The information collection supports agency regulations governing the content and format of labeling for human prescription drug and biological products. Respondents to the collection are sponsors of new drug and biological product applications.
The latest form for Labeling Requirements for Human Prescription Drug and Biological Products expires 2022-01-31 and can be found here.
Document Name |
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Justification for No Material/Nonsubstantive Change |
Supporting Statement A |
Approved without change |
No material or nonsubstantive change to a currently approved collection | 2022-02-11 | |
Approved without change |
Revision of a currently approved collection | 2021-12-23 | |
Approved without change |
Extension without change of a currently approved collection | 2018-12-06 | |
Approved without change |
Extension without change of a currently approved collection | 2015-06-23 | |
Approved with change |
Revision of a currently approved collection | 2012-04-04 | |
Approved with change |
Extension without change of a currently approved collection | 2009-01-16 | |
Approved without change |
New collection (Request for a new OMB Control Number) | 2005-09-15 |