Information Collection Request
Authorization of Medical Products for Use Emergencies
ICR 202405-0910-004 · OMB 0910-0595 · Active
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0595 can be found here:
Forms and Documents
| Document | Type | Status | Availability |
|---|---|---|---|
 EUA Patient Caregiver and Parent Fact Sheet CDER Template.pdf |
Supplementary Document | Uploaded 2024-05-29 | Repair queued |
| EUA Patient Caregiver and Parent Fact Sheet CDER Template.pdf |
Supplementary Document | Uploaded 2024-05-29 | Repair queued |
| EUA Healthcare Provider Fact Sheet Template.pdf |
Supplementary Document | Uploaded 2024-05-29 | Repair queued |
| EUA Healthcare Provider Fact Sheet Template.pdf |
Supplementary Document | Uploaded 2024-05-29 | Repair queued |
 0595 83-C CDER 5-29-2024.docx |
Justification for No Material/Nonsubstantive Change | Uploaded 2024-05-29 | Available |
| 0595 83-C CDER 5-29-2024.docx |
Justification for No Material/Nonsubstantive Change | Uploaded 2024-05-29 | Repair queued |
| 0595 EUA 83C for MPOX templates DEC 2022.docx |
Justification for No Material/Nonsubstantive Change | Uploaded 2022-12-29 | Repair queued |
| 0595 EUA 83C for MPOX templates DEC 2022.docx |
Justification for No Material/Nonsubstantive Change | Uploaded 2022-12-29 | Missing upstream |
| 0595 EUA change for CDRH templates SEPT 2022.docx |
Justification for No Material/Nonsubstantive Change | Uploaded 2022-09-25 | Repair queued |
| 0595 EUA change for CDRH templates SEPT 2022.docx |
Justification for No Material/Nonsubstantive Change | Uploaded 2022-09-25 | Missing upstream |
| 0595 EUAs SSA Ext 2022.docx |
Supporting Statement A | Uploaded 2022-07-22 | Available |
| 0595 EUAs SSA Ext 2022.docx |
Supporting Statement A | Uploaded 2022-07-22 | Repair queued |
IC Document Collections
| IC ID | Collection | Type | Status | Form |
|---|---|---|---|---|
| 43607 |  Requests for substantive amendment to an existing EUA |
Other-Guidance | Unchanged | |
| 254792 | 3rd PARTY DISCLOSURE: Dissemination of required information by EUA holder or authorized stakeholder |
Other-Statutory Authority | Unchanged | |
| 254791 | RECORDKEEPING: EUA holders |
Other-Statutory Authority | Unchanged | |
| 236302 | RECORDKEEPING: Public Health Authorities |
Other-Guidance | Unchanged | |
| 191144 | Public Health Authorities; request for extension of expiration date |
Other-Guidance | Unchanged | |
| 191143 | Public Health Authorities; request for EUA dispensing order |
Other-Guidance | Unchanged | |
| 191142 | Public Health Authorities; unapproved EUA product |
Other-Guidance | Unchanged | |
| 191141 | Submitting information required under conditions of aurhorization |
Other-Guidance | Unchanged | |
| 191140 | Pre-EUA submissions or amendments |
Other-Guidance | Unchanged |
ICR Details
| Status | Active |
|---|---|
| Agency/Subagency | HHS/FDA |
| OMB Control No | 0910-0595 |
| Type of Information Collection | No material or nonsubstantive change to a currently approved collection |
| Previous ICR Reference No | 202212-0910-015 |
| Agency Tracking No | CROSS CENTER |
| Date Submitted to OIRA | 2024-05-30 |
| Requested Expiration Date | 1969-12-31 |