Reports of Serious Adverse Drug Events

Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application

OMB: 0910-0636

IC ID: 186860

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Reports of Serious Adverse Drug Events CDER
 
No Modified
 
Mandatory
 
21 CFR 379aa(b) and (c)  (To search for a specific CFR, visit the Code of Federal Regulations.)

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

Health Public Health Monitoring

 

50 0
   
Private Sector Businesses or other for-profits
 
   100 %

  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 12,500 0 0 0 0 12,500
Annual IC Time Burden (Hours) 75,000 0 0 50,000 0 25,000
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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