Adverse Drug Event Recordkeeping -- 314.80(i)

Postmarketing Adverse Drug Experience Reporting

OMB: 0910-0230

IC ID: 188678

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

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

Health Consumer Health and Safety

 

352 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 658,240 0 0 290,448 0 367,792
Annual IC Time Burden (Hours) 10,531,840 0 0 4,647,168 0 5,884,672
Annual IC Cost Burden (Dollars) 25,000 0 0 4,771 0 20,229

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