Guidance on How to Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway

Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine Using the FDA Electronic Submission Gateway

OMB: 0910-0454

IC ID: 6144

Information Collection (IC) Details

View Information Collection (IC)

Guidance on How to Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway CVM
 
No Modified
 
Required to Obtain or Retain Benefits
 
21 CFR 11.2

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction FDA 3538 Electronic Submission System Participant Management Form 0454_Form FDA 3538_2019.pdf Yes Yes Fillable Fileable Signable
Other-Guidance 0454_Guidance_2019.pdf No   Paper Only

Health Consumer Health and Safety

 

193 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 251 0 0 213 0 38
Annual IC Time Burden (Hours) 20 0 0 17 0 3
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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