Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (

Components of Participating Organizations
National Institute of Neurological Disorders and Stroke (NINDS), (

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

Announcement Type


Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number:  RFA-NS-10-001

Catalog of Federal Domestic Assistance Number(s)

Key Dates
Release Date: October 6, 2009
Letters of Intent Receipt Date: November 10, 2009
Application Receipt Date:  December 10, 2009
Peer Review Date(s): March/April 2010
Council Review Date(s): May 2010
Earliest Anticipated Start Date: July 1, 2010
Expiration Date:  December 11, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
   D.  Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives


Parkinson’s disease (PD) is a chronic, progressive movement disorder that affects the lives of at least one million patients across the United States. The average onset of characteristic motor symptoms, which are initially subtle and impact purposeful movement, occurs in the sixth decade. 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 developed in honor of former Congressman Morris K. Udall of Utah. Diagnosed with PD in 1979, Representative Udall remained active in Congress until his retirement in May 1991. He died in 1998 after a long battle with the disease.  On November 13, 1997, the President of the United States signed the Morris K. Udall Parkinson’s Disease Research Act of 1997 into law (P.L. 105-78). In 2009, there are fourteen active Udall Centers across the United States. Udall Centers utilize a multidisciplinary research approach to elucidate the fundamental causes of PD as well as to improve the diagnosis and treatment of patients with Parkinson’s and related neurodegenerative disorders (  

After more than 10 years, the Morris K. Udall Centers of Excellence Program continues to forge a strong and innovative path in PD research. These Centers carry out important research on PD, including the identification and characterization of candidate and disease-associated genes, examination of neurobiological and neuropathological mechanisms underlying PD, establishment of improved PD models, development and testing of potential therapeutics, and novel avenues of clinical research. The complex research problems pursued at each Center are best addressed by a collaborative and multidisciplinary approach, wherein the integration of talent and effort leads to the most rapid advances in PD research and treatment.

The NINDS recently requested an independent evaluation of the Centers, which included a related series of recommendations from a working group of the National Advisory Neurological Disorders and Stroke (NANDS) Council. The working group identified both a number of clear strengths as well as areas for increased emphasis, including improved coordination and cooperation between existing Centers, and enabling infrastructure designed to optimize a flexible approach to pursue unexpected scientific avenues and the rapid translation of basic, translational and clinical research into clinical practice. 

At this critical juncture for PD research and in the evolution of the Udall Centers program, this FOA solicits applications with concentration in an identified area of need: the translation of basic and clinical research into clinical practice. While basic research has served and will continue to serve as the foundation of discovery, each proposed Center must include at least one, early stage pre-clinical and/or clinical translational project designed to bridge the gap between research and treatment. Inclusion of an integrated clinical component, including a clinical translational research project plus a clinical resource core, is encouraged. Proposed studies must be feasible within the budget limits described elsewhere in this FOA.


The ultimate goal of the NINDS Udall Centers of Excellence program is to establish a network of Centers that work independently as well as collaboratively to define the causes of and discover a cure for PD. A more immediate goal for the Centers is to further our understanding of PD by pursuing unique, high-impact, integrative research programs, as well as to serve as local and/or national resources for PD research and treatment.

The overall theme of each Center, proposed research projects, and scientific and/or clinical cores should relate directly to the etiology, pathogenesis or treatment of 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 Disease (LBD), Multiple System Atrophy (MSA), and Progressive Supranuclear Palsy (PSP). 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 rapidly advance PD research towards improved treatment.

Applicants should examine the network of existing Udall Centers and identify the unique contributions of the proposed Center toward advancing the stated goals of the program. Preference will be given to those applications that demonstrate the capacity for unique and innovative contributions to PD research, as well as potential to collaborate effectively across Centers. Although new Centers are not expected to have pre-existing collaborations with established Centers, potential areas of shared interest with existing Centers should be considered and identified (see      

Responsive applications will demonstrate proven ability or considerable potential to pursue rapid translation of research to clinical practice; contribute unique knowledge and scientific advances to the Udall Centers program; collaborate effectively with existing Centers; and serve as local and/or national resources for PD research. In response to this call for specialized Centers, applicants must propose a high-impact spectrum of research activities using an integrated, multidisciplinary approach to understand PD. Resource-related Cores must accelerate the pace of discovery: each proposed Core must be essential to conduct and complete proposed research projects. Investigators seeking support for other multi-component research projects, including those focused on basic neurobiological mechanisms underlying PD, should utilize alternative grant mechanisms; such applications will not be accepted under this FOA.

Scope of Research

The overall theme of the Center, proposed research projects and resource-related Cores must relate directly to the etiology, pathogenesis or treatment of PD.  Proposed Centers must include at least one pre-clinical and/or clinical translational project, defined below, and an Administrative Core; beyond this, the components of each Center should be designed to optimize the accomplishment of Center and the Udall program goals. Topics of investigation within a Center might include, but are not limited to, the following examples of basic and translational research on PD.

1.     Basic research

Basic research projects are those investigations in model systems designed to elucidate disease mechanisms, and should be directed toward identification of optimal therapeutic intervention points for PD. While serving as the basis for discovery, this research should be informed and refined by the results of well-designed clinical studies on PD. Examples of basic research projects include, but are not limited to, the following:

2.     Translational research

In general, translational research is the process of applying 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. Both pre-clinical and clinical translational research projects, defined below, are responsive to this FOA. As translational research is intrinsically interdisciplinary, these projects will involve cooperation among basic researchers and clinicians, and may include the participation of private-sector companies and voluntary organizations. Such relationships should be detailed. Applicants must describe the expected clinical or public health impact of the translational projects, and provide potential avenues by which these projects would be brought effectively to clinical practice.

2a. Pre-clinical Translational Research: Pre-clinical translational research is herein defined as  pre-IND/IDE (Investigational New Drug/Investigational Device Exemption) stage research in model systems that is specifically intended to complete preliminary steps in the pipeline for therapeutic development for PD. Responsive projects will develop tools and generate proof-of-principle. Only Aims required for therapy development can be supported in Udall Center pre-clinical translational projects: this definition excludes basic research on studies of disease mechanism. Responsive studies may include the following:   

Such projects, if successful, should lead directly to a subsequent project that will include all remaining activities for submission of an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to the Food and Drug Administration (FDA). A well-structured pre-clinical translational subproject will include proof of principle on efficacy, so that the project will be eligible for transition to Cooperative Agreement funding in the NINDS Translational Research Program at the end of the Udall budget period; for further information, see

2b. Clinical Translational Research: Clinical translational projects are early-stage studies that represent first steps toward transformation of scientific discoveries arising from basic research, clinical research or population studies into new modalities for the prevention, treatment and cure of PD. Clinical translational projects must advance beyond observational studies to define disease mechanism and include manipulations or interventions designed to provide early proof-of-principle for advancement of research results to clinical trials.  

While not intended to assess therapeutic effect, these small-scale projects should be designed to inform subsequent studies, including early phase clinical trials, and provide evidence for the early-stage validation of prior research findings. Areas of investigation may include, but are not limited to, the following examples:

Considering the current scope of the Udall Center mechanism, clinical translational studies should be performed in small numbers of subjects, along the lines of a Phase 0 or Phase I clinical trial. More advanced clinical studies designed to evaluate therapeutic interventions for the treatment of PD or to optimize data for clinical trials are currently beyond the scope of this Udall Center announcement. Interested applicants should instead consult the announcement: Preliminary Investigations Leading To Optimal Trials In Neurology (R01;  and other funding opportunities available through the NINDS Office of Clinical Research (

In order to insure that the proposed clinical translational project is responsive to this FOA, applicants are strongly encouraged to contact the program official listed below. To increase the impact of a clinical translational project, applicants are also strongly encouraged to strengthen their proposed investigation through collaboration with other active Udall Centers containing established clinical components and patient cohorts.

Budget Limits

NINDS policy for Udall Centers establishes the following limits to requested budgets: new or competing renewal applications may request maximum annual direct costs of $1,000,000; a requested budget of $1,500,000 is permitted with inclusion of a clinical component, including a clinical translational research project and a clinical resource core. As the clinical component encompasses both projects and a core, related budget requests must be presented and justified. Cost of living is included in the direct costs cap. Applications may not exceed this cap in any one year. Any Udall Center application may be submitted for up to 5 years of funding.

Description of Udall Center Components

Research Projects

The proposed Center must include at least one pre-clinical and/or clinical translational research project, as defined above. Applications should include two or more interdisciplinary research projects, each similar in scope and budget to a small R01, and a complement of Cores necessary to accomplish proposed research. If only two research projects are included, applicants must provide additional justification as to how the proposed combination of projects and cores constitute a multidisciplinary Center of Excellence. Pilot projects should not be proposed within new or renewal applications. 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.

Resource-related Cores

Udall Centers of Excellence are distinguished from other multi-component research projects by the inclusion of specially designed, resource-related Cores that accelerate the collective research goals of each Center. Proposed Cores therefore must be integral to the theme of the Center and of common utility, such that the resources provided will be utilized by one or more research projects in the proposed Centers. An Administrative Core is required for all Centers. Applicants must propose additional Cores that provide specialized support to advance the Aims of the Center. Cores should not include general resources that could be provided at an institutional level, nor should cores replace or centralize resources supported by individual projects. Udall Centers may, as needed, budget for use of institutional facilities (e.g. fees for shared equipment usage) or personnel (e.g. partial effort for technical assistance) within Cores. However, there should be no functional overlap between proposed Udall core facilities and other pre-existing core facilities at the applicant institution.

Proposed Cores must be essential to accomplishing the stated Aims of each Center. Core concentrations may include, but are not limited to:

Establishment and maintenance of brain banks and other resources of broad interest to the PD research community are not supported by this FOA; funding for such efforts should be pursued via the Resource-related Research Project-Cooperative Agreement (U24) mechanism:

Administrative Core:

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

Clinical Component

Applicants may request up to $1,500,000 (direct costs, per year) for Centers including a clinical translational research project plus an associated Clinical Resource Core. Detailed budget justification is required for all clinically-related components of the application. Examples of responsive research projects are listed in “Scope of Research” section, above. Clinical translational projects must be clearly related to other projects in the Center. Clinical Research Cores must be well-integrated with one or more Center research projects, and must be clearly defined for purposes of responsiveness to this FOA; further information is available below. When possible, applicants at research institutions are encouraged to establish strong relationships with neighboring clinical centers in order to advance translation of research projects to clinical practice. Data from clinical projects must be deposited and shared via the Parkinson’s Disease Data and Organizing Center (PD-DOC; and/or another database(s) to be named by the NINDS.

For the purposes of the Udall Centers Program, clinical research components may include patient-oriented research. Clinical translational research is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator directly interacts with human subjects. Studies are not considered clinical translational research if they involve only human specimens without information identifying the subjects.

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

Clinical Resource Core:

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

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

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

Research Training and Education:

The NINDS envisions that the Udall Center program will play a major role in training the next generation of PD researchers, ensuring that a diverse pool of highly trained scientists will be available to make future research advances that will reduce the burden of PD. Therefore, proposed Centers must provide an optimal environment for trainees and junior faculty to acquire research skills and experience in interdisciplinary PD research. Centers are strongly encouraged to include a Research Training and Education Core.

At a minimum, each application must include a specific mission statement for training. This mission must include a coherent, comprehensive training plan for all students, postdoctoral fellows, and junior faculty participating in Center activities. Center applications should include a detailed plan for recruitment and advancement of trainees and junior faculty. The Center PI, project leaders, and core leaders must have an excellent record in the successful mentoring of researchers; this must be documented within the overall plan. The training goal of the Center is to foster proficiency across the broad spectrum of basic, translational and clinical concepts, as well as practical skills, that are necessary to successfully establish an independent PD research program. Proof of institutional support for these efforts should be included.

A mechanism must be described through which non-clinician scientists will gain understanding of and exposure to the clinical aspects of PD research, such that basic research is approached as it relates to the clinical manifestation of the disease. Conversely, clinician scientists must have exposure to and training in the basic science that contributes to discovery of disease mechanisms and therapeutic targets. Centers should also train medical residents in the skills necessary to eventually obtain an NIH career development award, including the collection of preliminary data, grant writing skills, and an understanding of the neurobiological mechanisms underlying PD. Training activities might include didactics, regular attendance at grand rounds, a targeted seminar series, regularly scheduled meetings, 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 an innovative program to facilitate continuous interaction and promote comprehensive discussion among Center researchers, trainees and junior faculty. Related activities might include regular meetings among basic, clinical and translational participants, invitation of outside speakers to address defined topics, and annual conferences with poster and platform presentations.  The Core could also serve as a local resource via the inclusion of PD trainees and researchers from neighboring departments and/or institutions in Core activities. The roles of Udall Center faculty within these Core activities should be defined; optimally, all investigators will participate actively in these cross-training efforts. The proposed Core budget should not request funds for trainee or junior faculty slots; these positions should be budgeted as needed within the research projects and resource-related cores.  

Public Outreach and Dissemination:

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

Udall Investigators: Qualifications and Effort

Center Director

The Udall Center Director (PI) must be an established leader in scientific research with a history of successful NIH funding and proven expertise in research project and personnel management. Other qualifying factors include current research funding and productivity, capacity for visionary leadership of a multidisciplinary team, and demonstrated experience in mentoring of trainees and junior faculty. Expertise in areas beyond Parkinson’s disease research is appropriate if it is clear that the Director’s skills can be applied in novel ways to the translation of Parkinson’s disease research into clinical practice. Center Directors must also lead a project and/or core within the Center. Anticipated duties and responsibilities of the Center Director should be clearly defined and a substantial commitment of effort proposed.

Research Project and Core Leaders

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

Center Administrator

As recommended by the Udall Center Program Evaluation Working Group of the National Advisory Neurological Disorders and Stroke (NANDS) Council, each Center should include a Center Administrator ( This position must be filled by an expert administrator, not the Center Director or Project and Core Leaders, and will be included within the budget. The Administrator must have expertise in grants management and business practices, and must demonstrate proficiency in the coordination of large research projects. In addition to oversight of Center administration, duties will include collection of standardized data, including information on research discoveries, publications, funding sources, outreach and education efforts, and training outcomes, as well as information required in the annual progress report. All Center Administrators will be required to attend the annual meeting in order to discuss areas of common interests and share best practices. Travel costs should be included within the budget.

Other Center Components

Executive Committee

Each Center should contain an Executive Committee, consisting of the Center Director, Center Administrator and all subproject and core investigators. This group will assist the Director with scientific and administrative decisions, and should meet regularly. This committee must meet annually with the External Advisory Panel regarding the development and direction of the program.

External Advisory Panel

Each Udall Center must have an External Advisory Panel (EAP), composed of at least five outside experts who can provide unbiased evaluation of the program. Ideally, the scientific expertise of the EAP would complement current projects as well as anticipated future directions of the Center. The EAP will meet annually to review and provide guidance to the Center investigators. A description of proposed EAP activities should be included in the application. However, to avoid impacting the pool of potential peer reviewers, EAP members should not be contacted, named, or selected until an award has been made. EAP activities should be included in the proposed budget. An annual EAP evaluation, including recommendations, is to be included in each noncompeting continuation report.

Institutional Commitment 

Each Center application must include a statement that addresses how the institutional commitment will be established and sustained, how the institution will maintain accountability for promoting scientific excellence, and how the Udall Center research effort will receive high priority within the institution (relative to other research efforts and non-NIH supported programs).  The institutional commitment may be in the form of support for recruitment of scientific talent, provision of discretionary resources to the Udall Center Director, assignment of specialized research space, cost sharing of resources, and/or other ways proposed by the applicant institution.  The primary institution is strongly encouraged to demonstrate its commitment to the Udall Center by providing financial support to the support of Cores, pilot projects, and other programmatic needs identified as high priority in the application. Letters from a high-level institution official(s) (e.g., Dean of the School of Medicine, Vice President for Research) should be attached confirming this commitment.  If the proposed Center involves a consortium arrangement between two or more institutions, the institution that submits the P50 application must receive a formal written agreement(s) from the other participant organization(s).  This agreement should clearly delineate the institutional commitment of the participating organization(s) (in the ways outlined above) to the Program.

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

Opportunities for Partnership

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

Udall Centers are also encouraged to leverage additional partnership opportunities, both within and outside of the NIH, to further program goals.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the NIH Specialized Centers (P50) award mechanism, which is designed to support a high-impact spectrum of basic, translational and clinical research activities using an integrated, multidisciplinary approach to improve understanding of and treatment for Parkinson’s disease. Moreover, the pace of discovery in a Center is accelerated by integral Resource Cores that are essential to support advancement of one or more of the proposed research projects. Investigators seeking funding for other multi-project research proposals focused on a common research theme, including basic neurobiological mechanisms underlying neurological disorders, should utilize other multiple-investigator grant mechanisms; such applications will not be accepted under this FOA.    

The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see 

2. Funds Available

The estimated amount of funds available for support of 4 projects awarded as a result of this announcement is $9,000,000 for fiscal year 2010. Future year amounts will depend on annual appropriations.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

NIH grants policies as described in the NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided they are scientifically distinct. Only one Udall Center may be awarded to any one institution.

Resubmissions.  Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are permitted to compete with new applications in response to this FOA.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email:

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: November 10, 2009
Application Receipt Date: December 10, 2009
Peer Review Date(s): March/April 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 1, 2010

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

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

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3201
Bethesda, MD 20892-9529
Telephone:  (301) 496-9223

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at:

4. Intergovernmental Review

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. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement

6. Other Submission Requirements

Special Requirements

Annual Udall Center Director Meetings

Annual meetings of Udall Center Directors are held each autumn; hosting duties rotate among active Centers. Meeting planning duties will be shared among the NINDS, the host Director, and the Udall Center Coordinating Committee. The meeting is designed to provide an optimal environment in which participants, including junior investigators, can discuss emergent issues and approaches in the research and treatment of Parkinson’s disease. Participants from relevant NIH Institutes, Government Agencies and Non-Governmental Organizations are also invited to attend. By providing a focused and interactive Agenda, the annual Meeting fosters the initiation and maintenance of collaborative efforts among the Centers. Applications should budget for travel for the Center Director, Center Administrator, and other select staff to the annual meeting. Attendance by young investigators is particularly encouraged.

 Udall Center Coordinating Committee (UCCC)

In response to a major recommendation from the 2007 Udall Centers evaluation (see ), Center Directors will convene the Udall Center Coordinating Committee (UCCC) to promote collaboration and strengthen cooperation among the Centers. The UCCC function is to:

The Chair’s Center grant must be actively funded during his or her term of service. The UCCC Executive Committee will consist of past, current and rising Chairs, for a total of three years of service per Chair. Each Center Director will be expected to serve on the UCCC for the duration of funding of her/his Center. The UCCC will also include: three unaffiliated members with expertise in both research on neurodegenerative disorders and experience in running successful multidisciplinary programs in related areas, plus two representatives from the patient community and Non-Governmental Organizations (NGOs) to provide input and a broader perspective. Terms of service for these members will be two years. The NINDS program officer should be included as an ex officio participant in all meetings and correspondence.

Funds for yearly activities of the UCCC will be provided via an administrative supplement from the NINDS to the hosting Center. The UCCC should schedule quarterly phone conferences, and will meet annually just prior the annual Udall Centers meeting. Minutes from the meetings will be made available to the Udall Centers and to the NINDS via a shared website. 

The UCCC will provide annual written reports to the National Advisory Neurological Disorders and Stroke Council (NANDS). These reports should be 5-10 pages in length, and forwarded to the NINDS Committee Management Officer ( one month in advance of the May Council meeting; for the NANDS meeting schedule, see

Center Website

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

Pre-application Procedures

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

The NINDS program officer will be available for pre-application telephone conferences in advance of the submission date.

New Applications

New applications should detail how the proposed Center will advance the goals of the Udall Centers program. The potential for unique contributions of the Center to the overall Udall Centers Program and to the translation of basic research into clinical practice should be described. Although it is not expected that new Centers would have pre-existing collaborations with established Centers, areas of shared interest and potential collaborations with existing Centers should be considered and identified (see      

Renewals (Competing Continuations)

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

Noncompeting Renewal Applications (Progress Reports)

In response to the 2007 evaluation by the Udall Center Program Evaluation Working Group of the National Advisory Neurological Disorders and Stroke (NANDS) Council, Centers should include the following information in noncompeting renewal applications:

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, 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.

Recognizing that the established Udall Centers are poised to swiftly pursue new research opportunities, and in response to a recommendation from the recent Udall Centers evaluation, it is highly likely that the NINDS will implement future supplement programs for pilot and collaborative projects. Separate funding for pilot projects should not be included within new or renewal applications.

Research Plan Page Limitations

As a part of the Enhancing Peer Review initiative, the NIH will soon implement reduced Research Plan page limits on all grant applications ( In anticipation of this change, submission of Udall Center applications will now be subject to revised page limits, as described below.  Within this format, applicants must insure that the project reads as a cohesive whole, rather than a collection of projects, and is accessible to a broad, general audience.

Information for the Overall Center

In addition to the PHS 398 instructions, applicants should follow the following guidelines and page limits:

Introduction to the Overall Center (not to exceed 12 pages)

The Introduction should include the following components: Center Overview and Statement of Objectives; Feasibility and Preliminary Findings (new applications) or Progress Report for previous funding period (renewal applications); Operational Plan for the entire Center.

Center Overview and Statement of Objectives (2 pages)

The overview should be directed to a broad audience, limited to 2 pages, and include a vision statement for the Center, including overarching goals to be achieved. This section should also justify the strengths of the interdisciplinary approach and the use of the specialized Center mechanism to achieve stated goals.

New Applications: Feasibility and Preliminary Findings (not to exceed 6 pages): 

This section should include evidence for feasibility and preliminary findings.  This section should also present compelling evidence that the assembled research team has been/will be able to work together effectively to accomplish the research proposed in the projects.

Renewal Applications: Progress Report for Previous Funding Period (not to exceed 6 pages)

This section is required only for competitive renewal applications from established Centers, and should describe the overall accomplishments of the Udall Center during the last funding period. Applicants should include a discussion of the leadership that the Center has exerted in PD research; a brief synopsis of the goals and accomplishments of projects from the last funding period, including the overall scientific/clinical merit and impact of those projects and of the Udall Center as a whole; the synergy the Center has fostered among the participating investigators; establishment of new collaborations; the effectiveness of the core resources and facilities. Also include a listing of published and in press original articles, reviews, and book chapters that acknowledge Udall Center support and were, therefore, a direct result of studies funded in the previous project period (this listing does not count against the section page limit). Detailed descriptions of the progress of any projects that are proposed for competitive renewal should be included with the appropriate project section and not included in this section.

Operational Plan for the Overall Center (not to exceed 6 pages): 

This section should describe the working administrative and logistical arrangements, as well as the resource support necessary to implement the research.  When multiple institutional sites are involved, a detailed description of the cooperative administrative arrangements should be included (documentation of these arrangements should be included in the “Letters of Support” section).  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 (and reallocated, as necessary) to meet those goals. It is anticipated that the success of a Udall Center will require considerable scientific and managerial oversight by the Center Director. Cost sharing or institutional support, if any, should be described in this section.

The plan should also include an illustrative representation of the planned interactions between proposed Projects and Cores, as well as an overall timeline for 5 years of study provided with Udall Center funds.

This section should also describe plans for convening the advisory board, the sharing of research data and research resources such as model organisms and software, and plans for the establishment of the Center website.

Information for Each Project or Core

Overview (not to exceed 1 page; required for each individual project)

The overview is required for each project and core, and should describe the impact of the science or resource proposed in relation to the state-of-the-art of the field for a broad audience.  This section must also explain the contribution of the component to the scientific objective of the overall Center and how the project will interact and benefit from other components of the Center. 

Specific Aims (1 page)

Research Strategy (not to exceed 12 pages for an individual project and 6 pages for each core)

This section should include the following (items # 3 - 6 do not count towards the page limits):

1.      Significance (for individual project components only).  Describe how the work is innovative. 

2.      Research Design and Methods, including preliminary data and progress report for a competing continuation application.  It is important to clarify the appropriateness of the center approach and environment in addition to detailing the research design.  For the cores, the description should indicate how the core will contribute to the overall goals of the Center as well as which projects will be supported by the core and the manner in which that support will be rendered by the core.  The description of each core should clearly indicate the facilities, resources, services, and professional skills that the facility will provide to the proposed Center. 

3.      Human Subjects

4.      Vertebrate Animals

5.      Literature cited

6.      Letters of support

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and

Sharing of Data and Materials

Udall Centers are expected to comply with specific policies regarding submission of data and materials to the appropriate facility. Plans for submission of data and materials to these facilities should be included within the application. 

Parkinson’s Disease Data and Organizing Center (PD-DOC)

Udall Centers are required to submit eligible data in a standardized format to the NINDS-supported Parkinson’s Disease Data and Organizing Center (PD-DOC, or other facilities to be named by the NINDS. PD-DOC organizes and facilitates research on PD by serving as a central source for shared resources, including a standardized clinical database as well as data sets from translational and clinical research projects. Inclusion and award of a clinical component requires compliance with collection and submission of the PD-DOC Core Data Set. For further information, see

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

The NINDS has established specific requirements for selection and banking of samples for PD and related parkinsonian disorders. Selected samples generated by the Udall Centers may be eligible for deposition at the NINDS Repository at Coriell. This facility receives, stores, and distributes standardized samples suitable for genome-wide association and other high throughput genotype/phenotype studies. For further information, contact the program officer listed below, and see 

Database of Genotypes and Phenotypes (dbGaP)

SNP genotyping data obtained with Udall Center funding, together with corresponding phenotypic data, must be deposited at dbGaP. The lead investigator for the SNP genotyping study is responsible for the overall process of data submission. Further information is available at

Biological samples (with relevant subsets of associated phenotypic data) as well as genetic data resulting from Center research should be submitted to dbGaP prior to publication, with the understanding that the data will be subject to an embargo period. Submitters of controlled-access data housed in dbGaP may retain the exclusive right to publish an analysis of their submitted data for a specified period of time; users wishing to access this data must submit a Data Use Certificate (DUC) for review and approval by an NIH Data Access Committee (DAC). Additional details are available at

In addition, all data obtained with Udall Center funding must be shared immediately with the research community upon publication or upon public disclosure of a submitted patent, whichever is earlier. At the latest, data must be shared no later than within one year of the completion of the funded project period for the parent award.  Such sharing is expected prior to submission of a competing renewal application in every case.  Continuation awards are contingent upon deposition of all eligible samples and data collected into the appropriate repository or database, within the timeframe specified by that resource and the NINDS.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NINDS and in accordance with NIH peer review procedures (, using the review criteria stated below.

As part of the scientific peer review, all applications will:

The following will be considered in making funding decisions:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

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

Core Review Criteria.  Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, 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?

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

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders justified in terms of the scientific goals and research strategy proposed?

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

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.

Review of Overall Center

Udall Center applications should include the following components: two or more scientific Research Projects (on the scale of a small R01), an Administrative Core and Research Resource Cores. If only two research projects are included, applicants must provide additional justification as to how the proposed combination of projects and cores constitute a multidisciplinary Center of Excellence. Research Training and Education, and Public Outreach and Dissemination Cores may also be included. An overall priority score will be assigned to the center application subsequent to the review of the individual projects and cores. The overall score will reflect a) the scientific merits of the research project(s), b) the overall effectiveness of core resources and facilities c) the qualifications of the Center Director, Project Leaders and Core Leaders, d) the quality of the plans for management and oversight of the Center, e) the synergy among the components and overall impact of the Center, and f) the institutional commitment.  The overall score for the center application may be higher or lower than the average of the individual components based on reviewer assessment of whether the whole is greater than the sum of its parts

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

For competing renewal applications: Has the Center met previously stated goals? What notable research discoveries have resulted? What has been the quality/impact of publications, honors and awards, grant funding, as well as research projects supported by core resources including collaborative research? Has the Center remained on the cutting edge of Parkinson’s disease research, and does the Center have the capacity to pursue a strong translational research project?

For both new and competing renewal applications: Do projects directly address the pathology, progression and treatment of PD? Has the Center demonstrated ability (competing renewal) or does the Center have the capacity (new applications) to mobilize local resources and contribute to Parkinson’s disease research at a local and national level?

Does the proposed Center demonstrate appropriate organization and core management? Is the organizational plan and management structure adequate to meet Center goals? Are the procedures for internal communication and cooperation among the investigators adequate?

Center Director: Will the Udall Center Director provide visionary scientific leadership of the Center? Does the Director have prior project management experience that predicts success of the Center? Does the Director have active NIH funding? 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? 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?

Investigators: Is the Project Leader at the forefront of the area of science proposed?  Does the Project Leader have a productive record of bringing novel and significant projects to fruition as an independent, R01 funded principal investigator?  Will the expertise of Project and Core leaders advance research in Parkinson’s disease? Is the seniority of Project and Core leaders appropriate? Is there evidence of collaboration among the Project and Core Leaders? Do the investigators have appropriate experience to mentor trainees and junior faculty involved in proposed projects and cores?

Environment: Does the institution provide an environment and core resources which will enhance cutting-edge research by bringing together multidisciplinary investigators? Are the proposed facilities sufficient for the advancement of the proposed research? Will the Udall Center serve as a local resource for PD research? If the institution houses other large-scale Centers, especially those involving research on PD and related disorders, does the Udall Center add unique expertise and perspective to ongoing research? Is there adequate description of the potential relationship between the proposed Udall Center and the other Center(s)? Is there potential overlap between the Udall and other large-scale, PD-related research efforts housed at the institution? If Center investigators are located at more than one institution, is the geographic relationship and planned communication between facilities adequately described?

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 proposed management 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? Is the Center scientific and administrative structure sufficient, including its internal and external procedures for monitoring and evaluating the proposed research projects and core facilities/resources? Are there appropriate plans for management and sharing of data, animal models and other resources? Are there appropriate plans for establishing the External Advisory Panel and will this panel contribute to the oversight of Center research projects, and other components?

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

Research Project(s): For each scientific project, peer reviewers will evaluate the significance, investigator, innovation, approach and environment as described above.  The following additional criteria will also be considered in determining the score. Are the experimental design and methods adequate to achieve the research objectives? For all types of research projects, do the problems to be addressed require both a Center mechanism and an intensive collaborative effort for successful completion? Do the participating investigators have sufficient experience and expertise for the proposed project and are time/effort commitments sufficient? Do the collaborative efforts require substantial, and not token, contributions from the partners for successful completion? Are the proposed protections for humans, animals, or the environment, to the extent they may be adversely affected by the projects proposed in the application, adequate?

Pre-Clinical translational Research Projects: Is it likely that completion of the translational research objectives will assist with translation of basic observations into one or more therapeutic, diagnostic or intervention for PD? For pre-clinical translational components, is a plan provided as to how these efforts help to support the therapeutic development pipeline for Parkinson’s disease? Do pre-clinical translational projects include proof-of-principle on efficacy that would allow transition of the project to Cooperative Agreement funding in the NINDS Translational Research Program?

Clinical Translational Research Projects: Does the proposed clinical translational project build on prior research, i.e. is there a sufficient body of high quality preclinical or clinical research that supports the rationale for the proposed study?  Does the clinical translational project fit within the goals and the scope of the Udall Center?  Do proposed clinical translational projects have the potential to lead to the development of a new therapy, diagnostic, or intervention? 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 practice, address an innovative hypothesis or critical barrier to progress in the field? Is the work proposed appropriate to the experience level of the principal investigator and other researchers?

Clinical Resource Core: Is the Core essential for the support one or more of the research projects? Are there appropriate plans for the rigorous management and quality control of any research data or materials to be obtained from human subjects? If included, is the patient cohort well-defined and appropriately diverse? Are plans in place for patient recruitment? Do plans include a patient registry and associated database? Have standard operating procedures been established for collection and storage of biological samples and/or for -genotype/phenotype information? Is the timeline for Core activities included and adequate?  

 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, described in the application or in a dedicated Core, to train students, postdoctoral fellows, and junior faculty within the Udall Center? Does the application provide evidence that the Director, project leaders and core leaders have excellent records in mentoring, including evidence of successful transition of trainees to more advanced research positions? If a training Core is proposed, does the Center have access to sufficient pool of academically strong trainees, well-qualified mentors and commensurate experience to justify the proposed training activities? Is there an appropriate plan for training of basic research trainees in clinical aspects of PD, and clinical trainees in basic mechanisms of the disease? Is there an adequate plan for providing training in the responsible conduct of research?

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

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

NIH considers the following in evaluating Center grant applications:

Additional Review Criteria 

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, 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.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

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.

Renewal Applications.  When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

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.

Additional Review Considerations 

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

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

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).

Applications from Foreign Organizations.  Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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 (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (; and 3) Genome Wide Association Studies (GWAS) (

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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. See Also Section IV.5. Funding Restrictions.

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 (

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

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

2. Peer Review Contacts:

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3201
Bethesda, MD 20892-9529
Telephone:  (301) 496-9223

3. Financial or Grants Management Contacts:

Tijuanna DeCoster, MPA
Grants Management Officer, Grants Management Branch
National Institutes of Neurological Disorders and Stroke
6001 Executive Blvd
Room 3258, MSC 9537
Bethesda MD 20892-9537
(Rockville, MD 20852 for express/courier service)
Telephone: (301) 496-9231

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals ( as mandated by the Health Research Extension Act of 1985 (, and the USDA Animal Welfare Regulations ( as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts,

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (; a complete copy of the updated Guidelines is available at The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding ( It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy ( investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (, to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website ( provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at and is not subject to the intergovernmental review requirements of Executive Order 12372. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see:

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