OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

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 0920-1366 · HHS/CDC.

OMB 0920-1366

Latest Forms, Documents, and Supporting Material

Document Name
IRB Authorization Agreement (COMPLETION) Form and Instruction
IRB Authorization Agreement (REVIEW) Form and Instruction
Emergency Review Request Memo - Monkeypox-Central IRB for TPOXX IND-Rev-03AUG2022.docx Supplementary Document
Supporting Statement A_MPX_IRB Emergency ICR_03AUG2022 FINAL.docx Supporting Statement A
6402_EA IND_TPOXX_Attachment-1-Informed-Consent.pdf Supplementary Document
6402_EA IND_TPOXX_Protocol.pdf Supplementary Document
6402-EA IND_TPOXX_CDC-IRB-Approval-Continuation.pdf Supplementary Document
Supporting Statement B_MPX_IRB Emergency ICR 28JUL2022.docx Supporting Statement B
IRB Authorization Agreement (COMPLETION) Form and Instruction
IRB Authorization Agreement (REVIEW) Form and Instruction

All Historical Document Collections

202207-0920-012

Approved without change

New collection (Request for a new OMB Control Number)

2022-08-03