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f. ERP makes its decision
i. Decide if it is an editorial change, then it goes to publications, no change in
First or Final Action status.
ii. Decide if the method modification is substantiated by the submitted
supporting documentation
iii. Decide if the method modification cannot be approved at all.
g. If the method is approved, it continues on through the normal pathway. It goes
back to First Actions status.
h. If method is not approved, there are three possibilities
i. The ERP needs additional clarification or some missing piece of pertinent
information is needed prior to approval.
1. Applicant notified that additional clarification or information is
needed. Applicant can decide to submit clarification or information
for the ERP’s consideration.
ii. The ERP determined that the supporting information does not support the
modification, etiher in appropriate conclusions, etc…
1. Applicant notified that applicability, method, and/or documentation
are not adequately supported. Applicant can decide to do a new
submission or not.
iii. The ERP cannot make a decision due to a need for additional consensus
from community/stakeholders.
1. Applicant notified that standards development is needed. Applicant
can decide what to do.
Key points are:
1. OMB maintains its oversight
2. Input is sought
3. Still need to decide on new OMA number verses old OMA number
4. ERP maintains its role
AOAC OMB Meeting
February 10-11, 2016
92