Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

OMB Meeting 4-11-2019 Pre-read Materials

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AOAC   Reviewed and Recognized P rogram   Policies and Procedures 

POLICIES and PROCEDURES

1.  Purpose The AOAC Reviewed and Recognized program provides an independent third‐party review of  Application Notes for proprietary instruments and equipment.  Application Notes provided by  technology providers that contain procedures and claims that are verified for specific  analyte/matrix are granted AOAC Reviewed and Recognized  status.  Technology providers of  AOAC Reviewed and Recognized approved Application Notes are licensed to use the AOAC  Reviewed and Recognized  certification mark. The AOAC Reviewed and Recognized  certification  mark assures users that an independent assessment has found that the performance claims  contained in approved Application Notes meets an appropriate standard for the claimed  intended use.   2.  Background The AOAC Research Institute (AOAC RI) is a nonprofit division of the AOAC INTERNATIONAL.    The mission of the AOAC Research Institute is to promote and carry out activities related to the  development, improvement and verification of proprietary methods. A list of AOAC Reviewed  and Recognized Application Notes can be found at the AOAC Research Institute website at  [future URL].  The AOAC Reviewed and Recognized Application Notes program is designed to be  complementary to the Performance Tested Methods  SM  (PTM) and Official Methods of Analysis SM (OMA) programs.   3.   Overview

The AOAC Reviewed and Recognized Application Notes program has five distinct phases:   

1) 2) 3) 4) 5)

Consulting (optional) 

Reviewed and Recognized Application   Technology Provider Verification Plan 

Verification Study Report  Application Notes Review 

The Reviewed and Recognized evaluation begins with an optional Consulting phase in which the  Technology Provider and an AOAC RI Technical Consultant discuss and decide the aims of the  verification.   The technology, target analyte, matrices, market, and regulatory issues are all considered at this  stage.  The AOAC RI Technical Consultant works with the Technology Provider to prepare a 

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© 2019 ‐ AOAC Research Institute 

04/05/2019