Mandatory View Using Direct Gateway-to Gateway Transmission

Electronic Submission of FDA Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting Portal

OMB: 0910-0645

IC ID: 189647

Information Collection (IC) Details

View Information Collection (IC)

Mandatory View Using Direct Gateway-to Gateway Transmission
 
No Removed
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-screenshots 1005_Mandatory-Initial-Part_4-Adulteration_Origination_Site-040109.pdf Yes Yes Fillable Fileable
Other-screenshots 1005 Mandatory-Initial-Subview Questions & Explanatory Notes-040109.doc Yes Yes Fillable Fileable
Other-screenshots 1005_Mandatory-Initial-Part_3-Problem_Summary-040109.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

2,578 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 0 0 -513,613 0 0 513,613
Annual IC Time Burden (Hours) 0 0 -1 0 0 1
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
No associated records found
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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