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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 Reporting Using FDA Form 1932
Modified
17897
17883
0
Form and Instruction
Form FDA 1932
Veterinary Adverse Drug Reaction; Lack of Effectiveness or Product Defect Report
AdverseDrug Experiences & Product /Manufacturing Defects Voluntary Reporting Using Form FDA 1932a
New
82
82
0
Form and Instruction
1932a
Veteinay Adverse Drug Reaction Lack of Effectiveness
Requirement for Applicants & NonApplicants to Establish and Maintain Records & files of New Animal Drug Data That Had Not Been Submitted As Part of the Application
New
4651
65117
0
Requirements for Submission of Special Drug Experience Reports More Frequently - Form FDA 2301
New
2604
52
0
Form and Instruction
2301
Transmittal of Periodic Reports and Promotional Material
Requirements for Submitting Advetisement & Promotional Labeling- Form FDA 2301
New
2856
5698
0
Form and Instruction
2301
Tansmittal of Periodic Reports and Promotional Material
Requirements for Submitting Distributor Statements- Form FDA 2301
New
49
98
0
Form and Instruction
2301
Transmittal of Periodic Reports and Promotional Material
Six Month Periodic Drug Experience Report ( submit annually after first 2 years)- Paper Form FDA 2301
New
1428
22848
0
Form and Instruction
2301
Transmittal of Periodic Reports and Promotional Material
Total burden requested under this ICR:
29567
111778
0
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