MEMORANDUM
Date:
January 14, 2016
To:
AOAC INTERNATIONAL Official Methods Board Sole Source OMA
Modification Working Group
From:
Deborah McKenzie, Sr. Director, Standards Development & Research
Institute
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.
AOAC OMB Meeting
February 10-11, 2016
91