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