Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
MedWatch 3500 for VOLUNTARY reporting of adverse events, product problems and product use errors Modified 22700 13620 0 Form and Instruction FDA 3500 MedWatch for VOLUNTARY reporting of adverse events, product problems and product use errors
MedWatch 3500B Consumer reporting New 11500 4792 0 Form and Instruction FDA 3500b MedWatch Consumer Reporting
MedWatch 3500a for use by user-facilities, importers, distributors and manufacturers for MANDATORY reporting New 752573 835173 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: 786773 853585 0  
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