Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	Fogarty International Center (FIC) National Cancer Institute (NCI) National Institute on Drug Abuse (NIDA)
Funding Opportity Title	International Tobacco and Health Research and Capacity Building Program (R01)
Activity Code	R01 Research Project Grant
Announcement Type	Reissue of RFA-TW-06-006
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-TW-11-003
Companion FOA	None
Number of Applications	Only one application may be submitted from an institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.989, 93.399, 93.279
FOA Purpose	This Funding Opportunity Announcement (FOA) solicits collaborative research and capacity building projects that address the burden of tobacco use in low-and middle-income countries (LMIC) by (1) pursuing observational, intervention and policy research of LMIC relevance and (2) building capacity in epidemiological and behavioral research, prevention, treatment, communications, implementation, health services and policy research. The level of research and research training specialization in any given project will vary based on the strengths of the particular investigators and institutions and the specific need to build capacity to support locally relevant research on tobacco control interventions. The overall intent of the program is to encourage trans-disciplinary research to the international tobacco epidemic and to reduce the global burden of morbidity and mortality caused by tobacco use. The program is designed to promote international cooperation between investigators in the U.S. or other high-income countries (HIC) pursuing research programs on tobacco control, and scientists and institutions in LMIC where tobacco consumption is a current or anticipated public health urgency. The program allows U.S. and other HIC investigators to gain expertise working under LMIC-specific conditions and strengthens the research base of the U.S. and foreign institution(s), especially those institutions in LMIC. To this end, capacity strengthening must be an integrated and significant part of the research proposal. Note that in this FOA, the term tobacco includes both smoked and smokeless (non-combusted) forms of tobacco.

Posted Date	July 12, 2011
Open Date (Earliest Submission Date)	August 15, 2011
Letter of Intent Due Date	August 15, 2011
Application Due Date(s)	September 15, 2011, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	February/March 2012
Advisory Council Review	May 2012
Earliest Start Date(s)	July 2012
Expiration Date	September 16, 2011
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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

Background

Tobacco use is a leading cause of preventable death worldwide; the World Health Organization (WHO) has estimated that, globally, smoking is responsible for 12% of male deaths and 6% of female deaths. It is estimated that total global tobacco-attributable deaths will rise from 5.4 million in 2005 to 6.4 million in 2015 and 8.3 million in 2030. Increasingly, the burden of tobacco mortality is shifting from high-income countries (HIC) to low-and middle-income countries (LMIC); between 2002 and 2030, tobacco-attributable deaths in LMIC are projected to double from 3.4 million to 6.8 million, while deaths in HIC are projected to decline by 9%. Already, a disproportionate share of the global tobacco burden falls on LMIC, where 84% of the world’s 1.3 billion current smokers reside. Additionally, in many countries, the burden of tobacco use is stratified by socio-economic status and other variables, and is an important contributor to disparities in health outcomes.

Tobacco use is a significant risk factor for several diseases and a major contributor to global morbidity. For example, active smoking is causally linked to lung and other cancers, coronary heart disease, atherosclerotic peripheral vascular disease, stroke, chronic obstructive pulmonary disease, asthma, and other respiratory effects, and adverse reproductive health effects in women. Globally, WHO estimates that smoking causes about 71% of lung cancer, 42% of chronic respiratory disease and nearly 10% of cardiovascular disease. Additionally, recent research has demonstrated a strong interaction between tobacco use and tuberculosis. A systematic review published by WHO and the International Union Against Tuberculosis and Lung Disease concluded that smoking or exposure to secondhand smoking (SHS) is significantly associated with tuberculosis infection and disease, and that (active) smoking is significantly associated with recurrent tuberculosis and tuberculosis mortality. It has been estimated that more than 20% of global TB incidence may be attributed to tobacco smoking.

In many LMIC, use of diverse forms of smoked and smokeless tobacco, including some produced in small cottage industries, is common. In addition to manufactured cigarettes, smoked tobacco products include cigars, pipes, bidis (hand-rolled Indian cigarettes), chutta (hand-made Indian cigars), kreteks (clove cigarettes) and waterpipe tobacco smoking; dozens of different oral smokeless tobacco products are also marketed. Although prevalence data are often lacking, in some countries the use of non-cigarette tobacco products is thought to be as or more prevalent than the use of manufactured cigarettes. In contrast to manufactured cigarettes, the adverse health effects of non-cigarette tobacco products on the user (and for smoked types, those around him/her) are often not well understood.

Worldwide, an estimated 41.1% of men and 8.9% of women (aged ≥ 15 years) smoke tobacco products, including nearly half of men (47.7%) in LMIC. Culture, tradition, limited economic means and other factors have long constrained women’s tobacco smoking in many LMIC, where the prevalence of women’s smoking remains less than 5% overall. However, women’s smoking prevalence appears to be increasing in some countries, fueled in part by transnational tobacco companies marketing efforts. An increased prevalence of tobacco use by women will have grave consequences for the health of women and their families, and threatens to undermine hard won health gains in maternal and child health outcomes. Research is needed to assist countries to decrease or at least maintain the relatively low prevalence that exists among women in many LMIC.

Tobacco use has been called a pediatric disease because initiation of tobacco use occurs at a young age in many countries. Age of initiation is an important factor determining the ultimate health effects of tobacco use; those who begin using tobacco in childhood or adolescence are more likely to become highly addicted to nicotine, have greater difficulty quitting, use tobacco for longer periods, and experience morbidity and mortality from tobacco use. The Global Youth Tobacco Survey (GYTS), a school-based survey of students aged 13-15 years, collects standardized data on the prevalence of cigarette and other tobacco use, perceptions and attitudes about tobacco, access and availability of tobacco products, and exposure to SHS, school curricula, media and advertising and smoking cessation interventions. GYTS data collected between 1999-2005 found that worldwide, nearly one in five youth (17.3%) was a current tobacco user, that use of tobacco products other than cigarettes is as high as cigarette smoking in many world regions, and that the difference in current cigarette smoking between boys and girls is narrower than expected in many regions of the world. Research is needed to understand the broad range of determinants of youth tobacco use and to develop effective intervention strategies that can be used in LMIC.

The adverse health effects of exposure to SHS (also known as passive smoking, or environmental tobacco smoke) are now well documented. Exposure of adults to SHS has immediate adverse effects on the cardiovascular system and causes coronary heart disease and lung cancer; children exposed to secondhand smoke are at increased risk for sudden infant death syndrome (SIDS, cot death), acute respiratory infections, ear problems, and more severe asthma. Worldwide, 40% of children, 33% of male nonsmokers and 35% of female nonsmokers were exposed to SHS in 2004; this exposure was estimated to have caused 603,000 deaths in 2004, about half of which occurred in women. It is estimated that, currently, 93% of the world’s population lives in countries that lack comprehensive protections from SHS in public places and work places. Research is needed to identify effective strategies to decrease exposure of nonsmoking adults and children to SHS in public places and in private settings, taking in to account culture and other factors in LMIC.

Promoting cessation among current tobacco users is a key strategy to reduce global morbidity and mortality from tobacco use. All tobacco products are addictive because they contain nicotine and employ delivery strategies that have often been highly engineered to enhance the addiction risk of their products; thus, most people find quitting very difficult. Data from the International Tobacco Control Policy Evaluation Project indicates that global demand for cessation is high, even in LMIC, where knowledge of the harmful health effects of smoking is comparatively low. Research conducted in HIC has demonstrated the efficacy of employing both population-level approaches, such as mass media campaigns and tobacco quitlines, and individual-level approaches, such as provision of tobacco dependence medications and treatment services to tobacco users. Research is needed to develop and understand how best to implement effective cessation strategies in LMIC, especially in resource-poor environments where access to health care providers may be limited or nonexistent. Additionally, the experience of HIC demonstrates that significant disparities in successful cessation exist, based on socioeconomic and other factors. Research in LMIC should help ensure that all population sub-groups benefit from the implementation of cessation intervention strategies.

The Framework Convention for Tobacco Control (FCTC), the first treaty ever negotiated under the auspices of WHO, aims to protect present and future generations from the devastating health, social, and environmental and economic consequences of tobacco consumption and exposure to tobacco smoke by providing a framework for tobacco control measures. The FCTC was unanimously adopted by the World Health Assembly in May 2003, and entered into force in February 2005. As of January 2011, 172 countries are parties to the FCTC, and are required to put in place evidence-based measures to reduce the demand for and supply of tobacco products. The FCTC is now widely recognized as a crucial force spurring the adoption of evidence-based tobacco control policies around the world. The FCTC recommendations are not being implemented in an identical form or timeline in all countries; research is needed to examine the effect of tobacco control policies adopted in response to the FCTC, to understand how best to implement policy interventions in LMIC, and to design additional policy and programmatic interventions.

Carrying out this research agenda will require increased scientific capacity in LMIC that are or will be confronted with high burdens of tobacco use. In-country scientists in-depth knowledge of local contexts makes them uniquely poised to identify priority research questions and to design appropriate interventions. Therefore, increased in-country capacity to conduct global tobacco control research is critical to the development and implementation of effective interventions, as these interventions must be responsive to local populations and contexts. In addition, robust local capacity enhances the sustainability of evidence-based policies and programs, as local researchers and institutions are well-positioned to respond to changes in the tobacco control environment over time by generating new, relevant knowledge to inform modifications or new approaches.

This FOA, responding to the goals in the FIC and participating ICs' strategic plans, is the second reissue of the International Tobacco and Health Research Program, and reflects changes in the tobacco control environment and new challenges in global tobacco control. The goal of this RFA is to solicit applications for hypothesis-testing and hypothesis-generating studies, and to train LMIC investigators who will examine the manifestations, determinants and outcomes of diverse forms of tobacco use, and evaluate interventions in a range of areas. This FOA is also intended to support research that identifies strategies to effectively translate scientific findings into sound, evidence-based policies related to tobacco control.

This FOA is not intended toprovide support for basic biomedical research. Additionally, because of the advent of the Global Tobacco Surveillance System (http://www.cdc.gov/tobacco/global/gtss/index.htm), it is also not intended to provide support for surveillance, or research focusing primarily on determining the prevalence of tobacco use or SHS exposure.

Scientific Objectives

1. Research: This FOA encourages trans-disciplinary research. Applications may address one or more of the following categories of research. Both research and capacity strengthening must be included in the application. Categories of research may include, but are not necessarily limited to, the following research areas:

a. Epidemiological Research: Epidemiological research may be useful to enhance knowledge of tobacco-related health problems and risks relevant to LMIC.

Describe patterns and trends in tobacco-attributable morbidity and mortality, especially health risks of particular importance in LMIC;

Examine the potential interaction between exposures to SHS and to occupational or ambient air pollutants (including indoor air pollution from household use of solid fuels) on the pathogenesis of disease; and

Document and monitor trends in the nature, extent, and patterns of co-occurring tobacco and drug use and/or abuse (including polydrug use) and drug-related behavioral and social consequences in general and in special populations, such as youth, adolescents and young adults.

b. Susceptibility and Risk: Research may examine how tobacco initiation, dependence and cessation and/or SHS exposure differ by variables relevant to LMIC, such as gender, ethnicity, culture, income and/or educational level.

Identify factors that increase susceptibility to initiate tobacco use and prompt tobacco dependence, to better characterize high-risk individuals and populations;

Examine how characteristics and patterns of use of different tobacco products, (e.g., cigarettes, waterpipes, bidis, and other forms of smoked tobacco, as well as smokeless tobacco products) influence rates of tobacco initiation, dependence, cessation and disease risks; and

Examine co-morbid mental health disorders (e.g., depression, anxiety) and medical conditions (e.g. heart disease, cancer and tuberculosis) associated with tobacco use. Identify risk and protective factors for co-morbidity, and develop and test new intervention strategies.

c. Behavioral and Social Science Research: Behavioral and social science research can be used to explore tobacco advertising and promotional strategies, public knowledge of the harms of tobacco use, factors related to tobacco initiation, dependence and cessation, and intervention strategies sensitive to the cultural differences and needs of LMIC.

Understand the influence of advertising, promotion, mass media, tobacco packaging and other strategies aimed at encouraging tobacco use;

Examine consumer reactions to tobacco package health warnings, plain packaging, mass media interventions, and other strategies aimed at reducing tobacco use;

Identify levels of awareness of health risks associated with tobacco use among different segments of the population; and

Identify socio-cultural, psychological, physiological and genetic factors that influence smoking initiation, progression to nicotine addiction, and smoking cessation.

d. Intervention Research: Building on established intervention research conducted in HIC, studies may examine different methods of tobacco control implementation and interventions that are responsive to individual LMIC needs, infrastructure and resources.

Conduct research on prevention and treatment interventions suitable for LMIC environments, including differential responsiveness to interventions based on age, sex, race/ethnicity, educational level and other social determinants;

Examine community-level interventions that have the potential to impact large populations, such as those using evidence-based behavioral, sociological, and health communication methods;

Examine the effectiveness and consequences of prevention interventions that employ single-risk versus multiple-risk strategies, especially in youth, adolescents, and young adults;

Evaluate new pharmaceutical and/or behavioral interventions and delivery mechanisms, their cost-effectiveness and impact in diverse socio-cultural, physiological and genetic subgroups;

Develop and evaluate interventions to increase knowledge of the health risks of tobacco use among diverse populations in low-resource settings, especially among low literacy populations, and in settings where multiple languages are spoken; and

Identify models for integrating tobacco interventions into health systems and healthcare delivery settings.

e. Policy-Related Research: Policy-related research may examine current tobacco control policy implementation and enforcement, or lack thereof, in LMIC. Studies may also determine the impact of current or proposed tobacco control policies on public health and the risk factors associated with tobacco use relevant to LMIC.

Examine the effect of implementing and enforcing SHS protections, bans on advertising, marketing and sponsorship and other measures required by the FCTC to contribute to tobacco use reduction in LMIC;

Examine the effect of specific regulatory and legal approaches to reducing tobacco initiation and promoting tobacco cessation;

Consider the effect of counter-advertising and other measures aimed at changing social norms and/or stigmatizing tobacco use, on initiation, dependence, and cessation, on the population overall, and by demographic subgroups;

Assess the long-term health and economic implications of failure to implement effective tobacco control and prevention measures;

Examine the influence of trade policies on tobacco consumption and tobacco control measures; and

Assess the use of morbidity and mortality data and related information on the development of government tobacco use reduction policies; and examine the impact of tobacco control policies adopted in response to the FCTC, including research regarding what has worked, what has not worked, and why.

f. Research on the economics of tobacco use and tobacco control: Research from HIC demonstrates that tobacco use exacts a heavy economic toll in health care costs and lost productivity on individual users, families, communities and countries. Research may be conducted to document the economic burden of tobacco use and/or the potential benefits of tobacco control in LMIC. Research that demonstrates the increase in lifetime health care costs and lost productivity caused by tobacco use;

Examine the impact of higher taxes and prices on tobacco products in LMIC on tobacco initiation, dependence and cessation overall and on sub-populations such as youth and women, as well as the impact on government revenues;

Consider the link between tobacco use and poverty, the current and future economic burden of tobacco use on individuals and families, and the potential effects of reduced tobacco use on individual and family income and expenditures on health, education, shelter and other necessities;

Address the impact of increasing taxes on tobacco products on illicit trade, and effective measures to curb illicit trade; and

Consider the optimal type and structure of tobacco taxes to maximize public health and government revenue.

2. Research Capacity Building: A strategic goal of this FOA is to strengthen research capacity in LMIC. Capacity building promotes the advancement of research and enhances the number and the knowledge of tobacco investigators in LMIC. A long-term outcome of capacity building is the improved ability to augment scientific competence and skills nationally and internationally, and the development of a cadre of tobacco researchers with appropriate research training and support who can continue to conduct tobacco control research in LMIC beyond the term of the award. Capacity building activities also provide opportunities for investigators from HIC to gain knowledge of and experience in tobacco control issues in LMIC. Research capacity building is an important part of this FOA.

The research grants funded from this FOA will provide research training for individuals associated with an institution related to tobacco control research in LMIC. Research capacity building activities should be performed in conjunction with the proposed research objectives/aims of the grant. Collaborations should extend or enhance, in a mutually beneficial manner, the tobacco control research interests of both HIC and LMIC Investigators. Research capacity building activities should increase the capacity of the LMIC investigators or institutions to improve sustainable and productive behavioral, intervention and policy research.

We encourage research capacity building activities that promote institutional capacity strengthening in multidisciplinary tobacco control research through support for and linking of relevant departments or institutions working on tobacco-related scientific research in LMIC. We also support the development of in-country tobacco control infrastructure at the institution, academic, and non-government organization (NGO) level. The infrastructure includes institutionalized research capacity as well as the capacity for translating research evidence into tobacco control policies, on country- and project-specific basis.

Applicants should include a research capacity building plan in the application, which: (1) demonstrates the need and rationales for proposed research capacity building activities; (2) specifies the types of activities being performed; (3) documents how the proposed activities will be performed; and (4) presents the expected outcomes of the proposed research capacity building activities.

3. Special Requirements

Collaborations: This program is intended to generate useful scientific information and promote collaboration between investigators and institutions in the United States or other HIC and LMIC with shared interests in reducing the consequences of tobacco consumption. To achieve this, research and capacity strengthening may reflect new or ongoing activities and may demonstrate collaboration between Principal Investigators (PI) from the U.S. or other HIC and Co-Investigator(s) from LMIC. The Foreign Collaborators must be at institutions in LMIC.

If the Program Director/Principal Investigator (PD/PI) is from a LMIC, the application will be developed jointly by the PD/PI and one from the U.S. or other HIC. Collaboration between the foreign investigators and U.S. investigator(s) is highly encouraged. Research findings must be relevant to the collaborating LMIC. (For operational and analytic purposes, the World Bank’s main criterion for classifying economies, gross national income per capita, will be employed for this RFA to determine eligibility. A list of countries representing LMIC, which are eligible for this program, may be found at (http://data.worldbank.org/about/country-classifications/country-and-lending-groups). Interdisciplinary approaches to examining the dynamics of tobacco consumption are especially encouraged. Advances are most likely to be achieved through interdisciplinary collaborations (i.e., economics, epidemiology, demography, anthropology, sociology, communications, behavioral science, basic biological sciences, psychology and pediatrics).

Establishing Research Priorities: The applicant should demonstrate that the research proposed relates to the burden of tobacco use and reflects the priorities of the collaborating LMIC, and should describe in detail the procedures to ensure that both research and research training reflect these priorities.

Dissemination: All applications should describe dissemination strategies to be employed by the research project. Useful dissemination strategies may include: publication of research overviews, summary reports or other materials aimed at the general public, in the language(s) of the LMIC; participation in conferences, workshops, or other meetings focused on disseminating research results to the general public; and participation in media efforts to disseminate research results to broader audiences. Where appropriate, applications should include a detailed discussion of a) how the results of the research being proposed can be rapidly disseminated and adopted on a large scale; and b) why the results of the research being proposed, if disseminated and adopted on a large scale, could have a significant effect on the reduction of tobacco use in the community, host country or region. Where appropriate, applications should include plans to collaborate with other stakeholders in the dissemination process (e.g., civil society and advocacy groups, non-governmental organizations, local and national policymakers) to help to facilitate the translation of research findings into policy and practice.

Continued Collaboration: Descriptions of plans for continued collaboration with foreign collaborators and investigators after trainees return home must be included in the application, including strategies for continued mentoring of trainees and tracking career paths of trainees after they have returned home. Tracking of short- and long-term research training and other institutional capacity strengthening, including mentoring, may be facilitated by a web-based reporting system, Annual Reports and other means.

Grantees of the previous International Tobacco and Health Research and Capacity Building Program should demonstrate both the capacity-building success and research success of the previous grant in their renewal submissions. This could potentially be demonstrated by the return of trainees to their home countries and the establishment of research programs there, as well as the trainees publication records.

Network Meetings: There will be periodic network meetings of awardees, co-funding agencies, and selected international tobacco researchers in Bethesda, Maryland or at another mutually acceptable site, possibly in conjunction with national or international meetings. Those receiving awards will be expected to participate in these meetings (generally one annual two-day meeting). The purpose of these meetings will be to exchange and benefit from research and research-training experiences and to coordinate program activities. In Year One, PDs/PIs should budget for themselves and their Co-Investigator(s) to attend the annual network meeting. In subsequent years, PDs/PIs should budget for themselves, their Co-Investigator(s) and two to three other project personnel (selected trainees and/or program administrators) to attend. Funds for this two-day activity (travel, lodging and per diem) should be included in the budgetary requests. Consideration will be given to holding annual network meetings in LMIC when this would provide benefits to those persons and be cost-effective.

Evaluation: A plan for self-evaluation of the program should be included in the application. Where appropriate, this plan should include specific methods for tracking trainees for at least five years after completion of their training.  Where appropriate, awardees are strongly encouraged to track and document the long-term impact of this program on the research capacity in tobacco research at the foreign institution(s).  Among widely recognized and validated measures of capacity building are the number and quality of publications, presentations, courses developed, professional awards, grant funding, career advancement and subsequent employment that demonstrates sustained commitment to a health research career; contributions to future international research collaborations and research training; and influence on the development and use of research findings in their countries. Evaluation metrics should encompass both the success of the research elements of the program and where appropriate, the success of individual trainees and the impact of the program on research capacity. The self-evaluation plan’s merits will be assessed based upon the awardee’s use of relevant and appropriate metrics.  Applicants should include in the plan for self-evaluation, a mechanism for periodic review of the effectiveness of the program which may consist of regular meetings among faculty participating in the program or periodic review by an outside group of consultants.

Funding Instrument	Grant
Application Types Allowed	New Renewal The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications. The FIC and NIH partner components will commit a total of $3.3 million to fund up to 10 awards in Fiscal Year 2012.
Award Budget	An applicant may request a project period of up to five years and a budget in direct costs of up to $250,000 per year.
Award Project Period	The total project period for an application submitted in response to this Funding Opportunity Announcement may not exceed 5 years.

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

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)
• Eligible Agencies of the Federal Government
• 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) 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 must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) 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 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 SF 424 (R&R) Application Guide.

Principal Investigators from the U.S. or other HIC are required to collaborate with (an) investigator(s) from one or more LMIC. Program Directors/Principal Investigators (PDs/PIs) from a LMIC are required to collaborate with the U.S. and/or other HIC.

NIH strongly encourages applications from women and individuals from underrepresented racial, ethnic and socially disadvantaged groups. Where appropriate, the design of the projects should take into account potential sex and gender differences that may affect the questions asked and the analyses performed. These might include different responses to and impacts of health interventions, differences in physiology, and different behavioral bases for disease prevention strategies.

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

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, 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 research
• Name, address, and telephone number of the PD(s)/PI(s)
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

The letter of intent should be sent to:

Xingzhu Liu, M.D., Ph.D.
Division of International Training and Research
Fogarty International Center (FIC)
Building 31, Room B2C39
31 Center Drive, MSC-2220
Bethesda, MD  20892-5475
Telephone: 301-496-1653
Email: [email protected]

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

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

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

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

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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.

The major portion of the research must be conducted in the collaborating LMIC and greater than 50 percent of the direct costs requested must be used in the LMIC in research and research capacity building.

It is expected that the majority of funds awarded will be used for supplies, training costs, equipment, services, travel, and personnel at both the NIC and LMIC sites; and that any funds spent at the HIC site will be directly related to the collaborative research and research capacity building for LMIC. 

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted. Guidance for International Applicants Blocked from Registration Websites can be found at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-090.html.

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.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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.

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 Central Contractor Registration (CCR). 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 by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NCI Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Inclusion of Student and Post-Doctoral Research Assistants/Associates: Post-doctoral and degree candidates must be listed as research associates on PHS application Form 398, page DD, and would be considered as having an employee-employer relationship. Salaries, tuition remission, and other forms of compensation paid as, or in lieu of, wages to degree candidates or to post-doctoral trainees to conduct research related to the goals of this FOA are allowable. Costs and plans must be included in the text of the application and reflected in the application’s budget.

Letter of Support: Letters of support for the proposed research and capacity strengthening program from the collaborating institution(s) must be submitted with the application. The types of supports may include:

• Mobilizing human resources/expertise necessary for a successful collaboration of the project;
• Providing in-kind resources inputs (office space, equipment, library, logistic management etc.);
• Facilitating dissemination of the research results;
• Supporting the process of translating research evidence into practices/policies;
• Institutionalizing the improved research capacity resulted from this project.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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.

Reviewers will provide an overall impact/priority 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.

Significance

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? Does the project address a significant problem of relevance to the collaborating LMIC?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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?

Innovation

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?

Approach

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 clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

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? Is there evidence of the ability to utilize and sustain the research and research capacity building provided through the FOA after the completion of the grant period?

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/priority score, but will not give separate scores for these items.

Research Capacity Building:

Does the proposed program contribute to the capacity of scientists and institutions in LMIC to perform research related to reducing tobacco use? Does the proposed program contain explicit strategies or plans to strengthen this capacity through research training, career development, mentoring and other modes? Will enhancement of specific departments in foreign institutions lead to overall institutional excellence?

International Research Collaboration:

In the course of research, will collaborating foreign scientists and their institutions develop the capacity to become independent investigators and national leaders in tobacco research and public health interventions (i.e., develop their independently supported research and capacity development programs and obtain financial support nationally and internationally)? How will this occur?

Dissemination:

Does the project provide a well-developed plan for dissemination of research results to broader audiences in LMIC?

Does the proposed project present special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the U.S. or that augment existing U.S. resources?

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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.

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

Not Applicable.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

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/priority 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.

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).

Resource Sharing Plans

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) Genome Wide Association Studies (GWAS).

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Cancer Institute (NCI) , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments 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/priority score.
• Will receive a written critique.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of 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.
• Interest of co-funding partners.
• Geographic balance.
• Likelihood of sustainability as evidenced by the commitment and support of collaborating institutions, including their willingness to contribute resources to this proposed project.

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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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 Non-Competing Continuation Grant Progress Report (PHS 2590) 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.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

FIC/NIH:

Xingzhu Liu, M.D., Ph.D.
TOBAC Program Officer
Division of International Training and Research
Fogarty International Center (FIC)
Building 31, Room B2C39
Building 31, Room B2C39
31 Center Drive, MSC-2220
Bethesda, MD 20892-5475
Telephone: 301-435-6031
Email: [email protected]

NCI/NIH:

Michele Bloch, M.D., Ph.D.
Tobacco Control Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute (NCI)
National Institutes of Health
6120 Executive Boulevard, EPN Room 4044, MSC 7337
Bethesda, MD 20892-7337 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS courier/express delivery)
Telephone:  301-402-5284
Fax:  301-496-8675
Email:  [email protected]

NIDA/NIH:

Steven W. Gust, Ph.D.
Director, NIDA International Program
National Institute on Drug Abuse (NIDA)
National Institutes of Health
31 Center Drive, MSC 8010
Building 31, Room 1B59
Bethesda, MD 20892-8010
Telephone: 301-443-6480
Fax: 301-443-9127
Email: [email protected]

Kirt Joseph Vener, PhD
REVEIW AND LOGISTICS BRANCH
National Cancer Institute
Building 6116 - 6116 Executive Boulevard, 8061
6116 Executive Blvd
Rockville, MD
Tel: 301-496-7174
E-mail: [email protected]

FIC/NIH:

Farah Bader, M.P.H.
Grants Management Specialist
Division of International Training & Research (DITR)
Fogarty International Center (FIC)
National Institute of Health (NIH)
31 Center Drive
Building 31, Room B2C39
Bethesda, Maryland 20892
Telephone: 301-402-5011
FAX: 301-594-1211
E-mail: [email protected]

NCI/NIH:

Carol A. Perry
Branch Chief, Branch C
Cancer Control and Population Sciences Branch
Office of Grants Administration 
National Cancer Institute
National Institutes of Health
6120 Executive Blvd., Suite 243
Bethesda, MD 20892 (for regular mail)
Rockville, MD 20852 (for hand delivered mail)
Telephone: 301-496-7205
FAX(s): 301-496-8601 or 301-480-3691
Email: [email protected]

NIDA/NIH:

Pam Fleming, Chief
Grants Management Branch
National Institute on Drug Abuse (NIDA)
National Institutes of Health
6001 Executive Blvd., Room 4128, MSC-9541
Rockville, MD  20892-9541
Telephone: 301-253-8729
Email: [email protected]

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, 284 and 287 (b)) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.