Major Functions and Responsibilities
The Office of Scientific Coordination (OSC) provides the professional support necessary to conduct toxicology studies in support of FDA/NCTR’s research mission.
The components of OSC that facilitate the FDA/NCTR research mission are:
- Veterinary Services
- Microbiological Surveillance
- Analytical Chemistry
- Experimental Support
- Animal Care Contract
- Pathology Services Contract
- Equipment Maintenance and Repair Contract
- Program support for the NIEHS/National Toxicology Program (NTP) and the FDA Center for Tobacco Products (CTP)
Research and Support Services
Veterinary Services staff play a key role in the research at NCTR, where they ensure the health and welfare of all animals used in research. The veterinarians participate in the review and monitoring of animal use through the Institutional Animal Care and Use Committee (IACUC). They participate in the research by advising study scientists regarding study design, performing surgery on animals, and monitoring the overall health of the animal program. Veterinary Services also includes the Microbiology Surveillance Support staﬀ. This facility has been AAALAC accredited since 1977.
Microbiological surveillance staff ensure the animals, environment, food and bedding, and test articles are free from opportunistic pathogens. They are a resource for scientists investigating suspected contaminated cell lines. They support personnel health by microbiological testing of NCTR water and environmental samples.
Analytical chemistry research and support are conducted using trained staff and state of the art instrumentation for processing of a wide range of samples. Test articles and their metabolites are assayed in blood, tissues or urine to provide measures of exposure, and for genotoxic compounds, DNA adducts are measured. The high quality of studies at NCTR is ensured by verification of test article identity and purity, concentration certification and stability of test articles in dosing solutions and vehicles, and the routine surveillance of animal study materials (bedding, water and diet).
The statistical support staff provides traditional statistical support for the various toxicity studies conducted at NCTR. The services provided include: statistical consultation during protocol development, statistical randomization, statistical analysis, and statistical reporting.
Experimental support staff provide computer-based and in-life support for animal studies. The staff reviews study protocols and works with research and support staff to enter study parameters in the animal data collection system, reviews data, and generates reports at the conclusion of the in-life portion of the study.
NCTR and the Oﬃce of Regulatory Aﬀairs (ORA) jointly operate and maintain the NCTR/ORA Nanotechnology Core Facility (NanoCore). This core facility is equipped with the appropriate equipment and trained staﬀ to properly characterize and detect nanoscale materials. The NanoCore has been designed to support research investigators with nanomaterial characterization, develop standard operating procedures for consistent measurement of the nanomaterials, and develop new procedures to detect nanomaterials in biological matrices in support of toxicology studies in vitro and in vivo.
NCTR maintains an on-site contract for animal care services. The contractor provides trained and proficient staff to perform the tasks necessary for in-life study support including husbandry, environmental enrichment of all animals, formulation and administration of test articles, sample collection, and data collection. The contractor works with the Veterinary Services veterinarians and the IACUC to ensure the health and welfare of the animals.
NCTR maintains an on-site pathology contract for veterinary pathology and histopathology services. The contractor maintains a staff of three veterinary pathologists and a highly trained staff that provide NCTR with services including: necropsy, clinical pathology, histopathology slide preparation, rigorous pathology examination, and complete histopathology and pathology reports for each study.
NCTR maintains a contract for equipment maintenance and repair that supports the routine preventative maintenance and calibration of equipment, manufacture of minor equipment to support customized research needs, and repair of equipment that is not on a service agreement with the manufacturer.
OSC oversees the Performance Agreement between the Center for Tobacco Products (CTP) and NCTR, coordinates research progress communications, and provides programmatic support for the CTP-sponsored tobacco regulatory science research portfolio.
OSC also oversees the facilities and contracts supporting an InterAgency Agreement between NIEHS/NTP and FDA/NCTR and assists in the generation of background documents and final reports of FDA-nominated chemicals to the NTP.
Resources for You
- National Center for Toxicological Research
Food and Drug Administration
3900 NCTR Rd
Jefferson, AR 72079
- (870) 543-7121