Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

U.S. Food and Drug Administration (FDA)

Components of Participating Organizations

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute on Drug Abuse (NIDA)

National Institute of Environmental Health Sciences (NIEHS)

National Cancer Institute (NCI)

Funding Opportunity Title
Tobacco Regulatory Science (R01 Clinical Trial Optional)
Activity Code

R01 Research Project Grant

Announcement Type
Reissue of RFA-OD-21-002
Related Notices
  • November 27, 2023 - Notice of Correction to the Assistance Listing Number(s) for RFA-OD-23-017. See Notice NOT-OD-24-030.
  • NOT-OD-22-195 New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023

    NOT-OD-22-189 Implementation Details for the NIH Data Management and Sharing Policy

    NOT-OD-22-198 Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023

    NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available

    Notice of Funding Opportunity (NOFO) Number
    RFA-OD-23-017
    Companion Funding Opportunity
    None
    Assistance Listing Number(s)
    93.077
    Funding Opportunity Purpose

    The purpose of this Notice of Funding Opportunity (NOFO) is to invite R01 applications to support biomedical and behavioral research that will provide scientific data to inform regulation 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). The awards under this NOFO 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 NOFO 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.

    Key Dates

    Posted Date
    May 04, 2023
    Open Date (Earliest Submission Date)
    September 06, 2023
    Letter of Intent Due Date(s)

    60 days prior to the application due date. Please note, although LOIs are typically due 30 days before the due date, for this NOFO LOIs are due 60 days prior to the application date.

    Application Due Dates Review and Award Cycles
    New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
    October 06, 2023 October 06, 2023 Not Applicable February 2024 May 2024 July 2024
    May 06, 2024 May 06, 2024 Not Applicable July 2024 October 2024 December 2024
    October 04, 2024 October 04, 2024 Not Applicable February 2025 May 2025 July 2025
    May 02, 2025 May 02, 2025 Not Applicable July 2025 October 2025 December 2025

    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 Funding Opportunity Announcement.

    Expiration Date
    May 05, 2025
    Due Dates for E.O. 12372

    Not Applicable

    Required Application Instructions

    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 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.

    There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

    1. Use the NIH ASSIST system to prepare, submit and track your application online.
    2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

    3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


    4. Table of Contents

    Part 2. Full Text of Announcement

    Section I. Notice of Funding Opportunity Description

    Background

    Since 2009, FDA has regulated cigarettes, smokeless, and roll-your-own tobacco. FDA finalized a rule, effective August 8, 2016, to regulate all tobacco products including electronic nicotine delivery systems or ENDS (e.g., vapes, vaporizers, vape pens, hookah pens, electronic cigarettes (e-cigarettes or e-cigs), and e-pipes), cigars, pipe tobacco, gels, hookah (waterpipe) tobacco, and future tobacco products. Tobacco products are subject to provisions outlined in the FD&C Act. FDA also has the authority to develop tobacco product standards, when appropriate for the protection of public health.

    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-table-contents

    Program Scope and Research Objectives

    The FDA and NIH share interest in supporting research that could inform FDA's tobacco regulatory authorities. To that end, the research encouraged by this NOFO is expected to provide additional scientific data to the research base to inform regulation of tobacco products to protect public health. Although a vast and sound science base exists with regard to numerous areas related to the FSPTCA, new research will provide additional science for the FDA to consider as it implements the FSPTCA.

    Consistent with the FDA CTP mission, this NOFO encourages research applications that address such Scientific Domains as: 1) understanding the composition and design of tobacco products, 2) approaches that test the toxicity of tobacco smoke, aerosol, or specific constituents, 3) the effect of tobacco product characteristics on addiction and abuse liability, 4) the short- and long-term health effects of tobacco products, 5) understanding the knowledge, attitudes, perceptions, and behaviors related to tobacco product use, 6) understanding how to effectively communicate the health effects of tobacco products use, 7) the influences of tobacco marketing, and 8) understanding the impact of potential FDA regulatory actions.

    Where appropriate to the research question, applications may focus on populations or groups that bear disproportionate burden of tobacco product risk and harm. If a population experiencing tobacco-related disparities 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. Populations can include (but are not limited to):

    Youth and young adults

    Those from lower socioeconomic backgrounds (e.g., those with lower household incomes or lower educational attainment)

    Racial or ethnic minorities

    Sexual and/or gender minorities

    Rural populations

    Those pregnant or trying to become pregnant

    Active-duty military or veterans

    Those who are or have been incarcerated

    Those with mental health conditions or substance use disorders

    SCIENTIFIC DOMAINS

    Product Composition and Design Understanding the chemical constituents in tobacco products and the methods for measuring them across products with diverse characteristics*. Priorities include:

    • Determination of smoking, heat-generating, or aerosol-generating regimen to be used for measuring harmful and potentially harmful constituents (HPHC) in smoke (e.g., cigarettes, pipes) and aerosols (e.g., ENDS, heated tobacco products);
    • Identification, quantification, and determination of the formation of the chemical constituents of novel tobacco products including ENDS aerosols or other aerosol-generating tobacco products;
    • Determination of relationship between the nonadjustable or user adjustable design parameters of heating element temperature/wicking material/air flow of ENDS devices or other aerosol-generating tobacco products and constituent yields/particle size in the aerosol;
    • Determination of the relationship between waterpipe materials/design of waterpipe devices and constituent yields in the waterpipe smoke;
    • Development of internationally recognized analytical methods applicable to various tobacco types;
    • Development of methods to evaluate nicotine release across different smokeless tobacco products (e.g., snuff/dip, snus, chew);
    • Characterization of the antimicrobial activity of propylene glycol (PG), vegetable glycerin (VG), and flavor ingredients;
    • Determination of relationship between humectant concentration or type and water activity of waterpipe, pipe, and cigar tobacco;
    • Characterization of the relationship between intrinsic/extrinsic factors (e.g., battery design; environmental conditions, use conditions [e.g., changing battery, charging]) and ENDS battery overheating, fire, or explosion incidents.

    Toxicity Understanding how tobacco products and changes to tobacco product characteristics* affect their potential to cause morbidity and mortality in users and nonusers through secondary exposure; including animal (in vivo) and cell culture (in vitro) models, as well as novel alternative toxicology approaches that test the toxicity of tobacco smoke (other than cigarette), aerosols, or specific constituents in tobacco and the tobacco product. Priorities include:

    • Evaluation of toxicity from exposures to complex mixtures of tobacco-related constituents in ENDS aerosol, waterpipe smoke, cigar smoke, and smokeless tobacco using toxicological assays such as in vivo, in silico, as well as in vitro models that are more physiologically relevant to humans.
    • How product design characteristics* (variation(s) in those characteristics*) impact constituent exposure and toxicity from tobacco products;
    • Biomarkers to assess exposure, as well as biomarkers to assess harm or toxicity of products other than conventional cigarettes, including ENDS and waterpipes; and toxicological impact of nicotine, flavors, and other constituents across different concentrations, patterns of use behavior (dual/poly use, product switching) and routes of exposure.

    Addiction Understanding the effect of tobacco product characteristics* on addiction and abuse liability across populations. Priorities include:

    • Impact of changes in tobacco product characteristics* (such as flavors, product design, and nicotine formulation) on dependence and use behaviors;
    • Correlation of ENDS use behaviors with pharmacokinetic and pharmacodynamics effects of nicotine and other HPHCs delivered by ENDS; and the relationship between specific flavor categories in ENDS (including, but not limited to, tobacco, menthol, fruit, and sweet/dessert) and adult users interest in cessation as well as quit attempts, reduced cigarette use and/or switching to potentially less harmful tobacco products;
    • ENDS users biomarkers of exposure during ENDS experimentation, regular ENDS use, and dual use of ENDS and cigarettes (with reduced cigarettes per day and maintaining cigarettes per day);
    • Impact of synthetic coolants in ENDS and cigarettes on product abuse liability (e.g., nicotine pharmacokinetics, product subjective effects), dependence, and use behaviors (such as progression to regular product use, switching, and cessation).

    Health Effects Understanding the short- and long-term health effects of tobacco products (excluding conventional cigarettes) with priority on longitudinal data. Areas of interest include cardiovascular, cancer, neurological (e.g., seizures), oral, reproductive, and respiratory health effects (including inflammation and lung disorders (e.g., asthma, COPD). Priorities include:

    • Impact of tobacco product characteristics* (such as e-liquid non-tobacco flavors, product design, e-liquid nicotine concentration, nicotine formulation) on human health;
    • Impact of novel product use (e.g., ENDS, heated tobacco products) on biomarkers of exposure and biomarkers of potential harm;
    • Association between exclusive products other than conventional cigarette-related exposures and disease risk; association between dual/poly use of tobacco products and disease risk;
    • Identifying biomarkers of potential harm to assess short- and long-term health effects of tobacco products, with a focus on products other than conventional cigarettes, including deemed products or other novel products;
    • Association between cigar sub-types use and disease risk;
    • Association between waterpipe and waterpipe materials use and disease risk.

    Behavior Understanding the knowledge, attitudes, perceptions, and behaviors related to tobacco product use and the impact of tobacco product characteristics* on behaviors across populations, as appropriate. Priorities include:

    • The impact of tobacco product characteristics* (such as e-liquid flavors, product design, nicotine concentration, and formulations) on tobacco use preferences and behaviors (such as intentions to use, experimentation, initiation, progression, dual/poly tobacco use, switching, and cessation-related behaviors) among youth, young adults, and adults;
    • Innovative methods, measures, and study designs to assess tobacco use knowledge, attitudes, perceptions, and behaviors; including measures to best predict future use of tobacco products other than conventional cigarettes (e.g., cigars, waterpipe, heated tobacco products, ENDS);
    • Innovative measures, methods, or study designs to assess the likely impact of ENDS and heated tobacco products, other novel products, and/or potential modified risk tobacco products on relevant outcomes, including precursors to tobacco use (e.g., perceptions, intentions, susceptibility), and tobacco use behaviors including experimentation, initiation, progression, dual/poly use, complete switching, and cessation-related behaviors.

    Communications Understanding how to effectively communicate to the public regarding nicotine and the health effects of tobacco products through media campaigns and digital media. Priorities include:

    • Identifying effective tobacco education messages, message components, and communication channels to prevent initiation and to counter uptake of ENDS use and other novel product use by youth and young adults;
    • Developing methods to measure and track attention to tobacco education messages delivered on digital channels;
    • Developing strategies to increase attention to and engagement with tobacco education messages delivered on digital channels;
    • Identifying messages to effectively communicate about the risks associated with nicotine use and the potential relative harms of tobacco products other than conventional cigarettes use;
    • Developing methods and messages for communicating complex scientific concepts to the general public, including information about the relative risks and harms of tobacco use (e.g., continuum of harm/harm reduction) while assessing and minimizing unintended consequences of such messages;
    • Evaluating the effectiveness of text and pictorial warnings for tobacco products other than conventional cigarettes;
    • Developing effective messages and communication for educating consumers about the health effects of cigars, waterpipe, heated tobacco products, ENDS, and novel tobacco products; and their relative harms as compared to cigarettes.

    Marketing Influences Understanding the impact of marketing on susceptibility to and initiation of using tobacco products (both classes of products and products within classes) and transitions between experimentation, initiation, regular use, product switching, dual use, and cessation-related behaviors among different populations. Topics may include marketing such as advertising, digital media, and promotions. Priorities include:

    • Methods, measures, and study designs to best assess the impact of tobacco product marketing (advertising and promotion) restrictions on users and non-users of tobacco with attention to populations that bear disproportionate burden of tobacco product risk and harm (if appropriate), including marketing of new/novel tobacco products;
    • Understanding what components of ENDS marketing have the greatest impact on youth and young adults ENDS knowledge, attitudes, perceptions, beliefs, and behaviors;
    • Understanding how labeling, marketing, and advertising impact abuse liability, appeal, perceptions, and intentions to use different tobacco products;
    • Examining the impact of potential marketing restrictions of new/novel tobacco products on various initiation and use behaviors (e.g., experimentation, initiation, use, and cessation) across developmental age groups (e.g., youth, young adult, non-user), as well as on adult continued use, dual use, switching, and cessation;
    • Examining the impact of exposure to digital tobacco marketing on youth tobacco initiation and sustained use, including prevalence and frequency of exposure on different digital channels and the impact of social media influencers and other marketing partners (e.g., musicians).

    Impact Analysis Understanding the potential or actual impact of FDA regulatory actions. Priorities include:

    • Evaluation of local, state, federal, and international policies that are relevant to FDA CTP regulatory authorities (e.g., flavor bans, specific constituent changes or bans, minimum legal sales age, FDA-required cigarette health warnings), with a focus on effects on tobacco use/behavioral outcomes, including tobacco initiation and increasing use among youth and young adults, cigarette cessation and product switching among users, and prevalence change in populations that bear disproportionate burden of tobacco product risk and harm; as well as unintended consequences;
    • Evaluation of tobacco product marketing authorizations of new/novel products (e.g., PMTA, MRTPA), such as potential impact on health outcomes and effects on tobacco use/behavioral outcomes, including patterns of use among users (e.g., dual use vs. switching) and initiation among unintended users (e.g., use by youth);
    • Behavioral economics experiments and population-based modeling studies to estimate the range of potential impacts on behavior and health of potential FDA regulatory actions such as product standards addressing toxicity, appeal, and addiction (e.g., such as a ban on flavored cigars, a ban on menthol in cigarettes and cigars, lowering nicotine in combustible cigarettes, and ban on flavors that appeal to youth in any tobacco product);
    • Evaluations of the differential impact and/or possible unintended consequences of tobacco regulatory actions among specific populations and, as appropriate, addressing how such actions may affect populations that bear disproportionate burden of tobacco product risk and harm;
    • Health risk analysis at the population level to estimate the potential public health impacts of FDA regulatory actions such as tobacco product marketing authorizations of new/novel products (e.g., PMTA).

    *The term characteristic encompasses materials, ingredients (including additives, nicotine formulations, and flavors), design, composition, heating source, and other features of a tobacco product, including harmful and potentially harmful constituents. Product characteristics can be incorporated into all the above topics.

    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 NOFO and will be deemed non-responsive:

    • Studies of short-term health effects and/or acute topography/clinical pharmacology testing of early generation ENDS products;
    • Mechanistic studies (i.e., basic science of disease development) unless biomarkers of harm with predictive value for disease development associated with tobacco product use is an outcome;
    • Short-term studies of the acute effects of reduced nicotine content cigarettes;
    • Studies developing or testing or evaluating graphic health warnings for cigarette packages and advertisements;
    • Communicating harmful and potentially harmful constituents to the public;
    • Impacts of marketing restrictions on adults except for studies on newly authorized products;
    • Descriptive studies of demographics and/or risk perceptions that describe only exposure to advertising without linking exposure to tobacco use behaviors;
    • Studies of retailer compliance to the tobacco product regulations not associated with user behaviors or marketing strategies;
    • Studies of health care provider/lay health worker knowledge, attitudes, perception, and behaviors toward the use of ENDS or other tobacco products;
    • Studies identifying biomarkers of secondary and tertiary exposure to tobacco products;
    • Studies of in-utero exposure to tobacco products and subsequent behavioral effects in off-spring;
    • Studies using neuroimaging as a biomarker of tobacco product exposure or nicotine dependence;
    • Studies identifying DNA methylation biomarkers and other epigenetic alternations associated with tobacco use.

    Projects must propose research aims that are within the regulatory authority of FDA CTP and the scientific interest areas identified in this NOFO in order to be considered responsive to this NOFO. As such, investigators are strongly encouraged to discuss whether their application is responsive to this NOFO with a Scientific/Research Contact listed in Section VII before submission of their application and to review additional information available, including research priorities and a Frequently Asked Questions document.

    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 conducting human-subjects studies to incorporate measures from the PhenX Toolkit (www.phenxtoolkit.org), including measures from the Tobacco Regulatory Research Collections. The PhenX Toolkit provides standard measures for inclusion in human subjects research to enable sharing, comparing, and combining of data and results.
    • 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://www.drugabuse.gov/funding/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

    Funding Instrument

    Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

    Application Types Allowed
    New
    Renewal
    Resubmission

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

    Clinical Trial?

    Optional: Accepting applications that either propose or do not propose clinical trial(s).

    Funds Available and Anticipated Number of Awards

    NIH, via support from the FDA Center for Tobacco Products (CTP), intends to fund up to 6 R01s, corresponding to a total of up to $4 million, for fiscal year 2024. Future year amounts will depend on the availability of funds.

    Award Budget

    Application budgets are limited to $500,000 in direct costs per year.

    Award Project Period

    The scope of the proposed project should determine the project period. The maximum project period is 5 years.

    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

    Eligible Organizations

    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)
    Foreign Institutions

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

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

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

    Required Registrations

    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.

    • 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.

    Eligible Individuals (Program Director/Principal Investigator)

    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 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 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 SF424 (R&R) 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
    Fax: 301-480-5588
    Email: TRSP@nih.gov

    Page Limitations

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

    Instructions for Application Submission

    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.

    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.

    The research findings generated from this Notice of Funding Opportunity (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 (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 Management and Sharing Plan

    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.

    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.

    Foreign Institutions

    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 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 or non-compliant, 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 TRSP@mail.nih.gov when the application has been submitted. Please include the NOFO number and title, PD/PI name, and application title.

    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.

    Overall Impact

    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).

    Scored Review Criteria

    Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.


    Does the project address an important issue or a critical barrier in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge and/or technical capability be improved? How will successful completion of the aims affect the concepts, methods, and technologies related to the manufacture, distribution, and marketing of tobacco products?

    In addition, for applications involving clinical trials:

    Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for the concepts, methods, and technologies that could inform the manufacture, distribution, and marketing of tobacco products in order to protect public health? For trials focusing on behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding that could help inform the manufacture, distribution, and marketing of tobacco products in order to protect public health?


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

    In addition, for applications involving clinical trials

    With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?


    Does the application challenge and seek to shift current research in the field of tobacco science as it relates to the manufacture, distribution, and marketing of tobacco products? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, or instrumentation proposed? Will the outcomes of the project provide new information to further develop the knowledge base that informs the manufacture, distribution, and marketing of tobacco products in order to protect public health?

    In addition, for applications involving clinical trials:

    Does the design/research plan include refined or improved elements, as appropriate, that enhance its sensitivity, potential for information, or potential to advance scientific knowledge that informs the manufacture, distribution, and marketing of tobacco products in order to protect public health?


    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

    In addition, for applications involving clinical trials

    Does the application adequately address the following, if applicable

    Study Design

    Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

    Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

    Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

    Data Management and Statistical Analysis

    Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?


    Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

    In addition, for applications involving clinical trials

    If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

    Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

    If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

    If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

    Additional Review Criteria

    As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.


    Specific to applications involving clinical trials

    Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

    Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?


    For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

    For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.


    When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.


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


    Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.


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


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


    Not applicable.

    Additional Review Considerations

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


    Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.


    Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).


    Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.


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


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

    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 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, the 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:

    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.

    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.

    Cooperative Agreement Terms and Conditions of Award

    Not Applicable

    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, as well as the annual progress report. Electronic copies should be sent to the Grants Management Specialist listed on the Notice of Grant Award. 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.

    Application Submission Contacts

    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: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-637-3015

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Rachel Grana Mayne, PhD, MPH
    National Cancer Institute (NCI)
    Telephone: 240-276-5899
    Email: Rachel.Mayne@nih.gov

    Lisa Postow, PhD
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-435-0202
    Email: Lisa.Postow@nih.gov

    Mary Kautz, PhD
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-443-3206
    Email: NIDATRSprogram@nida.nih.gov

    Fred Tyson, PhD
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984-287-3334
    Email: Fred.Tyson@nih.gov

    Peer Review Contact(s)

    Center for Scientific Review (CSR)

    Email: FOAReviewContact@csr.nih.gov

    Financial/Grants Management Contact(s)

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

    Judy Sint
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-480-1307
    Email: Judy.Sint@nih.gov

    Amy Bucheimer
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-827-6694
    Email: Amy.Bucheimer@nih.gov

    Michelle Victalino
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984-287-3336
    Email: Michelle.Victalino@nih.gov

    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.

    Authority and Regulations

    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.

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