Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Records of Adverse Events, Including Records of Efforts to Obtain the Data Elements for Each Adverse Event Report Unchanged 55 880 0
Submission of Adverse Event Reports Including Copy of Labeling and Other Information as Described in the Guidance Unchanged 55 61 0
Total burden requested under this ICR: 110 941 0  
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