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CBER, Form FDA 3500A

IC 272442 under ICR 202603-0910-005 · OMB 0910-0291.

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CBER, Form FDA 3500A
 
No Unchanged
 
Mandatory
 
21 CFR 600.80 21 CFR 1271.350

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Instruction Yes Yes Fillable Fileable
Form 3500A Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

599 0
   
Private Sector Businesses or other for-profits
 
   20 %

  Requested 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 58,702 0 0 0 0 58,702
Annual IC Time Burden (Hours) 71,029 0 0 0 0 71,029
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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