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-11-004

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-NS-12-009

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 improved treatments for Parkinson’s disease (PD). A more immediate goal for each Center is to rapidly advance synergistic basic, translational and clinical research programs while serving as local resources and national leaders in PD research. The overall theme, proposed research projects, and associated 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, with at least one translational research project focusing on the development of therapeutics, diagnostics, devices or clinical criteria that would ultimately lead to new approaches for the treatment of PD; 2) Cores that are essential to accomplish the Aims of proposed research projects, plus an Administrative Core; and 3) a specific plan to provide for training (as a separate Core or within the Administrative Core). 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. 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 decisions will focus on those applications evincing the capacity for innovative contributions to PD research, as well as the potential to contribute new ideas and collaborate effectively across the Centers program. 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 encouraged.

Key Dates
Posted Date

December 16, 2011

Letter of Intent Due Date

January 21, 2012

Application Due Date(s)

February 21, 2012  

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March/April 2012  

Advisory Council Review

May 2012

Earliest Start Date(s)

July 1, 2012

Expiration Date

February 22, 2012

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 500,000 people across the United States, a figure that is expected to increase as our population ages. 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 Arizona who died in 1998 after a long battle with PD. In 2012, this program continues to forge a strong and innovative path in PD research. Udall Centers apply multidisciplinary research approaches 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.

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 improved treatments for PD. Udall Centers advance understanding of PD by pursuing high-impact, integrative research programs while serving as local resources for and national leaders in PD research and treatment development. 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 sharing data and research resources developed through this Centers program.

Basic research has served and will continue to serve as the foundation of discovery in the Udall Centers program.  This FOA solicits applications that will build upon this vital foundation to translate basic and clinical research observations into improved treatments for PD. 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). Research Cores must accelerate the pace of discovery via essential support for the aims of proposed research projects. Hypothesis-driven Aims are not permitted in Cores.

Investigators seeking support for multi-component research projects focused solely on clinical studies or solely on basic neurobiological mechanisms underlying PD should utilize alternative grant mechanisms; such applications will not be accepted in response to 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 decisions will focus on those applications evincing the capacity for innovative contributions to PD research, as well as the potential to contribute new ideas and collaborate effectively across the Centers program.  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/).

NINDS encourages rigorous study design and transparency of reporting for preclinical and clinical studies (see http://grants.nih.gov/grants/guide/notice-files/NOT-NS-11-023.html and related policy at http://www.ninds.nih.gov/funding/transparency_in_reporting_guidance.pdf). There is increasing awareness within and beyond the PD research field that the predictive value of preclinical research is improved when information is made available about study design, execution, analysis and interpretation. Udall Center applicants are strongly encouraged to address these elements directly in their applications. 

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.

Pursuant to the goals of this FOA, translational research includes: 1) preclinical research in model systems that is specifically intended to complete early steps in the pipeline for therapeutic development for PD and/or 2) pre-interventional clinical research designed to support discovery of novel targets for therapeutic interventions or develop outcome measures for future interventional trials.

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

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

1. Preclinical translation

A responsive preclinical translational project using model systems will include early stage therapeutic discovery activities including proof-of-principle for therapeutic efficacy or establishment of assays, technologies or models necessary to advance the PD therapeutic pipeline.  Such studies should move therapeutic strategies supported by high quality proof-of-principle data toward an IND/IDE (Investigational New Drug/Investigational Device Exemption) application. Only those Aims required for therapeutic development can be supported in proposed preclinical 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.

If a proposed lead therapeutic candidate is supported by sufficiently promising and rigorous proof-of-principle data, applicants may propose more extensive translational studies and related therapeutic development as Core activities within the $1.5 million budget cap.

The establishment of institutional infrastructure for therapeutic development activities is beyond the scope of this FOA. It is expected that applicants will leverage existing institutional or collaborative infrastructure for proposed Udall Center preclinical translational projects.

At the end of the budget period, successful projects may transition to funding initiatives sponsored by the NINDS Office of Translational Research or other related NIH funding opportunities. For additional information about translational research opportunities at the NINDS, please see: http://www.ninds.nih.gov/funding/areas/technology_development/index.htm.

Detailed budget justification is required for the proposed preclinical translational project(s) and related core components of the application.

2. Patient-oriented translation

Translational projects involving clinical cohorts are first steps toward transformation of scientific discoveries arising from basic research, clinical research or population studies into new PD treatment modalities. These projects should provide early proof-of-principle for advancement of research results to clinical trials. Observational studies to define disease mechanism, studies designed to assess therapeutic effect of an intervention and basic research using human postmortem tissues are not responsive to this requirement.

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

Consistent with the current scope of the Udall Center mechanism, feasibility studies may 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 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).

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.

Description of Udall Center Components

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

Research Projects

Responsive applications will include a minimum of three interdisciplinary research projects, including at least one translational research project, and a complement of Cores necessary to accomplish the aims of the Center. Patient-oriented translational research projects should be supported by an associated Clinical Resource Core, described below. Pilot projects are excluded from this FOA.  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.

Cores

Udall Centers of Excellence are distinguished from other multi-component research programs by the inclusion of specially designed Research Cores that 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 PD 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. Core concentrations may include, but are not limited to:

Hypothesis-driven aims are not appropriate within Research Cores. Moreover, proposed assays must be clearly described and be generally accepted, standardized methodologies that clearly support the research Aims of associated 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. Functional and funding overlap between proposed Udall core facilities and other pre-existing core facilities at the applicant institution should be avoided.

Resources generated in Cores should be shared within and optimally beyond the Udall Center. Use of Udall Center Cores as the sole source of funding to establish and maintain broad institutional infrastructure, brain banks and other resources of broad interest to the PD research community is not allowed under this FOA.

Clinical Resource Core

A Clinical Resource Core cannot be proposed as a stand-alone entity, and can only be included to support proposed patient-oriented translational research project(s). This Core should not propose research Aims.  Ideally, this Core should collaboratively serve multiple Udall Centers via sharing of resources and data. The primary goals of the Clinical Resource Core may include, but are not limited to, the following:

Subjects who participate in Udall Center 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.

Additional considerations include the following: funds dedicated to this Core must be utilized only to support clinical activities relevant to the Udall Center; the Core cannot be used to collect extensive cohorts, populations or samples that are not utilized within the proposed Center. Plans for any non-Udall research projects or trials that will utilize Core cohorts and/or resources should be detailed within the application. Every effort should be made to serve diverse racial and ethnic populations with this Udall Center core.

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 and sharing with other active Udall Centers containing established clinical components and patient cohorts.

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, description of planned service activities 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 PD/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. All Center trainees should receive instruction the principles of rigorous study design, control of bias, and transparency of reporting. 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 (PD/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 the Director’s skills can be applied in novel ways to the translation of PD research into improved treatments and clinical practice. 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 (R01 level and beyond) and excellent scientific productivity. Core leaders must have appropriate expertise, as well as a record of productivity and collaboration, to ensure success of 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.

Collaborations with NIH Intramural Scientists

NIH intramural researchers may serve as collaborators or consultants on Udall Center projects. Such proposed substantial involvement must be consistent with NIH policy: http://sourcebook.od.nih.gov/ethic-conduct/coop-agr.htm and http://sourcebook.od.nih.gov/ethic-conduct/IRP-ERP-Cover-Memo-10-27-99.htm.  Participation of intramural investigators must be funded by the respective NIH Institute/Center (IC) intramural program; receipt of extramural funds from the Udall Center grant is not permitted. At an early stage in the application process, intramural researchers must provide their Scientific Director copies of formal letters of collaboration, and in turn obtain written approval from the Scientific Director. The Director's letter should be included with the application, and must specify: the amount of intramural resources to be allocated to the project, and that the conduct of the project will comply with the DHHS regulations for research involving human subjects (if applicable) and with the PHS policy on vertebrate animal research (if applicable). All requests for substantial intramural involvement in extramural research activities must also be approved by the Ethics and Grants Management Offices from the respective NIH IC.

According to NIH policy, successfully reviewed applications with substantial intramural involvement will be converted to a cooperative agreement mechanism, with related terms and conditions, prior to award of funds. NIH extramural program staff will also have substantial involvement with the cooperative agreement.

At an early planning stage, Udall Center applicants intending to collaborate with NIH intramural investigators should contact the NINDS program official listed below.

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 program-related guidance and evaluation. Ideally, the scientific expertise of the EAP would complement current projects as well as anticipated future directions of the Center. While annual in-person meetings may not be feasible, it is strongly recommended that Center Directors hold in-person EAP meetings early, mid-way and toward the end of the project period, to obtain timely external assessments of Center progress and recommendations for future direction prior to the competing renewal application. In new applications, a description of proposed EAP activities should be included in the application. However, to avoid negative impact upon the pool of potential peer reviewers, EAP members should not be contacted, named, or selected until an award has been made. For competing renewals, prior activities of the EAP should be described. EAP activities must 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.  The NINDS program officer should be invited to EAP meetings as an observer and resource for NINDS and NIH policies. Regular EAP updates and evaluations are to be included in noncompeting continuation reports.

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 NIH and non-NIH funded 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 means.  The primary institution is strongly encouraged to demonstrate its commitment to the Udall Center by providing necessary infrastructure, financial support to Cores, funding for 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 with other, actively-funded, large-scale PD-related research projects or Centers (e.g. NIEHS Center for Neurodegenerative Science, Parkinson’s Disease Foundation Center, National Parkinson Foundation Center of Excellence Grant, large-scale Michael J. Fox Foundation projects) must detail lack of overlap with those awards, the unique contributions of the Udall Center to the institutional PD research effort, how project interaction will advance PD research, and provide 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 beyond the program.  For example, opportunities may exist for collaboration with the Clinical and Translational Science Awards (CTSA), a consortium of NIH-funded academic health centers (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 fund up to 2 awards, corresponding to a total of $4,500,000, for fiscal year 2012. Future year amounts will depend on annual appropriations.

Award Budget

The maximum allowable direct cost per year is $1,500,000 (exclusive of facilities and administrative costs of subcontracts with collaborating institutions). Requested budgets should reflect actual needs of the proposed Center.

Award Project Period

An award 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

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, 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.

The Program Director/Principal Investigator (PD/PI) 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/Principal Investigator)

Any individual 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.

Multiple PD(s)/PI(s) 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:

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 and the Table of Page Limits must be followed for Face Page, Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells, Detailed Budget for Initial Budget Period, Budget for Entire Proposed Period of Support, Biographical Sketch, Resources, All Personnel Report.

Include a detailed Table of Contents with pagination (numeric only). Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application.  Bearing in mind that the application will be scientifically reviewed project by project and core by core, the Table of Contents should enable reviewers to readily locate specific information pertinent to the overall application as well as to each component research project and core.

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.

For Udall Center applications, page limits are as follows:

Center Overview: 12 pages

Research Projects:

Research and Resource Cores:

Research Plan

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

1. Overview of the Udall Center 

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

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): only those publications supported specifically by the Udall Center should be listed.

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: 

•   All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Udall Centers are expected to comply with specific policies regarding submission of data and materials to the appropriate facility. Plans for submission of data and materials to these facilities should be included within the application. All data obtained with Udall Center funding are expected to be shared immediately with the research community upon publication or upon public disclosure of a submitted patent, whichever occurs earlier, consistent with achieving the goals of the program. At the latest, data are expected to be shared no later than within one year of the completion of the funded project period for the parent award.  Such sharing is expected prior to submission of a competing renewal application in every case.  Continuation awards are contingent upon deposition of all eligible samples and data collected into the appropriate repository or database, within the timeframe specified by that resource and the NINDS. Each Center should also store preclinical and clinical data in an open format that could be easily transported to a central database should such be named.

•   NINDS Human Genetics DNA and Cell Line Repository, Coriell Institute for Medical Research

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.

•   Database of Genotypes and Phenotypes (dbGaP)

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.    

•   NINDS Common Data Elements

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. 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. Meeting planning duties will be shared between the NINDS and the Udall Center Coordinating Committee (UC3). The meeting is designed to provide dedicated time during which Center investigators can discuss emergent issues and approaches in the research and treatment of PD. 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 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. For example, UC3 functions to:

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; respective 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 Non-Governmental Organizations (NGOs). 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 UC3 will hold regular teleconferences, 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 list of research resources as well as 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.

For this particular announcement, note the following:

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. 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 project 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? 

Is there strong evidence that the proposed Center will advance research in Parkinson’s disease and parkinsonism, through both its scientific projects and cores? Will the proposed Center effectively meet the stated goals of the Udall Centers Program? Are there appropriate plans for the Center to collaborate and otherwise contribute to the overall Udall Centers program, through participating in collaborative efforts, the Udall Centers Coordinating Committee, the annual Center Directors' meeting, and other program-wide activities?

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

•   For new applications: Do the stated goals of the proposed Center demonstrate potential for the translation of basic research to clinical practice for Parkinson’s disease? Is there a critical mass of high quality research in PD and parkinsonian disorders in the proposed Center? Have the investigators described what knowledge and resources will be contributed to the Udall Centers Program, and to PD research at the local and national levels? 

•   For renewal applications: Has the Center met previously stated goals and generated high-impact research discoveries? Has the Center remained on the cutting edge of Parkinson’s disease research, and does the Center have the capacity to pursue a strong translational research project moving forward? Has the Center established proven or proposed new collaborations with other Udall Centers?

•   For both new and renewal applications: Do projects directly address the pathology, progression and treatment of PD? Has the Center demonstrated ability (competing renewal) or does the Center have the capacity (new applications) to mobilize local resources and contribute to Parkinson’s disease research at a local and national level? Does the proposed Center demonstrate appropriate organizational and managerial structure to meet Center goals? Is there strong evidence for communication and cooperation among Center investigators?    

Investigator(s)

Are the PD(s)/PI(s), 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, 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:

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? Is the Director an established leader in scientific research with a history of successful funding? 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?

Reviewer considerations for Research Project and Core Leaders are listed under Investigator in "Scored Review Criteria for Individual Research Projects," below.

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 applicant institution houses other large-scale Centers, especially those involving research on PD and related disorders: 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 planned communication and collaboration adequately described?  

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): Is the expertise of the research project leader, collaborators, and other researchers well suited to the project? Does the project lead have a productive record of bringing novel and significant projects to fruition as an independent, R01-funded principle investigator? Does the investigator have current NIH funding? Is sufficient effort dedicated to the research project and Center activities? Does the investigator have appropriate experience to mentor trainees and junior faculty involved in the proposed project?

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 basic or preclinical research, is there evidence of sufficient rigor in terms of experimental design and strategies to minimize bias?

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 essential to advance the scientific aims of one or more proposed research projects? How is the core connected to the central theme of the overall program? How valuable 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)? 

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?

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?

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.

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

Applications from Foreign Organizations are not permitted in response to this FOA.

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 the 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:

Appeals of initial peer review will not be accepted for applications submitted response to this FOA.

Applications will be assigned 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’s 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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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.

Communication with the NINDS program officer (Scientific/Research Contact, below) at early stages of Udall Center 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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