Adverse Drug Event Recordkeeping -- 314.80(i)

Adverse Drug Experience Reporting

OMB: 0910-0230

IC ID: 188678

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Adverse Drug Event Recordkeeping -- 314.80(i)
 
No Modified
 
Mandatory
 
21 CFR 301

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

Health Public Health Monitoring

 

665 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 399,998 0 0 -2 0 400,000
Annual IC Time Burden (Hours) 6,399,968 0 0 -32 0 6,400,000
Annual IC Cost Burden (Dollars) 22,000 0 0 40 0 21,960

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