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Individual Interview Study of Healthcare Provider Perceptions of Boxed Warnings
Data to Support Drug Product Communications
OMB: 0910-0695
IC ID: 230240
OMB.report
HHS/FDA
OMB 0910-0695
ICR 201712-0910-001
IC 230240
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0695 can be found here:
2024-03-07 - Extension without change of a currently approved collection
2022-06-30 - No material or nonsubstantive change to a currently approved collection
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
View Information Collection (IC)
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
Form No.
Form Name
Instrument File
URL
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
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:
100
Number of Respondents for Small Entity:
0
Affected Public:
Individuals or Households
Percentage of Respondents Reporting Electronically:
0 %
Approved
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
100
0
100
0
0
0
Annual IC Time Burden (Hours)
60
0
60
0
0
0
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
OMB approval memo
0695 OMB approval memo for HCP Perceptions of Boxed Warnings.docx
02/23/2018
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.