OMB control number
Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Proposed Rule
OMB 0910-0757 · HHS/FDA.
OMB 0910-0757
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 SUPPORTING STATEMENT 11-26-13.doc | Supporting Statement A |
 Proposed Verification Requirements for NDA and BLA Holders Under 314.70(c)(8) and 601.12(f)(2)(iii) |
Information collection |
| Proposed Requirements for ANDA Holders under 314.70(c)(8) and 314.70(c)(8)(ii) |
Information collection |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 201312-0910-001 | New collection (Request for a new OMB Control Number) | 2013-12-06 | Comment filed on proposed rule |