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 is listed under ICR 202408-0910-009.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 0572 Rx Labeling Requirements SSA 2025 REV.docx | Supporting Statement A |
| 0572_Change Request.docx | Justification for No Material/Nonsubstantive Change |
 Drug labeling requirements; prescription drugs |
Information collection |
| Safety Labeling Changes; Posting Approved Labeling on Application Holder's website |
Instruction |
| Safety Labeling Changes (Section 505(o)(4) of the FD&C Act)-- Rebuttal Statemen |
Instruction |
| Exemption Request from Bar Code Label Requirements |
Information collection |
| Supporting cardiovascular claims |
Instruction |
| Strategic National Stockpile (SNS) Labels |
Information collection |
| Labeling requirements; medical gas containers |
Information collection |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 202408-0910-009 | Revision of a currently approved collection | 2025-01-31 | ||
| 202202-0910-001 | No material or nonsubstantive change to a currently approved collection | 2022-02-11 | Approved without change | |
| 202112-0910-008 | Revision of a currently approved collection | 2021-12-23 | Approved without change | |
| 201810-0910-004 | Extension without change of a currently approved collection | 2018-12-06 | Approved without change | |
| 201506-0910-012 | Extension without change of a currently approved collection | 2015-06-23 | Approved without change | |
| 201204-0910-001 | Revision of a currently approved collection | 2012-04-04 | Approved with change | |
| 200901-0910-004 | Extension without change of a currently approved collection | 2009-01-16 | Approved with change | |
| 200509-0910-002 | New collection (Request for a new OMB Control Number) | 2005-09-15 | Approved without change |
OMB Details
Drug labeling requirements; prescription drugs
Federal Enterprise Architecture: Health - Consumer Health and Safety