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 FOA is responding to the goals of Fogarty International Center (FIC) and participating National Institutes of Health Institutes and Centers (ICs) and reflects changes in the tobacco control environment and new challenges in global tobacco control, including introduction of new tobacco and related products, continuation of use of traditional tobacco products and the impact of economic changes on tobacco consumption in low and middle-income countries (LMICs). The goal of this FOA is to solicit applications for hypothesis-testing and hypothesis-generating studies in LMICs, and to continue to build a cadre of investigators in LMICs able to address the scientific challenges of a changing global tobacco prevention and control environment. This FOA is also intended to support research that identifies strategies to effectively translate scientific findings into sound, evidence-based policies and interventions related to tobacco control specific to LMICs.

Worldwide, tobacco use is the leading cause of mortality and morbidity causing approximately 6 million deaths in 2015. The World Health Organization (WHO) estimates that global deaths from tobacco use will increase to 8 million annually by 2030, contributing to 12% and 6% of deaths among males and females, respectively. The global burden of tobacco use has shifted over the past decades from high-income countries (HICs) to LMICs, where over 80% of the current 1.3 billion smokers reside. Thus, the future morbidity and mortality resulting from tobacco use will be increasingly concentrated in LMICs, where resources and infrastructure to address resulting complex chronic health conditions may be limited. Additionally, in most countries, the greatest impact of premature morbidity and mortality from tobacco use is born by individuals of lower socioeconomic status, further increasing disparities in health within and across LMICs.

Tobacco is a significant risk factor for six of the world s eight leading causes of death, including cancer, ischemic heart and cerebrovascular disease, lower-respiratory infections, chronic obstructive pulmonary disease, and tuberculosis. Globally, WHO estimates that smoking is responsible for about 71% of all lung cancer deaths, 42% of chronic obstructive pulmonary disease deaths and nearly 10% of cardiovascular deaths. Furthermore, it is estimated that more than 20% of global tuberculosis incidence may be attributed to tobacco use. Active smoking and exposure to second hand smoke are known to increase the risk of tuberculosis infection, disease progression, and related mortality.

Diverse forms of smoked and smokeless tobacco are widely available in LMICs, including manufactured and hand-rolled cigarettes and cigars, pipes, bidis (hand-rolled cigarettes), chutta (hand-made cigars), clove and flavored cigarettes, waterpipe (hookah), and dozens of different oral smokeless tobacco products. In some countries, use of smokeless tobacco products is as prevalent as or more so than cigarette smoking. However, data on the prevalence and manner of use of non-cigarette tobacco products and their ingredients is often limited. In addition to these traditional non-cigarette forms of tobacco, new products like electronic nicotine delivery systems (ENDS) are becoming more popular, in part due to aggressive marketing of e-cigarettes as an alternative to conventional cigarettes. A better understanding of the adverse health effects of non-cigarette tobacco products is needed, along with potential interventions for prevention and/or cessation.

Expansion of tobacco use by women presents a major public health threat. It is estimated that about 7% of women worldwide use tobacco products compared with 36% of men. However, smoking by women varies widely across regions and appears to be increasing in some countries, in part fueled by marketing efforts along with socioeconomic changes. This presents an urgent need for further research to assist countries to decrease or prevent a further increase in tobacco consumption among women in many LMICs.

Tobacco use among children and adolescents presents a particular concern. Early age of initiation is associated with higher addiction rates, increased difficulty quitting, and higher morbidity and mortality. Research is needed to understand the determinants of child and adolescent tobacco use and develop effective intervention strategies that can be deployed in LMICs.

The adverse health effects of exposure to second-hand smoke (SHS; also known as passive smoking, involuntary smoking or environmental tobacco smoke) are well documented. Exposure to SHS is estimated to have killed more than 600,000 non-smokers in 2010, with ischemic heart disease, lower respiratory tract infections, asthma, and lung cancer as the most common causes of death from SHS. Globally, women and children experience the greatest burden from SHS with approximately 40% of children, 33% of male nonsmokers and 35% of female nonsmokers exposed to SHS. People can be exposed to SHS in private and public settings, including public spaces, workplaces, homes, cars, and multiunit dwellings. Additionally, in some jurisdictions, existing smoke-free laws (including smoke-free public spaces) may not extend to non-cigarette tobacco products, such as hookah or e-cigarettes, prompting a need to study the potential effects of SHS and vapor being released from the use of these products. Furthermore, research is needed to identify effective strategies to decrease exposure of nonsmoking adults and children to SHS in public and private settings, taking into account culture and other country-specific factors.

Promoting cessation among current tobacco users is an essential component of a comprehensive tobacco control strategy, along with other tobacco control policies and programs. All tobacco products are addictive, as they contain nicotine, and most people find quitting very difficult. Data from the International Tobacco Control Policy Evaluation Project indicates that global demand for cessation products is high, even in LMICs, where knowledge of the harmful health effects of smoking is comparatively low. However, most of the existing evidence base for effective cessation strategies comes from HICs and may not be directly applicable to LMICs. Research is needed to develop and understand how best to implement effective cessation strategies in LMICs, especially in resource-poor environments where access to health care providers may be limited or nonexistent. In particular, the use of mhealth interventions and medications like cytisine in LMICs, has been a neglected area for research. Additionally, the experience of HICs demonstrates that significant disparities in cessation rates exist within countries, based on socioeconomic and other factors. Research in LMICs should help ensure that all population sub-groups benefit from the implementation of cessation intervention strategies.

The World Health Organization Framework Convention for Tobacco Control (WHO FCTC; http://www.who.int/fctc/text_download/en/), the first treaty ever negotiated under the auspices of the 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 WHO FCTC was unanimously adopted by the World Health Assembly in May 2003, and entered into force in February 2005. As of March 25, 2016, 180 countries are parties to the WHO FCTC, and are required to put in place evidence-based measures to reduce the demand for and supply of tobacco products. WHO introduced the MPOWER (Monitor, Protect, Offer, Warn, Enforce and Raise) measures to assist in the country-level implementation of effective interventions to reduce the demand for tobacco, through the Monitor tobacco use and prevention policies; Protect people from tobacco smoke; Offer help to quit tobacco use; Warn about the dangers of tobacco; Enforce bans on tobacco advertising, promotion and sponsorship, and Raise taxes on tobacco. As countries adopt tobacco control policies and programs following WHO FCTC and MPOWER, research is needed to assess the impact of these efforts and introduction of new methodologies in different country settings and to understand factors that impact the successful development and implementation of tobacco control interventions in LMICs.

Addressing these research needs will require increased scientific capacity in LMICs. In-depth, locally relevant knowledge is necessary to identify appropriate research priorities and to design effective interventions. Therefore, programs to increase in-country capacity to conduct tobacco control research, including strengthening of new researchers, are critical. 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, pertinent knowledge to inform modifications or new approaches.

This FOA is the third reissuance of the International Tobacco and Health Research and Capacity Building Program (TOBAC). Over the past fifteen years, the TOBAC program has had a substantial impact on expanding research activity and capacity in LMICs. An evaluation of the first ten years of TOBAC, from 2002 through 2012, reported that the program awarded 34 research grants in more than 30 countries, resulted in over 400 peer reviewed publications, and enhanced research capacity of over 3,500 researchers and health professionals. This activity has contributed to development of a cadre of tobacco researchers active in LMICs as well as the building of international research networks and new collaborations. TOBAC researchers have studied a wide range of topics, including the epidemiology of tobacco product use, environmental and cultural influences on tobacco use behavior, tobacco dependence and treatment interventions for low-resource settings, barriers to effective implementation of tobacco control polices, and the economic impacts of tobacco use.

This FOA is not intended to provide support for basic biomedical research. Additionally, because of the existence 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.

This FOA builds on the previous history of the TOBAC program. A review of research and capacity building activity over the past fifteen years provides a focus for future directions in tobacco control research in LMICs. While previous projects have yielded important findings and have contributed to building research capacity in a number of countries, substantial gaps remain in tobacco control research and capacity in LMICs. Changing patterns of tobacco product use, an evolving tobacco product market, the implementation of new tobacco control policies and programs, and the availability of new strategies and technologies for tobacco cessation treatment all contribute to new research questions and opportunities. This FOA also encourages trans-disciplinary research and multi-sectoral engagement to increase the impact that research findings have in-country. Suggested areas of research interest include, but are not limited to the following:

A. Susceptibility and Risk research, examining initiation, dependence, characteristics, patterns of use and cessation of tobacco products, particularly those novel or traditional products for which limited data is available, such as waterpipes, hand-rolled cigarettes and cigars, or ENDS; identification of factors promoting susceptibility to tobacco use and dependence across and within high-risk individuals and populations, in particular associated with the products mentioned above; identification of risk and protective factors and development/testing of intervention strategies for persons with co-morbid conditions.

B. Behavioral and Social Science Research exploring the impact of tobacco advertising and promotional strategies across different social and cultural contexts, public understanding of the harms of tobacco use, socio-cultural, psychological, physiological and genetic factors related to tobacco initiation, dependence and cessation, and intervention strategies sensitive to the cultural and country-specific needs of LMICs. Understanding factors that contribute to tobacco use patterns among youth and women in LMICs are also of interest.

C. Intervention Research that is responsive to the needs, infrastructure, resources and cultural differences across LMICs; prevention and treatment protocols evaluating pharmaceutical, social, behavioral and other interventions, based on age, sex, race/ethnicity, linguistic, literacy and educational levels and other social determinants; and community-level interventions with the potential to impact the general population. Researchers may also take advantage of novel treatment strategies or tools (such as SMS text messaging programs) that show promise for low resource environments.

D. Policy-Related Research may examine any aspect of current tobacco control policy implementation and enforcement, or lack thereof, in LMICs. Studies may also determine the impact of current or proposed tobacco control policies on public health; effect of implementation and enforcement of WHO FCTC articles; and regulatory and legal approaches to reducing tobacco initiation and promoting cessation.

E. Research on the economics of tobacco use and control may focus on the economic burden of tobacco use and/or potential benefits of tobacco control in LMICs is encouraged, including but not limited to: assessing the lifetime health care costs and lost productivity caused by tobacco use; measuring the impact of higher taxes and prices of tobacco products on tobacco initiation, dependence and cessation, and on government revenues; understanding the links between tobacco use and poverty; evaluating the effectiveness of measures to address tax evasion and avoidance in different settings.

Research Capacity Building is an integral part of this FOA. The applications funded in response to this FOA should provide research strengthening for scientists involved in tobacco control research in LMICs. 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 aims of both U.S. and LMIC investigators. Research capacity building activities should increase the capacity of the LMIC investigators or institutions to conduct 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 LMICs. This FOA will also support the development of tobacco control collaborations between LMIC institutions and dissemination activities that will increase the impact of research findings. LMIC needs include institutionalized research capacity, as well as the capacity for translating research evidence into tobacco control policies, on country- and project-specific bases.

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)

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)

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

• At least one institution in the U.S. and one in an LMIC must be involved as partners in the grant application.
• Direct applications from LMIC institutions are encouraged.

Note: Hong Kong-based institutions are not eligible. Institutions in mainland China are eligible as an UMIC institution.

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.

• Program Directors/Principal Investigators (PDs/PIs) from a U.S. institution are required to collaborate with (an) investigator(s) from one or more LMIC institutions.
• Scientists from the U.S. submitting an application with a partner in UMIC are required to have an additional lower-middle or low-income country partner.
• Scientists from lower-middle and low-income countries are eligible to submit as PDs/PIs, but only with a U.S. institution/scientist partner.
• Scientists from institutions in UMICs are eligible to submit applications as PDs/PIs with a partner in a lower-middle or low-income country.
• Scientists from institutions in UMICs are not required to partner with a U.S. investigator/institution.

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 obtain 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:

Marya Levintova, Ph.D.
Telephone: 301-496-1653
Fax: 301-402-0779
Email: [email protected]

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

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

Project Narrative: Please include the name of the country/institution and briefly describe public health relevance of the planned research project.

All instructions in the SF424 (R&R) Application Guide must be followed. Include key collaborators in the foreign country(s).

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

Grantee Meetings will be convened periodically and may be organized as satellite meetings during tobacco control conferences (e.g. Society for Research on Nicotine and Tobacco, SRNT). The purpose of these meetings will be to exchange research and research-strengthening experiences and to coordinate program activities. Investigators should allocate funds for participation of both U.S. and LMIC partner(s) in three such conferences during the duration of the grant (years 1, 3, and 5).

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: Applicants should include a research capacity building plan, that: 1) demonstrates the need and rationale for the particular research capacity building activities proposed; 2) specifies the types of activities to be performed; 3) documents how the proposed activities will be performed; and 4) presents the expected outcomes of the proposed research capacity building activities. Where appropriate, awardees are strongly encouraged to track and document the impact of grant activities on tobacco control research capacity in the LMIC(s).

Establishing Research Priorities: The applicant should describe in detail how the proposed research relates to the burden of tobacco use and reflects the priorities of the collaborating LMIC(s).

Dissemination: All applications should describe dissemination strategies to be employed by the research project. In addition to publication of research results in the peer-reviewed literature, 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. Applications should include a detailed discussion of 1) how the results of the research being proposed can be rapidly disseminated and 2) how implementation of research findings could significantly reduce tobacco use in the community, country or region. Where appropriate, applications may include plans to collaborate with other stakeholders in the dissemination process (e.g., civil society or non-governmental organizations) to help to facilitate the translation of research findings into policy and practice.

Sustained Collaboration: Descriptions of plans to sustain research capacity in the LMIC must be included in the application, such as strategies for continued mentoring, which may be facilitated by a web-based reporting system, annual reports or other means.

Renewals: Grantees of the previous rounds of the International Tobacco and Health Research and Capacity Building Program should demonstrate both the capacity-building and research accomplishments of the previous grant period in their renewal submissions. This could be demonstrated by describing original research findings and publications, dissemination activities or the impact of research results, sustained or new collaborations among research partners, and the establishment of research programs in the LMIC.

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

1. Mobilizing human resources/expertise necessary for a successful collaboration of the project;

2. Providing in-kind resources (office space, equipment, library, logistic management etc.);

3. Facilitating dissemination of the research results;

4. Supporting the process of translating research evidence into practices/policies;

5. Institutionalizing the improved research capacity that results from this project.

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, 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.

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

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

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

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

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

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

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

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. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

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

See more tips for avoiding common errors.

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

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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 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? Is there a strong scientific premise for the project? 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?

Are the PD(s)/PI(s), 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?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Research Capacity Strengthening:

Does the proposed research strategy contain appropriate plans to develop related research capacity at the LMIC institution(s) as needed through mentoring and other models? In the course of research, will collaborating LMIC scientists and their institutions strengthen the capacity to conduct independent research and develop as 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)?

Dissemination:

Does the project provide a well-developed plan for dissemination of research results to various populations in LMICs?

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?

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?

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?

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.

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

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.

Not Applicable

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

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, methodologies 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 (GDS).

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

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 NCI, 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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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 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.
• Relevance of the proposed project to priorities of co-funding components.
• Geographic balance of programs.

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

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

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.

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

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

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 Service Desk (Questions regarding ASSIST, 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: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Marya Levintova, Ph.D.
Fogarty International Center (FIC))
Telephone: 301-496-1653
Email: [email protected]

Mark Parascandola, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6871
Email: [email protected]

Steve Gus, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-1118
Email: [email protected]

Referral Officer
National Cancer Institute
Telephone: 240-276-6390
Email: [email protected]

Mollie Shea
Fogarty International Center (FIC)
Telephone: 301-452-6830
Email: [email protected]

Carol Perry
National Cancer Institute (NCI)
Telephone: 240.276.6282
Email: [email protected]

Pam Fleming
National Institute on Drug Abuse (NIDA)
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 Part 75.