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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
Modified
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
1782
1782
0
Form and Instruction
Form FDA 1932
Veterinary Adverse Drug Reaction; Lack of Effectiveness or Product Defect Report
Medicated feed reports
New
5
1
0
Recordkeeping requirements under 510.301 and 514.80
Modified
4655
65117
0
Reporting: Requirement for Submission of Special Drug Experience Report More Frequently - Form FDA 2301
Removed
0
0
0
Form and Instruction
2301
Transmittal of Periodic Reports and Promotional Material
Other-Screenshots - Proposed Electronic Submitter System
Reporting: Requirement for Submitting Advertisement & Promotional Material - Form FDA 2301
Removed
0
0
0
Form
2301
Transmittal of Periodic Reports and Promotional Material forNew Animal Drugs
Other-Screenshots - Proposed Electronic Submitter System
Reporting: Requirement for submitting Distributor statements - Form FDA 2301
Removed
0
0
0
Form and Instruction
2301
Transmittal of Periodic reports and Promotional Material
Other-Screenshots - Proposed Electronic Submitter System
Voluntary adverse event reporting
Modified
197
197
0
Form and Instruction
1932a
Veterinary Adverse Drug Reaction, Lack of Effectiveness
Total burden requested under this ICR:
12418
101363
0
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