NOTICE IS HEREBY GIVEN that pursuant to ss.
961.11 (1) and
961.16, Stats., and according to the procedure set forth in s.
227.16 (2) (e), Stats., the Controlled Substances Board will adopt the following rule as proposed in this notice, without public hearing unless, within 30 days after publication of this notice on September 30, 2010, the Controlled Substances Board is petitioned for a public hearing by 25 natural persons who will be affected by the rule; a municipality which will be affected by the rule; or an association which is representative of a farm, labor, business or professional group which will be affected by the rule.
Submittal of Written Comments
Comments may be submitted to Pamela Haack, Department of Regulation and Licensing, Division of Board Services, 1400 East Washington Avenue, Room 116, P.O. Box 8935, Madison, Wisconsin 53708-8935, or by email at
pamela.haack@wisconsin.gov. Comments must be received on or before
October 15, 2010 to be included in the record of rule-making proceedings.
Analysis Prepared by the Department of Regulation and Licensing
Statutes interpreted
Statutory authority
Explanation of agency authority
The Controlled Substances Board is authorized by s.
961.11 (1), Stats., to add substances to or delete or reschedule substances listed under schedule II, in s.
961.16, Stats., pursuant to the rule-making procedures of ch.
227, Stats.
Related statute or rule
21 CFR Sec. 1308.12 (d) (5)
Plain language analysis
By final rule of the Drug Enforcement Administration (DEA), adopted effective June 4, 2007, lisdexamfetamine was classified as a schedule II controlled substance under the federal Controlled Substances Act (CSA). Lisdexamfetamine has not been so scheduled under the Wisconsin Controlled Substances Act in ch.
961, Stats. The objective of this proposed rule-making is to bring the treatment of this drug into conformity with that at the federal level.
Drugs that are classified as “controlled substances" under federal and state laws are subject to higher civil and criminal penalties for their illicit possession, distribution and use. Health care providers are also subject to greater recordkeeping requirements regarding procuring, prescribing and dispensing of such drugs. This is because certain drugs, like lisdexamfetamine, have a greater likelihood of abuse, addiction and adverse consequences to patient health if utilized inappropriately, than do other drugs.
Lisdexamfetamine is also known by the trade name Vyvanse TM and has the DEA Drug Code 1205. It will be marketed as a prescription drug product for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The DEA found reason to classify Lisdexamfetamine, including its salts, isomers, and salts of isomers, as a schedule II drug based on the following findings:
(1) Lisdexamfetamine has a high potential for abuse;
(2) Lisdexamfetamine has a currently accepted medical use in treatment in the United States; and
(3) Abuse of lisdexamfetamine may lead to severe psychological or physical dependence.
Comparison with federal regulations
21 CFR Sec. 1308.12 (d) (5)
Lisdexamfetamine has been classified as a schedule II controlled substance in the federal Controlled Substances Act since June 4, 2007. This regulation change will make Wisconsin regulations consistent with the federal CSA.
Comparison with rules in adjacent states
Illinois:
Not scheduled. Provisions relating to permit authorization application requirements and renewal: Federal registration is required before activity can occur. Illinois grants an “independent activity" license that expires on December 31 of even-numbered years. A registered person who fails to renew before the expiration date of the registration must apply for a new registration. The registration expires on the date specified. Section 3100, Illinois Rules.
Iowa:
Schedule II Controlled Substance. House File 2167, Sec. 2. Provisions relating to permit authorization application requirements and renewal: Iowa's regulations identify who must register and include application requirements. A $100 late renewal fee is assessed if there is a failure to remit payment by the first day of the month following expiration. Grounds for revocation, suspension and denial are specified. Section 657, Iowa Administrative Code.
Michigan:
Not scheduled.
Provisions relating to permit authorization application requirements and renewal: Michigan requires a research license. Rules deal separately with personal training for euthanasia, thefts and diversion, storage, employees and records. Chapter
338, Michigan Rules.
Minnesota:
As of March 8, 2010, Minnesota classified lisdexamfetamine as a schedule II controlled substance.
Summary of factual data and analytical methodologies
The Wisconsin Controlled Substances Board reviewed the federal rule summary and supplemental information for the scheduling of this substance, and agrees with the conclusions therein regarding the potential for abuse.
Analysis and supporting documents used to determine effect on small business
Since there is no anticipated impact on small business from this rule, no additional compliance, bookkeeping, reporting, recordkeeping or professional skills are required.
Section
227.137, Stats, requires an “agency" to prepare an economic impact report before submitting the proposed rule-making order to the Wisconsin Legislative Council. The Department of Regulation and Licensing is not included as an “agency" in this section.
Anticipated Costs Incurred By Private Sector
The department finds that this rule has no significant fiscal effect on the private sector.
Small Business Impact
These proposed rules will not have any significant economic impact on a substantial number of small businesses, as defined in s.
227.114 (1), Stats. The Department's Regulatory Review Coordinator may be contacted by email at
hector.colon@wisconsin.gov, or by calling (608) 266-8608.
Fiscal Estimate
There is no fiscal impact on the department.
Agency Contact Person
Pamela Haack
Department of Regulation and Licensing
Division of Board Services
1400 East Washington Avenue, Room 116
P.O. Box 8935, Madison, WI 53708-8935
Telephone: (608) 266-0495
Text of Proposed Rule
SECTION 1. CSB 2.35 is created to read:
CSB 2.35 Addition of lisdexamfetamine to schedule II. (1) Section
961.16 (5) (e) is created to read:
Section
961.16 (5) (e) lisdexamfetamine, commonly known as “Vyvanse TM."
Notice of Hearing
Military Affairs
NOTICE IS HEREBY GIVEN that pursuant to s.
321.45 (2), Stats.,the Department of Military Affairs will hold a public hearing on emergency rules and the promulgation of permanent rules to create Chapter
DMA 1, relating to Military Family Financial Aid.
Hearing Information
Date: Wednesday, October 13, 2010
Time: 1:00 p.m. – 2:00 p.m.
Location: MADISON
Witmer Hall
2400 Wright St.
Madison, WI 53704
The public hearing site is accessible to people with disabilities. If you have special needs or circumstances that may make communication or accessibility difficult at the hearing, please contact Randi Milsap at (608) 242-3072.
Copies of Proposed Rule
Copies of the proposed rule will be provided at the public hearing. Copies may also be obtained at no charge by emailing a request to Randi Milsap at
randi.milsap@wisconsin.gov
Submittal of Written Comments
The public record on this proposed rule making will be held open until close of business the day of the hearing to permit the submission of comments in lieu of public hearing testimony or comments supplementing testimony offered at the hearing. Any such comments should be submitted to Randi Milsap, Department of Military Affairs, 2400 Wright St., P. O. Box 14587, Madison, WI 53708-0587. You may also contact Randi Milsap by phone at (608) 242-3072 or email
randi.milsap@wisconsin.gov.
Analysis Prepared by Department of Military Affairs
Statute interpreted
Statutory authority
Explanation of agency authority
The Department of Military Affairs is charged with promulgating rules to administer Military Family Financial Aid under Wis. Stat. 321.45 (2).
Related statute or rule
Plain language analysis
The proposed rule, DMA 1, is being promulgated under the statutory authority of Wis. Stat. s.
321.45 (2) and is designed to provide the process for application and distribution of funds from the military family relief fund for the payment of financial aid to military families as provided under Wis. Stat. s.
20.465 (2) (r).
This rule establishes the eligibility criteria, the amount of financial aid and the application process for military family financial aid. The purpose of the military family financial aid is to provide financial support to service members and their immediate families dealing with emergency situations. The rule requires applicants be a member of the immediate family of a service member, that the service member and the applicant are residents of the state, and that the service member is serving on active duty in the U.S. armed forces.
The application is available free of charge and the fund administrator will make a decision to approve or deny an application within 14 days of the receipt of a completed application. An applicant has 30 days to appeal any final determination by the fund administrator in writing and an addition 30 days to appeal the administrator's decision to the adjutant general.
A governing board comprised of military officials and the fund's executive director will provide oversight of the family aid process, and application records will be archived for 5 years.
Comparison with federal regulations
Each military branch has its own emergency relief organizations. This rule most closely resembles Army Regulation 930-4, which sets out rules for the administration of Army Emergency Relief (AER) assistance.
Active Duty service members, their dependents, some retired service members, and surviving spouses and orphans of service members who died on active duty are eligible to receive aid through AER. Military Family Financial Aid funds are available only to service members on active duty and their immediate family members. Both Army Emergency Relief and Military Family Financial Aid are funded through donations. Military Family Financial Aid will be administered by a Fund Administration committee as the Wisconsin Department of Military Affairs. Army Emergency Relief provides loans and grants to service members, whereas Military Family Financial Aid provides only grants. That aside, the substantive provisions of the Military Family Financial Aid Rule were based in large part on Army Emergency Relief.
Comparison with rules in adjacent states
Illinois:
The Illinois Military Family Relief Fund (IMFRF) is authorized by Title 95 Chapter
2 Part 200 of the Illinois Administrative Code and is funded by a voluntary check off on Illinois individual income tax forms.
