Interconnection Feasibility Study means either a Generation Interconnection Feasibility Study or Transmission Interconnection Feasibility Study.
Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.
Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.
service delivery and budget implementation plan means a detailed plan approved by the mayor of a municipality in terms of section 53(1) (c) (ii) for implementing the municipality’s delivery of municipal services and its annual budget.
Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.
Final Approval Hearing means the hearing before the Court where the Parties will request the Final Judgment to be entered by the Court approving the Settlement Agreement, the Fee Award, and the incentive award to the Class Representative.
Step therapy protocol means a protocol or program that establishes the specific
Protocol means, in respect of any category of object and associated rights to which this Convention applies, the Protocol in respect of that category of object and associated rights;
Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.
Protocols means written directions and orders, consistent with the department’s standard of care, that are to be followed by an emergency medical care provider in emergency and nonemergency situations. Protocols must be approved by the service program’s medical director and address the care of both adult and pediatric patients.
Generation Interconnection Feasibility Study means a study conducted by the Transmission Provider (in coordination with the affected Transmission Owner(s)) in accordance with Tariff, Part IV, section 36.
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;
Monitoring Indicator means a measure of HSP performance that may be monitored against provincial results or provincial targets, but for which no Performance Target is set;
Firm Transmission Feasibility Study means a study conducted by the Transmission Provider in accordance with Tariff, Part II, section 19.3 and Tariff, Part III, section 32.3.
Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).
Final Approval Order means the proposed Order Granting Final Approval to the Settlement, to be entered by the Court with terms to be agreed upon by the Parties and consistent with this Agreement.
Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:
Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist who 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.
Project Implementation Manual or “PIM” means the manual setting out the measures required for the implementation of the Project, as the same may be amended from time to time, subject to prior approval of the Association;
FDA Approval means the approval, license, clearance or authorization of the FDA necessary for the marketing and sale of a product for human use in the United States.
Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.
Program Parameter means, in respect of a program, the provincial standards (such as operational, financial or service standards and policies, operating manuals and program eligibility), directives, guidelines and expectations and requirements for that program;
Project Implementation Plan means the detail plan submitted by the Developer with regard to development of Project Facilities and its operation and management thereof in accordance with this Agreement and to be appended as Schedule 9 to this Agreement.
Clean 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. The federal contribution for a qualifying project shall be at least 20 percent of the total cost of the demonstration project.
Collaborative 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.
Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).