November 14 2019 OMB Meeting Materials

AOAC OMB MEETING MATERIALS

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III. AOAC CONSENSUS STANDARDS ‐ DETAILED PROCESS STEPS FOR DEVELOPMENT & APPROVAL   121

Step 1:

Agreement on Scope of Work and Project Initiation a. AOAC Advisory Panel agree on scope of work, deliverables, and standard(s) to be developed. b. Identification of key expertise, relevant authorities, and stakeholder organizations. AOAC Notification, Education, Engagement, and Outreach a. Assignment of OMB liaison to begin oversight of standards development activity(ies) for the standard(s) audit(s). b. Invitations sent to identified experts, authorities, and stakeholder organizations; c. Network leveraging to identify scientific advisor and working group chair(s) and volunteer role orientation; d. Announcement of upcoming standards activity published in AOAC venues at a minimum to build mailing list and working group member applications e. Working group roster and communication stream finalization. f. Announcements of upcoming meetings/events related to initiating standards development activities Standards Activities Launched a. Working group chair(s) launch standards activities with a fit for purpose statement based on the scope of work and supporting background information b. Working group begins draft standard virtually and electronically until initial draft is completed. c. Working group members review initial draft for individual input, objections, etc… 1) Any objections or appeals will be considered prior to consensus. d. Working group reconciles document and reach consensus on draft standard. e. The working group’s consensus document is a Working Group Draft Standard (WGDS). 1) Consensus is represented by 2/3 vote in favor of entering the WGDS into the public comment period. f. Announcements sent to inform stakeholders and public of the public comment period and invite opportunities to provide stakeholder input. Public Comment Period a. WGDS is published for a minimum of 30 days for the purpose of collecting comments both written and orally (as part of a virtual public comment forum). b. Commentary received is reviewed to assess balance and overall total input into the WGDS from a variety of perspectives Comment Reconciliation and Revising the WGDS a. Working group chairs initiate reconciling the public stakeholder comments received and proposing a revised WGDS to working group members. 1) Any objections and appeals will be considered. b. Working groups may meet or via electronic communication, review and WGDS revision standard as needed until working group consensus is reached. c. Proposed revised WGDS may be sent to working group members to ensure their individual input 1) Any objections and appeals will be considered. d. Working group reconciles document and reach consensus on draft standard. e. The working group’s consensus document is a Working Group Draft Standard ‐ Revision 1 (WGDS ‐ R1). 1) Consensus is represented by 2/3 vote in favor of sending the WGDS ‐ R1 to the stakeholder assembly. f. Announcements sent to inform stakeholders of process for stakeholder assembly consensus on the WGDS ‐ R1 and any upcoming venues during which consensus may be requested and/or demonstrated by the stakeholder assembly. g. Copies of the WGDS ‐ R1 is sent in advance to the stakeholder assembly. Stakeholder Assembly Consensus Consideration of WGDS ‐ R1 a. Working group chair(s) present to the stakeholder assembly in person, virtually, or electronically a summary of the working group effort in drafting the WGDS, including key DRAFT

Step 2:

STAGE 1

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STAGE 2

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Step 5:

STAGE 3

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Step 6:

STAGE 4

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

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12/11/2019