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  
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