PART 314: Subparts E through I

Applications for FDA Approval to Market a New Drug

OMB: 0910-0001

IC ID: 184605

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PART 314: Subparts E through I CDER
 
No Modified
 
Mandatory
 
21 CFR 314.200-314.650

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

Health Consumer Health and Safety

 

378 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 1,253 0 0 215 0 1,038
Annual IC Time Burden (Hours) 89,708 0 0 26,390 0 63,318
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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