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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Adverse Drug Experiences & Product / Manufacturing Defects Voluntary Reporting Using Form FDA 1932a
New
82
82
0
Form and Instruction
1932 A
Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report
Adverse Drug Experiences & Product / Manufacturing Defects Reporting Using FDA Form 1932
Modified
17881
17881
0
Form and Instruction
Form FDA 1932
Veterinary Adverse Drug Reaction; Lack of Effectiveness or Product Defect Report
Requirement for Applicant & Non Applicant to Establish and Maintain Records & Files of New Animal Drug Data That Had Not Been Submitted As Part of The NADA Application
New
4651
65117
0
Requirement for Submission of Special Drug Experience Reports More Frequently Form FDA 2301
New
26
52
0
Form and Instruction
2301
Transmittal of Periodic Reports and Promotional Material for New Animal Drugs
Requirement for Submitting Advertisement & Promotional Labeling- Form FDA 2301
New
2849
5698
0
Form and Instruction
2301
Transmittal of Periodic Reports and Promotional Material for New Animal Drugs
Requirement for Submitting Distributor Statements - Form FDA 2301
New
49
98
0
Form and Instruction
2301
Transmittal of Periodic Reports and Promotional Material for New Animal Drugs
Six Month Periodic Drug Experience Report( Submit annually after the first 2 years) Form FDA 2301
New
1428
22848
0
Form and Instruction
2301
Transmittal of Periodic Reports and Promotional Material for New Animal Drugs
Total burden requested under this ICR:
26966
111776
0
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