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 3500B Consumer reporting New 11500 4792 0 Form and Instruction FDA 3500b
MedWatch 3500a for use by user-facilities, importers, distributors and manufacturers for MANDATORY reporting New 752573 835173 0 Form and Instruction FDA 3500a
Total burden requested under this ICR: 786773 853585 0  
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