CDER Export Certificate (FDA 3613b)

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

OMB: 0910-0498

IC ID: 188595

Documents and Forms
Information Collection (IC) Details

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CDER Export Certificate (FDA 3613b)
 
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 FDA 3613b Supplementary Information Certificate of a Pharmaceutical Product FDA-3613b.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 -1,795 7,046 0
Annual IC Time Burden (Hours) 10,502 0 0 3,456 7,046 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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