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General Licensing Provisions: Changes to an Approved Application; Labeling; and Revocation and Suspension

IC 37629 under ICR 200208-0910-007 · OMB 0910-0315.

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General Licensing Provisions: Changes to an Approved Application; Labeling; and Revocation and Suspension
 
No Migrated
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form FDA-2567 Yes Yes


    

190 0
   
Private Sector Businesses or other for-profits
 
   10 %

  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 3,768 0 0 0 0 3,768
Annual IC Time Burden (Hours) 112,360 0 0 0 0 112,360
Annual IC Cost Burden (Dollars) 655,000 0 0 0 0 655,000

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