AOAC OMB Meeting Book 2-10-16

AOAC OMB Meeting

MEMORANDUM 

Date:  

January 14, 2016 

To: 

AOAC INTERNATIONAL Official Methods Board Sole Source OMA  Modification Working Group  Deborah McKenzie, Sr. Director, Standards Development & Research  Institute 

From: 

Subject: 

Revised Flow for Sole Source Modifications 

During the last teleconference of the working group, the following suggestions were made regarding  the flow chart based on discussions of the latest version of the flow chart and the new proposal on  handling method modifications:  1. Revise the flow chart to a hybrid between both the process for new methods and the process for discussed previously by the working group. a. Let the ERP determine type of modification b. OMB can provide guidance c. Can publish the modification d. Working will still need to consider impact on OMAs 2. Both the modification proposal and the Call for Experts for the ERP can be posted at the same time. 3. ERP makes the decision on type of modification. Attached is a revised flow chart that combines the procedures for submission of new methods and  the flow charts.   There are some things that are reworded or reconfigured:  1. ERPs review submitted methods and documentation for review of First Action and they track methods and make a recommendation to OMB on Final Action status or not.   Keeping this  theme, the following are changes to the flow chart:  a. CSO review of the application prior to posting for public comment was removed as it is not defined what purpose it serves at this point.   b. Call for Experts will be posted with the posting of the modification proposal, although not on the flow chart, this is part of our internal process in anticipation of  any ERP.  The earlier we can issue the Call, the better.  c. Applicant can decide to proceed onward or withdraw the proposal based on CSO review and reconciliation of the comments received from the posting.   d. If the Applicant withdraws, then no further action is needed and ERP recruitment ceases with notification to all parties.  e. If the Applicant continues, then the ERP meets and reviews the information on the method.  

February 10-11, 2016

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