Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds

Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds

OMB: 0910-0445

IC ID: 6129

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Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds
 
No Migrated
 
Voluntary
 

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


    

107 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 164 0 -18 0 0 182
Annual IC Time Burden (Hours) 46,576 0 -5,112 0 0 51,688
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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