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.46.116(a) and (b) (Pre-2018 Requirements)/ .46.116 (b), (c) and (d) [2018 Requirements] – Elements of informed consent and broad consent

IC 246944 under ICR 202407-0990-001 · OMB 0990-0260.

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.46.116(a) and (b) (Pre-2018 Requirements)/ .46.116 (b), (c) and (d) [2018 Requirements] – Elements of informed consent and broad consent
 
No Unchanged
 
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 %

  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 150,000 0 0 0 0 150,000
Annual IC Time Burden (Hours) 75,000 0 0 0 0 75,000
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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