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Associate Director: Bradley J. Schnackenberg, Ph.D.

Nanotechnology: Over a Decade of Progress and Innovation at FDA
Presented by Anil Patri, Ph.D.

Watch the Recorded Presentation

Meet the Principal Investigators — Scientific Coordination

The components of OSC that facilitate the FDA/NCTR research mission are: 

• Veterinary Services
• Microbiological Surveillance
• Analytical Chemistry
• Statistics
• Experimental Support
• Nanotechnology
• 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)

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Research and Support Services

Veterinary 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 Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accredited since 1977.

Microbiological Surveillance

Microbiological Surveillance staff ensure the animals, environment, food, 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

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 1) verification of test-article identity and purity, 2) certification of concentration and stability of test articles in dosing solutions and vehicles, and 3) surveillance of animal study materials (bedding, water, and diet) performed routinely.

Statistics

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

Experimental Support staff provide computer-based 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 study.

Nanotechnology

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.

Animal Care Contract

NCTR maintains an on-site contract with trained and proficient staff to provide 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.

Pathology Services Contract

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: clinical pathology, histopathology slide preparation, rigorous pathology examination, and complete histopathology and pathology reports for each study.

Equipment Maintenance and Repair Contract

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.

Program Support for National Toxicology Program (NTP) and Center for Tobacco Products (CTP)

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.

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Resources for You

• NCTR Grand Rounds: "Nanotechnology: Over a Decade of Progress and Innovation at FDA"
  (Presentation recorded in Adobe Connect on August 13, 2020)
• Annual Report
• Nanotechnology at NCTR
• Meet the Principal Investigators

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