Recordkeeping associated with 21 CFR parts 50 and 56

Protection of Human Subjects and Institutional Review Boards

OMB: 0910-0130

IC ID: 5743

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Recordkeeping associated with 21 CFR parts 50 and 56
 
No Modified
 
Mandatory
 
21 CFR 50 21 CFR 56

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, Not-for-profit institutions
 
   100 %

  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 137,616 0 0 0 0 137,616
Annual IC Time Burden (Hours) 1,522,104 0 0 -104,655 0 1,626,759
Annual IC Cost Burden (Dollars) 0 0 0 -58,400,115 0 58,400,115

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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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