Information Collection Request
[OS] Centralized Institutional Review for the CDC Expanded Access Investigational New Device (EA-IND) for "Use of Tecovirimat (TPOXX®) for Treatment of Human Non-Variola Orthopoxvirus Infections.
ICR 202302-0920-004 · OMB 0920-1404 · Received in OIRA
Forms and Documents
| Document | Type | Status | Availability |
|---|---|---|---|
 Form 0920 CDC IRB Authorization Agreement (COMPLETE) |
Form and Instruction | New | Repair queued |
| Form 0920 IRB Authorization Agreement (REVIEW) |
Form and Instruction | New | Repair queued |
 Supporting Statement B - TPOXX.docx |
Supporting Statement B | Uploaded 2023-02-27 | Repair queued |
| Emergency Review Request Memo - Monkeypox-Central IRB for TPOXX IND-Rev-03AUG2022 (2).docx |
Supplementary Document | Uploaded 2023-02-27 | Repair queued |
 EA IND_TPOXX_Informed-Consent.pdf |
Supplementary Document | Uploaded 2023-02-27 | Repair queued |
| 6402_EA IND_TPOXX_Protocol (1).pdf |
Supplementary Document | Uploaded 2023-02-27 | Repair queued |
| 6402-EA IND_TPOXX_CDC-IRB-Approval-Continuation (1).pdf |
Supplementary Document | Uploaded 2023-02-27 | Available |
| Supporting Statement A - TPOXX.docx |
Supporting Statement A | Uploaded 2023-02-27 | Repair queued |
| Authorizing Legislations.docx |
Supplementary Document | Uploaded 2023-02-27 | Repair queued |
IC Document Collections
| IC ID | Collection | Type | Status | Form |
|---|---|---|---|---|
| 258781 |  CDC IRB Authorization Agreement (COMPLETE) |
Form and Instruction | New | |
| 258780 | IRB Authorization Agreement (REVIEW) |
Form and Instruction | New |
ICR Details
| Status | Received in OIRA |
|---|---|
| Agency/Subagency | HHS/CDC |
| OMB Control No | 0920-1404 |
| Type of Information Collection | New collection (Request for a new OMB Control Number) |
| Agency Tracking No | 0920-22HY |
| Date Submitted to OIRA | 1969-12-31 |
| Requested Expiration Date | 1969-12-31 |