Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements (Cognitive Interviews)

Data to Support Drug Product Communications as Used by the Food and Drug Administration

OMB: 0910-0695

IC ID: 216972

Information Collection (IC) Details

View Information Collection (IC)

Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements (Cognitive Interviews) CDER
 
New
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Testing Guide RISK DISCLOSURE - COGNITIVIE TESTING GUIDE 6-9-2015.docx Yes Yes Fillable Fileable
Other-Screener FDA DISCLOSURE - COGNITIVE TESTING SCREENER 6-9-2015.docx Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

498 0
   
Individuals or Households
 
   100 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 498 0 498 0 0 0
Annual IC Time Burden (Hours) 32 0 32 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
OMB Justification Memo OMB Justification for generic clearance in Risks in DTC Prescription Drug TV Ads 6-9-2015.docx 06/10/2015
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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