Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)
Fogarty International Center (FIC)

Funding Opportunity Title

Sub-Saharan African Collaborative HIV and Cancer Consortia (U54)

Activity Code

U54 Specialized Center - Cooperative Agreements

Announcement Type

New

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-CA-13-010

Companion Funding Opportunity

None

Number of Applications

See  Section III. 3. Additional Information on Eligibility.

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

93.393, 93.394, 93.395, 93.396 , 93.399, 93.989

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to promote and facilitate research on HIV and cancer in Africa through collaborative efforts between investigators in United States (U.S.) and investigators in sub-Saharan African countries. The FOA solicits applications for Specialized Center Cooperative Agreements (U54) for research on HIV-associated cancers from research institutions in the U.S. and sub-Saharan Africa.  Each application is required to propose between two to four research projects that address high-priority questions relevant to the African country.  The proposed projects may range, as appropriate, from basic research to translational efforts as well as population and implementation studies. Clinical trials, however, will not be supported.  In addition, the proposed Consortium must include two mandatory cores; an Administrative/Coordinating Core and a Mentoring/Career Development Core.  Additional cores such as any technical shared resources cores may be included as appropriate for the needs of the projects.

Key Dates
Posted Date

October 25, 2013

Letter of Intent Due Date(s)

December 17, 2013

Application Due Date(s)

(Extended to January 27, 2014 per NOT-CA-14-015), Originally January 17, 2014  

AIDS Application Due Date(s)

(Extended to January 27, 2014 per NOT-CA-14-015), Originally January 17, 2014

Scientific Merit Review

March-April, 2014  

Advisory Council Review

May 2014

Earliest Start Date

August 2014

Expiration Date

(Extended to January 28, 2014 per NOT-CA-14-015), Originally January 18, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. See NOT-OD-13-075 and  NIH’s Applying Electronically website for more information.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Purpose

The purpose of this FOA is to solicit competitive research applications for inter-disciplinary research in HIV-associated malignancies in sub-Saharan Africa, to be conducted by collaborative consortia between African and United States (U.S.) institutions.  The FOA will also further provide the opportunity for enhancement of research capacity of African institutions with the ultimate goal of such institutions developing progressively as independent competitive research centers. It is anticipated that this initiative will ultimately generate research collaborations, exchange knowledge and experiences within and across programs in the consortia so that they can potentially develop into an African collaborative network for HIV and cancer research.

Global cancer research, particularly in resource-constraint areas, is one of the priorities for the NCI. The NCI Office of HIV and AIDS Malignancy (OHAM) leads and coordinates efforts in the NCI on HIV-associated malignancies, and OHAM has as a priority the study of HIV-associated cancers in sub-Saharan Africa.  In conducting international research in HIV-associated malignancies, OHAM works with the NCI Center for Global Health (CGH), which coordinates the overall NCI global cancer research efforts. This FOA contributes to both missions by building cancer research capacity in sub-Saharan Africa.

This FOA was developed in collaboration with the Fogarty International Center (FIC).  The initiative also addresses the goals of the strategic plans of NIH's Office of AIDS Research (OAR) Trans-NIH Plan for HIV-Related Research (http://www.oar.nih.gov/strategicplan/).

The FOA will be open to all qualified applicants from U.S. and African institutions, i.e., an application can either be submitted by a U.S. institution or by an institution in sub-Saharan Africa. However, each application must be based on collaborations between researchers in a U.S. institution and researchers in a sub-Saharan African institution(s).  Eligible "sub-Saharan African countries" are the ones listed as such by the World Bank at http://data.worldbank.org/region/sub-saharan-africa.

Background

Sub-Saharan Africa is the epicenter of the HIV epidemic; more than two-thirds of HIV-infected persons live in sub-Saharan Africa.  Interwoven into the HIV epidemic is the rising cancer incidence in HIV-infected persons.  Even prior to the AIDS epidemic, various cancers particularly viral-associated cancers have been endemic in sub-Saharan Africa.  However, the burden of these cancers, especially AIDS-defining cancers such as Kaposi’s sarcoma (KS) and  non-Hodgkin lymphoma (NHL), has increased substantially with the progression of the HIV epidemic.  AIDS-defining cancers are now among the most common cancers in sub-Saharan Africa.

In the developed world, the incidence of HIV-associated malignancies is known to be influenced by the widespread use of combination anti-retroviral therapy (cART).  The impact of cART on cancer incidence in sub-Saharan region remains unclear.  Nevertheless, based on trends in the developed world, it is quite possible that wider cART use will result in a decrease in AIDS-defining cancers with a concomitant increase in non-AIDS defining cancers.

Given the scale of the HIV/AIDS epidemic and the cancer surge in Africa of HIV-associated malignancies, it is critical to improve research capacity that addresses loco-regional questions and strategies that will improve cancer prevention and care in Africa.  To attain these goals, NCI and FIC have focused efforts in developing research capacity in the region.  NCI and FIC have previously supported research training through several initiatives including an initiative (RFA-CA-09-016) that focused on training a cadre of scientific experts that would in the future  participate in hypothesis driven studies in HIV-associated malignancies.  The natural next step in building research capacity is to directly support research projects that are primarily conducted in sub-Saharan Africa by African investigators.    

Objectives and Scope

The major goal of this FOA is to support highly meritorious, inter-disciplinary multi-project research efforts in the area of HIV-associated malignancies. These research efforts must be conducted jointly by U.S. investigators and investigators in sub-Saharan African countries and must be focused on the specific needs of a given African country.  The proposed consortium should also enhance the ability of the partnering African institutions to serve as a national/regional resource in research, training, and career development for new African scientific leaders in HIV and cancer. 

Central Research Theme. Each proposed Consortium is expected to identify a distinct research theme and focus its activities around that theme. The research theme for the proposed consortium may be in various areas relevant to HIV and cancer provided that it addresses issues that are of high-priority to the partnering African country. It is essential that the proposed research activities have clearly defined potential to reduce the burden of HIV-associated cancers in the partnering African country. 

Cancer Categories. Each application should describe research projects that address a variety of topics for a single cancer category or one topic for a related group of cancer categories.  Cancer categories to consider may include, for example, hematological malignancies, infection-related cancers, and other cancers that significantly affect HIV-infected people in sub-Saharan Africa.

Areas of studies may include but are not be limited to the following examples:

1. Studies that define the pathogenesis and involved mechanisms in HIV-associated cancers;

2. Studies addressing the biological differences of HIV-associated tumors from sub-Saharan Africa, as compared to similar tumors arising in individuals without HIV;

3. Epidemiological studies on HIV-associated cancers;

4. Pathology and diagnosis research that clarify and define disease subtypes and effective diagnostic strategies in the disease entity;

5. Prevention and screening approaches applicable to reducing the cancer burden in HIV-infected people in sub-Saharan Africa;

6. Assessment of risk factors that impact cancer in Africa in the context of HIV infection;

7. Determination of population based cancer rates in the HIV-positive population in the context of developing policies and understanding the impact of cART on the burden of cancer;

8. Clinical studies to improve the treatment outcomes of cancers in the HIV-positive patients;

9. Studies that are focused on the complexities of treating additional concurrent co-morbidities such as tuberculosis (TB) and cancer in HIV-positive persons.

The proposed research may either address several areas for a single cancer category or one area for a related group of cancers.  A consortium that proposes focusing on multiple areas AND multiple cancer categories is strongly discouraged.

Non-responsiveness Criteria

No clinical trials will be supported, including clinical trials of drugs, biologics, or diagnostics; see the NIH definition of clinical trials at http://grants.nih.gov/grants/funding/424/SupplementalInstructions.pdf.  For NIH definitions of clinical research vs. clinical trials, please see http://grants.nih.gov/grants/glossary.htm#C. Applications proposing clinical trials will be considered non-responsive. Non-responsive applications will not be reviewed.

Consortium Organization

The proposed Consortium must include all the required components listed below.

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 staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the PHS 398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The NCI will allocate $5 million and FIC $0.4 million in fiscal year 2014 to jointly fund approximately six to seven awards.

Future year amounts will depend on annual appropriations.

Award Budget

Application budgets should be commensurate with the scope of research activities proposed but must not exceed $750,000 per year in total costs.

Award Project Period

Applicants may request up to 5 years of support.

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

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

Governments

Other

The only foreign institutions eligible to apply are those located in sub-Saharan African countries.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply, but only if they are located in sub-Saharan African countries.
Non-domestic (non-U.S.) components of U.S. Organizations are  eligible to apply, without geographical restrictions.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed, without geographical restrictions.

The FOA will be open to all qualified applicants from U.S. and African institutions, i.e., an application can either be submitted by a U.S. institution or by an institution in sub-Saharan Africa. However, each application must be based on collaborations between researchers in a U.S. institution(s) and researchers in a sub-Saharan African institution(s).  Eligible "sub-Saharan African countries" are the ones listed as such by the World Bank at http://data.worldbank.org/region/sub-saharan-africa.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the PHS 398 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.

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

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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. Additional information relevant for foreign applicants can be found at:

http://grants.nih.gov/grants/foreign/index.htm and

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-090.html.

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 PHS 398 Application Guide.

Applicants are strongly encouraged to take advantage of the multiple PDs/PIs option so that both U.S. and African investigators share responsibility for the consortium at the leadership level.

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS 398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent via e-mail to:

Geraldina Dominguez, Ph.D.
Office of HIV and AIDS Malignancies
Office of the Director
National Cancer Institute (NCI)
Telephone: 301-496-3204
Email: domingug@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute (NCI)
9609 Medical Center Drive, Room 7W412
Bethesda, Maryland 20892-9750 (for Express mail, use Rockville, MD 20850)
Telephone: 240-276-6390
Fax: 240-276-7682
Email: ncirefof@dea.nci.nih.gov

Page Limitations

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, in addition to the following page limitations to the Research Strategy section of each component of the application.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the PHS 398 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall Component

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Title of Project should reflect major theme of the consortium.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Overall)

All instructions in the PHS 398 Application Guide must be followed. 

Under the "Description", include the name of the participating African country and define the specified scientific theme for the proposed Consortium.

Under the "Performance Sites", include the applicant institution, the collaborating African institution if the applicant institution is in the U.S., and any other participating institutions, both U.S. and foreign.

Under "Key Personnel", for applications from U.S. institutions, include the name of one person at the collaborating African institution who will serve as the main collaborator (select “Other,” and list their role as “Key Collaborator).” Include at least one person at all of the other U.S. and foreign participating institutions as senior/Key Personnel and identify their role.

Table of Contents (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Provide a summary budget for the entire application.

All PDs/PIs (both from the U.S. and the African country) will be expected to have a significant effort commitment of at least 1.2 person-months.

Salary support for faculty and research staff from institutions in Africa must follow salary guidelines of the institute as confirmed by a senior institutional official [see Letters of Support (Overall) section below].

Budget for Entire Proposed Period of Support (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Biographical Sketch (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Biographical sketches are required for PDs/PIs, the Core leaders,  Research Project leaders, and all key personnel participating in the consortium.  Beginning with PDs/PIs, and following in alphabetical order.

Resources (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Applicants should include a description of available resources, naming which collaborative partner is contributing which resources. Indicate which specific resources will be available to other partners in the consortium (e.g., individual contributions of specific reagents, patient samples, compounds, and access to populations for epidemiologic studies). Commitments must be confirmed by letters from respective  senior institutional officials [see Letters of Support (Overall) section below].

Research Plan (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims:  Describe the overall scientific aims of the consortium and goals to accomplish the integration of its components.

Research Strategy:  Describe the consortium's overarching goals and objectives. Explain the significance of the chosen research theme and the proposed projects to country-specific needs. Provide details on how the consortium is anticipated to contribute scientific knowledge about HIV-associated malignancies, especially knowledge that will improve prevention, diagnosis, and treatment of these malignancies in sub-Saharan Africa.  Applicants should also address how the outcome of the proposed research may reduce the burden of HIV-associated cancers in the targeted country.

Applicants should also highlight how the scientific aims and goals of the consortium will synergize to increase research capacity and develop new scientific leadership in the country.  Each application must provide a description of how the consortium will accelerate research in sub-Saharan Africa and how it will foster research collaborations and experiences within the consortium and across other consortia that can serve to form a collaborative network for HIV and cancer research in sub-Saharan Africa.

In addition the Overall Section must include the description of the following elements:

The collaborative experiences of the participating investigators in HIV/AIDS, oncology or chronic diseases research and provide evidence that those collaborations have been productive and have substantially increased in-country research capacity. Indicate how the collaboration among the partners involved  has benefited the institution in Africa.

The structure of the consortium and individual responsibilities for all key personnel.  The application should describe the roles and responsibilities of the U.S. and African investigators in accomplishing the proposed research aims, training and career development activities, and in managing the consortium.  Project leaders and core directors can be either from the U.S. or African institutions.  However, the overall application should clearly provide evidence of equal and shared partnership and it is therefore encouraged that a balance of research and core leadership reflects such partnership.  Applicants should articulate the process for communicating with members of the consortium, decision making, and conflict resolution.  It should include contingency plans addressing solutions to setbacks and delays including those related to logistics, ethical approvals, travel/visa issues and other possible hurdles in developing the U.S.-Africa consortium.  As part of the proposed structure, applicants must address the following aspects:

The Plans for External Advisory Group.  Each consortium will have to organize an external group which is suggested to include, community advocates, policy makers, health education specialists, institutional and government leaders, and key opinion leaders from the African country.  The External Advisory Group will serve as the bridge between the research projects and the community at large and help identify research outcomes that might inform health policy changes. In this section, outline the anticipated role the External Advisory Group and characterize its desirable composition. Describe desirable profiles of members of such panel and how their expertise may enhance the consortium. However, to facilitate the review of the applications, do not list any names of potential members of the Advisory Group and do not contact such individuals.

Letters of Support : Letters of support from senior institutional officials must be provided that detail the institutional and leadership commitment from the participating institutions. In addition, for African institutions involved (either as applicant or a partner), a letter from a senior institutional official  needs to be provided to document that salary requests for personnel are consistent with the salary guidelines for that African institution.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide With the following additional instructions:

Applicants must address this for the complete application but only include it once in the "Overall" component.

Research Projects

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Research Projects)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Provide a descriptive name for each project proposed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Research Projects)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Research Projects)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Research Projects)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Budgets for individual research projects are not restricted but the combined budget for all research projects must not exceed 60% of direct costs for the entire application.

Budget for Entire Proposed Period of Support (Research Projects)

All instructions in the PHS 398 Application Guide must be followed.

Biographical Sketch (Research Projects)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Biographical Sketches for key personnel from each project should be included in the Overall component.

Resources (Research Projects)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Provide documentation of the scientific environment in which the research projects will be conducted including facilities, space, and any equipment that will be available for the research projects.  In addition, list any special facilities that will be available to conduct the research as well as any special equipment that will be available for the research projects. The documentation provided should include the resources available for the proposed research project at the African institution as well as at the U.S. institution(s).

Research Plan (Research Projects)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims: Outline the hypothesis (or central problem) to be tested and explain how it fits into the overall research theme of the consortium.  

Research Strategy: Describe the research strategy of the project in a similar format and level of detail as required for an investigator-initiated single-project grant application.  Each project should have the following sub-sections: Background and Significance, Rationale, and Approach.

Background and Significance.  Describe the central problem/hypothesis to address and describe how the proposed research will contribute to meeting the goals and objectives of the consortium and its primary theme.  Indicate the project's relevance to the specific situation of the partnering African country and how it will leverage and strengthen existing research capacity at the African institution(s).

Rationale.  Include any data and rationale supporting the proposed hypothesis and/or focal point of the research project.  Original research preliminary data are not required but encouraged if available. Regardless of the availability of own preliminary data, the concepts for the proposed projects must be well developed and rigorous. All projects are expected to be supported by a strong rationale that is based on integrating to the extent possible the available relevant information from various sources.

Approach.  Explain the rationale for selecting the methods to accomplish the Specific Aims of the project.  This section should focus on the specific strategies, innovation, leadership, and environment. Describe the research design, conceptual procedures, and analyses to be used.  Describe any new methodology and its advantage over existing methodologies.  Describe any novel concepts, approaches, tools, or technologies for the proposed studies.  Discuss associations with clinical project(s).  Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims.  As part of this section, provide a tentative sequence or timetable for the project.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide with the following additional instructions:

Do not complete this item for this component but do address its counterpart under "Overall".

Administrative/Coordinating Core

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Administrative/Coordinating Core)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Administrative/Coordinating Core)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Administrative/Coordinating Core)

All instructions in the PHS 398 Application Guide must be followed,.

Detailed Budget for Initial Budget Period (Administrative/Coordinating Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:  

Consortia Meeting: Each application is required to budget for supporting travel to the annual meeting of the consortia investigators.  It is anticipated that every meeting will be attended by the PDs/PIs and selected project and core leaders.  Applicants must plan that at least one of the Consortia Meetings during the project period will be held in or near Bethesda, Maryland. 

In the budget for this component, include also essential items related to the activities of the planned External Advisory Group such as modest travel costs and consultant costs.

Travel cost for the Consortia Meeting and any additional travel relevant to the goals of the consortium must not exceed $20,000 per year in direct costs. 

Budget allocation for enhancing administrative capabilities in the partnering African institution is suggested not to exceed 5% of the direct costs for the entire Administrative/Coordinating Core.  Costs associated with research administration may include, but are not limited to, the following activities: hiring new sponsored program staff, coursework on fiscal and grants management, purchasing new computers to ensure proper administrative and fiscal management to meet U.S. Federal requirements, developing improved institutional policies and procedures, and hire staff for Institutional Review Board (IRB) and ethics staff.

Budget for Entire Proposed Period of Support (Administrative/Coordinating Core)

All instructions in the PHS 398 Application Guide must be followed.

Biographical Sketch (Administrative/Coordinating Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Biographical Sketches for core director and any key personnel from the core should be included in the Overall section.

Resources (Administrative/Coordinating Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: The Administrative/Coordinating Core should provide oversight of the resource sharing plans of the consortium. 

Research Plan (Administrative/Coordinating Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims:  Provide the specific aims for the Administrative/Coordinating Core.  

Research Strategy: Describe how the core will oversee the overall administration, coordination and management of the consortium.  It is expected the contact PD/PI will lead the Administrative/Coordinating Core.  It is also expected that the Administrative/Coordinating Core coordinate the planning of the annual Consortia Meeting.

Where such expertise (e.g., grants administration, etc.) is not completely developed at the African site, a description of the plans to help develop these capacities may be included, such that the African institutions will progress towards self-sufficiency in this area in the near future. If appropriate, describe other ongoing efforts to enhance research administration at the institution and how the funds budgeted for the core may help fill previously identified gaps at the institutional level.

Provide details on how the core will coordinate, supervise and manage all consortium's activities, including activities that increase collaborations with other programs and across consortia.  This core should provide a supportive structure sufficient to ensure the accomplishment of the consortium's goals.

Indicate any plans to interact with other institutions in Africa (e.g.,  educational and governmental institutions as well as community organizations) to improve the technical capacity and clinical research practices at the partnering African institution(s).

Describe how the Administrative/Coordinating Core will assist Research Project and Core leaders with administrative aspects of their projects, such as gathering of progress reports and facilitating other communications with awardees and their mentors and how it will communicate and interact with NCI staff members.

Provide details on the process the core will follow in assembling the External Advisory Group. When discussing potential members of the External Advisory Group it may be limited to the expertise that is required for the success of the Consortium or names of potential members and biographical sketches

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide with the following additional instructions:

Do not complete this item for this component but do address its counterpart under "Overall".

Mentoring/Career Development Core

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Mentoring/Career Development Core)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Mentoring/Career Development Core)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Mentoring/Career Development Core)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Mentoring/Career Development Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:  

The budget of this core must include funds for training and career development activities directly in Africa.  In addition, it must include a fund for mentored pilot research projects conducted by African investigators.  Cost must not exceed $25,000 direct costs per year.  Note that activation of the funds for inter-consortia joint pilot projects will be subject of approval by the Steering Committee. 

Budget for Entire Proposed Period of Support (Mentoring/Career Development Core)

All instructions in the PHS 398 Application Guide must be followed.

Biographical Sketch (Mentoring/Career Development Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Biographical Sketches for core director and any  key personnel from the core should be included in the Overall section.

Resources (Mentoring/Career Development Core)

All instructions in the PHS 398 Application Guide must be followed. 

Research Plan (Mentoring/Career Development Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims:  Provide the specific aims for the Mentoring/Career Development Core.  

Research Strategy: The goal of this Core is to support future scientific training capacity and leadership development of the African investigators.  Describe how the U.S. and African institutions will develop collaborative plans for career development, including focused training, and mentoring activities for young and established investigators that develops research leadership at the African institution(s). These plans are also expected to include mentored research pilot projects that will either fall within the overall theme of the consortium or will be conducted as inter-consortia joint projects.

Note: The plans for the mentored research pilot projects must include the need to address various specific requirements when seeking approval for such a project. These requirements include documentation of education in the protection of human subjects for the trainee, compliance with the required federal citations, and approval from an institutional (or ethical) review board or committee at the applicant institution and, if different, at the institution in which the research is being conducted.

Describe collaborative plans between U.S. and African institutions for career development for young investigators in Africa as well as plans to support mentoring activities for established African investigators.  Include how the participating African institution(s) will support the career development of the African investigators.

Describe the career development plan for assisting African investigators towards a career path of becoming independent researchers.  Outline how the proposed activities are expected to advance the career development of these investigators. Define how an individual career development plan will be established for each African investigator supported under this core.  The applicant should also describe strategies and mechanisms to help  investigators obtain independent research funding to sustain their future research.  Examples of the type of activities that can be included are:  scientific training (e.g., data analysis), workshops on mentoring, manuscript writing, and personal career development.

Describe how the Mentoring/Career Development Core will solicit/develop pilot projects and the mechanism for approving these pilot projects.  In addition, describe how the proposed consortium could participate in joint inter-consortia pilot projects.  For both situations, consider how these pilot projects can be used to enhance the future development of young African investigators. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide with the following additional instructions:

Do not complete this item for this component but do address its counterpart under "Overall".

Shared Resources Cores

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Optional Shared Resources Cores (not to exceed two) may be proposed as required for the proposed research projects ( e.g., Clinical/Translational, Epidemiology, Biostatistics, or Laboratory Core).  Any proposed core must support at least two of the research projects.

Face Page (Shared Resources Cores)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Shared Resources Cores)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Shared Resources Cores)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Shared Resources Cores)

All instructions in the PHS 398 Application Guide must be followed.

Budget for Entire Proposed Period of Support (Shared Resources Cores)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Biographical Sketch (Shared Resources Cores)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Biographical Sketches for core director and any  key personnel from the core should be included in the Overall section.

Resources (Shared Resources Cores)

All instructions in the PHS 398 Application Guide must be followed. 

Research Plan (Shared Resources Cores)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims:  Provide the specific aims for the particular core outlining which projects it will serve.  

Research Strategy:  Describe how the proposed core will fit into the overall theme of the application and how it will support the proposed projects. Outline how the proposed core will support the projects and the overall consortium.  Explain the rationale for selecting the general methodologies and approaches for that core.  A Resource Core must support at least two of the research projects and must not duplicate an existing resource.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide with the following additional instructions:

Do not complete this item for this component but do address its counterpart under "Overall"

Appendix for the Entire Application

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

Foreign Institutions

Foreign (non-U.S.) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the PHS 398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS 398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the NCI, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-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.

The emphasis and priority of this FOA are on the creation and support of well integrated U.S.-African Consortia that are capable of proposing and conducting rigorous research projects in HIV-associated malignancies.  These projects must be strictly focused on high-priority, specific needs of the partnering sub-Saharan African country.  Equal partnerships between the U.S. and African institutions and shared responsibilities are also essential.  An additional priority will be given to those proposed consortia which are most likely to enhance the ability of the African institutions to serve as a national/regional resource for research and the development of scientific leaders in cancer research.

Overall Impact - Overall

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

Scored Review Criteria - Overall

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

Significance

Does the consortium  address an important problem or a critical barrier to progress in the field? If the aims of the consortium  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 for this FOA: How well does the chosen research theme address the needs of the African country? How significant will the proposed activities of the consortium be on advancing the African institution(s) ability to become independent research center(s)? How does the proposed consortium enhance the partnering African institution's ability to be a resource in research, training and career development for new African scientists?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the consortium? 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?

Specific for this FOA: How will the technical or clinical expertise of the African research project leaders and core directors support the mission of the consortium? How well are the leadership responsibilities of the cores and research projects shared among the African and U.S. investigators?

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?

Specific for this FOA: How innovative are the consortium efforts to improve the technical capacity and clinical research practices at the partnering institution(s) in Africa, e.g., in terms of  utilizing the educational, governmental and community linkages in Africa?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the consortium? 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 research project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Specific for this FOA: How will the consortium's activities accelerate knowledge in the areas of prevention, diagnosis, and treatment of HIV-associated malignancies in sub-Saharan Africa? How suitable are the consortium's choices of research projects  and plans for cores for the goal of advancing the African institution as an independent research center for HIV-related malignancies in Africa?

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 for this FOA: What are the commitments made that indicate a significant demonstration of institutional support from the African institution(s)?  How does the institution(s) provide evidence for future independent sustainment of research in the area of HIV and cancer?

Additional Review Criteria - Research Projects and Cores

As applicable for the research projects and cores  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.

Research Projects    

How will the proposed research projects address topics that are high priority to the African country?  Does the application identify a major research theme and are the proposed research projects linked to the theme? For each project, are the strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the research project?  Are potential problems, alternative strategies, and benchmarks for success presented? How will the scientific knowledge gained from the proposed research projects improve the outcomes of people in sub-Saharan Africa with HIV-associated malignancies?

Administrative/Coordinating Core

Is the proposed Administrative Core well matched to the needs of the overall consortium?  Is the management proposed appropriate for scientific administration as well as fiscal administration, procurement, and personnel management? Are the plans for establishing the External Advisory Group appropriate? Is its role in the consortium clearly defined? If appropriate, how well do the proposed activities for strengthening research administration address the needs of the African institution?

Mentoring/Career Development Core

Does the application provide evidence that it will develop in-country leadership such that they can become independent research leaders?  Will the proposed career development activities have an impact on the careers of the African investigators and on building HIV-associated malignancy research capacity at the African institutions?  Will the proposed research training and mentoring activities have an impact beyond the project period?  Are there well defined strategies to help young investigators at the African institution(s) obtain independent research funding support?

If the application is from a recipient of a D43 research training award (RFA-CA-09-016), does the application have previously trained trainees in leadership roles (e.g., project leaders or as leaders of the cores)?  How aligned is the role of the African investigator to their past training?

Review Criteria for Shared Resources Cores (if applicable)

Each Shared Resource Core must provide essential functions or services for at least two projects.  The merit of each shared resource core will be assessed based on the following criteria:

Is the proposed Shared Resource Core well matched to the needs of the research being proposed by the consortium? Does it provide essential facilities or services for two or more research projects? What is the overall quality of the proposed core services?  Are there adequate quality control processes proposed for the facilities or services provided by the Shared Resource Cores (including procedures, techniques, and quality control)? What are the criteria for prioritization and usage of Core products and/or services? Are the qualifications, experience, and commitment of the Shared Resource Core Lead(s) and other key personnel adequate and appropriate for providing the proposed facilities or services? Will the proposed shared resource core(s) provide cost effective services to the consortium? Is the environment for the shared resource core adequate to support the program as proposed?

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 research project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the 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 - Overall

As applicable for the consortium 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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NCI 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:

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

Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Prior Approval of Pilot Projects

Awardee-selected projects that involve clinical studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation. 

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

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

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

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

A PD/PI will be expected to maintain significant effort commitment not smaller than that stated in the application (at least 1.2 person-months).

Consortia Meetings:  Investigators from all the individual consortium should meet annually at one of the consortium sites to present updates on progress, to exchange ideas, to develop inter regional collaboration and to discuss problems encountered.  It is required that at least PDs/PIs, key personnel, and project and core leaders will attend these meetings. 

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

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

A designated NCI Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.  The NCI Project Scientist will be the main NCI contact for all facets of the scientific interaction with the awardees and will provide advice to the awardee on specific scientific and/or analytic issues in addition to programmatic issues.  As needed, additional NCI scientific staff members with relevant expertise may also become substantially involved in the Consortium activities as Projects Scientists.  The responsibilities of substantially involved NCI Program Staff members will include the following aspects.

The FIC Program staff member(s) will support the substantially involved NCI Program staff members by providing  technical assistance and advice, by participating as a non-voting member of the Consortia Steering Committee, and by serving as a liaison among the awardees and other relevant FIC-supported programs.

NIH staff members who are substantially involved in the program activities will not attend peer review meetings of renewal and/or supplemental applications.  If such participation is essential, these individuals will seek an NCI waiver according to the NCI procedures for management of conflict interest.

In addition, an NCI Program Official will be responsible for the normal scientific and programmatic stewardship of the award, and will be named in the award notice.  If this individual becomes substantially involved in the Consortium activities, he/she will not attend peer review meetings of renewal and/or supplemental applications or will seek NCI waiver if such participation is essential.

Areas of Joint Responsibility

Consortia Steering Committee.  The Consortia Steering Committee will be responsible for guiding the overall scientific directions of the consortia, developing collaborations across the consortia, and promoting inter-consortia pilot projects.  The Steering Committee will be composed of the following voting members:

The Consortia Steering Committee will be in charge of the following activities:

The Consortia Steering Committee will meet three times a year; two by teleconference and once at the annual Consortia Meeting.    

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 arbitration.  A Dispute Resolution Panel composed of three members will be convened.  It will have three members: a designee of the Consortia Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee.  This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or 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 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 Commons Help Desk (Questions regarding 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)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov  

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Geraldina Dominguez Ph.D.
National Cancer Institute (NCI)
Telephone: 301-496-3204
Email: domingug@mail.nih.gov

Jeanne McDermott Ph.D.
Fogarty International Center (FIC)
Telephone: 301-496-1492
Email: jeanne.mcdermott@nih.gov

Peer Review Contact(s)

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov

Financial/Grants Management Contact(s)

Rebecca Brightful
National Cancer Institute (NCI)
Telephone: 301-631-3011
Email: brightfr@mail.nih.gov

Kasima Brown
Fogarty International Center (FIC)
Telephone: 301-496-1670
Email: Kasima.Brown@nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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