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

“OMICS” Technologies For Predictive Modeling of Infectious Diseases (U19)

Activity Code

U19 Research Program – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AI-12-027

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 purpose of this FOA is to develop and validate predictive models of infectious disease initiation, progression and outcomes. These models will be derived from the study of the architecture and dynamics of systems-wide host/pathogen molecular interaction networks during infection, using integrated datasets generated from a combination of “omics” technologies. 

Key Dates
Posted Date

June 8, 2012

Letter of Intent Due Date

September 7, 2012

Application Due Date(s)

October 8, 2012   

AIDS Application Due Date(s)

Not Applicable. 

Scientific Merit Review

February, 2013   

Advisory Council Review

May, 2013 

Earliest Start Date(s)

July, 2013

Expiration Date

October 9, 2012 

Due Dates for E.O. 12372

Not Applicable.

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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.

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

BACKGROUND

The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) supports research related to the basic understanding, treatment and ultimately prevention of infectious, immunologic and allergic diseases that threaten millions of human lives.  The NIAID Division of Microbiology and Infectious Diseases (DMID) supports a comprehensive extramural research program focused on the prevention and control of diseases caused by virtually all infectious agents (with the exception of the Human Immunodeficiency Virus). This includes basic research, such as studies of microbial biology and physiology; applied research, including the development of medical diagnostics, therapeutics and vaccines; and clinical trials to evaluate experimental drugs and vaccines.

NIAID/DMID has recognized the potential of microbial genomic research and, in the last few years, has made a significant investment in genomic-related activities that provide to the scientific community comprehensive, publicly accessible resources for genome sequencing, transcriptomics, proteomics and bioinformatics, as well as rapid availability of data and reagents for basic and applied research (http://www.niaid.nih.gov/topics/pathogenGenomics/research/Pages/relatedInitiatives.aspx) in support of the Institute’s mission. NIAID-supported genomic research programs include:

To build upon the objectives of the NIAID Genomics programs and continue to address the Institute’s needs, NIAID is expanding its Systems Biology Program  (see: http://www.niaid.nih.gov/labsandresources/resources/sb/Pages/default.aspx ).

In 2008 NIAID established four Systems Biology Centers for Infectious Diseases that utilize  a combination of computational and experimental high-throughput methodologies (transcriptomics, proteomics, metabolomics and lipidomics) to conduct research projects to analyze, identify, quantify, model, and predict the overall structure and dynamics of the molecular networks of the cellular components of microbial pathogens and their interactions with the host cells. The research findings provide a deeper understanding of the overall complexity of the biological and biochemical molecular processes in the pathogen’s cells as well as how the molecular events within the pathogen lead to the initiation and progression of infectious disease in the host. The knowledge generated from the research projects, including research data, analytical software tools, computational models, experimental protocols, and reagents, is widely disseminated to the scientific community through publicly accessible databases and reagent repositories. The systems biology program was established not only to build upon, expand and integrate the data, resources and technologies generated through the NIAID Genomics and other programs but also, more importantly, to encourage a shift of thinking to adopt less traditional, more global and high-throughput approaches to conduct infectious diseases basic research, in order to provide insights into the biology of microbes, their role in pathogenesis and their interactions with the host.

PURPOSE

The purpose of this initiative is to establish a Program that utilizes a combination of computational approaches and “omics” technologies to develop predictive modeling of infectious disease initiation, progression and outcome. The Program should have a solid foundation on data analysis and mathematical modeling  to identify, quantify, model and predict the architecture and dynamics of systems-wide host/pathogen molecular interaction networks, including metabolic, regulatory and signaling networks, at different stages of infection.  

State-of-the-art next-generation sequencing, transcriptomics, proteomics, metabolomics  and other high-throughput "omics" technologies enable the efficient generation of very large experimental data sets that can be integrated to build/train predictive computational models of complex biological systems.  This vast amount of data presents a number of challenges for data integration and analysis; however, it also provides an unprecedented opportunity for generating robust predictive models of the molecular processes occurring in the pathogen and the host at different stages of infection. The availability of predictive models of host/pathogen interaction networks is anticipated to significantly increase the scientific community’s understanding of how changes at the molecular level relate to the phenotypes observed within a biological system during infection. This may result in the identification of novel strategies to counteract pathogen-mediated cellular alterations in the host, and consequently, the development of new therapeutic interventions. For example, modeling of host regulatory pathways targeted by viral strains of high/low pathogenicity may facilitate the prediction of strain-specific host response to antiviral therapies that involve those pathways.

NIAID strongly endorses the rapid release and public dissemination of experimental data, metadata, statistical models, new analysis tools, novel reagents and other resources generated under the Program to enable the broad scientific community to utilize the available resources and pursue new research hypotheses.  The Programs funded under this FOA are expected to follow the requirements and timelines described in the NIAID Data and Reagents Sharing and Release Guidelines (http://www.niaid.nih.gov/LabsAndResources/resources/dmid/gsc/Pages/data.aspx) as well as those in the Data Sharing Guiding Principles for the NIAID/DMID Systems Biology Program (http://www.niaid.nih.gov/LABSANDRESOURCES/RESOURCES/DMID/SB/Pages/DataReleaseGuidelines.aspx)

Research Projects

 This initiative will support Programs that include at least two synergistic Research Projects that utilize a systems biology approach to identify, quantify, model and predict the overall architecture and dynamics of the molecular interaction networks of pathogenic organisms with their host cells during infectious disease. All research projects should be organized around a central theme and have their foundation on one primary, biological hypothesis about the infectious disease/s to be investigated under the proposed Program. Activities related to experimental data integration, analysis, model development and validation are as important to this Program as experimental high-quality data generation.

Research projects must apply a systems biology approach and should include, but is not limited to the following characteristics:

This FOA will not support Programs that focus exclusively on the molecular interaction networks of the pathogen with no consideration of those in the host, and vice versa. Examples of Programs that are not responsive include:

A Steering Committee will be established by the NIAID in collaboration with the awardees to review the progress in meeting the goals of all Programs funded under this FOA and will make recommendations for the continuation or re-direction of all projects and activities of the funded Programs on an ongoing basis and in consultation with the NIAID staff. The Steering Committee is expected to consist of investigators who are not current collaborators of the funded programs.

Applications must also include the following required cores (see below): Administrative Core; Technology Core(s); Modeling Core; Data Management and Resource Dissemination Core. Applications can also include optional Scientific Cores which provide(s) scientific services or resources to at least two Research Projects and that are not duplicative of other services or facilities available in the required cores.  In addition, each Core must support two or more projects.

ADMINISTRATIVE CORE (Required)

Each application must include an administrative core headed by the contact PD/PI.  An administrative core is a resource to the multi-project grant, providing overall management, coordination and supervision of the Program.  The Administrative Core should specifically address communications within the Program and the NIAID, data and information sharing within the Program, group meetings and teleconferences, presentation and publication of data, public dissemination of data, models and other resources generated under the program (refer to the Terms and Conditions of the Award), awareness of development progress and outcomes of other projects within the program, the identification and resolution of problems, and engagement of the Steering Committee and NIAID. The Administrative Core should evaluate and monitor the performance of the Program with respect to the proposed timelines and milestones for all the activities to be performed.

The administrative core is also responsible for the following activities:

Staffing and Administrative Plan

The Administrative Core should provide a Staffing and Administrative Plan that includes a discussion of the structure and roles of scientific and administrative staff, including the training and experience of proposed staff and the functions to be performed; how resources will be prioritized, allocated and managed.

Milestones and Timelines

In addition, applicants are also required to provide integrated overall Program milestones, timelines and performance objectives in a section of the Core entitled “Milestones and Timelines” which should include those of the Research Projects and Core activities.

Training Program Plan

A training program for the broader infectious disease scientific community should be provided to promote the use of the systems biology approach that is based on the combined use of “omics” technologies and mathematical modeling. The Training Program will begin in the second year of the award and is expected to instruct and increase the number of infectious disease researchers that can use the approaches/methodologies and resources (datasets, analysis tools, models, etc.) utilized and generated under this initiative. Appropriate training programs include, for example, the organization of hands-on workshops to promote the use by non-modelers of the predictive models and analysis tools developed by the program; the opportunity for post-doctoral candidates and junior faculty from the broad scientific community in the areas of microbiology and infectious diseases to spend extended periods of time at the high-throughput technology facilities and/or with the modeling laboratories, the hosting of summer schools, etc. Funding for the overall administrative efforts for the Training Programs should be requested in the Administrative Core as a separate line item starting in year 2 of the budget. 

Pilot Research Program Plan

In order to facilitate the development of innovative concepts to study infectious diseases with systems biology and advanced technologies, NIAID is also interested in supporting under this initiative a Pilot Research Program that must relate to the overall Program’s theme. The Pilot Research Program is expected to begin on the second year of the award and pilot research projects should be short-term and focused on high-risk, innovative approaches or applications. Examples of appropriate pilot research projects are the use of proteomics and metabolomics technologies to functionally characterize microbial communities from in vivo infected samples, development and testing of imaging techniques to study the epigenetics processes of the host in response to infection, development of high-throughput assays to characterize and/or validate the biochemical or/and physiological role of targeted proteins or genes, development of high-throughput single cell assays that probe individual host cell responses  to infection.

Applicants may not submit in their application descriptions of the projects that would be supported by the Pilot Research Program; these will be proposed, selected and approved after the award. Each applicant must submit a Pilot Research Program Plan that describes procedures for soliciting applications for the Pilot Research Projects, selecting the most promising projects for review and concurrence by the NIAID, and monitoring progress of the projects and the management of the funds associated with each with the Pilot Research Program.

The Pilot Research Program will begin not earlier than the second year of the award, with Pilot Research Projects phased in during the duration of the award. While the specific number of Pilot Research Projects to be supported is at the discretion of the Program’s leadership, total funding for these projects may not exceed $200,000 in total costs in any one year and the Pilot Project leader must commit at least 1.2 person months effort.

Funding for the overall administrative efforts for the Training Program should be requested in the Administrative Core as a separate line item starting in year 2 of the budget.  Do not include the funds for the Pilot Research projects in the budget.

Annual Programmatic Meetings

These meetings will be held to highlight recent findings, share knowledge of innovative technologies and methodologies, and encourage collaborations. Each awarded Program will assume responsibility for the meetings’ organization once over the award period. The meetings are expected to be attended by the PD(s)/PI(s), Research Projects and Core Leaders and other key personnel, Steering Committee members and NIAID staff. These meetings are anticipated to be held at a location at/near Bethesda, MD or at another NIAID-approved site and will last for 1-2 days. Each awardee should budget for travel to the yearly meeting. Costs for organizing the annual meeting should not be included in the budget.   

The programmatic kick-off meeting will be held within 3 months of award and will be organized by the NIAID Project Scientist in coordination with all funded Programs at a location at/near Bethesda (MD).

Technology Cores (required)

Each Program must include 2 or more high-throughput “omics” technologies organized into one or more Cores to provide shared resources to the Research Projects. Examples of “omics” technologies of interest include but are not limited to those for next-generation sequencing, transcriptomics, proteomics, metabolomics, lipidomics, and others. These technologies should be used to conduct not only systems-wide molecular profiling studies but also more targeted measurements, such as quantitative targeted proteomics  (e.g. MRM: Multiple Reaction Monitoring) and validation of protein/protein or protein/DNA interactions.

Modeling Core (required)

The modeling core is responsible for identifying, quantifying, modeling and predicting the overall architecture and dynamics of the molecular interaction networks of pathogenic organisms with their host cells during infectious disease. The core is also expected to contribute to the statistical experimental design of the Research Projects including, for example, power calculations, the sampling times and number of replicates in a time course infection study, etc.

Applicants should provide the plan to integrate experimental datasets and develop predictive models of infection to be inferred from the study of molecular networks of systems-wide interactions between the pathogen and the host. The Plan should also describe how the systems biology approach will be utilized to undergo iterative cycles of modeling of networks’ architecture and dynamics, predictions of microbial and host systems’ responses to changes/perturbations/alterations of experimental conditions and models' experimental validations.

Data Management and Resources Dissemination Core (required)

It is expected that a vast amount of data and other types of resources will be generated by the application of omics and other technologies on a large number of samples. The ability to perform sample tracking, data integration and management of data and information from a variety of experimental technologies and collaborating sites is essential for the efficient and successful performance of the Program.

In addition, NIAID strongly endorses the rapid release and public dissemination of experimental data, metadata, statistical models, new analysis tools, novel reagents (e.g., expression vectors, expression arrays, libraries, protein clones), and other resources generated under the Program to enable the broad scientific community to utilize the available resources and pursue new research hypotheses.  The Programs funded under this FOA are expected to follow the requirements and timelines described in the NIAID Data and Reagents Sharing and Release Guidelines (http://www.niaid.nih.gov/LabsAndResources/resources/dmid/gsc/Pages/data.aspx) as well as those in the Data Sharing Guiding Principles for the NIAID/DMID Systems Biology Program (http://www.niaid.nih.gov/LABSANDRESOURCES/RESOURCES/DMID/SB/Pages/DataReleaseGuidelines.aspx)

Applications submitted in response to this FOA should provide details of the data integration, management and tracking activities of the Program and include a Plan for public dissemination of generated resources to the scientific community.

Other Scientific Cores (optional)

These optional cores should provide scientific services or resources to at least two Research Projects. Cores must be well justified and clearly not duplicative of other services or facilities available in the required cores.  Examples of acceptable cores include: an imaging core, an animal infection core, etc.

Each required and optional core should be headed by a Core Leader who commits at least 1.2 person-months effort to the Core. Applications must give a clear description of the facilities, techniques and skills that each core will provide to the research projects, the role of the core leader and key personnel. A budget must be provided for each Core.

Note: Applications lacking the required cores will be deemed not responsive and will not be reviewed.

Note: Costs associated with prospective human sample collection will not be covered by the grant.

Section II. Award Information
Funding Instrument

Cooperative Agreement

Application Types Allowed

New

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIAID intends to commit $13 million in FY 2013 to fund 4 awards.

Award Budget

Application budgets are not limited, 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 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

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 PHS398 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 Director(s)/Principal Investigator(s) (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 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending 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 PHS398 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:

Eleazar Cohen, Ph.D.
Division of Extramural Activities 
National Institute of Allergy and Infectious Diseases
Room 3129, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
FEDEX zip code: 20817
Phone: (301) 435-3564
Fax: (301) 480-2408
email:  ecohen@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:

Eleazar Cohen, Ph.D.
Division of Extramural Activities 
National Institute of Allergy and Infectious Diseases
Room 3129, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
FEDEX zip code: 20817
Phone: (301) 435-3564
Fax: (301) 480-2408
email:  ecohen@niaid.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.

Budget for Entire Proposed Period of Support

Funding for the overall administrative efforts for the Training and Pilot Research Programs should be requested in the Administrative Core as separate line items starting in year 2 of the budget.  Do not include the funds for the Pilot Research projects in the budget.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Supplemental Instruction for the Preparation of Multi-Project Applications

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. 

The supplemental instructions for multi-project applications below are divided as follows:

A. General Instructions – addresses collaborative efforts among research projects, the administrative and organizational structure as well as the overall facilities and environment, and the overall budget.

B. Specific Instructions for Individual Research Projects – describes modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the Project.

C. Specific Instructions for Cores – Describes modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the Core.

A. General Instructions

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

1. Face Page

Items 1 - 14: complete these items as instructed. This should be the first page of the entire application and all succeeding pages should be numbered consecutively.

2. Description

Using Page 2 of Form 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

Under "Key Personnel", list the PD(s)/PI(s) of the multi-project application, followed by the Research Projects and Core Leaders of the component research projects and cores, and other key personnel and then other significant contributors.

3. Table of Contents

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."

4. Composite Budget

Do not use Form Page 4 of PHS Form 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

 

 

 

 

 


5. Total Direct Costs for the Entire Budget Period

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).

6. Biographical Sketch

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

7. Resources

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

8. Program Overview (Research Objectives and Strategic Plan)

Specific Aims (Limited to 1 page)

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 (Limited to 12 pages)

This 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. If possible, provide evidence that the applicant and the proposed collaborators have prior experience of using a systems biology approach, highlight accomplishments in the field and describe the synergy and collaborations that occurred.

This section should also highlight past performance and major accomplishments in the area of “omics” technologies, systems biology, predictive modeling and infectious diseases.

9. Checklist

One Checklist, placed at the end of the application, is to be submitted for the entire application.

10. Appendix Materials

Refer to Section IV.6. “Appendix Materials” below, for instructions on submitting appendix materials.

For each project or core in the multi-project application, 3 publications plus other approved material are allowed. 

B. Specific Instructions for Individual Research Projects

Except for the requirements below, follow the PHS 398 Specific Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each research project.

For each individual Research Project, include:

Cover page (see special instructions, below)

Description & Key personnel (PHS 398 Form Page 2)

Table of Contents (PHS 398 Form Page 3)

Budget Pages (PHS 398 Form Pages 4 and 5); with budget justifications

Research Plan

Resources

1. Cover Page

The Face Page of the 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):

2. Description

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

Project/Performance Sites

List the performance sites where the research will be conducted.

Key Personnel

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

3. Table of Contents

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

4. Detailed Budget for Initial Budget Period

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

5. Individual Research Project Research Plan

(A minimum of two individual research projects are required)

Specific Aims (Limited to 1 page.)

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 Program’s goals and how it relates to other projects or cores.

Research Strategy (Limited to 12 pages.)

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, Section 5.5. 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 of the Research Strategy section.

Research Projects

Describe the research design conceptual procedures, and analyses to be used to accomplish the specific aims of the project. Indicate the targeted microbial organism/s and the related human infectious disease; if relevant, identify the related species/strains/genera that will be used to study and compare the behavior of pathogen’s and/or host’s molecular interaction networks in response to related infections. 

In vitro studies alone in the absence of in vivo studies are not responsive to the FOA. If proposing to use samples from human subjects indicate the source of the samples and provide evidence that the samples are appropriate for use by the project, for example the number of samples available, relevant sample metadata, expected quality and quantity of materials for “omics” profiling, sample de-identification protocol, etc.  If available, copies of the IRB documentation, protocol/s and consent form/s should be added in an Appendix of the application. If using animal models for the infection studies, provide a description of how the research findings are applicable and relevant to the study of the infectious diseases in humans.  As noted previously, costs associated with prospective human sample collection will not be covered by the grant. 

Describe how the Technology, Modeling, Data Management and Dissemination and Other Scientific cores will, both individually and in a complementary manner, contribute to the project. Describe how cycles of experimental data generation, analysis and integration, modeling, prediction and validation will be accomplished in a systems biology approach. Describe any new methodology and its advantage over existing methodologies. Describe any novel concepts, approaches, tools, or technologies for the proposed studies. Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims.

6. Resources

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.

7. Biographical Sketch

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). 

C. Specific Instructions for Core(s)

Except for the requirements below, follow the PHS 398 Specific Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each proposed core.

For each individual Core, include:

Cover page (see special instructions, below)

Description & Key personnel (PHS 398 Form Page 2)

Table of Contents (PHS 398 Form Page 3)

Budget Pages (PHS 398 Form Pages 4 and 5); with budget justifications

Core Services Plan

Resources Format Page

1. Cover Page

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

The following are specific instructions for sections of the PHS 398 application form that are to be completed differently than usual.  For all other items in the core application, follow the usual PHS 398 instructions.

2. 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 objectives.

Project/Performance Sites

List the performance sites where the core activities and services will be conducted.

Key Personnel

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

3. Table of Contents

Prepare a Table of Contents for the core using page 3 of Form PHS 398. 

4. Budget Pages

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

5. Individual Core Services Plan

Specific Aims (Limited to 1 page.)

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 core’s relationship to the Program’s goals and how it relates to two or more individual research projects or other cores in the application.

Each core should be headed by a Core Leader with at least 1.2 Person Months of effort committed to the Core. A budget must be provided for each Core.

Administrative Core (required) (Limited to 12 Pages)

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 a Training Program and a Pilot Research Program beginning with the second year of the award. In addition, applicants are also required to provide overall Program’s milestones, timelines and performance objectives in a section of the application entitled “Milestones and Timelines”, which must include also those of the Research Projects and all Core activities. The budget request should also include travel funds for the PI(s)/PD(s), Research Projects and Core Leaders to participate in Annual Programmatic Meetings of all Programs funded under this FOA, including the kick-off meeting. Provide a management plan for fiscal accountability and communication within the Program.

Technology Cores  (limited to 12 pages)

Use this section to describe how the proposed core activities will contribute to meeting the Program's goals and objectives and explain the rationale for selection of the general methods and approaches proposed to accomplish the specific aims.  In addition, this section should indicate the relevance of the core to the primary theme of the application.

Organize the Core Services Plan in the specified order as stated in the PHS 398 Instructions, Section 5.5.  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 new cores must be included as part of the approach section and must be contained within the page limits of the Core Services Plan section.

Modeling Core (required) (Limited to 12 Pages)

Provide the plan to contribute to the experimental design of the proposed research projects and to integrate experimental datasets and develop predictive models of infection to be inferred from the study of molecular networks of systems-wide interactions between the pathogen and the host. Describe how the models will be tested and experimentally validated.

Data Management and Resources Dissemination Core (required) (Limited to 6 Pages)

Provide details of the data integration, management and tracking activities of the Program and include a Plan for public dissemination of generated resources to the scientific community that is consistent with the guidelines and timelines described in the NIAID Data and Reagents Sharing and Release Guidelines (http://www.niaid.nih.gov/LabsAndResources/resources/dmid/gsc/Pages/data.aspx) as well as those in the Data Sharing Guiding Principles for the NIAID/DMID Systems Biology Program (http://www.niaid.nih.gov/LABSANDRESOURCES/RESOURCES/DMID/SB/Pages/DataReleaseGuidelines.aspx).

Other Scientific Cores (optional) (Limited to 6 Pages)

Provide details of the services or resources provided by the optional cores to at least two Research Projects and clarify how the optional cores are not duplicative of other services or facilities provided by the required cores.

6. Resources

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.

7. Biographical Sketches

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).

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 PHS398 Application Guide, with the following modification:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Foreign Institutions

Foreign (non-US) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the PHS398 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 PHS398 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.  

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, and technologies that drive this field?   

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(s)/PI(s), 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 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 the targeted pathogens (species, strains, genera) and host systems adequate?  Are the proposed human primary cells adequate and human samples, if proposed, well-documented and characterized? If using animal models, is the model relevant and appropriate to investigate human infectious diseases?  Are the samples technically adequate for analyses by HTP “omics” and other technologies with respect to quality and quantity of the materials? Are the contributions of each core involved in this project appropriate and well integrated with the aims of the project?

Is the project’s implementation of a systems biology approach adequate?

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.   

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

Not Applicable.

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.

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.

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/priotity score, and will give a separate score for each Core, but not the individual items.

Administrative Core

Technology, Modeling, Data Management and Resources Dissemination, Other Scientific Cores

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NIAID,  in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments 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 l. 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(s)/PI(s) 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, CCR 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.

Principal Investigator Rights and Responsibilities

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:

The multi-disciplinary and collaborative nature of the Programs funded under this FOA creates an extraordinary opportunity for information exchange and scientific advancement of systems biology applied to infectious diseases research.  Programs’ investigators are expected to take advantage of this opportunity by participating in both formal events established expressly for this purpose and informal investigator-initiated dialogues.

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: 

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.

The Programs funded under this FOA are expected to follow the requirements and timelines described in the NIAID Data and Reagents Sharing and Release Guidelines (http://www.niaid.nih.gov/LabsAndResources/resources/dmid/gsc/Pages/data.aspx) as well as those in the Data Sharing Guiding Principles for the NIAID/DMID Systems Biology Program (http://www.niaid.nih.gov/LABSANDRESOURCES/RESOURCES/DMID/SB/Pages/DataReleaseGuidelines.aspx) Program-generated data and software should be made available through publicly accessible web and database sites, including the Web Portal, the BRCs (http://www.niaid.nih.gov/dmid/genomes/brc/default.htm), the NCBI (http://www.ncbi.nlm.nih.gov/) and/or other public repositories, as identified by the Steering Committee in consultation with the NIAID.

Program-generated data and software include, for example:

Whenever possible, the awardee shall provide software certified by the Open Source Initiative (http://www.opensource.org/licenses/), to guarantee the right of others to read, redistribute, modify, and freely use the software.

Program-generated novel reagents (e.g., expression vectors, mutant strains, libraries, protein clones), should be made available through NIAID-supported repositories, such as the NIAID BEI Resources (http://www.beiresources.org/) or in other repositories as identified by the Steering Committee in consultation with the NIAID.

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 prior to the submission to the 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.

Steering Committee

A Steering Committee will be established by the NIAID to review the progress in meeting the goals of all Programs funded under this RFA, including also the activities of all Training and Pilot Research Programs as well as the data/other resources’ dissemination activities.  The PD(s)/PI(s) of the awarded programs will provide NIAID with suggestions for members of the Steering Committee within the first 6 months from award. The Steering Committee is expected to consist of approximately 13 individuals who are not key personnel or collaborators of the key personnel of any of the awardees. The Steering Committee will make recommendations for the continuation or re-direction of all projects and activities of the funded Programs on an ongoing basis and in consultation with the NIAID staff. The NIAID may re-budget individual U19 funds based on recommendations of the Steering Committee.

The Steering Committee will prepare concise (3-4 pages) summaries of the Steering Committee meetings which will be delivered to members of the group and NIAID within 30 days. The Committee will meet on an annual basis in conjunction with the Annual Programmatic Meetings and on ad-hoc basis by conference calls, as needed. Committee’s meetings will include NIAID staff, and may include   PD(s)/PI(s) and other members of the funded Programs as necessary.

The Steering Committee will select one member to be the Chair of the Committee and the Chair will not be a NIAID staff member. 

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

The role of the NIAID/NIH Project Scientist in the cooperative agreement is to support and encourage the recipient's activities by substantial involvement as partners and facilitators in the process without assuming responsibilities that remain with the PDs/PIs.  The NIAID Project Scientist will work closely with the PD(s)/PI(s) and other Program member scientists to facilitate collaborations and to leverage the resources available to the Program.

The NIAID Project Scientist will monitor the progress of the Program, help coordinate research approaches among all Programs funded through the FOA, and contribute to the shaping of research projects or approaches as warranted. The NIAID Project Scientist will support and facilitate this process but will not direct it. 

The NIAID Project Scientist will keep the Program informed about other ongoing studies supported by NIAID to avoid duplication of effort and encourage sharing/collaboration in infectious diseases research.  The NIAID Project Scientist will coordinate access for the Program to other NIAID resources, as well as assist the research efforts of the Program by facilitating access to fiscal and intellectual resources provided by industry, private foundations, NIH intramural scientists and other federal government agencies as appropriate.

The NIAID Project Scientist will serve as a non-voting member of the Steering Committee and will assist in developing the operating guidelines and consistent policies for dealing with situations that require coordinated action.

The NIAID Project Scientist will review, make recommendations and provide suggestions for Pilot Research Project applications.

The NIAID Project Scientist will retain the option to recommend, with the advice of the Steering Committee, the withholding or reduction of support from any cooperative agreement that substantially fails to achieve its goals according to the milestones agreed to at the time of the award or fails to comply with the Terms and Conditions of the award.

Additionally, a NIAID program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned program official may also serve as the NIAID Project Scientist.

Collaborative Responsibilities

The NIAID Project Scientist will provide overall coordination across all funded Programs, will coordinate with the PD(s)/PI(s) and hold regular program-wide discussions to facilitate the achievement of program goals. In the event that some members of the Programs develop common research interests working groups may be formed to pursue collaborative activities.

In addition, PD(s)/PI(s), Research Project and Core Leaders and the NIAID Project Scientist will participate in the Steering Committee activities as needed. 

Arbitration Process
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 arbitration. An Arbitration 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 arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 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) 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)

Valentina Di Francesco
Division of Microbiology and Infectious Diseases
Room 4802, MSC-6603
6610 Rockledge Drive
Bethesda, MD 20892-6603
Phone:  (301) 496-1884
email: vdifrancesco@niaid.nih.gov

Peer Review Contact(s)

Eleazar Cohen, Ph.D.
Division of Extramural Activities 
National Institute of Allergy and Infectious Diseases
Room 3129, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
FEDEX zip code: 20817
Phone: (301) 435-3564
Fax: (301) 480-2408
email:  ecohen@niaid.nih.gov

Financial/Grants Management Contact(s)

Cheryl Wall, M.S.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2231, MSC-7614
6700B Rockledge Drive
Bethesda, MD 20892-7614  (express 20817)
Phone: (301) 451-2696
Fax: (301) 493-0597
email: wallcy@niaid.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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