06-1796. National Institute on Disability and Rehabilitation Research-Disability and Rehabilitation Research Projects and Centers Program-Spinal Cord Injury Model Systems Centers (SCIMS Centers) and Disability Rehabilitation Research Projects (DRRPs)

AGENCY:

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

ACTION:

Notice of final priorities for SCIMS Centers and DRRPs.

SUMMARY:

The Assistant Secretary for Special Education and Rehabilitative Services announces a final priority for Spinal Cord Injury Model Systems Centers (SCIMS centers) and a final priority and selection criterion for the Disability and Rehabilitation Research Projects (DRRPs) administered by the National Institute on Disability and Rehabilitation Research (NIDRR). The Assistant Secretary may use these priorities and selection criterion for competitions in fiscal year (FY) 2006 and later years. We take this action to focus research attention on areas of national need. We intend these priorities and selection criterion to improve rehabilitation services and outcomes for individuals with disabilities.

DATES:

Effective Date: These priorities are effective March 29, 2006.

FOR FURTHER INFORMATION CONTACT:

Donna Nangle, U.S. Department of Education, 400 Maryland Avenue, SW., room 6030, Potomac Center Plaza, Washington, DC 20202-2700. Telephone: [phone] or by e-mail: [e-mail].

If you use a telecommunications device for the deaf (TDD), you may call the Federal Relay Service (FRS) at 1-800-877-8339.

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:

Spinal Cord Injury (SCI) Model Systems Program

The Spinal Cord Injury Model Systems (SCIMS) program is designed to study the course of recovery and outcomes following the delivery of a coordinated system of care for individuals with SCI. Under this program, SCIMS centers provide comprehensive rehabilitation services to individuals with SCI and conduct spinal cord research, including clinical research and the analysis of standardized data in collaboration with other related projects.

Each SCIMS center funded under this program establishes a multidisciplinary system for providing rehabilitation services specifically designed to meet the special needs of individuals with SCI. These services include acute care as well as periodic inpatient or outpatient follow-up and vocational services. Centers demonstrate and evaluate the benefits and cost effectiveness of their systems for providing rehabilitation services to individuals with SCI and demonstrate and evaluate existing, new, and improved methods and equipment essential to the care, management, and rehabilitation of individuals with SCI. Centers also demonstrate and evaluate methods of community outreach and education for individuals with SCI in connection with the problems these individuals experience in such areas as housing, transportation, recreation, employment, and community activities. SCIMS centers engage in initiatives and new approaches and maintain close working relationships with other governmental and voluntary institutions and organizations to unify and coordinate scientific efforts, encourage joint planning, and promote the interchange of data and reports among SCI researchers. Additional information on the SCIMS program can be found at: http://www.ed.gov/​rschstat/​research/​pubs/​res-program.html#model.

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 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 (Act). An applicant for assistance under this program must demonstrate in its application how it will address, in whole or in part, the needs of individuals with disabilities from minority backgrounds (34 CFR 350.40(a)). The approaches an applicant may take to meet this requirement are found in 34 CFR 350.40(b). Additional information on the DRRP program can be found at: http://www.ed.gov/​rschstat/​research/​pubs/​res-program.html#DRRP.

We published a notice of proposed priorities (NPP) for these programs in the Federal Register on December 13, 2005 (70 FR 73738). The NPP included a background statement that described our rationale for proposing these priorities. This NFP contains several changes from the NPP. We fully explain these changes in the Analysis of Comments and Changes section that follows.

Analysis of Comments and Changes

In response to our invitation in the NPP, 12 parties submitted comments on the proposed priorities. An analysis of the comments and the changes in the priorities since publication of the NPP follows. We discuss major issues according to subject.

Generally, we do not address technical and other minor changes and suggested changes we are not authorized to make under the applicable statutory authority.

Priority One—Collaborative Research Module Projects

Comment: One commenter was unclear about the relationship between the module projects in Priority One and the multi-site collaborative projects in Priority Two.

Discussion: In Priority One, NIDRR is requiring that the SCIMS centers participate in at least one collaborative research module project. These modules are designed to encourage collaboration among the SCIMS centers during the funding cycle. All centers will participate in at least one module project. Centers will determine which module projects they wish to participate in once the project directors and NIDRR select the module projects at the beginning of the funding cycle. NIDRR is recommending that each center set aside up to 15 percent of its budget for participating in these module projects.

The Priority Two competition is a separate competition. While only SCIMS centers selected for funding under the Priority One competition may compete under Priority Two, there is no requirement that the SCIMS centers funded under Priority One compete in the Priority Two competition.

Change: None.

Comment: One commenter asked if NIDRR would clarify that, under Priority One, applicants must both propose at least one and participate in at least one collaborative module project.

Discussion: NIDRR agrees that clarification of this requirement would be helpful to applicants.

Change: The priority has been changed to clarify that, to meet the requirements of Priority One, an applicant must propose at least one collaborative research module project and participate in at least one collaborative research module project.

Comment: Five commenters raised concerns about the difficulty of budgeting for the collaborative research module project required under Priority One.

Discussion: NIDRR acknowledges that additional direction would facilitate budgeting and therefore planning for the module projects. For planning purposes, we suggest that applicants allot no more than 15 percent of their budget to the module project.

Change: None.

Comment: One commenter asked if the module projects as implemented will be held to the actual parameters as presented in the proposal.

Discussion: The module project proposals of applicants selected for funding under Priority One will be reviewed by all project directors and key NIDRR staff and projects will be selected for implementation. Since these are peer-reviewed projects, it is expected that the projects will be implemented as proposed with adjustments as necessary to accommodate unexpected contingencies. In accordance with NIDRR policy, any substantial changes to project scope must be approved by the assigned NIDRR project officer.

Change: None.

Comment: Two commenters asked whether the module projects can involve non-SCIMS centers.

Discussion: Participation in the module projects will be limited to the funded SCIMS centers.

Change: The priority has been modified to clarify that participation in these module projects is limited to funded SCIMS centers.

Comment: One commenter suggested that NIDRR require that some of the Priority One collaborative research module projects focus on SCI outcome measures.

Discussion: While NIDRR agrees that outcome measures might be an excellent subject for the Priority One module projects, it does not believe that all applicants should be required to propose module projects that focus only on outcomes. Nothing in the priority precludes an applicant from suggesting such a research focus, however. The peer review process will evaluate the merits of the proposals.

Change: None.

Comment: One commenter suggested that NIDRR clarify whether SCIMS centers funded under Priority One will be able to participate in more than one collaborative research module project.

Discussion: NIDRR does not stipulate that applicants participate in only one module project. The number and subject of the modules selected for implementation will not be known, however, until after the first Project Directors' meeting. Each successful applicant will work with NIDRR staff to determine if allocations of staffing and budget allow participation in more than one module project.

Change: None.

Comment: Two commenters asked NIDRR to clarify whether the Priority One module projects must focus on intervention studies or whether these module projects can truly be innovative and pilot in nature.

Discussion: While NIDRR supports the idea that the module projects can be innovative and pilot in nature, NIDRR is not prescribing that only these types of projects can be proposed under Priority One. NIDRR suggests that applicants clearly identify the research question the project will address, its importance, and its proposed outcomes and clarify the nature of the project so that reviewers can determine whether the scope and format of the project is appropriate.

Change: None.

Comment: One commenter asked whether applicants are expected to establish collaborative relationships with other centers prior to submitting their applications and whether applicants can propose the same module projects in their applications.

Discussion: NIDRR is not requiring applicants to identify or to have established relationships with their collaborators when they submit their applications. As stated in the priority, the decisions regarding selection of module projects for implementation will be made by the project directors of the newly awarded centers in conjunction with NIDRR staff. Each center will then be required to participate in at least one of these projects. There is nothing to prohibit applicants under Priority One from proposing the same module project.

Change: None.

Priority One—SCIMS Database

Comment: Several commenters asked that NIDRR clarify whether the requirement that at least 30 subjects be enrolled per year applies to the longitudinal portion of the database (FORM I) or the registry portion of the database.

Discussion: This requirement is for full enrollment into the longitudinal portion of the database. Thus, these subjects must be enrolled with the expectation that they will be followed long-term.

Change: The priority has been changed to reflect this requirement.

Comment: One commenter recommended that NIDRR increase the required number of subjects enrolled in the longitudinal database to 40 instead of 30 subjects.

Discussion: This is the first time that NIDRR has specified a minimum number of subjects for database enrollment. NIDRR based the requirement on an analysis of historical trends within the database. At the present time, SCIMS centers are required to enroll all eligible subjects into the database, and many centers enroll more than 30 subjects. While nothing in the priority precludes an applicant from enrolling more than 30 subjects, NIDRR does not believe that all applicants should be required to enroll at least 40.

Change: None.

Comment: Two commenters asked NIDRR whether there will be differential funding for centers with markedly different workloads for follow-up data collection associated with the longitudinal database. This differential workload occurs when existing centers have large numbers of enrolled subjects in the longitudinal database compared to new centers with none.

Discussion: NIDRR agrees that there should be differential funding associated with the longitudinal database portion of the priority. Information on these funding level differences will be provided in any notice we publish in the Federal Register inviting applications for funding under Priority One.

Change: None.

Comment: One commenter recommended that there be a maximum number of enrollees per year in order to relieve the burden on centers that are successful in enrolling large numbers of subjects.

Discussion: NIDRR agrees that this is an issue and plans to work with the project directors and others to determine a scientific basis for limiting enrollment in the database. For the purpose of this priority, however, it is recommended that centers budget for enrolling all eligible subjects into the database, with appropriate adjustment, based on previous experience, for refusals to participate.

Change: None.

Comment: One commenter asked whether subjects enrolled into the longitudinal database must have a traumatic etiology or could have a nontraumatic etiology.

Discussion: The inclusion criteria specify that subjects entered into the database must have a clinically discernible degree of neurologic impairment caused by a traumatic event.

Change: None.

Priority One—Site-Specific Research Projects

Comment: One commenter expressed concern that the requirement to conduct no more than one site-specific project would force existing SCIMS centers that receive funding under this priority to interrupt or eliminate specific ongoing research projects. The concern is that research that is ongoing and is designed to be carried out in a step-wise fashion over multiple funding cycles will not be continued because of the limit on site-specific projects.

Discussion: NIDRR agrees that this is a valid concern. The decision to limit the number of projects reflects a concern that SCIMS centers devote sufficient resources to site-specific research to allow rigorous methods to be used and to conduct research that is robust enough to engender confidence in the results.

Change: NIDRR will balance these concerns by allowing applicants to propose no more than two site-specific research projects and will allow the peer review process to judge the scientific merit of the proposals and the feasibility of the implementation of up to two projects. NIDRR will not accept applications that propose more than two site-specific projects. The priority has been changed to reflect the requirement regarding the maximum number of site-specific projects that an applicant may propose.

Comment: One commenter asked NIDRR to clarify whether there will be weighting of priorities so that preference is given to intervention studies as the subject of the site-specific research project.

Discussion: NIDRR is encouraging applicants to test innovative approaches to treatment and evaluation of SCI outcomes. This focus on treatment supports an emphasis on interventions research; however, NIDRR suggests that applicants could consider the ways in which prognostic or diagnostic research can support the development of interventions that improve outcomes for persons with SCI. Nothing in the priority would preclude an applicant from suggesting such an approach. The peer review process will evaluate merits of the proposals.

Change: This priority has been changed to clarify the focus on rehabilitation interventions.

Priority One—General

Comment: One commenter suggested that NIDRR require that projects submitted under Priority One focus on the unique issues, including health disparities, faced by persons with SCI from minority backgrounds who live in rural areas.

Discussion: NIDRR agrees that persons with SCI who live in rural areas may experience unique issues, including significant health disparities. NIDRR also agrees that these disparities may be significant for individuals from minority populations. Nothing in the priority precludes an applicant from addressing these issues. However, NIDRR does not believe that all SCIMS centers should be required to address these problems. The peer review process will evaluate the merits of the proposals.

Change: None.

Comment: One commenter suggested that NIDRR require that SCIMS centers have the technology and capacity to lead clinical trials.

Discussion: NIDRR agrees that SCIMS centers must have the capacity to conduct rigorous research. However, NIDRR does not believe that all centers should be required to demonstrate their ability to lead clinical trials.

Change: None.

Comment: One commenter expressed concern regarding requirements for dissemination activities within the SCIMS program.

Discussion: On February 7, 2006, NIDRR published a combined notice of proposed priorities, which included a priority for the funding of a Model Systems Knowledge Translation Center (MSKTC) (71 FR 6317) that will focus on cross-model system dissemination efforts. Applicants are encouraged to review this priority and determine and discuss in their applications what resources will be required to provide information to this center.

Change: None.

Comment: Several commenters noted that the criteria for inclusion in the model SCI systems database, which were described in the background section of the proposed priority, were overly inclusive and did not reflect recent changes to the inclusion criteria.

Discussion: NIDRR acknowledges that there has been recent tightening of the inclusion criteria to require that subjects enrolled into the database must complete inpatient acute rehabilitation at the Model SCI system, not just receive care at one component of the model system of care. These criteria are now as follows:

Eligible subjects must—

(a) Complete inpatient acute rehabilitation at the model SCI system, expire during Model SCI system hospitalization, or achieve complete recovery or minimal deficit status at the time of discharge from the model SCI system; (b) Be treated at a Model SCI system within one year of the injury; (c) Sign a consent form and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization; (d) Reside in a geographic catchment area of the model system at the time of the injury; and (e) Be a U.S. citizen.

Change: None.

Priority Two—General

Comment: Two commenters stated that the timeline for making the awards may not allow sufficient time for applicants to develop successful proposals for collaborative projects for the Priority Two competition.

Discussion: NIDRR recognizes that the timeline for these competitions is tight. NIDRR, however, believes that there is sufficient time to conduct these competitions in the remainder of this fiscal year, and anticipates that applicants for the Priority Two competition will have 60 days to submit their applications following notification of their success in the Priority One competition. Because the priorities for these two competitions are being announced simultaneously, potential applicants will have many months to consider their applications for Priority Two.

Change: None.

Comment: One commenter urged NIDRR to require that applicants for funding under Priority Two recognize clinical practice guidelines (CPGs) in formulating their proposals.

Discussion: While NIDRR agrees that CPGs may be proposed for research under Priority Two, NIDRR does not believe that all applicants should be required to take this approach. Nothing in the priority precludes an applicant from suggesting such an approach. The peer review process will evaluate merits of the proposals.

Change: None.

Comment: None.

Discussion: The NPP specified in paragraph 4 of Priority Two that an applicant must not request an amount in excess of $800,000 to cover startup costs. Upon internal review we are removing this dollar amount to provide applicants with greater flexibility to estimate their startup costs.

Change: We have modified paragraph 4 in Priority Two to remove the reference to the $800,000 cap on startup costs.

Note:

This notice does not solicit applications. In any year in which we choose to use these final priorities and selection criterion, we invite applications through a notice in the Federal Register. When inviting applications we designate the priority as absolute, competitive preference, or invitational. 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 either (1) awarding additional points, depending on how well or the extent to which the application meets the competitive priority (34 CFR 75.105(c)(2)(i)); or (2) selecting an application that meets the competitive 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 invitational priority. However, we do not give an application that meets the invitational priority a competitive or absolute preference over other applications (34 CFR 75.105(c)(1)).

Note:

This notice of final priorities is in concert with President George W. Bush's New Freedom Initiative (NFI) and NIDRR's Final Long-Range Plan for FY 2005-2009 (Plan). The NFI can be accessed on the Internet at the following site: http://www.whitehouse.gov/​infocus/​newfreedom.

The Plan, which was published in the Federal Register on February 15, 2006 (71 FR 8166), can be accessed on the Internet at the following site: http://www.ed.gov/​about/​offices/​list/​osers/​nidrr/​policy.html.

Through the implementation of the NFI and 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.

Priorities

Priorities and Selection Criterion

In accordance with section 204(b)(4) of the Act, and 34 CFR part 359, Priority One will provide for the funding of SCIMS centers that will build upon the work of the currently-funded SCIMS centers, to provide comprehensive rehabilitation services to individuals with SCI and conduct spinal cord research, including clinical research and the analysis of standardized data in collaboration with other related projects.

Priority Two, authorized under section 204(a) of the Act and 34 CFR part 350, will provide for the funding of DRRPs to conduct multi-site research that contributes to evidence-based rehabilitation interventions and clinical practice guidelines that improve the lives of individuals with SCI. These projects will serve the overall purpose of the DRRP program, which is to plan and conduct research, demonstration projects, training, and related 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 Act. DRRPs carry out one or more of the following types of activities, as specified in 34 CFR 350.13 through 350.19: research, development, demonstration, training, dissemination, utilization, and technical assistance.

The Department is interested in ensuring that grantees use rigorous methods to carry out multi-site research conducted under Priority Two. Therefore, we are establishing an additional selection criterion to address methods for carrying out multi-site research collaboration for Priority Two. This criterion is intended to emphasize the importance of multi-site research collaboration.

To be eligible under Priority Two, an applicant must have received a grant under Priority One. The Department intends to announce the competition for Priority Two awards after selecting the grantees from the Priority One competition. Only successful applicants from the Priority One competition will be eligible to apply for awards under the Priority Two competition.

Priority One—SCIMS Centers

The Assistant Secretary establishes a priority for the funding of Spinal Cord Injury Model Systems (SCIMS) centers to conduct research that contributes to evidence-based rehabilitation interventions and clinical and practice guidelines that improve the lives of individuals with spinal cord injury (SCI). Each SCIMS center must—

1. Contribute to continued assessment of long-term outcomes of SCI by enrolling at least 30 subjects per year into the longitudinal portion of the SCIMS database, following established protocols for the collection of enrollment and follow-up data on subjects;

2. Contribute to improved outcomes for persons with SCI by proposing at least one collaborative research module project and participating in at least one collaborative research module project, which may range from pilot research to more extensive studies. (At the beginning of the funding cycle, the SCI model systems directors, in conjunction with NIDRR, will select specific modules for implementation from the approved applications.) Participation in these module projects is limited to funded SCIMS centers; and

3. Contribute to improved long-term outcomes of individuals with SCI by conducting no more than two site-specific research projects to test innovative approaches that contribute to rehabilitation interventions and evaluating SCI outcomes in accordance with the focus areas identified in NIDRR's Final Long-Range Plan for FY 2005-2009 (Plan). Applicants who propose more than two site-specific projects will be disqualified.

In carrying out these activities, applicants may select from the following research domains related to specific areas of the Plan: Health and function, employment, participation and community living, and technology for access and function.

In addition, applicants must address the following requirements:

• Provide a multidisciplinary system of rehabilitation care specifically designed to meet the needs of individuals with SCI. The system must encompass a continuum of care, including emergency medical services, acute care services, acute medical rehabilitation services, and post-acute services.
• Address the needs of people with disabilities including individuals from traditionally underserved populations.
• Coordinate with the NIDRR-funded Model Systems Knowledge Translation Center to provide scientific results and information for dissemination to clinical and consumer audiences.
• Ensure participation of individuals with disabilities in all aspects of SCIMS research.

Priority Two—Spinal Cord Injury Model Systems (SCIMS) Multi-Site Research Projects—and Selection Criterion for SCIMS Multi-Site Research Projects Priority

The Assistant Secretary establishes a priority for the funding of Spinal Cord Injury Model Systems (SCIMS) multi-site research projects to conduct research that contributes to evidence-based rehabilitation interventions and clinical practice guidelines that improve the lives of individuals with spinal cord injury (SCI).

To be eligible under this priority, an applicant must have received a grant under the SCIMS Centers priority. Following completion of a competition under the SCIMS Centers priority, the Department will invite successful applicants under that competition to apply for funding as a lead center under this SCIMS Multi-Site Research Projects priority.

Each SCIMS multi-site research project must—

1. Ensure utilization of SCIMS capacity by collaborating with three or more of the NIDRR-funded SCIMS centers (for a minimum of four SCIMS sites). Applicants may propose to include other SCI research sites that are not participating in a NIDRR-funded program in their multi-site research projects;

2. Contribute to improved long-term outcomes of individuals with SCI by conducting multi-site research on questions of significance to SCI rehabilitation, using clearly identified research designs. The research must focus on one or more specific domains identified in NIDRR's Final Long-Range Plan for FY 2005-2009 (Plan), including health and function, participation and community living, technology, and employment, and ensure that the research study has appropriate research hypotheses and methods to generate reliable and valid findings;

3. Demonstrate the capacity to carry out multi-site research projects, including the ability to coordinate research among centers; maintain data quality; and adhere to research protocols, confidentiality requirements, and data safety requirements; and

4. Specify startup activities that will be required to mount the proposed multi-site research project, including infrastructure requirements and measurement tools. Applicants must specify in their applications the amount requested to cover these startup costs.

In addition, applicants must address the following requirements:

• Address the needs of people with disabilities, including individuals from traditionally underserved populations.
• Coordinate with the NIDRR-funded Model Systems Knowledge Translation Center by providing scientific results and information for dissemination to clinical and consumer audiences.
• Ensure participation of individuals with disabilities in all aspects of model systems research.

Selection Criterion

In accordance with the provisions of 34 CFR 350.53 and 350.54 and in addition to the selection criteria specified in those sections, the Secretary will consider the following factor in evaluating applications submitted under the SCIMS Multi-Site Research Projects priority:

The extent to which the applicant clearly documents its capacity to manage multi-site research projects, including administrative capabilities, experience with management of multi-site research protocols, and demonstrated ability to maintain standards for quality and confidentiality of data gathered from multiple sites.

Executive Order 12866

This notice of final priorities has been reviewed in accordance with Executive Order 12866. Under the terms of the order, we have assessed the potential costs and benefits of this regulatory action.

The potential costs associated with the notice of final priorities are those resulting from statutory requirements and those we have determined as necessary for administering these programs effectively and efficiently.

In assessing the potential costs and benefits—both quantitative and qualitative—of this notice of final priorities, we have determined that the benefits of the final priorities justify the costs.

Summary of potential costs and benefits:

The potential costs associated with these final priorities are minimal while the benefits are significant.

The benefits of the SCIMS and DRRP programs have been well established over the years in that similar projects have been completed successfully. These final priorities will generate new knowledge and technologies through research, development, dissemination, utilization, and technical assistance projects.

Another benefit of these final priorities are that the establishment of new SCIMS centers and the DRRPs conducting SCIMS multi-site research projects will support the President's NFI and will improve the lives of persons with disabilities. These centers and DRRPs will generate, disseminate, and promote the use of new information that will improve the options for individuals with disabilities to perform regular activities in the community.

Applicable Program Regulations: 34 CFR parts 350 and 359.

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Note:

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(Catalog of Federal Domestic Assistance Number 84.133N, Model Spinal Cord Injury Centers and 84.133A, Disability Rehabilitation Research Projects).

Program Authority: 29 U.S.C. 760, 764(a), and 764(b)(4).

Dated: February 22, 2006.

John H. Hager,

Assistant Secretary for Special Education and Rehabilitative Services.