OMB Meeting Book (June 22, 2017)

198

ERP SUMMARY FOR FIRST TO FINAL ACTION METHOD RECOMMENDATION

AOAC 2016.02 

Determination of biotin by liquid chromatography coupled with  immunoaffinity column clean‐up extraction 

GUIDANCE FOR AOAC ERPS ‐ APPENDIX G 1 Considered? Comments/Reference if applicable Method Applicability  Yes  Meets SMPR  ERP First Action to Final Action  recommendations & improvements  Yes  Draft Final Action method reviewed by ERP Yes  Completed in June 2017  Safety Concerns  Yes  ReferenceMaterials  Yes  NIST 1849a and SPIFAN Materials  Single Laboratory Validation  Yes  Joseph et al.: Journal AOAC Int Vol. 99, 4 (2016)  p.1110  Reproducibility/Uncertaintyand  Probability of Detection  Yes  In publication, pending review  Comparison to SMPR ( SMPR criteria met?)  Yes  Meets AOAC SMPR 2014.005  Feedback from Users of Method  Yes  All Addressed 

Comments

DOCUMENTATION Safety Evaluation  ReferenceMaterials 

Available?

Yes  Yes  Yes  Yes  Yes  Yes  Yes  Yes  Yes  Yes  Yes 

NIST 1849a and SPIFAN Materials 

Joseph et al.: Journal AOAC Int Vol. 99, 4 (2016)  p.1110 

SLV or PTM 

OMA Appendix L 

Approved Validation Protocols 

Statistics Review 

Method Published in OMA 

Meets AOAC SMPR 2014.005 

Method Performance vs SMPR criteria 

All addressed 

Feedback Information  Additional Recognition(s) 

Method is a working item in ISO  3‐16‐2016; 9‐20‐2016; 3‐16‐2017 

ERP Reports 

Joseph et al.: Journal AOAC Int Vol. 99, 4 (2016)  p.1110 (SLV); MLT publication in process  

Manuscript(s) Published in JAOAC 

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.”