: (CLEARINGHOUSE RULE 20-076)
An order of the Controlled Substances Board to create CSB 2.74 relating to scheduling of lemborexant.
Analysis prepared by the Department of Safety and Professional Services.
Statutes interpreted: s. 961.20, Stats.
Statutory authority: ss. 961.11 (1) and (4), Stats.
Explanation of agency authority:
The controlled substances board shall administer this subchapter and may add substances to or delete or reschedule all substances listed in the schedules in ss. 961.14, 961.16, 961.18, 961.20 and 961.22 pursuant to the rule-making procedures of ch. 227. [s. 961.11 (1), Stats.]
If a substance is designated, rescheduled or deleted as a controlled substance under federal law and notice thereof is given to the controlled substances board, the board by affirmative action shall similarly treat the substance under this chapter after the expiration of 30 days from the date of publication in the federal register of a final order designating the substance as a controlled substance or rescheduling or deleting the substance or from the date of issuance of an order of temporary scheduling under 21 USC 811 (h), unless within that 30−day period, the board or an interested party objects to the treatment of the substance. If no objection is made, the board shall promulgate, without making the determinations or findings required by subs. (1), (1m), (1r) and (2) or s. 961.13, 961.15, 961.17, 961.19 or 961.21, a final rule, for which notice of proposed rulemaking is omitted, designating, rescheduling, temporarily scheduling or deleting the substance. If an objection is made the board shall publish notice of receipt of the objection and the reasons for objection and afford all interested parties an opportunity to be heard. At the conclusion of the hearing, the board shall make a determination with respect to the treatment of the substance as provided in subs. (1), (1m), (1r) and (2) and shall publish its decision, which shall be final unless altered by statute. Upon publication of an objection to the treatment by the board, action by the board under this chapter is stayed until the board promulgates a rule under sub. (2). [s. 961.11 (4), Stats.]
Related statute or rule: s. 961.14, Stats.
Plain language analysis:
The Controlled Substances Board did not receive an objection to treating lemborexant as a schedule IV controlled substance under ch. 961, Stats., based upon the federal scheduling. The Controlled Substances Board took affirmative action on May 8, 2020 to similarly treat lemborexant under chapter 961 effective May 18, 2020 to allow for publication in the Administrative Register. The Affirmative Action Order will expire upon promulgation of a final rule.
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.
Links to Admin. Code and Statutes in this Register are to current versions, which may not be the version that was referred to in the original published document.