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BLA 761108/S-021 Page 4 We also remind you that you must submit a REMS assessment when you submit a supplemental application for a new indication for use, as described in section 5051(g)(2)(A) of the FDCA. This assessment should include:

If the assessment instruments and methodology for your REMS assessments are not included in the REMS supporting document, or if you propose changes to the submitted assessment instruments or methodology, you should update the REMS supporting document to include specific assessment instrument and methodology information at least 90 days before the assessments will be conducted. Updates to the REMS supporting document may be included in a new document that references previous REMS supporting document submission(s) for unchanged portions. Alternatively, updates may be made by modifying the complete previous REMS supporting document, with all changes marked and highlighted. Prominently identify the submission containing U.S. Food and Drug Administration Silver Spring, MD 20993 www.fda.gov