TITLE 1. ADMINISTRATION
STATE BOARD OF ELECTIONS
Report of Findings
Pursuant to §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the State Board of Elections conducted a periodic review and a small business impact review of 1VAC20-20, General Administration, and determined that this regulation should be amended. The department is publishing its report of findings dated January 19, 2022, to support this decision.
The regulation is necessary for the protection of the public health, safety, and welfare as it is coincides with statutory mandates that prescribe the State Board of Elections (SBE) and the Department of Elections' (ELECT's) organization to ensure the efficient and effective administration of elections. The regulation is clearly written and easily understandable.
ELECT recommends this regulation remain in effect with amendments. The amendments to this regulation reflect the structural changes after the creation of ELECT and the increase in membership of the SBE. The Commissioner of ELECT handles administrative matters for the SBE.
This regulation is authorized by statute. ELECT has determined this regulation is effective as amended and does not burden small businesses. There are no further known overlaps or conflicts with federal or state law.
Contact Information: Ashley Coles, Agency Regulatory Coordinator, Department of Elections, Washington Building, 1100 Bank Street, First Floor, Richmond, VA 23219.
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TITLE 12. HEALTH
STATE BOARD OF BEHAVIORAL HEALTH AND DEVELOPMENTAL SERVICES
Report of Findings
Pursuant to §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the State Board of Behavioral Health and Developmental Services conducted a periodic review and a small business impact review of 12VAC35-105, Rules and Regulations for Licensing Providers by the Department of Behavioral Health and Developmental Services, and determined that this regulation should be amended. The department is publishing its report of findings dated February 15, 2022, to support this decision.
This regulation is necessary to carry out the licensure requirements of Title 37.2 of the Code of Virginia and meets the requirements of Executive Order 14 (2018) in that the regulation helps to protect the health, safety, and welfare of individuals needing licensed services as it articulates specific standards for licensing of organizations and facilities that provide behavioral health and developmental disability services. The structure of the regulation is straightforward.
Related to this periodic review, an overhaul of this regulation has been underway since the last periodic review. Three of six planned draft chapters (one general chapter and five service-specific chapters) were published for public comment in May 2021 and can be viewed at https://www.townhall.virginia.gov/L/GeneralNotice.cfm?BoardID=65&DateSelection=Expired.
The regulation is needed to carry out the licensure requirements in Title 37.2 of the Code of Virginia. The nature of complaints or comments received concerning the regulation during the periodic review related to one specific situation and termination and discharge criteria set by providers. The complexity of the regulation is straightforward. It articulates specific standards for licensing of organizations and facilities that provide behavioral health and developmental disability services. The regulation is intended to establish structures for the health, safety, and welfare of some of Virginia's most vulnerable citizens; therefore, some parts of the regulation are more detailed by necessity to help ensure the safety standards.
There are parts of the regulation that are closely associated with regulations from the Department of Health Professions Board of Counseling, the Virginia Department of Health, and the Department of Medical Assistance Services, but the regulation does not overlap, duplicate, or conflict with federal or state law or regulation. The regulation was evaluated four years ago and an overhaul of the regulation has been underway since that time. Technology, economic conditions, or other factors changed during the pandemic. While the department anticipates some of these factors will someday return to their pre-pandemic status, there is also an understanding that some systemic changes resulting from COVID may be more permanent. The overhaul of the Licensing Regulations will address any permanent changes.
The agency's decision to amend the chapter may minimize the economic impact of the regulation on small businesses by clarifying expectations for providers. The agency's decision to amend the chapter may also cause an economic impact on small businesses as a goal of the overhaul is to raise the bar of licensing.
Contact Information: Ruth Anne Walker, Director of Regulatory Affairs, Department of Behavioral Health and Developmental Services, Jefferson Building, 1220 Bank Street, 4th Floor, Richmond, VA 23219, telephone (804) 385-6549.
Report of Findings
Pursuant to §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the State Board of Behavioral Health and Developmental Services conducted a periodic review and a small business impact review of 12VAC35-115, Regulations to Assure the Rights of Individuals Receiving Services from Providers Licensed, Funded, or Operated by the Department of Behavioral Health and Developmental Services, and determined that this regulation should be amended. The department is publishing its report of findings dated February 14, 2022, to support this decision.
This regulation is necessary to carry out the human rights requirements of Chapter 4 (§ 37.2-400 et seq.) of Title 37.2 of the Code of Virginia and meets the requirements of Executive Order 14 (2018) in that the regulation helps to protect the health, safety, and welfare of individuals receiving services as it provides clarity for individuals, providers, and other stakeholders about the structure for support of assured rights and establishes procedures when these rights are violated or are in dispute. The structure of the regulation is straightforward and succinct and written to provide clarity for providers and individuals receiving services.
There are amendments expected in an action to be brought for promulgation in 2022, to clarify processes and provide stakeholders with information necessary to help assure the rights of individuals receiving services from providers licensed, funded, or operated by the Department of Behavioral Health and Developmental Services. The planned amendments will also identify and amend any incorrect, incomplete, or outdated legal references.
The regulation is needed to carry out the human rights requirements of Chapter 4 of Title 37.2 of the Code of Virginia. One comment was received concerning the regulation. The regulation is straightforward and minimal while meeting requirements for establishing a structure for helping to assure the rights of individuals receiving services. The regulation does not overlap, duplicate, or conflict with federal or state law or regulation. It has been four years since the regulation was reviewed; technology, economic conditions, or other factors have not changed in the area affected by the regulation.
The agency's decision will have no economic impact on small businesses. Planned amendments are to make the regulation clearer to understand, which would help providers.
Contact Information: Ruth Anne Walker, Director of Regulatory Affairs, Department of Behavioral Health and Developmental Services, Jefferson Building, 1220 Bank Street, 4th Floor, Richmond, VA 23219, telephone (804) 225-2252.
Report of Findings
Pursuant to §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the State Board of Behavioral Health and Developmental Services conducted a periodic review and a small business impact review of 12VAC35-190, Regulations for Voluntary Admissions to State Training Centers, and determined that this regulation should be amended. The department is publishing its report of findings dated February 15, 2022, to support this decision.
This regulation is necessary to carry out the requirements of § 37.2-806 B of the Code of Virginia and meets the requirements of Executive Order 14 (2018) in that the regulation helps to protect the health, safety, and welfare of individuals needing training centers services as the regulation (i) clearly articulates criteria and procedures required to admit a person to an intellectual disability training center; (ii) clearly defines due process protections afforded to persons with intellectual disability who are being admitted to a training center and to their families; and (iii) helps to ensure that training center admission procedures are minimally intrusive for individuals and their families and have the minimum possible cost to training centers.
There are amendments expected in an action to be brought for promulgation in 2022, primarily to add two definitions and have the regulations reflect the current admissions practice since the last update in 2018. Namely, the planned action would add "community resource consultant," and "Critical and Complex Consultation Team" or "C3T."
The regulation is needed to carry out the requirements of § 37.2-806 B of the Code of Virginia. One comment was received concerning the regulation. The regulation is straightforward and minimal while meeting requirements for admission processes. The regulation does not overlap, duplicate, or conflict with federal or state law or regulation. It has been four years since the regulation was reviewed; technology, economic conditions, or other factors have not changed in the area affected by the regulation.
The agency's decision will have no economic impact on small businesses.
Contact Information: Ruth Anne Walker, Director of Regulatory Affairs, Department of Behavioral Health and Developmental Services, Jefferson Building, 1220 Bank Street, 4th Floor, Richmond, VA 23219, telephone (804) 225-2252.
Report of Findings
Pursuant to §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the State Board of Behavioral Health and Developmental Services conducted a periodic review and a small business impact review of 12VAC35-200, Regulations for Emergency and Respite Care Admission to State Training Centers, and determined that this regulation should be amended. The department is publishing its report of findings dated February 15, 2022, to support this decision.
This regulation is necessary to carry out the requirements of § 37.2-807 of the Code of Virginia and meets the requirements of Executive Order 14 (2018) in that the regulation helps protect the health, safety, and welfare of individuals needing emergency and respite care training centers services as the regulation (i) clearly articulates requirements that must be met to access emergency services and respite care in an intellectual disability training center and (ii) helps to ensure that procedures for obtaining emergency services and respite care in a training center are minimally intrusive for individuals and their families. The structure of the regulation is straightforward and succinct.
There are amendments expected in an action to be brought for promulgation in 2022, primarily to add two definitions and have the regulations reflect the current admissions practice since the last update in 2018. Namely, the planned action would add "community resource consultant," and "Critical and Complex Consultation Team" or "C3T."
The regulation is needed to carry out the requirements of § 37.2-807 of the Code of Virginia. One comment was received concerning the regulation. The regulation is straightforward and minimal while meeting requirements for emergency and respite admission processes. The regulation does not overlap, duplicate, or conflict with federal or state law or regulation. It has been four years since the regulation was reviewed; technology, economic conditions, or other factors have not changed in the area affected by the regulation.
The agency's decision will have no economic impact on small businesses.
Contact Information: Ruth Anne Walker, Director of Regulatory Affairs, Department of Behavioral Health and Developmental Services, Jefferson Building, 1220 Bank Street, 4th Floor, Richmond, VA 23219, telephone (804) 225-2252.
Report of Findings
Pursuant to §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the State Board of Behavioral Health and Developmental Services conducted a periodic review and a small business impact review of 12VAC35-210, Regulations to Govern Temporary Leave from State Facilities, and determined that this regulation should be amended. The department is publishing its report of findings dated February 15, 2022, to support this decision.
This regulation is necessary to carry out the requirements of § 37.2-837 of the Code of Virginia and meets the requirements of Executive Order 14 (2018) in that the regulation helps to protect the health, safety, and welfare of individuals needing state facility services as the regulation clearly articulates the general process and requirements related to temporary leave from state facilities. The regulation establishes the conditions for granting leave and includes provisions to ensure accountability and appropriate care for persons who are on leave status.
There are amendments expected in an action to be brought for promulgation in 2022, including clarifications around the role of authorized representatives.
The regulation is needed to carry out the requirements of § 37.2-837 of the Code of Virginia. One comment was received concerning the regulation. The regulation is straightforward and minimal while establishing requirements for leave from state facilities. The regulation does not overlap, duplicate, or conflict with federal or state law or regulation. It has been four years since the regulation was reviewed; technology, economic conditions, or other factors have not changed in the area affected by the regulation.
The agency's decision will have no economic impact on small businesses.
Contact Information: Ruth Anne Walker, Director of Regulatory Affairs, Department of Behavioral Health and Developmental Services, Jefferson Building, 1220 Bank Street, 4th Floor, Richmond, VA 23219, telephone (804) 225-2252.
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TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
BOARD OF PHARMACY
Report of Findings
Pursuant to §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the Board of Pharmacy conducted a periodic review and a small business impact review of 18VAC110-40, Regulations Governing Collaborative Practice Agreements, and determined that this regulation should be retained as is. The department is publishing its report of findings dated February 10, 2022, to support this decision.
Provisions of 18VAC110-40 were initially effective in January of 2001 to implement legislation passed in 1999. The regulation was amended in 2007 for clarification and adoption of less burdensome requirements and was amended again in 2014 and 2020 to incorporate changes in the enabling legislation. The regulation continues to be effective in protecting the public by setting rules for agreements between pharmacists and practitioners to ensure prescribing and dispensing of drugs to patients are efficacious. Whenever amendments are promulgated, language is reviewed to ensure that it is clearly written and easily understandable.
The board has recommended that the regulation be retained without amendments at this time.
There is a continued need for the regulation since § 54.1-3300.1 of the Code of Virginia provides: "The Boards of Medicine and Pharmacy shall jointly develop and promulgate regulations to implement the provisions of this section and to facilitate the development and implementation of safe and effective collaborative agreements between the appropriate practitioners and pharmacists. The regulations shall include guidelines concerning the use of protocols, and a procedure to allow for the approval or disapproval of specific protocols by the Boards of Medicine and Pharmacy if review is requested by a practitioner or pharmacist." Such regulation can only occur through the continuation of 18VAC110-40.
The board has not received any of complaints or comments concerning the regulation. Practitioners do not find the regulation to be overly complex, but the board is always open to comment on whether requirements could be simplified or clarified. There is no overlap, duplication, or conflict with federal or state law or regulation. The board has continually updated regulations while protecting the safety, integrity, and efficacy of dispensing medications.
Contact Information: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4456.
Report of Findings
Pursuant to §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the Board of Pharmacy conducted a periodic review and a small business impact review of 18VAC110-50, Regulations Governing Wholesale Distributors, Manufacturers, Third-Party Logistics Providers, and Warehousers, and determined that this regulation should be retained as is. The department is publishing its report of findings dated February 10, 2022, to support this decision.
In 2006, it was determined that Regulations Governing the Practice of Pharmacy (18VAC110-20) had become so extensive and complex that the board proposed the adoption of a new chapter, 18VAC110-50, to incorporate the regulations for wholesale distributors, manufacturers, third-party logistics providers, and warehousers and to delete requirements for those entities in 18VAC110-20.
The regulation has been amended 12 times since 2006 to clarify provisions, add protections against counterfeiting of drugs in the wholesale market, and regulate third party logistic providers as mandated by the Code of Virginia. Whenever amendments are promulgated, language is reviewed to ensure that it is clearly written and easily understandable.
The board has recommended that the regulation be retained without amendments at this time.
There is a continued need for the regulation as the Code of Virginia requires these facilities to be regulated and for the board to promulgate such regulations relating to the storage, handling, and distribution of prescription drugs as necessary to prevent diversion of prescription drugs, and to protect the public. Such regulation can only occur through the continuation of 18VAC110-50.
The board has not received any complaints or comments concerning the regulation. Facilities regulated by 18VAC110-50 do not find the regulation to be overly complex, but the board is always open to comment on whether requirements could be simplified or clarified. There is no overlap, duplication, or conflict with federal or state law or regulation. Manufacturers are required to follow the federal rule, Good Manufacturing Practice for Finished Pharmaceuticals regulations set forth in 21 CFR Part 211. The board has continually updated regulations while protecting the safety, integrity, and efficacy of dispensing medications.
Contact Information: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4456.
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TITLE 22. SOCIAL SERVICES
STATE BOARD OF SOCIAL SERVICES
Report of Findings
Pursuant to §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the State Board of Social Services conducted a periodic review and a small business impact review of 22VAC40-141, Licensing Standards for Independent Foster Homes, and determined that this regulation should be retained as is. The department is publishing its report of findings dated February 16, 2022, to support this decision.
The regulation meets the criteria set out in Executive Order 14 (2018), as amended. The regulation is necessary for the protection of public health, safety, and welfare of children receiving care, maintenance, protection, and guidance by an independent foster home.
The State Board of Social Services recommends that this regulation remain in effect without change, as there have been no changes to the law on which it is based. There are no licensed independent foster home providers in the state.
The regulation is necessary for the protection of public health, safety, and welfare of the children placed in independent foster homes. No public comments were received. The regulation is concise and understandable. The regulation does not overlap or duplicate any other federal or state law. While this regulation has not been amended recently, there are no licensed providers that use this regulation and no changes are needed. This regulation has no impact on existing or potential Virginia employers’ ability to maintain and increase the number of jobs in the Commonwealth. The regulation neither impacts small businesses nor includes limitations or requirements for small businesses. There is no cost to the general public.
Contact Information: Tammy Trestrail, Department of Social Services, 801 East Main Street, Richmond, VA 23219, telephone (804) 726-7132.