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In addition, for purposes of determining weighted averages, any benefits that are not within a category that is subject to a separately-designated dollar limit under the plan are taken into account as a single separate category by using an estimate of the upper limit on the dollar amount that a plan may reasonably be expected to incur with respect to such benefits, taking into account any other applicable restrictions under the plan

In that time, FDA will respond with either a May Proceed, Hold or possibly a Detention notice

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No, it is a far, far better thing that you remember me as I was, your sweet, innocent friend, Karen