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

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0695 can be found here:

Documents and Forms

Document Name Document Type
FDA DISCLOSURE - COGNITIVE TESTING SCREENER 6-9-2015.docx Other-Screener
RISK DISCLOSURE - COGNITIVIE TESTING GUIDE 6-9-2015.docx Other-Testing Guide
OMB Justification for generic clearance in Risks in DTC Prescription Drug TV Ads 6-9-2015.docx OMB Justification Memo IC Document

Information Collection (IC) Details

IC Title:	Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements (Cognitive Interviews)	Agency IC Tracking Number:	CDER

IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 498	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	498	498
Annual IC Time Burden (Hours)	32	32
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

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.