Information Collection

Conducting Focus Groups & In Depth Interviews to Understand and Differentiate the Impact of REMS/ETASU on Prescriber Practices

IC 204195 under ICR 201404-0910-001 · OMB 0910-0497.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0497 can be found here:

Documents and Forms

Documents and forms in this information collection
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

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:

table that charts list of instruments
Document Type	Instrument File	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

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 %

table that charts list of burden
	Requested	Previously Approved
Annual Number of Responses for this IC	108	108
Annual IC Time Burden (Hours)	216	216
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
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.