OMB.report

Federal forms, ICRs, and supporting documents

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.

View the official OMB control history on Reginfo.gov.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Form FDA 3613g Certificate To Foreign Government For Device Not Exported From the United States RequestsForm and Instruction
Form FDA 3613c Supplementary Information Non-Clinical Research Use Only CertificateForm and Instruction
Form FDA 3613b Supplementary Information Certificate of a Pharmaceutical ProductForm and Instruction
Form FDA 3613a Supplementary Information Certificate of Exportability RequestsForm and Instruction
Form FDA 3613 Supplementary Information Certificate to Foreign Government RequestsForm and Instruction
Form FDA 3613 CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g)Form and Instruction
Form FDA 3613f REQUEST FOR CERTIFICATE OF A PHARMACEUTICAL PRODUCT FOR CDER PRODUCTSForm and Instruction
Form FDA 3613 Request for Certificate Supplementary InformationForm and Instruction
Form FDA 3613b SUPPLEMENTARY INFORMATION CERTIFICATE OF A PHARMACEUTICAL PRODUCTForm and Instruction
Form FDA 3613a SUPPLEMENTARY INFORMATION CERTIFICATE OF EXPORTABILITY REQUESTSForm and Instruction
Form FDA 3613 SUPPLEMENTARY INFORMATION CERTIFICATE TO FOREIGN GOVERNMENT REQUESTSForm and Instruction
Form FDA 3613 CVM Export Certificate (FDA 3613, 3613a, 3613b)Form and Instruction
Form FDA 3613g Certificate To Foreign Government For Device Not Exported From the United States RequestsForm and Instruction
Form FDA 3613c Supplementary Information Non-Clinical Research Use Only CertificateForm and Instruction
Form FDA 3613a Supplementary Information Certificate of Exportability RequestsForm and Instruction
Form FDA 3613 Supplementary Information Certificate to Foreign Government RequestsForm 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.docxSupporting Statement A
CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g) Form and Instruction
CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g) Form and Instruction
CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g) Form and Instruction
CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g) Form and Instruction
CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g) Form and Instruction
CBER Export Certificate (FDA 3613, 3613a, 3613b, 3613c, 3613g) Form and Instruction
CDER Export Certificate (FDA 3613f) 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
CVM Export Certificate (FDA 3613, 3613a, 3613b) Form and Instruction
CVM Export Certificate (FDA 3613, 3613a, 3613b) Form and Instruction
CVM Export Certificate (FDA 3613, 3613a, 3613b) Form and Instruction
CVM Export Certificate (FDA 3613, 3613a, 3613b) Form and Instruction
CDRH Export Certificate (FDA 3613, 3613a, 3613c and 3613g) Form and Instruction
CDRH Export Certificate (FDA 3613, 3613a, 3613c and 3613g) Form and Instruction
CDRH Export Certificate (FDA 3613, 3613a, 3613c and 3613g) Form and Instruction
CDRH Export Certificate (FDA 3613, 3613a, 3613c and 3613g) Form and Instruction
CDRH Export Certificate (FDA 3613, 3613a, 3613c and 3613g) Form and Instruction

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202308-0910-003 Revision of a currently approved collection 2024-04-29 Approved without change
202303-0910-018 No material or nonsubstantive change to a currently approved collection 2023-03-27 Approved without change
202208-0910-015 No material or nonsubstantive change to a currently approved collection 2022-09-07 Approved without change
202101-0910-012 Revision of a currently approved collection 2021-03-03 Approved without change
202009-0910-006 Revision of a currently approved collection 2020-09-16 Approved without change
202003-0910-012 No material or nonsubstantive change to a currently approved collection 2020-03-19 Approved without change
201801-0910-007 Extension without change of a currently approved collection 2018-03-27 Approved without change
201603-0910-008 No material or nonsubstantive change to a currently approved collection 2016-03-09 Approved without change
201506-0910-026 No material or nonsubstantive change to a currently approved collection 2015-06-26 Approved without change
201506-0910-019 No material or nonsubstantive change to a currently approved collection 2015-06-18 Approved without change
201506-0910-016 No material or nonsubstantive change to a currently approved collection 2015-06-13 Approved without change
201502-0910-003 Revision of a currently approved collection 2015-02-10 Approved with change
201305-0910-001 No material or nonsubstantive change to a currently approved collection 2013-05-08 Approved with change
201210-0910-004 No material or nonsubstantive change to a currently approved collection 2012-10-23 Approved without change
201203-0910-005 Reinstatement without change of a previously approved collection 2012-03-23 Approved without change
201010-0910-002 Extension without change of a currently approved collection 2010-10-12 Improperly submitted and continue
200903-0910-006 Extension without change of a currently approved collection 2009-03-30 Approved with change
200601-0910-003 Extension without change of a currently approved collection 2006-01-26 Approved with change
200210-0910-002 New collection (Request for a new OMB Control Number) 2002-10-01 Approved with change

OMB Details

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

Federal Enterprise Architecture: Health - Consumer Health and Safety

Information collection instruments
FormNameElectronic accessType
Form FDA 3613bSupplementary Information Certificate of a Pharmaceutical ProductFillable Fileable SignableForm and instruction
Form FDA 3613gCertificate To Foreign Government For Device Not Exported From the United States RequestsFillable Fileable SignableForm and instruction
Form FDA 3613cSupplementary Information Non-Clinical Research Use Only CertificateFillable Fileable SignableForm and instruction
Form FDA 3613aSupplementary Information Certificate of Exportability RequestsFillable Fileable SignableForm and instruction
Form FDA 3613Supplementary Information Certificate to Foreign Government RequestsFillable Fileable SignableForm and instruction

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