2011-14350. Final Priorities and Selection Criterion; National Institute on Disability and Rehabilitation Research (NIDRR)-Spinal Cord Injury Model Systems (SCIMS) Centers and SCIMS Multi-Site Collaborative Research Projects

AGENCY:

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

ACTION:

Notice of final priorities and selection criterion.

SUMMARY:

The Assistant Secretary for Special Education and Rehabilitative Services announces (1) a priority under the Special Projects and Demonstrations for Spinal Cord Injuries Program for SCIMS Centers (priority 1), and (2) a priority and selection criterion for Disability and Rehabilitation Research Projects (DRRPs) that will serve as the SCIMS Multi-Site Collaborative Research Projects (priority 2). The Assistant Secretary may use one or more of these priorities and selection criterion for competitions in fiscal year (FY) 2011 and later years. We take this action to focus attention on areas of national need.

DATES:

Effective Date: These priorities and selection criterion are effective July 11, 2011.

FOR FURTHER INFORMATION CONTACT:

Lynn Medley, U.S. Department of Education, 400 Maryland Avenue, SW., room 5140, Potomac Center Plaza (PCP), Washington, DC 20202-2700. Telephone: [phone] or by e-mail: [e-mail].

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

SUPPLEMENTARY INFORMATION:

This notice of final priorities and selection criterion (NFP) is in concert with NIDRR's currently approved Long-Range Plan (Plan). The Plan, which was published in the Federal Register on February 15, 2006 (71 FR 8165), can be accessed on the Internet at the following site: http://www.ed.gov/​about/​offices/​list/​osers/​nidrr/​policy.html.

Through the implementation of the Plan, NIDRR seeks to: (1) Improve the quality and utility of disability and rehabilitation research; (2) foster an exchange of expertise, information, and training to facilitate the advancement of knowledge and understanding of the unique needs of traditionally underserved populations; (3) determine the best strategies and programs to improve rehabilitation outcomes for underserved populations; (4) identify research gaps; (5) identify mechanisms of integrating research and practice; and (6) disseminate findings.

This notice proposes priorities and a selection criterion that NIDRR intends to use for competitions in FY 2011 and possibly later years. However, nothing precludes NIDRR from publishing additional priorities if needed. Furthermore, NIDRR is under no obligation to make an award using either of the priorities or the selection criterion. The decision to make an award will be based on the quality of applications received and available funding.

Purpose of Programs: The SCIMS centers are funded through the Special Projects and Demonstrations for SCI Program and the SCIMS Multi-Site Collaborative Research Projects are funded as DRRPs.

Special Projects and Demonstrations for Spinal Cord Injuries Program

The SCIMS centers program is funded through the Special Projects and Demonstrations for Spinal Cord Injuries Program. This program provides assistance for projects that provide comprehensive rehabilitation services to individuals with spinal cord injuries, and conducts spinal cord research, as specified in 34 CFR 359.10 and 359.11.

Disability and Rehabilitation Research Projects (DRRPs) Program

The SCIMS Multi-Site Collaborative Research Projects are funded as DRRPs. DRRPs are designed to improve the effectiveness of services authorized under the Rehabilitation Act by developing methods, procedures, and rehabilitation technologies that advance a wide range of independent living and employment outcomes for individuals with disabilities, especially individuals with the most severe disabilities. DRRPs carry out one or more of the following types of activities, as specified and defined in 34 CFR 350.13 through 350.19: research, training, demonstration, development, dissemination, utilization, and technical assistance.

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

Applicable Program Regulations: 34 CFR parts 350 and 359.

We published a notice of proposed priorities and selection criterion (NPP) for NIDRR's Disability and Rehabilitation Research Projects and Centers Program in the Federal Register on March 22, 2011 (76 FR 15961). That notice contained background information and our reasons for proposing the SCIMS Center priority and the SCIMS Multi-Site Collaborative Research Projects priority and selection criterion.

Public Comment: In response to our invitation in the NPP, nine parties submitted comments on the proposed priorities and selection criterion.

Generally, we do not address technical and other minor changes. In addition, we do not address general comments that raised concerns not directly related to the proposed priorities and selection criterion.

Analysis of Comments and Changes: An analysis of the comments and of any changes in the priorities and selection criterion since publication of the notice NPP follows. We discuss substantive issues under the priorities or selection criterion to which they pertain.

General

Comment: One commenter noted that the proposed priorities focus on acquired spinal cord injuries, and not on developmental disabilities or other conditions that affect the spinal cord. This commenter recommended that the priorities be expanded to include any conditions that affect the spinal cord and subsequent human physical activity and movement.

Discussion: We are establishing the SCIMS Centers priority under section 204(b)(4) of the Rehabilitation Act, the statutory authority for the Special Projects and Demonstrations for Spinal Cord Injuries program. Section 204(b)(4) of the Rehabilitation Act and 34 CFR part 359, the implementing regulations for this program, clearly specify a focus on spinal cord injury, and on services provided to individuals following a spinal cord injury. We are funding the SCIMS Centers priority under this statutory authority to build upon the specialized research capacity that NIDRR has established under the SCIMS program. NIDRR developed the SCIMS Collaborative Research Projects priority to capitalize on this specialized research capacity. Therefore, both of the priorities announced in this notice focus on spinal cord injuries, and not other conditions that affect the spinal cord and subsequent physical activity and movement, as suggested by the commenter.

Changes: None.

Spinal Cord Injury Model Systems (SCIMS) Centers Funded Under the Special Projects and Demonstrations for Spinal Cord Injuries

Comment: Six commenters asked whether applicants under the SCIMS Centers priority would be required to propose a module project in their proposals. Four of these commenters asked for clarification on the mechanism that will be used to develop and decide upon module projects.

Discussion: Applicants are not required to propose a specific collaborative module project that they will implement in their proposals. Collaborative research projects cannot be developed in a thoughtful manner without knowledge of the capacity, interests, and expertise of the participating collaborators. For this reason, the priority does not require the SCIMS Centers to develop a collaborative module project. Rather, each SCIMS Center is required to participate in at least one collaborative module. Accordingly, applicants must demonstrate their capacity to successfully engage in multi-site collaborative research. This capacity includes access to research participants, the ability to maintain data quality, and the ability to adhere to research protocols.

Following the announcement of new awards under this priority, SCIMS Centers that are interested in developing module projects may identify module topics, identify potential collaborators from among the other new SCIMS Centers, and develop research protocols for the potential modules. At the first SCIMS Project Directors' meeting, Project Directors will review, discuss, and decide upon specific module projects to implement. NIDRR staff will facilitate this post-award discussion and selection of module topics for implementation among new SCIMS Center grantees. Once these module projects are agreed upon by the Project Directors, each SCIMS Center will be required to participate in at least one of the module projects.

Changes: NIDRR has modified the note under paragraph (d) of this priority to clearly indicate that applicants should not propose a specific module project in their application, and to clarify the mechanism that will be used to develop and decide upon the module projects in which the SCIMS Center grantees will participate.

Comment: Two commenters asked how NIDRR would assess applicants' capacity to participate in multi-site collaborative research.

Discussion: Because the SCIMS Centers will be funded under the Special Projects and Demonstrations for Spinal Cord Injuries program, the regulations in 34 CFR 359 apply. Under those regulations, peer reviewers will use selection criteria in 34 CFR 359.31 to evaluate the quality of applications under this program, including applicants' descriptions of their capacity to engage in collaborative research. Specifically, the peer review criteria under CFR 359.31(c) and (e) are directly applicable to the evaluation of applicants' capacity to engage in multi-site collaborative research.

Changes: None.

Comment: One commenter asked how NIDRR would assess applicants' capacity to enroll at least 30 participants per year in the database.

Discussion: Under the applicable program regulations for the Special Projects and Demonstrations for Spinal Cord Injuries program in 34 CFR part 359, peer reviewers will use selection criteria under 34 CFR 359.31 to evaluate the quality of applications under this program, including proposed plans to recruit at least 30 participants per year into the SCIMS database. We expect applicants to describe their capacity to meet this minimum requirement in their applications so that peer reviews can assess this capacity under 34 CFR 359.31. In addition, we note NIDRR will continue to closely monitor the capacity of its funded SCIMS Centers to enroll the minimum number of participants into the SCIMS database each year of the project period.

Changes: None.

Comment: One commenter asked whether NIDRR intended to require applicants to budget “at least 15 percent” of its budget to participate in module projects, or if NIDRR intended to require applicants to budget “no more than 15 percent” for this activity.

Discussion: NIDRR intends paragraph (d)(2) of this priority to require that SCIMS Centers propose to spend at least 15 percent of their annual budget on module participation.

Changes: None.

Comment: One commenter asked how applicants should describe their module participation in their proposed budgets.

Discussion: In order to meet paragraph (d) of the priority, a grantee must participate as a research collaborator in at least one module project. As discussed earlier in this Analysis of Comments and Changes section, we do not expect applicants to propose or describe a module project. Rather, we require applicants to propose to spend at least 15 percent of their annual budget on participating in a module project. Accordingly, the only information regarding participation in the module project that is needed in the application is a single line item for module participation that is at least 15 percent of the overall budget. No additional information is required.

Changes: None.

Comment: One commenter noted that the requirements under paragraph (c) of the priority are overly restrictive, in that they require projects to test both innovative approaches to treating SCI and innovative approaches to assessing outcomes. This commenter stated that it would be more reasonable to require projects to test either innovative approaches to treating SCI or innovative approaches to assessing outcomes. This commenter also suggested that NIDRR broaden the types of possible research that can be proposed under this priority to include research that uses advanced methods to collect other information of clinical and/or scientific value that is of relevance to SCI.

Discussion: NIDRR agrees that the language in proposed paragraph (c) of the priority is overly restrictive and is changing the priority to require that applicants propose research to test innovative SCI treatments, or research to test innovative approaches to assessing outcomes of spinal cord injury.

In response to the second point raised by the commenter, NIDRR would like to maintain focus on the testing of interventions or the development of new outcomes measures and assessments. Through sustained funding of its SCIMS program, NIDRR has created a mature research infrastructure that will support the testing of interventions. NIDRR's emphasis on the testing of interventions and the development of measures to support that testing is intended to build upon this infrastructure to improve the outcomes of individuals with spinal cord injury. For this reason, we decline to revise this requirement to broaden the types of research that can be supported under this priority.

Changes: NIDRR has made minor modifications to paragraph (c) of the priority to clarify that applicants can propose research to test innovative SCI treatments, or research to test innovative approaches to assessing outcomes of spinal cord injury.

Comment: None.

Discussion: Paragraph (c) of this priority states that each SCIMS Center must propose and conduct at least one, but no more than two, site-specific research projects. We intend this language to prohibit applicants from proposing and conducting more than two site-specific research projects. To avoid any confusion on this point, we believe it would be helpful to applicants to add language clearly stating that applicants who propose more than two site-specific research projects will be disqualified.

Changes: NIDRR has revised paragraph (c) of this priority by adding a sentence stating that applicants who propose more than two site-specific research projects will be disqualified.

SCIMS Multi-Site Collaborative Research Projects

Comment: One commenter asked NIDRR to expand the eligibility criteria for serving as the lead applicant for one of the SCIMS Multi-Site Collaborative Research Projects, so that the two NIDRR-funded Rehabilitation Research and Training Centers on Secondary Conditions in Rehabilitation of Individuals with Spinal Cord Injury would be eligible to apply.

Discussion: NIDRR's SCIMS Centers program has evolved into a multi-site platform that can serve as a resource for testing promising interventions and building the evidence base for spinal cord injury rehabilitation. NIDRR has designed this priority to directly utilize this platform for collaborative research on interventions. Therefore, only SCIMS Centers are eligible to apply. These SCIMS Centers have direct access to individuals with SCI who will participate in the collaborative research. They also maintain comprehensive systems of clinical services for individuals with SCI. Applicants that are not SCIMS Centers will not have direct access to these resources, which are necessary for leading collaborative research within the SCIMS program. While only SCIMS Centers can apply as lead applicants for the SCIMS Multi-Site Collaborative Research grants, applicants may include as part of their multi-site collaborative research project other SCI research sites that are not participating as a SCIMS Center.

Changes: None.

Final Priorities

Priority 1—Spinal Cord Injury Model Systems Centers

The Assistant Secretary for Special Education and Rehabilitative Services establishes a priority for the funding of Spinal Cord Injury Model Systems (SCIMS) centers of care (SCIMS Centers). The SCIMS Centers must provide comprehensive, multidisciplinary services to individuals with spinal cord injury (SCI) as a basis for conducting research that contributes to evidence-based rehabilitation interventions and clinical and practice guidelines. The SCIMS program is designed to generate new knowledge that can be used to improve outcomes of individuals with SCI in one or more domains identified in NIDRR's currently approved Long Range Plan, published in the Federal Register on February 15, 2006 (71 FR 8165): health and function, participation and community living, technology, and employment. Each SCIMS Center must contribute to this outcome by—

(a) Providing 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;

(b) Continuing the assessment of long-term outcomes of individuals with SCI by enrolling at least 30 subjects per year into the SCIMS database, following established protocols for the collection of enrollment and follow-up data on subjects;

(c) Proposing and conducting at least one, but no more than two, site-specific research projects to test innovative approaches to treating SCI or to assessing outcomes of individuals with SCI in one or more domains identified in the Plan: health and function, participation and community living, technology, and employment.

Note:

Applicants who propose more than two site-specific research projects will be disqualified.

(d) Participating as research collaborators in at least one module project. Module projects are research collaborations with one or more other SCIMS Centers on topics of mutual interest and expertise. These module projects are carried out as part of the SCIMS Centers' activities. They are not part of the SCIMS Multi-Site Collaborative Projects, which are funded under a separate priority.

Note:

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

Each applicant under this priority must—

(1) Demonstrate, in its application, its capacity to successfully engage in multi-site collaborative research. This capacity includes access to research participants, the ability to maintain data quality, and the ability to adhere to research protocols; and

(2) Propose to spend at least 15 percent of its annual budget on participating in a module project, as described in paragraph (d) of this priority;

(e) Addressing the needs of persons with disabilities including individuals from traditionally underserved populations;

(f) Coordinating with the NIDRR-funded Model Systems Knowledge Translation Center (MSKTC) to provide scientific results and information for dissemination to clinical and consumer audiences; and

(g) Ensuring participation of persons with disabilities in conducting SCIMS research.

Priority 2—Spinal Cord Injury Model Systems (SCIMS) Multi-Site Collaborative Research Projects

The Assistant Secretary for Special Education and Rehabilitative Services establishes a priority for the funding of Disability and Rehabilitation Research Projects (DRRPs) to serve as Spinal Cord Injury Model Systems (SCIMS) multi-site collaborative research projects. To be eligible under this priority, an applicant must have received a grant under the SCIMS Centers priority (Proposed Priority 1 in this notice). Following completion of a competition using the SCIMS Centers priority, the Department will invite successful applicants under that competition to apply for funding under this SCIMS Multi-Site Collaborative Research Projects priority.

Each SCIMS multi-site collaborative research project must be designed to contribute to evidence-based rehabilitation interventions and clinical practice guidelines that improve the lives of individuals with spinal cord injury (SCI) through research, including the testing of approaches to treating SCI or the assessment of the outcomes of individuals with SCI. Each SCIMS multi-site collaborative research project must contribute to this outcome by—

(a) Collaborating with three or more of the NIDRR-funded SCIMS centers (for a minimum of four SCIMS sites). Applicants may also propose to include as part of their multi-site collaborative research project other SCI research sites that are not participating in a NIDRR-funded program;

(b) Conducting multi-site research on questions of significance to SCI rehabilitation, using clearly identified research designs. The research must focus on outcomes in one or more domains identified in NIDRR's currently approved Long Range Plan, published in the Federal Register on February 15, 2006 (71 FR 8165): Health and function, participation and community living, technology, and employment;

(c) Demonstrating the capacity to carry out multi-site collaborative research projects, including administrative capabilities, experience with management of multi-site research protocols, and demonstrated ability to maintain standards for quality and confidentiality of data gathered from multiple sites;

(d) Addressing the needs of people with disabilities, including individuals from traditionally underserved populations;

(e) Coordinating with the NIDRR-funded Model Systems Knowledge Translation Center (MSKTC) to provide scientific results and information for dissemination to clinical and consumer audiences; and

(f) Ensuring participation of individuals with disabilities in conducting SCIMS research.

Types of Priorities

When inviting applications for a competition using one or more priorities, we designate the type of each priority as absolute, competitive preference, or invitational through a notice in the Federal Register. The effect of each type of priority follows:

Absolute priority: Under an absolute priority, we consider only applications that meet the priority (34 CFR 75.105(c)(3)).

Competitive preference priority: Under a competitive preference priority, we give competitive preference to an application by (1) awarding additional points, depending on the extent to which the application meets the priority (34 CFR 75.105(c)(2)(i)); or (2) selecting an application that meets the priority over an application of comparable merit that does not meet the priority (34 CFR 75.105(c)(2)(ii)).

Invitational priority: Under an invitational priority, we are particularly interested in applications that meet the priority. However, we do not give an application that meets the priority a preference over other applications (34 CFR 75.105(c)(1)).

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 Collaborative Research Projects priority:

The extent to which the applicant clearly documents its capacity to carry out a multi-site research project, including demonstrated administrative capabilities, experience with managing and following multi-site research protocols, and ability to maintain and meet standards for quality and confidentiality of data gathered from multiple sites.

This notice does not preclude us from proposing additional priorities, requirements, definitions, or selection criteria, subject to meeting applicable rulemaking requirements.

Note:

This notice does not solicit applications. In any year in which we choose to use these priorities, we invite applications through a notice in the Federal Register.

Executive Order 12866: This notice 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 final regulatory action.

The potential costs associated with this final regulatory action are those resulting from statutory requirements and those we have determined as necessary for administering this program effectively and efficiently.

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

Summary of Potential Costs and Benefits

The benefits of the Disability and Rehabilitation Research Projects and Centers and the Special Projects and Demonstrations for Spinal Cord Injuries Programs have been well established over the years in that similar projects have been completed successfully. These final priorities and selection criterion will generate new knowledge through research and development. Another benefit of these final priorities and selection criterion is that the establishment of new SCIMS Centers and the DRRPs conducting SCIMS multi-site research projects will generate new knowledge to improve the lives of individuals with disabilities. The new SCIMS Centers and the SCIMS multi-site research projects will generate, disseminate, and promote the use of new information that will improve the options for individuals with spinal cord injury to perform activities of their choice in the community.

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Dated: June 6, 2011.

Alexa Posny,

Assistant Secretary for Special Education and Rehabilitative Services.