CDER: IND Required Recordkeeping

Investigational New Drug Regulations

OMB: 0910-0014

IC ID: 189340

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CDER: IND Required Recordkeeping
 
No Modified
 
Mandatory
 
21 CFR 312

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

Health Consumer Health and Safety

 

58,116 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 76,576 0 0 76,073 0 503
Annual IC Time Burden (Hours) 4,137,622 0 0 4,136,616 0 1,006
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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