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Federal forms, ICRs, and supporting documents

Information Collection

CDER Export Certificate (FDA 3613f)

IC 217014 under ICR 202308-0910-003 · OMB 0910-0498.

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

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 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
Form and Instruction FDA 3613f REQUEST FOR CERTIFICATE OF A PHARMACEUTICAL PRODUCT FOR CDER PRODUCTS FDA-3613f_Stat_Sec_Ext_02-24-23_0.pdf 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.