Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

Morris K. Udall Centers of Excellence for Parkinson’s Disease Research (P50)   

Activity Code

P50 Specialized Center

Announcement Type

Reissue of  RFA-NS-10-001

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-NS-11-004

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

 93.853

FOA Purpose

The National Institute of Neurological Disorders and Stroke (NINDS) invites new and renewal applications for the Morris K. Udall Centers of Excellence for Parkinson’s Disease Research program. The overarching goal of the specialized Udall Centers program is to establish a network of Centers that work independently as well as collaboratively to define the causes of and discover a cure for Parkinson’s disease (PD). A more immediate goal for each Center is to rapidly advance synergistic, high-impact research programs while serving as local resources and national leaders in PD research and treatment. The overall theme, proposed research projects, and associated scientific/clinical cores must relate directly to the etiology, pathogenesis or treatment of PD. Investigations on related parkinsonian disorders may be included, to the extent that these directly inform research on PD. Required components include: 1) a minimum of three interdisciplinary research projects, which must include one early-stage translational research project (see below); 2) a complement of resource-related Cores essential to accomplish the Aims of proposed research projects; 3) an early-stage translational research project. In this context translational research is defined as investigations focusing on the development of therapeutics, diagnostics, devices or clinical criteria that would ultimately lead to new approaches for the treatment of PD; 4) an Administrative Core; and 5) at a minimum, in the absence of a dedicated Research and Education Core, each application must include a specific mission statement for training within the Administrative Core section. Inclusion of other research and core components is flexible within stated budget limits, and should optimize the potential of each Udall Center and address overall programmatic goals.  Because basic research serves as the foundation for discovery in the Udall Centers program, preference will be given to applications that propose a basic research project. A considerable degree of synergy must be evident among Center research projects and cores, such that successful completion of the Aims requires the support of the Center structure. Inclusion of an integrated clinical component, i.e. a clinically oriented translational research project plus an appropriately matched Clinical Resource Core, is encouraged.  Because Udall Centers also serve as resources for research training and public outreach, Center activities in this area are strongly encouraged for inclusion as optional Cores. The Udall Center Director (PD/PI) must be an established leader in scientific research with visionary leadership skills and proven expertise in research project and personnel management. Eligible institutions must demonstrate commitment to and support for the establishment and continuation of the proposed Udall Center. Funding priorities will focus on those applications evincing the capacity for unique and innovative contributions to PD research, as well as the potential to collaborate effectively across Centers. Successful applicants will participate in a network of existing Udall Centers to foster the translation of scientific findings and technological developments into novel treatments for PD. Contact with the NINDS program officer at early stages of program planning is strongly recommended.

Key Dates
Posted Date

March 4 , 2011

Letter of Intent Due Date

April 10, 2011

Application Due Date(s)

May 10, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

July 2011  

Advisory Council Review

August 2011  

Earliest Start Date(s)

September 30, 2011

Expiration Date

May 11, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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.

Table of Contents

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 Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

Parkinson’s disease (PD) is a chronic, progressive movement disorder that affects the lives of at least one million people across the United States. The average onset of characteristic motor symptoms, which are initially subtle and increasingly impact purposeful movement, occurs in the sixth decade of life. People with PD also experience significant non-motor symptoms including changes in cognition and mood, sleep disturbances, and autonomic dysfunction. Currently available pharmacological and surgical treatments provide relief from some motor symptoms, but do not halt the ultimate progression of the disease. Although significant research advances have been made, including the recent identification of possible environmental and genetic risk factors, a clear cause and a definitive cure for PD have remained elusive.

The NINDS Centers of Excellence for Parkinson’s Disease Research program was established as part of the Morris K. Udall Parkinson’s Disease Research Act of 1997 (P.L. 105-78), legislation passed to honor the distinguished Representative from Utah who died in 1998 after a long battle with PD. In 2011, this program continues to forge a strong and innovative path in PD research. Udall Centers utilize a multidisciplinary research approach to elucidate the fundamental causes of PD as well as to improve the diagnosis and treatment of patients with Parkinson’s and related parkinsonian disorders. Udall Centers have identified and characterized candidate and disease-associated genes, examined neurobiological and neuropathological mechanisms underlying  PD, established improved PD models, developed and tested potential therapeutics, and explored novel avenues of clinical research. The complex research programs pursued at each Center are best addressed by a collaborative and multidisciplinary approach, wherein the integration of talent and effort leads to the most rapid advances in PD research and treatment.

Purpose

The overarching goal of the NINDS Udall Centers of Excellence program is to establish a network of Centers that work independently as well as collaboratively to define the causes of and discover a cure for PD. A more immediate goal for the Centers is to further our understanding of PD by pursuing unique, high-impact, integrative research programs, as well as to serve as local resources and national leaders in PD research and treatment. A key to successful research is sharing of information in a collaborative fashion. Accordingly, another goal of this program is to further PD research and collaboration by broadly sharing data and research resources developed through this Centers program.

While basic research has served and will continue to serve as the foundation of discovery in the Udall Centers program, this FOA solicits applications that also build upon this vital foundation to translate basic and clinical research observations into improved treatments to slow disease progression and to identify cures. Therefore, each proposed Center must include at least one translational project designed to address the gap between PD research and treatment (defined below). Proposed studies must be feasible within the budget limits described elsewhere in this FOA.

Scope of Research

The overall theme of each Center, proposed research projects, and cores must relate directly to the etiology, pathogenesis or treatment of PD. At least one early-stage translational project, as defined below, is required within the spectrum of proposed research projects. Additional requirements include an Administrative Core and a mission statement for research training and education. The proposed components of each Center should be designed to optimize the potential accomplishments of that Center and the overall advancement of Udall program goals.

Responsive applications will demonstrate proven ability or considerable potential to pursue rapid translation of research to clinical practice; to contribute unique knowledge and scientific advances to the Udall Centers program; to collaborate effectively with existing Centers; and to serve as local resources and national leaders in PD research. In response to this call for specialized Centers, applicants must propose a high-impact spectrum of research activities using an integrated, multidisciplinary approach to understand PD. Investigations on related parkinsonian disorders may also be included, to the extent that these inform and/or expand research on PD. Such disorders include, but are not limited to, Corticobasal Degeneration (CBD), Lewy Body Disorders (LBD), Multiple System Atrophy (MSA), and Progressive Supranuclear Palsy (PSP). Resource-related Cores must accelerate the pace of discovery: each proposed scientific Core must be essential to conduct and complete proposed research projects. Investigators seeking support for other multi-component research projects, including those focused solely on clinical studies or on basic neurobiological mechanisms underlying PD, should utilize alternative grant mechanisms; such applications will not be accepted under this FOA.

Center applications are expected to emphasize novel ideas and approaches, as well as use of state-of-the-art technologies and a team-based approach to achieve stated goals. Funding priorities will focus on those applications evincing the capacity for unique and innovative contributions to PD research, as well as the potential to collaborate effectively across Centers. Although new Centers are not expected to have pre-existing collaborations with established Centers, potential areas of shared interest with existing Centers should be considered and included in the application (see http://www.ninds.nih.gov/research/parkinsonsweb/udall_centers/).

Topics of investigation within a Center might include, but are not limited to, the following examples of basic and translational PD research:

Basic research

Basic research projects are investigations in model systems designed to elucidate disease mechanisms and identify optimal targets for therapeutic intervention. While serving as the basis for discovery, this research should be informed and refined by the results of well-designed clinical studies on PD. Preference will be given to applications that include a well-integrated basic research project. Examples of basic research projects include, but are not limited to, the following:

Translational research

In general, translational research applies ideas, insights, and discoveries generated through basic scientific inquiry to the treatment or prevention of human disease. The specific goal of the Udall Centers’ translational research projects is to accelerate discoveries that will lead to early human testing of a new drug, biologic, diagnostic screen, or other therapeutic, diagnostic or preventative intervention for PD. Founded on a multidisciplinary, team-based approach, Udall Centers are well-poised to translate biomedical research advances into improved  treatments.

Regarding the goals of this FOA, translational research is defined as either research in model systems that is specifically intended to complete preliminary steps in the pipeline for therapeutic development for PD or research that represents first steps toward transformation of scientific discoveries arising from clinical observations into new modalities for the prevention, treatment and cure of PD.

A responsive translational project using model systems will include early proof-of-principle of therapeutic efficacy or establishment of assays, technologies or models necessary to advance the PD therapeutic pipeline.  Such studies represent first steps toward an IND/IDE (Investigational New Drug/Investigational Device Exemption). Only Aims required for therapy development can be supported in Udall Center translational projects. Responsive studies may include but are not limited to the following:

Basic research Aims designed to elucidate the underlying neurobiology of disease mechanism in cell and animal models are not responsive to this translational research requirement. Such Aims may be included in another, complementary basic research subproject within the Center application.

At the end of the budget period, projects should be well-positioned for application to funding initiatives sponsored by the NINDS Translational Research Program or other related NIH funding opportunities. Examples of programs available through the NINDS Office of Translational Research include the R21 mechanism referenced above and the NINDS Cooperative Program in Translational Research (U01; http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-08-233.htm). For additional information about translational research opportunities at the NINDS, please see: http://www.ninds.nih.gov/funding/areas/technology_development/index.htm.

Translational projects involving a clinical component will represent first steps toward transformation of scientific discoveries arising from basic research, clinical research or population studies into new modalities for the prevention, treatment and cure of PD.   These projects should include manipulations or interventions that provide early proof-of-principle for advancement of research results to clinical trials. Observational studies to define disease mechanism and studies designed to assess therapeutic effect of an intervention are not responsive. Clinical translational research is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator directly interacts with human subjects.

Areas of investigation may include, but are not limited to, the following examples:

Considering the current scope of the Udall Center mechanism, clinically oriented translational studies should be performed in small numbers of subjects, similar in scope to a Phase 0 or Phase I clinical trial. More advanced clinical studies designed to evaluate therapeutic interventions for the treatment of PD or to optimize data for clinical trials are currently beyond the scope of this Udall Center announcement. Interested applicants should instead consult the announcement: NINDS Exploratory Clinical Trials (R01; http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-10-199.htm) and other funding opportunities available through the NINDS Office of Clinical Research (http://www.ninds.nih.gov/research/clinical_research/basics/index.htm).

Applicants must also describe facilities available for proposed translational studies, as well as planned utilization of existing institutional, industry or NIH resources. Applicants are encouraged to leverage such facilities as available.

As translational research is intrinsically interdisciplinary, these projects will involve collaboration among basic researchers and clinicians, and may include the participation of private-sector companies and voluntary organizations. Such relationships should be detailed. Applicants must describe the expected clinical or public health impact of the translational projects, and outline potential avenues by which these projects would be brought effectively to clinical practice.

To determine whether a proposed translational project is responsive to this FOA, applicants are strongly encouraged to contact the program official listed below.

Description of Udall Center Components

This section will describe in detail the required and optional components for Udall Center applications.

Research Projects

The proposed Center should include a spectrum of research disciplines and must include at least one, early-stage translational research project, as defined above. Applications should include three interdisciplinary research projects, each similar in scope and budget to a small R01, and a complement of Cores necessary to accomplish proposed research. A substantial level of synergy must be evident among Center research projects and cores, the Aims of which cannot be achieved without the support of the Center structure.

Pilot projects should not be proposed within new or renewal applications.

Clinical Component

For the purposes of the Udall Centers Program, clinical research components include patient-oriented research. The clinical component is defined as a clinically oriented translational research project conducted with human subjects, plus an associated Clinical Resource Core. Examples of responsive research projects are listed in “Scope of Research” section, above. Clinical translational projects must be clearly related to other projects in the Center. Clinical Research Cores must be well-integrated with one or more Center research projects, and must be clearly defined for purposes of responsiveness to this FOA; further information is available below.

When possible, applicants at research institutions are encouraged to establish strong relationships with neighboring clinical centers in order to advance translation of research projects to clinical practice. Data from clinical projects must be deposited and shared via database(s) to be named by the NINDS. Detailed budget justification is required for all clinically-related components of the application.

Subjects who participate in Udall Center clinical research projects and cores should be fully informed, under informed consent procedures. The consent form for funded projects should specifically address the following: (1) disclosure that biological materials and clinical data  may be distributed to other researchers; (2) assurance that such data will be stored and maintained without personal identifiers; (3) disclosure that analyses of these data  may be conducted by other scientists currently not included within the current research team, potentially including those with commercial interests; (4) that the data collected by the researchers may be used as necessary to study additional, related disorders.

Clinical Resource Core

The Clinical Resource Core must provide essential support for one or more Center research projects; this component cannot be proposed as a stand-alone entity. This Core itself should not propose research aims, beyond work to improve methodologies or services.  If included, the primary goals of the Clinical Resource Core may include, but are not limited, to:

A detailed subject recruitment strategy is required, including strategies for outreach to minority communities and for retention of minority subjects. Every effort should be made to serve diverse racial and ethnic populations with this Udall Center core.

The Clinical Resource Core should serve more than one project of the Udall Center; ideally, it should collaboratively serve multiple Udall Centers. Unique aspects of the assembled cohort must be described. Importantly, this Core must be utilized only to support components for which other funding or institutional resources are not available. Plans for any non-Udall research projects or trials that will utilize Core resources should be detailed within the application. Applicants must include a timeline of Core activities planned within the 5 years of Udall Center funding, and describe any potential plans beyond this period of support.

To increase the impact of a proposed clinical component, applicants are also strongly encouraged to strengthen their proposed investigation through collaboration with other active Udall Centers containing established clinical components and patient cohorts.

Cores

Udall Centers of Excellence are distinguished from other multi-component research programs by the inclusion of specially designed Research Cores that are required to accelerate the collective research goals of subprojects within each Center. In addition, optional Service Cores (e.g. education, outreach) increase the impact of each Center via service to the broader research and patient communities, reflecting the role of Udall Centers as local resources for PD research.

Administrative Core

An Administrative Core is required for all Centers. Core personnel must include a Center Administrator, who will dedicate substantial effort to Core activities, and who will collaborate closely with the Center Director. Functions of this core should include, but are not limited to, the following:

Research Cores

Proposed research Cores must be integral to the Aims of the Center and of common utility, such that the resources provided will be utilized by one or more research projects in the proposed Centers. Applicants must propose additional Cores that provide specialized support to advance the Aims of the Center. Core concentrations may include, but are not limited to:

Proposed resource-related 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. Udall Centers 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 Cores. However, there should be no functional overlap between proposed Udall core facilities and other pre-existing core facilities at the applicant institution.

Establishment and maintenance of brain banks and other resources of broad interest to the PD research community are not supported by this FOA  funding for such efforts may be pursued via the Resource-related Research Project-Cooperative Agreement (U24) mechanism: http://www.ninds.nih.gov/funding/grant_mechanisms.htm#U24.

Service Cores

These Cores provide service beyond the immediate requirements of Center researchers, supporting the broader research and patient communities and emphasizing the role of Udall Centers as local resources for PD research. While inclusion of Service Cores is optional, evidence of broader service within the application is encouraged. Service Cores can include, but are not limited to, the following:

Research Training and Education Core: the NINDS expects that the Udall Center program will play a major role in training the next generation of PD researchers. Therefore, proposed Centers must provide an optimal environment for trainees and junior faculty to acquire research skills and experience in interdisciplinary PD research. Centers are strongly encouraged to include a Research Training and Education Core. At a minimum, each application must include a specific mission statement for training within the Administrative Core section; applications lacking this information will not be considered responsive to this FOA. Proposed cores should include a comprehensive training plan for all students, postdoctoral fellows, and junior faculty participating in Center activities, as well as plans for recruitment and advancement of trainees and junior faculty. The Center PI, project leaders, and core leaders must have an excellent record in the successful mentoring of researchers; this must be documented within the overall plan. The training goal of the Center is to foster proficiency across the broad spectrum of basic, translational and clinical concepts, as well as practical skills, that are necessary for trainees to successfully establish an independent PD research program. Proof of institutional support for these efforts should be included.

Udall Centers should provide resources via which non-clinician scientists will gain understanding of and exposure to the clinical aspects of PD research, such that basic research is approached as it relates to the clinical manifestation of the disease. Conversely, clinician scientists must have exposure to and training in the basic science that contributes to discovery of disease mechanisms and therapeutic targets. Centers should also train medical residents in the skills necessary to eventually obtain an NIH career development award, including the collection of preliminary data, grant writing skills, and an understanding of the neurobiological mechanisms underlying PD. Training activities might include didactics, regular attendance at grand rounds, a targeted seminar series, a Center training retreat, and other activities designed specifically to address cross-disciplinary issues. The Center should also provide training in the responsible conduct of research (RCR). Although the NIH does not require a specific format, each Center is strongly 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.

If proposed, a dedicated Research Training and Education Core will work to eliminate barriers to the advancement of PD research by providing an infrastructure within which basic, clinical and translational scientists will successfully inform each other’s expertise and research. Therefore, each Core must design, institute and coordinate a program to facilitate continuous interaction and promote comprehensive discussion among Center researchers, trainees and junior faculty. Related activities might include regular meetings among basic, clinical and translational participants, invitation of outside speakers to address defined topics, and annual conferences with poster and platform presentations.  The Core could also serve as a local resource via the inclusion of PD trainees and researchers from neighboring departments and/or institutions in Core activities. The roles of Udall Center faculty within these Core activities should be defined; optimally, all investigators will participate actively in these cross-training efforts. The proposed Core budget should not request funds for trainee or junior faculty slots; these positions should be budgeted as needed within the research projects and resource-related cores.  

Public Outreach and Dissemination Core

Applicants are encouraged to include outreach efforts as an integral part of the Udall Center. Any planned outreach activities must be detailed within the budget, whether included as part of the Administrative Core, Clinical Resource Core, or as a stand-alone Core. Planned activities should inform and educate the local patient community about PD and the research efforts of the Center, while in turn assisting each Center in the design of studies that target outreach and research to the needs of people with PD and their caretakers. Planned or established methods for effective outreach should be detailed, including whether proposed outreach activities will occur at the academic institution, in the community and/or in assisted living facilities. Creative, evidence-based approaches to simultaneously educate and promote wellness in people with Parkinson’s are encouraged. Outreach and dissemination to underserved communities must be described. Where applicable, these activities should be coordinated with the Center’s Clinical Resource Core to recruit, retain and inform the patient cohort. Evidence of service to the local community should be documented.

Udall Investigators: Qualifications and Effort

Center Director

The Udall Center Director (PI) must be an established leader in scientific research with a history of successful funding and proven expertise in research project and personnel management. Center Directors must lead a project and/or core within the Center. Other qualifying factors include current research funding and productivity, capacity for visionary leadership of a multidisciplinary team, and demonstrated experience in mentoring of trainees and junior faculty. Expertise in areas beyond PD research is appropriate if it is clear that the Director’s skills can be applied in novel ways to the translation of PD research into clinical practice. It is anticipated that the success of a Udall Center will require considerable scientific and managerial oversight by the Center Director. The Center Director is responsible for ensuring that scientific goals are met and for developing and managing a decision-making structure and process that will allow resources to be allocated to meet stated Center goals. Anticipated duties and responsibilities of the Center Director should be clearly defined and a substantial commitment of effort proposed.

Research Project and Core Leaders

Project leaders must demonstrate a successful history of NIH funding (at the R01 level and beyond), current funding, and excellent scientific productivity. Core leaders must have a record of scientific productivity and collaboration in the scientific area covered by the core. All investigators must contribute to, and share in, the responsibilities of fulfilling Center objectives. As noted for Center Directors, the expertise of Project and Core Leaders may also be in areas outside of PD research, if relevant skills can be readily applied to the goals of the Center.

Center Administrator

Each Center should include a Center Administrator. This position must be included in the proposed budget, and filled by an expert administrator, not by the Center Director or by Project or Core Leaders. Effort should be commensurate with required duties. The Administrator must have proficiency in administrative oversight and coordination of large research projects. Additional duties will include coordination of data for the annual progress report, including information on research discoveries, publications, funding sources, outreach and education efforts, and training outcomes. Attendance at the annual meeting is recommended to facilitate communication and share best practices. Travel costs should be included within the budget.

Other Center Components

This section describes additional considerations for applicants, including the establishment of an internal Executive Committee, an external Advisory Panel, degree of institutional commitment, and identification of opportunities for partnership.

Executive Committee

Each Center should contain an Executive Committee, consisting of the Center Director, Center Administrator and all subproject and core investigators. This group will assist the Director with scientific and administrative decisions, and should meet regularly to discuss the development and direction of the program.

External Advisory Panel

Each Udall Center must appoint an External Advisory Panel (EAP), composed of at least five outside experts who can provide unbiased evaluation of the program. Ideally, the scientific expertise of the EAP would complement current projects as well as anticipated future directions of the Center. The EAP will meet regularly to review and provide guidance to the Center investigators. While it may not be feasible to have an annual in-person meeting, it is strongly recommended that Center Directors hold in-person meetings early, mid-way and toward the end of the project period, so that the EAP can provide timely assessments of Center progress and recommendations for future direction. A description of proposed EAP activities should be included in the application. However, to avoid impacting the pool of potential peer reviewers, EAP members should not be contacted, named, or selected until an award has been made. EAP activities should be included in the proposed budget. Changes in the EAP, which may be necessary e.g. due to novel project directions, should be relayed to the program officer.  Regular EAP updates and evaluations are to be included in each noncompeting continuation report.

Institutional Commitment 

Each Center application must include a statement that addresses how the institutional commitment will be established and sustained, how the institution will maintain accountability for promoting scientific excellence, and how the Udall Center research effort will receive high priority within the institution (relative to other research efforts and non-NIH supported programs).  The institutional commitment may be in the form of support for recruitment of scientific talent, provision of discretionary resources to the Udall Center Director, assignment of specialized research space, cost sharing of resources, and/or other ways proposed by the applicant institution.  The primary institution is strongly encouraged to demonstrate its commitment to the Udall Center by providing financial support to the Cores, pilot projects, and other programmatic needs identified as high priority in the application. 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 Center involves a consortium arrangement between two or more institutions, the institution that submits the P50 application must receive a 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.

Only one Udall Center may be awarded to any one institution. Institutions that currently support other large-scale PD-related research projects or Centers (e.g. NIEHS Center for Neurodegenerative Science, Parkinson’s Disease Foundation Center, large scale Michael J. Fox Foundation projects) must detail the unique contributions of the Udall Center, how the projects will interact to advance PD research, and outline commitment to the support of the Udall Center program in this context.

Opportunities for Partnership

The Udall Centers are strongly encouraged to pursue collaborative efforts with the Clinical and Translational Science Awards (CTSA), a consortium of academic health centers funded by the National Center for Research Resources (NCRR), NIH (http://www.ctsaweb.org/).  Areas of CTSA emphasis include: development of novel translational and clinical methodologies and resources, fostering pilot and collaborative studies, development of biomedical informatics tools, training of translational and clinical researchers, community outreach, and public-private partnership. Udall Centers are also encouraged to leverage additional partnership opportunities, both within and outside of the NIH, to further program goals.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal

The OER Glossary and the PHS398 Application Guide provide details on these application types.

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 applications.

The NINDS intends to award up to 3 Udall Centers, corresponding to an estimated total of $6,750,000 for fiscal year 2011.

Award Budget

Application budgets should reflect actual needs of the proposed project.  Applicants should request no more than $1,000,000 direct costs per year (exclusive of facilities and administrative costs of subcontracts with collaborating institutions), unless an optional clinical component is proposed. Applications including a clinical component, i.e. a clinical translational research project plus a clinical resource core, may request $1,500,000 direct costs per year. Cost of living is included in the direct costs cap. Applications may not exceed this cap in any one year.

Award Project Period

 An award project period of up to 5 years may be proposed.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

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 registrations.

All Program Directors/Principal Investigators (PD/PIs) 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 least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) 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 Udall Center Director (PD/PI) must be an established leader in scientific research with a history of successful NIH funding and proven expertise in research project and personnel management. Other qualifying factors include: current research funding (R01 equivalent) and recent productivity, capacity for visionary leadership of a multidisciplinary team, demonstrated leadership of large-scale, integrated research projects, and track record of mentoring of trainees and junior faculty. Research expertise in areas beyond Parkinson’s disease (PD) is appropriate if it is clear that those skills can be applied in novel ways to the goals of the Udall Centers program. Anticipated duties and responsibilities of the Center Director should be clearly defined and must include a substantial commitment of effort.

 Multiple PDs/PIs are not permitted in response to this FOA. 

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

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.

Section 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 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 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.

Letter of Intent

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 IC staff to estimate the potential review workload and plan the review.

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:

Beth-Anne Sieber, PhD
Division of Extramural Research, Neurodegeneration Program Cluster
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 2223
Bethesda, MD 20892-9525
(Rockville, MD 20852 for express/courier service)
Telephone: (301) 496-5680
Email: sieberb@ninds.nih.gov

Application Submission

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
Bethesda, MD 20892-9529
Telephone:  (301) 496-9223
Email: nindsreview.nih.gov@mail.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide must be followed for:  Face Page, Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Detailed Budget for Initial Budget Period, Budget for Entire Proposed Period of Support, Biographical Sketch, Resources, All Personnel Report.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Page Limits

For Udall Center applications, page limits are as follows:

Center Overview: 12 pages

Research Projects:

Cover Page: 1 page

Description: 1 page

Specific Aims: 1 page

Research Strategy: 12 pages

Research and Resource Cores:

Cover Page: 1 page

Description : 1 page

Core Structure and Services: 6 pages          

Format of the PHS 398 application: the following guidelines provide directions for preparing each section of the application.  The Table of Contents described for PHS-398 Form Page 3 should contain the headings outlined below in Section l —Preliminary Pages and Section ll – Research Plan.   The Table of Contents should be paginated to enable reviewers to readily find specific information.  

SECTION I:  PRELIMINARY PAGES

1.  Face Page (Form Page 1): complete all items on the application's face page.  For Item 2, enter the number of this FOA and the title, "NINDS Udall Centers Program (P50)”.  Number succeeding pages consecutively.

2.  Description: Project Summary and Relevance, Project/Performance Site(s), Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (Form Page 2 and 2-continued)

3.  Table of Contents (Form Page 3): prepare the Table of Contents including the major headings as noted above.

4.  Budget Instructions (Form Page 4): prepare a series of composite budget tables for the P50 application as requested below, followed by a detailed budget for each Research Project component and each Resource Core.

A.    Composite Budget

Use PHS-398 Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD,"  to present the total budget for all requested support for the first year. For each category, such as "Personnel," "Equipment," etc., give the amount requested for each Research Project component and each Core unit, with subtotals.

If consortium arrangements involving other institutions or organizations are anticipated, include total (direct and indirect) costs associated with such third-party participation in the Consortium/Contractual Costs category. Costs for purchased services should be itemized under the "Other Expenses" category.

Use PHS-398 Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," to prepare a budget, by category, that provides totals for each year of requested support. Requests for any increases in succeeding years must be justified in the individual Research Project and Core budgets.

B.  Budgets for Individual Research Project Components and Core Components 

Budget Justifications and Explanations: Describe the specific functions of all key personnel, consultants, collaborators, and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations.

PLEASE NOTE: Consortium budgets (if applicable) should be presented as described in A, including budget for the entire proposed project period. Total direct and indirect costs of sub-awardees are to be shown under Consortium/Contractual costs on the individual component budget and a detailed sub-awardee budget is to be placed following the appropriate Research Project or Core budget.

5.   Biographical Sketch (Biographical Sketch Format Page):

Follow the instructions on the Biographical Sketch Format Page. This section must contain the biographical sketches of all individuals listed as Senior/Key Personnel and Other Significant Contributors, following the order listed on Form Page 2.  Biographical sketches are required for all key personnel participating in the Research Project components and Cores.   Begin with the P50 overall PD/PI and thereafter, in alphabetical order, submit biographical sketches as described in the Instructions for Form PHS-398.

6.   Resources (Resources Format Page)

Complete the "Resources" page of PHS-398 for the overall project. Briefly describe the features of the institutional environment that are or would be relevant to the effective implementation of the proposed program. As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources.

SECTION II - RESEARCH PLAN

Include a detailed Table of Contents with pagination (numeric only) at the beginning of Section II.

Identify each Research Project component and each Core unit by title. Assign each Research Project component a Roman numeral (I, II, III) and assign each Core unit a capital letter (A, B, C) that reflects the order in which they are presented.

For each Research Project component and Core unit, provide the name of the responsible investigator, and biographical sketches for personnel not identified previously.

1. Overview of the Udall Center (12 pages)

A.  Purpose of the Program.   Discuss the overall Udall Center program's objectives and general plans for the proposed grant period. Include a vision statement for the Center, including overarching goals to be achieved. Justify the proposed multidisciplinary approach and the use of the specialized Center mechanism (P50) to achieve stated goals.

B. Administration, Organization, and Operation.  Include information on the support and commitment of the parent institution for the program, the authority of the PD/PI, the use of advisory committees, and space assignment. Describe organizational framework and provide an organizational chart. The expertise to be represented in the external advisory committee should be described, but potential members of the committee should NOT be named and letters from such individuals should NOT be included.

C. Research Program.  Discuss the proposed research program, highlighting its central theme. Describe the relationship between the projects and the Cores and their relationship to the central theme. Detailed descriptions of preliminary data for new projects (new and renewal applications) or progress on existing projects (renewal applications) should be included within the relevant subproject section, not in the Overview. New and renewal applications should include the following information:

D. Description of Assurances and Collaborative Agreements.  Provide an overview and rationale for any collaborative and cooperative endeavors or subcontracts. Cost sharing or institutional support, if any, should be described in this section. When multiple institutional sites are involved, a detailed description of the cooperative administrative arrangements should be included Letters of agreement for these arrangements are included in Item 6. Letters of Assurance/agreement as described below.

2. Research Project Descriptions (12 pages for each Research Strategy component)

Identify each project by a Roman numeral (I, II, III...) and a title. A full description of each project is to be provided following the format and instructions for Form PHS-398 (http://grants.nih.gov/grants/funding/phs398/phs398.html).

Begin the presentation of each Research Project component on a separate page, and include the following: 

A. Research Project Cover Page (1 page) with Title of Project, Name, Title, and Affiliation of Research Project Director /Principal Investigator, and then names titles, and affiliations of other investigators

B. Description: Project Summary and Relevance (1 page; use PHS-398 Form Page 2):   Discuss the purpose and nature of the project and its relevance to the Center's overall theme.

C. Content of Research Plan (Begin each section with a section header)

Specific Aims (1 page)

Research Strategy (12 pages; Significance, Innovation, and Approach):   Start each section with the appropriate section heading—Significance, Innovation, Approach.

For new applications and new subprojects in renewal applications, include information on Preliminary Studies.  For continuing projects in renewal applications, provide a Progress Report.

Provide supportive rationale for use of specific Core services including why the core services are needed and the advantages and cost effectiveness of Core usage for the project.

For off-site projects, justification should be provided for the project's location, and plans for interaction and cooperation with the other components of the program should be addressed.

3. Core Descriptions

Identify each proposed Core by a letter (A, B, C...) and a title (e.g., Administrative Core, Clinical Core, etc.).  The Administrative Core should be designated Core A. A full description of each Core is to be provided following the format presented in Form PHS-398.  Begin the presentation of each Core on a separate page.   Include the following:

A. Core Cover Page (1 page) that includes the title of the core unit, and the name, title, and affiliation of the Core Director.

B. Description: Project Summary and Relevance (1 page; use PHS-398 Form Page 2):   Include an Abstract that identifies and describes the purpose of the proposed Core.  Summarize the Core overall objectives.

C. Specific Aims (1 page)

D. Core Structure, Administration and Services Provided (6 pages): include justification of services provided in terms of planned contribution to Center productivity and quality. Include organizational charts as needed. For research-related Cores, list research subprojects that will utilize the Core, and provide the percentage use by each subproject. For renewal applications, if continuation of a previously awarded Core is proposed, describe major accomplishments during the prior funding period.

4. Progress Report Publication List (for renewal applications only): list publications prepared during current grant period (or the past five-year period) which report results of research supported by the grant.

5. Letters of Assurance/Agreement: any arrangements for collaborative and cooperative endeavors or subcontracts should be highlighted. Include letters of agreement from consultants. For projects to be conducted off site, i.e., at an institution other than the applicant institution, a PHS-398 face page or other documentation, signed by the off-site institutional officials, must be submitted with the application.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide, with the following modifications:

The NINDS has established specific requirements for selection and banking of samples for PD and related parkinsonian disorders. Selected samples generated by the Udall Centers may be eligible for deposition at the NINDS Repository at Coriell. This facility receives, stores, and distributes standardized samples suitable for genome-wide association and other high throughput genotype/phenotype studies. For further information, contact the program officer listed below, and see http://ccr.coriell.org/Sections/Collections/NINDS/Parkinsonism.aspx?PgId=193&coll=ND  

It is expected that SNP genotyping data obtained with Udall Center funding, together with corresponding phenotypic data, will be deposited at dbGaP. The lead investigator for the SNP genotyping study is responsible for the overall process of data submission. Further information is available at http://www.ncbi.nlm.nih.gov/sites/entrez?Db=gap. Biological samples (with relevant subsets of associated phenotypic data) as well as genetic data resulting from Center research should be submitted to dbGaP prior to publication, with the understanding that the data will be subject to an embargo period. Submitters of controlled-access data housed in dbGaP may retain the exclusive right to publish an analysis of their submitted data for a specified period of time; users wishing to access this data must submit a Data Use Certificate (DUC) for review and approval by an NIH Data Access Committee (DAC). Additional details are available at http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/about.html

Project and Core Directors for the Clinical Component must utilize the NINDS Common Data Elements Resource when constructing data element forms http://www.commondataelements.ninds.nih.gov.  Inclusion and award of a clinical component requires compliance with collection and submission of the  NINDS Core Data Elements (CDE).

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the NINDS, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

New Applications

New applications should detail how the proposed Center will advance the goals of the Udall Centers program. The potential for unique contributions of the Center to the overall Udall Centers Program and to the translation of basic research into clinical practice should be described. Although new Centers are not expected to have pre-existing collaborations with established Centers, areas of shared interest and potential collaborations with existing Centers should be considered and identified (see http://www.ninds.nih.gov/research/parkinsonsweb/udall_centers/).       

Renewal Applications

Renewals will be permitted under this FOA; applications should highlight advances made by the Center, and include a description of the following in the progress report for the prior funding period, including:

Annual Udall Center Director Meetings

Annual meetings of Udall Center Directors are held each autumn in Washington, DC or at another pre-selected location. Meeting planning duties will be shared between the NINDS and the Udall Center Coordinating Committee (UC3). The meeting is designed to provide an optimal environment in which Center investigators can discuss emergent issues and approaches in the research and treatment of PD. Participants from NIH Institutes, Government Agencies and Non-Governmental Organizations are also invited to attend. By providing a focused and interactive Agenda, the annual Meeting fosters the initiation and maintenance of collaborative efforts among the Centers. Applications should budget for travel for the Center Director, Center Administrator, and other select Project and Core leaders to the annual meeting.

Udall Center Coordinating Committee (UC3)

The Udall Center Coordinating Committee (UC3) promotes collaboration and strengthens cooperation among the network of active Udall Centers. UC3 functions include:

The UC3 is led by a Chair and an Executive Committee, who work with the NINDS program officer to achieve these goals. The Chair’s term is one year, to start and end at the annual Directors’ meeting. The UC3 Executive Committee will consist of past, current and rising Chairs, for a total of three years of service per Chair; their Center grants must be actively funded during their term of service. Each Center Director will be expected to participate on the UC3 for the duration of funding of her/his Center. The UC3 will also include two representatives from the patient community and Non-Governmental Organizations (NGOs) to provide input and a broader perspective. Terms of service for these members will be two years. Additional outside members from the research community will be added on an ad hoc basis to address emergent issues within the program. The NINDS program officer should be included as an ex officio participant in all meetings and correspondence.

The UCCC should schedule quarterly phone conferences, and will meet annually just prior the annual Udall Centers meeting. Minutes from the meetings will be made available to the Udall Centers and to the NINDS via a shared website. 

Center Website

Because the Udall Centers serve as the nexus for NINDS-funded Parkinson’s disease research, members of the research community and the general public have considerable interest in remaining informed on progress at each Center.  Each Center must therefore establish and maintain a website for the timely dissemination of information to these groups. Plans for constructing and/or updating this website should be included in the application as part of the Data Management Core, or in the absence of that component, the Administrative Core. The website should contain a prominently placed, brief (1 paragraph) Public Health Statement, which describes the goals and recent discoveries of the Center in lay language. This summary should also relay recent Center contributions to understanding the etiology and pathogenesis of PD, as well as how ongoing research will lead to the development of new treatments. Updates should be sufficiently frequent to reflect recent discoveries. Progress on and improvements to the website should be reported in noncompeting continuation applications. The NINDS Udall website provides links to all active Center websites: http://www.ninds.nih.gov/research/parkinsonsweb/udall_centers/      

Administrative Supplements

The NINDS recognizes the value of insuring the long-term success of the Udall Centers program in the current fiscal climate. Therefore, under extenuating fiscal circumstances and if fiscal appropriations allow, the NINDS may selectively provide administrative supplements to existing Udall Centers to address either of the following cases: 1) for interim funding to allow maintenance of important Center resources; 2) if a competing renewal application fails to meet the NINDS funding pay line, to sunset that Center in an orderly fashion. Such awards will be at the discretion of the NINDS, and will be dependent upon the availability of funds. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Udall Center applications should include the following components: one translational research project, a minimum of three Research Projects, an Administrative Core and essential Research Cores. Preference will be given to applications including a well-integrated basic research project. Optional Cores include Research Training and Education, and Public Outreach and Dissemination Cores may also be included. Important note: in the absence of an optional Research and Education Core, the Administrative Core must contain a mission statement for research training.

The overall score for a Udall Center application may be higher or lower than the average of the individual components based on reviewer assessment of whether the whole is greater than the sum of its parts.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the proposed Udall Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Center proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a subproject or Core that by its nature is not innovative may be essential to advance a field.

Significance

Does the proposed Udall Center address an important problem or a critical barrier to progress in the field? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Will the proposed Center effectively meet the stated goals of the Udall Centers Program? Will clear scientific merit and thematic cohesion result from the combination of proposed Projects and Cores? Are the aggregate quality and novelty of the Center’s research base sufficient and are the proposed research projects highly relevant to the overall goal of advancing translational research in Parkinson’s disease? Is the physical distribution of Center investigators and core resources conducive to the synergy necessary for a successful Udall Center? Are there appropriate plans for the Center to collaborate and otherwise contribute to the program, through participating in collaborative efforts, the Udall Centers Coordinating Committee, the annual Centers meeting, and other program-wide activities? Is there clear evidence that the Center will advanceresearch in Parkinson’s disease and parkinsonism, through both its scientific projects and  cores?

In addition, reviewers will be asked to evaluate the overarching Significance of the proposed Udall Center for new and competing renewal applications:

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the stated goals of the Udall Center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Reviewers will be asked to consider the following during evaluation of the Center Director:

Will the Udall Center Director provide visionary scientific leadership of the Center? Does the Director have prior project management experience that predicts success of the Center? Does the Director have active NIH funding at the R01 level and beyond? Has the Director made an appropriate time commitment to the Center, including leadership of a project and/or core? Does the Director have demonstrated experience in mentoring of trainees and junior faculty? Does the Director have leadership experience of large-scale, interdisciplinary research programs? If the Director’s primary area of expertise is in an area other than PD research, it is clear that the Director’s skills can be applied in novel ways to the advancement of PD research?   

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? 

During evaluation of the proposed Center applications, reviewers will be asked to consider the level of innovation specifically as related to the state-of-the-art PD research, including the following:  Does the Center take novel approaches to advancing the goals of the Udall Center programs, i.e., advancement of therapies for PD? Are the proposed projects likely to make major rather than incremental advances toward this goal?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Udall Center? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the Center involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?   

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

In addition, reviewers will be asked to consider the following: If the institution houses other large-scale Centers, especially those involving research on PD and related disorders, does the Udall Center add unique expertise and perspective to ongoing research? Is there adequate description of the potential relationship between the proposed Udall Center and the other Center(s) or project(s)? Is there potential overlap between the Udall and other large-scale, PD-related research efforts housed at the institution? If Center investigators are located at more than one institution, are the geographic relationship and planned communication between facilities adequately described? 

Additional Review Criteria - Overall

As applicable for the Udall Center proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Institutional Commitment: Is there evident, strong institutional commitment to the establishment and/or continued growth of the Udall Center? Do the institutional administration and environment provide opportunities for Center growth? Will the institution provide incentives and rewards to promote the mission of team-based research? Is there substantial institutional commitment to tenured faculty positions, dedicated space and other resources, and sufficient time release to allow the investigators to pursue the goals of the Udall Center? If applicable, are there sufficient commitment and support on the part of institutions associated with the Udall Center through consortium agreements? If other large-scale PD projects are housed at the institution, is there sufficient institutional commitment to the Udall Center mission and goals?

Scored Review Criteria for Individual Research Projects

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for each project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance: Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How will the project contribute to the overall success of the program project?

Investigator(s): Are the PD/PIs, collaborators, and other researchers well suited to the project? If in the early stages of independent careers, do they have appropriate experience and training to successfully complete the Aims? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

Reviewers will be asked to assess the following regarding Subproject Directors:  does the Subproject Leader have a productive record of bringing novel and significant projects to fruition as an independent, R01-funded principal investigator?  Will the expertise of the Project leader advance research in Parkinson’s disease? Is the seniority of the Project leader appropriate? Is there evidence of close collaboration among the Project leader and other member of the investigative team? Do Project leaders dedicate sufficient effort to the proposed projects and to Center activities? Do the investigators have appropriate experience to mentor trainees and junior faculty involved in proposed projects and cores?

Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

The following additional criteria will also be considered in determining the scores for the mandatory translational research project but will not receive individual criterion scores:

Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

Review Criteria for Cores

Cores are evaluated and either approved or disapproved rather than receiving numeric scores, and individual criterion scores are not provided. The review criteria for the individual cores are given below.

For the Administrative Core:  Does the Center Administrator have appropriate expertise and provide adequate support for the program? Is the line of communication clear between the Center Director and Administrator? Is the proposed management structure appropriate for scientific administration as well as fiscal administration, procurement, property and personnel management, planning and budgeting? Is there an appropriate plan for establishing and maintaining effective communications and cooperation among Center investigators and with investigators outside the Center? Are there internal and external procedures for monitoring and evaluating the proposed research projects and core facilities/resources? Are there appropriate plans for management and sharing of data, animal models and other resources? Are there appropriate plans for establishing the External Advisory Panel and will this panel contribute to the oversight of Center research projects, and other components? In the absence of a Research Training and Education Core, does the Administrative Core contain the required mission statement for training?   

For Scientific Cores:  Is the scientific core necessary? Does it support at least two research projects? How is the core connected to the central focus of the overall program? How good are the facilities or services provided by the core (including procedures, techniques, and quality control)? Are they being used effectively? Are the core leader and key personnel well-qualified to provide the core service(s)?  Are they committed to operating the core?  If human subjects, vertebrate animals, or biohazards are to be used in a core, the adequacy of these sections will be assessed and will be considered in evaluating the individual core.

For the Clinical Resource Core: Is the Core essential for the support of the proposed clinically oriented translational research project? Does the Core Leader have the appropriate expertise and seniority to direct the proposed clinical Core facility? Will his/her expertise advance research in Parkinson’s disease? Are there appropriate plans for the rigorous management and quality control of any research data or materials to be obtained from human subjects? If included, is the patient cohort well-defined and appropriately diverse? Are plans in place for patient recruitment? Do plans include a patient registry and associated database? Have standard operating procedures been established for collection and storage of biological samples and/or for genotype/phenotype information? Is the 5-year timeline for Core activities included and adequate?

For optional Service Cores:

Training and Education:  Is the training mission of the proposed Center appropriate to the goals of the Udall Center program, i.e., to ensure the future availability of highly trained researchers who will work to reduce the burden of PD?  Are there adequate plans to train students, postdoctoral fellows, and junior faculty within the Udall Center? Does the application provide evidence that the Director, project leaders and core leaders have excellent records in mentoring, including evidence of successful transition of trainees to more advanced research positions? If a training Core is proposed, does the Center have access to a sufficient pool of academically strong trainees, well-qualified mentors and commensurate experience to justify the proposed training activities? Is there an appropriate plan for training of basic research trainees in clinical aspects of PD, and clinical trainees in basic mechanisms of the disease? Is there an adequate plan for providing training in the responsible conduct of research?

Public Outreach and Dissemination: Are there adequate plans, described either in the Administrative Core or a dedicated Outreach Core, for public outreach by the Center? Are there appropriate plans for outreach activities that will contribute to the education and/or direct involvement of patients and patient advocates in the research conducted by the Center? Does planned outreach support the Center’s role as a local and/or national resource for PD? 

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Resubmissions are not permitted in response to this FOA.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Revisions are not permitted in response to this FOA.

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.  

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NINDS , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Neurological Disorders and Stroke (NANDS) Council. The following will be considered in making funding decisions:

Additional NINDS considerations during the selection of Udall Center grant applications include:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Contact with the NINDS program officer at early stages of program planning is strongly recommended.  

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Beth-Anne Sieber, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301- 496-5680
Email: sieberb@ninds.nih.gov

Peer Review Contact(s)

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email: nindsreview@mail.nih.gov

Financial/Grants Management Contact(s)

Tijuanna DeCoster, MPA 
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@ninds.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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