Imports and Electronic Import Entries

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 2023-06-30 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form FDA 5054 FDA Form 5054: New Inquiry Form/CDER Import Compliance Branch Form and Instruction
Form FDA 766 Application for authorization to relabel and recondition Form and Instruction
ACE NPRM SSA FINAL.docx Supporting Statement A
Importers submission of data elements
Proposed rule: ONGOING gathering and entering STN into filer's internal database
Proposed rule: ONE-TIME gathering and entering STN into filer's internal database
FDA Form 5054: New Inquiry Form/CDER Import Compliance Branch Form and Instruction
Application for authorization to relabel and recondition Form and Instruction
PLAIR Submissions
ITACS; creation of new account
WEF participants
Entry filers (applies to unique lines only) Other-list of examples

All Historical Document Collections

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

OMB Details

Importers submission of data elements

Federal Enterprise Architecture: Health - Consumer Health and Safety