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Focus Groups on FDA's Accelerated Approval Process
Focus Groups as Used by the Food and Drug Administration
OMB: 0910-0497
IC ID: 229723
OMB.report
HHS/FDA
OMB 0910-0497
ICR 201911-0910-015
IC 229723
( )
⚠️ Notice: This information collection may be referencing outdated material.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
FDA Accelerated Approval Focus Groups_Screener_Task1.2_122917.docx
Other-Respondent Screener
FDA_AA_Moderators Guide_Task1.1_122917.doc
Other-Moderator's Guide
FDA AcceleratedApproval_FocusGroups_Informed Consent_Task1.2 120517.docx
Other-Informed Consent
Accelerated Approval_information chart_Task1.1_122917.pptx
Other-Information Chart
OMB memo AcceleratedApproval Focus Groups.doc
Accelerated Approval Focus Groups
IC Document
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Focus Groups on FDA's Accelerated Approval Process
Agency IC Tracking Number:
CDER
IC Status:
Unchanged
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-Respondent Screener
FDA Accelerated Approval Focus Groups_Screener_Task1.2_122917.docx
Yes
Yes
Printable Only
Other-Moderator's Guide
FDA_AA_Moderators Guide_Task1.1_122917.doc
No
Printable Only
Other-Informed Consent
FDA AcceleratedApproval_FocusGroups_Informed Consent_Task1.2 120517.docx
No
Printable Only
Other-Information Chart
Accelerated Approval_information chart_Task1.1_122917.pptx
No
Printable Only
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:
472
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
472
0
0
0
0
472
Annual IC Time Burden (Hours)
104
0
0
0
0
104
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
Accelerated Approval Focus Groups
OMB memo AcceleratedApproval Focus Groups.doc
01/11/2018
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.