This information collection supports FDA regulations governing recalls. The information collection provisions apply to all regulated products (i.e., food, including animal feed; drugs, including animal drugs; medical devices, including in vitro diagnostic products; cosmetics; biological products intended for human use; and tobacco). Respondents to the collection are those who introduce FDA-regulated products into interstate commerce or who are otherwise subject to the applicable regulations.
The latest form for FDA Recall Regulations expires 2021-04-30 and can be found here.
Approved without change |
Extension without change of a currently approved collection | 2021-04-14 | |
Approved with change |
Revision of a currently approved collection | 2018-03-08 | |
Approved without change |
Extension without change of a currently approved collection | 2015-02-27 | |
Approved with change |
Extension without change of a currently approved collection | 2011-11-28 | |
Approved without change |
Extension without change of a currently approved collection | 2008-10-15 | |
Approved with change |
Revision of a currently approved collection | 2005-08-09 | |
Approved without change |
Extension without change of a currently approved collection | 2001-09-06 | |
Approved without change |
Extension without change of a currently approved collection | 1998-09-01 | |
Approved without change |
Extension without change of a currently approved collection | 1995-05-16 | |
Approved without change |
Reinstatement with change of a previously approved collection | 1992-04-10 | |
Approved without change |
New collection (Request for a new OMB Control Number) | 1988-08-08 |
Federal Enterprise Architecture: Health - Public Health Monitoring