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OMB Expectation Parameters
M th d e o
Feedback from
End Users
Consider any positive or negative
feedback on overall method
performance, applicability,
availability of reference
materials, matrix scope, method
component sourcing, robustness
or ruggedness parameters.
Documentation Needed
Method Safety Evaluation
Reference Materials
Evidence of Single Laboratory Validation or equivalent
Evidence of Reproducibility Assessment
Published First Action OMA
Method Performance versus SMPR or acceptance criteria
Final draft of First Action OMA to be considered for status update
Rationale or Justification for Repeal or Continuance of First Action OMA