Information Collection Request

Export Certificates for FDA Regulated Products

ICR 202308-0910-003 · OMB 0910-0498 · Received in OIRA

Forms and Documents
DocumentTypeStatusAvailability
Form FDA 3613 CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g) Form and Instruction Modified Repair queued
Form FDA 3613 CVM Export Certificate (FDA 3613, 3613a, 3613b) Form and Instruction Modified Repair queued
Form FDA 3613 CDRH Export Certificate (FDA 3613, 3613a, 3613c and 3613g) Form and Instruction Modified Repair queued
21 USC 381 Exports under FFDCA.pdf Supplementary Document Uploaded 2023-03-25 Repair queued
0498 Export Certs 83-C for 3613g MARCH 2023.docx Justification for No Material/Nonsubstantive Change Uploaded 2023-03-25 Repair queued
0498ExportCertsSSA 03-04-24.docx Supporting Statement A Uploaded 2024-03-04 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
6208 CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g) Form and Instruction Modified
217014 CDER Export Certificate (FDA 3613f) Other-Screenshots of electronic submission of API Drug Modified
188597 CVM Export Certificate (FDA 3613, 3613a, 3613b) Form and Instruction Modified
188596 CDRH Export Certificate (FDA 3613, 3613a, 3613c and 3613g) Form and Instruction Modified
ICR Details
StatusReceived in OIRA
Agency/SubagencyHHS/FDA
OMB Control No0910-0498
Type of Information CollectionRevision of a currently approved collection
Previous ICR Reference No202303-0910-018
Agency Tracking NoCROSS CENTER
Date Submitted to OIRA1969-12-31
Requested Expiration Date1969-12-31