This rule creates s. 961.20 (2) (eqm), Stats., which adds lemborexant to schedule IV. Summary of, and comparison with, existing or proposed federal regulation:
On April 7, 2020, the Department of Justice, Drug Enforcement Administration published its final rule in the Federal Register placing lemborexant into Schedule IV of the federal Controlled Substances Act.
Summary of public comments received on statement of scope and a description of how and to what extent those comments and feedback were taken into account in drafting the proposed rule: N/A
Comparison with rules in adjacent states:
Illinois: Illinois has not scheduled lemborexant.
Iowa: Iowa has not scheduled lemborexant.
Michigan: Michigan has not scheduled lemborexant.
Minnesota: Minnesota has not scheduled lemborexant.
Summary of factual data and analytical methodologies:
The methodology was to schedule lemborexant to conform with the federal Controlled Substances Act.
Analysis and supporting documents used to determine effect on small business or in preparation of economic impact report:
This rule schedules a drug and does not have an effect on small business. The rule draft was published on the department website for 14 days to solicit economic impact comments from small businesses. No comments were received.
Fiscal Estimate and Economic Impact Analysis:
The Fiscal Estimate and Economic Impact Analysis is attached.
Effect on small business:
These proposed rules do not have an economic impact on small businesses, as defined in s. 227.114 (1), Stats. The Department’s Regulatory Review Coordinator may be contacted by email at Daniel.Hereth@wisconsin.gov, or by calling (608) 267-2435. Agency contact person:
Kevyn Radcliffe, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 4822 Madison Yards Way, P.O. Box 8366, Madison, Wisconsin 53708; telephone 608-266-0797; email at DSPSAdminRules@wisconsin.gov. ------------------------------------------------------------------------------------------------------------
TEXT OF RULE
Section 1. CSB 2.74 is created to read:
CSB 2.74 Addition of Lemborexant to schedule IV. Section 961.20 (2) (eqm), Stats., is created to read:
961.20 (2) (eqm) Lemborexant.
Section 2. EFFECTIVE DATE. The rules adopted in this order shall take effect on the first day of the month following publication in the Wisconsin Administrative Register, pursuant to s. 227.22 (2) (intro.), Stats. ------------------------------------------------------------------------------------------------------------
(END OF TEXT OF RULE)
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Dated ___7/9/2021_______ Agency __________________________________
Chairperson
Controlled Substances Board
