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Applicants That Do Not Have a Periodic Safety Update Report Waiver For an Approved Applications
GFI: Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format
OMB: 0910-0771
IC ID: 211858
OMB.report
HHS/FDA
OMB 0910-0771
ICR 201706-0910-017
IC 211858
( )
Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Applicants That Do Not Have a Periodic Safety Update Report Waiver For an Approved Applications
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Unchanged
Obligation to Respond:
Voluntary
CFR Citation:
21 CFR 314.80(c)(2)
21 CFR 600.80(c)(2)
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Health Care Services
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
29
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
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
67
0
0
0
0
67
Annual IC Time Burden (Hours)
134
0
0
0
0
134
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
No associated records found
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.