Export Certificates for FDA Regulated Products

OMB 0910-0498

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.

All Historical Document Collections
Revision of a currently approved collection 2021-03-03
Approved without change
Revision of a currently approved collection 2020-09-16
Approved without change
No material or nonsubstantive change to a currently approved collection 2020-03-19
Approved without change
Extension without change of a currently approved collection 2018-03-27
Approved without change
No material or nonsubstantive change to a currently approved collection 2016-03-09
Approved without change
No material or nonsubstantive change to a currently approved collection 2015-06-26
Approved without change
No material or nonsubstantive change to a currently approved collection 2015-06-18
Approved without change
No material or nonsubstantive change to a currently approved collection 2015-06-13
Approved with change
Revision of a currently approved collection 2015-02-10
Approved with change
No material or nonsubstantive change to a currently approved collection 2013-05-08
Approved without change
No material or nonsubstantive change to a currently approved collection 2012-10-23
Approved without change
Reinstatement without change of a previously approved collection 2012-03-23
Improperly submitted and continue
Extension without change of a currently approved collection 2010-10-12
Approved with change
Extension without change of a currently approved collection 2009-03-30
Approved with change
Extension without change of a currently approved collection 2006-01-26
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 3613Supplementary Information Certificate to Foreign Government RequestsFillable FileableForm and instruction
Form FDA 3613cSupplementary Information Non-Clinical Research Use Only CertificateFillable FileableForm and instruction
Form FDA 3613bSupplementary Information Certificate of a Pharmaceutical ProductFillable FileableForm and instruction
Form FDA 3613aSupplementary Information Certificate of Exportability RequestsFillable FileableForm and instruction

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


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