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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
CBER Export Certificate (FDA 3613, 3613b, 3613c)
Unchanged
2651
2651
463925
Form and Instruction
FDA 3613
Supplementary Information Certificate to Foreign Government Requests
Form and Instruction
FDA 3613a
Supplementary Information Certificate of Exportability Requests
Form and Instruction
FDA 3613b
Supplementary Information Certificate of a Pharmaceutical Product
Form and Instruction
FDA 3613c
Supplementary Information Non-Clinical Research Use Only Certificate
CDER Export Certificate (FDA 3613f)
Unchanged
3680
3680
644000
Form and Instruction
3613f
Request for Certificates of a Pharmaceutical Product for CDER Products
Other-Screenshots of electronic submission of API Drug
Other-Screenshots of electronic submission of Approved Drug
Other-Screenshots of electronic submission for CDER OTC Drug
Other-Screenshots of electronic submission of Unapproved Drug
CDRH Export Certificate (FDA 3613, 3613a, 3613c)
Unchanged
11175
22350
1955625
Form and Instruction
FDA 3613
Supplementary Information Certificate to Foreign Government Requests
Form and Instruction
FDA 3613a
Supplementary Information Certificate of Exportability Requests
Form and Instruction
FDA 3613c
Supplementary Information Non-Clinical Research Use Only Certificate
CVM Export Certificate (FDA 3613, 3613b)
Modified
1925
1925
336875
Form and Instruction
FDA 3613
SUPPLEMENTARY INFORMATION CERTIFICATE TO FOREIGN GOVERNMENT REQUESTS
Form and Instruction
FDA 3613a
SUPPLEMENTARY INFORMATION CERTIFICATE OF EXPORTABILITY REQUESTS
Form and Instruction
FDA 3613b
SUPPLEMENTARY INFORMATION CERTIFICATE OF A PHARMACEUTICAL PRODUCT
Total burden requested under this ICR:
19431
30606
3400425
To view an IC, click on IC Title