Information Collection Request

Export Certificates for FDA Regulated Products

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

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

ICR Details

Status	Received in OIRA
Agency/Subagency	HHS/FDA
OMB Control No	0910-0498
Type of Information Collection	Revision of a currently approved collection
Previous ICR Reference No	202303-0910-018
Agency Tracking No	CROSS CENTER
Date Submitted to OIRA	1969-12-31
Requested Expiration Date	1969-12-31