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CBER, Form FDA 3500A
FDA Adverse Event and Product Experience Reporting Systems (MEDWATCH and SPS electronic and paper-based collection)
OMB: 0910-0291
IC ID: 272442
OMB.report
HHS/FDA
OMB 0910-0291
ICR 202411-0910-004
IC 272442
( )
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:
CBER, Form FDA 3500A
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
New
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR 600.80
21 CFR 1271.350
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Instruction
Yes
Yes
Fillable Fileable
Form
3500A
MedWatch 3500A
Yes
Yes
Fillable Fileable
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:
599
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
20 %
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
58,702
0
0
58,702
0
0
Annual IC Time Burden (Hours)
71,029
0
0
71,029
0
0
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.