Export Certificates for FDA Regulated Products

OMB 0910-0498

Section 801(e)(4) of the Act provides that persons exporting certain FDA-regulated products may request that FDA certify that the products meet the requirements of sections 801(e) or 802 or other requirements of the Act. The Act does not require FDA to issue certificates for food, including animal feeds, food and feed additives, and dietary supplements, or cosmetics. However, since foreign governments may require certificates for these types of products, the agency intends to continue to provide this service as resources permit. Section 801(e)(4) of the Act also provides that FDA may charge a fee of up to $175 if FDA issues a certificate within 20 days of receipt of a complete request for such a certificate. This fee may vary depending on the product type, but it will not exceed $175.

The latest form for Export Certificates for FDA Regulated Products expires 2021-03-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form FDA 3613 CBER Export Certificate (FDA 3613, 3613b, 3613c) Form and Instruction
Form FDA 3613 CBER Export Certificate (FDA 3613, 3613b, 3613c) Form and Instruction
Form FDA 3613 CVM Export Certificate (FDA 3613, 3613b) Form and Instruction
Form FDA 3613 CVM Export Certificate (FDA 3613, 3613b) Form and Instruction
Form FDA 3613 CDRH Export Certificate (FDA 3613, 3613a, 3613c) Form and Instruction
Form FDA 3613 CDRH Export Certificate (FDA 3613, 3613a, 3613c) Form and Instruction
21 USC 381 Exports under FFDCA.pdf Supplementary Document
21 USC 381 Exports under FFDCA.pdf Supplementary Document
0498 Export Certs 83-C for 3613g MARCH 2023.docx Justification for No Material/Nonsubstantive Change
0498 Export Certs 83-C for 3613g MARCH 2023.docx Justification for No Material/Nonsubstantive Change
0498 Export Certs SSA REV 2021.docx Supporting Statement A
0498 Export Certs SSA REV 2021.docx Supporting Statement A
CBER Export Certificate (FDA 3613, 3613b, 3613c) Form and Instruction
CBER Export Certificate (FDA 3613, 3613b, 3613c) Form and Instruction
CDER Export Certificate (FDA 3613f) Other-Screenshots of electronic submission of API Drug
CVM Export Certificate (FDA 3613, 3613b) Form and Instruction
CVM Export Certificate (FDA 3613, 3613b) Form and Instruction
CDRH Export Certificate (FDA 3613, 3613a, 3613c) Form and Instruction
CDRH Export Certificate (FDA 3613, 3613a, 3613c) Form and Instruction

All Historical Document Collections

202303-0910-018 Approved without change	No material or nonsubstantive change to a currently approved collection	2023-03-27
202208-0910-015 Approved without change	No material or nonsubstantive change to a currently approved collection	2022-09-07
202101-0910-012 Approved without change	Revision of a currently approved collection	2021-03-03
202009-0910-006 Approved without change	Revision of a currently approved collection	2020-09-16
202003-0910-012 Approved without change	No material or nonsubstantive change to a currently approved collection	2020-03-19
201801-0910-007 Approved without change	Extension without change of a currently approved collection	2018-03-27
201603-0910-008 Approved without change	No material or nonsubstantive change to a currently approved collection	2016-03-09
201506-0910-026 Approved without change	No material or nonsubstantive change to a currently approved collection	2015-06-26
201506-0910-019 Approved without change	No material or nonsubstantive change to a currently approved collection	2015-06-18
201506-0910-016 Approved without change	No material or nonsubstantive change to a currently approved collection	2015-06-13
201502-0910-003 Approved with change	Revision of a currently approved collection	2015-02-10
201305-0910-001 Approved with change	No material or nonsubstantive change to a currently approved collection	2013-05-08
201210-0910-004 Approved without change	No material or nonsubstantive change to a currently approved collection	2012-10-23
201203-0910-005 Approved without change	Reinstatement without change of a previously approved collection	2012-03-23
201010-0910-002 Improperly submitted and continue	Extension without change of a currently approved collection	2010-10-12
200903-0910-006 Approved with change	Extension without change of a currently approved collection	2009-03-30
200601-0910-003 Approved with change	Extension without change of a currently approved collection	2006-01-26
200210-0910-002 Approved with change	New collection (Request for a new OMB Control Number)	2002-10-01

OMB Details

CBER Export Certificate (FDA 3613, 3613b, 3613c)

Federal Enterprise Architecture: Health - Immunization Management

Form FDA 3613	Supplementary Information Certificate to Foreign Government Requests	Fillable Fileable	Form and instruction
Form FDA 3613c	Supplementary Information Non-Clinical Research Use Only Certificate	Fillable Fileable	Form and instruction
Form FDA 3613b	Supplementary Information Certificate of a Pharmaceutical Product	Fillable Fileable	Form and instruction
Form FDA 3613a	Supplementary Information Certificate of Exportability Requests	Fillable Fileable	Form and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.