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

Are the references complete and correctly annotated? ER 1 Yes ER 2 NA ER 3 Yes ER 4 Yes ER 5 Yes ER 6 Yes Does the method contain adequate safety precaution reference and/or statements? ER 1 Yes ER 2 Yes ER 3 Yes ER 4 Yes ER 5 Yes ER 6 Yes General Comments (3) Editorial ER 1 see above ER 2 Can I get a clean copy of the manuscript? I can’t read this thing. ER 3

There are a couple of reference citations that are still incomplete. There are some with periods in the wrong places. There is one citation with et al. not acceptable in this Journal.

ER 4 ER 5 ER 6

NA

The method is provided is in good format with enough details.

N/A

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