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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