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

Consortia for HIV/AIDS Vaccine Development (CHAVD) (UM1 Clinical Trial Not Allowed)

Activity Code

 UM1 Research Project with Complex Structure Cooperative Agreement

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AI-18-001

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

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

  93.855

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to solicit grant applications that propose to establish Consortia for HIV/AIDS Vaccine Development (CHAVD) to support a coordinated, multidisciplinary team(s) of researchers focused on iterative approaches to accelerate HIV vaccine development by addressing key immunogen design roadblocks to the discovery and development of a safe and effective antibody-mediated preventive HIV vaccine.  

Key Dates
Posted Date

February 7, 2018

Open Date (Earliest Submission Date)

May 28, 2018

Letter of Intent Due Date(s)

May 28, 2018

Application Due Date(s)

June 28, 2018 , by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

June 28, 2018, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on this date.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review

November 2018

Advisory Council Review

January 2019

Earliest Start Date

July 2019

Expiration Date

June 29, 2018  

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) 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. 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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information

    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description
    Purpose

    This FOA solicits applications to establish Consortium for HIV Vaccine Development (CHAVD). CHAVDs will support coordinated, multidisciplinary teams of researchers focused on multi-pronged approaches to accelerate HIV vaccine development by iteratively, as well as in parallel, addressing key immunogen design roadblocks to the discovery and development of a safe and effective antibody-mediated preventive HIV vaccine.

    Background

    There are approximately 38 million people worldwide infected with the human immunodeficiency virus (HIV), the virus that causes the Acquired Immune Deficiency Syndrome (AIDS). While promising prevention measures have been developed over the past decade, such as male circumcision and pre-exposure prophylaxis (PrEP), the transmission of HIV-1 remains at an unacceptably high rate. In 2016, approximately 1.8 million people became newly infected with HIV and projections indicate the number of new infections will remain high unless more effective preventive measures are instituted. The demonstrated effect of treatment as prevention offers some hope that mass treatment programs such as UNAIDS' 90-90-90 program will markedly reduce the global morbidity and mortality due to HIV/AIDS. Still, the human and economic tolls of HIV/AIDS demand that these largely therapeutic activities are complemented by accelerated efforts to develop a preventive HIV vaccine.

    Researchers have been working to develop a HIV vaccine since the identification of HIV as the etiologic agent of AIDS. Considerable progress has been made in understanding early immune responses to HIV infection and the antigenic constituents of the virus. However, only three vaccine concepts have been tested in clinical efficacy trials; two of these failed to show any efficacy while the other (the products studied in RV144, the Thai Trial) was only minimally efficacious. An efficacy trial designed to follow up the findings in RV144 is underway in Southern Africa (HVTN 702) and an efficacy trial (HVTN 705) of another candidate HIV vaccine (Janssen/Johnson & Johnson's Ad26 Mosaic prime/gp140 protein boost) is scheduled to start in the near future. Results from these trials will not be available until 2021 and 2022, respectively, and while the hope is that one or both trials will demonstrate sufficient efficacy on which to build, it is imperative that efforts to discover and test new vaccine concepts continue in the interim.

    Thus, 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 effort and expertise to this urgent public health problem.

    In June of 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 to HIV vaccine discovery, especially our lack of understanding of the host immune response during acute HIV infection.  The progress made in understanding early events in HIV infection through this research program demonstrated the productivity of large, collaborative and multidisciplinary teams in addressing complex research questions. The findings of CHAVI and others in: characterizing the transmitted/founder virus, explaining the lack of HIV neutralization by early anti-envelope 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, suggested innovative approaches to explore in HIV vaccine design.  Also, the results from the RV144 vaccine trial in Thailand (2003-6), which showed modest protection from infection, presented a significant new opportunity for discovery in HIV vaccine design; and CHAVI investigators played a key operational role in the immune correlates analysis performed to understand and build upon the modest efficacy observed.

    Thus, with the recommendation of the CHAVI external Scientific Advisory Board and the AIDS Vaccine Research Subcommittee (AVRS) of the NIAID AIDS Research Advisory Committee (ARAC), in 2012 NIAID funded two large research consortia (the Centers for HIV/AIDS Vaccine Immunology and Immunogen Discovery; CHAVI-ID) to accelerate HIV vaccine development. These Consortia support: (1) research into the immune responses that prevent or contain the virus, (2) discovery of new targets for antibody neutralization, and (3) the generation of immunogen constructs that will induce broad protection. The findings of the CHAVI-IDs and other HIV vaccine investigators on the evolution of anti-HIV envelope neutralizing antibody responses through extensive somatic hypermutation in concert with the evolution of the HIV-1 envelope protein give new hope for a path to the induction of such antibody responses by vaccination. Furthermore, it is hoped that the large neutralizing monoclonal antibody (VRC01) passive transfer study currently being conducted (HVTN 703/HPTN 081 and HVTN 704/HPTN 085, collectively called the AMP study) will provide clear-cut proof-of-concept that such antibodies can protect against human infection with HIV-1.

    Objective and Scope CHAVD

    The objective of this FOA is to exploit recent progress in vaccine science by establishing new, large research consortia, the Consortia for HIV/AIDS Vaccine Development (CHAVD), to undertake the next steps in protective antibody-inducing immunogen design research. This objective is envisaged to require parallel and iterative development in pre-clinical and phase I clinical studies to answer scientific questions to prepare a rationally designed vaccine for future efficacy trials. Over the 7-year period of award, these new research consortia should apply state-of-the-art technologies and immunologic tools to focus on iterative, rational vaccine design. The CHAVD research should elucidate how to elicit antibody response(s) capable of preventing acquisition of HIV infection. Approaches include, for example:

    • Identifying the epitopic specificity and other qualities of antibody responses that can provide protective immunity by (1) inducing durable broad-coverage virus neutralizing antibody responses, (2) inducing durable, broad-coverage antibody responses with other specific, protective antiviral function(s) such as antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cell-mediated virus inhibition (ADCVI), antibody-mediated phagocytosis, etc., that  may have contributed to efficacy in RV144, or (3) both (1) and (2)
    • Studying envelope isolates, constructs, modifications, fragments, combinations and sequences to induce broadly protective antibody coverage.
    • Exploring vectors/adjuvants/delivery technologies that facilitate the induction of different qualities and specificities of durably protective antibody responses.
    • Performing proof-of-concept active and passive protection studies in nonhuman primates or other relevant animal models.
    • Designing, performing GMP manufacturing process development, and manufacturing candidate immunogen constructs for iterative phase I clinical studies.
    Research Consortium Organization

    Each CHAVD will be composed of the following functional and structural units:

    • CHAVD Initial Research Focus (or Foci)
    • Management and Operations Unit
    • GMP Manufacturing Unit
    • Clinical Trials Sample Analysis Unit

    Each CHAVD may also contain additional Scientific Research Support Unit(s) as needed.

    CHAVD Initial Research Focus (or Foci). Each CHAVD will focus on (1) induction of durable broad-coverage virus neutralizing antibody responses, (2) the induction of durable broad-coverage antibody responses with other specific, protective antiviral function (ADCC, ADCVI, antibody-mediated phagocytosis, such as may have contributed to efficacy in RV144), or (3) both.

    Management and Operations Unit. A Management and Operations Unit will provide overall management, coordination and supervision of the Consortium activities. This Unit will monitor CHAVD progress, and ensure that the CHAVD research agenda is developed, reviewed and implemented effectively and efficiently. The CHAVD will be responsible for using a large number of resources and in the most appropriate manner in order to advance HIV vaccine discovery and design.

    Scientific Leadership Group: To assist the Management and Operations Unit and the CHAVD PD/PI, the CHAVD must have a Scientific Leadership Group (SLG) comprised of CHAVD scientists who will contribute to the planning, development, implementation and management of the research program. SLG members may be involved in any aspect of the CHAVD research agenda and are expected to work together in a highly collaborative and integrated manner and openly share information.  

    Based on the size and breadth of activities, it is anticipated that management of the Consortium will require considerable coordination of investigators, facilities, resources, and research/development activities across broad scientific areas and multiple institutions/organizations. 

    GMP Manufacturing Unit. The GMP Manufacturing Unit will be responsible for GMP manufacturing and preclinical development activities required to advance a candidate immunogen design into clinical trials. Activities include managing timelines, costs, translational analytics, Quality Assurance, performance of IND-enabling studies, and regulatory interactions.

    Clinical Trials Sample Analysis Unit. The Consortium will include a support unit to perform the research analyses that will inform iterative development of their candidate vaccine products.

    Clinical trials will not be funded by this award. However, CHAVD investigators are expected to participate in the intensive research analysis of samples obtained from the clinical trials of the vaccine constructs they design. The development of a vaccine that elicits broadly neutralizing antibodies (BNAbs) may benefit from intermediate analyses into the ability of constructs to engage specific germline antibody genes capable of evolving into BNAbs, and/or from structural analyses into the ability of boosting constructs to guide antibody evolution. Similarly, the development of vaccine candidates to improve the protection observed in RV144 will require detailed dissection of the quality and epitopic specificity of antibody responses, and extensive exploration of other parameters such as Fc-mediated antibody functions.

    Scientific Research Support Unit(s). The Research Support Unit(s) will consist of activities that can provide a service, develop a specific scientific resource, or expand an area of research relevant to immunogen design.

    The following activities will NOT be supported by this FOA.

    Applications containing activities in these areas will be considered non-responsive and will not be reviewed.

    • Vaccine protection where the major mechanism of protection is not antibody-mediated,
    • Clinical Trials or any facility, Research Focus or Research Support Unit to perform Clinical Trials of candidate HIV vaccines.

    The design and conduct of clinical trials instead will be expected to rely on infrastructure already supported through the HIV Vaccine Trials Network (www.hvtn.org).

    See Section VIII. Other Information for award authorities and regulations.

    Section II. Award Information
    Funding Instrument

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

    New  

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

     Not Allowed: Only accepting applications that do not propose clinical trials

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    NIAID intends to commit $34 M in FY 2019 to fund 1-2 awards.

    Award Budget

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

    Award Project Period

    The scope of the proposed project should determine the project period.  The maximum project period is 7 years.   

    NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Higher Education Institutions

    • Public/State Controlled Institutions of Higher Education
    • Private Institutions of Higher Education

    The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

    • Hispanic-serving Institutions
    • Historically Black Colleges and Universities (HBCUs)
    • Tribally Controlled Colleges and Universities (TCCUs)
    • Alaska Native and Native Hawaiian Serving Institutions
    • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    Nonprofits Other Than Institutions of Higher Education

    • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
    • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

    For-Profit Organizations

    • Small Businesses
    • For-Profit Organizations (Other than Small Businesses)

    Governments

    • State Governments
    • County Governments
    • City or Township Governments
    • Special District Governments
    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)
    • Eligible Agencies of the Federal Government
    • U.S. Territory or Possession

    Other

    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations
    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
    Foreign components, as defined in the NIH Grants Policy Statement, are  allowed.

    Required Registrations

    Applicant Organizations

    Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

    Program Directors/Principal Investigators (PD(s)/PI(s))

    All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

    For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

    The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

    • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
    • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
    Section IV. Application and Submission Information
    1. Requesting an Application Package

    Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

    It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) 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.

    For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

    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 activity
    • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
    • Names of other key personnel
    • Participating institution(s)
    • Number and title of this funding opportunity

    The letter of intent should be sent to:

    Peter R. Jackson, Ph.D.  
    Telephone: 240-669-5049
    Fax: 301-480-2408  
    Email: pjackson@niaid.nih.gov

    Page Limitations

    All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed with the following additional instructions.

    The Research Strategy must consist of the following sub-sections with the indicated page limits:

    Sub-section A. Overview of the proposed Consortium for HIV/AIDS Vaccine Development – one required - 30 pages

    Sub-section B. CHAVD Initial Research Focus (or Foci) – one required; maximum of two - 12 pages each

    Sub-section C. Management and Operations Unit– one required - 12 pages

    Sub-section D. GMP Manufacturing Unit – one required - 12 pages

    Sub-section E. Clinical Trials Sample Analysis Unit – one required - 12 pages

    Sub-section F. Scientific Research Support Unit(s) – optional - 6 pages each

    Instructions for Application Submission

    The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

    SF424(R&R) Cover

    All instructions in the SF424 (R&R) Application Guide must be followed.  

    SF424(R&R) Project/Performance Site Locations

    All instructions in the SF424 (R&R) Application Guide must be followed.  

    SF424(R&R) Other Project Information

    All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:

    Facilities &other Resources:  If applicable, applicants should describe in-house manufacturing facilities and indicate how they comply with regulatory requirements for GMP manufacturing of biologic products.

    SF424(R&R) Senior/Key Person Profile

    All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:

    The CHAVD PD/PI must have experience in directing complex, integrated and multifaceted research activities and this experience must be detailed in her/his BioSketch.

    R&R or Modular Budget

    All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:

    In the budget justification, provide budget breakout for activities under each unit. Budgetary requests for all activities should align with research activities detailed in the CHAVD Research Agenda. It is expected that the budget requested for the CHAVD will be apportioned in approximately the manner described below. Examples for funds in italicized text below are estimates for informational purposes.

    • CHAVD Initial Research Focus (or Foci), Scientific Research Support Unit(s), and Management and Operations Unit– starting at up to approximately 75% of direct costs requested (e.g. 75% in year one (1) decreasing to 25% per year in year seven (7) of direct costs requested).  Within the Research Foci budgets each year, the Principal Investigator is empowered, and expected, to exercise extensive authority in ending less productive or less urgent projects in order to add or increase effort on more important work. This budgeting flexibility should be used to optimize responsiveness to new scientific opportunities as needed to advance the overall CHAVD goals.
    • GMP manufacturing Unit– starting at up to approximately 25% of direct costs requested (e.g. 25% in year one (1) expanding to 75% per year in year seven (7) of direct costs requested for GMP immunogen manufacturing). Include a budget for the first candidate proposed for manufacture. Budgets for the candidate should include costs for product development, analytics, tech transfer, actual GMP manufacture, and IND-enabling studies.
    • Clinical Trials Sample Analysis Unit – (e.g. up to approximately 15% of direct costs requested.)
    • Include support for travel expenses of the CHAVD PD/PI and appropriate SLG members for 1 internal and up to 4 external meetings per year organized by NIAID for the purpose of coordinating the efforts of other large, NIAID-supported research consortia.
    • The CHAVD PD/PI must dedicate at least 6 person months for each year of the Consortium period.
    R&R Subaward Budget

    All instructions in the SF424 (R&R) Application Guide must be followed.

    PHS 398 Cover Page Supplement

    All instructions in the SF424 (R&R) Application Guide must be followed.  

    PHS 398 Research Plan

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: 

    Specific Aims: Outline the general objectives of the proposed Consortium for HIV/AIDS Vaccine Development and the overall approach to achieving these goals.

    Research Strategy: The Research Strategy section must consist of subsections A-E as designated below.

    Subsection A. Overview of the proposed Consortium for HIV/AIDS Vaccine Development

    The Overview should explain how the CHAVD's research agenda will contribute significantly to the development of an antibody-mediated preventative HIV/AIDS vaccine. The Overview must present a coherent, coordinated and synergistic vision of HIV/AIDS vaccine discovery, and must include the following:

    • Overall goals of the CHAVD.
    • A narrative including: (a) theories about why past HIV vaccine design/development approaches have not worked, (b) a description of knowledge gaps relevant to the systematic design and evaluation of immunogens, vectors and adjuvants eliciting persistent, protective antibody 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, (c) a description of promising product designs and anticipated scientific advances that open up promising new approaches to the induction of persistent antibody responses in humans that might reasonably be expected to prevent acquisition or establishment of HIV-1 infection, and (d) a discussion of immune response parameters to be measured in preclinical and clinical trials of candidate vaccine products and how those measurements will facilitate iterative product design.

    Sub-section B. CHAVD Initial Research Focus (or Foci)

    This sub section must explain how the proposed CHAVD Initial Research Focus (or Foci) and future possible Research Foci fit within the applicant's overview of the HIV vaccine development field. The application must not contain detailed research plans for the initial Research Foci rather discussion should address flexibility in growing and changing research direction to explore new technologies and scientific opportunities as they arise. Also, the CHAVD Initial Research Focus (or Foci) sub-section must not be written as a stand-alone entity comprised of severable parts as in a multi-Project application. Rather, this subsection is to have goals and objectives within a single coherent research program. The application must clearly describe how each Research Focus implements the initial research vision of the CHAVD and is integral to the CHAVD research agenda. The application must also describe how the CHAVD PD/PI will play a critical role in leading the research.

    Repeat this sub-section for each Research Focus proposed. Give each sub-section a title and number (e.g. "Sub-section B.2.").

    Sub-section C. Management and Operations Unit

    This sub-section of the application must describe in detail how the Management and Operations Unit will be responsible for the day-to-day management of all CHAVD activities including:

    • budgetary reallocation in support of changing research and manufacturing needs, and
    • using metrics and milestones to quantify and evaluate progress and productivity.

    Also, the application must explain how the Management and Operations Unit will provide the infrastructure that will enable the CHAVD leadership to oversee all other units and to ensure these units are operating in a well-coordinated and productive fashion. The application must also describe the significant role of the CHAVD PD/PI in leading the Management and Operations Unit. Applicants also must provide a plan delineating the processes and approaches to establish priorities; develop and review new Research Foci and Research Support Unit; identify and select immunogen constructs for GMP manufacture; and develop and implement a strategy for discontinuing the support of unproductive or unneeded Research Foci, or Scientific Research Support Units. Include within the discussion the coordination of the CHAVD PD/PI, SLG, and SAB.

    In addition to the overall management plan, the Management and Operations Unit sub-section of the application must identify three to six investigators who will constitute the SLG of the CHAVD. Although they should also participate as leading investigators in the execution of CHAVD-supported research, SLG members are not required to have the same institutional affiliation as the CHAVD PD/PI, and multi-institutional collaborations are strongly encouraged.

    The Management section also must include the criteria and processes for nominating CHAVD SAB members.  NOTE: POTENTIAL OR PROPOSED MEMBERS OF THE SAB ARE NOT TO BE NAMED IN THE APPLICATION AND SHOULD NOT BE CONTACTED.

    Sub-section D. GMP Manufacturing Unit

    This sub-section is to provide an overview of the applicant's conceptual approach to selecting and manufacturing candidate immunogens for clinical testing. Describe the down-selection process for choosing constructs for manufacture. Describe clearly the steps involved in the development and implementation of a manufacturing plan, and how quality oversight will be maintained throughout the implementation and operation of the manufacturing projects. Give sample timelines for manufacture of the types of products planned. Describe how manufacturing will be performed, including how and by whom the processes for manufacture and scale-up will be developed and validated. Describe how product analytics, tech transfer, regulatory and IP issues will be handled. The application may propose to perform many, or all, of the manufacturing steps in-house or to use Contract Manufacturing Organizations (CMOs). However, the application should discuss the potential limitations to the approach chosen and what obstacles are anticipated. If one, or more, CMO(s) are used the application must describe:

    • how they will be chosen and qualified,
    • how the precise extent of their responsibilities will be defined,
    • how their performance will be managed and evaluated,
    • how oversight and guidance in the down-selection of candidate vaccine products with respect to manufacturability issues and product modifications to ensure manufacturability will be exercised, and
    • how tech transfer, IP issues, and quality oversight will be handled.

    The application must describe the likely first vaccine candidate to be proposed for manufacture as an example of the manufacturing strategy. Provide a timeline for the vaccine candidate's GMP production, the scientific rationale for its choice for manufacture, and the plans for the use of any subcontractor manufacturing organizations.

    Sub-section E. Clinical Trials Sample Analysis Unit

    The sub-section must describe in detail the strategy for the analysis of samples from clinical trials of the products. Also, describe the assays that will be used. Detail how these assays differ in terms of the type of data they will yield from the validated assays used by the HVTN (i.e. Env IgG and IgA magnitude by BAMA, Tier 1 and Tier 2 neutralization by TZM-bl, T-cell magnitude based on cytokine expression by ICS, Innate cell population frequencies by Trucount, and Concentration of serum cytokines by MBA) to determine candidate HIV vaccine product comparability for making decisions on advanced clinical testing (applicants are encouraged to contact the HVTN at www.hvtn.org for more detail about HVTN laboratory assays). Explain how the data collected will inform decisions for the iterative design of better immunogens.

    Sub-section F. Scientific Research Support Units  

    Describe the proposed Scientific Research Support Unit activities that may provide a service (e.g., structural biological analysis of antigens/candidate immunogens, host genomic analysis or antibody sequence analysis in support of targeted immune responses, etc.); or may develop a specific scientific resource (e.g., collection/isolation of monoclonal antibodies of differing specificities, etc.); or that may expand an area of research relevant to immunogen design (e.g., identification of relevant Tfh epitopes, exploration of different vectors for immunogen delivery, etc.). This sub-section of the application should present a clear picture of the techniques and skills that each Scientific Research Support Unit will provide and its role in implementing the research agenda of the Consortium.

    Repeat this sub-section for each Scientific Research Support Unit proposed.  Give each sub-section a title and number.

    Letters of Support:  The application must include a Letter of support from the Consortium applicant institution documenting its commitment to facilitate the administration of the CHAVD Management and Operations Unit and inter-institutional activities of the Consortium. Letter(s) of support from other institution(s) involved in the Consortium and its initial Research Foci and Scientific Research Support Units should also be provided.

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

    Appendix:

    Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

     
    PHS Human Subjects and Clinical Trials Information

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed.

    Delayed Onset Study

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    PHS Assignment Request Form

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    3. Unique Entity Identifier and System for Award Management (SAM)

    See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

    4. Submission Dates and Times

    Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

    Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

    Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

    Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. 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.

    7. Other Submission Requirements and Information

    Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

    Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

    For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

    All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

    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:

    In their evaluation of the CHAVD application, reviewers will emphasize the Overview of the research agenda, the research program, and the demonstration of the capacity to implement and manage the research program.

     
    Overall Impact

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

    Scored Review Criteria

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

    Significance

    Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

    Specific to this FOA: Is the Consortium as a whole scientifically compelling? Are the overall Consortium goals, as expressed in the Overview, significant and how well do they address the key immunological roadblocks to the development of a safe and effective HIV vaccine development? Does the scientific program address the concept of iterative product design?  Will the research plan, if successful, have a highly consequential influence on advancing progress toward an effective HIV vaccine?   

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?

    Specific to this FOA: Does the PD/PI have documented experience in directing complex, integrated and multifaceted research activities?  Will the PD/PI and other Research Foci/Support key personnel devote adequate time and effort to the Consortium? 

    Innovation

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

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 

    If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed? 

    Specific to this FOA: Is the approach of the research agenda to HIV/AIDS vaccine discovery and design coherent and focused? Is the plan feasible and does it have high technical merit for the implementation of the research agenda of the proposed CHAVD?

    Management and Operations Unit: Are there appropriate and feasible mechanisms to select, review and incorporate new research activities and/or scientific support resources/facilities in response to emerging opportunities, and also to reduce or eliminate less-productive or non-productive research and/or resources/facilities? Are there appropriate plans and mechanisms for budgetary reallocation in support of changing research and manufacturing needs? Are the proposed metrics and milestones to quantify and evaluate progress and productivity all meaningful, appropriate and feasible?

    GMP Manufacturing Unit: Is the approach to manufacturing well-informed and well-reasoned? Does the application reflect an adequately comprehensive understanding of the requirements and risks associated with making the kinds of immunogens being proposed? Does the approach appropriately explain how the investigators will identify and address important gaps in any part of the pathway from research-grade material to vialed GMP-grade clinical trial material including advance evaluation of manufacture feasibility, process development, scale-up, product analytics, and performance of IND-enabling studies? Does the manufacturing plan appropriately consider timelines, costs, and Quality Assurance? Are timelines and cost predictions realistic? Is there evidence of familiarity with regulatory requirements related to GMP production of biological products?  Are any in-house facilities capable of meeting the regulatory requirements for GMP manufacturing of biological products? Is the applicant sufficiently aware of limitations and trade-offs in the manufacturing strategy chosen? If applicable, are the criteria for selecting, evaluating, and changing CMO partners for any aspects of the manufacturing process appropriate? Are there clear descriptions of how sub-contractor responsibilities will be defined in advance and how sub-contractor accountability will be ensured?  

    Clinical Trials Sample Analysis Unit: Is the strategy for in-depth testing of samples from clinical trials of candidate immunogens well described? Is the testing strategy well-conceived? Are the correct assays planned? Are the testing laboratory facilities adequately resourced and experienced? Are the proposed assays adequately current? Will the studies planned give information different from the HVTN comparability assays that will adequately inform iterative construct/product design?

    Scientific Research Support Unit(s): Are the proposed Scientific Research Support Units scientifically justified and integral for the success of the Consortium? Are the proposed assays/systems/processes of the Scientific Research Support Unit appropriate for the activities it is supporting within the Consortium?  

    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?  

    Specific to this FOA: Is there evidence in the letters of support of adequate institutional commitment and capacity to provide effective administrative and managerial support for a highly complex Consortium?  

    Additional Review Criteria

    As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact 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 Guidelines for the Review of Human Subjects.

    Inclusion of Women, Minorities, and Children 

    When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

    Biohazards

    Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

    Resubmissions

    Not Applicable

    Renewals

    Not Applicable

    Revisions

    Not Applicable

    Additional Review Considerations

    As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact 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)  Genomic Data Sharing Plan (GDS).

    Authentication of Key Biological and/or Chemical Resources:

    For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

    Budget and Period of Support

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

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Allergy and Infectious Diseases , in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

    As part of the scientific peer review, all applications:

    • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
    • Will receive a written critique.

    Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

    Applications will be assigned  to the appropriate NIH Institute or Center. Applications 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 . The following will be considered in making funding decisions:

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.
    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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

    Section VI. Award Administration Information
    1. Award Notices

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

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

    Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

    Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this 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.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator's scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 "Federal awarding agency review of risk posed by applicants."  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    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:

    • 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.
    • Providing written materials and oral presentations to NIAID staff regarding the status of ongoing research activities, future plans (including proposed new research activities/investigators), plans to curtail, discontinue and/or modify current research activities, and documentation required by NIAID staff to approve release of award funds for GMP manufacturing activities.
    • Providing upon request any vaccine or related product materials manufactured for clinical research use with these awarded funds. In addition, if required for regulatory agency submission, all process and technical documentation, manufacturing records, manufacturing deviations and investigations, and other information may be required.

    Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

    NIH staff 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 Project Scientist. The NIAID Project Scientist, 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 the normal program stewardship role for grants, as described below.
    • During performance of the award, the NIAID Project Scientist, 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., advising 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 Project Scientist 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, except with regard to approval for use of award funds for GMP manufacturing activities, 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, but the NIAID Project Scientist will not be a voting member on any committee. The manner of reaching consensus and the final decision-making authority will rest with the Principal Investigator (CHAVD PD/PI).
    • Prior to final selection of vaccine immunogen constructs for GMP manufacture NIAID will require the submission of the following documents:
    • Description of the vaccine candidate proposed for manufacture,
    • Projected timeline of GMP production,
    • A description of the scientific rationale for the specific vaccine candidate,
    • A draft budget for the anticipated duration of the manufacturing project,
    • In addition, if proposing one or more subcontractor CMO(s) the request must also document the following:
    • Adequacy of relevant experience
    • Performance: approach and track record for ensuring product quality
    • Capacity: adequacy of facilities and technical fit of CMO prior experience with the proposed manufacture project
    • Detailed description of the specific contract responsibilities of the proposed CMO
    • Use of funds for GMP manufacturing will only be allowable if explicitly stated in the Notice of Grant Award (NoA).
    • NIAID reserves the right to approve all CMO(s)
    • On an annual basis, NIAID may seek evaluation, advice and recommendations concerning ongoing and planned research activities of the CHAVD from an external advisory working group, such as the AIDS Vaccine Research Subcommittee (AVRS), a working group of the Global HIV Vaccine Enterprise, or an independently formed Scientific Advisory Board (SAB) to be identified at a later date with the approval of the Division of AIDS Vaccine Research Program (VRP) Director. Such review activity may occur through the advisory working group's attendance at a regular CHAVD/NIAID meeting organized by the CHAVD Management and Operations Unit, and/or at separate meetings to be arranged by NIAID. Recommendations for new or expanded Research Foci or termination of Research Foci after year one will require review and approval by the CHAVD SLG, and an NIAID-approved external Scientific Advisory Board, and NIAID. In addition to the usual annual reviews there will be an intensive, concerted review of progress and ongoing research plans by Program with an External Scientific Advisory Body near the end of year 4 to determine the level of funding in years 6 and 7 of this award.
    • 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.

    Areas of Joint Responsibility include:

    CHAVD Executive Committee (CEC): The CHAVD PD/PI and the CHAVD Scientific Leadership Group members shall constitute the executive governing committee of the CHAVD. The NIAID Vaccine Research Program (VRP) Director (or designee), the NIAID Project Scientist, and others nominated by the CHAVD PD/PI and approved by the VRP Director will serve as non-voting members of the CEC. Additional NIAID Program Staff may participate as non-voting members. The CEC may recommend establishment of new Research Foci and Support Components or redirection of certain scientific activities in cases where results and data suggest the research is no longer feasible or progressing toward the defined goals. 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, the Global HIV Vaccine Enterprise, and the Food and Drug Administration.

    Meetings

    Annual HIV Vaccine Meetings: The CHAVD PD/PI and members of the CHAVD SLG will participate in annual meetings of the HIV/AIDS vaccine research community, such as the biennial HIVR4P (HIV Research for Prevention) conference organized by the Global HIV Vaccine Enterprise or the annual Keystone HIV vaccine meetings.

    Regular CHAVD/NIAID Meetings and Teleconferences: The CHAVD PD/PI, SLG members, and all key investigators of CHAVD-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. These meetings will be organized by the CHAVD PD/PI and the dates will be determined by mutual agreement between the CHAVD PD/PI and the NIAID Project Scientist. In addition, the CHAVD PD/PI will also be responsible for organizing and conducting regular teleconferences with CHAVD-supported investigators and other award staff as necessary to coordinate and manage the research activities being supported.

    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 CHAVD PD/PI and/or selected members of the SLG will be asked to participate in as many as 3-4 such meetings a year.

    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 Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

    A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

    Section VII. Agency Contacts

    We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Scientific/Research Contact(s)

    Stuart Z. Shapiro, M.D., Ph.D.
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-292-6155
    Email: sshapiro@niaid.nih.gov

    Peer Review Contact(s)

    Peter R. Jackson, Ph.D.
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 301-669-5049
    Email: pjackson@mail.nih.gov

    Financial/Grants Management Contact(s)

    Devon Bumbray
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-669-2950
    Email: Db400w@nih.gov

    Jenny Greer
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-669-2949
    Email: jenny.greer@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 Part 75 .

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