Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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. Notice of Funding Opportunity Description

Pre-Application Webinar

NIH anticipates holding a pre-application web-based teleconference to which all interested prospective applicants are invited. NIH Program and Review and FDA CTP staff persons will explain the goals and objectives of the notice of funding opportunity (NOFO), discuss the application peer review process, and answer questions. Information about this pre-application conference call will be available at (https://prevention.nih.gov/tobacco-regulatory-science-program).

Purpose

This Notice of Funding Opportunity (NOFO) invites applications for a Cooperative Agreement (U01) that will utilize health communication research to better understand the impact that messaging about the continuum of risk for tobacco products may have on various segments of the population. Applications should consider effects on audiences for whom the messaging could potentially be useful (i.e., adults who use combustible products) and on those for whom the messaging could have negative consequences (e.g., youth).

The NIH and the FDA have formed an interagency partnership to foster research relevant to tobacco regulatory science within the framework of the Family Smoking Prevention and Tobacco Control Act (FSPTCA). The awards under this NOFO will be administered by NIH using designated funds from the FDA Center for Tobacco Products (CTP) for tobacco regulatory science mandated by the FSPTCA. Funds for this program have been made available through the FSPTCA (P.L. 111-31). 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.

Additionally, the NIH and FDA recognize the need to diversify the scientific workforce within the NIH Tobacco Regulatory Science Program (TRSP) portfolio by enhancing the participation of individuals from diverse backgrounds, including those from groups identified as underrepresented (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html) in the biomedical, clinical, behavioral and social sciences research workforce. Diversity at all levels from the kinds of science to the regions in which it is conducted to the backgrounds of the people conducting it contributes to excellence in research training environments and strengthens the research enterprise. The NIH and FDA encourage applications proposing to support investigators from diverse backgrounds, including those from groups identified as underrepresented (see, e.g., NOT-OD-20-031) in the biomedical, clinical, behavioral, and social sciences research workforce.

Background

The 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA) granted FDA the authority to regulate the manufacture, marketing, and distribution of tobacco products in order to protect public health. To protect Americans from tobacco-related disease and death, FDA CTP provides information about the harms and risks associated with tobacco products and the dangers they pose to the public. Preventing and reducing tobacco use and exposure to secondhand smoke are key national public health goals.

Public education and communication efforts designed to discourage tobacco use have demonstrated effectiveness in educating about risks and harms of tobacco use, changing social norms and attitudes about tobacco use, reducing youth initiation of tobacco products, and encouraging tobacco cessation. While commercial combustible cigarette smoking has declined to historic lows over the last several decades, it remains the leading cause of preventable disease, disability, and death in the U.S. Additionally, disparities in tobacco-related behaviors, beliefs, and perceptions are well-documented, including greater burden of tobacco use among LGBTQ+ people, people with lower levels of educational attainment, and people of certain racial and ethnic groups. For example, although blacks initiate smoking at an older age than whites, they are more likely to die from smoking-related disease such as heart disease, and diabetes. Moreover, people with low-income experience unique social and environmental contextual challenges such as greater environmental cues to smoke and greater levels of perceived stress and social discrimination which impact the public health burden of tobacco use.

Over the past decade, the tobacco product marketplace has expanded to include an expansive landscape of both combustible and noncombustible tobacco products. There is no safe tobacco product. Therefore, abstaining from all tobacco product use confers the greatest benefit to health. Adults who use any tobacco products are advised to quit completely and should use FDA-approved cessation methods and evidence-based counseling.

Tobacco products are not uniform in the health risks they pose to users of the products. Combustible tobacco products (e.g., combustible cigarettes) generally pose the highest level of risk compared to non-combustible tobacco products. For adults who use combustible tobacco products, complete switching to lower-risk tobacco products may be considered. However, many people who use tobacco products hold inaccurate beliefs and misperceptions about nicotine and the risks of the various tobacco products currently on the U.S. market.

Research is needed to better understand these perceptions and examine how messaging about a continuum of risk for tobacco products may potentially impact various audiences. To date, the impact of such messaging has not been widely studied. For instance, a potential positive impact of this messaging may be that exposing adults who use combustible tobacco products who have not yet been able to quit to messaging about the continuum of risk for tobacco products may result in higher likelihood of completely switching to a lower risk non-combustible tobacco product. Alternatively, exposure to such messaging may also lead to negative effects, such as increasing initiation of these tobacco products among youth, inadvertently promoting multiple tobacco product use, and initiation of tobacco products among adults who formerly smoked.

Specific Research Objectives and Scope

The purpose of this Notice of Funding Opportunity (NOFO) is to seek applications for a single grant to understand the impact of continuum of risk messaging. The grantees will work collaboratively with NIH and FDA CTP to conduct research to inform the FDA CTP on the effects of potential health communication messaging about the continuum of risk for tobacco products.

The impact of messaging and education focused on the continuum of risk for tobacco products has not been widely studied, and more research, including behavioral impact studies, is needed to examine the effects of any such messaging on various audiences. This NOFO seeks prospective studies that investigate the effects of continuum of risk messaging on tobacco use behavior and other relevant outcomes on various audiences. This research should focus on (1) identifying effective messages and message characteristics about the continuum of risk for tobacco products, (2) how this messaging impacts perceptions, beliefs, comprehension, and behavioral intentions (e.g., intention to quit tobacco use completely, intention to switch from a higher risk to a lower risk tobacco product), and 3) tobacco product use behaviors (including cessation, dual/poly use, significant reduction in tobacco product use, and complete switching/substitution behaviors). To be responsive to the RFA, applications must examine the impact of such messaging on both (a) perceptions, beliefs, comprehension, and intentions; and (b) tobacco use behaviors.

Research findings should be applicable to risk perceptions, beliefs, intentions, and behaviors for specific product categories (such as combustible cigarettes, electronic nicotine delivery systems or ENDS, or smokeless tobacco products). This research must test continuum of risk messages and stimuli (with both text and visual components) to be provided by FDA. Additionally, this research may adapt FDA-provided stimuli/messaging and/or develop additional stimuli/messaging for testing, as appropriate. Any proposed messaging or stimuli for testing must rely on and present evidence-based scientific information.

This research must be conducted among adult users of tobacco products and youth, as described in areas 1 and 2 below. Participants must represent a mix of demographic characteristics (e.g., age, race, ethnicity, gender identity, sexual orientation, disability status, region/location and/or socio-economic status), so that study findings can be interpreted at the general population level. To examine the impact of messaging on adult subgroups, the studies may choose to segment adult populations by motivation to quit (e.g., those who do not intend to quit vs. those who intend to quit; those who are not ready to quit vs. those who are ready to quit; those who are not open to quitting vs. those who are open to quitting), while measuring sociocultural and contextual factors that are barriers to quitting. Additionally, the research should provide findings and insights for groups that experience tobacco-related health disparities where possible, such as conducting adequately-powered subgroup analyses. Other populations such as specific sociocultural or demographic subgroups, pregnant women, or people with chronic health conditions (e.g., cardiovascular disease) may be included, but if so, must be a secondary focus.

Investigators must address all areas below (i.e., 1a,b,c and 2a,b,c) to be responsive to this RFA.

1. Quantitative studies that examine effect of exposure to messaging about the tobacco product continuum of risk among adults who use combustible tobacco products). Additionally, the research must provide findings and insights for the following subgroup: adults who use combustible products and have not yet been able to quit. The studies must assess the effect of exposure to messaging about the continuum of risk on:

a. Message receptivity (e.g., perceived effectiveness, emotional response, psychological reactance to messaging), AND

b. Precursors to behavior (e.g., risk perception, beliefs, comprehension, susceptibility, change in intentions, motivation to quit at follow-up(s) compared to baseline), AND

c. Tobacco use behaviors (e.g., cessation, dual/poly use, partial reduction in tobacco product use, and complete switching/substitution behaviors) measured with at least one 6-month follow-up timepoint post exposure to messaging.

2. Quantitative studies that examine the effect of exposure to messaging about the tobacco product continuum of risk among other population(s) that could be impacted by messaging. These studies must include both youth (or proxies) who have never used tobacco products and youth (or proxies) who currently use non-combustible tobacco products. Applicants may propose to include proxies for certain youth populations (e.g., young adults aged 18-21 years old), if they provide adequate justification for why they are appropriate proxies and describe how findings can be extrapolated to youth. In addition, studies may include other populations such as adults who formerly used tobacco products; adults who have never used tobacco products; or adults who currently use non-combustible products but have never initiated combustible product use. The studies must assess the effect of exposure to messaging about the continuum of risk on:

a. Message response (e.g., emotional response, perceived relevance), AND

b. Precursors to behavior (e.g., risk perception, beliefs, comprehension, susceptibility, intentions, change in motivation to quit at follow-up(s) compared to baseline), AND

c. Tobacco use behaviors (e.g., cessation, initiation, dual/poly use, and completely switching/substitution behaviors) measured with at least one 6-month follow-up timepoint post exposure to messaging

Applications may also propose to conduct qualitative research, such as focus groups or in-depth interviews, with priority groups to assess (a) understanding and perceptions of continuum of risk for tobacco products to complement existing research in this area, and (b) comprehension, reactions, and responses to FDA-provided stimuli/messaging and/or researcher-developed stimuli/messaging on the continuum of risk for tobacco products.

Cooperative Agreement Governance:

Steering Committee: The grant activities will be governed by a Steering Committee, to be established. The Steering Committee shall monitor and advise on the following:

• Policies, procedures, and strategies that pertain to its health communication and messaging research activities; and
• Development of research activities, including identifying priority variables and populations for research, identifying message characteristics and message content to test; and
• Identification of findings that are priorities for reporting to the scientific community and other stakeholders.

Steering Committee Composition: The Steering Committee will work collaboratively across its membership, comprised of the following voting members:

• Recipients (PD(s)/PI(s))
• NCI Project Collaborator
• NIH TRSP Project Coordinator
• FDA CTP Scientific Staff
• FDA CTP Project Coordinator

Annual Steering Committee Meeting(s): An in-person Steering Committee meeting should be held at least one time a year. If conditions allow, the in-person meeting could be held in the Rockville/Bethesda, Maryland area to coincide with annual TRS grantee meetings. Applicants must budget appropriate funds to support travel of investigators and appropriate Center staff to in-person Steering Committee meetings.

Grantees will provide operational, administrative, and logistical support for Steering Committee meetings, including:

• Planning, organizing, and conducting meetings of the Steering Committee
• Compiling meeting minutes, delivering summary meeting reports, and coordinating post-meeting follow-up
• Providing technical or logistical support for meetings of subcommittees and workgroups including providing conference call lines and webinar support

Monthly Conference Calls: At minimum, a monthly virtual conference call that includes the federal partners should be held with the grantees (and external advisors as appropriate). During these monthly conference calls, the PD/PI(s) and selected members of their research team members will discuss scientific and administrative issues while providing updates to federal partners. In these meetings, PD/PI(s) and members of their research team personnel will provide operational, administrative, and logistical support, including planning, organizing, and conducting meetings, compiling meeting minutes, delivering summary meeting reports, and coordinating post-meeting follow-up. Federal partners are expected to participate and actively engage in the meetings and provide feedback/input.

External advisors: As appropriate, the Steering Committee may choose to consult external advisors with relevant expertise to address the goals of this NOFO and inform the measurement of subpopulations and contextual determinants that impact tobacco-related behaviors. When considering external advisors, applicants should not identify or contact proposed outside experts. Rather, they should explain what areas of expertise should be represented by outside experts who will serve throughout the grant period or on an ad hoc basis (e.g., areas of expertise plus analysis/methods, dissemination).

Notice of NIH's Interest in Diversity

Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further the NIH mission.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

Underrepresented Populations in the U.S. Biomedical, Clinical, Behavioral and Social Sciences Research Enterprise

In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences, such as:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering (http://www.nsf.gov/statistics/women/). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians, and other Pacific Islanders. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in this opportunity. For more information on racial and ethnic categories and definitions, see the OMB Revisions to the Standards for Classification of Federal Data on Race and Ethnicity (https://obamawhitehouse.archives.gov/omb/fedreg_1997standards).

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended (http://www.ada.gov/pubs/adastatute08.htm). See NSF data at, https://www.nsf.gov/statistics/2017/nsf17310/static/data/tab7-5.pdf.

C. Individuals from disadvantaged backgrounds, defined as those who meet two or more of the following criteria:

1. Were or currently are homeless, as defined by the McKinney-Vento Homeless Assistance Act (Definition: https://nche.ed.gov/mckinney-vento/);

2. Were or currently are in the foster care system, as defined by the Administration for Children and Families (Definition: https://www.acf.hhs.gov/cb/focus-areas/fostercare;

3. Were eligible for the Federal Free and Reduced Lunch Program for two or more years (Definition: https://www.fns.usda.gov/school-meals/income-eligibility-guidelines);

4. Have/had no parents or legal guardians who completed a bachelor’s degree (see https://nces.ed.gov/pubs2018/2018009.pdf);

5. Were or currently are eligible for Federal Pell grants (Definition: https://www2.ed.gov/programs/fpg/eligibility.html);

6. Received support from the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) as a parent or child (Definition: https://www.fns.usda.gov/wic/wic-eligibility-requirements).

7. Grew up in one of the following areas: a) a U.S. rural area, as designated by the Health Resources and Services Administration (HRSA) Rural Health Grants Eligibility Analyzer (https://data.hrsa.gov/tools/rural-health), or b) a Centers for Medicare and Medicaid Services-designated Low-Income and Health Professional Shortage Areas (https://www.qhpcertification.cms.gov/s/LowIncomeandHPSAZipCodeListingPY2020.xlsx?v=1) (qualifying zip codes are included in the file). Only one of the two possibilities in #7 can be used as a criterion for the disadvantaged background definition.

D. Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See e.g., From the NIH: A Systems Approach to Increasing the Diversity of Biomedical Research Workforce (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5008902/).

Women have been shown to be underrepresented in doctorate-granting research institutions at senior faculty levels in most biomedical-relevant disciplines, and may also be underrepresented at other faculty levels in some scientific disciplines (See data from the National Science Foundation National Center for Science and Engineering.

Statistics: Women, Minorities, and Persons with Disabilities in Science and Engineering, special report available at https://www.nsf.gov/statistics/2017/nsf17310/, especially Table 9-23, describing science, engineering, and health doctorate holders employed in universities and 4-year colleges, by broad occupation, sex, years since doctorate, and faculty rank).

Non-Responsive Research Topics

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

• Studies that only focus on modified risk tobacco products and modified risk claims as defined in section 911 of the Federal Food, Drug, and Cosmetic Act;
• Descriptive studies of consumer risk and harm perceptions that do not also examine the impact of exposure to messaging on tobacco use behaviors;
• Studies that develop, test, or evaluate health warning labels with graphics;
• Studies that develop, test, or evaluate packaging claims or descriptors found on packaging;
• Studies that examine non-tobacco products (e.g., cannabis or alcohol) on the continuum of risk for tobacco products;
• Studies that focus on risk and harm perceptions of nicotine replacement therapies (NRT), unless examined in comparison to tobacco products;
• Studies that focus on low nicotine content (LNC) or very low nicotine content (VLNC) tobacco products.

All proposed research specific aims must be within the regulatory authority of the FDA CTP in order to be deemed responsive to this NOFO. Applications that are nonresponsive will not be reviewed. As such, potential applicants are strongly encouraged to discuss responsiveness with the agency contacts named in Section VII of this RFA. Additional information, including Frequently Asked Questions and webinar announcements, 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 Harmonization for Tobacco Regulatory Research via the PhenX Toolkit: NIH and FDA encourage investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Tobacco Regulatory Research Collection of the PhenX Toolkit (www.phenxtoolkit.org).
• Tobacco Industry Funding of Applicants: The FDA CTP has adopted the following guidance regarding tobacco industry funding of applicants responding to this NOFO. 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. This includes any consulting relationships (paid or unpaid) with the tobacco industry or organizations supported in whole or in part by this industry. 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 NOFO.
• Recommended Guidelines for the Administration of Drugs to Human Subjects: NACDA also recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Web site at https://nida.nih.gov/research/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects.

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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 NOFO.

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)

Local 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)

Federal Governments

• 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 not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• 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.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; 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 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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

3. Additional Information on Eligibility

Number of Applications

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, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

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 NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity 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.

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 (TRSP)
Office of Disease Prevention
Telephone: 301-451-7464
Email: [email protected]

Page Limitations

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 NOFO.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed. The additional instructions apply:

Applicants must budget appropriate funds to support travel of investigators and appropriate Center staff to in-person Steering Committee meetings at least one time a year. If conditions allow, the in-person meeting could be held in the Rockville/Bethesda, Maryland area to coincide with annual TRS grantee meetings.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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 as provided in the SF424 (R&R) Application Guide.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.
• All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Center must provide NIH and FDA CTP with access to all the data generated under this award, subject to rules specified in any Certificate of Confidentiality obtained by the recipient.
• The research findings generated from this NOFO 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 (https://grants.nih.gov/policy/nihgps/index.htm).

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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.

PHS Assignment Request Form

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

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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 NOFO 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.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

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

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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 form. 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier 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 FDA and components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive to the scientific interest areas identified in this NOFO and/or proposing work outside FDA-CTP's regulatory authority will not be reviewed.

In order to expedite review, applicants are requested to notify the Tobacco Regulatory Science Program by email at [email protected] when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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.

Specific to this NOFO: does the application propose quantitative studies that examine effect of exposure to messaging about the tobacco product continuum of risk among adults who use combustible tobacco products, including the subgroup of adults who use combustible products and have not yet been able to quit? The studies must assess the effect of exposure to messaging about the continuum of risk on:

a. Message receptivity (e.g., perceived effectiveness, emotional response, psychological reactance to messaging), AND

b. Precursors to behavior (e.g., risk perception, beliefs, comprehension, susceptibility, change in intentions, motivation to quit at follow-up(s) compared to baseline), AND

c. Tobacco use behaviors (e.g., cessation, dual/poly use, partial reduction in tobacco product use, and complete switching/substitution behaviors) measured with at least one 6-month follow-up timepoint post exposure to messaging.

Specific to this NOFO: does the application propose quantitative studies that examine effect of exposure to messaging about the tobacco product continuum of risk among other population(s) that could be impacted by messaging including both youth (or proxies) who have never used tobacco products and youth (or proxies) who currently use non-combustible tobacco products. Do the studies assess the effect of exposure to messaging about the continuum of risk on:

a. Message response (e.g., emotional response, perceived relevance), AND

b. Precursors to behavior (e.g., risk perception, beliefs, comprehension, susceptibility, intentions, change in motivation to quit at follow-up(s) compared to baseline), AND

c. Tobacco use behaviors (e.g., cessation, initiation, dual/poly use, and completely switching/substitution behaviors) measured with at least one 6-month follow-up timepoint post exposure to messaging.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, 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 will receive a written critique.

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.

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

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 NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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

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

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

Milestones: Future support of a study funded under this NOFO is contingent upon adequate participant recruitment based on projected milestones.

Investigational Tobacco Products: Currently there are no federal regulations regarding clinical research involving the use of investigational tobacco products. The Draft Guidance on Use of Investigational Tobacco Products describes the Agency’s current thinking regarding the definition of investigational tobacco product and the kinds of information FDA intends to consider in making enforcement decisions regarding the use of investigational tobacco products until regulations are issued and become effective. In addition, FDA has provided information regarding research to be conducted using newly deemed tobacco products in the Guidance for Industry Investigational Use of Deemed Finished Tobacco Products that were on the U.S. Market on August 8, 2016, during the Deeming Compliance Periods.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

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 NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 45 CFR Part 75 and 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH and FDA programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH and FDA as defined below.

The PD/PI of the Center will have the following responsibilities:

• Defining objectives and approaches for individual research activities;
• Overseeing the planning and conducting of studies for their research projects, data analyses, and interpretation;
• Ensuring the conducted research remains within the scope of the regulatory authority of the FDA CTP;
• Ensuring and overseeing timely results reporting, including preparation and publication of scientifically rigorous manuscripts and dissemination of relevant findings by other appropriate means;
• Serving as members of the Steering Committee and participating in relevant subcommittees;
• Attending the annual TRS Investigator Meeting;
• Accepting and implementing priorities, procedures, and policies agreed upon by the Steering Committee to the extent consistent with applicable grant regulations;
• Overseeing the implementation for their projects approved by the Steering Committee;
• Informing the NIH Program Official of plans to change or modify any project’s specific aims or research strategy, and obtaining receipt of NIH and FDA approvals prior to the implementation of changes and expenditure of funds;
• Cooperating with other TRS-funded investigators, and with Federal staff members in various joint activities; examples include: research collaborations and working groups;
• Coordinating, as needed, activities associated with CTP-funded research projects; and
• Cooperating with the Federal staff members and/or external evaluators in the course of an evaluation process;

Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH and FDA staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

Designated NCI scientific staff, acting as the Project Collaborator, will have the following responsibilities reflecting substantial scientific-programmatic involvement:

• Reviewing the progress of the recipient;
• Serve as a resource for specific information on NCI's programmatic intentions and priorities, and help to foster collaborations between researchers, public health, and public policy partners both within and across other Federal agencies to increase the value of research to these participants;
• Providing advice and technical assistance regarding the conduct of research;
• Play an active role in developing innovative methodological strategies to support data harmonization (e.g., data quality control, assessing and resolving cross-site variation) comparability);
• Identify relevant research questions. He/she may cooperate with recipients in the development, design, and coordination of research plans and reports; and

In instances where significant involvement in the design of studies and/or analysis of results has occurred, the NIH and FDA may cooperate with recipients as coauthors in preparing publications of data resulting from the research. In this regard, he/she will be subject to the publication/authorship policies governing all participants. In addition, publications involving NIH and/or FDA staff require internal clearances.

In addition, a designated NCI program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NCI Program Official, who will not participate in the research or the preparation of publications, will be responsible for the oversight of the cooperative agreement. The Program Official carries primary responsibility for:

• Periodic review and monitoring, and approval of the progress of the research plans in relation to their stated objectives, including consistent communication with the PI and the project staff, as well as requests for additional reports or documentation;
• Making recommendations regarding continuance of the program. The NCI Program Official will be responsible for monitoring the conduct of the project and overseeing the project. The Program Official will receive all required progress reports to determine that satisfactory progress is being made and will work collaboratively with the NCI Grants Management Specialist to assure high-quality business management of the program, including the most effective use of Federal financial assistance provided through this cooperative agreement.

Designated NIH Tobacco Regulatory Science Program (TRSP) scientific staff, acting as a Project Coordinator, will have the following responsibilities reflecting substantial scientific-programmatic involvement:

• Serving as member of the Steering Committee;
• Providing technical assistance, advice, and coordination of efforts to recipient;
• Helping to coordinate collaborative efforts that involve multiple recipients;
• Identifying and providing relevant content expertise on behalf of NIH and FDA, and serving in a liaison role;
• Cooperating with the recipient to support the research and dissemination of findings of the individual projects;
• Assisting the Steering Committee in developing and drafting operating policies and policies for dealing with recurring situations that require coordinated action;
• Monitoring the project for responsiveness to FDA CTP regulatory authorities; and
• Reviewing (together with NIH and FDA partners) the research progress.

Designated Food and Drug Administration (FDA) Center for Tobacco Products (CTP) scientific staff, acting as Project Coordinators, will have the following responsibilities reflecting substantial scientific-programmatic involvement:

• Serving as members of the Steering Committee;
• Providing technical assistance, scientific input, and coordination of efforts to the project;
• Identifying and providing relevant content expertise to the research projects, as needed;
• Cooperating with the PDs/PIs to support the research and dissemination of findings;
• Assisting the Steering Committee in developing and drafting operating policies and policies for dealing with recurring situations that require coordinated action; and
• Reviewing (together with NIH program officials) the research progress and compliance with the components to collaborative efforts.

Additional NIH and FDA staff may participate in all project-related meetings and work groups as appropriate. Participation by staff from other federal agencies may also be appropriate and advantageous to facilitate the activities of the program.

The NIH reserves the option to recommend withholding or reduction of support from activities that fail to achieve their goal or comply with the Terms and Conditions.

The Government, via the NIH and FDA Project Coordinators, Project Collaborators, and Program Officials, will have access to data generated under this Cooperative Agreement through grantee meetings and progress reports. Federal staff may use information obtained from the data for the preparation of internal reports on the activities of the study.

Areas of Joint Responsibility include:

Steering Committee

Roles. The Steering Committee will be the main governing body for this initiative and will provide input on scientific matters. The Steering Committee members will provide scientific and technical input into discussions of collaborative research projects where relevant.

The Steering Committee, in partnership with NIH and FDA members, will monitor the progress of these projects, facilitate common data sharing and group publications and identify common resources to support such efforts.

• The recipient, NCI Project Collaborator, and TRSP and FDA Project Coordinators (federal partners) will jointly propose and select members of the Steering Committee. The Recipient and federal partners will jointly plan agendas for meetings.
• The dissemination plan will be jointly developed and mutually acceptable to both the recipient and federal partners.
• Status reports in the format of conference calls with federal partners will take place on a monthly basis or more frequently, as needed. These reports will include information concerning project progress, obstacles and steps taken to remedy them. Status reports will also discuss the results of studies as they become available.

Steering Committee Composition. The Steering Committee will consist of the following members:

• Recipients (PD(s)/PI(s))
• NCI Project Collaborator
• NIH TRSP Project Coordinator
• FDA CTP Scientific Staff
• FDA CTP Project Coordinator

NIH and FDA reserve the right to augment the scientific expertise of the Steering Committee as it deems necessary.

All Recipients will be required to accept and implement policies approved by the Steering Committee to the extent consistent with corresponding grant regulations.

NIH staff will maintain authority on all matters regarding funding or expenditure of funds.

Meeting(s)

An in-person Steering Committee meeting will meet, at minimum, one time a year. If conditions allow, the in-person meeting could be held in the Rockville/Bethesda, Maryland area to coincide with annual TRS grantee meetings.

Virtual conference calls will occur monthly, at minimum, and will include federal partners, recipients , and external advisors (as appropriate). During these monthly conference calls, the PD/PI(s) and selected members of their research team members will discuss scientific and administrative issues while providing updates to federal partners. In these meetings, PD/PI(s) and members of their research team personnel will provide operational, administrative, and logistical support, including planning, organizing, and conducting meetings, compiling meeting minutes, delivering summary meeting reports, and coordinating post-meeting follow-up. Federal partners are expected to participate and actively engage in the meetings and provide feedback/input.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A Mid-Period Progress Report (MPPR) will be due every six (6) months following the project start date, including during an extension year if applicable, in addition to the standard annual progress report. Electronic copies should be sent to the NCI Office of Grants Administration at [email protected]. The scientific summary should be a maximum of two (2) pages.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Maria Roditis, Ph.D., MPH
National Cancer Institute (NCI)
Telephone: (240) 276-5326
Email: [email protected]

Center for Scientific Review (CSR)
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.