Loren Data's SAM Daily™

fbodaily.com
Home Today's SAM Search Archives Numbered Notes CBD Archives Subscribe
SAMDAILY.US - ISSUE OF AUGUST 05, 2023 SAM #7921
SOLICITATION NOTICE

A -- Assessing Tobacco-related Clinical Outcomes and Human Behaviors in Tobacco Users

Notice Date
8/3/2023 3:22:33 PM
 
Notice Type
Combined Synopsis/Solicitation
 
Contracting Office
FDA Office of Acquisitions and Grants Services Rockville MD 20857 USA
 
ZIP Code
20857
 
Solicitation Number
FDA-RFP-75F40123R00028
 
Response Due
8/18/2023 1:00:00 PM
 
Archive Date
09/02/2023
 
Point of Contact
Lisa Jackson, Phone: 240-402-0093, Erika Eam, Phone: 240-402-2413
 
E-Mail Address
lisa.jackson@fda.hhs.gov, erika.eam@fda.hhs.gov
(lisa.jackson@fda.hhs.gov, erika.eam@fda.hhs.gov)
 
Description
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.
 
Web Link
SAM.gov Permalink
(https://sam.gov/opp/0e786a39e29a42ae879c8958bdfe09c8/view)
 
Place of Performance
Address: USA
Country: USA
 
Record
SN06775042-F 20230805/230803230048 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

FSG Index  |  This Issue's Index  |  Today's SAM Daily Index Page |
ECGrid: EDI VAN Interconnect ECGridOS: EDI Web Services Interconnect API Government Data Publications CBDDisk Subscribers
 Privacy Policy  Jenny in Wanderland!  © 1994-2024, Loren Data Corp.