Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title

Modeling Immunity for Biodefense (U19)

Activity Code

U19 Research Program – Cooperative Agreements

Announcement Type

New

Related Notices
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number

RFA-AI-14-028

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.855, 93.856 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) solicits applications from single institutions, or consortia of institutions, to participate in a network of research groups developing computational models of immunity to infectious diseases other than HIV/AIDS. Applications are sought to develop, refine and validate computational models of immune responses (1) during or following infection, and/or (2) before and after vaccination against an infectious disease, through an iterative approach involving computational studies and immunological experimentation. The main goal of this FOA is to advance our understanding of the complex immune mechanisms triggered by infection and/or vaccination through the development and application of computational models of immunity, coupled with immunological experimentation to validate and improve the utility and robustness of the computational models.  Another goal of this FOA is to make the computational models and data developed under this initiative readily available to the broader research community for further refinement or direct use in biological experimentation. This program will also support pilot projects, workshops, and symposia to foster the use of computational models of immunity by the broader research community.  

Key Dates
Posted Date

March 21, 2014

Open Date (Earliest Submission Date)

June 18, 2014  

Letter of Intent Due Date(s)

June 18, 2014  

Application Due Date(s)

July 18, 2014, by 5:00 PM local time of applicant organization.

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

November 2014  

Advisory Council Review

January 2015  

Earliest Start Date

June 2015 

Expiration Date

July 19, 2014  

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

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

Required Application Instructions

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

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This Funding Opportunity Announcement (FOA) solicits applications from single institutions, or consortia of institutions, to participate in a network of research groups developing computational models of immunity to infectious diseases other than HIV/AIDS. Applications are sought to develop, refine, and validate computational models of immune responses (1) during or following infection, and/or (2) before and after vaccination against an infectious disease through an iterative approach involving computational studies and immunological experimentation.

The purpose of this FOA is to advance our understanding of the complex immune mechanisms triggered by infection and/or vaccination through the development and application of computational models of immunity, coupled with immunological experimentation to validate and improve the utility and robustness of the computational models.  Another goal of this FOA is to make the computational models and data developed under this initiative readily available to the broader research community for further refinement or direct use in biological experimentation, with the ultimate goal of using immunological data and computational models to develop improved vaccines and therapeutics to prevent and treat infectious diseases.

The program will also support an Infrastructure and Opportunity Fund (IOF), pilot projects, workshops, and symposia to foster the use of computational models of immunity by the broader research community. 

Background

Generation of protective immunity to natural infections or vaccines requires a coordinated, carefully regulated series of events involving a variety of cell types within different tissues and organs. Computational modeling methods hold great promise to deepen our understanding of this dynamic system, as they have already provided novel insights into various aspects of immune system function, including: antibody production and maturation/somatic mutation; T cell activation; T cell development and differentiation; generation and maintenance of immunological memory; and host-pathogen interactions. Most computational modeling approaches utilize standard immunological assays as the basis for schematic representations of the immune system, or to integrate knowledge from different immune components to predict the effects of various perturbations on immune function.  Recent advances in high through-put technologies and systems biology approaches also offer a wealth of immunological data for computational modeling. In addition to providing novel insights of basic immune system function, computational models also may be developed to identify key variables and their importance in human immune responses to natural infection or experimental vaccines in silico, either through comparison of results from in vivo and in vitro animal studies with in vitro studies using human cells, or direct calculations from in vitro human studies coupled with analysis of in vivo human data from related infections/vaccines. Such studies would accelerate the development of vaccines and immune-based therapeutics for infectious diseases, and could be especially useful for vaccines against emerging/re-emerging infections and for infectious agents for which vaccine development has been difficult or sub-optimal (tuberculosis, malaria, pertussis, etc.).

Since 2005 NIAID has supported the Modeling Immunity for Biodefense (MIB) Program (RFP-NIH-NIAID-BAA-05-10 and BAA-NIAID-DAIT-NIHAI2009074) to support the development of novel or improved computational models to analyze and predict human immune responses to infection, vaccination, or immune-based therapeutics to protect against NIAID Category A, B and C Priority Pathogens (http://www.niaid.nih.gov/topics/biodefenserelated/biodefense/pages/cata.aspx). The prior MIB programs have provided computational models for analysis of adaptive immune response to influenza vaccination  and infection (https://cbim.urmc.rochester.edu/), effects of adjuvants on antibody responses to vaccination or infection   (http://www.bu.edu/computationalimmunology/index.html), human dendritic cell anti-viral responses (http://tsb.mssm.edu/primeportal/), and regulation of mucosal immune responses to enteric bacterial infections (http://modelingimmunity.vbi.vt.edu/).  In addition, all of the biological data used to develop the computational models are available at the ImmPort database (https://immport.niaid.nih.gov), an NIAID-supported public resource providing immunological datasets and data analysis tools to the broader research community.  The computational models and datasets developed under the original MIB projects could serve as a foundation for further advances in computational immunology. Recent advances in immunology, bioinformatics, and systems and computational biology by others provide additional sources for expanding the utility and accessibility of computational models to the field of immunology.

The broader field of computational biology has contributed significantly to our understanding of basic physiological mechanisms and is being applied to clinical diagnoses and/or therapeutic interventions.  For example, computational modeling of HIV viral replication dynamics has uncovered the major mechanism of anti-retroviral drug resistance and suggested possible treatments for long-term prevention of drug resistance and elimination of viral reservoirs in infected individuals.  Examples of the use of computational modeling in direct clinical care include the use of image-driven modeling for patient diagnosis and procedure planning for orthopedic and vascular surgeries, patient-specific modeling of ablation therapy for atrial fibrillation, and cardiac resynchronization therapy for congestive heart failure patients.  A major long-term goal of this program is to foster the use of computational modeling in immunology in order to take full advantage of the wealth of immunological data being generated and accelerate knowledge into clinical applications.  Such efforts may ultimately require high order modeling and/or the integration of computational models of specific immune parameters into a larger model of immune function.  Several hurdles currently exist in regard to model sharing and integration, including inaccessibility of the computational models due to inadequate annotation methods or lack of standards for model sharing.  In addition, gaps in knowledge of critical immune parameters and availability of quantitative immunological data inhibit model building.  The MIB program will support initial efforts in these areas through collaborative projects among the awardees to improve documentation, sharing, and integration of computational models of immunity.  These efforts to refine standards for sharing computational models of immunity and to support quantitative immunological studies will help advance the field of computational immunology and hasten the development of improved vaccines and therapeutics against infectious diseases.

Research Objectives and Scope

The goal of this program is to support the development and/or refinement and validation of computational models of immunity to infection or vaccination, through an iterative process that includes direct biological experimentation coupled with model development, refinement and validation. For the purpose of this FOA, computational modeling is defined as the use of mathematical approaches and/or computer simulations to represent or describe biological phenomenon, with the goal of advancing understanding of the biological processes being modeled.  The computational models developed under this program may use one or multiple scales of immunology from molecular to whole organism responses.  The immunological studies proposed in the application must be used to develop/refine, and validate the computational models being produced.

To promote public access to the computational models and data generated through the MIB program, all MIB Program Directors (PDs)/Principal Investigators (PIs) funded under this initiative will be expected to share their computational models through a publicly accessible repository such as BioModels.Net (http://biomodels.net/) and their data through ImmPort (http://immport.niaid.nih.gov ) or other public portals designated by NIAID.

This program is milestone-based and includes the flexibility to quickly redirect or replace research projects during the funding period. Milestones will be negotiated with NIAID staff prior to award.

Funding beyond the first year of award may be negotiated downward depending upon scientific progress, including meeting data sharing and model development milestones.

Specific Areas of Research Interest

Immunological areas of interest for computational model development, refinement and validation include, but are not limited to those listed below:

In addition to original experiments proposed by the applicants, all applicants are encouraged to utilize publicly available datasets and computational modeling frameworks for building/refining computational models to address the immunological questions proposed in their projects.

Applications that do not meet the following requirements will be considered non-responsive and will not be reviewed:

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

Required Organizational Structure

Each MIB application must include a minimum of 2 and a maximum of 4 synergistic Research Projects organized around a central scientific theme.  All applicants are encouraged to propose computational methods and modeling platforms that will allow ready integration with other models, and that are comprehensively annotated. Each application will include an Administrative Core and an Infrastructure and Opportunities Fund (IOF) Management Core. In addition, one or more Service Cores may be proposed.

Administrative Core

The Administrative Core will support the coordination of efforts across the component research projects and the service cores, and will support activities to advance integration into the broader MIB consortium and with the scientific community.

In addition, the Administrative Core may support an External Scientific Advisory Group (ESAG), to be formed after award at the discretion of the PDs/PIs.

Finally, each awardee will be required to develop two workshops and two scientific symposia focused on computational modeling of immunity during the funding period.

Steering Committee

A MIB Steering Committee will be established in collaboration with NIAID Program Officers to serve as the governing board of this collaborative research program.  Steering Committee responsibilities are described in more detail in Section VI.2. Cooperative Agreement Terms and Conditions of Award.

Infrastructure and Opportunities Fund (IOF) Management Core

From among the successful applicants, one institution will be chosen by NIAID after award to manage the IOF for the entire network. This institution must agree to take responsibility for managing the IOF, including disbursement and tracking of IOF funds, establishing an administrative structure to manage the IOF, and reporting on the status of IOF projects and expenditures to the NIAID and MIB Steering Committee.

The MIB network awardees will work together to facilitate validation and integration of the models being generated, and to build centralized resources, such as common meta-data standards and tools, to facilitate the use of computational models of immunity by the broader research community (e.g., biological ontologies, SBML extensions, annotation standards for computational models of immunity).  The IOF will be available after award to support these activities and a Steering Committee will be established to serve as the governing board of this collaborative research group.

Service Core(s)

One or more optional Service Cores may be proposed, but only if the Core will be used by at least two research projects. Service Cores are limited to providing standard assays, reagents, technologies, clinical services, repositories, statistical services, bioinformatics expertise, or other available services to investigators. They are intended to provide investigators within the U19 center with resources that already exist and have already been validated and refined for use. Any proposed development of new technologies, assays, etc. must be presented within a research project.

Applicants are encouraged to contact NIAID Scientific/Research staff well in advance of the application submission date to discuss the proposed research program and its responsiveness to this FOA. 

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New  

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

Funds Available and Anticipated Number of Awards

NIAID intends to commit $6.0 million in FY 2015 to fund 3 - 4 U19 awards and the Infrastructure and Opportunity Fund (IOF).

Award Budget

Application budgets are limited to $1.0 million direct costs per year, and need to reflect the actual needs of the proposed project.

Note that requested costs for the administration of the Infrastructure and Opportunity Fund (IOF) Management Core are NOT included in the $1.0 million direct costs per year limit. The budget for the IOF Management Core is limited to $120,000 direct costs per year.

Award Project Period

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

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

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

Required Registrations

Applicant Organizations

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

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.

The application must include at least one immunologist and one computational modeler as Multi-Program Directors/Principal Investigators for the entire program.

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.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

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

2. Content and Form of Application Submission

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

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

Letter of Intent

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

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

The letter of intent should be sent to:

Quirijn Vos, Ph.D.
National Institute of Allergy and Infectious Diseases
6700B Rockledge Drive, Room 3137
Bethesda, MD 20817
Telephone: 301-451-2666
Fax: 301-480-2408
Email: qvos@niaid.nih.gov

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12 pages

Admin Core

  6 pages

Core (Use for IOF Management and Service Cores)

  6 pages each

Project (Use for Research Projects)

12 pages each

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

Instructions for the Submission of Multi-Component Applications

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

The application should consist of the following components:

Overall Component

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

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

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

Research & Related Senior/Key Person Profile (Overall)

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

Each U19 application must include at least one immunologist and at least one computational modeler as Multiple PDs/PIs of the entire program.  Applicants should provide evidence demonstrating the PDs/PIs abilities and capabilities to provide leadership, guidance and direction over the proposed U19 program, including the duties/leadership roles of each PD/PI.

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 in priority order the broad, long-range objectives and goals of the proposed program. Describe the immunological hypothesis or hypotheses to be tested and how the proposed computational models will facilitate testing of these hypotheses.  

Research Strategy: This narrative section summarizes the overall research strategy for the multi-project application and explains how the proposed program satisfies the purpose and objectives of this FOA as delineated in Section I. Applications responding to this FOA should describe the central theme of the proposed program and explain how the proposed research projects are synergistic and fit under the overarching program 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 section 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 attacking the problems. As the strategy develops, each project and core should be cited briefly as to its place in the overall scheme. Summarize the special features in the environment and/or resources that make this application strong or unique. If possible, provide evidence that the applicants and all proposed collaborators have prior experience in the research areas proposed, and highlight accomplishments in the field and describe the synergy and collaborations that occurred. If there was no prior experience of collaboration among the investigators, explain why the proposed investigator collaborations will result in synergy.  

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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Administrative Core

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

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

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)

Budget (Administrative Core)

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

Include a budget to:

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. Describe the work to be completed to address issues of program coordination, communication, and management. Describe the work to be completed to support execution of two workshops and two scientific symposia over the life of the award focused on computational modeling of immunity.   

Research Strategy: Provide a staffing and administrative plan that includes a discussion of the structure and roles of administrative and scientific/educational staff for the core, including: how the training and experience of proposed staff applies to  the functions to be performed; and how resources will be prioritized, allocated, and managed. Provide a management plan for fiscal accountability and communication within the program.

Describe how the Administrative Core will support the coordination of efforts across the component research projects and the service cores.

Provide plans for organization, management, decision-making, and periodic evaluations within the individual center, as well as regulatory compliance, involvement of institutional and programmatic resources, shared publications, and data- and other resource-sharing within the consortium and through public databases and repositories.

Describe the plans for the Administrative Core in ensuring the appropriate and timely submission of data, data analyses and computational models obtained under this award to the ImmPort database and BioModels.Net (or other appropriate public repositories).

Provide a plan for tracking community usage of the computational models developed under the U19 program and for development and maintenance of a program-specific website (if one is proposed).

Provide a plan for creating and implementing administrative and leadership mechanisms that will  foster effective interactions with other MIB network PDs/PIs and institutions, as well as within the individual center to promote synergistic research efforts through support of the activities of a Steering Committee.

Provide a plan for the organization and administration of two workshop and two symposia over the grant funding period that meet the following requirements:

The Administrative core also will support the activities of a Steering Committee and, if proposed, an External Scientific Advisory Group (ESAG).

An External Scientific Advisory Group (ESAG) is not required.  However, if an ESAG is proposed, specific potential members of a proposed External Scientific Advisory Group (ESAG) should NOT be named in the application and ESAG members must not be recruited or contacted prior to review and award. The ESAG would evaluate scientific progress and provide advice to the center on an annual basis. Note that a member of the MIB program may NOT serve as an ESAG member for a different MIB center. 

Letters of Support: Letters of support should be included from investigators providing reagents, samples, or other resources to the program. If human samples are being provided from a completed or ongoing clinical trial supported by independent funds, the PD/PI of the clinical trial(s) must provide a letter of support.  

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report  (Administrative Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Infrastructure and Opportunities Fund Management Core (IOF Management Core)

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

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

SF424 (R&R) Cover (IOF Management Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (IOF Management Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (IOF Management Core)

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

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

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (IOF Management Core)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (IOF Management Core)

Budget (IOF Management Core)

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

The budget request for this core should include the costs of administrative staff to manage the IOF and any needed supplies or services. This core budget may be modified by NIAID after award, but for purposes of the application, assume that: one full-time administrator will be needed; modest oversight effort will be needed from the PD/PI or other senior staff; and 10-20 subawards will be issued by this core annually.

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 (IOF Management Core)

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

Research Strategy: An IOF Management Core must be proposed. All projects supported by the IOF must be within the scientific scope of the investigators’ awards. The MIB Steering Committee will make recommendations as to the goals, priorities, and evaluation criteria use of the IOF. These recommendations should include: the size and content of the applications; the frequency of applications; the timeline from solicitation to funding; and the process to be used to evaluate the applications. Resources supported by the fund may be housed at particular MIB centers or may be supported by sub-awards to other facilities/institutions. Any activities funded through the IOF must comply with NIH policies. Monitoring compliance is the responsibility of the IOF Management Core and NIAID staff.

Use this section to describe how the IOF Management Core will operate to serve the MIB network, including descriptions of:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification.

Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable to this component.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (IOF Management Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (IOF Management Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Service Core(s)

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

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

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

Complete only the following fields:

PHS 398 Cover Page Supplement (Service Core(s))

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

Project Narrative:  Do not complete.

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

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Service Core(s))

Budget (Service Core(s))

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

Applications proposing a Service Core(s) should indicate the specific research projects to be served by that core and explain why the core resources are not otherwise available. The percentage of funds that will be required to support each component research project that will utilize the core should also be presented.

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 Core(s))

Specific Aims: List in priority order the broad, long-range activities and services of the proposed core. In addition, state the Core’s relationship to the program’s goals and how the Core relates to two or more individual research projects in the application.

Research Strategy: A Service Core must be used by at least two of the Research Projects. Use this section to describe how the core will serve the projects and explain why the core resources are not otherwise available. Service Cores must be well-justified and clearly non-duplicative of other services or facilities available to the center PDs/PIs. Applications proposing Service Cores should indicate the specific research projects to be served by each core.

Protection of Human Subjects: For Cores proposing the use of human samples to be obtained with funds from the MIB award, provide the information described in the SF424 (R&R) Application Guide.

When possible, it is strongly recommended that informed consent be used that allows broad use of de-identified stored samples and de-identified data for future studies, beyond the scope of the MIB study; including genetic studies and unrestricted sharing of the samples and data for use by other researchers, subject to IRB approval.

For Cores proposing the use of human samples to be obtained from independently-funded clinical trials, the materials to be included are described in the instructions for the Appendix section below.

When clinical studies are a component of the research proposed, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study (http://www3.niaid.nih.gov/research/resources/toolkit/standards.htm). An updated NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html.  The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.

Letters of Support: Letters of support should be included from investigators providing reagents, samples, or other resources to the Core.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

For Cores proposing the use of human samples to be obtained from independently-funded clinical trials, the following materials should be included:

When human samples are to be collected from an independently-funded clinical trial, to the extent permitted by applicable laws and regulations, NIH will treat as confidential trial information that the trial sponsor deems proprietary.

Planned Enrollment Report  (Service Core(s))

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Service Core(s))

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Research Projects

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

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

Applications must include a minimum of 2 and may include a maximum of 4 research projects organized around a central scientific theme.

SF424 (R&R) Cover (Research Projects)

Complete only the following fields:

PHS 398 Cover Page Supplement (Research Projects)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Projects)

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

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

Project Narrative:  Do not complete.

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

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Research Projects)

Budget (Research Projects)

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

In cases where human samples are to be collected from an independently-funded clinical trial, applicants can include in their budgets the costs of additional clinical trial-related activities such as the costs of re-consenting study participants, preparation of protocol or IND amendments, and additional sample collection, preparation, and shipping.

Each research project should request support for designated personnel to manage and analyze the data, and prepare data for transfer to the ImmPort database, and transfer of computational models to a public repository such as BioModels.Net in keeping with the data and model/resource sharing requirements. Alternatively, these functions and support might be provided by a Service Core.

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

PHS 398 Research Plan (Research Projects)

Specific Aims: List the broad, long-range objectives and goals of the proposed project. Concisely and realistically describe the work to be completed. In addition, state the individual project’s relationship to the program’s goals and how the project relates to other projects or cores to create synergy.

Research Strategy: Each project must focus on the development, refinement and validation of computational models of immunity, or on the generation of immunological data to support the computational model development, refinement and validation.  The program should address a common immunological theme such that synergy is clearly evident among all the proposed research projects.

At least one project should focus on development/refinement and validation of a computational model(s) of immunity. At least one project should focus on generation of the immunological data for the computational model building and validation project(s).  Each project should describe how the proposed research will contribute to meeting the program’s goals and objectives and explain the rationale for selecting the methods to accomplish the specific aims. In addition to stating the biological significance of the research, indicate the project’s relevance to the primary theme of the application and how it will synergize with the other projects. Results from preliminary studies should be included as part of the approach section, and must be contained within the page limits of the Research Strategy section.

Applications that do not meet the following requirements will be considered non-responsive and will not be reviewed:

Clinical trial definition: For this FOA, a clinical trial is defined as a prospective study of human subjects designed to answer questions about the safety and effectiveness of biomedical or behavioral interventions. All clinical studies that require an Investigational New Drug (IND) application from the U. S. Food and Drug Administration (FDA) to conduct a clinical investigation WOULD be considered clinical trials. Studies using FDA approved interventions (e. g. licensed vaccines), that are prescribed for use as described in the intervention’s product label and are exempt per regulation from needing an IND for a clinical investigation, for the purposes of studying detailed immune response to that intervention, WOULD NOT be considered clinical trials. Applicants should contact the FDA directly to discuss the possible need for an IND application. If an IND waiver is obtained from the FDA, a copy of the waiver should be included in the application. NIAID reserves the right to decide whether a proposed clinical study is, or is not, a clinical trial based on the definitions and guidance provided above for purposes of determining whether the proposed study is responsive to the FOA.  If there are any questions, applicants are strongly encouraged to contact one of the NIAID Scientific/Research staff listed in Section VII.  Examples to further clarify the definition of a clinical trial for the purposes of this FOA are given below:

It is strongly recommended that applications include the following:

Protection of Human Subjects: For projects proposing the use of human samples to be obtained with funds from the MIB award, provide the information described in the SF424 (R&R) Application Guide.

When possible, it is strongly recommended that informed consent be used that allows broad use of de-identified stored samples and de-identified data for future studies, beyond the scope of the MIB study; including genetic studies and unrestricted sharing of the samples and data for use by other researchers, subject to IRB approval.

For cores proposing the use of human samples to be obtained from independently-funded clinical trials, the materials to be included are described in the instructions for the Appendix section below.

When clinical studies or trials are a component of the research proposed, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study  http://www.niaid.nih.gov/labsandresources/resources/toolkit/pages/standards.aspx. An updated NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html.  The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.

Letters of Support: Letters of support should be included from investigators providing reagents, samples, or other resources to the project.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) 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.

The Resource Sharing Plans should include a statement of agreement that investigators funded under MIB will abide by the data- and model-sharing plans and other resource-sharing plans finalized after award through negotiation with NIAID. Data, computational models, software and other resources developed with MIB funds are expected to be made as widely and freely available as possible, while safeguarding the privacy of participants and protecting confidential and proprietary information. It is expected that all MIB-supported data will be made publicly accessible. Data, computational model and other resource dissemination are expected to be implemented through ImmPort, BioModels.Net or other appropriate publicly accessible web site(s) as determined by NIAID. All MIB PDs/PIs will be expected to adhere to the final data-sharing and other resource-sharing plans negotiated with NIAID (see Section VI.2.).

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

For projects proposing the use of human samples to be obtained from independently-funded clinical trials, the following materials should be included:

When human samples are to be collected from an independently-funded clinical trial, to the extent permitted by applicable laws and regulations, NIH will treat as confidential trial information that the trial sponsor deems proprietary. 

Planned Enrollment Report (Research Projects)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Research Projects)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. Other Submission Requirements and Information

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

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 by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact - Overall

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

Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit.

Overall Impact –Individual Research Projects

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for each 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? 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? What is the likelihood that the results of the study will provide valuable computational models of immunity and facilitate discovery of important new knowledge on human immune status and responses to infection or vaccination?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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 project? 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?  If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?   

Computational Models project(s): Is there a predominant focus on developing computational models of immune responses to infection or vaccination? Will the computational models being developed advance our understanding of immunity to infection or vaccination? If development/refinement of bioinformatics tools are included in the application, are these activities necessary for completion of the proposed studies and do they constitute only a minor effort within the project? Are adequate resources available to conduct the proposed studies? Will data collection and analysis methods be appropriate in terms of quantitation, controls, and development/refinement/validation of the computational models of immunity?

Immunology project(s): Will the immunological experiments proposed provide the required data for the computational modeling component(s) of the program?  Are the human subject cohorts to be analyzed well characterized and appropriate for the study goals, available in sufficient numbers, and are the sample times appropriate for the stated goals? If animal studies are included, is the justification for the species chosen, number of animals to be studied, and the relevance to human immunity appropriate? Are adequate resources available to conduct the proposed studies? Will data collection and analysis methods be appropriate in terms of quantitation, controls, and development/refinement/validation of the computational models of immunity?

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 – Individual 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.

Review Criteria – Individual 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
Service Core(s)
Additional Review Criteria - Overall, Research Projects, Cores

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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, Cores

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

Infrastructure and Opportunity Fund (IOF) Management Core

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) Genome Wide Association Studies (GWAS).

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 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:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA. 

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

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

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Prior Approval of IOF Projects

Awardee-selected projects that involve animal and/or clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation. 

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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

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

The PDs/PIs will have the primary responsibility for:

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

Areas of Joint Responsibility include:

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 Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, 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. 

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 Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Alison Deckhut Augustine, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3475
Email: Augustine@niaid.nih.gov

Timothy Gondré-Lewis, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3566
Email: tglewis@niaid.nih.gov

Peer Review Contact(s)

Quirijn Vos, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-451-2666
Email: qvos@niaid.nih.gov

Financial/Grants Management Contact(s)

Kim L. Cooper
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-451-4576
Email: kim.cooper@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 Parts 74 and 92.


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