Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)
National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

Center without Walls for Mechanisms of Neurodegeneration in Frontotemporal Dementia (FTD) (U54 Clinical Trial Not Allowed)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

New

Related Notices
None
Funding Opportunity Announcement (FOA) Number

RFA-NS-21-003

Companion Funding Opportunity

None

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

93.853, 93.866

Funding Opportunity Purpose

The goal of the Frontotemporal Dementia (FTD) Centers Without Walls (CWOW) is to improve our understanding of the mechanisms underlying neurodegeneration in FTD through multi-disciplinary, team-based science to address a specific challenge or challenges in the field that could not be achieved through individual research projects.

Key Dates
Posted Date

August 24, 2020

Open Date (Earliest Submission Date)

October 2, 2020

Letter of Intent Due Date(s)

October 2, 2020

Application Due Date(s)

November 2, 2020  

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date. 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

February 2021

Advisory Council Review

May 2021

Earliest Start Date

July 2021

Expiration Date

November 3, 2020

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.



  3. 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
    Background

    Significant advances in our understanding of FTD molecular and genetic pathogenesis have been made in recent years, however many challenges remain. At the 2019 Alzheimer's Disease-Related Dementias (ADRD) Summit hosted by NINDS and NIA, the top research priority remained better understanding the basic science underlying FTD, including clarifying cellular mechanisms related to tau pathogenesis, C9orf72 expansion, and GRN mutations and pathways. Additional challenges discussed were the need for advanced computing and cloud-based data infrastructure to support management and analysis of data from FTD studies, and data integration and analysis across complex data modalities. The full list of recommendations can be found under Topic 6 of the 2019 ADRD Summit Report to the National Advisory Neurological Disorders and Stroke Council at https://www.ninds.nih.gov/sites/default/files/2019_adrd_summit_recommendations_508c.pdf

    Overview

    The goal of the Frontotemporal Dementia (FTD) Centers Without Walls (CWOW) is to improve our understanding of the mechanisms associated with neurodegeneration in FTD through multi-disciplinary, team-based science to address a specific challenge in the field that could not be achieved through individual research projects. Each Center is expected to address a specific challenge in the field involving unique and/or converging molecular/cellular/circuit/systems-level mechanisms that lead to neurotoxicity in FTD, including those associated with tau, TDP-43, and FUS pathologies and underlying genetic causes and risk factors such as C9orf72 hexanucleotide repeat expansions, and GRN, MAPT, and FUS mutations. At the end of the project period, each Center will be expected to have generated data/tools/resources addressing the specific challenge to the field which will be available to the broader research community.

    Scope and Research Objectives

    Based on the recommendations from the 2019 ADRD Summit, the purpose of this Centers Without Walls FOA is to support multidisciplinary, diverse teams to undertake an in-depth investigation into the mechanisms underlying one of the various forms of FTD (FTD-Tau, FTD-TDP-43, FTD-FUS). The investigator team should propose a specific challenge to address based on the 2019 ADRD recommendations and propose  data/tools/resources that can be shared with the research community by the end of the five-year project period. These outputs should be defined by the applicant and could include but are not limited to: data, resources, tools, services, etc. that relate to the specific goal of the center, would be of significant benefit to the field, and can be shared or utilized broadly by the research community. The challenge to be investigated and data/tools/resources produced, provided, or shared should be ones that would best be accomplished through a collaborative, multi-investigator, multidisciplinary, complementary team-based approach such as this Centers Without Walls mechanism as opposed to independent investigator mechanisms. The inclusion of investigators with FTD expertise as well as investigators that may not have FTD expertise but have unique expertise or skill sets relevant to the approach(es) proposed is encouraged to support multi-disciplinary approaches to addressing the focus of the center.

    A partial list of challenges/questions from the 2019 ADRD Summit are included below but note that projects do not need to be limited to any of these below:

    • Investigate the mechanism of tau-driven neurotoxicity and its relationship to the formation and spreading of tau pathological inclusions
    • Characterize the predominant mechanism(s) of C9orf72 hexanucleotide expansion pathogenesis
    • Clarify fundamental mechanisms associated with TDP-43 and FUS proteinopathies
    • Elucidate mechanistic pathways that may account for health disparities and investigate potential opportunities for precision medicine approaches
    Requirements
    • Stated and justified singular focus of the center on a major challenge in unravelling the mechanisms of a particular FTD subtype (FTD-Tau, FTD-TDP-43, FTD-FUS) that can best be addressed through a multi-investigator (at least three), multi-component, multidisciplinary, diverse, team-based approach. The focus should be within one of the 2019 ADRD Summit FTD research recommendations.
    • The center should generate data/tools/resource(s) or other products or services based on the goal(s) of the center that would benefit the field and can be shared broadly. Some examples could include but are not limited to:
    • Comprehensive data sets describing disruptions to protein degradation and/or RNA metabolism pathways in FTD
    • New models of inherited and sporadic FTD ranging from animal models to human iPSC, tissue chip, and organoid models with associated phenotyping
    • Freely-accessible, web-based multi-scale computational models/simulators aimed at integrating the current understanding of pathological processes at the molecular, cellular, circuit, network, and functional levels to generate novel hypotheses, model disease progression, and potentially serve as clinical trial simulators.
    • An administrative core which should provide overall coordination and support for Center activities.  In addition, the administrative core will be responsible for development and maintenance of a Center website which will inform the broader research community of center activities and resources/data availability.
    • A center structure with at least four components (including the administrative core) led by at least three different investigators, including at least one research project and at least one research or resource core. Investigators should propose the number of project(s) and core(s) that best addresses the question(s) being investigated. If only one project is proposed, it should be an over-arching project requiring at least three principal investigators co-leading the project
    • 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.
    Out of Scope
    • Clinical Trials
    • Centers with less than four components (research projects or cores, including the admin core)
    • Centers with less than three different investigators if only a single research project is proposed

    See Section VIII. Other Information for award authorities and regulations.

    Section II. Award Information
    Funding Instrument

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.  

    Application Types Allowed

    New

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

    Clinical Trial?

    Not Allowed: Only accepting applications that do not propose clinical trials

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    NINDS intends to commit $3.4M in FY 2021 to fund up to two awards.

    Award Budget

    Application budgets are limited up to $1.15M direct cost.

    Award Project Period

     The scope of the proposed Center should determine the project period.  The maximum project period is 5 years.  

    NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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)
    • Eligible Agencies of the Federal Government
    • U.S. Territory or Possession

    Other

    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations
    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) – 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • 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.

    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.

    The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

    • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
    • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
    Section IV. Application and Submission Information
    1. Requesting an Application Package

    The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

    It is critical that applicants follow the Multi-Project (M) Instructions 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.

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

    The letter of intent should be sent to:

    Tom Cheever, PhD
    Telephone: 301-496-5680
    Email: thomas.cheever@nih.gov

    Page Limitations

    Available Component Types

    Research Strategy/Program Plan Page Limits

    Overall

    12

    Admin Core

    6

    Core

    6

    Project

    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: required
    • Administrative Core: required, maximum of 1
    • Cores: required, minimum of 1
    • Projects: required, minimum of 1
    Overall Component

    When preparing your application, use Component Type ‘Overall’.

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

    SF424 (R&R) Cover (Overall)

    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.

    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 Center without Walls

    Research Strategy: The Overall section should state the main challenge the center is working to address, the outputs (including but not limited to data sets, resources, tools, services) to be delivered no later than the end of the project, and provide an overview of integration and synergy of center activities. The Research Strategy should be organized into sections that address Significance, Innovation, Approach, and Milestones.

    Significance: Describe the FTD subtype (FTD-Tau, FTD-TDP-43, or FTD-FUS) and main challenge in understanding the mechanisms of FTD the Center will work to address and how that focus aligns with the research recommendations from the 2019 ADRD Summit. Describe the data/tools/resource(s) outputs planned from the Center, how they can best be developed from a Center structure rather than an individual mechanism, and how they will advance and accelerate progress in the field.

    Innovation: Describe the technical and/or conceptual innovation that will be brought to this project through aspects including but not limited to: novel approaches and technologies, unique or novel investigator expertise, and unique or novel collaborations. Describe how these innovative aspects will advance the goals of the Center and advance our understanding of FTD.

    Approach: Provide a high-level overview of the proposed research program and how it fits together to address the overall central theme of the center. Describe why the specific number and configuration of Research Cores and Projects (minimum of one each) was chosen (with a minimum of four components including the administrative core with at least three different investigators involved in leading those components), and how the different components synergize to accomplish the goal(s) of the Center and how the work being proposed is best supported by a Center without Walls structure. Provide evidence that supports the feasibility, formation, and successful implementation of a Center that encompasses cutting edge technologies, novel approaches, and utilization of existing resources where relevant to advance our understanding of the mechanisms underlying FTD. Describe the composition of the investigator team and how their expertise is complementary and synergistic to meet the goals of the center. Describe how the diversity of investigators (such as gender, race/ethnicity, career stage, background/expertise, etc) will bring unique and diverse perspectives to the team. Detailed descriptions of preliminary data should be included within the relevant Research Project and Core sections, not in the overall overview.

    Milestones: Define milestones for assessing progress towards the aims of the center by year for the overall center associated with clear, quantitative criteria for success.   

    Letters of Support: The Letters of Support attachment of the application should include a cover page listing the name, institution, and proposed role for each individual providing a letter of support. Provide (no more than 20) letters here pertaining to active collaborations with:

    • Institutional commitments, collaborations with other institutional or consortium efforts in FTD or related dementias
    • National research resources and programs
    • Large-scale FTD-related clinical research projects
    • Nongovernmental organizations and philanthropic entities.

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

    All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing and Resource Sharing Plan. The plans should include an overall description of the anticipated data, resource, tools, services or other products as output from the center, how they will be advertised and made available to the broad, diverse community, and on what timeline. Applicants should describe plans for tracking requests for resources, any prioritization plans, and how the monitoring and timely accomplishment of the activities described in the sharing plans will be tracked.

    Appendix:

    Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.   

    PHS Human Subjects and Clinical Trials Information (Overall)

    When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed

    Delayed Onset Study

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

    All instructions in the SF424 (R&R) Application Guide must be followed

    PHS Assignment Request Form (Overall)

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    Administrative Core

    When preparing your application, use Component Type ‘Administrative 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.

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

    Research & Related Senior/Key Person Profile (Administrative Core)
    • 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.
    • Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged at all levels of the Center. See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html
    Budget (Administrative Core)

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

    Budget for the following Center without Walls-specific activities should be included in the Administrative Core:

    • Annual Center without Walls Meetings: Include meeting room rental, audiovisual support, travel and lodging costs for the Center Director, Center Administrator, and Project and Core Leads to attend the annual center without walls meetings.  To promote efficient spending, budgeted costs for External Advisory Committee 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. Costs for holding virtual annual meetings are also allowable.
    • External Advisory Committee (EAC): Include all EAC-related costs (meeting and travel) in the proposed budget. To promote efficient spending, budgeted costs for EAC member travel will be within range of local per diem rates (as per General Services Administration (GSA) guidance) and follow general NIH guidelines for travel. The EAC committee members should not be identified until after funding decisions are made and at that time, the EAC membership should be determined in collaboration with NINDS program staff expense reimbursement rates.
    • Center Website: Include all costs for the development and maintenance of a Center Website. Related costs for development of social media outreach strategies may also be included.
    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, Approach, and Milestones.

    Significance: Describe how the Administrative Core will serve as the organizational foundation for research activities of the Center without Walls. Justify the proposed interdisciplinary research strategy governance, including coordination with foreign institutions and other funding entities.

    Innovation: Describe whether or how the Administrative Core utilizes innovative approaches to maximize synergy among Center 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, and how the team composition and organization are best suited to accomplish the goals of the Core:

    • Promote the integration and function of Center components and activities.
    • Provide support for the Center Director(s) in oversight of Center governance.
    • Provide support for the Center Director(s) in oversight of external collaborations that support Center research projects and/or cores through provision of existing resources or infrastructure.
    • Organize a Center Steering Committee made up of the Center Director(S), Lead(s) for each Research Project and Research Core, as well as appropriate NIH program staff.
    • Provide support for the Center Director(s) in management of Center committees and cores including but not limited to the Steering Committee and any others that may arise to best support the activities of the Center.
    • After funding decisions have been made, work with NINDS program staff to identify an External Advisory Committee to provide high level guidance to the center on how well it is addressing needs in the field on a regular basis. Do NOT list potential names in the application.
    • Organize timely meetings of the External Advisory Committee.
    • Maintain an accounting of resource generation and related utilization and steps taken to maximize the research utilization of these resources within and beyond the Center without Walls.
    • Provide advance notice of manuscripts and publications to the NINDS program officer; work with the NINDS Office of Communications on press releases highlighting Center accomplishments.
    • Prepare and submit annual progress reports.
    • Provide assurance of compliance with NIH policy requirements.
    • Establish and maintain the Center's website focused on dissemination of center activities and data/resource/tool outputs as defined above, and include a plan for advertising to a diverse audience

    Milestones: Define milestones by year for the Administrative Core associated with clear and (where relevant) quantitative criteria for success.

    Letters of Support: Only letters of support specific to this component should be attached to this section

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

    All applications, regardless of the amount of direct costs requested for any one year, should address a Data and Resource Sharing Plan. The Resource Sharing Plan for the Administrative Core should complement the plan(s) from the Overall Section, and specifically address how the Administrative Core will integrate data and resources generated from all the Center components into a format that will be readily shareable with the broader research community in an equitable manner.

    Appendix:

    Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.   

    PHS Human Subjects and Clinical Trials Information (Administrative Core)

    When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed

    Delayed Onset Study

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed

    Research or Resource Core

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

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

    SF424 (R&R) Cover (Research or Resource Core)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates
    PHS 398 Cover Page Supplement (Research or Resource Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Research or Resource 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 or Resource Core)

    List all performance sites that apply to the specific component.

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

    Research & Related Senior/Key Person Profile (Research or Resource Core)
    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. 
    • The Core Lead must have appropriate expertise, as well as a record of productivity and collaboration, to ensure success of the Core. Expertise of the Core Lead may be in areas outside of specific FTD biology if relevant skills can readily be applied to achievement of Center goals
    • Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged at all levels of leadership and conduct of core activities. See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html
    Budget (Research or Resource Core)

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

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

    PHS 398 Research Plan (Research or Resource Core)

    Specific Aims: Describe the goals and planned activities of the Core, as well as its essential relationship to the aims of at least one other Center component.  

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

    Significance: Describe how the core will advance the aims of the center and the understanding of the mechanisms of FTD. Describe what gaps the resources, tools, or services provided will fill in the field, and how they will contribute to addressing the overall challenge being addressed by the center.

    Innovation: Describe how any technical or conceptual innovation from the core will advance our understanding of the underlying mechanisms driving pathology in FTD.

    Approach: Describe how the resources, services, or tools will be generated or how the services will be performed. Provide details on which services or resources will be utilized by which other center components. If the resources or services could be used by the broader research community, describe how these resources or cores will be advertised and accessed including communication to diverse investigators and institutions. Include a plan for how utilization and performance will be tracked. Describe how the composition of the core leadership and team is suited for performing the roles of the core and how a diversity of perspectives has been included where appropriate.

    Research Core approaches could include but are not limited to:

    • Development of antibodies or other reagents to support research projects
    • Support for -omic (transcriptomics, proteomics, metabolomics, epigenomics) analyses of model systems and human biospecimens and/or postmortem human tissue
    • Generation of unique model systems
    • Support for structural biology approaches such as NMR, crystallography, cryoEM, etc)
    • Computational biology support including multi-scale model generation and disease progression modeling

    Milestones: Define milestones by year for the Core associated with clear, quantitative criteria for success. Milestones for the Research Core should provide metrics for demonstrating the sharing of core resources, services, or tools within the center and to the broader research community where applicable.

    Letters of Support: If resources and/or services will be available to the broader research community, provide letters of support attesting to their value from members of the broader community. Only letters of support specific to this component should be attached to this section and no more than five letters will be permitted to limit conflicts with the application.

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

    Provide a description for how the resource, service, and/or tool outputs from the core will be shared with the community, either as a direct resource to the community during the project, or how the outputs of the core will be packaged into the overall data/tool/resource output(s) from the Center and made available by the end of the project period. Include how equitable sharing will be promoted. The plan should include an overall description of the anticipated data and/or resource output(s) from the core, and how they will be advertised and made available to a broad and diverse investigator community.

    PHS Human Subjects and Clinical Trials Information (Research or Resource Core)

    When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed

    Delayed Onset Study

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed

    Research Project

    When preparing your application, 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.

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

    Research & Related Senior/Key Person Profile (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.
    • Expertise of the Project Lead may be in areas outside of FTD biology if relevant skills and expertise can be readily applied to the achievement of Center goals. Collaborations with Early Stage Investigators or those in the early stages of independent careers are encouraged
    • Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged at all levels of leadership and conduct of the research project. See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html
    Budget (Research Project)

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

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

    PHS 398 Research Plan (Research Project)

    Specific Aims: State the aims of the research project and the hypothesis/es to be tested.   

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

    Significance: Describe the contributions of the research project to the goals of the Center.

    Innovation: Describe the technical and/or conceptual innovation of the project including but not limited to novel concepts, models, research approaches and/or techniques, and how they will contribute to the enhanced understanding of the mechanisms underlying FTD.

    Approach: Describe the experimental approaches and systems utilized to address the specific aims, as well as why this project could best be facilitated through a Centers mechanism like this. Describe how the project is integrated into the center through interactions with other components. Discuss the composition of the leadership and research team, and how their expertise or skill set is complementary and synergistic with others in the Center. Describe how a diversity of perspectives will be brought to bear on the main research question(s). Collaborations should strive to promote ethnic, racial, gender, and career stage diversity. Include a milestone plan that identifies timelines for data/tool/resource(s) outputs, interactions with supporting research cores or other projects, and resource and data sharing.

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

    Milestones: Define milestones by year for the Research Project associated with clear, quantitative criteria for success.

    Letters of Support: Only letters of support specific to this component should be attached to this section.

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

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

    PHS Human Subjects and Clinical Trials Information (Research Project)

    When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed

    If you have FOA-specific instructions for any of the study record fields, add the field label and specific instruction here within the study record section.

    Full study records include a number of fields and attachments related to human subjects and clinical trials. FOA-specific instructions can be provided to add to the information requested. Do not repeat or contradict information requested in the Application Guide. Be mindful of character limits noted in the Application Guide for text entry fields. This internal reference document (https://nih-extramural-hghbnintranet.od.nih.gov/d/sites/default/files/study-record-field-notes-internal-use.docx )

    lists specific field labels, the format of information submitted, and system restrictions.

    Delayed Onset Study

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed

    3. Unique Entity Identifier and System for Award Management (SAM)

    See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

    4. Submission Dates and Times

    Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

    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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

    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.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. 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.

    7. 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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

    Section V. Application Review Information
    1. Criteria

    Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission 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 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 or core that by its nature is not innovative may be essential to advance a field.

    Significance

    Does the Center address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous?  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?

    Specific for this FOA:  How well do the goals of the center advance the mechanistic understanding of FTD? How significant will the data/tool/resource output(s) produced/provided by the center be for advancing and accelerating progress in the FTD research field?

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? If Early Stage Investigators or those 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?

    Specific for this FOA: Does the Center propose a collaborative, multi-investigator, multidisciplinary, and complementary team? Does the Center include expertise appropriate for the management and sharing of the data/tool/resource output(s) being developed? Does the Center PD(s)/PI(s) have the appropriate scientific and administrative qualifications and leadership ability to direct this center? Is his/her commitment to the Center adequate to ensure its success? Do the investigators on the separate projects and cores show evidence of collaborating to advance the goals of the overall Center? Is a diversity of perspectives represented in the Center leadership and research team? 

    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?

    Specific for this FOA: How well does the combination of different cores and projects into a single overall Center enhance the innovation and increase the novelty of the proposed research? 

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?  

    Specific for this FOA: Are the number, configuration, and fit between individual projects and cores clear, scientifically well-justified, and synergistic? Is the proposed structure adequate to support and encourage optimal interaction, communication, and collaboration among participants of the overall research effort and provide the specified data/tool/resource output(s)? Are there clear plans for developing data/tool/resource output(s) available to the broader research community and addressing a specific challenge in the FTD field?

    Environment

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

    Review Criteria for Administrative Core

    Reviewers will provide overall numeric scores; individual criterion scores are not provided.

    The following criteria will be used for the evaluation of the Administrative Core:

    • How clear and effective is the plan for managing the Center's research and administration, including the integration and function of center components and activities?
    • Are plans for support and functioning of the Center Steering and External Advisory Committee appropriate and well designed?
    • Are the core personnel well suited to accomplish the goals of the administrative core?
    • Is there an organizational structure that will facilitate communication, collaboration, coordination, integration, and timely evaluation of activities and progress?
    • Are plans for integrating data/tools/resources from center components well designed for promoting equitable access and utilization within the center and beyond?
    Review Criteria - Research or Resource Core

    Reviewers will provide overall numeric scores; individual criterion scores are not provided.

    Each Research Core should provide essential functions or services to one or more other components of the Center. Reviewers will assign an impact score for core unit components.

    The following review criteria will be used for evaluation of the individual Cores:

    • How well does the proposed Research or Resource Core meet gaps identified in the FTD field?
    • How well does the Research or Resource Core support other components in the center to advance the goals of the overall Center?
    • Are plans for advertising the data, resources, tools, and/or services provided by the core sufficient to promote utilization within the center and beyond if appropriate?
    • Assess the criteria for prioritization and usage of Research or Resource Core products and/or services?
    • Is the leadership of the Research or Resource Core and other key personnel well suited to performing the role(s) of the core and bringing a diversity of perspectives where appropriate?
    • Is the environment for the Research or Resource Core adequate to support the Center as proposed?
    Scored Review Criteria - Research Project

    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? Is the prior research that serves as the key support for the proposed project rigorous?  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?

    Specific for this FOA: How does the focus of the research project enhance the potential impact of the overall center on FTD research? Does the research project enhance the depth of focus of the overall center?

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?

    Specific for this FOA: How well are multiple investigator perspectives integrated if an application proposes only one over-arching 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?

    Specific for this FOA: Does the project bring technical and/or conceptual innovation, such as novel concepts, models, research approaches, and/or techniques that might contribute to enhanced understanding of the mechanisms underlying FTD?  

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

    Specific for this FOA: How well integrated is the project and approaches proposed in the overall FTD Center without Walls? Are the approaches sufficiently robust to enhance the outcomes of the overall center?   

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

    Milestones

    Are the milestones in the research projects and cores appropriate for assessing progress and associated with clear, quantitative criteria for success? Will the overall Center milestones provide adequate information to evaluate annual progress of the Center as a whole? Are the timelines proposed for achieving the milestones realistic and inclusive of necessary steps, but also efficient without adding unnecessary steps? Are the milestones complete - do they sufficiently cover the main goal(s) of the center?

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the 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 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 Individuals Across the Lifespan  

    When the proposed Center 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 individuals of all ages (including children and older adults) 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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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) Genomic Data Sharing Plan .

    Authentication of Key Biological and/or Chemical Resources

    For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

    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 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 on the basis of established PHS referral guidelines 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.  
    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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

    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 terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

    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.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex.  This includes ensuring programs are accessible to persons with limited English proficiency.  The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS.  Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

    HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.  For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

    Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.   

    In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    Cooperative Agreement Terms and Conditions of Award

    The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

    The administrative and funding instrument used for the Center without Walls will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below. Awardee will retain custody of and have primary rights to the data and software developed under this award, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

    The PD(s)/Pl(s) will have the primary responsibility for:

    • the overall functioning of the Center;
    • defining objectives and approaches, and for planning, conducting, analyzing, interpreting, publishing and sharing results;
    • developing and proposing rigorous milestones that will be achieved during the project period;
    • providing progress reports with completeness that include experimental design with rigor, including assumptions for the design of the experiments, the results of the investigations, interpretations of the results, and for concluding whether milestones have been met or not. In cases when NIH program staff request raw data, awardees agree to provide the data;
    • and promoting collaborative interactions between all Center investigators, steering committee, and NINDS representatives.

    NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

    The NINDS Project Scientist will work closely with the PD/PI, the Steering Committee, and the PIs of all projects/cores in order to ensure proper conduct of the Center. The NINDS Project Scientist will be responsible for: (1) overseeing the activities of the Center, along with the other entities delineated above, to ensure that studies are properly conducted and completed in a timely fashion; (2) providing advice and guidance to ensure that the Center runs in accordance with NINDS policies and procedures, and is consistent with the mission of the NINDS to improve public health; (3) serving as a point of contact for investigators with the NINDS; and (4) disseminating information from the Institute and communicating with Institute leadership to ensure that the Center operates smoothly. In addition, an NINDS Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the notice of award.

    Milestones: Milestones are goals that are quantifiable for measuring success of each Research Project or Research Core and should have quantitative criteria associated with them (see Section IV.2 for details). Milestones should also be included for each of the Overall Center Specific Aims and should inform annual evaluations of progress of the Center as a whole.

    Prior to funding an application, the NINDS Project Scientist will contact the applicant to discuss the proposed milestones and any concerns raised by the NINDS review panel or NINDS program staff. A final set of NINDS-approved milestones will be specified prior to award.

    Progress towards achievement of the final set of milestones will be evaluated by the NINDS Project Scientist and program staff. NINDS program staff may consult with independent experts as necessary. If justified, future milestones may be revised based on data and information obtained during the previous budget period. If, based on the progress report, a project does not meet the milestones, funding for the project may be reduced or discontinued. In addition to milestones, the decision regarding continued funding will also be based on the overall progress, NINDS portfolio balance and program priorities, competitive landscape, and availability of funds.

    Areas of Joint Responsibility include:

    • None: all responsibilities are divided between awardees and NIH staff as described above.

    Dispute Resolution:

    Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee , and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50,Subpart D and DHHS regulation 45 CFR Part 1

    3. Reporting

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

    In the section pertaining to the Research Core, a table should be provided listing requests for resources or services. The table should include: the requested resource or service, the requestor and institution, the date of the request, the date of request fulfilment, and if the request was not granted the reason for non-fulfillment.

    A final RPPR, 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. 

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

    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 Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Tom Cheever, PhD
    National Institute of Neurological Disorders and Stroke (NINDS)
    Telephone: 301-496-5680
    Email: thomas.cheever@nih.gov

    Peer Review Contact(s)

    Chief, Scientific Review Branch
    National Institute of Neurological Disorders and Stroke (NINDS)
    Telephone: 301-496-9223
    Email: nindsreview.nih.gov@mail.nih.gov

    Financial/Grants Management Contact(s)

    Anna Taylor, PhD
    National Institute of Neurological Disorders and Stroke (NINDS)
    Telephone: 301-827-3565
    Email: Anna.Taylor@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 Part 75.    

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