AER under 314.80 (marketing applications) - quarterly reports

Postmarketing Adverse Drug Experience Reporting

OMB: 0910-0230

IC ID: 188676

Documents and Forms
Information Collection (IC) Details

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AER under 314.80 (marketing applications) - quarterly reports CDER
 
No Unchanged
 
Mandatory
 
21 CFR 314.80(c)(2)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance 0230 GFI Periodic Postmarket Reports in ICH E2C(R2) Format.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

820 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 14,202 0 0 0 0 14,202
Annual IC Time Burden (Hours) 852,120 0 0 0 0 852,120
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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