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-12-009

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-NS-13-006

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.853 

Funding Opportunity 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 collaboratively as well as independently 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 inform 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, or clinical criteria that would ultimately lead to new approaches for the treatment of PD; 2) Research 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 of PD researchers. Because basic research serves as the foundation for discovery in the Udall Centers program, NINDS programmatic priorities will focus on applications that propose multidisciplinary programs including a well-integrated basic research project. A considerable degree of synergy must be evident among Center research projects and Cores, such that successful completion of the aims could not be accomplished without 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 to 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 initial stages of program planning is encouraged.

Key Dates
Posted Date

November 23, 2012

Open Date (Earliest Submission Date)

December 23, 2012

Letter of Intent Due Date(s)

December 23, 2012

Application Due Date(s)

January 23, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March 2013

Advisory Council Review

May 2013  

Earliest Start Date

July 2013

Expiration Date

January 24, 2013

Due Dates for E.O. 12372

Not Applicable

**ASSIST – electronic application submission required**

This FOA uses NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. 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 the 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 2013, 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 collaboratively as well as independently 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 research 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

NINDS Udall Center program priorities encourage the submission of innovative research proposals with significant potential for discovery. The overall theme of each Center, proposed research projects, and Cores will inform the etiology, pathogenesis or treatment of PD. At least one translational research project, as defined below, is required within the spectrum of proposed research projects. Additional requirements include an Administrative Core and a mission statement for and description of research training and education. Because basic research serves as the foundation for discovery in the Udall Centers program, programmatic priority will be given to multidisciplinary applications that propose a well-integrated basic research project. 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 (renewals) or considerable potential (new applications) to: contribute unique knowledge and scientific advances to the Udall Centers program;  collaborate effectively with existing Centers; pursue translation of research to clinical practice; and to serve as local resources and national leaders in PD research. In response to this call for specialized Centers, applicants are encouraged to propose an innovative 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.

The NIH specialized Centers mechanism (P50) supports integrative, multidisciplinary activities that are beyond the scope of other NIH single (R01) and multi-component (P01) activities. 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. 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.

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 to 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 active NINDS Udall Centers should be considered and included in the application. The NINDS will consider the full scope of Udall Center programmatic activities when making funding decisions; applications proposing goals identical to or largely overlapping with active Udall Centers will receive lower program priority. The NINDS will prioritize innovative, multidisciplinary applications with a well-integrated basic research project.

The NINDS is dedicated to improving the quality of NINDS-supported preclinical and clinical research through rigorous study design and transparent reporting. There is increasing awareness among the PD and other neurological disease communities that assessment of the predictive value of preclinical research is improved when sufficient information is made available regarding study design, execution, analysis and interpretation of results. Udall Center applicants are strongly encouraged to consider these elements when describing supportive data and to address these issues directly in the design of proposed studies. 

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.

To determine whether a proposed translational research project is responsive to this FOA, applicants are encouraged to contact the program official listed as the Scientific/Research Contact(s) in Section VII, below.

1. Preclinical translation

A responsive preclinical translational project using model systems will include therapeutic discovery activities including proof-of-principle for therapeutic efficacy or establishment of assays or models necessary to advance the PD therapeutic pipeline.  Such studies will provide rigorous proof-of-principle for movement of therapeutic strategies toward an Investigational New Drug (IND) application to the Food and Drug Administration (FDA). 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.

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 initial proof-of-principle for advancement of research results to clinical trials.

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

Studies designed to assess therapeutic effect of an intervention and basic research using human postmortem tissues are not responsive to this requirement. Consistent with the current scope of the Udall Center mechanism, pilot studies may be performed in small numbers of subjects, similar in scope to a Phase 0 (exploratory investigational new drug, eIND) study. While planned exploratory studies may provide information relevant to future clinical trials, proposed research should have limited duration and no therapeutic or diagnostic intent. More advanced clinical studies designed to evaluate the dose, safety and tolerance of 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) and other funding opportunities available through the NINDS Office of Clinical Research.

Data and biospecimens from clinical projects must be deposited and shared via the NINDS Data Management Resource (DMR) described below.

Description of Udall Center Components

Each Udall Center application must include:

1) a minimum of three interdisciplinary research projects, with at least one translational research project focusing on the development of therapeutics, diagnostics, or clinical criteria that would ultimately lead to new approaches for the treatment of PD;
2) Research 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, summarized within the Administrative Core or detailed in a dedicated Training and Education Core.

Because basic research serves as the foundation for discovery in the Udall Centers program, NINDS programmatic priorities will focus on applications that propose multidisciplinary programs including a well-integrated basic research project.

The following sections describe the required and optional components for Udall Center applications.

Center Overview

Each application will include an overview for the proposed Center, which includes overarching goals and program objectives, as well as proven track record and/or the potential for unique contributions to the overall Udall Centers program and to the translation of basic research into therapeutic development and improved clinical practice for PD.

Research Projects

Responsive applications will include a minimum of three interdisciplinary research projects, including at least one translational research project, and a complement of research cores necessary to accomplish the aims of the Center. Patient-oriented translational research projects are supported by an associated Clinical Resource Core, described below. 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 multidisciplinary approach to PD research and 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.

An Administrative Core is required for all Centers. An identified Center Administrator will collaborate closely with the Center Director and dedicate substantial effort to Core activities. 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 preferably more research projects in the proposed Centers. Research Core concentrations may include, but are not limited to:

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 is required to support proposed patient-oriented translational research projects; a clinical core cannot be proposed as a stand-alone entity.  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:

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.

Subjects who participate in Udall Center patient-oriented translational research projects and in the associated Clinical Resource Core 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 in both academia and in industry; (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 any other disorder.

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 extended 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.

·         Service Cores (Optional)

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. Centers are strongly encouraged to include a Research Training and Education Core. At a minimum, each application must include a specific mission statement and description of planned training activities within the Administrative Core section; applications lacking this information will not be considered responsive to this FOA. If proposed, a dedicated Research Training and Education core will 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 primary training goal of the Udall Centers program 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.

·         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 application, whether included as part of the Administrative Core, Clinical Resource Core, or as a stand-alone Core. Planned activities will 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. Where applicable, these activities will be coordinated with the Center’s Clinical Resource Core to recruit, retain and inform the patient cohort.

Udall Center Oversight and Planning

Executive Committee

Each Center will convene an Executive Committee, consisting of the Center Director, Center Administrator and all Project Leaders and Core Leaders. This group will assist the Director with scientific and administrative decisions, and will meet regularly to discuss the development and direction of the program.

External Advisory Committee

Each Udall Center will convene an External Advisory Committee (EAC), composed of at least five outside experts who can provide unbiased programmatic evaluation and scientific input. Directors are encouraged to include committee members from beyond the Udall Centers program Descriptions of Proposed EAC activities, but not proposed members, are to be included in the application (see Section IV). Ideally, the scientific expertise of the EAC would complement current projects as well as anticipated future directions of the Center; changes in EAC membership, which may be necessary during the course of the grant period, should be relayed to the program officer.   While annual in-person meetings may not be feasible, it is strongly recommended that Center Directors hold in-person EAC 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 a competing renewal application. The NINDS program officer will attend EAC meetings as an observer and to serve as a resource for NINDS programmatic questions and NIH policies. Regular EAC updates and evaluations are to be included in noncompeting continuation reports.

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 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 UC3 will hold regular teleconferences, and will meet annually during the Udall Centers meeting. The NINDS program officer should be included as an ex officio participant in all meetings and correspondence.

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 and resource sharing among the Centers. Applications will include budget for travel for the Center Director, Center Administrator, and Project and Core leaders (see Section IV).  

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 shall be included in the Administrative Core as described below. 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 plain 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. The NINDS Udall Centers website provides links to all active Centers.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The NINDS intends to commit $4,500,000 in fiscal year 2013 to fund up to two awards.

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

A 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

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 SF424 (R&R) 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(s)/PI(s)) and component Project Leads that are not yet registered in eRA Commons must work with their institutional officials to register. Also, institutional officials at the applicant organization should ensure that the eRA Commons account for the contact PD/PI is affiliated with their organization.

eRA Commons accounts are necessary to use ASSIST to prepare and submit applications.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 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(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

Udall 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 junior faculty and trainees. 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.

Udall Center Research Project and Core Leaders

Project leaders must demonstrate independent, R01-equivalent funding 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.

Udall Center Administrator

Each Center shall include a Center Administrator. This position will be filled by an expert administrator, not by the Center Director or by Project or Core Leaders. Effort shall 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.

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. Only one Morris K. Udall Center of Excellence may be awarded to any one institution.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (see NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

Applicants will use NIH’s ASSIST system, rather than Grants.gov’s downloadable forms, to prepare and submit applications through Grants.gov to NIH.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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 submitted to this FOA will be made up of a collection of application components. All applications will include an ‘Overall’ component that provides information regarding the application as a whole, as well as a combination of additional component types. Applicants should select the appropriate application component types in ASSIST when preparing applications. Note, eRA Commons accounts are necessary to use ASSIST to prepare and submit applications.

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12

Research Project

12

Administrative Core

6

Core (includes Research Cores, Clinical Resource Core and Service Cores)

6


Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

General Instruction Clarifications for Multi-Project Applications

The following table provides instruction clarification for the information required in the Overall component of a multi-project application versus information required for all other components included in the application.

Form

Overall component

All other components

SF424 (R&R) cover

Complete entire form

Complete only the following fields:

Applicant Information

Type of Applicant (optional)

Descriptive Title of Applicant’s Project

Proposed Project Start/Ending Dates

Project /Performance Site Location(s)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

List all performance sites that are part of the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Budget

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Research & Related Senior/Key Person Profile

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field in the Project Director/Principal Investigator section.

List Senior/Key persons that are working in multiple components in each relevant component.

Include a single 4-page Biographical Sketch for each Senior/Key person covering the entire application regardless of the number of components in which they participate.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Research & Related Other Project Information

Follow standard instructions.

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Optional

PHS 398 Cover Page Supplement

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Enter Human Embryonic Stem Cells in each relevant component.

PHS 398 Research Plan

For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Additional Component-Specific Instructions

Each Udall Center application will include the following components:

Overall Component

When preparing your application in ASSIST, use Component Type ‘Overall’.

R&R Other Project Information

The following information should be loaded as individual files under the "R&R Research & Related Other Project Information" under "Other Attachments."  The filename provided for each attachment will be the name used for the bookmark in the application image.

Table of Research Core Utilization. In order to assist the reviewers in determining the relationship between the Research Cores and the Research Projects, a table should be provided that indicates the percentage use of each core relative to the individual projects. The table should be loaded as a file titled "Table of Research Core Utilization" under the "R&R Research & Related Other Project Information" under "Other Attachments."

PHS398 Research Plan

Research Strategy:

Progress Report Publication List (For RENEWAL applications):

A list of published articles, reviews, and book chapters that acknowledge Udall Center support and were, therefore, a direct result of studies funded in the previous project period should be included in the Progress Report Publication List.

Consortium/Contractual Arrangements: 

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 attachment. When multiple institutional sites are involved, a detailed description of the cooperative administrative arrangements should be included. 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 shall clearly delineate the institutional commitment of the participating organization(s) to the Program. 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.

Letters of Support:

·         Institutional Commitment. Applications shall include letters from a high-level institution official(s) (e.g., Dean of the School of Medicine, Vice President for Research) to confirm institutional commitment to the Udall Centers program. The letter will 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, funding for pilot projects, 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 and other programmatic needs identified as high priority in the application.

Official letters from applicant institutions with other, actively-funded, large-scale PD-related research projects or Centers (e.g. NIEHS Center for Neurodegenerative Science, Parkinson’s Disease Foundation (PDF) Center, National Parkinson Foundation (NPF) Center of Excellence Grant, Department of Defense Neurotoxin Exposure Treatment Parkinson's Research (NETPR) program funding, large-scale Michael J. Fox Foundation (MJFF) 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.

Resource Sharing Plan:

A Resource Sharing Plan should be included, as appropriate, for the overall Center for data-sharing activities that involve multiple projects and/or cores.  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 SF424 (R&R) Application Guide, with the following modification:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Research Project Components

When preparing your application in ASSIST, use Component Type ‘Research Project’.

PHS398 Research Plan

Research Strategy:

Discuss the purpose and nature of the project and its relevance to the Udall Center's overall theme. For new applications and new subprojects in renewal applications, include information on Preliminary Studies.  For continuing projects in renewal applications, provide a Progress Report. 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. Provide supportive rationale for use of specific Core services, including the advantages and cost effectiveness of Core usage for the project.

Translational Research Projects:

When preparing your application in ASSIST, use Component Type ‘Research Project’.

PHS398 Research Plan

Research Strategy:

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. Relationships with and complementary support from biotech, pharmaceutical companies and nongovernmental organizations should be described.

Core Components

All Core Components must provide justification of services provided to specific projects, as well as contribution to overall Center productivity and quality. The description of each Core should clearly indicate the facilities, resources, services, and professional skills that the facility will provide to the proposed Center.

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.

Administrative Core Component

When preparing your application in ASSIST, use Component Type ‘Admin Core’.

Other Project Information Component

Other Attachments. Within the Administrative Core, all applications must include an “Other attachment” with a description of planned training activities that address the goals of the Udall Centers program, i.e. to foster proficiency across the broad spectrum of basic, translational and clinical concepts, as well as develop practical skills, that are necessary for trainees to successfully establish an independent PD research program. If a dedicated Research Training and Education Core is proposed, the following information should still be provided in this attachment: a mission statement and brief overview of planned activities. In the absence of a dedicated core, this attachment should also provide an overview of available infrastructure and resources, as well as ongoing training activities. The qualifications and participation of Udall Center faculty should also be documented in the overall plan.  Renewal applications should detail training milestones achieved in the prior funding period.

PHS398 Research Plan

Research Strategy:

The Administrative Core must effectively coordinate Center components and activities. In the absence of separate Cores, the Administrative Core must also contain details on plans for website development and/or maintenance, data management, and compliance with NIH policies.

A description of proposed EAC activities and related budget should be included in the application. However, to avoid negative impact upon the pool of potential peer reviewers, EAC members should not be contacted, named, or selected until an award has been made. Competing renewal applications will include a description of EAC activities during the prior award period.

The Administrative core must also include plans for constructing and/or updating a website for the timely dissemination of information to members of the research community and the general public. 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 plain 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.

R&R Budget

All EAC-related costs must be included in the proposed budget. The proposed budget for this Core must contain travel for the Center Director, Center Administrator, and Project and Core leaders to the annual meeting. It must also include travel for EAC meetings.

To promote efficient spending, budgeted costs for EAC member travel will be within range of local per diem rates (as per General Services Administration guidance) and follow general NIH guidelines for travel and expense reimbursement rates.

Research Core Components:

When preparing your application in ASSIST, use Component Type ‘Core’.

PHS398 Research Plan

Research Strategy:

Research Cores cannot propose hypothesis-driven aims. Moreover, proposed core assays must be generally accepted, standardized methodologies that clearly support the research aims of associated projects.  Each Research Core should indicate percent use by proposed Research Projects. For renewal applications, if continuation of a previously awarded Core is proposed, major accomplishments during the prior funding period must be described.

Clinical Resource Core Component:

When preparing your application in ASSIST, use Component Type ‘Core’.

PHS398 Research Plan

Research Strategy:

Applicants will provide a timeline of Core activities planned within the 5 years of Udall Center funding, and describe any potential plans beyond this period of support.

Udall Center clinical research cores will be required to include NINDS Common Data Elements (CDEs) as described below.

Applicants should confirm that the consent forms for funded projects specifically address the following: (1) disclosure that biological materials and clinical data  may be distributed to other researchers in both academia and in industry; (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 any other disorder.

Research Training and Education Core (Optional):

When preparing your application in ASSIST, use Component Type ‘Core’.

PHS398 Research Plan

Research Strategy:

If proposed, a dedicated Research Training and Education core will 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.

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 on 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. In addition, the Core may be utilized for the training of clinical research coordinators and program managers as appropriate to the goals of the Center.

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 roles of Udall Center faculty within these Core activities should be defined; optimally, all investigators will participate actively in these cross-training efforts.

R&R Budget

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.   Proof of institutional support for these efforts should be included.

Public Outreach and Dissemination Core (Optional):

When preparing your application in ASSIST, use Component Type ‘Core’.

PHS398 Research Plan

Research Strategy:

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. Evidence of service to the local community should be documented. Where applicable, these activities will be coordinated with the Center’s Clinical Resource Core to recruit, retain and inform the patient cohort.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the deadline in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

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 submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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.

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. Information is available through PA-12-100, Administrative Supplements to Existing NIH Grants and Cooperative Agreements.

Collaborations with NIH Intramural Scientists

NIH intramural researchers may serve as collaborators or consultants on Udall Center projects.

During the application process, intramural researchers must provide their Scientific Director with copies of formal letters of collaboration, and in turn obtain written approval from the Scientific Director for inclusion within the Udall Center application. 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 Institute or Center (IC).

If selected, appropriate funding will be provided by the NIH Intramural Program.  Budget requests by NIH intramural scientists will be limited to the incremental costs required for participation.   As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs).  These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses.  Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights. 

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 in the Scientific/Program Contact(s).

Biospecimens

Biospecimens must be collected under protocols of the Parkinson Progression Markers Initiative (PPMI). If site logistics are challenging regarding the PPMI protocols, then the Alzheimer’s Disease Neuroimaging Initiative (ADNI) protocols could be used as an alternative, as long as they are justified.

Biospecimens collected could include whole blood, plasma, serum, cerebrospinal fluid (CSF). Fibroblasts may be appropriate for special populations, such as those with known genetic variants causal for disease; collection of these or other biospecimens must be justified in the application and will require programmatic approval.

Consent forms (submitted as appendix material) must make it clear that any biological samples and de-identified clinical data will be shared with academics or industry and must be consistent with the NINDS Repository and NINDS PDBP Data Management Resource (DMR) consent requirements (see https://ccr.coriell.org/Sections/Collections/NINDS/InvestigatorFAQ.aspx?PgId=150&coll=ND). A copy of the consent form for each subject should be kept on file by the investigator but does not need to be sent with each sample. 

Newly collected samples must be submitted to the NINDS repository within 24 hours of each subject visit. Existing sample collections may be submitted to the repository if specific conditions for NINDS approval are met. In general, the following volumes must be submitted to the NINDS Repository for each sample type for each visit submission in order to be considered acceptable and counted towards the deliverables for each project:

All fibroblasts must be sent as skin biopsies directly to the NINDS Repository; please contact the NINDS program officer (listed under Scientific/Research Contacts, below) if you plan to submit this type of material.  Previously established fibroblast lines will not be accepted except under special circumstances, requiring NINDS approval.  All biospecimens submitted must be accompanied by a full set of clinical common data elements (CDEs) as defined below.

NINDS Common Data Elements (CDEs)

In order to maximize data standardization across studies, the NINDS strongly encourages researchers to use the NINDS Common Data Elements.  The NINDS PDBP DMR, referenced below, will develop web-based forms to assure ease of data entry and quality assurance. Some of these assessments may be self-administered in order to reduce subject and study burden. Udall Center clinical research projects and cores will be required to include the following General and PD-specific CDEs:

General CDEsAll “core” General CDE items and forms will be required in the following domains for all subjects:

PD-Specific CDEs

All “core” and the following “recommended” items and forms will be required in the domains listed below, both for PD subjects and for those at risk for PD (i.e., pre-symptomatic, gene carriers, etc.).  Items that are duplicative of those in the General CDEs need not be collected twice.

In addition to the above, Udall applicants may employ supplementary assessment and measurement tools if relevant to addressing the specific hypotheses proposed in their application.  If other tools are proposed, applicants are strongly encouraged to use those suggested or provided by the NINDS CDE program

Data Management and Storage

Udall Centers will use the NINDS Data Management Resource (DMR), recently established for the NINDS Parkinson's Disease Biomarkers Program (PDBP), to store biospecimen-related and clinical data collected for Center projects and cores. The PDBP DMR will provide an essential data coordination tool for the entire PD research community through the development of a web-based data management system that provides tools to NINDS-supported projects for both the collection and quality assurance of data in a standardized format.  The DMR will also coordinate the assembly of de-identified data into a common database thus enabling the query and distribution of aggregate data for the acceleration of PD research.  For NINDS Udall Center projects, patient consent must allow broad sharing of de-identified data and biospecimen resources though the PDBP DMR and the NINDS Human Genetics DNA and Cell Line Repository at the Coriell Institute for Medical Research ("NINDS Repository"), respectively.

Activities that are the sole purview of the DMR include: 1) development of standardized electronic data forms, data formats and software for use across multiple cohorts and projects; 2) development of software to support subject scheduling, site tracking, and facilitation and coordination of de-identified clinical and biospecimen data collection across multiple new and existing cohorts and projects through an easy to use web-based entry system for submitters; 3)  quality assurance checks of data entry and collection; 4) development of a user-friendly query system for users to evaluate availability of data and biospecimens within and across Udall Centers; 5) development of aggregate data report formats that are user-friendly and supported by well documented data dictionaries;  6) training for both data submitters and data users; 7) coordination of data and biospecimen summary reports and postings in collaboration with the NINDS Repository; and 8) public outreach for data submission and data use.  Development of all electronic data entry forms and quality assurance checks of de-identified data will be done by the DMR. Within the appropriate Core(s), Center applications will identify key personnel whose responsibility will be to ensure and facilitate data quality, transfer, sharing, and biological specimen submission to the DMR and NINDS Repository, respectively. For those with existing studies already utilizing a data management core or resource, successful implementation of a de-identified data transfer plan from the study site to the DMR will be required as a first year milestone. Quarterly deposition of all de-identified clinical data into the PDBP DMR is a requirement of the Udall Centers program.

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.

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 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 therapeutic development and/or 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 been productive and generated high-impact research discoveries during the prior funding period? Has the Center remained on the cutting edge of PD 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 have the potential to inform the pathology, progression and treatment of PD? Has the Center demonstrated ability (competing renewal applications) 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? Does the application include a well-conceived mission statement and overview for research training? Does the application include protocols for biospecimen and clinical data collection? Are appropriate plans provided for data and biospecimen sharing among the Udall Centers? 

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 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 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? 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?

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 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?

Does the application describe use of the NINDS Common Data Elements (CDEs) for collection of clinical data? 

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 consider the following:

If the applicant institution houses other large-scale Centers or multi-project efforts, 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?

Does the application include a statement of institutional commitment to the Udall Centers program, and a confirmatory letter from a high-level institutional official? Is there reasonable evidence that the institution will provide support for the Center, e.g. recruitment of scientific talent, provision of discretionary resources to the Udall Center Director, assignment of specialized research space, cost sharing of resources, funding for pilot projects, and/or by other means?

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 Udall Center?

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 principal investigator? If the investigator does not have current NIH funding, does (s)he have active, independent funding that is the equivalent of an NIH R01? 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 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(s):

Preclinical Translational Research Projects: Does the model-based translational project propose proof-of-principle for therapeutic efficacy or establishment of assays or models necessary to advance the PD therapeutic research pipeline? Does the project exclude basic research on disease mechanism? Is it likely that completion of the stated translational research objectives will assist with translation of basic observations into one (or more) therapeutic, diagnostic, or intervention for PD? Is there a plan to transition projects to funding mechanisms available through the NINDS Office of Translational Research initiatives or other related NIH programs?

Patient-oriented Translational Research Projects: Does the proposed clinical translational project have the potential to lead to the development of a new therapy, diagnostic, or intervention? Is the project rationale based upon a sufficiently rigorous body of high quality preclinical or clinical research?  Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well-reasoned, and appropriate to the aims of the project? Does the project challenge existing paradigms or clinical standards, address an innovative hypothesis or critical barrier to progress in the field? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Will biospecimen collection adhere to protocols of the NINDS PD Biomarkers Program (PDBP)? Will clinical data be collected using the NINDS Common Data Elements (CDEs)?    

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?   

Scored Review Criteria for Cores

Reviewers will provide overall numeric scores; individual criterion scores are not provided. The review criteria for the individual cores are given below.

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 Committee and will the EAC 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 and brief overview for training?  

Research 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.

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 transmission of data to the designated NINDS Data Management Resource (DMR)? Have standard operating procedures been established for collection and storage of biological samples and/or for genotype/phenotype information? Will biospecimen collection follow protocols of the NINDS PD Biomarkers Program (PDBP)? Will clinical data be collected using the NINDS Common Data Elements (CDEs)? Is the 5-year timeline for Core activities included and adequate?

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, junior faculty and other experts, including clinical research coordinators and research program managers as appropriate, 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? 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: If proposed, are there adequate plans, described either in the Administrative Core, Clinical 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 project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact 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 Center 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

Not Applicable

Renewals

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

Revisions

Not Applicable

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 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. Assignment to a Scientific Review Group 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 in response to this FOA.

Applications will be assigned to the NINDS. Applications 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:

The NINDS will consider the full scope of Udall Center programmatic activities when making funding decisions; applications proposing goals identical to or largely overlapping with active Udall Centers will receive lower program priority. The NINDS will prioritize innovative, multidisciplinary applications with a well-integrated basic research project. In addition, based on initial peer review as well as upon subsequent considerations of the National Advisory Neurological Disorders and Stroke (NANDS) Council, the NINDS may remove poorly scored projects from otherwise successful applications prior to funding.

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, SAM 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 annual non-competing progress report (PHS 2590 or RPRR) and financial statements, as required in the NIH Grants Policy Statement. Regular EAC updates and evaluations are to be included in noncompeting continuation reports.

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.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

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)

Birgit Neuhuber, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-3562
Email: neuhuber@ninds.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.


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