Information Collection Request
Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Medical Gases and Active Pharmaceutical Ingredients)
ICR 202304-0910-008 · OMB 0910-0139 · Received in OIRA
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0139 can be found here:
Forms and Documents
| Document | Type | Status | Availability |
|---|
IC Document Collections
| IC ID | Collection | Type | Status | Form |
|---|---|---|---|---|
| 37604 |  Recordkeeping CGMP for Finished Pharmaceuticals |
Unchanged | ||
| 259864 | Pharmaceutical Voluntary Consensus Standard Recognition |
Other-Agency Guidance | New | |
| 248022 | Recordkeeping CGMP APIs |
Unchanged | ||
| 215453 | Recordkeeping CGMP for Medical Gases, Containers, and Closures |
Other-Agency Guidance | Unchanged |
ICR Details
| Status | Received in OIRA |
|---|---|
| Agency/Subagency | HHS/FDA |
| OMB Control No | 0910-0139 |
| Type of Information Collection | Revision of a currently approved collection |
| Previous ICR Reference No | 202105-0910-004 |
| Agency Tracking No | CDER |
| Date Submitted to OIRA | 1969-12-31 |
| Requested Expiration Date | 1969-12-31 |