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

Background

Chronic Non-communicable Diseases and Disorders (NCDs) are steadily increasing around the world, including in Low and middle-income countries (LMICs), and will soon account for more than 50% of the expenditures for health care and more than 60% of the disability adjusted life years (DALYs). In 2013, the World Health Organization (WHO) endorsed a global action plan for the prevention and control of NCDs (2013-2020) that included the promotion and support of national capacity for high-quality research and health system development. To address the WHO goals, in-county research expertise is needed to identify research questions, needs and gaps about the burden, causes, prevention, treatment and long-term care of NCDs within regional and local contexts. Advancing research on prevention and control of the dual burden of communicable and non-communicable diseases and disabilities is a key goal of the FIC 2014-2019 Strategic Plan http://www.fic.nih.gov/About/Pages/Strategic-Plan.aspx.

Purpose

The Fogarty International Center (FIC), together with the participating Institutes Centers and Offices: National Institute of Environmental Health Sciences (NIEHS), National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), National Center for Complementary and Integrative Health (NCCIH), National Institute on Aging (NIA) encourages applications for the Chronic, Non-Communicable Diseases and Disorders Across the Lifespan: Fogarty International Research Training Award (NCD-LIFESPAN) D43 program for institutional research training programs in low- and middle-income countries (LMICs, as defined by the World Bank classification system). The application must propose a collaborative research training program in an LMIC involving either a U.S. institution and institution(s) in an LMIC or applications developed and submitted directly by LMIC institutions with substantial research and research training program experience to work with LMIC institutions with less capacity.

Programs must sustainably strengthen the capacity of LMIC institutions and investigators to conduct research on NCDs. Sustainable NCD 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 them to conduct independent, internationally-recognized NCD research relevant to the health priorities of their country. This NCD-LIFESPAN program supports institutional research training awards for training programs designed to strengthen the capacity of the LMIC institution(s) to support independent research through the education and career development of individual researchers and key personnel. The trainees are expected to contribute to the research capacity in the LMIC upon completion of their training.

The long-range goal is to provide a solid foundation in LMICs for development and implementation of evidence-based interventions, relevant to NCD's across the life-span. Sufficient evidence may exist upon which to base research for interventions and implementation strategies. However, often the evidence base is not well developed or not relevant to the given country or culture. Therefore, training across the spectrum of research disciplines is encouraged as needed, from basic biomedical, behavioral and social science to clinical and applied sciences, including translational and implementation science that emphasizes the resources, context and needs of multiple stakeholders in local settings.

New research training programs are expected to focus on collaboration with a single LMIC institution as the major partner.

Previously established collaborative research training programs are expected to expand and network for research training and capacity building with other institutions within the LMIC country and region.

NOTE: LMIC institutions, in collaboration with a U.S. institution, may apply for a one-year D71 planning grant, (PAR-17-097) "Planning Grant for Chronic, Non-Communicable Diseases and Disorders Across the Lifespan: Fogarty International Research Planning Award (NCD-LIFESPAN) (D71)" to support the development and submission of D43 research training program proposals in a subsequent year.

This program does not support HIV/AIDS research training. Applicants interested in NCD co-morbidities in the context of 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).

Special Program Objectives and Considerations

The objectives of the NCD-LIFESPAN research training program are:

• To strengthen the capacity of LMIC institutions to conduct NCD research and to train a cadre of experts who can assess the magnitude, etiology of, interventions for and other aspects of NCDs. Over time, the goal is for these institutions to become national, regional and international centers of expertise in NCD research;
• To support multidisciplinary research training in basic through translation and implementation science to address NCDs;
• To develop a cadre of research experts who are most likely to contribute to science advances and affect clinical practice and public health policy in their country;
• To support training-related research (degree-related or mentored research projects) that is directly relevant to the health priorities of the LMIC and to global health;
• To strengthen the research and research training capacity required for success by building on existing research and public health programs in the LMIC;
• To integrate, whenever possible, with other efforts to strengthen core research support capabilities needed to manage research and research training grants at the LMIC institution: including expertise in ethics and compliance issues, protection for human subjects, animal welfare, fiscal management, budgeting, program and grants administration, grant and report writing, preparation of scientific manuscripts, information technologies, technology transfer and management of intellectual property, data management, and Internet connectivity.
• To build on established research training programs to network for research training among institutions within a country and regionally between countries

All applications to this program should have a central NCDs across the lifespan-related theme or focus although the theme may be as narrow or broad as deemed appropriate for the goals outlined in the FOA.

The specific NCDs that may be addressed must be relevant to the stated interests of the participating institutes, centers and offices (see "Specific Interests of the FOA Sponsors" section).

Research training programs are especially encouraged:

• That are relevant across NCDs.
• That emphasize lifecycle studies and early life determinants of chronic diseases (including genetic, epigenetic, environmental and lifestyle factors), co-morbid conditions and common risk factors and interventions relevant to multiple NCD conditions and their prevention.
• For training in implementation research for NCDs in general.

The programs are expected to both support trainees to conduct research and, as appropriate and needed to go beyond traditional training models to develop multifaceted and novel training paradigms targeted to the special needs of LMIC investigators and institutions.

Where well established research and/or research training programs exist in LMIC institutions, proposals for research training hubs and networks within countries or regions are encouraged.

The Need for a Multidisciplinary Approach:

Risk factors for NCDs are complex and differentially amenable to control. Environmental influences, lifestyle factors and diverse socio-economic influences and epigenetic changes interact with the proximal causes (such as genetic vulnerability, trauma and infection) of many chronic disorders to influence their trajectory and severity.

Increasing evidence for the prenatal and childhood roots of chronic NCDs provide possible avenues for early prevention of and intervention for NCDs. During the past several decades, improvements in health care have led to a decrease in child mortality and an increase in life expectancy in LMICs. However, many of the factors that previously contributed to early mortality remain and influence later health outcomes. These positive trends have, therefore, set the stage for a complex epidemiology of health and disease as more children survive into adulthood predisposed by early disease, malnutrition and adverse environmental and psychological influences and experiences to later development of chronic diseases such as cardiovascular and cerebrovascular disease, diabetes, cancer, mental illness, substance abuse, developmental and neurodegenerative diseases and disorders.

During the remainder of the lifecycle, social and environmental factors such as environmental pollutants and chronic stress continue to influence health. However, individual behaviors and exposures such as physical inactivity, poor diet, tobacco, alcohol and drug abuse become increasingly important risk factors influencing the trajectory of NCDs. It is critical to develop a deeper understanding of the complex motivations that contribute to decision making and risky behavior in resource poor settings.

In addition to generating evidence to prevent and treat chronic diseases, it is imperative that the research findings be incorporated into community practice in an efficient and timely manner. Because of the formidable gap between innovations in health and their delivery to communities, another goal of the FIC Strategic plan is to "bridge the training gap in implementation research." Implementation Research is the scientific study of methods to promote the integration of research findings and evidence-based interventions into health care policy and practice with a greater emphasis on the resources and context of local care settings and the needs of multiple stakeholders. Training researchers in the nascent field of implementation science is strongly encouraged as part of research training programs under this FOA.

The factors that are responsible for onset and prevention of chronic disease are so diverse that it is essential that those trained gain a broad appreciation for the need for research across health disciplines as diverse as genetics, medicine, nutrition, psychology, behavioral health, epidemiology, population studies, health law, environmental health, and public health, as well as many disciplines not traditionally associated with health research such as business administration, economics, urban planning, information science, communications, organizational and management theory, finance, individual and systems-level behavioral change, statistics, anthropology, learning theory, and marketing. While no one trainee can acquire expertise in all these fields, training might include development of team projects that include trainees from multiple fields of expertise.

Types of Training:

In the context of this FOA, "trainees" are individuals from the host/target LMIC(s) eligible for research training under this FOA and according to the applicant's proposed selection criteria.

The proposed training is expected to strengthen sustainable research and research training capacity at the LMIC institution. The program application should incorporate an appropriate mix of long-, medium- and short-term training opportunities and in-country mentored research to address the research training needs for NCDs identified for the LMIC. Applicants are encouraged to design multidisciplinary research training programs and teams.

Training can take place in the U.S. or LMIC, with the goal for most of the training to occur within the LMIC by the end of the initial grant award period. Applications involving already existing research training collaborations under other programs at the same LMIC sites are expected to begin with a substantial level of research training within the LMIC which take advantage of the research training infrastructure already created (such as faculty and courses). Training-related research should always be carried out in the LMIC. In addition to early career short-, medium- and long-term training, mid-career training is also allowed. The actual training mix should be justified according to the assessed needs and already existing infrastructure and the level of research capacity and training infrastructure in the LMIC.

For example:

• In LMICs with weak research infrastructure and where few established NCD-related researchers and potential faculty exist to support an institutional research training program, more degree-related research training in the U.S. may be necessary to develop the initial cadre of researchers who can then go on to be mentors and faculty in the LMIC for future trainees.
• In LMICs where substantial research and training infrastructure and expertise already exist, but without a strong focus on NCDs, a mix of activities that augment existing research, training and personnel resources at the LMIC institution(s) may be proposed. The LMIC activities would enhance their individual and institutional capacity to identify, undertake and successfully complete NCD studies and to utilize the results from research that they and others conduct to influence teaching, implementation and country policy.

While innovative research training models for NCDs are encouraged, typically research training programs involve the following:

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

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

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.

Scientific research training for clinicians and healthcare professionals including physicians, nurses, dentists, social work professionals and other practitioners is encouraged.

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

Advanced in-country mentored research may be undertaken by the trainee in his/her home country upon completion of his/her initial period of long-term training under the program (Master's, Ph.D., post-doctoral or other long-term training).

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

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

This NCD-LIFESPAN program strongly encourages principal investigator/program directors (PIs/PDs) to include women, and individuals from groups underrepresented in biomedical and behavioral research in the country (including individuals from racial, ethnic and socially disadvantaged backgrounds and those living with disabilities), as faculty and research trainees at all sites.

Specific Interests of the FOA Sponsors

NIH institutes and Centers (ICs) participating in this announcement will consider applications for funding. Consultation with NIH staff before submitting an application is strongly encouraged. Applicants should carefully note which ICs participate in this announcement and view their respective areas of research interest and requirements below in this FOA. Applicants can obtain additional information and research interests for each of the FOA's sponsoring partners by contacting the partner program official listed in this announcement (Section VII. Agency Contacts).

The Fogarty International Center (FIC) is interested in all eligible applications relevant to its mission. However, FIC is most interested in and will prioritize research training applications that 1) cover multiple NCD areas/topics and co-morbid conditions and/or 2) train in research disciplines applicable across NCD areas/topics, co-morbid conditions and settings (for example, but not limited to, training in epidemiology, demographics, implementation science, genetics/epigenetics, bioinformatics, biomedical engineering, health technology). For RENEWAL applications FIC will only fund direct applications from the LMIC site. The FIC Strategic plan (http://www.fic.nih.gov/About/Pages/Strategic-Plan.aspx) 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.

NIH IC Partner Interests

Following are examples of specific areas of interest provided by the participating NIH partners:

The National Institute of Neurological Disorders and Stroke (NINDS) encourages the development of innovative research training programs in mechanistic, epidemiological, prevention, translational and clinical research in the areas of neurological disorders and stroke (please see: http://www.ninds.nih.gov/disorders/disorder_index.htm for specific diseases and disorders of interest to NINDS).

The mission of the National Institute of Environmental Health Sciences (NIEHS) is to discover how the environment affects people in order to promote healthier lives. The NIEHS is interested in supporting research training in LMICs that address or seek to understand how exposures to toxic environmental insults alter biologic processes, are linked to disease initiation, progression or morbidity, and activities that lead to the development of prevention and intervention strategies to reduce environmentally induced diseases. Examples of environmental exposures relevant to the mission of the NIEHS include industrial chemicals or manufacturing byproducts, e-waste, metals, pesticides, herbicides, and inhaled toxicants including indoor air pollutants from cooking and other sources. Topics and disease outcomes of particular interest include airway diseases, CVD and neurological disorders, children's environmental health and the unique vulnerability of developing children to harmful environmental exposures including outcomes such as low birth weight or premature birth, climate change and human health, and research exploring exposures during early life stages or critical windows of susceptibility that may directly or indirectly affect the risk of developing disease.

The National Center for Complementary and Integrative Health (NCCIH) is interested in supporting training programs investigating the use of complementary approaches for Chronic, Non-Communicable Diseases and Disorders, for which these approaches are most frequently used. These would include, but not be limited to, investigations of the impact of complementary health modalities in alleviating chronic pain syndromes and inflammatory processes, and improving health and wellness. Complementary health approaches of interest to NCCIH include both mind-body and natural product approaches. Training programs can propose secondary data analyses, non-interventional, observational, or epidemiological clinical research, or basic mechanistic and non-clinical translational research. NCCIH will not support training programs proposing interventional clinical trial research through this FOA. Applicants are strongly encouraged to contact NCCIH program staff prior to submission.

The National Institute of Mental Health (NIMH) is interested in training programs that provide education in state-of-the-art research skills (e.g., novel study designs, data analytic and modeling techniques, data collection tools, conceptual approaches, bioinformatic methods, genotyping technologies) needed for addressing the objectives of the current NIMH Strategic Plan. NIMH encourages but does not limit research training to educational activities that provide trainees with the expertise and tools to:

• chart the course of neuropsychiatric disorders over the lifespan in order to understand ideal times and methods for intervention to prevent, preempt progression of, or treat mental disorders and hasten recovery;
• describe the molecules, cells, and circuits associated with typical and atypical behavior;
• identify genomic, epigenomic, and other factors such as the environment and experience across diverse populations that are associated with mental illnesses
• Identify clinically useful biomarkers and behavioral indicators that predict change across the trajectory of illness examine the interactions of neurobiological and environmental/social factors that affect brain development, resulting in behavioral outcomes (e.g. expression of cognitive impairment, coping, adaptation, response to interventions);
• conduct psychosocial and biomedical intervention trials that identify and test the mechanisms, moderators, and predictors (e.g. biological, genetic, behavioral, experiential, environmental) of intervention response and side effects in different patient populations;
• develop new preventive and treatment interventions based on discoveries in genomics, neuroscience, and behavioral science;
• develop innovative approaches for the delivery of psychosocial and biomedical interventions by different kinds of providers and within different service settings;
• develop and test models and methods for implementing mental health interventions: 1) in diverse systems of health care; and 2) to meet the needs of groups with inadequate access to evidence-based mental health services (e.g. based on age, sex, gender, stage of illness, race/ethnicity, rural or urban setting, or other factors);
• improve the efficiency and effectiveness of existing mental health services; and
• develop innovative service delivery models to optimize the outcomes of mental health services received in diverse communities and populations

The National Institute on Aging (NIA) promotes strategies to build global aging research capacity and supports collaborative research between U.S. scientists and those in other countries, to influence the development of biomedical and behavioral research internationally related to aging. Studies that draw data from across the lifespan are especially encouraged.

National Institute on Drug Abuse (NIDA) - Research priority areas have been identified that are international in scope, are associated with substantial detrimental health consequences, and for which international collaborative research may provide a unique opportunity to expand our knowledge and ability to effectively respond.
The following areas of research are current priority areas:
Opioid overdose and addiction have been increasing in the United States and other countries, with synthetic opioids accounting for an increasing share of these problems. Studies are needed regarding trans-national drug markets for synthetic and other opioids, novel approaches to preventing opioid use, injection, and overdose, and novel approaches to treating opioid addiction and delivering services to reduce opioid use and its infectious disease consequences on a population basis.
Research on marijuana, its acute and chronic effects, especially on the neurobiology and function of the brain, are encouraged. In addition, research on the impacts of policies and laws regarding marijuana possession and use are encouraged.
Active drug use, across a variety of substances and modes of administration, is often associated with increased risk of HIV transmission, non-adherence to antiretrovirals (ARVs), or lapses in HIV treatment participation. Studies are needed to discern the best strategy to reach and test high-risk individuals and initiate and monitor ARV therapy for those who test positive
Abuse of Amphetamine-type stimulants, in particular cocaine, methamphetamine, and new psychoactive substances also called synthetic or designer drugs is a growing problem in the United States and in many other countries. Studies are encouraged to assess the nature and extent of stimulant use (including patterns of distribution), their public health consequences and novel approaches to prevention and treatment of stimulant use. Studies are also encouraged that increase our understanding of designer drugs, including their short- and long-term sequelae, the course of designer drug use and abuse, as well as prevention and treatment approaches and the character of transnational drug markets for these substances.
Inhalant abuse continues to be an under-recognized public health problem in many countries. Studies are encouraged to improve epidemiological data on the nature and extent of abuse, to develop and implement effective prevention programs, to better understand the neurobiological impacts of these agents, and to increase public awareness of their impact.
Smoking during pregnancy studies are encouraged to increase our knowledge of the prenatal impact of smoking and the effects of early exposure to tobacco and marijuana in young people and adolescents on development of addiction and other diseases and on cognitive development.
Drugged driving studies are encouraged to develop and utilize accurate drug testing technologies to assess the prevalence of driving under the influence of drugs, the role of drugs in accidents, and to assess the costs and benefits of laws and other programs to reduce the incidence and impact of drugged driving.

Special Note: Because of the differences in individual Institute and Center (IC) program interests for this FOA, prospective applicants MUST consult the IC-Specific Information, Requirements and Staff Contacts, to make sure that their application is appropriate for the requirements of one of the participating NIH ICs. Prior consultation with NIH staff is strongly encouraged.

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)

Nonprofits Other Than Institutions of Higher Education

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

Governments

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

Other

• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• 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 directly by eligible LMIC institutions or by eligible domestic (U.S.) institutions that demonstrate collaborations with eligible LMIC institutions named in their application. New proposed research training programs are advised to focus on collaboration with a single LMIC institution as the major partner. Previously established collaborative research training programs are expected to expand and network with other institutions within the LMIC and region.

Low and middle-income country (LMIC) categories 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).

For FIC D43 programs "Eligible LMICs" do not include G20 countries in the "upper-middle-income country" category (UMIC/G20) for funding (except for Sub-Saharan Africa). UMIC/G20 sites may be involved as additional training sites if no faculty or trainees from that UMIC/G20 institution are supported by the proposed D43. For details see Notice of Change in Country Eligibility for Fogarty International Training Grants and Country Eligibility for details of the D43 definition of "eligible LMIC" used in this FOA: .

Hong Kong is part of China but is classified as a high-income economy so institutions there are not eligible as primary LMIC research training sites. Institutions in Hong Kong may be included as collaborating sites but no faculty or trainees from Hong Kong may be supported under the NCD-LIFESPAN D43 at these sites.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are 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 applicant PD/PI must have strong research and research-training program experience.

The applicant PD/PI must name at least one individual at each collaborating institution as the major collaborator for that institution. Individuals chosen as major collaborators should be researchers with whom the Principal Investigator or key personnel named in the application have had prior successful collaborations. These collaborations should be described in the application.

The PD/PI and collaborators will be responsible for the overall conduct of the grant. The role of the collaborators in setting the research agenda and in conceptualizing and mentoring research projects should be described in the application.

All applicants should explain in detail how their relevant research grant support and activities are related to the proposed research training plan.

The PD/PI or key personnel listed in the application must be designated as the PD of at least one active research award (with at least 18 months of support remaining as of the application due date) that is directly relevant to the research training proposed in the LMIC. The research awards may be funded by the NIH or by other national or international organizations. The applicants need to document this existing research support in their application. If an award is pending, to use that grant to meet the eligibility requirement, the applicant must provide documentation from the institution issuing the grant that the award is expected, and it will have sufficient remaining resources to continue the research project.

LMIC PD/PIs who are not LMIC citizens, must be designated by the eligible LMIC as a permanent resident (or equivalent status in the LMIC in question, to be verified by the applicant institution).

More than one Training PD/PI (multiple PD/PIs), may be designated on the application for research training programs that require a team approach and therefore clearly do not fit the single PD/PI model, e.g., interdisciplinary or multidisciplinary training. A single Contact PD/PI must be designated for communicating with the NIH, although other individuals may contact the NIH on behalf of the Contact PD/PI when necessary. Because training programs are intended to be coherent, a single award will be made. NIH will not allocate the budget or training positions between multiple PD/PIs. That is the responsibility of the contact PD/PI.

Multiple PD/PI applications should include reasonable numbers of PD/PIs and each should be included for a specific purpose. Multiple PD/PI applications should not include all mentors of the training grant as PD/PIs, except in unusual cases. The decision to apply with a single PD/PI or multiple PD/PIs is the responsibility of the investigators and applicant organizations and should be determined and justified by the goals of the training program.

Applications for grants with multiple PD/PIs require additional information. When considering multiple PD/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PI will be factored into the assessment of the overall scientific merit of the application. Multiple PD/PIs on a program share the authority and responsibility for leading and directing the research training program, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization for the proper conduct of the program, including the submission of required reports.

Applications with multiple Training PD/PIs must provide a Leadership Plan that emphasizes how leadership by multiple PD/PIs will benefit the research training program and the trainees.

Non-U.S. faculty from other high-income countries (HICs) may be included only as consultants if their participation is well justified to fill a unique research training expertise not available among U.S. or LMIC investigators.

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

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.

All faculty mentors should have research and/or research training experience in the LMIC and on topics which are the focus of the application

Trainee Eligibility. Trainees should be from the LMIC(s) for which the research training program is being designed. Only individuals who are citizens of LMICs are eligible for research training support or other training activities, as verified by the PD(s)/PI(s). Individuals who have permanent residency in the U.S., other high-income countries or ineligible countries described above are not eligible for support as trainees.

Research training may be offered at the masters, doctoral, professional degree and postdoctoral levels and for short-term training to a wide range of scientists, including but not limited to laboratory and field scientists, social scientists, clinicians and other health professionals, as well as non-health academics and professionals who with training intend to use their expertise to address gaps in NCD research. Training of technical and administrative staff may also be needed to help close research capacity gaps at the LMIC institution.

Attention should be given to recruiting and retaining LMIC trainees from groups underrepresented in NCD research in the LMIC context. The NCD-LIFESPAN program strongly encourages PDs/PIs to include women and individuals from underrepresented racial, ethnic or socially disadvantaged groups in the country as trainees.

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

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:

Kathleen Michels, Ph.D.

Telephone: (301) 496-1653

Fax: 301-402-0779

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. Include the applicant institution and all the collaborating institutions, both U.S. and foreign, as performance sites.

Follow all instructions provided in the SF424 (R&R) Application List the name(s) of the LMIC(s) and the topical/scientific and/or discipline research training areas in the Project Summary and Abstract.

Describe the topical/scientific and/or discipline research training areas and public health relevance to the LMIC in Project Narrative.

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

Other Attachments. Provide a plan for the appointment of a Training Advisory Committee (TAC) 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. The TAC should be composed of experts and relevant professionals from all the countries involved. TAC members should not be directly involved in the training program or in mentoring trainees. They should be included as key personnel as described in SF 424 (R&R) Senior/Key Person Profile Expanded Component.

Describe how the TAC will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of candidates, scientific review of trainees' projects, and the evaluation of the overall effectiveness of the program. Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. 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.

- For applications from U.S. institutions, include the name of one person at the main LMIC institution who will serve as the main collaborator(s), select "Other," and list their role as "Key Collaborator."

- Include at least ONE person at all the other U.S. and foreign participating institutions as senior/Key Personnel and identify their role

- List all members of the Training Advisory Committee (TAC) as Senior/Key Personnel, select "Other" and list their role as "TAC member".

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

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

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 https://grants.nih.gov/grants/forms/data-tables.htm.

Training Program

Program Plan

Background

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

Applications should document the existing NCD 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 by 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. If there are multiple PDs/PIs, then the plan for Program Administration is expected to synergize but not overlap with the "Multiple PD/PI Leadership Plan" section of the application.

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 may be proposed, provide documentation of the PD/PI(s) and Faculty mentors' expertise, experience, and ability to oversee the organization, management and implementation of the clinical trial, including any feasibility or ancillary study, proposed by trainee(s).

Program Faculty

Describe the leadership, administrative skills, scientific research and training experience of the faculty (including for U.S. or other HIC collaborators, their LMIC research and research training experience in the country that is the focus of the application) and how these qualities are related to the proposed roles in the training program.

Provide a description of how the ongoing collaborative research among the PI/PD(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.

Proposed Training.

Describe in detail in the program plan the proposed didactic and technical training and research experiences, along with the training components and the career development activities relevant to the needs of the trainee and proposed duration of training. Include processes for determining projected training needs and a plan to monitor progress towards accomplishing desired goals.

When it is necessary to begin training activities in the U.S. or other non-LMIC site, program plans should describe a timeline and process for transfer of as many of the proposed training activities as feasible during the grant period to the LMIC institution, consistent with the overall goal 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 develop skills in understanding research, in applying their critical abilities to identify problems, conduct research and, in the process of conducting research, in raising questions and proposing solutions to resolve problems. Trainees should be prepared to utilize their research findings as they pursue future research.

Describe how the proposed programs will provide all LMIC trainees with professional development skills and individualized career guidance including instruction and training in grant writing in order to apply successfully for future career development and independent research support. All postdoctoral trainees should also be provided with instruction in project management. As part of these activities, program plans may propose mentorship training for proposed faculty.

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:

- Explain what distinguishes this program from the others and how these programs will synergize with one another, if applicable.

- Describe how the pools of faculty, potential LMIC trainees, and resources are robust enough to support additional programs.

For any clinical trial the D43 trainees will participate in provide documentation of the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the clinical trial, including any feasibility or ancillary study.

Applicants should in addition:

• Describe the proposed research training program, including the goals, objectives and how the program will meet the objectives outlined in this FOA and the needs of the LMIC and LMIC institution.
• Describe a plan for providing mentoring that will support trainees in formal educational programs and in conducting training-related research.
• Describe the plans for the integration of the research capacity building activities at the LMIC institution(s).
• Describe how the proposed research training program may serve as a bridge among the academic research community, policy makers and public health communities in the country.
• Describe and provide rationale for the balance of research training options (degree-related and non-degree, long-, medium- and short-term training) and disciplines to match the needs of the trainees and their LMIC institution.
• Describe plans to include instruction about the inclusion of children, women and individuals from underrepresented racial, ethnic and disadvantaged groups in research conducted in their country.
• Describe strategies that will be used to achieve a wider regional impact. This could be done for example through involving trainees in engaging with and educating policy makers, or by strengthening other institutions in the LMIC country or in neighboring countries ("south to south" training).
• Describe the plans for strengthening core research support capabilities necessary for long-term sustainability, such as library science, scientific writing and presentation, grant writing, bioinformatics, bioethics, good clinical practice, good lab practice, biosafety, data management, research administration, the management of intellectual property and English as a second language

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 NCD research training and sustainable capacity building objectives. Describe plans to expand or network with additional departments of the original LMIC institution, with other country institutions and/or with institutions within the region, using the original institution/program as a hub and/or node for expanded and networked NCD research training, research opportunities for trainees and research training information.

Trainee Candidates.

Describe, in general terms, the size and qualifications of the pool of trainee candidates including information about the types of prior educational background and applied experience, clinical and research training and career level required for the program. Do not name prospective Trainees.

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 trials, including feasibility or ancillary studies.

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 NCD 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 the Program.

Provide assurance from the sponsoring institution of 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.

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.

Applicants are strongly encouraged to develop courses in the responsible conduct of research adapted to the locally relevant scientific context at the LMIC institution that include LMIC faculty.

Appendix

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to 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 appointee Trainee begins independent 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. Note, however, that pre-award costs are not allowable charges for stipends or tuition/fees on institutional training grants because these costs may not be charged to the grant until a trainee has actually been appointed and the appropriate paperwork submitted to the NIH awarding component. Any additional costs associated with the decision to allow research elective credit for short-term research training are not allowable charges on an institutional training grant.

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.

In order to expedite review, applicants are requested to notify FIC by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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 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) 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

• Does the application identify an NCD 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 NCD research and research training of importance to that country?
• Are the research facilities and research environment conducive to preparing trainees for successful careers as biomedical and health research scientists?
• Does the proposed program provide suitable training for the level of trainees being proposed?
• 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 trainees to acquire state-of-the-art scientific knowledge, methods, and tools that are relevant to the goals of the training program?
• Are there plans to provide instruction in data management and statistics as appropriate for the proposed research training areas including those relevant to clinical trials?
• Does the program provide appropriate inter- or multidisciplinary research training opportunities?
• Is the proposed training program likely to ensure trainees will be well prepared for research-intensive and research-related careers?
• Is the level of 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 institution?
• 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?
• Does the proposed program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements?
• When applicable, is there adequate documentation describing the responsibilities of the training advisory committee regarding the provision of input, guidance and oversight of the program?
• If building on an existing/ previously established collaborative research training program(s) are there plans to expand and network for research training and trainee research with other institutions within the LMIC country and region?
• If training activities begin in the U.S. or other non-LMIC site, do program plans describe a timeline and process for transfer of as many of the proposed training activities as feasible by the end of the grant period to the LMIC institution, consistent with the overall goal to build research capacity there?
• If clinical trials may be proposed as a component of research training, are the administrative, data coordinating, enrollment and laboratory/testing centers, available and 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))

• Regarding the proposed leadership for the D43 research training, do the PD/PI(s) have the expertise, experience, and ability to oversee the organization, management and implementation?
• Does the PD(s)/PI(s) have the scientific background, expertise, LMIC experience and administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program?
• Does the PD(s)/PI(s) plan to commit sufficient effort to ensure the program's success?
• Does the application provide 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?

For applications designating multiple PDs/PIs:

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

Preceptors/Mentors

• Are sufficient numbers of experienced U.S. and LMIC mentors with appropriate expertise, LMIC experience and research funding available to support the number and level of LMIC trainees (including short-term trainees, if applicable) proposed in the application?
• Do the U.S. and LMIC mentors have strong records as researchers, including recent publications and successful competition for research support in areas directly related to the proposed research training program?
• Do the U.S. and LMIC mentors have strong records of training individuals at the level of LMIC trainees (including short-term trainees, if applicable) proposed in the program?
• Is the Training Advisory Committee proposed likely to achieve its functions defined by the application?
• Do the mentors who will supervise the trainee(s) have the expertise, experience, and ability to provide guidance in the organization, management and implementation of a clinical trial, ancillary, or feasibility study and help him/her to meet 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?
• Do prospective trainees have the potential to organize, manage, and implement a 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

For renewal applications or those built on previous research training programs:

• How successful are the LMIC trainees (or, for new applications, other LMIC students/postdoctorates in previous similar training by the PD/PI) 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.

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:

• 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 and other assigned and participating 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. Consideration of 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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.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 http://www.hhs.gov/ocr/civilrights/understanding/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 http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

Not Applicable

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

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

• Grantees must enter trainee information into the CareerTrac reporting system. Information will be included with the Notice of Grant Award.

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.

Grantees are expected to keep track of their trainee's progress and development during the grant period. Grantees must enter trainee information into the CareerTrac reporting system. Information will be included with the Notice of Grant Award.

The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:

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

Because of the difference in individual Institute and Center (IC) program requirements for this FOA, prospective applications MUST consult the Table of IC-Specific Information, Requirements, and Staff Contacts, to make sure that their application is responsive to the requirements of one of the participating NIH ICs. Prior consultation with NIH staff is strongly encouraged.

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]

Lynn Mertens King, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5006
Email: [email protected]

Kathleen Michels, Ph.D.
Fogarty International Center (FIC)
Telephone: 301-496-1653
Email: [email protected]
Email: [email protected]

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

Michael Humble Ph.D
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3272
Email: [email protected]

Lanay Mudd Ph.D
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-9346
Email: [email protected]

Richard T. Benson, MD, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Phone: 301-496-9135
E-mail: [email protected]

Chhanda Dutta Ph.D
National Institute on Aging (NIA)
Telephone: 301-496-4161
Email: [email protected]

Steven Gust, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301 402 1118
Email: [email protected]

Makeda Williams, PhD, MPH
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-496-1051
Email: [email protected]

Seetha Bhagavan Ph.D
Center for Scientific Review (CSR)
Telephone: 301-237-9838
Email: [email protected]

Diana Rutberg, M.B.A.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: [email protected]

Satabdi Raychowdhury
Fogarty International Center (FIC)
Telephone: 301-496-1653
Email: [email protected]

Lesa McQueen
National Institute on Aging (NIA)
Telephone: 301-496-1472
Email: [email protected]

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: [email protected]

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: [email protected]

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

Ashley Singh
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3323
Email: [email protected]

Pamela Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301 480 1159
Email: [email protected]

Ryan Lombardi
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8042
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 287b) and under Federal Regulations 42 CFR Part 63a.