STATE OF WISCONSIN
CONTROLLED SUBSTANCES BOARD
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IN THE MATTER OF RULE-MAKING
:
PROPOSED ORDER OF THE
PROCEEDINGS BEFORE THE
:
CONTROLLED SUBSTANCES BOARD
CONTROLLED SUBSTANCES BOARD
:
ADOPTING RULES
(CLEARINGHOUSE RULE
)
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PROPOSED ORDER
An order of the
Controlled Substances Board
to
create CSB 2.3
8
relating to scheduling
Suvorexant
as a schedule IV controlled substance.
Analysis prepared by the Department of
Safety and Professional Services
.
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ANALYSIS
Statutes interpreted:
s.
961.20
, Stats.
Explanation of agency authority:
961.11(2)
After considering the factors enumerated in sub. (1m), the controlled substances board shall make findings with respect to them and promulgate a rule controlling the substance upon finding that the substance has a potential for abuse.
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:
Summary of, and comparison with, existing or proposed federal regulation:
On August 28, 2014, the United States Food and Drug Administration, Drug Enforcement Administration published its final rule in the Federal Register placing Suvorexant into schedule IV of the federal Controlled Substances Act. The scheduling action was effective September 29, 2014.
Plain language analysis:
The Controlled Substances Board did not receive an objection to treating
Suvorexant
as a schedule IV under ch.
961
, Stats
. based upon the federal scheduling. The Controlled Substances Board took affirmative action on
October 8
, 201
4
to similarly treat
Suvorexant
under chapter 961 effective
November
1, 2014 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
)(
mr
)
, Stats. which adds
Suvorexant
to schedule IV.
Comparison with rules in adjacent states:
Illinois
: Illinois has not scheduled Suvorexant.
Iowa
: Iowa is in the process of promulgating an administrative rule to amend the Iowa statutes to schedule Suvorexant as a schedule IV controlled substance.
Michigan
: Michigan has not scheduled Suvorexant.
Minnesota:
Minnesota has not scheduled
Suvorexant
.
Summary of factual data and analytical methodologies:
The methodology was to schedule
Suvorexant
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
:
None.
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
Tom.Engels
@wisconsin.gov
, or by calling (608) 266-8608.
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 8935, Madison, Wisconsin 53708; telephone 608-
261-2377
; email at
Sharon.Henes
@wisconsin.gov
.
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 8
366
, Madison, WI 53708-8935, or by email to
Sharon.Henes
@wisco
ns
in.gov
. Comments must be received on or before
February 16, 2015
to be included in the record of rule-making proceedings.
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TEXT OF RULE
Section
1. CSB 2.36 is created to read:
CSB 2.36 Addition of
Suvorexant
to schedule IV
. Section
961.20(
2
)(
mr
)
, Stats., is created to read:
961.20(
2
)(
mr
)
Suvorexant
.
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.
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(END OF TEXT OF RULE)
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