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

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Parkinson’s disease (PD) is a chronic, progressive movement disorder that affects the lives of at least 500,000 people across the United States, a figure that is expected to increase as our population ages. The average onset of characteristic motor symptoms, which are initially subtle and increasingly impact purposeful movement, occurs in the sixth decade of life; onset at much younger ages is also possible. 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 fail to attenuate the ultimate progression of the disease. While significant research advances have been made, including the identification of possible environmental and genetic risk factors, a clear cause and a definitive cure for PD have remained elusive.

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 passed to honor the distinguished Representative from Arizona who died in 1998 after a long battle with PD. NINDS Udall Centers have since identified and characterized candidate and disease-associated genes, examined neurobiological and neuropathological mechanisms underlying PD, established improved PD models, developed and tested potential therapeutics, and explored novel avenues of clinical research.

In 2015, there are nine Udall Centers across the United States.

The overarching goal of the NINDS Udall Centers of Excellence program is to establish a network of Centers that work collaboratively as well as independently to define the causes of and discover improved treatments for PD. Udall Centers 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 through 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 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 research activities. Programmatic requirements include: three or more Research Projects, 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, and a plan for periodic outreach activities to the local patient/advocacy community. 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 and justified within the budget limits described elsewhere in this announcement.

The following activities are beyond the scope of this FOA:

• Pilot research projects.
• Clinical trials.
• Research, discovery or method development Aims within Cores.

Responsive applications will demonstrate proven ability (renewals) or considerable potential (new applications) to: address critical challenges in PD research; contribute unique knowledge and scientific advances to the Udall Centers program; 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, career enhancement activities for Center investigators, and meaningful community outreach activities. Although new Centers are not expected to have pre-existing collaborations with established Centers, potential areas of shared interest with active NINDS Udall Centers should be considered and included in the application.

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 across the Centers program. 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 with active Udall Centers will receive lower program priority. In addition, the NINDS may also consider whether proposed research addresses recommendations from the NINDS conference "Parkinson's Disease 2014: Advancing Research, Improving Lives."

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

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

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 of Higher Education:

• 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 Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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

Applicant Organizations

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.

• Dun and Bradstreet 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) (formerly CCR) 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.
  • NATO 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program 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.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

The Udall Center Director (PD/PI) must be an established leader in scientific research with a history of successful funding and proven expertise in the stewardship of large-scale research programs. Center Directors must lead a Project and/or Core within the Center. Other qualifying factors include current research productivity, active funding (NIH R01-equivalent or greater), capacity for visionary leadership of an interdisciplinary team, and demonstrated experience in mentoring of junior faculty and trainees. Expertise in areas beyond PD research is encouraged if the Director’s skills can be applied in novel ways to the translation of PD research into improved treatments and clinical practice.

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

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 not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• 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).

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

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed 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:

Beth-Anne Sieber, PhD
Division of Extramural Research, Neurodegeneration Program Cluster
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: (301) 496-5680
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core	6
Core (use for Research Core and Clinical Core)	6
Project (use for Research Projects)	12

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required
• Research Cores: required; minimum of 1
• Clinical Core: required for support of Research Project(s) proposing use of human subjects
• Research Projects: required; minimum of 3
  • Research Project categories include: Basic, Translational, and Clinical

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

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete entire form.

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

Follow standard instructions.

Other Attachments: The following information should be uploaded as individual attachments. The filename for each attachment is indicated below; filenames will be used to bookmark the attachments in the application image.

• Center Organizational Structure: provide a diagram demonstrating interactions among Center components
• Udall Center Interactions:
  • New Applications: provide a table that identifies potential interactions with current Udall Centers
  • Renewal Applications: provide a table that documents interactions across Udall Centers, including sharing of resources and data as appropriate and consistent with achieving the goals of the program.

Enter primary site only.

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

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

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

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

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

Specific Aims: Describe the overall aims of the proposed Udall Center.

Research Strategy: The Overall section states the theme, vision and rationale for the proposed Udall Center, and provides an overview of planned synergistic activities. Organize the Research Strategy into sections on Significance, Innovation and Approach.

Significance: State the overall theme and define the critical PD research challenge(s) to be addressed in the proposed Udall Center. Provide a vision statement for the Center, including justification for the stated theme and expected contributions to the advancement of PD research and treatment. Include the overall Udall Center program objectives and related implementation plan for the proposed grant period. Justify the proposed interdisciplinary approach and the use of the specialized Center mechanism (P50), including the potential contribution (new application) or proven capacity (renewal application) as a national leader in PD research; related justification may include, but is not limited to, broad sharing of data and research resources.

Innovation: Describe how novel approaches, investigator expertise, and collaborative activities 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.

Approach: Describe the general research framework of the Center. Discuss the proposed research program, highlighting its central theme. 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 new projects (new and renewal applications) and/or progress on existing projects (renewal applications) should be included within the relevant Research Project section, not in the Overview. If foreign components are included, describe how those present special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and are not readily available in the United States or augment existing U.S. resources.

New and renewal applications should include the following information:

New applications: Provide summary evidence for feasibility, including preliminary findings, that support the formation of a Udall Center. 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. Describe potential to serve as a national leader in PD research. Outline potential for effective sharing of research resources and data with the scientific community.

Renewal applications: Provide a brief synopsis of the overall accomplishments of the Udall Center during the prior funding period, including the overall scientific/clinical merit and impact of projects/cores and of the Udall Center as a whole. Provide examples of Center leadership in the advancement of PD research. Highlight collaborative interactions among the Center investigators; establishment of new collaborations within the Udall Centers network; and the effectiveness of the core resources and facilities for collaborations within and beyond the Center.

Letters of Support:

Institutional Commitment (required): Include a letter from a high-level institution official(s) (e.g., Dean of the School of Medicine, Vice President for Research) to confirm institutional commitment to the Udall Centers program. The letter should provide details on how institutional commitment will be established (new applications) and sustained (renewal applications), examples of how the institution maintains and promotes scientific excellence in PD research, and how the Udall Center research effort will be prioritized within the institution (relative to other NIH and non-NIH funded programs). Examples of institutional commitment may include, but are not limited to: provision of discretionary resources to the Udall Center Director, funding for pilot projects, support for recruitment of scientific talent and career enhancement activities, access to institutional infrastructure, assignment of specialized research space, funding and resources for community outreach activities, and/or other means of support. The letter should describe the role of the institution in conflict arbitration and resolution, should such arise among Udall Center investigators.

The letter should also detail collaborative efforts and/or opportunities with other, ongoing institutional programs. For example, opportunities may exist for collaboration with the Clinical and Translational Science Awards (CTSA), a consortium of NIH-funded academic health centers that accelerate the process of translating laboratory discoveries into treatments for patients, train a new generation of clinical and translational researchers, and engage communities in clinical research efforts. Similarly, opportunities for collaboration with the National Institute on Aging's Alzheimer's Disease Research Centers may be identified and described. Udall Centers are also encouraged to leverage additional institutional partnership opportunities to further program goals.

Applicant institutions receiving funding from other, large-scale PD-related research projects or Centers, including but not limited to: Parkinson's Disease Foundation (PDF) Center, National Parkinson Foundation (NPF) Center of Excellence Grant, Department of Defense Neurotoxin Exposure Treatment Parkinson's Research (NETPR) program funding, large-scale Michael J. Fox Foundation (MJFF) projects, and NINDS Parkinson's Disease Biomarkers Program (PDBP), should detail the unique contributions of the Udall Center to the institutional PD research effort, how interaction among these projects will advance PD research, and provide commitment to the support of the Udall Center program in this context.

Collaboration with Nongovernmental Organizations (if applicable): Udall Centers and nongovernmental patient advocacy organizations have common goals for improving treatment and understanding causes of PD. Letters should detail planned or ongoing partnerships between Udall Centers and these groups, including collaboration on planned Center community outreach efforts such as the annual symposium.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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

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

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

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

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

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components

Facilities and Other Resources: As part of the description of the institutional environment, applications must provide a description of Center career enhancement activities that will address the goals of the Udall Centers program by fostering investigator proficiency across the broad spectrum of basic, translational and clinical concepts necessary for investigators to successfully and independently navigate critical issues in PD research.

Capitalizing on the unique interdisciplinary teams within Udall Centers, planned activities will provide opportunities for non-clinician scientists to 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 will gain exposure to and understanding of the basic science that contributes to discovery of disease mechanisms and therapeutic targets.

Career enhancement activities organized by the Udall Center must be above and beyond institutional training programs, and focus on activities that inform across the interdisciplinary Center program. Provide information on the following:

• Mission statement for Center-specific career enhancement activities.
• Complementarity to and collaborations with existing institutional programs.
• Brief overview of planned activities over the five year period.
• Include plans for cross-training of basic and clinical researchers
• Provide evidence of career enhancement activities accomplished during the prior funding period (renewal application) or plans for (new application) local leadership in career enhancement activities for Center investigators.

Other Attachments: The following information should be uploaded with the filename indicated below; filenames will be used to bookmark the attachment in the application image.

Community Outreach Activities: The Administrative Core will serve as the point of information for the general public, and as a resource for the local patient community. Outreach activities must be specific to the Udall Center, and thus will be designed to inform and engage the public about ongoing Center research approaches, as well as how Center findings relate to current advances in PD research and treatment. Active participation of patient advocacy groups in the planning and conduct of outreach activities is encouraged. Provide a description of planned outreach to the local and national PD patient community, including:

• Plans for an annual symposium to present Udall Center research results to the local patient community.
• Involvement of Center investigators in outreach activities.
• Innovative means through which the Center will relay research advances to the lay community.
• Dissemination of results to research study participants.
• Broad outreach efforts including Center website, social media approaches.
• Partnership with nongovernmental PD organizations.
• Inclusion of a local patient advocate on the External Advisory Committee.
• A lay language summary of Udall Center goals and research activities.
• Provide evidence of (renewal application) or plans for (new application) effective outreach to the local patient/advocacy community.

List all performance sites that apply to the specific component

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Center Director will lead the Administrative Core.
• An Associate Director may be named, who will assist the Center Director with oversight of the administrative and scientific efforts of the Center.
• A Center Administrator must be named. The administrator must be familiar with NIH grant policies and business practices, and provide consultation in matters of fiscal administration.
• Effort of Administrative Core personnel must be commensurate with the time required to perform proposed duties effectively.

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

Budget for the following Udall Center-specific activities should be included in the Administrative Core:

Annual Udall Center Directors' Meeting: Include travel and lodging costs for the Center Director, Center Administrator, and Project and Core Leads to attend the annual Udall Centers meeting.

External Advisory Committee (EAC): Include all EAC-related costs (meeting and travel) in the proposed budget. To promote efficient spending, budgeted costs for EAC member travel will be within range of local per diem rates (as per General Services Administration (GSA) guidance) and follow general NIH guidelines for travel and expense reimbursement rates.

Center Website: Include all costs for the development (new applications) or maintenance (renewal applications) of the Center Website. Related costs for development of social media outreach strategies may also be included.

Community Outreach Activities: Include funds for an annual symposium at which Udall Center investigators speak to the local community about research ongoing at the Center, as well as funds for other planned Center outreach activities.

Overarching Career Enhancement Activities: Include funds for general career enhancement activities for Center investigators. Administrative Core funds may not be budgeted for ongoing institutional programs or for support of individual investigators; associated costs for the latter should be included in the Research Project(s) in which the investigators participate.

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

Specific Aims: Describe the goals and planned activities of the Administrative Core.

Research Strategy:

Organize the Research Strategy into sections on Significance, Innovation and Approach.

Significance: Describe how the Administrative Core will serve as the organizational foundation for research activities of the Center, as well as how the Core will effectively support Center service as 1) a national resource for PD research; 2) a resource for career enhancement of Udall Center investigators; and 3) an effective organizer of periodic outreach activities for the local PD patient/advocacy community.

Innovation: Describe how the Administrative Core utilizes novel approaches to maximize synergy among Udall investigators, and fosters relationships with the broader research and advocacy communities.

Approach: Describe the proposed activities of the Core, including but not limited to the following:

• Promote the integration and function of Center components and activities.
• Provide support for the Center Director in oversight of Center governance.
• Organize regular meetings of the Center Executive Committee.
• Organize timely meetings of the External Advisory Committee.
• Develop and execute periodic community outreach efforts, including an annual symposium for local PD patients.
• Coordinate career enhancement activities within the Center.
• Coordinate Center participation in the annual Udall Center Directors' meeting. Maintain an accounting of resource generation and related utilization, and steps taken to maximize the research utilization of these resources within and beyond the Udall Center.
• Provide advance notice of manuscripts and publications to the NINDS program officer; work with the NINDS Office of Communications on press releases highlighting Center accomplishments.
• Prepare and submit annual progress reports.
• Provide assurance of compliance with NIH policy requirements.
• Establish and maintain the Center's website, as well as any proposed social media presence.

Renewal applications should also describe the accomplishments of the Administrative Core during the prior funding period.

The Approach section should also include plans for the following:

• Administrative Structure: Describe the administrative structure of the Udall Center, including lines of communication, decision-making processes, and procedures for resolving conflicts. Describe the administrative, technical, and scientific responsibilities for Center personnel and collaborators.
• Center Governance: Describe plans to convene (new application) or continue (renewal application) an internal Executive Committee, consisting of the Center Director, Associate Director (if applicable), Center Administrator, Project Leaders and Core Leaders, to assist the Director with scientific and administrative decisions. Describe Executive Committee activities, including regular meetings to discuss Center activities and direction. Describe inclusion of institutional officials. Describe conflict resolution strategy.
• External Advisory Committee (EAC): Describe plans for the EAC, to be composed of at least five outside experts to provide unbiased scientific and programmatic evaluation. Committees will include some members from outside the Udall Centers program; a patient advocate, preferably from the local community, must also be included on the EAC. Ideally, EAC scientific expertise will complement current projects as well as anticipated future directions of the Center. While annual meetings may not be feasible, it is strongly recommended that Center Directors hold in-person EAC meetings early, mid-way and toward the end of the project period, to obtain timely external assessments of Center progress and recommendations for future direction. Regular EAC updates and evaluations are to be included in noncompeting continuation reports. The program officer will attend EAC meetings as an observer and resource for NIH programs and policies.
  • New Centers: describe the anticipated expertise required on the EAC, but do not name or include letters from potential EAC members.
  • Renewal Centers: describe the activities and influence of the EAC during the prior budget period.
• Center Website: Include plans for establishing (new) and maintaining (renewals) a Center website; plans for constructing and/or updating this website should also be included. Because the Udall Centers serve as the nexus for NINDS-funded Parkinson’s disease research, members of the research community, advocacy organizations, people with PD and the general public have considerable interest in remaining informed on progress at each Center. The website should contain a list of research resources as well as a prominently placed, brief (1 paragraph) statement on Public Health Relevance, which describes the goals and recent discoveries of the Center in plain language. This summary should also relay recent Center contributions to understanding the etiology and pathogenesis of PD, as well as how ongoing research will lead to the development of new treatments. Updates should be sufficiently frequent to reflect recent discoveries. The NINDS Udall Centers website provides links to all active Centers.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modifications:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• Describe how this component will facilitate timely transfer of information to appropriate databases to fulfill data sharing goals as appropriate.
• Describe how this component will facilitate sharing of data, reagents and biospecimens with other Udall Centers and the PD research community as appropriate.

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

Not Applicable

Not Applicable

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

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Core)

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

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

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research Core)

List all performance sites that apply to the specific component.

Research & Related Senior/Key Person Profile (Research Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Research Core Lead must have appropriate expertise, as well as a record of productivity and collaboration, to ensure success of the Core. The expertise of the Core Lead may be in areas outside of PD research, if relevant skills can be readily applied to achievement of Center goals.
• Effort of Research Core personnel must be commensurate with the time required to perform proposed duties effectively.

Budget (Research Core)

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

Budgeting of funds to obtain biospecimens, including postmortem tissues, for direct use in Udall Center Research Projects is permitted; the NINDS will not, however, provide funds to support infrastructure for general brain or biospecimen banking efforts in a Udall Center Research Core. For NINDS policy on support for related efforts, see: Notice of Change in Funding Mechanism for Brain Banks.

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

PHS 398 Research Plan (Research Core)

Specific Aims: Describe the goals and planned activities of the Research Core, as well as the specific means by which it will directly address the overarching theme of the proposed Udall Center.

Research Strategy: Organize the Research Strategy into sections on Significance, Innovation and Approach.

Significance: Describe the essential relationship of the Research Core to at least two proposed Research Projects, the means through which this Core will advance the aims of each associated project, and what resources will be generated and shared, and how the Core will support the Center's status as a local and national resource for PD research.

Innovation: Describe how the standardized approaches and facilities utilized will both address the theme of the Udall Center and advance PD research.

Approach: Indicate percent usage by proposed Research Projects. For renewal applications, if continuation of a previously awarded Core is proposed, major accomplishments during the prior funding period must be described, including how resources generated in Research Cores are shared within and optimally beyond the Udall Center as appropriate.

Research Core approaches may include, but are not limited to:

• Shared, standardized assays.
• Standardized animal models.
• Neuropathology.
• Genetics/genomics and epidemiology.
• Proteomics, metabolomics.
• Statistics and data management.

Research Core approaches cannot include the following:

• Hypothesis- or discovery-driven Aims.
• Method or tool development.
• Establishment and maintenance of institutional infrastructure and generalized resources (including biospecimen repositories); such activities are beyond the scope of this FOA and other funding mechanisms should be utilized for those purposes.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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

Planned Enrollment Report (Research Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Research Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Clinical Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Clinical Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Clinical Core)

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

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

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Clinical Core)

List all performance sites that apply to the specific component.

Research & Related Senior/Key Person Profile (Clinical Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Clinical Core Lead must have appropriate expertise, as well as a record of productivity and collaboration, to ensure success of the Core. The expertise of the Core Lead may be in areas outside of PD research, if relevant skills can be readily applied to achievement of Center goals.
• Effort of Clinical Core personnel must be commensurate with the time required to perform proposed duties effectively.

Budget (Clinical Core)

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

Udall Center Clinical Core budget should include adequate costs for proactive subject recruitment and retention. Recruitment of subjects from diverse populations is an essential element of Udall Center clinical research; allocation of funds for special community outreach programs to increase diversity in Udall Center subject cohorts is strongly encouraged.

Funds dedicated to this Core must be utilized only to support those specific clinical activities necessary to support the Udall Center Clinical Research Project(s); the Core cannot be used to follow extended cohorts or populations or collect samples that are not directly related to activities of the proposed Center.

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

PHS 398 Research Plan (Clinical Core)

Specific Aims: Describe the subject population and related clinical data and biospecimens to be collected, as well as the specific means by which the Clinical Core will directly address the overarching theme of the proposed Udall Center.

Research Strategy: Organize the Research Strategy into sections on: Significance, Innovation and Approach.

Significance: Describe contributions of the Clinical Core to the goals of the Udall Center and its essential relationship to the complementary Clinical Research Project(s).

Innovation: Describe how the activities of the Clinical Core, including subjects chosen for study, will both address the theme of the Udall Center and advance PD research.

Approach: Describe the proposed activities of the Clinical Core which may include, but are not limited to, the following:

• Follow a defined cohort of patients and control subjects studied in Udall Center research projects.
• Collect standardized clinical data that conforms to NINDS Common Data Elements (CDEs) for PD as well as to NINDS PDBP core assessments and visit schedule.
• Deposit eligible data in the NINDS Data Management Resource (DMR).
• Standardize collection and storage of approved biospecimens according to the NINDS Parkinson's Disease Biomarkers Program (PDBP) protocols.
• Deposit approved biospecimens in the designated NINDS repository, including Human Genetics DNA and/or Cell Line Repositories (or other NINDS-designated repository).
• Provide information and samples to other Centers and researchers as requested.
• Promote patient education and community outreach, in collaboration with the Administrative Core.
• Integrate new technologies (e.g. mobile technologies, wearable devices, telemedicine) to improve data collection and subject participation.
• Center renewal applications should provide historical information on the cohort(s) followed in the Udall Center, and justify the need to continue following prior cohorts.

Applicants should provide a timeline of Core activities planned within the project period of Udall Center funding, and describe plans for continuation of the research cohort that would be required beyond that period of support.

Applicants are strongly encouraged to establish relationships with PD patient and advocacy groups and solicit their input on recruitment and the clinical meaningfulness of the question under study.

Every effort should be made to serve diverse racial and ethnic populations with this Core.

Recruitment and retention plans, including a discussion of the availability of subjects for the proposed study and the ability of enrolling centers to recruit and retain the proposed number of subjects, including women and minorities, should be included. Recruitment and retention strategies should be tailored and targeted for specific populations as appropriate. Strategies should be proven or creative/innovative. Data supporting recruitment and retention estimates should be provided. For multi-site studies, a site activation and management plan should be included. Study timeline, including enrollment period, and completion stage, should be described.

Collection of biospecimens and clinical data will follow policies and procedures of the NINDS Parkinson's Disease Biomarker Program (PDBP). A Global Unique Identifier (GUID), assigned by the PDBP Data Management Resource (DMR), is required for each enrolled participant. Clinical assessments will include core PDBP clinical elements, and will follow the assessment schedule outlined for the PDBP program. Collection of clinical assessments beyond the PDBP core assessment should be coordinated with the NINDS. All clinical data will be entered through the Protocol and Forms Research Management (ProFoRMS) module of the PDBP DMR. Subject consent must allow for broad data sharing with both industry and academic investigators through the NINDS PDBP DMR, as appropriate and consistent with achieving the goals of this program.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• Use of NINDS Common Data Elements (CDEs) to standardize the collection of clinical data is strongly encouraged; the NINDS PDBP utilizes the NINDS CDEs for data collection. To increase the impact of a proposed clinical component, applicants are also strongly encouraged to strengthen their proposed investigation through collaboration and sharing within and beyond the Udall Centers program as appropriate and consistent with achieving the goals of the program.

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

Subject consent: Describe how participating subjects will be fully informed, under informed consent procedures. Center consent forms should specifically address the following: (1) disclosure that de-identified biological materials and clinical data may be distributed to other researchers in both academia and in industry; (2) assurance that such data will be stored and maintained without personal identifiers; (3) disclosure that analyses of these data may be conducted by other scientists currently not included within the current research team, potentially including those with commercial interests; (4) disclosure that the data collected by the researchers may be used as necessary for future unspecified research; (5) allowance for whole genome sequencing and sharing of data through a cloud-based computing services resource (related information is available through NOT-OD-15-086).

Planned Enrollment Report (Clinical Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Clinical Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

Basic research projects are hypothesis-driven investigations designed to elucidate disease mechanisms and identify optimal targets for therapeutic intervention. Basic research may utilize model systems or exempt (de-identified) human biospecimens. While serving as the basis for discovery, this research should be informed and refined by the results of well-designed clinical studies on PD.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Basic Research Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Basic Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Basic Research Project)

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

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

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Basic Research Project)

List all performance sites that apply to the specific component.

Research & Related Senior/Key Person Profile (Basic Research Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Basic Research Project Lead must demonstrate active, R01-equivalent, independent funding and excellent scientific productivity. The expertise of Project Lead may be in areas outside of PD research, if relevant skills can be readily applied to achievement of Center goals.
• Effort of Basic Research Project personnel must be commensurate with the time required to perform proposed duties effectively.

Budget (Basic Research Project)

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

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

PHS 398 Research Plan (Basic Research Project)

Specific Aims: State the aims of the basic research project and the hypotheses to be tested. Justify need for the Udall Center structure to accomplish the proposed aims.

Research Strategy: Organize the Research Strategy into sections on Significance, Innovation and Approach.

Significance: Describe and justify the identified basic research need in the context of the critical PD research challenge identified by the Center theme. Describe the contributions of the basic research project to the goals of the Udall Center. Detail how successful completion of the proposed studies will inform and advance PD research and treatment, especially the crucial challenge identified by the Center theme.

Innovation: Provide evidence that use of novel concepts, models, and/or techniques will contribute to the advancement of PD research.

Approach: Describe the experimental approaches and model system(s) utilized to address the specific aims. Examples of basic research projects include, but are not limited to, the following:

• Characterization of cellular and molecular mechanisms of disease processes.
• Elucidation of the mechanism of action, including neural pathways and systems contexts, of identified PD risk genes.
• Identification and characterization of genetic and/or environmental risk factors that predict disease onset and progression.
• Identification of novel therapeutic targets and pathways via hypothesis-driven, mechanistic studies.
• Development of improved animal models, and their use for investigation of disease pathophysiology, progression and efficacy of therapeutic intervention.
• Research in model systems designed to validate clinically identified biomarkers for disease onset, progression, and response to treatment.
• Use of de-identified human biospecimens, including postmortem tissues and other biospecimens, to elucidate idiopathic or genetic disease mechanisms.

Requested support for the creation of model systems, including but not limited to animal models and induced pluripotent stem cells (iPSC), requires strong justification and will not be provided if proposed studies recapitulate currently available resources. Applicants proposing to develop iPSC lines should review NINDS Requirements for Induced Pluripotent Stem Cell Development and Resource Sharing (NOT-NS-14-032).

Provide a strong biological rationale for the intended approach. The NINDS urges applicants to consider the rationale for the chosen model(s) and endpoints, adequacy of controls, justification of sample size, statistical methods, blinding methods, strategies for randomization, and robustness and reproducibility of results. Where appropriate, potential conflicts of interest should be noted when describing supporting data and designing the proposed studies. Applicants are strongly urged to address these criteria when describing supporting data and designing the proposed studies (as appropriate).

Letters of Support:

Collaboration with NIH Intramural Researchers (if applicable): Include a letter from the Scientific Director of the collaborating NIH Institute or Center. The letter must describe the role of intramural staff, and specify the nature and amount (funding) of NIH intramural resources to be allocated to the proposed project. In addition, the letter should state that the conduct of the project will comply with the DHHS regulations for research involving human subjects (if applicable) and with the PHS policy on vertebrate animal research (if applicable).

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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

Planned Enrollment Report (Basic Research Project)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Basic Research Project)

Not Applicable

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

In general, translational research applies ideas, insights, and discoveries generated through basic scientific inquiry to the treatment or prevention of human disease. The specific goal of the Udall Centers translational research project is to accelerate discoveries leading to early human testing of a new drug, biologic, or other therapeutic or preventative intervention for PD. Successful translational research projects will demonstrate that proposed therapeutic agent(s) have sufficient biological activity to warrant further development for the treatment of PD.

Pursuant to the goals of this initiative, Udall Center translational research projects should be directed towards the subsequent pursuit of IND-enabling studies (e.g. through programs sponsored by the NINDS Office of Translational Research, including Cooperative Research to Enable and Advance Translational Enterprises (CREATE) BIO and the NIH Blueprint Neurotherapeutics Network for Small Molecule Development, and/or by collaboration with industry partners). For example, Udall Center translational research projects could be directed toward characterization of candidate therapeutic leads, including demonstration of clear dose-response relationships, in vivo efficacy using clinically relevant outcome measures, and in vivo target engagement. Only those targeted activities leading to future IND-enabling studies may be included in a translational research project; mechanistic studies are appropriate for basic research projects only.

Applicants must identify designated translational projects within the application.

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

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Translational Research Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Translational Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Translational Research Project)

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

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

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Other Attachments: Applicants should include an attachment titled, "Intellectual Property" to address the following considerations, consistent with achieving the goals of the program. Applicants are encouraged to prepare this section of the application in consultation with their institutional technology transfer official(s).

• Describe the intellectual property landscape surrounding the therapeutic candidate, including any known constraints that may impede the development (e.g., certain restrictions under transfer or sharing agreements, applicants' previous or present intellectual property filings and publications, similar therapeutics that are under patent and/or on the market, etc.) and how these constraints could be addressed.
• Address any questions regarding freedom to operate.
• If applicable, describe plans for filing intellectual property as appropriate.
• Clarify how intellectual property will be shared or otherwise managed as appropriate if there are multiple institutions or entities involved in proposed work.

Project /Performance Site Location(s) (Translational Research Project)

List all performance sites that apply to the specific component.

Research & Related Senior/Key Person Profile (Translational Research Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Translational Research Project Lead must demonstrate active, R01-equivalent, independent funding and excellent scientific productivity. The expertise of Project Lead may be in areas outside of PD research, if relevant skills can be readily applied to achievement of Center goals.
• Effort of Translational Research Project personnel must be commensurate with the time required to perform proposed duties effectively.

Budget (Translational Research Project)

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

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

PHS 398 Research Plan (Translational Research Project)

Specific Aims: State the aims of the translational research project and the therapeutic strategy to be developed. Explain why the Udall Center structure is required to accomplish the proposed translational project aims.

Research Strategy: Organize the Research Strategy into sections on Significance, Innovation and Approach.

Significance: Describe how proposed translational studies will advance development of novel or improved PD therapeutic entities. Describe how proposed studies address the critical challenge identified by the Center theme. State how, if successful, proposed studies will support further development of candidate therapeutics for the treatment of PD, including steps toward IND-enabling research, e.g. via entry into subsequent translational research programs and/or collaborations with industry partners.

Innovation: Describe novel aspects of the research (e.g. target, method(s), model(s)) and potential to advance state-of-the-art therapeutic strategies for PD.

Approach: Describe proposed therapeutic development activities. State the biological rationale for the intended approach, including supporting data from rigorously designed experiments. Indicate the methodological rigor of proposed studies. Provide the rationale for the chosen model(s) and endpoints, adequacy of controls, route and timing of therapeutic dosing, justification of sample size, statistical methods, blinding methods, strategies for randomization, and robustness and reproducibility of results. Describe how results of the proposed studies will be applied to advance preclinical development, including a plan for continued therapy development that demonstrates an awareness of future goals and challenges. Include preliminary plans to establish the necessary collaborations and funding to further the translational research project.

Responsive translational research studies may include, but are not limited to, the following:

• Target validation, including readouts for target engagement, target activity, and phenotypic result in model biological systems.
• Characterization of candidate therapeutics, including pharmacokinetics, biophysical or physico-chemical characteristics, and pharmacodynamic/pharmacokinetic relationship.
• Demonstration of target engagement by the candidate therapeutic.
• Development of pharmacodynamic biomarkers, including those that allow for the direct or downstream readout of target engagement of an intended therapeutic; biomarker studies must comply with policy delineated in NOT-NS-13-020.
• Evaluation of preclinical in vivo efficacy using animal models of PD, particularly in relationship to candidate therapeutic exposure.
• Development and validation of animal models of PD which include physiologically meaningful endpoints of disease that can be tested in both preclinical and clinical settings.

Out of scope projects include, but are not limited to:

• Basic research and studies of disease mechanism.
• Development of animal models to be used solely for hypothesis-driven research on disease mechanism.
• Use of tool compounds to identify targets relevant to disease.
• Development of risk, detection, diagnostic, prognostic, predictive, and prevention biomarkers.
• IND-enabling studies, such as GLP toxicology, formulation and manufacturing.
• Clinical studies involving non-exempt human subjects.

Discovery and development of therapeutic devices.

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

Requested support for the creation of model systems, including but not limited to animal models, requires strong justification and will not be provided if proposed studies recapitulate currently available resources.

Letters of Support:

Collaboration with NIH Intramural Researchers (if applicable): Include a letter from the Scientific Director of the collaborating NIH Institute. The letter must describe the role of intramural staff, and specify the nature and amount (funding) of NIH intramural resources to be allocated to the proposed project. In addition, the letter should state that the conduct of the project will comply with the DHHS regulations for research involving human subjects (if applicable) and with the PHS policy on vertebrate animal research (if applicable).

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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

Planned Enrollment Report (Translational Research Project)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Translational Research Project)

Not Applicable

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

Udall Center clinical research projects include patient-oriented research, i.e. research that involves direct investigator interaction with human subjects, with a specific focus on understanding the mechanism of human disease. According to NIH policy, in vitro studies that utilize de-identified samples (i.e. those falling under 45 CFR part 46.101(b) (4) (Exemption 4)) are not considered clinical research. For purposes of this announcement, such studies should be proposed as basic research projects. Clinical trials, as defined by NOT-OD-15-015, are beyond the scope of the Udall Center FOA.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Clinical Research Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Clinical Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Clinical Research Project)

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

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

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Clinical Research Project)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Clinical Research Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons who are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Clinical Research Project Lead must demonstrate active, R01-equivalent, independent funding and excellent scientific productivity. The expertise of Project Lead may be in areas outside of PD research, if relevant skills can be readily applied to achievement of Center goals.
• Effort of Clinical Research Project personnel must be commensurate with the time required to perform proposed duties effectively.

Budget (Clinical Research Project)

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

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

PHS 398 Research Plan (Clinical Research Project)

Specific Aims: State the research goals of the clinical research project and expected contributions to the goals of the Udall Center. Explain why the Udall Center structure is essential to accomplish the proposed aims.

Research Strategy: Organize the Research Strategy into sections on Significance, Innovation and Approach.

Significance: Describe the rationale for proposed clinical studies based on unmet medical need for PD. Describe and clearly justify the identified research need. Address how successful completion of the proposed studies will inform and advance future PD research and clinical trials.

Innovation: Describe novel aspects of clinical studies and potential to inform disease mechanisms and advance state-of-the-art treatment strategies for PD.

Approach: Describe how proposed clinical studies will improve understanding and treatment of PD. State the biological rationale for the intended approach, including supporting data from rigorously designed preclinical experiments and clinical studies. Indicate the methodological rigor of proposed studies. Provide the rationale for the chosen subjects and endpoints, adequacy of controls, justification of sample size, statistical methods, and robustness and reproducibility of results. Areas of investigation may include, but are not limited to, the following examples:

• Development of biomarkers for disease risk, onset, progression, detection, and prevention; biomarkers studies must comply with policy outlined in NOT-NS-13-020.
• Improved understanding of prodromal disease and identification of pre-symptomatic PD patients.
• Elucidation of non-motor aspects of Parkinson’s disease, including alterations in mood and cognition, behavioral changes, sleep disturbances, fatigue, autonomic dysfunction, gastrointestinal problems.
• Identification of patient subgroups and at-risk subjects to inform clinical trial design.
• Studies to support discovery of novel targets for therapeutic interventions or develop outcome measures for future interventional trials.
• Determination of whether a clinical manipulation produces sufficient evidence of short-term activity, e.g. biomarker activity, target engagement, pharmacokinetic/ pharmacodynamic response.
• Clinical trials are beyond the scope of Udall Center applications. The recently revised NIH definition of "clinical trial" is: " A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes (NOT-OD-15-015)." Applicants should instead refer to funding opportunities available through the NINDS Office of Clinical Research, including NINDS Exploratory Trials (PAR-13-281) and NINDS Phase III Investigator-Initiated Multi-Site Clinical Trials (PAR-13-278). Pre-submission consultation with the NINDS Scientific/Research staff regarding the scope of proposed clinical studies is recommended.

Letters of Support:

Collaboration with NIH Intramural Researchers (if applicable): Include a letter from the Scientific Director of the collaborating NIH Institute. The letter must describe the role of intramural staff, and specify the nature and amount (funding) of NIH intramural resources to be allocated to the proposed project. In addition, the letter should state that the conduct of the project will comply with the DHHS regulations for research involving human subjects (if applicable) and with the PHS policy on vertebrate animal research (if applicable).

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• Eligible data and biospecimens from Udall Center clinical research projects are expected to be shared via the NINDS Data Management Resource (DMR) described in "Other Submission Requirements and Information," below, consistent with achieving the goals of the program. For more information regarding consent requirements, see the Parkinson's Disease Biomarkers Program Data Management Resource consent language guidelines. While these guidelines are listed regarding Biomarkers projects, it is expected that all projects under the Udall Program meet these requirements in order to allow broad sharing.

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

Planned Enrollment Report (Clinical Research Project)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Clinical Research Project)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

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

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

See more tips for avoiding common errors.

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

Biospecimen Collection and Distribution

Biospecimens must be collected using protocols of the NINDS Parkinson's Disease Biomarkers Program (PDBP) Laboratory Manual. If site logistics are challenging regarding the PDBP protocols, then the Alzheimer s Disease Neuroimaging Initiative (ADNI) protocols could be used as an alternative, pending approval of the NINDS program officer. Biospecimens collected must include whole blood and serum; collection of peripheral blood mononuclear cells (PBMC) and cerebrospinal fluid (CSF) are encouraged. Collection of additional biospecimens (e.g. fibroblasts) should be justified within the application and will require NINDS approval.

Consent forms (submitted as appendix material) must clearly state that any biological samples and de-identified clinical data will be appropriately shared with academics or industry and must be consistent with the designated NINDS Repository and NINDS PDBP Data Management Resource (DMR) broad consent requirements. A copy of the consent form for each subject should be kept on file by the investigator but does not need to be sent with each sample.

NINDS Common Data Elements (CDEs)

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

General CDEs

All "core" General CDE items and forms will be required in the following domains for all subjects:

• Participant/Subject Characteristics (Demographics).
• Participant/Subject History (Medical History and Behavioral History).
• Assessments and Examinations (Physical/Neurological Exam, Vital Signs, Laboratory Tests and Biospecimens/Biomarkers).
• Treatment/Intervention Data (Prior and Concomitant Medications).
• Protocol Experience (Inclusion and Exclusion Criteria, Informed Consent and Enrollment).

PD-Specific CDEs

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

• Participant/Subject Characteristics (Demographics).
• Participant/Subject History and Family History (Medical History, Family History).
• Assessments and Examinations (MDS-UPDRS, Hamilton Depression and Anxiety Rating Scales, Montreal Cognitive Assessment, Epworth Sleepiness Scale, RBD Screening Questionnaire, and University of Pennsylvania Smell Identification Test (UPSIT)).
• Treatment/Intervention Data (PD Medication Log).
• Outcomes and End Points (PDQ-39).
• Additionally, the Schwab and England ADL Scale will be required.

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

As appropriate, applicants are encouraged to make use of the following resources for clinical research:

• NeuroQOL (http://www.neuroqol.org).
• NIH Toolbox (http://www.nihtoolbox.org).
• PROMIS (http://www.nihpromis.org).

Data Management and Storage

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

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

Collaborations with NIH Intramural Scientists

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

During the application process, intramural researchers must provide their Scientific Director with copies of formal letters of collaboration, and in turn obtain written approval from the Scientific Director for inclusion within the Udall Center application. All requests for substantial intramural involvement in extramural research activities must also be approved by the Ethics and Grants Management Offices from the respective NIH Institute or Center (IC).

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

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

At an early planning stage, Udall Center applicants intending to collaborate with NIH intramural investigators are encouraged contact the NINDS Scientific/Research personnel, below.

Participation in Annual Udall Center Meetings

Annual meetings of Udall Center Directors are held each autumn in Bethesda, MD. Meeting planning duties will be shared between the NINDS and the Udall Center Coordinating Committee (UC3). The meeting is designed to provide dedicated time during which Center investigators can discuss emergent issues and approaches in the research and treatment of PD. By providing a focused and interactive Agenda, the annual meeting fosters the initiation and maintenance of collaborative efforts and resource sharing among the Centers.

Participation in Udall Center Coordinating Committee (UC3) Activities

The Center Director will participate in activities of the Udall Center Coordinating Committee (UC3), which promotes collaboration and strengthens cooperation among the network of active Udall Centers. For example, the UC3 functions to:

• Strengthen communication and data sharing among Udall Centers.
• Define and share best practices and resources.
• Identify novel collaborative research opportunities.
• Pursue mechanisms for translation of research findings toward clinical realization.
• Coordinate activities in areas of common interest, including investigator career enhancement and community outreach.
• Facilitate interdisciplinary collaboration in PD research among and beyond the Udall Centers.
• Develop, implement and monitor metrics for the evaluation of program progress.

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

Post Submission Materials

Add modifications only if your FOA will deviate from the Notice by adding bullets describing the modification (otherwise delete modifications text and replace with . )

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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

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

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

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

Does the proposed Center identify and address a critical challenge in PD research? Is there strong evidence that the proposed Center will advance research in PD, through both its scientific projects and cores? Will the proposed Center effectively meet the stated goals of the Udall Centers Program, i.e. to rapidly advance an innovative, interdisciplinary, highly impactful research program while serving as a national leader in PD research? Is the use of the Specialized Center (P50) mechanism justified and will the proposed research benefit from the Center structure?

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

For new applications: Do the stated goals of the proposed Center demonstrate the potential for research discoveries of high significance? Is there a critical mass of high quality research in PD and parkinsonian disorders in the proposed Center? Have the investigators described what knowledge and resources will be contributed to the Udall Centers program, and to PD research at the local and national levels?

For renewal applications: Has the Center been productive and generated high-impact research discoveries during the prior funding period? Has the Center remained on the cutting edge of PD research, and does the Center have the infrastructure and assembled team to pursue the proposed objectives? Is there evidence that the Center has served as a national leader in PD research?

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

Reviewers will consider the following during evaluation of the Center Director:

Will the Udall Center Director provide visionary scientific leadership of the Center? Does the Director have appropriate leadership experience, including leading a large-scale research program, that predicts success of the Center? Is the Director an established leader in scientific research with a history of successful funding, as well as currently active funding? Has the Director made an appropriate time commitment to the Center, including leadership of the Administrative Core? If the Director s primary area of expertise is in an area other than PD research, is it clear that the Director’s skills can be applied in novel ways to the advancement of PD research and treatment?

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

During evaluation of the proposed Center applications, reviewers will consider the level of innovation specifically related to state-of-the-art PD research, including the following: Does the Center take novel approaches to advancing the stated goals of the proposed Udall Center, i.e., will proposed research advance understanding of PD and development of novel and/or improved therapies? Are the proposed projects likely to make major rather than incremental advances toward this goal?

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

If the Center involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Is the Center organized around a clearly articulated central theme? Is the synergistic relationship among the Center components, especially the scientific and collaborative approaches that will ensure thematic coherence of Center research and activities, clearly described? Is there sufficient scientific evidence to support the formation of a new or continuation of an existing Udall Center?

Will successful completion of proposed objectives directly inform the pathology, progression and treatment of PD? Is there evidence that individual Center investigators will function as an effective collaborative team to achieve the goals of the Center? Has the Center demonstrated ability (renewal applications) or does the Center have the capacity (new applications) to mobilize local resources and contribute to PD research at a local and national level?

Are there appropriate plans for the Center to collaborate and otherwise contribute to the overall Udall Centers program, through participating in collaborative efforts, the Udall Centers Coordinating Committee, the annual Center Directors' meeting, and other program-wide activities?

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

In addition, reviewers will consider the following:

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

Does the applicant institution support a strong research base on PD and/or other neurodegenerative disorders? If the applicant institution houses other large-scale, PD-related research efforts, is there adequate description of the relationship between the proposed Udall Center and those projects, and is potential overlap addressed appropriately?

If Center investigators are located at more than one institution, are planned communication and collaboration strategies detailed and appropriate?

Scored Review Criteria - Research Projects

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

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How will the project contribute to the overall success of the Udall Center? Will the proposed research result in major rather than incremental advances in PD research?

Investigator(s)

Is the expertise of the research project leader, collaborators, and other researchers well suited to the project? Does the project lead have a productive record of bringing novel and significant projects to fruition as an independent principal investigator? If the investigator does not have current NIH funding, does (s)he have active, independent funding that is the equivalent of an NIH R01? Is sufficient investigator effort dedicated to the research project and Center activities?

Innovation

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

Does the project challenge existing paradigms or clinical standards, address an innovative hypothesis or critical barrier to progress in the field? Is the work proposed appropriate to the expertise of the PD/PI and other researchers?

If applicable, does the proposed basic research project show evidence of rigor in terms of rationale, preliminary data, experimental design and strategies to minimize bias?

If applicable, does the proposed translational project have the potential to lead to the development of a novel or improved therapy? Is the study defined appropriately to demonstrate whether or not proposed therapeutic agent(s) will have sufficient biological activity to warrant further development? Does the translational project contain rigorous proof-of-principle for therapeutic efficacy or establishment of assays or models necessary to advance the PD therapeutic research pipeline? Is the model, including timing of treatment and route of delivery, justified and are appropriate endpoints included? Will successful completion of proposed studies lead to further IND-enabling research, either via entry into translational programs and/or industry partnerships? Are the applicants aware of goals and challenges, as well as necessary collaborative interactions required, for future therapy development?

If applicable, is the proposed clinical project rationale based upon a sufficiently rigorous body of high quality preclinical or clinical research? Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well-reasoned, and appropriate to the aims of the project? Are the subject population and stated endpoints well-justified?

Environment

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

Review Criteria - Cores

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

Administrative Core

Does the Administrative Core Lead/Center Director have appropriate expertise and dedicate sufficient time to administrative activities? If an Associate Director is named, does that person have required expertise to effectively assist the Center Director with scientific and administrative management? Does the Center Administrator have sufficient expertise with NIH policies, practices and fiscal management to provide support for the program?

Is the line of communication clear between the Center Director and Center Administrator? Is there an appropriate plan for establishing and maintaining effective communications and cooperation among Center investigators and with investigators outside the Center? Is the proposed management structure appropriate for scientific administration, coordination of resource generation and utilization, as well as fiscal administration, procurement, property and personnel management, planning and budgeting? Does the Core support the Center's role as a national leader in PD research?

Are there internal and external procedures for monitoring and evaluating the proposed research projects and core facilities/resources? Are there appropriate plans for management of data, animal models and other resources?

Are there appropriate plans for establishing the External Advisory Committee (EAC), and will the EAC contribute to the oversight of Center research projects, and other components? Are there plans to appoint a patient advocate to the EAC?

Does the Administrative Core contain the required mission statement for and overview of career enhancement activities? Are proposed activities well-integrated into the theme of the Center? Are proposed career enhancement activities specifically designed for Udall Center investigators, i.e. are activities separate from and do they enhance/build upon existing institutional resources and programs? For renewals, are accomplishments from the prior funding period described?

Does the Administrative Core contain the required Attachment describing Community Outreach activities? Is there a clear strategy for the organization of an annual local outreach event? Are proposed outreach activities designed to inform and engage the public about research ongoing in the Udall Center, as well as how that research integrates into current advances in PD research? Do Center investigators participate in community outreach efforts to increase awareness and convey the importance and implications of their research activities to the patient and advocacy communities? Is the Center website established and maintained (renewals), or are plans to do so described (new applications)?

Research Cores

Is the Research Core essential to advance the scientific aims of at least two proposed research projects? Does the Core address the central theme of the overall program? Will the facilities or services provided by the Core (including procedures, techniques, and quality control) be used effectively? Are the Core Lead and key personnel well-qualified to provide the Core service(s)? Does the Core generate and share resources that support the Center's status as a national resource for PD research (renewals) or have the potential to do so (new applications)? For proposed continuation Cores in renewal applications, was the previous Core successful in achieving its stated goals?

Clinical Core

Is the Clinical Core essential for the support of the proposed clinical research project(s)? Does the Core Leader have the appropriate expertise and seniority to direct the proposed Clinical Core facility? Are there appropriate plans for the rigorous management and quality control of any research data or materials to be obtained from human subjects?

Are plans in place for subject recruitment? Is there a specific and feasible plan for inclusion of diversity in subject recruitment? Is the proposed subject cohort well-defined and appropriately diverse? Are proposed plans for recruitment and retention of the population adequate?

Have standard operating procedures been established for collection and storage of biological samples and/or for genotype/phenotype information? Will biospecimen collection adhere to protocols of the NINDS PD Biomarkers Program (PDBP)? Is the deposition of biospecimens in the NINDS or other designated repository addressed? Will clinical data be collected using the NINDS Common Data Elements (CDEs)? Do plans include standardized collection and transmission of data to the designated NINDS Data Management Resource (DMR)?

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

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

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

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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

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.

Not Applicable

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

Not Applicable

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

Intellectual Property (for Translational Research Projects only)

Is the intellectual property (IP) landscape for the therapeutic candidate described? Are potential issues regarding the IP landscape for the therapeutic being addressed? Do the IP Strategy attachment and related letters of support address potential concerns? Are there any known constraints that could impede the development of the therapeutic? If applicable, are IP filing plans described? If multiple institutions or entities are involved, is IP sharing addressed?

Not Applicable

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).

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

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the National Institute of Neurological Disorders and Stroke (NINDS) in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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

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

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Areas of complementarity to existing Udall Centers
• Compliance with data and resource sharing policies.
• Number of applications from each institution (only one NINDS Morris K. Udall Center of Excellence may be awarded at any one institution).
• Consideration of NINDS programmatic priorities may also include relevance of proposed studies to priorities identified in NINDS PD2014 research recommendations.

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

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

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

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

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Beth-Anne Sieber, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-5680
Email: [email protected]

Birgit Neuhuber, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-3562
Email: [email protected]

Tijuanna DeCoster, PhD, MPA
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and the Morris K. Udall Parkinson’s Disease Research Act of 1997 Public Law 105-78.