Establishing and Maintaining Lists of U.S.Product Manufacturers/Processors With Interest in Exporting CFSAN-Regulated Products

OMB 0910-0509

This ICR supports agency programs by which respondents who satisfy specified criteria may voluntarily be included on established lists of those wanting to export FDA-regulated products to foreign countries. Respondents who wish to be included on the list will voluntarily send information to FDA, including the name and address of the firm and the manufacturing plant, a list of products presently shipped and expected to be shipped in the future, and identities of agencies that inspect the plant, plant number and copy of last inspection.

The latest form for Establishing and Maintaining Lists of U.S.Product Manufacturers/Processors With Interest in Exporting CFSAN-Regulated Products expires 2022-07-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0509 CFSAN Mfr Export List SSA 2022 EXT.docx Supporting Statement A
Occasional Update of Information
Biennial Update of Infomation
New Written Request to be Placed on the List Other-E-form Screenshots
Third-Party Certification Information (including updates)

All Historical Document Collections

202206-0910-004 Approved without change	Extension without change of a currently approved collection	2022-06-29
201907-0910-016 Approved without change	Revision of a currently approved collection	2019-07-18
201806-0910-001 Approved without change	No material or nonsubstantive change to a currently approved collection	2018-06-11
201708-0910-015 Approved without change	Reinstatement with change of a previously approved collection	2017-10-04
201605-0910-016 Approved with change	No material or nonsubstantive change to a currently approved collection	2016-05-26
201407-0910-006 Approved with change	Revision of a currently approved collection	2014-07-08
201405-0910-024 Improperly submitted and continue	Extension without change of a currently approved collection	2014-05-29
201310-0910-004 Approved without change	Revision of a currently approved collection	2013-10-28
201303-0910-005 Approved without change	Extension without change of a currently approved collection	2013-03-25
201001-0910-014 Approved with change	Extension without change of a currently approved collection	2010-01-29
200612-0910-006 Approved without change	Extension without change of a currently approved collection	2006-12-18
200503-0910-007 Approved without change	No material or nonsubstantive change to a currently approved collection	2005-03-10
200310-0910-009 Approved without change	Extension without change of a currently approved collection	2003-10-27
200304-0910-004 Approved with change	New collection (Request for a new OMB Control Number)	2003-04-11

OMB Details

New Written Request to be Placed on the List

Federal Enterprise Architecture: Health - Consumer Health and Safety