Sponsor Reporting to FDA on DMC Recommendations

Establishment and Operation of Clinical Trial Data Monitoring Committees

OMB: 0910-0581

IC ID: 6304

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Sponsor Reporting to FDA on DMC Recommendations CBER
No Unchanged
21 CFR 312.50 21 CFR 312.56 21 CFR 812.46 21 CFR 812.40

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

Health Health Care Services


37 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 37 0 0 0 0 37
Annual IC Time Burden (Hours) 19 0 0 0 0 19
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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