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
Adverse Drug Experiences & Product / Manufacturing Defects Reporting Using FDA Form 1932 Modified 17881 17881 0 Form and Instruction Form FDA 1932
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
Requirement for Submitting Advertisement & Promotional Labeling- Form FDA 2301 New 2849 5698 0 Form and Instruction 2301
Requirement for Submitting Distributor Statements - Form FDA 2301 New 49 98 0 Form and Instruction 2301
Six Month Periodic Drug Experience Report( Submit annually after the first 2 years) Form FDA 2301 New 1428 22848 0 Form and Instruction 2301
Total burden requested under this ICR: 26966 111776 0  
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