Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Drug experience reports; advertisements and promotional labeling; distributor statements Modified 5779 34266 0 Form and Instruction 2301
Other-Screenshots - Proposed Electronic Submitter System
Mandatory adverse event reporting Modified 1782 1782 0 Form and Instruction Form FDA 1932
Medicated feed reports New 5 1 0
Recordkeeping requirements under 510.301 and 514.80 Modified 4655 65117 0
Reporting: Requirement for Submission of Special Drug Experience Report More Frequently - Form FDA 2301 Removed 0 0 0 Form and Instruction 2301
Other-Screenshots - Proposed Electronic Submitter System
Reporting: Requirement for Submitting Advertisement & Promotional Material - Form FDA 2301 Removed 0 0 0 Form 2301
Other-Screenshots - Proposed Electronic Submitter System
Reporting: Requirement for submitting Distributor statements - Form FDA 2301 Removed 0 0 0 Form and Instruction 2301
Other-Screenshots - Proposed Electronic Submitter System
Voluntary adverse event reporting Modified 197 197 0 Form and Instruction 1932a
Total burden requested under this ICR: 12418 101363 0  
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