Disability and Rehabilitation Research Project; Traumatic Brain Injury Model Systems Centers, 13578-13582 [2012-5576]

Agencies

• DEPARTMENT OF EDUCATION

[Federal Register Volume 77, Number 45 (Wednesday, March 7, 2012)]
[Notices]
[Pages 13578-13582]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5576]


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DEPARTMENT OF EDUCATION


Disability and Rehabilitation Research Project; Traumatic Brain 
Injury Model Systems Centers

AGENCY: Office of Special Education and Rehabilitative Services, 
Department of Education.

ACTION: Notice.

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    Overview Information:
    Proposed priority--National Institute on Disability and 
Rehabilitation Research--Disability and Rehabilitation Research 
Projects and Centers Program--Disability and Rehabilitation Research 
Project--Traumatic Brain Injury Model Systems Centers.
    CFDA Number: 84.133A-5.
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 Disability 
and Rehabilitation Research Projects (DRRPs) to serve as Traumatic 
Brain Injury Model Systems (TBIMS) 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 traumatic brain injury.

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

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 ``Proposed Priority 
for Traumatic Brain Injury Model Systems (TBIMS) Centers'' 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), 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 February 15, 2006 (71 FR 8165), 
can be accessed on the Internet at the following site: https://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

[[Page 13579]]

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 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, 
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.
    Traumatic Brain Injury Model Systems (TBIMS) Centers.
    Background:
    The Centers for Disease Control and Prevention (CDC) report that 
each year in the United States at least 1.7 million people sustain a 
traumatic brain injury (TBI). Of these, approximately 52,000 die, 
275,000 are hospitalized, and 1.3 million are treated and released from 
emergency departments (CDC, 2010; Faul, Xu, Wald, & Coronado, 2010). 
These estimates do not include those individuals who sustained a TBI 
and did not seek medical care, those seen only in private doctors' 
offices, or those treated in military or veteran health care 
facilities. The leading causes of TBI are falls (35.2 percent), motor 
vehicle/traffic collisions (17.3 percent), struck by/against events 
(16.5 percent), and assaults (10 percent) (Faul et al., 2010). Blasts 
are a leading cause of TBI among active duty military personnel serving 
in war zones (Defense and Veterans Brain Injury Center, 2011a). The 
number of TBIs experienced by members of the U.S. Armed Forces between 
the start of 2000 and the end of the second quarter of 2011 is reported 
to be 220,430 (Defense and Veterans Brain Injury Center, 2011b).
    Common disabilities resulting from TBI include problems with 
cognition, sensory processing, communication, and behavioral or mental 
health; and some TBI survivors develop long-term medical complications 
(National Institute of Neurological Disorders and Stroke, 2011). Direct 
medical costs and indirect costs such as lost productivity associated 
with TBI totaled an estimated $76.5 billion in the United States in 
2010 (CDC, 2011). Despite the prevalence of TBI and the disabilities 
that often follow, less than 20 percent of the management guidelines 
for TBI are supported by either Class I (prospective, randomized, 
controlled trials with masked outcome assessment, in a representative 
population) or Class II (prospective matched group cohort study in a 
representative population with masked outcome assessments) research 
evidence (Maas, Roozenbeek, & Manley, 2010).
    The Traumatic Brain Injury Model Systems Centers (TBIMS Centers) 
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 TBI. The mission of the TBIMS Centers is to improve the lives 
of persons who experience TBI, and of their families and communities, 
by creating and disseminating new knowledge about the natural course of 
TBI and rehabilitation treatment and outcomes following TBI. The 
influence of the program was expanded in the current grant cycle 
through numerous TBI interagency initiatives with the U.S. Departments 
of Veterans Affairs and Defense, the National Institute of Neurological 
Disorders and Stroke, the Centers for Disease Control and Prevention, 
and the Defense and Veterans Brain Injury Center.
    NIDRR currently funds 16 TBIMS Centers, which are located 
throughout the United States. These centers provide comprehensive 
systems of brain injury care to individuals who sustain TBI and conduct 
TBI research, including clinical research and the analysis of 
standardized data in collaboration with other related projects. 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 Centers. (Additional information on 
the TBIMS database can be found at https://tbindsc.org). The TBI 
National Data and Statistical Center for the TBIMS Centers coordinates 
data collection, manages the TBIMS database, and provides statistical 
support to the model systems projects. As of December, 2011, TBIMS 
Centers have contributed 10,631 cases to the TBIMS database, with 
follow-up data available to date for 8,136 participants at 1 year post 
injury; 6,889 at 2 years post injury; 4,425 at 5 years post injury; 
1,834 at 10 years post injury; and 484 at 20 years post injury.
    Through this priority, we seek to fund new TBIMS Centers that will 
continue to provide a coordinated, multidisciplinary system of 
rehabilitation care specifically designed to meet the needs of 
individuals with TBI. These services would span the continuum of 
treatment from acute care through community re-entry. Under this 
priority, TBIMS 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

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interchange of data and reports among TBI researchers. As part of these 
cooperative efforts, TBIMS Centers would participate in collaborative 
research projects that range from pilot research to more extensive 
studies.
    A committee consisting of the individual TBIMS project directors 
has, since its inception, guided the TBIMS Centers program. This group 
meets bi-annually in Washington, DC, and, in consultation with NIDRR, 
develops and oversees the policies of the TBIMS Centers. NIDRR intends 
to form such a committee with the project directors awarded grants 
under this proposed priority.
    References:

    Centers for Disease Control and Prevention. (2010). Injury 
prevention & control: Traumatic brain injury. Retrieved December 2, 
2011, from www.cdc.gov/traumaticbraininjury/statistics.html.
    Centers for Disease Control and Prevention. (2011). Severe 
traumatic brain injury. Retrieved December 2, 2011, from 
www.cdc.gov/TraumaticBrainInjury/severe.html.
    Defense and Veterans Brain Injury Center. (2011a). TBI facts: 
What is a traumatic brain injury? Retrieved December 2, 2011, from 
www.dvbic.org/TBI_-The-Military/TBI-Facts.aspx.
    Defense and Veterans Brain Injury Center. (2011b). DOD worldwide 
numbers for TBI--Archives. Retrieved December 2, 2011, from 
www.dvbic.org/Archive-of-DoD-Numbers-for-TBI.aspx.
    Faul, M., Xu, L., Wald, M.M., & Coronado, V.G. (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.
    Maas, A.I.R., Roozenbeek, R., & Manley, G.T. (2010). Clinical 
trials in traumatic brain injury: Past experience and current 
developments. Neurotherapeutics, 7, 115-126.
    National Institute of Neurological Disorders and Stroke (NINDS). 
(2011, April). Traumatic brain injury: Hope through research. 
Bethesda, MD: National Institutes of Health. NIH Publication No. 02-
2478. Retrieved December 2, 2011, from www.ninds.nih.gov/disorders/tbi/detail_tbi.htm.
    Proposed Priority:
    The Assistant Secretary for Special Education and Rehabilitative 
Services proposes a priority for the funding of Traumatic Brain Injury 
Model Systems (TBIMS) Centers under the Disability and Rehabilitation 
Research Projects (DRRP) program. The TBIMS Centers must provide 
comprehensive, multidisciplinary services to individuals with traumatic 
brain injury (TBI) and conduct research that contributes to the 
development of evidence-based rehabilitation interventions and clinical 
and practice guidelines.
    For purposes of this priority, the term traumatic brain injury or 
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 
examination or mental status examination. Both penetrating and non-
penetrating wounds that fit this criteria are included, but, primary 
anoxic encephalopathy is not.
    The TBIMS Centers must generate new knowledge that can be used to 
improve outcomes of individuals with TBI 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 8165): Health and 
function, community living and participation, technology, and 
employment. Each TBIMS Center must contribute to this outcome by:
    (a) Providing a multidisciplinary system of rehabilitation care 
specifically designed to meet the needs of individuals with TBI. 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 TBI by enrolling at least 35 subjects per year into the TBIMS 
database, following established protocols for the collection of 
enrollment and follow-up data on subjects (found at https://www.tbindsc.org/);

    Note: TBIMS Centers will be funded at varying amounts up to the 
maximum award based on the numbers of TBIMS database participants 
from whom TBIMS Centers must collect follow-up data. TBIMS Centers 
that have previously been TBIMS grantees with large numbers of 
database participants will receive more funding within the specified 
range than TBIMS 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 TBI or to assess outcomes of individuals with TBI. 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.

    (d) Participating as research collaborators in at least one module 
project. Module projects are research collaborations with one or more 
TBIMS Centers on topics of mutual interest and expertise. Such module 
projects must be carried out as part of the TBIMS Centers' activities. 
They must not be part of a current TBIMS Multi-Site Collaborative 
Project, which the Department funded under a separate priority (see the 
notice inviting applications, published in the Federal Register on 
February 1, 2008 (73 FR 6162) and the associated notice of final 
priority, published in the Federal Register on February 1, 2008 (73 FR 
6132).

    Note: Applicants should not propose a specific module project in 
their application. While all TBIMS Centers grantees are required to 
participate as research collaborators in at least one module 
project, they are not required to develop any module project on 
their own. Immediately following the announcement of awards under 
this priority, TBIMS Centers that are interested in proposing module 
projects may identify module topics, identify potential 
collaborators from among the other TBIMS Centers, and propose 
research protocols for the potential modules. At the first TBIMS 
Centers Project Directors' meeting, Project Directors will review, 
discuss, and decide upon specific module projects to implement. 
NIDRR staff will facilitate this post-award discussion and 
negotiation among TBIMS Centers grantees. Once these module projects 
are agreed upon by the Project Directors, each TBIMS Center must 
participate in at least one of them.

    (e) Demonstrating, in its application, its capacity to successfully 
engage in multi-site collaborative research on TBI. This capacity 
includes access to research participants, the ability to maintain data 
quality, and the ability to adhere to research protocols;
    (f) Spending at least 15 percent of its annual budget on 
participating in a module project, as described in paragraph (d) of 
this priority;
    (g) Spending $5,000 of its total budget towards the costs of a 
state-of-the-science conference to be planned and executed with input 
and participation by the TBIMS Centers;
    (h) Coordinating with the NIDRR-funded Model Systems Knowledge 
Translation Center (MSKTC; https://www.msktc.org/) to provide scientific 
results and information for

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dissemination to clinical and consumer audiences;
    (i) Addressing the needs of individuals with TBI, including 
individuals from one or more traditionally underserved populations; and
    (j) Ensuring that the input of individuals with TBI is used to 
shape 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 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 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 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

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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. 2012-5576 Filed 3-6-12; 8:45 am]
BILLING CODE 4000-01-P