Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title

Autoimmunity Centers of Excellence, Basic Research Program (U19 Clinical Trial Not Allowed)

Activity Code

U19 Research Program – Cooperative Agreements

Announcement Type

Reissue of RFA-AI-12-060

Related Notices

None

Funding Opportunity Announcement (FOA) Number

 RFA-AI-18-002

Companion Funding Opportunity

 RFA-AI-18-003, UM1 Research Project with Complex Structure Cooperative Agreement

Number of Applications

Only one application per institution is allowed, as defined in  Section III. 3. Additional Information on Eligibility.

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

 93.855

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications to participate in the NIAID Autoimmunity Centers of Excellence (ACE), a cooperative network intended to improve the understanding, prevention, and treatment of autoimmune diseases (www.autoimmunitycenters.org). The ACE was founded on the premise that collaborations among basic and clinical scientists can accelerate both fundamental and applied research. The ACE combines Basic and Clinical research programs. This FOA solicits applications for the Basic research program; a companion FOA solicits applications for the Clinical research program. Members of the Basic research program will conduct innovative studies of human autoimmunity within Principal, Pilot, and Collaborative Projects. Members of the Basic and Clinical ACE will work together to design and conduct studies of autoimmune disease pathogenesis and mechanisms of action of immune-modulating agents being tested in ACE clinical trials.

Key Dates

 

Posted Date

March 8, 2018

Open Date (Earliest Submission Date)

May 22, 2018

Letter of Intent Due Date(s)

May 22, 2018 

Application Due Date(s)

June 22, 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 this date.

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

November 2018

Advisory Council Review

January 2019

Earliest Start Date

April 2019

Expiration Date

June 23, 2018

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH's new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the 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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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 FOA solicits applications for the Basic research program of the Autoimmunity Centers of Excellence (ACE). The companion FOA, RFA-AI-18-003, solicits applications to the Clinical research program of the ACE. The goal of the ACE is to conduct insightful analyses of human immunology as it applies to autoimmune disease(s) within and among collaborative Centers and especially in the context of Clinical Projects, i.e., clinical trials with integrated mechanistic studies. The members of the Basic and Clinical ACE will work together after award to design, develop, and conduct studies of autoimmunity and autoimmune diseases in humans. This approach is expected to advance our fundamental understanding of human autoimmunity, identify common and distinct mechanisms in the pathogenesis of autoimmune diseases, and clarify mechanisms of action of immune-modulating agents used in therapy or tested in clinical trials.

    Introduction

    The ACE program was founded in 1999 to accelerate the discovery and translation from lab to clinic of therapies for autoimmune diseases. The ACE conducts cooperative clinical, mechanistic, and basic studies, fosters intellectual and material collaborations among scientists, and facilitates the study of clinical samples by research scientists. The ACE combines two research programs -- Basic and Clinical -- that align grant awards with responsibilities. The Clinical research program develops and conducts Clinical Projects (i.e., clinical trials with integrated mechanistic studies) as well as Collaborative Projects investigating fundamental human immunology. The Basic research program provides a solid scientific foundation and conducts advanced investigations into fundamental and applied human autoimmunity through innovative Principal, Pilot, and Collaborative Projects.  

    The members of the Basic and Clinical programs will work closely together to fully develop and conduct Clinical Projects and other studies of mechanism and pathogenesis. The ACE has conducted Clinical Projects in systemic lupus erythematosus, multiple sclerosis, rheumatoid arthritis, Sjögren's Syndrome, ulcerative colitis, scleroderma, and pemphigus vulgaris (partial list: ClinicalTrials.gov). The collaborative ACE Research Plan and annual progress reports of the current ACE are available on the public ACE website.  

    Collaborations among basic and clinical scientists have been productive though challenging to initiate and maintain.  A 2005 Trans-NIH Autoimmune Diseases Research Plan advocated for clinical trials with integrated mechanistic studies that "utilize materials and data from clinical trials to elucidate underlying mechanisms of drug activity and immune response." This Plan also acknowledged that clinical trials are lengthy, risky, and expensive, conceding "many agents that show promising results in preclinical studies do not advance to clinical trials" and noting that new treatments are sometimes discovered "when practitioners identify new uses for medications originally approved for other conditions."  The importance of informative clinical trials in developing new therapies and evaluating existing therapies was also emphasized in a report from the Institute of Medicine, "Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020:Workshop Summary". Well-designed clinical studies of immune-modulating agents can be fundamentally informative whether or not an investigational agent ultimately advances to licensure and clinical practice. 

    Research Objectives and Scope

    The objectives of the ACE are to accelerate the discovery and translation from lab to clinic of therapies for autoimmune diseases. The ACE program approaches these objectives by conducting cooperative basic, clinical, and mechanistic studies, fostering intellectual and material collaborations among basic and clinical scientists, and facilitating the study of clinical samples by basic research scientists. Projects designed to test explicit hypotheses are preferred though 'data-driven' projects are permitted. The program is expected to advance our fundamental understanding of human autoimmunity, identify common and distinct mechanisms in the pathogenesis of autoimmune diseases, and clarify mechanisms of action of immune-modulating agents used in therapy or tested in clinical trials. 

    Research Scope: All projects must investigate autoimmune disease in humans. 

    Principal, Pilot, and Collaborative Projects: These Projects may use samples from previously completed clinical trials or studies but they may not support a clinical trial. For these Projects, specific areas of interest include, but are not limited to:

    • Pathogenesis of human autoimmune disease;
    • Mechanisms of action of existing therapies for autoimmune disease;
    • Biomarkers for autoimmune disease status, including diagnosis, disease progression, prediction of remission or relapse, therapeutic response, and stratification;
    • Sex-based differences in autoimmune disease; 
    • Mechanisms responsible for the initiation, maintenance, or loss of tolerance;
    • Cellular diagnosis or cell therapy, including adult stem cells, regulatory B and T cells, and antigen-presenting cells;
    • Single-cell or clonal analysis of genetic variation (including epigenetic) contributing to autoimmunity;
    • Influence of histocompatibility genes (e.g., HLA) on autoimmunity; and
    • Novel mechanistic approaches to therapy applying advances in fundamental immunity and biology, such as gene therapy, regulating gene transcription (epigenetics, methylation, acetylation), RNA metabolism (splicing, stability, miRNA, RNAi), antigen receptors or Natural Killer (NK) inhibitor receptors (KIR), lymphocyte subsets, dendritic cells, cytokines, chemokines, proteins mediating signal transduction (immune synapse, intracellular pathways), metabolomics and the microbiome.    

    Applications proposing the following will be considered non-responsive and will not be reviewed:

    • Large scale epidemiology;
    • Research using animal models of human disease ("humanized" animals are not permitted);
    • Clinical trials;
    • Projects focused on primary immune deficiency or cancer (though studies of autoimmunity including these patient populations are responsive);
    • Projects focused on HIV/AIDS;
    • Projects that do not investigate autoimmune disease in humans.
     
    Program Components of the Basic Research ACE

    A Basic ACE Research application must include a Principal Project, a Pilot Project, a Collaborative Project, an Administrative Core, and an ACE Funds Management Core. These components are described below:        

    Administrative Core: The administrative core is responsible for providing overall leadership to the Center, including management, coordination, and oversight for the Center activities. 

    ACE Funds Management Core (AFMC):  This core will administer, on behalf of the entire ACE, two funds: the Clinical Project Fund for support of the Clinical Projects and the Collaborative Research Fund for support of the Collaborative Projects and additional studies required for achieving the aims of the ACE Research Agenda. One of the applicants will be selected by NIAID after award to administer the AFMC.

    Research Projects: Each ACE Basic Research Program must include three research projects: a Principal Project, a Pilot Project, and a Collaborative Project. The projects should be designed to advance our understanding of autoimmune disease in humans.

    The Principal Project should incorporate the theme of the Center, exploit the applicant's expertise, and test hypotheses through Specific Aims that advance our mechanistic understanding of autoimmune diseases. 

    The Pilot Project should be designed as an innovative and exploratory investigation pursuing intriguing observations that may lead to discoveries or breakthroughs.  Pilot Projects are designed to be shorter duration (2 years) with benchmarks for evaluating progress part way through the project.  

    The Collaborative Project should be designed to test at least one specific hypothesis on the nature of human autoimmunity, exploit particular strengths of the applicant, and engage other members of the ACE after award. The goals should exceed the reach of a single Center and produce a greater-than-additive return. It is recognized that applicants will NOT know in advance with whom they will be collaborating because the members of the ACE will not be known before award; therefore, applicants should make reasonable assumptions as to the types of collaborations that will be available and build flexibility into their research plans. The ACE will fully develop the Collaborative Projects after award and they should be designed to become part of the ACE Research Agenda (see below). Collaborative Projects may be expanded or reduced after award, depending upon how well they are ultimately integrated within the ACE. 

    ACE Program

    The ACE will coordinate the activities of the Clinical and Basic Research programs through the following elements: 

    Steering Committee: A Steering Committee will be formed with the PDs/PIs of the Basic and Clinical Research programs. The Steering Committee will have responsibility for collaboratively formulating the ACE Research Agenda, and for helping develop, finalize, and implement Clinical and Collaborative Projects.

    ACE Research Agenda: The Steering Committee will formulate an ACE Research Agenda that includes overarching themes, goals, and approaches for the period of award. The Agenda will incorporate the best themes and goals from the individual Centers as well as the Clinical Projects and the Collaborative Projects.  The Research Agenda of the current ACE cycle and their annual progress reports are posted on the public ACE website. The ACE will be responsible for on-going "legacy" Clinical Projects.  

    Plenary Meeting: The ACE will convene an annual plenary meeting, preceding one of the twice-annual face-to-face Steering Committee meetings, to exchange information and develop collaborations among the investigators.   All key personnel, including project leaders, are expected to attend and participate. The aims and status and highlights of all projects from all Centers will be presented in brief talks.   

    Resources Provided by NIAID

    Statistical, Data Management, Site Monitoring, and Operations Support: NIAID will provide statistical, data collection and management, site monitoring, and clinical trial operations support through a separately-funded Statistical and Clinical Coordinating Center for Autoimmune Diseases Group (SACCC ADG) grant.  Clinical product support will be provided as needed through the NIAID Division of Allergy, Immunology, and Transplantation (DAIT) Clinical Products Center (CPC).

    Note: For more information, please refer to the Questions and Answers web site for this FOA.

    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
    Renewal

    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

    NIAID plans to commit $8.48 million overall to the ACE in fiscal year 2019, which includes direct costs of up to $3.2M annually to support an ACE Clinical Project Fund and an ACE Collaborative Project Fund.   NIAID anticipates 3-5 awards within the ACE Basic Research Program.

    Award Budget

    Application budgets are limited to $675,000 in direct costs per year which includes up to $150,000 annual direct costs each for the Principal and Collaborative Projects, up to $75,000 annual direct costs for Pilot Projects, up to $50,000 annual direct costs for the Administrative Core, and up to $250,000 in annual direct costs for the ACE Funds Management Core (AFMC). The Administrative Core, the Principal Project, and the Pilot Project of each ACE will be awarded directly by NIAID. Collaborative Projects will be supported through consortium agreements by the AFMC, which will be awarded up to approximately $3.2M annual direct costs for the ACE Clinical Project Fund and Collaborative Project Fund. One ACE awardee will be selected to receive funds for the AFMC and ACE Clinical Project Fund and Collaborative Project Fund.

    Award Project Period

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

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Higher Education Institutions

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

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

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

    Nonprofits Other Than Institutions of Higher Education

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

    For-Profit Organizations

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

    Governments

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

    Other

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

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

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

    An individual may serve as PD/PI on an application to either this Basic ACE program FOA or the companion Clinical ACE program FOA (RFA-AI-18-003) but not both. An individual may serve as Project Leader or in another role (non-PD/PI) on applications to both FOAs. 

    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

    A button to access the online ASSIST system 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.

    Most applicants will use NIH's ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

    2. Content and Form of Application Submission

    It is critical that applicants follow the 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.

    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:

    Thomas Conway, PhD
    Telephone: 240-669-5075
    Fax: 301-480-2408
    Email: thomas.conway@nih.gov

    Page Limitations

    Component Types Available in ASSIST

    Research Strategy/Program Plan Page Limits

    Overall

    12

    Admin Core

    6

    Core (Use for ACE Funds Management Core)

    6

    Project (Use for Principal Project and Collaborative Project)

    12

    Pilot Project

    6

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

    Instructions for the Submission of Multi-Component Applications

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

    The application should consist of the following components:

    • Overall: required
    • Administrative Core: required; 1 maximum
    • ACE Funds Management Core: required; 1 maximum
    • Principal Project: required, 1 maximum
    • Collaborative Project: required, 1 maximum
    • Pilot project: required, 1 maximum
    Overall Component

    When preparing your application in ASSIST, use Component Type 'Overall'.

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

    SF424 (R&R) Cover (Overall)

    Complete entire form.

    PHS 398 Cover Page Supplement  (Overall)

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

    Research & Related Other Project Information (Overall)

    Follow standard instructions.

    Project/Performance Site Location(s) (Overall)

    Enter primary site only.

    A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

    Research & Related Senior/Key Person Profile (Overall)

    Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

    The Biographical Sketch should include the following: Describe the experience of the PD(s)/PI(s) in developing and conducting collaborative research, highlight any participation in clinical studies with mechanistic studies and describe the synergies and collaborations that occurred.

    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:   Briefly introduce and describe the approach of the Center to autoimmune disease research and therapy, specifically including the:

    • theme and overall goals of the Center,
    • most important questions in autoimmune disease research and therapy, and
    • how the questions will be answered (outline here, provide details in the projects).

    Research Strategy:  This narrative section summarizes the overall research strategy for the multi-project application and explains how the proposed Center satisfies the purpose and objectives of this FOA to accelerate the discovery and translation from lab to clinic of therapies for autoimmune diseases.

    Applicants should describe how the proposed Principal, Pilot, and Collaborative Projects are interrelated, synergistic, and fit under an overarching common theme and provide scientific gains beyond those achievable if each project were pursued independently. As the strategy develops, cite each project and core briefly as to its place in the overall scheme. Each project in this multi-project application must have its own scientific merit and complement the others.  This section is an opportunity for the investigators to give conceptual wholeness to the overall program – by stating the general problems and by presenting a comprehensive strategy for solving them. Include a description of the advantages the proposed Center will gain from participating in the ACE Program and what the Center will contribute to the overall group.

    If the application is a renewal, in addition to discussing results from individual projects, describe the synergies and collaborations that occurred within the Center and with other Centers.  Renewal applications may propose to renew and continue on-going Collaborative projects or else to begin entirely new research projects.  For research projects that will be continued as part of a renewal application, provide a progress report within the Research Strategy of the appropriate research project.

    Advisory Committee (optional): For applicants proposing to appoint an advisory committee, describe the expertise and responsibilities of the potential committee members.  For new applications, do not name or contact potential members.  For renewal applications, provide the names of current and former members.

    Leadership Succession Plan: Briefly present a plan in the case the PD/PI is for any reason unable to continue as leader of the program, without repeating information from the Multiple PD/Multiple PI Leadership Plan, if applicable. 

    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:

    Resource and Data Sharing Plans are not applicable for the Overall component.

    Appendix:

    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, with the following additional instructions:

    For studies involving the use of identifiable human biospecimens collected from independently funded clinical research or clinical trials, applicants should include both historical and current study information that is clearly distinguishable within the information requested in the study record forms.

    Delayed Onset Study

    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 in ASSIST, use Component Type 'Admin Core.'

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

    SF424 (R&R) Cover (Administrative Core)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant's Project
    • Proposed Project Start/Ending Dates
    PHS 398 Cover Page Supplement (Administrative Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Administrative Core)

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

    Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

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

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

    List all performance sites that apply to the specific component.

    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. 
    • The Administrative Core must be headed by the PD/PI or one of the PD/PIs on a multi-PD/PI application. Multiple Core Leaders are NOT permitted. 
    Budget (Administrative Core)

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

    Applicants may request up to $50,000 direct costs per year. Applicants must request at least 1.2 person months effort by the PD/PI(s) (or 1.2 person months in total for multiple PDs/PIs). Funds must be budgeted for the PD(s)/PI(s) to attend the twice-yearly Steering Committee face-to-face meetings, one of which will overlap with the annual ACE plenary meeting, and for the PD(s)/PI(s) and all Project leaders to attend the annual ACE plenary meeting.  Both meetings will be held in the Bethesda MD area.    

    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: List in priority order the Specific Aims of the Administrative Core. Also state the core's relationship to the Program's goals and projects in the application.        

    Research Strategy:

    • Provide a Staffing and Administrative Plan for the program that discusses the structure and roles of administrative and scientific staff, including the functions to be performed and how resources will be prioritized, allocated and managed.
    • Provide overall milestones, timelines and performance objectives for the program which should include all Core activities. Provide a management plan for fiscal accountability and communication within the Center.  

    Letters of Support:  Provide all appropriate letters of support, including any letters necessary to demonstrate the support of consortium/site participants, cores, laboratories, pharmacies and other collaborators. If parts of the costs of the Core are to be borne by sources other than NIH, these contributions must be presented in detail as part of supporting letters signed by individuals who have the authority to make fiduciary commitments on behalf of the institution. These outsource costs do not constitute cost sharing as defined in the current NIH Grants Policy Statement and should not be presented either as part of the requested budget or as Estimated Project Funding.

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

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
    • All investigators funded under this FOA will be expected to share their data publicly through ImmPort or other public portals approved by NIH. Therefore, the Data Sharing plan should include a summary of how the applicant will manage data submission and interactions with ImmPort or other, NIH-approved public portal.

    Appendix:

    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

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

    ACE Funds Management Core

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

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

    SF424 (R&R) Cover (ACE Funds Management 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 (ACE Funds Management Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (ACE Funds Management 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) (ACE Funds Management 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 (ACE Funds Management Core)

    • In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Project Lead' and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
    • The AFMC Core must be headed by the PD/PI or one of the PD/PIs on a multi- PD/PI application.  Multiple Core Leads are NOT permitted for the AFMC 

    Budget (ACE Funds Management Core)

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

    The ACE Funds Management Core application budgets must include the following costs:

    • The proposed budget for administrative costs for the AFMC is capped at $250,000 annual direct costs. Direct costs to include:
    • A minimum of 1.2 person months PD/PI effort as the AFMC Leader.
    • A minimum of 6 person months salary for an AFMC administrator and a maximum of 6 person months for Information Technology staff (if required by the AFMC) to be included in the Other Personnel category.
    • IT computing services, if required by the AFMC.
    • The AFMC will support ongoing "legacy" Clinical Projects in addition to new Clinical Projects and Collaborative Projects.
    • The AFMC should plan to issue consortium agreements with up to approximately $3.2M in direct costs annually for all costs related to Clinical Projects and Collaborative Projects. For the purpose of the application, assume 100 consortium agreements with 50 different sites and that each site invoices at least $25,000 per year. The costs may be included in the Other Expenses category because all consortium agreement expenses will be unknown to applicants.
    • Travel for either the AFMC administrator or staff member to attend one of the two annual "face-to-face" Steering Committee meetings in the Bethesda/Rockville, Maryland area. 

    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 (ACE Funds Management Core)

    Specific Aims:  List in priority order the proposed activities and services of the AFMC. In addition, state the Core's relationship to the goals of the ACE.  

    Research Strategy:

    List in priority order the proposed activities and services of the AFMC. The ACE Funds management plan must include:

    • an administrative structure and plans for staffing;
    • plans to negotiate, write, review, revise as needed, execute, and administer budgets and consortium agreements;
    • a description of a draft template for Clinical Project consortium agreement budgets.
    • plans to receive, review, revise as needed, approve and pay invoices in a timely manner;
    • plans to identify and resolve problems;
    • plans for accountability and communication with the Steering Committee and with NIAID;
    • a description of a draft template of a quarterly report to NIAID on the status of the Clinical Project and Collaborative Project Funds.
    • IT support for the maintenance and/or development of an internal website, if required. 

    Letters of Support: Provide all appropriate letters of support, including any letters necessary to demonstrate the support of consortium/site participants, cores, laboratories, pharmacies and other collaborators. If parts of the costs of the Core are to be borne by sources other than NIH, these contributions must be presented in detail as part of supporting letters signed by individuals who have the authority to make fiduciary commitments on behalf of the institution. These outsource costs do not constitute cost sharing as defined in the current NIH Grants Policy Statement and should not be presented either as part of the requested budget or as Estimated Project Funding.

    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:

    • Resource Sharing Plans are not applicable for this component.

    Appendix:

    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, with the following modifications. 

    1. Attach a file named "Clinical Trial Budget Template" showing a draft template for budgets supporting Clinical Projects.

    2. Attach a file named "Quarterly Funds Report" showing a draft template for reporting the status of funds to NIAID.

    PHS Human Subjects and Clinical Trials Information (ACE Funds Management 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

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

    Principal Project

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

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

    SF424 (R&R) Cover (Principal Projects)

    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 (Principal Project)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Principal  Projects)

    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) (Principal Project)

    List all performance sites that apply to the specific component.

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

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

    • In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Project Lead' and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
    • Each Project must be led by one person. Co-leaders of projects are not allowed.  

    Budget (Principal Project)

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

    Principal Project:  Applicants may request up $150,000 direct annual costs for 5 years. The Project Leader must commit at least 1.2 person months effort to the project. 

    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 (Principal Project)

    Specific Aims:  Introduce the hypothesis or hypotheses to be tested.  Outline the approach to achieving the aim(s) and testing the hypothesis/hypotheses. In addition to stating the biological and clinical significance of the research, indicate the project's relevance to the theme of the application and how it relates to other projects.

    Research Strategy: Use this section to describe and explain the strategy proposed to achieve the specific aims.  Explain the rationale for selecting the methods proposed to achieve the specific aims.

    Special Instructions for the Principal Project:  This project should incorporate the theme of the Center, exploit the applicant's expertise, and test hypotheses through Specific Aims that advance our mechanistic understanding of autoimmune diseases.  The Principal Project must include a 5-year research plan and benchmarks for evaluating progress.

    Letters of Support: Provide all appropriate letters of support, including any letters necessary to demonstrate the support of consortium/site participants, cores, laboratories, pharmacies and other collaborators. If any costs are to be borne by sources other than NIH, these contributions must be presented in detail as part of supporting letters signed by individuals who have the authority to make fiduciary commitments on behalf of the institution. These outsource costs do not constitute cost sharing as defined in the current NIH Grants Policy Statement and should not be presented either as part of the requested budget or as Estimated Project Funding.

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

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
    • All investigators funded under this FOA will be expected to share their data publicly through ImmPort or other public portals approved by NIH. Therefore, the Data Sharing plan should include a summary of how the applicant will manage data submission and interactions with ImmPort or other, NIH-approved public portal.

    Appendix:

    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 (Principal Project)

    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 with the following additional instructions:

    For studies involving the use of identifiable human biospecimens collected from independently funded clinical research or clinical trials, applicants should include both historical and current study information that is clearly distinguishable within the information requested in the study record forms.

    Delayed Onset Study

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

    Collaborative Project

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

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

    SF424 (R&R) Cover (Collaborative Project)

    Complete only the following fields:

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

    PHS 398 Cover Page Supplement (Collaborative Project)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Collaborative Project)

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

    Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

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

    Project/Performance Site Location(s) (Collaborative Project)

    List all performance sites that apply to the specific component.

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

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

    • In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Project Lead' and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
    • Each Project must be led by one person. Co-leaders of projects are not allowed.  

    Budget (Collaborative Project)

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

    Collaborative Project:  Applicants may request up to $150,000 annual direct costs for 5 years. The budget should include the anticipated costs of the proposed collaborations.

    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 (Collaborative Project)

    Specific Aims:  Introduce the hypothesis or hypotheses to be tested.  Outline the approach to achieving the aim(s) and testing the hypothesis/hypotheses. In addition to stating the biological and clinical significance of the research, indicate the project's relevance to the theme of the application and how it relates to other projects.

    Research Strategy: Use this section to describe and explain the strategy proposed to achieve the specific aims.  Explain the rationale for selecting the methods proposed to achieve the specific aims.

    Special Instructions for the Collaborative Project: Describe and explain the strategy to test the proposed hypothesis or hypotheses for the Collaborative Project. Outline the approach and explain the rationale for selecting the methods proposed to test the hypothesis/hypotheses. In addition to stating the biological and clinical significance of the research, indicate the project's relevance to the primary theme of the applicant's proposed Center and how it relates to other projects. Since applicants will not know in advance what other ACE Centers may be funded, applicants may consider proposing projects that start from their own specific expertise and disease focus and later seek to generalize observations and mechanisms to other autoimmune diseases.  This could be accomplished with collaborators who have complementary strengths and skills. The Collaborative Project must be coherent, but it may lack some details if they can be reasonably developed with additional ACE collaborators after award. The Collaborative Project must include a 5-year research plan and plans for formulating annual benchmarks for evaluating progress on the research project.

    The ACE will fully develop the Collaborative Projects after award and they should be designed to become part of the ACE Research Agenda. Collaborative Projects may be expanded or reduced after award, depending upon how well they are ultimately integrated within the ACE. 

    Letters of Support: Provide all appropriate letters of support, including any letters necessary to demonstrate the support of consortium/site participants, cores, laboratories, pharmacies and other collaborators. If any costs are to be borne by sources other than NIH, these contributions must be presented in detail as part of supporting letters signed by individuals who have the authority to make fiduciary commitments on behalf of the institution. These outsource costs do not constitute cost sharing as defined in the current NIH Grants Policy Statement and should not be presented either as part of the requested budget or as Estimated Project Funding.

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

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
    • All investigators funded under this FOA will be expected to share their data publicly through ImmPort or other public portals approved by NIH. Therefore, the Data Sharing plan should include a summary of how the applicant will manage data submission and interactions with ImmPort or other, NIH-approved public portal.

    Appendix:

    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 (Collaborative Project)

    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 with the following additional instructions:

    For studies involving the use of identifiable human biospecimens collected from independently funded clinical research or clinical trials, applicants should include both historical and current study information that is clearly distinguishable within the information requested in the study record forms.

    Delayed Onset Study

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

    Pilot Project

    When preparing your application in ASSIST, use Component Type 'Pilot Project.'

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

    SF424 (R&R) Cover (Pilot Project)

    Complete only the following fields:

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

    PHS 398 Cover Page Supplement (Pilot Project)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Pilot Project)

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

    Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

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

    Project /Performance Site Location(s) (Pilot Project)

    List all performance sites that apply to the specific component.

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

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

    • In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Project Lead' and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. 
    • Each Project must be led by one person. Co-leaders of projects are not allowed.

    Budget (Pilot Project)

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

    Applicants may request up to $75,000 annual direct costs for 2 years.

    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 (Pilot Project)

    Specific Aims:  Introduce the hypothesis or hypotheses to be tested.  Outline the approach to achieving the aim(s) and testing the hypothesis/hypotheses. In addition to stating the biological and clinical significance of the research, indicate the project's relevance to the primary theme of the application and how it relates to other projects. The theme of the Pilot Project must be related to the overarching goals of the applicant's proposed Center.

    Research Strategy:  Describe an innovative and exploratory Pilot Project that pursues intriguing observations that may lead to discoveries or breakthroughs. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for the Pilot Project; however, they may be included if available. The Pilot Project must include a 2-year research plan and benchmarks for evaluating progress at 18 months. The Pilot Project may be extended, expanded, or terminated after 2 years based on the Steering Committee's evaluation of progress and the availability of funds.  

    Letters of Support: Provide all appropriate letters of support, including any letters necessary to demonstrate the support of consortium/site participants, cores, laboratories, pharmacies and other collaborators. If any costs are to be borne by sources other than NIH, these contributions must be presented in detail as part of supporting letters signed by individuals who have the authority to make fiduciary commitments on behalf of the institution. These outsource costs do not constitute cost sharing as defined in the current NIH Grants Policy Statement and should not be presented either as part of the requested budget or as Estimated Project Funding.

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

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
    • All investigators funded under this FOA will be expected to share their data publicly through ImmPort or other public portals approved by NIH. Therefore, the Data Sharing plan should include a summary of how the applicant will manage data submission and interactions with ImmPort or other, NIH-approved public portal.

    Appendix:

    Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

    PHS Human Subjects and Clinical Trials Information (Pilot Project)

    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 with the following additional instructions:

    For studies involving the use of identifiable human biospecimens collected from independently funded clinical research or clinical trials, applicants should include both historical and current study information that is clearly distinguishable within the information requested in the study record forms.

    Delayed Onset Study

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

    Overall Impact - Overall

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the program 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 program proposed).

    Review Criteria - Overall

    Reviewers will consider each of the review criteria below in determination of scientific and technical merit and in providing an overall impact score, but will not give separate scores for these items.

    • Is the Program scientifically compelling as a whole?
    • Are the overall Program goals significant and focused on studies that accelerate the discovery and translation from lab to clinic of therapies for autoimmune diseases?
    • Will the integration of the individual projects into a single Program provide synergy that will be more beneficial than pursuing each project independently?
    • Have the applicants and collaborators made a significant contribution to the field of autoimmune diseases?
    • Have the applicants and collaborators successfully developed and conducted collaborative research projects?
    • Do(es) the PD(s)/PI(s) have the leadership and scientific ability to develop an integrated and focused research Program?
    • Is there adequate evidence of sufficient institutional support for the PDs/PI(s) in terms of laboratory space, equipment and other resources?
    • Is the Leadership Succession Plan adequate and feasible?
    • For applications designated multiple PDs/PIs, is the Leadership Plan adequate and appropriate to ensure that there will be sufficient coordination and communication among the PDs/PIs?
    • For renewal applications, has substantial progress been made in the preceding period of support?
     
    Overall Impact - Individual Research Projects

    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 - Individual Research Projects
     

    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?

    Specific to this FOA

    Principal Project: Does the Principal project address key aspects of the Center's theme?

    Collaborative Project: Does the Collaborative Project address an aspect of the Center's theme?

    Pilot Project: Does the Pilot Project address an aspect of the Center's theme?

    Investigator(s)

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

    Specific to this FOA

    Principal Project: Does the project exploit the strengths of the applicant's expertise?

    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?   

    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?

    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?  

    Specific to this FOA

    Collaborative Project: Does the Project seek to answer broader questions beyond the capabilities of a single Center?  Does the proposed Collaborative Project have a good probability of establishing useful, productive collaborative investigation? 

    Pilot Project: Are the benchmarks well-defined and appropriate?

    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?   

    Overall Impact - Administrative Core

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Core 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 core proposed).

    Review Criteria – Administrative Core

    Reviewers will consider each of the review criteria below, as appropriate for the individual core, in the determination of merit and will give an overall impact score for each Core but will not give separate scores for each criterion.

    • Is the Staffing and Administrative Plan appropriate for the objectives of the proposed Program?
    • Are the experience, level of commitment, and availability of the Core Leader adequate to manage the overall Program?
    • Are the plans for coordination, problem identification and resolution and the establishment of a strong collaborative environment for the program appropriate?
    • Are the proposed timelines, milestones and performance objectives for the overall Program adequate?
    • Is the management plan for fiscal accountability and communication within the Program appropriate? 
    Additional Review Criteria - Overall, Cores, and Research Projects

    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.

     ACE Funds Management Core

    Are the administrative structure and plans for staffing appropriate to manage the program funds? Have adequate plans been made to receive, review, and implement budgets and execute consortium agreements? Have adequate plans been made to receive, review, pay invoices, and report status to NIAID in a timely manner? Are the clinical trial budget and quarterly reporting templates appropriate?  

    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

    For Renewals, the committee will consider the progress made in the last funding period.

    Revisions

    Not Applicable

    Additional Review Considerations - Overall, Cores, and Research Projects

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

    Applications from Foreign Organizations

    Not Applicable

    Select Agent Research

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

    Resource Sharing Plans

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

    Authentication of Key Biological and/or Chemical Resources

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

    Budget and Period of Support

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

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the National Institute of Allergy and Infectious Diseases  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 Allergy and Infectious Diseases 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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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 primary responsibility for:

    • Advancing and coordinating the activities at their Center, scientifically and administratively;
    • One PD/PI from each Center will attend meetings and serve as a voting member of the Steering Committee;
    • Participating actively in the formulation and implementation of the ACE Research Agenda;
    • Implementing policies approved by the Steering Committee or emplaced by NIAID;
    • Providing the SACCC with all clinical study data for management, quality control, and analysis, using procedures and standards determined by NIAID; 
    • Sharing all data publicly through ImmPort, ImmuneSpace, or other public portals designated by NIAID, as appropriate and consistent with achieving the goals of the program. The PD/PI will establish procedures within the center to ensure that all members of that center, including any scientists added via AFMC support, conform to the data sharing and other resource-sharing plans;
    • Complying with the NIAID Clinical Terms of Award. The full policy, including terms and conditions of award, is available at: https://www.niaid.nih.gov/grants-contracts/niaid-clinical-terms-award.

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

    • An NIAID Program Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. NIAID staff assistance will be provided by DAIT Project Scientists along with other NIH staff. They will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination, including participation in periodic on-site monitoring with respect to compliance with Federal regulations, quality control, accuracy of data recording, sample accrual, etc.;
    • Facilitate collaborations with and access to other NIAID-supported research resources and
    • Services;
    • Serve as liaison/facilitator among awardees and with the data portals ImmPort and ImmuneSpace;
    • Provide oversight for human subjects protections and provide monitoring for any studies that
    • involve more than minimal risk for participants or that involve vulnerable populations;
    • Provide assistance to the Steering Committee in the development of procedures for evaluating the performance of research studies and monitoring any Clinical Trials;
    • Participate on the Steering Committee as a voting member and coordinate Steering Committee activities and implementation of its recommendations, decisions, and policies;
    • Share information regarding promising new agents, strategies, and developments when appropriate;
    • Identify scientific gaps and organize meetings to facilitate exchange of scientific and regulatory information, including during meetings;
    • Oversee resources that:
    • provide statistical and data management support,
    • provide regulatory support services,
    • conduct external site monitoring, and
    • manage and distribute investigational agents.
    • Participate in the presentation of research results, including publications;
    • Oversee clinical site operations to include development of template informed consent documents as well as site specific consents for IRB submission, operational activation of ACE clinical sites, and review and evaluation of site monitoring reports.

    Protocol review. NIAID staff will review all protocols and approval is required for initiation. The Program Scientist or designee will return comments and recommendations to the ACE protocol team after review. The protocol team must address in writing all safety, regulatory, ethical, and conflict of interest concerns raised by NIAID to the satisfaction of NIAID before participant enrollment can begin. If a protocol is disapproved, NIAID will not provide investigational products or permit expenditure of NIH funds for the proposed investigation. If a protocol is not initiated within twelve months of NIAID approval, re-review and approval by NIAID will be required.

    Clinical Study Termination.  NIAID staff reserves the right to terminate or curtail a clinical study for any reason.  Examples include, but are not limited to, risks to subject safety, failure to achieve recruitment goals, and reaching a major study endpoint substantially before schedule with persuasive statistical significance.

    Clinical Data Access. NIAID has the right of access to all clinical data generated (raw and analyzed) and may periodically review it. This includes data as recorded on the case report forms and in the central databases, and external checking against the original source documentation as required by federal regulation and NIAID as the IND sponsor. NIAID staff may request from ACE protocol teams specific data analysis needed for programmatic activities or for issues related to NIAID plans with other partners.  

    Areas of Joint Responsibilities include:

    Steering Committee

    A Steering Committee will serve as the coordinating body for the ACE research program. It will be formed by a single PD/PI from each ACE U19 and each ACE UM1 and representatives from the SACCC and from NIAID. It will be chaired by a PD/PI chosen by a majority vote of the Steering Committee, with terms determined by the committee. Each member of the Steering Committee will have one vote. The SACCC and NIAID representatives will be voting members, but will not serve as the Chair of the Steering Committee.  All participants in the ACE program are bound by the policies and procedures developed by the Steering Committee. 

    The Steering Committee responsibilities include:

    • Composing soon after award an ACE Research Agenda establishing goals and priorities for the entire program term.  The Agenda will be based on the Clinical and Collaborative Projects but may include additional plans in order to foster collaborations among all of the members of the ACE.  The Agenda will include but is not limited to the following items:
    • Overall goals and Specific Aims,
    • Clinical and Collaborative Projects to be initiated within the coming year, and
    • Benchmarks and Timelines for accomplishing the work.
    • Composing an annual collaborative group report and posting it along with the ACE Research Agenda on the public ACE website (www.autoimmunitycenters.org);
    • Helping to develop and implement the Clinical Projects, including the associated mechanistic studies and the Collaborative Projects;
    • Determining how data from multiple Centers collaborating on a study will be shared and analyzed: investigators wishing to perform their own analysis of local data or of single site studies must obtain approval for the planned analysis from the Steering Committee;
    • Developing policies for use of the ACE Clinical Project Fund and the Collaborative Research Fund;
    • Establishing procedures for reporting results of ACE trials/studies, including composing and approving a Publications Policy governing the initial public release of ACE clinical trial-related information;

    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 arbitration. An Arbitration Panel composed of three members will be convened. The members shall be: (1) one designee of the Steering Committee chosen without NIH staff voting, (2) one NIH designee, and (3) one designee with expertise in the relevant area who is chosen by the other two members. In the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 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)

    David Johnson, Ph.D.
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-669-5075
    Email: DRJohnson@niaid.nih.gov

    Peer Review Contact(s)

    Thomas Conway, PhD
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-669-5075
    Email: thomas.conway@nih.gov

    Financial/Grants Management Contact(s)

    Cheryl Y. Wall
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-669-2956
    Email: wallcy@niaid.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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