Firm Initiated Recall

FDA Recall Regulations

OMB: 0910-0249

IC ID: 5832

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Firm Initiated Recall ORA
 
No Modified
 
Voluntary
 
21 CFR 7.46

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

Health Public Health Monitoring

 

3,801 0
   
Private Sector Businesses or other for-profits
 
   95 %

  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 3,801 0 0 -31,278 0 35,079
Annual IC Time Burden (Hours) 95,025 0 0 -348,795 0 443,820
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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