Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

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

Activity Code

P50 Specialized Center

Announcement Type

Reissue of RFA-NS-13-006

Related Notices

  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • May 5, 2014 - See Notice NOT-NS-14-030. Notice to Correct the Advisory Council Review Date and Start Date.

Funding Opportunity Announcement (FOA) Number

RFA-NS-14-003

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.853

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications for the Morris K. Udall Centers of Excellence for Parkinson’s Disease Research program. The overarching goal of the specialized Udall Centers program is to establish a network of Centers that work collaboratively as well as independently to define the causes of and discover improved treatments for Parkinson’s disease (PD). A more immediate goal for each Center is to rapidly advance synergistic, interdisciplinary research programs while serving as local resources and national leaders in PD research. The overall theme, proposed research projects, and associated cores must inform the etiology, pathogenesis or treatment of PD. Investigations on related synucleinopathies may be included, to the extent that these directly inform PD research. Required components include: 1) a minimum of three research projects; 2) research cores that are essential to accomplish the aims of proposed research projects, plus an Administrative Core; and 3) a specific plan for training of PD researchers. The NINDS Udall Centers program prioritizes innovative and integrative research with significant potential for discovery. A considerable degree of synergy must be evident among Center research projects and cores, such that successful completion of the aims could not be accomplished without the Center structure. The Udall Center Director (PD/PI) must be an established leader in scientific research with visionary leadership skills and proven expertise in research project and personnel management. Eligible institutions must demonstrate commitment to and support for the establishment and continuation of the proposed Udall Center. Funding decisions will focus on those applications most likely to make innovative contributions to PD research, as well as those with greatest potential to contribute new ideas to and collaborate effectively across the Centers program.

Key Dates
Posted Date

April 28, 2014

Open Date (Earliest Submission Date)

May 30, 2014

Letter of Intent Due Date(s)

May 30, 2014

Application Due Date(s)

June 30, 2014 , by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October, 2014

Advisory Council Review

(New Date January, 2015 per NOT-NS-14-030), Originally January, 2014

Earliest Start Date

(New Date March, 2015 per NOT-NS-14-030), Originally March, 2014

Expiration Date

July 1, 2014

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

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.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

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 Centers of Excellence for Parkinson’s Disease Research program was established as part of the Morris K. Udall Parkinson’s Disease Research Act of 1997 (P.L. 105-78), legislation passed to honor the distinguished Representative from Arizona who died in 1998 after a long battle with PD. In 2014, 10 NINDS Udall Centers apply multidisciplinary research approaches to elucidate the fundamental causes of PD as well as to improve the diagnosis and treatment of patients with PD.

The overarching goal of the NINDS Udall Centers of Excellence program is to establish a network of Centers that work collaboratively as well as independently to define the causes of and discover improved treatments for PD. Udall Centers advance understanding of PD by pursuing high-impact, integrative research programs while serving as local resources for and national leaders in PD research and treatment development. Another important goal of this program is to further PD research and collaboration by sharing data and research resources developed through this Centers program. Udall Centers have identified and characterized candidate and disease-associated genes, examined neurobiological and neuropathological mechanisms underlying PD, established improved PD models, developed and tested potential therapeutics, and explored novel avenues of clinical research.

The NINDS Udall Centers program prioritizes innovative and integrative research with significant potential for discovery. The overall theme of each Center, proposed research projects, and cores will inform the etiology, pathogenesis or treatment of PD. Each applicant team has the flexibility to submit the combination of projects (basic, translational, clinical research) that will address the stated theme.  Basic research has served and will continue to serve as the foundation of discovery in the Udall Centers program; therefore applicants are encouraged to build upon this vital foundation to translate basic and clinical research observations into improved treatments for PD. Inclusion of a translational research project is optional but strongly encouraged. The design of each application should optimize the potential contributions of that proposed Center to PD research as well as contribute to the advancement of the overarching goals of the NINDS Udall Centers program.

Udall Center applications are expected to emphasize novel ideas and approaches, as well as use of state-of-the-art technologies and a team-based approach to achieve stated goals. Responsive applications will demonstrate proven ability (renewals) or considerable potential (new applications) to: contribute unique knowledge and scientific advances to the Udall Centers program; collaborate effectively with existing Centers; pursue translation of research to clinical practice; and to serve as local resources and national leaders in PD research. Applicants are encouraged to propose an innovative spectrum of research activities using an integrated, interdisciplinary approach to rapidly advance PD research. Investigations on related synucleinopathies may also be included, to the extent that these inform research on PD. Applicants are strongly encouraged to include at least one translational research project designed to address the gap between PD research and treatment (defined below). Pilot research projects are not permitted. Research Cores must accelerate the pace of discovery via essential support for the aims of proposed research projects; neither hypothesis nor discovery-driven research aims can be included in Cores. Additional requirements include an Administrative Core and a mission statement for and description of research training. The Udall Centers program also requires potential for (new applications) or evidence of (renewal applications) service as a local and national resource for PD research. Related, supportive factors include, but are not limited to, broad sharing of data and resources and clearly defined community outreach activities. Proposed studies must be feasible within the budget limits described elsewhere in this announcement. The NIH Specialized Centers mechanism (P50) supports integrative, multidisciplinary activities; investigators seeking support for multi-component research projects focused solely on clinical studies should utilize alternative grant mechanisms.

Clinical studies designed to evaluate the dosage, safety, tolerability or efficacy of an intervention for the treatment of PD are beyond the scope of this Udall Center announcement; 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)

NINDS funding decisions will focus on those applications that are most likely to make innovative contributions to PD research, that demonstrate the potential to contribute new ideas to and collaborate effectively across the Centers program, and that address research recommendations from the recent NINDS conference "Parkinson's Disease 2014: Advancing Research, Improving Lives

("NINDS PD2014 recommendations")." Although new Centers are not expected to have pre-existing collaborations with established Centers, potential areas of shared interest with active NINDS Udall Centers should be considered and included in the application. The NINDS will consider the full scope of Udall Center programmatic activities when making funding decisions; applications proposing goals identical to or largely overlapping with active Udall Centers will receive lower program priority.

The NINDS 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.  

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New
Renewal

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

Funds Available and Anticipated Number of Awards

The NINDS intends to commit approximately $9,000,000 in fiscal year 2014 to fund up to 4 new and/or renewal awards. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Applicants may request up to $1,000,000 direct costs per year (exclusive of facilities and administrative costs of subcontracts with collaborating institutions) with the following exception:  applications containing a translational research project and/or a clinical component (i.e. a clinical research project plus a clinical core) may request up to $1,500,000 direct costs per year.  Requested budgets should be clearly justified by the research requirements of the proposed Udall Center.

Award Project Period

5 years 

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

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Eligible institutions should support an active base of high-quality research on PD and related neurodegenerative diseases.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

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.

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.

Eligible Individuals (Program Director/Principal Investigator)

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

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

Udall Center Director

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

Udall Center Research Project and Core Leaders

Project leaders must demonstrate active, R01-equivalent, independent funding and excellent scientific productivity. Core leaders must have appropriate expertise, as well as a record of productivity and collaboration, to ensure success of the Core. All investigators must contribute to, and share in, the responsibilities of fulfilling Center objectives. As noted for Center Directors, the expertise of Project and Core Leaders may also be in areas outside of PD research, if relevant skills can be readily applied to the goals of the Center.

Udall Center Administrator

Each Center shall include a Center Administrator. This position will be filled by an expert administrator, not by the Center Director or by Project or Core Leaders. The Administrator must have proficiency in administrative oversight and coordination of large research projects. Additional duties will include coordination of data for the annual progress report, including information on research discoveries, publications, funding sources, outreach and education efforts, and training outcomes.

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct. Only one Udall Center can be awarded and active at any institution. Simultaneous Udall Center (P50) and NINDS Exploratory Grant (P20) awards will not be made at any one institution.

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

Section IV. Application and Submission Information


1. Requesting an Application Package

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

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.

2. Content and Form of Application Submission

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

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

Letter of Intent

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

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

The letter of intent should be sent to:

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

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12

Admin Core

6

Core (use for Research Cores, Clinical Cores, and Service Cores)

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.

Instructions for the Submission of Multi-Component Applications

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

The application should consist of the following components:

Overall Component

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.

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

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

Center Organizational Structure: a diagram demonstrating interactions among Center components.

Research Core Utilization: to assist reviewers in determining the relationship between Research Projects and Cores, provide a table that indicates percentage use of each core relative to the individual projects.

Project/Performance Site Location(s) (Overall)

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.

Research & Related Senior/Key Person Profile (Overall)

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.

Budget (Overall)

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.

PHS 398 Research Plan          (Overall)

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

Research Strategy:  The Overall section states the 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:  Provide a vision statement for the Center, including 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 local and national resource for PD research; related justification may include, but is not limited to, broad sharing of data and resources, community outreach activities.

Innovation: Describe how novel approaches, investigator expertise, and collaborative activities will advance the goals of the Udall Centers program, including unique contribution of knowledge to developing improved therapeutic advances for PD.

Approach:  Describe the general research framework of the Center. Discuss the proposed research program, highlighting its central theme. Describe the synergistic relationship among the Center components, especially the scientific and collaborative approaches that will ensure thematic coherence of Center research and activities. Clearly relate the goals of the Udall Center to the NINDS PD2014 recommendations. Detailed descriptions of preliminary data for new projects (new and renewal applications) or progress on existing projects (renewal applications) should be included within the relevant 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. Highlight potential to collaborate with existing Udall Centers. Define the potential role of the Center as a local and national resource for PD research, including but not limited to PD research resource and data sharing, as well as outreach to the PD patient and advocacy communities.

Renewal applications: Describe the overall accomplishments of the Udall Center during the last funding period, including a brief synopsis of the goals and accomplishments of prior projects, including the overall scientific/clinical merit and impact of those projects and of the Udall Center as a whole. Provide examples of Center leadership in and contributions to the advancement of PD research. Highlight synergistic interactions among the Center investigators; establishment of new collaborations; and the effectiveness of the core resources and facilities for collaborations within and beyond the Center. Detail training outcomes and any outreach/education activities. Describe integration into the Udall Center network via collaboration, publication, sharing of resources, etc. Describe past and planned activities that support service of the Center as a local and national resource for PD research.

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 training activities, access to institutional infrastructure, cost sharing, assignment of specialized research space, 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 describe collaborative efforts and/or opportunities with other 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), 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 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).

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 community outreach efforts.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Administrative Core

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.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative 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.

Other Attachments: All applications must include an attachment titled "Description of Research Training" that addresses the goals of the Udall Centers program, i.e. to foster proficiency across the broad spectrum of basic, translational and clinical concepts, as well as develop practical skills, that are necessary for trainees to successfully establish an independent PD research program. The following information should be provided:

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

List all performance sites that apply to the specific component.

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

Budget (Administrative Core)

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 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.

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          (Administrative Core)

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 a local and national resource for PD research.

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:

The Approach section should also include plans for the following:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Planned Enrollment Report 

  Not Applicable.

PHS 398 Cumulative Inclusion Enrollment Report

  Not Applicable.

Research Core

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

Proposed Research Cores are a required component, and must be integral to the aims of the Center and of common utility, such that the resources provided will be utilized by one or, much preferably, more Research Projects in the proposed Centers. Research Cores cannot propose hypothesis or discovery-driven aims. Proposed Research Core assays must be generally accepted, standardized methodologies that clearly support the research aims of associated Research Projects.

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:

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)

Budget (Research Core)

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

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

PHS 398 Research Plan          (Research Core)

Specific Aims:   Describe the goals and planned activities of the Research Core, as well as its essential relationship to one or more proposed Research Projects.

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

Significance: Describe the essential relationship of the Research Core to one or more proposed Research Projects, the means through which this Core will advance the aims of each associated project, and what resources generated 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 Cores are shared within and optimally beyond the Udall Center.

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

Use of Udall Center Cores to establish and maintain institutional infrastructure and generalized resources (including biospecimen repositories) is not permitted in response to this FOA; 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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Planned Enrollment Report  (Research Core)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Research  Core)

Not Applicable

Clinical Core

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

A Clinical Core is required to support proposed Clinical Research Projects including human subjects research. A clinical core cannot be proposed in the absence of a Clinical Research Project, nor can it include hypothesis-driven aims or clinical pilot studies. Clinical subjects should be recruited and maintained by the Udall Center. Ideally, this Core should collaboratively serve multiple Udall Centers via sharing of resources and data.

Applicants are strongly encouraged to establish relationships with patient groups and solicit their input on the clinical meaningfulness of the question under study, the relevance of the proposed clinical outcomes, protocol and consent development and the burden of participation, recruitment and retention plans, and development of marketing materials. 

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:

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)

Budget (Clinical Core)

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

Adequate costs for proactive recruitment and retention plans should be included within the Clinical Core budget.

Include costs for outreach activities, if such are not included in the Administrative Core or a dedicated Outreach Core.

Funds dedicated to this Core must be utilized only to support clinical activities relevant to the Udall Center; 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.

PHS 398 Research Plan          (Clinical Core)

Specific Aims:  Describe the subject population and related clinical data and biospecimens to be collected.

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 one or more proposed research projects.

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:

Use of NINDS Common Data Elements (CDEs) to standardize the collection of clinical data is strongly encouraged. 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. Every effort should be made to serve diverse racial and ethnic populations with this Core.

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) is required for each enrolled participant. Clinical assessments will include core PDBP clinical elements, and will follow the assessment schedule outlined for the PDBP Data Management Resource (DMR). Collection of clinical assessments beyond the PDBP core assessment should be coordinated with the NINDS.  All clinical data will be entered through the ProFoRMS module of the PDBP DMR.  Patient 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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Include the following information:

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. 

Public Outreach and Education  Core

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

Service Cores promote Center-based activities beyond the immediate requirements of Center research projects, emphasizing especially the role of Udall Centers as local resources for PD research and information for the broader patient and advocacy communities. While inclusion of a Public Outreach and Education  Core is optional, inclusion of related activities within the other application components is encouraged.  Because the Udall Centers are to serve as local and national resources for PD, applicants are strongly encouraged to include outreach efforts as an integral part of the Udall Center. Any planned outreach activities must be detailed within the application, whether included as part of the Administrative Core, Clinical Core (if applicable), or as a dedicated Core.

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

SF424 (R&R) Cover (Public Outreach and Education Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Public Outreach and Education Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Public Outreach and Education 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) (Public Outreach and Education Core)

List all performance sites that apply to the specific component.

Research & Related Senior/Key Person Profile (Public Outreach and Education Core)

Budget (Public Outreach and Education Core)

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

PHS 398 Research Plan          (Public Outreach and EducationCore)

Specific Aims: State the planned activities of the Public Outreach and Education Core.

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

Significance: Describe the role of the Outreach Core in supporting the Center's function as a local resource for PD research and related information.

Innovation: Describe how the Outreach Core will utilize both standard and emergent methods (e.g. social media) to communicate Center activities to the public in a timely and clear manner.

Approach: Describe how planned activities will inform and educate the local patient and advocacy communities about PD and the research efforts of the Center, while in turn assisting each Center in the design of research studies that address the needs of people with PD and their caretakers. Describe strategy for an inclusive outreach strategy, which may include collaboration with state and local agencies, nongovernmental and advocacy organizations, community/service groups, hospitals, religious organizations, business groups, local medical societies. Include descriptions of avenues of outreach (e.g., committees, seminars, printed brochures/newsletters, video, website, media interviews/appearances, social media strategies) to be developed and implemented by the Center. New applications should describe any prior experience with outreach for neurodegenerative disease research and any advance organizational efforts for PD outreach. Renewal applications should describe outreach efforts in the prior funding period.

Letters of Support:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Planned Enrollment Report  (Public Outreach and Education Core)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Public Outreach and Education  Core)

Not Applicable 

Basic Research Project

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. Programmatic priority will be given to applications that include a well-integrated basic research project that addresses relevance to the NINDS PD2014 recommendations.

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:

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)

Budget (Basic Research Project)

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

PHS 398 Research Plan          (Basic Research Project)

Specific Aims: State the aims of the basic research project and the hypotheses to be tested.

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

Significance: Describe the contributions of the basic research project to the goals of the Udall Center. Explain why the Udall Center structure is required to accomplish proposed aims. Describe relevance to NINDS PD2014 recommendations, if applicable; alternatively, describe and justify the specific research need to be addressed. Address how successful completion of proposed studies would advance PD research.

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:

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

Each proposed basic research project should have a strong biological rationale for the intended approach. The NINDS urges applicants to the program 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).

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Planned Enrollment Report  (Basic Research Project)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Basic Research  Project)

Not Applicable 

Translational Research Project

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 that will lead to early human testing of a new drug, biologic, diagnostic screen, or other therapeutic, diagnostic, or preventative intervention for PD.

Pursuant to the goals of this initiative, a translational research project may include preclinical research in model systems specifically intended to complete early steps in the pipeline for therapeutic development for PD. Only those Aims required for therapeutic development may be included in a translational research project. To determine whether a proposed translational research project is responsive to this announcement, applicants are encouraged to contact the program official listed as 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:

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: Include an attachment titled, "Intellectual property" to address the following issues. Applicants are encouraged to prepare this section of the application in consultation with their institutions' technology transfer officials, if applicable.

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)

Budget (Translational Research Project)

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

PHS 398 Research Plan          (Translational Research Project)

Specific Aims: State the research goals of the translational research project and expected contributions to the goals of the Udall Center. Explain why the Udall Center structure is required to accomplish proposed aims. Address how successful completion of proposed studies will advance therapeutic opportunities for PD.

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

Significance: Describe how proposed translational studies will advance development of improved PD therapeutic strategies. Describe relevance to NINDS PD2014 recommendations, if applicable; alternatively, describe and justify the specific research need to be addressed.

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 discovery activities such as establishment of assays or models, and rigorous proof-of-principle studies for therapeutic efficacy in model systems necessary to advance the PD therapeutic pipeline. 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, an awareness of the future goals and challenges, and a plan to establish the necessary collaborations and funding to reach IND.

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

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

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.

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

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

At the end of the budget period, successful projects may transition to funding initiatives sponsored by the NINDS Office of Translational Research or other related NIH funding opportunities.     

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Planned Enrollment Report  (Translational Research Project)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Translational Research  Project)

Not Applicable 

Clinical Research Project

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.

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:

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.

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

Budget (Clinical Research Project)

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

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 required to accomplish proposed aims. Address how successful completion of proposed studies will inform and advance future PD research and clinical trials.

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 relevance to NINDS PD2014 recommendations, if applicable; alternatively, describe and justify the specific research need to be addressed.

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 experiments. 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:

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.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

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. 

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

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

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.

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the National Institute of Neurological Disorders and Stroke (NINDS), 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). If site logistics are challenging regarding the PDBP protocols, then the Alzheimer’s Disease Neuroimaging Initiative (ADNI) protocols could be used as an alternative, as long as they are justified and approved by the NINDS program officer. Biospecimens collected could include whole blood, plasma, serum, cerebrospinal fluid (CSF). Fibroblasts may be appropriate for special populations, such as those with known genetic variants causal for disease; collection of these or other biospecimens must be justified in the application and will require programmatic approval.

Consent forms (submitted as appendix material) must make it clear that any biological samples and de-identified clinical data will be shared with academics or industry and must be consistent with the NINDS Repository and NINDS PDBP Data Management Resource (DMR) consent requirements. 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, referenced below, 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:

PD-Specific CDEs

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

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

Data Management and Storage

Udall Centers will use the NINDS Data Management Resource (DMR), recently established for the NINDS Parkinson's Disease Biomarkers Program (PDBP), to store biospecimen-related and clinical data collected for Center projects and cores. The PDBP DMR 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 at the Coriell Institute for Medical Research ("NINDS Repository"), respectively.

Activities that are the sole purview of the DMR include: 1) development of standardized electronic data forms, data formats and software for use across multiple cohorts and projects; 2) development of software to support subject scheduling, site tracking, and facilitation and coordination of de-identified clinical and biospecimen data collection across multiple new and existing cohorts and projects through an easy to use web-based entry system for submitters; 3) quality assurance checks of data entry and collection; 4) development of a user-friendly query system for users to evaluate availability of data and biospecimens within and across Udall Centers; 5) development of aggregate data report formats that are user-friendly and supported by well documented data dictionaries; 6) training for both data submitters and data users; 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.

NIH Database of Genotypes and Phenotypes

As stipulated in the 2007 Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS), all investigators who receive NIH funding to conduct genome-wide analyses of genetic variation are expected to make their data available for secondary research through the NIH GWAS data repository (i.e., the Database for Genotypes and Phenotypes, dbGaP). Submitting investigators are expected to provide basic study information such as the type of data that will be submitted to dbGaP and a description of the study, as well as a certification that includes any limitations on the secondary use of the data as determined by the informed consent (e.g., the data cannot be shared with for-profit companies, the data can be used only for research of particular diseases). NIH has developed an online system intended to reduce the burden for researchers and their institutional officials to register studies and access data in dbGaP. For further information, see NOT-OD-14-065.

Induced Pluripotent Stem Cells

Use of Udall Center funds to develop induced pluripotent stem cell (iPSC) lines currently represented in the NINDS Repository is not permitted. Applicants proposing to develop isogenic lines should consult the program officer prior to submission. New iPSC lines developed must meet the following criteria: 1) patient consent must allow for broad data and resource sharing (academic and industry investigators) including use for genetic studies, wherein part or all of the genome may be sequenced; 2) the institution/facility must have licenses for iPSC and related (e.g. genome editing, reporter use)  technologies that allow deposition and broad distribution of resulting iPSC lines through the NINDS Repository); 3) for iPSC lines currently available through the NINDS repository, gene correction experiments must be done in these lines; 4)  a timeline must be provided for banking of available iPSC lines with the NINDS repository; 5) all iPSC lines derived must be characterized for sterility and be free of mycoplasma contamination, have normal karyotypes, normal growth rates and colony morphology, demonstrated pluripotency through a pluritest, scorecard test or equivalent test, demonstrated surface antigen expression of stem cell markers, demonstrated ability to form embryoid bodies and demonstrated transgene silencing for the reprogramming factors used. For gene correction/gene editing projects, investigators will be asked to whole genome sequence the original and edited clones and deposit this data with the NINDS Parkinson’s Disease Biomarkers Program (PDBP) Data Management Resource (DMR).

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 staff.

Participation in Annual Udall Center Meetings

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

Participation in Udall Center Coordinating Committee 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:

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

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

Section V. Application Review Information


1. Criteria

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

Overall Impact - Overall

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

Scored Review Criteria - Overall

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

Significance

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

Does the Center address an important problem or critical barrier to progress in PD research? Is relevance to the NINDS PD2014 recommendations discussed? Is there strong evidence that the proposed Center will advance research in Parkinson’s disease, 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 a synergistic, interdisciplinary research program while serving as a local resource and national leader in PD research?  

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

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

For renewal applications: Has the Center been productive and generated high-impact research discoveries during the prior funding period? Has the Center remained on the cutting edge of PD research, and does the Center have the infrastructure and assembled team to pursue the proposed objectives? Has the Center established proven or proposed new collaborations with other Udall Centers? Is there evidence that the Center has served as a resource at the local and national levels?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the stated goals of the proposed Udall Center i.e.  rapidly advance a synergistic, interdisciplinary research program while serving as a local resource and national leader in PD research?  ? 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 of 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? Has the Director made an appropriate time commitment to the Center, including leadership of a project and/or 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? Has the Director made an appropriate time commitment to the Center, including leadership of a project or core?

Innovation

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

During evaluation of the proposed Center applications, reviewers will consider the level of innovation specifically 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 therapies? Are the proposed projects likely to make major rather than incremental advances toward this goal?   

Approach

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

If the Center involves 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?

Will successful completion of proposed objectives directly inform the pathology, progression and treatment of PD? 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? Does the proposed Center demonstrate appropriate organizational and managerial structure to meet Center goals? Is there strong evidence for communication and collaboration among Center investigators? Does the application include a well-conceived mission statement and overview for research training? If applicable, does the application include protocols for biospecimen and clinical data collection?

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?

Environment

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

In addition, reviewers will consider the following:

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, cost sharing 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 PD Centers or multi-project research efforts, is there adequate description of the potential relationship between the proposed Udall Center and the other Center(s) or project(s)? Is potential overlap between the Udall Center and other large-scale, PD-related research efforts addressed?

If Center investigators are located at more than one institution, are planned communication and collaboration adequately described?

Scored Review Criteria for Cores

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

Administrative Core

Does the Administrative Core Lead have appropriate expertise and dedicate sufficient time to administrative activities? Does the Center Administrator have sufficient experience to provide support for the program? Is the line of communication clear between the Center Director and Center Administrator? Is the proposed management structure appropriate for scientific administration as well as fiscal administration, procurement, property and personnel management, planning and budgeting? Is there an appropriate plan for establishing and maintaining effective communications and cooperation among Center investigators and with investigators outside the Center? Are there internal and external procedures for monitoring and evaluating the proposed research projects and core facilities/resources? Are there appropriate plans for management of data, animal models and other resources? Are there appropriate plans for establishing the External Advisory Committee and will the EAC contribute to the oversight of Center research projects, and other components? Does the Administrative Core contain the required Attachment containing the mission statement for and overview of training activities? If a dedicated Outreach Core is not proposed, does the Administrative Core describe planned activities?

Research Cores

Is the Research Core essential to advance the scientific aims of one or more proposed research projects? Is the Core connected to the central theme of the overall program? How valuable are the facilities or services provided by the Core (including procedures, techniques, and quality control)? Are they being used effectively? Are the Core Lead and key personnel well-qualified to provide the Core service(s)?

If human subjects, vertebrate animals, or biohazards are to be used in a core, the adequacy of these sections will be assessed and will be considered in evaluating the individual core.

Clinical Core

Is the Core essential for the support of the proposed clinical research project? 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? If included, is the patient cohort well-defined and appropriately diverse? Are plans in place for patient recruitment? 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)? Have standard operating procedures been established for collection and storage of biological samples and/or for genotype/phenotype information? Will biospecimen collection follow protocols of the NINDS PD Biomarkers Program (PDBP)? Is the 5-year timeline for Core activities included and adequate? If patient community outreach activities are not described in the Administrative Core or in a dedicated Core, are they herein described and sufficiently reflective of the Udall Center's position as a local resource for PD research?

Public Outreach and Education Core

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

Scored Review Criteria for 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?

Investigator(s)

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

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 the project involves basic or preclinical research, is there 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 new therapy, diagnostic, or intervention? Is the intellectual property clearly explained? 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 it likely that completion of the stated translational research objectives will result in improved treatment for PD?

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? Will biospecimen collection adhere to protocols of the NINDS PD Biomarkers Program (PDBP)? Will clinical data be collected using the NINDS Common Data Elements (CDEs)?

Environment

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

Additional Review Criteria - Overall

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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.

Vertebrate Animals

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

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

For renewal applications, the committee will consider the progress made in the last funding period:

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? Has the Center established proven or proposed new collaborations with other Udall Centers? Is there evidence that the Center has served as a resource at the local and national levels?

Revisions

Not Applicable

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Groupconvened by the NINDS in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

Applications will be assigned to the 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:

Additional NINDS considerations during the selection of Udall Center grant applications include:

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information


1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

Udall Center progress reports should include the the report from External Advisory Committee meetings.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Finding Help Online: http://grants.nih.gov/support/index.html

TTY: 301-451-5939
Email: commons@od.nih.gov

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: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Beth-Anne Sieber, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-5680
Email: sieberb@ninds.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Tijuanna DeCoster, PhD, MPA
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@ninds.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.  The NINDS Centers of Excellence for Parkinson’s Disease Research program was established as part of the Morris K. Udall Parkinson’s Disease Research Act of 1997 (P.L. 105-78).


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