NCTR Office of Scientific Coordination Also referred to as: OSC
Associate Director: Bradley J. Schnackenberg, Ph.D.
Director, Nanotechnology Core Facility: Anil Patri, Ph.D.
FDA Grand Rounds: Electron Microscopy, Still a Powerful Research Tool
Presented by Angel M. Paredes, Ph.D.
FDA Grand Rounds: Electron Microscopy, Still a Powerful Research Tool
Presented by Angel M. Paredes, Ph.D.
About the Office
Mission
Provide the professional support necessary to conduct toxicology studies that support FDA’s and NCTR’s research mission, to include:
- Analytical Chemistry
- Experimental Support
- Microbiological Surveillance
- Nanotechnology
- Statistics
- Veterinary Services
- Onsite Support Contracts
- Animal Care Contract
- Pathology Services Contract
- Equipment Maintenance and Repair Contract
Research and Support Services
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) formulation of dosing solutions, 3) certification of concentration and stability of test articles in dosing solutions and vehicles, and 4) routine surveillance of animal study materials (bedding, water, and diet).
- Developed high-performance liquid chromatography-mass spectrometry (HPLC-MS) methods to analyze several opioids (methadone, morphine and buprenorphine) and verify the concentration of oral-dose formulations in a rat study. Analyzed rat plasma samples from these studies to determine the achieved in vivo exposures.
- Added the preparation of dose formulations to the Analytical Chemistry Group’s support functions.
- Developed a gas chromatography with flame-ionization detection method to evaluate the purity of tritiated 1,4-dioxane test article and provided an evaluation of several lots of material provided by the manufacturer.
- Investigated possible formulations to be used in a high-dose studies of acetaminophen, glyburide, and metformin in rats. Conducted dose certifications of these suspensions prior to their use in these animal studies.
- Upgraded instrumentation with the purchase of two new ultra-performance liquid chromatography-tandem mass spectrometer systems which will be used in bioanalytical projects supporting multiple studies and FDA Centers. Also replaced two obsolete HPLC systems with a new HPLC system that will be used to conduct dose formulation certification studies.
- Conducted analysis of nicotine, propylene glycol, and vegetable glycerin in filters and liquid exposure inserts from a conventional cigarette smoking robot to ensure proper validation of target exposures for future in vitro studies.
Experimental Support
Experimental Support staff provides 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.
Microbiological Surveillance
The Microbiology Surveillance Laboratory staff ensures research animals, environments, food, bedding, and test articles are free from opportunistic pathogens and supports personnel health by routinely monitoring the microbiological quality of NCTR drinking water and environmental samples. They provide accurate and timely identification and characterization of microbes using advanced technologies including biochemical metabolism, MALDI-TOF mass spectrometry, and NGS. The laboratory staff also supports other microbiology-related research studies from the research divisions.
In 2023, the microbiology surveillance unit developed two new diagnostic methods for use within the unit:
- Sequencing-based Diagnostic Methods — A new 16s rRNA sequence-based method was introduced and is currently extending its services for more organisms
- Endotoxin assay — Optimization is currently underway and the test will be available to NCTR investigators in 2024
Nanotechnology
The NCTR/ORA NanoCore supports collaborative nanotechnology research within FDA and research between FDA and other government agencies and universities. This facility is well-equipped with advanced analytical equipment for nanomaterial assessment. Apart from these, laboratories are equipped for in vitro and in vivo biological studies. NanoCore research provides information on nanomaterial characterization and the safety of products containing nanomaterials in FDA-regulated products. This research data is also used in staff and reviewer training and in establishing standards for use by stakeholders developing nanotechnology products.
- In 2023, the NanoCore completed two key projects:
- Evaluation of the migration and toxic potential of silver nanoparticles in feminine hygiene products
- Investigation into reported differences in Doxil and generic liposomal doxorubicin products
- U.S. Environmental Protection Agency released the draft strategy “National Strategy to Prevent Plastic Pollution,” which includes ambitious actions to eliminate the release of plastic and other waste from land-based sources into the environment by 2040. NCTR’s NanoCore developed a baseline reference dataset of most common environmental polymers that would assist in developing a collaborative, global, comprehensive, and curated public database for the identification and quantitation of various micro/nano plastics and mixtures.
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.
Veterinary Services
Veterinary Services staff 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 advise 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.
- Supported IACUC with administrative functions and active participation of 2 voting members.
- Maintained high standards of animal care including compliance with the Animal Welfare Act and regulations, Public Health Service regulations, and AAALAC standards.
- Assisted in the implementation of three new animal models to answer critical questions with agents of concern to the FDA.
Onsite Support Contracts
NCTR maintains on-site contracts for animal care services, veterinary pathology services, and equipment maintenance services.
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, administration of test articles, sample collection, and data collection. The contractor works with the veterinary staff 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 two full-time 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.
Collaborations, Presentations, and Outreach
- Updated FDALabel to version 2.8 with new features focusing on interface and search capability enhancements to make the tool more user-friendly and resourceful. This is a collaborative effort with the Center for Drug Evaluation and Research, NCTR’s Division of Bioinformatics and Biostatistics, and OSC.
- FDA Grand Rounds Presentation, “Electron Microscopy, Still a Powerful Research Tool” (Dr. Angel Paredes)
- NanoDay Symposium 2023: “Continuous Manufacturing of Nanomaterials,” co-organized by NanoCore and CDER-Small Business and Industry Assistance.
- Nanotechnology Workshop at Global Summit on Regulatory Science (GSRS23), chaired by Dr. Patri.
- NanoCore staff gave three presentations at the American Society for Testing and Materials (ASTM) Meeting (Washington, D.C.), and two presentations at the ASTM E56 Committee Meeting (Denver, CO).
Resources for You
- OSC Fact Sheet
- NCTR Grand Rounds: "Electron Microscopy, Still a Powerful Research Tool" (Presentation recorded in Zoom on May 11, 2023)
- 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
- About the National Center for Toxicological Research
Contact Us
- NCTR
- National Center for Toxicological Research
Food and Drug Administration
3900 NCTR Rd
Jefferson, AR 72079
-
Hours Available
- NCTRResearch@fda.hhs.gov
- (870) 543-7121