Required Application Instructions

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

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This Funding Opportunity Announcement (FOA) invites exploratory applications for the development of innovative, collaborative biomedical or behavioral/social science research in the areas of non-communicable diseases (NCDs) and injury throughout life, relevant to low- and middle-income countries (LMICs). Basic to clinical and translational research including implementation science approaches and interdisciplinary research on the intersection of a number of NCDs, or of HIV- or other communicable diseases and non-communicable diseases, are encouraged in addition to specific NCD or injury focused areas. Collaborations must be proposed between investigators in the United States (U.S) and any LMIC or between upper middle income country (UMIC) investigators and their partners in any other LMIC.

Background

Globally, NCDs kill more than 36 million people each year with 80 percent of these deaths occurring in LMICs, where they contribute significantly to the overall burden of disease (http://www.who.int/about/structure/organigram/nmh/en/). Data published in the Global Burden of Disease 2010 ( http://www.who.int/healthinfo/global_burden_disease/gbd/en/ ), show that NCDs are also rapidly becoming the dominant causes of poor health globally, including all LMIC regions, except sub-Saharan Africa where they are second only to the disease burden of HIV/AIDS.

Globally, a large proportion of reported NCD deaths and chronic illnesses are reported to be caused by cardiovascular disease, cancer, chronic respiratory diseases, and metabolic and digestive disorders such as diabetes although other conditions also contribute to the burden of disease and disability, are often under-researched, and may be of particular importance in certain populations. The chronic sequelae of injury and trauma add substantially to the burden of disability. Together the care and treatment of NCDs, and of injury and trauma consequences, strain existing health care systems and lead to lost economic productivity. Although neurological and neuropsychiatric disorders also contribute substantially to the global NCD disease burden these topics are eligible for the companion Global Brain R21.

At the same time, during the past several decades, improvements in health care have led to a decrease in mortality (including and especially among children) and an increase in life expectancy in LMICs. These positive trends have set the stage for a complex and paradoxical epidemiology of health and disease as more children survive into adulthood affected by the sequelae of combined early illness, environmental toxins, malnutrition and other adverse experiences. These exposures can advance the onset and severity of chronic diseases in later life. Similarly, socio-economic factors, such as poverty, conflict, stigma and gender inequalities, contribute to the initial causes of many chronic disorders.

Maternal, perinatal and nutritional conditions still contribute disproportionately to Disability Adjusted Life Years (DALYs, a measure of overall disease burden, expressed as the number of years lost due to ill-health and disability or early death) in LMICs as compared to high income countries. All of these conditions may also lead to or exacerbate chronic NCDs as common risk factors (http://www.who.int/healthinfo/global_burden_disease/gbd/en/ ).

Environmental exposures to toxins in air, water and food from before birth and throughout life in the home, public places and in the workplace are important, and often modifiable, factors contributing in different ways alone and in combination to the onset and course of different NCDs. Conversely the contribution of positive environmental exposures/changes in environment and nutrition for NCD disease prevention and NCD treatment as well as promoting good health remains an important research area especially for resource limited settings.

Infectious and parasitic diseases, such as HIV/AIDS, tuberculosis, malaria and other neglected tropical diseases, are a particular burden for LMICs, especially in sub-Saharan Africa. They continue to be important causes of DALYs by themselves and due to their long term effects, particularly on children. However, very limited data are available on the epidemiology, natural history and pathogenesis of NCDs in the context of infectious diseases such as HIV-AIDS, or on prevention and treatment of associated opportunistic infections and NCD co-morbidities (and vice versa) in LMIC settings. For example, there is a scarcity of research on the drug-drug interactions in patients receiving various treatments for an NCD (for example chemotherapy) and ART for HIV/AIDS or treatments for other infectious diseases. Contribution of socioeconomic factors in the diagnosis, treatment and management of NCDs and HIV/AIDS and other infectious diseases as comorbid conditions in LMICs remains an imperative research area.

The contribution of NCDs and injuries to the global disease burden has been increasingly recognized. In 2013, the World Health Organization (WHO) endorsed a global action plan for the prevention and control of NCDs (2013-2020) that included the promotion and support of national capacity for high-quality research and health system development. In order to address the WHO goals, critical information is needed about the burden, causes, prevention, treatment and long term care of NCDs and injuries within regional and local contexts. Advancing research on prevention and control of the dual burden of communicable and non-communicable diseases and disabilities is a key goal of the FIC 2014-2019 Strategic Plan.

Specific Objectives

These developmental/exploratory research grants are expected to prepare the foundation for more comprehensive research programs that enrich the knowledge base and contribute to the long-term goals of sustainably strengthening research capacity in LMICs. The specific objectives of this FOA are to:

1) Identify NCD and injury research questions and needs in the participating LMIC;

2) Support locally-relevant and catalytic pilot research addressing prevention or reduction of morbidity and mortality attributable to NCDs or injury, or improving quality of life of persons living with NCDs;

3) Support development of diagnostics, prevention, treatment and implementation strategies;

4) Provide research opportunities for LMIC investigators including former FIC program trainees and Fellows from LMICs; and

5) Lay the foundation for more comprehensive research proposals to NIH or other funders.

6) Support activities that develop a base for research networking and for evidence-based policy beyond the specific research projects.

Research Topics and Approaches

Relevant research topics for this FOA are related to NCDs and trauma/injury from birth to advanced age and across generations, and must be relevant to the collaborating LMICs. Relevant topics include but are not limited to risk factors and epidemiology; etiology, prevention, and treatment; palliative care; the influence of sociocultural and environmental factors; co-morbidities, especially of people living with HIV/AIDS or other chronic infectious diseases; technology development or implementation for monitoring and rehabilitative interventions; and other conditions. Applicants are especially encouraged to propose research in cross-cutting areas at different life stages and across the lifespan.

Influences on chronic disease across the lifespan include, but are not limited to, factors affecting the immune system and development, function and disease of specific organ systems. Examples include the chronic sequelae of injury due to violence and accidents, genetic predispositions , epigenetic changes in response to pre-, peri- and post-natal trauma and environmental factors (such as maternal nutrition, in-utero chemical exposure, perinatal hypoxia, and nutritional deficiencies), and infection by viral and parasitic diseases (such as HIV/AIDS, malaria). Other factors affecting healthy physical and immunological development include access to appropriate health care and socioeconomic factors.

Examples of some cross-cutting areas for research are:

• Ethnographic studies and other areas of social science, particularly to address health systems, availability of resources, preventive or screening practices, and appropriate interventions within a given society or group;
• Sex and gender -related physiological, socio-cultural and economic factors in the etiology, prevention and treatment of the disorders to be addressed;
• The influence of socio-cultural or other environmental variables on the natural history of common diseases/disorders and how this knowledge can be used for treatment and intervention;
• Factors associated with aging affecting physical health and survival in older persons along with interventions and treatments;
• Co-occurring risk factors or conditions, especially common in the LMIC or region (e.g. toxic or traumatic insult plus infectious disease and/or malnutrition);
• NCD comorbidities of people living with HIV/AIDS;
• Mechanisms (e.g. molecular, epigenetic) underlying the interaction of genetic, environmental, social and economic factors that affect organ system and immune or physiological function.
• Descriptive epidemiology to describe and define the problem in the countries in question by assessing the needs and determining the magnitude of factors involved in the problem to be addressed (e.g., research on trends in incidence, prevalence or mortality; distribution of disease; determination of population at risk; determination of case definition/disease classification).
• Analytical epidemiology to identify potential etiological factors in the populations of interest, including factors responsible for predispositions to consequences of various infection and/or exposures (e.g., identification of risk factors for / consequences of disease onset or progression; classification and measurement of exposure; magnitude and distribution of known risk factors).
• Operational research to leverage existing cohorts and care systems, for example for infectious diseases, to include NCDs.

Relevant types of research for these applications are not limited and may range from basic science to epidemiological, demographic, clinical, health services, implementation and translational (e.g. translation of basic research to therapy and of clinical research to applications in the field). This FOA encourages development of multidisciplinary and interdisciplinary research. The research must be relevant to the needs and priorities of the LMIC and must improve the capacity in the LMIC to conduct such research.

For applications on any research topic related to the brain, nervous system, mental health and substance abuse, please see the companion FOA: PAR-14-331 "Global Brain and Nervous System Disorders Research Across the Lifespan (R21)". These topics should not be the main focus of applications to this NCD and injury FOA.

Research Capacity Building

The proposed collaborative exploratory/developmental research is expected to help build the capacity for full research programs by improving the research environment and strengthening LMIC individual and institutional research capabilities in the proposed research areas. The proposed work and follow up research are expected to contribute to the long-term goals of building sustainable research capacity for chronic NCDs and injury in LMICs. The proposed project may also contribute to the development of research networks and evidence-based policy.

For purposes of the research capacity building and networking encouraged in this FOA, and for background, applicants are also encouraged to use as a resource the compilation of the past awards under the FIC NCD-Lifespan and NCoD research training programs (http://www.fic.nih.gov/Grants/Search/Pages/search-grants.aspx?program=chronb7h ).

Specific Research Interests of the FOA Sponsors

Participating NIH institutes and Centers (ICs) provided specific statements of interest for this FOA, below. Applicants can obtain more information on research interests for each of the NIH participants in this FOA at their web sites and through their Scientific/Research contact listed in this announcement.

The Fogarty International Center (FIC) is interested in all eligible applications relevant to its mission. The FIC Strategic plan (http://www.fic.nih.gov/About/Pages/Strategic-Plan.aspx) states the following relevant goals: 1) Build research capacity through individuals, institutions, and networks to meet future and evolving global health challenges; 2) Stimulate innovation in the development and implementation of technologies and other locally relevant solutions to address global health problems; 3) Support research and research training in implementation science; 4) Advance research on prevention and control of the dual burden of communicable and non-communicable diseases and disabilities; and 5) Build and strengthen partnerships to advance global health research and research capacity.

The National Cancer Institute (NCI) coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients. NCI's interest in this FOA is in funding exploratory research along the cancer continuum (prevention, detection, diagnosis, treatment and survivorship) including well-designed epidemiology studies on common risk factors (social, biological, occupational, environmental) for cancer, use of mobile technologies such mHealth, cancer health disparities/inequities, cancers associated with chronic infections including malignancies in the context of HIV infection, ecological-niche cancers, cancer surveillance including use of cancer registry data for research, and implementation science approaches that analyze ways to achieve economic efficiencies in the management of cancer and translational research.

The National Center for Complementary and Integrative Health (NCCIH).

Complementary health interventions of interest to NCCIH include both mind-body and natural product approaches. Studies focusing on complementary health interventions and on the conditions for which they are most frequently used are particularly encouraged. These would include, but not be limited to, investigations of the impact of complementary health modalities in alleviating chronic pain syndromes and inflammatory processes, and improving health and wellness. Applications to conduct new clinical trials with the goal of evaluating the efficacy or effectiveness of an intervention are not appropriate for this FOA. Applicants can propose mechanistic studies of complementary or integrative interventions as long as the study does not propose to be powered to measure clinical outcomes such as efficacy or effectiveness.

The National Institute on Minority Health and Health Disparities (NIMHD) leads scientific research to improve racial/ethnic minority health and eliminate health disparities in the United States. As noncommunicable diseases are rapidly becoming a dominant cause of poor health globally, NIMHD has an interest in funding exploratory research, including biological, environmental, sociocultural, clinical, and behavioral research in LMIC regions and countries that have significant immigration to the United States.

The Office of Research on Women's Health (ORWH) is interested in funding applications that address the significant role of sex and gender in the onset, prognosis, treatment, and prevention of NCDs. ORWH is also interested in funding applications focused on investigating the contribution of sex and gender in injury, including but not limited to those injuries associated with intimate partner violence, domestic violence, and violence against women. Information about the ORWH mission and strategic plan can be found at: http://orwh.od.nih.gov/research/strategicplan/ORWH_StrategicPlan2020_Vol1.pdf

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

To determine country income categories, please see: http://data.worldbank.org/country . The subcategories of LMICs are: upper-middle-income (UMIC), lower-middle-income and low-income countries.

At least one institution in the U.S. or an UMIC, and at least one institution in a LMIC must be involved as partners in the grant application (UMIC institutions are eligible to partner either with U.S. institutions or directly with other LMIC institutions). Direct applications are encouraged from the LMIC institutions. LMIC components of US organizations must apply as the US partner in a collaboration involving a different LMIC.

Note that Hong Kong-based institutions are not eligible as applicant or primary LMIC partner institutions due to its high-income status. As long as China remains a LMIC, a second institution in mainland China must be involved as the primary collaborating UMIC institution with a non-Chinese LMIC.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are 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))

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

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA provides an avenue for investigators in the U.S. and LMICs, with shared interests in chronic NCDs and injury research, to establish collaborative research and research capacity strengthening activities. . Use of the multiple PD/PI format is encouraged. Where there are multiple PD/PIs, the contact PD/PI may be from the LMIC institution or from the U.S. but the collaborators are expected to prepare the application jointly.

Non U.S. High Income Country (HIC) investigators are not eligible as PD/PIs

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

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

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the "Apply for Grant Electronically" button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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, prospective applicants are asked to submit a letter of intent that includes the following information:

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

The letter of intent should be sent to:

Kathleen Michels, Ph.D.
Telephone: 301-496-1653
Fax: 301-402-0779
Email: FIC-NCD@mail.nih.gov

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.

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

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

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

This FOA provides an avenue for investigators in the U.S. and LMICs, with shared interests in chronic NCDs and injury research, to establish collaborative research and research capacity strengthening activities. Therefore, one or more investigators from an institution in the U.S. (or UMIC) and one or more from an institution in a LMIC (see definitions above, in the "Eligible Institutions" section) must collaborate on the application. UMIC applicants must partner with individuals in a different LMIC and do not require a U.S. partner.

Non U.S. High Income Country (HIC) investigators may be included as consultants, especially if they present special opportunities for furthering research programs through the use of unusual talent, or provide resources relevant to the proposed project that either are not readily available in the eligible LMIC or the U.S. institution, or which augment existing resources.

All instructions in the SF424 (R&R) Application Guide must be followed. It is expected that the majority of funds awarded (greater than 51% of the total direct costs) will be used for supplies, research capacity building costs, equipment, services, travel, and personnel at the LMIC site(s). Any funds spent at the U.S. (or UMIC PD/PIs institution) site must be directly related to the collaborative research or research capacity building activities under the grant.

Supplemental Budget Information:

Networking meetings (3 days) involving grantees of these awards will be held at a site in the U.S. or elsewhere each year. A meeting focusing on evidence based dissemination and implementation policy, but in a regional context, may also be convened.

Funds should be budgeted for travel to at least one three day networking meeting per year (in the U.S. or other country to be determined by year) by the PDs/PIs, LMIC collaborators, and/or other relevant individuals with significant day-to-day involvement in the activities performed under this award.

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

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

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

Research Strategy: The R21 grant will provide support to assess needs, to initiate preliminary studies and strengthen research capabilities, and to organize, plan, prepare, and assemble or solidify partnerships, additional expertise, information and data as needed for an application for a more comprehensive research grant (e.g. a R01 involving collaboration between U.S. or UMIC and LMIC investigators in the proposed research area(s) relevant to this FOA, or an application to another funder). The application should define an exploratory research project and associated plan for assessing, developing and strengthening research capabilities.

Applicants should describe how they will:

• Assess research needs (define the problem and determine the magnitude of and factors involved in the problem to be addressed in the countries in question);
• Assess research capabilities needed to carry out the proposed research;
• Develop plans to address these needs to enable the proposed research and capacity building to be successfully carried out;
• Develop and solidify collaborative relationships and understandings with the partners in the countries involved;
• Test the feasibility of the approach proposed and generate preliminary data for the collaborative research to be proposed in a follow-up research grant submission;
• Integrate research capacity strengthening into the proposed research program;
• Assess current institutional resources and processes to carry out any proposed research involving human or animal subjects, including those of the performance site institutional review board (IRB), or community advisory board and begin to address any needs and gaps in knowledge or practice.
• As appropriate, applicants may also identify opportunities for, and begin to develop, relevant research networks within and/or between institutions, countries and regions.

Applicants should propose specific milestones and a timeline to meet these goals.

Meetings, workshops and small conferences may be conducted as necessary to develop research plans and collaborations or for assessment of needs. New analyses of extant data sets and development or use of new methodologies or approaches may also be proposed. These activities may also serve to identify which specific research questions show the greatest promise for advancement in specific countries and settings. Travel among sites for these purposes may be proposed.

The relevance of the proposed research to the health of the host endemic country should be justified. Describe how the proposed research is relevant to NCD or injury related issues or priorities in the LMIC and to the stated NCD or injury related interests (including co-morbid conditions) of one or more of the participating NIH Institutes, Centers or Offices.

In addition, the role of this research and planned involvement, if any, of the LMIC institution and faculty in formulating treatment and prevention policies locally, nationally, regionally or internationally should be noted.

Collaboration

Plans for coordination of research (and activities to strengthen LMIC research capabilities) between the partner country institutions should be described and should include regular meetings (virtual and/or physical).

Networking

All applicants are encouraged to become familiar with other relevant research and research training being conducted at the LMIC institution, and more widely within the country and region as feasible. Applicants may discuss the potential to take advantage of synergies for networking and collaboration for research and for activities to strengthen research capabilities.

Such activities may include but are not limited to:

- leveraging NIH or other funder investments already in place in specific foreign countries,

- using common measures/data elements across research studies in a country/region,

- sharing or pooling data or creating data repositories,

- making efficient use of local/regional oversight bodies such as IRBs, DSMBs

- sharing education platforms to develop expertise across programs.

Letters of Support: Letters of support should be provided by each collaborator and collaborating institution.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. 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.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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

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

This initiative is not subject to intergovernmental review.

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

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

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.

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.

In order to expedite review, applicants are requested to notify the FIC Program Officer by email at FIC-NCD@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow our Post Submission Application Materials policy.

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

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:

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of 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. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the research on a problem of particular relevance and importance for the LMIC involved?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? If planning for a larger mission-centered research network is proposed, are investigators identified who can function as hubs and nodes in that network?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the project make use of unique or special expertise, resources, circumstances or environment of the LMIC site to frame or address the research question? Does the project incorporate innovative strategies for strengthening research capabilities in the research proposed?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed? For projects with multiple sites and/or multidisciplinary components, is there an adequate plan to coordinate and integrate the research among the sites/components? Are the administrative plans for the management of the research project appropriate, including plans for resolving conflicts?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Does the application include a feasible and relevant plan to assess specific resource and research capacity strengths, needs, and gaps for research on NCDs and/or injury at the LMIC site(s) and to follow up to use the strengths and address the needs in the proposed pilot (and future) research?

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.

Research Capacity Strengthening

Does the proposed developmental/exploratory research strategy contain appropriate plans to develop related research capacity at the LMIC institution(s) as needed through research methodology training, professional development, mentoring and other models?

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.

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.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Not Applicable

Not Applicable

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

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.

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).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center of Scientific Review (CSR), 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 second level review by the Fogarty International Center Advisory Board. The following will be considered in making funding decisions:

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

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.

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

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

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

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

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

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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.

A final progress report, 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.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: support@grants.gov

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

Rebecca Henry, PhD, BSN, RN
National Institute of Nursing Research (NINR)
Telephone: 301-594-5976
Email: Rebecca.Henry@nih.gov

Mary Ellen Michel, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-5289
Email: mm108w@nih.gov

John Haaga, Ph.D
National Institute on Aging (NIA)
Telephone: 301-496-3131
Email: John.Haaga@nih.gov

Wendy Smith, Ph.D
Office of Behavioral & Social Sciences Research (OBSSR)
Telephone: 301-435-3718
Email: smithwe@mail.nih.gov

Kathleen Michels, Ph.D.
Fogarty International Center (FIC)
Telephone: 301-496-1653
Email: FIC-NCD@mail.nih.gov

Eve Reider, PhD
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-443-8374
Email: ereider@mail.nih.gov

Damali Martin, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6746
Email: martinda@mail.nih.gov

Shannon Silkensen, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5809
Email: silkensens@mail.nih.gov

Lisa Neuhold, Ph.D.
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: lneuhold@mail.nih.gov

Rebecca Henry, PhD, BSN, RN
National Institute of Nursing Research (NINR)
Telephone: 301-594-5976
Email: rebecca.henry@nih.gov

Cindy D. Davis, Ph.D.
Office of Dietary Supplements (ODS)
Telephone: 301-496-0168

Amy Mistretta
Office of Research on Women's Health (ORWH)
Telephone: 301-402-1770
Email: mistrettaac@mail.nih.gov

Rick Berzon, DrPH, PA
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8949
Email: rick.berzon@nih.gov

Fungai Chanetsa , Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-408-9436
Email: Fungai.Chanetsa@nih.gov

Lisa N. Steele, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-257-2638
Email: steeleln@mail.nih.gov

Oster, Kelli
National Institute of Nursing Research (NINR)
Telephone: 301-594-2177
Email: osterk@mail.nih.gov

Ted Williams
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-326-6450
Email: williate@mail.nih.gov

Linda Whipp
National Institute on Aging (NIA)
Telephone: 301-402-7731
Email: whippl@nia.nih.gov

Satabdi Raychowdhury
Fogarty International Center (FIC)
Telephone: 301-496-9750
Email: raychowdhurys@mail.nih.gov

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: carows@mail.nih.gov

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

William Darby
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: darbyw@mail.nih.gov

Judy Sint
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959
Email: sintj@mail.nih.gov

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: pg38h@nih.gov

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 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.