[Federal Register Volume 78, Number 40 (Thursday, February 28, 2013)]
[Proposed Rules]
[Pages 13600-13604]
From the Federal Register Online via the Government Publishing 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: [email protected]. 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: [email protected].
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