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 Name	Status
Form 0920 CDC IRB Authorization Agreement (COMPLETE) Form and Instruction	New
Form 0920 IRB Authorization Agreement (REVIEW) Form and Instruction	New
Supporting Statement B - TPOXX.docx Supporting Statement B	2023-02-27
Emergency Review Request Memo - Monkeypox-Central IRB for TPOXX IND-Rev-03AUG2022 (2).docx Supplementary Document	2023-02-27
EA IND_TPOXX_Informed-Consent.pdf Supplementary Document	2023-02-27
6402_EA IND_TPOXX_Protocol (1).pdf Supplementary Document	2023-02-27
6402-EA IND_TPOXX_CDC-IRB-Approval-Continuation (1).pdf Supplementary Document	2023-02-27
Supporting Statement A - TPOXX.docx Supporting Statement A	2023-02-27
Authorizing Legislations.docx Supplementary Document	2023-02-27

IC Document Collections

IC ID	Document Title	Status
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