License application for

The dataset used in this example comprised two phase III placebo-controlled studies used in the license application for oseltamivir (Tamiflu ). See Patel, Kay and Rowell (2006) for further details. Pre-defined symptoms consisted of cough, nasal congestion, headache, sore throat, fatigue, myalgia and feverishness and each of these was assessed on an ordinal scale none, mild, moderate, severe. Alleviation was recorded as the day on which all symptoms... 

Following FDA s review of a license application for a new indication, the sponsor and the FDA may present their findings to the FDA s Vaccines and Related Biological Products Advisory Committee. This independent expert committee (scientists, physicians, biostatisticians, and a consumer representative) provides advice to the Agency regarding the safety and efficacy of the vaccine for the proposed indication. 

Elimination of establishment license application for specified biotechnology and synthetic biological products. Federal Register 1996, 61(94), 24227-24233. 

The work described in the paper was performed at the Center for Nuclear Regulatory Analyses, Southwest Research Institute , San Antonio, Texas, U.S.A., on behalf of the U.S. Nuclear Regulatory Commission (NRC) Office of Material Safety and Safeguards, Division of Waste Management. This paper is an independent product of the CNWRA and does not necessarily reflect the views or regulatory position of the NRC. The NRC staff views expressed herein are preliminary and do not constitute a final judgment of the matter addressed or of the acceptability of a license application for a geologic repository at Yucca Mountain. 

AR473 3.5 Standard format and content of license applications for uranium mills (for comment)... 

IAEA (1979), Information to be submitted in support of licensing applications for nuclear power plants , IAEA Safety Series 50-SG-G2, Vienna. 

SG-G2 Information to be Submitted in Support of Licensing Applications for Nuclear Power Plants (1979)... 

INTERNATIONAL ATOMIC ENERGY AGENCY, Information to be submitted in support of licensing applications for nuclear power plants. Safety Series No. 50-SG-G2, Vienna (1979). Guideline for evaluation of PWR design during accident, 23, Abs.3, Public Notice, Federal Radiation Protection Ordinance No.245a, GRS, Dec. 1983, FRG. 

FDA Final Rule Elimination of Establishment License Application for Specified Biotechnology and Specified Synthetic Biological Products (61 FR 24227 May 14, 1996)... 

The ACRS is an independent statutory committee that advises the Commission on reactor safety, and reviews each application for a construction permit or an operating license. It is composed of a maximum of fifteen members appointed by the Commission for terms of four years each. 

The Food and Drug Administration (FDA) also accept submissions prepared according to the CTD format. However, they have not directly incorporated the CTD format into US regulatory requirements, which are detailed in Title 21 CFR, Part 514.50 in the case of a New Drug Application (NDA), or Title 21 CFR Part 601.2 (a) in the case of a Biologies License Application (BLA). Rather, they have introduced the CTD format via Guidance for Industry documents. The correlation between the requirements in 21 CFR Part 514.50 and the CTD format is shown in Table 6.2. 

Application for at least one Product License supported by an outline of production, information on master seeds/master cells and bio-containment if applicable, and protocols for studies of host animal safety and efficacy... 

In addition, nuclear utilities in the United States are also extending plant operating lives. Baltimore Gas and Electric is seeking an extension of the license for its Calvert Cliffs facility -the news out of the NRC is favorable - and Duke Power has submitted an application for the license renewal of its Oconee plant. Extension of the licenses of such economically-competitive plants can make an important contribution to meeting our environmental goals. 

Last December, Secretary Richardson submitted the Viability Assessment of a Repositoy at Yucca Mountain to Congress and the President. We are on track for a 2001 suitability decision on Yucca Mountain as the location of a repository, and, assuming suitability, to submit a license application to the NRC in 2002. 

Two companies are in the process of renewing their operating licenses at five reactors with the Nuclear Regulatory Commission for an additional 20 years of operation. We expect the NRC to approve the first of those requests—BaltimorSas and Electric s application for its two-unit Calvert Cliffs Nuclear Power Plan—neMarch. 

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