OMB Meeting Book_9-11-14

Vitamin A & E MLT Protocol For ERP Use Only DO NOT DISTRIBUTE

Receipt and Storage of Materials

a) You will receive 1 or 2 courier shipment(s) containing practice samples and test samples. The samples pack(s) will also include packaging labels and customs declaration documents. Because it is not certain how the transport documentation or sample labels will be retained/added to/modified by Customs Officials (likely to vary from country to country), it is preferred that you have a colleague, not directly involved in the study, remove all documentation not required for the study. The samples will arrive double bagged. Please have a colleague carefully remove the outer bag (which is labeled with customs declarations) and discard, and present to you just the inner sample presentations that have the designated sample name labels . Use only the designated sample names for the study and reporting results.

Note: Samples are intended for the use of this study only; and are not for human consumption. You do not need to return the samples.

b) The shipment will also contain a receipt acknowledgement form for you to return, indicating receipt and condition of the items shipped.

c) Samples are to be kept at room temperature until the start of analysis.

d) Samples are to be prepared and used on the same day. No storage of samples for next day analysis is allowed.

e) All work should be completed within 30 days of receipt of the materials, unless other prior arrangements are made. If this schedule cannot be met, the Study Director should be notified as soon as possible.

System Suitability Checks

a) System suitability checks as outlined in the method should be analyzed as part of each analytical run and should meet the outlined acceptance criteria.

Analysis of the Practice Samples

a) The practice samples should be prepared and analyzed with a freshly prepared 6 point calibration curve.

b) Once the practice samples have been successfully analysed, the results are reviewed and cross checked please send via e-mail to the study director for review and approval. Include all data, appendixes 3 and 4 and a copy of all chromatograms.

c) Once the practice sample results have been approved by the study director, the analyst may proceed with the analysis of the actual test materials.

Analysis of Test Materials

a) The analysis of the test materials should be initiated immediately after the approval of a successful analysis of the practice samples by the SD.

b) The test materials will consist of 20 randomly coded samples, a mix of powder and liquids presentions. Refer to Appendix 2 for a list of the test sample codes.

c) Each of the samples is to be prepared fresh singly and analysed once along with a single preparation of each the practice samples. As the number of samples exceeds the recommended number to be prepared in a single day, analysis will need to take place over two days running 12 samples on day one,10 test samples and the two practice samples and 10 samples on day two, 8 samples and two practice samples.

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