IRB Written Notification to Approve or Disapprove Research, 56.109(e); Continuing Review, 56.109(f); Elements of Informed Consent (IC), 50.25; Documentation of IC, 50.27

Protection of Human Subjects: Informed Consent; Institutional Review Boards

OMB: 0910-0755

IC ID: 207941

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Document Type
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IRB Written Notification to Approve or Disapprove Research, 56.109(e); Continuing Review, 56.109(f); Elements of Informed Consent (IC), 50.25; Documentation of IC, 50.27
 
No New
 
Required to Obtain or Retain Benefits
 
21 CFR 56 21 CFR 50

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Consumer Health and Safety

 

6,000 0
   
Private Sector Businesses or other for-profits
 
   60 %

  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 240,000 0 240,000 0 0 0
Annual IC Time Burden (Hours) 240,000 0 240,000 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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