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

IC 6038 under ICR 199904-0910-002 · OMB 0910-0389.

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Guidance for Industry: Fast Track Drug Development Programs Designation, Development, and Application Review
 
No Migrated
 
Required to Obtain or Retain Benefits
 

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


    

60 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 114 0 0 0 0 114
Annual IC Time Burden (Hours) 9,000 0 0 0 0 9,000
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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