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

National Institutes of Health (NIH)

Components of Participating Organizations

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

Funding Opportunity Title

Pathway and Target Identification for Alzheimer's Disease Related Dementias (ADRDs) (U01 Clinical Trial Not Allowed)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-18-661

Companion Funding Opportunity

None

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

93.853, 93.866 

Funding Opportunity Purpose

The purpose of the FOA is to support the large scale molecular platform analysis of brain tissue, human biofluid or human induced pluripotent stem cell resources for the identification of targets and pathways associated with Alzheimer's Disease Related Dementias (ADRDs) pathophysiology.

Key Dates
Posted Date

February 14, 2018

Open Date (Earliest Submission Date)

March 16, 2018

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

April 16, 2018, 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

July, 2018

Advisory Council Review

August, 2018

Earliest Start Date

September 2018

Expiration Date

April 17, 2018

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) 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. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. 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

    The purpose of the FOA is to support the identification of targets and pathways impacting the pathophysiology of ADRDs, through use of large scale robust and reproducible molecular platforms and extensively phenotyped human brain tissue, biosamples and cell resources.

    Background

    In 2016, NINDS organized a conference on Alzheimer's Disease Related Dementias (ADRDs) which focused on  frontotemporal degeneration (FTD), Lewy body dementias (LBD) (including dementia with Lewy bodies (DLB)), Parkinson disease dementia (PDD), vascular cognitive impairment and dementia (VCID), mixed dementias including the associated diagnostic challenges of multiple etiology dementias (MED), and issues related to health disparities. The conference complemented the National Institute on Aging’s “Alzheimer’s Disease Research Summit 2015: Path to Treatment and Prevention.”  Both conferences responded to the National Alzheimer’s Project Act that was signed into law in January 2011. The objective of the ADRD conference was to contribute to the efforts directed at preventing and effectively treating Alzheimer’s disease, including Alzheimer’s disease‐related dementias, by 2025.  The Alzheimer’s Disease‐Related Dementias Summit solicited input from internationally recognized experts to develop prioritized recommendations to guide scientific research in the next 5 to 10 years. 

    Advances in molecular platforms that enable large scale robust and reproducible analysis of transcriptional, epigenomic, proteomic and metabolomic states now provide an opportunity to discover target and pathways that contribute to the complex biology of Alzheimer's Disease Related Dementias (ADRDs). Successful application of these platforms requires the use of human brain autopsy tissue, biofluid or induced pluripotent stem cell resources with extensive pathological, clinical, and genetic data available for sharing with the broad research community.  This FOA addresses the following 2016 ADRD milestones: 1) Multiple etiology Dementias milestone 1 in focus area 2 centered on basic and clinical research in multi-etiology dementias to address molecular pathways involved in cognitive dysfunction; 2) Frontotemporal Lobar Degeneration focus area 1, basic science milestones 1, 2, 3 and 4 focused on the biology related to PGRN, C9ORF72 and MAPT mutations; and 3) LBD focus area 2, milestone 1 centered on discovering disease mechanisms through brain mapping and genetics.

    Scope of studies supported under this FOA

    Examples of studies appropriatefor this FOA include but are not limited to:

    • Comprehensive omics analysis of cellular pathways using single cell RNA sequence, methylome, epigenomic, proteomic and/or metabolomic analysis of human brain tissue using scalable experimental approaches that will maximize the discovery and classification of all brain cell types. Molecular signatures from single cell brain tissue analysis may include, but are not limited to:
    • generating spatially defined single cell transcriptome data to unveil brain cell classes and types based on transcriptome signatures;
    • generating immunohistochemistry and immunocytochemistry data using validated protein affinity reagents to identify specific cell types and neurite projections;
    • generating spatially defined single cell epigenome data (e.g., chromatin accessibility, DNA methylation) to help define brain cell types;
    • determining microenvironment, tissue composition and ratio of various cell types (e.g., neurons, glial cells, vascular cells, immune cells, progenitor cells, synapses, spines, stroma) in the brains.
    • Proteomic analysis using state-of-the-art platforms for large scale analysis of global or targeted proteomic profiles from CSF, plasma and serum samples;
    • Extracellular RNA (exRNA) sequence analysis of CSF and plasma samples;
    • RNA and protein analysis of exosomes isolated from CSF and plasma samples;
    • Whole transcriptome RNA sequence analysis of biofluid-derived RNA samples;
    • Epigenomic analysis of chromatin structure from blood based biofluid samples;
    • Metabolomic analysis from plasma samples;
    • Comprehensive omics analysis of cellular pathways using single cell RNA sequence analysis, epigenomic analysis, proteomics and/or metabolomic analysis of iPSC-derived neurons, microglia and/or astrocytes from cell sources derived from ADRD natural history studies with extensive clinical data.

    Areas of Focus and Integration for this FOA

    A preferred area of focus for this FOA, is the application of single cell omic approaches currently utilized in the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative® to the study of ADRD human brain tissue.  Single cell ‘omics’ analyses (transcriptomics, epigenomics, and proteomics) will help define unique cell type markers and unveil the regulatory code that controls cell type formation, maintenance, and transition in health and disease.  Coordination with single cell approaches utilized in the BRAIN Initiative will help advance our understanding of cell type specific molecular changes that are associated with ADRDs and enable investigators to utilize comprehensive BRAIN datasets generated from the analysis of healthy human brain tissue cell types.  Applicants are encouraged to adopt technology platforms that enable acquisition of multimodal datasets from the same cells with adequate throughput. For example, RNA fluorescence in situ hybridization (FISH) may be combined with immunohistochemistry labeling to monitor both RNA and protein molecules in the same cells.  All brain tissue utilized for single cell omics analysis should have accompanying whole genome sequence (WGS), pathological and associated clinical data available for broad data sharing with the research community.  If WGS data is not available on the brain tissue to be analyzed, WGS analysis should be included in the research plan.  Collaboration with investigators responsive to NOT-NS-18-018 is strongly encouraged and information collected from this notice regarding the availability and characterization of ADRD brain tissue is available on the NINDS Resource webpage.

    A second focus area of this FOA is the utilization of existing biofluid (CSF, plasma, serum and RNA) resources for the analysis of ADRD targets and pathways.  These biofluid resources should have extensive clinical data available from broad sharing with the research community and should include common standardized sample collection procedures and extensive quality assessment. To ensure that rigor and reproducibility are part of the experimental design, samples must be processed in a blinded fashion, where the platform configuration has been addressed in advance to allow for balance of key criteria such as, but not limited to gender, case versus control (healthy and disease control), and cross-sectional versus longitudinal design.  All platform runs must include reference pool standards to enable quality assessment of platform performance between runs and across cohorts.  Healthy or disease control samples for platform analysis, must have common clinical assessments and biosample collection and processing procedures to the cases chosen.

    The third focus area of this FOA is the utilization of human induced pluripotent stem cell (iPSC) sources from cohorts where extensive clinical data is available for sharing with the broad research community, for large scale omics analysis.  iPSC resources must have been developed using non-integrating reprogramming technologies and with quality assessment measures that include, but are not limited to analysis of sterility, normal karyotype, pluripotency assessment and differentiation potential.

    Sample size is critical for large scale omics analysis, so use of single or aggregated cohorts with small sample sizes is not appropriate for this funding announcement.  iPSC resources must be associated with well characterized clinical cohorts where a substantial number of individual lines are available within the timeline of the funding announcement.

    Resources Available

    Examples of resources that meet the above criteria for large scale omic platform analysis include, but are not limited to the NIH funded natural history studies of Frontotemporal Lobar Dementias such as the Longitudinal Evaluation of Familial Frontotemporal Dementia (LEFFTDS) the Advancing Research and Treatment for Frontotemporal Lobar Degeneration Consortium (AFTFL) cohorts and Parkinsonisms, and Lewy Body Dementia cohorts collected under the NINDS Parkinson's Disease Biomarkers Program (PDBP).  Biosample resources collected from these cohorts are available through the National Cell Repository for Alzheimer's Disease (NCRAD) for LEFFTDS and ARTFL samples, the NINDS BioSEND Biosample Repository for PDBP Parkinsonisms and Lewy Body Dementia cohorts and the NINDS Human Cell and Data Repository (NHCDR) for iPSC resources from all cohorts.  Postmortem healthy human brain tissues are available with minimal tissue degradation (e.g., NIH NeuroBioBank; GTEx program, Biopreserv Biobank).  ADRD brain tissue resources have been identified through NOT-NS-18-018 and are listed on the NINDS Resource webpage.

    Available Data Analysis and Integration Tools

    The BRAIN Initiative Cell Census Network (BICCN) is establishing stringent data quality standards and quality control and quality assurance processes for experimental and statistical approaches, so that the data generated will be broadly referenced and used by the research community.  Much progress has also been made to develop and implement common coordinate systems for human brain (e.g., BigBrainBrainSpan, Talairach Coordinate System, MNI Coordinate System) and image segmentation and registration tools (e.g, Insight Segmentation and Registration Toolkit (ITK)) that allow individual labs to integrate their data to the common coordinate systems.  Analysis tools that provide pipelines for platform and data integration, for projects using human biosamples or iPSC sources, have been developed in collaboration with the NIH Library of Integrated Network Cellular Signatures (LINCS) data coordinating and integration center, the NeuroLINCS data generating center, and the Accelerating Medicine Partnerships in Parkinson's disease (AMP PD) and Alzheimer's disease (AMP AD).  Most analytical pipeline resources are available through Github. Use of these data standards and pipelines will be an essential component of the application, as they will provide standardized datasets for comparison across existing data. Use of additional analytical approaches in addition to the standardized pipelines is encouraged.

    All data from brain tissue, biofluid or iPSC resource analysis, are expected to be submitted to a common NIH database for data sharing with the broad research community, as appropriate and consistent with achieving the goals of the program."  Costs for clinical and biological data deposition and annotation should be included in the budget.  The common NIH database will be identified within six months of the release of the year one funding award and in collaboration with NINDS staff.

    Studies not appropriatefor this FOA:

    • Large scale whole genome or whole exome sequencing of biosamples
    • Use of animal models for target and pathway identification
    • Single or aggregate cohorts with small biosample sizes are not appropriate for this funding announcement.
    • Analysis of small numbers of iPSC lines are not appropriate for this funding announcement
    • Early stage technology development.
    • Collection of new biospecimens
    • Generation of new iPSC lines

    Applicants are strongly encouraged to consult with NINDS Scientific/Research Staff at the beginning of the planning stage of their application (see Agency contacts, Section VIII).

    Projects involving partnerships with industry, small businesses or non-government organizations are encouraged under this FOA. The policy of the NIH is that the results and accomplishments of the activities that it funds and supports should be made available to the public.

    Program Technical Assistance Note:

    An Applicant Informational Webinar will be held on February 19, 2018 at 1:00 p.m. Eastern Time to provide an overview of the FOA and key requirements. The webinar is open to all prospective applicants. Participation in the teleconference is not a prerequisite for applying,and is not required for a successful application. Information about how to participate in the webinar will be posted at http://www.ninds.nih.gov. Potential applicants are encouraged to submit their questions or comments to sutherlandm@ninds.nih.gov prior to the meeting. Afterwards, the webinar slides and a summary of the questions and answers will be posted on the same site. NIH will also post a list of Frequently Asked Questions (FAQs) and answers; this information may be updated without additional notice.

    WebEx Information

    https://nih.webex.com/join/sutherlandmnih.gov

    Phone: 1-650-479-3208 Call-in toll number (US/Canada)   

    Access code: 622 274 563 

    Global call-in numbers 

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

    Section II. Award Information
    Funding Instrument

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

    Application Types Allowed

    New

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

    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

    The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

    NIH intends to fund an estimate of 2-3 awards, corresponding to $2,500,000 in total costs, for fiscal year 2018. Future year amounts will depend on annual appropriations.

    Award Budget

    Application budgets are not limited but need to reflect the actual needs of the proposed project.

    Award Project Period

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

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

    Nonprofits Other Than Institutions of Higher Education

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

    For-Profit Organizations

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

    Governments

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

    Other

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

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

    Required Registrations

    Applicant Organizations

    Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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

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

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

    Eligible Individuals (Program Director/Principal Investigator)

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

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

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

    Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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

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

    Buttons to access the online ASSIST system or to download application forms are 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 Research (R) Instructions in the SF424 (R&R) Application Guide,  except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

    Letter of Intent

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

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

    • Descriptive title of proposed activity
    • Name(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:

    Margaret Sutherland, PhD
    Telephone: 301-496-5680
    Fax: 301-480-1080
    Email: sutherlandm@ninds.nih.gov

    Page Limitations

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

    Instructions for Application Submission

    The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

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

    SF424(R&R) Senior/Key Person Profile

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

    R&R or Modular Budget

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

    Budget considerations should include, but are not limited to:

    • Inclusion of travel costs for PD/PIs to attend an annual face to face meeting in the continental USA.
    • Costs of a data full time employee (FTE) to support data submission and annotation to a NIH-supported database
    • Costs for WGS analysis if not available for the brain tissue to be studied.
    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

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

    Specific Aims:

    • Provide the overall goals or hypotheses for the entire project. State in priority order the aims of the proposed project.

    Research Strategy:

    Under this FOA the research strategy should include the following components relevant to the brain tissue, biospecimen or iPSC sources to be utilized in the experimental design:

    • State the issues (general and specific), gaps, and challenges in the use of brain tissue, biosamples or iPSC sources for targets and pathways research;
    • Describe innovative aspects of the project including the generation of novel datasets and/or analysis tools.
    • Overall description of the data and resource production and research theme(s) to be addressed;
    • Description of currently existing data and the state-of-the art approaches used;
    • Describe production workflow including throughput as well as rate-limiting steps, and provide plans for assessing and improving the pipeline;
    • Describe how to optimize experimental procedures to reduce technical noise and enhance data quality;
    • Describe quality control/quality assurance measures and decision-making process;
    • Describe scalable methods with preliminary data and case studies to support their feasibility of generating high-quality data;
    • Include power analysis and sample size
    • Provide current estimates of data quality and plans for how data quality will be evaluated during the project period;

    Experimental Design Considerations for specific sample types

    Brain Tissue Studies

    • Description of the brain samples and structures/regions to be analyzed;
    • Propose experimental design to ensure the data generated are rich in content and spatially annotated on a common brain atlas for the dissemination and use by the broad research community;
    • Define “comprehensiveness and completeness” or “breadth and depth” for the proposed project, describing how close to that target the proposed project will get in a three-year timeframe for each data element being investigated; 
    • Describe if applicable, the adoption of technology platforms that can acquire multimodal datasets from the same cells with adequate throughput. For example, RNA fluorescence in situ hybridization (FISH) may be combined with immunohistochemistry labeling to monitor both RNA and protein molecules in the same cells.
    • Include consideration of workflow for the incorporation of computational analysis of brain tissue cell types to be established by the BRAIN Initiative Cell Census Network (BICCN).
    • Describe the whole genome sequence (WGS), pathological and associated clinical data associated with the brain tissue proposed for analysis.
    • Describe the data sharing plan and the standardized data submission formats to be used for all datatypes associated with the brain tissue to be analyzed.

    Biosample (CSF, plasma, serum, RNA) Studies

    • Description of the cohort(s) to be used in the study. If multiple cohorts will be used to address sample size, clinical assessments and diagnostic criteria for a specific disease entity should be identical across cohorts;
    • Describe the sample quality assessments and processing procedures that guarantee uniformity in sample quality and handling across cohorts. 
    • Propose experimental design to ensure the data generated are rich in content including metadata standards to ensure dissemination and use by the broad research community;
    • Describe the reference pools available for the specific biosample type to be utilized and plans for incorporation of reference pools for cross validation of platform performance;
    • Describe the blinding process to be used for biosample processing and the unblinding process to be used following data acquisition;
    • Describe the data sharing plan and the standardized data submission formats to be used for all datatypes associated with the biosamples to be analyzed;
    • Describe plans for integration of global unique identifiers (GUIDs) for the biosamples to be used;
    • Describe the quality assessments currently available for the biosamples to be analyzed;
    • Describe the incorporation of LINCS or AMP analytical pipelines for data analysis, as well as any additional data analysis strategies to be utilized.

    iPSC Studies

    • Propose experimental design to ensure the data generated are rich in content including metadata standards used by NIH LINCS initiative to ensure dissemination and use by the broad research community;
    • Describe the pipelines to be used for data analysis, including the use of current LINCS pipelines for iPSC omics analysis;
    • Describe the data sharing plan and the standardized data submission formats to be used for all datatypes associated with the iPSC lines to be analyzed;
    • Describe plans for integration of global unique identifiers (GUIDs) for the iPSC lines to be used;
    • Describe the quality assessments currently available for the iPSC lines to be analyzed;
    • Describe the incorporation of LINCS analytical pipelines for data analysis, as well as any additional data analysis strategies to be utilized.

    Milestone Plan

    A milestone plan that includes platform analysis parameters and specific cut-off standards for analysis of reproducibility within samples and across samples as well as selectivity and sensitivity standards appropriate to the populations being analyzed.  The milestone plan should also include a timeline for sample/cell line analysis, data analysis and data deposition with a NIH supported database.

    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:

    • Description of what specific data, analysis tools and resources will be shared (e.g., single cell transcriptome data, immunohistochemistry data, cell morphology data);
    • Schedule/timeline for availability of data and resources to other users

    Data Sharing Plan. Applicants are expected to provide a specific proposal for data sharing in the application, and address the issues related to the public release of data and data analyses (see the rationale for FAIR (Findability, Accessibility, Interoperability, and Reusability) Data Principles).  After the initial review, NINDS program staff will be responsible for any additional administrative review of the plan for sharing data and may negotiate modifications of the data sharing plan with the prospective awardee prior to award. The final negotiated version of the data sharing plan will become a term and condition of the award of the cooperative agreement.  Applicants should address whether they anticipate any of their data will require controlled access.

    Appendix:

    Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. Appendix Material Required if Applicable

    • Protocols for biosample collection and processing;
    • Protocols for brain tissue collection and processing.

    Letters of Support if Applicable:

    • Letter of approval for brain tissue or biosample access;
    • Letters of support for collaborative projects involving more than one institution and/or investigator.
    PHS Human Subjects and Clinical Trials Information

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) 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 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

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

    PHS Assignment Request Form

    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). 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.

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

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

    Important reminders:

    All PD(s)/PI(s) 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. See Section III of this FOA for information on registration requirements.

    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. 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

    Requests of $500,000 or more for direct costs in any year

    Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

    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. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

    Overall Impact

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

    Scored Review Criteria

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

    Significance

    Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the project support the FOA goals for ADRD pathway and target identification

    Investigator(s)

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

    Innovation

    Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the application describe evidence that demonstrates the novelty of omics data and tools to be generated? Will the novel data and/or analysis tools lead to transformative, paradigm-shifting advances of the field? 

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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?

    Does the investigator(s) state the issues (general and specific), gaps, and challenges in the use of human brain tissue, biospecimens or iPSC sources for targets and pathways research and are these challenges addressed in the research plan? 

    Does the investigator(s) address the quality control/quality assurance measures to be applied and are they adequate for the omics platform(s) to be used? 

    Does the application include the use of scalable omic methods with preliminary data provided to support the feasibility of generating high-quality data in a cost-effective manner?

    Does the investigator provide a description of currently existing data and the state-of-the art approaches used?  Is preliminary data provided to support the feasibility of generating high-quality data? 

    Does the investigator provide a production workflow that includes an analysis of the rate limiting steps and plans for assessing and improving the pipeline?

    Does the experimental design include power analysis and justification for the sample size proposed and does the sample size address the requirement for large scale omic platform analysis?

    For Brain Tissue Studies

    Is a description of the brain samples, associated clinical and pathological data and structures/regions to be analyzed provided and does the quality of the material to be used meet current standards for large scale omics analysis? Does the proposed experimental design ensure that the data to be generated are rich in content and spatially annotated on a common brain atlas for the dissemination and use by the broad research community? Does the investigator include the use of currently existing data and does the research plan incorporate state-of-the art approaches for data acquisition and analysis?  Are experimental procedures optimized to reduce technical noise and enhance data quality?  Is there an estimate of comprehensiveness and completeness of the proposed project within the three-year timeframe for each data element being investigated?  Does the investigator include a workflow that when available can incorporate the computational analysis of brain tissue cell types established by the BICCN and will this workflow generate datasets that are interoperable across projects?  Does the investigator include the adoption of technology platforms that can acquire multimodal datasets from the same cells with adequate throughput, if applicable to the research design? Are protocols provided for tissue collection and processing at time of autopsy?  

    For Biosample Studies:

    Is a description of the cohort(s) to be used in the study provided and does the selection of cohorts include consideration of common clinical assessments across cohorts and the use of common diagnostic criteria for a specific disease entity?  Does the proposed experimental design ensure the data generated are rich in content including metadata standards to ensure dissemination and use by the broad research community?  Does the investigator provide a current estimate of data quality and plans for how data quality will be evaluated during the course of the project?  Does the investigator provide a description of the reference pools to be utilized and plans for incorporation of reference pools for cross validation of platform performance?  Is a plan for blinding of biosamples provided?  Is a plan provided for integration of GUIDs for the biosamples to be used?  Are protocols for biosample collection and processing included and are these collection and processing protocols common for all biosamples to be analyzed?  Does the investigator provide information on quality assessments currently available for the biosamples to be utilized?  If no quality assessments of biosamples are currently available are plans included for those analyzes?

    For iPSC Studies

    Does the proposed experimental design ensure the data generated are rich in content including metadata standards to ensure dissemination and use by the broad research community? Are the analytical pipelines to be used for data analysis adequate for the omic platform(s) used and if appropriate is there a plan for data integration across platforms that would significantly advance identification of targets and pathways?  Does the analytical data plan include the use of current LINCS pipelines for iPSC omics analysis?  Is a plan provided for integration of GUIDs for the iPSC lines to be used?  Are the iPSC lines of sufficient quality for large scale omics analysis?

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

    Environment

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

    Additional Review Criteria

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

    Milestones:

    • Are the milestones proposed rigorous in terms of replication standards for in sample and across sample measurements?
    • Are the milestones proposed statistically justified for achieving defined sensitivity and specificity measurements across the platform(s) proposed?
    • Is a timeline provided for sample analysis, data analysis and data deposition?
    Protections for Human Subjects

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

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

    Inclusion of Women, Minorities, and Children 

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

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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

    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 (GDS). Is the data sharing plan consistent with broad data sharing with the research community?  

    Authentication of Key Biological and/or Chemical Resources:

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

    Budget and Period of Support

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

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIH Center for Scientific Review (CSR), 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.

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

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.
    3. Anticipated Announcement and Award Dates

    After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

    Section VI. Award Administration Information
    1. Award Notices

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

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

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

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

    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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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

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

    The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

    • Determining experimental approaches, designing protocols, setting project timelines and conducting experiments;
    • Adhere to FOA requirements regarding data sharing and analysis, as appropriate and consistent with achieving the goals of the program:
    • Adhere to publication, and other policies that might be established during the course of this activity;
    • Report to NINDS Scientific Program staff regarding timeline and project achievements during the course of the project, as delineated in the terms and conditions of award;
    • Submit annual progress reports during the funding period, in a format as agreed upon by NINDS program staff;
    • Attend in-person meetings to be held annually and organized in collaboration with NINDS program staff where PD(s)/PI(s) will present up to date findings (including unpublished results) on ongoing projects.  The cost of these meetings will be covered under the current funding for this application.
    • Awardees are expected to make new information and materials known to the research community not only in the annual meetings but also in a timely manner through publications, web announcements, reports to NINDS program staff, and other mechanisms.
    • Awardees will retain custody of and have primary rights to the data and resources developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

    Publications:

    • The PD(s)/PI(s) will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by project investigators and supported in whole or in part under this Cooperative Agreement. The PD(s)/PI(s) and Project Leaders are requested to submit manuscripts to the NIH Project Scientists within two weeks of acceptance for publication so that an up-to-date summary of program accomplishments can be maintained. Publications and oral presentations of work conducted under this Cooperative Agreement are the responsibility of the PD(s)/PI(s) and appropriate Project Leaders and will require appropriate acknowledgement of NINDS support. Timely publication of major findings is required.

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

    • NINDS program staff will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination. However, the role of NINDS Project Scientists will be to facilitate and not to direct the activities.

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

    • NINDS program staff will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination. However, the role of NINDS Project Scientists will be to facilitate and not to direct the activities.
    • Contribute to the adjustment of research protocols, project milestones or approaches as warranted;
    • Serve as a liaison between the awardees, the NINDS Advisory Council and the larger scientific community;
    • Coordinate the efforts of the awardees with others engaged in ADRD research, including other awardees funded by related NIA and NINDS programs;
    • Assist in promoting the availability of data and resources developed in the course of this project to the scientific community at large;
    • Assist awardees in the development, if needed, of policies for dealing with situations that require coordinated action;
    • Retain the option to recommend the withholding or reduction of support from any cooperative agreement that either substantially fails to maintain state-of-the-art capabilities, or fails to comply with the Terms and Conditions of the award.
    • Additionally, an NINDS program official or NINDS program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

    Areas of Joint Responsibility include:

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

    Dispute Resolution:

    Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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

    Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

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

    Scientific/Research Contact(s)

    Margaret Sutherland, PhD
    National Institute of Neurological Disorders and Stroke (NINDS)
    Telephone: 301-496-5680
    Email: sutherlandm@ninds.nih.gov

    Peer Review Contact(s)

    Carole Jelsema, Ph.D.
    Center for Scientific Review (CSR)
    Telephone: 301-435-1248
    Email: jelsemac@csr.nih.gov

    Financial/Grants Management Contact(s)

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

    Section VIII. Other Information

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

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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