Information Collection Request
Prescription Drug Product Labeling; Medication Guide Requirements
ICR 202210-0910-010 · OMB 0910-0393 · Received in OIRA
Forms and Documents
| Document | Type | Status | Availability |
|---|---|---|---|
 0393 Patient Medication Guides SSA 2022 EXT.docx |
Supporting Statement A | Uploaded 2022-10-31 | Repair queued |
 PDUFA User Fee Schedule 87 FR 61063 Oct 7 2022.pdf |
Supplementary Document | Uploaded 2022-10-24 | Repair queued |
IC Document Collections
| IC ID | Collection | Type | Status | Form |
|---|---|---|---|---|
| 6050 |  Content and Format of a Medication Guide |
Modified | ||
| 205325 | Distributing and Dispensing a Medication Guide to Patients |
Modified | ||
| 188594 | Distributor Provides Medication Guide to Dispenser |
Unchanged | ||
| 187331 | Exemptions and Deferrals |
Unchanged | ||
| 187330 | Supplements and Other Changes to an Approved Application |
Removed |
ICR Details
| Status | Received in OIRA |
|---|---|
| Agency/Subagency | HHS/FDA |
| OMB Control No | 0910-0393 |
| Type of Information Collection | Extension without change of a currently approved collection |
| Previous ICR Reference No | 201908-0910-014 |
| Agency Tracking No | CDER |
| Date Submitted to OIRA | 1969-12-31 |
| Requested Expiration Date | 1969-12-31 |