November 14 2019 OMB Meeting Materials

AOAC OMB MEETING MATERIALS

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e. Consensus – General agreement, but not necessarily unanimity, and includes a process for attempting to resolve objections and reconciles varying perspectives. Each objector is advised of the disposition of his or her objection(s) and the reasons why, and the consensus body is given an opportunity to change their votes after reviewing the comments (Office of Management and Budget (OMB) Executive Office of the President,

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2016).

f. Dominance – A position or exercise of dominant authority, leadership, or influence by reason of superior leverage, strength, or representation that excludes consideration of other perspectives ( (Office of

Management and Budget (OMB) Executive Office of the President, 2016) (ANSI, 2019).

g. Due Consideration – All view points and perspectives, including supporting or objecting view points or perspectives shall be considered, whether received in writing or orally during the development of the draft

and during the public comment period (

h. Due Process – Any individual, organization, company, or government agency with a direct and material interest has the right to participate and can express a position and the rationale for it, have that position considered and appeal if adversely affected. It includes openness, transparency, lack of dominance, balance of perspectives, due consideration of varying views, demonstration of consensus, and appeals (ANSI, 2019) i. NTTAA – National Technology Transfer and Advancement Act was passed as Public Law 104 ‐ 113 and it directs “federal agencies to focus on increasing their use of [voluntary consensus] standards whenever possible.” It authorizes the US NIST as the “federal coordinator for government entities responsible for the development of technical standards and conformity assessment activities. The law gives agencies discretion to use other standards in lieu of voluntary consensus standards where use of the latter would be “inconsistent with applicable law or otherwise impractical.” Policies established from the law are articulated j. Openness – Activities shall be open to all individuals and entities that are directly and materially impacted. There shall be no excessive or undue financial barrier to participation. Voting qualifications on a consensus body shall not be contingent upon any organizational membership, any undue technical qualifications, or other such requirements. There shall be timely and appropriate notification of activities and any action to pertaining to a standard, including, creating, revising, confirming, and withdrawing. This also includes DRAFT formation of new consensus bodies (ANSI, 2019). k. Parliamentary Procedure – Rules of engagement that considers the rights of the majority, minority, individual members, absentee members, all of these groups taken together (Robert’s Rules of Order  ‐  latest (Breitenberg, 2009). in the Office of Management and Budget (US OMB) Circular A ‐ 119 (NTTAA PL 104 ‐ 113).

edition).

l. Performance Standard  ‐ States requirements in terms of required results with criteria for verifying compliance but without stating the methods for achieving required results (US OMB Circular A ‐ 119). m. Standard Method Performance Requirements (SMPR®) – An AOAC specific type of voluntary consensus performance standard for methodology. It includes applicability, method performance criteria, and varying parameters to support optimum method development, performance, and is used as part of the AOAC method approval process. An SMPR is a service mark of AOAC INTERNATIONAL (OMA, Appendix F). n. Stakeholder  ‐ An individual or entity with a direct or material interest, impact, risk or investment in an issue DO NOT DISTRIBUTE or concern and/or outcomes (AOAC). o. Stakeholder Assembly – Gathering or meeting of the stakeholders in attendance (AOAC). p. Stakeholder Assembly Chair or Moderator  ‐ Appointed by AOAC as the presiding officer for the stakeholder assembly to moderate and facilitate stakeholder discussions, maintain order and goals of meeting, and

facilitate consensus process of the assembly as needed (AOAC).

Title revision, terminology addition, and streamlined proposed policy statement – v3 (November 2019) 

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