Stroke Prevention Research Program

Stroke Prevention Research Program is sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Supports research focused on identifying and mitigating risk factors for stroke.

Expired RFA-NS-12-007: Stroke Prevention/Intervention Research Program (SPIRP) (U54) This notice has expired. Check the NIH Guide for active opportunities and notices. Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating National Institute of Neurological Disorders and Stroke ( NINDS ) Funding Opportunity Title Stroke Prevention/Intervention Research Program (SPIRP) U54 Specialized Center- Cooperative Agreements December 20, 2011 - See Notice NOT-NS-12-006. Notice of Technical Assistance Workshop.

Funding Opportunity Announcement (FOA) Number Additional Information on Eligibility . Catalog of Federal Domestic Assistance (CFDA) Number(s) The National Institute of Neurological Disorders and Stroke ( NINDS ) invites applications for participation in the Stroke Prevention/Intervention Research Program (SPIRP).

The goal of the program is to develop high-impact stroke disparities interventions and research projects that have the ability to reduce stroke disparities in minority communities in the United States using effective and culturally appropriate methods.

Required components include: (1) an intervention or prevention project to reduce stroke disparities in minority communities; (2) at least one additional stroke disparities research project that will address knowledge gaps or opportunities to improve the understanding of stroke disparities (race/ethnicity, rural, or low socio-economic); (3) resource-related cores that are essential to accomplishing the Specific Aims of the proposed research project and provide training/education.

This FOA will utilize the U54 activity code.

The U54 mechanism is a solicited, multi-component award mechanism in which substantial NIH scientific and/or programmatic involvement is anticipated throughout the Letter of Intent Due Date AIDS Application Due Date(s) Required Application Instructions It is critical that applicants follow the instructions in Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information I.

Funding Opportunity Description purpose of this funding opportunity announcement (FOA) issued by the National Institute of Neurological Disorders and Stroke (NINDS) is to solicit exceptional research applications for the Stroke Prevention/Intervention Research Program (SPIRP) that will directly and demonstrably contribute to the reduction of stroke disparities.

This program will implement several scientifically rigorous stroke prevention/intervention projects in minority communities in the United States in addition to multiple research projects that address major contributors to stroke disparities.

Another important goal is to train individuals or groups that will significantly contribute to stroke disparities research or significantly contribute to the implementation of stroke disparities intervention/prevention strategies. This FOA directly responds to the recommendations provided by the NINDS Advisory Panel on Health Disparities ( http://www. ninds.

nih. gov/about_ninds/plans/NINDS_health_disparities_rpt. pdf ) and the Health and Human Services plan for addressing health disparities ( http://www.

minorityhealth. hhs. gov/npa/files/Plans/HHS/HHS_Plan_complete.

pdf ). Specific instructions are provided for the application submission and should be followed closely. Stroke is the fourth leading cause of death and a leading cause of long-term disability.

Stroke disparities are a major public health problem in the United States due to the higher incidence and prevalence of disease, excess mortality, and worse outcome in minority populations. To address these disparities, effective strategies that will directly reduce the incidence, morbidity, and mortality of stroke in racial/ethnic minority communities that are within the programmatic priority of NINDS are needed.

Scientific discovery, implementation of stroke prevention guidelines, and technological innovation have contributed to the reduction of stroke in the general population; however, racial/ethnic minorities (African Americans, Hispanic/Latinos, Asian American, American Indians/Alaska Natives, Native Hawaiians and other Pacific Islanders) continue to experience more strokes, worse outcomes, and more disability from stroke.

Numerous valuable epidemiologic studies have documented the disproportionate burden of disease in these racial/ethnic groups; these studies have also identified potential intervention targets and areas for additional research. The knowledge gained from these epidemiology studies will be critically important to identifying comprehensive targets for prevention/intervention studies.

Developing and implementing prevention strategies or interventions that address health disparities, in general, and stroke disparities, specifically, are challenging.

The underlying causes of the observed disparities are frequently complex and require multiple strategies or approaches to provide long-term solutions; therefore, we anticipate trans-disciplinary research will be needed for effective initiation and implementation of the proposed intervention/prevention research projects.

The overarching goal of the NINDS Stroke Prevention/ Intervention Research Program is to develop high-impact stroke disparities interventions and research projects that have the ability to reduce stroke disparities in minority communities in the United States, using effective and culturally appropriate methods.

Overview of Program Structure For the purposes of this announcement, stroke is defined broadly and may address ischemic or hemorrhagic stroke disparities in minority communities.

The NIH has identified the following types of health disparities populations in the United States and its territories: race/ethnicity (African Americans, Hispanic/Latinos, Asian American, American Indians/Alaska Natives, Native Hawaiians and other Pacific Islanders), low socioeconomic status and rural populations.

This announcement is to solicit two types of projects: (1) a prevention/intervention project which must address racial/ethnic stroke disparities. (2) stroke disparities research projects (up to four projects) which may address multiple types of health disparities (race/ethnicity, low socioeconomic status, and rural disparities).

Each SPIRP application (or program) must contain at least one stroke prevention/intervention project directly addressing racial/ethnic stroke disparities and at least one additional stroke disparities research project. (Programs may contain more than one prevention/intervention project.)

The proposed components of each application should be designed to optimize the accomplishments of the program and the advancement of the SPIRP program goals. Projects may use tools such as community engagement, decision analysis, economic analysis, and patient-centered outcomes to enhance the overall SPIRP. Behavioral and social sciences, including studies of the social determinants of health, are important and are encouraged.

All projects must be stroke projects and relevant to the NIH and NINDS mission. Numerous large-scale epidemiologic studies have documented the disproportionate burden of stroke and risk factors contributing stroke racial/ethnic disparities. These studies have also identified potential intervention targets and areas for additional research.

The knowledge gained from these studies is critically important to identifying comprehensive targets for intervention studies.

Therefore, we strongly encourage research projects that address prevention/intervention targets identified in large-scale epidemiology studies such as Reasons for Geographic And Racial Differences in Stroke (REGARDS), Brain Attack Surveillance In Corpus Christi (BASIC), Northern Manhattan Stroke Study (NOMAS), Atherosclerosis Risk in Communities (ARIC), and Greater Cincinnati/Northern Kentucky Stroke Study.

We encourage prevention/intervention projects and stroke disparities projects that include children. Mobile technologies/devices are of particular interest that do not contain a prevention/intervention project to address the racial/ethnic disparities of stroke will not be considered responsive to the FOA.

Prevention/Intervention Project For each of the stroke prevention/intervention studies, the research team should include appropriate experts in subject areas such as stroke neurology, epidemiology, social and behavioral sciences, health policy, economics, biostatistics, and dissemination/implementation research.

For the prevention/intervention project, applicants should clearly identify the scope and breadth of the targeted stroke disparities issues, the health and non-health components that contribute to the disparity, and the mechanisms that the intervention addresses. The applicant should quantify the expected improvement in the stroke disparity as measured by stroke reduction, lives saved, or reduced morbidity/mortality.

Conceptual models identifying the cause and effect relationships of these elements should be included. The applicant should discuss the target population and expected populations for generalization of the intervention. Applications that include modeling that predicts the direct and indirect disparities reduction due to the intervention or prevention strategy are encouraged.

The primary outcome of this research must be clinically meaningful stroke reduction or stroke risk reduction in the defined population, clinical setting, or community setting. This improvement must be documented by reliable, objective and quantifiable measures. The adherence to the intervention must be documented and evaluated in the research design.

Research findings and interventions that work are not always implemented effectively. Therefore, the intervention/prevention project should include a plan to disseminate the project broadly which may include implementation at the state, regional, or national level. The plan should identify the principles used, potential to generalize, and scientific challenges of prevention/intervention scale-up.

(More instructions regarding this section may be found in Section The stroke disparities project(s) may range from basic science through outcomes research. There should be at least one stroke disparities project but no more than four. Additional prevention/intervention projects are of interest.

The project(s) should aim to identify, monitor or target biologic, environmental, social, or healthcare system factors that result in stroke disparities due to racial/ethnic, rural, or socioeconomically disadvantaged populations . Applications may have cores that are directly related and essential to the administration, training/education, or scientific function of the program.

Cores that increase the impact or accelerate the research goals of the subprojects within each SPIRP are encouraged. The Administrative Core is a required element of the application. Other than the Administrative Core, all other Cores must be significant to the support of at least two of the proposed research projects .

Examples of the responsibilities of the Administrative Core and other potential types of cores are: has personnel that includes a SPIRP Administrator, who will dedicate substantial effort to the administrative core activities and who will collaborate closely with the SPIRP Director.

Functions of this core should include, but are not limited to, the following: the integration and function of the SPIRP components and activities; meetings with the NINDS or SPIRP meetings; timely information and sample transfer to fulfill data sharing goals; assurance of compliance with NIH policy requirements; and Resource Core (CRRC) (optional) can provide support for clinical research projects of the SPIRP.

This core cannot be proposed as a stand-alone entity without substantial contributions to the SPIRP projects.

Responsibilities may include: and follow a defined cohort of patients and/or control subjects; clinical data conforming to NINDS and NIH requirements; efficiency and productivity metrics for accrual and retention; standardized recruitment tools to participating sites; the efficiency of site activation; development of communication plans and recruitment/retention strategies such as development of a recruitment mission statement, message development, message dissemination strategies, and specify target recruitment efforts; patient education and community outreach, in the absence of a separate core.

Unique aspects of the assembled cohort must be described. Importantly, the CRRC must be utilized only to support components for which other funding or institutional resources are not available. Plans for any non-SPIRP research projects or trials that will utilize Core resources should be detailed within the application.

Applicants must include a timeline of CRRC activities planned within the 5 years of SPIRP funding and describe any potential plans beyond this period of support. must be integral to the aims of the SPIRP and of common utility.

Applicants may propose additional research cores that provide specialized support to advance Proposed resource-related research cores should not include general resources that could be provided at an institutional level, nor should cores replace or centralize resources supported by individual projects.

SPIRP applicants may, as needed, budget for use of institutional facilities (e.g. fees for shared equipment usage) or personnel (e.g. partial effort for technical assistance) within the research cores. However, there should be no functional overlap between proposed core facilities and other pre-existing core facilities at the applicant institution.

Education and Training Plan: (required) The NINDS requires that the SPIRP will play an important role in education and training that will contribute to stroke disparities research.

This may be accomplished in several valuable ways Training the next generation of investigators; Training to support scientific research personnel (particularly in the Alaska Native, Native Hawaiian, and American Indian communities); Educating key community members or stakeholders such as community physicians, community health workers, or community health advocates/organizations so that they substantially contribute to stroke disparities research.

proposed Research Education and Training Plan must include a plan of action and a defined goal to be accomplished. This goal must contribute to decreasing stroke disparities or significantly enhancing the ability to perform stroke disparities research in a stated community.

The application should clearly define the value of the undertaken activities to stroke disparities research, the SPIRP, and the NINDS; these activities may address barriers to the advancement of stroke disparities research or the understanding of stroke disparities research. Applications lacking a plan for research training and education will not be considered responsive to this FOA.

The SPIRP PD(s)/PI(s), project leaders, or core leaders must have an excellent record in successful mentoring or educating which must be documented within the overall education/training plan. Proof of institutional support for these efforts should be included.

Although the NIH does not require a specific format, each SPIRP is encouraged to consider instruction in the following areas: policies regarding the use of human and animal subjects; data acquisition, management, sharing and ownership; publication practices and responsible authorship; collaborative science; conflict of interest, responsible authorship and policies for handling research misconduct.

The application should describe as appropriate the relationship to existing training resources and the resources available to assist transition to independence such as grant writing The roles of SPIRP faculty within these education/training activities should be defined; optimally, all investigators will participate actively in these cross-training efforts.

The proposed Research Education/Training Plan budget should not request funds for trainee or junior faculty Outreach and Dissemination: (required) Applicants must include outreach efforts as an integral part of the SPIRP. Outreach and dissemination activities should be detailed within the budget, whether included as part of the Administrative Core, Clinical Resource Core, or as a core.

Planned activities should inform and educate the local patient or participant community about stroke or stroke disparities and the research efforts of the SPIRP, while in turn assisting each SPIRP in the design of studies that target outreach and research to the needs of people with stroke and their caretakers. Planned or established methods for effective outreach should be detailed.

Where applicable, these activities should be coordinated with the SPIRP’s CRRC to recruit, retain and inform the patient cohort. Evidence of service to the local community should be The SPIRP will be comprised of an Executive Committee, an Administrative Director for the Administrative Core, an external Program Advisory Committee (PAC), and the NINDS Program Director.

In instances where the SPIRP has multiple PD(s)/PI(s), they will share responsibilities for ensuring their SPIRP meets the goals, objectives, and measurements for success proposed in the application and project periods; however, one PD/PI must be designated as the SPIRP The SPIRP Director must be an established leader in scientific research with appropriate expertise for the proposed SPIRP and have a proven expertise in research project and personnel management.

The SPIRP Director must lead a project and/or core within the program. Other qualifying factors include current research funding, current productivity, and a capacity for visionary leadership of a trans-disciplinary team.

The success of the program will scientific and managerial oversight by the SPIRP Director, who will have overall administrative and scientific responsibility for overseeing the research design, implementation, and timely dissemination of results as well as for the proposed goals, outreach.

The SPIRP Director will also be responsible for implementing the education and training plan, developing strategies for dissemination, and implementing a management plan, and will assume responsibility and accountability to the applicant institution and to the NINDS for the performance and proper conduct of the research in accordance with the Terms and Conditions of Award.

The SPIRP Director should significantly contribute to the success of the program with responsibilities and effort clearly outlined in Due to the size and scope of the program, each SPIRP must have an administrative director with expertise in grants management, who can demonstrate the ability to coordinate large research projects, and who has the ability to improve the efficiency of the program.

The Administrative Director will be responsible for the activities of the Administrative Core and should not be the SPIRP Program Director. The Administrative Director should have expertise in the areas outlined in the Administrative Core description and should coordinate effectively with research projects and personnel, the cores, and educational activities of the program.

Project and core leaders must demonstrate a successful and meaningful history of leading scientific projects. The investigator should demonstrate excellent scientific productivity as supported by publications and contributions to science.

These leaders should significantly contribute to the success of the program with responsibilities and efforts clearly outlined in The SPIRP application should identify the leadership structure of the program which will comprise an Executive Committee, which will be the primary leadership structure of the program and will include the Program and Administrative Directors, project leaders and core directors.

The Chair of the Executive Committee will be the SPIRP Program Director. The NINDS Scientific Program Director will be a voting, ex officio member of the Executive Committee. The Executive Committee will be responsible for regularly contributing to scientific and administrative decisions.

The Executive Committee will meet annually in a face-to-face meeting with the Program The independent and external Program Advisory Committee (PAC) is responsible for providing advice and guidance to the SPIRP.

The PAC will conduct, at a minimum, an annual review of the goals of the SPIRP including goals related to training and career development, implementation of outreach activities, progress towards reaching the goals of the SPIRP as a whole, and progress towards reaching the goals of the individual projects. The PAC will generate a written report summarizing its evaluations and recommendations which will be advisory to the SPIRP.

The NINDS Scientific Program Director is an ex officio member of the PAC. The PAC is composed of at least three external advisors who will provide unbiased recommendations to the SPIRP. The composition of the PAC should include at least an expert performing research in the proposed minority community, a stroke expert, a statistician, and an expert in each of the proposed project areas so that there can be appropriate evaluation.

The Program may consider having a community member or community health leader as a PAC member or PAC advisor. A description of the PAC activities, including at least an annual face-to-face meeting, should be included in the application. Funds for the annual meeting will come from the SPIRP and should be budgeted through the Administrative Core.

To avoid impacting the pool of potential peer reviewers or conflict of interest, PAC members should not be named, contacted, or selected until an award has been made. The institutional commitment will be important to each funded program. Letters from a high-level institution official(s) (e.g., Dean of the School of Medicine, Vice President for Research) should be attached confirming this commitment.

If the proposed SPIRP involves a consortium arrangement between two or more institutions, the institution that submits the SPIRP application must receive formal written agreement(s) from the other participant organization(s). This agreement should clearly delineate the institutional commitment of the participating organization(s) (in the ways outlined above) to the Program.

The institution should provide a statement that includes information regarding: how the program fits within the larger goals of the institution; support for activities integral to the scientific and administrative success including timely provisions for space and support use of valuable and necessary resources within the institution; time by the investigators to conduct the proposed research; plans for the support commitment to foster core and other activities including training, education and community outreach; and plans for institutional officials to interact with the program Stroke Disparities Meeting To foster an environment for learning about stroke disparities research and activities, an annual meeting will be held to discuss scientific outcomes, administrative challenges, best practices for recruitment, and emerging issues.

Participants will include each SPIRP PD(s)/PI(s), Administrative Director, the leaders for each research project, as well as NIH officials and invited participants from other government agencies and non-governmental organizations. The project leaders are expected to participate in the development of the agenda and to serve as the representative of his/her program at the meeting.

Applicants should budget for travel to the annual meeting as a line item in the budget section entitled Annual Meeting . (This meeting is in addition to the annual PAC face-to-face meeting. The SPIRP programs and their outcomes will be of interest to the scientific community.

The Administrative Core for each program is expected to develop and maintain a website for use by the SPIRP program and interested parties. Website components should describe the scientific, educational, and outreach activities of the program. Applicants should budget for website development and maintenance in the Administrative Core budget entitled SPIRP Website.

Application Types Allowed Glossary and the PHS398 Application Guide provide details on these application Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious The NINDS intends to fund up to two awards, corresponding to a total of $1. 5 million per year direct cost per program, for fiscal year 2012.

Future year amounts will depend on annual appropriations. Application budgets are limited to $1. 5 million direct costs per program per year.

The budget needs to reflect the actual needs of This is a one-time solicitation to fund programs for up to Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Foreign institutions are eligible to apply; however, the participant population must be in the United States of America and the measures of efficacy or effectiveness for the project must be stroke reduction or stroke risk reduction in the United States of America.

Foreign (non-US) Institutions must follow policies described Grants Policy Statement , and procedures for foreign institutions described throughout the PHS398 Application Guide. Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award.

Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s)) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. The PD(s)/PI(s) of the program must be an established leader in scientific research with proven expertise in research project and personnel management. SPIRP Directors must lead a project and/or core within the program.

Other qualifying factors include current research funding, current productivity, and capacity for visionary leadership of a trans-disciplinary team. The success of the program will require significant scientific and managerial oversight by the PD(s)/PI(s).

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide. The multiple PD(s)/PI(s) strategy is allowed; however, it is the responsibility of the investigators and the applicant organization to make this determination.

This decision should be determined by the scientific goals of the project. The structure and governance of the PD(s)/PI(s) leadership team as well as the skills, knowledge, and experience of the individual PD(s)/PI(s) will be factored into the review process as determined by the overall scientific merit of the application. This FOA does not require cost sharing as defined in the NIH Grants Policy Statement .

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

The NINDS encourages collaboration between institutions for the submission of individual applications. There are no limitations on the number of inter-institutional partnerships that an institution may establish. An institution may be the lead organization on an application and the non-lead partner or consortium member on a separate and scientifically distinct application.

Duplicative costs are not allowed. Applicants will be required to declare and resolve any real or potential scientific or budgetary overlap issues prior to the award. IV.

Application and Submission Information 1. Address to Request Application Package Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Form of Application Submission It is critical that applicants follow the instructions in Application Guide , except where instructed in this funding opportunity announcement to do otherwise.

Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NINDS staff to estimate the potential review workload By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed research Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this funding opportunity The letter of intent should be sent to: Program Director, Health Disparities National Institute of Neurological Disorders and Stroke, NIH Office of Clinical Research 6001 Executive Blvd, NSC, Suite 2205 Rockville, MD 20852 (for Express/Courier Service) Telephone: (301) 496-9135 Meeting: The SPIRP staff is planning to host a technical assistance discussion in February 2012 for applicants to discuss this FOA and to ask specific questions.

The time and format of this discussion will be announced in a separate Notice in the NIH Guide. Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application.

Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail) Bethesda, MD 20817 (for express/courier service; non-USPS service) At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to: Chief, Scientific Review Branch National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Room 3201 Telephone: (301) 496-9223 All page limitations described in the PHS398 Application Page Limits must be followed, with the exception of Project I as described in the second bullet below: The overview of the proposed SPIRP application is limited to 12 The stroke disparities prevention/intervention project, which should be labeled as Project I , may include a Research Strategy section of up to 30 pages.

The additional pages were permitted because of the required sections listed below in Section IV. 2. Research Plan Subsection II.

2. Project I is also required to have a Study Protocol. The completed Study Protocol for Project I should be included in the Appendix and should follow the Protocol Template at http://www.

ninds. nih. gov/research/clinical_research/toolkit/protocoltemplate.

htm . For each scientific project (up to 4 stroke disparities projects), the research strategy section is limited to 12 pages per project. If the program has more than one prevention/intervention project, the additional project is limited to 12 pages.

The Administrative Core and Research Education/Training Plan may be up to 12 pages. All other Cores are limited to 6 pages. All instructions in the PHS398 Application Guide must be followed, with the following additional instructions: should include the following information in the relevant subsections: I: Administration and Budget 1): Complete all items on the application's face page.

For the number of this FOA and the title, "Stroke Prevention/Intervention Research Program (SPIRP) (U54)". The applicant should number succeeding pages consecutively with integers.

(Form Page 2): Project Summary and Relevance, Project/Performance Site(s), Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells Describe briefly the proposed research program, indicate the research emphasis of the component Research Projects, and identify the purpose of the proposed core units.

As well, list the relationship between each core and its corresponding projects; for example, Administrative Core