Information Collection Request
Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
ICR 202210-0910-015 · OMB 0910-0800 · Received in OIRA
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0800 can be found here:
Forms and Documents
| Document | Type | Status | Availability |
|---|---|---|---|
 0800 503A 503B SSA 2022 REV.docx |
Supporting Statement A | Uploaded 2022-10-25 | Repair queued |
IC Document Collections
| IC ID | Collection | Type | Status | Form |
|---|---|---|---|---|
| 256583 |  Outsourcing Facilities: Registration and reporting of drugs under 503B(b) |
Other-Statutory Authority | New | |
| 241793 | 503A; Disclosure |
Other-Memorandum of Understanding | Unchanged | |
| 241792 | 503A; Recordkeeping |
Other-Memorandum of Understanding | Unchanged | |
| 241791 | 503A; Reporting |
Other-Memorandum of Understanding | Unchanged | |
| 217572 | 503B Recordkeeping; AERs |
Other-Guidance | Unchanged | |
| 217571 | 503B Reporting: AERs |
Other-Guidance | Unchanged |
ICR Details
| Status | Received in OIRA |
|---|---|
| Agency/Subagency | HHS/FDA |
| OMB Control No | 0910-0800 |
| Type of Information Collection | Revision of a currently approved collection |
| Previous ICR Reference No | 202005-0910-004 |
| Agency Tracking No | CDER |
| Date Submitted to OIRA | 1969-12-31 |
| Requested Expiration Date | 1969-12-31 |