OMB control number
[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.
OMB 0920-1404 · HHS/CDC.
OMB 0920-1404
This information request is essential to CDC’s response to the Monkeypox outbreak consistent with requirements set forth by the Food and Drug Administration (FDA). CDC, in partnership with FDA, has made it easier for healthcare providers to provide tecovirimat (TPOXX) treatment to patients with monkeypox under the expanded access investigational new drug (EA-IND). CDC holds an intermediate-size patient population EA-IND (IND 116,039/Protocol 6402) to allow access to and use of TPOXX for treatment of orthopoxvirus infections, including monkeypox. The EA-IND provides an umbrella regulatory coverage so that clinicians and facilities do not need to request and obtain their own INDs.
The latest form for [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. expires 2026-05-31 and is listed under ICR 202302-0920-004.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 Form 0920 CDC IRB Authorization Agreement (COMPLETE) | Form and Instruction |
| Form 0920 IRB Authorization Agreement (REVIEW) | Form and Instruction |
 Supporting Statement B - TPOXX.docx | Supporting Statement B |
 Emergency Review Request Memo - Monkeypox-Central IRB for TPOXX IND-Rev-03AUG2022 (2).docx | Supplementary Document |
| EA IND_TPOXX_Informed-Consent.pdf | Supplementary Document |
| 6402_EA IND_TPOXX_Protocol (1).pdf | Supplementary Document |
| 6402-EA IND_TPOXX_CDC-IRB-Approval-Continuation (1).pdf | Supplementary Document |
| Supporting Statement A - TPOXX.docx | Supporting Statement A |
| Authorizing Legislations.docx | Supplementary Document |
 CDC IRB Authorization Agreement (COMPLETE) |
Form and Instruction |
| IRB Authorization Agreement (REVIEW) |
Form and Instruction |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 202302-0920-004 | New collection (Request for a new OMB Control Number) | 2023-02-28 | Approved without change |
OMB Details
IRB Authorization Agreement (REVIEW)
Federal Enterprise Architecture: Health - Public Health Monitoring
| Form | Name | Electronic access | Type |
|---|---|---|---|
| Form 0920 | CDC IRB Authorization Agreement (COMPLETE) | Fillable Fileable | Form and instruction |
Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.