![]() ![]() ![]() ![]() Independent testing laboratory means an independent organization, accepted by the Contracting Officer, engaged to perform specific inspections or tests of the work, either at the site or elsewhere, and report the results of these inspections or tests. Phase II Clinical Trials means those trials in the Territory on a limited number of patients that are designed to establish the safety and biological activity of a drug for its intended use and to define warnings, precautions and adverse reactions that are associated with the drug in the dosage range to be prescribed. Research facility means buildings and structures, including machinery and equipment, used or to be used primarily for research or experimentation to improve or develop new tangible goods or materials or to improve or develop the production processes thereto. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States. Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties. Non-Participating Clinical Laboratory means a Clinical Laboratory which does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan provide services to you at the time services are rendered. Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records. Laboratory or “LANL” means the geographical location of Los Alamos National Laboratory, a federally funded research and development center owned by the DOE / NNSA. Testing laboratory means a laboratory, facility, or entity in the state that offers or performs tests of cannabis or cannabis products and that is both of the following:ĭental laboratory means a person, firm or corporation The federal contribution for a qualifying project shall be at least 20 percent of the total cost of the demonstration project.Ĭollaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol. ![]() Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.Īpproved laboratory means a laboratory that is listed in the national conference of interstate milk shipments list of sanitation compliance and enforcement ratings distributed by the United States food and drug administration and as approved by the director.Īnalytical x-ray system means a group of components utilizing x-rays to determine the elemental composition or to examine the microstructure of materials.Ĭlean coal technology demonstration project means a project using funds appropriated under the heading “Department of Energy-Clean Coal Technology,” up to a total amount of $2,500,000,000 for commercial demonstration of clean coal technology, or similar projects funded through appropriations for the Environmental Protection Agency. Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition. ![]()
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