Investigational New Drug Regulations

Investigational New Drug Regulations

OMB: 0910-0014

IC ID: 5669

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Investigational New Drug Regulations
 
No Modified
 
Mandatory
 
21 CFR 314.50

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

Health Consumer Health and Safety

 

28 0
   
Private Sector Businesses or other for-profits
 
   0 %

  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 44 0 0 -1,277,473 0 1,277,517
Annual IC Time Burden (Hours) 1,056 0 0 -71,368,469 0 71,369,525
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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