Adverse Event Recordkeeping -- 310.305(f)

Postmarketing Adverse Drug Experience Reporting

OMB: 0910-0230

IC ID: 188677

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Adverse Event Recordkeeping -- 310.305(f) CDER
 
No Unchanged
 
Mandatory
 
21 CFR 310.305(f)

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

Health Public Health Monitoring

 

25 0
   
Private Sector Businesses or other for-profits
 
   90 %

  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 25 0 0 0 0 25
Annual IC Time Burden (Hours) 400 0 0 0 0 400
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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