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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
All Centers - Form 3500B (Consumer Reporting)
New
13750
6325
0
Form and Instruction
FDA 3500B
MedWatch Consumer Reporting
Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)
New
14727
9720
0
Form and Instruction
FDA 3500
MedWatch for VOLUNTARY reporting of adverse events, product problems and product use errors
Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research - Form 3500A (MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY report
New
58702
71029
0
Form and Instruction
FDA 3500A
MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting
Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research - Form 3500A (Outsourcing Facilities)
New
100
121
0
Form and Instruction
FDA 3500A
MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting
Center for Devices and Radiological Health - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)
New
5233
3454
0
Form and Instruction
FDA 3500
MedWatch for VOLUNTARY reporting of adverse events, product problems and product use errors
Center for Devices and Radiological Health - Form 3500A (MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting)
New
673992
815530
0
Form and Instruction
FDA 3500A
MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting
Center for Food Safety and Applied Nutrition - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)
New
1793
1183
0
Form and Instruction
FDA 3500
MedWatch for VOLUNTARY reporting of adverse events, product problems and product use errors
Center for Food Safety and Applied Nutrition - Form 3500A (MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting)
New
1659
2007
0
Form and Instruction
FDA 3500A
MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting
Center for Tobacco Products - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)
New
39
26
0
Form and Instruction
FDA 3500
MedWatch for VOLUNTARY reporting of adverse events, product problems and product use errors
MedWatch 3500 for VOLUNTARY reporting of adverse events, product problems and product use errors
Removed
0
0
0
Form and Instruction
FDA 3500
MedWatch for VOLUNTARY reporting of adverse events, product problems and product use errors
MedWatch 3500B Consumer reporting
Removed
0
0
0
Form and Instruction
FDA 3500b
MedWatch Consumer Reporting
MedWatch 3500a for use by user-facilities, importers, distributors and manufacturers for MANDATORY reporting
Removed
0
0
0
Form and Instruction
FDA 3500a
MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting
Total burden requested under this ICR:
769995
909395
0
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