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

Understanding the Functions of Uncharacterized Genes in Infectious Disease Pathogens (U19)

Activity Code

U19 Research Program – Cooperative Agreements

Announcement Type

New

Related Notices

  • September 12, 2012 - See Notice NOT-AI-12-050. Notice of Change in Part 2. Full Text of Announcement Section I. Funding Opportunity Description.

Funding Opportunity Announcement (FOA) Number

RFA-AI-12-028

Companion Funding Opportunity

None 

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.855; 93.856  

Funding Opportunity Purpose

The purpose of this FOA is to create a program to conduct functional genomics research that will increase our knowledge of the specific biochemical function(s) of hypothetical genes and unknown open reading frames (ORFs), and the function(s) of noncoding RNAs in the annotated genomes of infectious disease pathogens.

 
Key Dates
Posted Date

July 20, 2012

Letter of Intent Due Date

October 12, 2012

Application Due Date(s)

November 13, 2012   

AIDS Application Due Date(s)

Not Applicable. 

Scientific Merit Review

March, 2013   

Advisory Council Review

May, 2013 

Earliest Start Date(s)

July, 2013

Expiration Date

November 14, 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

Purpose

The purpose of this FOA is to create a program to conduct functional genomics research that will increase our knowledge of the specific biochemical function(s) of hypothetical genes, and unknown open reading frames (ORFs), and the function(s) of noncoding RNAs in annotated genomes of NIAID Category A through C and Emerging/Re-Emerging Diseases (priority lists available at (http://www.niaid.nih.gov/topics/emerging/pages/list.aspx)).  Although applications that are not directed specifically at the targeted pathogens are also responsive to this FOA, applicants must be aware that very limited funding is available for those types of pathogens.  

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.

The NIAID/DMID has recognized the potential of microbial genomic research and 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:

• Genome Sequencing Centers for Infectious Diseases provide rapid and cost-efficient production of high-quality genome sequences of human pathogens and related organisms, invertebrate vectors of infectious diseases, human and microbial genotyping and metagenomics analysis.

• Bioinformatics Resource Centers collect, integrate and provide open access to research data of microbial organisms and vectors of infectious diseases in a user-friendly format, develop and  share open source software tools, and provide bioinformatics services and training to the scientific community.

• Clinical Proteomics Centers for Infectious Diseases and Biodefense identify candidate pathogen and host biomarkers important for infectious diseases.

• Systems Biology Centers for Infectious Diseases identify and analyze molecular interaction networks of microbial pathogens and their host cells through a combination of computational and experimental high-throughput technologies.

• Structural Genomics Centers for Infectious Diseases experimentally characterize the three-dimensional atomic structure of proteins of pathogenic organisms.

To build upon the objectives of the NIAID Genomics programs and continue to address the Institute’s needs, NIAID is establishing a program to define the biochemical roles of hypothetical genes, and unknown ORFs, and the functions of noncoding RNAs in the annotated genomes of infectious disease pathogens.

Genomics analyses for microbial pathogens have repeatedly demonstrated there are many uncharacterized regions of these genomes including hypothetical genes, open reading frames with no known function(s), and potential genes for noncoding RNAs.  Some of these potential genes are evolutionarily conserved in microbial pathogens, implying these sequences may encode important and/or novel functions in the pathogen.  Utilization of state-of-the-art technologies is required to achieve breakthroughs in characterizing these components of sequenced genomes and understanding the relationship between a pathogen’s genes and gene products and their disease-causing effects in humans.  Increased understanding of the specific biochemical and physiological roles of these components of pathogen genomes will improve the annotation of these genomes and provide the foundation for the development of potential new targets for medical diagnostics, therapeutics and vaccines for infectious diseases.

Research Goals and Objectives

Research projects for each award in the program will focus on generating experimental evidence to determine the biochemical function(s) of hypothetical genes, unknown open reading frames (ORFs), and the function(s) of noncoding RNAs.  While the goal of this program is to determine the functions of as many genes as possible, all applicants must propose to study a minimum of 10 genes per year in each of the three categories of uncharacterized genes and include a focus on one or more NIAID Category A-C pathogens and Emerging/Re-Emerging pathogens

For this FOA:

Although the use of computational approaches is allowed and encouraged to develop predictions about the possible biochemical functions of gene products, the focus of the research conducted by each awardee of this Program must be to generate new experimental data from biochemical assays that confirms or elucidates the specific biochemical function(s) (enzyme, regulator, binding and transport, signal transduction, etc.) of protein products from hypothetical genes and unknown ORFs, and confirms or elucidates the biochemical role (inhibitor, activator, structural, etc.) of the noncoding RNAs.

Notes:

A Steering Committee will be established by NIAID in collaboration with the awardees to review the progress in 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 NIAID staff.  The Steering Committee is expected to consist of investigators who are not current collaborators of the funded programs.  Do not contact, recruit, or name potential Steering Committee members in your application.

In addition, an Annual Programmatic Meeting will be held to highlight recent findings, share knowledge of innovative technologies and methodologies, and encourage collaborations.  The meetings are expected to be attended by the PDs/PIs, 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 awarded Cooperative Agreement will assume responsibility for the meetings’ organization on a rotating basis.

Since the major goal of this FOA is to increase the infectious disease research community’s understanding of the specific biochemical function(s) of hypothetical genes and unknown ORFs and function(s) of noncoding RNAs , awardee(s) are encouraged to make the data and resources generated from this Program publicly available and easily accessible to the scientific community that is compliant with the NIAID Data and Reagents Sharing and Release Guidelines (http://www.niaid.nih.gov/LabsandResources/resources/dmid/gsc/Pages/data.aspx).  Awardees should communicate with the NIAID Bioinformatics Center(s) or their successors as one of the approaches to make information generated by this program available to the scientific community.

Applications must also include the following required cores (see below):  Administrative Core; Technology Core(s); 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 core(s).  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 cooperative agreement, and will provide overall management, coordination and supervision of the Program.  The Administrative Core will also specifically address communications within the Program and NIAID, data and information sharing within the Program, group meetings and teleconferences, presentation and publication of data, public dissemination of data and other resources generated under the program (refer to the terms and conditions of the award), awareness of development, progress, and outcomes of other awards in the program, the identification and resolution of problems. 

The administrative core is also responsible for:

TECHNOLOGY CORE(S) (Required)

Each award must include development and maintenance of one or more core resources/facilities that are essential for generating experimental evidence from biochemical assays to determine the biochemical function(s) of hypothetical genes and unknown ORFs, and function(s) of noncoding RNAs.  The role the core will play and its value to the program must be clearly described and justified.  The technologies should generate targeted measurements to achieve breakthroughs in characterizing hypothetical genes, unknown ORFs, and noncoding RNAs.

DATA MANAGEMENT AND RESOURCE DISSEMINATION CORE (Required)

Each awardee must include a Data Management and Resource Dissemination Core.  It is expected that a vast amount of data and other types of resources will be generated by this program.  The ability to perform sample tracking, data integration and management of data and information from a variety of experimental technologies is essential for the efficient and successful performance of the program.

In addition, NIAID strongly endorses the rapid release of experimental data, metadata, new analysis tools, novel reagents (e.g., expression vectors, expression arrays, libraries, protein clones, etc.) 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 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).

The contact PD/PI should commit at least 1.2 person-months (10% full-time professional effort) effort to the Administrative Core.  The Core Leaders of the Technology Core(s) and the Data Management and Resource Dissemination Core should commit at least 1.2 calendar months to their respective Cores.  Applications must give a clear description of the facilities, technologies and skills available for each Core, the role of the Core Leader and key personnel.  A budget must be provided for each Core.

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 $7.1 million in FY 2013 to fund 3-5 awards.

Award Budget

Application budgets are not limited, but need to reflect actual needs of the proposed project. 

Award Project Period

The 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 least4-6 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:

Frank De Silva, Ph.D.
Division of Extramural Activities
National Institutes of Allergy and Infectious Diseases
Room 3144, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817-7616 (for express/courier service; non-USPS service)
Telephone: 301-594-1009
FAX: 301-480-2408
Email: fdesilva@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:

Frank De Silva, Ph.D.
Division of Extramural Activities
National Institutes of Allergy and Infectious Diseases
Room 3144, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817-7616 (for express/courier service; non-USPS service)
Telephone: 301-594-1009
FAX: 301-480-2408
Email: fdesilva@niaid.nih.gov

Page Limitations

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

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/PI of the multi-project application, followed by the Project 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.

125,000

130,000

135,200

140,608

146,232

677,040

Project 2.

125,000

130,000

135,200

140,608

146,232

677,040

Project 3.

100,000

104,000

108,160

112,486

116,985

541,631

Core A. Admin. Core.

50,000

52,000

54,080

56,243

58,493

270,816

Core B. Technology Core

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 is limited to (12) pages. Describe how the proposed research program will increase the infectious disease research community’s understanding of the specific biochemical function(s) of hypothetical genes and unknown open reading frames (ORFs), and function(s) of noncoding RNAs in NIAID Category A through C and Emerging/Re-Emerging Diseases (priority lists available at (http://www.niaid.nih.gov/topics/emerging/pages/list.aspx)).  While the goal of this program is to determine the functions of as many genes as possible, all applicants must propose to study a minimum of 10 genes per year in each of the three categories of uncharacterized genes.  List which hypothetical genes and unknown open reading frames (ORFs) and noncoding RNAs will be studied for each pathogen included in the program and justify why these were selected for analysis.  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.

9 Checklist

One Checklist, placed at the end of the application, is to be submitted for the entire application Also, include checklists for each proposed sub award or consortia.

10. Appendix Materials

Refer to Section IV.9. “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:

Face 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):

Project Number and Title:  (e.g., 1. Preclinical Evaluation of Microbicides)

Name of Project Leader:  (e.g., Jones, Roberta A.)

Human Subjects: (Yes or No)

If Yes:

Exemption number, -or-

IRB Approval Date (e.g., 12/13/2006, or "Pending"), and Federal wide Assurance (FWA) number

Vertebrate Animals: (Yes or No)

If Yes:

IACUC Approval Date (e.g., 11/17/2006, or Pending) and Animal welfare assurance number:

Proposed Period of Support:

From: (mmddyy - e.g., 07/01/2007)

To: (mmddyy - e.g., 06/30/2112)

Costs Requested for Initial Budget Period: (e.g. 07/01/2007-06/30/2008)

Direct Costs: (e.g., $ 150,000)

Total Costs: (e.g., $162,000)

Costs Requested for the Entire Budget Period: (e.g., 07/01/2007-06/30/2112)

Direct Costs: (e.g., $700,000)

Applicant Organization (full address)

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.

Budget requests should include travel funds for the PD(s)/PI(s), Key Personnel, and Core Leaders to participate in the Kick-off meeting and Annual Programmatic Meetings.

5. Individual Research Project Research Plan

(A minimum of two individual research projects are required)

Specific Aims (Limited to 1 page.)

List in priority order, 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 all projects must 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.  Describe how the experimental evidence from biochemical assays generated by each research project will increase the infectious disease research community’s understanding of the specific biochemical function(s) of hypothetical genes and unknown open reading frames (ORFs), and function(s) of noncoding RNAs.  Describe any new methodology and its advantage over existing methodologies. Describe any novel concepts, approaches, tools, or technologies for the proposed studies. Discuss associations with clinical project(s). Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. As part of this section, provide a tentative sequence or timetable for the project.

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):

Core Letter and Core Title:  (e.g., A. Monoclonal Antibody Production Core)

Name of Core Leader:  (e.g., Smith, Robert A.)

Human Subjects (Yes or No)

If Yes,

Exemption Number, -or-

IRB Approval Date (e.g., 5/14/06, or Pending), and Federal wide Assurance (FWA) number

Vertebrate Animals (Yes or No)

If Yes,

IACUC Approval Date (e.g., 4/15/07, or Pending), and Animal welfare assurance number

Proposed Period of Support

From: (mmddyy, e.g., 07/01/2007)

To: (mmddyy, e.g., 06/30/2012)

Costs Requested for Initial Budget Period

Direct Costs (e.g. $50,000)

Total Costs (e.g. $70,000)

Costs Requested for the Entire Budget Period

Direct Costs (e.g. $212,323)

Total Costs (e.g. $297,252)

Applicant Organization (ABC University; 111 Main Street; Anywhere, Else 99999)

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 cores, (Administrative, Technology (ies), and Data Management and Resource Dissemination) list in priority order the broad, long-range objectives and goals for each core. In addition, state the core’s relationship to the Program’s goals and how it relates to the individual research projects or other cores in the application.

Core Services

Use this section to describe how the proposed core activities will contribute to meeting the Center'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 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 the Technology cores must be included as part of the approach section and must be contained within the page limits of the Core Services Plan section.

Each Core should be headed by a Core Leader with at least 1.2 Person-Months (10% full-time professional effort) of effort committed to the Core. Applications must give a clear description of the facilities, technologies and skills available for each Core, the role of the Core Leader and key personnel.  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 overall Program milestones, timelines and performance objectives (for example propose number of hypothetical genes, unknown open reading frames and noncoding RNAs to be analyzed per year) in a section of the application entitled “Milestones and Timelines”, which must also include milestones, timelines and performance objectives for each Core.

Technology Core(s) (required) (limited to 12 pages)

Provide a Staffing Plan that includes a discussion of the structure and roles of the core staff, including the committed level of effort, the training and experience of proposed staff.  Describe technology or technologies to be utilized in each core, equipment available for use on this project, throughput of the technology and staff experience utilizing each technology.

Data Management and Resource Dissemination 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 details of the data analyses, 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)

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 modifications:

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). 

Is the Program as a whole scientifically compelling?  Are the hypothetical genes and unknown open reading frames (ORFs) and noncoding RNAs from each pathogen in the program considered to be important and is there appropriate justification for their selection for analysis?  Are there coordination and synergy of the individual research projects and cores toward achievement of the central objectives of the Program? Are overall Program goals significant and focused on studies to generate experimental data to elucidate the specific biochemical function(s) (enzyme, regulator, binding and transport, signal transduction, etc.) of protein products from hypothetical genes and unknown ORFs, and the biochemical role (inhibitor, activator, structural, etc.) of the noncoding RNAs?  Will integration of the projects into a single Program be more beneficial than pursuing each project independently?  Do(es) the PD(s)/PI(s) have the leadership and scientific ability to develop, integrate, and implement a successful research Program? For applications designated multiple PD(s)/PI(s), is the Leadership Plan both adequate and appropriate to ensure that there will be sufficient coordination and communication among the PD(s)/PI(s)?  Are the overall Program milestones, timelines and performance objectives appropriate and feasible? Is the management plan for communication and fiscal accountability within the Program appropriate? Is there adequate evidence of sufficient institutional support for the PD(s)/PI(s) in terms of laboratory space, equipment and other resources?

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? If successful will the results of the project significantly increase the scientific community’s understanding of the specific biochemical function(s) (enzyme, regulator, binding and transport, signal transduction, etc.) of protein products from hypothetical genes and unknown ORFs, and the biochemical role (inhibitor, activator, structural, etc.) of the noncoding RNAs?  Will the successful completion of the aims change the understanding of the basic biology of the pathogen(s) included in the program, concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(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 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? Does the approach represent the best use of current or emerging technologies and appropriate collaborations to achieve the research objectives? 

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?  Is the proposed research likely to generate sufficient experimental data so that the specific biochemical function(s) of protein products from hypothetical genes and unknown ORFs, and noncoding RNAs are likely to be elucidated? 

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? Is an appropriate information technology capability and computational infrastructure available to support the data management, data analysis, data sharing, and computational requirements to conduct the project?       

Additional Review Criteria

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

Additional Review Criteria – Cores

Administrative Core

Technology Core(s)

Data Management and Resource Dissemination Core

Scientific Core(s)

Are the optional Scientific Cores justified and relevant to the theme of the overall Program? Is adequate justification provided that it will support at least two Research Projects?

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 Program   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

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), 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 Disease 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 U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

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

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

The Program Director/Principal Investigator is the designated contact PD/PI for multiple investigator awards. PD(s)/PI(s) will have the primary responsibility for coordinating the projects and Cores within the overall Program.

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 the scientific community’s understanding of the functions of hypothetical gene, unknown open reading frames and noncoding RNAs.  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 Program are expected to follow 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).  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:

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 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 Steering Committee is expected to consist of approximately 5-7 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 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 an NIAID Project Scientist.

Areas of Joint Responsibilities include:

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. 

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 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)

Maria Y. Giovanni, Ph.D.
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases (NIAID)
Room 4807, MSC-6603
6610 Rockledge Drive
Bethesda, MD 20892-6603
Telephone:  301-496-1884
FAX:  301-480-4528
E-mail: mgiovanni@niaid.nih.gov

Peer Review Contact(s)

Frank De Silva, Ph.D.
Division of Extramural Activities
National Institutes of Allergy and Infectious Diseases
Room 3144, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817-7616 (for express/courier service; non-USPS service)
Telephone: 301-594-1009
FAX:  301-480-2408
Email: fdesilva@niaid.nih.gov

Financial/Grants Management Contact(s)

Regina Kitsoulis
Division of Extramural Activities
National Institutes of Allergy and Infectious Diseases
Room 2246, MSC-7614
6700B Rockledge Drive
Bethesda, Maryland 20892-7614
Overnight Mail Only: Use Zip 20817
Telephone:  301-402-6245
FAX: 301-493-0597
Email: kitsoulisre@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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