CDRH Export Certificate (FDA 3613, 3613a, 3613c and 3613g)

Export Certificates for FDA Regulated Products

OMB: 0910-0498

IC ID: 188596

Information Collection (IC) Details

View Information Collection (IC)

CDRH Export Certificate (FDA 3613, 3613a, 3613c and 3613g)
 
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
Form and Instruction FDA 3613 Supplementary Information Certificate to Foreign Government Requests FDA-3613_Stat_Sec_Ext_04-25-24.pdf Yes Yes Fillable Fileable Signable
Form and Instruction FDA 3613a Supplementary Information Certificate of Exportability Requests FDA-3613a_Stat_Sec_Ext_04-25-24.pdf Yes Yes Fillable Fileable Signable
Form and Instruction FDA 3613c Supplementary Information Non-Clinical Research Use Only Certificate FDA-3613c_Stat_Sec_Ext_04-25-24.pdf Yes Yes Fillable Fileable Signable
Form and Instruction FDA 3613g Certificate To Foreign Government For Device Not Exported From the United States Requests FDA-3613g_Stat_Sec_Ext_04-25-2024.pdf Yes Yes Fillable Fileable Signable

Health Consumer Health and Safety

 

11,175 0
   
Private Sector Businesses or other for-profits
 
   100 %

  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 11,175 0 0 0 0 11,175
Annual IC Time Burden (Hours) 22,350 0 0 0 0 22,350
Annual IC Cost Burden (Dollars) 1,955,625 0 0 0 0 1,955,625

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