Regulatory fees

Applicable taxes and state regulatory fees are not included in quoted process ... 

Congress and the Department of the Interior should provide a mechanism... for the payment of regulatory fees, for adequate, stable, and secure funding to the key regulatory agencies—Interior, Coast Guard, and NOAA... 

The TGA in Australia, the MEB in the Netherlands and the Medicines Control Agency in Zimbabwe are financed entirely by the fees and charges they collect. Unlike the countries mentioned above, these dmg regulatory authorities have full powers to dispose of the revenue they collect. And because their financial viability depends on the revenue they generate, fees and charges reflect the real cost of services. 

Type II Costs Indirect and hidden costs Reporting Monitoring Regulatory (e.g., operating permits and fees)... 

A report by the National Renewable Energy Laboratory, studied 65 distributed energy projects and found that various technical, business practice, and regulatory barriers can block distributed generation projects from being developed. These barriers include lengthy approval processes, project-specific equipment requirements and high standard fees. 

Medical devices were first made subject to FDA regulation under the FD C Act of 1938. At that time, the statute included no requirement for premarket testing or approval. Congress enacted the Medical Device Amendments of 19766 to require pre-market notification for all medical devices, and pre-market approval for some old and new devices for which there is no adequate assurance of safety and effectiveness. The 1976 Amendments established a broad new array of statutory requirements and enforcement provisions. This new regulatory approach was supplemented by the Safe Medical Devices Act of 1990 3 and further refined by the Medical Device Amendments of 1992,61 Food and Drug Administration Modernization Act of 1997,6 jj g Medical Devise User Fee and Modernization Act... 

Once a patent is granted (or issued ) it will remain in force subject to payment of renewal fees. Typically, the duration of a patent is twenty years from the filing date. In general the patent monopoly extends until the expiry of the patent. However, in the European Union and some other European countries, and in the USA and elsewhere, there are provisions for extending the term of protection for a specific approved medical product which is covered by a patent when there have been delays in obtaining regulatory approval. For example, in European Union countries a supplementary protection... 

REIMBURSABLE DEVELOPMENT EXPENSES shall mean all internal and external direct, actual and documented costs incurred by Origin8or after the Effective Date to develop the Oral Formulation of the Product, including, without limitation, pre-dinical and clinical trial expenses (including, without limitation, the direct cost of clinical trial materials), reasonable Third Party costs, Regulatory Approval expenses and fees, and costs associated with scientific personnel dedicated to development of the Oral Formulation of the Product, where scientific personnel costs shall be calculated at a rate of Two Hundred Thousand Dollars ( 200,000) per FTE. The purchase of raw materials or supplies or external Third Party services shall be calculated using actual direct costs incurred by the Parties for such Third Party goods or services. 

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