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

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Funding Opportunity Purpose

This Funding Opportunity Announcement invites new and renewal applications from U.S. institutions for support of a collaborative research training program that will strengthen the capacity of institutions in LMICs to conduct collaborative research, data management, training, curriculum and outreach material development, practical approaches for assessment and control of environmental and workplace hazards, and policy support around priority local, national and regional environmental and occupational health threats.

The purpose of this FOA, as one of two linked FOAs comprising the GEOHealth Hub program, is to support research training programs that address priority LMIC environmental and occupational health issues that are integrated with associated LMIC research activities. Therefore, applications in response to this FOA must be developed in close coordination with linked applications under RFA-TW-21-001 Hubs of Interdisciplinary Research and Training in Global Environmental and Occupational Health (GEOHealth) Collaborative Research (U01 Clinical Trial Optional) .

Background

The World Health Organization estimates that nearly a quarter of all deaths are attributed to living or working in an unhealthy environment, and environmental risk factors, such as air, water and soil pollution, chemical exposures, climate change, and ultraviolet radiation, contribute to more than 100 diseases and injuries (1). The burden is highest in Low- and Middle-Income Countries (LMICs), and environmental health risks especially affect women and children because they are more vulnerable socially and because exposures to environmental contaminants create greater risks for children’s developing bodies and cognitive functions (2).

Although LMICs suffer adverse and sometimes catastrophic health effects from environmental contamination and occupational hazards, in many cases inadequate capacity exists to study and mitigate these problems. Addressing these challenges requires a critical mass of scientists with expertise in large-scale environmental and occupational health analysis, complementary skills such as data management, and appropriate understanding of the socioeconomic and policy context that influences the effectiveness of interventions. Research partnerships can enhance access to expertise and resources to improve research capacity for environmental and occupational health in LMICs. Additionally, environmental health problems often cross national boundaries, as air and water pollutants travel thousands of miles impacting neighboring countries and locations around the world. Collaborative multi-country research on environmental and occupational health topics provides opportunities to address variation in exposure levels and inclusion of more extensive population genetic backgrounds that inform not only local health problems but also broader U.S. and international environmental and occupational health questions.

In 2012, FIC launched the Global Environmental and Occupational Health (GEOHealth) Hub program in order to develop a handful of regional science hubs, based in LMICs, that would become internationally-recognized centers for the collection, management, synthesis and interpretation of data on environmental and occupational health, ideally serving the multinational regions in which they reside (3). GEOHealth Hubs are supported by two linked cooperative agreement awards: a research award to the LMIC institution and a research training award to the US institution. Additional information about the program can be found on the program webpage at https://www.fic.nih.gov/Programs/Pages/environmental-occupational.aspx

New in this FOA

This FOA contains several updates to the previous GEOHealth FOAs, including the following:

• Updated funding partners (see Participation Organizations in Part I.)
• Guidance for the inclusion of an External Advisory Committee.
• Application instructions and review criteria for renewal applications (new applications are also eligible).
• Guidance to include a "Policy Training Plan"
• Guidance to include a "Plan for Partnership" in both U01 and U2R applications.
• Exclusion of programs focused on trauma and injury research training without direct environmental exposures.
• Application instructions to document policies, procedures and oversight related to harassment and discrimination.

Goals of the GEOHealth Program

The goals of the GEOHealth program are to strengthen environmental and occupational health-related research collaborations, enhance research training, create relevant advanced educational curricula and outreach material, support research needed to identify and design mitigation strategies for the adverse consequences of environmental and occupational exposures, and inform nationally-relevant policy development in LMICs. Each Hub will provide training and curricular resources to academic institutions in the region. Hubs are expected to have collaborative relationships with ministries of health and other key planning and operating agencies that oversee health-affecting activities, such as agriculture, labor and public works, to serve as a source of scientific evidence for policy formulation related to environmental and occupational health.

Together the GEOHealth Hubs form the GEOHealth Network which will serve as a platform for coordinated environmental and occupational health research and research training activities. It is anticipated that the GEOHealth Hubs will not only leverage the current investments of national governments and international research agencies and donors, but also become attractive for further investments in these institutions in the future. In doing so, the Hubs can also become magnets that attract, develop and retain the best environmental and occupational health scientists in LMICs, key collaborators for scientists from the U.S. and international partners, and among the most credible sources in the world for state-of-the-art knowledge on environmental and occupational health.

GEOHealth Hub Characteristics

A GEOHealth Hub is defined as a multidisciplinary group of researchers and their institutions based in a LMIC, who, with their collaborators, focus on a core set of common research and training topics that address environmental and/or occupational health priorities in the LMIC and/or the region. For the purposes of the GEOHealth Program linked FOAs (RFA-TW-21-001 and RFA-TW-21-002), a pair of institutions (one LMIC institution and one U.S. institution) should form a consortium to support the GEOHealth Hub with other collaborating institutions in the U.S. and LMIC linked as spokes . The GEOHealth Hub should serve as a focal point for all proposed research, research capacity-building, training, and collaborative activities, in which "spoke" institutions may participate. The U.S. applicant responding to this FOA should propose research training activities and the LMIC institution responding to RFA-TW-21-001 should propose research activities based on a set of common environmental or occupational health topics. Both applications must demonstrate a commitment to extensive coordination between these two awards to meet goals of the GEOHealth program.

Funding Opportunity Objectives

The objectives of the Hubs of Interdisciplinary Research and Training in Global Environmental and Occupational Health (GEOHealth) Collaborative Research Training (U2R Clinical Trial Optional) are to:

• Develop research training and career development programs for LMIC scientists and health research professionals in a variety of disciplines directly in support of and informed by the research activities supported by the linked research award (RFA-TW-21-001) in order to identify, prevent and mitigate environmental and occupational health risks in LMICs. Training must be targeted toward individuals from LMICs who will pursue responsible academic and/or public health-oriented research positions in environmental and occupational health in their home countries.
• Provide mentored training-related research experiences that are directly relevant to the health priorities of the LMIC and directly relevant to the research activities supported by the linked research award (RFA-TW-21-001).
• Facilitate the transition of trainees to positions of responsibility, authority, and influence in their home countries, regionally and internationally.
• Strengthen the capacity to conduct independent, sustainable environmental and occupational health research, including implementation and evaluation of practical interventions, at LMIC institutions and directly relevant to the research activities supported by the linked research award (RFA-TW-21-001).
• Build in-depth scientific expertise in fields such as exposure science and epidemiology, and enhance complementary skills such as data management, scientific communication, implementation research, policy engagement and ethical treatment of human subjects, among others.
• Develop and strengthen regional collaborations, including partnerships among governmental and non-governmental organizations, research institutions, and health service groups.

Scientific Area

GEOHealth Hubs are expected to bring together multiple disciplines to advance the pace of scientific discovery in environmental and/or occupational health. The environmental or occupational health-related research training areas should be selected by the applicants, based upon expertise within the proposed consortium to address a priority public health need in the country and/or region and to closely align with the focal research area(s) in the linked U01 application. Applicants are encouraged to develop a deliberate process that builds on demonstrated capacity and may increase in scientific scope over the life of the grant.

• The scientific area of proposed research training may include, but is not limited to: outdoor and indoor air quality, electronic waste, extractive industries, food safety, water quality, toxic waste, climate change health science, agricultural health, occupational health, informal work, and disaster response, among others.
• The scientific approach of the proposed research training may include the following relevant disciplines and methodologies: epidemiology, surveillance, biostatistics, genetics, clinical research, environmental science, industrial hygiene, workplace risk assessment, systems science, toxicology, behavioral science, social science, exposure assessment, biomarkers, hazardous waste assessment, implementation science, community-based research, and other research areas that will inform environmental and occupational health disease prevention and control programs, including cost-benefit analyses.
• Health status or disease areas that may be addressed by the proposed research training include cancers, developmental disorders, neurological disorders, mental disorders, heart disease, respiratory disease, trauma and injury, obesity, immune function, type 2 diabetes, infectious diseases, and aging-related diseases (including Alzheimer’s Disease and Alzheimer’s Disease Related Dementias (AD/ADRD)), among others, in the context of environmental exposures.

Research training that addresses the interactions between exposure factors is strongly encouraged. Research training that addresses vulnerable or under-researched LMIC populations, including women, children, and aging populations, is encouraged.

A needs assessment including relevant local and global burden of disease estimates for the proposed country or region of work, consideration of the policy environment in the LMIC, and assessment of the public health and science needed to support relevant policy development, should be provided in the rationale for the proposed research training program as described in Section VI (Research Training Program Plan. Background).

Attention should be given to recruiting and retaining women, individuals with disabilities, individuals from disadvantaged backgrounds, and individuals from racial or ethnic groups underrepresented in the biomedical, behavioral and clinical sciences in the LMIC context.

Partnerships

Applicants are encouraged to involve multiple U.S. and LMIC partner institutions in the proposed research training program, as scientifically appropriate and justified. As with the scientific focus, applicants are encouraged to develop a deliberate process for adding partners over the life of the grant. Partnerships with appropriate LMIC governmental organizations, non-governmental organizations (NGOs), and academic institutions are encouraged.

Initial inclusion of more than four LMIC or four non-LMIC partner institutions in the overall hub structure for new applications is likely to be very challenging and should only be undertaken if there is strong justification, including how the partnership will be managed and how the support and responsibilities will be distributed. Renewal applications may expand their partnership network as appropriate and justified.

Although new data collection is allowed, applicants are encouraged to use secondary data, tools and resources available through other sources. Letters of support that include descriptions of such resources should be included in the application.

Applicants are encouraged to explore the potential for future partnerships that include additional investment in the GEOHealth Hub, particularly with national governments of Upper-Middle Income and High-Income Countries, international donors, and other organizations in order to leverage local institutional capacities and to increase prospects for sustainability of the Hub.

The GEOHealth Hubs are expected to provide leadership in environmental and occupational health research and in training a new generation of environmental and occupational health experts.

Regions

Research must be conducted in World Bank designated LMICs in one of the following geographic regions:

• East Asia and the Pacific (including Southeast Asia)
• Europe and Central Asia
• Latin America and the Caribbean
• Middle East and North Africa
• South Asia
• Sub-Saharan Africa

To support a global network of GEOHealth Hubs, the FIC and partners aim to fund one Hub in most of the above regions, depending on merit, coordination with the linked application, and availability of funds. Grants will be prioritized to ensure appropriate geographic and scientific representation, and special consideration will be made regarding activities in countries and regions where environmental and occupational health conditions adversely impact public health and economic progress (see Section V.2 Review and Selection Process).

Interests of Participating Components

The Fogarty International Center (FIC) is dedicated to advancing the mission of the NIH by supporting and facilitating global health research conducted by U.S. and international investigators, building partnerships between health research institutions in the U.S. and abroad, and training the next generation of scientists to address global health needs. FIC supports a diversity of research and research training grants that advance basic to implementation science with a focus on Low- and Middle-Income Countries. The GEOHealth program reflects FIC's Strategic Plan (http://www.fic.nih.gov/about/pages/strategic-plan.aspx).

The National Institute on Aging (NIA) mission is to support and conduct genetic, biological, clinical, behavioral, social, and economic research on aging; foster the development of research and clinician scientists in aging; provide research resources to facilitate innovative aging research; and disseminate information about aging and advances in research to the public, health care professionals, and the scientific community, among a variety of audiences. NIA’s interest in this FOA is research and research training to understand the influences of environmental and occupational exposures on life course aging and health, including Alzheimer’s Disease and Alzheimer’s Disease Related Dementias (AD/ADRD), in Low and Middle Income Countries (LMIC). Specific areas of interest include, but are not limited to research and research training that integrate environmental and occupational risk factors into longitudinal cohort studies in high exposure areas; molecular epidemiologic methods that elucidate the sequence of events that ultimately lead to AD and ADRDs resulting from exposure to environment and/or occupational factors; studies that use animal models to understand environmental effects/exposures on aging, AD, ADRD; elucidating life course pathways via environmental and occupational circumstances leading to disparities in mid and later-life cognitive and health outcomes; international comparative research to further our understanding of how different social, familial, environmental, geographic, cultural and institutional contexts influence the aging process, cognition and health; the relationships between labor market change, participation and associated occupational exposures with health and disability at older age, the consequences of occupational and workplace policies (e.g. shift work, high-risk jobs, etc.) on health outcomes at older ages; how early life exposure to acute or chronic stress as well as differences in educational quality or attainment affect cognitive and health outcomes; how differences in social isolation or integration caused by the built environment, family structure, or occupational experiences serve as risk or protective for cognitive and health outcomes; how differences in built environmental are related to health and cognitive outcomes via changes in physical activity or access to higher quality educational or work opportunities; and translation of discoveries into policy and practice designed to reduce disability and/or prevent or slow additional decline among persons with cognitive, sensory, or motor disabilities as they continue to age.

The National Cancer Institute (NCI) coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients. NCI’s interest in this FOA is in research and research training directed toward understanding the carcinogenic consequences of environmental or occupational exposures of regional importance in LMICs. Priorities for NCI include research and research training in the following areas: well-designed epidemiologic studies to assess short- and long-term carcinogenic effects of environmental or occupational exposures (including environmental and occupational components of cohort studies); population-based studies of cancer prevention and control interventions targeting environmental or occupations exposures; application of molecular epidemiologic methods that elucidate the sequence of events that lead to cancer resulting from exposure to chemical, biological, or physical exposures in the environment or occupational settings; the integration of environmental or occupational components in existing local and regional cancer registries or other surveillance efforts that are established or in development in LMICs; environmental and occupational exposure assessment; the application of technologies to investigate biological changes resulting from potentially adverse environmental or occupational exposures; and studies of the translation of environmental and occupational health and cancer scientific discoveries into policy and practice designed to prevent and control cancer.

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

The Office of Research on Women’s Health (ORWH) is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and Centers to ensure that women's health research is part of the scientific framework at the NIH, and throughout the scientific community. ORWH is interested in research that considers the influence of sex and gender on health and disease, and the total health of women across the full spectrum of research. Given the burden of environmental and occupational exposures on women’s health globally, ORWH is specifically interested in innovative and multidisciplinary research to understand sex and gender differences in global environmental health, and the importance of building a diverse research workforce in the field of global environmental and occupational health. ORWH encourages interdisciplinary approaches and partnerships to support research that examines ways to integrate evidence-based practices, interventions, and policies into practice settings to improve the health of women. For more information on ORWH and the Trans-NIH Strategic Plan for the Health of Women covering FY 2019 2023, please visit ORWH website (https://www.nih.gov/women/strategicplan) for additional guidance.

Citations

1) Pr ss-Ust n A, Wolf J, Corval n C, Bos R and Neira M. 2016. Preventing disease through healthy environments: A global assessment of the burden of disease from environmental risks. World Health Organization. ISBN 978 92 4 156519 6. https://www.who.int/quantifying_ehimpacts/publications/preventing-disease/en/ Accessed 18 June 2020.

2) Neira M, Fletcher E, Brune-Drisse.MN, Pfeiffer M, Adair-Rohani H and Dora C. 2017. Environmental health policies for women s, children s and adolescents health Bulletin of the World Health Organization 2017;95:604-606. doi: http://dx.doi.org/10.2471/BLT.16.171736. https://www.who.int/bulletin/volumes/95/8/16-171736/en/ Accessed 18 June 2020.

3) Rosenthal J, Jessup C, Felknor S, Humble M, Bader F, and Bridbord K. 2012. International Environmental and Occupational Health: From Individual Scientists to Networked Science Hubs. Am J Ind Med 55:1069-1077. http://onlinelibrary.wiley.com/doi/10.1002/ajim.22130/pdf. Accessed 18 June 2020.

See Frequently Asked Questions for the GEOHealth Hubs for more information.

Note: This Funding Opportunity Announcement (FOA) allows appointment of Trainees 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.

Applications Not Responsive to this FOA

1. Applications submitted by an eligible U.S. institution without an eligible linked application in response to RFA-TW-21-001.

2. Applications that propose research training exclusively at the U.S. institution.

3. Applications that propose exclusively short-term training experiences of less than one month.

4. Applications that focus on tobacco use and cessation (but projects that address secondhand smoke exposure will be considered).

5. Applications that focus on HIV/AIDS research training (projects that address HIV comorbidities that are exacerbated by environmental exposures will be considered).

6. Applications that address occupational exposure to HIV.

7. Applications that focus on injury and trauma research training without direct relevance to environmental exposures.

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

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

Applications must be submitted by eligible domestic (U.S.) institutions that demonstrate collaborations with eligible Low- and Middle-Income Country (LMIC) institutions named in their application by documented joint publications, grants or previous research training activities.

LMICs are defined by the World Bank classification (http://data.worldbank.org/about/country-classifications/country-and-lending-groups) and include low-income, lower-middle-income, and upper-middle-income countries. See Notice of Change in Country Eligibility for Fogarty International Training Grants (NOT-TW-12-011) and Country Eligibility for additional restrictions.

Applications received without an eligible linked application in response to RFA-TW-21-001 will be considered incomplete and will not be reviewed.

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program. The letter should describe how the proposed research training will coordinate with other research and research training programs at the institution.

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

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

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

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

Applicant Organizations

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

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training program as the Training Program Director/Principal Investigator (Training PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Institutions/organizations must propose multiple PD(s)/PI(s) in response to this FOA. Each PD/PI on the linked U01 research application (RFA-TW-21-001) must be designated as a multiple PD/PI on this research training application, and each PD/PI on this U2R research training application must be designated as multiple PD/PI on the U01 research application. Visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The PDs/PIs should be established investigators in the environmental and occupational health area on which the application is focused and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The Training 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 PDs/PIs should have research and research training experience in the LMIC country that is the focus of the application.

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

An institution (normally identified by having a unique DUNS number and NIH Institutional Profile File (IPF) number) can only submit one application in response to this FOA. The applicant institution may receive a sub-award through the linked research application. The applicant institution may also participate as a partner via a sub-award or associate program in one additional GEOHealth Hub through an application submitted by another institution. The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

This FOA only accepts applications that are part of a collaborative set of multiple applications. A set must contain two applications: one U01 application in response to RFA-TW-21-001 and one U2R application in response to RFA-TW-21-002.

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

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

Only individuals who are citizens of eligible LMICs (defined by the World Bank classification system; also refer to "Notice of Change in Country Eligibility for Fogarty International Training Grants" NOT-TW-12-011 for additional restrictions) are eligible for research training support or other training activities (as verified by the PDs/PIs).

Individuals who have dual citizenship or permanent residency in the U.S., other high income countries or ineligible countries described above are not eligible for support.

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

Attention should be given to recruiting and retaining LMIC trainees from groups underrepresented in environmental and occupational health in the partnering country.

All medium- and long-term trainees (more than 1 month) are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies.

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

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Christine Jessup, PhD.

Telephone: 301-496-1653

Email: christine.jessup@nih.gov

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

Instructions for Application Submission

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

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

Descriptive title of applicant's project: To allow NIH to identify linked applications as a related pair of collaborative applications, the titles for each application must have the following format: a N/2 indicator + Identical title + Country of Applicant Institution (e.g., "1/2", where 1/2 means that this is site 1 of 2 sites in the pair. The other site will be labeled as 2/2 and have the same descriptive title). For example, 1/2-GEOHealth Hub Descriptive title-Zambia and 2/2-GEOHealth Hub Descriptive title-U.S. . Titles may not exceed 200 characters in length, including the tag, e.g.,1/2, at the beginning of the title and the country at the end of the title.

Proposed Project Start Date:

Use the "Earliest Anticipated Start Date" given in this FOA as the Proposed Project Start Date.

Cover Letter Attachment: The Cover Letter is one PDF file only. In addition to the instructions in the SF424 (R&R) Application Guide, the following collaborative information is required in the Cover Letter: a listing of both linked applications (U01 and U2R) in response to RFA-TW-21-001 and RFA-TW-21-002, including for each 1) the PDs/PIs names, 2) the Title (including the tag, e.g. 1/2 or "2/2", and the applicant's country), and 3) the Applicant Institution. Each linked application should submit an identical listing.

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

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

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

Does this project involve activities outside of the United States or partnerships with international collaborators? Check YES and list the foreign countries for all of the performance sites listed in the SF 424(R&R) Project/Performance Site Locations Form.

Project Summary/Abstract. Provide a succinct and accurate description of the entire application. Include the objectives, rationale and design of the research training program, as well as key activities in the training plan. Indicate the planned duration of training, the projected number of trainees including their levels (i.e., predoctoral, postdoctoral, short-term faculty), and expected increase in research capacity in the selected scientific areas at the end of the five-year award period. Include the name of the partner LMIC institution submitting the linked U01 application and any other collaborating institutions and include the environmental and occupational health focus of the proposed research training.

Project Narrative. Describe the public health relevance of the proposed environmental and occupational health research training to the LMIC.

Facilities and Other Resources. Include descriptions of facilities and other resources to be used for research training at all U.S. and foreign performance sites.

Other Attachments. A plan must be provided for an External Advisory Committee to advise the PDs/PIs. External Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Potential members should not be named in the application and should not be contacted until after the review to avoid potential conflict situations in review; instead indicate the areas of expertise and anticipated input, as well as any critical considerations in the selection of members. Renewal applications with similar Advisory Committees should include the names of all committee members during the past project period. Please name your file "External_Advisory_Committee.pdf". This attachment should not exceed 5 pages.

The plan should include composition, roles, and responsibilities of committee members, frequency of committee meetings, and other relevant information. The External Advisory Committee should be composed of experts and relevant professionals from the U.S., LMICs or other countries. LMIC members should constitute a minimum of 50% of the committee. Members should be external to participating Departments and at least one member should be external to participating Universities or Institutions. At least one member should have relevant research expertise to provide input into the proposed research training; at least one member should have relevant experience in research training in LMICs; and at least one member should be able to provide input into the translation of research to policy and practice. Committee members should not be directly involved in the research project(s), the research training program, or in mentoring trainees. Committee members should be included as key personnel as described in SF 424 (R&R) Senior/Key Person Profile Expanded Component.

Describe how the External Advisory Committee will contribute to 1) the development, implementation and evaluation of the overall effectiveness of the linked research and research training programs; 2) ensuring that the research and research training activities are relevant to policy and practice; and 3) the identification of additional partnership opportunities. The External Advisory Committee is expected to meet at least annually to provide ongoing assessment of the progress of the research and research training, discuss future research and training goals, aims and ideas. It is expected that face-to-face meetings of the External Advisory Committee will be convened at least twice during the five-year grant period (once in years 1-2, and once in years 3-4).

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

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

Include all PD(s)/PI(s) on the linked U01 research application (RFA-TW-21-001) as PDs/PIs. Include at least one person at all the other U.S. and foreign participating institutions and identify their role. List all invited members (and, for renewal applications, all previously serving members) of the External Advisory Committee as Senior/Key Personnel, select "Other" and list their role as "EAC member". Include biosketches for all Senior/Key Personnel.

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

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

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

• The budget justification should summarize the total direct and indirect costs for both linked applications. Do not include the detailed budget for the linked U01 application.
• Use the Other Personnel section to submit costs for salary support for administrative staff.
• Use the Travel section to submit costs for selected key personnel and faculty travel, including travel to attend meetings of their GEOHealth Hub at least annually and travel to attend the annual network meeting of all funded GEOHealth Hubs.
• Use the Participant/Trainee Support Costs section to submit costs for Trainees and training-related expenses. Include health insurance under Training Related Expenses (not in Tuition/Fees/Health Insurance). Do not use the Subsistence category. Provide details of trainees and training related expenses in the budget justification and identify by name any continuing trainees.
• Use the Other Direct Costs section to submit costs for other direct costs related to training activities. Describe fully in the budget justification

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

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

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

• International Program Training Data Tables are required.
• 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.

Training Program

Background

The Background section for the research training application should address the following points:

Scientific topic and rationale

• Identify an environmental and occupational health scientific focus directly supporting the research activities in the linked research application (RFA-TW-21-001) and directly relevant to the LMIC’s environmental and occupational health priorities. For scope of scientific area, scientific approach and health status or disease area, see Part 2. Section I. Funding Opportunity Description above.
• A needs assessment , including relevant local and global burden of disease estimates for the proposed country or region of work, consideration of the policy environment in the LMIC, and assessment of the public health and science needed to support relevant policy development, should be provided in the rationale for the proposed research training. The policy relevance of the proposed activities should be clearly described. The assessment of needs and opportunities should address the policy environment in the LMIC, and the public health and science needed to support relevant policy development. This may include documentation of: existing policies; implementation of multilateral agreements; existing funding allocations; health-relevant environmental monitoring systems and indicators; existing intersectoral assessments of the health implications of decisions in other sectors; existing advisory bodies with a mandate and capacity to direct research agendas and provide synthesis information to policy makers; societal awareness of health threats posed by environmental risks and potential solutions; and community engagement around environmental and occupational health research.
• Explain how the linked U01 research application (RFA-TW-21-001) and other relevant research grant support and activities are related to the proposed research training plan.
• Document the existing research capacity in the chosen scientific focus and define measurable increased research capacity parameters expected as a result of the proposed research training activities at the end of the grant period. Describe successes of trainees (or for new applications, other past students or 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.

LMIC participation

• Describe how the LMIC institutional leadership and relevant professional staff from the LMIC institution were involved in the planning, decision-making and development of the application.

Partnerships

• Briefly describe the prior and current environmental and occupational health collaborations among the applicant institution, the LMIC institution, and other partners, including relationships at the appropriate decision-making level for the topic addressed and region of focus. (Details about how these collaborations will support the proposed training, as well as plans to expand these relationships, should be included in the Plan for Partnership in the Program Plan.)

Policy Relevance

• Describe the policy relevance of the proposed training and linked research.
• Describe the depth and nature of collaboration with decision makers (such as government, sub-national, private sector, and regulatory).

Other training activities

• Describe how the proposed program relates to prior and current environmental and occupational health training activities by both the U.S. and LMIC institutions, regardless of funding source, that are relevant to the specified scientific topic.
• Provide justification for more research training at the LMIC institution and describe how the proposed training will leverage and support, but not duplicate, other environmental and occupational health research training activities.

Other research activities

• Include short descriptions of all relevant on-going environmental and occupational health research at the LMIC, regardless of funding source, and describe how the proposed training in the specified scientific topic will support this research.

Sustainability

• Describe how the proposed GEOHealth Hub research training activities may contribute to public health and potentially inform policy and practice.
• Describe career paths, including mentorship, placement and future research support for trainees that will facilitate the retention of the benefits of the training program in-country.
• Describe how the proposed program will balance research, training, and infrastructure development.
• Describe how the intended outcomes will be evaluated and sustained. Applicants should also outline plans for sustaining the GEOHealth Hub beyond the duration of an award through the GEOHealth program.

Program Plan

Program Administration

• Without duplicating information in the biosketches, describe leadership and administrative skills, scientific research and training experience, and active research of the PDs/PIs, and major training site collaborator(s) and how these strengths are related to the management of the training program. Include relevant scientific or professional background and research training experience in the specific LMIC. Relate these strengths to the management of the training program, the development of partnerships, and coordination with the research activities under the linked U01 application.
• Describe a plan for an Administrative Oversight Committee. This committee must include the PIs/PDs of both linked awards. Other members may be included as appropriate and justified. The AOC is responsible for the overall management, communication, coordination, oversight, evaluation and supervision of the linked awards. The AOC will 1) ensure that research training activities are in support of the research activities, 2) ensure that the research activities include full collaboration from investigators on the research training award, 3) coordinate data management through identifying, developing or enhancing tools to facilitate data sharing, integration, management and interpretation within the hub and across the network of GEOHealth Hubs, 4) coordinate communications and outreach with policy and decision makers to ensure more direct and relevant scientific inquiry and to inform policies, incentives and regulations, 5) identify and develop additional partnerships relevant to the core areas of the GEOHealth Hub, and 6) coordinate with and receive input from the External Advisory Committee.
• Describe the planned strategy to be used to oversee and monitor the program. The plan for Program Administration is expected to synergize with the Administrative Oversight Committee section and the External Advisory Committee attachment.
• Indicate the level of effort and activities for which the PDs/PIs will be responsible. Describe how decisions regarding the proposed components of the research training program will be made in consultation with the proposed U.S. and LMIC faculty and the External Advisory Committee.
• Describe the processes that will be used to provide independent scientific review for trainee research projects, and document education in the protection of human subjects, compliance with federal requirements for the protection of human subjects and animals in medical research, and annual approval from relevant institutional (or ethical) review board(s) or committee(s). All mentored research projects under this award must receive independent scientific review through procedures established by the applicant and must obtain required approvals for human subjects and animal research from the applicant institution and, if different, the institution where the research is to be conducted. Projects must be in compliance with the federal requirements for the protection of human subjects and animals in medical research. Include a section in the Program Administration section titled: "Coordination". The Coordination section should be identical in the linked applications. This section should describe the coordination of 1) the proposed research and research training activities, 2) the respective administration of the research and research training activities, 3) the monitoring and evaluation of progress of the overall GEOHealth Hub, 4) the roles of the External Advisory Committee, the Administrative Oversight Committee and other planned committees, 5) strategies that would involve both the research and research training awards in strengthening research capacity of the LMIC institutions and contribute to overall institutional excellence, and 6) planning for new activities building on the Hub's strengths.
• Include a section titled "Plan for Partnership". This section should be identical in the linked applications. It should describe a plan that 1) identifies and organizes a network of partners and stakeholders, 2) describes how prior and current collaboration among partners will support both research and research training, 3) describes how trainee projects will be developed collaboratively with hub partners and in consultation with stakeholders so that trainees may develop relationships that will impact the implementation of their research throughout their careers, 4) describes a deliberative process for adding partners.
• Describe plans for ensuring access to data by all sites, analytic resources, publication and authorship rights, the possibility of public use of research materials and data, or other means of distributing research and training materials to the wider community, and a means of arbitrating disagreements on publication and other issues.
• Describe how the proposed research training program will complement or synergize (but not duplicate) the activities of other ongoing research training and scientific career development programs at the LMIC institution. Descriptions of the current NIH-supported research training grants can be identified using the NIH Research Portfolio Online Reporting Tools Expenditures and Results module (RePORTER) query form (https://projectreporter.nih.gov/reporter.cfm). Applicants should explain how the pool of faculty, potential trainees and resources at the LMIC institution will be robust enough to support additional programs.
• If a clinical trial training is proposed, provide documentation of the PD/PI(s) expertise, experience, and ability to oversee the organization, management and implementation of the clinical trial, including any feasibility or ancillary study.

Program Faculty

• Describe the leadership, administrative skills, scientific research and training experience of the faculty and how these strengths are related to the proposed roles in the training program.
• Provide a description of how the ongoing collaborative research among the PD/PI(s) and faculty, as well as proposed collaborative research in the linked U01 application and other relevant research at the collaborating institutions will provide opportunities for mentored trainee research. Explain how the relevant research grant support and activities of the PD(s)/PI(s) and proposed mentors are related to the proposed research training plan.
• Without duplicating information in the biosketches, describe the experience of PD/PI(s) and faculty in mentoring and training LMIC trainees at the proposed career stage(s).
• Describe the criteria used to appoint and remove faculty as Program Faculty and to evaluate their participation.
• 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 mentor's expertise, experience, and ability to provide guidance in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help to meet the study timelines.

Proposed Training

• The research training proposed should provide environmental and occupational health scientists from LMICs with the necessary skills for careers in research and public health in their home countries. Proposed research training may take place in the U.S. or a foreign country, but training-related research should be carried out mainly in the LMIC.
• Provide detailed descriptions of the didactic and technical training components and the LMIC career development activities that will be supported. Include information about planned courses, mentored research experiences, and any activities designed to develop specific technical skills or other skills essential for the proposed research training. Applicants are encouraged to include a timeline which includes all proposed training activities.
• Describe a training program that includes short- (less than one month), medium- (over one month and up to six months) and/or long- (six months and longer, including degree) term training to address the environmental and occupational health research training capacity needs identified in the LMIC and clearly linked to the proposed research under the U01 FOA (RFA-TW-21-001). Applications that propose exclusively training experiences of less than one month are not responsive.
• For programs that include short-term training, any didactic training must be well structured and appropriately justified for the duration of the training experience. Short-term mentored research trainees must have the opportunity to carry out supervised biomedical, behavioral, or clinical research with the primary objective of developing or enhancing their research skills and knowledge in preparation for a research or public health career.
• Short-term training, if proposed, should provide selected trainees a thorough exposure to the principles and skills of specific research methods or research related competencies to enable immediate incorporation into current trainee research or career development activities. Mentorship should be provided to ensure short-term training meets these goals. Evaluation plans (see section below) should include specific assessments of the effectiveness of the short-term training activities proposed. Short-term training may include:

o Training in specific research skills or methods directly applicable to trainee research projects

o Research leadership, management or career development skills such as expertise in research ethics and compliance issues, grant management and administration, grant and scientific manuscripts writing, information technology and data management, technology transfer and intellectual property, and science policy and decision-making support.

• If short courses at U.S. institutions are included, describe a plan that addresses how short courses will integrate with and/or evolve into courses at partner LMIC institutions.
• Research training may be delivered by interactive distance learning technology, if appropriate and sustainable for the LMIC participants and institutions involved. Applicants are encouraged to maximize training in the use of information technology to facilitate trainee data management, access to online scientific information and collaborative interaction.
• Describe how the proposed program will provide all trainees with additional professional development skills and career guidance including instruction and training in scientific writing and presentation in order to apply successfully for future fellowships and independent research support and lead to productive research and/or public health careers. All postdoctoral trainees should also be provided with instruction in laboratory and project management.
• Describe a plan for LMIC trainees to disseminate research results at scientific conferences and in peer-reviewed publications.
• Describe how the hub will conduct policy-relevant research and research training including involvement of appropriate governmental, subnational, private sector, and regulatory decision makers.
• Program plans may include a "Policy Training Plan" that describes policy development training or policy analysis training in order for trainees to obtain critical skills that enhance the likelihood of trainee research having a policy impact.
• When it is necessary to begin training activities in the U.S. or other non-LMIC site, program plans should describe a timeline and process for transfer of as many of the proposed training activities as feasible during the grant period to the LMIC institution, consistent with the overall goal to build research capacity there.
• Describe how the proposed training activities directly support the research activities in the linked research application (RFA-TW-21-001) and are directly relevant to the LMIC environmental and occupational health priorities. In addition to describing the research training program around the one scientific area (the same area proposed in the linked U01 application), applicants should briefly describe a strategic plan for building upon the proposed activities to develop a Hub that becomes the most credible source for state-of-the-art knowledge on environmental and occupational health in the region.
• Describe how the proposed programs will develop skills in understanding research, in applying their critical abilities to identify problems, conduct research and, in the process of conducting research, in raising questions and proposing solutions to resolve problems. Trainees should be prepared to utilize their research findings as they pursue future research.
• Program plans may include mentorship training for proposed faculty. The proposed training programs may provide administrative staff with training in compliance issues, grant management and administration.
• The training-related research should be designed to incorporate research methods and processes that enhance research reproducibility, take into account potential sex and gender differences, and take into account age differences (including children (under 10 years of age), adults (18-64 years of age), and older adults (over 64 years of age) 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.
• If human subjects are involved, the trainee must receive education in the protection of human subjects, and the research must receive annual approval from an institutional (or ethical) review board or committee at the applicant institution and, if different, at the institution in which the research is conducted. If animals are involved, institutions where research is conducted need to have Animal Welfare Assurance.
• For applications proposing training in clinical trials, the recruitment and selection plans should include specific strategies to identify trainees who have the potential to organize, manage and implement clinical trials. The research training should include training that incorporates research methods and processes that enhance research reproducibility, as recently highlighted by NIH. Plans for training in data management and statistics relevant to clinical trials, good clinical practice (GCP) and good laboratory practice (GLP) should be included. English as a second language training may be supported, if needed.
• Applicants should describe a plan to construct and maintain a Hub website in conjunction with the linked U01 application for dissemination of research data, software, curricula, and other resources of the project, such as practical tools and materials. Applicants should also describe a plan for contributing to public databases and/or developing their own (local) databases to meet their needs. Such databases should have the capability for collecting, integrating, and rapidly disseminating the data that would be collected through the GEOHealth Hub. Plans for dissemination should be closely coordinated with associated activities through the linked U01 application. Training associated with data management is appropriate.
• For renewal applications, highlight how the training program has evolved in response to changes in relevant scientific and technical knowledge, educational practices, and to evaluation of the training program.

o Provide a detailed description of the progress made in the previous funding period to achieve proposed environmental and occupational health research training and sustainable capacity building objectives (e.g., documenting that former trainees have obtained their own grants or have progressed in their careers, including assuming research leadership positions).

o Describe any plans to expand or network with additional departments of the partner LMIC institution (linked U01 applicant institution), with other country institutions and/or with institutions within the region, using the partner LMIC institution as a hub and/or node for expanded and networked environmental and occupational health research training, research opportunities for trainees and research training information.

Training Program Evaluation

• Describe a plan to review and determine the quality and effectiveness of the training program as well as the overall success in building research capacity at the LMIC institution.
• Describe the roles of faculty and professional staff at the applicant and LMIC institutions and all other participating institutions, and the roles of the External Advisory Committee, and Administrative Oversight Committee in the evaluation process.
• Include the metrics to be evaluated (including program activities completed, degree completion (if applicable), publications, fellowships/honors, and subsequent positions) as well as plans to obtain feedback from current and former trainees to help identify weaknesses and to provide suggestions for program improvements. Specified evaluation metrics should be tied to the goals of the program.
• Describe how the data for those measures will be collected and how they will be monitored over the award period.
• Describe strategies for evaluating the development of the LMIC institution's research capacity in serving as a regional hub and a research training center for the specified scientific topic.
• Include a plan for data entry of trainee information into CareerTrac, the web-based Fogarty Trainee Tracking System (see Section VI.3 Other Reporting Requirements below).

Trainee Candidates

• Describe, in general terms, the size and qualifications of the pool of trainee candidates including information about the types of prior clinical and research training and career level required for the program. In general, do not name prospective Trainees, but continuing trainees on renewal applications should be named.
• Describe specific plans to recruit candidates, including the role of the LMIC institution faculty in the trainee recruitment process, and the roles of the Administrative Oversight Committee and External Advisory Committee.
• Describe recruitment efforts to attract women and other populations who are under-represented in sciences in the LMIC to apply for training opportunities.
• If a clinical trial is proposed, discuss the potential of prospective trainees to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study.

Institutional Environment and Commitment to Training

The U.S. and LMIC 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. As part of the Letters of Support, include signed letters, on institutional letterhead, signed by the president, the provost, a dean, or another key institutional leader with institution-wide responsibilities that contains a description of the U.S. and LMIC institution’s commitment to the planned program to ensure its success. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program. The letter may also describe any support that is expected to be provided by the LMIC or LMIC institution to trainees upon completion of their training.

In the same letters include descriptions of the U.S. and LMIC institutional commitment to harassment and discrimination protections that:

1) Ensure proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices.

2) Respond appropriately to allegations of discriminatory practices.

3) Adopt and follow institutional procedure for requesting NIH prior approval of a change in the status of the program director/principal investigator (PD/PI) or other senior/key personnel if administrative or disciplinary action is taken that impacts the ability of the PD/PI or other key personnel to continue his or her role on the NIH award described in the grant application.

See https://grants.nih.gov/grants/policy/harassment/policy-requirement.htm for more information.

Plan for Instruction in the Responsible Conduct of Research

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

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

Multiple PD/PI Leadership Plan

A Multiple PD/PI Leadership Plan is required. In addition to the instructions in the SF424 (R&R) Application Guide, the plan should address the Multiple PD/PI governance and roles of the U.S. and LMIC PDs/PIs on the linked U01 and U2R applications.

Progress Report

In addition to the instructions in the SF424 (R&R) Application Guide, the report should

• Summarize information about current positions, including countries and responsibilities, for trainees during the prior funding period.
• Summarize major contributions to environmental and occupational health research capacity at the LMIC institution(s) in the previous grant period. Include significant publications, research grants in which current or former trainees contributed.
• Provide a detailed description of the progress made in the previous funding period to achieve proposed environmental and occupational health research training and sustainable capacity building objectives (e.g., documenting that former trainees have obtained their own grants or have progressed in their careers, including assuming research leadership positions; documenting direct awards to the LMIC institution for related research and/or research training).
• Summarize contributions to translation of research into practice, practical approaches for interventions, policies, and promotion of health and protection from environmental and occupational exposures.

Letters of Support

The application should include letters of institutional commitment from all partners. Applicants are encouraged to include letters of support from officials at appropriate LMIC government entities, non-governmental organizations (NGOs), and academic institutions that describe how they will support and collaborate with the proposed research and research training.

Appendix

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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 trainee begins independent clinical trial research.

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement. Any additional costs associated with the decision to allow research elective credit for short-term research training are not allowable charges on an institutional training grant.

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

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

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

Important reminders:

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

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed. Each application of a collaborative set must be complete, compliant, and responsive.

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

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

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

In addition, for applications involving clinical trials:
Reviewers will consider the nature of the research experience proposed by the trainee(s) and the scope of proposal relative to the available resources, including the mentor's and/or co-mentor's research support.

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

• Are the research facilities and research environment at the U.S. and LMIC institutions conducive to preparing LMIC trainees for successful research and public health careers in environmental and occupational health?
• Does the assessment of needs and opportunities presented in the Training Program provide appropriate justification for the proposed program of training?
• Does the proposed program contain explicit strategies to strengthen capacity through the linked U01 Research application and does the proposed collaboration lead to sustainable enhancement of the LMIC institution's research capacity and contribute to overall institutional excellence?
• Are the expected contributions of the proposed research training likely to strengthen the ability of the LMIC institution to conduct ongoing research of importance to that country and serve as a regional hub for environmental and occupational health?
• Does the program include the appropriate network of partners to address the public health and science needs identified in an assessment of needs and opportunities?
• Is a significant level of U.S. and LMIC institutional commitment to the program evident and is the level of institutional commitment to the program, including administrative and research training support, sufficient to ensure success of the program?
• Does the applicant have sufficient capacity in human subjects protection, vertebrate animal care, biosafety, biomedical libraries, information technology, international research management and English as a second language, if needed, to support the research training proposed?
• Does the proposed training program incorporate research methods and processes that enhance research reproducibility. take into account potential sex and gender differences, and take into account age differences (including children, adults, and older adults) that may affect the questions asked and the analyses performed?
• Does the application articulate a robust plan for program evaluation, including appropriate metrics, to assess the quality and effectiveness of training, curriculum and outreach material development, data management, policy support, and ongoing integration of research training activities with the research proposed under the linked research program (RFA-TW-21-001)? Are effective mechanisms described for obtaining feedback from current and former trainees?
• Do letters of support from officials in LMIC government entities and/or non-governmental organizations (NGOs) show evidence for collaborative relationships that will enable research findings to inform environmental and occupational health policy formulation and public health practice?
• Are the External Advisory Committee and Administrative Oversight Committee constructed to achieve the functions defined in this FOA? Does the planned committee composition include appropriate expertise, roles, responsibilities and activities to fully integrate the research training program with the research proposed under the linked U01 research program?
• If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers at the U.S. and LMIC institutions, appropriate for the clinical trials training proposed? Does the application adequately address training in the capabilities and abilities needed for trainees to conduct the trial feasibility or ancillary study at the proposed LMIC site(s) or centers?

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

• Do the Training PDs/PIs have the scientific background, expertise, LMIC experience, and administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program?
• Do the Training PDs/PIs plan to commit sufficient effort to ensure the program’s success?
• Are LMIC PDs/PIs and collaborators actively involved in all aspects of the research training?
• Does the leadership team bring complementary and integrated expertise to the program?
• Does the application provide adequate information on how decisions regarding the proposed components of the research training program will be made in consultation with the proposed U.S. and LMIC faculty and the External Advisory Committee?
• Are the PDs/PIs currently engaged in research relevant to the scientific area of the proposed program?
• If applicable, do the PD/PI(s) have the expertise, experience, and ability to oversee training in the organization, management and implementation of clinical trials?
• Because applications are required to use multiple PDs/PIs:
• Is a strong justification provided that the multiple PD/PI leadership approach will benefit the training program and the LMIC trainees?
• Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the training program and the complementary expertise of the PDs/PIs?

Preceptors/Mentors

• Are sufficient numbers of experienced U.S. and LMIC preceptors/mentors with appropriate expertise and funding available to support the number and level of trainees (including short-term trainees, if applicable) proposed in the application?
• Do the U.S. and LMIC preceptors/mentors have strong records as researchers, including recent publications and successful competition for research support in areas directly related to the proposed research training program?
• Do the U.S. and LMIC preceptors/mentors have strong records of training LMIC individuals at the level of trainees (including short-term trainees, if applicable) proposed in the program?
• Are the mentors currently engaged in research relevant to the LMIC environmental and occupational health priorities?
• Are the U.S. and LMIC preceptors/mentors engaged in both the research training program and the linked research program in order to achieve maximal integration?
• If the program will support clinical trial research experience for the trainees, do the U.S. and LMIC mentor(s) who will supervise the trainee(s) have the expertise, experience, resources, and ability to provide appropriate guidance?

Trainees

• Is a recruitment plan proposed with strategies likely to attract well-qualified LMIC trainees for the training program?
• Is there a competitive applicant pool of sufficient size and quality, at each of the proposed levels (predoctoral, postdoctoral and/or short-term), to ensure a successful training program?
• Are there well-defined and justified selection and retention strategies?
• Is a recruitment plan proposed with strategies likely to successfully recruit and retain women, individuals with disabilities, individuals from disadvantaged backgrounds, and/or individuals from racial or ethnic groups underrepresented in the biomedical, behavioral and clinical sciences in the LMIC context?

In addition, for applications involving clinical trials training

• If clinical trials training is proposed, are strategies identified to select trainees who have the potential to organize, manage, and implement clinical trial, feasibility or ancillary studies?
• Are there plans to provide instruction in data management and statistics, including those relevant to clinical trials, to the prospective trainees?
• Are there plans to provide instruction in good clinical practice (GCP) and good laboratory practice (GLP) to the prospective trainees involved in clinical trials?

Training Record

• How successful are the trainees (or, for new applications, other past LMIC students/postdoctorates in similar training) in completing the program?
• Has the training program ensured that trainees are productive (or, for new applications, other past students/postdoctorates in similar training) in terms of research accomplishments, publication of research conducted during the training period, and subsequent training appointments and fellowship or career development awards?
• How successful are the trainees (or, for new applications, other past 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?
• How successful is the training program (or, for new applications, other past training efforts with LMIC institutions) in strengthening the environmental and occupational health research capacity of the LMIC institution?
• How successful is the training program in retaining trainees in positions conducting environmental and occupational health research at the LMIC institution?
• To what extent do trainees subsequent positions in industrial, academic, government, non-profit, or other sectors benefit from their GEOHealth research training and directly benefit environmental and occupational health research and practice?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Coordination and integration of linked applications

• Do the linked applications show evidence of coordination, integration and mutual reinforcement between the research training and research?
• Is the research training well-integrated with, informed by and in support of the research activities in the linked application?
• Are sufficient and feasible mechanisms in place to ensure collaboration across sites to achieve integration of research, research training, overall managerial and administrative responsibilities, planning for data management, analysis and reporting of results?
• Do the PDs/PIs demonstrate a commitment to extensive coordination with the linked application?
• Are there adequate plans for shared decision making among PDs/PIs with regard to personnel, changes in study protocol, and authorship?
• Does the team demonstrate its willingness and capability to engage in collaborative research and capacity building activities across the network of funded GEOHealth Hubs to enhance the GEOHealth program's productivity?

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.

Resubmissions

Not Applicable.

Renewals

For Renewals, the committee will consider the progress made in the last funding period, including on the Training in the Responsible Conduct of Research.

• Does the application describe accomplishments over the past funding period that reflect coordination and integration with the linked research award?
• Is the program achieving its training objectives?
• Has the program evaluated the quality and effectiveness of the training experience (and when applicable, short-term training experience), and is there evidence that the evaluation outcomes and feedback from trainees have been acted upon?
• Are changes proposed that are likely to improve or strengthen the research training experience during the next project period (may not be applicable to short-term training)?
• Does the program continue to evolve and reflect changes in the research area in which the training occurs?
• Does the application describe accomplishments that reflect coordinated activities with other GEOHealth Hubs in the GEOHealth network?

Revisions

Not Applicable.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Recruitment Plan to Enhance Diversity

Not Applicable.

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the training program, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

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

Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Review in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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

Applications will be assigned to the Fogarty International Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the Fogarty International Center Advisory Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Relevance of the proposed project to the GEOHealth FOA, FIC priorities (FIC strategic plan http://www.fic.nih.gov/about/pages/strategic-plan.aspx) and the missions of other participating components.
• Scientific content for program balance.
• Geographic balance.
• Extent of coordination between and integration of linked applications, potential impact of the proposed training program on the linked research, and scientific quality of the linked application.
• Potential to contribute to other NIH- and U.S. government-supported research initiatives in participating LMICs.
• Potential for coordination with other major environmental and occupational health initiatives in participating LMICs.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

1. Defining research objectives and approaches (plan, conduct, analyze, and publish results, interpretations, and conclusions of the research conducted); and defining research training objectives and approaches, the mentored research training projects, and other research training activities within the guidelines of the linked RFAs and in accordance with the terms and conditions of the award.

2. Establishing an Administrative Oversight Committee (AOC) to facilitate coordination between the research training (U2R) and research (U01) awards that comprise a GEOHealth Hub. The AOC is responsible for the overall management, communication, coordination, oversight, evaluation and supervision of the awards. The PDs/PIs on both linked awards will serve on the AOC. Other members may be included as appropriate and justified.

3. Establishing an External Advisory Committee (EAC) of experts not involved in the GEOHealth Hub awards to advise the PDs/PIs as described in the linked RFAs.

4. Implementing the research and research training proposed and reporting on all activities supported. The PDs/PIs must assure compliance with applicable host country regulations; and assure compliance with all applicable DHHS/NIH/FIC policies for conduct of research and research training.

5. Submitting interim progress reports, when requested, to the FIC Program Director. Such reports are in addition to the required annual noncompeting continuation progress report.

6. Holding face-to-face meetings at least annually for their GEOHealth Hub to be attended by all affiliated Hub award PDs/PIs, key personnel, program partners, in order to review progress, plan and design activities, and establish priorities. The FIC Program Official, U.S. Government Project Collaborator(s), and members of the Steering Committee may attend these meetings, when possible.

7. Attending the annual GEOHealth Program Network meeting. The venue for the annual GEOHealth Program Network meeting may vary between U.S. and LMIC sites. The PDs/PIs may be asked to organize one GEOHealth Program Network Meeting over the award project period.

8. Serving on a Steering Committee with other GEOHealth PDs/PIs, program and scientific staff from NIH, and funding partners, to collaborate and coordinate activities and assess priority needs and opportunities. PDs/PIs will participate in Steering Committee meetings and teleconferences and accept the participation and assistance of NIH and funding partner staff in accordance with the guidelines described in Section VI.2 Cooperative Agreement Terms and Conditions of Award: NIH and Funding Partner Staff Responsibilities.

9. Facilitating the formation of and participating in appropriate Working Groups to promote the exchange of information, experiences, protocols, and ideas across GEOHealth Hubs to enhance coordination and collaboration.

10. Ensuring that research, research training, and research capacity building activities conducted under this cooperative agreement employ an approach in which research and research training are driven by priority LMIC needs to provide the evidence base for environmental and occupational health interventions and policies in LMICs. The PDs/PIs will provide an ongoing process for assessing priority needs and a process for assessing ongoing research and research capacity building projects. They will modify, redirect, and/or curtail ongoing research activities to reflect local changes/shifts based on emerging needs or changing epidemiological conditions within the geographic regions.

11. Regularly briefing the U.S. Government Project Collaborator(s) on activities of the hub and hub committees, including the AOC and the EOC.

12. Submitting all abstracts, manuscripts and reviews (co-)authored by members of the grant and supported in part or in total under these Cooperative Agreements. Manuscripts must comply with the NIH Public Access Policy (see http://publicaccess.nih.gov/). Publications or presentations of work performed under this Cooperative Agreement will require appropriate acknowledgement of support in language similar to the following: This investigation was supported by the Fogarty International Center [add other funding partners specified in the Notice of Grant Award] under the Global Environmental and Occupational Health program award [grant number(s)].

13. Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards:

One or more U.S. Government staff, such as NIH Program Directors, will be substantially involved in each of the GEOHealth Hubs as U.S. Government Project Collaborators. The U.S. Government Project Collaborators will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. The role of the U.S. Government Project Collaborators will be to facilitate and not to direct the activities. It is anticipated that the Project Collaborators will provide advisory input.

The U.S. Government Project Collaborator(s) will be the appointed by FIC and will be primary Government contact with the PDs/PIs for scientific and technical issues. During performance of the award, the U.S. Government Project Collaborator(s) may provide appropriate assistance and advice in the design of activities, facilitate liaison activities for partnerships, and provide assistance in the identification of and access to NIH and other scientific resources. Other appropriate U.S. Government staff assistance may be coordinated by the U.S. Government Project Collaborator(s)as needed.

The U.S. Government Project Collaborator with substantial programmatic involvement may:

1. Provide input and support in the design, implementation and analysis of research and research training activities as agreed to by the PDs/PIs, and suggest studies and research training activities within the scope of the funded research and research training activities.

2. Provide programmatic support during the accomplishment of research and research training activities.

3. Advise in management and technical performance.

4. Participate in scheduled meetings and teleconferences to discuss program coordination and/or progress and encourage close coordination of activities under the linked research and research training awards.

5. Participate as a voting member in Steering Committee meetings as described in Section VI.2 Cooperative Agreement Terms and Conditions of Award: Areas of Joint Responsibility".

6. Facilitate collaboration with other NIH- and U.S. Government-supported researchers and research resources.

7. Serve as a resource for all major transitional changes that the awardees might propose (e.g., a change in partnership organization) and advise on their appropriateness prior to implementation to assure consistency with the goals of this FOA.

8. Assist in avoiding unwarranted duplication of effort with other NIH efforts.

9. Make recommendations to the Network Scientific Advisory Group (NSAG; described below) for continued funding based on: (a) overall research and research training progress; (b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and (c) maintenance of high-quality research and research training

A Network Scientific Advisory Group (NSAG) will be appointed by the FIC and its U.S. Government partners to review the progress and provide scientific advice for the intersecting and joint activities of all grants that receive funding under this FOA. The NSAG will be comprised of scientifically appropriate extramural and intramural staff, as well as other Federal and non-Federal experts selected by FIC and its U.S. Government partners to participate in NSAG activities in an advisory capacity when appropriate. The NSAG will meet at the annual Network Meeting of GEOHealth Hubs and may meet more frequently through virtual meetings. The FIC Program Official will serve as Secretariat for the NSAG. U.S. Government Project Collaborators will synthesize and present GEOHealth Hub progress to the NSAG. Members of the NSAG will be invited to attend all Steering Committee meetings described in Section VI.2 Cooperative Agreement Terms and Conditions of Award: Areas of Joint Responsibility".

The FIC Program Official will be responsible for the normal scientific and programmatic stewardship of the award. The FIC Program Official will be the primary U.S. Government contact for the PDs/PIs for issues relating to program administration, funding, and policy.

FIC and its U.S. Government partners may elect, following consultation with grantees, to publish summary results from program activities to fulfill its responsibility to disseminate lessons learned from the program.

FIC reserves the right to terminate or curtail an award in the event of substantial lack of planned program activity completion, shortfall in trainee recruitment, incomplete or delayed reporting, or other major NIH research or research training policy breach.

Areas of Joint Responsibility:

GEOHealth Steering Committee. PDs/PIs of each GEOHealth award, U.S. Government Project Collaborators, and funding partner staff will be active members of the GEOHealth Steering Committee. On voting matters, each funded project will have one vote and each funding partner will have a single vote. Other individuals may participate as non-voting members. U.S. Government voting membership will not exceed non-U.S. Government voting membership. The chairperson will be selected by the Steering Committee with years of service determined by the Committee. The chairperson is responsible for preparing meeting agendas, for scheduling and chairing meetings, and for preparing concise minutes which will be delivered to the Steering Committee members. The Steering Committee will develop Terms of Reference including details about meeting frequency (virtual meetings are appropriate), establishment of subcommittees as deemed appropriate, and development of any harmonized research and research training activities. The Steering Committee may develop a Data Sharing Policy that describes the sharing of methods, data, and information, including but not limited to protocols, questionnaire results, monitoring data, exposure data, and others, among network participants and collaborating organizations. GEOHealth awardees are expected to accept and implement the Policy developed by the Steering Committee.

Dispute Resolution

Any disagreement that may arise on scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: one designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and DHHS regulation at 45 CFR Part 16.

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

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

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

• Recipients are requested to annually update and maintain data regarding their trainees in NIH's CareerTrac (https://careertrac.niehs.nih.gov/)
• Peer-reviewed trainee publications that arise from support of the training grant must be submitted to PubMed Central in accord with the Public Access Policy, and the PubMed Central reference number (PMCID) or NIH Manuscript Submission reference number (NIHMS ID) provided. Guidance is provided in http://publicaccess.nih.gov/. In addition, news releases and other documents about the project must acknowledge federal funding.

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

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

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

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

eRA Commons Help Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Christine Jessup, Ph.D.
Fogarty International Center (FIC)
Telephone: 301-496-1653
Email: Christine.Jessup@nih.gov

Curt DellaValle, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-7225
Email: curt.dellavalle@nih.gov

Damali Martin, Ph.D., M.P.H.
Division of Neuroscience, National Institute on Aging (NIA)
Telephone: 301-402-8310
Email: martinda@mail.nih.gov

John Phillips, Ph.D.
Division of Behavioral and Social Research, National Institute on Aging (NIA)
Telephone: 301-827-4137
Email: john.phillips@nih.gov

Michael C. Humble, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3272
Email: humble@niehs.nih.gov

Regine A. Douthard, MD, MPH
Office of Research on Women's Health (ORWH)
Telephone: 301-451-2729
Email: douthardr@mail.nih.gov

Seetha Bhagavan, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-237-9838
Email: bhagavas@csr.nih.gov

Mollie Shea
Fogarty International Center (FIC)
Telephone: 301-496-9750
Email: Mollie.Shea@.nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@gab.nci.nih.gov

Jeffrey Ball
National Institute on Aging (NIA)
Telephone: 301-402-7732
Email: ballj@nia.nih.gov

Jenny L Greer
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3332
Email: jenny.greer@nih.gov

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