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)
National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

HLA and KIR Region Genomics in Immune-Mediated Diseases (U19 Clinical Trial Not Allowed)

Activity Code

U19 Research Program – Cooperative Agreements

Announcement Type

Reissue of RFA-AI-14-013

Related Notices
  • August 23, 2019 - Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137.
  • July 26, 2019 - Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128.
Funding Opportunity Announcement (FOA) Number

RFA-AI-19-044

Companion Funding Opportunity

RFA-AI-19-041, U01 Research Project – Cooperative Agreements  

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

93.855, 93.853 

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications from investigators to participate in the HLA and KIR Region Genomics in Immune Mediated Diseases Consortium (HLARGC). This cooperative research group supports projects defining the association between variations in the human leukocyte antigen (HLA), also known as the Major Histocompatibility Complex (MHC), and natural killer cell immunoglobulin-like receptor (KIR) genetic regions and immune-mediated diseases, including outcomes following cell, tissue, and organ transplantation.  

Key Dates

 

Posted Date

May 2, 2019

Open Date (Earliest Submission Date)

August 5, 2019

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

September 4, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on 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

February 2020

Advisory Council Review

May 2020

Earliest Start Date

June 2020

Expiration Date

September 5, 2019

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


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

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

  3. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description
    Purpose

    The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications from institutions to participate in the HLA and KIR Region Genomics in Immune-Mediated Diseases Consortium (HLARGC).  This cooperative research initiative supports studies to discover and characterize associations between polymorphisms in the human leukocyte antigen (HLA, also known as the Major Histocompatibility Complex or MHC), and natural killer cell immunoglobulin-like receptor (KIR) genomic regions and (1) immune-mediated diseases, including risk and phenotype, and (2) cell, tissue, and organ transplantation outcomes, including rejection, tolerance, and graft-versus-host disease (GVHD).

    In addition to supporting HLA and KIR region association studies, a major goal of this program is the assemblage of high-quality, high-resolution genetic data with accompanying disease state and phenotype information.  The data generated by the HLARGC will be submitted to the NIAID Bioinformatics Information Support Contract database, the Immunology Database and Analysis Portal (ImmPort). Where appropriate, data from these studies will also be submitted to Database of Genotypes and Phenotypes (dbGaP) and other publicly accessible databases.

    Background

    The HLA genomic region is the most polymorphic and gene-dense region in the human genome.  This four-megabase region on chromosome 6 contains at least 150 protein-coding genes, and includes the HLA Class I, II, and III gene families.  The Class I and Class II genes encode molecules responsible for the presentation of endogenously and exogenously derived peptides to T cells.  The Class III region contains genes encoding a variety of immune response mediators, including some complement components and cytokines.  Many of these genes are implicated in the development of immune-mediated diseases.  In addition to their role in peptide presentation, HLA Class I molecules act as ligands for KIR on natural killer (NK) cells.  The interaction between HLA and KIR results in either inhibition or, less commonly, activation of NK cell cytotoxic activity.  KIRs are encoded by a highly polymorphic region of chromosome 19 and have evolved to enable swift immune responses to a variety of threats.  Specific combinations of KIR and HLA haplotypes have been linked to immune-mediated diseases and transplantation outcomes, suggesting that the study of these molecules in tandem may be especially valuable.

    The primary goal of this program is to define associations between sequence variations in the HLA and KIR genomic regions with susceptibility or resistance to immune-mediated diseases, including autoimmune diseases, primary immunodeficiencies, and outcomes of cell, tissue, and organ transplantation.  Genome-wide association studies (GWAS) of these diseases consistently show the highest level of association within these regions.  However, conventional GWAS techniques are inadequate when applied to this dense, highly polymorphic cluster of genes.  The HLA region also displays a high degree of linkage disequilibrium, complicating its study.  For these reasons, this FOA solicits applications that propose high-resolution approaches specifically targeting the HLA and KIR regions.

    The formation of the HLARGC cooperative group has facilitated the exchange of reagents and technologies, fostered collaborations across diseases areas and disciplines, and revealed how common sequence variations within these regions may be linked to multiple diseases.  Previous studies carried out by members of the HLARGC have focused on autoimmune diseases (multiple sclerosis, rheumatoid arthritis, juvenile idiopathic arthritis, myasthenia gravis, systemic lupus erythematosus, Crohn’s disease, ulcerative colitis, Behcet’s disease, systemic sclerosis, ankylosing spondylitis, and narcolepsy/hypocretin deficiency), primary immunodeficiencies (IgA deficiency and common variable immune deficiency), and hematopoietic stem cell and cord blood transplantation outcomes. 

    Research Objectives and Scope

    The goal of this FOA is to continue support of the HLARGC program to further identify, map, and characterize how genetic variants within these regions may influence disease phenotype, progression, and severity; predict health outcomes; and direct treatment strategies, with an emphasis on population diversity.  In addition, high quality, high-resolution HLA and KIR region genomic and phenotype data produced from these projects will populate publicly accessible databases such as dbGaP.

    This initiative will support prospective and/or retrospective studies investigating the role of the HLA and/or KIR genomic regions in immune-mediated diseases and transplantation outcome.  Research projects must be focused on the correlation between sequence variations in the HLA and/or KIR genomic regions with disease clinical phenotype, risk, severity, progression, and/or response to therapy, or transplantation outcomes.  Studies investigating associations linked to race or ethnicity are especially encouraged.  In addition, as the independent segregation of HLA and KIR genes results in diverse HLA-KIR combinations between individuals, studies of HLA-KIR region gene combinations are especially encouraged.  Studies may examine polymorphisms in the protein coding and/or non-coding regions with the HLA and KIR regions, as well as non-classical genes residing in these regions.

    Potential areas of research include, but are not limited to, the following:

    • The association of HLA and/or KIR region genes, including non-HLA and -KIR genes residing in these regions, or specific combinations of HLA/KIR molecules with susceptibility, resistance, progression, phenotype, and/or response to therapy of immune-mediated diseases, including autoimmune diseases and primary immunodeficiency diseases.
    • Associations between transplantation outcomes, including graft rejection, acceptance/tolerance, or GVHD, with varying degrees of donor/recipient mismatch at HLA and/or KIR loci, polymorphisms in the HLA and/or KIR regions, or specific combinations of HLA and KIR molecules in the donor, recipient, or both.
    • Mechanistic studies of HLA and KIR interactions, disease associations, and the functional basis of the observed association.
    • Association studies of immune-mediated diseases disproportionately affecting specific racial, ethnic, or gender groups, especially minority populations.
    • Examples of appropriate immune-mediated diseases include, but are not limited to:
    • GVHD
    • Allograft rejection (acute and chronic), and survival/tolerance
    • Autoimmune diseases, except type 1 diabetes
    • Primary immunodeficiency diseases (e.g., common variable immune deficiency and IgA deficiency)

    Applications including the following types of studies will be considered non-responsive and will not be reviewed:

    • Type 1 diabetes association studies
    • Infectious disease and vaccine response association studies
    • Interactions between HLA or KIR region genes and genes outside these regions, including but not limited to interactions between HLA molecules and antigen receptors
    • Animal studies, including the development or analysis of animal models for HLA- or KIR-related disease studies
    • Population diversity studies, unless they are directly linked to immune-mediated disease prevalence or severity studies
    • Clinical trials
    • Serology-based HLA or KIR typing projects
    • HIV/AIDS associated studies

    Applicants are strongly encouraged to contact the Scientific Research Contacts well in advance of the application submission deadline to discuss the proposed research program. 

    Steering Committee

    A Steering Committee made up of the Program Directors (PDs)/Principal Investigators (PIs) from U01 and U19 projects funded under this program will serve as the main governing body for the HLARGC.  Among other responsibilities, it will identify scientific opportunities, emerging needs and impediments; ensure the timely release of data through publications and/or release of data to public databases; develop guidelines for the publication of collaborative research project results and establish collection standards in collaboration with ImmPort that will facilitate meta-analysis across studies and disease areas. 

    NIAID Bioinformatics Information Support (ImmPort)

    The ImmPort program will provide technical assistance and data submission support for HLARGC awardees. The portal provides online tools that allows users to analyze data and visualize results, integrate data from a variety of laboratories, and supports collaboration between scientists.  The data generated by the HLARGC will be submitted to the ImmPort database.  ImmPort will be responsible for data receipt, deposition, archive and backup, and subsequent data deposition into dbGAP or other appropriate public databases. ImmPort will communicate with the data liaison of each U01 and U19 project.   

    Program Structure

    This research program will consist of an Administrative Core, Scientific Core(s) (optional), and a minimum of two Research Projects organized around a common theme or hypotheses. Component projects and cores within a single application should not only relate to a central theme relevant to the association between variations in the HLA and KIR genetic regions in immune-mediated diseases, but also relate to the other components within the same application. The components of an application include:

    Administrative Core

    This core will provide the management, coordination, and supervision of both the scientific and fiscal aspects of the overall program.

    Research Projects

    Each application must include a minimum of two interrelated individual Research Projects.

    Scientific Cores (Optional)

    An application may include development and maintenance of one or more Scientific Core(s). Scientific Cores must provide scientific resources, facilities, and/or support services to two or more Research Projects.

    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

    The following NIH components intend to commit the following amounts in FY 2020 to fund 5-7 awards (U01 and/or U19):

    NIAID, $2.4 M (total costs);

    NINDS, $750K (total costs).

    Award Budget

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

    Award Project Period

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

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    Nonprofits Other Than Institutions of Higher Education

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

    For-Profit Organizations

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

    Governments

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

    Other

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

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

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

    Required Registrations

    Applicant Organizations

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

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

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

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

    Eligible Individuals (Program Director/Principal Investigator)

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

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

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

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

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

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

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

    2. Content and Form of Application Submission

    It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    Letter of Intent

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

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

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

    The letter of intent should be sent to:

    Thomas Conway, Ph.D.
    Telephone: 240-669-5075
    Email: thomas.conway@nih.gov  

    Page Limitations

    Available Component Types

    Research Strategy/Program Plan Page Limits

    Overall

    12 pages

    Admin Core (Use for Administrative Core)

      6 pages

    Core (use for Scientific Core[s])

      6 pages each

    Project (use for Research Projects)

    12 pages each

    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: 1 required
    • Scientific Core(s): optional, no maximum
    • Research Projects: 2 required, no maximum
    Overall Component

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

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

    SF424 (R&R) Cover (Overall)

    Complete entire form.

    PHS 398 Cover Page Supplement  (Overall)

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

    Research & Related Other Project Information (Overall)

    Follow standard instructions.

    Project/Performance Site Location(s) (Overall)

    Enter primary site only.

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

    Research & Related Senior/Key Person Profile (Overall)

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

    A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

    Budget (Overall)

    The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.  

    PD(s)/PI(s) must commit a minimum of 1.8 person months per year to this program.  For multi-PD/PI applications, only the contact PD/PI must commit a minimum of 1.8 person months per year.

    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:  List the Specific Aims of the proposed program. Concisely describe the hypothesis or hypotheses to be tested. In addition, state the program’s relationship to the goals of the HLARGC.   

    Research Strategy:  Include the following:

    • A description of the central theme of the proposed program, including an explanation of how the proposed Research Projects and Core(s) are synergistic, interrelated and complementary towards achieving the central objectives of the program.
    • A discussion of how this program will significantly advance understanding of the role of the HLA and/or KIR genomic regions in immune-mediated diseases and/or transplantation outcomes.
    • A description of how the proposed research will contribute to meeting the HLARGC's goals and objectives. A discussion of each Research Project and Scientific Core with respect to: their scientific merit, cohesiveness and how they fit into a common theme.
    • A discussion of measures to optimize the sharing of data and resources between Research Projects.
    • A section entitled "Timelines and Annual Milestones" with clearly stated interim and long-term objectives and annual milestones (e.g., data deposition into ImmPort) to be achieved during the program, identify critical decision points, and provide a detailed timeline for the completion of each goal of the proposed research projects.

    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.

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information (Overall)

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

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

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

    PHS Assignment Request Form (Overall)

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

    Administrative Core

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

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

    SF424 (R&R) Cover (Administrative Core)

    Complete only the following fields:

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

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Administrative Core)

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

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

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

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

    List all performance sites that apply to the specific component.

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

    Research & Related Senior/Key Person Profile (Administrative Core)
    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
    • For institutions/organizations proposing a single PD/PI, the PD/PI must serve as the Administrative Core Leader. For institutions/organizations proposing multiple PD(s)/PI(s), the contact PD/PI must serve as the Administrative Core Leader.
    • Include in the biosketch details of the experience and ability of the Administrative Core Leader and key staff to manage the overall program, provide leadership and guidance to scientific teams, and provide fiscal oversight.  
    Budget (Administrative Core)

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

    Include travel funds for the PD(s)/PI(s), Research Project Leaders, Core Leader(s) and the project biostatisticians to the annual Steering Committee meeting (for a one-day meeting) in Rockville, MD.

    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 the broad, long-range objectives and goals of the proposed Core.   

    Research Strategy: Provide a plan that addresses the short- and long-term management of the program, describing how the Administrative Core will support the overall research program.  Include a description of the administrative and organizational structure, plans for project communication and coordination, internal data and resource sharing, and problem identification and resolution among the Research Projects and Scientific Core(s). 

    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.

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information (Administrative Core)

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

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

    Scientific Core(s)

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

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

    SF424 (R&R) Cover (Scientific Core(s))

    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 (Scientific Core(s))

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Scientific Core(s))

    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.

    Facilities & Other Resources: Provide a description for facilities necessary to accomplish the mission of the Scientific Core.

    Equipment: Provide a description of the equipment necessary to accomplish the mission of the Scientific Core.

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

    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 (Scientific Core(s))
    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
    • If biostatistical analysis will be performed by a Core, include the biosketch(es) for a biostatistician detailing their qualifications to serve as the program's statistical expert with direct responsibility for analysis, and to act as a data liaison to ImmPort, to format and submit data to public databases, and to disseminate information to the scientific community at large.
    Budget (Scientific Core(s))

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

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

    PHS 398 Research Plan (Scientific Core(s))

    Specific Aims: List the broad, long-range objectives and goals of the proposed Core.  In addition, state the Core's relationship to the goals of the overall program and how it relates to individual Research Projects in the application.   

    Research Strategy: Describe how the proposed Core activities will provide scientific resources, facilities, and/or support services to two or more Research Projects. Explain why the Core resources are not otherwise available. In addition, indicate the relevance of the Core to the primary theme of the application.

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

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

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

    PHS Human Subjects and Clinical Trials Information (Scientific Core(s))

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

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

    Research Projects

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

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

    SF424 (R&R) Cover (Research 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 (Research Projects)

    Enter Human Embryonic Stem Cells in each relevant component.

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

    List all performance sites that apply to the specific component.

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

    Research & Related Senior/Key Person Profile (Research Projects)
    • 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.
    • Unless biostatistics support will be provided by a Core, include the biosketch for a biostatistician detailing their qualifications to serve as the project's statistical expert with direct responsibility for analysis, and to act as a data liaison to ImmPort, to format and submit data to typical public databases, and to disseminate information to the scientific community at large. Note: the same individual may be named as the biostatistician for multiple Research Projects.
    Budget (Research Projects)

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

    Research Project Leaders must commit at least 1.2 person months per year 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 (Research Projects)

    Specific Aims:  List the Specific Aims of the proposed project. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the individual Research Project’s relationship to the HLARGC goals and how they relate to other Research Projects or Cores in the application. 

    Research Strategy:  Include the following:

    • A description of how the proposed research will contribute to meeting the HLARGC's goals and objectives. Explain the rationale for selecting the methods to accomplish the Specific Aims and address how the project will advance understanding of the role of HLA and/or KIR region genes in immune-mediated diseases and/or transplantation.  In addition to stating the biological significance of the research, indicate the project's relevance to the primary theme of the application.
    • A section entitled "Timelines and Annual Milestones" containing clearly stated interim and long-term objectives and annual milestones to be achieved during the project, identifying critical decision points, and providing a detailed timeline for the completion of each goal of the proposed research project.  Note: timelines for clinical research are requested as part of the PHS Human Subjects and Clinical Trials information and should not be repeated in this section.
    • A section entitled "Data and Statistical Plan" containing a detailed description of the statistical considerations used in determining sample size and study power, a justification for the required sample size; details of data collection; and the capture and validation of demographic and phenotypic information as well as linkage to later analyses.
    • A description of how interactions with ImmPort will be conducted. 

    Note: Specific details for human samples collected from independently-funded clinical trials and studies, and supplied to the PD(s)/PI(s) using patient identifiers will be captured using the PHS Human Subjects and Clinical Trials Information. Do not duplicate information requested under the PHS Human Subjects and Clinical Trials Information.

    Letters of Support: If the proposed study includes samples and clinical data that are not currently in the possession of the PD/PI, include a letter of support from the person or institution controlling the samples indicating that the samples and associated clinical/phenotypic data will be made available to the applicant.

    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.
    • Informed consent forms for all human samples must allow data sharing with ImmPort and other projects within the HLARGC.

    Appendix:

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

    For all human samples, provide sample informed consent form(s) that were used to obtain consent for future use. This may be one informed consent document for the entire sample collection, or several different documents, as applicable.

    Note: IRB approval of the consent form(s), if applicable, is not required at the time of submission of the application but will be required before the proposed research studies on those samples is begun.

    PHS Human Subjects and Clinical Trials Information (Research Projects)

    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:

    Section 2 - Study Population Characteristics

    2.7 Study Timeline

    If applicable, timelines should address the time needed to acquire samples from independently funded clinical research or clinical trials.

    Delayed Onset Study

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

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

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

    4. Submission Dates and Times

    Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

    Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

    Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

    Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

    All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

    7. Other Submission Requirements and Information

    Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

    For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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

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

    Important reminders:

    All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

    See more tips for avoiding common errors.

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

    Post Submission Materials

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

    Section V. Application Review Information
    1. Criteria

    Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

    Overall Impact - Overall

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

    Scored Review Criteria - Overall

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

    Significance

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

    How will the program significantly advance understanding of the role of the HLA and/or KIR genomic regions in immune-mediated diseases and/or transplantation outcomes?

    Investigator(s)

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

    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 program? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    If the program involves human subjects and/or NIH-defined clinical research, are the plans to address:

     1) the protection of human subjects from research risks, and

     2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?  

    Specific to this FOA:

    How do the proposed Research Projects and Core(s) synergize and contribute to the overarching program goals? Are the projects interrelated and complementary? How do the plans described optimize the sharing of data and resources between Research Projects? How adequately does the application describe the scientific merit of each Research Project and Core and how they relate to the theme of the program as a whole? How appropriate are Timelines and Annual Milestones identified to measure against progress? 

    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 program proposed? Will the program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

    Overall Impact - Research Projects

    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).

    Scored Review Criteria - 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 the prior research that serves as the key support for the proposed project rigorous?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

    Specific to this FOA:

    How will the project significantly advance understanding of the role of HLA and/or KIR region genes in immune-mediated diseases and/or transplantation?

    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:

    If no Bioinformatics Core is proposed: How appropriate is the experience of the Research Project biostatistician to serve as the project’s statistical expert, to act as the data liaison to ImmPort, to format and submit data to typical public databases and provide information to the scientific community at large?

    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 investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

     1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

    Specific to this FOA:

    Evaluate the appropriateness of: the proposed timelines and annual milestones, the statistical power of the study, the Data and Statistical Plan and interactions with ImmPort. How appropriate is the description of how phenotypic data will be captured, validated, and linked to later analyses? How adequate is the evidence presented that the human samples from clinical trials or studies were consented to allow for use in the proposed studies, and that the genetic material and phenotypic data necessary for the proposed project will be available within an acceptable timeframe?

    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, Scientific Core(s)

    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, Scientific Core(s)

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

    Administrative Core

    How appropriate is the administrative and organizational structure to facilitate attainment of the objective(s) of the proposed program? How adequate is the level of commitment and experience in organizing multi-project and cores of the Administrative Core Leader and staff to manage the overall program? How adequate are the plans for communication and coordination, internal data and resource sharing, and problem identification and resolution to the attainment of the objective(s) of the proposed program?

    Scientific Core(s) (if applicable)

    Is provision of resources and Core services for the individual Research Projects and the central focus of the overall research program justified? How appropriate is the quality of the relevant facilities, equipment or services provided? How appropriate are the qualifications, competence, and commitment of the Core Leader and key personnel? If a Biostatistics Core is proposed, how appropriate is the experience of the key person(s) to act as the data liaison to ImmPort, to format and submit data to typical public databases, and provide information to the scientific community at large?

    Additional Review Criteria - Overall, Core(s) 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.

    Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan  

When the proposed 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 individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed.  For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

Additional Review Considerations - Overall, Scientific Core(s) 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 on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory 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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

Cooperative Agreement Terms and Conditions of Award

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

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

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

  • PDs/PIs will collect and assure the quality of the data; interact with ImmPort staff through the data liaison; submit data to ImmPort, and agree to the subsequent submission of these data to dbGaP by ImmPort in accordance with policies established by NIAID and NCBI and the NIH data sharing policy available at: https://grants.nih.gov/grants/policy/data_sharing/.
  • Each PD/PI will serve as a voting member of the Steering Committee (one PD/PI if multiple PDs/PIs) and participate in HLARGC activities.

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

  • The NIH Project Scientist(s) will coordinate NIH staff assistance, including interactions with ImmPort and provide assistance with the design of the Steering Committee technical and management activities.
  • The NIH reserves the right to terminate or curtail a study in the event of a substantial shortfall in milestones, participant recruitment, follow-up, data reporting, quality control, or other major breach of the approved project. Future year funding may be negotiated downward depending on the progress towards achieving the previously agreed upon research goals, interim objectives and annual milestones.
  • Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

Steering Committee

A Steering Committee will serve as the governing board of the HLARGC.  All consortium investigators will be required to accept and implement common guidelines and procedures approved by the Steering Committee. 

  • The voting members of the Steering Committee will include one PD/PI from each U01 and two from each U19.  Additional PDs/PIs, Project Leaders, and NIH Program Officer(s) will serve as non-voting Steering Committee members.
  • NIH may appoint up to two external scientists or additional staff to the Steering Committee as non-voting members.  The Steering Committee may appoint additional non-voting members by majority vote.

The Steering Committee will:

  • Serve as the main governing board;
  • Identify scientific opportunities, emerging needs, impediments, and opportunities for collaboration;
  • Provide guidance and recommendations to investigators regarding study implementation and conduct;
  • Establish policies for joint publication, data handling, including protocols and standards for data collection, analysis, and management that supports data sharing across studies and disease areas and ensure the timely release of data though publication or release to public databases.
  • Develop guidelines and policies for publication of collaborative project results;
  • Prepare reports on cumulative progress of the cooperative group, as requested by the NIH Program Officer(s);
  • Establish subcommittees as needed to provide recommendations on shared aspects of the cooperative research group, including but not limited to the activities listed above.
  • NIAID intends to support the peer-reviewed studies proposed in the awarded grant applications.  However, under special circumstances (e.g., duplicative or overlapping specific aims among awardees), the Steering Committee will establish guidelines and review procedures, and will evaluate and recommend to the NIAID opportunities for collaboration, redirection or modification of the peer-reviewed or new projects when applicable and necessary. This policy is in keeping with the terms and conditions of the cooperative agreement mechanism.  Any recommendations that result in a change in the research projects must be approved by the NIH Program Officer(s).
  • It is anticipated that most steering committee decisions will be reached by consensus and the NIH staff will be given the opportunity to offer input into this process, but the manner of reaching this consensus and the primary decision-making responsibility will rest with the Steering Committee, except where stated otherwise in this FOA.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel having three members (a designee of the Steering Committee who is not involved in the dispute, one NIH participant, and a third person from within or outside of the consortium who has relevant expertise and who is chosen by the other two) will be convened.  This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

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

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

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

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

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

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

Scientific/Research Contact(s)

Jeffrey Rice, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3552
Email: ricejs@mail.nih.gov

Ursula Utz, Ph.D.
National Institute of Neurologic Disorders and Stroke (NINDS)
Telephone: 301-496-1431
Email: utzu@ninds.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Regina Kitsoulis
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2946
Email: Kitsoulisre@niaid.nih.gov

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

Section VIII. Other Information

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

Authority and Regulations

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


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