Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
All Centers - Form 3500B (Consumer Reporting) Unchanged 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) Unchanged 14727 9720 0
Center for Devices and Radiological Health - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors) Unchanged 5233 3454 0
Center for Food Safety and Applied Nutrition - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors) Unchanged 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) Unchanged 1659 2007 0
Center for Tobacco Products - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors) Unchanged 39 26 0
Electronic Submissions of Voluntary Submissions including via SRP New 4088 2452 0
Electronic Submissions via ESG - Mandatory Reports New 1836 1486 0
Written Request for temporary waiver of mandatory electronic reporting Unchanged 1 1 0
Total burden requested under this ICR: 43126 26654 0  
To view an IC, click on IC Title