.117(c)(2) [Pre-2018 and 2018 Requirements] – Written statement about the research when informed consent documentation is waived

Protection of Human Subjects: Common Rule (56 FR 28001)

OMB: 0990-0260

IC ID: 246949

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.117(c)(2) [Pre-2018 and 2018 Requirements] – Written statement about the research when informed consent documentation is waived
 
No Modified
 
Mandatory
 
45 CFR 46

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, Not-for-profit institutions
 
   25 %

  Requested 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 30,000 0 -30,000 0 0 60,000
Annual IC Time Burden (Hours) 15,000 0 -45,000 0 0 60,000
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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