DMC Meeting Records

GFI: Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees

OMB: 0910-0581

IC ID: 203247

Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
Information Collection (IC) Details

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DMC Meeting Records CBER
 
No Unchanged
 
Voluntary
 
21 CFR 312.50 21 CFR 312.56 21 CFR 812.40 21 CFR 812.46

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

Health Health Care Services

 

370 0
   
Private Sector Businesses or other for-profits
 
   25 %

  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 370 0 0 0 0 370
Annual IC Time Burden (Hours) 740 0 0 0 0 740
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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