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Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank

IC 6153 under ICR 200711-0910-004 · OMB 0910-0459.

Documents and Forms
Document Name
Document Type
Other-Guidance document
Information Collection (IC) Details

View Information Collection (IC)

Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank
 
No Modified
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance document 0459 FDA guidance.doc No No Printable Only

Health Consumer Health and Safety

 

5,332 0
   
Private Sector Businesses or other for-profits
 
   100 %

  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 10,664 0 0 -27,850 0 38,514
Annual IC Time Burden (Hours) 49,054 0 0 -128,111 0 177,165
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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