Plain language analysis:
This rule schedules Zuranolone as a schedule IV controlled substance. The Controlled Substances Board will promulgate a final rule, without making the determinations or findings required by ss. 961.11(1), (1m), (1r) and (2) or s. 961.19 and omitting the notice of proposed rulemaking, listing Zuranolone as a schedule IV controlled substance. Pursuant to s. 961.11(4), Stats., the Controlled Substances Board by affirmative action similarly treats Zuranolone under chapter 961, Stats. by creating the following: CSB 2.004 Addition of Zuranolone to Schedule IV. Section 961.20 (2) (r), Stats., is created to read: 961.20 (2) (r) Zuranolone.
The Affirmative Action order, dated January 24, 2024, took effect on February 5, 2024, upon publication in the Administrative Register and expires upon promulgation of a final rule.
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 listed Zuranolone as a schedule IV controlled substance [720 Illinois Compiled Statutes 570/210].
Iowa: Iowa has not listed Zuranolone as a schedule IV controlled substance [Iowa Code 124.210].
Michigan: Michigan has not listed Zuranolone as a schedule IV controlled substance [Michigan Compiled Laws s. 333.7218]. Minnesota: Minnesota has not listed Zuranolone as a schedule IV controlled substance [Minnesota Statutes 152.02 (5)].
Summary of factual data and analytical methodologies:
The methodology was to schedule Zuranolone 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 analysis:
The proposed rule was posted for a period of 14 days to solicit public comment on economic impact, including how the proposed rules may affect businesses, local government units, and individuals. 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 Jennifer.Garrett@wisconsin.gov, or by calling (608) 266-2112. Agency contact person:
Nilajah Hardin, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 4822 Madison Yards Way, P.O. Box 8366, Madison, Wisconsin 53708; email at DSPSAdminRules@wisconsin.gov. Place where comments are to be submitted and deadline for submission:
Comments may be submitted to Nilajah Hardin, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 4822 Madison Yards Way, Madison, WI 53708-8366, or by email to DSPSAdminRules@wisconsin.gov. Comments must be received by September 20, 2024 to be included in the record of rulemaking proceedings. ---------------------------------------------------------------------------------------------------------------------
TEXT OF RULE
Section 1. CSB 2.004 is created to read:
CSB 2.004 Addition of Zuranolone to Schedule IV. Section 961.20 (2) (r), Stats., is created to read: 961.20 (2) (r) Zuranolone.
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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