ICR Documents

Supporting Statement A Document Date Uploaded SUPPORTING STATEMENT 0014 FINAL VERSION 1-7-2016.doc 01/08/2016 Supporting Statement B Document Date Uploaded Supplementary Documents Title Document Document Type Date Uploaded FDA Form 1571 PROPOSED FDA Form 1571 PROPOSED.PDF Supplementary Document 09/21/2017 0014 Non Substantive Change Request 0014 Non sub change 2017.doc Justification for No Material/Nonsubstantive Change 09/21/2017 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received