OMB control number
Controlled Correspondence Related to Generic Drug Development
OMB 0910-0797 · HHS/FDA.
OMB 0910-0797
This Information Collection Request (ICR) supports agency guidance. The guidance document provides recommendations for generic drug manufacturers and related industry who wish to submit a controlled correspondence related to generic drug development to the Food and Drug Administration (FDA). The guidance document supports FDA's commitments under the Generic Drug User Fee Amendments.
The latest form for Controlled Correspondence Related to Generic Drug Development expires 2023-06-30 and is listed under ICR 202002-0910-011.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 Controlled Correspondence Related to Generic Drug Development |
Information collection |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 202002-0910-011 | Revision of a currently approved collection | 2020-04-28 | Approved with change | |
| 201808-0910-011 | Extension without change of a currently approved collection | 2018-09-25 | Approved without change | |
| 201808-0910-003 | Extension without change of a currently approved collection | 2018-08-21 | Improperly submitted and continue | |
| 201507-0910-003 | New collection (Request for a new OMB Control Number) | 2015-07-09 | Approved without change |