Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Recordkeeping - (21 U.S.C. 379aa(e)(1)) Modified 20000 100000 0
Reports of serious adverse drug events (21 U.S.C. 379aa((b) and (c)) Modified 12500 25000 0
Total burden requested under this ICR: 32500 125000 0  
To view an IC, click on IC Title