Part 1. Overview Information

Key Dates

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this program is to foster the next generation of global health scientists by providing trainees, early in their careers, a one-year mentored research training experience in global health at established biomedical and behavioral research institutions and project sites in LMICs. The focus of this FOA is on U.S. and LMIC post-doctoral and U.S. pre-doctoral trainees. In support of the program's overarching goal to expand access to global health training and research in the U.S., the inclusion of individuals from diverse backgrounds and institutions that have shown a historical commitment to educating students from groups underrepresented in biomedical research at the graduate and post-graduate levels is strongly encouraged. The program also endeavors to help sustain research in the LMICs by strengthening and expanding scientific collaborations between LMIC research institutions and project sites and U.S. partners and to further enhance research capacity by providing financial support and training for early career researchers at those institutions and sites.

Background

Established in 2004, the Fogarty Scholars Program provided early research training and career opportunities for doctoral students in the health professions from the U.S. and LMICs to participate in one-year mentored clinical research projects in LMICs. An expansion of the program added opportunities for post-doctorates from the U.S. and LMICs (Fellows Program) in 2008. The program was restructured in 2012 as the Global Health Program for Fellows and Scholars (R25) and again in 2017 as an international research training grant (D43), which better aligned with the purpose of the program.

Collectively, these programs have supported over 1,300 pre- and post-doctoral trainees and other health-related professional participants, whose research experiences have led to over 2,400 peer-review publications in a wide variety of infectious and non-communicable disease areas. In the current program, awards were made to six (6) U.S. consortia to support research training at over 133 collaborating institutions and sites in 41 LMICs. Reflecting the breadth of research projects, trainee support was provided in the last round of the program by the following NIH institutes, centers, and offices (ICOs): FIC, NIMH, NINDS, NHLBI, ORWH, OBSSR, OAR, NIDDK, NIEHS, NCI, NICHD, NEI, NIDCR, NIDCD, NIAMS, NINR, NIBIB, ORIP, NIDA, and NCCIH. For more information on the current program, see:http://www.fic.nih.gov/Programs/Pages/scholars-fellows-global-health.aspx.

Objectives of this FOA

As we look to the future of global health research, not only do we aspire to work cooperatively and equitably to continue to further develop evidence-based procedures, practices, and policies to save lives and improve health globally, but also to transform the global health landscape with innovative thinking and challenging of long-held scientific and medical dogma. To this end, Fogarty's Launching Future Leaders in Global Health (LAUNCH) Research Training Program brings together cohorts of diverse trainees and research institutions from across the U.S. and low- and middle-income countries (LMIC), supports research that will lead to findings and lessons with global application, and promotes broader access to global health training and research in the US and LMIC.

For the purpose of this FOA, the following definitions will be used:

• Low and middle income countries (LMIC) is defined by the World Bank classification system (https://datahelpdesk.worldbank.org/knowledgebase/articles/906519) and as restricted by NOT-TW-12-011:Notice of Change in Country Eligibility for Fogarty International Training Grants.
• Predoctoral trainees are students in pre-doctoral and pre-professional degree programs.
• Postdoctoral trainees are recent graduates of doctoral and professional degree programs, usually within 6 years of obtaining their terminal degree.

This FOA provides opportunities for up to six consortia to develop and support global health research training programs that meet the following objectives:

• Provide one-year mentored research training for pre-doctoral trainees from the U.S. and post-doctoral and post-professional trainees from the U.S. and LMICs in global health research at established biomedical and health research institutions and project sites in LMICs, particularly those supported by the NIH.
• Provide training opportunities within broad areas of research relevant to the health priorities of collaborating LMICs and aligned with the scientific priorities across the NIH ICOs.
• Provide the solid scientific research foundation needed for trainees to rigorously develop and conduct research and effectively communicate research findings with increasing independence, with the goal of enhancing the global health research career potential of the trainees.
• Provide more equitable access to and inclusive participation in this program to diverse populations in the U.S..

Mentored Research Training Program

Trainee Research. Consortia for this program are expected to provide supportive mentorship, research opportunities, and a collaborative research training environment for trainees to enhance the potential of trainees to develop into productive, independent researchers in global health. The research training opportunities should be in priority health areas in LMICs. The program should encourage trainee projects in a broad range of areas that are of interest to the NIH ICOs. Such areas include, but are not limited to, communicable diseases including HIV/AIDS and chronic non-communicable diseases, such as cancer, cardiovascular diseases, lung diseases, blood diseases, mental health disorders, neurological diseases and stroke, diabetes and other metabolic diseases, and endocrine diseases. Cross-cutting global health research areas are also encouraged.

Due to NIH's interest in and commitment to HIV/AIDS research, approximately 40% of the budget is expected to support research projects focused on HIV/AIDS or HIV/AIDS comorbidities in the context of people living with HIV/AIDS. These projects must be consistent with the NIH guidance for high priority HIV/AIDS projects (https://www.oar.nih.gov/hiv-policy-and-research/research-priorities).

Training Program. The training program should provide instruction and training in scientific methods (e.g., rigorous research design, methods, and statistical analysis), skills (e.g., scientific writing and presentation and grant writing), and research practices (e.g., research ethics, good clinical practice, good laboratory practice, biosafety, and research administration) that provide a solid foundation for independent research. The training programs also will ensure that the trainees engage in structured professional development activities (e.g., Individual Development Plans, workshops or networking activities) that support a successful career in research.

The program will support pre- and post-doctoral trainees from the U.S. and post-doctoral trainees from LMICs. All trainees are expected to carry out research training activities in an LMIC. However, applicants should propose short-term (i.e., 2-3 month) research training and skill development activities for LMIC trainees at U.S. institutions and research sites that are nested within the year-long training, or with rare exceptions, at other LMIC sites that offer exceptional and strategic training opportunities (e.g., access to highly specialized equipment and/or expertise).Training abroad is expected to give all trainees the opportunity to broaden their global perspective on research and health by advancing their development of intercultural competence, appreciation of indigenous knowledge, acquisition of special skills, growth from alternative research practices and networking with potential future collaborators.

To optimize program design/direction, an evaluation plan is expected to allow for timely and informed decision-making regarding program direction, approaches, and resource allocation. The evaluation plan is expected to include plans to track training alumni during the active award period to contribute to our understanding of how the program impacts the careers of trainees and the capacity of participating U.S. and LMIC institutions.

Consortium Institutions. The consortium is expected to include four (4) U.S. academic institutions and six (6) or more additional collaborating institutions and/or research project sites in LMICs. In choosing consortium partners and collaborators, consideration should be given to U.S. and LMIC institutions and research project sites that provide faculty mentors with a wide range of expertise, established ongoing relevant and high quality research projects, a prior history of successful collaboration among the partners, and a wide pool of outstanding trainee candidates. The lead investigator at each partnering U.S. institution is expected to be designated as PD/PI or MPD/MPI on the award.

At least one of the U.S. consortium partners is strongly encouraged to be an institution that has shown historical commitment to educating students from groups underrepresented in biomedical research at the graduate and/or post-graduate levels. Such inclusion will support broader access to global health research, thereby introducing more diverse perspectives and potential experiences of diaspora populations that can contribute to the discussions on long-standing health challenges.

The training program is encouraged to make use of the collaborative nature of the consortium as well as the expertise and networks of its partner institutions to increase resources and opportunities available to trainees, strengthen their institutions global health programs, and further strengthen partnerships between U.S. and LMIC research institutions.

LMIC Research Training Collaborators. The research training collaborators in LMICs are expected to have existing capacity to provide an outstanding mentored research training experience. Each LMIC research collaborator is expected to have capacity for strong ethical review and oversight of research, committed interest and expertise in mentoring trainees, appropriate research facilities, and at least one active multi-year research training grant, research education grant, or on-going research project funded by NIH and/or other international funding agencies. Applicants are encouraged to consider including collaborating LMIC institutions and/or research project sites that hold grants supported by the NIH participating components on this FOA. The proposed collaboration should be complementary to and synergistic with activities initiated on existing awards. Compensation of the LMIC institutions and/or research project sites and LMIC mentors for their participation in these training activities should be thoughtfully detailed. More concerted efforts to support capacity building at LMIC institutions and research sites are available through other FIC research training and research education programs (https://www.fic.nih.gov/Programs/Pages/default.aspx).

Research Trainees. Applicants are encouraged to recruit graduates from NIH-funded T32 post-doctoral research training programs as one source of U.S. post-doctoral candidates for the program. Applicants also are encouraged to include advanced doctoral students (such as those taking time off from their degree programs or incorporating the research training into their doctoral research) and post-doctoral scientists in the health professions (e.g., medicine, dentistry, nursing, public health, and veterinary) from both the U.S. and LMICs as potential trainees. At least 60% of trainees supported by committed funds should be U.S. postdoctoral trainees, recognizing that all other Fogarty D43 training programs are exclusively targeted for LMIC trainees. LMIC partners may consider graduates of other FIC and NIH training and education programs at their institutions, or students trained under NIH research grants, as one source of LMIC trainees. However, this program must not duplicate other funded research training opportunities at the participating institutions. The consortium is expected to select outstanding candidates each year to meet the funding available in the award. An additional list of outstanding alternate candidates with broad research interests may be submitted for consideration of ad hoc funding by other ICOs through an administrative supplement request.

The inclusion of distinct perspectives of U.S. trainees from diverse backgrounds, such as those from underrepresented groups in biomedical, clinical, behavioral and social sciences (see NOT-OD-20-031: Notice of NIH’s Interest in Diversity, https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html) should be an important consideration in designing the research program.

Interests of Specific Institutes/Centers

The scientific interests of the participating Institutes and Centers (ICs) are summarized below.

The Fogarty International Center (FIC)

FIC is interested in all eligible applications relevant to its mission. The FIC Strategic Plan states the following relevant goals: 1) Build research capacity through individuals, institutions, and networks to meet future and evolving global health challenges; 2) Stimulate innovation in the development and implementation of technologies and other locally relevant solutions to address global health problems; 3) Support research and research training in implementation science; 4) Advance research on prevention and control of the dual burden of communicable and non-communicable diseases and disabilities; and 5) Build and strengthen partnerships to advance global health research and research capacity.

National Cancer Institute (NCI)

NCI is interested in applications from individuals committed to an independent career in global cancer research, who propose mentored research projects in topics relevant to the LMIC where the research will be conducted. NCI is interested in applications that include, but are not limited to, studies in cancer biology and genetics, and cancer epidemiology; research in cancer primary and secondary prevention; clinical and translational research, HIV-associated malignancies and other malignancies that develop in individuals infected with HIV, implementation science and health systems research, and health surveillance and cancer informatics research; studies in integrative oncology and cancer survivorship; and investigations that employ technology (including mhealth and ehealth) to address cancer control. Applications that propose capacity development in research methods across disciplines that might be relevant to LMIC setting including, but not limited to, clinical and translational research, behavioral and social sciences research, patient reported outcomes research, are encouraged.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIDDK has major interests in diabetes, endocrine disorders, and metabolic disorders. Organ-specific complications of diabetes (except for diabetic nephropathy) are not within NIDDK’s mission interests and are best directed to other Institutes. NIDDK also supports studies focused on obesity, as well as nutrition as they aim to treat diseases within the mission of the NIDDK or to improve health. Diseases of the alimentary tract, liver, and pancreas are also supported. NIDDK has a significant interest in research focused on understanding the causes and progression of kidney diseases, benign urological conditions, and hematological disorders. In all areas described above, research focused on malignant diseases are not supported by the NIDDK. NIDDK is particularly interested in research focused on the consequences of HIV infection in organ systems of interest to the NIDDK (renal, digestive, urologic, e.g.) or HIV-related complications in organ systems of interest in individuals living with HIV.

National Institute of Mental Health (NIMH)

NIMH is interested in applications that focus on mental disorders in LMICs, specifically conditions and disorders that affect cognition, perceptions, mood, social and emotional processing, daily functioning, behavior and relationships. Mental Disorders are a leading cause of disease burden worldwide, estimated based on disability adjusted life years (DALYs). For example, disorders of interest include, but are not limited to depressive disorders, schizophrenia, bipolar disorder, autism spectrum disorders, anxiety disorders, trauma and stressor-related disorders such as posttraumatic stress disorder. NIMH is particularly interested in research that addresses disparities in access to mental health care in LMICs, better understanding the root causes, risk and protective factors, early detection and early intervention, integration of mental health care into care for chronic, non-communicable or communicable diseases and/or implementation science in LMIC contexts, including the care of individuals living with HIV, or placed at risk for HIV. NIMH is also interested in applications that investigate the optimal combination of mental health interventions (e.g., screening and care). These themes are consistent with A, B, C, E, and F of the Grand Challenges in Global Mental Health (i.e., identify root causes, risk and protective factors; advance prevention and early intervention; improve treatments and expand access to quality care; build human resource research capacity; and transform health system and policy responses; Grand Challenges in Global Mental Health).

National Institute of Neurological Disorders and Stroke (NINDS)

NINDS is interested in supporting mechanistic, epidemiological, prevention, translational and clinical research across the spectrum of neurological, neuromuscular and neurovascular diseases and disorders. In addition to prevalent neurological disorders and stroke, NINDS is also interested in supporting research in areas of rare and neglected neurological diseases that are relevant to low- and middle- income countries (NINDS Disorder Index http://www.ninds.nih.gov/disorders/disorder_index.htm).

Applications Not Responsive to this FOA:

Applications will be considered nonresponsive to or outside the scope of this FOA and, consequently, withdrawn from review and consideration of funding if the application does not propose:

• a plan to recruit and support broad areas of research within global health
• an explicit plan to promote diversity among U.S. trainees
• full-time (40 hours per week for 12 months) training experiences
• significant research focus (i.e., approximately 40% of training funds) and resources (e.g., institutional capacity and personnel) to support HIV/AIDS research

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the staff of the NIH awarding component. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Note: This Funding Opportunity Announcement (FOA) allows mentored training of trainees to serve as the lead investigator of an independent clinical trial or a separate ancillary clinical trial, or to gain research experience in a clinical trial led by another investigator, as part of their research and career development.

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

Section II. Award Information

Other Award Budget Information

Section III. Eligibility Information

1. Eligible Applicants

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)

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 strong and high-quality research programs in collaboration with LMIC institutions in some of the area(s) proposed for training documented by collaborative publications and research grants. The applicant institution must have the requisite faculty and staff to serve as U.S. mentors and potential trainee pool and facilities at the partnering LMIC sites to conduct the proposed 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.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. Only institutions and research sites in LMICs, as defined by the World Bank classification system (http://data.worldbank.org/about/country-and-lending-groups) and as restricted by NOT-TW-12-011 'Notice of Change in Country Eligibility for Fogarty International Training Grants', are eligible to participate; foreign trainees must be nationals of these eligible countries.

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

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 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 one of the scientific areas in which the application provides research training and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI and MPDs/MPIs, working with collaborating partners at LMIC institutions and/or research project sites, will be responsible for the recruitment and selection of trainees, and for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the day-to day-administration of the program and is responsible for appointing members of the Training Advisory Committee, using their recommendations to determine the appropriate allotment of funds.

2. Cost Sharing

3. Additional Information on Eligibility

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

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).

Each U.S. institution may have a role as the applicant institution or as a member of a consortium designated in an application from another U.S. institution, but may not participate in two different consortia.

A consortium is expected to include four (4) U.S. academic institutions.

Research training institutions and research project sites in LMICs can participate in more than one consortium if they have established collaborations with at least one U.S. faculty member of each consortium.

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.

Trainees

For U.S. trainees, the individual to be trained must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship, training period, and aggregate duration of support are available in the NIH Grants Policy Statement. LMIC trainees must be a citizen of an eligible LMIC (as defined in Section 1), in most cases as a citizen of the country in which the research will be conducted.

All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Trainees are expected to spend 12 months in training. In rare instances, an outstanding trainee may be renewed for a full or partial second year in order to allow completion of promising research.

Predoctoral trainees must be enrolled in a program leading to a PhD or in an equivalent research doctoral degree program. Health-professional students who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs, are also eligible.

Postdoctoral trainees must have received, as of the beginning date of the training period, a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Comparable doctoral degrees include, but are not limited to, the following: D.M.D., DC, DO, DVM., OD, DPM, ScD, EngD, DrPH, DNSc, DPT, PharmD, ND (Doctor of Naturopathy), DSW, PsyD, as well as a doctoral degree in nursing research. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of the training appointment is acceptable. Individuals in postgraduate clinical training, who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs, are also eligible. In recognition of the multidisciplinary demands of global health and that some professions do not normally award doctoral degrees, candidates may be accepted if they have completed the normal terminal degree in their field and can be considered a post-professional degree candidate.

Section IV. Application and Submission Information

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:

UnJa Hayes, Ph.D.
Telephone: 301-827-7024
Fax: 301-402-0777
Email: [email protected]

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

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.

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

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

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

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 projected number of trainees including their levels (i.e., predoctoral or postdoctoral), and intended trainee outcomes.

A Training Advisory Committee (TAC) is a required component of a training program. Provide a plan for the appointment of an Advisory Committee to monitor progress of the training program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. A wide range of scientific expertise to reflect the scope of the training proposed is recommended. The TAC should include representatives from collaborating LMIC institutions. Do not name individual members. Describe how the Advisory Committee will evaluate the overall effectiveness of the program and may contribute to the selection of trainees. Advisory Committees may be composed of external members and/or individuals associated with the U.S. and LMIC consortium institutions. Please name your file 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.

Each institution leader within the U.S. consortium should be designated as PD/PI or MPD/MPI. Key collaborators at the LMIC training sites should be named and included as key personnel on the application. A lead LMIC collaborator should be named for each proposed LMIC institution and research project site.

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

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

Research & Related (R&R) Budget

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

• Use the Other Personnel section to submit costs for salary support for administrative staff.
• Use the Travel section to submit costs for key personnel and faculty travel including the annual orientation 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
• 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

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

Particular attention must be given to the required Training Data Tables. Use the International Training Submit Tables (New or Renewal/Revision, as appropriate). Applicants should summarize, in the Research Training Program Plan of the application, key data from the tables that highlight the characteristics of the applicant pool, faculty mentors, the educational and career outcomes of participants, and other factors that contribute to the overall environment of the program.

For renewal applications, only include trainees supported during the prior grant period for applications funded in response to RFA-TW-16-002 and indicate this on the International Training Submit Tables. For new applications, only submit data for individuals who were trained in the last five years by the key personnel listed on this application, and list only pre-doctoral and post-doctoral trainees from LMICs or U.S. trainees who conducted research projects in LMICs.

No other training data tables should be included.

Training Program

Program Administration

Describe the leadership and administrative skills, research training experience, scientific expertise, and active research of the PD/PI, MPDs/MPIs, and LMIC collaborating leadership. Relate these strengths to the proposed management of the training program. Describe the planned strategy and administrative structure to be used to oversee and monitor the program. Describe the roles of LMIC faculty in recruitment, selection, and mentoring of trainees in the program.

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

The plan for Program Administration is expected to synergize with the Multiple PD/PI Leadership Plan section of the application.

Program Faculty Mentors

The application must include information about the U.S. and LMIC program faculty mentors who will be available to serve as preceptors/mentors and provide guidance and expertise appropriate to the level of trainees proposed in the application. Describe the complementary expertise and experiences of the proposed program faculty mentors, including active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring and training individuals at the proposed career stages from the U.S. and LMICs. A significant number of the U.S. and LMIC faculty should have HIV/AIDS research experience, and the faculty overall should have the breadth of expertise to cover the range of scientific areas proposed for training. Describe the criteria used to select and remove faculty as Program Faculty Mentors and to evaluate their participation. Describe prior collaborations between U.S. and LMIC faculty mentors.

If faculty mentors will supervise trainees proposing to either lead a clinical trial or gain research experience in a clinical trial, provide documentation of their expertise, experience, and ability to provide guidance in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help trainees to meet the study timelines.

Proposed Training

Mentored Research. Provide an overview of the proposed program. Outline the objectives of the program and the program activities that will be used to meet these objectives. The application should propose a training program where the trainees receive a rigorous one-year mentored training experience at a collaborating LMIC institution/research facility. The research projects should examine a wide range of global health priority areas, that is non-communicable and communicable diseases, including HIV/AIDS. Include a plan for LMIC trainees that also includes a 2- to 3-month training experience at a U.S. site. The proposed training experience for LMIC trainees should add a unique scientific or technical dimension to their research experiences that could not be provided at their LMIC research institution. In rare cases, training can occur at another LMIC institution if it offers an exceptional opportunity relevant to the trainee’s research project.

Applications should describe how training research projects will be developed and trainees will be matched to LMIC and U.S. sites. Include the role of pre-existing collaborative research grants. Describe how the training projects will receive an independent scientific review, according to scientific review procedures established by the consortium. If it is anticipated that trainee research projects will involve human subjects or vertebrate animals, applications should describe how these trainees will receive education in the protection of human subjects or vertebrate animals, respectively, and obtain approval from an institutional (or ethical) review board or committee at the U.S. applicant institution and at the institution where the research will be conducted.

Trainee Recruitment. The program should include both pre-doctoral trainees from the U.S. and post-doctoral trainees from the U.S. and LMICs. As this is the only Fogarty D43 training program that supports trainees from the U.S., at least 60% of training slots supported by the award budget should be reserved for U.S. postdoctoral trainees each year. The application should include an explicit and aggressive plan for strategic recruitment and selection to ensure fulfilment of program goals, e.g., inclusive participation of diverse U.S. trainees, such as those from groups underrepresented in biomedical research. In addition to funds provided in the award from the participating ICs listed in this FOA, additional funds may become available each year from other ICOs to support individual trainees whose projects align with ICO mission areas.

Applications should describe plans for how qualified U.S. and LMIC trainees will be recruited for the proposed research training program. Considerations may also include a strategic plan to identify and recruit US and LMIC trainees that might fill expertise gap areas at the LMIC institutions and can add value through research, teaching, and clinical skills. It is expected that the majority of trainees will be recruited from the participating U.S. and LMIC institutions involved in the consortium. However, candidates outside the consortium partnership may be considered for strategic recruitment at the discretion of each program. Each year, a significant number of trainee projects should focus on HIV high priority research areas (https://www.oar.nih.gov/hiv-policy-and-research/research-priorities), consistent with the award budget for AIDS funds. In rare instances, at the discretion of the PDs/PIs or leadership committee, outstanding trainees may be extended for up to one additional year, to allow them to complete their projects.

The application should include a thoughtful and detailed Recruitment Plan to Enhance Diversity that discusses outreach strategies and activities designed to recruit U.S. participants from diverse backgrounds, such as those from underrepresented groups in biomedical research. Discuss any relevant past efforts to recruit U.S. participants from underrepresented groups in biomedical research and how it informed specific actions proposed in the program’s plan to enhance diversity.

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

Mentored Training Activities. The focus of the program should be to provide all trainees with instruction and training in rigorous research design, research ethics and statistical analysis through mentored research training experiences. In addition, short supplemental training may be provided for individual trainees in specific research skills or methods directly applicable to trainee research projects; or for enhancing research leadership, management or career development skills, including in oral and written presentation and in skills needed to apply for individual fellowship or grant support. All trainees should be provided with instruction in laboratory, field, and/or project management. These complementary trainings may take place at any participating institution in the U.S. or the LMIC.

Special activities to enhance the quality of the research training, such as workshops to strengthen faculty mentoring skills, may also be supported and would contribute to research capacity building at the partnering and collaborating institutions.

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.

Program Evaluation. Applications must include an evaluation plan to assess progress towards training program goals as well as help identify unanticipated challenges. This plan should include well-defined and quantitative milestones, metrics, and a timeline for assessing progress. The evaluation plan may include plans to track trainees after they complete the program (this may be aided by CareerTrac, https://careertrac.niehs.nih.gov/auth/login) and the outputs, outcomes, and impacts of the program on the careers of trainees and the capacity of participating U.S. and LMIC institutions.

Research Training Institutions

U.S. Consortium Partners. Describe how the networks, training experience, and other strengths of the partner institutions will be used to contribute to the research training program, including increasing diversity of the candidate pool. While the consortium is required to have a prior history of successful collaboration with collaborating LMIC partners, discuss how the program will broaden and/or further strengthen partnerships between U.S. and LMIC research institutions.

Priority will be given to those applications that propose a consortium that includes at least one U.S. partner institution that has shown a historical commitment to educating students from underrepresented groups in biomedical research at the graduate and/or postdoctoral levels.

LMIC Research Training Collaborators. Applicants are encouraged to include at least six (6) collaborating LMIC institutions and/or research project sites in each consortium to provide broad research training experiences in a wide range of health areas for the trainees. A significant number of the collaborating LMIC institutions and/or research project sites must have HIV/AIDS research opportunities and grant support. Additional LMIC institutions and/or research project sites may be added after award to meet the training interests of trainees. These sites will be subject to the same criteria listed below and will require approval from the FIC program official. For each proposed collaborating LMIC research site:

• Document that it has at least one active multi-year research, research training or research education grant, funded by the NIH (preferred) or by other U.S. government or international funding agencies; strong ethical review and oversight of research; committed interest and experience in mentoring students; appropriate research facilities; appropriate faculty expertise to oversee trainee projects (as documented by publications and funding in those areas); written personal safety procedures in place; and the ability to comply with U.S. government regulations for research grants.
• Document that it has an established collaboration (of at least two years duration) with at least one faculty member of the U.S. consortium institutions in research, research training or research education.
• Give examples of the types of potential research projects that can be supported and relate these areas to important health challenges in the LMIC or critical issues in Global Health.
• Describe how this program will contribute to the research training needs and research capacity of the collaborating LMIC institutions.
• Applicants with existing related research training programs must explain what distinguishes the proposed program from existing programs at the U.S. or LMIC institution, how these programs will synergize with one another, if applicable, and demonstrate that the pool of faculty, potential trainees, and resources are robust enough to support an additional program.

Institutional Environment and Commitment to the Program

The application should describe the institutional environment and commitment of the US and LMIC members of the consortium. This might include the availability of T32 programs at the U.S. institutions and other sources from which U.S. trainees will be recruited, and training programs and other sources from which LMIC trainees will be recruited. Include letters of support from collaborating institutions.

Applicants should describe the research environment, potential research training scientific areas, and corresponding scientific expertise for mentoring trainees available at the collaborating LMIC institutions and research project sites.

Plan for Instruction in the Responsible Conduct of Research

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

Appendix:

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

PHS Human Subjects and Clinical Trials Information

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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.

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.

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

Section V. Application Review Information

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.

For this particular announcement, note the following:

Reviewers should evaluate the potential of the proposed training program to provide the mentored research experiences needed to develop the next generation of global health researchers in the U.S., including those from groups underrepresented in biomedical research, and LMICs.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed.

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

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

• Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the training program and the complementary expertise of the PD(s)/PI(s)?
• Do the PD(s)/PI(s) and MPD/MPIs have complementary scientific background, expertise, and administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program related to global health?
• If the program will support clinical trial research training, do the PD(s)/PI(s) and MPD/MPIs have the expertise, LMIC clinical trial experience, resources, and ability to provide appropriate guidance on the organization, management and implementation of the proposed clinical trial?

Preceptors/Mentors

• Do the preceptors/mentors have strong records of training individuals at the predoctoral and postdoctoral levels? Are appropriate plans in place to ensure that preceptors/mentors lacking sufficient research training experience are likely to provide strong and successful mentoring?
• Are sufficient numbers of experienced U.S. and LMIC preceptors/mentors with appropriate expertise and funding available to support the research areas as well as number and level of trainees proposed in 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 trainees for the training program from both the U.S. and participating LMIC research institutions?
• Is there likely to be a sufficient pool of potential trainees available to meet the needs for a broad training program covering multiple scientific areas?
• Does the training program propose a viable, proactive strategy to enhance participation of U.S. students with diverse perspectives, including those from underrepresented groups in biomedical research?
• Are there well-defined and justified selection criteria and a well-defined selection process?

Training Record and Evaluation Plan

• How successful has the training program been in fostering productive trainees (or, for new applications, other past 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?
• Does the program propose a rigorous evaluation plan to assess progress towards achievement of program objectives, including the ability to make mid-course changes based on data collected?

Protections for Human Subjects

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Training in Methods for Enhancing Reproducibility

Does the plan for Instruction in Methods for Enhancing Reproducibility describe how the program will provide training in scientific reasoning, rigorous research design, relevant experimental methods, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, quantitative approaches, and data analysis and interpretation, appropriate to field of study and the level and prior preparation of the trainees?

Resubmissions

Not Applicable

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 areas in which the training occurs?
• Is a collaborative effort in training and management evident among the collaborating institutions?
• Has the program successfully recruited participants from diverse backgrounds, including those from underrepresented groups in biomedical research and supported research projects in a broad range of scientific areas? Has the PD/PI effectively shaped the recruitment plan in response to recruitment outcomes?

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

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

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the training program, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? 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 the 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 will receive a written critique.

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.

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

Applications will be assigned on the basis of established PHS referral guidelines 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 Council or 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

• Relevance to the priorities of the participating ICs.
• Geographic balance in the distribution of collaborating LMIC institutions.
• Inclusion of at least one U.S. partner institution that has shown a historical commitment to educating students from underrepresented groups in biomedical research at the graduate and/or postdoctoral levels in the U.S. consortium.

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

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

Section VI. Award Administration Information

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 recipient’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 and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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.

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, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides 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/fact-sheet-guidance/index.html and https://www.lep.gov. 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 https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• 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.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.

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 recipient 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 agreementsare 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.

Applicants are strongly encouraged to use the FIC CareerTrac System (https://careertrac.niehs.nih.gov/auth/login) to annually update data on all U.S. and LMIC trainees during their training period.

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.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, 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 processes and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

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

UnJa Hayes, Ph.D.
Fogarty International Center (FIC)
Telephone: 301-827-7024
Email: [email protected]

Susannah Allison, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 240-627-3861
Email: [email protected]

Stacey D. Chambers, M.S.
National Institute of Neurological Disorders and Stroke (NINDS)
Phone: 301-496-0690
Email: [email protected]

Sudha Sivaram
National Cancer Institute (NCI)
Phone: 240-276-5804
E-mail: none

Johnan Augustine Kaleeba
National Cancer Institute (NCI)
Phone: 301-451-4439
E-mail: none

Tracy Rankin, Ph.D., M.P.H.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4748
Email: [email protected]

Xenia Tigno
Office Of Research On Women's Health (ORWH)
Phone: 301-435-0202
E-mail: [email protected]

Regine Douthard
Office Of Research On Women's Health (ORWH)
Phone: 301-594-3283
E-mail: [email protected]

CSR Peer Review Point of Contact
Telephone: 301-435-1111
Email: FOA_[email protected]

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

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: [email protected]

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]

Dawn M Mitchum
National Cancer Institute (NCI)
Phone: 240-276-5699
E-mail: none

Aricia Ajose
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-9023
Email: [email protected]

Section VIII. Other Information

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.