Information Collection

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

IC 216972 under ICR 201409-0910-020 · OMB 0910-0695.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
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

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:

table that charts list of 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 %

table that charts list of burden
	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

table that charts IC Documents
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.