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 Environmental Health Sciences (NIEHS

Funding Opportunity Title

Immune Development in Early Life (IDEaL) (U19 Clinical Trial Not Allowed)

Activity Code

U19 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AI-20-078   

Companion Funding Opportunity

RFA-AI-20-077 - U01 Research Project – Cooperative Agreements 

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

93.855; 93.113

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement is to support research to define the mechanisms regulating the establishment, development, and maintenance of immunity throughout childhood (from birth to less than 18 years of age), including the impact of pathogenic or commensal microbes or vaccination against infectious diseases, allergens, and environmental pollutants on immune ontogeny and function. This program will establish collaborations among immunologists, neonatologists, pediatricians, systems biologists, and microbiologists to expand our knowledge of the developing immune system. Knowledge obtained through this program may be applied to the design of improved vaccines and immunotherapies to combat infections or treat/prevent immune-mediated diseases in this vulnerable population.

Key Dates
Posted Date

January 12, 2021

Open Date (Earliest Submission Date)

May 4, 2021

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

June 4, 2021

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed 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)

June 4, 2021

All applications are due by 5:00 PM local time of applicant organization.

All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on the listed 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.

Scientific Merit Review

October 2021

Advisory Council Review

January 2022

Earliest Start Date

March 2022

Expiration Date

June 5, 2021

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 support research to define the mechanisms regulating the establishment, development, and maintenance of immunity throughout childhood (from birth to less than 18 years of age), including the impact of pathogenic or commensal microbes or vaccination against infectious diseases, allergens, and environmental pollutants on immune ontogeny and function.  This program will establish collaborations among a diverse set of experts (e.g., immunologists, neonatologists, pediatricians, systems biologists, and microbiologists) to investigate the dynamics and drivers of immune development, regulation, and function throughout childhood (birth to less than 18 years old). Studies may include SARS-CoV-2, cytomegalovirus (CMV), herpes simplex virus (HSV), congenital syphilis, human immunodeficiency virus or acquired immunodeficiency syndrome (HIV/AIDS), tuberculosis (Mycobacterium tuberculosis), and other infections that affect children within this age range. Awardees will partner with other researchers to conduct longitudinal studies of existing cohorts of mother-infant dyads and/or children and adolescents from birth to less than 18 years of age.  The ultimate goal of this program is to expand knowledge of immune development and functionality in children that will provide foundational information to improve immune health and vaccine efficacy in this vulnerable population.

    Background

    Rapid changes occur during the development of the human immune system in early life when there is an increased risk of infection and associated morbidity and mortality. Globally, 85% of deaths among children and young adolescents in 2018 occurred in the first five years of life, accounting for 5.3 million deaths (WHO). Of these, 23% of neonatal deaths were due to infections such as sepsis, meningitis, pneumonia, tetanus, and diarrheal diseases.  In contrast, in approximately 1 million children aged 5-14 years (WHO 2018 estimate), the leading causes of death included injuries and lower respiratory tract infections; by comparison, in the United States, adolescents and youth comprised approximately 21% of new HIV diagnoses.

    The immune system in children is distinct from that of adults and is characterized by a suboptimal response to infections and vaccines predominantly in the first two to three years of life. The current severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic, for example, has brought to light some differences in disease susceptibility, severity, and manifestation in children. While children of all ages may become ill with SARS-CoV-2, most do not develop severe disease. However, several infected children develop a condition known as multisystem inflammatory syndrome in children (MIS-C), a clinical presentation that is observed in children with a median age of 8 years, and infrequently reported in adolescents and adults. The ability of an infectious agent, like SARS-CoV-2, to induce distinct disease manifestations stratified by age highlights the importance of characterizing immune developmental and functional stages throughout childhood. In addition, while immune function in children appears to be sufficient to allow survival to adulthood, impaired responses to a range of pathogens and vaccines do result in susceptibility to severe disease in a significant proportion of this population. For example, young children are at increased risk of severe disease from influenza viruses, HIV, and other infections. Worldwide, polysaccharide-encapsulated bacteria (Streptococcus pneumoniae, Hemophilus influenza type b and Neisseria meningitidis) are the leading causes of serious bacterial infection in young children. Although vaccines are available to protect against these organisms, a huge burden of disease and death is still present. Furthermore, there are currently no vaccines for certain childhood pathogens, such as respiratory syncytial virus, that commonly cause very serious infections in infants and young children.

    The immune differences that render young children susceptible to infections also reduce their immune responses to most vaccines. A mechanistic understanding of how immune ontogeny and functionality in early life transitions from neonatal to adult functional capacity in the context of vaccines or other preventive interventions remain to be clearly elucidated. There is scant characterization of immune development in healthy young children beyond the first few years of life. Much remains to be learned about age-dependent maturation of immune components in different populations. Whereas longitudinal age-related changes in the numbers and function of immune cells in tissues that include the skin, gut, and respiratory mucosae are beginning to be investigated, functional maturation of different cell types (e.g., eosinophils, basophils), postnatal ontogeny of pattern recognition receptors and their responses to cognate ligands, and environmental influences upon immune developmental processes require further investigation.

    A safe and effective HIV vaccine remains a critical need in the fight against the HIV pandemic, especially to prevent emerging infections in infants, adolescents, and young adults. Recent studies highlighting the differences in immune responses between adults and children have suggested that implementation of an HIV vaccine or non-vaccine biomedical HIV prevention interventions during early life may afford an opportunity to protect prior to the vulnerable period of adolescence and sexual debut. Studies evaluating viral and bacterial vaccines also have shown that vaccine-induced immunity wanes rapidly after vaccination in infancy and requires multiple booster injections to induce long-term protection. For example, routine diphtheria, tetanus toxoid, acellular pertussis (DTaP) vaccination provides moderate protection during the first year and wanes within the subsequent 2-3 years, reducing protection from pertussis outbreaks in adolescents. Thus, understanding the immunological mechanisms in children will help inform the design and development of improved vaccine strategies that contribute to durable immune responses and maintenance of immunological memory in these populations.

    Different exposures early in life, such as a farm environment, caesarean section, breast-feeding, birth history or environmental pollutants can alter the risk of allergic diseases and asthma. Understanding the impact of such exposures on immune function and potential immunological mechanisms that either protect from or predispose to immune-mediated disease would provide strategies for the development of preventive approaches. The immune system can be a target for toxic effects caused by a wide variety of environmental agents. Heavy metals, polychlorinated biphenyls (PCBs), polybrominated biphenyls (PBBs), and certain air pollutants may cause immune dysregulation and contribute to increased rates of immune-mediated or infectious diseases. Children are susceptible to such perturbations that may not necessarily lead to immediately detectable clinical manifestations. Environmental factors may act on the host for many years before clinical disease becomes apparent. Additionally, clinical disease may only become evident after the immune system is challenged by other factors such as viral infection. Although immune development has not been completely characterized, there is increasing evidence that immune-associated diseases are dependent upon specific windows of early life exposure, sex of the offspring, and epigenetic influences among others. Children's susceptibility to environmental toxicants such as per- and polyfluoroalkyl substances (PFAS) not only increases their propensity for asthma in their youth, but may also affect vaccine responses as adults, lowering their resistance to disease.

    The Immunity in Neonates and Infants program began in 2012 and was renewed in 2017 to support U01 cooperative agreement awards. While the program has supported several advances that contribute to our understanding of the immune landscape in the first year of life, knowledge gaps remain. This initiative, Immune Development in Early Life (IDEaL) (U19) and the companion initiative,  Immune Development in Early Life (IDEaL) (U01), collectively referred to as the IDEaL research program, will facilitate a collaborative effort with shared resources to address known gaps in knowledge and expand the understanding of the fundamental mechanisms of immune maturation, function, and regulation beyond the first year of life through adolescence. For example, research might focus on studies that investigate how metabolic changes support or influence immune cell function; explore mechanisms of immunological memory in innate cells; address the role of epigenetic changes in regulating immune development and function; and the application of new assays and technologies to enable the assessment of immune cell populations and interactions in systems that closely reflect their physiological environments.

    Research Objectives and Scope

    The ultimate goal of the IDEaL research program is to expand knowledge of immune development and functionality in children that will provide foundational information to improve immune health and vaccine efficacy in children from birth through adolescence (defined as birth to less than 18 years of age).  The program will support mechanistic, hypothesis-driven studies that focus on defining fundamental aspects of immune development and function in response to vaccines and other prevention strategies, pathogenic infections, commensal microorganisms, allergens, and/or environmental pollutants. Interdisciplinary research teams with expertise in immunology, pediatrics, infectious diseases, vaccinology, and immune-mediated diseases may be established to address areas of interest. It is important to understand the development and function of the immune system using longitudinal assessments, either through establishment and follow-up of a new cohort or by following an established cohort over the course of several years to understand how intrinsic and extrinsic exposures affect immune maturation and functional capabilities. The population of interest for this FOA are infants, children, and adolescents ages birth to less than 18 years, though subsets within this age range can be the focus of a particular application.  Applications are expected to be integrated and synergistic, containing Research Projects and Cores connected by a common theme that produce scientific gains beyond those achievable if each project were performed independently. An application may include different pathogens or commensal microbes, vaccines, allergens, or environmental pollutants to investigate common immune pathways or mechanisms; or may analyze different aspects of the immune response to the same vaccine, infection, allergen, or environmental pollutant. Animal studies (small and/or large animal models) may be included to extend or guide mechanistic analyses of human samples; note that HIV research studies that include animal models may only use non-human primates.

    Examples of research areas of interest include, but are not limited to:

    • Mechanisms regulating the generation and maintenance of T and B cell memory;
    • Molecular mechanisms of innate immunity, including trained immunity;
    • Effect of the microbiota on host immune development and response;
    • Mechanisms of tissue-specific and mucosal immunity;
    • Role and mechanisms of action of adjuvants/immune-potentiating molecules or compounds for improving protective immune responses in children;
    • Impact of sex differences on innate and adaptive immune development and function;
    • Impact of maternal factors on immune system development in early life that include examination of longer-term effects in the child;
    • Mechanism by which environmental exposures affect the functionality of the pediatric immune system;
    • Mechanisms regulating exhaustion of the immune response to chronic infection or exposure, and impact on vaccine responses;
    • Metabolic and/or epigenetic regulation of the pediatric immune response;
    • HIV:
    • Key factors impacting the pediatric immune response and efficacy of HIV vaccine candidates and other HIV-prevention strategies;
    • Broadly neutralizing antibody development during pediatric immune maturation;
    • Longitudinal imaging of immune cell dynamics and immune responses to vaccines or other prevention strategies in the pediatric population;
    • Development of mucosal immunity in the context of vaccine/prevention strategies;
    • Studies testing or proposing development of drugs/vaccines to prevent infection that is specific to the pediatric population.

    Applications proposing the following studies or topic areas will be considered non-responsive and will not be reviewed:

    • Studies in children with known genetic abnormalities, including primary immunodeficiencies; children undergoing cancer chemotherapy; children who are undergoing transplantation procedures; children with autoimmune diseases, or receiving immunosuppressive therapy;
    • Studies that focus on non-immune mechanisms of infectious diseases (e.g., transmission, carriage, pathogenesis, or vaccine development/testing) instead of immunological response mechanisms;
    • Studies on exposures to alcohol, chemotherapeutic agents, radiation (which is not a result of an ambient environmental exposure), drugs of abuse, and pharmaceuticals;
    • Clinical trials. However, analysis of samples from completed clinical trials,  samples obtained from clinical trials supported by other mechanisms (e.g., SARS-CoV-2 or HIV vaccine studies supported by separate grants or contracts) , or samples obtained from human subjects immunized with licensed vaccines, where the vaccine is administered according to the product label instructions, are permitted. A definition of clinical trials is available at https://grants.nih.gov/grants/glossary.htm#ClinicalTrial;
    • Genome-wide association studies (GWAS);
    • Behavioral research;
    • Studies that solely focus on characterization of microbiome;
    • HIV studies focused on animal model development and animal models other than non-human primates;
    • Studies, other than HIV research, testing or proposing development of drugs and/or vaccines to treat or prevent an infection;
    • Studies that focus on individuals 18 years of age or older. However, individuals 18 years of age or older may be included as a comparator for younger age groups.
    IDEaL Research Program Components

    Administrative Core (required): The Administrative Core will be responsible for the overall management, communication, coordination and supervision of the program, including monitoring progress, developing and implementing a project management plan, defining timelines, and overseeing adherence to compliance with data sharing. The PDs/PIs of each U19 award will be responsible for the development and implementation of a U19-wide Project Management Plan (PMP) to assist with monitoring progress towards defined milestones based on the research conducted within each U19. Additional professional staff may be involved with development, implementation, monitoring and updating the PMP.  

    Data Management and Analysis Core (required): This core will be responsible for providing central data storage, data management with safeguards to protect the integrity of the data to all projects and cores within an IDEaL U19 application, and will be responsible for ensuring the submission of data, meta-data and related data analyses to the ImmPort database, or other appropriate public databases recommended by NIAID. This core will provide bioinformatics expertise and data integration and analysis support, including computational modeling if necessary, as well as study design and statistical support/services, as needed.

    Service/Resource Core(s) (optional): If proposed, Service Cores will support the research projects with technologies or services that have already been validated and refined for use (e.g. existing assays, reagents, technologies, clinical, informatics or other services). A Service Core must be used by at least two of the Research Projects. If proposed, Service Cores are limited to no more than three per U19.

    Research Projects (required): Each application must contain at least two, but no more than three, research projects that should show synergy and be organized around a common central theme and/or overall hypothesis.

    Awardees under this FOA will participate in the IDEaL Research Program including participation in the Annual Program Progress Meetings, service on the IDEaL Steering Committee (and subcommittees), and review by the External Scientific Group.  These activities are described below.

    IDEaL Annual Program Progress Meeting:  All awardees will participate in an annual one and a half to two-day programmatic meeting arranged by NIH and held after award in the Rockville, MD area. The purpose of these annual meetings is to discuss individual project progress and foster collaborations among the PDs/PIs, scientific staff and other program personnel funded by the IDEaL research program of U01 and U19 awardees.  The annual meetings are open to investigators supported under this FOA and to NIH extramural staff.

    IDEaL Steering Committee: A Steering Committee (SC) will be established by NIH to serve as the governing body of the IDEaL research program.  The purpose of the SC is to coordinate and facilitate the research and activities of the IDEaL research program; review the progress of awardees; identify scientific opportunities, emerging needs and challenges; ensure the timely release of data through publications; facilitate access and use of ImmPort; develop guidelines for the publication of collaborative research program results; facilitate resource sharing; prepare cumulative research program progress reports; promote scientific collaboration and exchange of scientific findings among the awardees; develop and implement sub-committees to facilitate and promote common IDEaL-wide collaborations and procedural harmonizations such as data sharing, data harmonization, integration and analyses; and to develop/follow policies and procedures enacted by the SC with concurrence of the NIH Project Scientist(s). 

    Membership of the SC will consist of individuals from the U01 and U19 awards, NIH extramural staff, and other subject matter experts, as determined by NIH.  Awardees of the U01 will provide one PD/PI (only one individual if multi-PDs/PIs leadership) and awardees of the U19 will provide one PD/PI (only one individual if multi-PDs/PIs leadership) to serve as voting members of the IDEaL Steering Committee. NIH extramural staff from the NIH ICs funding the IDEaL research program will be non-voting members of the Steering Committee and will participate in all Steering Committee activities. Members of the SC will participate in all SC activities, and attend the Annual Program Progress meeting, and other SC meetings or teleconferences, as determined by NIH.  

    IDEaL External Scientific Group:  An External Scientific Group (ESG) will be established by NIH in consultation with the IDEaL awardees to provide external perspective and informed guidance for accomplishing the goals of the program. The purpose of the ESG is to review progress and provide recommendations to the awardees regarding the current status of the research, the progress related to stated goals or outcomes, and address concerns about the focus or direction of the research. The ESG members will attend the Annual Program Progress meeting with awardees and NIH staff.  DO NOT NAME OR CONTACT potential members of the ESG either within the application (name) or before, during or after application submission (contact), respectively.  

    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 project 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. Only those application types listed here are allowed for this FOA.

    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

    Issuing IC and partner component intend to commit an estimated total of $7.6M in FY 2022 to fund 2-3 awards.

    Award Budget

    Application budgets are limited to $1.0 M in direct costs per year and must reflect the actual needs of the proposed project.

    Award Project Period

    The scope of the 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  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.
    • o   NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

    Eligible Individuals (Program Director/Principal Investigator)

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

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

    An individual may serve as PD/PI on a single PD/PI application or a PD/PI on a multi-PDs/PIs application on either an IDEaL U19 or U01 application, but not both. PD/PIs may serve as Project leaders, Core leaders or collaborators on an application where they are not the PD/PI on a single PD/PI application or a PD/PI within a multiple PDs/PIs application.

    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:

    Maggie Morris Fears, Ph.D.
    Telephone: 301-761-5444
    Email: maggie.morrisfears@nih.gov   

    Page Limitations

    Available Component Types

    Research Strategy/Project Plan Page Limits

    Overall

    12

    Administrative Core

    6

    Data Management and Analysis Core

    6

    Service/Resource Core(s) (optional)

    6 (each)

    Research Project(s)

    12 (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: required, maximum 1
    • Data Management and Analysis Core: required, maximum 1
    • Service/Resource Core(s): optional, maximum 3 (each core must support at least two Projects)
    • Research Projects: required, minimum 2, maximum 3
    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.  

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

     

    PHS 398 Research Plan (Overall)

     

    Specific Aims:  Describe the central scientific theme of the proposed research program and list the broad, long-range objectives and goals of the proposed overall program.    

     

    Research Strategy: This narrative section summarizes the overall research plan for the multi-project application and explains how the proposed research supports mechanistic studies on the development, regulation, and function of human immune responses and fulfils the purpose and objectives of this FOA. Describe the central theme of the proposed project and explain how the proposed Research Projects are synergistic and fit under the overarching project theme. The multi-project application should be viewed as a confederation of interrelated projects, each capable of standing on its own scientific merit, but complementary to one another. This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program – by giving a statement of the general problem area and by laying out a broad strategy for addressing the problems. As the strategy develops, each project and core should be cited briefly as to its place in the overall scheme. Briefly summarize the special features in the environment and/or resources that make this application strong or unique. As applicable, describe the synergy and collaborations that are expected to occur. To highlight program synergy, applicants may describe how the individual components (research projects and shared service/resource cores) will be coordinated and work together to address the overall goals and aims of the program, and indicate collaborations, shared expertise, and leveraging of resources, as applicable. In addition, applicants may address optimizing interactions between projects and cores to achieve specific objectives of the research program.

    Include a schematic overview of the interactions and collaborations among the components (projects and cores), indicate collaborations among members and relevant publications co-authored by members of the program. Project synergy may also be addressed in other sections of the application, as appropriate.

    Letters of Support:  Provide any institutional letters of support specific to the Overall Component.

     

    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.

     

    Awardees will be expected to deposit data and data analyses into ImmPort or other public data portal as designated by NIAID.    

     

    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 human subjects research, clinical research, and/or NIH-defined 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.   
    Budget (Administrative Core)

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

    Within the budget, applicants should request funds for the following:

    • Travel of the PDs/PIs, Administrative Core Leader (unless the same as PDs/PIs) and other required personnel to participate in the Annual Program Progress meeting (one 2-day meeting per year to be held in the Rockville, MD area).  Applicants may propose travel funds only for attendance at program meetings related to this FOA.
    • Include funds for the overall administrative effort, including administrative services, such as a Project Manager or Administrative Assistant responsible for day to day administrative management of the award, collaborative activities, communications, and publications.

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

    PHS 398 Research Plan (Administrative Core)

    Specific Aims:  List in priority order the proposed activities and services of the Administrative Core. Concisely describe the work to be completed to address issues of program coordination, communication, and management.

    Research Strategy:  

    • Describe the organizational and administrative structure, and a complete staffing plan for the proposed research program. Include plans on how the scientific and administrative leadership of the U19 will interact with Project and Core Leaders to exchange information about progress, performance issues and other matters related to the functional requirements of the U19.
    • Describe specific opportunities for coordination, administration and collaboration among leaders and staff.
    • Provide an administrative plan that includes a discussion of the structure and roles of administrative staff, including the functions to be performed, how fiscal and other resources will be prioritized, allocated and managed, how  communications will be facilitated; how conflict resolution will be attained; how research related travel and training will be managed. Present a leadership succession plan.
    • Discuss how the staffing plan for the Administrative Core incorporates anticipated needs for professional staff to serve as effective administrators for specific functions. 
    • Describe how the Project Management Plan (PMP) will be developed, implemented, monitored and updated. In addition, describe how the PMP will be used to track and monitor the proposed timelines and milestones, and how this plan will inform the PDs/PIs, Core Leaders and other project staff about progress and timeliness in achieving progress towards individual and collective goals. Describe general plans for PMP staffing to ensure effective project management for the U19.   

    Letters of Support: Provide any institutional letters of support specific to the Administrative Core.

    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.

    Awardees will be expected to deposit data and data analyses into ImmPort or other public data portal as designated by NIAID. 

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

    Data Management and Analysis Core

    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 (Data Management and Analysis 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 (Data Management and Analysis Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Data Management and Analysis 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) (Data Management and Analysis 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 (Data Management and Analysis Core)

    ASSIST will default to “Core Lead”. If you would like to use a different category, then replace “Project Lead” below with a different Category (e.g., Core Lead).

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

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

    Within the budget section, applicants should request funds to support the following:

    • Central data storage, data management, safeguards to protect the integrity of the data for all projects and cores, and submission of data and data analyses to  ImmPort or other databases designated by NIAID.
    • Travel for the Data Management and Analysis Core Leader (or their representative) and other required Core personnel to participate in the Annual Program Progress meeting (one 2-day meeting per year to be held in the Rockville, MD area).  Applicants may propose travel funds only for attendance at program meetings related to this FOA.

    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 (Data Management and Analysis Core)

    Specific Aims:  List in priority order the proposed activities and services of the Core. Clearly describe the relationship of the Core to the overall U19 goals and how the proposed activities relate to the other research projects and cores.

    Research Strategy:

    • Describe the overall function of the Core and describe how the services of this Core will support and advance the outcomes from the proposed research program.
    • Explain the role of this Core in the research program. Discuss how the Core Leadership will support and facilitate data management, data analysis, and data sharing.
    • Discuss the staffing plans that will support the functions associated with this Core, including any professional staff or staff with specialized skills to fully address the extent of Core needs.
    • Describe the processes, procedures, methods and plans to provide the bioinformatics infrastructure support for the following:

     

    • Statistical consideration of study design;
    • Data collection, cleaning, and tracking;
    • Database infrastructure;
    • Information management and monitoring;
    • Management of complex cross-sectional or longitudinal data;
    • Computational modeling (as needed);
    • Data-sharing, as appropriate;
    • Sample size and power calculations;
    • Statistical analysis and data integration methods.
    • Describe how the Core staff will apply meaningful data or statistical analyses to ensure studies (especially those with small sample sizes, or descriptive data) are adequately powered and interpreted. If primary study results will be descriptive in nature, the methods that are used should ensure sufficient precision in the proposed estimates. If primary hypotheses are being formally tested, applicants must demonstrate sufficient statistical power to elucidate key differences that support these primary hypotheses.
    • For clinical studies, applicants should provide specific statistical design and power information under the PHS Human Subjects and Clinical Trials Information and these should not be duplicated under the Research Strategy.

    Letters of Support:  Provide any letters of support from collaborators that are specific to the Data Management and Analysis Core.

    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:

    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 (Data Management and Analysis Core )

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

    Service/Resource Core (Optional)

    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 (Service/Resource 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 (Service/Resource Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Service/Resource 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) (Service/Resource 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 (Service/Resource Core)

    In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.

    In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

    Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

    If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

     

    Budget (Service/Resource Core)

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

    Within the budget section, applicants should request funds to support the following:

    Travel for the Service/Resource Core Leader (or their representative) and other required Core personnel to participate in the Annual Program Progress meeting (one 2-day meeting per year to be held in the Rockville, MD area).  Applicants may propose travel funds only for attendance at program meetings related to this FOA.

    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 (Service/Resource Core)

     

    Specific Aims:  List in priority order the proposed activities of the Service/Resource Core. Clearly describe the relationship of the Core to the overall U19 goals and how the proposed activities relate to the other research projects and cores in the application.    

     Research Strategy:

    • Describe the overall function of the Core and how this Core will support and advance the outcomes from the research program.
    • Discuss how the Core Leadership will support and facilitate the functions provided by the Core. Describe and discuss the staffing plan requirements to ensure specialized staffing needs are available that reflect the core functions.  Note that a Service/Resource Core must support at least two research projects.
    • Describe the processes, procedures, and methods associated with the prioritization of the core functions. 
    • Explain the scientific rationale for selecting the methods, technologies, and strategies to accomplish the aims of the Core.
    • Describe any novel concepts, approaches, tools, or technologies for the proposed studies, including their advantage over existing methodologies.

     Letters of Support:

    • Provide letters of support from the PDs/PIs of the clinical study or clinical trial from which samples were obtained indicating access to the samples has been granted and the timeframe for acquisition.
    • Provide letters of support for access to unique assays, reagents or technologies that may be required to perform the work conducted by the Core.

    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.
    • Awardees will be expected to deposit data and data analyses into ImmPort or other public data portal as designated by NIAID. 

    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 (Service/Resource Core)

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

    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 Project)

    Complete only the following fields:

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

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Research Project)

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

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

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

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

    List all performance sites that apply to the specific component.

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

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

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

    Within the budget section, applicants should request funds to support the following:

    • Travel funds for the Research Project Leader (or their representative) and other required Project personnel to participate in the Annual Program Progress meeting (one 2-day meeting per year to be held in the Rockville, MD area). Applicants may propose travel funds only for attendance at program meetings related to this FOA
    • If applicable, request funds associated with acquiring biological samples from independently funded, ongoing or completed clinical studies or clinical trials:  those costs might include for example, the costs of re-consenting study participants, preparation of protocol amendments, and additional sample collection, preparation, and shipping.

    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 Project)

    Specific Aims:  List the broad long-range objectives and goals of the proposed project. Describe the hypothesis or hypotheses to be tested. In addition, state the individual project's relationship to the overall U19 goals and how it relates to other Projects or Cores.     

    Research Strategy:  

    • Describe how the proposed studies will utilize the appropriate tools, methods, technologies and approaches (e.g., primary human immune cells, tissues or fluids, and if needed, relevant animal models) to provide mechanistic insights that will advance our understanding of immune development, function or regulation over time applicable to adaptive, innate, and/or mucosal immune responses to pathogen infection, vaccination, microbiome, allergens, and environmental pollutants in children.
    • Explain the rationale for selecting the tools, methods, technologies, and approaches to accomplish the specific aims.
    • Clearly describe the rationale and approach for selection of cohort(s), the age range, sample sources and longitudinal assessments with respect to the specific aims and the overall goals of the U19.
    • Describe how the design of the study will address the requirement to perform longitudinal assessments of the proposed unit of data collection. Describe the proposed data and/or statistical analyses plans with respect to the study design.
    • If the research project uses samples from human subjects, describe and justify how the samples are appropriate for the hypothesis to be tested by the research project.  Discuss the details of sample collection, storage and nature of the assay with respect to the hypothesis to be tested.
    • State the biological significance of the research. Explain how the Research Project addresses the common immunological theme of the application and how the project contributes to the overall goals of the project.
    • If the research project uses an animal model, describe and justify the species (relevance to the human clinical condition) and age (with respect to the developmental time period of birth to less than 18 years of human development) of the animal used.  Describe the relevance of the chosen animal model to the study of selected infections, vaccines, allergens, or environmental pollutants in children from birth to less than 18 years of age. Explain how the results from the animal model will guide mechanistic insights into human immune development, function, or regulation and how they will extend or complement the findings of proposed human studies. Note that animal studies on HIV-related projects may only include non-human primates (NHP) as subjects.

    Letters of Support: Provide letters of support from collaborators that are applicable to the Research Project, including a Memorandum of Understanding (MOU) or Materials Transfer Agreement (MTA) that documents availability and/or access to human materials for each source (i.e. sample availability and timeline to acquire).

    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.
    • Awardees will be expected to deposit data and data analyses into ImmPort or other public data portal as designated by NIAID. 

    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 (Research Project)

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

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

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

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

    4. Submission Dates and Times

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

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

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

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

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

    7. Other Submission Requirements and Information

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

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

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

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

    Important reminders:

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

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

    See more tips for avoiding common errors.

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

    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:

    • If successful, will the outcomes from this research program help drive the current and future research about immune system development from birth through adolescence?
    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 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?  

    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:

    • To what extent does the integrated and collaborative approach through the use of hypothesis-testing, mechanistic, and longitudinal studies of the developing pediatric immune system sufficiently and comprehensively address the goals of the proposed research program? 
    • Are the proposed hypotheses clearly directed at addressing mechanisms of pediatric immune system development, regulation, and function?
    • Are there coordination and synergy of the individual projects towards the achievement of the central objectives of the research program? Will the integration of the individual projects into a single research program be more beneficial than pursuing each project independently? 
    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 - Research Projects

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

    Scored Review Criteria - 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:

    • To what extent will the outcomes from the research projects lead to new and potentially transformative discoveries in pediatric immune development and responses to pathogens, commensal microbes, vaccines, allergens or environmental pollutants? 

    Investigator(s)

    Are the Project Leads, 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-Lead, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

    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 for this FOA:

    • Will the longitudinal assessments proposed address the major theme of immune system development from birth through adolescence? Is justification provided for the human cohort(s) selected and the longitudinal assessment(s) proposed for the study?
    • For studies using human subjects/clinical samples, are the timeline for protocol development and implementation, plans for recruitment and retention of study participants, proposed study site(s), safety monitoring and plans for management and analysis of study data appropriate and feasible?
    • For studies proposing the use of animal models, if applicable, are the relevance of the proposed animal models to human diseases and the timing of immune development and function to the developmental age under study well-justified? Is there strong scientific potential for findings in animals to reflect or recapitulate human immune function?
    • In studies using human biospecimens collected from independently funded clinical research or clinical trials, are the timeline and documentation adequate and feasible to successfully obtain the samples and implement the proposed project(s)?
    • For studies involving human subjects, clinical samples or animal models, are the data and/or statistical analyses plans acceptable?

    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, Service/Resource (optional), Data Management and Analysis Cores

    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.

    Review Criteria - Administrative, Service/Resource (optional), Data Management and Analysis Cores 

    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
    • Is the proposed organizational and administrative structure of the application sufficient to implement the proposed research through completion? Does the staffing plan address specific opportunities for coordination, administration and collaboration among leaders and staff?
    • Is the plan for exchanging information among the project and core leaders adequate to achieve a thorough understanding of the day to day functioning of the U19, including identifying barriers to progress?
    • Are the plans for coordination, problem identification and resolution, and establishment of a strong collaborative environment for the project appropriate?
    • Are the plans for resource allocation within the project adequate and appropriate?
    • Is the management plan for fiscal accountability and communication within the project appropriate?
    • Is the Project Management Plan (PMP) sufficiently detailed to ensure compliance with the timelines and milestones for the project, and to achieve the stated goals and objectives of the U19?  Is the plan for monitoring and updating the PMP clearly articulated? 
    Data Management and Analysis Core
    • How well does the staffing plan address the unique needs for specialized staffing to achieve all the necessary functions of the core (including data transfer to ImmPort of other public portals designated by NIAID), and the extent to which the leadership of the core is appropriate to the outcomes?
    • Is there sufficient bioinformatics infrastructure to support the proposed activities?
    • If support is proposed for study design, statistical analyses and computational modeling (if applicable), are sufficient effort and expertise included in the core?
    • Are the data and/or statistical analyses plans meaningful, adequate and appropriate for the hypotheses proposed, including proposed power calculations and data analysis for the use of data derived from human clinical samples?
     
    Service/Resource Core (optional)
    • Does the Core provide support to two or more Research Projects?
    • Is there a clear relationship of the Core to the central scientific theme of the overall project?
    • Is the process for prioritization of Core functions appropriate and justified?
    • Does the staffing plan address the specific and unique needs of the service/resource core?
    • If a Clinical Core is included, does the leader have the experience and capabilities to guide and support the clinical research activities proposed in the application?
    Additional Review Criteria - Overall, Research Projects, and  Cores  

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

    Vertebrate Animals

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

    Biohazards

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

    Resubmissions

    Not Applicable

    Renewals

    Not Applicable

    Revisions

    Not Applicable

    Additional Review Considerations - Overall, Research Projects, and  Cores   

    As applicable for the program 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 National Institute of Allergy and Infectious Diseases (NIAID) 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 appropriate national Advisory Council or Board. 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.

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

    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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex.  This includes ensuring programs are accessible to persons with limited English proficiency.  The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS.  Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

    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.

    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.   

    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:

    • Serving as the lead for scientific and administrative oversight for the proposed research, including overseeing, managing, and coordinating the overall Program.
    • Providing oversight and coordination for the successful completion of the data- and other resource-sharing plans negotiated with NIAID. 
    • Ensuring adherence to the timelines and milestones within the Project Management Plan
    • Serve as voting member of the Steering Committee
    • Sharing reagents and resources with other investigators funded under this FOA as appropriate and 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 (Project Scientist) have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:  

    • Providing input into the design of research activities and oversight of technical performance.
    • Coordinating NIH staff assistance with regard to:
    • Oversight and monitoring of collaborative research
    • Feasibility of timely progress towards completion of planned activities
    • Facilitating collaborations with, and access to, other NIH-supported research resources and services
    • Facilitating collaborations within and outside of NIH
    • Facilitating compliance with data-sharing and other resource-sharing plans
    • Plans for incorporation of new technologies or other resources
    • Periodic on-site monitoring with respect to compliance with Federal regulations associated with scientific need, such as quality control, accuracy of data recording, sample accrual, etc.
    • Providing advice and input on modifications to data- and resource- sharing plans to ensure completion
    • Serving as a liaison/facilitator among awardees and with the NIAID ImmPort database and other web portals.
    • Periodically reviewing data and access confidential data generated under the award for use in the preparation of internal reports on the activities of the awardees.
    • Serve as a resource for scientific and policy information related to the goals of the awardees' research.
    • Serve as non-voting member of Steering Committee.
    • Appoint subject matter experts as non-voting members on Steering Committee.
    • 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:

    • Establish an External Scientific Group (ESG) 
    • Establish a Steering Committee consisting of awardees and NIH Project Scientists from funding ICs.
    • Review progress and foster collaborations

    Dispute Resolution:

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

    3. Reporting

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

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

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

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

    Section VII. Agency Contacts

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

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons, 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)

    Mercy Prabhudas, Ph.D., M.B.A.
    Division of Allergy, Immunology and Transplantation
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-627-3534
    Email: mprabhudas@niaid.nih.gov

    Que Dang, Ph.D.
    Division of AIDS
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-292-6181
    Email: que.dang@nih.gov

    Anjali Singh, Ph.D.
    National Institute of Allergy and Infectious Diseases (NIAID)
    Division of AIDS
    Telephone: 240-627-3030
    Email: anjalisingh@niaid.nih.gov

    Michael C. Humble, Ph.D.
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984-287-3272
    Email: humble@niehs.nih.gov

    Peer Review Contact(s)

    Maggie Morris Fears, Ph.D.
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 301-761-5444
    Email: maggie.morrisfears@nih.gov

    Financial/Grants Management Contact(s)

    Ashley Ranellone
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone:  301-594-8541
    Email:  ranelloneac@niaid.nih.gov

    James Williams
    National Institute of Environmental Health Science (NIEHS)
    Telephone: 984-287-3338
    Email: williamsjr@niehs.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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