GFI: Providing PSURs

Postmarketing Adverse Drug Experience Reporting

OMB: 0910-0230

IC ID: 250441

Information Collection (IC) Details

View Information Collection (IC)

GFI: Providing PSURs
 
No Unchanged
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance GFI Postmarket Safety Reports in ICH-E2C(R2)-Format-(Periodic-Benefit-Risk-Evaluation-Report) NOV 2016.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

84 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 254 0 0 0 0 254
Annual IC Time Burden (Hours) 321 0 0 0 0 321
Annual IC Cost Burden (Dollars) 0 0 0 0 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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