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
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
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
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
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
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
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
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
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 3500 for VOLUNTARY reporting of adverse events, product problems and product use errors Removed 0 0 0 Form and Instruction FDA 3500
MedWatch 3500B Consumer reporting Removed 0 0 0 Form and Instruction FDA 3500b
MedWatch 3500a for use by user-facilities, importers, distributors and manufacturers for MANDATORY reporting Removed 0 0 0 Form and Instruction FDA 3500a
Total burden requested under this ICR: 769995 909395 0  
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