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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Exemptions
New
228
684
0
Importer Reporting Malfunctions
New
25
25
0
Importer Reporting, Death and Serious Injury
New
1
1
0
MDR Files
New
30000
45000
0
MDR Procedures
New
220
2200
0
Manufacturer Reporting
Modified
301077
301077
0
Supplemental Reports
New
37448
37448
0
User Facility Annual Reporting FDA Form 3419
New
195
195
0
Form and Instruction
3419
User Facility Annual Report Form
User Facility Reporting
New
4896
4896
0
Total burden requested under this ICR:
374090
391526
0
To view an IC, click on IC Title