NIH rDNA MICROBE ENVIRONMENTAL RELEASE "POINTS TO CONSIDER"
Executive Summary
NIH rDNA MICROBE ENVIRONMENTAL RELEASE "POINTS TO CONSIDER" draft document is being developed by the NIH Recombinant DNA Advisory Cmte. (RAC) Working Group on Release into the Environment. The draft, which was considered during an Oct. 5 working group meeting, is a "checklist" of points to consider for scientists planning to submit proposals to NIH that would involve environmental release of rDNA microorganisms, Institute for Medical Research (New Jersey) Dept. of Microbiology Chief and Working Group Chairman Gerard McGarrity said. The draft would require information including "but not limited to" a summary of the proposed experiment, including the objectives, significance, and justification for the request, the document says. Investigators would be required to provide NIH with identification, taxonomy, source and strain of the recombinant organism to be released as well as a detailed description of the molecular biology of the rDNA organism's "construction method," "introduced genes," "stability in the lab," and "uniqueness," the draft states. NIH is currently enjoined from approving any federally-funded experiments involving the deliberate release of rDNA molecules into the environment, under a May 16 ruling by U.S. District Court Judge John Sirica. In addition to purely descriptive information about the modified microorganism and the organism donating the inserted DNA, the draft would call on scientists to provide a description of the ecological role of the non-modified organism and the expected role of the recombinant microbe. "The intent of gathering ecological information is to assess the likelihood of establishment, persistence and dispersal of the recombinant organism and the probability of an adverse effect," the draft says. "Data related to any anticipated or non-anticipated effects of the modified microorganism from microcosm, greenhouse, and/or growth chamber experiments that simulate natural conditions" is also requested under the draft.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth