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Conducting Focus Groups & In Depth Interviews to Understand and Differentiate the Impact of REMS/ETASU on Prescriber Practices
Focus Groups as Used by the Food and Drug Administration
OMB: 0910-0497
IC ID: 204195
OMB.report
HHS/FDA
OMB 0910-0497
ICR 201404-0910-001
IC 204195
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0497 can be found here:
2023-10-31 - Extension without change of a currently approved collection
2020-10-02 - Extension without change of a currently approved collection
Documents and Forms
Document Name
Document Type
Task1_REMS_Moderator Guide_v4_9c10e16b.docx
Other-Moderator Guide
Task1-REMS_Participant-Informed-Consent_v3_031312.doc
Other-Participant Informed Consent F
Task1-REMS_Screener_for_FocusGroups_Deloitte_v5_Q6.docx
Other-Screener
Task1-REMS_Interviewee_EmailInvitations_v5_031312.docx
Other-Interviewee Email Invitations
FDAFocusGroupGenICMemoREMS ETASU 11-8-12.doc
OMB Clearance Memo
IC Document
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Conducting Focus Groups & In Depth Interviews to Understand and Differentiate the Impact of REMS/ETASU on Prescriber Practices
Agency IC Tracking Number:
IC Status:
Unchanged
Obligation to Respond:
Mandatory
CFR Citation:
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Other-Moderator Guide
Task1_REMS_Moderator Guide_v4_9c10e16b.docx
Yes
No
Fillable Printable
Other-Participant Informed Consent Form
Task1-REMS_Participant-Informed-Consent_v3_031312.doc
Yes
No
Fillable Printable
Other-Screener
Task1-REMS_Screener_for_FocusGroups_Deloitte_v5_Q6.docx
Yes
No
Fillable Printable
Other-Interviewee Email Invitations
Task1-REMS_Interviewee_EmailInvitations_v5_031312.docx
No
No
Fillable Printable
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Illness Prevention
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
108
Number of Respondents for Small Entity:
0
Affected Public:
Individuals or Households
Percentage of Respondents Reporting Electronically:
0 %
Requested
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
108
0
0
0
0
108
Annual IC Time Burden (Hours)
216
0
0
0
0
216
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
OMB Clearance Memo
FDAFocusGroupGenICMemoREMS ETASU 11-8-12.doc
11/09/2012
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.