Part 1. Overview Information

Key Dates

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 theHow 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.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. 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.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
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 diverse 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 goal of the NIH International Research Career Development Award (K43) is to support research scientists from a low-or middle-income country (LMIC) who hold a junior faculty position at an academic or research institutions. In many LMIC institutions, there is insufficient support for junior faculty with long-term research training to launch an independent research career due to lack of protected time for research activities, inadequate pilot research project funding opportunities, insufficient training in advanced research methodology and data analysis, lack of mentorship in manuscript and grant writing and meager institutional support for developing, submitting and administering research applications and awards. This intensive, mentored research career development experience under the guidance of experienced LMIC and U.S. mentors is expected to foster an independently funded research career for LMIC junior research scientist faculty. Overall, it is expected that this program will increase the scientific capacity for health research at LMIC institutions and foster long term research collaborations with U.S. scientists.

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 Fogarty International Center (FIC) is interested in applications from individuals at LMIC institutions seeking to become independent investigators and international research leaders in any therapeutic or scientific area of health priority and scientific importance to the LMIC.  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 future scientists to address global health needs. FIC supports a diversity of research and research training grants that advance basic to implementation science with a particular focus on LMICs. The Fogarty Emerging Global Leader Award is responsive to the FIC Strategic Plan (http://www.fic.nih.gov/about/pages/strategic-plan.aspx) to build research capacity through individuals, institutions and networks by building future research leaders in the U.S. and in LMICs.

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 health equity; 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
• Gateway to Global Aging
• Alzheimer’s Disease Research Centers
• Alzheimer’s Disease Sequencing Project
• NIA’s Genetics of Alzheimer's Disease Data
• NIA Research Resources

The National Institute on Drug Abuse (NIDA) is interested in applications that advance science on drug use and addiction. Additional information on the scope of the NIDA mission can be found in the 2022 – 2026 NIDA Strategic Plan. NIDA is particularly interested in applications investigating the intersection of substance use disorders and HIV, including but not limited to mechanisms, prevention and treatment. The proposed career development and mentoring must be focused on developing independent researchers to increase the research capacity at the LMIC institution. The primary mentor at the applicant LMIC institution and the primary U.S. mentor should demonstrate a record of support for trainees and research substance use disorder and/or HIV research.

The mission of The National Institute on Deafness and Other Communication Disorders (NIDCD) is to improve the lives of the millions of people with hearing loss and other communication disorders, spanning functions of hearing, balance, taste, smell, voice, speech, and language. For the purpose of this initiative, NIDCD is especially interested in applications focused on the following topics within the NIDCD mission: otitis media, hearing loss, early hearing detection and intervention including newborn screening programs, chemosensory loss, health services, habilitation and rehabilitation services, dissemination and implementation research, and cultural and linguistic adaptations of diagnostic and intervention tools for communication disorders. Applications from institutions within a geographic region that share the same spoken language (e.g., Spanish in Latin America, Arabic in the Middle East and North Africa, etc.) could offer special opportunities for regional collaboration. Prospective applicants are encouraged to review the current NIDCD Strategic Plan on the NIDCD website.

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).
  • Basic Experimental Studies with Humans (BESH) (https://grants.nih.gov/policy/clinical-trials/besh.htm), defined as studies that prospectively assign human participants to conditions and studies that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind.
• 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, gender, and sexual orientation; 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).

The Office of Research on Women's Health (ORWH) mission is to improve the health of women. ORWH is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and ensures that research conducted and supported by the NIH addresses issues regarding women's health. ORWH works to stimulate and encourage basic and clinical research on the role of sex and gender in health and disease. ORWH promotes training and career development of a diverse biomedical research workforce to advance science for the health of women. ORWH also develops and supports initiatives that include efforts to promote equity and inclusion, through means consistent with applicable law, in the recruitment, retention and advancement of women in biomedical careers; and programs that support both women and men in women’s health and sex differences research careers. ORWH is interested in supporting applications that fulfill goal 1 and goal 4 of the NIH Strategic Plan for Women's Health and Sex Differences Research, which can be found at: https://orwh.od.nih.gov/sites/orwh/files/docs/ORWH_Strategic_Plan_2019_508C_0.pdf

Additional Information

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

Other Award Budget Information

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

1. Eligible Applicants

 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.

Applicant Organizations

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.

Mentors

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.

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. Individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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 center (P50) grants, or Project Leads of program project (P01) or center (P50) grants, other major individual career development awards (e.g., K01, K07, K08, K22, K23, K25, K76, K99/R00), or the equivalent to these grants/awards (including non-NIH equivalent grants/awards from other research funding organizations) are not eligible. Current and former PDs/PIs (including Multiple PDs/PIs) of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21/R33), Planning Grant (R34/U34), Dissertation Award (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible, as do PD/PIs of Transition Scholar (K38) awards and individuals appointed to institutional K programs (K12, KL2).

Prospective applicants are strongly encouraged to contact the FIC Scientific/Research contact prior to preparing an application to discuss their eligibility.

Faculty Position Requirement:  Applicants must currently hold as their primary appointment an academic junior faculty position or research scientist appointment supported by the applicant LMIC academic or research institution and have been in this position for at least one year at the time the application is submitted. For this NOFO, junior faculty are defined as those who hold entry to mid-level academic or research scientist positions, including but not limited to instructors, lecturers and assistant professors. 

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.

NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not have substantial scientific and/or budgetary overlap with the career award application. K award recipients are encouraged to obtain funding from NIH or other U.S. government sources either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-08-065.

At the time of award, the candidate must have a “full-time” appointment at the academic institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program. 

After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances.  See NOT-OD-18-156  and NIH Grants Policy Statement, Section 12.3.6.4 Temporary Adjustments to the Percent Effort Requirement for more details.

Mentor(s)

Before submitting the application, the candidate must identify a primary LMIC mentor based at the applicant LMIC institution and a primary U.S. mentor based at a collaborating U.S. institution who, together, will supervise the proposed career development and research experience. The LMIC primary mentor must hold a primary appointment at the LMIC applicant institution and should not be a U.S. citizen who holds a joint appointment at the LMIC institution. The institutional affiliations of the mentors should be clear from the biosketches, mentor support letters, and institutional letters. Candidates are encouraged to identify additional co-mentors to form a mentoring team if this is deemed advantageous for providing expert advice in all aspects of the research career development program. Additional mentors can be from other LMIC or high income countries. Mentors should include active researchers in the area of the proposed research and should be committed to the career development of the candidate. The candidate must work with all mentors (primary and co-mentors) in preparing the application. The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate’s career stage. 

The mentor(s) or mentoring team must demonstrate appropriate expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed research and clinical trial.

The LMIC applicant institution where the proposed K43 award's research will be conducted, and the collaborating U.S. institution (if activities at the U.S. institution are proposed) must have strong, well-established records of research and career development activities and faculty qualified in biomedical, behavioral, or clinical research to serve as mentors. The research career development program should maximize the use of U.S. and LMIC research institutional environments, including available facilities and resources.

Section IV. Application and Submission Information

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Career Development (K) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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

By the date listed in Part 1. Overview Information of this NOFO, 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 emailed to: 
Christine Jessup, Ph.D. 
Telephone: 301-496-1653 
Email: FogartyK43@nih.gov

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following modification also applies:

Institutional Commitment to Candidate's Research Career Development is limited to two pages.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

The following also applies:

Under PD/PI Contact Information, Position Title is required.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

The following also applies:

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

Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

. 

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

All instructions in the How to Apply - Application Guide must be followed.

The following also applies:

• For the required the primary LMIC and primary US mentors, enter "Other Professional" in the Project Role field, and enter "LMIC Primary Mentor" and “US Primary Mentor” in the Other Project Role Category field.
• When listing other individuals with a substantive role in the project, clearly label roles to distinguish "Co-Mentor", "Consultant", "Collaborator", etc.
• When listing applicant's research support in the Biographical Sketch, clarify PD/PI status (direct recipient) of awards.

IMPORTANT REMINDER: The personal profile associated with the eRA Commons username entered in the Credential field for the PD/PI (candidate) must include an 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.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

The following also applies: 

In the Budget Justification, provide detailed information about the total current salary amount that serves as the basis for calculating the salary support requested. Confirmation of LMIC institutional salary may be required prior to the issuance of an award.  

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Career Development Award Supplemental Form

The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:

Candidate
Research Plan
Other Candidate Information
Mentor, Co-Mentor, Consultant, Collaborators
Environment & Institutional Commitment to the Candidate
Other Research Plan Sections
Appendix

All instructions in the How to Apply - Application Guide must be followed.

Candidate Section

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

Candidate Information and Goals for Career Development

Candidate’s Background

• Describe the candidate’s prior training and how it relates to the objectives and long-term career plans of the candidate. 
• Describe the candidate’s prior research experience, including lead authorship of and/or significant contribution to research publications in peer-reviewed journals, and presentations at international meetings. 
• Describe all the candidate's professional responsibilities at the recipient LMIC institution and elsewhere and show the relation of these responsibilities to the proposed activities on the research career development award. 
• Justify the candidate's need for an additional mentored research experience in order to become an independent research scientist.

• If applicable, describe the candidate's ability to organize, manage, and implement the proposed clinical trial, feasibility or ancillary clinical trial.
• If applicable, describe the candidate's prior efforts, interests and experience in clinical trials research.

Career Goals and Objectives​

• Describe the candidate’s career goals and the specific objectives to reach each goal under this award, indicating linkages to prior experience and current research support.
• Describe the candidate’s potential to develop into a successful, independent LMIC-based investigator.

• The candidate must demonstrate they have received training or will participate in courses such as: data management, epidemiology, study design (including statistics), hypothesis development, drug development, etc., as well as the legal and ethical issues associated with research on human subjects and clinical trials.

Candidate’s Plan for Career Development/Training Activities During Award Period

• The candidate and the mentors are jointly responsible for the preparation of the career development plan.
• Describe a systematic and detailed plan that: (1) shows a logical progression from prior research and training experiences to the research and research career development activities proposed; and (2) utilizes the relevant research and educational resources of the LMIC institution and U.S. institution (if activities at the U.S. institution are proposed).
• The plan should include a description of the primary mentors, any secondary co-mentors, and any collaborators, contributors or consultants, as appropriate for the research and career development of the candidate. 
• The application must describe the relationship between the mentors' research and the candidate’s proposed research plan. The respective areas of expertise and responsibility should be described for both mentors. Although the candidate's research strategy may be related to the research activities of the mentors, it should not duplicate the mentors' research. 
• Provide a detailed description of proposed career development activities, including plans to obtain the necessary research skills and experience to launch an independent global health research career. 
• The description of the career development plan should include items such as advanced level courses, seminars, and opportunities for interaction with other scientists. Training in career skills, such as grant-writing and making effective scientific presentations, is strongly encouraged. The career development plan must be tailored to the needs of the individual candidate and the ultimate goal of achieving independence as a researcher. 
• Describe how the candidate plans to fulfill the requirement that he/she spend at least nine person months of effort conducting research or participating in research career development activities during each year proposed. A timeline that includes activities and time spent in the LMIC and in the U.S., if proposed, is recommended. 
• Applicants are encouraged to describe plans for outreach and dissemination of research findings both in the LMIC and in the U.S.

Research Plan Section

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy

• A sound research project that is consistent with the candidate’s level of research development and objectives of their career development plan must be provided. The research description should demonstrate the quality of the candidate’s research thus far, as well as the ability of the candidate to carry out the research. 
• The proposed research question, design and methodology should be novel, scientifically significant and creative in approach, 
• The application must also describe the relationship between the mentors’ research and the candidate’s proposed research plan. 
• The description of the proposed research project should indicate the extent to which the research will be conducted in the LMIC. 
• Candidates should provide a detailed explanation of the relevance of the proposed research to the health priorities of the LMIC and, where applicable, the relationship of the proposed research to any ongoing NIH or U.S. government research initiatives in the LMIC.

• Provide a strong and rigorous rationale for design of clinical trials proposed under this program. 
• Provide the appropriate independent data and safety monitoring to ensure that the trials done in the LMIC comply with local clinical trials rules and regulations and meet the standards for trials done in the US. 
• If proposing an ancillary study to an ongoing clinical trial, provide a brief description of its relationship to the larger clinical trial. 
• If proposing a feasibility study, to begin to address a clinical question, provide justification why this is warranted and how it will contribute to the overall goals of the research project including planning and preliminary data for future, larger scale clinical trials. 
• Describe the proposed timelines for the proposed clinical trial, feasibility study or ancillary clinical trial, including any potential challenges and solutions (e.g., enrollment shortfalls or inability to attribute causal inference to the results of an intervention when performing a small feasibility study). 
• Describe how the proposed clinical trial or ancillary clinical trial will test the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy. (This would not apply to a feasibility study.)

Training in the Responsible Conduct of Research

• All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). See How to Apply - Application Guide for instructions.
• Applicants are strongly encouraged to include courses and activities offered at the LMIC site.

Mentor, Co-Mentor, Consultant, Collaborators Section

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Plans and Statements of Mentor and Co-mentor(s)

• The candidate must name two primary mentors (one LMIC primary mentor at the applicant institution and one U.S. primary mentor) who, together with the candidate, are responsible for the planning, directing, monitoring, and executing the proposed program. The candidate may also nominate co-mentors as appropriate to the goals of the program. 
• Signed letters from the primary LMIC mentor, the primary U.S. mentor, as well as any co-mentors, are expected to provide an assessment of the candidate’s qualifications and potential for an independent research career. Mentor letters should describe relevant research expertise in the proposed applicant research area and document a record of success in training LMIC researchers, in particular, those who have gone on to become independent researchers in the LMIC that is the focus of the application. 
• Together, the mentors should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award. Each mentor statement should describe the research support, if any, that will be available to support the proposed candidate research project. 
• Include a statement that the candidate will commit at least 9 person months (75% of full-time professional effort) to the career development program and related career development activities. 
• Mentor statements should describe the nature of the supervision and mentoring that will occur during the proposed award period; provide a plan for career progression for the candidate to move from the mentored stage of their career to independent research investigator status during the project period of the award; and detail a plan for monitoring the candidate’s research, publications, and progression towards independence. 
• Similar information must be provided by any co-mentor. If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate, including the mechanism(s) and frequency of communication with the candidate and other mentors and the frequency of face-to-face meetings. 
• Both the LMIC primary mentor and the U.S. primary mentor must agree to provide separate annual evaluations of the candidate’s progress as required in the annual progress report.

• The mentor or mentoring team must provide evidence of expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed clinical trial, ancillary or feasibility study and help the applicant to meet timelines.

Letters of Support from Collaborators, Contributors and Consultants

• Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Unless also listed as senior/key personnel, collaborators and consultants do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. Collaborators/consultants are generally not directly involved in the development of the career of the candidate as an independent researcher.
• Advisory committee members (if applicable): Signed statements must be provided by each member of the proposed advisory committee.  These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute.  Unless also listed as senior/key personnel, these individuals do not need to provide their biographical sketches. 

Environmental and Institutional Commitment to the Candidate

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

Description of Institutional Environment

• Describe the scientific environment at the LMIC institution, resources and facilities that will be available to the candidate, research and career development programs related to the candidate's area of interest and key faculty members and researchers capable of productive collaboration with the candidate. If the candidate plans activities at the collaborating U.S. institution, a description of the relevant U.S. institutional environment must also be provided.

• Describe the resources and facilities that will be available to the candidate, including any clinical trial-related resources, such as specialized administrative, data coordinating, enrollment, and laboratory/testing support. If applicable, include a description of the resources and facilities available at international sites.

Institutional Commitment to the Candidate’s Research Career Development

• Appropriate officials at the LMIC institution (and the U.S. institution if activities are proposed there) must provide statements of commitment to the candidate's development into a productive, independent global health researcher.
• A letter of support confirming the applicant's ongoing position, start date, the amount of release time for proposed research and the commitment to retain the candidate in their current position by the appropriate institutional official should be submitted.  
• The LMIC institution must provide commitment to at least nine person months (75% full-time professional effort) for the award recipient.
• The LMIC institution (and the U.S. institution if activities are proposed there) must provide assurances that appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan will be provided.
• The institution must provide assurance that the candidate will have appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations) to carry out the proposed research plan.
• The LMIC and U.S. Institutional Commitment letters (if activities are proposed at the U.S. institution) should be included in this section as a single PDF and must not exceed two pages.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix:

Limited items are allowed in the Appendix.  Follow all instructions for the Appendix as described in the How to Apply - Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

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).

All instructions in the How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

Reference Letters

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.
 

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

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. 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) using ASSIST or other electronic submission systems. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - 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 the Fogarty International Center (FIC), NIH. Applications that are incomplete, non-compliant and/or non-responsive will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov. 

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate’s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

The reviewers will consider that the clinical trial may include study design, methods, and intervention that are not by themselves innovative, but address important questions or unmet needs. Reviewers should also consider the scope of the clinical trial relative to the available resources, including the possibility that research support provided through career development awards may be sufficient to support only small feasibility studies.

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.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policies and practices, 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.

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

• 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

• Geographic balance considerations.
• Relevance to the interests of co-funding partners.
• Potential to contribute other NIH- and U.S. government-supported research initiatives in LMICs.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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

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

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

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

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

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690).To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH 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 NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances. See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. For mentored awards, the Mentor’s Report must include an annual evaluation statement of the candidate’s progress. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR 200.301.

5. Evaluation

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

Section VII. Agency Contacts

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

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

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

Pre-application questions should be directed to the FIC Scientific/Research Contact

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

Sudha Sivaram, DrPH, MPH
National Cancer Institute (NCI)
Telephone: 240-276-5804
Email: sudha.sivaram@nih.gov

Fatou Jallow, PhD
National Cancer Institute (NCI)
Telephone: 240-620-0808
Email:  Fatou.jallow@nih.gov

Benjamin Philip Johns
ORWH - Office of Research on Women's Health
Phone: 301-402-1770
E-mail: benjamin.johns@nih.gov

Maria Carranza, Ph.D.
NIA Training Officer
National Institute on Aging (NIA)
Email: NIATraining@mail.nih.gov

Alberto L Rivera-Rentas
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: 301-496-1804
E-mail: riverara@mail.nih.gov

Stacey Chambers
NINDS - NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
Phone: 301-496-0690
E-mail: sc395c@nih.gov

Makeda Williams, PhD, MPH
National Heart, Lung, and Blood Institute (NHLBI)
Center for Translation Research and Implementation Science (CTRIS)
Telephone: 301-451-7594  
Email: makeda.williams@nih.gov

Carol Shreffler, PhD
NIEHS - National Institute of Environmental Health Sciences
Phone: 984-287-3322 or 919-316-9591
E-mail: shreffl1@niehs.nih.gov

Lindsey Friend, Ph.D.

National Institue on Drug Abuse (NIDA)

Phone: 301-402-1428

Email: NIDA_Training@NIDA.NIH.gov

Temesgen D Fufa
NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Phone: (301) 480-2280
E-mail: temesgen.fufa@nih.gov

Susannah Allison, PhD
National Institute of Mental Health (NIMH)
Telephone: 240-627-3861
Email: allisonsu@mail.nih.gov

Center for Scientific Review (CSR)

Email: ReviewContact@csr.nih.gov

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

Dawn M. Mitchum
National Cancer Institute (NCI)
Telephone: 240-276-5699
Email: dawn.mitchum@nih.gov

Jessi Perez
National Institute on Aging (NIA)
Telephone: 301-402-7739
Email Address: jessi.perez@nih.gov

Samantha J Tempchin
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: (301) 435-1404
E-mail: tempchins@mail.nih.gov

Laurel Kennedy, MA
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: (301) 827-4777
Email: laurel.kennedy@nih.gov

Jenny Greer
NIEHS - National Institute of Environmental Health Sciences
Phone: 984-287-3332 or 919-892-4180
E-mail: jenny.greer@nih.gov

Pamela G Fleming

National Institute on Drug Abuse (NIDA) 

Phone: 301-480-1159

Email: pfleming@mail.nih.gov

Deanna L Ingersoll
NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Phone: 301-435-7858
E-mail: deanna.ingersoll@nih.gov

Tamara A. Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tkees@mail.nih.gov

Section VIII. Other Information

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

Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of career development awards are encouraged to consider applying for an extramural LRP award.

Awards are made under the authorization of Sections 301, 307, and 405 of the Public Health Service Act as amended (42 USC 241, 284, and 287(b)) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.