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.

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

The overall intent of this funding opportunity is to support a LMIC-US collaborative planning process that will prepare faculty and design advanced courses and resources for a research training program to enhance capacity at LMIC institutions to conduct research directly related to prevention, treatment and control of infectious diseases causing major morbidity and mortality. Infectious diseases continue to impose a tremendous health burden in resource-poor countries throughout the world, claiming millions of lives annually and inflicting severe morbidity that results in significant losses in economic productivity and social progress. Attempts to control infectious diseases endemic to low and middle income countries (LMICs) suffer due to an incomplete understanding of the pathogens, disease manifestations and transmission mechanisms, inadequate preventive measures and interventions, and insufficient health services and disease control efforts. A major barrier to improved treatment and control of infectious diseases is the lack of capacity to conduct locally relevant infectious disease research, often due to the scarcity of scientists and health professionals in LMICs with relevant research expertise. Applications that include countries with little current research capacity are especially encouraged.

Purpose and Background Information

This Funding Opportunity Announcement (FOA) seeks applications for a Planning Grant for Global Infectious Disease Research Training program from LMIC research institutions. The application should propose a planning process with LMIC faculty and U.S. collaborators as well as activities to strengthen LMIC faculty, graduate student curriculum and research training resources relevant to the program to be planned. A detailed vision for a new research training program to strengthen the capacity of a LMIC institution to conduct infectious disease research that focuses on 1) major endemic or life-threatening emerging infectious diseases 2) neglected tropical diseases 3) infections that frequently occur as co-infections in HIV infected individuals or 4) infections associated with non-communicable disease conditions of public health importance in LMICs should be proposed.

FIC will support the planning of innovative research training programs that are designed to build sustainable infectious disease research capacity at an institution in an endemic LMIC. Sustainable infectious disease research capacity is known to require a critical mass of scientists and health research professionals with in-depth scientific expertise and complementary leadership skills that enable the institution to conduct independent, internationally-recognized infectious disease research relevant to the health priorities of their country. To integrate innovative research training approaches and create sustainable outcomes during the planning period, awards will support activities to strengthen LMIC faculty leadership and new research training skills as well as prepare advanced scientific didactic and methodology courses and training resources for the envisioned program that do not currently exist at the LMIC institution.

The proposed planning process is expected to lead to an application submitted in response to Global Infectious Disease Research Training Program (D43) FOA (see https://www.fic.nih.gov/Programs/Pages/infectious-disease.aspx) which provides up to five years of support for LMIC-U.S. collaborative research training.

This program does not support HIV/AIDS research training. Applicants interested in HIV research training should apply to the Fogarty HIV Research Training Program funding opportunities (see http://www.fic.nih.gov/Programs/Pages/hiv-aids-research-training.aspx-).

The objectives of the Planning Grant for the Global Infectious Disease Research Training program are:

- To assess the existing research and research training capacity for a new infectious disease scientific area at the LMIC applicant institution directly relevant to the LMIC health priorities;

- Based on this assessment, to develop a detailed vision and strategies for implementing an innovative research training and career enhancement program for multiple scientists and health research professionals to strengthen the applicant LMIC institution's capacity to conduct independent, sustainable infectious disease research;

-To identify the research training resources, faculty development, scientific environment contributions and administrative processes needed to undertake such a research training program;

-To increase leadership and innovative research teaching and grant writing skills of the LMIC faculty who will implement the envisioned program;

-To design and prepare or pilot advanced scientific didactic and methodology courses and research training resources for the envisioned program;

-To define a pool of the best potential LMIC trainees that can be recruited and the selection process for future research training;

-To define the collaborations and roles of all LMIC and U.S. individual and institutional partners for an effective organizational structure that will support the envisioned research training program; and

-To organize a process to submit a collaborative application to the Global Infectious Disease Research Training program (D43) FOA to support the research training planned

Planning Grant Activities

When considering the scientific focus, types of training to be planned and mentored trainee research that will be offered in the envisioned program, applicants should propose the following components:

1) A detailed planning process with LMIC faculty and U.S. collaborators to create innovative programmatic and implementation strategies to be embodied in a future Global Infectious Disease research training program D43 application.

2) The necessary faculty leadership and research training skill building activities (in areas such as scientific and grant writing and communication, project management, mentorship, evaluation, research ethics, adult pedagogy and distance learning teaching methods) and;

3) The design and preparation of new advanced scientific didactic and methodology courses and training resources such as orientation and training program guidance documents, individual development plans (IDPs) and mentorship materials, and LMIC focused case studies for responsible conduct of research and human subjects education modules.

Scientific Focus

As the rationale for a proposed planning grant, applications must identify an infectious disease scientific focus for the program to be planned that is directly relevant to the LMIC health priorities for which research capacity is limited or non-existent at the LMIC institution. Applications may focus on research training on an infectious disease that is:

1) A major endemic or life-threatening emerging infectious disease (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens)

2) A neglected tropical disease (https://www.niaid.nih.gov/research/neglected-tropical-diseases)

3) An infection associated with non-communicable disease conditions of public health importance or

4) An infection that frequently occurs as a co-infection in HIV infected individuals. However, applications that focus primarily on planning HIV/AIDS research training will not be supported in this program.

Applicants are encouraged to plan multidisciplinary research training programs with a focus on a global infectious disease theme. Training PDs/PIs are encouraged to plan training programs that will expose LMIC trainees to a diversity of scientific approaches, systems for study, innovative research methodologies, tools and technologies. Planners may consider novel team-based research approaches depending upon the goals of the training program envisioned. Research training related to infectious disease prevention, care and treatment in a broad range of areas (but not limited to those below) may be planned:

basic, epidemiologic, clinical, behavioral, and social science research;

bioengineering

bioinformatics, biostatistics, disease modelling

genetics/genomics

vector biology

pathophysiology, diagnostics and therapeutics research;

health economics, implementation, operations, health services, and health systems research;

competencies to support infectious disease prevention and treatment clinical trials;

Proposed planning LMIC and U.S. collaborators should have research expertise directly relevant to the proposed scientific focus of the research training program.

Types of Training to be Planned

Applicants should consider a planning process that incorporates the following characteristics into a newly designed training program:

-A strong foundation in research design, methods, and analytic techniques appropriate for the proposed infectious disease research area;

-The enhancement of the LMIC trainees ability to conceptualize and think through research problems with increasing independence;

-Experience conducting infectious disease research using state-of-the-art methods as well as presenting and publishing their research findings;

-The opportunity to interact with members of the scientific community at appropriate scientific meetings and workshops; and

-The enhancement of the LMIC trainees understanding of the health-related sciences and the relationship of their research training to health and disease.

The Global Infectious Disease Research Training program envisioned by the planners should be designed to move beyond training numbers of people for the next career level to demonstratively increasing sustainable, independently resourced infectious disease research capacity at the proposed LMIC institution.

The new institutional infectious disease research training program to be planned may complement other ongoing research training and career development programs at the applicant institution but must be clearly distinct from related programs.

Advanced degree and long-term non-degree research training supported at a U.S. or foreign institution should be considered as primary components for the future research training to be planned.

Short-term training components that provide selected LMIC trainees a thorough exposure to the principles and skills of specific new research methods or research related competencies to enable immediate incorporation into current trainee research or career development activities should be considered as secondary components for the future research training to be planned.

Transition of supported LMIC trainees to the next career stage should be an important consideration in designing a proposed research training program. Planners should consider how LMIC and U.S. mentors will provide scientific and career guidance.

Applicants are also encouraged to include the design of innovative training activities to strengthen the skills and knowledge necessary for long-term research career sustainability, such as scientific writing and presentation, grant writing, and expertise in bioinformatics, bioethics, good clinical practice, good laboratory practice, biosafety, research administration and English as a second language training, if needed.

The design of future research training may include interactive distance learning, if appropriate and sustainable for the LMIC participants and institutions involved. Planning grants that propose the development of distance learning components may include pilot training activities to explore the effective use of this approach.

All applicants are encouraged to develop research training approaches that include the use of information technology to facilitate trainee data management, access to online scientific information and collaborative interaction.

Planning Trainee Research

The proposed planning process should consider how to incorporate an appropriate mix of mentored research training opportunities to address the infectious disease-related research training capacity needs identified at the LMIC institution.

Applicants may propose planning for programs in which LMIC trainees are supported to participate in conducting research or analyses in clinical trials supported by other research grants. Programs planned to include training in clinicals trials must propose to design a Good Clinical Practice (GCP) course required for all faculty and trainees involved.

Planned research training can be conducted in the U.S. or another foreign country, but mentored training-related research should be carried out in the LMIC focus of the program as much as feasible.

The planning process should determine how all training-related research projects will be independently reviewed through scientific review procedures established by the program and obtain required approvals for human subjects and animal research.

The training program envisioned by the planners should anticipate ways that LMIC trainees will disseminate the results of their research at scientific conferences and in peer-reviewed publications during and after the training period.

Overall, regardless of whether the proposed planning process results in a successful Global Infectious Disease Research Training program (D43) application, the proposed activities should improve the research training capabilities of the LMIC faculty and research training resources at the LMIC institution.

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

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

• Non-domestic (non-U.S.) Entities (Foreign Institutions)

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 planning process and the future planned program.

Only higher education and research-intensive institutions in LMICs are eligible to apply. LMICs are defined by the World Bank classification system according to Gross National Income (GNI) per capita as low-income, lower-middle-income, and upper-middle-income (http://data.worldbank.org/about/country-classifications/country-and-lending-groups). See Notice of Change in Country Eligibility for Fogarty International Training Grants and Country Eligibility for definition of "eligible LMIC" used in this FOA.

Applications must be submitted by an eligible institution in a LMIC with a collaborating U.S. institution.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

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.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training program planning process 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/PI should be an established investigator in the scientific area in which the application is targeted and have research training experience in the LMIC that is the focus of the application. PD(s)/PI(s) from the applicant institution must be a citizen of an eligible LMIC.

The PD/PI from the LMIC applicant institution must not be a current or former PD/PI of a FIC research training grants (D43 or U2R awards).

The PD/PI should be capable of providing both administrative and scientific leadership to the development and implementation of the proposed planning activities. The PD/PI will be responsible for the overall direction, management, administration, and evaluation of the planning activities. The PD/PI will be expected to monitor and assess the program planning activities and submit all documents and reports as required.

Each PD/PI must be designated as the PD/PI of at least one research award that is directly relevant to the scientific focus of the research training proposed and with at least 18 months of support remaining at the time of submission of the application.

Due to the collaborative nature of this program, applicants are required to designate a U.S. collaborator as senior/key personnel or Multiple PD/PI. Collaborations in new scientific areas are encouraged. Previous and ongoing research collaborations can be documented by joint publications, grants or previous research training activities.

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

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)

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. Program faculty should also have a record of research training, including successful, former trainees who have established productive careers. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.

Research training programs must be planned only for individuals who are citizens or permanent residents of LMICs (defined by the World Bank classification system- also refer to NOT-TW-12-011"Notice of Change in Country Eligibility for Fogarty International Training Grants", for additional information). Individuals who have dual citizenship or permanent residency in the U.S., other high-income countries or ineligible countries described above will not be eligible for training support

Applicants should plan training programs in which the majority of 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.

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.

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:

Barbara Sina Ph.D.
Telephone: 301-402-9467
Fax: 301-401-0779
Email: [email protected]

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.

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

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

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

Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the research training program planning process, as well as key activities in the training plan. Include the name of the LMIC institution and infectious disease focus of the research training program that will be developed during the planning process. Describe the public health relevance of the proposed infectious disease focus of the research training to the named LMIC.

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

Include the name of one person at each collaborating institution who will serve as the primary collaborator for the research training program planning process at that site.

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

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

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 LMIC administrative staff.
• Use the Travel section to submit costs for key personnel and faculty travel including the annual network meeting.
• Use the Other Direct Costs section to submit costs for other direct costs related to planning process activities. Describe fully in the budget justification

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

Training Program Planning

Faculty 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:

Training Program Planning

Program Plan

Background

Provide the rationale for the proposed research training program to be planned in terms of the specific new infectious disease research capacity needs for the LMIC and LMIC institution. Applicants should describe the current level of research and expertise at the LMIC institution in the proposed scientific focus area and justify the need for new research training in this field.

Applicants must provide a specific justification for the need to support a two-year planning process, LMIC faculty strengthening activities and advanced course and training resource creation to develop a research training program application. Applicants should explain why the planning activities proposed would not be possible without support from a planning grant

Program Administration

Describe the leadership, administrative skills, scientific research and training experience of the PD/PI(s) and how these strengths will lead to the success of the planning process.

Describe the planned strategy and administrative structure to be used to oversee and monitor the research training program planning process.

The proposed planning process should define the roles of all individual and institutional partners for an effective organizational structure that will support the envisioned research training program.

Applicants should describe how decisions will be made in consultation with the proposed LMIC faculty and U.S. collaborators regarding the proposed components of the research training program being planned, LMIC faculty strengthening activities and advanced course and training resource development.

Faculty

The application must include information about the LMIC and U.S. faculty who will be available to contribute to the training program planning process without duplicating information in biosketches. Describe the complementary expertise and experiences of the proposed faculty planning participants, including active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring and training LMIC individuals.

Provide a description of how the previous and ongoing collaborative research among the PD/PI(s), LMIC and U.S. faculty as well as other relevant research at the collaborating institutions will provide a foundation for the research training program envisioned.

Particular attention must be given to the required International Program Training Data Tables. https://grants.nih.gov/grants/forms/data-tables.htm

Describe for whom the training program to be planned is intended, including the expected training level(s) of the LMIC trainees and the academic and research background expected to pursue the proposed training envisioned. The proposed planning process should define a pool of the best potential LMIC trainees that may be recruited, trainee selection criteria and mentorship during research training.

Institutions with existing research training program grants must explain how the planning process will determine 1) What distinguishes the research training program being developed from the others; 2) How their programs will synergize with one another, if applicable; and 3) That the pool of faculty, potential LMIC trainees, and resources are robust enough to support additional programs.

Applicants are encouraged to include a timeline for all proposed planning activities.

The proposed planning process must identify the research resources, scientific environment and administrative processes needed to undertake the research training program envisioned.

Applicants must plan a process by which all mentored trainee research projects will be independently peer-reviewed through a scientific review procedure or committee established by the applicant institution.

Applicants must plan how faculty mentors and LMIC trainees will be provided with education in the protection of human subjects and ethical review of the proposed trainee research by an institutional (or ethical) review board or committee for anticipated trainee research that involves human subjects.

Applicants must design a process to submit an application to the Global Infectious Disease Research Training program (D43) FOA.

Proposed Faculty Strengthening Activities

Include information regarding any activities for faculty designed to develop specific technical skills, leadership or other competencies essential for the research training envisioned. Research training leadership skills training for the LMIC PD/PI and faculty can be supported in areas such as grants writing, project management, conducting a needs assessment, evaluation, responsible conduct of research, adult pedagogy and distance learning. Mentorship training for proposed faculty is especially encouraged.

Proposed Development of Advanced Courses and Research Training Resources

Include information about the process for developing advanced scientific and methodological courses for the LMIC institution's curriculum that do not currently exist and mentored research experiences. Applicants can propose to design orientation and research training guidance materials or to pilot distance learning courses/modules.

Applicants should also describe the proposed program planning activities to develop innovative approaches to provide LMIC trainees with professional development skills and individualized career guidance, including the development of mentorship materials, where necessary.

Training Program Evaluation

Describe a plan to develop an evaluation process to determine the quality and effectiveness of the training program. This process should consider how to evaluate the training and mentorship activities envisioned as well as the overall success in building sustainable, independently resourced infectious disease research capacity at the LMIC institution

Institutional Environment and Commitment to the Program.

The sponsoring institution must assure support for the proposed research training program planning process, faculty strengthening activities and development of courses and training resources including assurance that sufficient time will be allowed for the PDs/PIs and other Program Faculty to contribute to the proposed program.

The application should include letters of support from institutional leaders of the collaborating institutions describing the possible institutional contribution and commitment to the research training program to be planned.

Plan for Instruction in the Responsible Conduct of Research

The proposed planning process should determine how future training program applications submitted to the GID D43 FOA will comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as described in the NIH Application Guide. Applicants are strongly encouraged to develop courses in the responsible conduct of research adapted to the locally relevant scientific context at the LMIC institution that include LMIC faculty.

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 the SF424 (R&R) Application Guide instructions.

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

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

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.

This initiative is not subject to intergovernmental review.

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. 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.

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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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.

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed research training program planning award will prepare LMIC faculty, research training courses and resources and plans for a research training program application that will successfully build sustainable infectious disease research capacity at the LMIC institution, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of the merit of the training program planning process, faculty strengthening and advance training course and resource and resource development, 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

• Does the applicant demonstrate the need to plan a new infectious disease research training program, strengthen faculty and develop advanced courses and training resources at the applicant LMIC institution?
• Does the applicant demonstrate that the proposed infectious disease scientific area for research training is directly relevant to the LMIC health priorities?
• Does the applicant propose a realistic plan for developing a successful application to the Global Infectious Disease Research Training program (D43) FOA?
• Is the proposed planning process likely to develop an innovative, high quality and scientifically rigorous research training and career enhancement program?
• Is there adequate potential for a supportive research training environment at the applicant LMIC and collaborating institutions as demonstrated by expert faculty mentors, institutional support, and on-going collaborative research projects in which LMIC trainees may participate?
• Will this planning grant contribute to improved research training capacity and resources at the LMIC institution regardless of the outcome of a subsequent application for a Global Infectious Disease Research Training program (D43) award?

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

• Does the PD/PI have the scientific background, expertise, and administrative and research training experience to provide strong leadership, direction, management, and administration of the proposed research training program planning process, faculty strengthening and advanced course and training resources development?
• Is there a history of research collaborations among the PD(s)/PI(s), the faculty and staff at the LMIC applicant and collaborating institutions?
• Does the PD/PI plan to commit sufficient effort to ensure submission of a meritorious application to the D43 FOA?
• For applications designating multiple PDs/PIs:
• Is a strong justification provided that the multiple PD/PI leadership approach will benefit the proposed research training program planning process, faculty strengthening and advanced course and training resources development?
• 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 proposed activities and the complementary expertise of the PDs/PIs?

Preceptors/Mentors

Are sufficient numbers of experienced LMIC and U.S. faculty mentors with appropriate expertise, appropriate ongoing research and collaborative experience available to contribute to the success of the proposed research training program planning process, faculty strengthening and advanced course and training resources development?

Do the faculty mentors have strong records of training individuals in research at the level of trainees? Are appropriate plans proposed to ensure that faculty lacking sufficient research training experience are likely to provide strong and successful mentoring?

Do the planned activities provide sufficient strengthening of faculty grantsmanship, mentorship and pedagogical skills to develop and implement the research training program to be planned?

Trainees

Does there seem to be an adequate pool of candidates for the future research training program proposed?

Are effective strategies and activities proposed for creating a recruitment and selection process to attract the best candidates as well as provide mentorship, advanced research training and career enhancement opportunities to facilitate their success as future researchers?

Training Record

How successful has the applicant LMIC institution been in previous research training efforts?

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 Children

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

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.

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? For renewal applications, are all training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 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

Not Applicable

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by { Center for Scientific Review } 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.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national 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 and the FIC Strategic Plan.
• Consideration of programmatic and geographic distribution

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.

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 all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. 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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

Not Applicable

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.

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.

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.

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

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: [email protected] (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Barbara Sina, Ph.D.
Fogarty International Center (FIC)
Telephone: 301-402-9467
Email: [email protected]

Email: [email protected]

Satabdi Raychowdhury
Fogarty International Center (FIC)
Telephone: 301-496-9750
Email: [email protected]

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.

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.