FDA states that it has analyzed this rule in accordance with the principles set forth in Executive Order 12612, Federalism, and has determined that the rule does not warrant the preparation of a Federalism Assessment.
The FDA states that preparation of a Federal Assessment is never necessary, as that practice is outdated. 
mnli hypothesis: The FDA states that preparation of a Federal Assessment is never necessary, as that practice is outdated.  premise: FDA states that it has analyzed this rule in accordance with the principles set forth in Executive Order 12612, Federalism, and has determined that the rule does not warrant the preparation of a Federalism Assessment.