NCTR Strategic Plan

In support of the FDA’s mission to promote and protect public health, NCTR’s Strategic Plan focuses on five strategic goals:

Goal 1: Advance scientific approaches and tools to promote personalized nutrition and medicine for the public 

In response to an identified need for personalized nutrition and medicine, FDA is committed to accelerating the development of safer and more effective 1) interventions for maintaining health that are based on the nutritional needs of an individual rather than “one-size-fits-all” recommendations for foods, and 2) individualized medical-product therapies. Recent advances in biotechnology have accelerated research on the development of molecular biomarkers for the diagnosis and treatment of disease. This research is a vital component of the FDA mission, especially in the area of incorporating pharmacogenomics and nutrigenomics into advancing personalized nutrition and medicine. Additionally, many interactions of foods, nutrients, and dietary supplements in individuals can now be characterized and this information can be used to address safety and health issues.

Goal 2: Develop science-based best-practice standards, guidance, and tools to incorporate toxicological advancements that improve the regulatory process 

An important function of the FDA is to identify risks associated with the use of food, food additives, food and feed contaminants, and medical products and devices. One FDA goal is to improve the translation of preclinical data on drugs and devices to advance clinical care, and reduce the occurrence of adverse events. Another goal is to understand and reduce the risk associated with food contaminants and constituents. NCTR responds to the research needs of the FDA Product Centers by using toxicological methods to identify the hazards, inform the mode of action assessment, quantify the dose-response for adverse effects, and provide mechanistic or predictive biomarkers to understand human risk.

Goal 3: Conduct research and develop strategic technologies to protect the food supply 

FDA is responsible for ensuring the safety of foods, food ingredients, and bioengineered foods; defending the food system against terrorist attacks; identifying food-related health hazards; and conducting research to provide a sound basis for regulatory decisions. The scope of the FDA’s responsibility encompasses ~ $450 billion in domestic and imported foods or 80% of the nation’s food supply. FDA has developed a comprehensive food protection strategy to protect the nation’s food supply from both unintentional contamination and deliberate attack. NCTR is integrating its research with other FDA centers and the Office of Regulatory Affairs to develop collaborative projects to develop methods to prevent outbreaks of foodborne illness caused by unintentional and intentional factors. Furthermore, in collaboration with the National Toxicology Program (NTP) and other FDA Centers, NCTR performs studies in vitro or in vivo to provide dose-response data. These technologies can also be applied to other FDA-regulated products.

Goal 4: Conduct bioinformatics research and development in support of FDA’s regulatory mission 

Developing a modern bioinformatics infrastructure for efficient electronic regulatory processes and incorporating new technologies, scientific methodologies, and global business activities is a major FDA initiative anticipated to span the next decade. NCTR will be a principal contributor to FDA’s bioinformatics modernization plan through formulating requirements, planning, and development efforts.

Goal 5: Strengthen and improve scientific and human capital management and expand training and outreach to retain and train scientific experts critical to address FDA’s scientific needs 

NCTR’s ability to efficiently and effectively manage its scientific infrastructure, recruit talented new scientists, and support e-government initiatives mandates the use of modern project and program planning using an integrated budget and performance process linked to the FDA’s improved financial performance system. Working collaboratively within FDA and with other government, academic, and industry groups, NCTR will enhance its current management infrastructure and expand the utilization of this agency-owned laboratory facility. NCTR scientists support the agency’s regulatory activities by providing technical expertise in the interpretation of data, the development and harmonization of guidelines, and by participating in national and international scientific workgroups and advisory panels.

FDA’s success in achieving its mission requires a well-trained scientific staff whose expertise and skills are optimally used to address the complex issues associated with agency-regulated products. As part of its mission of conducting research, NCTR provides the agency and the regulatory community with technical expertise, consultation, and training.