314.81(b)(1) [3331]

FDA Approval to Market a New Drug

OMB: 0910-0001

IC ID: 184597

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314.81(b)(1) [3331] CDER
 
No Unchanged
 
Mandatory
 
21 CFR 314.81(b)(1)

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

Health Public Health Monitoring

 

260 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 4,241 0 0 0 0 4,241
Annual IC Time Burden (Hours) 33,928 0 0 0 0 33,928
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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