Statement of Scope
Controlled Substances Board
Relating to
:
|
Scheduling of
brivaracetam
|
1. Finding/nature of emergency (Emergency Rule only):
N/A
2
.
Detailed description of the objective of the
proposed
rule
:
The objective of the rule is to schedule
brivaracetam
as
a
Schedule
V
controlled
substance.
3
.
Description of the existing policies relevant to the rule, new policies proposed to be included in the rule, and an analysis of policy alternatives
:
On May 12, 2016, the
United States Department of Justice, Drug Enforcement Administration
published its final rule in the Federal Register placing
brivaracetam
into Schedule
V
of the federal Controlled Substances Act.
The scheduling action was effective
May 12, 2016
. The Controlled Substances Board did not receive an objection to similarly treat
brivaracetam
as
a
Schedule
V
controlled substance under
ch.
961
, Stats within 30 days of the date of publication in the Federal Register of the final order designating
brivaracetam
as
a
controlled substance.
Pursuant to s.
961.11(4)
,
Stats.,
the Controlled Substances Board by affirmative action similarly treats
brivaracetam
under chapter 961, Stats.
by
creating the following:
CSB 2.43 Addition of
brivaracetam
to schedule V.
Section
961.22(6)
,
Stats.,
is created to read:
961.22(6)
Brivaracetam
.
Brivaracetam
((2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl
]
butanamide
), including its salts, isomers or salts of isomers.
The Affirmative Action order, dated
September 22
, 2016,
took effect on
September 26
, 2016
to allow for publication in the Administrative Register and expires upon promulgation of a final rule.
4
.
Detailed explanation of statutory authority for the rule
(including
the
statutory citation and language):
961.11 (1)
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
.
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).
5
.
Estimate of amount of time that state employees will spend developing the rule and of other resources necessary to develop the rule
:
25 hours
6
.
List with description of all entities that
may
be affected by the proposed rule
:
Law enforcement, district attorney offices, Dept of Justice, state courts and the Controlled Substances Board
7
.
Summary and preliminary comparison with any existing or proposed federal regulation that is intended to address the activities to be regulated by the proposed rule
:
On May 12, 2016, the
United States Department of Justice, Drug Enforcement Administration
published its final rule in the Federal Register placing
brivaracetam
into Schedule
V
of the federal Controlled Substances Act. The scheduling action was effective on
May 12, 2016.
8
. Anticipated economic impact of implementing the rule
(note if the rule is likely to have a significant economic impact on small businesses)
:
None to minimal. It is not likely to have a significant economic impact on small businesses.
Contact Person:
Sharon Henes, Administrative Rules Coordinator, (608) 261-2377
