contract 75F40124C00103 competed?
The extent of competition for 75F40124C00103 was competed under sap. The government received 1 offer.
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