Proposed Priority-National Institute on Disability, Independent Living, and Rehabilitation Research-Rehabilitation Research and Training Centers

AGENCY:

Administration for Community Living.

ACTION:

Notice of proposed priority.

SUMMARY:

The Administrator of the Administration for Community Living proposes a priority for the Rehabilitation Research and Training Center (RRTC) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, this notice proposes a priority for an RRTC on Self-Directed Care to Promote Recovery, Health, and Wellness for Individuals with Serious Mental Illness. We take this action to focus research attention on an area of national need. We intend this priority to contribute to improved employment for individuals with serious mental illness (SMI) and co-occurring conditions.

DATES:

We must receive your comments on or before March 27, 2015.

ADDRESSES:

Submit your comments through the Federal eRulemaking Portal or via postal mail, commercial delivery, or hand delivery. We will not accept comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments.

• Federal eRulemaking Portal: Go to www.regulations.gov to submit your comments electronically. Information on using Regulations.gov, including instructions for accessing agency documents, submitting comments, and viewing the docket, is available on the site under “Are you new to the site?”
• Postal Mail, Commercial Delivery, or Hand Delivery: If you mail or deliver your comments about these proposed regulations, address them to Patricia Barrett, U.S. Department of Health and Human Services, 400 Maryland Avenue SW., Room 5142, Potomac Center Plaza (PCP), Washington, DC 20202-2700.

Privacy Note:

The Department's policy is to make all comments received from members of the public available for public viewing in their entirety on the Federal eRulemaking Portal at www.regulations.gov. Therefore, commenters should be careful to include in their comments only information that they wish to make publicly available.

FOR FURTHER INFORMATION CONTACT:

Patricia Barrett. Telephone: (202) 245-6211 or by email: patricia.barrett@ed.gov.

If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.

SUPPLEMENTARY INFORMATION:

This notice of proposed priority is in concert with NIDRR's currently approved Long-Range Plan (Plan). The Plan, which was published in the Federal Register on April 4, 2013 (78 FR 20299), can be accessed on the Internet at the following site: www.ed.gov/about/offices/list/osers/nidrr/policy.html.

The Plan identifies a need for research and training regarding employment of individuals with disabilities. To address this need, NIDILRR seeks to: (1) Improve the quality and utility of disability and rehabilitation research; (2) foster an exchange of research findings, expertise, and other information to advance knowledge and understanding of the needs of individuals with disabilities and their family members, including those from among traditionally underserved populations; (3) determine effective practices, programs, and policies to improve community living and participation, employment, and health and function outcomes for individuals with disabilities of all ages; (4) identify research gaps and areas for promising research investments; (5) identify and promote effective mechanisms for integrating research and practice; and (6) disseminate research findings to all major stakeholder groups, including individuals with disabilities and their family members in formats that are appropriate and meaningful to them.

This notice proposes one priority that NIDILRR intends to use for one or more competitions in fiscal year (FY) 2015 and possibly later years. NIDILRR is under no obligation to make an award under this priority. The decision to make an award will be based on the quality of applications received and available funding. NIDILRR may publish additional priorities, as needed.

Invitation to Comment: We invite you to submit comments regarding this proposed priority. To ensure that your comments have maximum effect in developing the final priority, we urge you to identify clearly the specific topic within the priority that each comment addresses.

We invite you to assist us in complying with the specific requirements of Executive Orders 12866 and 13563 and their overall requirement of reducing regulatory burden that might result from this proposed priority. Please let us know of any further ways we could reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the program.

During and after the comment period, you may inspect all public comments by following the instructions found under the “Are you new to the site?” portion of the Federal eRulemaking Portal at wwww.regulations.gov. Any comments sent to NIDILRR via postal mail, commercial deliver, or hand delivery can be viewed in room 5142, 550 12th Street SW., PCP, Washington, DC, between the hours of 8:30 a.m. and 4:00 p.m., Washington, DC time, Monday through Friday of each week except Federal holidays.

Assistance to Individuals With Disabilities in Reviewing the Rulemaking Record: On request we will provide an appropriate accommodation or auxiliary aid to an individual with a disability who needs assistance to review the comments or other documents in the public rulemaking record for this notice. If you want to schedule an appointment for this type of accommodation or auxiliary aid, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

Purpose of Program: The purpose of the Disability and Rehabilitation Research Projects and Centers Program is to plan and conduct research, demonstration projects, training, and related activities, including international activities, to develop methods, procedures, and rehabilitation technology that maximize the full inclusion and integration into society, employment, independent living, family support, and economic and social self-sufficiency of individuals with disabilities, especially individuals with the most severe disabilities, and to improve the effectiveness of services authorized under the Rehabilitation Act of 1973, as amended (Rehabilitation Act).

Rehabilitation Research and Training Centers

The purpose of the RRTCs, which are funded through the Disability and Rehabilitation Research Projects and Centers Program, is to achieve the goals of, and improve the effectiveness of, services authorized under the Rehabilitation Act through well-designed research, training, technical assistance, and dissemination activities in important topical areas as specified by NIDILRR. These activities are designed to benefit rehabilitation service providers, individuals with disabilities, family members, policymakers and other research stakeholders. Additional information on the RRTC program can be found at: http://www2.ed.gov/programs/rrtc/index.html#types.

Program Authority: 29 U.S.C. 762(g) and 764(b)(2).

Applicable Program Regulations: 34 CFR part 350.

Proposed Priority: This notice contains one proposed priority.

RRTC on Self-Directed Care To Promote Recovery, Health, and Wellness for Individuals With Serious Mental Illness

Background

Mental health disorders are one of the leading causes of disability in the United States. In 2012, there were an estimated 9.6 million adults aged 18 or older in the U.S. with serious mental illness, representing 4.1 percent of all U.S. adults (U.S. Department of Health and Human Services, 2012a). Most individuals with mental illness today live in community settings—a result of the deinstitutionalization movement of the 1960s to 1980s, the Americans with Disabilities Act of 1990, and the 1999 U.S. Supreme Court Olmstead decision (National Council on Disability, 2008; Olmstead v. L.C., 527 U.S. 581 (1999); Salzer, Kaplan, & Atay, 2006). Individuals with mental illness are less likely to achieve successful employment outcomes than individuals without mental illness (Cook, 2006). For those who are employed, mental illness is associated with decreased productivity and lower levels of job retention (Cook, 2006; Lerner et al., 2012). In addition, individuals with mental illness experience higher mortality rates and poorer physical health than individuals without mental illness (Banham & Gilbody, 2010). This disparity in general health is exacerbated by barriers to healthcare delivery services for individuals with mental illness, at both the system and the individual levels (Kelly et al., 2014). Furthermore, employment outcomes and health are related in this population. At the individual level, mental illness symptoms and comorbid medical conditions are associated with poorer employment outcomes (Cook et al., 2007; Frey et al., 2008). At the system level, the relations among health care systems, and those between employment service systems and health care systems, are complex (Frey et al., 2008; Kelly et al., 2014).

Over the last few decades, the concept of self-determination has become more widespread in the design and conceptualization of services for individuals with mental illness. In this context, self-determination refers to individuals' rights to direct their own services, to be involved in decisions that impact their wellbeing, to be meaningfully involved in the design, delivery and evaluation of services and supports, and to develop and use their own personal goals to guide their lives and actions (Cook & Jonikas, 2002). Self-determination is a central component of the Substance Abuse and Mental Health Services Administration's definition of recovery (U.S. Department of Health and Human Services, 2012b) and has become an important component of recovery-oriented mental health treatment and services. It is closely related to the guiding principle of informed choice in vocational rehabilitation and supported employment (Drake, Bond & Becker, 2012; Workforce Innovation and Opportunity Act of 2014). In the field of general health care, self-determination principles are reflected in the concept of self-direction (e.g., Centers for Medicare and Medicaid Services, no date). Principles of self-determination can be incorporated into many types of services and supports for individuals with mental illness and into efforts to address system and individual-level barriers to health and employment services.

At the system level, the self-determination approach in health care has informed systems in which individuals with disabilities control the services they receive. These systems are known by a variety of names, (e.g., person-centered funding, person-directed services, participant-directed services, cash and counseling) (Barczyk & Lincove, 2010; O'Brien et al., 2005; Powers & Sowers, 2006; Robert Wood Johnson Foundation, 2006). When the system is designed for individuals with serious mental illness, this type of service is frequently referred to as self-directed care. It uses public funds to provide individuals with the cash value of services and allows individuals to choose, organize, and purchase services (Alakeson, 2008), thereby providing both self-direction and a mechanism to purchase services and goods traditionally covered by different funding sources. Individuals may choose services and supports that are not traditionally provided in the mental health system, such as wellness services, transportation, medical or dental services, and tangible items that support community participation (Cook et al., 2008). Individuals are provided with assistance to help them develop their own individual service plans and budgets. The mechanism involved can vary, (e.g., direct payments, individual budgets, flexible funds). Early data on the effectiveness of this approach for individuals with mental illness suggest that self-directed care can yield positive results for a variety of outcomes, including employment, quality of life, and service use (Alakeson, 2008; Cook et al., 2008; O'Brien et al., 2005; Webber et al., 2014). However, self-directed care has been implemented in few States, and very little is known about the effectiveness of this approach for many recovery-oriented outcomes, such as employment.

Other system-level approaches to improving both access to health care and the health of individuals with mental illness have incorporated principles of care coordination to integrate mental health services with general medical services (Barry & Huskamp, 2014; Croft & Parish, 2012; Druss et al., 2010; Kelly et al., 2014; Mechanic, 2014). Services provided through care coordination models can bridge the gap between mental health and general health services and improve outcomes both in mental and in general medical health (Woltmann et al., 2012). Although care coordination organizations do not necessarily incorporate self-determination features, they can do so. For example, care coordination models may include illness self management programs, which train individuals on how to manage their symptoms and improve their functioning and quality of life. In fact, the Improving Chronic Illness Care Initiative includes illness self-management as a core feature (Kelly et al., 2014; McDonald et al., 2007; Woltmann et al., 2012). Illness self-management interventions can be effective for people with mental illness dealing with general medical problems (Kelly et al., 2014) or mental illness (Roe et al., 2009). In addition, there is preliminary evidence that mental illness self-management may have positive effects on employment outcomes (Michon, 2011).

However, coordinated care systems can be complex for consumers to negotiate. Therefore, many systems provide staff who serve as navigators to help guide clients through the barriers of complex health care systems and provide support for consumers in such self-directed activities as developing plans and making choices. Early research indicates that provision of navigator services can improve health outcomes and use of medical services for individuals with mental illness (Griswold et al., 2010; Kelly et al., 2013). In addition, having peers serve either as navigators or to deliver mental or general healthcare interventions can be effective for individuals with mental illness (Brekke et al., 2013; Chinman et al., 2014; Kelly et al, 2014; Pitt et al., 2013).

Research on the use of self-directed services and supports, and self-directed care, for individuals with mental illness is in preliminary stages. There is a need for better understanding of the optimal use of self-directed strategies in the integration of general health care and mental health care, as well as the optimal involvement of peer supports for people with serious mental illness.

References:

Alakeson, V., (2008). Let patients control the purse strings. British Medical Journal, 336, 807-809.

Banham, L., & Gilbody, S. (2010). Smoking cessation in severe mental illness: What works? Addiction, 105 (7), 1176-1189.

Barczyk, A.N., & Lincove, J.A. (2010). Cash and counseling: A model for self-directed care programs to empower individuals with serious mental illnesses. Social Work in Mental Health, 8 (3), 209-224.

Barry, C.L., & Huskamp, H.A. (2011). Moving beyond parity—mental health and addiction care under the ACA. New England Journal of Medicine, 365 (11), 973-975.

Brekke, J.S., Siantz, E., Pahwa, R., Kelly, E., Tallen, L., & Fulginiti, A. (2013). Reducing Health Disparities for People with Serious Mental Illness. Best Practices in Mental Health, 9 (1), 62-82.

Centers for Medicaid and Medicare Services. (no date). Self directed services. Retrieved from: http://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Delivery-Systems/Self-Directed-Services.html.

Chinman, M., George, P., Dougherty, R.H., Daniels, A.S., Ghose, S.S., Swift, A., & Delphin-Rittmon, M.E. (2014). Peer support services for individuals with serious mental illnesses: assessing the evidence. Psychiatric Services, 65(4), 429-441.

Cook, J. (2006). Employment barriers for persons with psychiatric disabilities: Update of a report for the President's Commission. Psychiatric Services, 57 (10), 1391-1405.

Cook, J.A., & Jonikas, J.A. (2002). Self-Determination Among Mental Health Consumers/Survivors Using Lessons From the Past to Guide the Future. Journal of Disability Policy Studies, 13 (2), 88-96.

Cook, J.A., Razzano, L.A., Burke-Miller, J.K., Blyler, C.R., Leff, H.S., Mueser, K.T.,Gold, P.B., Goldberg, R.W., Shafer, M.S., Onken, S.J., McFarlane, W.R., Donegan, K., Carey, M.A., Kauffmann, C., & Grey, D.D. (2007). Effects of co-occurring disorders on employment outcomes in a multisite randomized study of supported employment for people with severe mental illness. Journal of Rehabilitation Research and Development, 44 (6), 837.

Cook, J., Russell, C., Grey, D., & Jonikas, J. (2008). Economic grand rounds: A self-directed care model for mental health recovery. Psychiatric Services, 59 (6), 600-602.

Croft, B., & Parish, S.L. (2013). Care integration in the patient protection and affordable care act: Implications for behavioral health. Administration and Policy in Mental Health and Mental Health Services Research, 40 (4), 258-263.

Drake, R.E., Bond, G. R., & Becker, D. R. (2012). Individual placement and support: An evidence-based approach to supported employment. Oxford University Press.

Druss, B.G., Zhao, L., von Esenwein, S.A., Bona, J.R., Fricks, L., Jenkins-Tucker, S., Sterling, E., DiClemente, R., & Lorig, K. (2010). The Health and Recovery Peer (HARP) Program: a peer-led intervention to improve medical self-management for persons with serious mental illness. Schizophrenia Research, 118 (1), 264-270.

Frey, W.D., Azrin, S.T., Goldman, H.H., Kalasunas, S., Salkever, D.S., Miller, A.L., Bond, G.R., & Drake, R.E. (2008). The mental health treatment study. Psychiatric Rehabilitation Journal, 31 (4), 306.

Griswold, K.S., Homish, G.G., Pastore, P.A., & Leonard, K.E. (2010). A randomized trial: Are care navigators effective in connecting patients to primary care after psychiatric crisis? Community Mental Health Journal, 46 (4), 398-402.

Kelly, E.L., Fenwick, K.M., Barr, N., Cohen, H., & Brekke, J.S. (2014). A Systematic Review of Self-Management Health Care Models for Individuals With Serious Mental Illnesses. Psychiatric Services, 65 (11), 1300-1310.

Kelly, E., Fulginiti, A., Pahwa, R., Tallen, L., Duan, L., & Brekke, J.S. (2013). A pilot test of a peer navigator intervention for improving the health of individuals with serious mental illness. Community Mental Health Journal, 50 (4), 435-446.

Lerner, D., Adler, D., Hermann, R.C., Chang, H., Ludman, E.J., Greenhill, A., Perch, K., McPeck, W.C., & Rogers, W.H. (2012). Impact of a work-focused intervention on the productivity and symptoms of employees with depression. Journal of Occupational and Environmental Medicine, 54( 2), 128.

Mechanic, D. (2014). Seizing opportunities under the Affordable Care Act for transforming the mental and behavioral health system. Health Affairs, 31 (2), 376-382.

Michon, H.W., Van Weeghel, J., Kroon, H., & Schene, A.H. (2011). Illness self-management assessment in psychiatric vocational rehabilitation. Psychiatric Rehabilitation Journal, 35 (1), 21.

National Council on Disability (2008). Inclusive livable communities for people with psychiatric disabilities. Washington, DC: National Council on Disability. Retrieved from www.ncd.gov/publications/2008/03172008.

O'Brien, D., Ford, L., & Malloy, J. M. (2005). Person centered funding: Using vouchers and personal budgets to support recovery and employment for people with psychiatric disabilities. Journal of Vocational Rehabilitation, 23, 71-79.

Pitt, V., Lowe, D., Hill, S., Prictor, M., Hetrick, S.E., Ryan, R., & Berends, L. (2013). Consumer-providers of care for adult clients of statutory mental health services. Cochrane Database Systematic Reviews, 3.

Powers L.E., & Sowers, J. (2006). A cross-disability analysis of person-directed, long-term services. Journal of Disability Policy Studies, 17, 66-76.

Robert Wood Johnson Foundation (2006). Choosing independence: An overview of the cash and counseling model of self-directed personal assistance services. Princeton NJ: Robert Wood Johnson Foundation.

Roe, D., Hasson-Ohayon, I., Salyers, M.P., & Kravetz, S. (2009). A one year follow-up of illness management and recovery: Participants' accounts of its impact and uniqueness. Psychiatric Rehabilitation Journal, 32(4), 285-291.

Salzer, M., Kaplan, K., & Atay, J. (2006). State psychiatric hospital census after the 1999 Olmstead decision: Evidence of decelerating deinstitutionalization. Psychiatric Services, 57(10), 1501-1504.

U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (2012a). Results from the 2012 National Survey on Drug Use and Health: Mental Health Findings. Retrieved from: http://www.samhsa.gov/data/sites/default/files/2k12MH_Findings/2k12MH_Findings/NSDUHmhfr2012.htm#sec2-2 .

U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (2012b). SAMHSA's Working Definition of Recovery. Retrieved from: http://store.samhsa.gov/shin/content//PEP12-RECDEF/PEP12-RECDEF.pdf.

Webber, M., Treacy, S., Carr, S., Clark, M., & Parker, G. (2014). The effectiveness of personal budgets for people with mental health problems: A systematic review. Journal of Mental Health, 23 (3), 146-155.

Woltmann, E., Grogan-Kaylor, A., Perron, B., Georges, H., Kilbourne, A.M., & Bauer, M.S. (2012). Comparative effectiveness of collaborative chronic care models for mental health conditions across primary, specialty, and behavioral health care settings: Systematic review and meta-analysis. American Journal of Psychiatry, 169 (8), 790-804.

Workforce Innovation and Opportunity Act of 2014. Public Law 113-128.

Definitions

The research that is proposed under this priority must be focused on one or more stages of research. If the RRTC is to conduct research that can be categorized under more than one research stage, or research that progresses from one stage to another, those research stages must be clearly specified. For purposes of this priority, the stages of research are from the notice of final priorities and definitions published in the Federal Register on June 7, 2013 (78 FR 34261).

(a) Exploration and Discovery means the stage of research that generates hypotheses or theories by conducting new and refined analyses of data, producing observational findings, and creating other sources of research-based information. This research stage may include identifying or describing the barriers to and facilitators of improved outcomes of individuals with disabilities, as well as identifying or describing existing practices, programs, or policies that are associated with important aspects of the lives of individuals with disabilities. Results achieved under this stage of research may inform the development of interventions or lead to evaluations of interventions or policies. The results of the exploration and discovery stage of research may also be used to inform decisions or priorities.

(b) Intervention Development means the stage of research that focuses on generating and testing interventions that have the potential to improve outcomes for individuals with disabilities. Intervention development involves determining the active components of possible interventions, developing measures that would be required to illustrate outcomes, specifying target populations, conducting field tests, and assessing the feasibility of conducting a well-designed interventions study. Results from this stage of research may be used to inform the design of a study to test the efficacy of an intervention.

(c) Intervention Efficacy means the stage of research during which a project evaluates and tests whether an intervention is feasible, practical, and has the potential to yield positive outcomes for individuals with disabilities. Efficacy research may assess the strength of the relationships between an intervention and outcomes, and may identify factors or individual characteristics that affect the relationship between the intervention and outcomes. Efficacy research can inform decisions about whether there is sufficient evidence to support “scaling-up” an intervention to other sites and contexts. This stage of research can include assessing the training needed for wide-scale implementation of the intervention, and approaches to evaluation of the intervention in real world applications.

(d) Scale-Up Evaluation means the stage of research during which a project analyzes whether an intervention is effective in producing improved outcomes for individuals with disabilities when implemented in a real-world setting. During this stage of research, a project tests the outcomes of an evidence-based intervention in different settings. It examines the challenges to successful replication of the intervention, and the circumstances and activities that contribute to successful adoption of the intervention in real-world settings. This stage of research may also include well-designed studies of an intervention that has been widely adopted in practice, but that lacks a sufficient evidence-base to demonstrate its effectiveness.

Proposed Priority

The Administrator of the Administration for Community Living proposes a priority for the Rehabilitation Research and Training Center (RRTC) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, this notice proposes a priority on Self-Directed Care to Promote Recovery, Health, and Wellness for Individuals with Serious Mental Illness. This RRTC will be jointly funded by NIDILRR and the Substance Abuse and Mental Health Services Administration. The RRTC will conduct research to develop, adapt, and enhance self-directed models of general medical, mental health, and nonmedical services that are designed to improve health, recovery, and employment outcomes for individuals with serious mental illness. The RRTC must conduct research, knowledge translation, training, dissemination, and technical assistance within a framework of consumer-directed services and self-management. Under this priority, the RRTC must contribute to the following outcomes:

(1) Increased knowledge that can be used to enhance the health and well-being of individuals with serious mental illness and co-occurring conditions. The RRTC must contribute to this outcome by:

(a) Conducting research to develop a better understanding of the barriers to and facilitators of implementing models that integrate general medical and mental health care for individuals with SMI. These models must incorporate self-management and self-direction strategies. This research must specifically examine models that incorporate peer-provided services and supports along with research-based service integration strategies such as health navigation and care coordination.

(b) Conducting research to identify or develop and then test interventions that use individual budgets or flexible funds to increase consumer choice. The RRTC must design this research to determine the extent to which the consumer-choice intervention improves health outcomes and promotes recovery among individuals living with SMI. In carrying out this activity, the grantee must investigate the applicability of strategies that have proven successful with the general population or other subpopulations to determine if they are effective with individuals with SMI and co-occurring conditions.

(2) Improved employment outcomes among individuals with SMI. The RRTC must contribute to this outcome by:

(a) Conducting research to develop a better understanding of the barriers to and facilitators of implementing vocational service and support models that incorporate self management and self-direction features. These features must include self-directed financing and flexible funding of services that support mental health treatment and recovery, general health, and employment. These services may include services and supports not traditionally supplied by mental health or general medical systems.

(3) Increased incorporation of research findings related to SMI, self-directed care, health management, and employment into practice or policy.

(a) Developing, evaluating, or implementing strategies to increase utilization of research findings related to SMI, co-occurring conditions, health management, and employment.

(b) Conducting training, technical assistance, and dissemination activities to increase utilization of research findings related to self-directed care of individuals living with SMI to promote and co-occurring conditions, health management, and employment.

Final Priority

We will announce the final priority in a notice in the Federal Register. We will determine the final priority after considering responses to this notice and other information available to the Department. This notice does not preclude us from proposing additional priorities, requirements, definitions, or selection criteria, subject to meeting applicable rulemaking requirements.

Note:

This notice does not solicit applications. In any year in which we choose to use this priority, we invite applications through a notice in the Federal Register or in a Funding Opportunity Announcement posted at www.grants.gov.

Executive Orders 12866 and 13563

Regulatory Impact Analysis

Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive Order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—

(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);

(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive Order.

This proposed regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.

We have also reviewed this regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—

(1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);

(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;

(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);

(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and

(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.

Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”

We are issuing this proposed priority only upon a reasoned determination that its benefits would justify its costs. In choosing among alternative regulatory approaches, we selected those approaches that would maximize net benefits. Based on the analysis that follows, the Department believes that this proposed priority is consistent with the principles in Executive Order 13563.

We also have determined that this regulatory action would not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.

In accordance with both Executive Orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.

The benefits of the Disability and Rehabilitation Research Projects and Centers Program have been well established over the years. Projects similar to one envisioned by the proposed priority have been completed successfully, and the proposed priority would generate new knowledge through research. The new RRTC would generate, disseminate, and promote the use of new information that would improve recovery, health, and wellness outcomes for individuals with serious mental illness (SMI) and co-occurring conditions.

Intergovernmental Review: This program is not subject to Executive Order 12372.

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