Tobacco Centers of Regulatory Science (TCORS) (FDA and NIH-funded)

Tobacco Centers of Regulatory Science (TCORS) (FDA and NIH-funded) is sponsored by U.S. Food and Drug Administration (FDA) and National Institutes of Health (NIH). This program funds centers that conduct research to inform government regulations overseeing tobacco and its marketing, with a focus on protecting young people.

Expired RFA-OD-22-004: Tobacco Centers of Regulatory Science (TCORS) for Research Relevant to the Family Smoking Prevention and Tobacco Control Act (U54 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. 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 ) of Participating Organizations National Cancer Institute ( NCI ) National Heart, Lung, and Blood Institute ( NHLBI ) National Institute on Drug Abuse ( NIDA ) National Institute of Environmental Health Sciences ( NIEHS ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention ( ODP ) Funding Opportunity Title Tobacco Centers of Regulatory Science (TCORS) for Research Relevant to the Family Smoking Prevention and Tobacco Control Act (U54 Clinical Trial Optional) Specialized Center- Cooperative Agreements April 22, 2022 - Notice of Correction to RFA-OD-22-004.

See Notice NOT-OD-22-116 March 16, 2022 - Notice of Change to RFA-OD-22-004, Tobacco Centers of Regulatory Science (TCORS) for Research Relevant to the Family Smoking Prevention and Tobacco Control Act (U54 Clinical Trial Optional) .

See Notice NOT-OD-22-094 March 8, 2022 - Notice of Pre-Application Webinar and Availability of FAQs for RFA-OD-22-004, Tobacco Centers of Regulatory Science (TCORS) for Research Relevant to the Family Smoking Prevention and Tobacco Control Act (U54 Clinical Trial Optional).

See Notice NOT-OD-22-090 Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Specialized Center- Cooperative Agreements Research Project Cooperative Agreements Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose The purpose of this Funding Opportunity Announcement (FOA) is to invite applications for Tobacco Centers of Regulatory Science (TCORS) 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 Objectives related to the regulatory authority of the Food and Drug Administration (FDA) Center for The awards under this FOA will be administered by NIH using funds that have been made available through FDA CTP and the Family Smoking Prevention and Tobacco Control Act (P. L. 111-31).

Research results from this FOA are expected to generate findings and data that are directly relevant in informing the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect the public health.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) While Letters of Intent are normally due one month before the due date, the Letter of Intent for this RFA is due 60 days prior to the All applications are due by 5:00 PM local time of applicant organization.

All types of non-AIDS applications allowed for this funding opportunity announcement are due on No late applications will be accepted for this Funding Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission AIDS Application Due Date(s) It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of the Announcement I. Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Full Text of Announcement Section I.

Funding Opportunity NIH anticipates holding a pre-application webinar to which all interested prospective applicants are invited.

NIH and FDA Program and Review staff persons will explain the goals and objectives of the Tobacco Centers of Regulatory Science (TCORS) for Research Relevant to the Family Smoking Prevention and Tobacco Control Act funding opportunity announcement (FOA), 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 . This Funding Opportunity Announcement (FOA) invites cooperative agreement (U54) applications for Tobacco Centers of Regulatory Science (TCORS) for research relevant to the Family Smoking Prevention and Tobacco Control Act.

The overall TCORS program objective is to conduct programs of multidisciplinary research that will inform the manufacture, distribution, and marketing of tobacco products related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP).

The research findings generated from this FOA are expected to provide additional scientific data to inform the regulation of the tobacco products to protect public The awards under this FOA will be administered by NIH using designated funds from FDA CTP for tobacco regulatory science mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31.

NIH and FDA have formed an interagency partnership to foster research relevant to tobacco regulatory science within the framework of the Tobacco Control Act. As cooperative agreements, NIH and FDA will be substantially involved with the awardees.

Separate FOAs will solicit cooperative agreement applications for a U54 Coordinating Center ( Center for Coordination of Analysis, Science, Enhancement, and Logistics (CASEL) for this program and a U01 Center for Rapid Surveillance of Tobacco (CRST).

CASEL will provide the necessary scientific leadership and administrative framework to facilitate interactive and integrative collaboration and communication among the awardees of the individual TCORS, NIH and FDA staff, and other FDA-funded investigators, as Consistent with the FDA CTP mission, this FOA encourages research applications that address such Scientific Domains as: 1) understanding 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, 7) the influences of tobacco marketing , and 8) of potential FDA regulatory actions.

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. 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 . Objectives and Administrative Structure Requirements The overall TCORS cooperative agreement research program objective is to conduct programs of multidisciplinary research that will inform FDA’s tobacco product regulatory activities.

The TCORS program will lead the establishment of a broad national scientific base of tobacco regulatory research. Although a vast and sound science base exists with regards to numerous areas related to the FSPTCA, new research will provide additional science for FDA to consider as it conducts regulatory activities.

Essential elements of TCORS applications include at least 3 discrete hypothesis driven Research Projects with a scientific Integrative Theme, an Administrative Core, a Career Enhancement Core, and optional cores as needed and justified. Research integrated across projects, where findings from one major project inform or complement those in another, is required.

Disciplinary integration within a TCORS, and within projects (where feasible) is also encouraged. Disciplinary diversity in a TCORS must support the objectives of the science and not merely reflect the training of the scientists. Meaningful collaboration is permitted across geographically separate sites within a funded TCORS.

Each TCORS funded under this announcement is expected to work with NIH and FDA staff to collaborate with other TCORS, a designated Coordinating Center, and a Center for Rapid Surveillance of Tobacco (CRST) , on a regular basis to share information, assess scientific progress in the field, identify new research opportunities, participate in one or more cross-site scientific working groups, address research gaps, and resolve areas of scientific disagreement.

Part A. Research Objectives Requirements Applicants will be required to identify an overall Integrative Theme for their proposed TCORS. The level of specialization in different dimensions of regulatory tobacco research will vary with each TCORS, e.g., topics, populations, levels of analysis, and types of research (e.g., cell culture, animal models, or human models; cross-sectional or longitudinal study designs).

However, TCORS should focus thematically on areas in which there are significant gaps in knowledge--where focused, collective, interdisciplinary efforts could make the greatest difference in reducing tobacco use and its adverse health consequences through the regulation of the manufacture, distribution, and marketing of tobacco products.

Individual TCORS may vary in their breadth or concentration across research foci (e.g., molecular to population-based research)*.

Integrative Themes may coalesce around a research gap that is tobacco product- or constituent-specific (e.g., cigars, flavors)* that addresses Scientific Domains (e.g., addiction, toxicity, effects)*, or may represent an integrative approach to generating data needed to regulate tobacco in a way that reduces use and harm in populations that experience greater tobacco related health disparities *.

It is expected that the TCORS will facilitate more rapid advances in knowledge than would be possible by depending on individual investigators working in relative isolation. *NOTE: Examples are for illustrative purposes and do not indicate particular priorities.

Consistent with the FDA CTP mission, this FOA encourages research applications that address such Scientific Domains as: 1) understanding 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) of potential FDA regulatory actions.

FDA encourages research studies to include, where appropriate to the research question, vulnerable populations, including (but 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, those pregnant or trying to become pregnant, active-duty military or veterans, those who are or have been and those with mental health conditions or substance use population will be included, applicants will be expected to identify the population and how the population is important to the research question, considering the impact on population health.

Health disparity considerations can be incorporated into all the topics below. A goal of the TCORS program will be to support a portfolio that is balanced across the Scientific Domains below. Any single project can focus on one or more of these domains.

However, applications must propose a program that includes two or more of the following Scientific Domains across Addressing many/all Scientific Domains in an individual TCORS is not advantageous. What is important regarding Scientific Domains is to demonstrate how the research proposed integrates with the center's overall theme to inform tobacco regulatory activities.

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 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 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 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 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.

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 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). 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)).

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 Association between cigar sub-types use and disease risk; Association between waterpipe and waterpipe materials use and 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.

- 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 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 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 vulnerable populations (if appropriate), including marketing of new/novel Understanding what components of ENDS marketing have the greatest impact on youth and young adults ENDS knowledge, attitudes, perceptions, Understanding how labeling, marketing and advertising impact abuse liability, appeal, perceptions, and intentions to use different tobacco 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 influencers and other marketing partners (e.g., musicians).

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 vulnerable populations; 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 vulnerable populations; 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.

Although the following research topics may be within FDA CTP’s regulatory authorities to fund, they are not to be included in the FOA and will be deemed non-responsive: 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 Studies developing or testing graphic health warnings for cigarette packages and advertisements Communicating harmful and potentially harmful constituents to the 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 Studies of retailer compliance to the tobacco product regulations not associated with user behaviors or marketing strategies Studies of physician or other health professional knowledge, attitudes, perception, and behaviors toward the use of ENDS or other tobacco Applications that are incomplete and/or non-responsive will not be reviewed.

As such, investigators are strongly encouraged to discuss whether their application is responsive to this FOA with a Scientific/Research Contact, listed in Section VII, prior to submission of their application. Additional information, including research priorities and a Frequently Asked Questions document can be found at: https://prevention. nih.

gov/sites/default/files/2021-05/GeneralResponsiveness-FAQs_508. pdf Part B. Administrative Structure Requirements Each TCORS must have, at minimum, three Research Projects, an Administrative Core, and a Career Enhancement Core.

At least three Research Projects and the Administrative and Career Enhancement Cores must be active at all times. Competitive applications will reflect more than an interesting collection of components; there must be evidence of the potential for a meaningful TCORS with an Integrative Theme and identity. The Center and its components should result in the generation of new knowledge in tobacco regulatory science.

Coordination, communication, and when appropriate, collaboration is expected across the components of each TCORS, as well as across the TCORS program. A program goal is improving the yield and impact of the tobacco regulatory science portfolio through enhanced capacity for sharing and comparing data, replicating findings, and integration of data from multiple sources.

As such, use of common study variables, criteria, and protocols, where appropriate, is strongly encouraged.

After awards are made, investigators will be expected to collaborate with other awardees, a designated Coordinating for Rapid Surveillance of Tobacco (CRST), and NIH and FDA CTP scientific staff on the development and use of shared and standardized measures, methods, and data management wherever feasible to facilitate data aggregation and collaborative activities across projects.

As such, investigators are expected to incorporate PhenX measures , other common data elements , and/or standard measures recommended by TRS working groups as appropriate.

NIH and FDA encourage investigators involved in human-subjects studies to consider 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 available in PhenX Toolkit , including the Tobacco Regulatory Research Core and Specialty Collections.

Please see NOT-OD-17-034 TCORS will be required to cooperate with a designated Coordinating Center ( CASEL ), for Rapid Surveillance of Tobacco (CRST) , and federal partners to foster collaborations and cross-site scientific working groups to identify and address overarching conceptual and methodological issues. A Steering Committee will be the governing body for all awardees funded under this FOA.

The TCORS Steering Committee will include a principal investigator from each TCORS, a Coordinating Center (CASEL) principal investigator with tobacco science expertise, and NIH and FDA representatives. A non-voting member with logistical/administrative expertise from the Coordinating Center will also be included.

A proposed Center application must include a minimum of three fully developed hypothesis-driven Research Projects that contribute individually to the goals of the larger TCORS program and collectively to the Integrative Theme. Each Research Project must address one or more of the eight Scientific Domains, as defined above (Section I.

, Part A, Research Objectives Requirements): Product Composition and Design, Toxicity, Addiction, Health Effects, Behavior, Communications, Marketing Influences, and/or Impact Analysis. The Research Projects in the Center application must collectively address no fewer than two of the Scientific Domains . Applications that choose fewer than two Scientific Domains will be deemed non-responsive.

Each proposed Research Project must provide a clear description of its major goals, objectives, and how it integrates with the other Research Projects and/or Center components. Each Research Project director should be a qualified investigator and will be responsible for the scientific direction and conduct of the individual Research Project.

Each applicant team should demonstrate in-depth expertise in all relevant scientific aspects of the proposed research activities. A description of how the aims of the Research Project will aid in the development and/or evaluation of tobacco product regulations is strongly advised. TCORS are required to have an Administrative Core.

The Administrative Core should promote an environment of communication and collaboration among investigators within the proposed TCORS, across the TCORS funded through this RFA, with the Coordinating Center (CASEL), with the Center for Rapid Surveillance of Tobacco (CRST) , and the FDA and NIH staff.

The Administrative Core must provide for central operations to coordinate, monitor and facilitate attainment of the proposed TCORS' objectives, including quality control and oversight mechanisms for ongoing projects. Each TCORS should have an External Advisory Board (EAB) that is charged to provide appropriate and objective advice and evaluation, as needed, to the Center.

Each TCORS will determine the structure, membership, and meeting frequency (at least once per year) of its EAB. Federal partners must be invited to participate in the meetings and given a minimum 90-day advance notice of the meeting dates.

EAB meetings are expected to take place at the TCORS institutions to permit the staff investigators (e.g., core leads and project leads) to attend and present progress and plans for their projects and cores. Adequate time should be allotted for robust discussion between TCORS investigators and EAB members.

Meeting format should include a closed session of the Board to articulate recommendations for advancing progress, followed by a final open session to review these with the PIs and Federal partners. It is expected that the EAB generate a report or summary of the TCORS progress and recommendations to be shared with PIs and Federal partners.

There is continued need for investigators who have the quality and breadth of experience necessary to conduct cutting-edge research related to the regulation of the manufacture, distribution, and marketing of tobacco products. As such, each TCORS application is required to have a Career Enhancement Core that will provide exposure to and experience in Tobacco Regulatory Science (TRS).

This core should focus on research experiences and related activities that will enhance development of TRS expertise, including aiding students, fellows, scholars, New and Early-Stage Investigators, and investigators new to TRS on their path towards becoming independent TRS investigators.

These activities should budget for dedicated pilot research studies, as well as travel to relevant conferences and to other TCORS for purposes of collaboration, learning and research opportunities. Note: All the activities proposed should be structured so that they not only benefit the development of TRS expertise for both students and investigators, but also support and contribute to the overarching research goals of the TCORS.

Career/research enhancement activities are expected to include supervised research pilot studies. The studies may either fall within the overall theme of the TCORS (i.e., connecting to TCORS Research Projects) or be conducted as inter-TCORS collaborative studies.

All proposed pilot projects will require prior approval from NIH and FDA CTP to assess responsiveness to FDA CTP Tobacco Regulatory Authorities before any expenditure of funds and/or work on the pilot project is initiated. A unique opportunity is afforded the TCORS program to create collegial and collaborative networks among the TCORS investigators.

TCORS are expected to develop mechanisms for establishing these networks and for sharing resources for development of TRS expertise, including existing curricula/courses, research opportunities, and the expertise of established Self-standing institutional training/education/career development programs are NOT appropriate for this core and must not be proposed.

For example, TCORS cannot support institutional National Research Service Award (NRSA) programs, such as T32 training grants. TCORS may propose additional Cores as needed and justified (e.g., data, biospecimens, statistical, etc.).

Applicants should keep the following special considerations in mind as they prepare their applications: Data Harmonization for Tobacco Regulatory Research via the PhenX Toolkit : This kit provides Core and Specialty Collections for inclusion in human subjects research to enable sharing, comparing, and combining of data and results.

Using common measures will also assist program assessment of scientific progress in the field, identification of new research opportunities, and formation of collaborations to promote discovery and to resolve areas of scientific controversy. The Coordinating Center will facilitate these collaborations amongst TCORS in conjunction with the NIH and the FDA CTP scientific, administrative, and program staff.

Tobacco Industry Funding of Applicants: The FDA CTP has adopted the following guidance regarding tobacco industry funding of applicants responding to this RFA.

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