Part 1. Overview Information

Key Dates

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from 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 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to invite R21 applications proposing the innovative analysis of existing (publicly available) nationally representative U.S. cross-sectional and longitudinal data, to investigate novel scientific ideas and/or to generate new models, systems, tools, methods, or technologies that have the potential for significant impact on biomedical or biobehavioral research in areas relevant to the Food and Drug Administration (FDA) - Center for Tobacco Products (CTP). Other publicly available data sets would be considered depending on the analyses to be conducted; however, nationally representative analyses will receive priority. Applications not using nationally representative data sets will need to provide justification why the data set is unique, and why the research questions cannot be answered from a (publicly available) nationally representative data set. This FOA encourages the analyses of public use datasets that may inform tobacco regulatory actions in the United States (U.S.).

The awards under this FOA will be administered by NIH using funds that have been made available through FDA-CTP and the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31). Research results from this FOA are expected to generate findings and data that are directly relevant in informing the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health. Research Projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) - Center for Tobacco Products (CTP).

Background

The Family Smoking Prevention and Tobacco Control Act (FSPTCA), signed by the President in June 2009, created the FDA Center for Tobacco Products and granted it authority to regulate the manufacture, marketing, and distribution of tobacco products in order to protect public health. Under the law, FDA regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products. The law also gave FDA the ability to regulate additional tobacco products, commonly referred to as deeming them through rulemaking. A full description of the FSPTCA can be found at: https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/family-smoking-prevention-and-tobacco-control-act-overview.

FDA finalized the deeming rule, effective August 8, 2016 "to regulate all tobacco products that were not under its jurisdiction that meets the statutory definition of tobacco product , including Electronic Nicotine Delivery Systems or ENDS (e.g., e-cigarettes, vape pens), cigars, pipe tobacco, gels, hookah (waterpipe) tobacco, and future tobacco products, but not including accessories of newly deemed products." Products deemed under this rule are subject to the same FD&C Act provisions that cigarettes, roll-your-own tobacco, and smokeless tobacco are subject to, including but not limited to: (1) required submission of ingredient listing and reporting of harmful and potentially harmful constituents (HPHCs) for all tobacco products; (2) prohibition against use of modified risk descriptors (e.g., light, low, and mild descriptors) and claims unless FDA issues an order permitting their use; and (3) premarket review requirements. These actions will improve the public health by affording FDA information regarding the health risks of such products, evaluating whether marketing of new products would be appropriate for the protection of public health or are substantially equivalent to an identified predicate product, and preventing misleading claims about the relative risk of tobacco products. In addition, FDA has the authority to develop product standards, when appropriate for the protection of public health.

Program Scope and Research Objectives

Science will inform the FDA in regulation of the manufacture, marketing, and distribution of tobacco products in order to reduce the public health toll from tobacco product use in the United States.

Existing Datasets

This mechanism may be used to analyze cross-sectional or longitudinal data including knowledge, attitudes, perceptions, behaviors, dependence, toxicity, and health effects. This includes, but is not limited to data from the Population Assessment of Tobacco and Health (PATH) Study, the National Youth Tobacco Survey (NYTS), the Tobacco Use Supplement to the Current Population Survey (TUS-CPS), the National Adult Tobacco Survey (NATS), the National Health Interview Survey (NHIS), the Behavior Risk Factor Surveillance System (BRFSS), the Monitoring the Future surveys (MTF), the National Survey on Drug Use and Health (NSDUH), the National Health and Nutrition Examination Survey (NHANES), the Health Information National Trends Survey (HINTS), and the NIH sponsored National Longitudinal Mortality Study-Tobacco Use Follow-up (NLMS). Additional NIH data repositories can be found at https://www.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html. Survey data sets may also be merged or linked to other existing datasets, e.g., geographic characteristics or policy information by region, state, or locality can be linked to existing national survey data, as appropriate to address a research question(s). Another type of example is linking directly or indirectly to the TUS-CPS public use datasets or to other CPS Supplement data due to the panel nature of the CPS such as the Internet and Computer Use, Annual Social and Economic Supplement (ASEC), and American Time Use Survey (ATUS), etc.

SCIENTIFIC INTEREST AREAS

FDA-CTP is particularly interested in innovative analyses of extant data, including new aims that are being addressed with existing data, new or advanced methods of analyses, or novel combination and integration of datasets to allow the exploration of new research questions. Applications should not propose to carry out currently ongoing data analysis or the maintenance and distribution of data sets. Research using extant data that analyzes effects or outcomes that were not previously examined in the original scope of research is a priority for this announcement. Thus, the proposed research should be distinct from the aims and methods of the primary research under which the data were collected. For example, datasets collected for other purposes might be reanalyzed to identify:

1) patterns of tobacco use, including associated factors

2) tobacco product characteristics, such as flavors

3) perceptions of product harm

4) health effects from tobacco use, and

5) tobacco marketing and communication practices

Applicants should consider the risk for spurious findings when conducting multiple analyses and/or using large datasets and are encouraged to address this potential concern in the application. Current FDA-CTP research priorities can be found here: https://prevention.nih.gov/tobacco-regulatory-science-program/tobacco-regulatory-research-priorities.

Priority research questions that fall within the scope of this FOA include, but are not limited to the following:

• Identify and explain between-persons differences and within-person changes in tobacco-use patterns, including the frequency and duration of use by specific product type and brand, product/brand switching over time, uptake of new products, and dual- and poly-use of tobacco products (i.e., use of multiple products within the same time-period and switching between multiple products);
• Examine the role of ENDS in the initiation of and use of other tobacco products, including the increase in tobacco product(s) use, cessation of tobacco product use, or relapse to tobacco. Planned analyses should take into consideration product characteristics such as flavors and/or device types;
• Identify tobacco use behavior patterns associated with cigarette smoking initiation, cessation, relapse and switching among tobacco products. Planned analyses should take into consideration product characteristics including flavors;
• Assess between-persons differences and within-person changes over time in attitudes, behaviors, exposure to tobacco products and related biomarkers among and within population sub-groups identified by such characteristics as race-ethnicity, gender, age, sexual orientation, SES, urban/rural, and/or time in the United States or by risk factors, such as pregnancy or co-occurring substance use or mental health disorders or by disease status;
• Examine the effect of different quantities and counts of tobacco products (e.g., amount of loose smokeless tobacco per package, number of cigars per package, number of snus pouches/portioned moist snuff per package) on trial, experimentation, and initiation among never tobacco using youth and young adults and increased use/frequency, product switching and delayed cessation among current tobacco users;
• Examine the pattern of use of flavored tobacco products (i.e., what flavors are used at what point during tobacco use transitions) associated with: 1) transitions from never use to established use of tobacco products (including ENDS); and 2) transitions from established use of tobacco products (including ENDS) to complete cessation of all tobacco products;
• Examine how measures of comprehension and understanding of tobacco product risk (both absolute and comparative) relate to tobacco product use;
• Examine how tobacco product marketing, packaging, and/or labeling of newly deemed tobacco products (across various types of tobacco product categories) relate to patterns of product use (including dual use, transitions, and switching behavior) among youth, young adults, and adults;
• Examine health outcomes from various tobacco product types, not to include cigarettes.
• Examine the long and short-term health effects of transitioning from combustible to non-combustible tobacco and from non-combustible to combustible tobacco, using biomarker and/ health outcomes; and
• Compare biomarker expression profiles with self-reported use of tobacco products, and analyze measures associated with biomarkers of exposure that may inform risk associated with tobacco exposure for mortality/morbidity by age, sex, and race/ethnicity.

Applications may focus on one or more classes of tobacco products. If a vulnerable population will be included, applicants will be expected to identify the population and how the population is important to the research question, considering the impact on population health. Vulnerable populations include:

• Youth and young adults
• Race/ethnicity
• Low SES
• Rural populations
• People with mental health or medical co-morbidities
• Military/veterans
• The LBGTQ community
• Pregnant women/women of reproductive age

NON-RESPONSIVE RESEARCH TOPICS

Although the following research topics may be within FDA CTP’s regulatory authorities to fund, they are not to be included in the FOA and will be deemed non-responsive:

• Applications that do not use existing data
• Applications focusing on non-tobacco products
• Graphic health warnings for cigarette packages and advertisements
• Communicating harmful and potentially harmful constituents to the public
• Impacts of marketing restrictions on adults
• Studies of demographics and/or risk perceptions that describe only exposure to advertising without linking exposure to tobacco use behaviors.

Projects must propose research aims that are within the regulatory authority of FDA CTP and the scientific interest areas identified in this FOA in order to be considered responsive to this FOA. Research proposed in applications from foreign institutions must be specific to the United States population and provide information that will be useful to United States regulations. As such, investigators are strongly encouraged to discuss whether their application is responsive to this FOA with a Scientific/Research Contact, listed in Section VII, prior to submission of their application. Additional information, including research priorities and a Frequently Asked Questions document can be found at: http://prevention.nih.gov/tobacco/

SPECIAL CONSIDERATIONS

Applicants should keep the following special considerations in mind as they prepare their applications:

Data used for these research projects should meet the below ethical conditions:

• Data used should be de-identified before release to the researcher;
• Study participants should have provided their consent, or it can be reasonably presumed that consent has been received;
• Outcomes of the analysis must not allow re-identifying participants; and
• Use of the data should not result in any damage or distress to study participants.
• Tobacco Industry Funding of Applicants: The FDA CTP has adopted the following guidance regarding tobacco industry funding of applicants responding to this FOA.
  • The National Advisory Council on Drug Abuse (NACDA) has set forth points with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community. Please see (https://www.drugabuse.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/council-statements/points-to-consider-regarding-tobacco-industry-funding-nida) for details. While this guidance was originally issued for NIDA applicants, it is relevant for all applications submitted under this FOA.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

• 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)

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) 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration , but all registrations must be in place by time of submission. 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.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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)

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

Letter of Intent

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:

Tobacco Regulatory Science Program
Office of Disease Prevention
6100 Executive Blvd.
Room 3B01, MSC 7530
Bethesda, MD 20892-7530 (use Rockville, MD 20852 for Express Mail)
Telephone: 301-451-7464
Fax: 301-480-2230
Email:[email protected]

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

Research Strategy: The research strategy must explicitly state how the expected results will inform tobacco product regulatory activities and actions.

The following modifications also apply:

The research findings generated from this FOA may be used to provide scientific evidence informing the regulation of the manufacture, distribution, and marketing of tobacco products to protect public health. If the research data are cited publicly in support of regulation, institutions of higher education, hospitals, and other non-profit organizations are subject to the Freedom of Information Act (FOIA) as outlined in 2 CFR 200 (http://gpo.gov/fdsys/pkg/CFR-2015-title2-vol1/pdf/CFR-2015-title2-vol1-part200.pdf ) and the NIH.

Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps_2011/nihgps_ch2.htm#info_confidentiality[).

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

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).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.

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

Awards funded under this FOA are not subject to SNAP authorities and do not have authority for the carryover of unobligated balances from budget period to any subsequent budget period without prior written approval from NIH. Special reporting requirements also apply, as described in Section VI.3. Reporting.