CDER Export Certificate (FDA 3613f)

Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802

OMB: 0910-0498

IC ID: 217014

Documents and Forms
Document Name
Document Type
Form and Instruction
Other-Screenshots of electronic subm
Other-Screenshots of electronic subm
Other-Screenshots of electronic subm
Other-Screenshots of electronic subm
Form and Instruction
Information Collection (IC) Details

View Information Collection (IC)

CDER Export Certificate (FDA 3613f)
 
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
Form and Instruction 3613f Request for Certificates of a Pharmaceutical Product for CDER Products FDA FORM 3613(f) CDER 0498 6-25-2015.pdf Yes Yes Fillable Fileable
Other-Screenshots of electronic submission of API Drug CDER eCATS API Drug FlowFINAL03072016.pdf Yes Yes Fillable Fileable
Other-Screenshots of electronic submission of Approved Drug CDER eCATS- Approved Drug FlowFINAL03072016.pdf Yes Yes Fillable Fileable
Other-Screenshots of electronic submission for CDER OTC Drug CDER eCATS- OTC Drug FlowFINAL03072016.pdf Yes Yes Fillable Fileable
Other-Screenshots of electronic submission of Unapproved Drug CDER eCATS -Unapproved Drug FlowFINAL03072016.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

5,251 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 5,251 0 0 0 0 5,251
Annual IC Time Burden (Hours) 10,502 0 0 0 0 10,502
Annual IC Cost Burden (Dollars) 695,758 0 0 0 0 695,758

Title Document Date Uploaded
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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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