The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Institute of Environmental Health Sciences (NIEHS), has a continuing need for chemistry support services.

The National Institute of Environmental Health Sciences (NIEHS), located in the Research Triangle Park, North Carolina, is one of the 27 Institutes and Centers comprising the National Institutes of Health. The NIEHS is a multidisciplinary research institution with the primary mission of conducting research to discover how the environment influences the development and progression of human disease in order to promote healthier lives. NIEHS focuses on basic science, disease-oriented research, global environmental health, clinical research, and multidisciplinary training for researchers.

The Division of Translational Toxicology (DTT) is an intramural division of the National Institute of Environmental Health Sciences, National Institutes of Health. DTT uses traditional and cutting-edge approaches to better understand how factors in the environment may impact human health. Such approaches include the conduct of toxicology studies on chemical, physical and biological agents, as well as non-chemical stressors, using in vitro and in vivo models of health and disease. Chemistry-related activities, including chemical characterization, formulation support, biosample analysis, ADME/TK and in vitro ADME studies, Omics, and support for medium to high throughput toxicology studies are required for the successful execution of these studies.

• Program management includes but is not limited to an effective quality program, an effective health and safety program, appropriate animal facilities management, effective communication between the contractor and the DTT, accurate and timely reporting of financial data, administrative data, and technical data, and appropriate usage of staff expertise and facilities

Functional Areas

• Logistics and Handling
  • Logistics and Handling typically involve performing any or all of the following activities: Procure test articles, analytical standards, or samples (e.g., rodent plasma) from commercial and/or non-commercial sources. Handle activities include, but are not limited to repackaging, milling, blending, storing, aliquoting, homogenizing, or photographing procured material. Ship and/or arrange for shipment of analytical standards, test articles, or samples to DTT-designated research facilities. Receive analytical standards, test articles, or samples from DTT-designated laboratories. Develop protocols for chemical handling and reanalysis, and dose formulation and analysis
• Characterization
  • Characterization typically involves performing any or all of the following activities: Determine physical properties (e.g., melting point, color, optical rotation). Establish identity and/or structure. Establish purity. Determine long-term storage stability
• Formulation
  • Formulation typically involves performing any or all of the following activities: Determine solubility, suspendability, and/or syringeability of a test article in a vehicle or vehicles designated by the COR. Develop methods for the formulation of a test article in a vehicle. For similar chemicals (e.g., a chemical class), a common preparation method shall be considered. Develop, qualify, and/or validate methods needed to perform an analysis of a formulation for test article concentration. For similar chemicals (e.g., a chemical class), a common analysis method shall be considered. Evaluate physical and chemical properties of a formulation, e.g., pH. Evaluate the homogeneity of formulations that are not solutions. Evaluate the stability of a formulation under several storage regimes, e.g., ambient temperature, refrigerator, and/or freezer conditions. Evaluate the stability of a formulation under conditions of dosing. Prepare and/or analyze formulations using qualified and/or validated analytical methods. Formulations to be analyzed may be prepared by the Contractor or supplied to the Contractor from a DTT-designated laboratory. Analyze vehicles used in formulations for conformance to DTT, US Pharmacopeia (USP), or other specified requirements. Prepare, analyze and/or ship prepared dose formulations to a DTT-designated laboratory, as directed by the COR
• Biosample Analysis
  • Biosample analysis typically involves performing any or all of the following activities: Develop, qualify, and/or validate methods needed to perform the analyses. Evaluate the stability of the analyte in the matrix during storage. Determine the concentration of an analyte in one or more matrices
• Animal Studies
  • Animal studies include all activities related to determining palatability; absorption, distribution, metabolism, and excretion (ADME) parameters; and/or toxicokinetic (TK) parameters of a test article administered to animals, typically rodents, via a route or routes of interest (e.g., oral gavage, drinking water, feed, and/or intravenous). All animal studies require a signed study protocol, which has been reviewed and approved by the Contractor’s Institutional Animal Care and Use Committee (or equivalent) and the DTT COR. All activities in this category shall be performed in accordance with the requirements set forth in the DTT Chemistry Specifications
• Special Studies
  • Special studies include, but are not limited to, performing any or all of the following activities: Performance of a portion or subset of any functional activity. For example, only determining the stability of the formulation would be a special task, because the formulation development and validation activity requirement includes developing and validating a formulation development and analysis method, in addition to determining stability. Performance of a combination of several portions or subsets of two or more functional activities as a single activity. For example, determining the test article identity and purity and formulation preparation and analysis is a combination of parts of the characterization and formulation analysis activities. Performance of activities such as extraction and analysis of samples other than biological matrices (e.g., PM2.5 filters), nontargeted analysis of mixtures (e.g., botanical dietary supplements), identification of a metabolite of a test article in a biological matrix, partition coefficient determination of an analyte between two matrices, protein binding of an analyte, and inhalation feasibility studies conducted in a small chamber to determine the ability of a chemical or test article to be generated as a uniform atmosphere in an inhalation chamber. Performance of activities to determine enzyme activity using probe substrates (e.g., use of midazolam to determine CYP 3A4 activity) and enzyme inhibition or induction following exposure to a test article (e.g., induction of CYP 1A1 following exposure to benzo(a)pyrene). Performance of the annual water analysis required to confirm the acceptability of water supplied to animals under study in the Contractor’s animal facility. Drafting of manuscripts and/or meeting abstracts and presentations for submittal to peer-reviewed journals or presentations for scientific conferences. All manuscript and presentation work must be initiated by DTT via the COR
• Omics
  • Omics, and typically involve performing any or all of the following activities: Performance of state-of-the-art nontargeted analysis approaches (e.g., high resolution mass spectrometry) to identify and/or quantify environmental chemicals in biological or environmental matrices (e.g., exposomics), as directed by the COR. Utilizing nontargeted analysis approaches to identify and/or quantify perturbations in the endogenous metabolome (i.e., metabolomics) or proteome (i.e., proteomics) following an insult (e.g., exposure to a test article), as directed by the COR
• In Vitro Assays
  • In vitro assays are anticipated to be performed under Option 4, In Vitro Assays. Examples of activities that fall under this Functional Area include, but not limited to: The performance of assay(s) using suitable model(s) to determine absorption of a test article (e.g., Caco-2 monolayer model to determine intestinal absorption). erformance of assay(s) using suitable model(s) to identify transporters responsible for ADME of a test article (e.g., Pgp GloTM assay to determine Pgp substrates). 3Performance of assay(s) using suitable model(s) to determine clearance and metabolism of a test article (e.g., cryopreserved primary rodent hepatocytes to determine hepatic clearance and metabolism). Performance of assay(s) using suitable model(s) to determine bioaccumulation of a test article following repeated exposure (e.g., HepatoPac or plateable hepatocyte model to determine bioaccumulation)
• Medium to High Throughput Screen (MHTS) Activities
  • These activities are anticipated to be performed under Option 5, Medium to High Throughput Screen (MHTS) Activities and involve: Test Article-Related Activities and MHTS Chemical Inventory