Manufacturing changes to an approved application

Reporting Associated with New Animal Drug Applications

OMB: 0910-0032

IC ID: 197513

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Manufacturing changes to an approved application
 
No Removed
 
Mandatory
 
21 CFR 514.8(b)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Consumer Health and Safety

 

169 16
   
Private Sector Businesses or other for-profits
 
   55 %

  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 -375 0 375
Annual IC Time Burden (Hours) 0 0 0 -13,125 0 13,125
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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