OMB Meeting Book (June 25-26, 2015)

4.2..7.1 The OMB may accept the CSO recommendation as written. 4.2..7.2 The OMB may have questions or have additional input. The CSO will revise the response to the applicant. Final version of the method modification response is sent to the applicant.

viii.

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Modified Method Submission i.

Applicant submits the final modified method (with any supporting documentation) The CSO reviews the submission and prepares a packet to submit to the OMB, which may include: 4.2..2.1 Summary of data 4.2..2.2 Copy of the modified method (with the changes from the current method tracked) 4.2..2.3 Notation of any deficiencies form the modification response CSO package is sent to the OMB for review 4.2..3.1 All OMB members will review the method modification package. 4.2..3.2 The OMB chair will typically appoint at least 2 OMB members to lead the discussion of the modification. These members will have experience with the method/technology and will perform an in Ͳ depth review. 4.2..3.3 At this point, the OMB may also decide to consult with additional SMEs. Based on the review and discussion, the OMB comes to a consensus: 4.2..4.1 The OMB may accept the method modification as submitted. 4.2..4.2 The OMB may not accept the method modification as submitted.

ii.

iii.

iv.

The reasons for not accepting must be clearly defined. The reasons and any recommendations will be forwarded to the applicant

v.

If/when the method modification is approved 4.2..5.1 The proposed modification will be posted for comment (60 Ͳ 90 days) 4.2..5.2 After the comment period, OMA will be changed

ACTION S: Share with Board of Directors; Staff to develop/revise related documentation.

c. All OMA modifications are date stamped. It was recommended to note on the method, what was corrected/revised.

d.

Review of Modification of AOAC Official Methods 2009.01 and 2011.25 ƒ Establish a review panel to discuss and recommend what additional work may be needed for Final Action consideration, MOTION: For OMB to establish a group of experts (ERP) to review requirements for Final

Action status for AOAC 2009.01 and AOAC 2011.25. Cook moved; Bhandari seconded. Vote: Unanimous ACTIONS: Issue a call for experts.

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Review of Modification of AOAC Official Method 932.14 Reviewed by Cook, Phillips and Bhandari