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Notice

Disability and Rehabilitation Research Project; Burn Model Systems Centers

Action

Notice.

Summary

The Assistant Secretary for Special Education and Rehabilitative Services proposes a priority under the Disability and Rehabilitation Research Projects and Centers Program administered by the National Institute on Disability and Rehabilitation Research (NIDRR). Specifically, this notice proposes a priority for DRRPs that will serve as Burn Model Systems (BMS) Centers. The Assistant Secretary may use this priority for competitions in fiscal year (FY) 2012 and later years. We take this action to focus research attention on areas of national need. We intend this priority to contribute to improved outcomes for individuals with burn injury.

 

Table of Contents Back to Top

Overview Information:

Proposed priority—National Institute on Disability and Rehabilitation Research (NIDRR)—Disability and Rehabilitation Research Projects and Centers Program—Disability and Rehabilitation Research Project (DRRP)—Burn Model Systems Centers.

CFDA Number: 84.133A-3.

DATES: Back to Top

We must receive your comments on or before April 6, 2012.

ADDRESSES: Back to Top

Address all comments about this notice to Lynn Medley, U.S. Department of Education, 400 Maryland Avenue SW., Room 5140, Potomac Center Plaza (PCP), Washington, DC 20202-2700.

If you prefer to send your comments by email, use the following address: lynn.medley@ed.gov. You must include “Proposed Priority for Burn Model Systems (BMS) Centers” in the subject line of your electronic message.

FOR FURTHER INFORMATION CONTACT: Back to Top

Lynn Medley. Telephone: (202) 245-7338 or by email: Lynn.Medley@ed.gov.

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

SUPPLEMENTARY INFORMATION: Back to Top

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 February 15, 2006 (71 FR 8165), can be accessed on the Internet at the following site: http://www2.ed.gov/legislation/FedRegister/other/2006-1/021506d.pdf.

Through the implementation of the Plan, NIDRR seeks to: (1) Improve the quality and utility of disability and rehabilitation research; (2) foster an exchange of expertise, information, and training to facilitate the advancement of knowledge and understanding of the unique needs of traditionally underserved populations; (3) determine best strategies and programs to improve rehabilitation outcomes for underserved populations; (4) identify research gaps; (5) identify mechanisms of integrating research and practice; and (6) disseminate findings.

This notice proposes a priority that NIDRR intends to use for a DRRP competition in FY 2012 and possibly later years. However, nothing precludes NIDRR from publishing additional priorities, if needed. Furthermore, NIDRR is under no obligation to make an award for this priority. The decision to make an award will be based on the quality of applications received and available funding.

Invitation to Comment: We invite you to submit comments regarding this notice. To ensure that your comments have maximum effect in developing the notice of final priority, we urge you to identify clearly the specific topic 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 about this notice in room 5140, 550 12th Street SW., PCP, Washington, DC, between the hours of 8:30 a.m. and 4 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).

Disability and Rehabilitation Research Projects Back to Top

The purpose of NIDRR's DRRPs, which are funded through the Disability and Rehabilitation Research Projects and Centers Program, are to improve the effectiveness of services authorized under the Rehabilitation Act of 1973, as amended, by developing methods, procedures, and rehabilitation technologies that advance a wide range of independent living and employment outcomes for individuals with disabilities, especially individuals with the most severe disabilities. DRRPs carry out one or more of the following types of activities, as specified and defined in 34 CFR 350.13 through 350.19: Research, training, demonstration, development, dissemination, utilization, and technical assistance.

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

Applicable Program Regulations: 34 CFR part 350.

Proposed Priority:

This notice contains one proposed priority.

Burn Model Systems (BMS) Centers.

Background:

The American Burn Association (ABA) reports that 450,000 persons in the United States receive medical treatment for burn injuries annually (ABA, 2011). Of these, 3,500 die and 45,000 are hospitalized. Of those hospitalized, 25,000 are treated in hospitals with burn centers. With advances in early medical response to burn injuries and advances in infection control, survival rates of those incurring large burns have significantly increased (ABA, 2011b; Soman, Greenhalgh, & Palmieri, 2010). For those who survive, there are often significant challenges that affect their functional outcomes. Physical challenges may include severe contractures, joint deformities, neurologic and musculosketal problems, scarring, pain, and fatigue (Dewey, Richard, & Parry, 2011; Gabriel, 2011; Schneider, Holavanahalli, Helm, Goldstein, & Kowalske, K., 2006; Schneider & Qu, 2011). Psychological challenges may include posttraumatic stress, depression, and anxiety (Fauerbach et al., 2007; Ullrich, Askay, & Patterson, 2009; Wiechman, 2011). Psychosocial and environmental factors make community integration, including return to school and work, difficult (Esselman, 2011; Schneider, Bassi, & Ryan, 2009). Improvements in survival rates have highlighted the need for comprehensive rehabilitation treatment teams that provide a continuum of coordinated services from admission to the burn unit to assistance with community reintegration, and a combined focus on physical and psychological rehabilitation (Esselman & Kowalske, 2011; Richard et al., 2008).

The Burn Injury Model Systems centers (BMS Centers) program was created by NIDRR in 1994 to provide leadership in rehabilitation as a key component of exemplary burn care and to advance the research base on effective rehabilitation services for burn survivors. The mission of the BMS Centers is to improve the lives of persons who experience burn injury and their families by creating and disseminating new knowledge about the natural course of burn injury and rehabilitation treatment and outcomes following burn injury. NIDRR currently funds 4 BMS Centers throughout the United States. Each BMS Center provides a coordinated system of burn injury care to individuals who sustain a burn injury and conducts burn research, including clinical research and the analysis of standardized data in collaboration with other BMS Centers. Since 1998, the BMS Centers have collected and contributed information on common data elements for a centralized BMS database, which is maintained through a NIDRR-funded grant for a National Data and Statistical Center for the BMS. (Additional information on the BMS database can be found at http://bms-dcc.ucdenver.edu/). The National Data and Statistical Center for the BMS coordinates data collection among the BMS Centers, manages the BMS database, and provides statistical support to the BMS Centers. As of December, 2011, BMS Centers have contributed 4,917 cases to the BMS database, with follow up data available for 3,419 participants at 6-months post injury; 2,998 at 1 year post injury; and 2,481 at 2 years post injury. During the 2007-2012 grant cycle, data collection was extended to include information from participants at 5 and 10 years post injury.

Through this priority, we seek to fund new BMS Centers that will continue to provide a multidisciplinary system of rehabilitation care specifically designed to meet the needs of individuals with burn injury. These services would span the continuum of treatment from acute care through community re-entry. Under this priority, BMS Centers would engage in initiatives and new approaches and maintain close working relationships with other governmental and non-profit institutions and organizations to coordinate scientific efforts, encourage joint planning, and promote the interchange of data and reports among burn injury researchers.

A committee consisting of the individual BMS project directors has, since its inception, guided the BMS Centers program. This group meets annually in Washington, DC and at the annual ABA meeting. They also meet by teleconference throughout the year. NIDRR intends to form such a committee with the project directors awarded grants under this proposed priority.

References:

American Burn Association. (2011). Burn Incidence and Treatment in the US: 2011 Fact Sheet. Retrieved December 1, 2011, from http://www.ameriburn.org/resources_factsheet.php.

American Burn Association. (2011b). National Burn Repository: 2011 Report Dataset Version 7.0. Retrieved December 2, 1011, from http://www.ameriburn.org/2011NBRAnnualReport.pdf.

Dewey, W.S., Richard, R.L., & Parry, I.S. (2011). Positioning, splinting, and contracture management. In P. C. Esselman, K. J. Kowalske, & G. H. Kraft (Eds.), Burn Rehabilitation, Physical Medicine and Rehabilitation Clinics of North America, 22(2), 229-247.

Gabriel, V. (2011). Hypertrophic scar. In P. C. Esselman, K. J. Kowalske, & G. H. Kraft (Eds.), Burn Rehabilitation, Physical Medicine and Rehabilitation Clinics of North America, 22(2), 301-310.

Esselman, P.C. (2011). Community integration outcome after burn injury. In P. C. Esselman, K. J. Kowalske, & G. H. Kraft (Eds.), Burn Rehabilitation, Physical Medicine and Rehabilitation Clinics of North America, 22(2), 351-356.

Esselman, P.C. & Kowalske, K. J. (2011). Burn Rehabilitation, Physical Medicine and Rehabilitation Clinics of North America, 22(2), xiii-xv.

Fauerbach, J.A., McKibben, J., Bienvenu, O.J., Magyar-Russell, G., Smith, M.T., Holavanahalli, R., Patterson, D.R., Wiechman, S.A., Blakeney, P., & Lezotte, D. (2007). Psychological distress after major burn injury. Psychosomatic Medicine, 69(5), 473-482.

Richard, R.L., Hedman, T.L., Quick, C.D., Barillo, D.J., Cancio, L.C., Renz, E.M., Chapman, T.T., Dewey, W.S., Dougherty, M.E., Esselman, P.C., Forbes-Duchart, L., Franzen, B.J., Hunter, H., Kowalske, K., Moore, M.L., Nakamura, D.Y., Nedelec, B., Niszczak, J., Parry, I., Serghiou, M., Ward, R.S., Holcomb, J.B., Wolf, S.E. (2008). A clarion to recommit and reaffirm burn rehabilitation. Journal of Burn Care & Research, 29(3), 425-432.

Schneider, J.C., Bassi, S., & Ryan, C.M. (2009). Barriers impacting employment after burn injury. Journal of Burn Care & Research, 30(2), 294-300.

Schneider, J.C., Holavanahalli, R., Helm, P., Goldstein, R., & Kowalske, K. (2006). Contractures in burn injury: Defining the problem. Journal of Burn Care & Research, 27(4), 508-514.

Schneider, J.C. & Qu, H.D. (2011). Neurologic and musculoskeletal complications of burn injuries. Burn Rehabilitation, Physical Medicine and Rehabilitation Clinics of North America, 22(2), 261-275.

Soman, S., Greenhalgh, D., & Palmieri, T. (2010). Review of burn injury research for the year of 2009. Journal of Burn Care & Research, 31(6), 836-848.

Ullrich, P.M., Askay, SW., Patterson, D.R. (2009). Pain, depression, and physical functioning following burn injury. Rehabilitation Psychology, 54, 211-216.

Wiechman, S.A. (2011). Psychosocial recovery, pain, and itch after burn injuries. In P. C. Esselman, K. J. Kowalske, & G. H. Kraft (Eds.), Burn Rehabilitation, Physical Medicine and Rehabilitation Clinics of North America, 22(2), 327-345.

Proposed Priority:

The Assistant Secretary for Special Education and Rehabilitative Services proposes a priority for the funding of Burn Model Systems centers (BMS Centers). The BMS Centers must provide comprehensive, multidisciplinary services to individuals with burn injury and conduct research that contributes to evidence-based rehabilitation interventions and clinical and practice guidelines. The BMS Centers must generate new knowledge that can be used to improve outcomes of individuals with burn injury in one or more domains identified in NIDRR's currently approved Long Range Plan, published in the Federal Register on February 15, 2006 (71 FR 8166): Health and function, participation and community living, technology, and employment. Each BMS Center must contribute to this outcome by—

(a) Providing a multidisciplinary system of rehabilitation care specifically designed to meet the needs of individuals with burn injury, including but not limited to physical, psychological, and community reintegration needs. The system must encompass a continuum of care, including emergency medical services, acute care services, acute medical rehabilitation services, and post-acute services;

(b) Continuing the assessment of long-term outcomes of individuals with burn injury by enrolling at least 30 subjects per year into the BMS database, and collecting follow-up data on all subjects enrolled in the database at 6 months, and at 1, 2, 5, and 10 years post injury (as is being done in the current grant cycle) and extending the assessment to every five years thereafter, following established protocols for the collection of enrollment and follow-up data on subjects;

Note:

BMS Centers will be funded at varying amounts up to the maximum award based on the numbers of BMS database participants from whom BMS Centers must collect follow-up data. BMS Centers that have previously been BMS grantees with large numbers of database participants will receive more funding within the specified range than BMS Centers with fewer participants, as determined by NIDRR after applicants are selected for funding. Applicants must include in their budgets specific estimates of their costs for follow-up data collection. Funding will be determined individually for each successful applicant, up to the maximum allowed, based upon the documented workload associated with the follow-up data collection, other costs of the grant, and the overall budget of the research project.

(c) Proposing and conducting at least one, but no more than two, site-specific research projects to test innovative approaches to treating burn injury or to assess outcomes of individuals with burn injury. Site-specific research projects must focus on outcomes in one or more domains identified in the Plan: health and function, community living and participation, technology, and employment;

Note:

Applicants who propose more than two site-specific research projects will be disqualified. Site-specific research projects may include collaborating entities as needed for execution of the research project.

(d) Coordinating with the NIDRR-funded Model Systems Knowledge Translation Center (MSKTC; http://www.msktc.org/) to provide scientific results and information for dissemination to clinical and consumer audiences;

(e) Spending $5,000 of its total budget toward the costs of a state-of-the-science conference, which will be planned and executed with input and participation by the BMS Centers;

(f) Addressing the needs of individuals with burn injuries, including individuals from one or more traditionally underserved populations; and

(g) Ensuring that the input of individuals with burn injuries is used to shape BMS research activities.

Types of Priorities:

When inviting applications for a competition using one or more priorities, we designate the type of each priority as absolute, competitive preference, or invitational through a notice in the Federal Register. The effect of each type of priority follows:

Absolute priority: Under an absolute priority, we consider only applications that meet the priority (34 CFR 75.105(c)(3)).

Competitive preference priority: Under a competitive preference priority, we give competitive preference to an application by (1) awarding additional points, depending on the extent to which the application meets the priority (34 CFR 75.105(c)(2)(i)); or (2) selecting an application that meets the priority over an application of comparable merit that does not meet the priority (34 CFR 75.105(c)(2)(ii)).

Invitational priority: Under an invitational priority, we are particularly interested in applications that meet the priority. However, we do not give an application that meets the invitational priority a preference over other applications (34 CFR 75.105(c)(1)).

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.

Executive Orders 12866 and 13563:

Regulatory Impact Analysis Back to Top

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 on 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 extentpracticable—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 taking this regulatory action only on a reasoned determination that its benefits justify its costs. In choosing among alternative regulatory approaches, we selected those approaches that 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 of this regulatory action. The potential costs associated with this regulatory action 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 Programs have been well established over the years in that similar projects have been completed successfully. This proposed priority would generate new knowledge through research and development. Another benefit of this proposed priority is that the establishment of new DRRPs would improve the lives of individuals with disabilities. The new DRRP would generate, disseminate, and promote the use of new information that would improve the options for individuals with disabilities to perform activities of their choice in the community.

Intergovernmental Review: This program is not subject to Executive Order 12372 and the regulations in 34 CFR part 79.

Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or computer diskette) by contacting the Grants and Contracts Services Team, U.S. Department of Education, 400 Maryland Avenue SW., Room 5075, PCP, Washington, DC 20202-2550. Telephone: (202) 245-7363. If you use a TDD, call the FRS, toll free, at 1-800-877-8339.

Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.gpo.gov/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

Dated: March 2, 2012.

Alexa Posny,

Assistant Secretary for Special Education and Rehabilitative Services.

[FR Doc. 2012-5568 Filed 3-6-12; 8:45 am]

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