Evaluating toxic interactions of aldehydes
Closed Solicitation Posted
- Solicitation number
- 75F40123R00152
- 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
- 541990 All Other Professional, Scientific, and Technical Services
- Place of performance
- Beltsville, Maryland 20704, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Food and Drug Administration seeks to award a firm-fixed price contract for a contractor to develop an aldehyde aerosol co-exposure system and utilize it along with a human airway tissue model to evaluate cytotoxic and genotoxic responses from single and combined exposures to formaldehyde and acrolein. The contractor must provide all necessary research facilities, trained personnel, protocols, analysis plans, and reports. Proposals are due by September 12, 2023 and will be evaluated based on technical approach, qualifications, and pricing.
This is not a small business set-aside, with a NAICS code of 541990 for research and development in the physical, engineering, and life sciences with a size standard of $19.5 million. The place of performance will be in Beltsville, Maryland and the period of performance is from September 30, 2023 to September 2025. Key deliverables include meeting minutes, draft and final reports to the FDA. Questions were answered on September 7, 2023 and an amendment revised the tasks and pricing structure to a firm-fixed price basis, clarifying the contractor must provide research facilities and personnel.
Notice text
Use of tobacco products expose the consumer to a variety of harmful and potentially harmful constituents (HPHCs) and other toxic chemicals that commonly result in the occurrence of adverse health outcomes. These HPHCs and other toxic chemicals may interact with each other in ways that enhance their toxic effects. There is a significant research knowledge gap in understanding the mechanisms and magnitude of these interactions between HPHCs and other toxic chemicals and if these interactions result in observable increases in toxic effects. These interactions and resulting enhanced toxicity may partially explain the observed discordance between predicted lifetime cancer risk associated with use of tobacco products and reported epidemiological data.
FDA seeks more information on the occurrence of interactions between HPHCs and other toxic chemicals present in tobacco products, and how these interactions may result in enhanced toxic effects.
Objectives
The objectives of this contract are to develop an aerosol co-exposure system for use with a human relevant in vitro air-liquid interface (ALI) airway tissue model, to characterize the occurrence of cytotoxic and genotoxic responses following exposure to single and combined aldehydes, and to assess the occurrence of enhanced cytotoxic and genotoxic responses following co-exposure to this aldehyde mixture to identify if toxic interactions between these HPHCs occur. The human relevant in vitro ALI airway tissue model will consist of differentiated normal human primary tracheobronchial epithelial cells collected from a single donor. This aerosol co-exposure system will utilize model aldehyde HPHCs (i.e., formaldehyde and acrolein) that likely undergo toxicologically relevant interactions and have complementary mechanisms of toxicity.
FDA expects the development of an aldehyde HPHC aerosol co-exposure system, using model aldehyde HPHCs (i.e., formaldehyde and acrolein), paired with a human relevant in vitro ALI airway tissue model consisting of differentiated normal human primary tracheobronchial epithelial cells collected from a single donor. FDA expects that this aerosol exposure system and human relevant in vitro model will be used to evaluate the occurrence of toxic responses following exposure to single aldehyde HPHCs and a mixture of aldehyde HPHCs. The toxicity data produced from this work will be used to evaluate the occurrence of toxicologically relevant interactions (i.e., additive, antagonistic, synergistic) between these aldehyde HPHCs.
Attachments
| File | Type | Posted |
|---|---|---|
| Questions and Answers_9-7-2023.pdf | ||
| 75F40123R00152_amend0001.pdf | ||
| 75F40123R00152_9-5-2023.docx | DOCX document |
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