OMB control number

Imports and Electronic Import Entries

OMB 0910-0046 ยท HHS/FDA.

OMB 0910-0046

This information collection supports FDA import operations and regulations in 21 CFR part 1, subparts D & E. The regulations describe reporting elements that must be submitted for FDA-regulated products being imported into the United States, and related recordkeeping.

The latest form for Imports and Electronic Import Entries expires 2026-08-31 and is listed under ICR 202303-0910-006.

View the official OMB control history on Reginfo.gov.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Form FDA 5054 New Inquiry Form CDER Import Compliance BranchForm and Instruction
Form FDA 5054 FDA Form 5054: New Inquiry Form/CDER Import Compliance BranchForm and Instruction
Form FDA 766 APPLICATION FOR AUTHORIZATION TO RELABEL OR RECONDITION NON-COMPLIANT ARTICLESForm and Instruction
Form FDA 766 APPLICATION FOR AUTHORIZATION TO RELABEL OR TO PERFORM OTHER ACTION OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT AND OTHER RELATED ACTSForm and Instruction
Form FDA 766 Application for authorization to relabel and reconditionForm and Instruction
ACE NPRM SSA FINAL.docxSupporting Statement A
ACE NPRM SSA FINAL.docxSupporting Statement A
Importers submission of data elements Information collection
Proposed rule: ONGOING gathering and entering STN into filer's internal database Information collection
Proposed rule: ONE-TIME gathering and entering STN into filer's internal database Information collection
FDA Form 5054: New Inquiry Form/CDER Import Compliance Branch Form and Instruction
FDA Form 5054: New Inquiry Form/CDER Import Compliance Branch Form and Instruction
Application for authorization to relabel and recondition Form and Instruction
Application for authorization to relabel and recondition Form and Instruction
Application for authorization to relabel and recondition Form and Instruction
PLAIR Submissions Information collection
ITACS; creation of new account Information collection
WEF participants Information collection
Entry filers (applies to unique lines only) Other-list of examples

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202408-0910-004 Revision of a currently approved collection 2024-08-19
202303-0910-006 Revision of a currently approved collection 2023-06-29 Approved with change
202107-0910-014 Revision of a currently approved collection 2021-07-15 Comment filed on proposed rule and continue
202011-0910-007 No material or nonsubstantive change to a currently approved collection 2020-11-19 Approved without change
202003-0910-011 Revision of a currently approved collection 2020-04-27 Approved without change
201706-0910-007 Revision of a currently approved collection 2017-06-15 Approved without change
201611-0910-008 Revision of a currently approved collection 2016-11-23 Preapproved
201607-0910-003 Revision of a currently approved collection 2016-07-13 Comment filed on proposed rule and continue
201601-0910-008 Revision of a currently approved collection 2016-05-12 Approved without change
201406-0910-004 Extension without change of a currently approved collection 2014-06-09 Approved without change
201403-0910-004 Extension without change of a currently approved collection 2014-03-19 Improperly submitted and continue
201102-0910-009 Revision of a currently approved collection 2011-02-23 Approved with change
200905-0910-006 Extension without change of a currently approved collection 2009-05-28 Approved without change
200511-0910-003 Extension without change of a currently approved collection 2005-11-14 Approved without change
200310-0910-005 Extension without change of a currently approved collection 2003-10-20 Approved without change
200006-0910-004 Extension without change of a currently approved collection 2000-06-29 Approved without change
199709-0910-003 Extension without change of a currently approved collection 1997-09-18 Approved without change
199407-0910-001 Revision of a currently approved collection 1994-07-06 Approved without change
199101-0910-002 Revision of a currently approved collection 1991-01-31 Approved without change
198906-0910-013 No material or nonsubstantive change to a currently approved collection 1989-06-16 Approved with change
198903-0910-006 Revision of a currently approved collection 1989-03-03 Approved without change
198602-0910-003 Reinstatement with change of a previously approved collection 1986-02-28 Approved without change
198301-0910-005 Revision of a currently approved collection 1983-01-24 Approved without change
197803-0910-004 Reinstatement with change of a previously approved collection 1978-03-13 Approved without change

OMB Details

Importers submission of data elements

Federal Enterprise Architecture: Health - Consumer Health and Safety