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)

Funding Opportunity Title

Strengthening Institutional Capacity to Conduct Global Cancer Research in Low- and Middle-Income Countries (D43 Clinical Trial Not Allowed)

Activity Code

D43 International Research Training Grants

Announcement Type

New

Related Notices
  • April 21, 2020 - Pre-Application Webinar for RFA-CA-20-031. See Notice NOT-CA-20-055 .
Funding Opportunity Announcement (FOA) Number

RFA-CA-20-031

Companion Funding Opportunity

None

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

93.398   

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to establish an institutional program for mentored training in global cancer research. This program will support research training led by the United States (U.S.)-based cancer research-intensive institutions working in collaboration with institutions in low and middle-income countries (LMICs). These training programs will be built upon the US institutions’ pre-existing training infrastructure and research collaborations with LMICs and will leverage these resources to expand the global cancer research workforce both in the US and in LMICs. The overarching goal of this initiative is to build capacity to conduct innovative and collaborative global research projects that will contribute to the advancement of basic, clinical, translational, and population-based cancer research in LMICs.

This FOA does not allow appointed trainees to lead an independent clinical trial but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor.

Key Dates
Posted Date

April 14, 2020

Open Date (Earliest Submission Date)

June 24, 2020

Letter of Intent Due Date(s)

30 days prior to application due date

Application Due Date(s)

July 24, 2020; June 24, 2021.

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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)

Not Applicable

Scientific Merit Review

September 2020; August 2021

Advisory Council Review

January 2021, January 2022

Earliest Start Date

March 2021, March 2022

Expiration Date

June 25, 2021

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Training (T) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

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

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

    Purpose   

    The long-term goal of this initiative is to build research capacity of investigators and health professionals who can develop the scientific expertise and leadership skills needed to conduct innovative and collaborative global research projects that will contribute to the advancement of basic, clinical, translational, and population-based cancer research. This initiative will support mentored training of both the U.S. and LMIC scientists and the development of multidisciplinary training curricula to address specific cancer research needs and opportunities in LMICs. These training programs will be built upon the institutions’ pre-existing training infrastructure and research collaborations with LMICs and will leverage these resources to expand the global cancer research workforce both in the U.S. and in LMICs.

    Key Terms for this FOA

    Low- and Middle-Income Countries:  LMICs are defined by the World Bank classification system, according to Gross National Income per capita as "low-income," "lower-middle-income," and "upper-middle-income". In this program, consistent with NIH and Fogarty programs, "Eligible LMICs" do not include G20 countries in the "upper-middle-income country" category (UMIC) for funding (except for Sub-Saharan Africa). G20 UMIC sites may be involved as additional training sites if no faculty or trainees from that G20 UMIC institution are supported by the proposed D43. For details on the D43 definition of "eligible LMIC" used in this FOA see Notice of Change in Country Eligibility for Fogarty International Training Grants.

    Trainee: In the context of this FOA, "trainees" are individuals both from the U.S. applicant institution and the collaborating LMICs. The applicant can propose to train pre-doctoral and postdoctoral candidates. Pre-doctoral trainees must be enrolled in a program leading to a master’s degree, PhD or an equivalent research doctoral degree program. Postdoctoral trainees must have received a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution.  Postdoctoral trainees also include clinical fellows and clinicians in residency training. 

    Background

    In the U.S., incidence rates for all cancer sites have decreased on an average 1.1% each year over the last 10 years, but significant disparities persist in cancer incidence and mortality among certain racial and ethnic minorities and immigrant communities. The primary drivers of these disparities such as higher prevalence of risky behaviors, inadequate prevention and early detection, presence of co-morbidities, and poor access to treatment services, also underlie the high cancer-related morbidity and mortality seen in LMICs.

    By 2030, 75% of the projected 21 million new cancer cases and 13 million annual cancer deaths worldwide will disproportionately occur in LMICs, where, in addition to the drivers noted above, genetic susceptibilities and cultural practices may also play a significant role in cancer risk. Cancer death rates are higher in these countries than for AIDS, tuberculosis, and malaria combined. These statistics reflect key trends in LMICs, including aging populations, the epidemiologic transition to more non-communicable diseases than infectious diseases, and environmental and lifestyle changes. This global epidemiology suggests that there may be several unique opportunities to study cancer by conducting investigations in LMICs.

    Understanding and addressing these global scientific opportunities requires a range of research skills at the individual level as well as the capacity to support cancer research at the institutional level in both the U.S. and LMIC settings. Research training to conduct investigations in global settings is limited in the U.S. and is profoundly lacking in LMICs. Researchers need training in the scientific and methodological aspects of cancer research across the cancer continuum and training to conduct research based on an understanding of the determinants - biological, social, economic – of cancer within the partner country.

    Program Objectives and Considerations

    This initiative proposes to strengthen the global cancer research community through support of training programs built upon preexisting, high-quality cancer research and training infrastructure in the U.S. cancer research-intensive organizations and collaborative LMIC institutions. Programs supported by this FOA are expected to:

    • Provide a strong foundation in research design, methods, and analytic techniques appropriate for the proposed cancer research area, with the goal of developing independent research careers for the U.S. and LMIC scientists;
    • Provide training in competencies necessary for cancer research inquiry in basic, clinical, translational, and population sciences;
    • Enhance trainees’ ability to conceptualize, analyze, and solve cancer research questions with increasing independence; and
    • Strengthen and develop global cancer research leadership and mentorship at the U.S. and LMIC institutions.
    The Need for a Multidisciplinary Approach

    Risk factors for cancer are complex and differentially amenable to control. Further, the factors that are responsible for onset, prevention, and management of cancer are so diverse that it is essential that those trained gain a broad appreciation for the need of research across disciplines. As the scientific focus may vary based on LMIC setting and the capacity building needs of the U.S.-LMIC collaboration, a broad range of training activities can be proposed. Research training topics supported by this FOA include, but are not limited to:

    • Etiology, prevention, and control of infection-associated cancers;
    • Cancer genetics and cancer biology;
    • Epidemiologic studies to understand cancer risk at the population, genetic, and molecular level;
    • Implementation, operations, health services, and health systems research across the cancer continuum;
    • Cancer surveillance, informatics and analytics, data integration, and data utilization (particularly data in the public domain);
    • Behavioral and social science research in cancer prevention, diagnosis, treatment and survivorship;
    • Clinical research to develop low-cost interventions that have the potential to be transferable to settings in other countries or locations; and
    • Research in integrative oncology that incorporates evidence-based complementary therapies with conventional treatments to help cancer patients.

    Applicants must provide all trainees instruction in research ethics and orientation to regulatory procedures governing research in US and LMIC institution setting, as well as in the broad principles of cross-cultural and cross-national collaboration.

    Trainee Selection

    In the context of this FOA, "trainees" are individuals both from the U.S. applicant institution and the collaborating LMIC(s). The applicant can propose to train pre-doctoral, postdoctoral, and pre-professional degree candidates.

    Types of Training

    While innovative cancer research training models are encouraged, typically research training programs may involve the following:

    • Long-term (master's or doctoral degree and other training that is six months or longer) training for the full range of skills necessary to plan, conduct, manage and disseminate the results of cancer research with the understanding that the focus of thesis and training-related research will be in the LMIC.
    • Medium-term (three to six months) training or mentoring, which may include specialized mentored research in the LMIC.
    • Short-term (less than three months) training or mentoring that focuses on research skills and methodology, laboratory skills necessary to support research, ethics and compliance issues, grant writing, peer review, preparation of scientific manuscripts, data management, technology transfer, medical informatics, and other relevant areas.

    The application should incorporate an appropriate mix of these types of training to address the cancer research training needs identified for the LMIC.

    Training may take place in the U.S. or LMIC, with the expectation for most of the training to occur within the LMIC by the end of the initial grant award period.

    Training for senior personnel to serve as mentors is strongly encouraged.

    Additional institutional capacity-building efforts are encouraged. These may include, but are not limited to, in-country training workshops in advanced techniques; distance learning; and interaction with other national and regional efforts to strengthen the ability of institutions to identify and undertake successful cancer research and research training.

    Trainee Research

    This FOA encourages mentored research projects in LMIC settings.

    All training-related research projects in which trainees are involved under this award must be independently peer-reviewed through scientific review procedures established by the applicant institution, have written evidence of documentation of education in the protection of human subjects for the trainee, and approval from an institutional (or ethical) review board or committee at the applicant institution and, if different, at the LMIC institution in which the research is being conducted.

    It is expected that trainees will disseminate the results of their research at scientific conferences and in peer-reviewed publications.

    Where appropriate, the design of training-related research projects should account for potential gender differences that may affect the questions asked and the analyses performed. These might include different responses to and impacts of health interventions, differences in physiology, and different behavioral bases for disease prevention strategies.

    This research training program strongly encourages Program Directors/Principal Investigators (PDs/PIs) to include women, and individuals from groups underrepresented in biomedical and behavioral research in the country (including individuals from racial, ethnic and socially disadvantaged backgrounds and those living with disabilities), as faculty and research trainees at all sites.

    Annual Meetings

    The awardee institution will be expected to participate in an annual investigators' meeting that may be hosted at NCI and/or on a rotating basis at the participating institutions. The meetings will provide a forum for presenting scientific findings from each of the funded studies and will facilitate interactions among the community of funded scientists. Applicants should budget for the PD(s)/PI(s) and one additional project personnel to attend the planned annual grantee meeting. Attendees to PI meeting should also include PD/PI/key personnel from the LMIC partner institution. Investigators will be expected to participate in conference calls for planning purposes biannually or at other appropriate intervals; they may also be asked to participate in committees that meet periodically by conference call.

    This Funding Opportunity Announcement (FOA) does not allow appointed Trainees to lead an independent clinical trial, but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor. NIH strongly supports training towards a career in clinically relevant research and so gaining experience in clinical trials under the guidance of a mentor or co-mentor is encouraged.

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

    Section II. Award Information
    Funding Instrument

    Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

    Application Types Allowed

    New

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

    Clinical Trial?

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

    Note: Appointed Trainees are permitted to obtain research experience in a clinical trial led by a mentor or co-mentor.

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    NCI intends to commit $1.08 million in FY2021 to fund up to 4 awards and $810,000 in FY2022 to fund up to 3 awards.

    Award Budget

    Application budgets are limited to $250,000 per year (total direct costs).

    Award Project Period

     The scope of the proposed project should determine the project period. The maximum project period is 5 years.       

    Other Award Budget Information
    Stipends, Tuition, and Fees

    Awards may provide stipends as a subsistence allowance to help defray living expenses during the research training experience. Awards may also contribute to the combined cost of tuition and fees at U.S. or foreign institutions.

    Stipend: Trainees may be paid a stipend comparable to their professional experience.

    Stipend for U.S. citizens and U.S. permanent residents: Stipends for trainees who are U.S. citizens or permanent residents is the same as for Ruth L. Kirschstein National Research Service Award (NRSA) fellowships. See: https://researchtraining.nih.gov/resources/policy-notices.

    Stipend for LMIC citizens: Stipends for LMIC trainees may be paid at a level comparable to their professional experience and commiserate with the institution at which they are training.

    Tuition and Fees: Tuition and fees are allowable trainee costs only if such charges are applied consistently to all individuals in a similar training status at the organization, without regard to their source of support. Tuition at the postdoctoral level is limited to that required for specific courses in support of the approved training program and requires NCI prior approval.

    Tuition and Fees for training at U.S. institutions: NCI will contribute to the combined cost of tuition and fees at the rate in place at the time of award, at the same level set for NRSA fellowships; see https://researchtraining.nih.gov/resources/policy-notices.

    Tuition and Fees for training at LMIC institutions: For predoctoral and Postdoctoral Trainees who train at LMIC institutions, a reasonable proportion of the tuition and fees may be requested not to exceed allowances for U.S. trainees.

    However, programs may seek cost sharing arrangements with the grantee institutions to provide reduced tuition for trainees.

    Trainee Travel

    Trainee travel to attend scientific meetings and workshops that the institution determines to be necessary for the individual’s research training experience is an allowable trainee expense for predoctoral and postdoctoral trainees. 

    Other Program Related Expenses

    Award will provide funds to help defray other research training expenses, such as health insurance, training equipment (up to $5000), trainee research supplies, computers and internet access, relevant journal subscriptions and publication costs and costs for short courses or workshops.  

    For trainees who are U.S. citizens or U.S. permanent residents, research training expenses can not exceed allowances provided in NRSA fellowships. See: https://researchtraining.nih.gov/resources/policy-notices.

    Applicants may include costs to support mentored research projects for medium- and long-term trainees as part of their training. Direct costs should be limited to up to $15,000 per project per long-term trainee. Similar costs for medium-term trainees should be commensurate with the amount of time spent on the research projects or the particular need for the project. These funds should not be used to support travel. Trainees will not be paid directly. All costs for mentored research projects will be awarded to the applicant institution. It is expected that the U.S. institution will make necessary arrangements with the collaborating LMIC institution(s) to support mentored research projects. Only one project is allowed per trainee.

    Faculty: Salary for the PD(s)/PI(s), other key personnel, training faculty, and administrative staff may be requested at levels commensurate with the salary structure and benefits at the institution where they are employed and within the limits described at https://grants.nih.gov/grants/policy/salcap_summary.htm. As this is a training award, it is expected that PD(s)/PI(s) will devote between 0.6 and 1.2 person months per year.  

    Collaborators at partner institutions may receive appropriate compensation for significant contributions to activities in the program, such as trainee recruitment and selection activities, as well as leading courses, supervising research projects, or other program-related roles.

    Funds may be requested to support faculty/staff travel directly related to the research training program, and to attend necessary training program associated meetings.

    Support for senior/key personnel, faculty and collaborators to attend other scientific meetings and conferences is not allowed.

    Indirect Costs

    Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, consortium costs in excess of $25,000, and expenditures for equipment), rather than on the basis of a negotiated rate agreement.

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Higher Education Institutions

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

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

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

    Nonprofits Other Than Institutions of Higher Education

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

    Governments

    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)
    • U.S. Territory or Possession

    Other

    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations

    The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

    U.S. institutions engaged in cancer research and that meet the following criteria are eligible to apply:

    • The applicant institution should focus on basic, clinical, translational, or population-based cancer research or a combination of these programs. It is anticipated that the participating trainees would be exposed to a broad spectrum of cancer research in addition to being trained in a specific area or a combination of several cancer research areas.
    • The applicant institution should demonstrate collaborations with eligible LMIC institution(s) named in the application that is documented by joint publications, grants or previous research training activities, as well as by support letters from LMIC institutions as well as other relevant organizations in the LMIC indicating commitment to the training program.

    As previously mentioned, LMICs are defined by the World Bank classification system, according to Gross National Income per capita as "low-income," "lower-middle-income," and "upper-middle-income". In this program, consistent with NIH and Fogarty programs, "Eligible LMICs" do not include G20 countries in the "upper-middle-income country" category (UMIC) for funding (except for Sub-Saharan Africa). G20 UMIC sites may be involved as additional training sites if no faculty or trainees from that G20 UMIC institution are supported by the proposed D43. For details on the D43 definition of "eligible LMIC" used in this FOA see Notice of Change in Country Eligibility for Fogarty International Training Grants.

    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 by 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) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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 training program as the Training Program Director/Principal Investigator (Training PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

    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 SF 424 (R&R) Application Guide.

     The PD(s)/PI(s) must be an established investigator with research and training experience in the LMIC country they seek to work with.

    The PD(s)/PI(s) listed in the application must be designated as the PD/PI of at least one active research award that is relevant to the research training proposed in the LMIC. The research awards may be funded by the NIH or by other national or international organizations.

    Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI is available at https://grants.nih.gov/grants/multi_pi. All PD(s)/PI(s) must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see https://era.nih.gov/reg-accounts/register-commons.htm for instructions).

    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 programmatically distinct.

    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).
    Preceptors/Mentors

    Program faculty should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program.  Non-U.S. faculty from other high-income countries (HICs) may be included only as consultants if their participation is well justified to fill a unique research training expertise not available among U.S. or LMIC investigators. Program faculty should also have a record of research training, including successful, former trainees who have established productive careers relevant to the NIH mission.  Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.

     It is expected that most, if not all, faculty mentors will have research and/or research training experience in the LMIC and on topics which are the focus of the application.

    Trainees

    Trainees may be U.S. citizens, U.S. permanent residents, U.S. nationals, or citizens/nationals of LMICs who are committed to a career in global cancer research.

    Trainees may be pre-doctoral students, postdoctoral and clinical fellows, and clinicians in residency training.

    U.S. citizens and permanent residents may only train at the postdoctoral level. This includes trainees who are clinical fellows and clinicians in residency levels.

    LMIC citizens may train at the predoctoral and postdoctoral level.

    The program is not an individual training fellowship program. Potential trainees are appointed by the PD(s)/PI(s) of the award and not by NCI/NIH.

    Pre-doctoral trainees must be enrolled in a program leading to a master’s degree, Ph.D. or an equivalent research doctoral degree program.  

    Postdoctoral trainees must have received a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. 

    Postdoctoral trainees must have protected time to conduct proposed research training.

    All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the awarding unit, or when trainees are appointed to approved, short-term training positions.

    In the training program plan, applicants are encouraged to achieve a balance of U.S. and LMIC trainees so that the goals of strengthening institutional capacity to conduct global cancer research can be achieved. By the end of the five-year program period, it is expected that at least 50% of trainees completing the medium- and long-term training will be from LMICs.

    Section IV. Application and Submission Information
    1. Requesting an Application Package

    The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

    It is critical that applicants follow the Training (T) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    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:

    Sudha Sivaram, DrPH, MPH
    Telephone: 240-276-5804
    Email: nciglobaltraining@nih.gov

    Page Limitations

    All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

    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

    Follow all instructions provided in the SF424 (R&R) Application Guide. 

    SF424(R&R) Project/Performance Site Locations

    Follow all instructions provided in the SF424 (R&R) Application.

    SF424 (R&R) Other Project Information

    Follow all instructions provided in the SF424 (R&R) Application

    Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the research training program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of trainees including their levels (i.e., predoctoral, postdoctoral), and intended trainee outcomes.

    Include the name of the LMIC institution and cancer focus of the proposed research training. Describe the public health relevance of the proposed research training to the named LMICs in Project Summary.

    Other Attachments.

    Advisory Committee: An Advisory Committee is not a required component of a training program.  However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the training program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Please name your file “Advisory_Committee.pdf”.

    LMIC institutions should provide letters of support and collaboration that also describe research partnerships with U.S. institutions and expected outcomes from the proposed collaboration. Support for trainees as described in the scope of project and commitment to their career development in the LMIC institution should be strongly indicated. If the LMIC institution collaborates with other regional institutions and seeks to train researchers from other countries, letters of support from institutions in these countries are to be included in the application. This will achieve the goal of building capacity in additional LMICs where cancer research is not as established as the primary collaborating LMIC.

    The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

    SF424(R&R) Senior/Key Person Profile Expanded

    Follow all instructions provided in the SF424 (R&R) Application.

    PHS 398 Cover Page Supplement

    Follow all instructions provided in the SF424 (R&R) Application.

    PHS 398 Training Subaward Budget Attachment(s)

    Follow all instructions provided in the SF424 (R&R) Application Guide

    Research & Related (R&R) Budget

    Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

    • Use the “Other Personnel” section to submit costs for salary support for administrative staff.
    • Use the “Travel” section to submit costs for key personnel and faculty travel including the annual network meeting.
    • Use the “Participant/Trainee Support Costs” section to submit costs for Trainees and training-related expenses.  Include health insurance under Training Related Expenses (not in Tuition/Fees/Health Insurance). Provide details of trainees and training related expenses in the budget justification and identify by name any continuing trainees.
    • Use the “Other Direct Costs” section to submit costs for other direct costs related to training activities. Describe fully in the budget justification
    PHS 398 Research Training Program Plan

    The PHS 398 Research Training Program Plan Form is comprised of the following sections:

    • Training Program
    • Faculty, Trainees, and Training Record
    • Other Training Program Sections
    • Appendix- Note that the Appendix should only be used in circumstances covered in the NIH policy on appendix materials or if the FOA specifically instructs applicants to do so.

    Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

    Particular attention must be given to the required International Program Training Data Tables: https://grants.nih.gov/grants/forms/data-tables.htm.  Applicants should summarize, in the body of the application, key data from the tables that highlight the characteristics of the applicant pool, faculty mentors, the educational and career outcomes of participants, and other factors that contribute to the overall environment of the program.

    Training Program

    Program Plan

    Background and Rationale:

    In addition to the instructions in the SF424 (R&R) Application Guide, briefly discuss the following points: 

    • Identify the LMIC institution(s) that will be the beneficiary(ies) of the proposed training.
    • Provide a rationale for the proposed program in terms of the specific cancer research capacity needs and priorities for the LMIC and LMIC institution.
    • The role of the LMIC collaborators in setting the research agenda and in conceptualizing and mentoring research projects should be described in this application.
    • Describe the current level of research capacity in the selected cancer research area at the proposed LMIC institution(s). Provide a list of other training programs, regardless of funding source, at the institution and justify the need for more research training in the selected area at the LMIC institution(s) if appropriate.
    • Describe how the leadership and professional staff from the LMIC institution(s) were involved in the planning, decision-making, and development of the application. All applicants should explain in detail how their relevant research grant support and activities are related to the proposed research training plan.
    • Describe prior and current cancer research collaborations among the applicant institution, LMIC institution(s) and other proposed participating institution(s), and how they serve as a research foundation to support the proposed training.

    Program Administration:

    In addition to the instructions in the SF424 (R&R) Application Guide:

    • Include the relevant scientific or professional background and research training experience of the Key Collaborator(s) at the applicant institution and the LMIC institution(s).
    • Describe the role of the Key Collaborator(s) at the partner institutions and LMIC institution(s) in the on-going administration of the proposed research training program.
    • Describe the processes that will be used to provide independent scientific review for trainee research projects, and document education in the protection of human subjects, compliance with federal requirements for the protection of human subjects and animals in medical research, and annual approval from relevant institutional (or ethical) review board(s) or committee(s).

    Program Faculty:

    In addition to the instructions in the SF424 (R&R) Application Guide:

    • Describe the leadership, administrative skills, scientific research and training experience of the faculty (including for U.S. or other HIC collaborators, their LMIC research and research training experience in the country that is the focus of the application) and how these qualities are related to the proposed roles in the training program.
    • Provide a description of how the ongoing collaborative research among the PD(s)/PI(s) and faculty as well as other relevant research at the collaborating institutions that will provide opportunities for mentored trainee research.
    • Explain in detail how the relevant research grant support and activities of the PD(s)/PI(s) and proposed mentors are related to the proposed research training plan.

    Proposed Training:

    In addition to the instructions in the SF424 (R&R) Application Guide:

    • Describe the proposed research training program, including the goals, objectives and how the program will meet the objectives outlined in this FOA and the needs and priorities of the LMIC and LMIC institution(s).
    • Describe in detail in the program plan the proposed long-, medium- and short-term training and provide a rationale for how this proposed training plan/combinations of training align with program goals as well as needs and priorities of the LMIC institution(s).
    • Include processes for determining projected training needs and a plan to monitor progress towards accomplishing desired goals.
    • When it is necessary to begin training activities in the U.S. or other non-LMIC site, program plans should describe a timeline and process for transfer of as many of the proposed training activities as feasible during the grant period to the LMIC institution(s), consistent with the overall goal to build research capacity there.
    • Applicants are encouraged to include a timeline which includes all proposed training activities.
    • Describe how the proposed programs will provide all trainees with professional development skills, individualized career guidance including instruction, and training in grant writing in order to apply successfully for future career development and independent research support. All postdoctoral trainees should also be provided with instruction in project management.
    • Describe a plan for providing mentoring that will support trainees in formal educational programs and in conducting training-related research. As part of these activities, program plans may propose mentorship training for proposed faculty.
    • Describe how peer learning will be encouraged between trainees and how program will encourage interactions between US and LMIC trainees

    Institutions with existing training programs:

    • Explain what distinguishes this program from the others and how these programs will synergize with one another, if applicable.
    • Describe how the pools of faculty, potential trainees, and resources are robust enough to support additional programs.

    Applicants should in addition:

    • Describe how the proposed research training program may serve as a bridge among the academic research community, policy makers and public health communities in the country.
    • Describe strategies that will be used to achieve a wider regional impact. This could be done, for example, through involving trainees in engaging with and educating policy makers, or by strengthening other institutions in the LMIC country or in neighboring countries ("south to south" training).
    • All training program plans must include training in bioethics, good clinical and laboratory practices, regulatory processes for research initiation and conduct in the LMIC institution, as well as scientific presentations and communications. All trainees must also receive appropriate orientation to the principles and norms of cross-national collaboration.
    • Other research support capabilities that are necessary for long-term sustainability may also be included, as needed. This includes, but is not limited to, fields such as library science, scientific writing and presentation, bioinformatics, biosafety, data management, research administration, the management of intellectual property, and English as a second language.
    Trainee Candidates

    In addition to the instructions in the SF424 (R&R) Application Guide:

    • Describe the size and qualifications of the pool of trainee candidates including information about the types of prior educational background and applied experience, clinical and research training and career level required for the program. Do not name prospective Trainees.
    • Attention should be given to recruiting and retaining LMIC trainees from groups underrepresented in cancer research in the LMIC context. This program strongly encourages PD(s)/PI(s) to include women and individuals from underrepresented racial, ethnic, or socially disadvantaged groups in the country as trainees.
    • Trainees should be selected based on documented evidence of research interest (cancer research experience, participation in research publications), commitment to work in the LMIC institution and commitment to working in global cancer research.
    • Describe the criteria that will be used to select LMIC trainees to ensure that trainees have appropriate prior training and experience, are likely to complete the training, and likely to contribute to the increased capacity of the LMIC institution in the selected scientific area as scientists and staff.
    • Describe the role of the LMIC institution faculty in the trainee recruitment process. Describe steps that will be taken to ensure that an available pool of eligible trainees will be available.
    • Describe recruitment efforts to attract women and other populations who are under-represented in sciences in the LMIC to apply for training opportunities.
    • Describe how the training advisory committee, if one is established, will provide feedback and advice to these processes.

    Institutional Environment and Commitment to the Program.

    The U.S. applicant institution and collaborating LMIC institution(s) must assure support for the proposed program. Appropriate institutional commitment to the program includes assurance that sufficient time will be allowed for the PD(s)/PI(s) and other Program faculty to contribute to the proposed program and protected time for trainees selected in the program to complete all proposed training activities. This commitment may also include PD(S)/PI(S) or faculty salary, stipend or tuition support for individuals involved in the training program, or other resources essential to a successful training program.

    Applicants must include letters of support from all participating institutions and should:

    • Describe the institutional support and commitment to the goals of the planning process by the applicant institution and other partner institutions.  
    • Include a description of support (financial or otherwise) to be provided to the proposed training program. This could include, for example, space, funds for curriculum development, release time for the PD(s)/PI(s) and/or participating faculty, or other innovative approaches to provide an academic and research environment for the success of the training program.

    Plan for Instruction in the Responsible Conduct of Research

    Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in the SF424 (R&R) Application Guide. 

    Appendix

    Limited items are allowed in the Appendix.  Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to theSF424 (R&R) Application Guide instructions.  

    PHS Human Subjects and Clinical Trials Information

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

    Study Record: PHS Human Subjects and Clinical Trials Information

    DO NOT USE. Attempts to submit a full, detailed study record will result in a validation error.

    Delayed Onset Study

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must complete a Delayed Onset Study.

    PHS Assignment Request Form

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

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

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

    4. Submission Dates and Times

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

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

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

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

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

    Pre-award costs are allowable only as described in the NIH Grants Policy Statement. Note, however, that pre-award costs are not allowable charges for stipends or tuition/fees on institutional training grants because these costs may not be charged to the grant until a trainee has actually been appointed and the appropriate paperwork submitted to the NIH awarding component. Any additional costs associated with the decision to allow research elective credit for short-term research training are not allowable charges on an institutional training grant.

    7. Other Submission Requirements and Information

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

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

    For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

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

    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 (SAM). 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 the NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

    Post Submission Materials

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

    Section V. Application Review Information
    1. Criteria

    Only the review criteria described below will be considered in the review process.

    Applications submitted to the NIH in support of the NIH mission 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 that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained 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 the merit of the training program and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

    Training Program and Environment

    Cancer Research Relevance to LMIC

    • Does the proposed training address a cancer research area that is of high priority to the LMICs involved?
    • Has the proposed training program been developed in collaboration with the LMIC institution?

    U.S.-LMIC Collaborative Research Capacity Strengthening

    • Will the proposed training fill a gap that is critical to cancer research capacity of the LMIC institution? Will the proposed training contribute to bringing the LMIC institutions to the next level of research capacity in the selected scientific area?
    • Is the history of research collaborations among the PD(s)/PI(s)/faculty/mentors at the participating institutions sufficiently strong to serve as a platform for the proposed training?
    • To what extent does the proposed training program take advantage of the existing research infrastructure, investments and support from NCI, NIH, and other organizations to the LMIC institution/s? Is the proposed training duplicative of existing research training provided by others at the LMIC institution(s)?
    • Does the program provide appropriate interdisciplinary or multidisciplinary research training opportunities? Is there an indication that the program will enhance sustainability of research capacity and support high quality research?
    • Is there evidence of a significant level of institutional commitment, including administrative and research training support, to support the training program and ensure its success?
    • Are the expected contributions of the proposed research training likely to strengthen the capacity of the LMIC institution to sustainably conduct independent cancer research and research training of importance to that country?
    • Does the proposed program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements?
    • If building on an existing/ previously established collaborative research training program(s) are there plans to expand and network for research training and trainee research with other institutions within the LMIC country and region?

    Content of Training Program

    • Do the objectives, design, direction, and mix of short-, medium- and long- term training proposed for the training program ensure effective research training in the selected cancer research area?
    • When applicable, is there sufficient documentation describing the responsibilities of the Training Advisory Committee regarding the provision of input, guidance and oversight of the program?
    • When applicable, is the Training Advisory Committee envisioned to achieve the functions defined in this FOA?
    • Are the plans for implementing mentored research projects adequate to provide independent, scientific review and ensure compliance with federal requirements for protection of human subjects and animals in medical research?
    • Are there plans to provide training designed to incorporate research methods and processes that consider rigor and reproducibility and that take into account potential sex and gender differences that may affect the questions asked and the analyses performed?
    • Are there plans to provide instruction in data management and statistics as appropriate for the proposed research training areas?
    • Is the proposed training program likely to ensure trainees will be well prepared for research-intensive and research-related careers?
    • Is it clear how the proposed training program is distinguished from other externally funded training programs at the institution?  
    • If training activities begin in the U.S. or other non-LMIC site, do program plans sufficiently describe a timeline and process for transfer of as many of the proposed training activities as feasible by the end of the grant period to the LMIC institution, consistent with the overall goal to build research capacity there?
    • Is the monitoring and evaluation plan for the proposed training program well-articulated and sufficient to achieve the training goals?

    Training Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

    • Regarding the proposed leadership for the D43 research training, do the PD(s)/PI(s) have the expertise, experience, and ability to oversee the organization, management and implementation?
    • Does the PD(s)/PI(s) have the scientific background, expertise, LMIC experience and administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program?
    • Does the PD(s)/PI(s) plan to commit sufficient effort to ensure the program's success?
    • Does the application provide information on how decisions regarding the proposed components of the research training program will be made in consultation with the proposed U.S. and LMIC faculty and Training Advisory Committee? Is this information and decision-making process sufficient  to achieving stated program goals?

    For applications designating multiple PD(s)/PI(s):

    • Is a strong justification provided that the multiple PD(s)/PI(s) leadership approach will benefit the training program and the trainees?
    • Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the training program and the complementary expertise of the PD(s)/PI(s)?

    Preceptors/Mentors

    • Are sufficient numbers of experienced U.S. and LMIC mentors with appropriate expertise, LMIC experience and research funding available to support the number and level of LMIC trainees (including short-term trainees, if applicable) proposed in the application?
    • Do the U.S. and LMIC mentors have strong records as researchers, including recent publications and successful competition for research support in areas directly related to the proposed research training program?
    • Do the U.S. and LMIC mentors have strong records of training individuals at the level of LMIC trainees (including short-term trainees, if applicable) proposed in the program?
    • Do the mentors who will supervise the trainee(s) have the expertise, experience, and ability to provide guidance in the organization, management and implementation of trainee research and help him/her to meet timelines?

    Trainees

    • Is a recruitment plan proposed with strategies likely to attract well-qualified trainees for the training program?
    • Is there a competitive applicant pool of sufficient size and quality, at each of the proposed levels (pre-doctoral, postdoctoral and/or short-term), to ensure a successful training program?
    • Are there well-defined and justified selection criteria as well as retention strategies?
    • Do prospective trainees have the potential to organize, manage, and implement a proposed research study?
    • How sufficient are plans to provide instruction in data management and statistics including those relevant to clinical trials to the prospective trainees?

    Training Record

           For applications that are built on previous research training programs:

    • How successful are LMIC students/postdoctorates in previous similar training by the PD(S)/PI(S) in completing the program?
    • How successful are past LMIC students/postdoctorates in similar training in achieving productive scientific careers, as evidenced by successful competition for research science positions in industry, academia, government or other research venues; grants; receipt of honors, awards, or patents; high-impact publications; promotion to scientific leadership positions; and/or other such measures of success?
    • Does the program propose a rigorous evaluation plan to assess the quality and effectiveness of the training? Are effective mechanisms in place for obtaining feedback from trainees?
    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

    Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.  

    Inclusion of Women, Minorities, and Individuals Across the Lifespan 

    Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

    Vertebrate Animals

    Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

    Biohazards

    Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

    Resubmissions

    For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.   

    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.

    Recruitment Plan to Enhance Diversity

    Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of prospective individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

    Training in the Responsible Conduct of Research

    All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR).  Taking into account the specific characteristics of the training program, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups, including face-to-face interaction?  (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter – Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction?  4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction – Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years? 

    Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

    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).

    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 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:

    • 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 response to this FOA.

    Applications will be assigned to the National Cancer Institute. . 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 Cancer Advisory Board. 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.
    • Geographic distribution.
    3. Anticipated Announcement and Award Dates

    After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date 

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

    Section VI. Award Administration Information
    1. Award Notices

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

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

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

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

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide to NIH copies of documents related to all major changes in the status of ongoing protocols.

    2. Administrative and National Policy Requirements

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

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex.  This includes ensuring programs are accessible to persons with limited English proficiency.  The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS.  Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

    HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.  For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

    Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.    

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

    Cooperative Agreement Terms and Conditions of Award

    Not Applicable

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.

    Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

    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. 

    Other Reporting Requirements

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

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

    4. Evaluation

    In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

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

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

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Sudha Sivaram, DrPH, MPH
    National Cancer Institute (NCI)
    Telephone: 240-276-5804
    Email: nciglobaltraining@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)

    Dawn Mitchum
    National Cancer Institute (NCI)
    Telephone: 240-276-5699
    Email: dm437a@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 287b) and under Federal Regulations 42 CFR Part 63a.

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