Electronic Complex
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

NINDS Exploratory Grant Program in Parkinson's Disease Research (P20)

Activity Code

P20 Exploratory Grants

Announcement Type

New

Related Notices
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number

RFA-NS-14-011

Companion Funding Opportunity
Catalog of Federal Domestic Assistance (CFDA) Number(s)

98.853 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA)requests Exploratory Grant (P20) applications for the planning and initiation of collaborative research activities to advance Parkinson's Disease (PD) research. The goal of this program is to formalize new collaborative teams and establish a foundation of research discovery necessary to address emergent issues in PD research, such that successful exploratory studies lead directly to a subsequent application for support of an NINDS Morris K. Udall Center of Excellence (P50). To foster the development of innovative research collaborations, this FOA will provide support for new projects, not continuation of projects that have already been initiated. Interventional clinical trials will not be supported by this FOA.

Key Dates

 

Posted Date

May 30, 2014

Open Date (Earliest Submission Date)

August 29, 2014

Letter of Intent Due Date(s)

August 29, 2014

Application Due Date(s)

September 29, 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

December 2014

Advisory Council Review

January 2015

Earliest Start Date

March 2015

Expiration Date

September 30, 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 at least half a million people in the United States, as well as having significant impact on the relatives and friends who care for them. The average age of onset is during the sixth decade, although earlier onset is also possible, and the incidence of PD is expected to increase as the population ages. While significant research advances continue, the full complexity of PD etiology is not yet evident. Moreover, currently available treatments are primarily symptomatic, and neither slow nor halt disease progression. Challenges posed by the inherent complexity of PD are often best addressed by multidisciplinary research teams working in tandem to surmount obstacles and seize opportunities to advance knowledge and improve treatment. However, development of an effective team, identification of an optimal strategy and collection of preliminary data to address a particular challenge in PD research require dedicated time and resources.

Therefore, this Funding Opportunity Announcement (FOA) solicits Exploratory Grant (P20) applications proposing planning and initiation of synergistic research activities to advance Parkinson's Disease (PD) research and treatment. The goal of this program is to formalize collaborative structures and establish a foundation of research discovery necessary to address emergent issues in PD research. Successful exploratory studies should lead to a subsequent application for support of a collaborative, multidisciplinary NINDS Morris K. Udall Center of Excellence (P50). To foster the development of innovative research collaborations, this FOA will provide support for new projects, not continuation of projects that have already been initiated.

Research Objectives

The purpose of this FOA for Exploratory Grant (P20) applications is to support the formation of new collaborative research programs to address current challenges in PD, especially improved translation of basic and clinical research into novel therapeutic strategies. Through this mechanism, the NINDS seeks to develop a proof-of-concept experimental framework to organize research efforts around specific thematic areas for which a team-based approach is required to surmount related obstacles and leverage emergent opportunities. The overall goal is to encourage the formation of new multidisciplinary teams who will collaborate to develop a research plan, construct an effective administrative organization, create related policies, and gather preliminary data in support of novel ideas in PD research. Successful Exploratory Grant activities should lead directly to the submission of an NINDS Morris K. Udall Center of Excellence (P50) application.

The intent of this NINDS P20 exploratory grant initiative is to provide up to two years of support for new collaborative teams to initiate planning, develop organizational structure, perform research feasibility studies and obtain preliminary data that will lead directly to the submission of competitive NINDS Udall Center grant applications. The Exploratory Grant mechanism provides each individual team with flexibility in project design and duration: a range of activities and timelines may be proposed. For example, some teams may have existing preliminary data for individual projects, and require minimal data gathering and a shorter time period to formalize a team approach; other teams may begin with an idea and require a longer timeframe for both thematic development and data collection. The collective expertise required to form effective partnerships and develop a rigorous evidence base may involve multiple sites and institutions.

Because a goal of this initiative is to establish productive collaborative interactions, preliminary data is not required for proposed research feasibility projects. This FOA is not intended for support of clinical trials, but does permit non-interventional clinical research. Applicants may also request support for establishment of administrative structures to form the foundation for future basic, translational and clinical research efforts. Applicants are strongly encouraged to link their proposed theme and activities to research recommendations from the recent NINDS conference, "Parkinson's Disease 2014: Advancing Research, Improving Lives" (PD2014.)

This initiative is intended to provide new teams with the flexibility to design activities to strengthen their specific collaborative efforts. Full-scale multicomponent research projects from established investigative teams, with requirements for supportive research Cores, are best suited to the NINDS Research Program Project Grant (P01) mechanism or the NINDS Udall Centers of Excellence (P50) program itself; such applications are not responsive to this announcement. Research cores and/or cores for the establishment of research infrastructure are not included in this FOA. Support for the development of research resources, including but not limited to animal models and induced pluripotent stem cells, are best pursued through alternative mechanisms described on the NINDS Grants Mechanisms website. Support for interventional clinical trials, also beyond the scope of this P20 mechanism, is available through funding opportunities described on the NINDS Office of Clinical Research website.   

There is increasing awareness among the PD and neurological disease communities that the predictive value of preclinical research is improved when sufficient information is available about study design, execution, analysis, and interpretation. Examples of the critical elements of a well-designed study are summarized on the NINDS website (http://www.ninds.nih.gov/funding/grant_policy.htm). NINDS urges applicants to the program to consider these elements when describing supporting data and designing the proposed studies, and encourages the establishment of partnerships that will develop the rigorous evidence base needed to justify further pursuit of studies for promising therapeutic interventions.

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

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 fund up to 4 awards in FY2015, corresponding to a total of $1.0 million in direct costs. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are limited to $250,000 direct costs per year (exclusive of facilities and administrative costs of subcontracts with collaborating institutions). Budget requests should reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 2 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

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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.

The PD/PI should be a scientific leader experienced in PD and/or other neurodegenerative disease research and must have the seniority to coordinate the establishment of this exploratory project as well as to lead a future NINDS Udall Center application.

Current Udall Center Directors and investigators are not eligible to apply or to participate in P20 projects.

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 Exploratory Grant can be awarded and active at any institution. Institutions that house current NINDS Udall Center awards are ineligible to apply for this P20 program.

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:

  • To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
  • Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
  • Of an application with a changed grant activity code.
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:

  • Descriptive title of proposed activity
  • Name, address, and telephone number of the PD/PI
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Beth-Anne Sieber, PhD
Neurodegeneration Program Cluster
National Institute of Neurological Disorders and Stroke (NINDS)
6001 Executive Boulevard, Room 2223
Bethesda, MD 20892-9525
Telephone: 301-496-5680
Email: sieberb@ninds.nih.gov  (preferred method for submission of Letters of Intent)

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

6

Admin Core

6

Project

6

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: required
  • Administrative Core: required; will include all proposed planning activities.
  • Project: required; will include a miminum of three research feasibility studies.
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.

Foreign Justification: 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 (U.S.) or augment existing U.S. resources.

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.

The PD/PI must be an established investigator with expertise running successful large-scale research programs, eminently qualified to provide effective oversight of administrative activities and leadership of scientific efforts of the consortium. Other important considerations include current research funding and productivity, as well as capacity for effective leadership of an innovative, multidisciplinary team. Expertise in areas outside of PD research is encouraged if the PD/PI's knowledge can provide novel insight into PD. The PD/PI is responsible for ensuring that consortium goals are met, for developing and managing a decision-making structure, and for allocation of resources to meet stated goals.

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: All planned activities will be relevant to the subsequent preparation of a full-scale NINDS Udall Center application. Describe the goals of the collaborative project and outline how the proposed activities will contribute to advancement of these goals and result in the submission of a Udall Center application.   

Research Strategy:  The Overall section provides an overview, rationale and timeline for activities leading to the subsequent NINDS Udall Center application. Applicants must present a compelling vision and propose a spectrum of activities best suited to their collaborative goals, such as planning meetings, research feasibility studies, and generation of preliminary data. Organize the Research Strategy into sections on Significance, Innovation and Approach.

Significance: Provide a vision statement for the Exploratory Grant, including expected contributions to the advancement of PD research and treatment. Describe (i) the importance of the PD research challenge to be addressed, and when possible its relationship to NINDS PD2014 recommendations ; (ii) how establishment and advancement of the proposed collaboration will improve scientific knowledge, treatment and/or clinical practice; and (iii) the strategy by which the proposed studies will be advanced into an NINDS Udall Center.

Innovation: Provide evidence that the proposed activities will advance PD research through use of novel concepts, collaborations, and approaches.

Approach: Detail how proposed activities will synergistically address a defined PD research challenge and describe the strategy by which the goals of the collaboration will be met. Clearly state the overarching theme and objectives of the proposed project. For each objective, include a brief statement describing the contributions of individual team members toward completion of common goals. When appropriate directly relate the theme and objectives to the NINDS PD2014 recommendations; alternatively, describe and justify the specific research need to be addressed. Describe the collaborative planning process, and any related research project(s). Include a narrative timeline or table outlining specific yearly objectives, including transition from planning to implementation phase (i.e. submission of an NINDS Udall Center application).

Describe the leadership structure, the research team and the role of its members in addressing the stated research challenge and meeting collaborative goals. To optimize novel team approaches while building upon available knowledge, it is recommended that teams include at least one individual with expertise outside of the PD field and at least one individual with PD expertise. For members with expertise beyond the PD field, describe how their expertise can be brought to bear to advance project goals. Describe the novel contributions of the team to PD research. Provide confirmation of the commitment of team members to partner around common long-term goals to advance PD research. Provide a plan for team continuity and for conflict resolution.

Outline envisioned contributions of the proposed activities to the NINDS Udall Centers program, including how these contributions will complement (not overlap with) ongoing Udall Center projects.  

Letters of Support:

Institutional Commitment (required): Describe endorsement by appropriate institutional officials, including allocation of available resources to PD research, including collaborative opportunities with other institutional programs. Applicant institutions receiving funding from other large-scale, PD-related research projects should detail how interactions with the Exploratory Grant effort will advance PD research and provide a foundational environment for a future NINDS Udall Center application.

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): PD researchers and nongovernmental patient advocacy and funding organizations have common goals for improving treatment and understanding causes of PD. Letters should detail planned partnerships between the collaborative team and these groups.

Letters of support from current Udall Center Directors and investigators are not required.

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:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
  • The overall Resource Sharing Plan should address plans for sharing data beyond the immediate collaborative Exploratory Grant team.
  • Information in the Overall component should complement but not duplicate that provided in Research Project "Resource Sharing Plans."

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:

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

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.

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)

ASSIST will default to “Project Lead”. If you would like to use a different category, then replace “Project Lead” below with a different Category (e.g., Core Lead).

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

  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

Budget (Administrative Core)

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

Administrative support: Include costs for administrative personnel who will assist the PD/PI with organizational aspects of the project.

Travel: Include costs for travel of project personnel to attend planned meetings of the collaborative team.

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 role of the Administrative Core in coordination of consortium planning and research activities and as the organizational basis for a future NINDS Udall Center application.  

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 planning and research activities of the Exploratory Grant.

Innovation: Describe how the Administrative Core utilizes novel approaches to maximize synergy among investigators to advance the stated goals of the consortium.

Approach: Describe the role of the Administrative Core in i) supporting collaborative activities, including investigator meetings, travel and coordination of multiple research sites (as applicable); (ii) establishing an evaluation plan for project activities, iii) coordinating administrative responsibilities between the collaborating institutions, organizational components, investigators, and staff;  iv) coordinating activities for preparation of a full-scale Udall Center application; and v) coordinating with the institution and local regulatory bodies to ensure that human subject and/or vertebrate animal research is in compliance with appropriate regulations and guidelines.

 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:

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

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

Planned Enrollment Report  (Administrative Core)

Not Applicable 

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

Not Applicable 

Research Project

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

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

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (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) (Research Project)

List all performance sites that apply to the specific component.

Describe the existing infrastructure and institutional resources available to the collaborative team, and how these resources will be utilized in research feasibility studies. 

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

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. 
  • Research Project investigators must demonstrate active, R01-equivalent independent funding and excellent scientific productivity. As noted for the PD/PI, investigator expertise may also be in areas outside of PD research, if relevant skills can be readily applied to the goals of the collaborative project. At least one investigator leading a projects should have proven expertise in PD research. To incorporate new approaches, it is also recommended that the consortia include at least one member with expertise from beyond PD research.
  •  Identify key personnel who will ensure and facilitate data quality, transfer, sharing, and biological specimen submission to the PDBP DMR and NINDS Repository, respectively.

Budget (Project)

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

Allocation of budget to research feasibility projects is flexible within the stated budget cap; provide rationale for the specific budgetary needs for research required to meet stated goals.

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

PHS 398 Research Plan (Research Project)

This component should be used to describe each research project. While preliminary data is not required, applicants should provide sufficient evidence of feasibility to support proposed studies. Specific studies must be described; open-ended requests for pilot funds are not responsive to this announcement. Requested support for the creation of model systems, including but not limited to animal models and induced pluripotent stem cells (iPSC), requires strong justification and will not be provided if proposed studies recapitulate currently available resources; for specific information on iPSC, please see section IV. 6 "Other Submission Requirements and Information" below.

Specific Aims:  Describe proposed research activities that will advance the stated goal of the consortium and lead to an NINDS Udall Center application.  

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

Significance: Describe  how proposed basic, translational and/or clinical studies will address the overarching theme of the Exploratory Grant, and how proposed research will advance knowledge of PD. If applicable describe relevance to the NINDS PD2014 recommendations; alternatively, describe and jusify the specific PD research need to be addressed.

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

 Approach: Describe proposed research feasibility studies. Explain how each proposed research aim relates to the overall priorities of the collaboration and the stated research problem. Describe, as appropriate for the nature of the project, experimental methods and study design, as well as innovation and potential significance to PD research and treatment. Provide justification for and address the validity of proposed PD model systems. If multiple institutions are involved, identify which aspects of the feasbility study will be conducted at which sites. In the absence of preliminary data, provide compelling rationale for the project and the innovative contribution to PD research. Describe the scientific rigor of the experimental design and the strategies used to minimize bias; include consideration of alternative interpretations.

 Letters of Support:

Collaboration with NIH Intramural Researchers (if applicable): Include a letter from the Scientific Director of the collaborating NIH Institute, which must specify the amount of 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 Industry (if applicable): Provide letters detailing planned collaborations with industry partners, including specific roles of industry and academic investigators. Letters should clearly describe any related intellectual property issues and/or agreements.

All letters of support should be concatenated and uploaded as a single PDF attachment.

 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:

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

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

Planned Enrollment Report  (Research 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 (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 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, the Alzheimer’s Disease Neuroimaging Initiative (ADNI) protocols are an appropriate alternative, requiring justification by the investigator and approval 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. P20 clinical research projects will be required to include the following General and PD-specific CDEs:

 General CDEs

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

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

PD-Specific CDEs

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

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

In addition to the above, applicants may employ supplementary assessment and measurement tools if relevant to address 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

P20 research feasibility projects 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 NINDS-funded PD projects. 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 proposed clinical 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 projects; 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. For those with existing studies already utilizing a data management core or resource, successful implementation of a de-identified data transfer plan from the study site to the DMR will be required. Quarterly deposition of all de-identified clinical data into the PDBP DMR is a requirement of the NINDS Exploratory Grant program.

NIH Database of Genotypes and Phenotypes, Genomic Data Sharing Policy

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 Exploratory Grant funds to develop induced pluripotent stem cell (iPSC) lines already 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 P20 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 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, applicants intending to collaborate with NIH intramural investigators are encouraged to contact the NINDS Scientific/Research Contact(s).

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 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).

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 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?

Is there a stated unifying theme for the P20? Is the consortium poised to bring new perspective and innovation to PD research?

If successful, will the exploratory project establish a "proof of concept" experimental and organizational framework that serves as the basis for a full-scale Udall Center application?

How significant would the reduction in PD disease burden be if subsequent full-scale efforts are successful? 

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? 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?

Is the PD/PI a scientific leader with experience in PD and/or other neurodegenerative disease research? Does the PD/PI have the seniority and experience to coordinate the establishment of this exploratory project as well as to lead a future NINDS Udall Center application?

Is the proposed collaborative team comprised of independent investigators who would be the leading participants in a full-scale Udall Center on this topic? Are the roles of team members clearly defined? Does the consortium represent a new, rather than established, collaborative effort?

Does the research team include at least one investigator from within and at least one investigator from beyond the PD research field? Will investigator expertise advance the stated goals of the project? 

Innovation

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

Does the proposed project address a defined and timely research challenge in Parkinson's disease? Is the collaborative project novel?  Is it unique in comparison with existing Udall Centers?  

Approach

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

If the project involves 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?   

Does the proposed collaborative structure serve as effective foundation for planning activities and a future Udall Center application?

If proposed, does the overall goal of research feasibility studies address a critical PD research challenge? Are the studies synergistic and aligned with planning activities of the consortium? Are proposed projects based on sound rationale? Are the proposed experimental models justified? Are the experiments rigorously designed? Is the approach multidisciplinary and likely to advance scientific knowledge, move toward translation of results, and enhance clinical practice for PD?

Is there a timeline detailing yearly objectives and goals, ending with a proposed Udall Center application submission date?

If the aims of the Exploratory Grant are successfully completed, will the investigative team have a rigorous evidence base and adequate plan for a subsequent NINDS Udall Center application?   

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?

Is there evidence of institutional commitment to the goals of the research consortium?

Does the application address how existing resources will be leveraged to advance project goals?

If participating investigators are at different institutions, is there a clear plan in place for regular communication?

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

Not Applicable

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 Group(s), convened by the NINDS  in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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

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

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
  • Compliance with data and resource sharing policies.
  • Number of applications from each institution (only one NINDS Exploratory Grant may be awarded at any one institution).

Additional NINDS considerations during the selection of Exploratory grant applications include:

  • The qualifications and experience of the PD/PI and other key personnel.
  • The statutory and program purposes to be accomplished.
  • The potential to rapidly advance PD research toward treatment using innovative approaches.
  • The capacity for unique and collaborative contributions to the Udall Centers program.
  • Relevance to the NINDS PD2014 research recommendations.

The NINDS will consider the full scope of PD 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 applications with greatest potential to develop a subsequent Udall Center application.

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.

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

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.

 

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