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. The Tobacco Control Research Branch (TCRB) leads and collaborates on research and disseminates evidence-based findings to prevent, treat, and control tobacco use in order to create a world free of tobacco use and related cancer and suffering. We combine rigorous research with investigative techniques to examine corporate influences on health and health policies. To ensure that tobacco use in the U.S. continues to decline, innovative research at the State and community levels is needed to identify the most effective tobacco control policies and media interventions for diverse populations, and to better understand the tobacco companies’ continuing efforts to promote tobacco use. The recipient must also make semiannual disclosures regarding such proceedings. Primary research topics that fall within the scope of this FOA include, but are not limited to the following: 1. Less restrictive marijuana laws are widely expected to influence tobacco use patterns and may influence population subgroups differently. Awardees must comply with any funding restrictions described in Section IV.5. 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. In addition, for applications involving clinical trials: 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. Scientific and technical merit of the proposed project as determined by scientific peer review. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. Investigators should describe the communication plan and detailed list of responsible parties for decision-making and dissemination of research findings. That’s an impressive number, and dwarfs the 2,581 warning letters issued for … African American Tobacco Control Leadership Council, Hercules, California. 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. Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? This initiative is not subject to intergovernmental review. A 2016 editorial in JAMA Oncology notes the close link between tobacco use rates and overall cancer mortality, stating, “the variation [in overall cancer death rates] across states today is greater than the overall improvement in mortality over the past 40 years: cancer mortality varies as much as 30% across states, and is strongly associated with state-level tobacco use.” Differences in tobacco use are also strongly linked to differences in overall mortality between population subgroups. Applications should reflect current conditions and may consider interactions between tobacco prevention and control policies and factors related to the pandemic. More information is provided at Award Conditions and Information for NIH Grants. Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Designs that might be proposed include a parallel group- or cluster-randomized trial, a stepped-wedge group- or cluster randomized trial, a multiple baseline design, or another quasi-experimental design. Part I. Overview Information contains information about Key Dates and times. If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Please see. Despite this progress, tobacco use remains the leading cause of preventable premature death in the U.S., as it does in most other high-income nations. All PD(s)/PI(s) must have an eRA Commons account. Excellent interpersonal skills, and the ability to work independently and as part of a research team . Email: Bob.Vollinger@nih.gov. Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity? This FOA is proposed in response to the March 2016 Report to the NCI Board of Scientific Advisors, titled “Tobacco Control Research Priorities for the Next Decade: Working Group Recommendations for 2016-2025.” This report concluded that “research is needed to identify innovative local, state, federal and private sector policy approaches that will advance the goal of eliminating tobacco use and its resultant harms, as well as effective strategies to more completely disseminate these approaches” and that research is needed “to identify and implement tobacco control policies that reduce or eliminate tobacco-related inequalities.” Health Equity in Tobacco Prevention and Control describes "health equity as the opportunity for everyone to reach their full potential, regardless of any socially determined circumstance. Components of Participating Organizations, Funding Opportunity Announcement (FOA) Number, Catalog of Federal Domestic Assistance (CFDA) Number(s), Optional: Accepting applications that either propose or do not propose clinical trial(s), Funds Available and Anticipated Number of Awards, Eligible Individuals (Program Director/Principal Investigator), SF424(R&R) Project/Performance Site Locations, PHS Human Subjects and Clinical Trials Information, 7. ty for tobacco control in every country are critical if the WHO FCTC is to succeed. However, gaps in our understanding of tobacco control policies remain, especially as they relate to the ability of new and existing policies to reduce disparities in tobacco use and tobacco-related cancers and to promote health equity across all populations. Specific for applications involving clinical trials. The communication and media landscape is complex and rapidly changing, and online user-generated content and social networking sites (such as Facebook, Instagram, Twitter, and YouTube) have become an integral part of the communication landscape. Simon Chapman is Professor in Public Health at the University of Sydney. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. (PDF of letter)This is yet another example of tobaco companies misrepresenting FDA action on their products. All applications must include an overall strategy that builds upon rigorous dissemination and implementation science. This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 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. FDA’s draft guidance on Principles for Designing and Conducting Tobacco Product Perception and Intention Studies appropriately highlights the importance of determining whether consumers understand the risks of new tobacco products and modified risk claims, Tobacco Companies to force a referendum on California state flavored tobacco product ban, Two big national studies show E-cigarettes Won’t Help Smokers Quit, but they may become Addicted to Vaping, Gov Newsom signs Calif ban on sales of flavored tobacco products. Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. The DSHS Tobacco Prevention and Control Branch (TPCB) is determined to reduce the toll of tobacco on the health, safety, and well-being of Texans. Consumer Responds to Tobacco Control. This blog post was drafted by Lauren Lempert. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects. 35- Since 1981, thirteen Gulf symposia for tobacco control were held, the last was held in the kingdom of Bahrain in January, 2010. Three (3) letters of recommendation (At least one letter must talk about your impact/role in the tobacco control field) Anticipated Course Schedule Scholarship students should download the pre-filled Anticipated Coursework Schedule, insert your name, save the file as a JPEG, and upload the document in SOPHAS express. Joint Letter to FDA Requesting Public Disclosure of New Tobacco Products For Which Pre-market Applications Have Been Filed (4/23/20) Letter to the CDC Commenting on "Achieving Health Equity in the Advancement of Tobacco Control Practices to Prevent Initiation of Tobacco Use among Youth and Young Adults" (3/20/20) 35- Since 1981, thirteen Gulf symposia for tobacco control were held, the last was held in the kingdom of Bahrain in January, 2010. Are potential problems, alternative strategies, and benchmarks for success presented? Email:brightfr@mail.nih.gov. Apply to Customer Service Representative, Pharmacy Technician, Inventory Manager and more! The description in the sub-section must address and provide the necessary supporting details explaining how the proposed project will meet the following key dissemination and implementation science requirements: 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. 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. 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. Apply to Customer Service Representative, Pharmacy Technician, Inventory Manager and more! This FOA does not require cost sharing as defined in the NIH Grants Policy Statement. Is the projected timeline feasible and well justified? fostering transparency and protecting citizens’ right to know. A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. 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. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s). Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. Applicant organizations may submit more than one application, provided that each application is scientifically distinct. Key challenges include the following: We understand in this environment of the COVID-19 pandemic that the broader health, social, cultural and economic conditions may impact the adoption and implementation of tobacco prevention and control policies. Telephone: 240-276-6919 Application Requirements To be considered for this position, the following materials must be submitted: 1.over Letter C Explain your interest in tobacco control, your professional development goals , … Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html. Application Requirements To be considered for this position, the following materials must be submitted: 1.over Letter C Explain your interest in tobacco control, your professional development goals , … Obtaining an eRA Commons account can take up to 2 weeks. See Part 1. These efforts hold promise to reduce tobacco use, including among populations with higher prevalence. 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. Tobacco Regulatory Science (TRS) (Tob Regul Sci, Electronic ISSN 2333-9748) is a rigorously peer-reviewed online scientific journal for the dissemination of research relevant to the regulation of tobacco products. All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? other promising public and private tobacco control policy approaches. Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Corinne Pierce, Volunteer, … FDA has “accepted” e-cigarette PMTA submissions: What does that mean and what should we expect after September 9? 34- The Executive Board established a Gulf committee fot tobacco control, it is one of the very active committees and it held so far 20 meeting , the last of which was early in 2010, in the United Arab Emirates. Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. See Section III of this FOA for information on registration requirements. The following NIH Offices may co-fund applications assigned to those Institutes/Centers. Applicants submitting applications related to health economics are encouraged to consult NOT-OD-16-025 to ensure that the research projects align with NIH mission priorities in health economics research. The Tobacco Control Act requires that smokeless tobacco packages and advertisements have larger and more visible warnings. 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? Consumer Responds to Tobacco Control. Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. ); and. Investigators should describe the communication plan and detailed list of responsible parties for decision-making and dissemination of research findings. Public/State Controlled Institutions of Higher Education, 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 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 (Other than Small Businesses), Indian/Native American Tribal Governments (Federally Recognized), Indian/Native American Tribal Governments (Other than Federally Recognized), Eligible Agencies of the Federal Government, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations (other than Federally recognized tribal governments), Faith-based or Community-based Organizations. For this particular announcement, note the following: The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. Office of Disease Prevention- Shared Interest. 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. Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Organizations are not eligible to apply. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Evidence-based policy approaches to tobacco prevention and control have the potential to further decrease the health and economic burdens of tobacco use and to reduce the wide disparities in tobacco use and tobacco-caused cancers across various subpopulations in the U.S. Policy interventions prioritize population-level outcomes by seeking to change the social-environmental context in which decisions about tobacco use are made They may be especially valuable for reducing disparities in tobacco use and promoting health equity among all populations because of their broad reach, ability to change social norms, and because they can be implemented at much lower cost than interventions that target individuals. Additional research … Public support for introducing cigarette pack inserts in Australia (13 February, 2020) Policies related to coverage for tobacco dependence treatment (e.g., state, local and or federal policies affect access to, affordability, and use of cessation services among high risk populations, and the impact of surcharges on tobacco users); 4. In addition, for applications involving clinical trials: If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed? Is the prior research that serves as the key support for the proposed project rigorous? The HP 2020 goal combines both concepts to achieve health equity, eliminate disparities, and improve the health of all groups. Does the application propose to use existing available resources, as applicable? 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). Please see, Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Program Directors/Principal Investigators (PD(s)/PI(s)). All applications must include an overall strategy that builds upon rigorous dissemination and implementation science. In a Jan. 31 BMJ blog post [1], Dr. Ruth Malone, editor of Tobacco Control, excoriated the Food and Drug Administration for proposing “facilitated dialogue” with the “tobacco industry.”This assertion was based on her perception that such dialogue would lend the “tobacco industry” legitimacy that they do not deserve. See the NIH Grants Policy Statement for additional information on this reporting requirement. Investigators who wish to evaluate the effect of a policy on a health-related biomedical or behavioral outcome may propose a study design in which groups that are subject to the policy are compared to groups that are not subject to the policy. All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. 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? Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. Social media interactions may be used to promote tobacco prevention and control strategies, but may also have adverse effects on tobacco use, through the spread of inaccurate health information, the emergence of online communities with norms that support tobacco use, tobacco industry promotional efforts, and other means. Tobacco prevention and control efforts implemented since the 1964 Surgeon General’s report are estimated to have prevented 8 million premature smoking-attributable deaths in the United States and to have extended mean life span by 19-20 years, between the years 1964 and 2012. Without these actions, FDA is not protecting the public health. We don’t know if or how Puff Bar and/or the other companies responded. Innovative dissemination and implementation of research findings. In addition, some tobacco products, especially cigars, cigarillos, and ENDS, are now commonly used together with marijuana (cannabis) or cannabis oil. Effective tobacco control policies help denormalize smoking, decrease smoking prevalence 1, and reduce morbimortality attributable to tobacco 2.Many efforts have been made globally to tackle the tobacco epidemic 3, stimulated by the enforcement of the Framework Convention on Tobacco Control.In the European Union (EU), the Tobacco Products Directive has driven the … Specific to this FOA: If the aims of the proposed project are achieved, how will the research findings be disseminated to relevant communities? An application does not need to be strong in all categories to be judged likely to have major scientific impact. This includes ensuring programs are accessible to persons with limited English proficiency. An R21 grant application need not have extensive background material or preliminary information. This FOA seeks applications for research projects to help reduce disparities in tobacco use and secondhand smoke (SHS) exposure in the United States and promote health equity through scientific inquiry focused on innovative state and local tobacco prevention and control policies including, but not limited to: The long-term goal of this FOA is to reduce tobacco-related cancer health disparities, and in doing so, to promote health equity among all populations. And FDA must be transparent about all of its, and its regulated companies’ actions (and inactions). The purpose of this Funding Opportunity Announcement (FOA) is to support observational or intervention research focused on reducing disparities in tobacco use and secondhand smoke (SHS) exposure in the U.S. Policies to reduce the appeal of tobacco products through advertising and marketing restrictions at the state or local level, or reduce the demand for tobacco products with various pricing interventions; 3. 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