Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Adverse Drug Event Recordkeeping -- 314.80(i) New 400000 6400000 21960
Adverse Drug Experience Reporting -- 310.305(c)(5) Modified 1 1 2
Adverse Event Recordkeeping -- 310.305(f) New 25 400 1
Adverse Event Reporting -- 314.80(c)(2) New 11478 688680 24988
Adverse Event Reporting--314.80(c)(1)(iii) New 5 5 11
Total burden requested under this ICR: 411509 7089086 46962  
To view an IC, click on IC Title