Information Collection

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

IC 216972 under ICR 201711-0910-001 · 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⚠️ Notice: This information collection may be referencing outdated material.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: Unchanged

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-Screener					Yes	Yes	Fillable Fileable
Other-Testing Guide					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
	Requested	Previously Approved
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		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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