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

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. Therefore, the overall intent of this funding opportunity is to engender scientific knowledge and skills that will enhance capacity at LMIC institutions to conduct research directly related to prevention, treatment and control of infectious diseases causing major morbidity and mortality. Applications that include countries with little current research capacity are especially encouraged.

Purpose and Background Information

This Funding Opportunity Announcement (FOA) encourages applications for the Global Infectious Disease Research Training program from U.S. and LMIC research institutions. The application should propose a collaborative research training program that will 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. FIC will support 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.

Another funding opportunity PAR-17-058, Planning Grant for Global Infectious Disease Research Training Program (D71) provides one year of support for eligible LMIC applicants to develop full research training program applications for this funding opportunity.

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 Global Infectious Disease Research Training program are:

- To develop research training opportunities and career development activities for a cadre of LMIC scientists and health research professionals to strengthen the capacity to conduct independent, sustainable infectious disease research at a LMIC institution.

- To provide mentored training-related infectious disease research experience that is directly relevant to the health priorities of the LMIC.

- To strengthen the capabilities of trainees at LMIC institutions to lead, manage and train others in infectious disease research.

The training program should provide:

• 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 trainees 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 programs 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. It is expected that the training strategies employed will contribute to measurable enhancement of defined infectious disease research capacity outcomes.

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

Scientific Focus

As the rationale for a proposed training program, applications must identify an infectious disease scientific focus directly relevant to the LMIC health priorities for which research capacity is limited at the LMIC institution. Applications may focus on research training on infectious diseases which are:

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

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

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

4) Infections that frequently occur as co-infections in HIV infected individuals. However, applications that focus exclusively on research training to address HIV/AIDS or co-infections in the context of HIV will not be supported in this program.

Applicants are encouraged to design multidisciplinary research training programs with a focus on a global infectious disease theme. Training PDs/PIs are encouraged to develop training programs that will expose LMIC trainees to a diversity of scientific approaches, systems for study, research approaches, and tools and technologies. Consideration of team-based research approaches may also be warranted depending upon the goals of the proposed training program. This FOA can support research training related to infectious disease prevention, care and treatment in a broad range of areas:

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 clinical trials;

Proposed faculty mentors should have research expertise directly relevant to the proposed scientific focus of the research training program.

The program application should incorporate an appropriate mix of training opportunities to address the infectious disease-related research training capacity needs identified at the LMIC institution.

Advanced degree or non-degree research training may be supported at a U.S. or foreign institution. Research trainees who are also training as clinicians must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience.

Transition of supported LMIC trainees to the next career stage should be an important consideration in designing the proposed training program. Each trainee should be matched to both a U.S. and LMIC mentor to provide scientific and career guidance. Mentorship training may be provided for faculty mentors involved in the proposed program. Training programs should make available structured, career development advising activities (for example, Individual Development Plans, career related practicum experiences and rotations or networking activities). Applicants are also encouraged to include plans for strengthening associated 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 the management of intellectual property. English as a second language training may be supported, if needed.

Short term training (less than 1 month) may be proposed in addition to long term training to meet the objectives of the proposed program. Short-term training should provide competitively selected LMIC trainees a thorough exposure to the principles and skills of specific research methods or research related competencies to enable immediate incorporation into current trainee research or career development activities. Mentorship should be provided to ensure short term training meets this expectation. Evaluation plans (see section below) should include specific assessments of the effectiveness of the short-term training activities proposed. Short term training support is limited to:

A. Training specific research skills or methods directly applicable to trainee research projects.

B. Research leadership, management or career development skills.

Research training may be delivered by interactive distance learning technology, if appropriate and sustainable for the LMIC participants and institutions involved. Applicants are encouraged to maximize training in the use of information technology to facilitate trainee data management and analysis, access to online scientific information and collaborative interaction.

Trainee Research

Proposed research training can take place in the U.S. or a foreign country, but training-related research should be carried out in the LMIC as much as feasible.

All training-related research projects must be independently reviewed through scientific review procedures established by the program and obtain required approvals for human subjects and animal research from the applicant institution and if different, at the institution in which the research is conducted.

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

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.

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)
• 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 planned program.

The applicant institution must have a strong and high quality research program in the area(s) proposed under this FOA and must have the requisite faculty, staff, potential trainees and facilities to conduct the proposed institutional program. In many cases, it is anticipated that a substantial number of program faculty will have active research projects in which participating trainees may gain relevant experiences consistent with their research interests and goals.

Applications may be submitted by an eligible foreign institution in a LMIC with a collaborating U.S. institution or by an eligible domestic (U.S.) institution that demonstrates collaborations with an LMIC institution named in the application by documented joint publications, grants or previous research training activities. Applicants are encouraged to contact the FIC Scientific/Research Contact if more than one U.S. and one LMIC institution will be proposed as training sites.

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.

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.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

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

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

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

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/PI should be an established investigator in the infectious disease area for which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program.

The PD/PI should have research and research training experience in the LMIC which is the focus of the application.

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.

PD/PIs proposed by non-U.S. applicants must be permanent residents of eligible LMICs (to be verified by the applicant institution).

U.S. applicants must identify at least one LMIC scientist with expertise in the infectious disease focus area of the proposed research training program from the proposed collaborating LMIC institution as the main foreign collaborator for coordinating training program activities at that site. Due to the collaborative nature of this program, applicants are encouraged to designate the main LMIC collaborator who meets the parent grant eligibility requirement as a Multiple PD/PI.

The PD(s)/PI(s) will be responsible for overseeing the proposed process of bringing trainees into the research training program, and for the overall direction, management, administration, and evaluation of the program. The PD(s)/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required. The PD(s)/PI(s) has responsibility for the day to day administration of the program and is responsible for appointing members of the Advisory Committee (when applicable), using their recommendations to determine the appropriate allotment of funds.

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 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.

Faculty mentors should have research and/or research training experience in the LMIC which is the focus of the application.

Only individuals who are citizens 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) are eligible for research training support or other training activities (as verified by the PD(s)/PI(s). Individuals who have dual citizenship or permanent residency in the U.S., other high income countries or ineligible countries described above are not eligible for support.

Research training may be offered to a wide range of scientists, including laboratory scientists, social scientists, clinicians and other health professionals, as well as technical and administrative staff in order to meet the needs for research capacity gaps at the LMIC institution.

Attention should be given to recruiting and retaining LMIC trainees from groups underrepresented in infectious disease research in the LMIC context.

All long-term trainees (more than 1 month) 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.

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

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.

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

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, as well as key activities in the training plan. Indicate the planned duration of training, the projected number of trainees including their levels (i.e., predoctoral, postdoctoral, short-term faculty), and intended LMIC institution research capacity outcomes. Include the name of the LMIC institution and infectious disease focus of the proposed research training.

Project Narrative. Describe the public health relevance of the proposed infectious disease focus of the research training to the LMIC.

Other Attachments. A plan must be provided for the appointment of a Training Advisory Committee to monitor progress that includes a majority of members not affiliated with the program and representation from participant U.S. and LMIC institutions. LMIC members should constitute a minimum of 50% of the committee. Composition, responsibilities, frequency of meetings, and other relevant information should be included. Describe the composition of the Training Advisory Committee, identifying the role and the expertise of members. A plan for Training Advisory Committee approval in the process of selecting participants and their research projects should be included. Describe how the Training Advisory Committee will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of candidates, and the evaluation of the overall effectiveness of the program. Please name your file "Training_Advisory_Committee.pdf".

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

Follow all instructions provided in the SF424 (R&R) Application. Include the name of at least one person at each collaborating institution who will serve as the primary collaborator for training at the site.

List all members of the Training Advisory Committee.

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 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). Do not use the Subsistence category. 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

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.

Training Program

Program Plan

Background

Provide the rationale for the proposed program in terms of the specific infectious disease research capacity needs for the LMIC and LMIC institution.

Applications should document the existing infectious disease research capacity in the chosen scientific focus and define measurable research capacity parameters expected to increase as a result of the proposed research training activities at the end of the grant period.

Applicants should outline the research training and LMIC institutional research capacity objectives of the program and the program activities that will be used to meet these objectives in the overview of the program plan.

Program Administration.

Describe the leadership, administrative skills, scientific research and training experience of the PD(s)/PI(s) and major training site collaborator(s) and how these strengths are related to the management of the training program. This information should not be duplicated content found in biosketches.

Applicants should describe 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.

If a clinical trial training is proposed, provide documentation of the PD/PI(s) expertise, experience, and ability to oversee the organization, management and implementation of clinical trials.

Program Faculty

Describe the leadership, administrative skills, scientific research and training experience of the faculty and how these strengths are related to the proposed roles in the training program.

Provide a description of how the ongoing collaborative research among the PD/PI(s) and faculty as well as other relevant research at the collaborating institutions will provide opportunities for mentored trainee research. Applicants should 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.

If clinical trials training is proposed, provide documentation of the faculty mentors expertise, experience and ability to oversee the organization management, and implementation of a clinical trail.

Proposed Training.

The program plan should include detailed descriptions of the didactic and technical training components and the LMIC trainee career development activities that will be supported. Program plans should consider how to transfer as many of the proposed training activities as feasible during the grant period to the LMIC institution consistent with the overall goals to build research capacity there. Include information about planned courses, mentored research experiences, and other activities designed to develop specific technical or other skills essential for the proposed research training. Applicants are encouraged to include a timeline which includes all proposed training activities.

Describe how the proposed programs will provide all LMIC trainees with professional development skills and individualized career guidance. As part of these activities, program plans may propose mentorship training for proposed faculty.

For applications proposing training in clinical trials the recruitment and selection plans should include specific strategies to identify trainees who have the potential to organize, manage and implement clinical trails.

Training program plans must include a description of the process for independent scientific review of all training-related research projects. In addition, program plans should describe how approvals for human subjects and animal trainee research will be obtained. Documentation of trainee education in the protection of human subjects, compliance with required federal regulations (including those related to animal research), 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 is required.

Institutions with existing programs must explain what distinguishes this program from the others, how their programs will synergize with one another, if applicable, and make it clear that the pool of faculty, potential LMIC trainees, and resources are robust enough to support additional programs.

For applications proposing training in clinical trials research plans for training in data management and statistics relevant to clinical trials, good clinical practice (GCP) and good laboratory practice (GLP) should be included.

If a clinical trial training is proposed, provide documentation of the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the clinical trial at the training sites.

For renewal applications, highlight how the training program has evolved in response to changes in relevant scientific and technical knowledge, educational practices, and to evaluation of the training program. Applicants should provide a detailed description of the progress made in the previous funding period to achieve proposed infectious disease research training and sustainable capacity building objectives.

Program Evaluation

Describe a plan to review and determine the quality and effectiveness of the training program. Applications must include a plan for evaluating the proposed training and mentorship activities supported as well as the overall success in building sustainable, independently resourced infectious disease research capacity at the LMIC institution. This plan should include the metrics to be evaluated as well as plans to obtain feedback from current and former LMIC trainees and faculty to identify weaknesses and provide suggestions for program improvements. Specified evaluation metrics should be tied to the goals of the program for training and increasing institutional research capacity

Institutional Environment and Commitment to Training

The sponsoring institution must assure support for the proposed program including assurance that sufficient time will be allowed for the PD(s)/PI(s) and other Program Faculty to contribute to the proposed program, and that there will be protected time for LMIC trainees selected for the program.

The application should include letters of support from institutional leaders of the collaborating institutions describing the institutional contribution and commitment to the proposed research 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.

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

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.

If you check the "Anticipated Clinical Trial" box within your Delayed Onset Study, then the Justification attachment must acknowledge that additional clinical trial information will be provided to the awarding component before any trainee begins clinical trial research.

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

Important reminders:

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

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. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research training 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 training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) and on the infectious disease research capacity in LMIC institutions involved, 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, 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

• Are the research facilities and research environment at the U.S. and LMIC institutions conducive to preparing LMIC trainees for successful careers as biomedical research scientists?
• Are the objectives, design and direction of the proposed research training program likely to ensure effective training?
• Do the courses, where relevant, and research experiences provide opportunities for LMIC trainees to acquire state-of-the-art scientific knowledge, methods, and tools that are relevant to the goals of the training program?
• Does the program provide appropriate inter- or multidisciplinary research training opportunities?
• Is the proposed training program likely to ensure LMIC trainees will be well prepared for research-intensive and research-related careers?
• Is the level of U.S. and LMIC institutional commitment to the training program, including administrative and research training support, sufficient to ensure the success of the program?
• Is it clear how the proposed training program is distinguished from other externally funded training programs at the U.S. and LMIC institutions?
• Does the application identify an infectious disease scientific focus directly relevant to the LMIC health priorities for which research capacity is limited at the LMIC institution?
• Are the expected contributions of the proposed research training likely to strengthen the capacity of the LMIC institution to sustainably conduct independent infectious disease research and research training of importance to that country?
• Is the proposed training nested in historical and ongoing research collaborations among the faculty of the participating U.S. and LMIC institutions documented in joint grants and publications?
• If applicable, does the short-term training proposed provide selected LMIC trainees a thorough exposure to the principles and skills of specific research methods or research related competencies to enable immediate incorporation into current trainee research or career development activities?
• Does the applicant propose sufficient processes to insure human subject protection, vertebrate animal care, biosafety, biomedical library and information technology access, collaborative research management and English as a second language (if needed) at the U.S. and LMIC institutions to support the research training proposed?
• If proposed by Trainee(s) are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed? Does the application adequately address the capability and ability to conduct the trial feasibility or ancillary study at the proposed site(s) or centers? If applicable, are there plans to add or drop enrollment centers, as needed, appropriate? If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial? If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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

• Do the PD/PIs have the scientific background, LMIC expertise, and administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program?
• Do the PD/PIs plan to commit sufficient effort to ensure the program's success?
• Does the application provide adequate 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?
• With regard to the proposed leadership for the training program, do the PD/PI(s) have the expertise, experience, and ability to oversee the organization, management and implementation of the proposed clinical trial?
• For applications designating multiple PDs/PIs:
• Is a strong justification provided that the multiple PD/PI 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 PDs/PIs?

Preceptors/Mentors

• Are sufficient numbers of experienced U.S. and LMIC preceptors/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 preceptors/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 preceptors/mentors have strong records of training individuals at the level of LMIC trainees (including short-term trainees, if applicable) proposed in the program?
• Is the Training Advisory Committee proposed likely to achieve its functions defined by the application?
• If the program will support clinical trial research experience for the trainees, do the mentor(s) who will supervise the trainee(s) have the expertise, experience, resources, and ability to provide appropriate guidance and help the trainee(s) to meet the timelines?

Trainees

• Is a recruitment plan proposed with strategies likely to attract well-qualified LMIC 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?
• If clinical trials training is proposed, are strategies identified to select trainees have the potential to organize, manage, and implement clinical trial, feasibility or ancillary studies?
• Are there plans to provide instruction in data management and statistics including those relevant to clinical trials to the prospective trainees?
• Are there plans to provide instruction in good clinical practice (GCP) and good laboratory practice (GLP) to the prospective trainees involved in clinical trials?
  
  
• Do prospective trainees have the potential to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study?
• Are there plans to provide instruction in data management and statistics including those relevant to clinical trials to the prospective trainees?

Training Record

• How successful are the LMIC trainees (or, for new applications, other past LMIC students/postdoctorates in similar training) in completing the program?
• Has the training program ensured that LMIC trainees are productive (or, for new applications, other past LMIC students/postdoctorates in similar training) in terms of research accomplishments, publication of research conducted during the training period, and subsequent training appointments and fellowship or career development awards?
• How successful are the LMIC trainees (or, for new applications, other 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 current and former LMIC trainees?

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

For Renewals, the committee will consider the progress made in the last funding period, including on the Recruitment Plan to Enhance Diversity, and Training in the Responsible Conduct of Research. Does the application describe the program's accomplishments over the past funding period(s)? Is the program achieving its training objectives? Has the program evaluated the quality and effectiveness of the training experience (and when applicable, short-term training experience), and is there evidence that the evaluation outcomes and feedback from trainees have been acted upon? Are changes proposed that are likely to improve or strengthen the research training experience during the next project period (may not be applicable to short-term training)? Does the program continue to evolve and reflect changes in the research area in which the training occurs?

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.

Recruitment Plan to Enhance Diversity

Not Applicable

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?

For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?

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.

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. Following initial peer review, recommended applications will receive a second level of review by The Fogarty International Center 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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as 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.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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 http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at 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.

Awards made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required, as described in the NIH Grants Policy Statement.

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

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

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

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

Stephanie M. Coomes, Ph.D
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-6855
Email: [email protected]

Alexander Politis Ph.D
Center for Scientific Review (CSR)
Telephone: 301-435-1150
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 Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66.

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.