Morris K. Udall Centers of Excellence for Parkinson's Disease Research (P50 Clinical Trial Optional)

Morris K. Udall Centers of Excellence for Parkinson's Disease Research (P50 Clinical Trial Optional) is sponsored by National Institute of Neurological Disorders and Stroke (NINDS). This Funding Opportunity Announcement invites applications for the Morris K.

Expired RFA-NS-21-001: NINDS Morris K. Udall Centers of Excellence for Parkinson's Disease Research (P50 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices.

Department of Health and Human Services Part 1. Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations National Institute of Neurological Disorders and Stroke ( NINDS ) Funding Opportunity Title NINDS Morris K.

Udall Centers of Excellence for Parkinson's Disease Research (P50 Clinical Trial Optional) NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice NOT-OD-22-018 .

September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements.

See Notice NOT-OD-21-170 April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109 August 11, 2020 - Notice of Change: Late Application Policy for September 28, 2020, Application Due Date for RFA-NS-21-001. See Notice NOT-NS-20-097 .

Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity RFA-NS-21-002 , P20 Research Program Projects and Centers Additional Information on Eligibility . Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose This Funding Opportunity Announcement (FOA) invites applications for the Morris K. Udall Centers of Excellence for Parkinson’s Disease Research program.

The overarching goal of this program is to support specialized research Centers that work collaboratively as well as independently to define the causes of and discover improved treatments for Parkinson’s disease (PD). A more immediate goal for each Center is to rapidly advance synergistic, interdisciplinary research programs while serving as national leaders in PD research.

Applicants will identify an overall research theme that directly addresses a critical challenge in PD research. The Center theme, proposed research projects, and associated cores will inform the etiology, pathogenesis, or treatment of PD; investigations on related synucleinopathies may be included if such directly address the identified PD research challenge.

Udall Centers also serve as local resources by providing research career enhancement activities for Center investigators and periodic outreach to the PD patient/advocacy community.

Required components of this FOA include: an Overall section describing the Center theme, vision and organization; three or more Research Projects, plus a dedicated Udall Catalyst research project led by an early career researcher poised to become an expert in PD research; an Administrative Core; at least one integrated Research Core that is essential to and accelerates the progress of two or more Research Projects; a mission statement for career enhancement of Center investigators, and a plan for periodic outreach to the local patient/advocacy community, including specific outreach events to convey Center research advances.

The NINDS Udall Centers program prioritizes innovative and integrative research with significant potential for discovery. Considerable synergy must be evident among Center research projects and cores, such that the Center structure is required for successful completion of the aims.

Funding decisions will focus on those applications most likely to make significant contributions to PD research, as well as those with greatest potential to collaborate effectively across the Udall Centers Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date September 28, 2020, September 28, 2021, September 28, 2022 All applications are due by 5:00 PM local time of applicant organization.

All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s). No late applications will be accepted for this Funding Opportunity Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s) 2021, February 2022, February 2023 May 2021, May 2022, May 2023 June 2021, June 2022, June 2023 It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ).

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

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

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

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

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Full Text of Announcement Section I.

Funding Opportunity Description Parkinson’s disease (PD) is a chronic, progressive movement disorder that affects the lives of at least half a million people across the United States, as well as having significant impact on the relatives and friends who care for them.

The average onset of characteristic motor symptoms, which are initially subtle and increasingly impact purposeful movement, most often occurs in the sixth decade of life; onset at much younger ages is also possible. Persons 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 fail to attenuate the ultimate progression of the disease. While significant research advances have been made, including the identification of environmental and genetic risk factors, a clear cause and a definitive cure for PD have remained elusive.

As our population ages, the number of persons with PD is projected to increase significantly. The NINDS Udall Centers of Excellence for Parkinson s Disease Research program was established in tandem with the Morris K. Udall Parkinson’s Disease Research Act of 1997 (P.

L. 105-78), legislation to honor the distinguished Representative from Arizona who lived with PD. NINDS Udall Centers have since identified and characterized disease-associated genes, examined neurobiological and neuropathological mechanisms underlying PD, established improved PD models, developed and tested potential therapeutics, and explored novel avenues of clinical research.

In 2020, there are eight Udall Centers across the United States. The overarching goal of the NINDS Udall Centers of Excellence program is to support specialized research Centers that work collaboratively as well as independently to define the causes of and discover improved treatments for PD.

Udall Centers pursue high-impact, synergistic research projects while serving as national leaders in PD research and local resources for research career enhancement and outreach to the PD patient/advocacy community. Another important goal is to further advance PD research through broad sharing of data and research resources developed in this Centers program.

The NINDS Udall Centers program prioritizes innovative and integrative research with significant potential for discovery. Udall Center applications are expected to identify, justify, and address an overall research theme that defines a critical challenge in PD research, emphasize novel ideas and approaches, as well as to utilize state-of-the-art technologies and a team-based approach to achieve stated goals.

The overall theme of each Center, proposed research projects, and cores will inform the etiology, pathogenesis, or treatment of PD; investigations on related synucleinopathies may be included if such studies directly address the identified PD research challenge. Each applicant team may submit the combination of research projects (basic, translational, clinical) that best address the stated theme.

Basic research has served and will continue to serve as the foundation of discovery in the Udall Centers program: applicants are encouraged to include basic research projects, as well as to continue to build upon this vital foundation with studies that translate basic and clinical research observations into improved treatments for PD.

Inclusion of a translational research project is optional but encouraged; such projects should provide initial proof-of-concept that a proposed therapeutic agent has sufficient biological activity to warrant further development for the treatment of PD. Clinical research projects include patient-oriented research with a specific focus on understanding disease mechanisms.

When formulating their applications, applicants are encouraged to consider the research recommendations resulting from the NINDS conference, "Parkinson's Disease 2014: Advancing Research Improving Lives." The Specialized Center (P50) mechanism supports interdisciplinary, hypothesis-driven, synergistic research activities.

Required research components of this FOA include: three or more Research Projects, plus a dedicated Udall Catalyst project, led by an early career researcher poised to make contributions to PD research.

In this context, "early career researcher" includes those who are about to transition, or have recently moved, to fully independent positions as investigators, faculty members or clinician scientists, and who focus on establishing themselves as experts in PD research.

For this initiative, "early career" is inclusive of Early Stage Investigators (ESI), as well junior faculty without current NIH R01-equivalent, independent support; New Investigators are eligible only if the criteria for "early career" are met. Leadership of a research feasibility project will allow ESI to retain ESI status according to NIH ESI policy .

Inclusion of an early career researcher is intended to provide a timely leadership development opportunity within the supportive and collaborative structure of the Udall Center program.

Additional required application components include: an Overall section describing the Center theme, vision and organization; an Administrative Core; at least one integrated Research Core that is essential to and accelerates the progress of two or more Research Projects; a mission statement for and description of career enhancement of Center investigators, including the Udall Catalyst project investigator; and a plan for periodic outreach activities to the local patient/advocacy community, including outreach events to convey Center research advances.

If at least one Clinical Research Project is proposed, a corresponding Clinical Research Core must also be included within the application.

Proposed studies must be feasible within the five-year project period and justified within the budget limits described elsewhere in this The following activities are nonresponsive to this FOA; applications containing any of these elements will not be reviewed: and maintenance of institutional infrastructure and generalized resources (including brain banks, biospecimen repositories, databases, and translational clinical data and/or biospecimens solely in local or institutional databases and/or enrollment, tracking of or collection of data, biospecimens from clinical cohorts beyond that required for proposed Udall Center clinical research studies.

the scope of defined Udall Center program community outreach activities, including general symposia on PD research and treatment, research-focused symposia for investigators and Continuing Medical Education (CME) programs for health care professionals Translational research projects containing: preclinical models for the purpose of understanding disease etiology. including use of tool compounds.

studies, such as GLP toxicology, formulation, and manufacturing. development of therapeutic devices. involving non-exempt human subjects research.

of institutional infrastructure for therapeutic development activities. Clinical research projects containing: designed to address safety, tolerability, clinical efficacy, effectiveness, clinical management, and/or implementation of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions.

Responsive applications must demonstrate considerable potential to address critical challenges in PD research; contribute unique knowledge and scientific advances to the Udall Centers program and beyond; collaborate effectively with existing Centers; and serve as national leaders in PD research.

Related, supportive factors include, but are not limited to, broad sharing of data and resources as appropriate and consistent with achieving the goals of the program. Udall Centers also serve as local resources for research career enhancement activities for Center investigators, and meaningful outreach activities to the local PD community.

Opportunities for collaboration with active NINDS Udall Centers may be considered and included in the application. Collection of biospecimens and clinical data will follow policies and procedures of the NINDS Parkinson's Disease Biomarker Program (PDBP) .

Applicants proposing to derive and characterize iPSC lines Requirements for Induced Pluripotent Stem Cell Development and Resource Sharing (NOT-NS-14-032) and Notice Announcing the Creation of a Dedicated NINDS Human Cell and Data Repository supporting the Reprogramming, Gene Editing, Banking and Distribution of Fibroblasts and Induced Pluripotent Stem Cells (iPSCs) for Neurological Disorders (NOT-NS-16-003) .

Applicants are strongly encouraged to use the services of the NINDS Human Cell and Data Repository (NHCDR) for iPSC derivation and genome editing (as well as for fibroblasts and peripheral blood mononuclear cells, PBMC). the NIH expects applicants to apply rigor in designing and performing scientific research according to the NIH Principles and Guidelines for Reporting Preclinical Research .

NINDS funding decisions will focus primarily on scientific merit, i.e., on those applications that are most likely to make innovative contributions to PD research and that demonstrate the potential to collaborate effectively and share broadly across the Centers program and beyond.

The NINDS will also consider the full scope of Udall Center programmatic activities when making funding decisions; applications proposing goals identical to or largely overlapping Udall Centers will receive lower program priority. In addition, the NINDS may also consider whether proposed research addresses recommendations from the NINDS Disease 2014: Advancing Research, Improving Lives."

Information for award authorities and regulations. Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA. Optional: Accepting applications that either propose or do not propose clinical trial(s) help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number The NINDS intents to commit up to $6,750,000 total costs in fiscal year (FY) 2021. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious Funds available in future years will depend on future annual appropriations.

Applicants may request up to $1,000,000 direct costs per year with the follow exception: applications containing a translational project and/or clinical component (i.e. clinical research project plus a clinical core) may request up to $1,500,000 direct costs per year. Application budgets must justify and reflect the actual needs of the proposed project.

The project period is limited to 5 years described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government - Including the NIH Intramural U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are not eligible Foreign components, as defined in the NIH Grants Policy Statement , are allowed.

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible.

The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission. Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations.

The same DUNS number must be used for all registrations, as well as on the grant application. System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration.

SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. must have an active DUNS number to register in eRA Commons.

Organizations can register with the eRA Commons as they are working through their SAM or Grants. gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

must have an active DUNS number and SAM registration in order to complete the Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) The Udall Center Director (PD/PI) must be a recognized leader in scientific research with proven capacity for visionary leadership of an interdisciplinary team.

Other qualifying factors include current research productivity and active research funding (NIH R01-equivalent or greater) and/or stewardship of multi-site clinical studies at time of application submission. To support stated career enhancement goals of the Center, the Director will have demonstrated success in mentoring of junior faculty, postdoctoral fellows, and students.

Expertise in areas beyond PD research is encouraged if the Director’s skills can be applied in novel ways to advancement of knowledge of PD causes and progression, with the overall goal of advancing PD research into improved treatments and clinical practice.

Center Directors must lead the Administrative Core and may lead no more than one additional component: the PD/PI is expected to commit substantive effort to ensure success of the Udall Center. This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time.

This means that the NIH will A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101 ). Only one Specialized Center (P50) will be awarded per applicant organization. i Section IV.

Application and Submission Information 1. Requesting an Application The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA.

See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2. Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions (R&R) Application Guide , except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.

gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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 By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: National Institute of Neurological Disorders and Strategy/Program Plan Page Limits Core (use for both research and clinical cores) Project (Research and Udall Catalyst) Additional page limits described in the SF424 Application Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component The application should consist of the following components: Overall: required, maximum of 1 Administrative (Admin) Core: required, maximum of 1 Research Core: required, minimum of 1 Clinical Core: required for support of Research Project(s) including Projects: categories include Basic, Translational and Clinical Research Project: required, minimum of 3 Udall Catalyst Research Project: required, maximum of 1 When preparing your application, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted. SF424 (R&R) Cover (Overall) PHS 398 Cover Page Supplement (Overall) Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component. Project Information (Overall) Follow standard instructions.

following information must be uploaded as individual attachments. The filename for each required attachment is indicated below; filenames will be used to bookmark the attachments in the application image. Organizational Structure: provide a diagram of Center components and related interconnections.

PD Research: Provide current institutional framework for PD research available to support or complement proposed Udall Center efforts. Detail how the Udall Center will serve as a nexus for institutional PD research. Include a description of extant institutional programs and resources available to advance the Aims of the proposed Center.

Describe existing large-scale research projects, including associated therapeutic development efforts, and define the envisioned contributions of the Udall Center within this context.

Examples include, but Parkinson's Disease Biomarkers Program (PDBP); NIH Accelerating Medicines Partnership for PD (AMP PD); NIA Alzheimer's Disease Centers or other significant NINDS/NIA programs in Alzheimer's Disease-Related Dementias (ADRD); Department of Defense Congressionally Directed Medical Research Programs- Parkinson's Research Program (DoD CDMRP-PRP); NCATS Clinical and Translational Science Awards (CTSA).

programs: Aligning Science Across Parkinson's (ASAP) Research Collaborative Network; Chan-Zuckerberg Initiative (CZI) Neurodegeneration Challenge; Parkinson's Foundation (PF) Research or Clinical Centers of Excellence; large-scale Michael J. Fox Foundation (MJFF) projects and/or consortia; American Parkinson's Disease Association (APDA) Centers for Advanced Research, and similar programs.

Justification: If foreign components are included, describe special resources or characteristics of the research project (e.g., human subjects, animals, disease, equipment, and techniques), including the reasons why the facilities or other aspects of the proposed project are more appropriate than a domestic setting.

For example, the justification may include how this component represents special opportunities for furthering proposed Udall Center research through the use of unusual talent, resources, populations, or environmental conditions that are not readily available or that augment existing resources in A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire The Udall Center Director (PD/PI) must be a recognized leader in scientific research with capacity for visionary leadership of an interdisciplinary team. An Associate Director may be named.

The Director and Associate Director (if applicable) will demonstrate current research productivity, active research funding (NIH R01-equivalent or greater) and/or stewardship of multi-site clinical studies at time of application submission. Additional qualifications include demonstrated experience in mentoring of early career researchers, junior faculty, postdoctoral fellows, and students.

The PD/PI is responsible for ensuring that Center goals are met, for developing and managing a decision-making structure, and for allocation of resources to achieve stated goals. If named, the Associate Director will partner with the PD/PI to facilitate and advance the goals of the Center. The PD/PI and Associate Director (if applicable) are expected to commit substantive effort to ensure success of the Udall Center.

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

The only budget information included in the Overall component is the Estimated Project Funding section of A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall) Specific Aims: Provide the overarching research theme and describe the overall aims of the proposed Udall Center. The Overall section states the theme, vision, and rationale for the proposed Udall Center, and provides an overview of planned synergistic activities to achieve stated Aims. Organize the Research Strategy into sections on Significance, Innovation and Approach.

a vision statement for the Center, including justification for the stated theme, chosen research challenge, scientific premise, and expected contributions to the advancement of PD research and treatment. Include the overall Udall Center program objectives and related implementation plan for the five-year grant period.

Justify the proposed interdisciplinary approach and the use of the specialized Center mechanism (P50), including the envisioned contribution as a national leader in and local resource for PD research; related justification may include, but is not limited to, broad sharing of data and research resources consistent with achieving the goals of the program.

Innovation: Describe novel approaches, investigator expertise, and collaborative interdisciplinary activities that will advance the goals of the Udall Centers program, including unique contributions that will elucidate the causes of and result in therapeutic advances for PD. the general research framework of the Center.

Discuss the proposed research program, highlighting its central theme and define the objectives for the five-year project period. Provide justification for and detail necessity of this specialized Udall Center structure to address the identified PD research gap. Highlight the selected interdisciplinary approaches that will contribute to research advances.

Describe the synergy among the Center components, including the Administrative and Research/Clinical Core(s), focusing on the scientific and collaborative approaches that will ensure thematic coherence of Center research and activities. Detailed descriptions of preliminary data for research projects should be included within the relevant Research Project, not in the Overall section.

If foreign components are included, describe how those present special opportunities for furthering research programs through unusual talent, resources, populations, or environmental conditions that exist in other countries and are not readily available in the United States (US) or that augment existing US resources. evidence of feasibility for the formation of a Udall Center of Excellence.

Present compelling evidence that the assembled research team will work together effectively to accomplish the goals of the proposed Center and advance research in PD. Detail institutional support for a strong research base on PD and/or other neurodegenerative disorders as well as infrastructure and resources that may be leveraged to support the Udall Center.

Describe potential to serve as a national leader in and local resource for PD research. Outline plans for effective sharing of research resources and data with the scientific community. Commitment (required): Include a letter of endorsement from a high-level institution official(s) (e.g., Dean of the School of Medicine, Vice President for Research, Provost; support from Department Chairs is not sufficient for this purpose).

The letter should confirm institutional commitment to the proposed Center, and provide details regarding: Intended institutional commitment.

Examples of institutional commitment may include but are not limited to: funding for pilot projects; support for recruitment of new scientific talent and career enhancement activities, such as support for a designated Udall Research Fellow; provision of discretionary resources to the Udall Center Director; access to institutional infrastructure; assignment of specialized research space; funding and resources for community outreach activities; and/or other means of support.

Institutional promotion and maintenance of overall scientific excellence in PD research, including prioritization and integration of the Udall Center into institutional efforts. Udall Centers are encouraged to pursue additional institutional partnership opportunities to further program goals. The role of the institutional official in conflict arbitration and resolution, should such arise among Udall Center investigators.

institutions receiving funding for other, significant PD-relevant research projects from Federal or Non-Federal entities: describe the unique contributions of the proposed Udall Center to the institutional PD research effort, how interactions among institutional PD-relevant projects will advance PD research and explicate institutional commitment to the support of the Udall Center program in this overall context.

Such projects include but are not limited to: programs: NINDS Parkinson's Disease Biomarkers Program (PDBP); NIH Accelerating Medicines Partnership for PD (AMP PD); NIA Alzheimer's Disease Centers or other significant NINDS/NIA programs in Alzheimer's Disease-Related Dementias (ADRD); Department of Defense Congressionally Directed Medical Research Programs- Parkinson's Research Program (DoD CDMRP-PRP); NCATS Clinical and Translational programs: Parkinson's Foundation (PF) Research or Clinical Centers