314.94(a)(7)

Requirements for Submission of In Vivo Bioequivalence Data

OMB: 0910-0630

IC ID: 186746

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314.94(A)(7) CDER
 
No Modified
 
Mandatory
 
21 CFR 314.94(a)(7)

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

Health Public Health Monitoring

 

84 0
   
Private Sector Businesses or other for-profits
 
   75 %

  Requested 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 84 0 0 12 0 72
Annual IC Time Burden (Hours) 6,048 0 0 2,376 0 3,672
Annual IC Cost Burden (Dollars) 0 0 -243,648 0 0 243,648

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