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Basics of Filing Series Cont'd - Variable Ranges

This week's tip addresses a very frequent time-sink for the filer and the reviewer. It may be tempting to include in the Statement of Variability as broad a range as possible for variable values in order to avoid refiling, but this approach actually slows down time to approval as unnecessarily broad variability generates compliance issues. For example, a range from 0.5% to 50% for a bonus may result in different compliance issues, causing the review to bog down addressing compliance for extreme values. A reasonable range would simplify review.

Uniform Standards require that the explanation of variable material include ranges that are "reasonable and realistic," as well as compliant with specific requirements under the Uniform Standards.  Limiting the range to meet these requirements as well as using a range for only what is intended to be offered is a best practice that helps reduce review time and generate faster approvals.

If an approved range requires updating, a Supporting Documentation Update (SDU) filing is used for this purpose.  These types of filings generally require less review time than that required of full product filings, which generally means a quicker time to approval.  Filing Information Notice 2017-1 provides additional filing guidance on SDU filings.