Individual Interview Study of Healthcare Provider Perceptions of Boxed Warnings

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⚠️ Notice: This information collection may be referencing outdated material.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-Screener
Moderator Guide.docx Other-Moderator Guide
Consent Form for Primary Care Providers.docx Other-Consent Form for PCP
Consent Form for Specialists.docx Other-Consent Form for Specialists
0695 OMB approval memo for HCP Perceptions of Boxed Warnings.docx OMB approval memo IC Document

Information Collection (IC) Details

IC Title:	Individual Interview Study of Healthcare Provider Perceptions of Boxed Warnings	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-Screener	Participant Screener.docx	Yes	Yes	Fillable Fileable
Other-Moderator Guide	Moderator Guide.docx	No		Paper Only
Other-Consent Form for PCP	Consent Form for Primary Care Providers.docx	Yes	Yes	Fillable Fileable
Other-Consent Form for Specialists	Consent Form for Specialists.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: 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)	60	60
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
OMB approval memo	0695 OMB approval memo for HCP Perceptions of Boxed Warnings.docx	04/11/2018

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