National Institute on Disability and Rehabilitation Research: Notice of proposed priority for a Traumatic Brain Injury Model Systems (TBIMS) Program [OSERS]

[Federal Register: March 5, 2002 (Volume 67, Number 43)]
[Notices]               
[Page 10093-10097]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05mr02-114]                         


[[Page 10093]]

-----------------------------------------------------------------------

Part IV





Department of Education





-----------------------------------------------------------------------



National Institute on Disability and Rehabilitation Research; Notice


[[Page 10094]]


-----------------------------------------------------------------------

DEPARTMENT OF EDUCATION

 
National Institute on Disability and Rehabilitation Research

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

ACTION: Notice of proposed priority.

-----------------------------------------------------------------------

SUMMARY: The Assistant Secretary for Special Education and 
Rehabilitative Services proposes funding a priority for a Traumatic 
Brain Injury Model Systems (TBIMS) Program under the Disability and 
Rehabilitation Research Projects (DRRP) Program for the National 
Institute on Disability and Rehabilitation Research (NIDRR) for fiscal 
year (FY) 2002. The Assistant Secretary takes this action to focus 
research attention on an identified national need. We intend this 
priority to improve the rehabilitation services and outcomes for 
individuals with Traumatic Brain Injury.

DATES: We must receive your comments on or before April 4, 2002.

ADDRESSES: Address all comments about this proposed priority to Donna 
Nangle, U.S. Department of Education, 400 Maryland Avenue, SW., room 
3412, Switzer Building, Washington, DC 20202-2645. If you prefer to 
send your comments through the Internet, use the following address: 
donna.nangle@ed.gov.

FOR FURTHER INFORMATION CONTACT: Donna Nangle. Telephone: (202) 205-
5880.
    If you use a telecommunications device for the deaf (TDD), you may 
call the TDD number at (202) 205-4475 or via the Internet: 
donna.nangle@ed.gov.
    Individuals with disabilities may obtain this document in an 
alternative format (e.g., Braille, large print, audiotape, or computer 
diskette) on request to the contact person listed under FOR FURTHER 
INFORMATION CONTACT.

SUPPLEMENTARY INFORMATION:

Invitation to Comment

    We invite you to submit comments regarding this proposed priority.
    We invite you to assist us in complying with the specific 
requirements of Executive Order 12866 and its overall requirement of 
reducing regulatory burden that might result from the proposed 
priority. Please let us know of any further opportunities we should 
take to 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 priority in room 3412, Switzer Building, 330 C 
Street SW., Washington, DC, between the hours of 8:30 a.m. and 4 p.m., 
Eastern time, Monday through Friday of each week except Federal 
holidays.

Assistance to Individuals With Disabilities in Reviewing the Rulemaking 
Record

    On request, we will supply an appropriate aid, such as a reader or 
print magnifier, to an individual with a disability who needs 
assistance to review the comments or other documents in the public 
rulemaking record for this proposed priority. If you want to schedule 
an appointment for this type of aid, please contact the person listed 
under FOR FURTHER INFORMATION CONTACT.
    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 or funding 
additional priorities, subject to meeting applicable rulemaking 
requirements.


    Note: This notice does not solicit applications. In any year in 
which we choose to use this proposed priority, we will invite 
applications through a notice in the Federal Register. When inviting 
applications we designate the priority as absolute, competitive 
preference, or invitational.

Disability and Rehabilitation Research Projects (DRRP) Program

    The purpose of the DRRP program is to plan and conduct research, 
demonstration projects, training, and related activities to:
    (a) 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; and
    (b) Improve the effectiveness of services authorized under the 
Rehabilitation Act of 1973 (the Act).

Description of Special Projects and Demonstrations for Traumatic Brain 
Injuries

    The Traumatic Brain Injury Model Systems (TBIMS) program requires 
excellence in clinical care, rehabilitation research, and relevance to 
consumers, principally individuals with traumatic brain injuries and 
their families. Each TBIMS project funded under this program must have 
an integrated continuum of care to support the rehabilitation of 
persons with TBI, with linkage to a trauma system project and 
community-based treatment settings. Each project must have capacity to 
enroll TBI subjects and conduct research on TBI.
    The Department is particularly interested in ensuring appropriate 
expenditure of public funds. Not later than three years after the 
establishment of any TBI project, NIDRR will conduct one or more 
reviews of the activities and achievements of each project to ensure 
that the grantee is carrying out proposed activities and contributing 
to the advancement of knowledge. In accordance with the provisions of 
34 CFR 75.253(a), continued funding depends at all times on 
satisfactory performance and accomplishment of stated objectives.
    The New Freedom Initiative (NFI) emphasizes the importance of 
assistive and universal designed technologies, other employment 
initiatives, and promotion of full access to community-based living. 
The NFI can be accessed on the Internet at the following site: http://
www.whitehouse.gov/news/freedominitiative/freedominitiative.html. 
NIDRR's published Long-Range Plan (the Plan), focusing on both 
individual and systemic factors that impact functional capability, 
includes the following elements: employment outcomes, health and 
function, technology for access, community integration and independent 
living, and associated activities such as development of outcome 
measures and disability statistics. The Plan can be accessed on the 
Internet at: http://www.ed.gov/offices/OSERS/NIDRR/Products.

Priority

Background:

    An estimated 5.3 million Americans currently live with disabilities 
resulting from TBI. The Centers for Disease Control (CDC) estimates 
that approximately 80,000 Americans experience the onset of 
disabilities resulting from traumatic brain injury each year. The three 
leading causes of TBI are motor vehicle crashes, violence, and falls, 
particularly among the elderly. Following TBI, individuals may have 
impairments in cognition, movement, and sensation (Thurman D.J., 
Alverson C.A., Dunn K.A., Guerrero J., Sniezek, J.E., Traumatic brain 
injury in the United States: A Public Health Perspective, Journal of 
Head Trauma Rehabilitation. 1999, 14(6): 602-615). The CDC maintains a 
website on ``Epidemiology of Traumatic Brain Injury in the United 
States'' at http://www.cdc.gov/ncipc/dacrrdp/tbi.htm.

[[Page 10095]]

    As stated in the 1998 National Institute of Health (NIH) Consensus 
Conference Proceedings, ``TBI may result in lifelong impairment of an 
individual's physical, cognitive, and psychosocial functioning.'' In a 
1995 review of the literature on TBI survivors, Morton and Wehman 
identified ``significant'' decreases in opportunities for social 
interaction and maintaining friendships as well as high levels of 
anxiety and depression lasting for prolonged periods following TBI 
(Morton M., Wehman P., Psychosocial and Emotional Sequelae of 
Individuals with Traumatic Brain Injury: A Literature Review and 
Recommendations, Brain Injury, 1995, Vol. 9, No. 1, 81-92). In the 
civilian population, it is estimated that fewer than 25% of persons 
experiencing TBI are ``able to gain and maintain employment'' 
(Kolakowsky-Hayner S., Kreutzer J.S., Miner K.D., Validation of the 
Service Obstacles Scale for the Traumatic Brain Injury Population, 
NeuroRehabilitation, 2000, Vol. 14, 151-158.) Other research has found 
high rates of rehospitalization after TBI, often for seizures and 
psychiatric difficulties (Marwitz J.H., Cifu D.X., Englander J., High 
W.M., A Multi-System Project Analysis of Rehospitalizations Five Years 
After Brain Injury, Journal of Head Trauma Rehabilitation, Aug. 16, 
2001, No. 4, 307-17).
    In 1987, NIDRR established the National Traumatic Brain Injury 
Model Systems (TBIMS) Program by funding four projects to provide 
comprehensive, multidisciplinary rehabilitation services to persons who 
experience TBI and to conduct research to foster advances in TBI 
rehabilitation. This number expanded to 17 projects in 1998. The TBIMS 
program is designed to study the course of recovery and outcomes 
following the delivery of a coordinated system of TBI care.

Contributions to the TBI National Data Center Project

    From 1989 to present, the TBIMS projects have collected information 
on common data elements and contributed to a centralized TBI database 
(additional information on TBIMS can be found at http://www.tbims.org). 
The TBI National Data Center (TBINDC) project coordinates data 
collection, manages the TBI database, and provides statistical support 
to the model system projects. To date, TBI projects have contributed 
2,553 cases to the national database, with follow up data currently 
extending to 12 years post injury. 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 due to brain trauma, post-
traumatic amnesia (PTA), skull fracture, or objective neurological 
findings that can be reasonably attributed to TBI on physical 
examination or mental status examination. Penetrating wounds fitting 
the definition listed above are included. Lacerations or bruises or 
both of the scalp or forehead without other criteria listed above are 
excluded. Primary anoxic encephalopathy is excluded.
    In the current TBIMS, participants must meet the following 
criteria: (a) Fit the above definition of TBI; (b) be 16 or older; (c) 
entered the Model System's acute care hospital emergency department 
within 24 hours of injury; (d) receive both acute hospital care and 
care on a designated inpatient rehabilitation unit within the model 
system; and (e) be able to understand and signs an informed consent 
form or, if unable, have a family or legal guardian who understands and 
sign the informed consent form. At the present time, TBIMS projects 
collects 429 data items on each individual during the initial 
hospitalization, and an additional 459 items during follow up.

TBI Rehabilitation

    In recent years, medical and pharmacological therapies have shown 
promise for preserving and enhancing function for individuals with TBI. 
The availability of drugs capable of regulating neurotransmitter 
release or receptor function has led to research into neuroprotective 
intervention in TBI (Verma A., Opportunities for Neuroprotection in 
TBI, Journal of Head Trauma and Rehabilitation, 2000; 15(5): 1149-
1161); (McIntosh T.K., Juhler M., et al., Novel Pharmacologic 
Strategies in the Treatment of Experimental Traumatic Brain Injury, 
Journal of Neurotrauma, Oct. 1998; 15(10): 731-69). 
Psychopharmacological agents such as amantadine have shown 
responsiveness to symptoms that include problems with short-term 
memory, attention, planning, problem solving, impulsivity, 
disinhibition, poor motivation, and other behavioral and cognitive 
deficits (Kraus M.F., Maki P.M., Effect of Amantadine Hydrochloride on 
Symptoms of Frontal Lobe Dysfunction in Brain Injury: Case Studies and 
Review, Journal of Neuropsychiatry and Clinical Neurosciences, Spring 
1997; 9(2): 222-30).
    Diagnostic data offer new promise for facilitating treatment 
interventions and impacting outcomes. For instance, evidence indicates 
that intracranial pressure (ICP) data can increase the confidence of 
outcome predictions that are based on the clinical examination alone 
(Bullock R., Chesnut R.M., et al., Guidelines for the Management of 
Severe Head Injury, Brain Trauma Foundation, European Journal of 
Emergency Medicine (England), June 1996; 3(2): 109-27). Magnetic 
resonance imaging (MRI) may clarify the relationship between chronic 
symptoms such as headaches and irritability after TBI and MRI 
abnormalities. MRI also appears to be the most sensitive imaging method 
for assessing mild TBI (MTBI) (Voller B., Auff E., et al., To Do or Not 
to Do? Magnetic Resonance Imaging in Mild Traumatic Brain Injury, Brain 
Injury, Feb. 2001; 15(2): 107-15).
    New technologies and therapeutic interventions have the potential 
to improve understanding and enhance access and function for 
individuals with TBI. Virtual reality (VR) technology can be used to 
assess TBI patients and enable them to relearn activities of daily 
living (ADL) in a safe, controlled, visually stimulating environment 
(Gourlay D., Lun K.C., et al., Virtual Reality for Relearning Daily 
Living Skills, International Journal of Medical Informatics, Dec. 2000; 
60(3): 255-61). Tele-rehabilitation is being used to conduct follow-up 
psychological testing of individuals with TBI who live in rural areas. 
This technology may facilitate access for individuals who must travel 
long distances to see providers.
    Research on improving employment outcomes has found that specific 
vocational interventions tailored to the needs of individuals with TBI 
may be effective despite significant neuropsychological impairments 
(Johnstone B., Schopp L.H., Harper J., Koscuilek J., Neuropsychological 
Impairments, Vocational Outcomes, and Financial Costs for Individuals 
with Traumatic Brain Injury Receiving State Vocational Rehabilitation 
Services, Journal of Head Trauma Rehabilitation, 1999, Vol. 14, 220-
232). Yet other research finds that ``significant service gaps remain, 
particularly in the area of employment outcomes'' (Goodall P., Ghilone 
C.T., The Changing Face of Publicly Funded Employment Services, Journal 
of Head Trauma Rehabilitation, 2001, Vol. 16, No. 1, 94-106).
    Despite the emergence of improved imaging techniques and 
psychopharmacologic treatments, the effectiveness of many 
rehabilitation interventions for persons with TBI has yet to be 
demonstrated conclusively. In work funded by the Agency for Health Care 
Policy and Research (now the Agency for Health Care Research and 
Quality), a panel of experts concluded that there is little evidence 
relating the

[[Page 10096]]

intensity of acute inpatient TBI rehabilitation to outcome. Research on 
TBI interventions must have methodological rigor that includes 
attention to study population, controls, hypotheses, appropriate 
measures, and appropriate statistical analysis methods (Evidence 
Report/Technology Assessment Number 2. Rehabilitation for Traumatic 
Brain Injury, AHCPR Publication No. 99-E006).
    NIDRR recently completed a Summative Program Review of the current 
TBIMS projects. Participants in the review process observed that the 
comprehensive continuum of quality care should continue to be a 
requirement for participation in the TBIMS projects program. In 
addition, the review panels identified longitudinal data collection and 
innovative research as achievements of the TBIMS. Reviewers also noted 
that uniformly comprehensive, high quality care, together with a common 
data collection system and administrative infrastructure, make the 
TBIMS program a valuable platform for various collaborative studies, 
including multi-system project trials of therapies and technologies as 
well as community-based interventions. NIDRR will hold a separate 
competition to foster collaborative research to take advantage of the 
multi-site capacities of the TBIMS.
    A committee consisting of the individual system project program 
directors has, since its inception, guided the TBIMS program. This 
group meets bi-annually in Washington, DC, and, in consultation with 
NIDRR, develops and oversees the policies of the TBIMS. It is 
anticipated that this mechanism will continue. In the current funding 
cycle, this governing body developed a set of strategic recommendations 
for the Model Systems. NIDRR intends to work through the system project 
directors to implement some of the recommendations of this group, 
including:
     Evaluation of the inclusion criteria and its impact on the 
population admitted to the model system;
     Systematic evaluation of the TBI longitudinal data set, 
with reduction in redundancy of data items and consideration of 
adoption of a minimal data set;
     Development of guidelines for public use of the data set, 
ensuring confidentiality of data; and
     Continued development of research management mechanisms 
that promote rigor in TBI studies.

Proposed Priority

    The Assistant Secretary proposes to establish an absolute priority 
for Traumatic Brain Injury Model System projects for the purpose of 
generating new knowledge through research to improve treatment and 
services delivery outcomes for persons with TBI. A TBIMS project must:
    (1) Have a multidisciplinary system of rehabilitation care 
specifically designed to meet the needs of individuals with TBI. This 
system must: (a) Encompass a continuum of care, including emergency 
medical services, acute care services, acute medical rehabilitation 
services, and post-acute services; and (b) demonstrate the ability to 
enroll adequate numbers of subjects in order to conduct rigorous 
research projects.
    (2) Conduct no more than three research studies focused on areas 
identified in the NFI and the Plan, ensuring that each project has 
sufficient sample size and methodological rigor to generate robust 
findings. These studies may be done in collaboration with other TBIMS 
projects.
    (3) Participate as directed by the Assistant Secretary in national 
studies of TBI by contributing to a national database and by other 
means as required by the Assistant Secretary, collect data on TBIMS 
participants, adhering to data collection and data quality guidelines 
developed by the TBINDC in consultation with NIDRR, and demonstrating 
capacity to maintain long-term retention of participants.
    (4) Disseminate research findings to clinical and consumer 
audiences, using accessible formats, and evaluate impact of these 
findings on improved outcomes for persons with TBI.
    (5) Collaborate, as appropriate, with other system projects in 
ongoing research and dissemination efforts, providing information on 
coordination mechanisms, quality control, and impact on overall 
management of the system project.
    In carrying out these purposes, the TBIMS project may select one of 
the following research objectives related to specific areas of the NFI 
or the Plan:
     Integrating Persons with Disabilities into the Workforce: 
(1) Develop and evaluate strategies that improve the employment 
outcomes of persons with TBI, particularly focusing on job quality and 
job stability; and (2) Investigate the relationship between treatment 
in TBIMS and improved employment outcomes for persons with TBI.
     Maintaining Health and Function: (1) Study the impact of 
diagnostic innovations, such as use of ICP and fMRI, in acute 
management on rehabilitation outcomes; (2) Identify pharmacologic 
interventions of psychoactive drugs and other pharmacologic agents to 
enhance cognitive and behavioral outcomes, (3) Design and test 
rehabilitation interventions that improve functional and long-term 
outcomes of persons with TBI; or (4) Examine treatment alternatives for 
depression and other affective disorders.
     Assistive and Universally Designed Technologies: (1) 
Evaluate the impact of selected innovations in technology or 
rehabilitation engineering or both on outcomes such as function, 
independence, and employment; or (2) Evaluate the impact of selected 
innovations in technology or rehabilitation engineering or both on 
service delivery to persons with TBI.
     Full Access to Community Life: (1) Develop and test 
strategies for improving the independent living/community integration 
outcomes of persons with TBI, including identifying predictors of 
community participation and interventions that may affect it; (2) 
Evaluate the role of family and social supports in facilitating the 
independent living/community integration outcomes of persons with 
disabilities; or (3) Examine the impact of environmental barriers on 
the outcomes of persons with TBI.
    In carrying out these purposes, the system project must:
     Involve, as appropriate, individuals with disabilities and 
individuals from minority backgrounds in all aspects of the research as 
well as in design of clinical services and dissemination activities.
     Demonstrate knowledge of culturally appropriate methods of 
data collection, including understanding of culturally sensitive 
measurement approaches;
     Collaborate with other related projects, including the 
other funded TBIMS projects.
    Applicable Program Regulations: 34 CFR part 350.

Electronic Access to This Document

    You may review this document, as well as all other Department of 
Education documents published in the Federal Register, in text or Adobe 
Portable Document Format (PDF) on the Internet at the following site: 
www.ed.gov/legislation/FedRegister.
    To use PDF you must have Adobe Acrobat Reader, which is available 
free at this site. If you have questions about using PDF, call the U.S. 
Government Printing Office (GPO), toll free, at 1-888-293-6498; or in 
the Washington, DC, area at (202) 512-1530.


[[Page 10097]]


    Note: 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 on GPO access at: http://
www.access.gpo.gov/nara/index.html.


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

(Catalog of Federal Domestic Assistance Number 84.133A, Disability 
Rehabilitation Research Project.)

    Dated: February 27, 2002.
Loretta L. Petty,
Acting Assistant Secretary for Special Education and Rehabilitative 
Services.
[FR Doc. 02-5230 Filed 3-4-02; 8:45 am]
BILLING CODE 4000-01-P