Assessing Tobacco-related Clinical Outcomes and Human Behaviors in Tobacco Users
Closed Solicitation Posted
- Solicitation number
- FDA-RFP-75F40123R00028
- 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 the Food and Drug Administration (FDA) seeking assistance in assessing tobacco-related clinical outcomes and human behaviors in tobacco users. The contract is an Indefinite Delivery, Indefinite Quantity (IDIQ) contract with a term of five years and five one-year ordering periods. The estimated value of the contract is $25,000,000 for the entire period of performance.
List of services to be provided by the contractor:
- Assist FDA in assessing tobacco product pharmacology and human behaviors in healthy volunteer male and female tobacco users.
- Develop scientific protocols and methodologies for clinical studies.
- Select a clinical research facility for the studies.
- Develop and/or validate laboratory assessments, measurement techniques, and study protocols.
- Obtain Investigational Tobacco Product (ITP) clearance, if appropriate.
- Provide documentation for protocol package submission to the FDA Institutional Review Board (IRB) and an external, local, IRB.
- Develop participant recruitment and retention plans.
- Execute recruitment, screening, and selection of participants.
- Administer tobacco products to participants and provide appropriate medical monitoring.
- Collect behavioral, biological, pharmacological, and toxicological data.
- Perform data analyses, including statistical analyses and interpretation to support the study objectives.
- Deliver tabulated interim raw data as well as the results of the data analyses.
- Develop a comprehensive quality assurance plan for each task order.
- Perform and document safety and quality assurance testing.
- Conduct scientific literature reviews.
- Provide intermediate and final data reports.
- Provide comprehensive minutes of meetings and conference calls and monthly progress reports.
Notice text
The primary objective of this IDIQ contract is to evaluate the impact of tobacco products on human behavior, toxicology, physiology, and pharmacology, including clinical pharmacokinetics and pharmacodynamics. To fulfill these objectives the Government seeks a Contractor to perform a series of studies (including chemical analyses) with a wide range of tasks
Studies may assess the impacts of tobacco products on a variety of outcomes in humans, including dependence, craving, withdrawal, choice behavior, switching behavior and topography, harm perception, subjective and sensory effects, pharmacokinetic and pharmacodynamic effects, toxicology, physiology, and measurements of biomarkers of exposure (e.g., nicotine, cotinine, CO, TSNAs). Laboratory studies may be required to follow Good Laboratory Practices. For all clinical pharmacology studies, use of a Clinical Pharmacology Unit and Good Clinical Practices are required. Data collected under this contract will inform FDA on the behavioral and pharmacological effects associated with tobacco product use and may guide tobacco product policies and regulations.
Files
| File | Type | Posted |
|---|---|---|
| Jackson et al attachment 5.pdf | ||
| RFP 75F40123R00028.pdf | ||
| Attachment 6.pdf | ||
| Task order 1-Attachment 3.pdf | ||
| SF 1449 75F40123R00028.pdf | ||
| Task order 2-Attachnent 4.pdf | ||
| Attachment 2 (1).pdf | ||
| Attachment 1.docx | DOCX document |
Similar open opportunities
| Opportunity | Agency | Set-aside | Responses due |
|---|---|---|---|
| FDA/CDRH Scientific Technical Capacity for Regulatory Review | FDA Office of Acquisition and Grant Services | No set-aside | |
| FDA Scientific & Regulatory Support Services(SRS) | FDA Office of Acquisition and Grant Services | Total Small Business |
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