International Research Career Development Award (K43 Clinical Trial Optional)

International Research Career Development Award (K43 Clinical Trial Optional) is sponsored by National Institutes of Health (NIH) Fogarty International Center (FIC). This FOA invites applications from scientists in Low- and Middle-Income Countries (LMICs) for an intensive, mentored research career development experience. The program aims to lead to an independently funded research career at an LMIC institution.

Expired PAR-21-251: Emerging Global Leader Award (K43 Independent Clinical Trial Required) This notice has expired. Check the NIH Guide for active opportunities and notices. 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 Cancer Institute ( NCI ) National Human Genome Research Institute ( NHGRI ) National Institute of Environmental Health Sciences ( NIEHS ) National Institute of Mental Health ( NIMH ) National Institute of Neurological Disorders and National Heart, Lung, and Blood Institute ( NHLBI ) National Institute on Deafness and Other Communication Disorders ( NIDCD ) 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 October 15, 2024 - This PAR has been reissued as PAR-24-295 .

April 7, 2023 - Notice of NIDCD Participation in PAR-21-251 "Emerging Global Leader Award (K43 Independent Clinical Trial Required)" and PAR-21-252 Emerging Global Leader Award (K43 Independent Clinical Trial Not Allowed) .

See Notice NOT-DC-23-007 NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 July 25, 2022 - Notice of NHLBI Participation in PAR-21-251 "Emerging Global Leader Award (K43 Independent Clinical Trial Required)".

See Notice NOT-HL-22-038 . October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice NOT-OD-22-018 .

September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements.

See Notice NOT-OD-21-170 April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109 Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity PAR-21-252 - Emerging Global Leader Award (K43 Independent Clinical Trial Not Allowed) See Section III. 3.

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

398, 93. 172, 93. 121, 93.

113, 93. 242, 93. 853, 93.

313, 93. 837, 93. 838, 93.

839, 93. 840, 93. 233, 93.

173 Funding Opportunity Purpose The purpose of the Fogarty Emerging Global Leader Award is to provide research support and protected time (three to five years) to an early career research scientist from a low- or middle-income country (LMIC) 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). 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 Funding Opportunity Announcement (FOA) 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 Funding Opportunity Announcement (FOA) 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 FOA PAR-21-252 . Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days before the application due date November 3, 2021, November 3, 2022, and November 3, 2023 by 5:00 PM local time of the applicant organization.

All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date . AIDS Application Due Date(s) December 9, 2021, December 9, 2022, and December 11, 2023 by 5:00 PM local time of the applicant organization.

All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

March 2022, March 2023, March 2024 May 2022, May 2023, May 2024 July 2022, July 2023, July 2024 Required Application Instructions It is critical that applicants follow the instructions in the Career Development (K) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Section VIII.

Other Information Part 2. Full Text of Announcement Section I. Funding Opportunity Description The overall goal 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 Extramural Training Mechanisms 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 funding by the end of the grant period.

This FOA invites applications from 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 from 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 Human Genome Research Institute (NHGRI) is interested in applications from individuals pursuing careers as researchers in the area of the ethical, legal, and social implications (ELSI) of genetics and genomics research or the use of genetics in clinical settings. Examples of topics appropriate for exploration can be found on the ELSI Research Priorities website at: http://www. genome.

gov/27543732 . NHGRI may also support applications from individuals who are developing methods and research resources that support, or are conducting basic and translational research in: genomic sciences, informatics, implementation of genomics in clinical care (genomic medicine), and cost-effectiveness of genomic interventions.

The specific research topic proposed should apply across a broad spectrum of diseases and health conditions and should not be specific to just one disease, except to the extent that a particular disease may serve as a model with projects that capitalize on unique opportunities to use, as models, diseases and conditions that are more difficult to study in the U.S. because of prevalence or other factors will be considered.

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 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 activities that lead 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, e-waste, metals, pesticides, herbicides, and inhaled toxicants including indoor air pollutants from cooking and other sources ( https://www. niehs. nih.

gov/about/strategicplan/ ).

Topics and disease outcomes of particular interest include airway diseases, CVD and neurological disorders, children's environmental health and the unique vulnerability of developing children to harmful environmental exposures including outcomes such as low birth weight or premature birth, 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 Mental Health ( NIMH ) is interested in applications that focus on mental disorders in LMICs, specifically conditions and disorders that affect cognition, perceptions, mood, social and emotional processing, daily functioning, behavior and relationships. Mental Disorders are a leading cause of disease burden worldwide, estimated based on disability adjusted life years (DALYs).

Mental disorders of interest include, but are not limited to depressive disorders, schizophrenia, bipolar disorder, autism spectrum disorders, anxiety disorders, trauma and stressor-related disorders such as posttraumatic stress disorder.

NIMH is particularly interested in research that addresses disparities in access to mental health care in LMICs, better understanding the root causes, risk and protective factors, early detection and early intervention, integration of mental health care into care for chronic, non-communicable or communicable diseases.

NIMH is also interested in applications that investigate the optimal combination of mental health interventions (e.g., screening and care), including those that leverage implementation science in LMIC contexts, and address the care of individuals living with HIV, or placed at risk for HIV.

These themes are consistent with many of the Grand Challenges in Global Mental Health (i.e., identify root causes, risk and protective factors; advance prevention and early intervention; improve treatments and expand access to quality care; build human resource research capacity; and transform health system and policy responses; Grand Challenges in Global Mental Health ).

NIMH is also interested in applications that target HIV-related research topics such as the epidemiology, natural history and pathogenesis of HIV-associated CNS dysfunction before and after treatment initiation in adult and pediatric populations; HIV persistence and cure in the CNS; examination of the neurobehavioral consequences of in-utero exposure to antiretroviral medication and/or HIV; basic and applied behavioral and social science to prevent new HIV infections and limit morbidity and mortality among those living with HIV, use of data science to support HIV prevention and care, and implementation science to determine best strategies for implementing and scaling up evidence-based interventions to prevent or treat HIV.

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 http://www. ninds. nih.

gov/disorders/disorder_index. htm ).

The National Institute on Aging (NIA) mission is to support and conduct biological, clinical, behavioral, social, and economic research on aging; foster the development of research and clinician scientists in aging; provide research resources to facilitate innovative aging research; and disseminate information about aging and advances in research to the public, health care professionals, and the scientific community, among a variety of audiences.

NIA is pursuing this initiative to recruit 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; the behavioral and social research on life course health, aging, and AD/ADRD using NIA-supported international studies in low and middle income countries ; 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.

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. For applications proposing HIV/AIDS research projects, applicants are encouraged to review the NIH HIV/AIDS Research Priorities , and the NIH Plan for HIV-Related Research for the year they are applying.

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 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 Opportunity Announcement (FOA) 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 FOA (PAR-21-252) . See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Grant: A support 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 SF424 (R&R) Application Guide provide 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 $75,000 (for a minimum of 75% effort or 9 person months) per year toward the salary of the career award recipient.

Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide. See also NOT-OD-17-094 . Confirmation of LMIC institutional salary may be required prior to the issuance of an award.

Fringe benefits, based on the sponsoring institution’s rate and the percent of effort, may be requested in addition to salary. The total NIH contribution to salary may not exceed the legislatively mandated salary cap. See: http://grants.

nih. gov/grants/policy/salcap_summary. htm .

Other Program-Related Expenses NIH will contribute up to $30,000 per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.

These funds may be used for the following expenses: (a) tuition and fees related to career development; (b) research-related expenses, such as supplies, equipment and technical personnel; (c) travel to research sites, research meetings or training; and (d) statistical services including personnel and computer time. 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 FOA. 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 FOA 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. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted.

Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission. Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number.

After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application. System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually.

The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants. gov registration.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.

gov registration. International applicants may obtain more information on the registrations required for grants. gov and eRA Commons at: http://grants.

nih. gov/grants/ElectronicReceipt/files/Tips_for_International_Applicants. pdf http://grants.

nih. gov/grants/ElectronicReceipt/files/international_support. pdf http://grants.

nih. gov/grants/ElectronicReceipt/files/international_qa. pdf http://grants.

nih. gov/grants/ElectronicReceipt/preparing_grantsgov_reg. htm Guidance for International Applicants Blocked from Registration Websites: NOT-OD-11-090 .

An NIH supported webinar on Electronic Submission of Grant Applications for Foreign Institutions can be found at http://grants. nih. gov/grants/webinar_docs/webinar_20120927.

htm 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. 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.

Individuals from underrepresented groups in the LMIC context, including racial and ethnic minorities, persons with disabilities, and women are encouraged to apply. Multiple PDs/PIs are not allowed. An applicant must be a citizen or permanent resident of an eligible LMIC.

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, and who are based at US institutions, are not eligible for this K43.

Degree and Research Experience Requirements : Candidates must hold at least a masters 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), Dissertation Award (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible. A candidate for this award may not concurrently apply for or have an award pending for any other NIH career development award.

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 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 FOA, 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. This FOA does not require cost sharing as defined in the NIH Grants Policy Statement. 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. The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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 NOT-OD-11-101 ) 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 nine person months of effort (i.e., 75% of full-time professional effort to their program of career development. Candidates may engage in other duties as part of the 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-09-036 for more details. Before submitting the application, the candidate must identify a primary mentor based at the applicant LMIC institution and a primary 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.

These primary mentors should be active researchers in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate's research. 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. The candidate must work with all mentors (primary and co-mentors) in preparing the application. 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.

Institutional Environment 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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the instructions in the Career Development (K) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications .

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 PAR-21-251 and PAR-21-252 , 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: All page limitations described in the SF424 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. Instructions for Application Submission Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages.

For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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