OMB Meeting Book - Jan. 11, 2018

2016.03 (Nov. 2017) - Chlor-02/04 Final Action Review FOR ERP USE ONLY DO NOT DISTRIBUTE

Collaborative Study Protocol Part 1:

All participant laboratories received two practice samples and were asked to analyze each of them in duplicate (two extractions from each reconstituted sample). Any deviation from the written method was to be recorded and reported. Results were communicated to the Study Director using the electronic template provided with the protocol. The participants were asked to report chloride results, titration volumes for standards and samples, and the different masses used during sample preparation. After review by the Study Director, results within a range of expected levels (average ± 2 x standard deviation of reproducibility) identified the laboratories qualified for the second part of the study. Part 2: All qualified laboratories received approval for the second phase of the study containing fifty coded products, corresponding to twenty five products in blind duplicates. The samples were a set of infant formula and adult nutritional products plus milk based matrixes, representing a wide range of commercially available products. The laboratories were asked to analyze all the samples (single extraction from each liquid or reconstituted powder) or milk based matrix.. The blind duplicates were assigned to be analyzed the same day. Results were communicated to the Study Director using an electronic template similar to the one used in Part 1. Two of the samples (Child Formula Powder Milk Based - Placebo and Adult Nutritional RTF High Fat -Placebo) failed to meet acceptance criteria during Part 2. Due to a suspicion on the integrity of the samples (some laboratories reported product spoilage), and the fact that they have reached their expiration date; they were excluded from review.

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