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

ERP - GLUTEN ASSAYS: AOAC 2015.05 FAR

ERP SUMMARY FOR FIRST TO FINAL ACTION METHOD RECOMMENDATION

AOAC 2015.05

Partially Hydrolyzed Gluten in Fermented Cereal‐Based Products R5  Competitive ELISA Submitter:  Patricia Meinhardt, R‐Biopharm, Inc., 870 Vossbrink Drive, Washington,  MO 63090

GUIDANCE FOR AOAC ERPS ‐ APPENDIX G 1 Considered? Comments/Reference if applicable Method Applicability  ERP First Action to Final Action  recommendations & improvements  Draft Final Action method reviewed by ERP  Safety Concerns  Yes  ReferenceMaterials  Single Laboratory Validation  Yes  JAOAC INT 98;5 (2015) 1346  Reproducibility/Uncertaintyand  Probability of Detection  Comparison to SMPR ( SMPR criteria met?) Feedback from Users of Method 

Comments

DOCUMENTATION Safety Evaluation  ReferenceMaterials  SLV or PTM 

Available?

Reviewed for First Action OMA consideration 

Yes 

JAOAC INT 98;5 (2015) 1346 

Yes 

Approved Validation Protocols  Statistics Review  Method Published in OMA 

Yes  Yes 

AOAC 2015.05 

Method Performance vs SMPR criteria  Feedback Information  Additional Recognition(s)  ERP Reports  Manuscript(s) Published in JAOAC 

3/2015 

Yes  Yes 

JAOAC INT 98;5 (2015) 1346;  MLT in Review by  ERP 

ERP Method Recommendation   (Final Action/Repeal/Continuation) 

1 Official Methods of Analysis of AOAC INTERNATIONAL , Appendix G: Procedures and Guidelines for the Use of AOAC Voluntary Consensus Standards  to Evaluate Characteristics of a Method of Analysis, p.3 “ First Action to Final Action Methods: Guidance for AOAC Expert Review Panels.” 

1