Title of Regulation: 22VAC30-50. Policies and Procedures for Administering the Commonwealth Neurotrauma Initiative Trust Fund (amending 22VAC30-50-10, 22VAC30-50-20, 22VAC30-50-30, 22VAC30-50-50 through 22VAC30-50-110; adding 22VAC30-50-120).

Statutory Authority: §§ 51.5-12.4 and 51.5-14 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comments: Public comments may be submitted until 5 p.m. on February 22, 2009.

Agency Contact: Vanessa S. Rakestraw, Policy Analyst, Department of Rehabilitative Services, 8004 Franklin Farms Drive, Richmond, VA 23229, telephone (804) 662-7612, FAX (804) 662-7696, TTY (800) 464-9950, or email vanessa.rakestraw@drs.virginia.gov.

Basis: Section 51.5-12.4 of the Code of Virginia requires the Commissioner of Rehabilitative Services to promulgate regulations establishing procedures and policies for soliciting and receiving grant applications and criteria for reviewing and ranking such applications. Section 51.5-14 grants general authority to the commissioner to promulgate regulations necessary to carry out the laws of the Commonwealth administered by the department.

Purpose: The regulations to administer the Commonwealth Neurotrauma Initiative (CNI) Trust Fund are essential to the integrity of the program. The CNI Trust Fund is designed to promote medical research into traumatic brain and spinal cord injuries and to provide treatment and care for individuals who have sustained such injuries. Moneys in the trust fund are to be used solely to support grants for Virginia-based researchers, organizations, and institutions that either conduct research into the mechanism of neurotrauma or that provide medical or rehabilitative treatment and care for individuals with such injuries. The amendment to this regulation will clarify that the fund is to be used for innovative research and treatment programs and is not to be used as a source for long-term funding. The amended regulation will also provide that the commissioner can reallocate a limited amount of unexpended balances to fund new research in the area of neurotrauma.

Substance: Most sections in this regulation contain only minor technical changes. The following sections contain substantive changes:

22VAC30-50-30 - Title of catchline has been changed to "Disbursement of funds" to more adequately describe this section. A phrase that funds are to be used for the development of innovative, model programs and services for individuals with neurotrauma has been added. Wording has been changed to ensure that "person first" language is used in the regulations.

22VAC30-50-60 - Section has been amended deleting the timeline for release of a request for proposals to allow more leniency to applicants or the advisory board in the deadline due date.

22VAC30-50-70 - Title of catchline has been streamlined from "Appointment of grant reviewers and technical advisors" to "Grant reviewers and technical advisors." The restriction that the chairperson of the advisory board of the Commonwealth Neurotrauma Initiative Trust Fund not be able to vote on applications for funds when reviewers and advisors sit as a committee has been removed.

22VAC30-50-80 - Section has been amended to stress that grant funds for rehabilitative services are to be used for the development of innovative, community-based rehabilitation programs and services and that when grant funds are not to be used for the long-term funding of research projects or service programs.

22VAC30-50-90 - Review of applications; stated priorities. This section has been amended to state that the advisory board may fund applicants who seek funds for research projects relevant to rehabilitative as well as medical inquiry. Additionally the detail under Option B was modified in an attempt to make submission requirements clear.

22VAC30-50-100 - Reviewing and ranking grant applications. The inclusion of an itemized list of weighted criteria with point values assigned to each criterion has been changed to an unweighted list of criteria, with specific point values to be assigned in the individual requests for proposals.

22VAC30-50-110 - Amount of grant awards; duration and availability of funding. A statement was added that provides that the selection of successful applications will be based on available moneys in the fund, the review and ranking of the applications by the advisory board, as well as information from grant reviewers or technical advisors appointed by the board.

22VAC30-50-120 - Unexpended funds. This new section has been added as the result of a 2005 budget amendment, which states that the commissioner may reallocate up to $500,000 from unexpended balances in the Commonwealth Neurotrauma Initiative Trust Fund to fund new grant awards for research on traumatic brain and spinal cord injuries.

Issues: The proposed regulatory action will provide citizens, applicants, consumers of services and their advocates with information on the Commonwealth Neurotrauma Initiative Trust Fund. The primary advantage of this regulatory action is that the integrity of the Commonwealth Neurotrauma Initiative Trust Fund will be maintained. This action provides an objective means of reviewing and ranking applications to the fund while allowing for flexibility in distributing the funds during times of economic change. No disadvantages to the public or the Commonwealth have been identified.

The Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The proposed changes will remove the assigned weights to the criteria that are used in reviewing and ranking grant applications, incorporate a legislative change occurred in 2004, and make numerous editorial and formatting changes.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. These regulations set out the rules for the Commonwealth Neurotrauma Initiative Trust Fund (CNI). The CNI Trust Fund is a non-reverting fund established to provide grants for up to three years to recipients who engage in research pertaining to brain and spinal cord injuries or recipients who provide community services to individuals who have suffered brain or spinal cord injuries. The fund receives moneys from the Virginia Department of Motor Vehicles from persons who apply for reinstatement of their drivers’ licenses after being convicted of certain specified dangerous driving offenses.¹

One of the proposed changes will remove the assigned weights to the criteria that are used in reviewing and ranking grant applications. This change is expected to allow evaluators to place greater emphasis on criteria that are most relevant for a specific research or community service project and give them greater discretion on ranking grant applications. As the importance of each criterion would be different for each specific project, this change is expected to produce net benefits.

Another proposed change will incorporate in the regulations a budget provision enacted during the 2004 General Assembly session stating that the Department of Rehabilitative Services Commissioner may reallocate up to $500,000 from unexpended balances in the CNI Trust Fund to fund new grand awards. Also, proposed changes include numerous changes that are technical and/or clarifying in nature such as re-arranging sections and updating current language. None of these changes are expected to create any significant change in practice. Thus, no significant costs or benefits are expected from these changes other than improving the clarity and consistency of the regulations.

Businesses and Entities Affected. These regulations primarily affect grant applicants. In 2007, there were seven applications from the University of Virginia, thirteen from the Virginia Commonwealth University, and one from another entity.

Localities Particularly Affected. The proposed regulations apply throughout the Commonwealth.

Projected Impact on Employment. No significant impact on employment is expected.

Effects on the Use and Value of Private Property. No significant impact on the use and value of private property is expected.

Small Businesses: Costs and Other Effects. No significant costs and other effects on small businesses are expected.

Small Businesses: Alternative Method that Minimizes Adverse Impact. No adverse impact on small businesses is expected.

Real Estate Development Costs. No adverse impact on real estate development costs is expected.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 36 (06). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB’s best estimate of these economic impacts.

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¹ These offenses include: DUI-related offenses, hit-and-run, reckless driving, and failure to comply with conditions imposed upon license probation for driving offenses.

Agency's Response to the Department of Planning and Budget's Economic Impact Analysis: The Department of Rehabilitative Services concurs with the economic impact analysis completed by the Department of Planning and Budget on July 1, 2008.

Summary:

The proposed amendments (i) clarify that the Commonwealth Neurotrauma Initiative Trust Fund is to be used for innovative research and treatment programs and is not to be used as a source for long-term funding; (ii) remove the assigned weights to the criteria that are used in reviewing and ranking grant applications; (iii) provide that the commissioner can reallocate a limited amount of unexpended balances to fund new research in the area of neurotrauma; and (iv) make clarification and editorial changes.

Part I
Definitions and General Information

22VAC30-50-10. Definitions.

The following words and terms when used in this chapter shall have the following meaning unless the context clearly indicates otherwise:

"Advisory board" means the Commonwealth Neurotrauma Initiative Advisory Board.

"Fund" means the Commonwealth Neurotrauma Initiative Trust Fund.

"Neurotrauma" means an injury to the central nervous system, i.e., a traumatic spinal cord or brain injury, which results in loss of physical functions, cognitive functions or both.

"RFP" or "request" means a request for proposals published issued by the advisory board seeking applications for grant moneys in the fund.

22VAC30-50-20. Statement of general policy.

The Commonwealth of Virginia has recognized the need to prevent traumatic spinal cord and brain injuries and is committed to improve improving the treatment and care of Virginians with traumatic spinal cord and brain injuries. By creating the fund and authorizing the advisory board to administer the fund, the Commonwealth makes grant funds available to Virginia-based organizations, institutions and researchers funds to address these needs. The advisory board seeks to administer administers the fund in order to carry out the intent of the law in accordance with its authority.

22VAC30-50-30. Purpose of chapter Disbursement of funds.

A. This chapter serves to (i) establish policies and procedures for soliciting and receiving applications for grants from the fund, (ii) establish criteria for reviewing and ranking such applications, and (iii) establish procedures for distributing moneys in the fund, which shall be used solely to provide grants to Virginia-based organizations, institutions, and researchers.

B. Forty-seven and one-half percent of the moneys shall be allocated for research on the mechanisms and treatment of neurotrauma; 47-1/2% of the moneys shall be allocated for rehabilitative services, i.e., the development of innovative, model community-based rehabilitative programs and services for injured individuals with neurotrauma; and 5.0% of the moneys shall be allocated for the Department of Rehabilitative Services' costs for administering and staffing the Commonwealth Neurotrauma Initiative Advisory Board Trust Fund and advisory board. Those applications for grants to conduct research on the mechanisms and treatment of neurotrauma shall be identified as Option A applications. Those applications for grants to provide rehabilitative services shall be identified as Option B applications.

22VAC30-50-50. Application of an exemption to the Virginia Freedom of Information Act.

Pursuant to a provision of the Virginia Freedom of Information Act, Chapter 37 (§ 2.2-3700 et seq.) of Title 2.2 of the Code of Virginia, records submitted to the advisory board as a grant application, or accompanying a grant application, to the advisory board pursuant to the law and this chapter are excluded from the requirement of open inspection to the extent that they contain medical or mental records or other data identifying individual patients, or proprietary business or research-related information produced or collected by an applicant in the conduct of or as a result of study or research on medical, rehabilitative, scientific, technical or scholarly issues,. This exemption shall apply when such information has not been publicly released, published, copyrighted or patented, if the disclosure of such information would be harmful to the competitive position of the applicant. The advisory board intends to rely upon this exemption in order to encourage the submission of applications.

Part II
Soliciting and Reviewing Applications

22VAC30-50-60. Requests for proposals.

The advisory board will solicit applications for grants of moneys from the fund by publishing issuing requests for proposals from time to time. Each application for a grant must be received in response to an actual request for proposals a proposal and by a deadline specified in the request, which will be no fewer than 60 days following publication of the request.

22VAC30-50-70. Appointment of grant Grant reviewers and technical advisors.

The advisory board may choose, at any time, to appoint grant reviewers or other technical advisors, or both, at any time to assist in reviewing and ranking applications. Such reviewers and advisors may represent medical researchers, medical practitioners, community-based service providers, consumers, or advocates for consumers, or others deemed appropriate by the advisory board for this purpose. Reviewers and advisors shall be appointed so as to provide equal representation from Virginia's three medical schools. Reviewers and advisors shall be selected so as to avoid any conflict of interests or the appearance thereof, and may be chosen because of their the advisory board may choose reviewers and advisors residing or working outside Virginia in order to ensure impartiality. Whenever reviewers or advisors sit as a committee, the chairman of the advisory board or his designee shall serve as chairman of the committee but shall not vote on individual applications.

22VAC30-50-80. Specification of Option A or B.

Each application shall clearly state a purpose to seek funds to carry out a program consistent with Option A or Option B. for projects to conduct research on the mechanisms and treatment of neurotrauma, which shall be referred to as "Option A," or to develop innovative, model community-based rehabilitative programs and services for individuals with neurotrauma, which shall be referred to as "Option B." Option A applications shall state and demonstrate a clear intention of researching the mechanisms of neurotrauma or the treatment of neurotrauma, or both. Option B applications shall state and demonstrate a clear intention to provide innovative, model community-based rehabilitative services by developing, expanding or improving community-based programs and facilities serving and treating individuals who have experienced services for people with traumatic brain injury or traumatic spinal cord injury, or both, and expanding opportunities for such individuals to become as independent and physically and functionally capable as possible. Neither Option A nor Option B grants are intended for long-term funding of research projects or service programs.

22VAC30-50-90. Review of applications; stated priorities. Submission of applications.

In reviewing applications submitted for grant awards, whether Option A or Option B, the advisory board will give priority to accept applications that:

1. Present a convincing and persuasive discussion of how the proposed project will carry out its intention as specified in accordance with 22VAC30-50-80, and describe in as much detail as possible its anticipated effectiveness in carrying out its intention.

2. Include a system for measuring outcomes and documenting project impact and effectiveness, including any anticipated long-term effect of the proposed project.

3. Provide the means for consumer involvement in the design, implementation and evaluation of the project as relevant to the intention of the proposed project;

4. Identify sources of funds, if known, and fundraising strategies to be used in sustaining the proposed project following termination of a grant award as relevant to the intention of the proposed project;

5. 2. Comply fully with additional informational and administrative requirements stated in the specific RFP to which applications applicants are responding;.

6. 3. In the case of an Option A application:

a. Discuss the relevance of the proposed project to an identified field of medical or rehabilitative inquiry,

b. Demonstrate the anticipated benefit of the proposed project in terms of expanding knowledge and understanding of neurotrauma,

c. Discuss any innovation or breakthrough the project seeks to promote, specifying outcome measures where possible for each of the preceding enumerated items in this subdivision, and

d. Describe efforts to ensure that the proposed project will does not duplicate completed previous or ongoing research; and

7. 4. In the case of an Option B application:

a. Describe and demonstrate the need for the Discuss the relevance of the proposed project to an identified need for innovative, model community-based rehabilitative services in terms of the absence of alternative programs, services, and resources and facilities available to the intended individuals and community,;

b. Demonstrate the avoidance of duplication of Describe efforts to ensure that the proposed project does not duplicate programs, services, or resources already available; and

c. State and emphasize a commitment to collaborative community planning involving consumer groups, service providers, employers, relevant state and local agencies, and other funding sources, as available or anticipated to become available, and relevant state and local agencies.

Part III
Specific Project Consideration and Application Criteria, Selection of Successful Applications and Amount and Announcement of Awards

22VAC30-50-100. Ranking and reviewing Reviewing and ranking grant applications.

A. The advisory board will distinguish the class of Option A applications from the class of Option B applications when soliciting, ranking and reviewing and ranking grant applications. Applications will be considered and ranked only among only other applications with the stated intention to address the same option submitted under the same stated option, either Option A or Option B. Applications initially deemed effective in serving meeting the purpose of either option a solicitation and to have substantially addressed the general considerations stated in Part II (22VAC30-50-60 et seq.) of this chapter, as applicable, will be subsequently ranked and reviewed and ranked according to their satisfaction of the following criteria, which will be weighted as indicated:

1. The purpose and significance of the project - 20 points;

2. The objectives and expected benefits of the project - 20 points;

3. The design of the project, means of assessing outcomes, methods to be employed, and the level of detail and feasibility of an included action plan - 25 points to include (i) methods, activities, and a timeline for achieving project goals and objectives, and (ii) a system for measuring outcomes and documenting project impact, effectiveness, and any anticipated long-term effects;

4. Detailed nature, completeness and feasibility of an included A detailed budget - 15 points that is reasonable and appropriate for the scope of the project;

5. The identification of potential sources of funds and fundraising strategies to be used in sustaining the proposed project following termination of a grant award as relevant to the intention of the proposed project;

5. 6. Demonstrated or anticipated capability of the existing or planned organizational structure - 15 points;

7. The means for consumer involvement in the design, implementation, and evaluation of the project as feasible and relevant to the intention of the proposed project;

6. 8. A commitment to include the participation of small, women-owned and minority businesses, as such are available and capable of participation - 5 points.

B. When initially reviewing applications or subsequently ranking and reviewing and ranking applications, the advisory board may ask applicants to provide required information that is missing from the application or additional clarifying information relating to their applications and proposed projects. Failure to provide missing information or failure to provide additional information that is material and relevant may result in the rejection or lowered ranking of an application.

22VAC30-50-110. Amount of grant awards; duration and availability of funding.

A. After reviewing all applications, duly received, for either Option A or Option B, the advisory board will determine which proposed projects will be offered funding. The selection of successful applications will be made based on (i) availability of moneys in the fund and, (ii) the criteria listed in this chapter review and ranking of the applications according to the criteria listed in this chapter, (iii) information from grant reviewers or technical advisors who the board may appoint to assist in evaluating applications, and (iv) the advisory board's assessment of those applications, which further the intentions and the purpose of the fund. Subsequent discussions Discussions and negotiations may be conducted between the advisory board and successful grant applicants in order to clarify any remaining issues relating to the proposed project.

B. In considering and determining the amount of a grant award and the duration of funding for a particular project, the advisory board will consider the requested amount, need, and the project design and justification. Actual grant awards will be made in amounts ranging from $5,000 to $150,000 per year for an anticipated duration, i.e., a total anticipated funding period, of one to three years as described in the proposal. The award and duration of funding for of a project of an anticipated duration exceeding to exceed one year will be contingent upon (i) the availability of moneys in the fund, whether so stated at the time of the award or not, and (ii) the grantee's successful completion of timelines and of interim objectives and milestones as proposed and approved in the grant application, grant award, and contract documents.

C. The award of grants to successful applicants will be made public within 60 days of the advisory board's decision regarding all applications submitted in response to a request for proposals.

D. C. In the event any timelines and interim objectives and milestones pertaining to a project are not completed to the satisfaction of the advisory board, the advisory board may act to withhold moneys not yet disbursed for such a project. In the event of a substantial decline in moneys in the fund, the advisory board will attempt to distribute moneys to projects of an anticipated duration greater than one year in a manner as fair and equitable as possible.

D. The award of grants to successful applicants will be made public within 60 days of the advisory board's decision regarding all applications submitted in response to a request for proposals.

22VAC30-50-120. Unexpended funds.

Notwithstanding any other law to the contrary, the Commissioner of the Department of Rehabilitative Services may reallocate up to $500,000 from unexpended balances in the Commonwealth Neurotrauma Initiative Trust Fund to fund new grant awards for research on traumatic brain and spinal cord injuries.