Research 8 Development exemption

I have included in today s presentation three of these issues first, the distinction between a "new" and a "naturally occurring" chemical substances for the purpose of the applicability of the premanufacture notification (PMN) requirement of TSCA second, the scope of the research and development exemption from the PMN requirements, and its implication for open field testing of microorganisms and third the type and amount of information that EPA might need for risk/benefit analyses of new microorganisms. I will also briefly mention some technical areas in which further research would greatly facilitate the processes of risk/benefit assessment. 

Id. at comment 38. The EPA noted that the burden of complying with TSCA for a pre-EUP substance may be lessened if the substance falls within the research and development exemption from 5 premanufacture notiftcation requirements. See Chapter 5, PMN Exclusions and Exemptions. 

See the discussion of the research and development exemption from the PMN requirement, infra. 

Therefore, even university researchers must be sure their substances are on the Inventory or qualify for an exemption from the PMN rules. Most university research that is not strictly academic and most industrial research can qualify for the research and development exemption from the PMN requirement if the laboratories comply with strict requirements that apply to the exemption. ... 

Chemicals that are handled in accordance with the research and development exemption from the PMN rules caimot be listed on the Inventory because 8(b) of TSCA, which requires the Inventory to be compiled, says ... 

Before designing the audit protocol, it is important to determine the purpose of the audit. For example, an audit of compliance with export notification requirements will have a different group of functions involved than an audit of how a laboratory manages compliance with the research and development exemption to the PMN requirements. 

Is the seller relying on a Research Development (R8cD) exemption ... 

A substance manufactured in small quantities for research and development may be eligible for the Research and Development exemption if special procedural and recordkeeping requirements are met, as specified at 40 CFR 720.36 and 720.78. 

Purpose The mission of the National Institute of Neurological Disorders and Stroke (NINDS) Office of Translational Research is to facilitate the pre-clinical discovery and development of new therapeutic interventions for neurological disorders. The Office supports pre-clinical projects from the discovery of candidate therapeutics through IND and Investigational Device Exemption (IDE) applications to the FDA. This is accomplished through both access to NINDS contract resources and direct funding mechanisms. 

Substances intended solely for scientific research and development at below 100 kg per year (per manufacturer) are exempt from notification. 

Substances placed on the market for process-orientated research and development (PORD) are exempt from notification for supply at justified quantities to specified industrial users. The safety data needed for a PORD application varies between the Member States, and may be up to Annex VIIB level (Table 2). PORD exemptions are only valid for 1 year, with the possibility of a 1-year extension. 

Substances used only for process-orientated research and development are exempt from registration for 5 years. The exemption can be extended for a further 5 years in exceptional circumstances, or 10 years for substances used exclusively to develop human or veterinary medicines. The manufacturer or importer has to inform the ECA of the substance identity, labelling and quantity, justify the quality, summarise the research programme and list the customers. 

The most recent interpretations indicate that if you experimentally practice technology that is patented with the intent of expanding scientific knowledge or conducting curiosity-driven or basic science, you are free to do so. However, if you are conducting that research with a profit motive in mind, if your intention is to develop a product for commerce or intellectual property for license, you do not qualify for the research exemption and are subject to any patent covering the technology in question. 

It is however visible that most of these constraints are not natural or naturally fixed , but can be removed by training, research and development measures specifically targeting organic exporters. A few exemptions are transportation infrastructures and long distances to markets, which cannot be shortened - except if new markets open up, like the Middle East for Africa, or growing domestic or intra-African markets, as well as local or export infrastructure and logistics (e.g. airfreights), which are subject to a more complex overall economic system. 

The Chemical Substances Control Law regulates chemical substances produced by chemical reaction excluding natural products. However, articles and substances regulated by other laws, such as the Food Sanitation Law in Japan and the Pharmaceutical Affairs Law, and exclusively used for the purposes covered by such laws, together with substances used for research and development, are also exempt from the Law. 

Increases the threshold in place for scientific Research and Development (R D) exemptions from 100 kg to 1 tonne. 

Extends process/product-oriented research and development (PPORD) exemptions from one to three years, up to a maximum of five years. 

The use of combinatorial technologies in pharmaceutical research has been vastly limited to the early phases of the process of dmg discovery (see Section 9.1), while later phases in the development of a drug and medical applications of library individuals have always been considered exempt from a combinatorial way of thinking. In fact, their synthetic throughput is usually low, because the efforts are extremely focused and parallel/combinatorial approaches are not considered necessary. 

Tax-exempt purposes, including research, public service and education, representation of private interests to government. About member s personal and professional development. 

The most significant developments in metered-dose inhaler technology to occur since the early 1990s have been the introduction of hydrofluoroalkane (HFA) systems as alternatives to chlorofluorocarbon (CFC) systems [174]. This has largely been caused by the link between the use of CFC systems and ozone depletion in the upper atmosphere [152,175]. Albuterol and beclomethasone have been reformulated in HFA products, but as yet the CFC products are still subject to an annually renewable medical exemption. The Food and Drug Administration has recently published its position on alternative propellant formulations, which should initiate the phase-out of CFCs [176]. In the meantime, a number of generic CFC products of albuterol have been manufactured. The opportunity for reformulation of products as they come of patent is likely to increase research and development in this area in the near future. New formulation opportunities will also arise from these developments, including solutions [177], micellar [178,179], and microemulsion [180]. 

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