Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Adverse Drug Event Recordkeeping -- 314.80(i) Unchanged 658240 10531840 25000
Adverse Drug Experience Reporting -- 310.305(c)(5) Unchanged 3 3 0
Adverse Event Recordkeeping -- 310.305(f) Unchanged 25 400 0
Adverse Event Reporting -- 314.80(c)(2) Unchanged 14178 835755 0
Adverse Event Reporting--314.80(c)(1)(iii) Unchanged 5 5 0
Recordkeeping (21 U.S.C. 379aa(e)(1) Unchanged 265700 2125600 0
Reports of serious adverse drug events (21 U.S.C. 379aa(b)and (c) Modified 200949 1428694 0
Total burden requested under this ICR: 1139100 14922297 25000  
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