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.

Documents and Forms

Document Name Document Type
IRB Authorization Agreement (REVIEW) Form and Instruction
IRB Authorization Agreement CDC_IRB_Authorization_Agreement_FINAL.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	IRB Authorization Agreement (REVIEW)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

Information Collection Instruments:

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

Line of Business: Health

Subfunction: Illness Prevention

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 5,000	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits, Not-for-profit institutions

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	5,000	5,000
Annual IC Time Burden (Hours)	5,000	5,000
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.