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Agenda
Reg Review
ICR
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
To view an IC, click on IC Title