Drug experience reports; advertisements and promotional labeling; distributor statements

Adverse Experience/Events with Approved New Animal Drugs

OMB: 0910-0284

IC ID: 197280

Information Collection (IC) Details

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Drug experience reports; advertisements and promotional labeling; distributor statements CVM
 
No Removed
 
Mandatory
 
21 CFR 514.80

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction 2301 Transmittal of Periodic Reports and Promotional Material Form FDA 2301.pdf No No Paper Only
Other-Screenshots - Proposed Electronic Submitter System 0284 Screenshots.doc Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

200 0
   
Private Sector Businesses or other for-profits
 
   100 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 0 0 0 -5,779 0 5,779
Annual IC Time Burden (Hours) 0 0 0 -34,266 0 34,266
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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