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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Drug experience reports; advertisements and promotional labeling; distributor statements
Unchanged
5779
34266
0
Form and Instruction
2301
Transmittal of Periodic Reports and Promotional Material
Other-Screenshots - Proposed Electronic Submitter System
Mandatory adverse event reporting
Modified
270
270
0
Form and Instruction
FDA 1932
Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report
Medicated feed reports
Unchanged
5
1
0
One time recordkeeping resulting from implementation of new requirements (New SOPs and training)
New
30
30
0
Recordkeeping requirements under 510.301 and 514.80
Unchanged
4655
65117
0
Request for waiver from electronic reporting requirement
New
1
1
0
Voluntary adverse event reporting
Unchanged
197
197
0
Form and Instruction
1932a
Veterinary Adverse Drug Reaction, Lack of Effectiveness
Total burden requested under this ICR:
10937
99882
0
To view an IC, click on IC Title