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

Impact of Initial Influenza Exposure on Immunity in Infants (U01 Clinical Trial Not Allowed)

Activity Code

U01 Research Project – Cooperative Agreements 

Announcement Type

New 

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AI-18-010

Companion Funding Opportunity

None   

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

 93.855

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to establish, follow, and characterize longitudinal cohorts of infants to determine how initial and repeated natural influenza infections and/or influenza vaccinations shape infant and childhood immunity to future influenza exposures. The ultimate goal of this research is to provide key information to facilitate design of durable, broadly protective influenza vaccines.

Key Dates

 

Posted Date

April 5, 2018

Open Date (Earliest Submission Date)

June 2, 2018

Letter of Intent Due Date(s)

June 2, 2018

Application Due Date(s)

July 2, 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

July 3, 2018

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

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

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


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

    The purpose of this Funding Opportunity Announcement (FOA) is to establish, follow, and characterize longitudinal cohorts of infants to determine how initial and repeated natural influenza infections and/or influenza vaccinations shape infant and childhood immunity to future influenza exposures. Research supported under this program will define and characterize immunity acquired upon initial exposure to influenza antigens from natural infections and/or vaccinations and examine how these exposures influence immune responses to subsequent influenza infections and/or vaccines. The ultimate goal of this research is to provide key information to facilitate design of durable, broadly protective influenza vaccines.

    Background

    Seasonal influenza outbreaks occur annually and cause significant worldwide morbidity and mortality, particularly in vulnerable populations such as infants, young children, and the elderly.  An even greater threat to the general population is the ever-present and unpredictable emergence of a novel pandemic strain. Influenza viruses exhibit frequent antigenic change and influenza vaccines are developed against the strains predicted to circulate in the upcoming influenza season and those with significant pandemic potential.  Therefore, annual vaccination remains the cornerstone for the control of influenza.  Seasonal influenza vaccines typically contain two strains of influenza A (H1N1 and H3N2) virus and one or more influenza B viruses formulated as trivalent or quadrivalent vaccines, respectively.  Currently available influenza vaccines provide suboptimal protection against seasonal influenza and provide limited protection against newly emerging strains. Numerous factors can significantly reduce vaccine effectiveness to circulating strains and contribute to waning immunity.  A major advancement in influenza control would be the development of a vaccine that confers broad, robust, and durable protection against most or all seasonal strains of influenza, as well as novel strains that could cause the next pandemic. 

    Humans encounter numerous influenza strains and receive numerous vaccinations throughout their lifetime.  Immune response to these exposures are determined by the genetics of the infecting viruses and intrinsic factors, including host genetics, exposure and vaccination history, age, the presence or absence of chronic illnesses, and immune status.  Additionally, one's initial infection with an influenza virus impacts immunity, including antibody responses, to subsequent infections with new strains.  This concept of "original antigenic sin" was proposed in 1960 by Thomas Francis, Jr. to describe the impact of pre-existing immunological memory from an initial influenza encounter upon exposure to a different influenza virus. Recent epidemiologic evidence suggests that exposure during early childhood elicits a lifelong immunologic "imprint" that impacts the ability to respond to subsequent novel strains, but that also can provide protection against novel hemagglutinin (HA) subtypes from the same phylogenetic group as the original infecting virus.  Immunological "imprinting" has important implications for public health because it may negatively influence responses to subsequent influenza infections and vaccinations.

    Recent technological advances now allow for the collection of smaller blood volumes, increased cell recovery, and the need for fewer cells for detailed immunological analyses.  With these improvements, it is now possible to conduct detailed immunological studies from clinical samples from infants. Such studies would provide new insights into the mechanisms by which immunity is acquired following initial exposure to influenza via infection or vaccination and help define which influenza antigen/epitope-associated responses result in more broad-based immunity. Additionally, understanding how infants' immune responses are altered or expanded by their encounter with subsequent influenza infections and/or vaccinations will be critical to define the breadth of immunological coverage that can be achieved with an effective universal influenza vaccine.  This initiative is intended to support focused multi-disciplinary prospective longitudinal infant cohort establishment and immunological research studies to address critical knowledge gaps.

    Research Objectives and Scope

    Despite early exposure to natural influenza infection or repeat vaccinations, influenza infections continue to occur throughout life.  Numerous studies have shown that one's initial influenza infection impacts immunity to subsequent infections with different influenza strains.  However, the impact of initial influenza infections and/or vaccinations on immunity to subsequent influenza exposures is not well understood.  This initiative responds to the need for increased investments in clinical and basic research in well-characterized infant cohorts by exploring the impact of birth year, vaccination, and natural infections on influenza immunity.  Recent innovations in the study of human immunology coupled with other advanced technologies can be leveraged to determine the critical immune components required for generation, maintenance, and evolution of broadly-protective immunity against influenza in humans.  Specifically, the research initiative will support cohort establishment and analyses of infant cohorts to determine how initial natural influenza exposure and/or primary influenza vaccination shape infant and childhood immune responses to subsequent influenza infections and/or vaccines.  The findings from this research will help to advance the design of a universal influenza vaccine. 

    This initiative will support an integrated, synergistic, cross-disciplinary effort to generate, coordinate, and integrate data from clinical research to address critical questions in influenza immune "imprinting" research.  The study findings will be made available to the public as rapidly as possible.  The clinical data and biological samples collected from the cohort(s) are expected to be available for sharing and use by the scientific community to continue research in this important field, as appropriate and consistent with achieving the goals of the program. 

    This FOA requires applicants to establish prospective cohort(s) of infants that will be followed prior to and after:

    • receiving their initial influenza vaccination (i.e. clinician routinely recommended vaccine); and/or
    • having an initial documented clinical diagnosis of influenza infection (i.e. clinician confirmed, molecularly diagnosed, and subtyped confirmed) prior to receiving their initial influenza vaccination. 

    Infant enrollment should occur minimally between birth and prior to initial influenza exposure.  These cohorts are expected to be enrolled over multiple influenza seasons and will be followed for at least three influenza seasons, with desired capabilities to follow for longer periods, to understand the impact of initial and subsequent influenza infections and/or vaccinations on the breadth and quality of influenza-specific humoral and T cell-mediated immune responses.

    Inclusion of domestic and international prospective cohorts is encouraged.

    Inclusion of pregnant women and post-partum mothers in the prospective cohorts is encouraged.  The pregnant women should be followed at least through the last trimester of pregnancy and post-partum mothers following through infant weaning.  Each mother's influenza exposure history (i.e. vaccine and natural infection) and circulating influenza-specific antibody responses should be captured during pregnancy, immediately post-partum, and through weaning in order to examine the effects of maternal influenza exposure and circulating maternal anti-influenza antibodies on infant immune responses to influenza vaccines or natural infection. 

    Areas of research should address the following topics:

    • Determination of the effect of repeated exposures to infections and/or vaccinations on the maintenance and evolution of influenza-specific humoral and T cell-mediated immunity in infants/young children, including;
    • Changes in antibody titer, specificity and function, including changes in post-translational modifications
    • Impact on B cell subset generation and maintenance, including plasmablasts, long-lived plasma cells and memory B cells; and
    • Impact on the differentiation, specificity, function and maintenance of effector and memory T cell populations
    • Comparison of immune mechanisms/components elicited by influenza vaccination versus natural infection, including:
    • Understanding the cross-talk between components of innate and adaptive immunity elicited by influenza vaccination versus natural infection that impacts acquired influenza immunity;
    • Comparison of B cell and T cell responses elicited by influenza vaccination versus natural infection; and
    • Comparison of the quality and functionality of antibodies induced by natural infections or vaccination, including hemagglutination inhibition assay (HAI), neutralizing antibody responses, neuraminidase antibody responses, as well as antibody-dependent cell-mediated cytotoxicity (ADCC) and stalk-binding assays.

    The approach taken to establish and characterize the cohort, including determination of the type of data and biological samples to collect, should provide the greatest degree of innovation possible to advance our understanding of rational universal influenza vaccine design.

    Given the importance of this prospective cohort generation, all data generated by the funded program is expected to be deposited in the ImmPort database or other portal(s) approved by NIAID and biological samples should be made available to the scientific community.  Influenza sequence and related data are expected to be deposited in the NIAID-supported Influenza Research Database.

    Program Infrastructure and Support

    Administration and Leadership Team

    The members of the Administration and Leadership Team, led by the Program Director(s)/Principal Investigator(s) [PD(s)/PI(s)], will be responsible for organizing, coordinating, and providing oversight for the implementation of activities that facilitate progress and completion of the research project.  This team will serve as the administrative oversight, coordination and communications hub for the entire study.  

    Data Management and Analysis Team

    The members of the Data Management and Analysis Team will be responsible for implementing procedures for the collection, oversight and inventory of data and biological samples, including, for example, harmonization, quality control, and uniformity of data collection processes, troubleshooting data system problems and developing solutions. Team members will also work with key personnel to develop efficient study designs and statistical calculations and provide support for the preliminary and final data analyses for the study.  This team will serve as the hub for expertise with sharing data with ImmPort or other portal(s), approved by NIAID, and for study design planning and data analyses. 

    Clinical Support Team

    The members of the Clinical Support Team will be responsible for coordinating the functions at individual enrollment sites to facilitate multiple study procedures related to recruitment, enrollment, data and biological sample collection. This team will serve as the process and procedure hub for the interaction among the clinical sites and other functional work areas.

    External Advisory Committee (EAC)

    An External Advisory Committee will be established to review progress and to provide recommendations to investigators as part of the annual programmatic meeting. The EAC will also make recommendations regarding the continuation or re-direction of the research program on an ongoing basis and in consultation with NIAID staff.  Note that applicants should not name or contact potential EAC members in their application. The EAC will be established after award.

    Annual Programmatic Meetings

    A kick-off meeting and annual program meetings will be held to articulate and establish the major roles and functions of the program and to facilitate collaborations, provide progress reporting, seek new research directions and ideas, and update NIAID on issues of need.  These meetings will be attended by the PD(s)/PI(s), Key personnel, NIAID staff, and the EAC membership.  

    Note that applications proposing any of the following topic areas will be considered nonresponsive and will not be reviewed:

    • Applications that are not focused on understanding how initial and repeated natural influenza infections and/or influenza vaccinations shape infant and childhood immunity to future influenza exposures.
    • Any Phase clinical trials.
    • HIV, SIV or AIDS studies.
    • Any animal studies.
    • Genome-wide association studies (GWAS).
    • Behavioral research.

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

    Section II. Award Information
    Funding Instrument

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

    Application Types Allowed

    New   

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

    Clinical Trial?

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

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    NIAID intends to commit $5.0 million in FY 2019 to fund one (1) award.

    Award Budget

     Recommended budgets for direct costs of up to $3.1 million per year may be requested.     

    Award Project Period

     The scope of the proposed project should determine the project period. The maximum period is 7 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
    • Non-domestic (non-U.S.) Entities (Foreign Institutions)
    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are   eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are   eligible to apply.
    Foreign components, as defined in the NIH Grants Policy Statement, are   allowed.

    Required Registrations

    Applicant Organizations

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

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

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

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

    Eligible Individuals (Program Director/Principal Investigator)

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

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

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

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

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

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

    Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

    It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

    Letter of Intent

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

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

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

    The letter of intent should be sent to:

    Maryam Feili-Hariri, PhD
    Telephone: 240-669-5026
    Email:  haririmf@niaid.nih.gov         

    Page Limitations

    All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exception:

    For this specific FOA, the Research Strategy is limited to 30 pages.  

    Instructions for Application Submission

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

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

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

    Facilities and Other Resources: In separate section titled "Information Technology Access," include a brief description of the features of the institutional environment that are relevant to the effective implementation of the proposed unified collaborations across Teams and functions. Describe available IT resources associated with the enrollment and field sites with respect to access to computers, source and status of reliable, secure internet connections, and other communications.

    In a separate section titled "Biological Sample Storage and Access," describe the facilities available to store, manage and retrieve biological specimens for use by the PD(s)/PI(s) and key personnel. 

    SF424(R&R) Senior/Key Person Profile

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

    • Within the Biosketch under Personal Statement, describe the leadership approach and experience of the PD(s)/PI(s) with respect to developing and executing multi-disciplinary research program(s) of a similar size and nature.
    • Within the Biosketch under Personal Statement, all Key Personnel should demonstrate strong administrative, technical, and management expertise in areas critical to the success of the application, including experience working productively in Team collaborative environments. Demonstrate how specific expertise supports the multi-disciplinary approach to guarantee a successful, integrated effort towards the goals of the research project.
    R&R or Modular Budget

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

    In Year 01, include funds in the budget for the PD(s)/PI(s), collaborators, site-specific personnel, and other key personnel and up to five members of the EAC to travel and attend a kickoff meeting to be held shortly after the award over 1 full day in the Bethesda, MD area.  Beginning in Year 02, include funds in the budget for an annual program meeting to be held over two full days in the Bethesda, MD area.  Do not include costs associated with organizing and holding the kickoff or annual program meetings.

    Include costs associated with submission of data into the ImmPort database or other publicly accessible portal(s) approved by NIAID.  Also include costs associated with biological sample collection, processing, shipping, and storage.

    If applicable, include costs associated with clinical protocol development, informed consent form development, development of a manual of procedures for the clinical protocol, development of case report forms, training of clinical personnel prior to protocol initiation (e.g., cGCP and protocol-specific training), clinical study monitoring, and capturing and reporting adverse events related to any procedure, and handling protocol deviations.

    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

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

    Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed research, and indicate how these goals will be accomplished based on the longitudinal cohorts and immunological studies.  Concisely describe the hypothesis or hypotheses to be tested. Indicate how the work proposed dovetails to address the overall goals and objectives of the research. 

    Research Strategy:

    • Describe how establishment and immunologic analyses of prospective cohorts will determine how initial and repeated natural influenza infections and/or influenza vaccinations impact infant and childhood immunity to future influenza exposures.
    • Describe the methods that will be used to detect subclinical influenza infections in all cohorts and if applicable, differentiate circulating maternal influenza-specific antibodies from infant-generated antibodies.
    • Describe the immunologic analyses that will be conducted to quantitate and characterize humoral and cell-mediated immune responses generated by initial and subsequent influenza vaccinations or natural influenza infections.
    • Describe strategies for oversight and implementation of standardized approaches in the identification and clinical characterization of human subjects, including the clinical meta-data that will be captured, and describe how the staff at each enrollment/collection site will be trained and comply with the quality standards for data and sample collection and compliance with the standardized procedures.
    • In a separate section labeled, "Administrative Management Plan," describe the administrative and organizational structure of the research study and the unique features of the organizational structure that serve to facilitate accomplishment of the long-range goals and objectives.  Describe how functional work Teams will provide relevant input and support for the Cohort establishment for addressing the research hypotheses.  Describe the overall management plan, including how resources will be managed, organized and prioritized, and how subcontracts and consultants, if applicable, will be selected/funded and monitored. Describe how communications will be planned, implemented and provided to collaborators, teams or sites. Describe an overall plan for nominating, vetting, and inviting membership on the EAC and for including the EAC recommendations in the overall research direction and progress towards milestones of the award. The EAC will be developed in collaboration with NIAID.  Note that applicants should not name or contact potential EAC members in their application. Without repeating information from individual biosketches, describe the team's experience with designing and implementing infant cohorts, and past accomplishments, specifically related to cohorts.  In addition, describe plans to achieve synergy and interaction among key investigators to ensure efficient cooperation, communication and coordination across the multiple sites and Team structure. 
    • In a separate section labeled, "Data Management Plan," describe internal and external data acquisition strategies to achieve harmonization of systems and procedures for data management, data quality, data analyses, and dissemination for all of the data and data-related materials generated by the research study.  Describe how uniformity of procedures and high-quality content from all study sites and the research study, in terms of the data collection, management and storage functions.  Within the plan, indicate the extent to which dedicated systems or procedures will be utilized to harmonize the acquisition, curation, management, inventory and storage of data and samples.  Describe how training for the data and sample collection, in terms of the use of electronic data capture systems, will be provided to all staff including those at enrollment sites. Describe how these data taken together will address the overall goals and objectives of the research study. 
    • In a separate section labeled, "Statistical Analysis Plan," describe the overall plan for biostatistical support systems and personnel to perform the following functions in support of the research project, for example: 1) preliminary data analyses, 2) estimates of power and sample size, 3) research study design and protocol development.  Describe plans to estimate and achieve adequate sample size to achieve the needs of the research program. Describe how unique and innovative approaches to statistical analysis of prospective observational cohort data will achieve the aims of the research study.   Describe the plan to support the data analytics and design features unique to the research study.
    • In a labeled section called, Project Milestones, describe specific quantifiable milestones by annum, and include annual projections for the overall research study and for tracking progress from individual sites, collaborators, and Teams.  Milestones must specify the outcome(s) for each activity. Milestones should be quantifiable and scientifically justified, and include the completion of major research study activities, including, for example, protocol development, case report forms, scheduled clinical visits, obtaining clearances study completion, and analysis of final data. Milestone criteria should not simply be a restatement of the specific aims.  Using a Gantt chart or equivalent tool, describe the associated timelines and identified outcomes for the research study.  Within this section, consider the use of existing resources that would facilitate the progress of the project in terms of enrollment or data collection, for example, practice-based research networks, electronic medical records, administrative database, or patient registries. 

    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 modifications:

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.  Within that plan, applicants should describe plans for transfer and uploading of all types of data from the program into the ImmPort database or other publicly accessible portal(s) approved by NIAID.  Applicants are also expected to provide a timeline for the planned acceptance, quality check, transfer and upload of data of all types.
    • All investigators funded under this FOA will be expected to share their data through ImmPort or other portal(s) approved by NIAID, as well as any collected biological samples. Therefore, the Resource Sharing plan should include a summary of how the applicant will manage data submission and interactions with the chosen portal(s), as well as sharing of biological samples with the scientific community.

    Letters of Support: Provide all appropriate letters of support, including any letters necessary to demonstrate the support of consortium/site participants.

    Appendix:

    Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide, with the following modifications:

    • As the first attachment, for clinical research protocol(s), attach "Clinical Research Protocol."  This attachment should contain the complete clinical research protocol.
    • As the second attachment, attach the informed consent forms for the proposed research project, "Informed Consent Forms."  Include the following items in the consent form or draft informed consent form(s): (1) all data and biological sample types that will be collected as part of the proposed study; (2) that no charges to the subject for participation in the proposed study are incurred; and (3) agreement to share the subject's de-identified data obtained from the proposed study. Any incentives provided to subjects to participate in the proposed study should be clearly described and justified.
    • As the third attachment, attach the informed assent forms for the proposed study, "Assent Forms."
    PHS Human Subjects and Clinical Trials Information

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Section 2 - Study Population Characteristics

    2.2 Eligibility Criteria

    Additional Instructions

    Describe in detail the inclusion and exclusion criteria for subject selection with respect to the required conditions: infants before initial influenza vaccination, infants after initial influenza vaccination, infants before initial documented clinical diagnosis of influenza (i.e. clinician confirmed, molecularly diagnosed, and subtyped confirmed influenza infection), infants after initial documented clinical diagnosis of influenza, or infants in cross category areas (e.g., infant after clinical diagnosis of influenza and after influenza vaccination). If applicable, include the inclusion and exclusion criteria for pregnant women, post-partum and nursing mothers.

    2.4 Inclusion of Women, Minorities and Children

    Additional Instructions

    Justify how the distribution of infants/pregnant women with respect to sex/gender and ethnicity will be achieved, maintained or altered in unknown situations (e.g., sex of fetus unknown at enrollment of pregnant women).  Outline how an understanding of these factors will impact the research hypotheses.

    Outline the minimum and maximum ages for eligibility of infants to meet the requirements of the research objectives, and to meet the requirement for following an enrolled infant for at least three influenza season cycles.

    2.5 Recruitment and Retention Plan

    Additional Instructions

    Describe how subjects for enrollment will be identified to enable implementation of the inclusion and exclusion criteria, and detail the verification process (e.g., medical record, clinical diagnostic tests) for conditions requiring verification (i.e., vaccination, influenza assay) through at least three influenza season cycles.

    2.7 Study Timeline

    Additional Instructions

    If applicable, address the timeline for the planned enrollment process with respect to the required conditions of the subject pool.

    Section 3 - Protection and Monitoring Plans

    3.1 Protection of Human Subjects

    3.1.1 Risks to Human Subjects

    3.1.1.a Human Subjects Involvement, Characteristics, and Design

    Additional Instructions

    Describe the study design, expected samples sizes per condition, and power analyses with respect to exposure, vaccination, and age-matched control subjects; and describe how the cohort will achieve adequate sample/subject size to support the successful completion of the goals and objectives of the proposed research project.

    3.1.1.b Study Procedures, Materials and Potential Risks

    Additional Instructions

    Describe how the samples will be processed according to standardized procedures appropriate to sample type and stored at the sites until needed.  Describe the quality control procedures for the data and biological specimens, and how to identify and resolve issues with quality control that maintains integrity of data and specimens.

    3.1.2 Adequacy of Protection Against Risks

    3.1.2.a. Informed Consent and Assent

    Additional Instructions

    Describe the unique consent and assent procedures to ensure protections for the diverse sample of human subjects (e.g., pregnant women/fetus, neonates, young infants, children) necessary to achieve success of the overall program.

    3.3 Data and Safety Monitoring Plan

    Additional Instructions

    Describe the appropriate oversight over the conduct of the clinical research, including at a minimum the clinical monitoring, safety monitoring, regulatory submissions and quality management.

    3.5 Overall Structure of the Study Team

    Additional Instructions

    Describe the plan to include functional working Teams with expertise in areas specific to meet the goals and objectives of the study.

    Delayed Onset Study

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

    PHS Assignment Request Form

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

    Foreign Institutions

    Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions.

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

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

    4. Submission Dates and Times

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

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

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

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

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

    Specific to this FOA:

    • Awards issued under this FOA will be incrementally funded awards for project periods of up to seven years.  Multi-year funded grants will not be awarded. 
    • Grants awarded under this FOA will be excluded from automatic carryover – all carryover requests must be approved. 
    • Grants awarded under this FOA will not be provided the authority to automatically extend the final budget period one time for up to 12 months beyond the original expiration date shown in the Notice of Award – all extensions, including the first extension, will require approval. 
    • Progress and financial reporting will be required and reviewed annually.
    • All funds must be expended within the approved project period. 
    7. Other Submission Requirements and Information

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

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

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

    Important reminders:

    All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review 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

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

    Scored Review Criteria

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

    Significance

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

    Specific to this FOA:  Does the proposed research determine the mechanism(s) to understand how initial and repeated natural influenza infections and/or influenza vaccinations shape infant and childhood immunity to future influenza exposures to help facilitate design of durable, broadly protective influenza vaccines?  How well will the proposed research improve understanding the mechanisms of infant immunity with respect to vaccination and/or natural influenza exposure, and how this information assists with the future design of durable, broadly protective influenza vaccines? 

    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:  Will the Team(s) expertise lead to the success of the assigned team function(s), and how well will the Team(s) contribute to the success of the overall cohort establishment and research study outcome? Is there a coordination and unifying infrastructure in place to support all phases of the prospective cohort establishment and analyses?

    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 for this FOA: Is the approach for the study well-conceived and appropriate to address the central theme of the program?  Is the administrative and organizational structure appropriate and sound to facilitate attainment of the objective(s) of the proposed study? Are plans for detecting subclinical influenza infections and influenza-specific antibodies appropriate and sound to facilitate attainment of the objective(s) of the proposed study?  Are plans for the immunologic analyses to quantitate and characterize humoral and cell-mediated immune responses appropriate and sound to facilitate attainment of the objective(s) of the proposed study?  Does the applicant provide an adequate plan for biological specimen and associated data collection procedures from the cohort, including specimen labeling, coding, tracking, storing, and inventory? Are plans for acquisition, curation, management, inventory and dissemination of data and samples to NIAID-approved repositories adequately described and reasonable? Is the training plan for site staff to capture all data types (e.g., clinical visit data, biological specimen collection, etc.) adequate to ensure high quality, uniform data collection?    If applicable, does the research project incorporate efficiencies and utilize existing resources (e.g., practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?  Are the milestones for the research study feasible based on the proposed time frames? Do they provide quantifiable measures for the achievement of intended outcomes for the program as a whole in a timely manner?  Does the study timeline account for start-up activities, engagement of multiple enrollment sites, the accurate identification and subsequent enrollment of participants, and all planned assessments and measurements on subjects (including collection of biological samples)?  Is the clinical research protocol adequately described, and do the consent forms and assent forms provide sufficient detail to clarify the process of subject participation?  Are the strategies for oversight and implementation of standardized approaches in the recruitment and clinical characterization of human subjects adequate to ensure a robust clinical sample?  Do the data analyses plans adequately describe the study design features, and estimates power and sample size to achieve the goals of the program?

    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? 

    Specific for this FOA:  Will the IT resources and environment as described support the activities of the research study?  Are the site-specific facilities purposed for biological sample storage adequate to meet the needs of the research study? 

    Additional Review Criteria

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

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

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

    Inclusion of Women, Minorities, and Children 

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

    Vertebrate Animals

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

    Biohazards

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

    Resubmissions

    Not Applicable  

    Renewals

    Not Applicable     

    Revisions

    Not Applicable    

    Additional Review Considerations

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

    Applications from Foreign Organizations

    Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

    Select Agent Research

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

    Resource Sharing Plans

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

    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 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:

    • Retaining primary responsibility for the planning, directing, and executing the proposed research study through oversight, management, and coordination of the participating sites, personnel and outcomes.
    • Serving as the administration oversight for the proposed research.
    • Awardees are expected to share data collected under this award through ImmPort (data/electronic) or other portal(s) approved by NIAID, as well as share any collected biological samples with the scientific community, consistent with achieving the goals of the program.
    • Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

    • The role of the NIH Project Scientist in the cooperative agreement is to support and encourage the recipient's activities by substantial involvement as partners and facilitators in the process without assuming responsibilities that remain with the PD(s)/PI(s).
    • Coordinate NIAID staff assistance, including participation in periodic on-site monitoring with respect to compliance with Federal regulations, quality control, accuracy of data recording, sample accrual, enrollment, etc.
    • Facilitate collaborations with and access to other NIAID-supported research resources and services.
    • Serve as liaison/facilitator between the awardee and with the ImmPort database and biological sample storage (approved by NIAID).
    • Establish an External Advisory Committee (EAC).
    • The NIH Project Scientist will review and assist in developing the operating guidelines and consistent policies for dealing with situations that require coordinated action.
    • The NIH Project Scientist will periodically review the data generated under this award.
    • The NIH Project Scientist will review progress towards achieving the final set of agreed upon milestones annually.  If justified, future year milestones may be revised based on data and information obtained during the previous year, and recommendations from the EAC. If, based on the progress report, the project does not meet the milestones, funding for the project may be either restricted or discontinued.
    • 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:

    • The PD(s)/PI(s) and NIH Project Scientist will review the entirety of program milestones annually and update them based on recommendations from the EAC.
    • The NIH Project Scientist and the PD(s)/PI(s) will coordinate the scientific objectives and progress at the annual workshop to facilitate the achievement of program goals.
    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)

    Kristina T. Lu, Ph.D.
    Division of Microbiology and Infectious Diseases (DMID)
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-627-3307
    Email: lukr@mail.nih.gov

    Mercy PrabhuDas, PhD, MBA
    Division of Allergy, Immunology and Transplantation (DAIT)
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-627-3534
    Email: mprabhudas@niaid.nih.gov

    Peer Review Contact(s)

    Maryam Feili-Hariri, Ph.D.
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-669-5026
    Email: haririmf@niaid.nih.gov 

    Financial/Grants Management Contact(s)

    Lebrit Nickerson
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-292-0157
    Email: lebrit.nickerson@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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