Export Certificates for FDA Regulated Products

ICR 202308-0910-003

OMB: 0910-0498

Federal Form Document

Forms and Documents

Document Name	Status
Form FDA 3613 CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g) Form and Instruction	Modified
Form FDA 3613 CVM Export Certificate (FDA 3613, 3613a, 3613b) Form and Instruction	Modified
Form FDA 3613 CDRH Export Certificate (FDA 3613, 3613a, 3613c and 3613g) Form and Instruction	Modified
21 USC 381 Exports under FFDCA.pdf Supplementary Document	2023-03-25
0498 Export Certs 83-C for 3613g MARCH 2023.docx Justification for No Material/Nonsubstantive Change	2023-03-25
0498ExportCertsSSA 03-04-24.docx Supporting Statement A	2024-03-04

IC Document Collections

IC ID	Document Title	Status
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