OMB control number
Labeling Requirements for Human Prescription Drug and Biological Products
OMB 0910-0572 ยท HHS/FDA.
OMB 0910-0572
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 2028-07-31 and can be found here.
Latest Forms, Documents, and Supporting Material
Document Name |
|---|
Supporting Statement A |
Justification for No Material/Nonsubstantive Change |
0572 Rx Labeling Requirements SSA 2025 REV.docx
Drug labeling requirements; prescription drugs All Historical Document Collections
| Revision of a currently approved collection | 2025-01-31 | ||
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Approved without change |
No material or nonsubstantive change to a currently approved collection | 2022-02-11 | |
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Approved without change |
Revision of a currently approved collection | 2021-12-23 | |
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Approved without change |
Extension without change of a currently approved collection | 2018-12-06 | |
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Approved without change |
Extension without change of a currently approved collection | 2015-06-23 | |
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Approved with change |
Revision of a currently approved collection | 2012-04-04 | |
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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 |
OMB Details
Drug labeling requirements; prescription drugs
Federal Enterprise Architecture: Health - Consumer Health and Safety