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

Center for HIV/AIDS Vaccine Immunology and Immunogen Discovery (CHAVI-ID) (UM1)

Activity Code

UM1 Multi-Component Research Project Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AI-11-002

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

 93.855; 93.856 

FOA Purpose

This FOA, issued by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, solicits grant applications that propose to establish a Center for HIV/AIDS Vaccine Immunology and Immunogen Discovery (CHAVI-ID) to support a coordinated, multidisciplinary team of researchers focused on multi-pronged approaches to accelerate HIV vaccine development by addressing key immunological roadblocks to the discovery and development of a safe and effective HIV vaccine.

Key Dates
Posted Date

March 29, 2011

Letter of Intent Due Date

August 8, 2011

Application Due Date(s)

September 8, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February, 2012   

Advisory Council Review

May, 2012 

Earliest Start Date(s)

July, 2012 

Expiration Date

September 9, 2011 

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 National Institute of Allergy and Infectious Diseases (NIAID) invites applications to establish a Center for HIV/AIDS Vaccine Immunology and Immunogen Discovery (CHAVI-ID). CHAVI-ID will support a coordinated, multidisciplinary team of researchers focused on multi-pronged approaches to accelerate HIV vaccine development by addressing key immunological roadblocks to the discovery and development of a safe and effective HIV vaccine.

BACKGROUND

There are approximately 33.4 million people worldwide infected with the human immunodeficiency virus (HIV), the virus that causes the Acquired Immunodeficiency Disease (AIDS). In 2009, approximately 2.7 million people became newly infected with HIV.  Projections show that the number of new infections will remain high unless more effective measures are taken to prevent new infections. The U.S. Government has led global efforts to combat the HIV/AIDS pandemic through the President’s Emergency Plan for AIDS Relief, and commitments to the Global Fund to Fight AIDS, Tuberculosis and Malaria, for more than $32B, which is more than half of international HIV/AIDS assistance through 2010. Still, the human and economic tolls of HIV/AIDS demand that these largely therapeutic activities be complemented by an accelerated effort to develop a preventive HIV vaccine.

Researchers have been working to develop an HIV vaccine since the discovery of HIV as the etiologic agent of AIDS. Considerable progress in understanding early immune responses to HIV infection and the antigenic constituents of the virus has been made. However, only three vaccine concepts have been tested in efficacy clinical trials; two of these failed to show any efficacy while the other (the product studied in RV144, the Thai Trial) was only minimally efficacious. Although the preclinical and early clinical pipeline has many new candidates undergoing evaluation, few may be expected to demonstrate enough promise to justify large scale efficacy trials.

Even with the progress to date, a safe and effective vaccine that provides a high degree of protection from HIV infection is not yet in sight. HIV vaccine development is one of the most difficult scientific endeavors of our time and considerable challenges remain. HIV presents formidable scientific obstacles, including an unusually large genetic diversity, an ability to escape immune surveillance, and the ability to integrate into host cell genomes creating a long-lived viral reservoir. In addition, HIV vaccine development is a long and costly process, and there are numerous disincentives for the private sector to bring its best effort and expertise to bear on this urgent public health problem.

In June, 2003, twenty four leaders of research in immunology, HIV/AIDS science, and public health published a call for the creation of a Global HIV Vaccine Enterprise (also known as the “Enterprise”), a consortium to accelerate HIV vaccine development through enhanced global coordination, information sharing and collaboration (Klausner RK, Fauci AS, et al. Science 300:2036, 2003). These leaders concluded that an organized, strategic, collaborative, and well-funded effort was needed to tackle the formidable scientific and operational obstacles to HIV vaccine development. In 2005, in response to this call NIAID funded a large research consortium, the Center for HIV/AIDS Vaccine Immunology (CHAVI) focused on the study of key scientific obstacles, especially our lack of understanding of the host immune response during acute HIV infection, in order to inform HIV vaccine discovery.  The progress made in understanding early events in HIV infection through this research program has demonstrated the productivity of large, collaborative and multidisciplinary teams in addressing some types of research questions. The findings of CHAVI and others in: characterizing the transmitted/founder virus, explaining the lack of HIV neutralization by early anti gp120 antibody responses after infection, and elucidating the reasons for impaired B cell development early in HIV infection and the rapidity with which HIV-1 infection suppresses host immune responses suggest new approaches to explore in HIV vaccine design.  Also, the results from the RV144 vaccine trial in Thailand, which showed modest protection from infection, present a significant new opportunity for discovery in HIV vaccine design.

OBJECTIVE AND SCOPE

The objective of this FOA is to establish a new, large research consortium, the Center for HIV/AIDS Vaccine Immunology and Immunogen Discovery (CHAVI-ID), to undertake immunological research directed at tackling major scientific problems that still hinder HIV vaccine design. Over the 7-year period of award, this new research consortium should build on and extend the published results of CHAVI and apply state-of-the-art technologies and immunologic tools to focus on rational vaccine design.  The design of the vaccine will be based on specifically targeted epitopes that induce defined immune responses to be present at the time and location of transmission. The research to be designed and conducted by CHAVI-ID should elucidate the specificity, quality, quantity, and localization of immune responses capable of preventing acquisition of established HIV/SIV infection by, for example,

Examples of activities NOT supported by this FOA are listed below. Applications containing activities in these areas will be considered non-responsive and will not be reviewed.

CHAVI-ID  COMPONENTS

1. Overview Component:  Scientific Agenda and Strategic Plan

It is expected that the CHAVI-ID research will evolve during the award as developing technologies provide new opportunities of investigation and as findings eliminate some approaches from further consideration. This evolution should be within the context of an overall Scientific Agenda, presented in the overview section of the application, which defines the overall mission and short- and long-term scientific goals for the period of award. The agenda should also explain how the CHAVI-ID will contribute significantly to the development of a preventative HIV/AIDS vaccine. The Scientific Agenda of the applicant should present a coherent, coordinated and synergistic vision of HIV/AIDS vaccine discovery, and must include the following:

(a) theories on why past approaches have not worked,

(b) a description of knowledge gaps relevant to the systematic design and evaluation of immunogens and adjuvants eliciting persistent immune responses in humans at different anatomic locations and of different qualities and specificities that might reasonably be expected to prevent acquisition of infection with HIV-1, and

(c) a description of promising, novel product designs and anticipated scientific advances that may enable new approaches to the induction of persistent immune responses in humans that might reasonably be expected to prevent acquisition of HIV-1 infection. 

Applicants must also provide a Strategic Plan delineating processes and approaches to be used by the CHAVI-ID PI (CHAVI-ID Director), the internal CHAVI-ID Scientific Leadership Group (SLG), and the external CHAVI-ID Scientific Advisory Board (SAB) to set priorities, develop, review and approve new Research Foci and Research Support Components, and recruit new research investigators in the implementation of the Scientific Agenda as opportunities evolve over the period of the award, and develop and implement a strategy for discontinuing unproductive or unneeded Research Foci, Support Components, and associated personnel that are no longer required. An Infrastructure and Opportunities Fund (IOF) should be budgeted for in the Operations and Management Support Component section of the application. This Fund should be designed and managed to provide the ability to shift the allocation of CHAVI-ID resources during the 7 year award period as needed to implement the Scientific Agenda and take advantage of changing scientific opportunities. The Scientific Agenda should discuss the potential uses of this Fund in the first year and the Strategic Plan should clearly delineate the procedures for scientific review and evaluation of concepts, decision making, and allocation of this Fund.

2. Research Program Component:  Initial Research Foci

The application should not attempt to cover all conceivable areas of possible research with separate Research Foci from the start of the award period, nor should it contain detailed seven-year research plans for the initial Research Foci, so that the CHAVI-ID will have flexibility in growing and changing research direction to explore areas of new technology and opportunity as they arise. The CHAVI-ID Research Foci should not be written as stand-alone, severable Projects as in a multi-Project grant, but rather as aims and sub-aims within a single coherent research program.  However, the application should explain how the proposed Research Foci and future possible Research Foci fit within the overall Scientific Agenda. Recommendations for new or expanded Research Foci or termination of Research Foci after year one will be reviewed and approved by the CHAVI-ID SLG, and an NIAID-approved external Scientific Advisory Board (SAB; see Section VI. Award Administration Information 2 for more detail on the SAB), and NIAID.

The Initial Research Foci may concentrate on (1) induction of durable broad-coverage antibody responses of specific antiviral function (neutralizing antibodies, ADCC, mucosal antibodies, etc.) that can be shown to provide immunity that prevents acquisition of HIV-1 infection, (2) T cell responses of specific quality/duration that can effectively limit virus replication, (3) innate responses that can be manipulated to augment or accelerate protection (e.g. NK cell subsets), or (4) other areas of research directly relevant to prophylactic HIV vaccine design and discovery. The Research Program Section must propose two or more initial Research Foci.

3. Operations and Management Support Component.

An operations and management Support Component is required as it will serve as a resource to the entire center, providing overall management, coordination and supervision of the Program. The CHAVI-ID Director will also serve as the Leader of the Operations and Management Support Component and, in collaboration with Operations and Management Support Component staff, will be responsible for managing and coordinating the entire range of CHAVI-ID activities, monitoring progress, and ensuring that the CHAVI-ID Scientific Agenda and Strategic Plan is developed, reviewed and implemented effectively and efficiently. Since the CHAVI-ID is responsible for a larger amount of resources than the usual multi- Project grant and is responsible for using these resources in the most appropriate manner to meet the needs of the field of HIV vaccine discovery and design, it has the authority to, and will be expected to, recommend changes in the allocation of resources, according to its operating policies and procedures. This includes the responsibility for providing recommendations to modify or discontinue research activities with little translational potential and the responsibility to initiate new research activities (foci) with greater translational potential as the program evolves and matures.

While the Operations and Management Support Component will be the primary group responsible for the CHAVI-ID management, it is anticipated that the management of the Program will require considerable coordination of resources, facilities, research and development activities and investigators across broad scientific areas and multiple institutions/organizations. This will likely require subcontracting and transfer of funds between institutions on a scale beyond the usual research grant. The commitment of the awardee institution to facilitate the administration of the CHAVI-ID Operations and Management Support Component and inter-institutional activities of the Center will be crucial to achieving success.

4. Infrastructure and Opportunities Fund

An Infrastructure and Opportunities Fund (IOF) should be budgeted for in the application. The budget for this Fund should be contained within the Operations and Management Support Component budget, as the Operations and Management Support Component staff, performing as the management and operations facility for the overall Program, will be procedurally involved in all reallocations of resources. This Fund should be designed and managed to provide the ability to shift the allocation of CHAVI-ID resources during the 7 year award period as needed to implement the Scientific Agenda and take advantage of changing scientific opportunities. The budgets in the application should plan for an initial allocation of 20% of total costs to this Fund (i.e. up to $6 million) with that portion rising to up to 70% of total costs in out years. In the Overview section of the application, the Scientific Agenda should discuss the potential uses of this Fund in the first year and the Strategic Plan should clearly delineate the procedures for scientific review and evaluation of concepts, decision making, and allocation of this Fund.

5. Scientific Research Support Component(s) (optional)

One or more scientific research support components may be proposed.  These components can provide a service (e.g., structural biological analysis of antigens/candidate immunogens, or host genomic analysis in support of targeted immune responses) or may develop a specific Scientific Resource (e.g., collection/isolation of monoclonal antibodies of differing specificities, or collection of clinical specimens to support immunogen discovery, etc.)

A component facility to perform GMP manufacture or other preclinical development activities required to advance a candidate immunogen design into clinical trial will not be funded in the first year of the award and should not be one of the Components proposed and described in the application. Also, while the CHAVI-ID Scientific Agenda may address the role of clinical trials of vaccine candidates in the process of iterative design of an HIV vaccine, clinical trials will not be funded by this award. Expansion of the number, type and/or size of the Scientific Research Support Components may be considered in future years. Recommendations for new or expanded scientific resources or termination of scientific resources will be reviewed and approved by the CHAVI-ID SLG and SAB.

6. Scientific Leadership Group

While the CHAVI-ID Director and Operations and Management Support Component will be responsible for managing and coordinating the entire range of CHAVI-ID activities, the Strategic Plan also must include a Scientific Leadership Group (SLG), a cadre of established scientists who will contribute to the planning, development, implementation and management of the Scientific Agenda; as well they should also participate as leading investigators in the execution of CHAVI-ID-supported research. Members of the SLG are not required to have the same institutional affiliation as the CHAVI-ID Director, and multi-institutional collaborations (including international collaborations) are strongly encouraged. SLG members must be committed to focusing their main research activities within the CHAVI-ID Scientific Agenda in a highly collaborative and integrated manner, openly sharing information and assuring that the Scientific Agenda is implemented. The initial membership of the SLG (named in the CHAVI-ID application) should be limited to the CHAVI-ID Director and three to five other individuals. Initial SLG members may or may not also be the Leaders of Research Foci or Scientific Research Support Components; additional members should be selected with careful consideration to ensuring the breadth of expertise that will be necessary to formulate and implement the CHAVI-ID Scientific Agenda over the 7-year project period.

Section II. Award Information
Funding Instrument

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

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 $27.58 million in FY 2012 to fund 1 or 2 awards.

Award Budget

Direct costs are limited to $19 million per year.

Award Project Period

The total project period for an application submitted in response to this FOA may not exceed seven 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 Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations 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 Directors/Principal Investigators (PD/PIs) 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 four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) 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.

 This FOA will NOT support multiple PDs/PIs. A single PD/PI should be named for the overall application.  

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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. NIH will not accept any application that is essentially the same as one already reviewed.

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:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Peter R. Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3119, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817-7616 (for express/courier service; non-USPS mail)
Telephone: (301) 496-3133
Email: pjackson@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:

Peter R. Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3119, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817-7616 (for express/courier service; non-USPS mail)
Telephone: (301) 496-3133
Email: pjackson@niaid.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

Research Plan

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

Supplemental Instruction for the Preparation of Multi-Component Applications

The following section supplements the instructions found in Form PHS 398 for preparing a multi-component grant application (UM1). 

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

A. General Instructions

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

See Section IV.2, “Content and Form of Application Submission” and additional text below for page limitations associated with multi-component applications.

1. Form Page 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. Form Page 2

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

List the performance sites where the research will be conducted.

Under "Key Personnel", list the PD/PI of the multi-component application, followed by the Component Leaders of the research component foci and research support components, and co-investigators. Do not name other key project personnel and other significant contributors.

3. Form Page 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-component application.

Bearing in mind that the application will be scientifically reviewed research focus by research focus and support component by support component; 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 focus and support component.  A page reference should be included for the budget for each research focus and each support component.  Further, each research focus should be identified by number (e.g., Research Focus 1), title, and responsible Component Leader, and each Support Component should be identified by letter (e.g., Support Component A), title, and responsible Component 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 support components.)

SAMPLE: Consolidated Direct Cost Budget (in thousands) for All Proposed Years of Support

Component

Year 1

Year 2

Year 3

Year 4

Year 5

Year 6

Year 7

All Years

Research Focus 1. Antibodies

3,300

2,400

2,800

2,100

1,400

1,000

500

13,500

Research Focus 2.    T cells

2,600

2,000

700

0

0

0

0

5,300

Research Focus 3. Mucosal

400

1,200

1,400

2,100

1,400

1,500

1,500

9,500

Support Component A. Operations/Management*

5,600

6,300

7,000

8,400

9,800

10,500

11,000

58,600

Support Component B. Host Genomics

1,400

1,400

1,400

700

700

300

300

6,200

Totals

13,300

13,300

13,300

13,300

13,300

13,300

13,300

93,100


*Note: The Operations and Management Support component budget contains the Infrastructure and Opportunities Fund. While the application budget should read with an increasing amount allocated to this Fund, it is expected that yearly renewal budgets will reflect the continued allocation of IOF funds to new Research Foci, pilot projects and Research Support Components as well as expansion of initially proposed research activities such that no subsequent yearly budget will have an IOF budget as large as indicated in the application budget.

5. Form Page 5

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 research focus and support component (see below).  Also, use a second Form Page 5 to reflect the additional budget years requested. 

6. Biographical Sketch Format Page

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

7. Resources Format Page

Do not complete.  Essential information is to be presented in the individual research foci and support component sections of the application.

8. Program Overview (Scientific Agenda and Strategic Plan of the CHAVI-ID, may not exceed 30 Pages)

Scientific Agenda: –. The application must include a Scientific Agenda that defines the overall mission and short- and long-term scientific goals for the 7 year period of award that the applicant envisions will contribute significantly to the development of a preventative HIV/AIDS vaccine. The Scientific Agenda should present a coherent and synergistic vision of HIV/AIDS vaccine development.

a. The Scientific Agenda should include:

Strategic Plan: The Overview section of the application must also include a Strategic Plan that details the scientific goals, and proposed scope of activities for the CHAVI-ID. The Strategic Plan must specifically include a description of how the CHAVI-ID Director will implement the plan to achieve a fully functional Center in the first award year, with timelines, and objective milestones of the proposed planning process. In addition, the Strategic Plan should identify three to five investigators who will constitute the initial Scientific Leadership Group (SLG) of the CHAVI-ID and who may also be investigators in initial CHAVI-ID Research Foci or Scientific Research Support Components. However, POTENTIAL CHAVI-ID INVESTIGATORS AND THEIR INSTITUTIONS (OTHER THAN THE CHAVI-ID DIRECTOR, INITIAL MEMBERS OF THE SLG, AND KEY PERSONNEL OF INITIAL RESEARCH FOCI AND SUPPORT COMPONENTS) ARE NOT TO BE NAMED IN THE APPLICATION.

This section of the application must also describe the proposed approach, including chronology and objective milestones, for identifying additional research and development activities and investigators to be funded through the CHAVI-ID program over the 7-year award period. The proposed process and criteria to be used to identify and assess potential research and investigators should be described, along with the types of expertise and research topics that may be sought and a discussion of how these research projects will contribute to the scientific goals of the proposed Center.

It is expected that additional specific research activities, investigators and their institutions will be identified during the Strategic Plan implementation phase that takes place over the 7 years of the project period.

b. The Strategic Plan should include a detailed delineation of the processes for:

Sections not subject to Page Limits:

9. Checklist

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

10. Appendix Materials

Refer to the end of Section IV.2. “Appendix” below, for instructions on submitting appendix materials.

For each research focus or support component in the multi-component application, 3 publications plus other approved material are allowed.  

B. Specific Instructions for the Research Program section (may not exceed 30 pages)

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 Component.

The multi-component (UM1) application must propose two or more initial Research Foci. These Foci may concentrate on (1) induction of durable broad-coverage antibody responses of specific antiviral function (neutralizing antibodies, ADCC, mucosal antibodies, etc.) that will provide immunity that interferes with acquisition of HIV-1 infection, (2) T cell responses of specific quality/duration that can effectively limit virus replication, (3) innate responses that can be manipulated to augment or accelerate protection (e.g. NK cell subsets), or (4) other areas of research directly relevant to prophylactic HIV vaccine design and discovery. While the initial Research Foci should include multi-pronged approaches to immunogen design, the application should not attempt to cover all conceivable areas of possible research with separate Research Foci from the start of the award period so that the Center will have flexibility in growing and changing research direction to explore areas of new technologic opportunity as they arise. The CHAVI-ID Research Foci should not be written as stand-alone, severable Projects as in a multi-Project grant, but rather as aims and sub-aims within a single coherent research program. The Research Program should explain how the proposed Research Foci and future possible Research Foci fit within the overall Scientific Agenda presented in the  overview section of the application. It should be clear how each Research Focus implements the initial research vision of CHAVI-ID and is integral to the CHAVI-ID Scientific Agenda.

It is expected that the CHAVI-ID Director will devote at least three (3) calendar months to one of the proposed Research Foci in addition to the three (3) calendar months devoted to the Operations and Management Support Component.

For the overall Research Program Component, include:

For each Research Focus, include:

1. Cover Page

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

Focus Number and Title:  (e.g., 1. Induction of durable broad-coverage neutralizing antibody responses)

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

Human Subjects: (Yes or No)

Vertebrate Animals: (Yes or No)

Proposed Period of Support:

Costs Requested for Initial Budget Period: (e.g. 07/01/2012-06/30/2013)

Applicant Organization (full address)

2. Form Page 2

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

List the performance sites where the research will be conducted.

Under "Key Personnel", list the Focus Leader, followed by co-investigators only. Do not name other key project personnel and other significant contributors.

3. Form Page 3

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

4. Budget Pages (PHS 398 Form Pages 4 and 5)

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

For The overall Research Program, include:

5. Research Plan

Research Program Overview

List in priority order, the broad, long-range objectives and goals of each proposed research focus. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the focus’ relationship to the multi-component program goals and how it relates to other research foci or support components.

Research Strategy (by Research Focus)

Use this section to describe how the proposed research (focus by focus) 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 Scientific Agenda 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, Investigator, and Environment, 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 Research Foci should be included as part of the approach section

6. Resources

Provide information on resources available for the research program.  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).

8. Select Agent Research (if applicable)

As directed in the PHS 398 Instructions, provide a description of all facilities where the Select Agent(s) will be used in the project.  Describe the procedures that will be used to monitor possession, use and transfer of the Select Agent(s).  Describe plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).  Describe the biocontainment resources available at all performance sites.

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:

C. Specific Instructions for Research Support Component(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 support component.

The multi-component (UM1) application may propose Research Support Components as necessary to facilitate the proposed research plan. An Operations and Management Support Component is a required component of a CHAVI-ID application.

Operations and Management Support Component (required; limited to 12 pages): The Operations and Management Support Component is a resource to the entire multi-component grant, providing overall management, coordination and supervision of the Program. The CHAVI-ID Director and Operations and Management Component staff will be responsible for managing and coordinating the entire range of CHAVI-ID activities, monitoring progress, and ensuring that the CHAVI-ID research program is developed, reviewed and implemented effectively and efficiently. The CHAVI-ID is responsible for using its resources in the most appropriate manner to meet the needs of HIV vaccine discovery and design. The CHAVI-ID will have considerable flexibility and authority to redirect research and resource funding, and to initiate new activities/resources that support its Scientific Agenda. As part of the Operations and Management Component, the applicant will provide an administrative plan that includes a discussion of the structure and roles of administrative staff, including the training and experience of proposed staff and the functions to be performed; how fiscal and other resources will be prioritized, allocated and managed; how communications will be facilitated; and how research related travel and training will be budgeted. Funding for the overall administrative efforts, including secretarial, and/or other administrative services, expenses for publications demonstrating collaborative efforts, and communication expenses, should be requested in this component.  A plan for the Operations and Management Component describing: the structure and roles of proposed personnel; lines of authority; how fiscal and other resources will be prioritized and allocated; how fiscal accountability will be ensured, how communications throughout the CHAVI-ID will be facilitated; and the structure and role of any major committees proposed to assist in managing the CHAVI-ID's fiscal, operational and scientific activities. Applicants should describe how proposed policies and procedures provide structure for decision-making and resource allocation/reallocation, and how each of the following individuals or groups would participate in the decision process: the CHAVI-ID Director, the Scientific Leadership Group, other CHAVI-ID-supported investigators, and the CHAVI-ID SAB. The Operations and Management Component is also responsible for ensuring that any shared scientific resources/facilities (Scientific Research Support Components) of the CHAVI-ID are utilized to the fullest extent possible and that procedures are developed and implemented to ensure that such components’ resources/facilities are available to qualified investigators outside the CHAVI-ID. The CHAVI-ID Director must serve as the Leader of the Operations and Management Component and must commit at least 25% effort to these responsibilities in each year of the award, in addition to his/her own CHAVI-supported research activity effort included in a Project.

The budget for the Infrastructure and Opportunities Fund (IOF) should be placed within the Operations and Management Component budget. This Fund should be designed and managed to provide the ability to shift the allocation of CHAVI-ID resources during the 7 year award period as needed to implement the Scientific Agenda and take advantage of changing scientific opportunities. The overall budget in the application should plan for an initial allocation of 20% of total costs to this Fund with that portion increasing to up to 70% of total costs in out-years. The Scientific Agenda should discuss the potential uses of this Fund in the first year and the Strategic Plan should clearly delineate the procedures for allocation and management of this Fund.  Applications that do not include an IOF management plan will be considered non-responsive and will not be reviewed.

Finally, applicants should describe the nature and scope of the awardee institution commitment to the administration and the inter-institutional activities of CHAVI-ID Program that will be crucial to success; this commitment must be reflected in the institutional letter of commitment from the awardee institution. Applicants should also indicate if there are institutional policies that would prohibit the CHAVI-ID Director from devoting 50% or greater effort to CHAVI-ID.

Scientific Research Support Components (optional; limited to 6 pages each):  This section of the application should present a clear picture of the facilities, techniques, and skills that the research support component will provide and describe the role of the Scientific Research Support Component Leader and each of the key participants. The apportionment of dollars or percentage of dollars that will be required to support each research focus that will utilize each scientific support component should also be included in the budget. While GMP manufacture and other preclinical development activities are required to advance a candidate immunogen design into clinical trial, it is anticipated that immunogen discovery with subsequent proof-of-concept immunization studies in non-human primates will initially be the primary task of CHAVI-ID; also expenditure of CHAVI-ID funds on GMP manufacture will require case-by-case approval from NIAID.  Thus a Support Component facility to perform GMP manufacture or other preclinical activities required to advance a candidate immunogen design into clinical trial will not be funded in the first year of the award and should not be one of the Support Components described in this part of the application. Nor should the application describe in detail the establishment, personnel, or budget for such a component in any year of the award period. However, the application budget and the Strategic Plan, and Operations and Management Component should be structured with the flexibility and managerial control to enable sufficient shifting of funds to provide for GMP manufacturing capability in later years if discoveries in immunogen design merit human clinical trials. Also, a Clinical Trials Component should not be proposed in the CHAVI-ID application as clinical trials of candidate HIV vaccines should be performed in collaboration with the NIAID-funded HIV Vaccine Trials Network and/or other allied groups. A modest clinical studies support component may be proposed if it is essential to collect human specimens for the immunogen discovery work of CHAVI-ID. Also, funds may be budgeted, in the Operations and Management Support Component, for coordination of analysis of clinical specimens collected in clinical trials of novel HIV/AIDS vaccines.

For each individual support component, include:

1. Cover Page.

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

Support Component Letter and Support Component Title:  (e.g., A. Host Genomics Research Support Component)

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

Human Subjects (Yes or No)

Vertebrate Animals (Yes or No)

Proposed Period of Support

Costs Requested for Initial Budget Period

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 support component application, follow the usual PHS 398 instructions.

2. Form Page 2.

Provide a Description (abstract) of the component 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 component services will contribute towards attainment of the Scientific Agenda of CHAVI-ID.

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

Under "Key Personnel", list the Component Leader, followed by co-PIs only. Do not name other key project personnel and other significant contributors.

3. Form Page 3.

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

4. Budget Pages (PHS 398 Form Pages 4 and 5)

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

5. Research Plan

Specific Aims (Limited to 1 page.)

List in priority order, the broad, long-range objectives and goals of the proposed component. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the component’s relationship to the CHAVI-ID Scientific Agenda and how it relates to the research foci or other components in the application.

Support Component Services Strategy (Limited to 6 pages; Operations and Management Support Component limited to 12 pages.)

Use this section to describe how the proposed support component 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 support component to the primary theme of the multi-component application.

Organize the Support Component Services 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. 

6. Resources

Provide information on resources available for the support component.  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.) 

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).

8. Select Agent Research (if applicable)

As directed in the PHS 398 Instructions, provide a description of all facilities where the Select Agent(s) will be used with respect to the support component.  Describe the procedures that will be used to monitor possession, use and transfer of the Select Agent(s).  Describe plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).  Describe the biocontainment resources available at all performance sites.

SPECIAL REQUIREMENTS

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".

1. The CHAVI-ID Director

The CHAVI-ID Director must dedicate at least 50% effort (6 person months) for each year of the project period (this includes the effort required as Component Leader of the Operations and Management Support Component and the effort as the leader of one of the Research Foci).

2. Mandatory Meetings

Annual HIV Vaccine Meetings: The CHAVI-ID Director and members of the CHAVI-ID SLG must participate in annual meetings of the HIV/AIDS vaccine research community, such as the annual AIDS Vaccine meeting organized by the Global HIV Vaccine Enterprise. Support for attendance at these annual meetings will be provided through the CHAVI-ID Operations and Management Support Component budget.

Regular CHAVI-ID/NIAID Meetings and Teleconferences: The CHAVI-ID Director, SLG members, and all Principal Investigators of CHAVI-ID-supported research activities will participate in regular meetings with NIAID staff to review progress, discuss current and future research directions, and ensure that the necessary interdisciplinary interactions/collaborations are taking place in an effective manner. Starting in the second half of year 1 of the award, these regular meetings will be held at least semi-annually, with the location alternating between the Washington, D.C. area and the location of the awardee institution. These meetings will be organized by the CHAVI-ID Director and the dates will be determined by mutual agreement between the CHAVI-ID Director and the NIAID Project Scientist. In addition, the CHAVI-ID Director will also be responsible for organizing and conducting regular teleconferences with CHAVI-ID-supported investigators and other award staff as necessary to coordinate and manage the research activities being supported. Support for these regular CHAVI-ID meetings will be provided through the CHAVI-ID Operations and Management Support Component budget.

Other Meetings: NIAID organizes periodic meetings for the purpose of coordinating the efforts of other large, NIAID-supported research consortia (e.g. the HVTN, Non-human primate research consortia, B Cell Immunology researchers), as well as regular meetings of the AIDS Vaccine Research Subcommittee of the NIAID AIDS Research Advisory Committee. The CHAVI-ID Director and/or selected members of the SLG will be required to participate in as many as 3-4 such meetings a year with support for attendance provided through the CHAVI-ID Operations and Management Support Component budget.

Budget

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

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.

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.

For this particular announcement, note the following:

THE MOST CRUCIAL FUNCTIONS OF CHAVI-ID ARE THE SCIENTIFIC AGENDA AND STRATEGIC PLAN, THE RESEARCH PROGRAM, AND THE DEMONSTRATED CAPACITY TO IMPLEMENT AND MANAGE THE SCIENTIFIC AGENDA, STRATEGIC PLAN AND RESEARCH PROGRAM.

Overall Impact - Overall

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

Scored Review Criteria - Overall

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

Significance

Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center 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? Is the program as a whole scientifically compelling? Are the overall Center goals, as expressed in the Scientific Agenda and Strategic Plan, significant and how well do they address the key immunological roadblocks to the discovery and development of a safe and effective HIV vaccine and support  multiple approaches to accelerate HIV vaccine development?Does the application have a high likelihood of developing critical new knowledge about HIV immunology and correlates of immunity leading to new candidate HIV vaccine designs?  

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the Center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the PD\PI have documented experience in directing large, complex, integrated and multifaceted research activities?  Will the PD\PI and other Research Foci\Support Component Leaders devote adequate time and effort to the program?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? 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 Center 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 there coordination and synergy of the individual research components and support components towards the achievement of the central objectives of the program? Will the integration of the individual research foci into a single program be more beneficial than pursuing each component independently? Is the approach of the Scientific Agenda to HIV/AIDS vaccine discovery and design coherent and focused? Is the Strategic Plan feasible and does it have high technical merit for the implementation the Scientific Agenda of the proposed CHAVI-ID? Are there appropriate plans and mechanisms for budgetary reallocation and for selecting, reviewing and adding new activities and recruiting new Research Foci and Support Component Leaders? Are there appropriate and feasible plans to incorporate new research activities and/or scientific resources/facilities in response to emerging opportunities or to eliminate unproductive research and/or resources/facilities? Are there appropriate and feasible plans for allocating and managing the Infrastructure and Opportunities Fund (IOF)? Are the proposed milestones, and metrics to monitor, quantify and evaluate progress and productivity appropriate and feasible?    

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 there adequate evidence of sufficient institutional support for the PI in terms of laboratory space, equipment, administrative and other resources?   

Additional Review Criteria - Overall

As applicable for the Center 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 Center 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

As applicable for the Center 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

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Review Criteria for the Research Program Component - Overall

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

Are the individual Research Foci well-reasoned and appropriate to accomplish the goals of the proposed Center?  Are there coordination and synergy of the individual research foci towards the achievement of the central goal of the Research Program? Is the Research Program well integrated into and synergistic with the overall application including the other components?

Overall Impact- Individual Research Focus

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the Research Focus 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 Research Focus proposed

Scored Review Criteria for the Individual Research Focus

Each individual Initial Research Focus proposed will receive an impact/priority score.  Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. A focus does not need to be strong in all categories to be judged likely to have major scientific impact.  For example, a research focus area that by its nature is not innovative may be essential to advance a field. 

Significance

Does the research focus address an important problem or a critical barrier to progress in the field?  If the aims of the focus 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?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the research plan?  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 do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the program?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the research focus?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the work is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

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 research proposed?  Will the research benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

Review Criteria for the Operations and Management Support Component

Reviewers will consider each of the criteria below in the determination of scientific merit and give one overall Impact Score for this Component: Is the administrative framework adequate and appropriate, with clear lines of authority and responsibility for the CHAVI-ID management? Is the management plan for fiscal accountability and communications within the CHAVI-ID and with the NIAID appropriate? Is the administrative framework adequate to address recruitment needs?  Are the administrative plans for the management of research, including plans for reallocating resources and resolving conflicts, appropriate?  Is there adequate evidence of sufficient institutional support for the PI in terms of administrative and other resources?

Review Criteria for Scientific Research Support Components (if applicable)

Reviewers will consider each of the criteria below in the determination of scientific and technical merit and give one overall impact score for each Research Support Component: Is provision of additional resources or component services for the Research Program critical and justified?  Is the relationship of  the scientific research support component to the central focus of the overall program strong?  Are the quality of the relevant facilities or services provided and criteria for prioritization and usage appropriate?  Are the qualifications, competence, and commitment of the Component Leader and key personnel appropriate?  Are the added component facilities appropriate and adequate to support the research program? Does the new component contribute to the central focus of the overall CHAVI-ID, and is this contribution well described and justified? Are the criteria for prioritization and usage of initial and supplemented component facilities or services (including procedures, techniques, and quality control) appropriate?

Additional Review Criteria

As applicable for the support component or research focus proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, 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.

Inclusion of Women, Minorities, and Children

When the proposed research or support component 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.

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, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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.

Additional Review Considerations

As applicable for the support component or research proposed, reviewers will address 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.

Select Agents 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 (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Budget and Period Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Allergy and Infectious Diseases, 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:

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:

The NIAID reserves the right to conduct site visits or reverse site visits prior to award when deemed essential.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee 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 reside 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:

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

Areas of Joint Responsibility include:

Dispute Resolution:

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

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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)

Stuart Z. Shapiro, M.D., Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-0122
Email: sshapiro@mail.nih.gov  

Peer Review Contact(s)

Peter Jackson, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: (301) 496-3133
Email: pjackson@niaid.nih.gov

Financial/Grants Management Contact(s)

Shellie M. Wilburn
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-594-9676
Email: swilburn@mail.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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NIH Funding Opportunities and Notices


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