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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Recordkeeping: Maintainence of Records ( data) by Applicants & Non Applicants That Was Not Submitted as Part of the NADA Application
Unchanged
4651
65117
0
Records and Reports Concerning Experience with Approved New Animal Drugs
Modified
1783
1783
0
Form and Instruction
Form FDA 1932
Veterinary Adverse Drug Reaction; Lack of Effectiveness or Product Defect Report
Reporting: Adverse Drug Experience & Product / Manufacturing Defects Voluntary reporting Using Form FDa 1932a
Unchanged
197
197
0
Form and Instruction
1932a
Veterinary Adverse Drug Reaction, Lack of Effectiveness
Reporting: Annual drug experience report Form FDA 2301
Modified
1622
25952
0
Form and Instruction
2301
Transmittal of Periodic Reports and Promotional Material
Other-Screenshots - Proposed Electronic Submitter System
Reporting: Requirement for Submission of Special Drug Experience Report More Frequently - Form FDA 2301
Modified
114
228
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
Modified
4024
8048
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
Modified
19
40
0
Form and Instruction
2301
Transmittal of Periodic reports and Promotional Material
Other-Screenshots - Proposed Electronic Submitter System
Total burden requested under this ICR:
12410
101365
0
To view an IC, click on IC Title