GFI: AER and Records During Pandemic

Postmarketing Adverse Drug Experience Reporting

OMB: 0910-0230

IC ID: 250440

Documents and Forms
Document Name
Document Type
Other-Agency Guidance
Other-Agency Guidance
Information Collection (IC) Details

View Information Collection (IC)

GFI: AER and Records During Pandemic
 
No Unchanged
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance 0701 AER Pandemic GFI 2020.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

350 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 1,150 0 0 0 0 1,150
Annual IC Time Burden (Hours) 13,400 0 0 0 0 13,400
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
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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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