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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 2011, the NSET developed a strategic plan that encompasses a comprehensive nanotechnology R&D initiative built on shared goals, priorities, and strategies that complement agency-specific missions and activities.
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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.
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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 2 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 Sudden Death in the Young Case Registry
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Resource Development
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CDC
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NHLBI, NINDS
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The SDY Case Registry is a collaborative effort between the National Institutes of Health, the Centers for Disease Control and Prevention, and the Michigan Public Health Institute. Its goals are to: 1) describe the incidence of SDY in the United States using population-based surveillance, 2) compile data from SDY cases to create a resource of information and deoxyribonucleic acid (DNA) samples for research, 3) encourage standardized approaches to investigation, autopsy, and categorization of SDY cases, 4) develop partnerships between local, state, and federal stakeholders towards a common goal of understanding and preventing SDY, and 5) support families who have lost loved ones to SDY by providing resources on bereavement and medical evaluation of surviving family members. The SDY Case Registry will provide valuable incidence data and will enhance understanding of characteristics of SDY cases to inform development of targeted prevention efforts.
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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 U.S. The missions of the 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 U.S. Food and Drug Administration (FDA) staff from the Center for Drug Evaluation and Research (CDER) meet on a semi-monthly basis to discuss projects for the TRND program. The purpose of this working group is to discuss the scientific progress toward the eventual goal of an Investigational New Drug Application for each project. Results of experiments are discussed, and TRND staff takes the feedback of FDA/CDER staff into consideration when developing future project plans.
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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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OD/DPCPSI/OBSSR, NCI, NHGRI, NHLBI, NIAAA, NIAID, NICHD, NIDA, NIEHS, NIMH, NINR, 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 U.S. Department of Health and Human Services agencies.
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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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Associations of cigarette and non-cigarette tobacco products with total and cause-specific mortality in Current Population Survey linked mortality dataset
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Tobacco Regulatory Science Program (TRSP)
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Research Initiative
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FDA
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OD/DPCPSI/ODP, CSR, NCI, NHLBI, NIAAA, NICHD, NIDA, NIDCR, NIEHS, OD/OER
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Located in the National Institutes of Health (NIH) Office of Disease Prevention, the Tobacco Regulatory Science Program (TRSP) coordinates the trans-NIH collaborative effort with the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) to conduct research to support its regulatory activities over tobacco products. Within the framework of the Tobacco Control Act, the NIH and FDA formed an interagency partnership to foster tobacco regulatory research. The NIH has the infrastructure for the solicitation, review, and management of research. The FDA has expertise in tobacco regulatory science and the authority and resources to support research responsive to FDA’s regulatory authority. Support from FDA was used to fund grants and to provide administrative support and oversight to manage Funding Opportunity Announcements (FOA), application review, policy implementation and oversight, and communicating and reporting to a variety of sources.
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Tox21 - Memorandum of Understanding on High Throughput Screening, Toxicity Pathway Profiling, and Biological Interpretation of Findings
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Research Initiative
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FDA
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NIEHS, NCATS
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This Memorandum of Understanding sets in place mechanisms to strengthen existing collaborations in the research, development, validation, and translation of new and innovative test methods that characterize key steps in toxicity pathways. Central is the exploration of high throughput screening assays and tests using phylogenetically lower animal species as well as high throughput whole genome analytical methods, to evaluate mechanisms of toxicity. Ultimately, the data generated by these new tools is to be provided to risk assessors to use in the protection of human health and the environment. Success is expected to result in test methods for toxicity testing that are more scientifically and economically efficient and models for risk assessment that are more biologically based.
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