November 14 2019 OMB Meeting Materials

AOAC CONSENSUS STANDARDS PROCESS FOR THE DEVELOPMENT AND APPROVAL IN 8 STEPS  AOAC OMB MEETING MA ERI LS

134

FOR REVIEW AS OF 10/25/2019

LEGEND TRANSPARENCY/OPENNESS BALANCE OF INTERESTS CONSENSUS (WG/SA/OMB) APPEALS (WG/SA) APPROVED AOAC STANDARD

AGREEMENT ON SCOPE OF WORK & STANDARDS TO BE DEVELOPED

IDENTIFY KEY EXPERTS, AUTHORITIES & STAKEHOLDERS TO ENGAGE

ADVISORY PANEL

START

STEP 1 –

WORK SCOPE

INVITE EXPERTISE & RECOMMENDED ORGANIZATIONS FOR PARTICIPATION

ASSIGN & ORIENT WG CHAIR

ASSIGN & ORIENT SCIENTIFIC ADVISOR

Notify Mailing List & WG of meeting(s) and broadly publicize upcoming meeting(s)/ event(s)

VET WG APPLICANTS & ESTABLISH WG ROSTER & ASSESS BALANCE

STEP 2  ‐ 

NOTIFY OMB

PUBLICIZE UPCOMING STANDARDS ACTIVITY & OPEN CALL FOR WG MEMBERS

BUILD MAILING LIST & ASSESS BALANCE

OUTREACH

WG DRAFT  STANDARD  (WGDS)

Notify Mailing List & WG of meeting(s) and broadly publicize public comment period/event(s)

INITIATE WG ‐ INCLUDING ORIENTATIONS & LAUNCH WG

WG MEET VIRTUALLY TO DRAFT STANDARD (MULTIPLE MEETINGS)

WG REACH CONSENSUS ON DRAFT

YES

STEPS 3 –

WG DRAFT

NO

WG DRAFT STANDARD POSTED FOR PUBLIC COMMENT ≥ 30 DAYS WILL INCLUDE VIRTUAL PUBLIC COMMENT FORUM TO SOLICIT COMMENTS

BASED ON COMMENTS, ASSESS BALANCE OF INPUT IN WG DRAFT STANDARD

STEP 4  ‐

COMMENTS

Notify Mailing List & WG of meeting(s) and broadly publicize upcoming meeting(s)/event(s)

WG RECONCILE ALL COMMENTS & FINALIZE DRAFT STANDARD

REV WG DRAFT  STANDARD

WG REACH CONSENSUS ON DRAFT

STEP 5 –

REV WG DRAFT

CONSENSUS DRAFT  STANDARD

YES

WG PRESENT FINAL DRAFT STANDARD FOR CONSENSUS TO STAKEHOLDER ASSEMBLY

STAKEHOLDER CONSENSUS

PUBLICIZE OUTCOMES

WG RECONCILE ALL COMMENTS, REVISE & FINALIZE DRAFT STANDARD

NO

STEP 6 – SA

CONSENSUS

OMB AUDITS NOTIFICICATION EFFORTS; PARTICIPATION EFFORTS, BALANCE & LACK OF DOMINANCE; OPPORTUNITIES FOR VARIOUS TYPES OF INPUT; RECONCILIATION OF COMMENTS, OBJECTIONS, APPEALS; PROOF OF COORDINATION & HARMONIZATION; AND DEMONSTRATION OF CONSENSUS STEPS

APPROVED  STANDARD

FINAL VERSION GO TO OMB: OMB LIAISON DISCUSSES PROGRESS OR AUDIT

YES

OMB CONSENSUS

PUBLICIZE OUTCOMES

STEP 7 – OMB AUDIT STEP 8  ‐ 

STAFF TO RECONCILE OMB COMMENTS

NO

APPROVED  STANDARD

PUBLICIZE PUBLICATION OF STANDARD

PUBLISHED IN OMA, STATUS IN ILM

END

PUBLICATION 12/11/2019

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