Reporting: Requirement for Submission of Special Drug Experience Report More Frequently - Form FDA 2301

Records and Reports Concerning Experience with Approved New Animal Drugs

OMB: 0910-0284

IC ID: 197281

Information Collection (IC) Details

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Reporting: Requirement for Submission of Special Drug Experience Report More Frequently - Form FDA 2301 CVM
 
No Removed
 
Mandatory
 
21 CFR 514.80(b)(5)(i)

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
 
   0 %

  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 -114 0 114
Annual IC Time Burden (Hours) 0 0 0 -228 0 228
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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