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New NDAs/ANDAs/BLAs/Efficacy Supplements Submitted on or After Effective Date, Including Amendments to Applications Pending on Effective Date

IC 185245 under ICR 201802-0910-006 · OMB 0910-0624.

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New NDAs/ANDAs/BLAs/Efficacy Supplements Submitted on or After Effective Date, Including Amendments to Applications Pending on Effective Date CDER
 
No Modified
 
Mandatory
 
21 CFR 314.50 21 CFR 314.60 21 CFR 314.70(b) 21 CFR 601.2 21 CFR 601.12(f)(1)

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

Health Public Health Monitoring

 

390 0
   
Private Sector Businesses or other for-profits
 
   100 %

  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 3,900 0 0 0 0 3,900
Annual IC Time Burden (Hours) 156,000 0 0 0 0 156,000
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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