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)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

Martin Delaney Collaboratories for HIV Cure Research (UM1)

Activity Code

UM1 Research Project with Complex Structure Cooperative Agreement

Announcement Type

Reissue of RFA-AI-10-009

Related Notices
Funding Opportunity Announcement (FOA) Number

RFA-AI-15-029

Companion Funding Opportunity

None

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

93.855; 93.856; 93.242; 93.279; 93.853 

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to address the problem of HIV persistence in HIV-infected persons treated with suppressive antiretroviral drug regimens.  This FOA will support coordinated basic, translational, and clinical research focused on developing strategies to achieve an HIV cure, defined as sustained HIV remission and/or eradication.  The application must include at least one private sector entity to facilitate rapid translation of basic discovery research into clinical studies.  Collaboratory research should be milestone-based and centered on specific innovative approaches spanning characterization and quantification of latent or persistent HIV-1 reservoirs, identification of therapeutic strategies that target these reservoirs and/or control viral rebound, and preclinical and clinical studies to test new single or combination strategies for an HIV cure. 

Key Dates
Posted Date

May 21, 2015

Open Date (Earliest Submission Date)

November 7, 2015  

Letter of Intent Due Date(s)

November 7, 2015  

Application Due Date(s)

December 7, 2015, by 5:00 PM local time of applicant organization. All types of 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)

December 7, 2015, by 5:00 PM local time of applicant organization. All types of 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

March 2016   

Advisory Council Review

May 2016  

Earliest Start Date

July 2016 

Expiration Date

December 8, 2015 

Due Dates for E.O. 12372

Not Applicable 

Required Application Instructions

It is critical that applicants follow the 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.

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

The cure of HIV infection is one of the highest priorities of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH).  This funding opportunity is part of the NIH commitment to reallocate additional funds in support of HIV cure research.  The goal of the Martin Delaney Collaboratory program is to accelerate progress towards developing strategies to achieve either eradication of HIV infection from the body or a functional cure, as defined by sustained viral remission following cessation of antiretroviral therapy.  Funded projects will be expected to expand the knowledge base on HIV latency and persistence in HIV-infected persons treated with suppressive antiretroviral drug regimens, design and evaluate innovative cure strategies, and translate findings to the clinical setting.  These goals will be achieved through dynamic, collaborative research programs with synergistic areas of scientific focus spanning basic, translational, and clinical research.  Rapid translation of basic research discoveries into clinical applications will be facilitated by partnerships among academia, government, the private sector, and community stakeholders. 

The Martin Delaney Collaboratory program was originally established by NIAID in partnership with NIMH in fiscal year 2011, and is now being expanded through open competition.  All qualified investigators are encouraged to apply; prior funding under this program is not required.

Background

Highly effective antiretroviral agents can reduce HIV viral load to levels below detection by standard assays, but they do not completely eliminate residual viral reservoirs.  Sensitive viral outgrowth assays demonstrate that HIV is still present in latently infected CD4+ T cells in the plasma of individuals despite long term treatment with potent combinations of antiretroviral drugs, and intensification of such regimens with new or different drugs does not eliminate residual virus.  The interruption of treatment predictably results in viral rebound within days to weeks in a majority of subjects.  Given the multiple challenges and risks involved in a lifetime of treatment, there is a crucial and unmet need for an effective, simple, safe, and scalable strategy for eradicating HIV infection from the body.

Research Objectives and Scope

The objective of this FOA is to support synergistic discovery research programs focused on specific strategies to achieve an HIV cure, defined as sustained HIV remission and/or eradication, through academic, industry, government, and community partnerships.  The proposed research should be innovative and must include a combination of basic, translational, and clinical research. 

Examples of areas of research interest include, but are not limited to:

  • Identification and characterization of the cellular, tissue, and anatomical reservoirs of HIV that persist in individuals treated with effective antiretroviral drug regimens and serve as the source of rebound viremia following cessation of therapy.
  •  Development of physiologically relevant assays for quantifying replication-competent latent HIV reservoirs and identification of biomarkers for predicting viral rebound.
  • Characterization of replication-competent latent HIV proviruses and variables affecting their control and, ultimately, viral rebound after cessation of antiretroviral therapy.
  • Identification of therapeutic strategies that target latent/persistent HIV reservoirs or that may lead to control of viral rebound (for example: latency reversal, immune enhancement, direct targeting and killing of latently infected cells, and cellular and gene therapies).
  • Preclinical development and initial testing of new agents/strategies and combination approaches in animal models in the context of optimized antiretroviral therapy.
  • Studies to establish how host factors and timing of antiretroviral treatment impact the HIV reservoir and efficacy of cure or eradication strategies.
  •  Patient-oriented clinical research studies, including those that involve early treatment following HIV infection and studies in pediatric populations and women.

Applications that include studies related to latent or persistent infection in the central nervous system and/or myeloid reservoirs and its impact on viral rebound and HIV cure strategies will be considered for co-funding by NIMH and NINDS.

The research proposed is expected to push the boundaries of what is currently feasible, and it is recognized that aspects of the plan necessarily will include high risk research or development of improved methodology and technology.  Development of combination treatment strategies would be particularly suitable for this FOA. 

Clinical research as defined by NIH (http://grants.nih.gov/grants/glossary.htm#ClinicalResearch) must be integrated into the research plan.  Pilot or proof-of-concept clinical trials are encouraged but not required; if included, these are anticipated to be few in number, of small size (less than 50 subjects), and subject to review by the Scientific Advisory Board and NIAID/DAIDS Clinical Science Review Committee prior to implementation. Each Collaboratory is expected to demonstrate an ability to provide regulatory support and infrastructure needed for carrying out clinical studies.  In most cases, it is expected that the NIAID will not hold the IND/IDE for clinical trials. While preparing applications for submission under this FOA, applicants are encouraged to review the NIAID Clinical Terms of Award and associated guidance documents (see http://www.niaid.nih.gov/researchfunding/sci/human/Pages/clinterm.aspx) and the DAIDS Clinical Research Policies and Standard Procedures Documents  for protocol templates and guidance and clinical research resources.

Non-Responsive Areas of Research

Applications focused on any of the following will be deemed non-responsive and will not be reviewed:

  • Strategies that rely solely on general activation of T cells (e.g. cytokine cocktails, agonistic antibodies, and similar approaches).
  • Studies on the mechanisms of virus control in persons who can suppress HIV to undetectable levels without antiretroviral drugs (elite controllers) or long-term non-progressors.
  • Strategies targeting only actively replicating virus, in the absence of approaches to impact latent infection.
  • Studies focused on in vitro cell models of latency that do not extend to primary cells isolated from treated HIV-positive individuals.
  • Strategies limited to intensified or early antiretroviral therapy without additional purging and eradication strategies.
  • Applications focused solely on one anatomical reservoir.
  • Applications focused exclusively on specific cellular reservoirs without addressing persistence in resting CD4+ T cells.
  • Applications without a private sector partner as defined below.
  • Applications that do not include basic science, translational and clinical research as part of the research strategy.
  • Applications proposing clinical trials beyond proof-of-concept.

Partnerships

An important part of this program is the establishment of partnerships between academia and industry to address the most important challenges in understanding and eradicating persistent HIV infection.  The key investigators and institutions should provide a broad range of expertise and resources needed to accomplish the overall research goals, while structured to maintain focus, productivity, effective communication, and efficient management of activities.  Cross-disciplinary partnerships to maximize innovation are highly encouraged and expected.  The breadth of expertise and resources is expected to involve approximately 8-15 investigators and multiple institutions.

The translation of basic science findings to evaluation in animals and humans is a critical goal of this program. To facilitate these activities, each application must include at least one private sector partner with commitment to contribute materially and intellectually to the overall goals and objectives of the Collaboratory.  Applicants are highly encouraged to seek partnerships with multiple private sector entities where possible.  No single private sector entity can be the exclusively named partner on more than one application.  However, a given private sector entity may be named as an exclusive partner on one application and a co-partner on other applications where additional private sector partners are named.  For the purpose of this FOA, the term “private sector” comprises large and small, domestic and foreign, for-profit pharmaceutical, biotechnology, bioengineering, and chemical companies.    Companies providing only fee-for-service type activities or access to materials or services without intellectual involvement in the proposed research may be included in the application, but will not meet the criteria for being considered a private sector partner for the purpose of satisfying these requirements. 

Intellectual Property

In light of the collaborative nature of this funding initiative, applicants are encouraged to reach consensus with any proposed partners, prior to application submission, regarding intellectual property, data sharing, and other legal matters that may arise during the project in order to ensure that the Collaboratory goals will be achieved. 

Collaboratory Structure

Research Program:  Initial Research Foci (IRF) will provide plans for synergistic discovery research activities focused on basic, translational, and clinical research strategies to achieve an HIV cure, defined as sustained HIV remission and/or eradication, through academic, industry, government, and community partnerships.

Scientific Research Supports will consist of activities that can provide a service unique to the program and may include technology development needed for accomplishment of the planned research, or may develop a specific Scientific Resource directly related to and necessary for accomplishment of one or more of the Research Foci. 

Management and Operations will provide the overall coordination for central Collaboratory activities such as administrative tasks, communication, data sharing, strategic planning, adherance to timelines, resource allocation, and establishing efficient processes for activities across multiple institutions

Community Engagement will provide a mechanism for forming and managing a productive partnership with the communities in which HIV Cure-related research will be conducted.

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.

Application Types Allowed

New

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

Funds Available and Anticipated Number of Awards

The following NIH components intend to commit the following amounts in FY 2016 to fund 3-4 awards:

NIAID, $19.5 million
NIDA, $1.5 million
NIMH, 1.0 million
NINDS, $0.75 million 

Award Budget

Application budgets are limited to $3.5 million Direct Costs per year, and should reflect the actual needs of the proposed project.

Award Project Period

The total project period may not exceed 5 years.

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

  • 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.
  • 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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed. However, a given institution may receive funds through subawards from more than one application.

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

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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 Jackson, Ph.D.  
Telephone: 240-669-5049
Email: pjackson@mail.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 requirements:

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

  • Overview:  Scientific Agenda and Strategic Plan: one required - 12 pages
  • Research Program:  Initial Research Foci: two required, up to four accepted - 12 pages each
  • Scientific Research Supports: optional, no limit - 6 pages each
  • Management and Operations: one required - 6 pages
  • Community Engagement Plan: one required - 6 pages
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 requirements:

Facilities & Other Resources:  For each clinical research site provide information on: the infrastructure for the research proposed such as clinical, laboratory, pharmacy, and space for document storage; available resources for laboratory testing, and institutional support for the conduct of clinical research under U.S., DHHS, and NIH regulations and policies regarding human subjects.   

Other Attachments:  Provide the following additional materials specified below in support of the application.

Provide the following information as a PDF file with the name “Organizational Data”:

  • Table of contents of the attachment
  • Diagram showing the overall organizational and leadership structure
  • Flow chart(s) showing processes for management and operations, including how decisions will be made regarding milestones, strategic planning, resource allocation, and policies
  • List of planned meetings and teleconferences to facilitate communication among Collaboratory investigators 
SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

Budgets should be included for the following:

  • A full-time Program Manager or Coordinator to oversee day-to-day operation, organization, communication, and coordination of collaborative activities. 
  • Expenses for communication among Collaboratory investigators and for outreach to outside researchers, community members, and industry partners, including establishment and maintenance of a Collaboratory website.
  • Travel and other expenses related to hosting an annual Collaboratory meeting for SAB evaluation and Strategic Planning activities.
  • Travel expenses for participation in annual joint-Collaboratory meetings to facilitate cross-Collaboratory interactions and communication.
  • Travel expenses for Community Advisory Board (CAB) members to participate in annual Scientific Advisory Board (SAB) meetings, and for at least two CAB representatives to participate in joint Collaboratory meetings once per year.

The budget justification should include a breakdown of the apportionment of funds for each of the proposed Initial Research Foci, Scientific Research Supports, Operations and Management, and Community Engagement activities for the first year.      

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 overarching long-range strategic objectives for the Collaboratory.  Concisely and realistically describe the problem(s), the hypothesis or hypotheses to be tested, and the plans to address the primary research questions. Although this is a reissue of RFA-AI-10-009, this FOA supports only new applications and specific aims should be new programs not supported under the previouis FOA.

Research Strategy: Research Strategy must consist of the clearly marked sub-sections A-E described below uploaded as a single PDF attachment:

Sub-section A.  Collaboratory Overview

The Overview is a narrative section that summarizes the overall mission and short- and long-term goals for the Collaboratory, and the vision of how interrelated and complementary research efforts through academic, government, and private sector partnerships will contribute to achieving the overall Aims in ways that cannot be easily accomplished through standard research grant mechanisms. 

  • The Scientific Agenda should include a narrative description of knowledge gaps relevant to the eradication of HIV infection and persistent infection, and how the overall goals for the Collaboratory will address the gaps through a dynamic program of collaborative and synergistic research strategies.  Define the overall scientific questions to be addressed and the conceptual framework for how the program will move the field forward.  Describe how interaction and collaboration among the proposed academic and private sector (industrial) participants will bring unique expertise, activities, resources, and processes to the program and how these will facilitate translation of basic research findings toward clinical application. 
  • The Strategic Plan will provide a comprehensive overview for implementing the overall Aims through innovative, interdisciplinary approaches.  The Strategic Plan will demonstrate how the Collaboratory will function to achieve the goals, including clear strategies for effective collaboration and decision-making as new findings emerge. Identification of potential bottlenecks and anticipated strategies to overcome major challenges should be included.  The rapid evolution of science in this area is expected to result in periodic changes in research priorities and significant funding reallocation over the award period.  The Strategic Plan should describe the following: 
    • Overarching milestones and timelines for the proposed research, alternative directions, and metrics for monitoring progress and performance toward scientific and product development goals.
    • Identification of three to five investigators who will constitute the Executive Committee (EC) for the Collaboratory, and how they will work with the PD(s)/PI(s) to facilitate changes in scientific focus, reallocation of funds and resources among projects and/or investigators, discontinuation of Research Foci, responses to SAB recommendations, sharing of data and scientific resources, and overall operations of the Collaboratory.  Members of the EC should be representative of the initial Research Foci; inclusion of industry partners and CAB representation on the Executive Committee as voting or non-voting members may be considered but is not required.  
    • Specific processes and approaches for activities of the PD(s)/PI(s) and EC, which may include but are not limited to the following:

      - Setting and regularly re-evaluating research priorities and milestones, with evaluation of outcomes and go/no-go decisions as appropriate;
      - Developing, reviewing, and approving new Research Foci and Research Support Components;

      - Engaging and incorporating new collaborators and/or technologies relevant to the scientific priorities as opportunities evolve over the period of the award;

    • Strategies for managing relationships with the private sector partner(s) and for facilitating engagement with future private sector partners over the entire funding period, including management of intellectual property, proprietary information, and confidentiality among collaborators to encourage participation by multiple industry partners.
    • Plans for convening a required external SAB, in consultation with and subject to the approval of the NIAID Program Official.  The SAB should consist of 4 members. The SAB will meet with the Collaboratory PD(s)/PI(s), EC, and other key personnel at least once a year to review progress and provide recommendations directly to the Collaboratory PD(s)/PI(s) and to inform and update NIAID.  The annual Collaboratory SAB meeting is an opportunity for scientific exchange and strategic planning for future research goals. The NIAID Program Official and other relevant NIH Program staff will attend each SAB meeting as observers.

      Candidates for the advisory board should not be named in the application or solicited prior to award.

Sub-section B.  Research Program Section:  Initial Research Foci (IRF)

Each Collaboratory should be organized around a single, complex research project that allows for flexibility in research direction as the project matures and as new findings, technologies, and opportunities arise.  As such, the Research Program Section should clearly delineate at least two but no more than four IRF (areas of initial research), written as integrated goals of a single research program.

Repeat this section for each IRF.  Identify each IRF with a title and number.  Describe the significance of the research, its relevance to the overall Aims and Scientific Agenda, and its synergy with other proposed research activities.  Each IRF should describe short-term objectives, with detailed plans for the first 1-2 years, followed by more general plans and alternate strategies for the remaining years. Measurable outcomes and go/no-go criteria should be provided where appropriate and a clear vision for future directions should be outlined, with flexibility to redirect or replace research projects as the research evolves.  Describe the research design, conceptual procedures, tools, technologies and analyses to be used to accomplish the objectives. Plans should include specific metrics for progress.  

Clinical research as defined by NIH (http://grants.nih.gov/grants/glossary.htm#ClinicalResearch) must be integrated into the research plan.  Pilot or proof-of-concept clinical trials are encouraged but not required; if included, these are anticipated to be few in number, of small size (less than 50 subjects), and subject to review by the Scientific Advisory Board and NIAID/DAIDS Clinical Science Review Committee prior to implementation. Each Collaboratory is expected to demonstrate an ability to provide regulatory support and infrastructure needed for carrying out clinical studies.  In most cases, it is expected that the NIAID will not hold the IND/IDE for clinical trials. While preparing applications for submission under this FOA applicants are encouraged to review the NIAID Clinical Terms of Award and associated guidance documents (see http://www.niaid.nih.gov/researchfunding/sci/human/Pages/clinterm.aspx) and the DAIDS Clinical Research Policies and Standard Procedures Documents  for protocol templates and guidance and clinical research resources.

Sub-section C.  Scientific Research Supports Section(s) (Optional)  

Describe proposed Scientific Research Supports activities which may provide a service unique to the Collaboratory, may include technology development needed for accomplishment of the planned research, or may develop a specific Scientific Resource directly related to and necessary for accomplishment of the Research Foci.  The application must indicate the specific needs to be served by the Scientific Research Supports and should demonstrate how each Support will add value to the Collaboratory and facilitate research activities, in ways that otherwise could not be achieved through the Research Foci. 

Repeat this section for each Scientific Research Supports proposed.  Give each a title and number. This section of the application should present a clear picture of the techniques and skills that each Support will provide.  Provide the rationale for selecting the methods, approaches and milestones and the relevance to the overall theme of the Collaboratory.

Address any intellectual property issues anticipated and any private sector involvement. 

In securing services and common resources to support the needs of the program, it is expected that applicants will leverage existing government-funded resources, such as Clinical and Translational Science Awards (http://www.ncats.nih.gov/ctsa/about/hubs) or Centers for AIDS Research (http://www.niaid.nih.gov/labsandresources/resources/cfar/pages/default.aspx) whenever possible, and provide documentation in the application that such services and resources will be available to the program.  Duplication of Research Support services should be avoided.

Sub-section D.  Management and Operations (MO) Section

Each Collaboratory must propose a Management and Operations Section responsible for the oversight and coordination of the program, including regular meetings among key personnel and day-to-day activities. The Collaboratory PD/PI will lead the Management and Operations activities, and have responsibility for coordinating the entire range of Collaboratory activities, with assistance from a required Program Manager for coordination, as well as from the EC for progress evaluation, strategic planning, and major decision-making.  It is expected that key personnel will devote substantial effort to the Collaboratory program, particularly those involved in the EC.   

The application should describe how the Management and Operations Section will serve as a hub for the entire Collaboratory for overall leadership and management, regular communication and information sharing, coordination of activities, data management, and supervision of the Program. Describe specific plans and processes for establishing, tracking, reviewing, and managing milestones, and for tracking and reporting productivity.  Define clear lines of authority involving the PD/PI, Program Manager, EC, Collaboratory key personnel, Scientific Advisory Board, and Community Advisory Board.  Clearly explain strategies for coordination of the program, problem identification and resolution, prioritization of resources, and the establishment of a strong collaborative environment for the Collaboratory, as well as plans for fiscal accountability among multiple institutions and investigators.  Describe the strategy for reallocating funds, such as when rapid deployment of clinical studies is needed, or when discontinuing unproductive or unnecessary Research Foci, Scientific Research Supports, and associated personnel.

Describe plans for coordination of resources, facilities, research and development activities and investigators across broad scientific areas and multiple institutions/organizations. This will likely require management of funds between institutions on a scale beyond the usual research grant. The commitment of the awardee institution to facilitate the administration and subcontracts of the Collaboratory will be crucial to achieving success.  

Meetings.  The Management and Operations section should include plans to coordinate and support the following meetings:

1.  A face-to-face kick-off meeting within three months of the award

2.  Annual Collaboratory meetings of all key personnel for progress evaluation by the SAB and strategic planning in conjunction with NIAID Program staff and CAB members.

3.  Regular Collaboratory teleconferences to facilitate internal sharing of information and resources, review progress, discuss current and future research directions, and ensure effective interdisciplinary interactions and collaborations. These teleconferences should include NIAID Program staff and CAB members.

4. Monthly teleconferences between the PD(s)/PI(s) and NIAID Program Staff to discuss research progress, award administration, EC activities, and issues regarding proposed changes in resources or scientific direction before they are implemented.

5. Regular teleconferences and meetings of the EC to discuss research progress, strategic planning, Collaboratory policies and their implementation, and potential changes in scientific direction or resources.

6.  Participation of Collaboratory key personnel, SAB members, and at least two CAB representatives from each Collaboratory in joint Collaboratory meetings to be held annually at a domestic location either as a stand-alone meeting or as a satellite meeting in conjunction with another scientific conference.  These meetings will serve to encourage information sharing and collaboration among the funded Collaboratories and other members of the scientific research community and to avoid duplication of efforts. This will also serve as the face-to-face meeting of the cross-Collaboratory CAB.

Subsection E.  Community Engagement Section

Each Collaboratory must propose a plan for community engagement, including support of a CAB that will promote interactions of a diverse group of community stakeholders 

Define the goal of the Community Engagement, including but not limited to any of the following:

  • Providing feedback on ethical and practical concerns to Collaboratory leaders in ongoing or anticipated Collaboratory research, particularly as research moves toward clinical application.
  • Providing input for improved communication and outreach efforts for clinical research participants.
  • Providing education of community stakeholders on HIV cure research and ongoing Collaboratory research activities and findings.

This section will include support for activities of the Community Advisory Board (CAB) and management of community engagement by Collaboratory staff, including regular teleconferences and meetings with community stakeholders, involvement in Collaboratory meetings and teleconferences, community education and outreach activities when appropriate.

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:  Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be 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.

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 NOT-OD-13-030.

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

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? 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?  Is the overall Scientific Agenda compelling, with clear rationale for the proposed approaches and areas of focus?  Are the individual Research Foci scientifically meritorious?  How likely is it that the partnerships and collaborations involved will lead to critical new knowledge about HIV persistence, latency, and what is needed for long term remission or cure?   Does the proposed private sector partnership(s) contribute materially and intellectually to the overall goals and objectives of the Collaboratory?   

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  Do(es) the PD (s)/PI(s) have documented leadership and management experience with large, complex, multidisciplinary research collaborations?  Will the PD(s)/PI(s) and other key investigators involved devote adequate time and effort to the Collaboratory?  Are the members of the Executive Committee likely to be able to effectively manage changes in research priorities and resource allocation?  Will the private sector partner(s) provide expertise and/or resources not generally available in academia?  Does the private sector entity have a record of past successes moving concepts to practical applications?  

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?  Do the proposed Scientific Research Supports provide cutting-edge technologies that are not available through other resources and that are critical to the success of the research?  

Approach

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

If the project involves 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?

Is the Strategic Plan feasible and compelling as a way to implement the Scientific Agenda? Are the approaches proposed in the Scientific Agenda coherent and focused on an important aspect of HIV cure research? How well do the overall Collaboratory goals, expressed in the Scientific Agenda and Strategic Plan, address important roadblocks to the discovery and development of a safe and effective strategy for eradication of HIV reservoirs and persistent infection? 

Is there synergy among the Individual Research Foci and Scientific Research Supports toward the central objectives of the Collaboratory?  Is the value of supporting the proposed research foci together significantly greater than what could be achieved through support of each separately? 

Are there appropriate plans and mechanisms for budgetary reallocation and for selecting and adding new activities, as well as adding Research Foci and Research Support personnel? Are there appropriate and feasible plans to incorporate new research activities and/or scientific resources/facilities in response to emerging opportunities or to eliminate unproductive research and/or resources/facilities? Is a clear decision-making process in place to allow shifts in research focus and/or funding allocation to maintain innovation as the research evolves? Are the proposed milestones, and metrics to monitor, quantify and evaluate progress and productivity appropriate and feasible?

Is the Community Engagement Plan sufficient to facilitate communication among Collaboratory investigators and community stakeholders? How well is private sector/industry partnership integrated into the planned studies?  Is there a sound plan to incorporate new partnerships and collaborations as needs arise?   

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?  

Has the applicant described plans to leverage existing Government funded resources and provided documentation that these resources will be available to the Collaboratory investigators? Is there adequate support to manage complex funding of sub-projects across multiple institutions? Is additional institutional support or other funding sources leveraged to create further synergy within the Collaboratory structure?   

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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the 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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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

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.

Cooperative Agreement Terms and Conditions of Award

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

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

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

  • Planning, directing, and executing the proposed research in accordance with the proposed timeline;
  • Establishing the membership and responsibilities of an Executive Committee, described below, within three months of the award;
  • Prior to implementation of any clinical study, demonstrating readiness with regard to the preclinical support for the study, the availability of funds to carry out the study, compliance with all applicable Federal, State, and Local regulatory requirements and with all applicable DHHS, NIH, and Institute/Center (IC)-specific policies and procedures for the conduct of clinical research; and a timeline consistent with completion of the study within the term of the award, compliance with the NIAID Clinical Terms of Award and associated guidance documents (see http://www.niaid.nih.gov/researchfunding/sci/human/Pages/clinterm.aspx) and the DAIDS Clinical Research Policies and Standard Procedures Documents  for protocol templates and guidance and clinical research resources.
  • Communication with the NIH Project Scientist regarding the status of ongoing research, particularly in the case of clinical activity (enrollment, adverse events, interactions with the FDA, problems and resolution of same, changes in personnel, protocol amendments, etc.);
  • Timely acquisition of any proprietary rights, including intellectual property rights, and all materials appropriate for performing the project(s);
  • As part of the annual progress report, provide a summary outlining interactions among the group members and with the NIH Project Scientist(s); and a complete, cumulative list of all publications attributable to the award;
  • Timely presentation/publication of work supported in part or whole by this Cooperative Agreement; prior notification of the NIAID Program staff regarding any presentations or publications and appropriate acknowledgement of NIH support;
  • Establishment of a Scientific Advisory Board (SAB), described below, within six months of the award and in consultation with the NIAID Project Scientist;
  • Holding an annual meeting to review progress, plan and design research activities, and establish priorities, to include the membership of the Executive Committee (described below), the Scientific Advisory Board (described below), the Community Advisory Board, and NIH Program representatives; 
  • Integrating and implementing the recommendations of the SAB into the activities of the Collaboratory.

Scientific Advisory Board:  The Scientific Advisory Board (SAB) for each Collaboratory will include at least 4 active members not affiliated with the applicant institution(s) or other institutions receiving funds from the award. The SAB will be an independent advisory body and act as a resource for the Principal Investigator and the Executive Committee, but will not be involved in the day to day activities of the Collaboratory.  Members of the SAB are expected to attend one Collaboratory meeting per year throughout the award period, and should be invited and encouraged to attend the joint Collaboratory meeting.  They will assist in review of research activities, progress toward the proposed goals, adherence to the original time frames, and the continued relevance of Research Foci and Scientific Support Components; the SAB may recommend new directions as appropriate. The named chairperson of the SAB will provide the PD (s)/PI (s) and the NIAID Program Official with a comprehensive written evaluation of Collaboratory activities, including the Board’s recommendations, within 30 days of the annual meeting.  In the case that the research reaches a point at which a test-of-concept clinical study is contemplated, the Scientific Advisory Board may be called upon, at the discretion of the NIAID Project Scientist, to evaluate the readiness of the group to undertake the study.

Executive Committee:  An Executive Committee of 3-5 voting members will serve as the governing body for the Collaboratory.  The Committee will be chaired by the PD (s)/PI (s), and membership should include 2-4 additional key personnel representing leadership for each of the Research Foci; inclusion of industry partners and CAB representation on the Executive Committee as voting or non-voting members may be considered but is not required.  The NIAID Project Scientist will act in an advisory capacity and be a non-voting member of the Committee.  The Program Manager may assist with Committee administration as a non-voting member. The Executive Committee may recommend redirection of certain scientific activities due to changes in priorities or lack of productivity. Any changes in scope of the proposed scientific agenda must be approved by the NIAID Program Official and the designated Grants Management Official.

Each full member will have one vote. Members of the Collaboratory will be required to accept and implement policies approved by the Executive Committee.

The Executive Committee will:

  • Assist the PD (s)/PI (s) in achieving the goals of the Collaboratory, setting and regularly re-evaluating research priorities and milestones, and preparing formal reports summarizing Collaboratory activities and/or progress, such as the Annual Progress Report;
  • Assist in protocol development for clinical studies and evaluate human subjects issues when required;
  • Develop and regularly implement a strategy for reallocating funds and modifying Research Foci and Support Components, including discontinuing unproductive or unnecessary studies and instituting changes in resources and personnel;
  • Identify policies and procedures to support operations and scientific progress, including development of needed working groups, engagement of new collaborators and/or technologies relevant to the evolving scientific priorities, and establishment of guidelines for publication of the results of collaborative projects;
  • Advise the NIH Project Scientist on scientific opportunities, emerging needs and impediments;
  • Ensure timely release of data to NIH-supported and/or public databases;
  • Ensure adherence to NIH policies on human subjects research, NIAID clinical terms of award (http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf), DAIDS policies and procedures for clinical research (http://www.niaid.nih.gov/labsandresources/resources/daidsclinrsrch/pages/default.aspx) and those of applicable institutional and regulatory bodies (IRB, IBC, FDA, RAC, other).
  • The NIH Project Scientist will participate in the activities of the Executive Committee as required, providing verbal or written responses to the Executive Committee or its designated committees.

NIH Responsibilities:

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

  • Participation in the design of activities;
  • Facilitating access to resources and information that otherwise might not be available to the awardee;
  • Advising on the management of the projects and technical performance, and coordinating with other appropriate NIAID staff to provide advice or assistance to the awardee on specific scientific, medical, technical, or management issues;
  • Facilitating interactions between the awardee and other groups of importance to the awardee, for example, IC clinical trials networks, the FDA, pharmaceutical and/or biotechnology companies;
  • Providing guidance and oversight on compliance with Federal regulations related to human subjects research and IC policy on clinical research, and communicating in a timely manner information that might affect the safety of subjects in grant supported studies;
  • Participation in the annual meeting, and other meetings as appropriate, to review research progress and direction and provide recommendations. 
  • The role of NIAID will be to facilitate and not direct the activities.  It is anticipated that decisions on all activities will be reached by consensus or Executive Committee majority vote and that appropriate NIAID Program staff as non-voting members will be given the opportunity to offer input. The NIAID Project Scientist will not participate as a co-author on any publications resulting from the research. 
  • Additionally, an agency Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.  The assigned NIAID Program Official may also serve as the NIAID Project Scientist.

Areas of Joint Responsibility include:

  • Attending an annual joint meeting of all Collaboratories funded under the Martin Delaney Collaboratory Program, including at minimum the PD(s)/PI(s) and key investigators, with the CAB and NIH staff for the purpose of communicating important findings and overall progress, facilitating interactions among Collaboratory programs, and establishing joint priorities;
  • PD(s)/PI(s) will submit protocols for clinical studies carried out under this FOA for review and approval by the appropriate IC protocol review group. The review will include assessment of the scientific objectives, design, safety, ethics, and feasibility of proposed research protocols.

Dispute Resolution 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 Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Executive 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. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See Section 8.4.1.5.5 of the NIH Grants Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

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

Application Submission Contacts

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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 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: 301-710-0267

Scientific/Research Contact(s)

Diane Lawrence, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3202
Email: lawrencedi@niaid.nih.gov

Jeymohan Joseph, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: (240) 627-3869
Email: jjeymoha@mail.nih.gov

Vishnudutt Purohit, DVM, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-594-5753
Email: vpurohit@nida.nih.gov

May Wong, Ph.D.
National Institute of National Institute of Neurological Disorders and Stroke
Telephone: 301-496-1431
Email: wongm@mail.nih.gov

Peer Review Contact(s)

Peter Jackson, Ph.D.
National Institute of Allergy and Infectious Diseases, (NIAID)
Telephone: 240-669-5049
Email: pjackson@mail.nih.gov

Financial/Grants Management Contact(s)

Julie Bergerud
National Institute of Allergy and Infectious Diseases, (NIAID)
Telephone: 240 669-2967
Email: BergerudJ@niaid.nih.gov

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: siscor@mail.nih.gov

Pamela G. Fleming
National Institute on Drug Abuse (NIDA)
Phone: 301-253-8729
Email: pfleming@nida.nih.gov

Tijuanna Decoster, Ph.D.
National Institute of Neurological Disorders and Stroke
Telephone: 301-496-9231
Email: decostert@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 .

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