Plain language analysis:
This rule schedules Ganaxolone as a schedule V 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 Ganaxolone as a schedule V controlled substance. Pursuant to s. 961.11(4), Stats., the Controlled Substances Board by affirmative action similarly treats Ganaxolone under chapter 961, Stats. by creating the following: CSB 2.95 Addition of Ganaxolone to schedule V. Section 961.22 (11), Stats., is created to read: 961.22 (11) Ganaxolone.
The Affirmative Action order, dated July 20, 2022, took effect on July 25, 2022, when it was published 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 Ganaxolone as a schedule V controlled substance [720 Illinois Compiled Statutes 570/212].
Iowa: Iowa has not listed Ganaxolone as a schedule V controlled substance [Iowa Code 124.212].
Michigan: Michigan has not listed Ganaxolone as a schedule V controlled substance [Michigan Compiled Laws s. 333.7220]. Minnesota: Minnesota has not listed Ganaxolone as a schedule V controlled substance [Minnesota Statutes 152.02 (6)].
Summary of factual data and analytical methodologies:
The methodology was to schedule Ganaxolone 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 rule schedules Ganaxolone as a Schedule V controlled substance which will not have any effect on small business.
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) 266-6795. 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; telephone 608-267-7139; 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 July 14, 2023 to be included in the record of rulemaking proceedings. TEXT OF RULE
Section 1. CSB 2.95 is created to read:
CSB 2.95 Addition of Ganaxolone to schedule V. Section 961.22 (11), Stats., is created to read: 961.22 (11) Ganaxolone.
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)
