Guidance for Industry: Fast Track Drug Development Programs - Designation, Development & Application Review

Guidance for Industry: Fast Track Drug Development Programs - Designation, Development & Application Review

OMB: 0910-0389

IC ID: 6039

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Guidance for Industry: Fast Track Drug Development Programs - Designation, Development & Application Review
 
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Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability


    

45 0
   
Private Sector Businesses or other for-profits
 
   10 %

  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 86 0 0 -28 0 114
Annual IC Time Burden (Hours) 6,480 0 0 -2,520 0 9,000
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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