CR 15-068 Rule Text

STATE OF WISCONSIN

CONTROLLED SUBSTANCES BOARD

--------------------------------------------------------------------------------------------------------------------- IN THE MATTER OF RULE-MAKING : PROPOSED ORDER OF THE

PROCEEDINGS BEFORE THE : CONTROLLED SUBSTANCES BOARD CONTROLLED SUBSTANCES BOARD : ADOPTING RULES

: (CLEARINGHOUSE RULE )

--------------------------------------------------------------------------------------------------------------------- PROPOSED ORDER

An order of the Controlled Substances Board to create CSB 2.39 relating to exclusion of naloxegol.

Analysis prepared by the Department of Safety and Professional Services.

--------------------------------------------------------------------------------------------------------------------- ANALYSIS

Statutes interpreted: s. 961.20, Stats.

Statutory authority: s. 961.11 (4), Stats.

Explanation of agency authority:

961.11(4) 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).

Related statute or rule: N/A

Summary of, and comparison with, existing or proposed federal regulation:

On January 23, 2015, the United States Department of Justice, Drug Enforcement Administration published its final rule in the Federal Register removing naloxegol from schedule II of the federal Controlled Substances Act. The scheduling action was effective January 23, 2015.

Plain language analysis:

The Controlled Substances Board did not receive an objection to excluding naloxegol as a schedule II under ch. 961, Stats. based upon the federal scheduling. The Controlled Substances Board took affirmative action on March 25, 2015 to similarly exclude naloxegol under chapter 961 effective April 1, 2015 to allow for publication in the Administrative Register. The Affirmative Action Order will expire upon promulgation of a final rule.

This rule amends 961.16(2)(a)(intro), Stats. which excludes naloxegol from schedule II.

Comparison with rules in adjacent states:

Illinois: Illinois does not exclude naloxegol from scheduling.

Iowa: Iowa does not exclude naloxegol from scheduling.

Michigan: Michigan does not exclude naloxegol from scheduling. Minnesota: Minnesota has a bill to exclude naloxegol from scheduling. Summary of factual data and analytical methodologies:

The methodology was to remove naloxegol from scheduling 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:

This rule was posted for 14 days for economic comments and none 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 [e-mail], or by calling [phone].

Agency contact person:

Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Board Services, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, Wisconsin 53708; telephone [phone]; email at [e-mail].

Place where comments are to be submitted and deadline for submission:

Comments may be submitted to Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Board Services, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, WI 53708-8935, or by email to [e-mail]. Comments must be received on or before October 2, 2015 to be included in the record of rule-making proceedings.