Center for HIV/AIDS Vaccine Immunology (CHAVI)

RFA Number: RFA-AI-04-051

Part I Overview Information

Department of Health and Human Services
(http://www.hhs.gov/)

Participating Organization:
National Institutes of Health (NIH), (http://www.nih.gov/)

Component of Participating Organization:
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)

Announcement Type:
New Announcement

Update: The following update relating to this announcement has been issued:


Catalog of Federal Domestic Assistance Number(s):

No. 93.855, Immunology, Allergy, and Transplantation Research
No. 93.856, Microbiology and Infectious Diseases Research

Key Dates
Release Date: September 30, 2004
Public Briefing: November 8, 2004
Letters Of Intent Receipt Date(s): January 21, 2005
Application Receipt Dates(s): February 23, 2005
Peer Review Date(s): June, 2005
Council Review Date(s): June, 2005
Earliest Anticipated Start Date: August, 2005
Additional Information To Be Available Date (URL Activation Date): http://www.niaid.nih.gov/ncn/budget/QA/rfa-04-051.htm
http://www.niaid.nih.gov/daids/chavi/default.htm October 1, 2004
Expiration Date: February 24, 2005

Due Dates for E.O. 12372
Not Applicable

Executive Summary

NIAID seeks to establish a Center for HIV/AIDS Vaccine Immunology (CHAVI) that will support intensive and highly collaborative projects addressing key immunological roadblocks to the discovery and development of a safe and effective HIV vaccine as defined by NIAID and identified by the Global HIV Vaccine Enterprise. Over the 7-year project period the research to be designed and conducted by CHAVI will address: (1) the elucidation of (a) early immunologic and virologic events after HIV-1 infection in humans, and/or (b) immune correlates for protection in animal models; (2) the systematic design and evaluation of immunogens and adjuvants eliciting persistent mucosal and/or systemic immune responses; and (3) the evaluation of vaccine candidates in early phase clinical trials. First year funding will support a CHAVI Director and the awardee institution for (1) the further development and initial implementation of a Scientific Agenda and Strategic Plan for all CHAVI activities; (2) the Management and Operations resources to coordinate and manage the entire range of CHAVI activities; (3) research, to be undertaken by the CHAVI Director and investigators in the CHAVI Scientific Leadership Group, focusing on: elucidation of early immunologic and virologic events after HIV infection, and/or elucidation of correlates of immune protection in non-human primate models; as well as initiating the systematic evaluation of vaccine candidates and immunization strategies to enhance mucosal immunity, potency, antigen presentation and immunogenicity; and (4) the development of scientific resources and facilities essential to implement the Scientific Agenda. Expanded funding in the second and subsequent years will support additional research and additional investigators to fully implement the CHAVI Scientific Agenda.

Telecommunications for the hearing impaired: TTY 301-451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

  Section I. Funding Opportunity Description
    1. Research Objectives

  Section II. Award Information
    1. Mechanism(s) of Support
    2. Funds Available

  Section III. Eligibility Information
    1. Eligible Applicants
      A. Eligible Institutions
      B. Eligible Individuals
    2.Cost Sharing
    3. Other - Special Eligibility Criteria

  Section IV. Application and Submission and Instructions
    1. Address to Request Application Information
    2. Content and Form of Application Submission
    3. Submission Dates
      A. Receipt and Review and Anticipated Start Dates
        1. Letter of Intent
      B. Sending an Application to the NIH
      C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements

  Section V. Application Review Information
    1. Criteria
    2. Review and Selection Process
    3. Merit Review Criteria
      A. Additional Review Criteria
      B. Additional Review Considerations
      C. Sharing Research Data
      D. Sharing Research Resources

  Section VI. Award Administration Information
    1. Award Notices
    2. Administrative and National Policy Requirements
     A. Cooperative Agreement Terms and Conditions of Award
        1. Principal Investigator Rights and Responsibilities
        2. NIH Responsibilities
        3. Collaborative Responsibilities
        4. Arbitration Process
    3. Award Criteria
    4. Reporting

  Section VII. Agency Contact(s)
    1. Scientific/Research Contact(s)
    2. Peer Review Contact(s)
    3. Financial/ Grants Management Contact(s)

  Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description

1. Research Objectives

PURPOSE

The National Institute of Allergy and Infectious Diseases (NIAID) invites applications to establish a Center for HIV/AIDS Vaccine Immunology (CHAVI). CHAVI will support intensive, coordinated, and multi-pronged approaches to address key immunological roadblocks to the discovery and development of a safe and effective HIV vaccine as defined by NIAID and as identified by the Global HIV Vaccine Enterprise. Over the 7-year project period, the research to be designed and conducted by CHAVI will address: (1) the elucidation of (a) early immunologic and virologic events after HIV-1 infection in humans, and/or (b) immune correlates for protection in animal models; (2) the systematic design and evaluation of immunogens and adjuvants eliciting persistent mucosal and/or systemic immune responses; and (3) the evaluation of vaccine candidates in early phase clinical trials. The first year of funding will provide support to the CHAVI Director and the awardee institution for (1) the further development and initial implementation of a Scientific Agenda and Strategic Plan for all CHAVI activities; (2) the Management and Operations resources to coordinate and manage the entire range of CHAVI activities; (3) research, to be undertaken by the CHAVI Director and investigators in the CHAVI Scientific Leadership Group, focusing on: elucidation of early immunologic and virologic events after HIV infection, and/or elucidation of correlates of immune protection in non-human primate models; as well as initiating the systematic evaluation of vaccine candidates and immunization strategies to enhance mucosal immunity, potency, antigen presentation and immunogenicity; and (4) the development of scientific resources and facilities essential to implement the Scientific Agenda. Expanded funding in the second and subsequent years will support additional research and additional investigators to fully implement the CHAVI Scientific Agenda.

PUBLIC BRIEFING

NIAID will hold an informational session on November 8, 2004 for representatives of groups considering submission of applications in response to this RFA. Details of the meeting will be published on the NIAID HIV vaccine web site http://www.niaid.nih.gov/daids/vaccine/default.htm and in the NIH Guide to Grants and Contracts. Representatives from the Division of AIDS (DAIDS) and the Division of Extramural Activities (DEA), NIAID will provide information and answer questions pertinent to preparation of applications in response to this RFA. This CHAVI RFA Public Briefing session will be available for remote viewing from the NIH VideoCast site at http://videocast.nih.gov. After the event the videocast will be saved to a web site to be announced later. Individuals with disabilities who need reasonable accommodation to participate in this event should contact Dr. Jody Sachs 301-896-4037 or jsachs@niaid.nih.gov, two weeks prior to the event.”

Research Objectives

Background

Every year approximately five million people worldwide are infected with the human immunodeficiency virus (HIV), the virus that causes the Acquired Immunodeficiency Disease (AIDS). Almost 14,000 people become newly infected each day and 45 million additional infections are projected to occur by 2010 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 an Emergency Plan for AIDS Relief, and commitments to the Global Fund to Fight AIDS, Tuberculosis and Malaria, for more than $1.96B, or approximately 36% of worldwide pledges through 2008. 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, and considerable progress has been made. One vaccine concept has been tested in large scale clinical trials, a second is currently in a phase III trial, and two more are poised to enter efficacy trials in the next few years. In addition, the preclinical and early clinical pipeline has many new candidates undergoing evaluation.

Even with this progress, 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 unusual genetic diversity, an ability to escape immune surveillance, and the ability to integrate into host cell genomes creating a long-time 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.

Global HIV Vaccine Enterprise: 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.

A series of meetings and consultations involving 120 experts from 15 countries and the WHO and UNAIDS ensued over the subsequent 12 months (see Klausner RK, Fauci AS et al Science 303:1296, 2004). These meetings culminated in reports from six working groups in the areas of: (1) vaccine discovery, (2) product development, (3) manufacturing, (4) laboratory standardization, (5) clinical trials capacity and, (6) regulatory and intellectual property issues. A Steering Committee, comprised of representatives of the Enterprise founders who authored the Science commentary and helped lead activity development to date, summarized common themes and scientific priorities that emerged from these discussions (NIAID will publish a Notice in the NIH Guide to Grants and Contracts referring interested investigators to the website for the Global HIV Vaccine Enterprise Scientific Blueprint referenced in this RFA, when it is posted; alternatively, the Blueprint can be obtained from the Division of AIDS Program Officer listed below.).

The development of a safe and effective prophylactic vaccine against HIV-1/AIDS is one of the highest priorities of the National Institutes of Health (NIH). Within NIH, the NIAID has a lead role in this endeavor and supports a number of research programs using multiple funding mechanisms. Two prominent examples of these research programs are the HIV Vaccine Design and Development Teams (HVDDT) and the Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) programs which have led to the development and manufacture of several products currently undergoing testing in Phase I and I/II clinical trials. However, more research is clearly needed to understand the immune parameters required for protection against infection from HIV-1, and for the design and development of adjuvants and/or other approaches that focus on the induction of persistent mucosal and/or systemic immune responses against HIV.

The focus of this RFA addresses: (1) the elucidation of (a) early immunologic and virologic events after HIV-1 infection in humans; and/or (b) immune correlates for protection in animal models; (2) the systematic design and evaluation of immunogens and adjuvants eliciting persistent mucosal and/or systemic immune responses that can be explored in animal models and human studies; and (3) the evaluation of vaccine candidates in early phase clinical trials. This focused approach is similar to the NIAID-supported intramural research and development programs of the Dale and Betty Bumpers HIV Vaccine Research Center (VRC), whose mission is to conduct research that facilitates the development of effective vaccines for multiple human diseases. The VRC is currently focused on the development of technology for the use of adenoviral vectors and DNA in delivering HIV immunogens to humans, and on novel envelope immunogens.

This RFA is designed to create an extramural HIV/AIDS vaccine center, like the VRC except focused solely on HIV/AIDS, to expand research addressing immunological roadblocks and the design and evaluation of adjuvants and/or other approaches to induce mucosal and/or persistent HIV-specific immunity.

Objectives and Scope

The objective of this RFA is to establish a Center for HIV/AIDS Vaccine Immunology (CHAVI) to undertake immunological research directed at tackling major scientific problems that hinder HIV vaccine design and testing, as defined by NIAID and as identified by the Global HIV Vaccine Enterprise (see note above for how to obtain the Global HIV Vaccine Enterprise “Blueprint”.). Over the 7-year project period, the research to be designed and conducted by CHAVI will address: (1) the elucidation of (a) early immunologic and virologic events after HIV-1 infection in humans; and/or (b) immune correlates for protection in animal models; (2) the systematic design and evaluation of immunogens and adjuvants eliciting persistent mucosal and/or systemic immune responses that can be explored in animal models and human studies; and (3) the evaluation of vaccine candidates in early phase clinical trials.

The first year of funding will support the CHAVI Director, the awardee institution, and investigators in the CHAVI Scientific Leadership Group to initiate implementation of a Scientific Agenda and Strategic Plan to apply state-of-the-art immunological approaches to investigate roadblocks in HIV vaccine design, and to translate the findings into improved vaccine design and/or incorporation of novel adjuvant combinations. Support for the first year of the project period will also enable (1) the establishment of Management and Operations resources to coordinate and manage all CHAVI activities; (2) research, to be undertaken by the CHAVI Director and investigators in the CHAVI Scientific Leadership Group; and (3) the development of scientific resources and facilities essential to perform the research program. Expanded funding in the second and subsequent years of the project will support full implementation of the Scientific Agenda and Strategic Plan, including the addition of research activities and investigators from multiple institutions to perform the mission of the Center. The overall goal is to assemble a team of highly committed individuals dedicated to the systematic evaluation and advancement of improved vaccine candidates into clinical testing. When appropriate, and in accordance with NIH policies ( http://grants.nih.gov/grants/policy/data_sharing and ( http://www.ott.nih.gov/policy/rt_guide_final.html) the awardee and CHAVI-supported investigators will be expected to collaborate; share novel research resources; and share both positive and negative results that would help guide the research and development activities within the scientific community.

The initial focus of CHAVI's research activity must be on one or both of the following areas of immunological investigation: (a) the elucidation of early immunologic and virologic events after HIV-1 exposure/infection in humans, including studies of exposed, uninfected persons and of HIV-infected persons during the acute to early stage of disease and/or; (b) the elucidation of the correlates of immune protection in non-human primate models in which there was protection from acquisition of infection (e.g., post-inoculation antiretroviral treatment to prevent establishment of persistent, productive SIV infection in macaques, or immunization with live, attenuated SIV and pathogenic virus challenge). If the Center chooses to focus on elucidation of the correlates of protection in non-human primate models, it may elect to conduct non-human primate studies independently, and/or in collaboration with other groups, to apply state-of-the-art immunological tools in a thorough and systematic manner to assess potential correlates. The research plan may call for the expansion of these research areas in the second and subsequent years.

In addition, in the first year of the project period, support will be provided to initiate the systematic evaluation of vaccine candidates and immunization strategies that enhance potency, antigen presentation and immunogenicity, with a focus on novel adjuvants, particularly molecular adjuvants with promise to augment memory immune responses and/or on approaches that induce persistent, mucosal immune responses. This work should expand after the first year. Vaccine candidates and immunization strategies to be evaluated may be developed by CHAVI-supported investigators, other investigators outside of the CHAVI scientific infrastructure, and/or the pharmaceutical industry. Such evaluations will follow a CHAVI-defined process for decision-making, use standardized immune measurements to allow for valid comparisons between candidate preclinical and clinical vaccines, and will be conducted in a closely coordinated and focused manner. In addition, CHAVI will be expected to advance vaccine candidates into pilot clinical trials independent of and/or in collaboration with NIAID-supported HIV vaccine trial network(s). Although research and development priorities may shift depending on how the field progresses and the Global Enterprise Strategic Plan evolves, the focus of the CHAVI will remain on the application of state-of-the-art immunological tools to address priority challenges in HIV vaccine design and development.

CHAVI Core Scientific and Management/Operations Structure

1. Scientific Agenda and Strategic Plan

Scientific Agenda

The Scientific Agenda defines the overall mission and short- and long-term scientific goals for the 7-year project period of award that will contribute significantly to the development of a preventive HIV/AIDS vaccine. The Scientific Agenda presents a coherent, coordinated and synergistic vision of HIV/AIDS vaccine development, and must include the following:

  1. A discussion of the state-of-the-art of research focused on elucidating (a) early immunologic and virologic events after HIV-1 infection of people; and/or (b) immune correlates for protection in animal models
  2. A description of knowledge gaps and scientific opportunities relevant to the systematic design and evaluation of immunogens and adjuvants eliciting persistent mucosal and/or systemic immune responses in humans
  3. A description of promising products and approaches to the induction of persistent mucosal and/or systemic immune responses in humans to HIV antigens
  4. A milestone-driven plan (with quantifiable go/no-go decision making criteria for advancement through product development) for the preclinical development and systematic evaluation of vaccine candidates in clinical trials.

Strategic Plan

The Strategic Plan details the scientific goals and scope of activities, milestones and timelines for the first year of the project period. The Strategic Plan also delineates the processes and approaches to be used by the CHAVI Director and leadership group to implement activities into a fully functional center, and defines the timelines, objective milestones, and measurable outputs of the Scientific Agenda and Strategic Plan. The Strategic Plan includes a detailed delineation of the processes for:

The Strategic Plan also includes the names of three to four initial members of the 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 as participate as principal investigators in the planning and execution of CHAVI-supported research. Members of the SLG are not required to have the same institutional affiliation as the CHAVI 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 Scientific Agenda in a highly collaborative and integrated manner, openly sharing information, assuring that the Scientific Agenda is implemented. Initial SLG members should be selected with careful consideration to ensuring the breadth of expertise that will be necessary to formulate and implement the CHAVI Scientific Agenda over the 7-year project period.

The specific details and steps involved in fully implementing the Scientific Agenda (e.g., identification of additional research activities and investigators, scientific resources and facilities, necessary support services, etc.) and the budget for these activities will be developed during the first year of the award and must be approved by the CHAVI Executive Committee (CEC). (Additional information on the CEC is provided under “COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD” below).

2. CHAVI Management and Operations Group

The CHAVI Director and Management and Operations Group staff will be responsible for managing and coordinating the entire range of CHAVI activities, monitoring progress, and ensuring that the CHAVI Strategic Plan is developed, reviewed and implemented effectively and efficiently. The CHAVI Director must serve as the director of the Management and Operations Group and must commit at least 25% effort to these responsibilities in all years of the award, in addition to his/her own CHAVI-supported research activity effort. The Management and Operations Group is responsible for developing and implementing policies, procedures and processes for the ongoing evaluation of CHAVI-supported research activities and for the assessment of new research activities to meet the priorities of NIAID and the Global HIV Vaccine Enterprise. The CHAVI is responsible for using its resources in the most appropriate manner to meet the needs of its Scientific Agenda. Thus it has the authority 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 for initiating new research activities with greater translational potential as the program evolves and matures. The CHAVI will have considerable flexibility and authority to redirect research and resource funding, and to initiate new activities/resources that support the Scientific Agenda. Any recommendations resulting in a change of scope in the funded Scientific Agenda requires approval of the NIAID Grants Management Official.

The Management and Operations Group director and staff are also responsible for the central administration and fiscal management of the CHAVI. This responsibility includes, but is not limited to, ensuring that appropriate systems are in place to provide for the biosafety and security of materials, data and facilities, including compliance with regard to animal use and research involving human subjects. Institutions must be in compliance with U.S. laws and regulations and DHHS and NIH policies in effect at the time of grant award and during the period of performance of the research.

While the Management and Operations Group will be the primary group responsible for the CHAVI management, it is anticipated that the management of CHAVI will require considerable coordination of resources, facilities, research and development activities and investigators across broad scientific areas and potential boundaries of 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 Management and Operations Group and inter-institutional activities of the Center will be crucial to achieving success.

3. Research Program of the CHAVI Director and CHAVI Scientific Leadership Group (SLG)

The CHAVI Director and investigators (including members of the CHAVI SLG) will perform research in the following scientific areas: (1) elucidation of (a) early immunologic and virologic events after HIV-1 infection in humans, including studies of exposed, uninfected persons and of HIV-infected persons during the acute to early stage of disease, with a focus on collaborating with HIV vaccine trial sites in resource-poor settings, and/or; (b) correlates of immune protection in non-human primate models where there was protection from acquisition of infection, and; (2) systematic evaluation of vaccine candidates and immunization strategies that enhance potency, antigen presentation and immunogenicity, with a focus on induction of persistent mucosal and/or systemic immune responses that may include use of novel adjuvants. While research in area 1 (above) must be the initial focus of the CHAVI, research in area 2 (vaccine development) must become an integral part of CHAVI. The CHAVI Director must devote at least 25% effort to the Research Program in the first year; this effort is expected to increase in subsequent years commensurate with budget growth.

4. CHAVI Scientific Resources

CHAVI will develop and oversee the operation of shared scientific resources and facilities as may be necessary and appropriate to support its research mission, including facilities to support the research activities of the CHAVI Director and CHAVI-supported investigators in implementing the CHAVI Scientific Agenda/Strategic Plan. Expansion of the number, type and/or size of shared scientific resources may be considered for future years. Recommendations for new or expanded scientific resources will be reviewed and approved by the CHAVI Executive Committee. The Management and Operations Group is responsible for ensuring that the shared scientific resources/facilities of the CHAVI are utilized to the fullest extent possible and that procedures are developed and implemented to ensure that such core resources/facilities are available to qualified investigators outside the CHAVI.

Section II. Award Information
1. Mechanism(s) of Support


This funding opportunity will use the U01 award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/modular/modular.htm).

The NIH (U01) is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section VI. 2. Administrative and National Policy Requirements, "Cooperative Agreement Terms and Conditions of Award".

The total project period for applications submitted in response to this RFA may not exceed seven years. At this time, the NIAID has not determined whether and how this solicitation will be continued beyond the present RFA.

2. Funds Available
The participating NIAID intends to commit approximately $14.9 million dollars in FY 2005 to fund one new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to seven years. It is anticipated that the CHAVI award will be expanded in the second and subsequent years, and NIAID intends to commit up to $49 million per year to support full implementation of the CHAVI research program.

Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

Foreign Institutions are not eligible however foreign collaborations are encouraged.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution 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 programs.

2. Cost Sharing
Not Applicable http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria
Not Applicable

Section IV. Application Submission Instructions

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.


2. Content and Form of Application Submission


Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

See Section VI.2 Administrative and National Policy Requirements for additional information.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.


3. Submission Dates
See Section IV. 3.A. for special receipt date.

3.A. Receipt, Review and Anticipated Start Dates

Letters Of Intent Receipt Date(s): January 21, 2005
Application Receipt Dates(s): February 23, 2005
Peer Review Date(s): June, 2005
Council Review Date(s): June, 2005
Earliest Anticipated Start Date: August, 2005

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Madelon Halula, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3116, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: 301-402-2636
FAX: 301-402-2638
Email: niaidchavi@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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 copies of the application and all copies of the appendix material must be sent to:


Madelon Halula, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3116, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: 301-402-2636
FAX: 301-402-2638
Email: niaidchavi@mail.nih.gov


Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date listed in the heading of this funding opportunity. If an application is received after that date, it will be returned to the applicant without review.

Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NIAID. Incomplete and non-responsive applications will not be reviewed. Applications that are complete and responsive to the funding opportunity will be evaluated for scientific and technical merit by an appropriate Peer Review Group convened by NIAID.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review

5. Funding Restrictions
Not Applicable

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (See also Section VI.3. Award Criteria).

6. Other Submission Requirements

The application should provide the following information and should be assembled in the order listed below:

PHS 398 Face page

PHS 398 Form Page 2 for the entire application

List of all key investigators/personnel affiliated with CHAVI

Overall table of contents

Summary budget (chart) for the entire CHAVI

PHS 398 Form Page 5

Biographical sketches of CHAVI Principal Investigator (Director) and the named CHAVI Scientific Leadership Group. These biosketches should document the experience of the proposed investigators in leading, as well as functioning as part of, an integrated scientific team. [DO NOT NAME OR INCLUDE BIOGRAPHICAL SKETCHES OF POTENTIAL INVESTIGATORS TO BE ADDED AFTER YEAR ONE OR POTENTIAL MEMBERS OF THE CEC.]

In the application budgets should be divided into three major sections:

Each section describing a major Budget Area should include a separate:

Please be reminded that each participating consortium/contractual organization must submit a separate detailed budget for both the initial budget period (Form Page 4) and the entire proposed project period.

The Application must contain the following three sections described below:

- Note that cover pages, biographical sketches, budget pages, literature citations, letters of support, checklists and other form pages are excluded from the page limits specified below.

1. MANAGEMENT AND OPERATIONS:

Scientific Agenda and Strategic Plan of the CHAVI

– May not exceed 50 pages.

The application must include a Scientific Agenda that defines the overall mission, 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.

The application must also include a Strategic Plan that details the scientific goals, proposed scope of activities, milestones and timelines for the first year of the project. The Strategic Plan must also include a description of how the CHAVI Director will implement the plan to achieve a fully functional Center with timelines, objective milestones and measurable outputs of the proposed planning process.

The Strategic Plan should identify a group of three to four investigators who will constitute the initial Scientific Leadership Group (SLG) of the CHAVI and who may also be investigators on initial CHAVI research activities.

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 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 will be sought and a discussion of how these research projects will contribute to the scientific goals of the proposed Center.

POTENTIAL CHAVI INVESTIGATORS AND THEIR INSTITUTIONS (OTHER THAN THE CHAVI DIRECTOR AND INITIAL MEMBERS OF THE SLG) ARE NOT TO BE NAMED IN THE APPLICATION.

Additional specific research activities, investigators and their institutions will be identified during the Strategic Plan implementation phase that takes place during the first year of the project period.

a. The Scientific Agenda should include:

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

CHAVI Management and Operations Group to include:

2. RESEARCH PROGRAM

Each application must include a full and complete description of the CHAVI Director's proposed research as a single Research Project as well as an outline of other proposed CHAVI-supported research activities to be conducted by members of the CHAVI SLG and possibly additional, unnamed investigators. The CHAVI Director's research plan should describe the focus of the initial research effort OF the Center and how expansion of the Center to include the proposed research of the SLG and other investigators in subsequent years will fulfill the goals of the Scientific Agenda. It should be clear how the Director's research plan implements the mandated initial research focus of CHAVI and is integral to the CHAVI Scientific Agenda. The section that describes the CHAVI-supported research activities of SLG members should be presented as less detailed concepts and should delineate how these proposed efforts will complement and synergize with the Center Director's research plan.

A single-project Research Project has a 25 page limit [sections A-D as defined in the PHS 398 instructions]. The inclusion of experimental procedures within the human subjects or vertebrate animal sections of the application, or in the appendix to circumvent page limits is not allowed.

3. SHARED SCIENTIFIC RESOURCES/FACILITIES

– May not exceed 10 pages each [sections A-D as defined in the PHS 398 instructions], with a maximum of 50 pages total.

SPECIAL REQUIREMENTS

1. The CHAVI Director

The CHAVI Director must dedicate at least 50% effort during the first year of the project period (this includes the 25% effort required as director of the Management and Operations Group) and plan to increase that level of effort in the second and subsequent years of the award commensurate with budget growth.

2. Mandatory Meetings

Global HIV Vaccine Enterprise Annual Meetings: The CHAVI Director and members of the CHAVI SLG must participate in the annual meetings of the Global HIV Vaccine Enterprise. Support for attendance at these annual meetings will be provided through the CHAVI Management and Operations Group budget.

Regular CHAVI/NIAID Meetings: The CHAVI Director, Scientific Leadership Group members, and all Principal Investigators of CHAVI-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 year 2 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 Director and the dates will be determined by mutual agreement between the CHAVI Director and the NIAID Scientific Coordinator. In addition, the CHAVI Director will also be responsible for organizing and conducting regular teleconferences with CHAVI-supported investigators and other Center staff as necessary to coordinate and manage the research activities being supported. Support for attendance at these regular CHAVI meetings will be provided through the CHAVI Management and Operations Group budget.

Bi-Annual Scientific Conference: NIAID will support a major scientific conference every two years to share scientific information, assess scientific progress, identify new research and development opportunities and potential collaborations with industry, private foundations, and other Federal agencies, and establish priorities to accelerate the translation of preclinical research findings into clinical applications. The CHAVI Director, the SLG members, and Principal Investigators for CHAVI-supported research activities will participate in these bi-annual scientific conferences with support for attendance provided through the CHAVI Management and Operations Group budget.

Specific Instructions for Modular Grant applications.

Not Applicable

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131. Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and the related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Award Criteria.

Section V. Application Review Information

1. Criteria
Not Applicable

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAID in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

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

3. Merit Review Criteria
Applications submitted in response to a funding opportunity will compete for available funds with all other recommended applications.

The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.

The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance : Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field?

Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?

Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?

3.A. Additional Review Criteria: (Addendum, see NOT-AI-05-024)

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

Overall Evaluation and Scoring

The overall application score will be based on review and merit of the individual components as well as the merit of the application taken as a whole. A single numerical priority score will be assigned to the whole application after consideration of all of the elements listed below. PLEASE NOTE THAT THE MOST CRUCIAL FACTORS IN EVALUATION OF THE APPLICATION 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.

(1) The Scientific Agenda/Strategic Plan; (2) the Management and Operations Group; (3) the research and development plans of the CHAVI Director and the CHAVI SLG, and the CHAVI Director's documented experience in directing large, complex, integrated and multifaceted research activities; and (4) shared scientific resources/facilities will contribute to the final application score. The overall score for the application will be based on the scientific merit of the individual components as well as the overall synergy and integration of the components, the effectiveness and adequacy of plans for developing and managing CHAVI, the overall program organization and capability of the associated personnel, the plans for expansion through addition of new research activities and PIs after year one, and the extent to which the proposed Center will contribute to the AIDS vaccine research, development and evaluation effort.

Criteria and Attributes to Consider for Evaluation of the Individual Application Components:

1. CHAVI Scientific Agenda/Strategic Plan

2. CHAVI Management and Operations Group

3. Research Plans

The following review criteria for each aspect of the research plan should be applied in the context of how the activity supports the strategic plan and advances the overall goals of the CHAVI:

4. Shared Scientific Resources/Facilities

Protection of Human Subjects from Research Risk : The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See also Section VIII - Other Information.

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See also Section VIII-Other Information .

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed.


3.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

3.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

3.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps and http://www.ott.nih.gov/policy/rt_guide_final.html. Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the Principal Investigator before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Award Criteria.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a summary statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm

A formal notification in the form of a Notice of award will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA (Notice of Grant Award) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.


2. Administrative and National Policy Requirements


All NIH Grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm.

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.


2.A. Cooperative Agreement Terms and Conditions of Award


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

The administrative and funding instrument used for this program will be the cooperative agreement (U01), 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.

1. Monitoring Clinical Studies

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

2.A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility for: Awardees will have primary responsibility for defining the research objectives, approaches and details of the research and development activities within the guidelines of the RFA and for performing the scientific activity. Specifically, awardees have primary responsibility as described below.

Data Rights: Awardees will retain primary custody of and have primary rights to the data developed under these awards, subject to government rights of access consistent with current HHS, PHS, and NIH policies. However, awardees must be committed to making the vaccines, diagnostic products, other research tools, and research materials developed under this award available to the research community, for example through the AIDS Research and Reference Reagent Program (http://www.aidsreagent.org).

Annual Progress Report: The awardee's annual progress report must include a description of ongoing, completed and planned activities, as well as accomplishments during the previous funding/reporting period. The report should clearly tie activities and accomplishments to the Scientific Agenda of CHAVI.

Awardees must adhere to the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources (64 Federal Register 72090). The Principles and Guidelines can be accessed electronically at: (http://ott.od.nih.gov).

When vaccine development efforts of CHAVI result in expanded phase clinical trials (Phase IIb “proof-of-concept” and/or Phase III efficacy studies), CHAVI will be expected to coordinate efforts with the NIAID-sponsored Partnership for AIDS Vaccine Evaluations (PAVE) (http://www.hivpave.org). The CHAVI will also be expected to participate in other activities of the PAVE when their expertise can help to further PAVE goals.

2.A.2. NIH Responsibilities
An NIH Project Scientist (NIAID Scientific Coordinator) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

NIAID staff assistance will be provided by a DAIDS Program Officer who will serve as the NIAID Scientific Coordinator. The NIAID Scientific Coordinator, and other DAIDS staff, will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below.

During performance of the award, the NIAID Scientific Coordinator, with assistance from other scientific program staff who are designated based on the research topic and their relevant expertise, may provide appropriate assistance, advice, and guidance by: participating in the design of the activities; advising in the selection of sources or resources (e.g., determining where a particular reagent can be found); coordinating or participating in the collection and/or analysis of data; advising in management and technical performance; or participating in the preparation of publications. The NIAID Scientific Coordinator will serve as a liaison/facilitator between the awardee, pharmaceutical and biotechnology industries, and other government agencies (e.g., FDA, CDC) and will serve as a resource of scientific and policy information related to the goals of the awardee's research. However, the role of NIAID will be to facilitate and not to direct the activities. It is anticipated that decisions concerning all activities will be reached by consensus and that NIAID staff will be given the opportunity to offer input during the process. The manner of reaching this consensus and the final decision-making authority will rest with the Principal Investigator (CHAVI Director).

When necessary, NIAID may seek evaluation, advice and recommendations concerning ongoing and planned research activities of the CHAVI from an external advisory working group, such as the AIDS Vaccine Research Working Group (AVRWG) or a working group of the Global HIV Vaccine Enterprise, to be identified at a later date. Such review activity may occur through the advisory working group's attendance at a regular CHAVI/NIAID meeting, and/or at a separate meeting to be arranged by NIAID. Investigators for CHAVI-supported research activities will participate in these reviews with support for attendance provided through the CHAVI Management and Operations Group budget, and will provide written materials and oral presentations regarding the status of ongoing research activities, future plans (including proposed new research activities/investigators), and plans to curtail, discontinue and/or modify current research activities.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities

CHAVI Executive Committee: A CHAVI Executive Committee (the CEC) will be established as the main governing body with responsibility for reviewing scientific progress and recommending modifications in scope/emphasis. The membership of the CEC includes the CHAVI Director, and the CHAVI Scientific Leadership Group members, as well as external advisors with necessary expertise or representing co-funding organizations should any be significantly involved in the support of CHAVI. The NIAID Vaccine & Prevention and Research Program (VPRP) Program Director (or designee), the NIAID Scientific Coordinator, and others nominated by the CHAVI Director and approved by the VPRP Program Director will serve as voting members of the CEC. Additional NIAID Program Staff may participate as non-voting members. The CEC may recommend redirection of certain scientific activities in cases where results and data suggest the research is no longer feasible or progressing toward the defined goals. Any changes in the scope of the CHAVI Scientific Agenda must be approved by the NIAID Grants Management Official. The CEC may also provide a forum for coordinating vaccine activities that require a liaison function with other Federal centers and agencies such as the NIAID Vaccine Research Center, PAVE, the Global HIV Vaccine Enterprise, and the Food and Drug Administration.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.


2.A.4. Arbitration Process
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements.

3. Award Criteria

The following will be considered in making funding decisions:

4. Reporting

Annual Progress Report: The awardee's annual progress report must include a description of ongoing, completed and planned activities, as well as accomplishments during the previous funding/reporting period. The report should clearly tie activities and accomplishments to the Scientific Agenda of CHAVI.

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually:
http://grants.nih.gov/grants/funding/2590/2590.htm and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Stuart Z. Shapiro, M.D., Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive
Room 5146, MSC 7628
Bethesda, MD 20892-7628
Telephone: 301-402-0122
FAX: 301-402-3684
Email: niaidchavi@mail.nih.gov


2. Peer Review Contacts:

Madelon Halula, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3116, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: 301-402-2636
FAX: 301-402-2638
Email: niaidchavi@mail.nih.gov


3. Financial or Grants Management Contacts:

Jane Unsworth
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2128, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: 301 402-6824
FAX: 301 480-3780
Email: niaidchavi@mail.nih.gov

Section VIII. Other Information
Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations ( http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity, and dose-finding studies (phase I); efficacy studies (Phase II) efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing

Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm.

Required Education on The Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html . Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov/) It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

Public Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalogue of Federal Domestic Assistance at http://www.cfda.gov/ in the following citations: No. 93.855, Immunology, Allergy, and Transplantation Research, No. 93.856, Microbiology and Infectious Diseases Research and No. 93.393-93.396, Cancer Cause and Prevention Research. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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