Single regulatory authority

Gas pipelines are subject to a single regulatory authority that licenses all new capacity and sets regulated pipeline prices based on its own new and meticulous accounting rules (1938). 

Essentially, the eCTD is a transport format for facilitating electronic submissions. The eCTD serves as an interface for industry-to-agency transfer of regulatory information while at the same time, taking into consideration the facilitation of the creation, review, life cycle management, and archival of the electronic submission. The eCTD specification lists the criteria that will make an electronic submission technically valid. The eCTD represents a major advance in the submission of information to support an NDA. In the future, companies may be able to send their submissions to several regulatory authorities simultaneously with a single stroke of a computer key. 

Required by Austrian Regulatory Authorities for injectable products, life - lifetime Single-single dose only — inappropriate or no experience. 

In therapeutic settings where there are practical reasons why two trials cannot be easily undertaken or where there is a major unfulfilled public health need, it may be possible for a claim to be based on a single pivotal trial. The regulatory authorities do allow this, but only under certain conditions. 

Historically, the United Kingdom and some other regulatory authorities have based EQS values on single-species tests and only used mesocosm data as corroborative evidence. Under the WFD, however, mesocosm no-effect data have recently been used directly to set a freshwater EQS for chlorpyrifos in the European Union, and similar action has been taken for atrazine in the United States (USEPA 2003a). It is clear that such data are more relevant to the natural environment than laboratory-based single-species tests. 

While industrial practice requires a trial burn and a facility may not operate until the data are accepted, industrial facilities obtain approval to process many different waste streams based on a single trial burn. In special situations, particularly with toxic materials such as polychlorinated biphenyls, both a surrogate burn and a trial burn would be required. RCRA regulations offer the option of allowing the use of data from another facility, under certain conditions, in lieu of a trial burn. However, industry has used this mechanism at only a few sites with similar units. It has been used twice by the CMA for the Tooele, Utah, disposal facility. The CMA should pursue this mechanism with the respective regulatory authorities. The committee believes that chemical agent disposal facilities are treated similarly to industrial facilities with respect to the conduct of trial bums. 

---