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  
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