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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
Unchanged
370
740
0
DMC reports of meeting minutes to the sponsor
Unchanged
740
740
0
Sponsor Reporting to FDA on DMC Recommendations
Unchanged
37
19
0
Sponsor notification to the DMC regarding waivers
Unchanged
1
0
0
Standard Operating Procuedres for Data Monitoring Committees
Unchanged
37
296
0
Total burden requested under this ICR:
1185
1795
0
To view an IC, click on IC Title