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)

Funding Opportunity Title

Exploratory Alzheimer's Disease Research Centers (P20 Clinical Trial Not Allowed)

Activity Code

P20 Exploratory Grants

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AG-20-023

 

Companion Funding Opportunity

None

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

 93.866

Funding Opportunity Purpose

This funding opportunity announcement invites applications to plan and initiate collaborative activities that will develop and implement infrastructure appropriate for an Alzheimer's Disease Research Center (P30). 

Key Dates
Posted Date

May 30, 2019

Open Date (Earliest Submission Date)

September 9, 2019

Letter of Intent Due Date(s)

September 9, 2019

Application Due Date(s)

October 9, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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/March 2020

Advisory Council Review

May 2020

Earliest Start Date

July 2020

Expiration Date

October 10, 2019

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

    Purpose

    This Funding Opportunity Announcement (FOA) invites applications to establish NIA Exploratory Alzheimer's Disease Centers. NIA's primary goal in offering this P20 funding opportunity is to incentivize innovative ideas and opportunities in Alzheimer's disease and Alzheimer's disease related dementias (AD/ADRD) research.

    As part of a network, Centers are expected to participate in collaborative efforts on a national scale. Applicants must agree to collect a standard clinical data set (the Uniform Data Set, or UDS) that is common to all Centers and to transmit that data to the National Alzheimer’s Coordinating Center (NACC). Applicants should contact NACC to learn more about NACC procedures, the structure of the UDS, and the regular updates to the datasets required from all Centers at  http://www.alz.washington.edu/

    To support the unique research needs of the NACC, most Centers collect additional data to supplement those required by the UDS. These should also be made readily available to qualified investigators. Similarly, Centers should demonstrate a readiness to provide biological samples and data, with proper consent from well-characterized populations, to enable participation in large-scale, collaborative, national, or international research projects. Sample sharing may be done either locally or centrally through the National Centralized Repository for Alzheimer's Disease and Related Dementias (NCRAD). Centers are a local, regional, national, and international resource.

    Exploratory Alzheimer's Disease Centers are required to include the following three cores:

    • Administrative - Manage and coordinate interactions among the Director, the core leaders, the principal investigators of research projects using the resources of the Center, other researchers at the applicant institution as well as outside institutions, appropriate institutional administrative personnel, the staff of the awarding agency, and the members of the community in which the Center is located.
    • Clinical - Establish and maintain a clinical enterprise that provides valuable, well-documented resources for cutting-edge clinical research for both Center personnel and the wider scientific community.
    • Additional - Propose an additional core that contributes to the overall focus of the planned Center that is scientifically justified, develops resources that support other research affiliated with the Center, and fits within the budget guidelines outlined in Section II: Award Information of the FOA.

    Exploratory Alzheimer's Disease Centers should describe their current related activities and infrastructure and the planned process to transform that into the infrastructure needed for an Alzheimer's Disease Research Center (ADRC). This may include, but is not limited to, the following planning activities:

    • Recruit faculty to build a cohesive, multidisciplinary interactive team to innovate AD/ADRD research;
    • Build unique resources that will advance the field of AD/ADRD research;
    • Create sustainable community partnerships to reflect local interest;
    • Leverage existing or create new training programs focused on AD/ADRD research;
    • Define a geographic catchment area that will maximize Clinical Core diversity and contribute to the ADRC network;
    • Define the scientific goal on which the Center and new teams will focus; and
    • Determine how the exploratory grant will contribute to and advance the AD field.

    The objectives of the NIA Alzheimer’s Centers Program are to foster highly interactive, cutting-edge AD/ADRD research through the following:

    • Create an environment that supports innovative research that has a significant impact on the field of dementia research and treatment;
    • Provide core services that leverage funding and unique expertise;
    • Raise awareness and interest in fundamental, clinical, and translational dementia research at institutions, as well as locally, regionally, and nationally;
    • Foster interdisciplinary collaborations, especially in emerging areas of research, to catalyze new ideas and scientific approaches;
    • Attract and retain early stage investigators and investigators new to dementia research;
    • Promote the translation of scientific discoveries from bench to bedside to community that improve public health and provide an opportunity for feedback, including validation and effectiveness measures;
    • Enable bi-directional translation aimed at accelerating the development of effective treatment and prevention for AD patients at all stages of the disease;
    • Provide rapid and broad sharing of analytic and research tools, as well as data, as appropriate and consistent with achieving the goals of the program; and
    • Enhance dementia-related research education and training opportunities for people with dementia, their care partners, students, scientists, and clinicians.

    NIA support of Alzheimer’s Centers is intended to foster excellence in research across a broad spectrum of scientific and medical concerns relevant to dementia. To facilitate discovery and its translation into direct benefit to people with dementia and the general public, the NIA awards ADRCs to institutions that have a critical mass of excellent dementia-relevant scientific research and share the resulting research resources widely for the greatest impact.

    Background

    Dementia is estimated to affect millions of people in the United States. Financially, medically, and emotionally, dementia is a devastating disease for individuals, their families, and society. It has been estimated that the United States spends well over $100 billion per year for the direct and indirect costs of care for people with AD/ADRD. The risk of AD increases greatly with age, and projections suggest that the numbers of people with AD will increase with the aging of the population unless effective interventions are found.

    In the United States, the executive and legislative branches of the federal government have both expressed concern about the enormity of the problem posed by AD. In 1984, Congress directed NIH, and in particular NIA, to foster further research related to AD, and in 2011, Congress passed the National Alzheimer’s Project Act (NAPA). The stated primary goal of the National Plan to Address Alzheimer's Disease is "to prevent and effectively treat Alzheimer's Disease and Related Dementias by 2025." NIA highlights a framework of specific steps/criteria towards this goal in a research implementation milestone database. This extraordinarily ambitious goal requires that substantial resources be brought to bear to help achieve it. Therefore, this FOA for Exploratory Alzheimer's Disease Research Centers invites novel approaches and offers an opportunity to augment and enhance the NIA's ADRC program commensurate with the increase in overall funding for AD/ADRD research.

    Both congressional and public interest has focused on funding for research on the causes, diagnosis, treatment, and prevention of the disease, as well as on disparities and on the cost and coordination of care. The NIA ADRC program is authorized by the Public Health Service Act, Section 445, and currently includes 30 NIA-designated ADRCs.

    In 2017, NIA completed a strategic planning process that resulted in a set of 166 recommendations. Leading experts from academia, industry, and non-profit foundations working in Alzheimer’s and other complex diseases were engaged to help ensure that the next generation of AD Centers is aligned with the key recommendations from the NIH AD and ADRD Research Summits.

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

    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.

    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

    NIH intends to fund up to two (2) awards, corresponding to a total of $1.5 million in direct costs, for Fiscal Year 2020.

    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 $750,000 in direct costs per year. Budget requests must reflect the actual needs of the proposed project.

    Award Project Period

    The maximum project period is 3 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:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   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

    Institutions with currently active NIA-funded Alzheimer's Disease Research Centers under RFA-AG-19-001 or RFA-AG-20-004 are not eligible to apply.  

    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 not 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.
    • o   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.

    Current Alzheimer's Disease Research Center Program Directors/Principal Investigators under RFA-AG-19-001 or RFA-AG-20-004 are not eligible to apply for this FOA.  

    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

    Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

    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:

    Nina Silverberg
    National Institute on Aging (NIA)
    Telephone: 301-496-9350
    Email: silverbergn@mail.nih.gov

    Page Limitations

    Available Component Types

    Research Strategy/Program Plan Page Limits

    Overall

    12

    Admin Core (Use for Administrative Core)

    12

    Clinical Core

    6

    Additional Core

    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; maximum of one
    • Administrative Core: required; maximum of one
    • Clinical Core: required; maximum of one
    • Additional Core: required; maximum of one
    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.

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

    Exploratory Grant Organizational Structure: Provide a diagram illustrating Exploratory Grant institutional, departmental, and interdepartmental cooperation and interaction.

    Exploratory Grant Timeline: Provide a timeline (in table, flow chart, or chronological narrative format) for activities to be completed within the three-year project period culminating in a P30 ADRC application. Describe the roles of the investigators and research sites in achieving timeline goals.

    Summary Tables Use summary tables to list related federally and non-federally funded grants that have utilized resources from proposed collaborators. Also include ongoing or planned funding for therapeutic trials and other grants from industry, as well as health disparities and diversity-related grants. Include a description of what resources were used for each. Sample formats of summary tables are available through NACC.

     

    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.

    Program Director/Principal Investigator: The PD/PI(s) should be a scientific leader experienced in the field of AD and/or other neurodegenerative disease research and should be able to coordinate, integrate, and provide guidance in the establishment of programs in AD research and allied areas.

    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 aims of the overall Exploratory Center and outline the innovative ideas and opportunities that will prepare the organization to become a NIA Alzheimer's Disease Research Center.  

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

    Significance: Describe how the proposed Exploratory Center will (i) improve scientific knowledge, technical capability, and/or clinical practice; and (ii) augment and enhance the current existing Center Network (https://www.nia.nih.gov/health/alzheimers-disease-research-centers).

    Innovation: Show how the proposed Exploratory Center seeks to shift current research or clinical practice paradigms through use of novel concepts, approaches, methodologies, instrumentation, or interventions.

    Approach: Describe the mechanisms that will facilitate the coherence of the Center around a focused theme representing a novel approach in AD/ADRD and pursue a multidisciplinary focus. State how the Center will promote the NAPA research implementation milestones and the goals of NAPA. Provide examples of how the presence of the proposed Center will bring new investigators into the field. Indicate the scientific opportunities contributed by each proposed investigator and how they will interact to achieve the proposed goals. Explain the plans to generate additional funding from future grants, as well as plans to leverage funds from donors and other private sources utilizing new resources developed in the Exploratory Center.

    Letters of Support: As attachments, include letters of support signed by the Dean and/or Hospital President, Department Chairs, and/or other appropriate institutional officials documenting specifics of institutional commitment, including allocation of available resources to AD/ADRD research; provision of long-term, stable support, including physical space, control over faculty recruitments, and commitment to facilitate research by clinician scientists; and a delineation of how this Exploratory Grant effort will provide a strong foundation for a subsequent NIA ADRC application. 

    Insert letters from additional collaborative investigators and community partnerships.

    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:

    In order to maximize the availability and usability of the data and research resources generated by NIA’s ADRC Program, and to comply with the NIH Genomic Data Sharing Policy and the NIA/NIH efforts aimed at increasing transparency, reproducibility, and translatability of research findings, the awardees are expected to engage in broad sharing of data and biological samples, analytical methodology, and disease models prior to publication, consistent with achieving the goals of the program. This should include adhering to FAIR principles, i.e., data should be findable, accessible, interoperable, and reusable; see box p. 6 of this document: https://datascience.nih.gov/sites/default/files/NIH_Strategic_Plan_for_Data_Science_Final_508.pdf.

    To this end, applicants should demonstrate efforts to make:

    • ·    All datasets used/generated by this project accessible and reusable by qualified individuals other than the original data generators via web-based resources with the capacity to store large and diverse datasets (such as data about clinical phenotypes and high-dimensional omic data - genomic, proteomic, and metabolomic) to enable multiple parallel approaches to data analysis and interpretation;
    • ·    All disease models generated in the course of the award available to qualified investigators to accelerate their characterization, validation, and translational utility; and
    • ·    All biological samples obtained or used to generate data with this award available to qualified investigators.

    To fulfill the above data- and resource-sharing expectations, the grantees can utilize the following NIA-supported repositories: NACC, NCRAD, NIAGADS, and the AMP-AD Knowledge Portal. Data can be made accessible via open or controlled access depending on the data type and data source and as determined by the informed consent documents for each study, as guided by the local IRB. A comprehensive listing of NIH data sharing repositories is available at https://www.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html.

    The Steering Committee of the NACC, in conjunction with the ADRC Directors and NIA, sets policies that allow the individual Centers to conduct unique research with participants while also sharing common data sets with NACC.

    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 NIH-defined human subjects research, clinical research, and/or 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 ‘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.

    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. 
    • ·    Core Leader (CL) must have demonstrated leadership and administrative skills. Specifically, the CL should be able to organize and administer the resources created by the core in such a way that they may be shared within the Center as well as with other interested scientists. Demonstrated leadership in training junior investigators is desirable.
    • ·    The PD/PI(s) of the proposed Center should also be the Administrative CL(s); sufficient time should be devoted to the core to ensure that the aims are met and required functions are carried out efficiently. The PD/PI’s biographical sketch should present evidence of scientific expertise relevant to the themes of the Center and demonstrate the capacity for leadership of an ADRC.
    • ·    The administrative requirements of the Center will necessitate the assistance of an administrator with business management expertise. It is important that such an individual be identified and be directly involved with the fiscal and administrative aspects of the application and grant. The administrator should be able to provide consultation in matters of fiscal administration and be familiar with NIH grant-related compliance policies.
    • ·    An Associate Director may be named who will be involved in the administrative and scientific efforts of the Center. 
    Budget (Administrative Core)

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

    A significant time commitment (2.4 person-months) should be made by the CL.

    Domestic and foreign travel of personnel directly related to the core and scientific activities of the Center is allowable. Budgeting should include travel and lodging for representatives of the Center to attend: 1) the semi-annual meetings of the ADRC directors; 2) annual meetings of administrators, clinical core leaders, education core leaders, data managers, and neuropathology core leaders; 3) ad hoc meetings called by the ADRCs or NIA to discuss research findings and plan cooperative projects, to promulgate data sharing, and to discuss standardization of procedures among the ADRCs; 4) at least two ad hoc meetings on special topics; and 5) for visits of Center investigators to other ADRCs for the exchange of scientific ideas, planning of multi-Center research projects, and to receive training in specialized techniques.

    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: Provide an overview of how the core will set the overall direction of the Center and ensure optimal utilization of Center resources within the project period. 

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

    Significance: Explain the role of the Administrative core in the Center as a whole and as a resource for other ongoing activities in AD and other neurodegenerative diseases. Specify how the core will assure success of the overall aims.

    Approach: Describe how the Center's administrative structure will facilitate the following:

    • ·    assurance that the proposed timeline is maintained and that updates are incorporated as appropriate;
    • ·    oversight of research and grants administrative processes (including preparation of annual Research Performance Progress Report (RPPR));
    • ·    coordination and integration of Center components and activities;
    • ·    direction for future planning and optimal utilization of resources;
    • ·    faculty recruitment, retention, tenure/promotion activities (including recognition of team science), and clear leadership succession planning;
    • ·    support and advice for the Center Director in oversight of the activities of the Center;
    • ·    interaction with the scientific and lay communities to develop relevant goals for the Center;
    • ·    coordination and organization of external and internal advisory committee meetings;
    • ·    assurance of compliance with human subjects, animal welfare, scientific integrity, data and sample sharing (as appropriate), and financial policy requirements of NIH;
    • ·    interaction with other Centers and other researchers to develop outside research projects that utilize the unique resources of the Center;
    • ·    timely and routine transmissions of appropriate Center data sets to the NACC;
    • ·    timely and routine submission of samples to NCRAD; and
    • ·    interaction and involvement with other research programs and grant administration of the University, including the provision of core resources for development of related research.

    Additionally, the Center's administrative structure should present plans to establish and operate Center advisory panels, including the following:

    • ·    An executive committee (composed of CLs and the administrator) to advise the Director in setting scientific and administrative goals to achieve success in the overall aims of the Center. The executive committee may consist of leaders both from within the institution and from other institutions and should provide guidance on monitoring and developing the scientific content and direction of the Center. The executive committee should take responsibility for assuring that appropriate database infrastructure is in place that will address the current and future needs of the Center as a whole and that will seamlessly integrate with the ADRC network in the subsequent P30 ADRC application.
    • ·    An External Advisory Committee (EAC) to conduct and provide annual evaluations of Center programs, research sharing and progress, the effectiveness of communications within and outside of the ADRC, interactions with NACC and NCRAD, and any other activities for which outside expertise is required or desirable. EAC members should not be named in the application and should not be contacted for participation in the committee prior to award. The NIA program officer should be invited to attend EAC meetings as a non-voting member. A copy of the advisory committee report should be routinely sent to NIA with the annual RPPR and should include a list of committee members after they have been appointed.

    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:

    In order to maximize the availability and usability of the data and research resources generated by NIA’s ADRC Program, and to comply with the NIH Genomic Data Sharing Policy and the NIA/NIH efforts aimed at increasing transparency, reproducibility, and translatability of research findings, the awardees are expected to engage in broad sharing of data and biological samples, analytical methodology, and disease models prior to publication, consistent with achieving the goals of the program. 

    To this end, applicants should demonstrate efforts to make:

    • ·    All datasets used/generated by this project accessible and reusable by qualified individuals other than the original data generators via web-based resources with the capacity to store large and diverse datasets (such as data about clinical phenotypes and high-dimensional omic data - genomic, proteomic, and metabolomic) to enable multiple parallel approaches to data analysis and interpretation;
    • ·    All disease models generated in the course of the award available to qualified investigators to accelerate their characterization, validation, and translational utility; and
    • ·    All biological samples obtained or used to generate data with this award available to qualified investigators.

    To fulfill the above data- and resource-sharing expectations, the grantees can utilize the following NIA-supported repositories: NACC, NCRAD, NIAGADS, and the AMP-AD Knowledge Portal. Data can be made accessible via open or controlled access depending on the data type and data source and as determined by the informed consent documents for each study, as guided by the local IRB. A comprehensive listing of NIH data sharing repositories is available at https://www.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html.

    The Steering Committee of the NACC, in conjunction with the ADRC Directors and NIA, sets policies that allow the individual Centers to conduct unique research with participants while also sharing common data sets with NACC.

    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 NIH-defined human subjects research, clinical research, and/or 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

     
    Clinical Core

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

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

    SF424 (R&R) Cover (Clinical Core)

    Complete only the following fields:

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

    PHS 398 Cover Page Supplement (Clinical Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Clinical Core)

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

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

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

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

    List all performance sites that apply to the specific component.

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

    Clinical cores of ADRCs may be based in university medical center neurology or psychiatry department memory disorders clinics, but they may also be based in other departments.

    Applicants are encouraged to include special populations, such as an underrepresented population, an existing epidemiologic cohort, or a community population living in elderly housing.

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

    • ·    In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • ·    In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • ·    Include a single Biographical Sketch for each Senior/Key person listed in the application, regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • ·    If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.  
    • ·     The Clinical Core Leader may be a neurologist, but may also be a neuropsychologist, psychiatrist, geriatrician, or other clinician with expertise in diagnosing Alzheimer’s and other neurodegenerative diseases. The Clinical Core Leader should have a track record of research in some aspect of neurodegenerative disease, including interactions with other key personnel as well as leaders in the field from other institutions. 

    Budget (Clinical Core)

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

    Research patient care costs (both inpatient and outpatient expenses) will be considered in the context of other existing institutional clinical resources. Attempts should be made by the applicant institution to utilize existing clinical facilities. Costs relating to the clinical efforts of the Center may be funded through the Center, provided there is no overlap of funding. Only those research patient costs directly related to Center activities may be charged to the Center.

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

    PHS 398 Research Plan (Clinical Core)

    Specific Aims: Clearly describe the target population for which the core will provide well-characterized, longitudinally followed research participants for cutting-edge research projects involving topics such as clinico-pathological correlations, comparison of disease states to normal aging (including those using biological samples or imaging), and drug/intervention studies. State whether and to what extent the selection of the target population will promote the NAPA research implementation milestones and the goals of NAPA.  

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

    Significance: Explain the role of the Clinical core in the Center and as a resource for other ongoing activities in Alzheimer’s disease and other neurodegenerative diseases. Establish and justify sample sizes for the cohort and for different subpopulations. If the Clinical core will include special populations, the applicant should describe the characteristics of the population and justify the added scientific value to research at the Center resulting from the inclusion of this group so that peer reviewers can evaluate the comparative strengths and weaknesses of the proposed clinical core.

    Approach: Describe preliminary organizational work, institutional experience with AD and other neurodegenerative disease research, potential for developing transformative research, and specific plans for implementation of the new program. 

    State how the Clinical core, in addition to participant recruitment, will provide evaluation and diagnosis, maintain a research volunteer registry that tracks number and reasons for those lost to follow-up, and conduct longitudinal follow up of registry participants. The participants in the registry may be considered a “trial-ready cohort” and may be assessed remotely, either by telephone, web-based assessment, or other mobile assessment tool. Clearly describe how participants are recruited into the registry (i.e., catchment area, geographic recruitment, internet-based, according to particular risk factors, etc.). Describe efforts to include and retain diverse participants in the registry.

    Describe procedures related to collection, storage, and distribution of biological samples that may include, but are not limited to, cell lines, cerebrospinal fluid (CSF), blood, and plasma. Centers are strongly advised to contact NCRAD as they prepare their application for assistance in meeting sample sharing requirements, including procedures, consent forms, and budget issues. Particular attention should be paid to best practices for collection and use of biospecimens, as detailed in documents available on the NACC website (https://www.alz.washington.edu/BiospecimenTaskForce.html). Applicants should describe and follow agreed-upon protocols for multi-center projects involving specimen collection.  

    Longitudinal data, including clinical, cognitive, behavioral, functional, imaging, and biomarker characterization on participants through the spectrum from normal aging to dementia, should be collected according to the UDS protocol and transmitted in a timely manner to NACC. Describe any additional data collected, including tools and procedures.

    Indicate how the Clinical core and the proposed Center as a whole will provide unique and innovative opportunities for the field and, specifically, how the resources created might be utilized in future studies as specified in the overall aims of the Center.

    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:

    In order to maximize the availability and usability of the data and research resources generated by NIA’s ADRC Program, and to comply with the NIH Genomic Data Sharing Policy and the NIA/NIH efforts aimed at increasing transparency, reproducibility, and translatability of research findings, the awardees are expected to engage in broad sharing of data and biological samples, analytical methodology, and disease models prior to publication, consistent with achieving the goals of the program. 

    To this end, applicants should demonstrate efforts to make:

    • ·    All datasets used/generated by this project accessible and reusable by qualified individuals other than the original data generators via web-based resources with the capacity to store large and diverse datasets (such as data about clinical phenotypes and high-dimensional omic data - genomic, proteomic, and metabolomic) to enable multiple parallel approaches to data analysis and interpretation;
    • ·    All disease models generated in the course of the award available to qualified investigators to accelerate their characterization, validation, and translational utility; and
    • ·    All biological samples obtained or used to generate data with this award available to qualified investigators.

    To fulfill the above data- and resource-sharing expectations, the grantees can utilize the following NIA-supported repositories: NACC, NCRAD, NIAGADS, and the AMP-AD Knowledge Portal. Data can be made accessible via open or controlled access depending on the data type and data source and as determined by the informed consent documents for each study guided by the local IRB. A comprehensive listing of NIH data sharing repositories is available at https://www.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html.

    The Steering Committee of the NACC, in conjunction with the ADRC Directors and NIA, sets policies that allow the individual Centers to conduct unique research with participants while also sharing common data sets with NACC.

    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 (Clinical Core)

    When involving NIH-defined human subjects research, clinical research, and/or 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.

     
    Additional Core

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

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

    SF424 (R&R) Cover (Additional 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 (Additional Core)

    Enter Human Embryonic Stem Cells in each relevant component.

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

    • ·    In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • ·    In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • ·    Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • ·    If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

    Budget (Additional 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 (Additional Core)

    Specific Aims: Clearly state how the core will contribute to the goals of the Center.  

    Demonstrate exactly how the proposed core would augment or enhance the present capabilities of investigators using Center resources to enhance or create research at the home Center, as well as at other Centers and in the wider research community.

    Describe how the core will advance and promote the NAPA research implementation milestones and the goals of NAPA.

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

    Describe the research that will or could use the resources of the proposed core.

    Describe preliminary organizational work, institutional experience with AD and other neurodegenerative disease research, potential for developing or contributing to new and exciting research, and specific plans for implementation of the new program.

    Present core objectives and any progress in meeting them. Any developmental work carried out by the core should also be described.

    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:

    In order to maximize the availability and usability of the data and research resources generated by NIA’s ADRC Program, and to comply with the NIH Genomic Data Sharing Policy and the NIA/NIH efforts aimed at increasing transparency, reproducibility, and translatability of research findings, the awardees are expected to engage in broad sharing of data and biological samples, analytical methodology, and disease models prior to publication, consistent with achieving the goals of the program. 

    To this end, applicants should demonstrate efforts to make:

    • ·    All datasets used/generated by this project accessible and reusable by qualified individuals other than the original data generators via web-based resources with the capacity to store large and diverse datasets (such as data about clinical phenotypes and high-dimensional omic data - genomic, proteomic, and metabolomic) to enable multiple parallel approaches to data analysis and interpretation;
    • ·    All disease models generated in the course of the award available to qualified investigators to accelerate their characterization, validation, and translational utility; and
    • ·    All biological samples obtained or used to generate data with this award available to qualified investigators.

    To fulfill the above data- and resource-sharing expectations, the grantees can utilize the following NIA-supported repositories: NACC, NCRAD, NIAGADS, and the AMP-AD Knowledge Portal. Data can be made accessible via open or controlled access depending on the data type and data source and as determined by the informed consent documents for each study, guided by the local IRB. A comprehensive listing of NIH data sharing repositories is available at https://www.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html.

    The Steering Committee of the NACC, in conjunction with the ADRC Directors and NIA, sets policies that allow the individual Centers to conduct unique research with participants while also sharing common data sets with NACC.

    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 (Additional Core)

    When involving NIH-defined human subjects research, clinical research, and/or 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.

    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 Center 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?

    What is the likelihood that the proposed Center will lead to a successful application for an NIA-funded ADRC?  

    How strong is the base of ongoing, high-quality research in AD and other related neurodegenerative disorders? How do the stated goals and plans demonstrate potential for contributing to cutting-edge research on normal aging and neurodegenerative diseases of aging? What are the scientific interactions across federally supported Center programs, non-governmental organizations (NGOs), and the local community? How well does the proposed Center accelerate the planned research, whether funded by the Center or not, that has, or will depend upon, resources provided? Importantly, how well does the proposed Center accelerate translational research across the spectrum of disease, with a focus on understanding the heterogeneity of AD and related dementias? Is there a clearly defined dementia research focus adding to the progress of the field? How well does the Center promote the NAPA research implementation milestones and goals?

    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?

    How well do the investigators and staff provide creative scientific and administrative leadership of the Center and demonstrate a commitment to devote adequate time to the management of the proposed program? What evidence is there of collaboration and interdisciplinary research among the investigators who will be associated with the Center? Does the group have stability and a track record of working together? Are plans for succession/recruitment of new personnel addressed? Is the PD/PI(s) a scientific leader experienced in the field of AD? Has the PD/PI(s) demonstrated that they can coordinate, integrate, and provide guidance in the establishment of programs in AD research and allied areas? How well is the PD/PI(s) effective in using institutionally designated authorities to manage and advance scientific objectives? How likely is it that the leadership can organize a future successful application?

    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? 

    How well do the proposed Center and each component demonstrate the capacity to develop critical new knowledge and unique and innovative contributions to AD and related dementia research locally, nationally, and internationally? Does the proposed Center add novelty and innovation to the existing ADRC network? 

    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?   

    How well does the proposed Center demonstrate appropriate organization and core management? Are the organizational plans and management structures adequate to meet Center goals? Are the procedures for internal communication and cooperation among the investigators adequate? Are the planning and evaluation of the Center strategies and activities appropriate? Do the cores proposed support the Center scientific theme(s) and advance the 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?

    How adequate are the relevant facilities for the proposed work? Does the geographic relationship between facilities seem reasonable to carry out the proposed work? Are the environment and core resources sufficient to enhance cutting-edge research by bringing together multidisciplinary investigators? How do institutional policies, including those related to promotion and tenure, recognize team science? How well do the letters of support demonstrate institutional commitment? What are the institutional commitments for the Center that are comparable or superior to that of departments? What are the assurances from institutional leaders that they will provide long-term stable support and facilitate research by clinician scientists? How well does the institutional commitment ensure the Center's stability and fulfillment of the Center's objectives?  

    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.

    Recruitment Plan to Enhance Diversity

    Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of individuals from underrepresented groups. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

    Training in the Responsible Conduct of Research

    Taking into account the specific characteristics of the proposed research education program and the level of participant experience, the reviewers will evaluate the adequacy of the proposed Responsible Conduct of Research (RCR) training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only online instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction –instruction must occur during each career stage and at least once every four years. See also: NOT-OD-10-019. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

     
    Additional Review Criteria - Cores

    As applicable for the core 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.

    Administrative Core

    Significance

    Is the administrative foundation adequate to support the proposed activities and affiliated research projects? How well does the Core Leader demonstrate the capacity for leadership of the Center?

    Approach

    How well does the proposed Center demonstrate appropriate organization and core management? Are the organizational plan and management structure adequate to meet Center goals? Are the procedures for internal communication and cooperation among the investigators adequate? How well described and appropriate is the description of directions for future planning and optimal utilization of resources? How does the administrative structure facilitate faculty recruitment, retention, and tenure/promotion activities, including recognition of team science?  

    Clinical Core

    Significance

    Do the stated goals, plans, and targeted population (including justification for sample size, description of demographic, and medical and diagnostic characteristics for each cohort) demonstrate potential for contributing to cutting-edge research on normal aging and neurodegenerative diseases of aging? If any special populations are proposed, are they clearly described, and does their inclusion contribute substantially to the overall goals of both the Center and the national network? How experienced is the Core Leader in the diagnosis of AD and related dementias? Does the Core Leader have a record of research in some aspect of neurodegenerative diseases?

    Approach

    How well does the application describe how the Clinical core recruits participants, provides regular evaluation and diagnosis according to UDS protocol, maintains a research volunteer registry that tracks the number of and reasons for those lost to follow-up, contributes to other related research (including clinical trials), and conducts longitudinal follow up of participants? How appropriate are the procedures for sample collection, storage, and evaluation? How appropriate are interactions and roles of other cores? Specifically, with the DMSC, is the continuum from data content through data collection to data base management and data analysis clearly described? Is there a clear linkage between the clinical, neuropathology, and biomarker data, including a clear description of procedures for working across the Center to increase the number of participants who agree to autopsy and biomarker collection and sharing, especially for diverse populations and other select groups? How clear is the description of how the UDS data will be provided in a timely manner to NACC?

    Does the core contribute to validation of biomarkers and other diagnostic measures? How well does it utilize high-quality data collected during clinical care? Are contributions to future patient care by developing, testing, and validating novel endpoints for translation into practice described?

    Additional Cores

    Significance

    How does the core contribute to the goals of the Center, as well as the national and international research goals focused on Alzheimer’s disease and other neurodegenerative diseases?

    Approach

    How well-reasoned and likely to contribute significantly to the specific aims of the Center are the overall strategy, methodology, and analyses? How strong are the 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? How strong are the plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    If the core 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?    

    How does the core augment or enhance the present capabilities of investigators using Center resources to enhance or create research at the home Center, as well as at other Centers and in the wider research community? What is the research that will or could use the resources of the additional core?    

    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.

    Additional Review Considerations - Administrative Core

    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.

    Resource Sharing Plans

    How does the organization structure support not only local, but also broad national and international data sharing including, but not limited to, timely and routine submission of data to NACC and samples to NCRAD?

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NIA 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 Council for Aging. 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.

    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 law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. 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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    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

    Not Applicable

    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.

    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)

    Nina B. Silverberg, Ph.D.
    National Institute on Aging (NIA) 
    Telephone: 301-496-9350 
    Email: silverbergn@mail.nih.gov

    Peer Review Contact(s)

    Ramesh Vemuri, Ph.D.
    National Institute on Aging (NIA)
    Telephone: 301-496-9666
    Email: ramesh.vemuri@nih.gov

    Financial/Grants Management Contact(s)

    Jennifer Edwards
    National Institute on Aging (NIA)
    Telephone: 301-827-6689 
    Email: edwardsj@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 Part 75.    

     

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