Additional Licensing Requirements

Form Approved 0MB No, P HHKW5. Exoiratton Date December 31.2007. 

NOTICE This report A required try law (2i C.P-R. 207 0). Failure to repon can result In imprlsonmeni for noi more than one yaat or a ime 61 nd more irun t,ODOi or boih. fdaC Aei. Saciion 3D3). 

SITE MAILING ADDRESS df(t f9nt from site aekfress) 

Addreatt Change MerQer iBuyoul Reentry mto Business with Same Name 

SECTION 6 - FIRM COMPLIANCE MAILING ADDRESS for Annual Lislino Report and/or Firm Correspondence 

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The cost of validation is much publicized as is the debate regarding the extent to which information systems should be validated. Validation is essentially the term adopted by the pharmaceutical industry and their regulators to define the additional rigor required to confirm GxP critical aspects of information systems throughout the development and operational life of those systems. Given that pharmaceutical regulators have the power to withhold, suspend, or withdraw product licenses. 

The following is the forward Fourier transform routine FOUR1 from J. C. Sprott, "Numerical Recipes Routines and Examples in BASIC", Cambridge University Press, Copyright (C) 1991 by Numerical Recipes Software. Used by permission. Use of this routine other than as an integral part of the present book requires an additional license from Numerical Recipes Software. 

NRC similarly keeps track of all fissile material. Various organizations participate in creating or managing records of packaging, transport, transfer, and disposal of licensed material. In addition, NRC requires records of inspections and tests of materials, facilities for use, or storage, radiation monitoring and other equipment. There are also requirements for security records for the transport, storage, and use of fissile material. NRC requires reports of lost, unaccounted for, or stolen material. 

Special features Simplified operational licensing requirements - Shop fabrication of reactor building - Shop fabrication of reactor conqxments - Incremental capacity addition (modules) - Extended fuel cycle 790 EFPD ... 

According to 10 CFR 50,73, the holder of an operating license for a nuclear power plant (the licensee) must submit an LER for a reportable event, within 30 days after discovery. An event b reportable regardless of the plant mode, power level, structure, system, or component that initiated the event. In addition the licensee must report the completion of any nuclear plant shutdown required by the plant s Technical Specifications or any operation or condition prohibited by the plant s Technical Specifications, or any deviation from the plant s Technical Specifications. LERs are available on the Internet at http //www.nrc.gov/NRR/DAILY/97mmdddr.htm, where inrn is the... 

In the near future new drugs for the treatment of Alzheimer s disease are expected to be licensed, and it would be extremely valuable to be able to compare them in a clear and well-defined framework. In addition, if economic evaluation is to inform health and social care providers and policy-makers about the potential impact of new interventions in practice, estimation of the value for money of these new interventions requires consideration of (a) the perceived and objective risks and benefits of care (b) attitudes of people with... 

MPC [Mitsui Petrochemical] A continuous process for polymerizing propylene, based on the Ziegler-Natta process, but using a much more active catalyst so that de-ashing (catalyst removal) is not required. The catalyst contains magnesium in addition to titanium successive versions of it have been known as HY-HS (high yield, high stereospecifity), HY-HS II, and T-catalyst. Developed jointly by Mitsui Petrochemical Industries, Japan, and Montedison SpA, Italy, in 1975, and now licensed in 56 plants worldwide. 

Oxypro (1) A process for making di-isopropyl ether (DOPE) from a propane/propylene stream from FCC. The catalyst system is superior to other acid catalysts such as zeolites because of its greater activity at low temperatures. The Oxypro catalyst functions at below 175°C, whereas zeolites require temperatures closer to 260°C. DOPE is used as a gasoline additive. Developed by UOP in 1994 first licensed in Chile in 1996 for completion in 1997. 

The analytical protocols and the handling and data security protocols are extremely important. I recently was reminded that if you have to ship samples to another country for analysis, that may require additional time, additional expense, and the customs, agriculture, and drug enforcement officials may want to thoroughly inspect your shipment thoroughly. Your laboratory may also require a special license to handle soil and water samples from out of the country. The logistics cannot be ignored, except at your peril. 

Registration involves completing a form for the gun itself, in addition to holding the necessary license or permit. California, Hawaii, Kansas (in some areas), Michigan, Nevada (in some areas). New York, and Ohio (in some areas) require registration. 

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