Comprehensive toxicity analysis of individual ENDS
Closed Solicitation Posted
- Solicitation number
- FDA-RFP-75F40123R00115
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541690 Other Scientific and Technical Consulting Services
- Place of performance
- United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Federal Contract Opportunity involves a comprehensive toxicity analysis of individual ENDS (Electronic Nicotine Delivery Systems) flavor ingredient chemicals alone and in complex with metals using high throughput approaches. The contractor will provide services associated with research requirements to study the potential toxicological implications of metals in e-liquids and aerosols, and the different toxicity that results from flavor ingredient chemicals when combined with metals. The contract term is a total of two years from the date of award, with the period of performance from 09/30/2023 to 09/29/2025.
Products and Services to be provided by the contractor:
- Comprehensive toxicity analysis of individual ENDS flavor ingredient chemicals.
- Research services to study the potential toxicological implications of metals in e-liquids and aerosols.
- Analysis of the different toxicity that results from flavor ingredient chemicals when combined with metals.
- Regular meetings and progress reports on the research.
- Final report detailing the objectives, methods, results of the analyses, and a summary of the findings and conclusions of the project.
Notice text
The Contractor shall investigate the toxicity of 125 flavor ingredient chemicals alone and combined with metal using high throughput assays. The FDA will produce a final library of 125 flavor ingredient chemicals based on the predicted propensity of flavor ingredient chemicals to interact with metals. The Contractor shall perform cytotoxicity assays and measurements of cytokine levels in the supernatant to determine appropriate sublethal concentrations of flavor ingredient chemicals and metals to use in subsequent mutagenic and genotoxic assays, which consist of assays in cells lines and in bacteria. The Contractor shall determine based on measurables of the mutagenic and genotoxic experiments a list of 20 flavor ingredient chemicals and 20 flavor-metal combinations and their concentrations to be tested in the reconstructed human lung tissue model to measure the effects on metabolism, membrane integrity, cell viability, inflammation, and DNA damage. The Contractor shall perform all data analyses, provide FDA all of the raw data, and write study reports.
Files
| File | Type | Posted |
|---|---|---|
| Final solicitation_Comprehensive toxicity analysis of individual ENDS .pdf |
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