OMB Meeting Book_9-11-14

II. CONTINUAL IMPROVEMENT GOAL- Method modification process (cont). Recommendation from OMB:

For the AOAC Board of Directors to review the following OMB consensus recommended method modification process (for methods without existing ERPs) and provide recommendations and/or feedback.

Proposed Modification Approval Process (for methods without ERPs)

Application Process

1. Modification Application is submitted a. The OMB has recommended that the application be modified to include a section that addresses potential impact on stakeholders 2. The method information and request for the proposed modification is posted for a 30 day comment period 3. To assist the OMB review, the CSO reviews the submission and any comments and recommends an appropriate response to the applicant. This includes any work that may be needed to support the modification of the method. 4. The method modification proposal, comments, and the CSO recommendations are forwarded to the OMB for review. 5. The method modification application, CSO recommendation and any supporting documentation is sent to the OMB. a. All OMB members will review the method modification package. b. The OMB chair typically appoints 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-depth review. c. The OMB may also decide to consult with additional SMEs 6. Discussion of the method modification is added to the next OMB teleconference or meeting. 7. Based on the review and discussion, the OMB comes to a consensus: a. The OMB may accept the CSO recommendation as written. b. The OMB may have questions or have additional input. The CSO will revise the response to the applicant. 8. Final version of the method modification response is sent to the applicant.