Information Collection

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

IC 246208 under ICR 202101-0910-007 · 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⚠️ Notice: This information collection may be referencing outdated material.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
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

View Information Collection (IC)

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:

table that charts list of 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

Federal Enterprise Architecture Business Reference Module

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 %

table that charts list of burden
	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

table that charts IC Documents
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.