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The Nanoscale Science, Engineering, and Technology (NSET) Subcommittee
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA
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NCI, NIBIB, OD/OSP
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This subcommittee of the National Science and Technology Council''s Committee on Technology is responsible for coordinating the National Nanotechnology Initiative (NNI). The NNI was established in 2001 to coordinate federal research and development in nanotechnology by providing a vision of the long-term benefits and opportunities offered by nanotechnology and acting as a locus for communication, cooperation, and collaboration between federal agencies involved in nanotechnology research and development. In 2016, the NSET updated its strategic plan to reflect the fact that nanotechnology is now a broadly enabling technology, not simply an area of research at the nanoscale. The new strategic plan outlines four goals: (1) advance a world-class nanotechnology research and development program, (2) foster the transfer of new technologies into products for commercial and public benefit, (3) develop and sustain educational resources, a skilled workforce, and a dynamic infrastructure and toolset to advance nanotechnology, and (4) support responsible development of nanotechnology.
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The Science of Sex and Gender in Human Health
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Training Initiative
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FDA
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OD/DPCPSI/ORWH
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This is a Web-based course that offers a scientific understanding of the major physiological differences between the sexes, their influence on illness and health outcomes, and their implications for policy, medical research, and health care. The course is under active review and revision, including the development of a new module that focuses on incorporating epidemiologic observations, basic/pre-clinical research findings, and clinical research results, with an emphasis on the basic science to highlight sex/gender-based influences for particular disease entities.
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The SMART Vaccines 2.0 Platform: Decision-Support for Prioritizing Vaccine R&D and Introduction (SMART Vaccines 2.0)
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Resource Development
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OS
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FIC
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The prototype decision-support tool, SMART Vaccines, was delivered to the National Vaccine Program Office (NVPO) by the Institute of Medicine (IOM) in early 2015. In support of the National Vaccine Action Plan, NVPO charged the IOM to develop a tool that reflected the dynamic and complex nature of decision-making among multiple stakeholders within the vaccine decision-making space—comprising the different interests, roles, and priorities of individuals engaged in vaccine research, research funding, purchasing, immunization programs, and policy.
The current design of the tool seeks to capture the components of this decision-making process and to model how those elements interact to ultimately influence how an individual or an organization might prioritize its strategic and financial investments in new research and targets for vaccines or newly available vaccines for introduction into national immunization schedules. By attempting to more uniformly define the components of the process and allowing individuals to rank the importance of each, the tool generates a score that allows for a comparison among different inputs of vaccine targets and/or existing vaccines and the impact of each on the resulting score.
NVPO and FIC are collaborating in support of both agencies’ missions related to developing and implementing strategies for increasing the prevention of human diseases through immunization. As part of a process to build a fully functional tool, SMART Vaccines 2.0, the NVPO and FIC are engaging relevant stakeholder organizations and individuals to assist in the prototype’s transformation to a more widely-accessible, relevant, and responsive tool for use in support of prioritizing the scientific, technical, and financial commitments of decision makers in the broad vaccine development and delivery community.
Collaboration efforts support the following objectives:
1) Provision of capabilities to transform the existing SMART Vaccines tool to a web-based platform (html open-source model) that can be supported and sustained for public access;
2) Iterative adaptation and refinement of the tool -or suite of tools- that is responsive to:
- dynamic and emerging information/inputs (e.g., disease burden, antigen-specific technology, and economic data);
- ongoing assessment/validation of methodologies; and,
- user/stakeholder feedback
3) Expansion and updating of the data warehouse (model supporting data) and standardized formats for data sharing;
4) Dissemination and use of the tool (and/or derivative tools) supported by direct engagement and training of the public sector, academic, and private sector stakeholders and decision-makers associated with vaccine development, purchasing, and deployment/implementation programs; and,
5) Identifying an external hosting organization for the tool that is sustainable and provides global access to the tool by embedding it an infrastructure that utilizes existing resources for maintenance of standards and capabilities.
To support these objectives, at least two piloting opportunities have been identified in which the relevant organizational stakeholders have agreed to utilize the SMART Vaccines 2.0 web-based tool in support of a targeted decision-making process. The focus of these decision-making efforts is related to the prioritization of resource-allocation for vaccine research and development and/or the introduction of new or existing vaccines into current immunization schedules. NVPO and FIC are supporting the following deliverables:
1) Provision of capabilities to utilize the web-based SMART Vaccines 2.0 platform in support of piloted applications;
2) Direct engagement of NVPO/FIC (and partner organizations) technical assets, staffing, and training in support of the pilot organization’s use of the SMART Vaccines 2.0 tool;
3) Modification and enhancement of the tool’s back-end model supporting algorithms and data-sourcing and acquisition capabilities for alignment with the pilot organizations specific decision-support needs;
4) Evaluation of the implementation and outcome of the piloted projects and the responsive of the SMART Vaccines 2.0 platform in this process;
5) Assessment of the long-term sustainability of the SMART Vaccines initiative based on the following:
- an evaluation of the tool produced from the pilot project and the feasibility of its on-going adaptation for other related decision-making processes;
- the opportunities and limitations associated with data availability in support of the SMART Vaccines approach;
- an evaluation of the likelihood of use by key decision-makers in the vaccine research, development, and delivery communities;
- the viability of commitments from external technical experts and organizations to continue to support the ongoing and dynamic modifications that will be required to adapt the SMART Vaccines tool for individual decision-making needs; and,
- the likelihood of external stakeholder funding opportunities to support the sustained human, technical, and financial needs required for long-term viability of a publicly accessible SMART Vaccines tool.
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The United States Renal Data System (USRDS)
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Resource Development
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CMS, HRSA
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NIDDK
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The United States Renal Data System (USRDS) is a national data system that collects, analyzes, and distributes information about chronic kidney disease and end-stage renal disease (ESRD) in the United States. The missions of USRDS are: (1) To characterize the total renal patient population and describe the distribution of patients by socio-demographic variables across treatment modalities; (2) To report on the incidence, prevalence, mortality rates, and trends over time of renal disease by primary diagnosis, treatment modality and other variables; (3) To develop and analyze data on the effect of various modalities of treatment by disease and patient group categories; (4) To identify problems and opportunities for more focused special studies of renal research issues; (5) To conduct cost effectiveness studies and other economic studies of ESRD; and (6) To make the data available to investigators, and by supporting investigator-initiated projects, to conduct biomedical and economic analyses of ESRD patients.
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Therapeutics for Rare and Neglected Diseases (TRND)/FDA Working Group
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Committee, Work group, Advisory group, or Task Force
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FDA
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NCATS
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A group of Therapeutics for Rare and Neglected Diseases (TRND) Program staff and US Food and Drug Administration (FDA) staff from the Center for Drug Evaluation and Research (CDER) meet on a monthly basis to discuss projects for the TRND program. The purpose of this working group is to discuss regulatory science toward the eventual goal of an Investigational New Drug Application. Results of experiments are discussed, and TRND staff and FDA/CDER staff exchange ideas that are taken into consideration when developing TRND project plans.
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Tissue Chip Testing Centers
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Research Initiative
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FDA
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NCATS
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NCATS-funded Tissue Chip Testing Centers (TCTC) scientists will use a reference set of validation compounds vetted by pharmaceutical representatives through an NCATS partnership with the IQ Consortium and the Food and Drug Administration (FDA) and will run tests to determine functionality, reproducibility, robustness, and reliability in these organ platforms. The TCTC scientists will coordinate activities among Tissue Chip program-funded investigators and the FDA to support the progress of these chips, with the goal of getting chips to be used widely as a validated research tool and qualified for use in pre-clinical drug testing.
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Tobacco and Nicotine Research Interest Group (TANRIG)
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA, SAMHSA
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NCI, NHGRI, NHLBI, NIAAA, NIAID, NICHD, NIDA, NIEHS, NIMH, NINR, OD/DPCPSI/OBSSR, OD/DPCPSI/ODP
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The Tobacco and Nicotine Research Interest Group (TANRIG) was formed in January 2003 with the goal of increasing collaboration, coordination, and communication of tobacco- and nicotine-related research among National Institutes of Health Institutes and Centers, as well as with other relevant US Department of Health and Human Services agencies.
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Tobacco and Reproductive Health Working Group
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA, HRSA
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NICHD, NCI, NIAAA, NIDA, NINR
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The purpose of this working group is to exchange information across agencies about research efforts concerning tobacco and reproductive health.
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Tobacco Centers of Regulatory Science (TCORS)
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Research Initiative
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FDA
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OD/DPCPSI/ODP
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The Tobacco Regulatory Science Program located in the NIH Office of Disease Prevention coordinates the trans-NIH collaboration effort with the Food and Drug Administration Center for Tobacco Products to conduct research that is needed to ensure that US tobacco regulatory actions and activities are based on sound and relevant scientific evidence. The P50 Tobacco Centers of Regulatory Science (TCORS) are the centerpiece of this NIH-FDA collaboration.
The TCORS are expected to demonstrate research excellence and leadership in tobacco regulatory science that will contribute to the science base that FDA will use to develop meaningful product regulation, which will, in turn, reduce the toll of tobacco-related disease, disability, and death in the United States. Essential elements of the TCORS include at least three theoretically grounded, strong research projects with an integrative theme; an Administrative Core and other cores as needed; the ability to conduct developmental/pilot and time-sensitive research; and a program for career development and training
Fourteen TCORS, made up of scientists with a broad range of expertise (e.g., epidemiology, economics, toxicology, addictions, and marketing) have been funded.
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Tobacco Product Disease Risks
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Research Initiative
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FDA
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NCI
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NCI and the FDA-Center for Tobacco Products, in collaboration with the US Census Bureau, co-lead this study, which harmonizes data on cigarette, cigar, and pipe use from various Tobacco Use Supplements that have been administered over the years as part of the Current Population Survey. The participants in these surveys have been followed for mortality by linkage to the National Death Index. These data are used to provide contemporary estimates of the mortality risks of daily and non-daily use of cigarettes, pipes, and cigars. The first manuscript from the project is in press.
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