Applicants That Do Not Have a Periodic Safety Update Report Waiver For an Approved Applications

GFI: Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format

OMB: 0910-0771

IC ID: 211858

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Applicants That Do Not Have a Periodic Safety Update Report Waiver For an Approved Applications
 
No Unchanged
 
Voluntary
 
21 CFR 314.80(c)(2) 21 CFR 600.80(c)(2)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Health Care Services

 

29 0
   
Private Sector Businesses or other for-profits
 
   0 %

  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 67 0 0 0 0 67
Annual IC Time Burden (Hours) 134 0 0 0 0 134
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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