Limited Competition: Clinical and Translational Science Award (CTSA) Program: Collaborative and Innovative Acceleration Award (UG3/UH3 Clinical Trial Optional)

Limited Competition: Clinical and Translational Science Award (CTSA) Program: Collaborative and Innovative Acceleration Award (UG3/UH3 Clinical Trial Optional) is sponsored by NIH Office of Disease Prevention (ODP). Supports collaborative and innovative acceleration in clinical and translational science.

PAR-25-296: Limited Competition: Clinical and Translational Science Award (CTSA) Program: Collaborative and Innovative Acceleration Award (UG3/UH3 Clinical Trial Optional) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. 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 National Center for Advancing Translational Sciences ( NCATS ) National Human Genome Research Institute ( NHGRI ) National Institute of Allergy and Infectious Diseases ( NIAID ) National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute of Dental and Craniofacial Research ( NIDCR ) National Institute of General Medical Sciences ( NIGMS ) 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 ) Office of Behavioral and Social Sciences Research ( OBSSR ) Office of Research on Women's Health ( ORWH ) Funding Opportunity Title Limited Competition: Clinical and Translational Science Award (CTSA) Program: Collaborative and Innovative Acceleration Award (UG3/UH3 Clinical Trial Optional) UG3 / UH3 Exploratory/Developmental Phased Award Cooperative Agreement March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. December 12, 2024 - Notice of Information: Technical Assistance Webinar for PAR-25-296: Limited Competition: Clinical and Translational Science Award (CTSA) Program: Collaborative and Innovative Acceleration Award (UG3/UH3 Clinical Trial Optional) . See Notice NOT-TR-25-004 .

April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 . August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023.

See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 .

Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3. Additional Information on Eligibility .

Assistance Listing Number(s) 93. 350, 93. 121, 93.

859, 93. 313, 93. 855, 93.

865, 93. 846, 93. 172, 93.

307 Funding Opportunity Purpose The CTSA Collaborative and Innovative Acceleration Award (CCIA) aims to accelerate the pace of translational research by supporting the collaborative development, dissemination, and sustainable implementation of innovative solutions across the CTSA Program Consortium and beyond.

This limited competition Notice of Funding Opportunity (NOFO) invites investigator-initiated applications to develop, demonstrate, and disseminate innovative new approaches, technologies, resources, or models that increase the impact of research across diseases, transform the field of translational science, and bring more treatments for all people more quickly.

Funding Opportunity Goal(s) The mission of the National Center for Advancing Translational Sciences (NCATS) is to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

Open Date (Earliest Submission Date) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

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

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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.

Use the NIH ASSIST system to prepare, submit and track your application online. 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. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II.

Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V.

Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII.

Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Key Terms, Definitions, and Uses in this NOFO CTS: Clinical and translational science CTSA Program: A national network of more than 50 medical research institutions / academic health centers and their partners and collaborators working together to speed translation of research discoveries into improved patient care by tackling system-wide problems in clinical and translational research that no single team can overcome.

CTSA Trial Innovation Network (TIN): The TIN is a collaborative initiative within the CTSA Program that was established to address critical roadblocks in clinical trials and to accelerate the translation of novel interventions into life-saving therapies. The TIN focuses on operational innovation, operational excellence, and collaboration and leverages the expertise and resources of the CTSA Program.

The goal of the TIN is not only to execute trials better, faster, and more cost-efficiently but also to be a national laboratory to study, understand, and innovate the process of conducting clinical trials. The TIN is composed two Trial Innovation Centers (TICs), One Recruitment Innovation Center (RIC), and the CTSA Program institutions.

The TICs were established to provide resources to enhance efficiency, improve trial start-up, speed recruitment, and harmonize processes across the CTSA Program for multi-site clinical studies.

The RIC was established to develop innovative solutions and demonstrate how these can be successfully applied to accelerate research participant recruitment and, over time, establish best practices that can be generalized to a broad range of research studies across the CTSA Program. Hub: Medical research institutions / academic health centers with CTSA hub awards maintain an integrated research and training environment for CTS.

Hubs play a central role in their local environments where they coordinate and collaborate with multiple “spokes” such as affiliated hospitals, clinics, and community health centers. Innovative Solutions: For purposes of this NOFO, innovative solutions are defined broadly to include, but not limited to, new approaches, methodologies, platforms, technologies, resources, devices, or models.

An innovative project could: (1) develop an innovative new solution, or (2) adapt, disseminate, and implement an existing solution in an innovative manner to advance translation. Partner/Partnering Institution(s): Must be effectively integrated into the proposed activities of the CTSA UM1 / UL1 hub and are necessary for attaining its strategic goals and research priorities.

A Partnering Institution may be included as a partner to only one CTSA hub. For purposes of this NOFO, CTSA partnering institutions are eligible to apply. Stakeholder: Includes individuals and/or organizations representing community members or advocacy groups; health care providers and health care systems; research participants; and patients.

Translation: Defined by NCATS as the process of turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and communities – from diagnostics, preventions, and treatments to medical procedures and behavioral changes. Translational Research (TR) : Defined by NCATS as the endeavor to traverse a particular step of the translational process for a particular target or disease.

Translational Science (TS): Translational science is the field that addresses longstanding scientific and operational challenges along the translational science spectrum through innovations that transform the way research is conducted, making it faster, more efficient, and more impactful. Translational scientists .

Multi-disciplinary academic and non-academic (e.g., community researchers, patient investigators) researchers that specialize in translation science and possess the skills and fundamental characteristics including domain expert, boundary crosser, team player, process innovator, skilled communicator, systems thinker, and rigorous researcher.

The CTSA Collaborative and Innovative Acceleration Award (CCIA) aims to accelerate the pace of translational research by supporting the collaborative development, dissemination, and sustainable implementation of innovative solutions across the CTSA Program Consortium and beyond.

This limited competition Notice of Funding Opportunity (NOFO) invites investigator-initiated applications to develop, demonstrate, and disseminate innovative new approaches, technologies, resources, or models that increase the impact of research across diseases, transform the field of translational science, and bring more treatments for all people more quickly.

The development and implementation of clinical interventions is a complex, iterative, and time-consuming process that takes years before discoveries in biomedical research result in health benefits for patients and communities.

The National Center for Advancing Translational Sciences (NCATS) has the unique charge of examining the translational research ecosystem at a systems level to determine where common pitfalls exist in the translational process and developing innovative solutions that will ultimately benefit research across a range of diseases and conditions.

This disease-agnostic approach to enhancing the efficiency and effectiveness of all translational research is known as translational science, which focuses on building the evidence base for effective scientific and operational approaches in translational research.

NCATS conducts and supports research in the science of translation to discover the scientific, mechanistic, and operational principles of the intervention development and dissemination processes, thereby providing the scientific foundation for improvements in translational efficiency that will accelerate the realization of interventions that improve human health.

To do this, NCATS relies on the power of data, bold new methods, technologies, boundary-crossing partnerships, community and stakeholder engagement, and multi-disciplinary team science to develop, demonstrate, disseminate and sustainably implement innovative healthcare solutions to make biomedical research advancements more impactful for patients and communities.

Advance CTS: develop, demonstrate, and disseminate scientific and operational innovations that improve the efficiency and effectiveness of clinical translation from identification to first-in-human studies to medical practice implementation to community health dissemination. Promote partnerships and collaborations to facilitate and accelerate translational research projects locally, regionally, and nationally.

Create, provide, and disseminate innovative research programs and partnerships across institutions and communities to address health needs of their populations and deliver the benefits of translational science to all. Create and implement scientific and operational innovations that increase the quality, safety, efficiency, effectiveness, and informativeness of clinical research.

Provide a national resource for the rapid response to urgent public health needs. Create, provide, and disseminate CTS training programs for clinical research professionals of all disciplines on the research team. Create, provide, and disseminate CTS training and career support programs for translational scientists.

Foster the development of the emerging field of translational science. The CTSA Collaborative and Innovative Acceleration Award (CCIA) aims to accelerate the pace of translational research by supporting the collaborative development, dissemination, and sustainable implementation of innovative solutions across the CTSA Program Consortium and beyond.

CCIA projects should: Build upon the unique and innovative activities, resources, expertise, and strengths of individual CTSA hubs Leverage existing or new partnerships to sustainably implement an innovative solution across multiple CTSA hubs, partners, collaborators, and/or other external stakeholders in a manner that no single organization can accomplish alone Demonstrate feasibility, in one or more use cases, for an innovative solution utilizing clear and meaningful metrics and outcomes Have a plan for the long-term adoption, implementation, and maintenance/sustainment of the innovative solution across the CTSA institutions, external stakeholders, and/or communities and patients, as appropriate NIH Institute-, Center-, and Office-Specific Research Interests Applications should be relevant to the purpose of this NOFO and to at least one of the NIH Institutes’, Centers’ and Offices' research interests outlined below.

U.S. Food and Drug Administration (FDA) The U.S. Food and Drug Administration (FDA) hosts the Centers of Excellence in Regulatory Science and Innovation (CERSI) Program to foster robust and innovative approaches to advance regulatory science.

The goal of the CERSI Program led by the Office of Regulatory and Emerging Science (ORES) , is to advance regulatory science individually and synergistically through collaborative interactions with FDA scientific experts and funding offices.

The FDA invites multi-site research projects from the collaborating CTSA Program and CERSI Program eligible organizations to advance the field of regulatory science by applying the NCATS’ translational science principles and the FDA’s regulatory science framework .

The Areas of Research Interest and Priority Include: Area 1 - Modernize Product Development, Evaluation, and Surveillance Methodologies Appropriate topics include, but are not limited to, the following: Strengthen surveillance and risk communication to patients and consumers Consider adoptability challenges in the process of product development evaluation Explore potential alternative methods to support product development and assessment Area 2 - Promote Public Health Preparedness for FDA, Patients and Consumers Appropriate topics include, but are not limited to, the following: Enhance FDA's ability and capacity to respond to public health threats nationally engaging communities Utilize novel approaches to minimize misinformation/disinformation for patients and consumers Area 3 - Data Science and Digital Health Technology Appropriate topics include, but are not limited to, the following: Utilize AI and real-world data for enhanced product evaluation and surveillance Explore innovative tools to support regulatory decision-making and adoption.

Area 4 - Workforce Development and Regulatory Science Training. A comprehensive approach to advancing Regulatory Science involves focusing on training and education, promoting collaboration, and establishing a robust Regulatory Science network.

Appropriate topics include, but are not limited to, the following: Adoption of regulatory science core competencies and curricular guidelines Dissemination of best practices to improve regulatory processes to enhance product safety and public health National Center for Advancing Translational Sciences (NCATS) Translational science projects that utilize boundary-crossing partnerships and cross-disciplinary team science to collaboratively develop, adapt, demonstrate, disseminate and sustainably implement innovative solutions that enhance the efficiency and speed of translational research.

These include but are not limited to: 1.

Topics of high priority Creation of infrastructure and processes to allow for rapid, robust, and ongoing evaluation and validation of emerging artificial intelligence/machine learning (AI/ML) enabled tools in the biomedical and healthcare space, ensuring that such tools perform to known and acceptable levels across health systems and allowing for rapid dissemination of “learning by doing” in safe and secure ways The development of a “Data-Science Innovation Program” for the dissemination and sustainable implementation across the CTSA consortium and beyond.

A Data-Science Innovation Program would accelerate TR/TS through multidisciplinary teams and networks that engage data scientists through: (1) the development and dissemination of resources and expertise to facilitate rigorous and innovative integration of cutting-edge data science across the CTSA consortium, and/or (2) practical consultations and partnerships to comprehensively and effectively integrate innovative data science into wide-ranging TR/TS CTSA activities.

Responsive applications could contain elements such as, but are not limited to: 1. Education and/or practical instruction from and for multidisciplinary teams that engage data scientists, highlighting whether, when and how data science can be incorporated into clinical and TS workflows, 2. Innovative methods and processes that integrate disparate data-based resources to increase the quality and efficiency of TR, 3.

Innovative programs that leverage disparate data-based resources to increase the quality, safety, efficiency, effectiveness and informativeness of clinical and translational research, and/or 4. Development, dissemination, and sustainable implementation of data-science-based consultative service models. Projects should engage data scientists as full scientific partners in every phase of the TR process.

As one conceptual example of how the different parts of a comprehensive program might work together, see NCATS’ Trial Innovation Network . 2. Community and multi-sectoral partnerships: Leverage use of large health data sets including those of state and local entities to create health solutions that are meaningful for communities.

Leverage community health analytic tools and methods including geocoding and appropriate collection of data to address health determinants. Community engagement methods and technologies that increase the efficiency and effectiveness of intervention development and deployment, and measurement of their effects on improving health outcomes.

Community engagement should be defined broadly to include local and distributed, physical and virtual communities. 3. Response to urgent public health need: Rapid response to urgent public health crises.

Improve the infrastructure and capability to conduct decentralized clinical research. Leverage of Veterans Health Administration for system-wide implementation of new and disruptive approaches to address the health burdens of veterans and improve veteran’s health. 4.

Transformative technologies: Technologies (such as digital health, telehealth, artificial intelligence) to increase efficiency during implementation of clinical research studies or clinical trials (e.g., study site selection and activation, recruitment and retention, patient reported outcomes, biomarker identification and validation, data collection and analysis, risk communication, clinical monitoring, data and safety monitoring, interoperability of electronic health record systems and clinical research data management systems).

Strategies leveraging real world evidence (RWE)/real world data (RWD) collection to identify and test new uses of off-patent drugs that are marketed in the U.S. for a different indication (Please see Envisioning an actionable research agenda to facilitate repurposing of off-patent drugs ).

Innovative applications and integration of data science, informatics tools and/or artificial intelligence/machine learning to make data more meaningful, open and accessible for the scientific community (predictive modeling, algorithms, simulation technologies, creation and dissemination of knowledge networks). 5.

Innovations in Advancing Recruitment through the Trial Innovation Network (AR-TIN) Innovations that are scientifically sound and use the latest evidence-based recommendations and guidelines that address critical barriers that hinder increasing the number of participant recruitment in clinical trials.

This includes tools and resources that: (1) transform, increase, and improve the recruitment of participants in clinical trials and (2) improve the use of participant-based information that will inform safety and efficacy for improving participant recruitment in clinical trials.

Examples include: Methods to improve disease progression modeling to advance the use of participant-based information that will inform safety and efficacy, Transformative tools and resources, such as but not limited to the use of artificial intelligence, that advance the digitalization of clinical trial activities, Innovative ways to incorporate clinical characteristics of intended populations in the absence of self-identification, Improved engagement of rural populations in centralized and decentralized clinical trials, User-friendly dynamic model on the study eligibility criteria and its impact on participant recruitment in clinical trials.

Strategies to improve the retention, safety and optimize the recruitment of participants in clinical trials. Clinical, genetic or machine-learning approaches that speed the identification or accurate diagnosis of rare disease patients to shorten the diagnostic odyssey encountered by rare disease patients.

Approaches that more rapidly identify the molecular underpinnings of rare genetic diseases and potential targets for therapeutics development, such as computationally assisted modeling. Development and use of master protocols, such as basket, umbrella or platform trials, that include “many-diseases-at-a-time” approaches for rare disease therapeutics development.

Clinical trial readiness strategies, such as adapting and validating clinical outcome assessment tools, e.g., patient-, observer- or clinician-reported outcomes or assessment tools or scales, for rare disease-specific indications. Novel approaches to increasing the efficiency of pre-clinical studies and/or clinical trials of “N-of-1" genetic therapies, e.g., antisense oligonucleotides. 7.

Opportunities for Academic Learning Health Systems. Including innovative solutions for integrating the full life cycle of translational research from hypothesis testing to implementation. Examples include: Innovative organizational approaches to improve patient care.

Innovation tools or approaches to engage communities. 8. Education and training: Artificial Intelligence in Healthcare Establishing and developing an entrepreneurial training center that applies translational science principles to catalyze the commercial development of innovative biomedical services or products.

Good Algorithm Practices (GAPs) which includes model validation, data integrity, and generalizability. Customized training modalities targeting the needs of academic and non-academic clinical researchers (e.g., study coordinators, research pharmacists, patient investigators, community health workers, doulas, physician assistants, nurse practitioners, midwives).

National Human Genome Research Institute (NHGRI) NHGRI supports resources, approaches, and technologies that accelerate genomic research focused on the structure and biology of genomes; the genomics of disease; the implementation and effectiveness of genomic medicine; computational genomics and data science. For this NOFO, NHGRI intends to support the development of tools and resources that foster the use of genomics in clinical trials.

Approaches that are comprehensive across the genome or are generalizable across variants, tissues, diseases, or function may be in scope for NHGRI to the extent they address priority areas described in the NHGRI 2020 Strategic Vision and on the web pages for the research mission of NHGRI’s Extramural Divisions and Offices: Division of Genome Sciences: https://www. genome.

gov/about-nhgri/Division-of-Genome-Sciences Division of Genomic Medicine: https://www. genome. gov/about-nhgri/Division-of-Genomic-Medicine Office of Genomic Data Science: https://www.

genome. gov/about-nhgri/Office-of-the-Director/Office-of-Genomic-Data-Science Applications for clinical trial tools and resources relevant only to a particular disease or organ system should be directed to the appropriate Institute or Center.

Applications whose primary scientific objective is to understand a single biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention, will not be in scope for NHGRI.

National Institute of Allergy and Infectious Disease (NIAID) The mission of the National Institute of Allergy and Infectious Diseases (NIAID) is to conduct and support basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases.

Under the Chemical Countermeasures Research Program (CCRP) , the NIAID supports projects across the NIH that focus on the research and early-stage development of medical countermeasures (MCMs) for situations of high consequence public health chemical emergencies.

The civilian chemical threat spectrum includes chemical warfare agents as well as various toxic industrial chemicals and materials that the U.S. Department of Homeland Security has identified as Chemicals of Concern (CoCs).

These CoCs can have a variety of toxic effects or toxidrome(s), including: Pulmonary, irritant, and corrosive agents that target the respiratory tract and may induce edema and/or other long-term pathologies, e.g., chlorine, phosgene, and oleum. Pharmaceutical-based agents, such as incapacitating compounds to include e.g., fentanyl, carfentanil, and nitazenes.

Vesicating agents that may cause dermal and ocular pathologies, e.g., sulfur mustard and nitrogen mustard. Cellular respiration inhibitors, such as blood, hemolytic, and metabolic agents, e.g., cyanide and hydrogen sulfide.

Cholinergic, convulsant, encephalopathic, and sympathomimetic/stimulant agents that target the nervous system inducing seizure and and/or neurodegeneration, e.g., organophosphorus pesticides and warfare agents Other agents such as those that induce coagulopathy, e.g., brodifacoum Only preclinical research will be supported.

Prospective applicants are strongly encouraged to contact the NIAID or NCATS Scientific Officials listed below to confirm eligibility to apply under this solicitation and/or to ensure the proposed research is within scope of the CCRP mission.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases.

In the context of this NOFO, the NIAMS is interested in research from collaborative research teams focused on innovative solutions designed to accelerate the translation of scientific knowledge to interventions that improve the treatment of NIAMS mission relevant diseases.

National Institute of Dental and Craniofacial Research (NIDCR) The NIDCR is interested in research from collaborative research teams focused on accelerating the translation of scientific knowledge about dental, oral, and craniofacial diseases and conditions into prevention, early detection, and/or treatment strategies to improve dental, oral, and craniofacial health across the lifespan.

For applications submitted to this NOFO, the contact PD(s)/PI(s) must have a primary appointment as a faculty member of a dental school in the United States. National Institute of General Medical Sciences (NIGMS) The NIH/NIGMS Institutional Development Award (IDeA) is a congressionally mandated program that builds research capacity in states that historically have had low levels of NIH funding.

It supports competitive basic, clinical, and translational research, career development, and infrastructure improvements.

One IDeA component is the IDeA Clinical and Translational Research (IDeA-CTR) Program, which supports clinical and translational research through programs that develop research infrastructure and human resources, enhance the ability of investigators and institutions to develop competitive clinical and translational research programs, and strengthen collaborative research that addresses the broad spectrum of health conditions prevalent in IDeA states.

Organizations holding active CTR-Network (CTR-N, P50) awards, its predecessor IDeA-CTR (U54) awards, and its companion CTR-Development (CTR-D, P20) awards are eligible to serve as CCIA partners; see the IDeA CTR Dashboard for a list of eligible award recipient.

Office of Disease Prevention (ODP) The Office of Disease Prevention (ODP) is the lead office at the NIH responsible for assessing, facilitating, and stimulating research in disease prevention. In partnership with the 27 Institutes and Centers of NIH, ODP strives to increase the scope, quality, dissemination, and impact of NIH-supported prevention research.

In general, ODP provides co-funding support for research that has strong implications for disease and injury prevention, and research that includes innovative and appropriate research design, measurements, and analysis methods.

Within ODP, the Tobacco Regulatory Science Program (TRSP) is an interagency partnership between NIH and the Center for Tobacco Products at the Food and Drug Administration (FDA), which fosters research in tobacco regulatory science.

As the tobacco-focused program within ODP, TRSP also monitors NIH investment in tobacco prevention and facilitates collaboration across NIH Institutes and Centers (ICs) for ODP-led opportunities to address research gaps in tobacco prevention that complement the FDA-supported program of tobacco regulatory research.

Office of Disease Prevention (ODP) and Tobacco Regulatory Science Program (TRSP) Areas of Research Interest Develop, demonstrate, and disseminate innovative new approaches, technologies, resources, or models that advance the following scientific domains: Product design. Understanding tobacco product composition and design Toxicity.

Approaches that test the toxicity of non-cigarette tobacco smoke, aerosol, or specific constituents Addiction. Effects of tobacco product characteristics on addiction and abuse liability Health Effects. Short- and long- term health effects of tobacco products Behavior.

Understanding of knowledge, attitudes and behaviors related to tobacco product use Communications. Understanding how to effectively communicate the health effects of tobacco products Marketing Influences. Influences of tobacco marketing Prevention and Treatment.

Prevention and/or treatment for tobacco product use and addiction Office of Research on Women’s Health (ORWH) The Office of Research on Women’s Health (ORWH) is part of the NIH Office of the Director, and works in partnership with the 27 NIH Institutes, Centers, and Offices (ICOs) to ensure that women's health research is part of the NIH scientific framework and supported throughout the biomedical research enterprise.

ORWH uses a multidimensional framework to represent the intersection of factors that underlie patterns of disease. Applications Not Responsive to this NOFO The following types of studies are not responsive to this NOFO.

Applications proposing such studies will be considered non-responsive and will not be reviewed or considered for funding: Applications that do not include at least three currently active, eligible organizations as of the due date of the application (see Section III. 1. Organizational Eligibility below) Applications that do not include a letter of support from each collaborating organization.

Applications that do not include a Milestone Plan attachment as described below. Applications that do not include a Sustainability Plan attachment as described below. Applications that do not include a signed Eligibility Statement attachment as described below.

Applications that do not include a Data Management and Sharing (DMS) Plan (see the NIH Data Management and Sharing Policy ). Please note the difference between a DMS Plan and a Resource Sharing Plan. See here to determine which sharing policies apply to the planned research.

Applications that propose to use funds to support any clinical trial beyond Phase IIB except for Phase III clinical trials for treatment of rare diseases. Projects that do not meet these clinical trial limitations will not be reviewed. See NOT-TR-18-025 .

Applications in response to the NICDR research priority statement that do not include PD(s)/PI(s) affiliated with one or more US dental schools. This NOFO will use the UG3/UH3 Cooperative Agreement mechanism. This funding mechanism involves two phases.

Both phases are required in the application. Delineation of scientific and/or operational milestones is a key characteristic of this NOFO. Each application must provide a fully developed research plan and budget for both UG3 and UH3 phases at the time of submission, with distinct Aims for each phase.

The UG3 Phase will support the development, adaptation, and/or demonstration of an innovative solution that accelerates the translational research process. A feasibility assessment should be conducted in the UG3 Phase to ensure that an innovative solution can be successfully disseminated and implemented during the UH3 Phase of the award.

The UH3 Phase will support the dissemination, implementation, and evaluation of the innovative solution that was developed during the UG3 Phase by all collaborating organizations for dissemination across multiple CTSA hubs and/or other stakeholders outside the Consortium. Transition from the UG3 to the UH3 Phase: Milestones provide quantifiable measures of success and are a key characteristic for this bi-phasic mechanism.

A milestone is defined as a finding or set of findings that signal the achievement of a Specific Aim in your research plan. Milestones should be comprised of three basic components: (1) a desired goal, (2) a timeline or decision point by which the goal must be accomplished, and (3) evidence that the goal has been accomplished based upon quantitative criteria.

For evaluative purposes, each application must include a Milestone Plan as a separate attachment (see Other Attachments below). The Milestone plan should include three separate components: A distinct set of annual milestones for both the UG3 and UH3 Phases related to assessing progress on each Aim of your project.

A set of quantitative, transitional milestones that will be used to evaluate overall progress made during the UG3 phase of the award and justify the transition into the UH3 phase of the award (i.e., go/no go criteria), and A Timetable (e.g., Gantt Chart) identifying when each of the key milestones will be met.

The timeline of UG3 activities should not extend into the UH3 Phase of the award as each Phase of the award should contain a distinct project. In the event of an award, the