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

ERP - GLUTEN ASSAYS: AOAC 2015.05 FAR

Attachment 1

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 TECHNICAL EVALUATION CRITERIA Is the test kit method scientifically and technically sound? ER 1 yes ER 2 yes ER 3 yes ER 4 yes ER 5 yes ER 6 yes Have sufficient controls been used, including those required to calculate the rate of false‐positive and false‐negative results where appropriate? ER 1 No ER 2 NA ER 3 Yes ER 4 Yes ER 5 Yes ER 6 Yes Is sufficient information included for system suitability determination and product performance or acceptance testing? ER 1 No ER 2 Yes ER 3 Yes ER 4 Yes ER 5 Yes ER 6 Yes Are the conclusions statements valid based upon data presented? ER 1 No ER 2 Yes ER 3 Yes ER 4 Yes ER 5 NA ER 6 No

Page 1 of 10

34