Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

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 inSection IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applicationsthat do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overall goal of the NIH Ruth L. Kirschstein National Research Service Award (NRSA) program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. In order to accomplish this goal, NRSA training programs are designed to train individuals to conduct research and to prepare for research careers. More information about NRSA programs may be found at the Ruth L. Kirschstein National Research Service Award (NRSA) website.

Purpose and Background Information

The NRSA program has been the primary means of supporting predoctoral and postdoctoral research training programs since enactment of the NRSA legislation in 1974. Research training activities can be in basic biomedical or clinical sciences, in behavioral or social sciences, in health services research, or in any other discipline relevant to the NIH mission.

Institutional NRSA programs allow the Training Program Director/Principal Investigator (Training PD/PI) to select the trainees and develop a program of coursework, research experiences, and technical and/or professional skills development appropriate for the selected trainees. Each program should provide high-quality research training and offer opportunities in addition to conducting mentored research. The grant offsets the cost of stipends, tuition and fees, and training related expenses, including health insurance, for the appointed trainees in accordance with agency-approved support levels.

Note: This Funding Opportunity Announcement (FOA) allows support appointment of trainees (D43) proposing to serve as the lead investigator of an independent clinical trial; or proposing a separate ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.

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). The World Health Organization (WHO) has endorsed a global action plan for the prevention and control of NCDs that includes the promotion and support of national capacity for high-quality research and health system development. To address these goals, in-country 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 most recent FIC 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 Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), National Institute on Alcohol Abuse and Alcoholism (NIAAA), Office of Womens Health Research (ORWH), and Office of Disease Prevention (ODP), 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.

New research training programs are expected to focus on collaboration with a single LMIC institution as the major partner unless that collaboration for research training is already well-established at the LMIC site to the extent that outreach to other sites can be well-justified. The ultimate goal is for the LMICs to run their own research training programs so all applications originating from the US institution must include plans to transition research training capabilities and management to the foreign site over the course of the grant period. Renewal applications from the US institution must also justify the continued need for leadership by the US awardee institution. Applicants with well-established programs at the LMIC site may reach out to form research training networks to develop the research capacity of other LMIC institutions.

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 lifespan. 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.

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 NIH institutes, centers and offices (see "Specific Interests of the FOA Sponsors" section).

Research training programs are especially encouraged:

• That are relevant across NCDs in the target LMIC(s)
• That emphasize research training for
  • 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, their prevention and treatment.
• For training in translation and 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 and/or regions are encouraged.

The Need for a Multidisciplinary Approach:

Risk factors for NCDs are complex and differentially amenable to control. Environmental influences, trauma, infection, lifestyle factors, diverse socio-economic influences and epigenetic changes interact with underlying genetic vulnerability to influence the trajectory and severity of many NCDs.

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, neurological 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 NCDs, the research findings must 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 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 complex, so trainees must gain a broad appreciation for the need for research across health disciplines that may encompass 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 and provide experience in collaborative interdisciplinary team research.

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 multi- and inter-disciplinary 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 that takes 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 NCD-oriented 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) and may be supported by the training program.

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 individuals from diverse backgrounds, including women and other 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. Because of the differences in individual Institute and Center (IC) program interests for this FOA, prospective applicants should carefully note which ICs participate in this announcement and view their respective areas of research interest and requirements below. Applicants can obtain additional information and research interests for each of the FOA's sponsoring partners at their websites and by contacting the partner program official listed in this announcement (Section VII. Agency Contacts).

NIH IC Partner Interests

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/or co-morbid conditions and risk factors across the lifespan 2) train in research disciplines applicable across NCD areas/topics, conditions and settings (for example, but not limited to, training in epidemiology, demographics, genetics/epigenetics, bioinformatics, biomedical engineering, health technology and prevention, translation, implementation and clinical research). For both new and renewal applications FIC will prioritize direct applications from the LMIC site for funding consideration. 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.

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

The NINDS strongly encourages training in scientific rigor and experimental design. Trainees should have a thorough understanding of the principles and practices of rigorous scientific research. These principles should be examined in the context of the collection, appropriate analysis and interpretation of scientific data. Programs are also encouraged to provide education in human decision-making tendencies and cognitive biases, and how they can lead to erroneous interpretation of data (c.f. Kahneman, D. 2011 Thinking, Fast and Slow. New York. Farrar, Straus and Giroux). Programs are expected to provide formal instruction in the principles of rigorous experimental design to ensure that trainees understand the practices required for robust hypothesis testing and the application of these principles and practices to their individual research (see: NINDS Rigor Resources: https://www.ninds.nih.gov/Current-Research/Trans-Agency-Activities/Rigor-Transparency/RigorChampionsAndResources).

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 of Dental and Craniofacial Research (NIDCR) is interested in research training programs that develop research capacity to improve dental, oral, and craniofacial health in LMICs across the lifespan. NIDCR supports basic, translational, and clinical biomedical and behavioral research training in the following areas: dental caries and periodontal diseases; oral infections and host-responses to oral infections; head and neck cancers; dental and craniofacial development; orofacial pain and other oral sensory and motor dysfunctions; salivary glands and disorders, Sj gren's Syndrome, immune dysfunctions in the oral cavity; population-based, oral health promotion and disease prevention; and restoration and regeneration of dental, oral and craniofacial structures. Focus of research training topics in LMICs include, but are not limited to: addressing disparities in access to oral health care; prevention, early detection and intervention relating to dental, oral and craniofacial diseases and disorders; development and application of genomics, bioinformatics, and computational biology expertise for basic and translational dental, oral, and craniofacial research; integration of oral health care into care for chronic, non-communicable diseases and disorders, and implementation science. See the following links for areas relevant to the NIDCR mission (www.nidcr.nih.gov/about-us/mission) and Strategic Plan (www.nidcr.nih.gov/about-us/strategic-plan). Potential applicants are encouraged to contact the NIDCR Program Officer to discuss the relevance of proposed research training.

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) fosters international collaboration in research and research training that advances the understanding of alcohol misuse and alcohol use disorder (AUD). This includes research on prevention of alcohol misuse of alcohol and alcohol use disorder, improving the health and well-being of individuals living with AUD and alcohol-associated pathology, such as fetal alcohol spectrum disorders (FASD) and organ damage, and reducing alcohol-related morbidity and mortality. Specifically, NIAAA supports international research that provides a unique opportunity to generate and disseminate fundamental knowledge on the effects of alcohol misuse on health and applies that knowledge for finding solutions to improve prevention and treatment of alcohol misuse and alcohol use disorder across the lifespan.

NIAAA encourages research training that capitalizes on emerging research opportunities and provides trainees with knowledge and advanced skills in areas that include, but are not limited to, the following:

• genetic, epigenetic, neurobiological, and behavioral mechanisms and interactions of individual and environmental factors that affect prevention, disease progression, and recovery in alcohol use disorder and alcohol-associated pathology across the lifespan,
• biomarkers and indicators that predict disease progression and response to interventions,
• translation of scientific discoveries to new interventions,
• novel approaches to prevention and treatment of alcohol misuse, alcohol use disorder, and related conditions,
• therapeutic approaches, medications, and other treatments to mitigate alcohol-associated deficits and disorders, such as alcohol-associated liver disease, across the lifespan, and
• innovation in identification and service delivery models to optimize the outcomes in diverse communities and populations.

Research shows that diverse teams working together outperform homogenous teams. Scientists and trainees from diverse backgrounds and with different life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. Diverse teams of scientists will lead the way to develop more innovative inclusive research that will more broadly enhance public health. Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support, and maintain the quality of our scientific workforce. NIAAA encourages research programs to include a diverse group of scientists, including individuals from underrepresented groups as per NOT OD 20-031 (Notice of NIH's Interest in Diversity). NIAAA is interested in enhancing representation of individuals from diverse backgrounds, including individuals from racial, ethnic and gender minorities and early-stage investigators.

Office of Disease Prevention (ODP) is the lead office at the NIH responsible for assessing, facilitating, and stimulating research in disease prevention. In partnership with the 27 NIH Institutes and Centers, the ODP strives to increase the scope, quality, dissemination, and impact of NIH-supported prevention research. The ODP is interested in providing co-funding support for research that has strong implications for disease and injury prevention and health equity and that include innovative and appropriate research design, measurement, and analysis methods. Furthermore, the ODP has a specific interest in projects that develop and/or test preventive interventions. For this NOSI, the ODP is interested in supporting innovative research training programs that address prevention science across the lifespan. Trainees should have a thorough understanding of the principles and practices of rigorous scientific research, as well as disease prevention and health promotion strategies. For additional information about ODP’s research priorities and interests, please refer to the ODP Strategic Plan for Fiscal Years 2019 2023.

The ODP does not award grants; therefore, applications must be relevant to the objectives of at least one of the participating NIH Institutes and Centers (IC) listed in this announcement. Please contact the relevant IC Scientific/Research Contact(s) listed for questions regarding IC research priorities and funding.

The Office of Research on Women's Health (ORWH) mission is to improve the health of women. ORWH is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and ensures that research conducted and supported by the NIH addresses issues regarding women's health. ORWH works to stimulate and encourage basic and clinical research on the role of sex and gender in health and disease. ORWH promotes training and career development of a diverse biomedical research workforce to advance science for the health of women. ORWH also develops and supports initiatives to recruit, retain, and advance women in biomedical careers; programs that support both women and men in women’s health and sex differences research careers. ORWH is interested in supporting research training in LMICs to address women’s cardiovascular diseases with a special interest in cardiovascular diseases of the peripartum period up to one year after delivery. Peripartum cardiomyopathy (PPCM) is relatively an uncommon condition in high income countries but its incidence may be rising in LMICs. The causes of PPCM are not well understood, but hypotheses including inflammatory processes, genetic predisposition, and stress-mediated antiangiogenic pathway suggest vascular causes triggered around delivery or immediately postpartum. Studies have indicated an association with preeclampsia, obesity, multifetal births. Because we still do not fully understand the causes of peripartum cardiomyopathy, there is a gap in research and research training to fill. ORWH is interested in supporting applications that fulfill goal 1 and goal 4 of the NIH Strategic Plan for Women's Health and Sex Differences Research, which can be found at: https://orwh.od.nih.gov/sites/orwh/files/docs/ORWH_Strategic_Plan_2019_508C_0.pd

Special Notes:

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).

For Cancer-focused D43 program proposals from US institutions, we encourage potential applicants to refer to the National Cancer Institute (NCI) Global Health research training opportunities: https://www.cancer.gov/about-nci/organization/cgh/research-training-programs/d43-global-research-training.

This program will continue to support Cancer-related D43 applications directly from LMIC institutions (with or without a U.S. partner).

This program does not support Trauma and Injury related Research Training with the exception of the long-term effects of trauma and injury and related rehabilitation research training, including implementation science across types of trauma and injury. For additional information on the Fogarty Global Trauma and Injury Research Training please visit https://www.fic.nih.gov/Programs/Pages/trauma-injury.aspx.

Note: This Funding Opportunity Announcement (FOA) allows appointment of Trainees (D43) proposing to serve as the lead investigator of an independent clinical trial; or proposing a separate ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.

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

Section II. Award Information

Other Award Budget Information

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

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)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

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.

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).

Applications may be submitted directly by eligible LMIC institutions or by eligible domestic (U.S.) institutions that demonstrate collaborations with eligible LMIC institution(s) named in their application. Foreign applications must come from eligible LMICs, not from high income countries (HICs). New proposed research training programs are advised to focus on collaboration with a single LMIC institution as the major partner. Direct applications from LMIC institutions are encouraged for both renewals and new submissions. For projects previously led by U.S. institution/PI(s), applicants are encouraged to transfer the leadership to the LMIC partner institution or explain why that is not appropriate at this time. Already well-established research training programs at the LMIC site are encouraged to expand and network with other institutions within the LMIC and region.

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 https://grants.nih.gov/grants/guide/notice-files/NOT-TW-12-011.html "Notice of Change in Country Eligibility for Fogarty International Training Grants and Country Eligibility", and for additional information see: https://www.fic.nih.gov/Grants/Pages/country-eligibility.aspx.

The applicant institution must have one or more strong and high-quality research program(s) in the area(s) proposed under this FOA and must have the requisite faculty, staff, potential trainees and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing research training programs occurring at the applicant institution and that one of more of the program faculty will have active research projects in which participating trainees may gain relevant experiences consistent with their research interests and goals.

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.

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.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
• Dun and Bradstreet Universal Numbering System (DUNS) Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, 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.
• eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active 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.

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 and 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.

The contact PD/PI should be an established investigator in the scientific area in which the application is targeted, must have strong research and research-training program experience and demonstrate administrative and scientific leadership appropriate to the development and implementation of the proposed program. The PD/PI will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the day-to-day administration of the program and is responsible for appointing members of the Advisory Committee (when applicable), using their recommendations to determine the appropriate allotment of funds.

The applicant institution 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 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 and/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).

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.

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 https://era.nih.gov/register-accounts/understanding-era-commons-accounts.htm for instructions).

2. Cost Sharing

3. Additional Information on Eligibility

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, per 2.3.7.4 Submission of Resubmission Application. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Program faculty should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program. Program faculty should also have a record of research training, including successful, former trainees who have established productive careers relevant to the NIH mission. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.

Trainees

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.

Only individuals who are citizens of LMICs (defined by the World Bank classification system- also refer to NOT-TW-12-011 "Notice of Change in Country Eligibility for Fogarty International Training Grants", for additional information) are eligible for research training support or other training activities (as verified by the PD(s)/PI(s)). Individuals who have dual citizenship or permanent residency in the U.S., other high-income countries or UMIC/G20 ineligible countries described above are not eligible for support.

Research training may be offered to a wide range of scientists, including field-based and laboratory scientists, social scientists, clinicians and other health professionals in order to fill research capacity gaps at the LMIC institution.

All long- and medium term (more than one month) trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies.

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 LMIC 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 LMIC trainees from groups underrepresented in NCD research in the LMIC context as potential participants in the program. The NCD-LIFESPAN program strongly encourages PDs/PIs to include individuals from diverse backgrounds, including women and other individuals from groups underrepresented in biomedical and behavioral research in the country, such as racial, ethnic or socially disadvantaged groups in the country as trainees.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Kathleen Michels, PhD
Telephone: 301-435-6031
Email: [email protected]

Page Limitations

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

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424 (R&R) Other Project Information

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

.

.

The following additional instructions apply:

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

Project Narrative

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

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

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

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

The following instructions apply to this FOA: Individuals involved in the program only as possible faculty mentors should NOT be named as key personnel.

PHS 398 Cover Page Supplement

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

PHS 398 Training Subaward Budget Attachment(s)

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

Include all personnel other than the Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.

Research & Related (R&R) Budget

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

• Use the Other Personnel section to submit costs for salary support for administrative staff.
• Use the Travel section to submit costs for key personnel and faculty travel including the annual network meeting.
• Use the Participant/Trainee Support Costs section to submit costs for Trainees and training-related expenses. Include health insurance under Training Related Expenses (not in Tuition/Fees/Health Insurance). 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.

PHS 398 Research Training Program Plan

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

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

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

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

Applicants should summarize, in the body of the application, key data from the tables that highlight the characteristics of the applicant pool, faculty mentors, the educational and career outcomes of participants, and other factors that contribute to the overall environment of the program. Only LMIC trainees should be included.

Training Program

Program Plan

Introduction

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

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.

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.

If building on existing/ previously well-established collaborative research training program(s), at the LMIC institution(s), then describe any current or future plans to expand and network for research training and trainee research with other institutions within the LMIC country and region.

Program Administration.

Describe the strengths, leadership and administrative skills, training experience, NCD and related expertise, and active research of the PD/PI(s). Relate these strengths to the proposed 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.

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

When a program administrator position is planned, a description of the scientific expertise, leadership, and administrative capabilities essential to coordinate the program must be included in the application.

Proposed Training

Describe and justify how the proposed training plan is appropriate to local priorities and context of the LMIC and LMIC institution.

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

Describe opportunities for LMIC trainees to acquire state-of-the-art scientific knowledge, methods, and tools that are relevant to the goals of the training program including but not limited to instruction in scientific rigor, data management and statistics as appropriate for the proposed research training areas including those relevant to clinical trials and appropriate inter- or multidisciplinary research training opportunities.

Describe program activities intended to develop the working knowledge needed for trainees to select among and prepare for the next step in varied research career options available in the LMIC biomedical workforce. For example, programs should provide all trainees with instruction and training in oral and written presentation and in skills needed to apply for individual fellowship or grant support. All postdoctoral trainees should also be provided with instruction in project management.

Include a timeline of proposed training activities.

For renewal applications provide a detailed description of the progress made in the previous funding period to achieve proposed NCD research training and sustainable capacity building objectives at the LMIC institution and in the target LMIC(s).

Renewal applications must propose new research training activities that will raise research capacity to the next level at the LMIC institution. Highlight how the training program proposed has been and will be modified in response to changes in relevant scientific and technical knowledge, educational practices, and in response to evaluation of the training program.

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

The sponsoring and collaborating institutions must assure support for the proposed program including assurance that sufficient time will be allowed for the PDs/PIs and other Program Faculty to contribute to the proposed program and protected time for LMIC trainees selected for the program to complete all proposed training activities. This commitment may also include PD/PI or faculty salary, stipend or tuition support for individuals involved in the proposed training program, or other resources essential to a successful training program.

Renewal applications from U.S. institutions must contain a plan to transfer substantial training program leadership to the collaborating LMIC institution during the award period. Plans may include specific leadership activities to enable LMIC collaborators to meet the PD/PI or MPI requirements for this research training grant opportunity.

Training Program

Program Plan

Program Administration.

In the event that a clinical trial may be proposed, provide documentation of the PD/PI(s) 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).

Proposed Training.

In the event that a clinical trial may be proposed, provide documentation of the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the clinical trial, including any feasibility or ancillary study, proposed by Trainee(s).

?????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.

Program Faculty

For U.S. and other High-Income Country (HIC) or UMIC/G20 faculty mentors, describe their research and research training experience in the LMIC country and relevant to the NCD or related topics that are the focus of the application.

Describe in detail the roles faculty and mentors from LMICs with expertise will play in the proposed programs to ensure the LMIC relevance of the proposed research training. Letters of support from proposed participating faculty mentors do not need to be included.

For applications proposing clinical trials, describe the expertise, experience and ability of the faculty mentors to provide guidance on the organization, management and implementation of clinical trials.

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

Trainee Candidates

Describe strategic plans for the recruitment, selection and training of a cohort of predoctoral and postdoctoral trainees most likely to result in a sustainable critical mass for leadership in the LMIC(s) relevant to NCD research and related teaching, clinical care and consultation at the LMIC institution.

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

Describe how LMIC predoctoral and postdoctoral trainees will be selected (for example based on interest in/ commitment to NCD research as documented by academic achievements, related degrees or experience, publications, fellowships or grants).

If the event that a clinical trial may be proposed, discuss the potential of prospective Trainees to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study.

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.

Appendix is not allowed.

PHS Human Subjects and Clinical Trials Information

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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 begins independent clinical trial research.

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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, that pre-award costs are not allowable charges for stipends or tuition/fees on institutional training grants. Any additional costs associated with the decision to allow research elective credit for short-term research training are not allowable charges on an institutional training grant

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form.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 unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Letters of Support:

Applicants should include a Table of Contents at the beginning of the letters of support file that distinguishes the types of letters included (institutional, key collaborators, TAC members, etc.). Letters of support from proposed participating faculty mentors do not need to be included.

In order to expedite review, applicants are requested to notify the 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.

Post Submission Materials

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

Section V. Application Review Information

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

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

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

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

• For the NCD scientific focus of the proposed research training, does the application demonstrate direct relevance 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 objectives, design and direction of the proposed research training program appropriate to the proposed pool of trainees and likely to ensure trainees will be well prepared for research-intensive and research-related careers?
• Do the courses 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 including those relevant to clinical trials?
• Does the program provide appropriate inter- or multidisciplinary research training opportunities?
• Is the level of institutional commitment to the training program, including administrative and research training support, sufficient to ensure the success of the program?
• 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?
• Are the research facilities and research environment conducive to preparing trainees for successful careers as biomedical and health research scientists?
• 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?
• 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 involving Trainee(s) (D43), are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed? Does the application adequately address the capability and ability to conduct the trial feasibility or ancillary study at the proposed site(s) or centers? If applicable, are there plans to add or drop enrollment centers, as needed, appropriate? If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial? If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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

• With regard to the proposed leadership for the training program, do the PD/PI(s) have the expertise, experience, and ability to oversee the organization, management and implementation of the proposed clinical trial?

• If the program will support clinical trial research experience for the Trainees, do the mentor(s) who will supervise the Trainee(s) have the expertise, experience, resources, and ability to provide appropriate guidance and help the Trainee(s) to meet the timelines?

• Do the preceptors/mentors have strong records of training individuals at the level of trainees (including short-term trainees, if applicable) proposed in the program? Are appropriate plans in place to ensure that preceptors lacking sufficient research training experience are likely to provide strong and successful mentoring for the LMIC trainees?
• Do the preceptors/mentors have strong records as researchers, including recent publications and successful competition for research support in areas directly related to the proposed research training program?
• Are sufficient numbers of experienced LMIC, U.S. or other HIC preceptors/mentors with appropriate expertise, and funded research projects, capable of supporting the number and level of LMIC trainees (including short-term trainees, if applicable) proposed in the application?

Trainees

• Are there well-defined and justified selection criteria as well as retention strategies?
• Is there a competitive LMIC applicant pool of sufficient size and quality, at each of the proposed levels (predoctoral, postdoctoral and/or short-term), to ensure a successful NCD research training program?
• Is a recruitment plan proposed with strategies likely to attract well-qualified LMIC trainees for the training program?

For programs that may involve trainees in clinical studies or trials:

• Is there a plan to assess the ability of and train prospective trainees as needed to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study?
• Are there plans to provide instruction in data management and statistics including those relevant to clinical trials to the prospective Trainees?

Training Record

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?

Protections for Human Subjects

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Training in Methods for Enhancing Reproducibility

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

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 Training in the Responsible Conduct of Research.

• Does the application describe the research training program’s accomplishments over the past funding period(s)?
• Is the program achieving its LMIC individual and institutional NCD research training objectives?
• Has the program evaluated the quality and effectiveness of the research training experience and LMIC institutional research capacity building (and when applicable, short-term training experience), and is there evidence that the evaluation outcomes and feedback from LMIC trainees have been acted upon?
• Are changes proposed that are likely to improve or strengthen the research training experience and LMIC institutional research capacity during the next project period (may not be applicable to short-term training)?
• Does the program continue to evolve and reflect changes in the NCD research area and in the LMIC and LMIC institution in which the research training occurs?
• Does the LMIC institution take the lead role in the proposed renewal?
• If the research training program is well-established at the LMIC institution, are plans, as proposed, appropriate to network to build research capacity with other institutions within the LMIC and/or region?

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 Center for Scientific Review in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board.

The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities

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

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

Section VI. Award Administration Information

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

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

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

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

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

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

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

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

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 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, recipients will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative 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.

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

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

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

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

Marya Levintova, PhD
Fogarty International Center (FIC)
Telephone: 301-496-9535
Email: [email protected]

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

Damali Martin, Ph. D., MPH
National Institute on Aging (NIA)
Phone: 301-402-8310
Email: [email protected]

Tatiana Nikolayevna Balachova
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: 301-443-5726
E-mail: [email protected]

Lynn M King, PhD
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: 301-594-5006
E-mail: [email protected]

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

Stacey D. Chambers, MS
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-0690
E-mail: [email protected]

Elizabeth Neilson, PhD, MPH, MSN
Office of Disease Prevention (ODP)
Phone: 301-827-5578
Email : [email protected]

Makeda Williams, Ph.D., M.P.H.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-451-7594
Email:[email protected]

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

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

Vicky Tran
Fogarty International Center (FIC)
Telephone: 301-594-1650
Email: [email protected]

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

Jermain Cooper
National Institute on Aging (NIA)
Telephone:301-402-7974
Email: [email protected]

Judy Fox
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: (301) 443-4704
E-mail: [email protected]

Diana Rutberg, MBA
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4798
E-mail: [email protected]

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

Kimberly Stanton
National Heart, Lung, and Blood Institute (NHLBI)
Phone: (301) 435-0166
Email:[email protected]

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

Section VIII. Other Information

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