Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

OMB Meeting 4-11-2019 Pre-read Materials

20

AOAC   Reviewed and Recognized P rogram   Policies and Procedures 

reviewer comments and questions in writing.  All responses and revised documents shall  be submitted to the Project Manager, who will forward them to the AOAC Volunteer  Expert and Expert Reviewers for additional comment or approval.  The process  continues until consensus is reached among the three reviewers for either approval or  rejection.     Criteria for Granting AOAC Reviewed and Recognized Status:  The AOAC Volunteer Expert and Expert Reviewers, acting as independent reviewers,  decide whether the results documented in the Verification Study Report merit awarding  AOAC Reviewed and Recognized  status.       The reviewers must be satisfied that results from the Technology Provider provide a  solid scientific case to for granting AOAC Reviewed and Recognized  status.  The criteria  for granting AOAC Reviewed and Recognized  status are based on:   Results from the Verification Study support and confirm all claims made in the  Application Note.  All results meet the acceptance criteria contained in the study protocols.  All results meet the minimum performance requirements of the application or  relevant SMPR (if one exists).  In some rare cases if an impasse develops between the Technology Provider and a  reviewer, it is the responsibility of the Senior Director of the AOAC RI to facilitate a  resolution.  If a resolution cannot be reached, then the Senior Director of the AOAC RI  may convene a special meeting to resolve all remaining questions.     1) 2)  5)  Certificate:   An AOAC Reviewed and Recognized  certificate is issued by the AOAC RI to the  Technology Provider for each Application Note granted AOAC Reviewed and Recognized status.  The certificate carries a unique certificate number and name of the approved  Application Note.  (See Appendix 13.) [to be added later]  5.8.1 Certificates Initially Granted Before October 1 st  of Any Given Year:  The initial AOAC Reviewed and Recognized  certificate is granted and effective  for a term expiring at the end of the current annual renewal cycle on December  31 st  of the same year.    5.8.2 Certificates Initially Granted On or After October 1 st  of Any Given Year:  The initial certificate is granted for a term expiring at the end of the next annual  renewal cycle on December 31 st  of the next  year. 

5.7 

5.8 

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04/05/2019