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CDER: 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications

IC 189331 under ICR 202509-0910-004 · OMB 0910-0014.

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CDER: 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications
 
No Modified
 
Mandatory
 
21 CFR 312.50-312.70 21 CFR 320.31

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

Health Consumer Health and Safety

 

4,657 0
   
Private Sector Businesses or other for-profits
 
   99 %

  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 25,081 0 0 0 0 25,081
Annual IC Time Burden (Hours) 2,000,704 0 0 0 0 2,000,704
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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