IRB Authorization Agreement (REVIEW)

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

IC ID: 255039

Documents and Forms
Document Name
Document Type
Form and Instruction
Form and Instruction
Information Collection (IC) Details

View Information Collection (IC)

IRB Authorization Agreement (REVIEW)
No New
Required to Obtain or Retain Benefits

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction NA IRB Authorization Agreement CDC_IRB_Authorization_Agreement_FINAL.pdf NA Yes Yes Fillable Fileable

Health Illness Prevention


5,000 0
Private Sector Businesses or other for-profits, Not-for-profit institutions
   100 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 5,000 0 5,000 0 0 0
Annual IC Time Burden (Hours) 5,000 0 5,000 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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