Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
All Centers - Form 3500B (Consumer Reporting) Modified 13750 6325 0
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) Modified 14727 9720 0
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 Removed 0 0 0
Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research - Form 3500A (Outsourcing Facilities) Removed 0 0 0
Center for Devices and Radiological Health - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors) Modified 5233 3454 0
Center for Devices and Radiological Health - Form 3500A (MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting) Removed 0 0 0
Center for Food Safety and Applied Nutrition - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors) Modified 1793 1183 0
Center for Food Safety and Applied Nutrition - Form 3500A (MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting) Modified 1659 2007 0
Center for Tobacco Products - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors) Modified 39 26 0
Written Request for temporary waiver of mandatory electronic reporting New 1 1 0
Total burden requested under this ICR: 37202 22716 0  
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