OMB Meeting Book-October 1, 2015

OMB MEETING MATERIALS - October 1, 2015

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PROPOSAL FOR MODIFICATION OF SOLE SOURCE METHODS Assumptions and Considerations:

1. Modifying an existing OMA must require consideration of method users and those who have a stake in method.

2. OMB maintains its oversight role of the entire process with specific decisions and review points, including OMB liaisons in each ERP.

3. Definitions or guidance for Editorial, Minor, or Major Modification still required, but to guide CSO, OMB and perhaps ERPs in making their deliberations and decision making.

4. Applicant has decision points that determine whether or not additional resources are applied to achieve method evaluation.

5. Roles of staff and volunteer bodies/groups are maintained and require no new definitions.

6. ERPs meet a minimum of twice per year: Mid Year Meeting and Annual Meeting. a. Time for applicant to make a decision. b. Time for OMB to meet and make a decision. 7. Process only applies to sole source methods. This does not apply to methods adopted with existing standards development and ERP activity. 8. Consistent with AOAC paradigm of getting experts together and generating productive discussions. 9. Application will need to include specific information that will assist CSO and OMB in making a decision on the application. a. Is the method adopted by another organization? b. Is the proposed modification under consideration or adopted by another organization? c. How does this proposed modification impact the results of the current OMA? d. List of potential stakeholders; and Others….