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 New 4651 65117 0
Records and Reports Concerning Experience with Approved New Animal Drugs Modified 17881 17881 0 Form and Instruction Form FDA 1932
Reporting: Adverse Drug Experience & Product / Manufacturing Defects Voluntary reporting Using Form FDa 1932a New 82 82 0 Form and Instruction 1932a
Reporting: Requirement for Submission of Special Drug Experience Report More Frequently - Form FDA 2301 New 26 52 0 Form and Instruction 2301
Reporting: Requirement for Submitting Advertisement & Promotional Material - Form FDA 2301 New 2849 5698 0
Reporting: Requirement for submitting Distributor statements - Form FDA 2301 New 52 98 0 Form and Instruction 2301
Reporting: six Month Periodic Drug experience report ( Submit Annually After First 2 Years) Form FDA 2301 New 1428 22848 0 Form and Instruction 2301
Total burden requested under this ICR: 26969 111776 0  
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