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Adverse Event Reporting -- 314.80(c)(2)
Postmarketing Adverse Drug Experience Reporting
OMB: 0910-0230
IC ID: 188676
OMB.report
HHS/FDA
OMB 0910-0230
ICR 202105-0910-002
IC 188676
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0230 can be found here:
2023-03-20 - No material or nonsubstantive change to a currently approved collection
2021-11-22 - Revision of a currently approved collection
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:
Adverse Event Reporting -- 314.80(c)(2)
Agency IC Tracking Number:
CDER
Is this a Common Form?
No
IC Status:
Unchanged
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR 314.80(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:
Consumer Health and Safety
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
810
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
100 %
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
14,178
0
0
0
0
14,178
Annual IC Time Burden (Hours)
835,755
0
0
0
0
835,755
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.