conformity assessment means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled;
Phase I assessment as described in, and meeting the criteria of, (i) Chapter 5 of the FNMA Multifamily Guide or any successor provisions covering the same subject matter in the case of a Specially Serviced Mortgage Loan as to which the related Mortgaged Property is multifamily property or (ii) the American Society for Testing and Materials in the case of Specially Serviced Mortgage Loan as to which the related Mortgaged Property is not multifamily property.
Needs assessment means a study or statistical analysis that examines the need for ground ambulance service within a service area or proposed service area that takes into account the current or proposed service area’s medical, fire, and police services.
Risk assessment means a programme to determine any risk associated with any hazard at a construction site , in order to identify the steps needed to be taken to remove, reduce or control such hazard;
conformity assessment body means a body that performs conformity assessment activities including calibration, testing, certification and inspection;
Family assessment means a comprehensive assessment of child
Site Assessment means a Site Assessment as defined in Paragraph 10(c).
Study means the investigation to be conducted in accordance with the Protocol.
Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.
Internal test assessment means, but is not limited to, conducting those tests of quality assurance necessary to ensure the integrity of the test.
Preliminary assessment means the first phase in the process of identifying areas of concern and determining whether contaminants are or were present at a site or have migrated or are migrating from a site, and shall include the initial search for and evaluation of, existing site specific operational and environmental information, both current and historic, to determine if further investigation concerning the documented, alleged, suspected or latent discharge of any contaminant is required. The evaluation of historic information shall be conducted from 1932 to the present, except that the department may require the search for and evaluation of additional information relating to ownership and use of the site prior to 1932 if such information is available through diligent inquiry of the public records.
Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.
Subsurface Borings and Testing means borings, probings and subsurface explorations, laboratory tests and inspections of samples, materials and equipment; appropriate professional interpretations of all the foregoing.
Phase I Environmental Assessment A “Phase I assessment” as described in, and meeting the criteria of, the ASTM, plus a radon and asbestos inspection.
Medical condition means either of the following:
Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).
Feasibility Study means the evaluation and analysis of the potential of a project, which aims at supporting the process of decision-making by objectively and rationally uncovering its strengths and weaknesses, opportunities and threats, as well as identifying the resources required to carry it through and ultimately its prospects for success;
Subsurface tracer study means the release of a substance tagged with radioactive material for the purpose of tracing the movement or position of the tagged substance in the well-bore or adjacent formation.
Screening Test means a drug or alcohol test which uses a method of analysis allowed by the Minnesota Drug and Alcohol Testing in the Workplace Act to be used for such purposes.
Debilitating medical condition means one or more of the following:
Functional behavioral assessment means an individualized assessment of the student that results in a team hypothesis about the function of a student’s behavior and, as appropriate, recommendations for a behavior intervention plan.
Serious Medical Condition means, for the purpose of interpreting Overseas Emergency Medical Evacuation and Repatriation cover, a condition which in the opinion of the Company or its authorised representatives constitutes a serious or life threatening medical emergency requiring immediate evacuation to obtain urgent remedial treatment in order to avoid death or serious impairment to an Insured Person’s immediate or long-term health prospects. The seriousness of the medical condition will be judged within the context of the Insured Person’s geographical location and the local availability of appropriate medical care or facilities.
Impact Assessment has the meaning given to it in Clause 22.1.3 (Variation Procedure);
Phase I Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.
Treatability study means a study in which a hazardous waste is subjected to a treatment process to determine: (1) Whether the waste is amenable to the treatment process, (2) what pretreatment (if any) is required, (3) the optimal process conditions needed to achieve the desired treatment, (4) the efficiency of a treatment process for a specific waste or wastes, or (5) the characteristics and volumes of residuals from a particular treatment process. Also included in this definition for the purpose of the § 261.4 (e) and (f) exemptions are liner compatibility, corrosion, and other material compatibility studies and toxicological and health effects studies. A “treatability study” is not a means to commercially treat or dispose of hazardous waste.
Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.