OMB control number
Export Certificates for FDA Regulated Products
OMB 0910-0498 ยท HHS/FDA.
OMB 0910-0498
This information collection supports FDA's export certificate program established under authority of sections 801(e)(4) and 802 of the Federal, Food, Drug, and Cosmetic Act. Respondents to the collection are those seeking to obtain export certificates for FDA-regulated products. We have developed associated forms, and fees not to exceed $175 per certificate may apply.
The latest form for Export Certificates for FDA Regulated Products expires 2027-06-30 and is listed under ICR 202308-0910-003.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 Form FDA 3613 CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g) | Form and Instruction |
 Form FDA 3613 CVM Export Certificate (FDA 3613, 3613a, 3613b) | Form and Instruction |
| Form FDA 3613 CDRH Export Certificate (FDA 3613, 3613a, 3613c and 3613g) | Form and Instruction |
| 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 |
| 0498ExportCertsSSA 03-04-24.docx | Supporting Statement A |
 CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g) |
Form and Instruction |
| CDER Export Certificate (FDA 3613f) |
Other-Screenshots of electronic submission of API Drug |
| CVM Export Certificate (FDA 3613, 3613a, 3613b) |
Form and Instruction |
| CDRH Export Certificate (FDA 3613, 3613a, 3613c and 3613g) |
Form and Instruction |
All Historical Document Collections
OMB Details
CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g)
Federal Enterprise Architecture: Health - Consumer Health and Safety
| Form | Name | Electronic access | Type |
|---|---|---|---|
| Form FDA 3613b | Supplementary Information Certificate of a Pharmaceutical Product | Fillable Fileable Signable | Form and instruction |
| Form FDA 3613g | Certificate To Foreign Government For Device Not Exported From the United States Requests | Fillable Fileable Signable | Form and instruction |
| Form FDA 3613c | Supplementary Information Non-Clinical Research Use Only Certificate | Fillable Fileable Signable | Form and instruction |
| Form FDA 3613a | Supplementary Information Certificate of Exportability Requests | Fillable Fileable Signable | Form and instruction |
| Form FDA 3613 | Supplementary Information Certificate to Foreign Government Requests | Fillable Fileable Signable | Form and instruction |
Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.