Mandatory Adverse Event Reporting via ESG (Gateway-to-Gateway transmission)

FDA Adverse Event and Products Experience Reports; Electronic Submissions

OMB: 0910-0645

IC ID: 192362

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Mandatory Adverse Event Reporting via ESG (Gateway-to-Gateway transmission)
 
No Modified
 
Mandatory
 
21 CFR 600; 803; 1271 21 CFR 310; 314; 329; 514  (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 Consumer Health and Safety

 

3,007,000 0
   
Individuals or Households
 
   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 3,007,000 0 0 1,142,965 0 1,864,035
Annual IC Time Burden (Hours) 1,804,200 0 0 685,779 0 1,118,421
Annual IC Cost Burden (Dollars) 141,084,984 0 0 141,084,984 0 0

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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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