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

Documents and Forms
Document Name
Document Type
Instruction
Information Collection (IC) Details

View Information Collection (IC)

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

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Instruction completeresponseguidance.pdf Yes Yes Printable Only

Health Public Health Monitoring

 

127 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 180 0 16 0 0 164
Annual IC Time Burden (Hours) 51,120 0 4,544 0 0 46,576
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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