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

View Information Collection (IC)

CDER Export Certificate (FDA 3613f)
 
No Modified
 
Required to Obtain or Retain Benefits
 
21 CFR 1.101

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Screenshots of electronic submission of API Drug Yes Yes Fillable Fileable
Other-Screenshots of electronic submission of Approved Drug Yes Yes Fillable Fileable
Other-Screenshots of electronic submission for CDER OTC Drug Yes Yes Fillable Fileable
Other-Screenshots of electronic submission of Unapproved Drug Yes Yes Fillable Fileable
Form and Instruction FDA 3613f Yes Yes Fillable Fileable Signable

Health Consumer Health and Safety

 

9,396 0
   
Private Sector Businesses or other for-profits
 
   95 %

  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 9,396 0 0 5,716 0 3,680
Annual IC Time Burden (Hours) 9,396 0 0 5,716 0 3,680
Annual IC Cost Burden (Dollars) 1,644,300 0 0 1,000,300 0 644,000

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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