Relating to
Granting a limited special use authorization permit.
Rule Type
Permanent.
1. Finding/Nature of Emergency (Emergency Rule Only)
N/A
2. Detailed Description of the Objective of the Proposed Rule
The objective of the proposed rule is to provide for the Controlled Substance Board to grant a limited special use authorization (SUA).
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
Section
961.335, Stats., provides that the controlled substances board may issue a permit authorizing a person to manufacture, obtain, possess, use, administer, or dispense a controlled substance for purposes of scientific research, instructional activities, chemical analysis, or other special uses, without restriction because of enumeration. Chapter
CSB 3 indicates that the SUA designates the controlled substance(s), amount, and project or use.
The policy to address is to allow the controlled substances board to grant a SUA with limitations rather than outright deny a SUA in specific circumstances. The circumstances may include the following:
• A person having violated the terms of a previous SUA could still obtain a SUA with terms and conditions to address past problems.
• A person that has impairment issues could still obtain a SUA with terms and conditions to address monitoring to ensure no diversion is taking place.
• Limitations placed by the federal government on their Drug Enforcement Administration registration being mirrored by limitations on the SUA.
The alternative to the proposed rule is for the controlled substances board to outright deny an applicant an SUA instead of granting a SUA.
4. Detailed Explanation of Statutory Authority for the Rule (Including the Statutory Citation and Language)
Section
961.335 (8), Stats.
The controlled substances board may promulgate rules relating to the granting of special use permits including, but not limited to, requirements for the keeping and disclosure of records other than those that may be withheld under sub. (7) submissions of protocols, filing of applications and suspension or revocation of permits.
5. Estimate of Amount of Time that State Employees Will Spend Developing the Rule and of Other Resources Necessary to Develop the Rule
75 hours
6. List with Description of all Entities that may be Affected by the Proposed Rule
Applicants for special use authorization permits.
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
Federal regulations requires any person who possess, manufactures, distributes or dispenses any controlled substances to register with the US Department of Justice, Drug Enforcement Administration, Office of Diversion Control. The proposed rule would allow the controlled substances board to mirror any limitations placed by the federal government on a person's DEA registration.
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 economic impact.
9. Contact Person
Sharon Henes, (608) 261-2377.
Safety and Professional Services —
Controlled Substances Board
This statement of scope was approved by the governor on May 17, 2013.
Rule No.
Relating to
Denial of special use authorization permit.
Rule Type
Permanent.
1. Finding/Nature of Emergency (Emergency Rule Only)
N/A.
2. Detailed Description of the Objective of the Proposed Rule
The proposed rule will identify the basis on which a person may be denied a special use authorization permit (SUA).
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
Section
961.335, Stats., provides that the controlled substances board may issue a permit authorizing a person to manufacture, obtain, possess, use, administer, or dispense a controlled substance for purposes of scientific research, instructional activities, chemical analysis, or other special uses, without restriction because of enumeration. While Administrative Code ch.
CSB 3 indicates the requirements for submitting an application for the special use authorization permit, the rule does not provide for the basis for which the controlled substances board may exercise its discretion and deny a person a special use authorization permit. The proposed rule will identify the basis on which a person may be denied a special use authorization permit.
The alternative to the rule is for the controlled substances board to deny an applicant on a basis for which the person was not given notice a denial could be the result or for the controlled substances board to appear arbitrary in its denials of applications.
4. Detailed Explanation of Statutory Authority for the Rule (Including the Statutory Citation and Language)
Section
961.335 (8), Stats.
The controlled substances board may promulgate rules relating to the granting of special use permits including, but not limited to, requirements for the keeping and disclosure of records other than those that may be withheld under sub. (7) submissions of protocols, filing of applications and suspension or revocation of permits.
5. Estimate of Amount of Time that State Employees Will Spend Developing the Rule and of Other Resources Necessary to Develop the Rule
75 hours.
6. List with Description of all Entities that may be Affected by the Proposed Rule
Applicants for special use authorization permits.
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
Federal regulations requires any person who possess, manufactures, distributes or dispenses any controlled substances to register with the US Department of Justice, Drug Enforcement Administration, Office of Diversion Control. The proposed rule would consider the criteria used by the federal government in granting/denying a DEA registration in that once the special use authorization permit is granted, the person would also need DEA registration.
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 economic impact
9. Contact Person
Sharon Henes, (608) 261-2377.
Safety and Professional Services —
Dentistry Examining Board
This statement of Scope was approved by the governor on June 19, 2013.
Rule No.
Relating to
Training unlicensed persons.
Rule Type
Permanent.
1. Finding/Nature of Emergency (Emergency Rule Only)
N/A.
2. Detailed Description of the Objective of the Proposed Rule
Chapter
DE 12, delegation of functions to unlicensed persons, has not been revised since 1991. The Dentistry Examining Board requests to repeal the requirements for the submittal of a form to verify a dentist's training and delegation of any dental procedure to an unlicensed person. In practice this process has not been followed and no form was approved by the board for such reporting or verification. Sections
447.065 and
447.06, Stats., provide authority to delegate procedures to unlicensed persons; this section does not mandate the maintenance of verifiable records or the use of a board-approved form to verify such delegation; in addition, the dentist delegating such functions is responsible for the unlicensed person's performance. Other minor corrections to this chapter, such as formatting and correcting typographical errors, may be included in this proposed rule revision.
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
The deletion of this procedure will represent current practice, makes the rule consistent with statutory authority and no new policy is being established.
Leaving the existing rule language in s.
DE 12.02 would not represent current practice and may burden the Dentistry Examining Board with the possible need to review such documentation, if and when submitted.
4. Detailed Explanation of Statutory Authority for the Rule (Including the Statutory Citation and Language)
Section
15.08 (5) (b), Stats., requires all examining boards to “
…promulgate rules for its own guidance and for the guidance of the trade or profession to which it pertains, and define and enforce professional conduct and unethical practices not inconsistent with the law relating to the particular trade or profession."
Section
227.11 (2) (a), Stats., authorizes all agencies to promulgate rules interpreting the statutes it enforces or administers, when deemed necessary to effectuate the purpose of such statutes.
Section
447.065(1), Stats., authorizes a dentist who is licensed to practice
dentistry under this chapter to delegate to an individual who is not licensed under this chapter only the performance of remediable procedures, and only if specific conditions are met.
Section
447.065 (3), Stats., authorizes a dentist who delegates to another individual the performance of any practice or remediable procedure be responsible for that individual's performance of that such practice or procedure.
5. Estimate of Amount of Time that State Employees Will Spend Developing the Rule and of Other Resources Necessary to Develop the Rule
The department estimates that approximately 60 hours will be needed to perform the review and develop any needed rule changes. This time includes meeting with the Dentistry Examining Board, drafting the rule changes and processing the changes through public hearing, legislative review, and adoption. The department will assign existing staff to perform the review and develop the rule changes; no other resources will be needed.
6. List with Description of all Entities that may be Affected by the Proposed Rule
Licensees and the Dentistry Examining 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
An Internet-based search of the U.S. Code and Federal Register did not reveal any laws or proposals related to the training of unlicensed persons by dentists or verification forms of such training.
8. Anticipated Economic Impact of Implementing the Rule (Note if the Rule is likely to Have a Significant Economic Impact on Small Businesses)
The Department believes that proposed revisions under chapter DE 12 will have no economic impact on small business.
9. Contact Person
Jean MacCubbin, (608) 266-0955.
Safety and Professional Services —
Pharmacy Examining Board
