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Written statement about minimal risk research when documentation of informed consent is waived 56.109(d)

IC 224395 under ICR 201610-0910-003 · OMB 0910-0755.

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Written statement about minimal risk research when documentation of informed consent is waived 56.109(d)
 
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

 

2,520 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 5,040 0 0 5,040 0 0
Annual IC Time Burden (Hours) 2,520 0 0 2,520 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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