Rapid Message Testing with Consumer Panel - Additional Testing of Drug Safety Communications About Misuse and Abuse of Over-the-Counter Medications (CDER)

Data to Support Drug Product Communications

⚠️ Notice: This information collection may be referencing outdated material.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
Cognitive Interview Guide.docx Other-Interview Guide
Screener.docx Other-Screener
Author Manuscript - Patient Understanding of Nonmedical Terms.pdf Other-Author Manuscript
FDA Drug Safey Communication - Benadryl.pdf Other-Drug Safety Communication - Be
FDA Drug Safety Communication - Imodium.pdf Other-Drug Safety Communication - Im
FDA Drug Safety Communication - Nasadrine.pdf Other-Drug Safety Communication - Na
0695 OMB Approval Memo - Misuse and Abuse of OTC Medications 2021.docx OMB Approval Memo IC Document

Information Collection (IC) Details

IC Title:	Rapid Message Testing with Consumer Panel - Additional Testing of Drug Safety Communications About Misuse and Abuse of Over-the-Counter Medications (CDER)	Agency IC Tracking Number:	CDER

IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Interview Guide	Cognitive Interview Guide.docx	Yes	Yes	Printable Only
Other-Screener	Screener.docx	Yes	Yes	Fillable Fileable
Other-Author Manuscript	Author Manuscript - Patient Understanding of Nonmedical Terms.pdf	Yes	Yes	Printable Only
Other-Drug Safety Communication - Benadryl	FDA Drug Safey Communication - Benadryl.pdf	Yes	Yes	Printable Only
Other-Drug Safety Communication - Imodium	FDA Drug Safety Communication - Imodium.pdf	Yes	Yes	Printable Only
Other-Drug Safety Communication - Nasadrine	FDA Drug Safety Communication - Nasadrine.pdf	Yes	Yes	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 750	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	750	750
Annual IC Time Burden (Hours)	45	45
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
OMB Approval Memo	0695 OMB Approval Memo - Misuse and Abuse of OTC Medications 2021.docx	03/11/2021

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.