Adverse Experience Reporting for Licensed Biological Products 21 CFR 600

Adverse Experience Reporting for Licensed Biological Products 21 CFR 600

OMB: 0910-0308

IC ID: 110014

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Adverse Experience Reporting for Licensed Biological Products 21 CFR 600
 
No Migrated
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form FDA-3500 No No
Form FDA-3500A No No


    

91 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 645 0 645 0 0 0
Annual IC Time Burden (Hours) 8,329 0 8,329 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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