Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
DMC Meeting Records Modified 370 740 0 Other-Guidance
DMC reports of meeting minutes to the sponsor Modified 740 740 0 Other-Guidance
Sponsor Reporting to FDA on DMC Recommendations Modified 37 19 0 Other-Guidance
Sponsor notification to the DMC regarding waivers Modified 1 0 0 Other-Guidance
Standard Operating Procuedres for Data Monitoring Committees Modified 37 296 0 Other-Guidance
Total burden requested under this ICR: 1185 1795 0  
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