View Information Collection (IC)
View Information Collection (IC)

View Information Collection (IC)

Subpart B - Applications
 
No Unchanged
 
Mandatory
 
21 CFR 310.306 21 CFR 314.50-314.90

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction FDA 3331a https://www.fda.gov/drugs/surveillance/field-alert-reports Yes Yes Fillable Fileable
Form FDA 2252 Yes Yes Fillable Fileable
Instruction Yes Yes Fillable Fileable
Form FDA 2253 Yes Yes Fillable Fileable
Instruction Yes Yes Fillable Fileable
Other-Performance Goals Yes Yes Paper Only
Other-Legislative Authority Yes Yes Paper Only
Other-Statutory Authority Yes Yes Fillable Fileable
Form FDA 356h Yes Yes Fillable Fileable
Instruction Yes Yes Fillable Fileable
Form FDA 3542a Yes Yes Fillable Fileable
Instruction Yes Yes Fillable Fileable
Form FDA 3542 Yes Yes Fillable Fileable
Instruction Yes Yes Fillable Fileable

Health Public Health Monitoring

 

354 0
   
Private Sector Businesses or other for-profits
 
   99 %

  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 57,630 0 0 0 0 57,630
Annual IC Time Burden (Hours) 1,084,042 0 0 0 0 1,084,042
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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