CBER: Part 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical stuides

Investigational New Drug Regulations

OMB: 0910-0014

IC ID: 189323

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CBER: Part 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical stuides
 
No Unchanged
 
Mandatory
 
21 CFR 312.110-312.145

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

Health Consumer Health and Safety

 

655 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 3,254 0 0 0 0 3,254
Annual IC Time Burden (Hours) 93,494 0 0 0 0 93,494
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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