[Federal Register: June 7, 2002 (Volume 67, Number 110)]
[Notices]               
[Page 39571-39577]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jn02-152]                         


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Part IV





Department of Education





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Disability and Rehabilitation Research Projects (DRRP) Program; Notices


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DEPARTMENT OF EDUCATION

 
Disability and Rehabilitation Research Projects (DRRP) Program

AGENCY: National Institute on Disability and Rehabilitation Research 
(NIDRR), Office of Special Education and Rehabilitative Services, 
Department of Education.

ACTION: Notice of final priorities.

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SUMMARY: The Assistant Secretary announces final priorities for one or 
more Burn Model Systems (BMS) Projects, one Burn Data Center (BDC), and 
for a Traumatic Brain Injury Model Systems (TBIMS) Program. The 
Assistant Secretary may use one or more of these priorities for 
competitions in FY 2002 and in later years. We take this action to 
focus research attention on identified national needs. We intend these 
priorities to improve the rehabilitation services and outcomes for 
individuals with severe burn injuries and Traumatic Brain Injury (TBI).

EFFECTIVE DATE: These priorities are effective June 7, 2002.

FOR FURTHER INFORMATION CONTACT: Donna Nangle, U.S. Department of 
Education, 400 Maryland Avenue, SW., Room 3412, Switzer Building, 
Washington, DC 20202-2645. Telephone: (202) 205-5880 or via the 
Internet: donna.nangle@ed.gov.
    If you use a telecommunications device for the deaf (TDD), you may 
call the TDD number at (202) 205-4475.
    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:
    The purpose of the DRRP Program is to plan and conduct research, 
demonstration projects, training, and related activities that help to 
maximize the full inclusion and integration of individuals with 
disabilities into society and to improve the effectiveness of services 
authorized under the Rehabilitation Act of 1973, as amended (the Act).
    This priority reflects issues discussed in the New Freedom 
Initiative (NFI) and NIDRR's Long-Range Plan (the Plan). The NFI can be 
accessed on the Internet at: http://www.whitehouse.gov/news/
freedominitiative/freedominiative.html.
    The Plan can be accessed on the Internet at: http://www.ed.gov/
offices/OSERS/NIDRR/Products.
    We published a notice of proposed priorities (NPP) for the Burn 
Model Systems (BMS) Projects and the Burn Data Center (BDC) in the 
Federal Register on March 5, 2002 (67 FR 10088). We also published a 
separate notice of proposed priority for Traumatic Brain Injury Model 
Systems (TBIMS) in the Federal Register on March 5, 2002 (67 FR 10094). 
We have combined in this notice of final priorities the priorities for 
the BMS, BDC, and TBIMS. This NFP contains several significant changes 
from the NPP. Specifically for the BMS, we have made the conference 
reflect the topic rather than the title. We will determine the location 
of the project directors' meeting after award, rather than specify at 
this time that the meeting must be held in Washington, DC. Specifically 
for the TBIMS, we added a priority on measures, we added neurological 
recovery as a possible research issue, and we expanded the settings in 
which research on diagnostic procedures can occur. We fully explain 
these changes in the Analysis of Comments and Changes elsewhere in this 
notice.
    The backgrounds for each of the priorities were published in their 
respective notices of proposed priority.

Analysis of Comments and Changes

    In response to our invitation in the NPPs, several parties 
submitted comments on the proposed priorities (seven parties for the 
BMS, one party for the BDC, and 28 parties for the TBIMS). An analysis 
of the comments and of any changes in the priorities since publication 
of the NPPs is published as an appendix at the end of this notice. We 
discuss comments under the priority to which they pertain.
    Generally, we do not address technical and other minor changes and 
suggested changes the law does not authorize us to make under the 
applicable statutory authority.

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

Priorities

Priority 1--Burn Model System Projects

    This priority supports one or more Burn Model System projects for 
the purpose of generating new knowledge through research to improve 
treatment and service delivery outcomes for persons with burn injury. A 
BMS project must:
    (1) Establish a multidisciplinary system that begins with acute 
care and encompasses rehabilitation services specifically designed to 
meet the needs of individuals with burn injuries. This system must 
encompass a continuum of care, including emergency medical services, 
acute care services, acute medical rehabilitation services, post-acute 
services, psychosocial/vocational services, and long-term community 
follow up.
    (2) Participate as directed by the Assistant Secretary in national 
studies of burn injuries by contributing to a national database and by 
other means as required by the Assistant Secretary; and
    (3) Conduct no more than five research studies in burn injury 
rehabilitation, ensuring that each project has sufficient sample size 
and methodological rigor to generate robust findings that will 
contribute to the advancement of knowledge in accordance with the NFI 
and the Plan. These studies may be done in collaboration with other BMS 
projects.
    In proposing research studies, applicants must demonstrate their 
potential impact on rehabilitation goals and objectives. Applicants may 
select from the following research directives related to specific areas 
of the NFI and the Plan:
     Integrating Individuals with Disabilities into the 
Workforce: (1) Assess intervention strategies for improving employment 
outcomes of individuals surviving severe burns; or (2) Identify 
environmental factors that either enable or impede community and 
workplace integration.
     Maintaining Health and Function: (1) Study interventions 
to improve rehabilitation potential in the acute care setting such as 
nutritional support, early therapeutic exercise to increase mobility, 
treatment for scar tissue, or the prevention and treatment of secondary 
conditions; (2) Develop and evaluate rehabilitation treatment/
interventions for individuals surviving severe burns; or (3) Design and 
test service delivery models that provide quality rehabilitation care 
for burn survivors under constraints imposed by recent changes in the 
health care financing system.
     Assistive and Universally Designed Technologies:
    (1) Evaluate the impact of selected innovations in technology 
(e.g., assistive devices, biomaterials) on outcomes such as function, 
independence, and employment of individuals with burn injuries; or (2) 
Investigate the impact of national telecommunications and information 
policy on the access of individuals with burn injuries to related 
education, work, and other opportunities.

[[Page 39573]]

     Full Access to Community Life: Assess the value of peer 
support and early onset of services from community and social support 
organizations to improve outcomes such as independence, community 
integration, employment, function, and health maintenance.
     Associated Areas: Develop and refine measures of treatment 
effectiveness in burn rehabilitation to incorporate environmental 
factors in the assessment of function.
    (4) Provide widespread consumer-oriented dissemination activities 
to other burn projects, rehabilitation practitioners, researchers, 
individuals with burn injuries and their families and representatives, 
and other public and private organizations involved in burn care and 
rehabilitation.
    In carrying out these purposes, the projects must:
     Involve individuals with disabilities or their family 
members or both, individuals who are members of groups that have 
traditionally been underrepresented, and consumers, as appropriate, in 
all stages of the research and demonstration endeavor;
     Demonstrate culturally appropriate and sensitive methods 
of data collection, measurements, and dissemination addressing needs of 
burn survivors with diverse backgrounds;
     Demonstrate the research and clinical capacity to 
participate in collaborative projects, clinical trials, or technology 
transfer with other BMS projects, other NIDRR grantees, and similar 
programs of other public and private agencies and institutions; and
     In conjunction with other BMS projects, plan and conduct a 
state-of-the-science conference late in the fourth year on new trends 
in burn injury rehabilitation and publish a comprehensive report on the 
final outcomes of the conference. The report must be published in the 
fifth year of grant.

Priority 2--Burn Data Center

    This priority supports a Burn Data Center (BDC) for the purpose of 
managing and facilitating the use of information collected by the BMS 
projects on individuals with burn injury. The BDC must:
    (1) Establish and maintain a database repository for data from BMS 
projects while providing for confidentiality, quality control, and data 
retrieval capabilities, using cost-effective and user-friendly 
technology;
    (2) Ensure data quality, reliability, and integrity by providing 
training and technical assistance to BMS projects on data collection 
procedures, data entry methods, and use of study instruments;
    (3) Provide consultation to NIDRR and to directors and staff of the 
BMS projects on utility and quality of data elements;
    (4) Support efforts to improve the research findings of the BMS 
projects by providing statistical and other consultation regarding the 
national database;
    (5) Facilitate dissemination of information generated by the BMS 
projects, including statistical information, scientific papers, and 
consumer materials;
    (6) Evaluate the feasibility of linking and comparing BMS data to 
population-based data sets or other available burn data and provide 
technical assistance for such linkage, as appropriate; and
    (7) Develop guidelines to provide access to BMS data by individuals 
and institutions, ensuring that data are available in accessible 
formats for individuals with disabilities.
    In carrying out these purposes, the center must:
     Demonstrate knowledge of culturally appropriate methods of 
data collection, including understanding of culturally sensitive 
measurement approaches; and
     Collaborate with other NIDRR-funded projects, e.g., the 
Model Spinal Cord Injury and TBIMS Data Centers, regarding issues such 
as database development and maintenance, center operations, and data 
management.

Priority 3--Traumatic Brain Injury Model Systems

    This priority supports Traumatic Brain Injury Model System projects 
for the purpose of generating new knowledge through research to improve 
treatment and services delivery outcomes for individuals 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 individuals 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 Individuals with Disabilities into the 
Workforce: (1) Develop and evaluate strategies that improve the 
employment outcomes of individuals with TBI, particularly focusing on 
job quality and job stability; and (2) Investigate the relationship 
between treatment in TBIMS and improved employment outcomes for 
individuals with TBI.
     Maintaining Health and Function: (1) Study the impact of 
diagnostic innovations, such as use of intracranial pressure and 
functional MRI, on management of 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 neurological 
recovery (including motor and cognitive recovery), functional, and 
long-term outcomes of individuals 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 individuals with TBI.
     Full Access to Community Life: (1) Develop and test 
strategies for improving the independent living/community integration 
outcomes of individuals with TBI, including identifying predictors of 
community

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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 individuals with disabilities; 
or (3) Examine the impact of environmental and attitudinal barriers on 
the outcomes of individuals with TBI.
     Associated Areas: Conduct research to develop new or 
assess existing measures to support the research goals described above.
    In carrying out these purposes, the TBIMS project must:
     Involve, as appropriate, individuals with disabilities or 
their family members or both, individuals who are members of groups 
that have traditionally been underrepresented 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.

Intergovernmental Review

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

    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 
and Rehabilitation Research Project)

    Dated: June 3, 2002.
Robert H. Pasternack,
Assistant Secretary for Special Education and Rehabilitative Services.

Appendix--Analysis of Comments and Changes

Priority 1--Burn Model Systems (BMS) Projects

    Comment: One commenter asked that the priority include a focus 
on unique issues regarding social integration and psychosocial 
rehabilitation faced by children with severe burn injuries.
    Discussion: An applicant could propose a study pertaining to 
these issues; however, NIDRR has no basis to determine that all 
applicants should be required to focus on these issues. The peer 
review process will evaluate merits of the proposal.
    Changes: None.
    Comment: Several commenters noted that the new model seems to 
emphasize the clinical and logistical aspects of rehabilitation 
(e.g., functional recovery, ADLs), but lacked emphasis on 
psychological interventions and treatments for targeting problems of 
self-image, pain, or depression.
    Discussion: Psychological treatment is an important component of 
burn care rehabilitation. An applicant could propose a study 
pertaining to these issues; however, NIDRR has no basis to determine 
that all applicants should be required to focus on these issues. The 
peer review process will evaluate merits of the proposal.
    Changes: None.
    Comment: One commenter suggested that, in the background 
statement, scars, contractures, etc. should be identified as primary 
complications rather than secondary complications.
    Discussion: NIDRR's concern is the impact of complications in 
general on outcomes of individuals with serious burns. An applicant 
could propose a study pertaining to these issues; however, NIDRR has 
no basis to determine that all applicants should be required to 
focus on these issues. The peer review process will evaluate merits 
of the proposal.
    Changes: None.
    Comment: One commenter stated that neuropathy is not a common 
complication.
    Discussion: Literature cited in the notice of proposed 
priorities identified neuropathy as a common complication in older 
and critically ill individuals with severe burn.
    Changes: None.
    Comment: One commenter asked that the state-of-the-science 
conference be held at Year five instead of Year four.
    Discussion: NIDRR views the state-of-the-science conference as 
an important dissemination effort to stakeholders, scientific, and 
consumer communities, as well as burn survivors and their families. 
On this basis, NIDRR decided that the conference should be held late 
in the Year four so that the conference proceedings can be published 
during Year five.
    Changes: None.
    Comment: One commenter suggested that the conference title be 
changed to ``Current Status of Burn Rehabilitation.''
    Discussion: Funded centers will have the opportunity to name the 
conference.
    Changes: Priority has been changed to reflect the conference 
topic rather than title.
    Comment: One commenter suggested that funded centers meet at the 
American Burn Association (ABA) once a year and not in Washington, 
DC.
    Discussion: Funded centers will have the opportunity to discuss 
this issue at the first Project Director's meeting in Washington, 
DC. Meeting in Washington, DC would allow other NIDRR staff to 
attend Project Directors' meetings.
    Changes: We are no longer requiring the meeting to be in held in 
Washington, DC. NIDDR will make this determination after award, 
rather than specify at this time that the meeting must be held in 
Washington, DC.
    Comment: One commenter suggested removing reference to crab 
shells research.
    Discussion: Applicants may choose to conduct research to 
evaluate the impact of selected innovations in technology. Choice of 
technologies for study, such as bio-technology based products, is up 
to the applicant; however, NIDRR has no basis to determine that all 
applicants should be required to focus on these issues. The peer 
review process will evaluate merits of the proposal.
    Changes: None.
    Comment: One commenter suggested expanding the focus on 
Telehealth.
    Discussion: NIDRR concurs that Telehealth has potential for 
advancing burn care rehabilitation. An applicant could propose a 
study pertaining to this; however, NIDRR has no basis to determine 
that all applicants should be required to focus on this issue. The 
peer review process will evaluate merits of the proposal.
    Changes: None.
    Comment: One commenter suggested that the background discussion 
of environmental factors reflect both reality and the new paradigm.
    Discussion: An applicant could propose a study pertaining to 
these issues; however, NIDRR has no basis to determine that all 
applicants should be required to focus on these issues. The peer 
review process will evaluate merits of the proposal.
    Changes: None.
    Comment: Several commenters asked for clarification regarding 
the number of proposed site-specific projects and collaborative 
projects.
    Discussion: Applicants may choose to propose up to five research 
projects. One project must be designed as a collaborative study. 
NIDRR imposed a limit of five projects in order to encourage 
applicants to focus and to design more rigorous studies. The peer 
review process will evaluate merits of the proposal.
    Changes: None.
    Comment: Several commenters asked about the funding level and 
number of proposed centers.
    Discussion: The Notice Inviting Applications will specify the 
proposed number of centers and the proposed funding level.
    Changes: None.

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    Comment: One commenter suggested that research on long-term 
behavioral adjustment not be limited to pediatric burn survivors.
    Discussion: An applicant could propose a study pertaining to 
these issues; however, NIDRR has no basis to determine that all 
applicants should be required to focus on these issues. The peer 
review process will evaluate merits of the proposal.
    Changes: None.

Priority 2--Burn Data Center (BDC)

    Comment: One commenter suggests that the BDC create formal 
linkages between the Burn Model Systems Data and the ABA/TRACS 
National Burn Repository.
    Discussion: NIDRR will explore the mechanism to link the two 
centers within the context of the Department's policy.
    Changes: None.

Priority 3--Traumatic Brain Injury Model Systems (TBIMS)--General 
Comments

Traumatic Brain Injury Model Systems (TBIMS)--General

    Comment: A number of commenters asked whether there is a 
requirement that three projects be proposed.
    Discussion: Applicants must conduct at least one but no more 
than three research studies. There is no requirement that applicants 
must propose three projects.
    Changes: None.
    Comment: A number of commenters asked whether the proposed 
research studies must fall within one single area or research 
objective.
    Discussion: There is no requirement that all projects fall into 
one area. Applicants may propose projects that fall into different 
areas or across areas.
    Changes: None.
    Comment: A commenter asked for clarification on how the proposed 
limit of no more than three studies will be applied over a multiyear 
grant. For instance, does NIDRR expect each study to run for the 
complete multiyear funding period? Can serial substudies be proposed 
over multiple years in a single study for up to three study areas?
    Discussion: The design and duration of research studies is left 
up to each individual applicant. There is no requirement that each 
study run for the complete multiyear funding period. Serial 
substudies can be proposed over multiple years in a single study for 
up to three study areas.
    Changes: None.
    Comment: Several commenters asked if multi-center collaborations 
are allowed in addition to the three projects referenced in the 
announcement, stressing the importance of such collaboration for 
increasing sample size and reducing repetitive efforts.
    Discussion: The purpose of the limit of three projects is to 
encourage applicants to focus and to design more rigorous studies. 
For this reason, NIDRR has determined that applicants should not 
propose more than three projects in total. However, nothing 
prohibits an applicant from proposing collaborative efforts as one 
of the three research projects. In fact, NIDRR has supported 
increased collaboration across centers and plans to fund multi-
center collaborative TBI research projects in FY03.
    Changes: None.
    Comment: One commenter asked if new applicants for TBMIS have to 
compete with currently funded projects.
    Discussion: The competition is for the next five years of 
funding for the TBMIS. It is open to all eligible applicants, 
including currently funded projects that must compete for renewed 
funding.
    Changes: None.
    Comment: One commenter asked how likely is it that newcomers 
(e.g., first-time applicants) could be successful in applying for 
this grant program.
    Discussion: Applications for the TBIMS grant program are subject 
to an independent peer review process. Each application is reviewed 
on its merits based upon the evaluation criteria published with the 
final notice. Prior membership in the TBIMS is not an evaluation 
criterion.
    Changes: None.
    Comment: A number of commenters requested that the priority 
include consideration of children age 16 and younger. Children 
sustain significant physical, neurocognitive, psychosocial, and 
developmental deficits as a result of TBI.
    Discussion: NIDRR is very concerned about the rehabilitation of 
children who experience TBI and currently funds several projects 
examining rehabilitation interventions and outcomes of individuals 
under age 16. The TBIMS projects were designed to focus on adult 
populations. At this time, NIDRR does not propose to expand the 
TBIMS projects to include children. However, NIDRR is considering 
mechanisms by which to expand research on rehabilitation for 
adolescents and children with TBI.
    Changes: None.
    Comment: One commenter noted that achieving good rehabilitation 
outcomes requires addressing the needs of the family system. 
Therefore, projects should examine the impact of brain injury on 
families and the impact of families on rehabilitation outcomes.
    Discussion: An applicant could propose a study pertaining to 
these topics; however, NIDRR has no basis to determine that all 
applicants should be required to focus on these issues. The peer 
review process will evaluate merits of the proposal.
    Changes: None.
    Comment: One commenter identified a need for the TBIMS projects 
to adopt a broader view of rehabilitation for brain injury. The 
TBIMS projects have historically been managed by medical schools and 
centers and, therefore, focused on medical models of rehabilitation. 
University-based schools of education, for example, could 
collaborate with other partners to examine such topics as education 
for children, youth, and young adults.
    Discussion: NIDRR will consider applications from any applicant 
that meets the statutory requirements under the funding authority, 
encompassing States, public or private agencies, including for-
profit agencies, public or private organizations, including for-
profit organizations, institutions of higher education, and Indian 
tribes and tribal organizations. The peer review process will 
evaluate the merits of the approach used by the applicant.
    Changes: None.
    Comment: Several commenters spoke to the need for TBIMS projects 
to collaborate formally or informally with other nationally funded 
projects, such as State projects funded by the Health Resources 
Services Administration's Maternal and Child Health Bureau, Center 
for Disease Control projects, or State initiatives.
    Discussion: NIDRR encourages collaboration across Federal, 
State, and other funding mechanisms. The peer review process will 
evaluate merits of the proposal. However, NIDRR has no basis to 
determine that all applicants should be required to collaborate with 
other national or State-funded projects.
    Changes: None.
    Comment: One commenter asked whether letters of collaboration 
are required for proposed collaboration sites.
    Discussion: The evaluation criteria include a requirement that 
evidence of commitment be provided for collaborators.
    Changes: None.
    Comment: One commenter asked how applicants can be expected to 
specify the type and number of staff, staff deployment, and training 
and supervision for longitudinal data collection when the priority 
does not specify what data will need to be collected, where, and 
with what frequency. Future changes in inclusion criteria could also 
have significant implications for the volume, site, and nature of 
data collection.
    Discussion: Applicants should budget costs associated with data 
collection on elements in the current data base (the data elements 
are available by linking to http://www.tbims.org
    Changes: None.
    Comment: One commenter expressed concern about using the current 
inclusion criteria for the TBIMS. These inclusion criteria target 
individuals who receive inpatient rehabilitation immediately 
following acute care. Four issues are identified: (1) a sample using 
this approach will be unrepresentative of persons with moderate and 
severe TBI; (2) required enrollment volumes will be increasingly 
difficult to maintain; (3) applications of individual centers in 
geographic areas with high managed care penetration may be 
penalized, and (4) recruitment and followup costs will be impossible 
to project if inclusion criteria are to be changed partway through a 
funding cycle.
    Discussion: Changing the inclusion criteria was a subject of 
considerable discussion among the model systems directors during the 
last funding cycle; however, the model systems' directors reached no 
final decision on this issue. NIDRR anticipates that further 
discussion of inclusion criteria will occur and that modifications 
to the inclusion criteria are likely. For purposes of this priority, 
applicants must use the existing criteria for making projections of 
the number of subjects submitted to the model system database. NIDRR 
will work collectively and individually with programs to solve any 
cost implications that may result from changes to the inclusion 
criteria during the funding cycle.
    Changes: None.

[[Page 39576]]

    Comment: One commenter recommended that a quota be established 
for national database enrollment so that all centers will be 
required to submit the same number of cases per year.
    Discussion: While not planning on establishing a quota for 
enrollment, NIDRR plans to monitor closely proposed and actual 
numbers of cases submitted to the national database during the 
funding cycle. Projects proposing to submit fewer than 35 cases per 
year would seem to be seriously limited in their ability to carry 
out rigorous research. The peer review process will evaluate merits 
of the proposal. For purpose of responding to this notice, 
prospective applicants should base their proposals on the 
anticipated numbers of individuals who meet the current inclusion 
criteria of the TBIMS.
    Changes: None.
    Comment: One commenter expressed concern that required 
collaboration could not take place if one or more of the involved 
projects are not funded.
    Discussion: It seems reasonable to assume that, given the 
anticipated number of centers, it will be possible to replace a 
collaborator who is not funded. NIDRR recommends that applicants 
propose collaborations as deemed necessary for the studies that each 
project undertakes. NIDRR will work with any center where the lack 
of funding of a proposed collaborator creates a problem.
    Changes: None.
    Comment: One commenter expressed concern about how changes to 
data requirements for the national dataset would impact 
collaborative and other research.
    Discussion: Changes involving the national dataset will be 
applied to every center equally. One criterion by which to evaluate 
decisions to remove data elements from the data set will be whether 
these are currently being used in a study. Also, an individual 
project or collaborating group has the option of continuing to 
collect data for purposes of an individual study even if the data 
are no longer required for the national dataset. Thus, it would 
appear that there is no limitation resulting from potential changes 
to the longitudinal dataset.
    Changes: None.
    Comment: One commenter expressed concern that the priority 
provides a disincentive to performance of high-quality efficacy 
research as planning multi-center treatment trials with unknown 
collaborators is virtually impossible.
    Discussion: NIDRR will be announcing its TBI collaborative 
research funding grant program soon after the announcement of awards 
for the TBIMS. NIDRR anticipates that there will be 2-3 awards under 
this program, with funding sufficient to carry out multi-center 
trials and maintain research management oversight. For the current 
competition, NIDRR recommends collaboration as appropriate to 
increase sample size.
    Changes: None.

Specific

    Comment: Several commenters expressed concern about the study of 
diagnostic interventions, inquiring about the acceptability of 
conducting studies of positron emission tomography (PET), SPECT, 
TMS, etc. on the management of rehabilitation outcomes.
    Discussion: The diagnostic procedures mentioned in the proposed 
priority are examples. An applicant could propose a study pertaining 
to these; however, NIDRR has no basis to determine that all 
applicants should be required to focus on these issues. The peer 
review process will evaluate merits of the proposal.
    Changes: None.
    Comment: Several commenters stated that the study of diagnostic 
innovations should not be limited to acute management (in reference 
to point 1 of the Health and Function research area). Persons with 
TBI in the post-acute period often have residual impairments that 
may benefit from innovative new diagnostic procedures that may lead 
to more appropriate treatments.
    Discussion: These comments make a valid point. NIDRR is 
interested in research that may improve outcomes for persons with 
TBI across the continuum of health care.
    Changes: The word acute has been eliminated from this point in 
the final priority.
    Comment: One commenter argued that research in the employment 
area should focus on developing a knowledge base to support specific 
interventions that address the unique challenges faced by 
individuals with brain injury while engaging in work.
    Discussion: NIDRR strongly supports efforts to translate 
research into practice. Employment is a critical issue for persons 
with TBI. Applicants could propose to address this issue within the 
priority areas outlined in the priority. The peer review process 
will evaluate merits of the proposal.
    Changes: None.
    Comment: One commenter urged NIDRR to consider the impact of 
failure to classify TBI properly in the emergency room or in other 
service delivery settings in establishing its priorities.
    Discussion: An applicant could propose a study pertaining to 
this; however, NIDRR has no basis to determine that all applicants 
should be required to focus on this issue. The peer review process 
will evaluate merits of the proposal.
    Changes: None.
    Comment: One commenter suggested that natural supports and 
volunteerism be included as possible research topics for the model 
systems.
    Discussion: An applicant could propose a study pertaining to 
these research topics; however, NIDRR has no basis to determine that 
all applicants should be required to focus on these issues. The peer 
review process will evaluate merits of the proposal.
    Changes: None.
    Comment: One commenter was concerned about a perceived emphasis 
on predictors within the priority, stating that predictors may be 
used to screen out people from treatments or resources.
    Discussion: NIDRR is interested in identifying factors that help 
predict whether interventions contribute to positive outcomes for 
persons with TBI. It is not interested in funding research that 
limits access to treatments or resources for individuals with TBI.
    Changes: None.
    Comment: Several commenters focused on the need for strong 
dissemination plans. TBIMS projects should be encouraged to have 
clear management plans with strong dissemination components. Model 
Systems should be charged with producing more materials that are 
research based and widely disseminated to the field, concerning 
subjects that are of importance to the field.
    Discussion: Dissemination and operational plans are selection 
criteria for TBIMS projects. Thus, applicants are encouraged to 
provide evidence of their strengths in both dissemination and 
management, providing, for example, information on strategies, 
tools, and personnel to manage the project and disseminate its 
findings. The peer review process will evaluate merits of the 
proposal.
    Changes: None.
    Comment: Applicants should be required to focus research in 
areas of critical need for research-to-practice and to provide 
strong training components within each project.
    Discussion: NIDRR supports training through a number of 
mechanisms, including the Fellowship program, the Advanced 
Rehabilitation Research Training program, and the Rehabilitation 
Research Training Center program. Because of funding levels, the 
TBIMS projects are not required to provide training as a component 
of the program but rather are required to emphasize service delivery 
and research as well as longitudinal data collection on the natural 
history of individuals with TBI.
    Changes: None.
    Comment: One commenter asked why the priority does not give 
mention activities described in Chapter 7 of NIDRR's Long-Range 
Plan, ``Associated Disability Research Areas.'' There is a need for 
validation and development of measures of environment and 
accommodation, especially as the latter may apply to cognitive 
abilities. Other constructs such as community integration and 
quality of life require measurement refinement. It was suggested 
that some mention be given to these areas as they might relate to 
the four areas of research delineated in the proposed priority.
    Discussion: NIDRR agrees that development of measures across the 
four areas delineated in the proposed priority could be an 
appropriate research activity for TBIMS projects.
    Changes: The priority has been modified to permit applicants to 
choose to do research on TBI measures.
    Comment: Consistent with the World Health Organization's shift 
to a multifaceted conceptualization of health and functioning as 
reflected in the recent publication of the International 
Classification of Functioning and Disability, TBIMS projects should 
focus on environmental barriers and facilitators.
    Discussion: An applicant could propose a study pertaining to 
these topics; however, NIDRR has no basis to determine that all 
applicants should be required to focus on these issues. The peer 
review process will evaluate merits of the proposal.
    Changes: None.
    Comment: The TBIMS would be able to recruit substantially more 
participants if they were permitted to enroll subjects at the point

[[Page 39577]]

of admission to acute rehabilitation instead of acute care. This 
option preserves premium rehabilitation care and enhances the 
national database.
    Discussion: The TBIMS project directors discussed this 
possibility during the last funding cycle. It is anticipated that 
there will be further discussion in the future.
    Changes: None.
    Comment: The use of the word ``impact'' in the priority, ``Study 
the impact of diagnostic interventions * * *'' suggests that the 
diagnostic innovations should be studied in relation to treatment 
interventions based on the results of the testing. However, basic 
studies establishing a relationship between neuroimaging results and 
rehabilitation outcome must be done before interventions can be 
designed. Can the priority include wording that allows for pre-
interventional studies such as those assessing the predictive 
ability of diagnostic innovations?
    Discussion: NIDRR funds applied rehabilitation research. While 
applicants are not precluded from proposing pre-interventional 
studies, they are urged to demonstrate the potential for designing 
new interventions. NIDRR has no basis to determine that all 
applicants should be required to focus on these issues. The peer 
review process will evaluate merits of the proposal.
    Changes: None.
    Comment: One commenter suggested that research on the use of 
homeopathic medicine in treating persons with traumatic 
rehabilitation be added to the priority.
    Discussion: An applicant could propose a study pertaining to 
this; however, NIDRR has no basis to determine that all applicants 
should be required to focus on this issue. The peer review process 
will evaluate merits of the proposal.
    Changes: None.
    Comment: In the ER setting, a person may be diagnosed with a 
spinal cord injury or multiple trauma. Due to the nature of the 
emergency, TBI, especially mild TBI, is frequently overlooked. Can 
NIDRR require that the TBIMS address these issues?
    Discussion: NIDRR agrees that mild TBI and dual diagnoses are a 
significant problem. TBIMS focus on moderate to severe health 
injury, but NIDRR funds other research on mild head injury. An 
applicant could propose a study pertaining to these topics; however, 
NIDRR has no basis to determine that all applicants should be 
required to focus on these issues. The peer review process will 
evaluate merits of the proposal.
    Changes: None.
    Comment: Several commenters urged NIDRR to ensure that the TBIMS 
projects have true participatory involvement of people who have 
sustained brain injuries.
    Discussion: NIDRR concurs with this comment, and the priority 
reflects its commitment to consumer participation.
    Changes: None.
    Comment: It is recommended that the TBIMS projects include 
development and evaluation of TBI education and service referral 
methods that will improve individual transition to the community, 
especially those individuals who have received medical and 
rehabilitation services at a location other than their home 
community.
    Discussion: An applicant could propose a study pertaining to 
this; however, NIDRR has no basis to determine that all applicants 
should be required to focus on this issue. The peer review process 
will evaluate merits of the proposal.
    Changes: None.
    Comment: One commenter encouraged the use of a variety of 
research methodologies based on the nature of the research question 
to be addressed as well as multidisciplinary research that 
encourages, respects, and validates the breadth of research 
perspectives.
    Discussion: NIDRR agrees with this comment and urges applicants 
to be cognizant of these issues in writing their applications.
    Changes: None.
    Comment: Add the following research objectives to the section on 
Integrating Persons with Disabilities into the Workforce: (a) 
Develop and evaluate strategies that improve employment outcomes of 
persons with TBI, including transition and youth; and (b) Identify 
effective employment strategies such as job sharing and self-
employment.
    Discussion: Applicants may propose these topics as they fall 
within the priorities as written. However, NIDRR has no basis to 
determine that all applicants should be required to focus on these 
issues. The peer review process will evaluate merits of the 
proposal.
    Changes: None.
    Comment: Add the following objective to Full Access to Community 
Life: a) Examine the impact of environmental and attitudinal 
barriers on the outcomes of persons with TBI.
    Discussion: NIDRR concurs with this recommendation.
    Changes: The priority has been modified to allow applicants to 
choose to do research on attitudinal barriers.
    Comment: One commenter proposed that the priority include a 
requirement to design and test rehabilitation interventions that 
improve neurological recovery (including motor and cognitive 
recovery), functional, and longterm outcomes for persons with TBI.
    Discussion: NIDRR concurs with this recommendation.
    Changes: The priority has been modified to include neurological 
recovery (including motor and cognitive recovery).

[FR Doc. 02-14384 Filed 6-6-02; 8:45 am]
BILLING CODE 4000-01-P