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[Federal Register Volume 78, Number 40 (Thursday, February 28, 2013)]
[Proposed Rules]
[Pages 13600-13604]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04699]

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DEPARTMENT OF EDUCATION

34 CFR Chapter III

Proposed Priority--National Institute on Disability and 
Rehabilitation Research--Traumatic Brain Injury Model Systems Centers 
Collaborative Research Project

[CFDA Number: 84.133A-7.]
AGENCY: Office of Special Education and Rehabilitative Services, 
Department of Education.

ACTION: Proposed priority.

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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 a Disability 
and Rehabilitation Research Project (DRRP) on Traumatic Brain Injury 
Model Systems Centers Collaborative Research Projects. The Assistant 
Secretary may use this priority

[[Page 13601]]

for competitions in fiscal year (FY) 2013 and later years. We take this 
action to focus research attention on areas of national need. We intend 
this priority to contribute to improved employment outcomes for 
individuals with disabilities.

DATES: We must receive your comments on or before April 1, 2013.

ADDRESSES: Address all comments about this notice to Marlene Spencer, 
U.S. Department of Education, 400 Maryland Avenue SW., room 5133, 
Potomac Center Plaza (PCP), Washington, DC 20202-2700.
    If you prefer to send your comments by email, use the following 
address: marlene.spencer@ed.gov. You must include the phrase ``Proposed 
Priority for Traumatic Brain Injury Model Systems Centers Collaborative 
Research Projects'' in the subject line of your electronic message.

FOR FURTHER INFORMATION CONTACT: Marlene Spencer. Telephone: (202) 245-
7532 or by email: marlene.spencer@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 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 currently approved Plan, NIDRR 
seeks to: (1) Improve the quality and utility of disability and 
rehabilitation research; (2) foster an exchange of expertise, 
information, and training methods 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 for integrating 
research and practice; and (6) disseminate findings.
    This notice proposes a priority that NIDRR intends to use for a 
DRRP competition in FY 2013 and possibly later years. However, nothing 
precludes NIDRR from publishing additional priorities, if needed. 
Furthermore, NIDRR is under no obligation to make an award using 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 5133, 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).

Disability and Rehabilitation Research Projects

    The purpose of NIDRR's DRRPs, which are funded through the 
Disability and Rehabilitation Research Projects and Centers Program, is 
to improve the effectiveness of services authorized under the 
Rehabilitation Act 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, utilization, dissemination, and technical 
assistance.
    An applicant for assistance under this program must demonstrate in 
its application how it will address, in whole or in part, the needs of 
individuals with disabilities from minority backgrounds (34 CFR 
350.40(a)). The approaches an applicant may take to meet this 
requirement are found in 34 CFR 350.40(b). Additional information on 
the DRRP program can be found at: www.ed.gov/rschstat/research/pubs/res-program.html#DRRP.
    Program Authority: 29 U.S.C. 762(g) and 764(a).
    Applicable Program Regulations: 34 CFR part 350.
    Proposed Priority: This notice contains 1 proposed priority.
    Traumatic Brain Injury Model Systems Centers Collaborative Research 
Projects.
    Background:
    The Centers for Disease Control and Prevention reports that 
approximately 1.7 million traumatic brain injuries (TBIs) were recorded 
annually between 2002 and 2006 (Faul et al., 2010). Of the persons 
incurring these TBIs, approximately 50,000 died, 275,000 were 
hospitalized, and 1.37 million were treated and released from emergency 
departments. These estimates do not include those individuals who 
sustained a TBI and failed to seek medical care, those treated in 
primary care settings, and those treated in military and Veterans 
Affairs hospitals. The Department of Defense reports that 235,046 
service members were diagnosed with TBIs between 2000 and the end of 
2011 (Defense and Veterans Brain Injury Center, 2012). The three 
leading causes of TBI for civilians are falls, motor vehicle accidents, 
and struck by/against events (i.e., events in which an individual 
collides with a moving or stationary object). The leading cause of TBI 
for military personnel is explosions/blasts (Sayer et al., 2008).
    Persons who sustain moderate to severe TBIs often require intensive 
medical treatment. Forty percent of those hospitalized with nonfatal 
TBIs experience impairments that result in long-term disability 
(Corrigan, Selassie, & Orman, 2010). Common disabilities resulting from 
TBIs include problems

[[Page 13602]]

with cognition, sensory processing, communication, and behavioral or 
mental health (National Institute of Neurological Disorders and Stroke 
(NINDS), 2002). Some TBI survivors develop physical complications, some 
of which may not become apparent until long after the injury (NINDS, 
2002).
    There have been several initiatives in recent years to review and 
synthesize the available evidence on outcomes following TBI (e.g., 
Guillamondegui et al., 2011; Institute of Medicine (IOM), 2008) and on 
the effectiveness of rehabilitation treatments for TBI (e.g., Brasure 
et al., 2012; IOM, 2011). There are, however, significant challenges to 
conducting and synthesizing research on these topics such as the 
complexity of the condition, the significant number of factors that 
affect recovery in this population, and the complexity of the 
interventions (Brasure et al., 2012). Experts agree that there remains 
a strong need for future research to better establish the evidence base 
for rehabilitation interventions for this population (Brasure et al., 
2012).
    The Traumatic Brain Injury Model Systems (TBIMS) program was 
created by NIDRR in 1987 to demonstrate the benefits of a coordinated 
system of neurotrauma and rehabilitation care and to conduct innovative 
research on all aspects of care for those who sustain TBIs. For 
purposes of the TBIMS, TBI is defined as damage to brain tissue caused 
by an external mechanical force as evidenced by loss of consciousness 
or post-traumatic amnesia due to brain trauma or by objective 
neurological findings that can be reasonably attributed to TBI on 
physical or mental status examination. Both penetrating and non-
penetrating wounds that fit these criteria are included, but primary 
anoxic encephalopathy is not.
    NIDRR currently funds 16 TBIMS centers throughout the United 
States. These centers provide comprehensive systems of brain injury 
care to individuals who sustain TBIs and conduct TBI research, 
including clinical research and the analysis of standardized data in 
collaboration with other related projects. The mission of the TBIMS is 
to improve the lives of persons who experience TBIs, and to help their 
families and communities, by creating and disseminating new knowledge 
about the natural course of TBI and rehabilitation treatment and 
outcomes following TBI.
    Since 1989, the TBIMS centers have collected and contributed 
information on common data elements for a centralized TBIMS database, 
which is maintained through a NIDRR-funded grant for a National Data 
and Statistical Center for the TBIMS. (Additional information on the 
TBIMS database can be found at https://www.tbindsc.org.) The TBI 
National Data and Statistical Center for the TBIMS coordinates data 
collection, manages the TBIMS database, and provides statistical 
support to the model systems projects. As of September 2012, the TBIMS 
centers have contributed 11,247 cases to the TBIMS database, with 
follow-up data extending 20 years after injury.
    In 2003 and again in 2008, NIDRR leveraged the capacity of the 
TBIMS program by funding large-scale collaborative research projects 
that required participation across TBIMS centers. The collaborative 
projects funded in 2008 included a randomized controlled trial of the 
effectiveness of amantadine hydrochloride in treating post-TBI 
irritability and aggression and a practice-based study of factors that 
predict the effectiveness of rehabilitation interventions following 
TBI. Through the funding of this priority, the TBIMS program will 
continue to serve as a platform for multi-site research that 
contributes to evidence-based rehabilitation interventions and improves 
the lives of individuals with TBIs.

References

Brasure, M., Lamberty, G.J., Sayer, N.A., Nelson, NW., MacDonald, 
R., Ouellette, J., Tacklind, J., Grove, M., Rutks, I.R., Butler, 
M.E., Kane, R.L., Wilt, T.J. (2012). Multidisciplinary postacute 
rehabilitation for moderate to severe traumatic brain injury in 
adults. (Prepared by the Minnesota Evidence-based Practice Center 
under Contract No. 290-2007-10064-I.) AHRQ Publication No. 12-
EHC101-EF. Rockville, MD: Agency for Healthcare Research and 
Quality. Retrieved September 6, 2012 from: 
www.effectivehealthcare.ahrq.gov/reports/final.cfm.
Corrigan, J.D., Selassie, A.W., Orman, J.A.L. (2010). The 
epidemiology of traumatic brain injury. Journal of Head Trauma 
Rehabilitation, 25(2), 72-80.
Defense and Veterans Brain Injury Center. (2012). DoD worldwide 
numbers for TBI (non-combat and combat injuries). Retrieved 
September 6, 2012 from: www.dvbic.org/TBINumbers.aspx.
Faul, M., Xu, L., Wald, M., et al. (March 2010). Traumatic brain 
injury in the United States: Emergency department visits, 
hospitalizations and deaths 2002-2006. Atlanta, GA: Centers for 
Disease Control and Prevention, National Center for Injury 
Prevention and Control.
Guillamondegui, O.D., Montgomery, S.A., Phibbs, F.T., McPheeters, 
M.L., Alexander, P.T., Jerome, R.N., McKoy, J.N., Seroogy, J.J., 
Eicken, J.J., Krishnaswami, S., Salomon, R.M., Hartmann, K.E. (April 
2011). Traumatic brain injury and depression. Comparative 
effectiveness review No. 25. (Prepared by Vanderbilt Evidence-based 
Practice Center under Contract No. 290-2007-10065-I.) AHRQ 
Publication No. 11-EHC017-EF. Rockville, MD: Agency for Healthcare 
Research and Quality. Retrieved September 6, 2012 from: 
www.effectivehealthcare.ahrq.gov/reports/final.cfm.
Institute of Medicine. (2008). Gulf War and health: Volume 7. Long-
term consequences of traumatic brain injury. Washington, DC: The 
National Academies Press. Retrieved September 6, 2012 from: 
www.iom.edu/Reports/2010/Gulf-War-and-Health-Volume-8-Health-Effects-of-Serving-in-the-Gulf-War.aspx.
Institute of Medicine. (2011). Cognitive rehabilitation therapy for 
traumatic brain injury: Evaluating the evidence. Washington, DC: The 
National Academies Press. Retrieved September 6, 2012 from: 
www.iom.edu/Reports/2011/Cognitive-Rehabilitation-Therapy-for-Traumatic-Brain-Injury-Evaluating-the-Evidence.aspx.
National Institute of Neurological Disorders and Stroke (NINDS). 
(2002). Traumatic brain injury: Hope through research. Bethesda, MD: 
National Institute of Health. NIH Publication No. 02-2478. Retrieved 
September 6, 2012 from: www.ninds.nih.gov/disorders/tbi/detail_tbi.htm.
Sayer, N.A., Chiros, C.E., Sigford, B., et al. (2008). 
Characteristics and rehabilitation outcomes among patients with 
blast and other injuries sustained during the global war on terror. 
Archives of Physical Medicine and Rehabilitation, 89(1), 163-70.

    Proposed Priority:
    The Assistant Secretary for Special Education and Rehabilitative 
Services establishes a priority for the funding of Disability and 
Rehabilitation Research Projects (DRRPs) to serve as Traumatic Brain 
Injury Model Systems (TBIMS) multi-site collaborative research 
projects. To be eligible under this priority, an applicant must have 
received a grant under the TBIMS centers priority (see https://www.federalregister.gov/articles/2012/06/11/2012-14115/disability-and-rehabilitation-research-projects-and-centers-program-traumatic-brain-injury-model). Each TBIMS multi-site collaborative research project 
must be designed to contribute to evidence-based rehabilitation 
interventions and clinical practice guidelines that improve the lives 
of individuals with traumatic brain injuries (TBIs) through research, 
including the testing of approaches to treating TBIs or the assessment 
of the outcomes of individuals with TBIs. Each TBIMS multi-site 
collaborative research project must contribute to this outcome by--
    (a) Collaborating with three or more of the NIDRR-funded TBIMS 
centers (for a

[[Page 13603]]

minimum of four TBIMS sites). In addition to the required TBIMS sites, 
applicants may also propose to include other TBI research sites that 
are not currently participating in the TBIMS program;
    (b) Conducting multi-site research on questions of significance to 
TBI rehabilitation, using clearly identified research designs. The 
research must focus on outcomes in one or more of the following domains 
identified in NIDRR's Long-Range Plan, published in the Federal 
Register on February 15, 2006 (71 FR 8165): health and function, 
participation and community living, technology, and employment;
    (c) Demonstrating the capacity to carry out multi-site 
collaborative research projects, including administrative capabilities, 
experience with management of multi-site research protocols, and 
demonstrated ability to maintain standards for quality and 
confidentiality of data gathered from multiple sites;
    (d) Addressing the needs of people with disabilities, including 
individuals from traditionally underserved populations;
    (e) Coordinating with the NIDRR-funded Model Systems Knowledge 
Translation Center to provide scientific results and information for 
dissemination to clinical and consumer audiences; and
    (f) Ensuring participation of individuals with disabilities in 
conducting TBIMS research.
    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 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

    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 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 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 the new DRRP have been completed successfully, and the new 
DRRP, established consistently with the proposed priority, is expected 
to improve the lives of individuals with disabilities and generate 
through research and development, disseminate,

[[Page 13604]]

and promote the use of new information that would improve the lives of 
individuals with disabilities who have experienced TBIs.
    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 compact disc) 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 or a TTY, 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: February 25, 2013.
Michael Yudin,
Acting Assistant Secretary for Special Education and Rehabilitative 
Services.
[FR Doc. 2013-04699 Filed 2-27-13; 8:45 am]
BILLING CODE 4000-01-P
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