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 New 55 880 0 Other-Guidance
Submission of Adverse Event Reports Including Copy of Labeling and Other Information as Described in the Guidance New 55 61 0 Other-Guidance
Total burden requested under this ICR: 110 941 0  
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