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

Immune Mechanisms of Virus Control (U19)

Activity Code

U19 Research Program – Cooperative Agreements

Announcement Type

Reissue of RFA-AI-08-013

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AI-12-048

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

The National Institute of Allergy and Infectious Diseases (NIAID) invites multi-project applications to be part of a network of synergistic research teams focused on the immunological parameters of virus infection and vaccination that are important for understanding the key molecular and cellular immune mechanisms involved in the natural control of infection, the induction of protective immunity by vaccination, or the immune-mediated processes that cause pathology after virus infection or vaccination.  Studies involving multiple viruses are encouraged to foster discovery of novel immune mechanisms and generalizable principles of anti-viral immunity.  The viruses of interest to the Immune Mechanisms of Virus Control (IMVC) program are listed as part of the NIAID Emerging and Re-emerging Infectious Diseases (http://www.niaid.nih.gov/topics/emerging/Pages/list.aspx).  The ultimate goal of this program is to discover and define novel basic immune mechanisms for controlling virus infections that will lead to new potential targets for developing future vaccines and therapeutics.

Key Dates
Posted Date

December 12, 2012

Letter of Intent Due Date(s)

March 15, 2013

Application Due Date(s)

April 16, 2013    

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

September, 2013   

Advisory Council Review

January, 2014 

Earliest Start Date

May, 2014

Expiration Date

April 17, 2013 

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 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. While some links are provided, 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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) represents the third phase of the NIAID Immune Mechanisms of Virus Control Program (IMVC).  The first phase was awarded as exploratory R21 grants in fiscal year 2007 (RFA-AI-07-008) and the second phase as either U01 or U19 cooperative agreements in fiscal year 2009 (RFA-AI-08-013). All qualified investigators are invited to apply to this FOA; prior funding under the first or second phases or through NIAID or NIH is NOT required.

The lack of effective vaccines and drug treatments for many viruses presents a health concern of significant proportions.  Host defenses against viruses involve both innate and adaptive immune mechanisms, but the basic processes and the interactions of these two arms of the immune response in anti-virus defense are not completely understood, especially in humans.  This FOA will continue to support basic immunological research focused on the parameters underlying the immune response to either virus infection or vaccination.  Studies involving multiple viruses are encouraged to foster discovery of generalizable principles of anti-viral immunity.  The goal of this program is to discover and define novel basic immune mechanisms that provide a more sophisticated understanding of the immune response to virus infection, and provide potential new targets for future vaccine and therapeutic drug development.  It is NOT the purpose of this program to apply currently accepted immunological concepts to the development of improved anti-virus vaccines or therapies.  For example, conventional antibody measurements used to test new vaccine candidates would not be considered responsive in the absence of studies on immune mechanisms of antibody protection.

Specific Areas of Research Interest

The National Institute of Allergy and Infectious Diseases invites multi-project applications to be part of a network of synergistic research teams focused on the immunological parameters of virus infection and vaccination that are important for understanding the key molecular and cellular mechanisms involved in the natural control of infection, the induction of protective immunity by vaccination, or the immune-mediated processes that cause pathology after virus infection or vaccination. 

The emphasis of research proposed in response to this FOA should be in defining novel cellular and molecular immune mechanisms involved in immunity to virus infection or vaccination.  Viruses of interest to this program are included as part of Groups I – III in the NIAID Emerging and Re-Emerging Diseases, listed at  http://www.niaid.nih.gov/topics/emerging/pages/list.aspx.  It is anticipated that proposed studies will be relevant to multiple viruses, therefore studies including multiple viruses are encouraged.  Studies involving viruses other than those on the NIAID Emerging and Re-Emerging list may be included as long as the chosen viruses pose serious threats to human health and at least one of the projects within the U19 is solely dedicated to one or more viruses from the NIAID Emerging and Re-Emerging list.  HIV studies are EXCLUDED from this FOA.

Topics of interest include, but are not limited to those listed below:

Research in Animal Models:  If animal studies are proposed, they must be well justified in terms of their relevance to human infection with or vaccination against emerging or re-emerging viruses.   Additionally, it is highly encouraged that validation studies be proposed in human cells where possible, but is not required.

In Vitro Work: in vitro work using human or other mammalian tissues, cells or molecules is permitted.

The following research areas will be considered non-responsive and applications proposing studies in the following areas will not be reviewed:

IMVC Annual Meetings

Each IMVC awardee will participate in a kickoff meeting soon after award, as well as meetings to be held annually thereafter.  The PD/PI from each U19, as well as the Project Leaders and other relevant staff, should participate in the annual IMVC meetings.  However, the maximum number of attendees from each Program is limited to six.   These meetings will be organized by the NIAID in order to: share both positive and negative results; share materials including reagents and techniques; evaluate progress; and identify new research opportunities with an emphasis on advancing the overall IMVC goals.  In the application, budget requests should include costs for attendance of the PD(s)/PI(s) and relevant staff.  These meetings will convene yearly in Bethesda, Maryland. 

Milestones of Progress

This program is milestone-based, and annual funding will depend on progress in meeting milestones negotiated with the NIAID Program Officer in the previous year.  Proposed annual milestones should be included within each research project in the application.

IMVC Steering Committee

A network of synergistic Immune Mechanisms of Virus Control (IMVC) centers will be established through this program to enable multidisciplinary approaches to advance this area of research.  The IMVC network will be governed by a Steering Committee to coordinate and facilitate research activities for the overall IMVC program, and to ensure optimal research flexibility, synergy, and efficiency.  The Steering Committee will include the PD/PI from each awarded U19 as a voting member and the NIAID Program Officer as a non-voting member.

IMVC members will cooperate within the program to share resources, methods, and data to facilitate progress.  The network investigators will also be provided opportunities to access resources from other NIAID-funded programs and to collaborate on research projects as appropriate.  All research groups will share responsibility for program development and resource coordination through the IMVC Steering Committee that will be established upon grant award.  When appropriate, and in accordance with NIH policies (http://grants.nih.gov/grants/policy/data_sharing/ and http://www.ott.nih.gov/policy/rt_guide_final.html), U19 awardees will be expected to collaborate; share novel reagents, assays, animal models, and human samples; and share both positive and negative results that would help guide the research activities of other IMVC network members.  The NIAID, in concert with the IMVC Steering Committee, will have the option to redirect research activities within IMVC grants if it is considered beneficial to the overall program.

Infrastructure and Opportunities Fund

An Infrastructure and Opportunities Fund (IOF) will be made available to the IMVC network after award to support IMVC activities, exploratory pilot research projects and/or research resource development projects to capitalize on emerging opportunities to understand novel molecular and cellular immune responses to viral infections and/or vaccines, or for the development, production, characterization, and distribution of shared reagents, shared resources, or access to a unique resource.  After all IMVC awards have been issued, one awardee institution will be selected by NIAID to administer the IOF.  The Steering Committee will establish goals, priorities, and evaluation criteria for the use of the IOF.  All IMVC awardees will be eligible to compete for IOF resources, and may include collaborations with investigators not directly supported by this FOA. The IOF is described further under Section VI.2, Cooperative Agreement Terms and Conditions of Award, “Areas of Joint Responsibility.”

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 staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
Renewal

The OER Glossary and the PHS 398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIAID intends to commit approximately $15 Million in FY 2014 to fund 5-7 U19 awards.

Award Budget

Application budgets are limited to $1.5 million direct costs per year, but need to reflect actual needs of the proposed project.

Award Project Period

Scope of the proposed project should determine the project period.  The maximum period is five 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 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 must complete the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

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. 

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:

A research project proposed as part of a U19 application under this FOA may also be submitted as an individual R01 application.  Should both applications then be deemed fundable, the applicant must accept the U19 award and decline the R01 award.

Only recipients of U19 grant from the previous solicitation (RFA-AI-08-013) are eligible to apply for a renewal application.  However, any qualified investigator may submit a new application. 

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS 398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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:

Zhuqing (Charlie) Li, Ph.D 
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3256, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: 301-402-9523
FAX: 301-480-2408
Email: liz@niaid.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Zhuqing (Charlie) Li, Ph.D 
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3256, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: 301-402-9523
FAX: 301-480-2408
Email: liz@niaid.nih.gov

Page Limitations

All page limitations described in the PHS 398 Application Guide and must be followed, with the following additional requirements for the Research Strategy sections:

Supplemental Instructions for the Preparation of Multi-Project Applications

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions. The following section supplements the instructions found in Form PHS 398 for preparing a multi-project grant application. Additional instructions are required because the Form PHS 398 is designed primarily for individual, free-standing research project grant applications, and has no specific instructions for multi-project applications consisting of research projects interrelated by a common theme.  All applications must be submitted on Form PHS 398.  The multi-project grant application should be assembled and paginated as one complete document. Instructions for the Overall Component are presented first, followed by instructions for Research Projects, followed by instructions for Cores

Essential elements of the multi-project U19 include:

Lack of synergy and interaction among the Research Projects and Scientific Cores may adversely affect the impact score of a U19 application, even if the Scientific and Technical merit of individual projects is high.

Instructions for Overall Component

All applications must be submitted on PHS Form 398.  The multi-project grant application should be assembled and paginated as one complete document.

Form Page 1. Face Page (Overall)

This should be the first page of the entire application and all succeeding pages should be numbered consecutively.

Form Page 2. Summary, Relevance, Project/Performance Site,Senior/Key Personnel, Other Signficant Contrbutor, and Human Embroyonic Stem Cells (Overall)

Description:  Using Form Page 2 of the PHS 398, provide a succinct but accurate description (abstract) of the OVERALL multi-project application addressing the major, common theme of the program.  Do not exceed the space provided.

Project/Performance Sites: List the performance sites where the research will be conducted.

Key Personnel (Overall): Under "Key Personnel", list the Program Director/Principal Investigator of the multi-project application, followed by the Project Leaders of the component research projects and cores, other key personnel, and then other significant contributors.

Form Page 3. Table of Contents (Overall)

Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application. 

Bearing in mind that the application will be scientifically reviewed project by project and core by core, prepare a detailed Table of Contents that will enable reviewers to readily locate specific information pertinent to the overall application as well as to each component research project and core.  A page reference should be included for the budget for each project and each core.  Further, each research project should be identified by number (e.g., Project 1), title, and responsible Project Leader, and each Core should be identified by letter (e.g., Core A), title, and responsible Core Leader.  The page location of a COMPOSITE BUDGET should be indicated in the Table of Contents.

Form Page 4. and Form Page 5  (Composite Budget - Overall)

Do not use Form Page 4 of the PHS 398.  Instead, using the suggested format presented below, prepare a composite budget for all proposed years of support.  (Justification for budget elements should not be presented here but in the individual budgets of the projects and cores.)

SAMPLE:  Consolidated Direct Cost Budget for All Proposed Years of Support

Component

Year 1

Year 2

Year 3

Year 4

Year 5

All Years

Project 1. Invest.

125,000

130,000

135,200

140,608

146,232

677,040

Project 2. Study

125,000

130,000

135,200

140,608

146,232

677,040

Project 3. Develop.

100,000

104,000

108,160

112,486

116,985

541,631

Core A.

50,000

52,000

54,080

56,243

58,493

270,816

Core B.

25,000

50,000

52,000

54,080

56,243

237,323

Totals

425,000

466,000

484,640

504,025

524,185

2,403,850

 

 

 

 

 

 

 

Complete the Total Direct Cost line entries for all requested budget periods (years) and the Total Direct Cost for Entire Period of Support entry.  Detailed budgets are required within the descriptions of each project and core (see below). 

IMVC Annual Meetings

In the application, budget requests should include costs for attendance of the PD(s)/PI(s) and relevant staff.  These meetings will convene yearly in Bethesda, Maryland. 

Biographical Sketch Format Page

Biographical sketches of all professional personnel for all components should be placed at the end of the application with the PD/PI first, followed by those of other key personnel in alphabetical order.

Resources Format Page

Do not complete.  Essential information is to be presented in the individual research project and core sections of the application.

Program Overview Reseach Plan (Research Objectives and Strategic Plan) Overall

Specific Aims

List in priority order, the broad, long-range objectives and goals of the proposed Program.  Concisely and realistically describe the hypothesis or hypotheses to be tested.

Overall Research Strategy

The narrative section summarizes the overall research plan for the multi-project application and explains how the proposed Program satisfies the purpose and all 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 research 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 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. 

For renewals, also include in this section progress made during the previous funding period.

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 PHS 398 Application Guide, with the following modification:

Checklist

One checklist, placed at the end of the application, is to be submitted for the entire application.  Individual research projects and cores do not require a checklist.

Appendix Materials

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide, with the following modifications:

Specific Instructions for Individual Research Projects

Except for the requirements below, follow the PHS 398 specific instructions found at http://grants.nih.gov/grants/funding/phs398/phs398.html in preparing each research project.

A minimum of two individual research projects are required.

For each individual Research Project, include:

Cover Page (Reseach Projects)

The Face Page of the PHS 398 Form should not be used as a cover page for individual research projects within a multi-project application.  Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual research project.  This Cover Page will demarcate each individual research project and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page):

If yes:  Exemption number or IRB Approval Date (e.g., 07/03/2012, or Pending) and Federal wide Assurance (FWA) number

If yes:  IACUC Approval Date (e.g., 07/03/2012, or Pending) and Animal welfare assurance number

From:  (mmddyyy - e.g., 07/01/2012) To:  (mmddyyyy - e.g., 06/30/2017)

Form Page 2. (Research Projects)

Description: Provide a Description (abstract) of the research proposed in the project according to the instructions on Form Page 2 of the PHS 398.  In addition, the abstract should contain a brief description of how the research project will contribute towards attainment of the multi-project program objectives.

Project/Performance Sites (Research Projects): List the performance sites where the research will be conducted.

Key Personnel (Research Projects)

Under "Key Personnel", list the Project Leader, followed by other key project personnel, and then other significant contributors.

Form Page 3. Table of Contents (Research Projects)

Prepare a Table of Contents for the research project using Form Page 3 of the PHS 398.

Form Page 4. and 5. Detailed Budget for Initial Budget Period (Research Projects)

Prepare a detailed budget and justification for the research project using Form Pages 4 and 5 of the PHS 398.

Individual Research Project Research Plan (Research Projects)

Specific Aims

List the broad long-range objectives and goals of the proposed project.  Concisely and realistically describe the hypothesis or hypotheses to be tested.  In addition, state the individual research project's relationship to the multi-project program goals and how it relates to other projects or cores.

Research Strategy

Use this section to 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. 

Organize the Research Strategy in the specified order as stated in the PHS 398 instructions.  Make sure to start each section with the appropriate section heading in order, Significance, Innovation, Approach, and include the appropriate information.  Experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy.  Preliminary Studies for projects should be included as part of the approach section, and must be contained within the page limits for the Research Strategy section.

For renewals also include in this section progress made during the previous funding period.

Milestones and Timeline: Within the research strategy, include a description of the yearly milestones that will be met by the proposed work and a corresponding timeline. 

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 PHS 398 Application Guide, with the following modification:

Resources Format Page (Research Projects)

Provide information on resources available for the project.  Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.)  For Early Stage Investigators, describe institutional investment in the success of the investigator.  If there are multiple performance sites, describe the resources available at each site.  Describe any special facilities used for working with biohazards or other potentially dangerous substances.

Biographical Sketch Format Page (Research Projects)

Do not repeat the biographical sketches of participating investigators since this information will be included at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).

Specific Instructions for Core(s)

Except for the requirements below, follow the PHS 398 Specific Instructions found at http://grants.nih.gov/grants/funding/phs398/phs398.html in preparing each proposed core. The admin core is required.  Scientific cores are optional.

For each individual Core, include:

Face Page (Cores)

The Face Page of the PHS 398 Form should not be used as a cover page for cores within a multi-project application.  Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual core.  This Cover Page will demarcate each individual research project and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page):

If yes:  Exemption number or IRB Approval Date (e.g., 07/03/2012, or Pending) and Federal wide Assurance (FWA) number

If yes:  IACUC Approval Date (e.g., 07/03/2012, or Pending) and Animal welfare assurance number

From:  (mmddyyy - e.g., 07/01/2012) To:  (mmddyyyy - e.g., 06/30/2017)

Format Page 2. (Cores)

Description: Provide a Description (abstract) of the core activities and services according to the instructions on Form Page 2 of the PHS 398.  In addition, the abstract should contain a brief description of how the core services will contribute towards attainment of the multi-project program objectives.

Project/Performance Sites (Cores): List the performance sites where the core activities will be conducted.

Key Personnel (Cores): Under "Key Personnel", list the Core Leader, followed by other key core personnel, and then other significant contributors.

Format Page 3. Table of Contents (Cores)

Prepare a Table of Contents for the research project using Form Page 3 of the PHS 398.

Format Page 4. and 5. Budget Pages (Cores)

Prepare a detailed budget and justification for the core using Form Pages 4 and 5 of the PHS 398.

Administrative Core Budget specifics:  Include travel funds for the PD/PI, Project Leaders and other relevant staff to attend the IMVC kickoff and annual meetings.  These meeting will take place in Bethesda, MD.  Total attendees at these meetings from each multi project program is limited to six.

Research Plan - Administrative and Scientific Cores

Specific Aims

For each of the required and optional cores, list in priority order the broad long-range objectives and goals of the proposed core.  In addition, state the individual core's relationship to the multi-project program goals and how it relates to two or more individual research projects or other cores in the application.

Research Strategy for Administrative Core (required)

Provide a Staffing and Administrative Plan that includes a discussion of the structure and roles of administrative and scientific staff, including, the committed level of effort, the training and experience of proposed staff and the functions to be performed; how resources will be prioritized, allocated, and managed.  Provide a plan to establish communication between the key personnel of individual research projects and cores. 

Applicants may propose to include an External Scientific Advisory Group (ESAG).  Specific potential members of the proposed ESAG should NOT be named in the application and ESAG candidates should NOT be recruited or contacted prior to review and award.  However, applicants may propose a plan describing the expertise needed for the external advisory group and descriptions of the types of individuals who would be asked to become advisory board members.  The applicant should explain the duties of the group and include costs for meetings of the group within the proposed budget.  NOTE:  renewal applicants MUST list the names of ESAG members from their previous U19 or U01 grant supported under the IMVC program.

Scientific Cores

Provide details of the services or resources provided by the optional cores to at least two Research Projects and explain the rationale for selecting the methods to accomplish the specific aims.  Describe how the core is essential to the overall multi-project program's efficiency and success.  Each proposed core MUST be utilized by a minimum of two Research Projects.

Resource Sharing Plan (Cores)

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 PHS 398 Application Guide, with the following modification:

Resources Format Page (Cores)

Provide information on resources available for the core.  Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.)  For Early Stage Investigators, describe institutional investment in the success of the investigator.  If there are multiple performance sites, describe the resources available at each site.  Describe any special facilities used for working with biohazards or other potentially dangerous substances.

Biographical Sketch Format Page (Cores)

Do not repeat the biographical sketches of participating investigators since this information will be included at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).

Foreign Institutions

Foreign (non-U.S.) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the PHS 398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS 398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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.  

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the PHS 398 Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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/priority 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).

Overall Impact– Individual Research Projects

Reviewers will provide an overall impact/priority 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 five scored review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria - Individual Research Projects

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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? Will the proposed studies foster the discovery of novel immune mechanisms and generalizable principles of anti-viral immunity?

Investigator(s)

Are the Research Project Leaders, 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?  Are novel immunological approaches proposed?

If animal studies are proposed, are they justified in terms of their relevance to human infection with or vaccination against viruses?

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?   

Additional Review Criteria – Overall, Projects, and 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/priority score, but will not give separate scores for these items.

Review Criteria - Cores

As applicable for the Cores proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, and will give a separate score for each Core, but not the individual items.

Administrative Core

Scientific Cores

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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

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

Revisions

Not Applicable

Additional Review Considerations - Overall, Projects, and 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/priority score.

Milestones and Timeline

Reviewers will comment on the feasibility and appropriateness of the proposed Milestones and Timelines within each project.              

Applications from Foreign Organizations

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

Select Agent Research

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

Resource Sharing Plans

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

Applications will be assigned to the appropriate NIH Institute or Center and 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 i. 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.

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 OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

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

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

PD(s)/PI(s) will have the primary responsibility for coordinating the Projects and Cores within the overall Program. Specifically, the PD(s)/PI(s) have primary responsibility as described below.

The PD(s)/PI(s) will be responsible for defining the research objectives, approaches and details of the projects within the guidelines of the FOA and retains primary responsibility for the planning, directing, and executing the proposed scientific activities.

The PD(s)/PI(s) will be responsible for:

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

An NIAID/NIH Program Officer will serve as the Project Scientist for the IMVC program and will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

Areas of Joint Responsibilities include:

A network of synergistic Immune Mechanisms of Virus Control (IMVC) centers will be established through this program to enable multidisciplinary approaches to advance this area of research.  The IMVC network will be governed by a Steering Committee to coordinate and facilitate research activities for the overall IMVC program, and to ensure optimal research flexibility, synergy, and efficiency.  The Steering Committee will include the PD/PI from each awarded U19 as a voting member and the NIAID Project Scientist as a non-voting member.  The PD/PI of each U19 will have one vote.  Awardees will be required to accept and implement policies approved by the Steering Committee.

The IMVC Steering Committee will meet quarterly by teleconference, except for one yearly face-to-face meeting in conjunction with the annual Scientific Meeting.  A Steering Committee Chair will be elected by majority vote from among the U19 PD/PI at the first Steering Committee meeting, and annually thereafter.

The responsibilities of the IMVC Steering Committee include the following:

An Infrastructure and Opportunities Fund (IOF) will be made available after award to support IMVC activities such as, exploratory pilot research projects and/or research resource development projects to capitalize on emerging opportunities to understand novel molecular and cellular immune responses to viral infections and/or vaccines, or for the development, production, characterization, and distribution of shared reagents, shared resources, or access to a unique resource. 

The IMVC Steering Committee will establish guidelines for the disbursal of the IOF.  These guidelines will include a process for:

After all IMVC awards have been issued, one awardee institution will be selected by NIAID to administer the IOF.  IOF expenditures will be restricted until a process for the prioritization, solicitation, and evaluation of applications and the disbursement of funds is established and agreed upon in writing by the Steering Committee.  Once this process is established, funds will be available for distribution.

Federally Mandated Regulatory Requirements for Clinical Research

Each institution participating in clinical research is required to meet DHHS regulations for the protection of human subjects.  At a minimum, this includes: 

Methods for assuring that each institution at which Program investigators are conducting clinical studies has registered with the Office of Human Research Protections (OHRP; http://www.hhs.gov/ohrp ) and has a Federal wide Assurance; that study protocols are reviewed and approved by the responsible Institutional Review Board (IRB) prior to participant entry; that active protocols are reviewed at least annually by the IRB, and that amendments are approved by the IRB.

Methods for assuring or documenting that each participant, or participant’s parent/legal guardian, gives fully informed consent to participation in a research protocol prior to the initiation of the intervention.

Intellectual Property

The awardee is solely responsible for the timely acquisition of all appropriate propriety rights, including intellectual property rights, and all materials needed for the awardee to perform the project.
Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the awardee any propriety rights, including intellectual property rights, or any materials needed by the awardee to perform the project.

The awardee is required to report to the U.S. Government all inventions made in the performance of the project, as specified by 35 U.S.C. Sect. 202 (Bayh-Dole Act).

Program Generated Data, Software and Other Resources

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 HHS, PHS, and NIH policies.  However, awardees must be committed to making research samples and tools, methods, data, and materials that they develop under the IMVC program available to other IMVC centers and the research community.

Publications

The PD(s)/PI(s) will be responsible for the timely submission to the NIAID of all abstracts, manuscripts and reviews (co)authored by members of the grant and supported in whole or in part under this Cooperative Agreement.  The PD(s)/PI(s) are requested to provide manuscripts to the NIAID Program staff at the time of acceptance by a Journal so that an up-to-date summary of program accomplishments can be maintained.  Publications and oral presentations of work conducted under this Cooperative Agreement are the responsibility of the PD(s)/PI(s) and appropriate Research Project and Core Leaders and will require appropriate acknowledgement of NIAID support.  Awardees are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, and reports to the NIAID, or other mechanisms.

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

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Lara R. Miller, M.S.
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-496-7551
Email: lrmiller@niaid.nih.gov 

Peer Review Contact(s)

Zhuqing (Charlie) Li, Ph.D 
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-9523
FAX: 301-480-2408
Email: liz@niaid.nih.gov  

Financial/Grants Management Contact(s)

Shellie Wilburn
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-594-9676
Email: sw270q@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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