OMB First to Final Action Recommendation Checklist 11-12-18

ERP - GLUTEN ASSAYS: AOAC 2015.05 FAR

AOAC RESEARCH INSTITUTE AOAC OFFICIAL METHODS OF ANALYSIS (OMA) OMAMAN-19: R-Biopharm, Competitive Enzyme Immunoassay Based On The R5

Monoclonal Antibody To Determine Partially Hydrolysed Gluten In Foods Containing Wheat, Rye, And Barley Study Director: Dr. Markus Lacorn, R-Biopharm AG, An der neuen Bergstraße 17, 64297 Darmstadt, Germany/ Co- Study Director: Patricia Meinhardt, R-Biopharm Inc., 870 Vossbrink Drive, Washington, MO 63090 EDITORIAL EVALUATION CRITERIA Is the Validation Study Manuscript in a format acceptable to AOAC? ER 1 Yes ER 2 Yes ER 3 Yes ER 4 Yes ER 5 Yes ER 6 Yes Is the method described in sufficient detail so that it is relatively easy to understand, including equations and procedures for calculation of results (are all terms explained)? ER 1 Yes ER 2 Yes ER 3 Yes ER 4 Yes ER 5 Yes ER 6 Yes Are the figures and tables sufficiently explanatory without the need to refer to the text? ER 1 Yes ER 2 Yes ER 3 Yes ER 4 Yes ER 5 Yes ER 6 Yes Are all the figures and tables pertinent? ER 1 Yes ER 2 Yes ER 3 Yes ER 4 No ER 5 Yes ER 6 Yes Could some be omitted and covered by a simple statement? ER 1 Yes ER 2 No ER 3 No ER 4 Yes ER 5 No ER 6 No

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