Information Collection Request
General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions
ICR 202212-0910-002 · OMB 0910-0340 · Received in OIRA
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0340 can be found here:
Forms and Documents
| Document | Type | Status | Availability |
|---|---|---|---|
 Form FDA 5009 OTC User Fee Program |
Form | Unchanged | Repair queued |
 0340 OTC Drug Labeling SSA 2022 REV.docx |
Supporting Statement A | Uploaded 2022-12-19 | Repair queued |
IC Document Collections
| IC ID | Collection | Type | Status | Form |
|---|---|---|---|---|
| 5943 |  Format & content for new OTC drug products (included FDA recommendations on statutory requirements) |
Other-Statutory Authority | Modified | |
| 250630 | Domestic Address or Phone Number Labeling Requirement (21 U.S.C. 352(x)) and Recommendation to Clarify its Purpose |
Other-Guidance | Removed | |
| 244708 | OTC User Fee Program |
Form | Unchanged | |
| 209796 | Format and Content Requirements; exemptions and deferrals |
Unchanged |
ICR Details
| Status | Received in OIRA |
|---|---|
| Agency/Subagency | HHS/FDA |
| OMB Control No | 0910-0340 |
| Type of Information Collection | Revision of a currently approved collection |
| Previous ICR Reference No | 202112-0910-002 |
| Agency Tracking No | CDER |
| Date Submitted to OIRA | 1969-12-31 |
| Requested Expiration Date | 1969-12-31 |