SUMMARY OF FINAL EVALUATIONS

Agent Degree of evidence of carcinogenicity Overall evaluation of carcinogenicity - to humans 

Compounds Reviewed in Plenary Sessions (Comprehensive Monographs) 

This substance was considered by previous Working Groups, in February 1978 (lARC, 1979) and March 1987 (lARC, 1987a). Since that time, new data have become available, and these have been incorporated into the monograph and taken into consideration in the present evaluation. 

107-13-1 Chem. Abstr. Name 2-Propenenitrile 

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Abstract This chapter discusses the evaluation of stability data. It follows the stability study information from the point that raw data is generated in the lab, calculations are performed to give test results, and test results are entered in the stability summary sheets, until data is finally entered into a stability report for submission purposes. This chapter also includes a summary of data evaluation addressed in ICH QIE and a discussion of Out-of-Speciflcation (OOS) and Out-of-Trend... 

The Federal Register advance notice is a preliminary notice, offering opportunity for comment and submission of new data for consideration. When all comments have been collected and evaluated, the FDA publishes a rule, also termed a tentative final monograph. This publication incorporates all changes that were made on the basis of the results of the first publication. There is a review of comments made and a summary of the basis for decisions regarding these comments. That is, the FDA prints a review of the nature of the comments or objections that were filed in response to the first notice and is obligated to respond to these comments. This should be carefully studied, because it reflects both the scientific viewpoint of the advisory panel and the FDA policy decisions. 

In each case the report includes a summary of the design given in the protocol, the tests and procedures used in the studies with the appropriate limits for evaluation, the stability data tables with the necessary batch documentation, and finally the discussion of results and conclusions. 

The point level sensor test program described herein was initiated in 1961 by the National Bureau of Standards as part of a state-of-the-art evaluation of cyrogenic instrumentation for the National Aeronautics and Space Administration, Lewis Research Center. This is a summary of the work reported in quarterly reports to the sponsor and a detailed final report currently in press. 

First, the results of a four-stage potential analysis developed by Merck (Darmstadt, Germany), together with the Technical University of Clausthal are discussed. This analysis starts with a technological evaluation of MRT to achieve finally a business view [4], Next, a short summary of a study from the fine chemical and pharmaceutical company Lonza (Visp, Switzerland) dealing with capital (CAPEX) and operational (OPEX) costs for several pilot microchemical processes is presented [5]. The picture is rounded off by cost analyses of the chemical producer AzurChem, prepared in... 

Thus, the next step in the evaluation was to establish the relationship between the number of hazardous debris pieces per unit area (the areal density) and the debris mass density. Based on the data sheets of the debris fields (Fig. 26.12), a debris size summation curve was developed for each field. A summary of the curves of all 23 fields is shown in Fig. 26.16. A regression with these data points was made (Fig. 26.17), and a final average distribution of the debris size (mass) versus number of debris pieces—standardized for an area of one m and a debris density of 1 kg per m —was the result. The data were evaluated to see if the distribution of the debris size depended on the distance from the crater or the angle from the tunnel axis, but neither were determined to be of significant influence within the range of interest of this study. 

Once all the data have been evaluated and the PHA worksheet is completed, a formal report should be written documenting the results of the analysis. The narrative report typically includes a summary of all significant findings associated with operational risk. Recommendations for hazard elimination/control are also included in the report as well as suggestions for follow-on analyses. Although not entirely necessary, depending on the nature of the operation, process, or system, it is also useful to include a brief description of the project itself, its purpose and/or function as it relates to overall operations. The PHA/PHL worksheets are usually provided in the report as backup data to verify the report contents. Finally, the PHA report should also include a brief discussion of the methods used to develop the analysis (ETBA, FMEA, checklists, matrices, etc.), so that the reader can validate the report data, if required (Stephenson 1991). 

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