OMB control number
Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
OMB 0910-0672 · HHS/FDA.
OMB 0910-0672
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 0672 Supporting Statement A 2016.pdf | Supporting Statement A |
 312.32(c)(1)(iv); IND Safety Reports |
Information collection |
| 312.32(c)(1)(ii) and (c)(1)(iii); IND Safety Reports |
Information collection |
| 320.31(d); Bioavailability and Bioequivalence Safety Reports |
Information collection |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 201610-0910-008 | Extension without change of a currently approved collection | 2016-10-24 | Approved without change | |
| 201311-0910-005 | Extension without change of a currently approved collection | 2013-11-13 | Approved without change | |
| 201009-0910-004 | New collection (Request for a new OMB Control Number) | 2010-09-10 | Approved without change |