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Agenda
Reg Review
ICR
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