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 the Nation's 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 objective of the Fogarty Emerging Global Leader Award(K43) is to support research scientists from a low-or middle-income country (LMIC) who hold junior faculty positions at an academic or research institutions. In many LMIC institutions there is little 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 the most promising 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 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 is highly relevant to the health priorities of their country. 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 the next generation of scientists to address global health needs. FIC supports a diversity of research and research training grants that advance basic to implementation science with a 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 NCI's Center for Global Health (CGH) will support intensive, mentored research career development for early stage investigators committed to a cancer research career. CGH is particularly interested in applications that include well-designed epidemiology studies on common risk factors (social, biological, occupational, environmental) for cancer, clinical and translational research, detection and diagnosis, health surveillance including cancer registry development, knowledge sharing, implementation science, informatics, mHealth, or malignancies associated with chronic infection. The research activities should be specifically focused on cancer. The career development plan should include training in advanced scientific skills, research methodology, data management and analysis, grant and manuscript writing, and research administration skills that are appropriate for the LMIC. The proposed career development and mentoring should 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 Dental and Craniofacial Research (NIDCR) is interested in applications with a research focus on dental, oral, or craniofacial conditions that occur more frequently in the LMIC or are of a high public health burden; research addressing health disparities in dental, oral, or craniofacial conditions; and research to achieve national or regional goals in oral and dental health such as those articulated by the World Health Organization. Examples include, but are not limited to: working with local communities to establish the best means of delivering preventive oral health care; establishing successful approaches to deliver fluoride to a local population, particularly in areas without potable water; studying oral pre-malignant lesions associated with betel nut use; and studying the interplay of genes and environment in dental, oral, or craniofacial health by leveraging environments specific to the country. The program and these topics are responsive to goals 2, 3, and 4 of the NIDCR Strategic Plan (http://www.nidcr.nih.gov/research/ResearchPriorities/StrategicPlan/).

The National Institute of Environmental Health Sciences (NIEHS)
#160;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 illness and mental disorders in LMICs, specifically conditions and disorders of brain structure and function that affect cognition, social and emotional processing, and behavior and are leading causes of disease burden worldwide, estimated on the basis of disability adjusted life years (DALYs). For example, disorders of interest include, but are not limited to depression, schizophrenia, bipolar disorder, autism spectrum disorders, and posttraumatic stress disorder. NIMH is particularly interested in research that addresses disparities in access to mental health care in LMICs, care for chronic, non-communicable diseases and/or implementation science in LMIC contexts. These themes are consistent with goals C, E, and F of the Grand Challenges in Global Mental Health (i.e., improve treatments and expand access to care; build human resource capacity; and transform health system and policy responses; http://www.nature.com/nature/journal/v475/n7354/pdf/475027a.pdf). NIMH is also interested in applications that target HIV/AIDS related topics of interest such as the epidemiology, natural history and pathogenesis of HIV-associated neurocognitive disorders (HAND) and neuropsychiatric disorders before and after treatment initiation in adult and pediatric populations; examination of the neurobehavioral consequences, with respect to in-utero exposure to a dysregulated immune environment and/or antiretroviral medication and consequences of being born to an HIV-positive mother. NIMH encourages development of common standardized assessment instruments with appropriate norms that can provide reliable and valid measurement of the neurobehavioral consequences of HIV and its treatments throughout the age-span in low and medium resource environments; and development of interventions to improve neurobehavioral functioning compromised by HIV/AIDS and its associated conditions that can be implemented in LMICs.

The National Institute of Neurological Disorders and Stroke (NINDS) is interested in supporting 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 Office of Research on Women's Health (ORWH) mission is to improve the health of women, and has made strides in doing so by ensuring that women and diverse populations are included in all clinical studies, sex and gender influences in health and disease are explored, and that women have the opportunity to advance in biomedical careers. ORWH will assess applications for their ability to directly fulfill the goals 4.0 and 6.0 of the NIH Strategic Plan for Women's Health and Sex Differences Research, which can be found at: http://orwh.od.nih.gov/research/strategicplan/ORWH_StrategicPlan2020_Vol1.pdf.

Additional Information

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.

Citizens, non-citizen nationals and permanent residents of the United States are not eligible for this K43 award but may apply for the International Research Scientist Development Awards (IRSDA (K01) PAR-18-539 or PAR-18-540 or other similar awards (see https://researchtraining.nih.gov/programs/career-development).

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 FOA.

Section III. Eligibility Information

1. Eligible Applicants

Non-domestic (non-U.S.) Entities (Foreign Institutions)

Applications 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 ). NOT-TW-12-011 'Notice of Change in Country Eligibility for Fogarty International Training Grants' applies to this FOA.

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

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.

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

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.? 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.

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

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 underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Multiple PDs/PIs are not allowed.

An applicant must be a citizen of an eligible LMIC and, at the time of award, may not be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

Degree and Research Experience Requirements : The candidate should be the PD/PI of the proposed activities. 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, sub-projects 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.

2. Cost Sharing

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 75% of full-time professional effort (i.e., a minimum of 9 person-months) to the award. 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-09-036 for more details.

Mentor(s)

Before submitting the application, the candidate must identify a primary mentor at the applicant LMIC institution and a primary mentor 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 affiliation of the mentors should be clear from the biosketch, 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.

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 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. 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.

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

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 the following additional instructions:

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

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

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

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

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

• Both the primary LMIC and primary US mentor must insert insert "Other" or "Other Professional" in the Project Role field, and enter "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 research support in the Biographical Sketch, clarify PD/PI status (direct recipient) of awards.

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

Applicants should identify specific expenses such as: (a) non-degree related tuition or registration fees for specific PD/PI career development activities; (b) research expenses such as supplies, equipment and technical personnel; (c) statistical and computational services, including technical personnel and computer time; (d) travel for mentors to collaborating institutions; (e) mentor and grantee communication costs; and (f) PD/PI travel and per diem expenses to field research sites, collaborating institutions, research or networking meetings, or research skills workshops or courses in the appropriate budget form category.

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.

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

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 SF424 (R&R) Application Guide must be followed.

Candidate Section

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

Candidate Information and Goals for Career Development

Candidate’s Background

• Describe the candidate's commitment to a health-related research career in an LMIC.
• Describe prior training and research efforts, and how they relate to the objectives and long-term research career plans of the candidate.
• Provide evidence of the candidate's potential to develop into a successful independent researcher (such as lead authorship of and/or significant contribution to research publications in peer-reviewed journals, presentations at international meetings, prior research interests and experience, research fellowships, and letters of reference).
• Include a description of all the candidate's professional responsibilities at the grantee 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 to become an independent research scientist.

• If applicable, describe the candidate's prior clinical trials research efforts, research interests and experience.

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.
• Explain how the career development award will contribute to career goals, and further the candidate’s global health research career.

• 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; (2) justifies the need for further research career development to become an independent researcher; and (3) 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 75% 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 SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy

• Provide a sound research project that is consistent with the candidate’s level of research development and the objectives of his/her career development plan.
• The research description should demonstrate the quality of the candidate’s research capabilities thus far, and the proposed research question, design and methodology should be novel, scientifically significant and creative in approach.
• Applicants should provide a detailed explanation of the relevance of the proposed research to the health priorities of the LMIC. Applicants should conduct most of the proposed research activities in the LMIC.
• Applicants are encouraged to propose research related to ongoing NIH and U.S. government supported research initiatives in the LMIC.
• Applicants may propose research in any health related discipline and that is highly relevant to the health priorities of the LMIC.

• Applicants proposing a clinical trial, ancillary or feasibility study should describe the planned analyses and statistical approach and how the expected analytical approach is suited to the available resources, proposed study design, scope of the project, and methods used to assign trial participants and deliver interventions.
• 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 or ancillary study, 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 study 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 SF424 (R&R) Application Guide for instructions.

Mentor, Co-Mentor, Consultant, Collaborators Section

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

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

• 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.
• Mentor statements should describe the career development plan for the candidate (coordinated with the candidate's research strategy) and explain how they will participate in this plan. Mentors should clearly describe how they will coordinate mentoring of the candidate with other proposed mentors, both primary and secondary co-mentors.
• Together, the mentors should provide evidence of 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.
• The primary LMIC mentor statement should 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 mechanism(s) and frequency of communication with the candidate, including the frequency of face to face meetings.
• Both primary mentors (U.S. and LMIC) must agree to provide 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 him/her 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.
• The U.S. Institutional Commitment letter, if applicable, should also be included in this section, following page limit requirements for this section. It should provide a statement of commitment to the candidate's development into a productive, independent researcher and provide assurances that appropriate time and support for the proposed mentor(s) and/or other staff consistent with the career development plan will be provided. All letters should be combined and submitted as a single PDF.

Environmental and Institutional Commitment to the Candidate

All instructions in the SF424 (R&R) 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 his/her current position by the appropriate institutional official should be submitted.
• The LMIC institution must provide commitment to at least 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 the 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 U.S. Institutional Commitment letter should be submitted via "Letters of Support from Collaborators, Contributors, and Consultants", following page limit requirements. The LMIC Institutional Commitment letter should be submitted here.

Appendix:

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

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 SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

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

All instructions in the SF424 (R&R) 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 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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 Policy on Late Application Submission.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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.

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 SF424 (R&R) Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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

Section V. Application Review Information

Important Update: See NOT-OD-18-229 for updated review language for due dates on or after January 25, 2019.

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:
Reviewers should evaluate the candidate's potential for developing an independent research program that will make important contributions to the field, taking into consideration the years of research experience and the likely value of the proposed research career development as a vehicle for developing a successful, independent research program.

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.

Candidate

• Does the candidate have the potential to develop as an independent and productive researcher addressing scientifically significant topics that reflect the health priorities of the LMIC?
• Are the candidate's prior training and research experiences appropriate for this award?
• Does the candidate have the research experience and skills needed to carry out the proposed research?
• Is the candidate’s academic, clinical (if relevant), and research record of high quality?
• Do the reference letters from at least three well-established scientists address the candidate’s potential for becoming an independent researcher?

• Does the candidate have the potential to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study?
• Does the candidate have training (or plans to receive training) in data management and statistics including those relevant to clinical trials?

• Is there evidence of the candidate's commitment to meeting the program objectives to become an independent researcher?

• Does the candidate justify the need for three to five years of mentored research experience in order to become an independent scientist?

Career Development Plan

• What is the likelihood that the career development plan will contribute substantially to the scientific development of the candidate and lead to research independence?
• Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence?
• Are there adequate plans for mentors to monitor and evaluate the candidate's research and career development progress?
• Does the career development plan demonstrate a clear commitment to a research career in the LMIC setting?

Research Plan

• Are the proposed research question, design, and methodology novel, scientifically significant, creative, and of technical merit?
• Is the research plan relevant to the candidate's research career objectives?
• Is the research plan appropriate to the stage of research development and as a vehicle for developing the research skills described in the career development plan?
• If applicable, are there adequate plans for data and safety monitoring of clinical trials?
• Does the research plan address an area of health priority and scientific importance to the LMIC?

• Are the scientific rationale and need for a clinical trial, feasibility or ancillary study well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms?
• If proposing a small feasibility study, is the study warranted and will it contribute to planning and preliminary data needed for design of future larger scale clinical trials?
• Is the clinical trial or ancillary study necessary for testing the safety, efficacy or effectiveness of an intervention, or in the case of a feasibility study necessary to establish feasibility of future clinical trial?
• Is the study design justified and relevant to the clinical, biological, and statistical hypothesis(es) being tested?
• Are the plans to standardize, assure quality of, and monitor adherence to, the protocol and data collection or distribution guidelines appropriate?
• Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions, if interventions are delivered?
• For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

• Are the primary U.S. mentor's and the primary LMIC mentor's research qualifications in the area of the proposed research appropriate, and is there evidence of previous research productivity and peer-reviewed support?
• Do the primary mentors and any co-mentors adequately address the candidate's potential and his/her strengths and areas needing improvement?
• Is there adequate description of the quality and extent of the primary U.S. mentor's and the primary LMIC mentor's proposed role in providing guidance and advice to the candidate?
• Are the mentors' descriptions of the elements of the research career development activities adequate?
• Is there evidence of the primary U.S. mentor's and the primary LMIC mentor's, any secondary co-mentors, consultant?s, collaborator?s previous experience in fostering the development of independent researchers in the LMIC proposed?
• Is active/pending support relevant to the candidate's proposed research project appropriate and adequate?
• Are there adequate plans for monitoring and evaluating the career development awardee?s progress toward independence?
• If a Mentoring Team is proposed, are the qualifications of the members, the quality of the planned roles for advice, and scheduled meeting frequency of the Mentoring Team with the candidate adequate?

• Does the mentor or mentoring team have the 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 him/her to meet timelines?
  

Environment & Institutional Commitment to the Candidate

• Is there clear commitment of the LMIC institution to ensure that the required minimum of the candidate's effort will be devoted directly to the research described in the application?
• Are the institutional commitments from the LMIC and U.S. collaborating institutions to the career development of the candidate and for the mentors appropriately strong?
• Are the research facilities, resources and training opportunities at the U.S. and LMIC institutions, including faculty capable of productive collaboration with the candidate, adequate and appropriate?
• Is the environment for scientific and professional development of the candidate of high quality?
• Is there assurance that the LMIC institution intends the candidate to be an integral part of its research program?

• Are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
• Does the application adequately address the capability and ability to conduct the trial feasibility or ancillary study at the proposed site(s) or centers? If applicable, are there plans to add or drop enrollment centers, as needed, appropriate?
• If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

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.

Study Timeline
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Renewals

Not Applicable

Revisions

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.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Resource Sharing Plans

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant's career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019.

Select Agent Research

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

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

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

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 policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

• Will receive a written critique.

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

The following will be considered in making funding decisions:

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

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

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 VI. Award Administration Information

1. Award Notices

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

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

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

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

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


ClinicalTrials.gov: If an award provides for one or more clinical trials, or a new ancillary study to an ongoing clinical trial. By law (Title VIII, Section 801 of Public Law 110-85), the lead investigator 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 of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

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

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

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

2. Administrative and National Policy Requirements

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

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.

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

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

4. Evaluation

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

Section VII. Agency Contacts

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

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

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

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

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

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

Jennifer L Troyer, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-2852
mail: troyerj@mail.nih.gov

Carol Shreffler, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1445
Email: shreffl1@niehs.nih.gov

Ishmael Amarreh, Ph.D.
National Institute of Mental Health (NIMH)
Telephone:(301) 451-5132
Email: ishmael.amarreh@mail.nih.gov

Lynn King, Ph.D.
National Institute on Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5006
Email: Lynn.King@nih.gov

Richard T. Benson, MD, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Phone: 301-496-9135
E-mail: Richard.benson@nih.gov

Katrina Serrano, Ph.D.
Office of Research on Women's Health (ORWH)
Telephone: 301-496-8931
Email: katrina.serrano@nih.gov

For NCI inquiries related to the HIV and AIDS Malignancy research aspects, contact:

Geraldina Dominguez, PhD,
National Cancer Institute ( NCI),
Telephone: 240-781-3291,
Email: domingug@mail.nih.gov

For NCI inquiries related to broader global health research aspects, contact:

Sudha Sivaram, PhD,
National Cancer Institute ( NCI),
Telephone: 240-276-5804,
Email: sivarams@mail.nih.gov

For NCI inquiries related to the career development aspects, contact:

Susan Lim, PhD,
National Cancer Institute ( NCI),
Telephone: 240-276-5630,
Email: lims@mail.nih.gov

Makeda Williams, PhD, MPH
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-496-1051
Email: willimak@mail.nih.gov

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

.

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

Dianne Patterson
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7861
Email: pattersond@mail.nih.gov

Barbara J. Gittleman
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0585
Email: gittlemanbj@mail.nih.gov

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

Diana Rutberg
National Institute on Dental and Craniofacial Research (NIDCR)
Telephone: 301-504-4798
Email: rutbergd@mail.nih.gov

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov

Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
Email: hines@mail.nih.gov

Ryan Lombardi
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8042
Email:lombardr@nhlbi.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.

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 Part 75.