Emerging Global Leader Award (K43 Independent Clinical Trial Required)

Emerging Global Leader Award (K43 Independent Clinical Trial Required) is sponsored by National Institute of Environmental Health Sciences (NIEHS). Supports early-career scientists from low- and middle-income countries to conduct independent environmental health research.

PAR-24-295: Emerging Global Leader Award (K43 Independent Clinical Trial Required) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations Fogarty International Center ( FIC ) National Heart, Lung, and Blood Institute ( NHLBI ) National Human Genome Research Institute ( NHGRI ) National Institute on Deafness and Other Communication Disorders ( NIDCD ) National Institute on Drug Abuse ( NIDA ) National Institute of Environmental Health Sciences ( NIEHS ) National Institute of Mental Health ( NIMH ) National Institute of Neurological Disorders and National Cancer Institute ( NCI ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

The following NIH Offices may co-fund applications assigned to those Institutes/Centers. Office of Research on Women's Health ( ORWH ) Funding Opportunity Title Emerging Global Leader Award (K43 Independent Clinical Trial Required) K43 International Research Career Development Award Notices of Special Interest associated with this funding opportunity April 06, 2026 - Implementation of Changes for Basic Experimental Studies with Humans.

See Notice NOT-OD-26-067 . January 28, 2026 - NIH Removing AIDS Application Due Dates from NOFOs. See Notice NOT-OD-26-029 March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Notice of Funding Opportunity International Research Career Development Award See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) 93. 989, 93.

398, 93. 113, 93. 242, 93.

173, 93. 279, 93. 837, 93.

233, 93. 838, 93. 839, 93.

840, 93. 313, 93. 866, 93.

853, 93. 172 Funding Opportunity Purpose The goal of the Fogarty Emerging Global Leader Award is to provide research support and protected time (three to five years) to a low- or middle-income country (LMIC) early career research scientist who holds a junior faculty position at an LMIC academic or research institution, as defined by the World Bank ( http://data. worldbank.

org/about/country-classifications/country-and-lending-groups , including “low-income,” “lower-middle-income,” and “upper-middle-income” countries, with exceptions below (see Section III. Eligibility Information)). This intensive, mentored research career development experience is expected to lead to an independently funded research career at the LMIC institution or in another LMIC.

This Notice of Funding Opportunity (NOFO) invites applications from LMIC scientists from any health-related discipline who propose career development activities and a research project that is relevant to the health priorities of their country under the mentorship of LMIC and U.S. mentors.

This Notice of Funding Opportunity (NOFO) is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial, as part of their research and career development.

Applicants not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion NOFO PAR-24-296. Open Date (Earliest Submission Date) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization.

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

Required Application Instructions It is critical that applicants follow the instructions in the Career Development (K) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the How to Apply - Application Guide , follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information Part 2. Full Text of Announcement Section I. Funding Opportunity Description Section II.

Award Information Other Award Budget 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 Part 2. Full Text of Announcement Section I. Funding Opportunity Description The overall purpose of the NIH Research Career Development program is to help ensure that a pool of highly trained scientists is available in appropriate scientific disciplines to address biomedical, behavioral, and clinical research needs.

NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals.

More information about Career programs may be found at the NIH Research Training and Career Development website. The award will provide salary and research project support. Awardees are expected to increase their capabilities in advanced research methodology, analysis and data management, research administrative skills, responsible conduct of research, scientific presentation, and manuscript and grant writing.

Applications should propose targeted activities and research projects that will propel awardees to become competitive principal investigators for new research project grant (e.g., R01) funding.

This NOFO invites applications in support of eligible LMIC research scientists at LMIC academic or research institutions who propose both critically needed career development activities and a research project that are highly relevant to the health priorities of their countries. The research activities should take place primarily in the LMIC.

Interests of Participating NIH Institutes, Centers and Offices The National Cancer Institute (NCI) is interested in applications in support of individuals committed to an independent career in global cancer research, who propose mentored research projects in topics relevant to the LMIC where the research will be conducted.

NCI is interested in applications that include, but are not limited to, studies in cancer biology and genetics, cancer epidemiology, research in cancer primary and secondary prevention, clinical and translational research, implementation science and health systems research, health surveillance and cancer informatics research, studies in integrative oncology, cancer survivorship as well as investigations that employ technology (including mhealth and ehealth) to address cancer control.

Applications that propose capacity development in research methods across disciplines that might be relevant to LMIC setting including, but not limited to, clinical and translational research, behavioral and social sciences research, patient reported outcomes research, are encouraged.

The proposed career development and mentoring must be focused on developing independent researchers in the field of cancer in a manner that increases the research capacity at the LMIC institution. Mentors should have a track record of research in cancer.

The National Heart, Lung, and Blood Institute (NHLBI) is interested in applications that promote the prevention and treatment of heart, lung, blood, or sleep (HLBS) disorders in low- and middle-income countries (LMICs). Examples of HLBS diseases and disorders include, but are not limited to, hypertension, obesity, rheumatic heart disease, chronic obstructive lung diseases, asthma, and sickle cell disease.

Training across the spectrum of research disciplines is encouraged, from basic biomedical, behavioral and social science to clinical and applied sciences, including translational and implementation science that emphasize the resources, context and needs of multiple partners in local settings.

Training on research skills, research design and methodology, ethics, data management and analysis, grant writing, manuscript writing, scientific presentations and research administration should be included in the career development plan. Mentors should have strong track records in HLBS research and training early-stage investigators for independent research careers.

The mentored research career development experience should lead to an independently-funded research career on HLBS diseases and disorders across the lifespan and build scientific capacity for HLBS research at LMIC institutions.

The National Human Genome Research Institute (NHGRI) is interested in applications in support of individuals pursuing careers as researchers in the area of the structure and biology of genomes; the genomics of disease; the implementation and effectiveness of genomic medicine; computational genomics and data science; the impact of genomic technology, advances, and implementation on health disparities; and ethical, legal, and social issues related to genomic advances.

NHGRI supports studies that provide generalizable methods and knowledge. Approaches that are comprehensive across the genome or are generalizable across variants, tissues, diseases, or function may be in scope for NHGRI to the extent they address priority areas described in the NHGRI 2020 Strategic Vision and on the web pages for the research mission of NHGRI’s Extramural Divisions and Offices: Division of Genome Sciences: https://www.

genome. gov/about-nhgri/Division-of-Genome-Sciences Division of Genomic Medicine: https://www. genome.

gov/about-nhgri/Division-of-Genomic-Medicine Ethical, Legal, and Social Implications Research Program: https://www. genome. gov/Funded-Programs-Projects/ELSI-Research-Program-ethical-legal-social-implications Office of Genomic Data Science: https://www.

genome. gov/about-nhgri/Office-of-the-Director/Office-of-Genomic-Data-Science Applications whose primary scientific objective is to understand a single biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention, will not be in scope for NHGRI except to the extent that a particular disease or condition may serve as a model for unique research opportunities.

Research on diseases and conditions that are more difficult to study in the U.S. because of prevalence or other factors may be considered if they offer significant insights or broader implications.

Examples of such conditions might include, but are not limited to, sickle cell disease and thalassemias, apoA-associated kidney disease, and severe adverse drug reactions with higher frequency outside the U.S., such as Stevens Johnson Syndrome (SJS). The National Institute on Aging (NIA) leads a broad scientific research effort to understand the nature of aging and to extend the healthy, active years of life.

NIA is also the primary federal agency supporting and conducting Alzheimer's disease and related dementias research.

NIA is pursuing this initiative to support early-stage investigators who have begun to establish research programs and who, through this award, will be prepared to assume leadership roles in their field of expertise and will be poised to influence theory, practice, and health outcomes related to the health of older individuals.

Research topics in aging include (but are not limited to) the basic, clinical and epidemiological studies that investigate neural and behavioral processes associated with normally aging brain and dementias; molecular, genetic, cellular, and physiological mechanisms underlying aging and age-related changes in humans and other organisms across numerous phyla; testing relationships between human microbiomes and accessible biomarkers in blood and plasma in relation to age-dependent changes in immune function and research for the development of new interventions for age-related conditions, prevention and treatment of multiple chronic conditions, and studies that help to promote evidenced-based geriatric care.

Additional areas of interests include behavioral and social research on life course health, aging, and AD/ADRD that address priority research areas of NIA covering areas related to the development of sampling frames and/or survey instruments that contribute to the development of infrastructure to support a cross-national laboratory for comparisons of policy, economic, social, cultural, and environmental factors on health, health behaviors, healthcare utilization, and AD/ADRD; causal inference, statistical methods, and analytic methods to support cross-national analyses and the development of experiments to help illustrate topics related to the influence of policy, economic, social, cultural, and environmental factors on health and aging-related outcomes, including AD/ADRD; genetic and other -omics data, including genome-wide association study or whole sequencing, epigenetics, transcriptomics, metabolomics, and proteomics in AD/ADRD; studies that examine the prevalence of co-morbidities (e.g., cardiovascular risk factors, diabetes, dyslipidemia, peripheral arterial disease, obesity, diabetes, hypertension, and other vascular contributions to cognitive impairment [VCID]), cognitive impairment, and AD/ADRD phenotypes; role of early life co-morbidities such as childhood infections and diseases prevalent in LMICs and AD/ADRD; environmental exposures including environmental toxicants, air pollution, and diet and AD/ADRD; identification of underlying mechanisms of resilience (e.g., protective genotypes of cognitive reserve); development of accessible low-cost tools for diagnosis of AD/ADRD and linguistic markers of AD/ADRD in different populations and different languages.

Applicants should review the Strategic Directions for Research, 2020 2025 . Applications whose research focuses on Alzheimer’s disease should also review the AD/ADRD Research milestones for more information on research priorities.

Related resources include: Harnessing Data Science of Health Discovery and Innovation in Africa (DSI-Africa) Global Environmental and Occupational Health program (GEOHealth) HRS International Family of Studies and the Harmonized Cognitive Assessment Protocol Before You Apply for a Global Aging Behavioral and Social Research Project Frequently Asked Questions for Global Aging Applications in the Behavioral and Social Sciences Alzheimer’s Disease Research Centers Alzheimer’s Disease Sequencing Project NIA’s Genetics of Alzheimer's Disease Data The National Institute of Environmental Health Sciences (NIEHS) is interested in applications that address or seek to understand how exposures to toxic environmental insults alter biologic processes, are linked to disease initiation, progression or morbidity, and research that leads to the development of prevention and intervention strategies to reduce environmentally induced diseases in LMICs.

Examples of environmental exposures relevant to the mission of the NIEHS include industrial chemicals or manufacturing byproducts, metals, pesticides, herbicides, microplastics and inhaled toxicants including indoor air pollutants from cooking and other sources ( https://www. nih. gov/sites/default/files/about-nih/strategic-plan-fy2021-2025-508.

pdf ).

Topics and disease outcomes of particular interest include airway diseases, CVD and neurological disorders, women’s environmental health, and the unique vulnerability of developing children to harmful environmental exposures including outcomes such as low birth weight or premature birth, and research exploring exposures during early life stages or critical windows of susceptibility that may directly or indirectly affect the risk of developing disease.

Career development applications that focus on the effects of alcohol, chemotherapeutic agents, smoking, except when considered as a secondary smoke exposure as a component in the indoor environment (particularly in children), drugs of abuse, pharmaceuticals, dietary nutrients, and infectious or parasitic agents are not of interest to NIEHS.

The National Institute of Neurological Disorders and Stroke (NINDS) is interested in supporting basic, mechanistic, epidemiological, prevention, translational and clinical research across the spectrum of neurological, neuromuscular and neurovascular diseases and disorders in all ages.

In addition to prevalent neurological disorders and stroke, NINDS is also interested in supporting research in areas of rare and neglected neurological diseases that are relevant to the Low- or Middle-Income Countries (NINDS Disorder Index https://www. ninds. nih.

gov/health-information/disorders ). NINDS encourages the development of networks in topical disease-related areas (e.g., stroke, epilepsy or other high burden neurological disorders in LMICs) or projects that are linked to existing programs or resources in LMICs, to share capacity building activities and conduct collaborative research.

For the current NOFO, the NINDS has interest in applications that lay the groundwork for future clinical trials, such as those that propose conducting surveys of available patient populations, developing clinical trial protocols and training materials, and establishing trial infrastructure for recruiting and treating subjects and collecting, receiving, storing and distributing study drugs, and processing data and laboratory specimens.

The NINDS has published guidelines for investigators regarding human research protection and clinical research data and safety monitoring ( https://www. ninds. nih.

gov/current-research/research-funded-ninds/clinical-research/ninds-guidelines-monitoring-clinical-trials ). The application's PHS Human Subjects and Clinical Trials Information, including the Data and Safety Monitoring Plan, should reflect the guidelines in the application.

Plans for the protection of research participants and data and safety monitoring will be reviewed by the NINDS for consistency with NINDS and NIH policies and federal regulations.

For applications proposing a clinical trial, please review the following definitions for this funding announcement: Clinical trials are research studies in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

NINDS will only support the following types of clinical trials under the Emerging Global Leader (K43 Independent Clinical Trial Required): Mechanistic trials (https://grants. nih. gov/policy/clinical-trials/glossary-ct.

htm#MechanisticStudy), defined as studies designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention (i.e., how an intervention works, but not if it works, or is safe). NIH Definition of Clinical Trial Case Studies: https://grants. nih.

gov/policy/clinical-trials/case-studies. htm#collapseS2_top Clinical trials that seek to answer specific questions regarding safety, tolerability, clinical efficacy, effectiveness, clinical management, and/or implementation of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions, preventive, therapeutic, and services interventions, will not be supported by NINDS under this K43.

Applicants interested in answering these types of questions are encouraged to refer to the NINDS listing of currently active clinical trial NOFOs (https://www. ninds. nih.

gov/Current-Research/Research-Funded-NINDS/Clinical-Research). NINDS, as part of NIH, strives for rigor and transparency in all research it funds. For this reason, NINDS explicitly emphasizes the NIH application instructions related to rigor and transparency ( https://grants.

nih. gov/policy/reproducibility/guidance. htm ) and provides additional guidance to the scientific community ( https://www.

ninds. nih. gov/funding/preparing-your-application/preparing research-plan/rigorous-study-design-and-transparent-reporting ).

For example, the biological rationale for the proposed experiments should be based on rigorous and robust supporting data, which means that data should be collected via methods that minimize the risk of bias and be reported in a transparent manner. If previously published or preliminary studies do not meet these standards, applicants should address how the current study design addresses the deficiencies in rigor and transparency.

Proposed experiments should likewise be designed in a manner that minimizes the risk of bias and ensures validity of experimental results. The National Institute of Mental Health (NIMH) encourages research on mental health disorders in LMICs to address disparities in access to mental health care.

Specific areas of research interest include: Research aimed at improving mental health literacy, reducing stigma, and promoting help-seeking behavior. This includes communication strategies, either as standalone interventions or as part of broader approaches to address barriers to mental health care and improve service utilization in LMICs.

Suicide prevention research with an emphasis on developing culturally sensitive, innovative interventions to identify and mitigate the risk of suicidal ideation, suicidal behavior (SIB), and non-suicidal self-injury (NSSI) in LMICs.

Research addressing the mental health of mobile populations such as refugees, internally displaced persons (IDPs), and migrants, with particular emphasis on multi-level interventions and approaches to improve access to services. Research promoting the integration of mental health care with services in health settings and beyond the health sector (non-health settings) particularly for chronic non-communicable and communicable diseases.

This includes innovative strategies to develop, refine, and assess methods that enhance access and quality of mental health care in LMICs. Research aimed at improving short- and long-term mental health outcomes of individuals with serious mental illnesses in LMICs.

NIMH is also interested in applications that focus on research and research training that will reduce the incidence of HIV worldwide and decrease the burden of living with HIV.

Specifically, NIMH is interested in applications that focus on our behavioral and/or social science research priorities (e.g., improving HIV prevention and care-related outcomes; understanding and addressing HIV-related health disparities, including but not limited to those linked to age or sex; using novel methodological, technological, and data science approaches; dissemination and implementation science research), and/or HIV neuroscience research (e.g., HIV/Central Nervous System (CNS) neuropathogenesis; genetics and therapeutics; HIV/CNS latency and cure strategies; examination of the neurobehavioral consequences of perinatal exposure to antiretroviral medication and/or HIV).

Applicants are encouraged to read current Notices of Special Interest (NOSIs) from NIMH Division of AIDs Research (DAR) for further information about the Division’s research priorities (NIMH DAR; https://www. nimh. nih.

gov/about/organization/dar/aids-related-funding-opportunity-announcements-foas ). For applications proposing HIV/AIDS research projects, applicants are encouraged to review the review NIH Office of AIDS Research (OAR) HIV/AIDS research priorities and NOT-20-018 . Applicants are encouraged to review answers to frequently asked questions about the Fogarty Emerging Global Leader Award program at http://www.

fic. nih. gov/Programs/Pages/emerging-global-leader.

aspx, which will be updated on a regular basis. Individuals who are citizens, non-citizen nationals or permanent residents of the United States, and individuals who are based at US institutions, are not eligible for this K43 award but may apply for the International Research Scientist Development Awards (IRSDA (K01) PAR-21-104 or PAR-21-015 or other similar awards (see https://researchtraining. nih.

gov/programs/career-development). Note: This Funding Notice of Opportunity (NOFO) is designed specifically for candidates proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial, as part of their research and career development.

Those not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion NOFO PAR-24-296 . Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the How to Apply - Application Guide provides details on these application types. Required: Only accepting applications that propose an independent clinical trial(s). Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Award budgets are composed of salary and other program-related expenses, as described below. The total project period should be a minimum of 3 years and may not exceed 5 years.

Other Award Budget Information NIH will contribute up to $100,000 per year toward the salary of the career award recipient for a minimum 75% effort or 9 person months.

The requested salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department. Confirmation of LMIC institutional salary may be required prior to the issuance of an award.

Any difference between the candidate's requested salary and the allowable amount for this category may not be allocated to increase the research development support requested in the application. Further guidance on budgeting for career development salaries is provided in the How to Apply - Application Guide .

In addition, the candidate may derive additional compensation for effort associated with other Federal sources or awards provided the total salary derived from all Federal sources does not exceed the maximum legislated salary rate (see http://grants. nih. gov/grants/policy/salcap_summary.

html ) and the total percent effort does not exceed 100%. See also NOT-OD-17-094. Fringe benefits, based on the sponsoring institution’s rate and the percent of effort, may be requested in addition to salary.

Other Program-Related Expenses NIH will contribute research development support of up to $40,000 per year for the award recipient.

These research development support funds may be used for the following expenses: (a) non-degree-related tuition and fees related to the candidate's career development; (b) research-related expenses, such as supplies, equipment and technical personnel; (c) candidate travel to research sites, collaborating institutions, research or networking meetings, and/or research skills workshops or courses; (d) statistical and computational services, including personnel and computer time; (e) travel for mentors to collaborating institutions; and (f) mentor and grantee communication costs.

The requested research development support may not exceed the allowable amount and the requested research development support funds may not be supplemented by any difference between the candidate's requested salary and the maximum allowable salary specified in this NOFO. Salary for mentors, secretarial and administrative assistants, etc. is not allowed.

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information Non-domestic (non-U.S.) Entities (Foreign Institutions) Applications for the K43 award must be submitted by academic education or research institutions in LMICs (as defined by the World Bank ( http://data. worldbank. org/about/country-classifications/country-and-lending-groups ; low-income, lower-middle-income, and upper-middle-income countries are included).

FIC's Country Eligibility Notice ( NOT-TW-12-011 Notice of Change in Country Eligibility for Fogarty International Training Grants ) applies to this NOFO and states that for competing and re-competing research training grant applications (including the K43 mechanism), with the exception of Sub-Saharan African countries, FIC will no longer accept applications from, or applications that involve training of scientists from upper-middle-income countries that are also members of the G20 major economies ( http://www.

g20. org/en/members ). For additional information see FIC's Country Eligibility page at https://www.

fic. nih. gov/Grants/Pages/country-eligibility.

aspx . Only non-domestic (non-U.S.) Entities (Foreign Institutions) in Low- or Middle-Income Countries are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement , are allowed. NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations.

See NIH Grants Policy Statement 16. 8 Collaborative International Research Awards. Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding.

This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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.

Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement 2. 3. 9.

2 Electronically Submitted Applications for additional information. System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration.

SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.

gov registration process. The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.

gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants.

gov – Applicants must have an active SAM registration in order to complete the Grants. gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account.

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

All PD(s)/PI(s) must be registered with ORCID . The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help .

The primary mentor at the applicant LMIC institution and the primary U.S. mentor must have eRA Commons accounts. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator) Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her primary mentors (one U.S.-based and one LMIC-based) and organization to develop an application for support. The candidate should be the PD/PI of the proposed activities.

Multiple PDs/PIs are not allowed. An applicant must be a citizen or permanent resident of an eligible LMIC (see NOT-TW-12-011 ) and must hold a primary appointment at the applicant LMIC institution. Legal verification of LMIC citizenship or Permanent Residency status may be requested prior to award.

It is the responsibility of the recipient institution to assure that the candidate remains eligible for the project period of the award. Individuals who are citizens, non-citizen nationals or permanent residents of the United States are not eligible. Individuals who are based at U.S. institutions are not eligible.

Degree and Research Experience Requirements : Candidates must hold at least a master's degree that required a research thesis. Candidates with doctoral research training are preferred. This award cannot support advanced degree training.

Current and former PDs/PIs (including Multiple PDs/PIs) on NIH research project (R01), program project (P01), research training (D43), or