Device Facility User Fee Cover Sheet (Form FDA 3601(a))

Medical Device User Fee Cover Sheet and Device Facility User Fee Cover Sheet — Form FDA 3601 and Form 3601(a)

OMB: 0910-0511

IC ID: 248796

Information Collection (IC) Details

View Information Collection (IC)

Device Facility User Fee Cover Sheet (Form FDA 3601(a))
 
No New
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form FDA 3601(a) Device Facility User Fee 0511_Form 3601(a).pdf Yes Yes Fillable Fileable Signable

Health Consumer Health and Safety

 

24,086 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 24,086 0 0 24,086 0 0
Annual IC Time Burden (Hours) 4,095 0 0 4,095 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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