The information collection supports agency regulations at 21 CFR 201.66. Respondents to the collection of information are producers or manufacturers of drug products requiring over-the-counter (OTC) labeling subject to these regulatory requirements.
The latest form for General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions expires 2022-12-31 and can be found here.
Document Name |
---|
Form |
Supporting Statement A |
Approved without change |
Revision of a currently approved collection | 2022-12-19 | |
Approved without change |
No material or nonsubstantive change to a currently approved collection | 2021-12-17 | |
Approved without change |
No material or nonsubstantive change to a currently approved collection | 2020-12-01 | |
Approved without change |
Extension without change of a currently approved collection | 2019-12-05 | |
Approved without change |
Extension without change of a currently approved collection | 2016-12-22 | |
Approved without change |
Extension without change of a currently approved collection | 2013-12-20 | |
Approved with change |
Reinstatement with change of a previously approved collection | 2010-08-26 | |
Approved without change |
Extension without change of a currently approved collection | 2005-04-22 | |
Approved without change |
Extension without change of a currently approved collection | 2002-03-14 | |
Approved without change |
Revision of a currently approved collection | 1999-03-25 |
Federal Enterprise Architecture: Health - Consumer Health and Safety