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FINAL RULE: Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigation

IC 263686 under ICR 202311-0910-012 · OMB 0910-0130.

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FINAL RULE: Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigation
 
No New
 
Mandatory
 
21 CFR 50.22 and 56.115

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

Health Consumer Health and Safety

 

551 0
   
Private Sector Businesses or other for-profits
 
   0 %

  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 1,102 0 0 1,102 0 0
Annual IC Time Burden (Hours) 1,102 0 0 1,102 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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