OMB Meeting Book (June 25-26, 2015)

2012.16. The ERP reviewed this information during their March 18, 2015 meeting and deemed that the 1 method sufficiently met AOAC SMPR 2012.009. 2 3 B. Data is present to assure the matrix and analyte scopes are covered. This is critical for methods 4 used for dispute resolution. 5 6 Both the SLV information and demonstration of reproducibility were considered the ERP determined 7 that the matrix and analyte scopes are addressed satisfactorily. The method author has developed and 8 submitted a method manuscript and this document has been reviewed by ERP members and has since 9 been accepted for publication in the Journal. 12 A. Document positive and negative feedback from users of the method during the trial period. 13 B. Feedback from users demonstrating method ruggedness should be documented. 14 C. Assess the future availability of vital equipment, reference materials, and supplies. 15 16 There were no comments submitted regarding this method during the two year period. However, there 17 were some comments that came out of the ERP meetings during which the method was adopted and 18 recommended. The first comment was that the method originally used reference material, NIST SRM 19 1846. AOAC SMPR 2012.009 states NIST SRM 1849a as the reference material. During the 20 reproducibility trials, the method was challenged with NIST SRM 1849a as stipulated by the AOAC SMPR 21 2012.009 and by a set of SPIFAN matrices. Additionally, there was a comment during the March 18, 22 2015 ERP meeting regarding drying of the calcium pantothenate standard prior to use and ensuring 23 control of the moisture content. The method author did provide clarification to address this matter in 24 the method manuscript since the March meeting. No other concerns were raised. ERP members 25 reviewed the manuscript and the manuscript has since been submitted and accepted for publication in 26 the Journal. 10 11 FEEDBACK FROM USERS OF METHOD:

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ATTACHMENTS AND REFERENCES:

1. Boyd, Delia, Meeting Proceedings of the AOAC Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) Stakeholder Meeting, September 29, 2012. http://stakeholder.aoac.org/SPIFAN/September_29_2012_Minutes.pdf . 2. Method Evaluation Form for AOAC 2012.16, Pantothenic acid (Vitamin B5) in Infant Formula and Adult/Pediatric Nutritional Formula UHPLC-MS/MS. 3. AOAC Committee on Safety and McKenzie, Deborah, AOAC Method Safety and Risk Assessment, AOAC Official Methods

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