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 following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS). We don’t know if or how Puff Bar and/or the other companies responded. 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? Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. The following will be considered in making funding decisions: Cooperative Agreement Terms and Conditions of Award, Tobacco Control Policies to Promote Health Equity (R21 Clinical Trial Optional), Section III. Investigators should describe the communication plan and detailed list of responsible parties for decision-making and dissemination of research findings. However, despite the threat made in FDA’s July 20 press release that a company’s failure to address violations could result in further actions including injunction or seizure, it appears that FDA has never taken either of these actions against tobacco products. Philosophy, Objectives, and Scope of the Journal. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. Our goals are: To keep young Texans from ever starting tobacco use. 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. 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. Applicants will need to show that their methods are appropriate given their plans for assignment of participants and delivery of interventions. We combine rigorous research with investigative techniques to examine corporate influences on health and health policies. FDA proudly announced these actions with great fanfare, stating in its press release that it notified Puff Bar and nine other e-cigarette companies “to remove their flavored disposable e-cigarettes and youth-appealing e-liquid products from the market,” and touted this action as part of “FDA’s ongoing, aggressive effort to act against illegally marketed tobacco products amid the public health crisis of youth e-cigarette use in America.”, FDA gave Puff Bar and the other companies 15 working days (until August 10, 2020) to respond with details about how each company would discontinue the sale or distribution of their illegal products and address other violations. As a result, states and localities have now begun to implement innovative policies in this area, such as measures that restrict point-of-sale tobacco advertising or the sale of flavored tobacco products. 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. 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. other promising public and private tobacco control policy approaches. This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. Tobacco Control Research/Data Analyst [Consultant, Remote] ... Tobacco Control Data Initiative (TCDI) - will be implemented in up to eight African countries. Most recently, on July 20, 2020, FDA sent a warning letter to Cool Clouds Distribution, Inc. dba Puff Bar for marketing Puff Bar without the required premarket authorization and making unauthorized modified risk claims, and warning letters to nine other e-cigarette companies for violations of tobacco laws and regulations. Applications that do not comply with these instructions may be delayed or not accepted for review. The Tobacco Center of Regulatory Science (TCORS) is a large center grant housed in UCSF’s Center for Tobacco Control Research and Education. No more than $200,000 may be requested in a single year. Internet Explorer may not work correctly. 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. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section. If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. Are the plans to add or drop enrollment centers, as needed, appropriate? Introduction Despite continuing efforts to reduce tobacco use in the USA, decline in smoking rates have stalled and smoking remains a major contributor to preventable death. Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP), R21 Exploratory/Developmental Research Grant, Reissue of PAR-18-674 - U.S. Tobacco Control Policies to Reduce Health Disparities (R21 Clinical Trial Optional), PAR-20-302 - Tobacco Control Policies to Promote Health Equity (R01 Clinical Trial Optional). These products also pose new challenges to comprehensive smoke free policies, which may differ between population subgroups. Recently issued trans-NIH policy notices may affect your application submission. 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. Nancy A. Rigotti, M.D., Professor of Medicine, Harvard Medical School; Director, Tobacco Research and Treatment Center, 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. In addition, we only include a copy of the SF 424 R&R Face Page, Project Summary/Abstract (Description), Project Narrative, Specific Aims, and Research Strategy; we do not include other SF 424 (R&R) forms or requisite information found in the full grant application (e.g., performance sites, key personnel, biographical sketches). 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). 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. Any instructions provided here are in addition to the instructions in the policy. Mobile technologies also offer the potential to reach rural populations, people with insufficient access to the health care system, and other high-risk groups. This initiative is not subject to intergovernmental review. Do they have appropriate expertise in study coordination, data management and statistics? Applicants are required to follow the instructions for post-submission materials, as described in the policy. All PD(s)/PI(s) must have an eRA Commons account. Overarching policy environment (e.g. The landmark 1964 Surgeon General’s report on smoking and health began a process of public education, programmatic and policy intervention, and social norm change that has revolutionized how most Americans view commercial tobacco use, and in particular cigarette smoking. Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Only limited Appendix materials are allowed. FDA has “accepted” e-cigarette PMTA submissions: What does that mean and what should we expect after September 9? Original research. If FDA was as vigorous in going after tobacco companies, CTP would have issued 4829 injunctions and seizures against tobacco products. 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