Applications investment materials

Unfortunately, most applications do not include sufficient supporting information regarding the proper identification of the specified material, including Latin binomial nomenclature, plant parts utilized, processing specifications, extraction procedure (if applicable), or method of identification. The failure to provide this basic information is a common oversight on the part of applicants. The industry s counterpoint is that some of the required information is proprietary and that the FDA does not provide sufficient protection of NDI applications that would prevent a competitor from utilizing the NDI after the initial applicant invests all the work and expense. 

Plastic materials are predominantly synthetic materials. Since their inception over a century ago they have enjoyed a growth that has been unequaled by any other group of materials. Tliis demand continues to increase, and the facilities for meeting the new requirements are being expanded continuously. There have been good reasons for the phenomenal application of plastics in order to justify the large investments needed to produce the raw materials and to convert them into finished products. 

Historically, once a new enzyme was identified, it was often a laborious effort to identify the correct conditions for small scale fermentation in order to produce enough material for laboratory scale testing. This meant a major investment in resources and equipment simply to determine if the enzyme was suitable for further analysis. Pilot scale quantities required an even greater expenditure of effort. With a recombinant approach, it is possible to rather quickly clone and express an enzyme at high enough levels to enable applications scientists to test its utility. By moving this analysis earlier into the project, decisions with regard to which can dates should be pursued can be made more effectively in terms of resources spent. 

Initial investment for the Idaho National Engineering Laboratory (INEL) Cols Test Pit demonstration was 2.3 million (1996 dollars). An estimated cost of 1250 (1996 dollars) per cubic yard of frozen material extracted is expected for large-scale, high-efficiency application of the technology (D15324C, p. 5). 

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