Requests for Information under 513(g) of the FFDCA

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: 259088

Documents and Forms
Document Name
Document Type
Other-Agency Guidance
Other-Digital Screenshot
Information Collection (IC) Details

View Information Collection (IC)

Requests for Information under 513(g) of the FFDCA
 
No Modified
 
Required to Obtain or Retain Benefits
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance 0511_513g guidance.pdf Yes Yes Fillable Fileable
Other-Digital Screenshot 513(g)eSTAR(flat).pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

118 0
   
Private Sector Businesses or other for-profits
 
   100 %

  Requested 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 118 0 0 0 0 118
Annual IC Time Burden (Hours) 1,416 0 0 0 0 1,416
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
No associated records found
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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