“Disease Awareness and Prescription Drug Promotion on Television”
(OMB Control Number 0910-0874)
January 27, 2020
The Food and Drug Administration is submitting this nonmaterial/non-substantive request to make minor modifications to our approved project, Disease Awareness and Prescription Drug Promotion on Television (#0910-0874). We conducted pretesting in order to assess the materials and procedures prior to main study administration. We are now proposing minor modifications to select materials based on findings from this pretesting. Affected materials are attached with our modifications shown with tracked changes. There is no change to the burden hours for this project.
The proposed changes are outlined below:
Study 1: Bolding and underlining a line that already exists telling participants they will be asked questions about the program and commercials both before and after watching the program (pg. 8)
Study 2: Adding the recontact schedule into the consent form.
Changing the subcontractor for Study 1 from Dynata to ProdegeMR.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Betts, Kevin |
| File Modified | 0000-00-00 |
| File Created | 2021-01-14 |