Rapid Message Testing with Consumer Panel - Medication Guide Template for Buprenorphine Products (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⚠️ Notice: This information collection may be referencing outdated material.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
Participant Screener.docx Other-Survey Instrument
Medication Guide - Cognitive Interview Guide.docx Other-Moderator Guide
Medication Guide Template Buprexil.docx Other-MG Template
0695 OMB Approval Memo - Medication Guide Template for Buprenophine 2020.docx OMB Approval Memo IC Document

Information Collection (IC) Details

IC Title:	Rapid Message Testing with Consumer Panel - Medication Guide Template for Buprenorphine Products (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-Survey Instrument	Participant Screener.docx	Yes	Yes	Fillable Fileable
Other-Moderator Guide	Medication Guide - Cognitive Interview Guide.docx	Yes	Yes	Printable Only
Other-MG Template	Medication Guide Template Buprexil.docx	Yes	Yes	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 100	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	100	100
Annual IC Time Burden (Hours)	13	13
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
OMB Approval Memo	0695 OMB Approval Memo - Medication Guide Template for Buprenophine 2020.docx	05/11/2020

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