Public disclosure

Unfortunately chemical process plant PSA have no requirements for public disclosure, consequently examples of their PSAs are hard to find. However the following are some examples from the open literature. They are similar to nuclear PSAs except less elaborate with more empahsis on consequences than on probabilities. 

The FDA Modernization Act of 1997 contains a requirement for public disclosure and congressional reporting by October 2001 of Phase IV studies. FDA intends to meet the public disclosure requirement by posting Phase IV study commitments, the projected end of the study, and the current status of the study on their web site [102]. Sponsors whose new drug was approved with a Phase IV study requirement must submit an initial status report to FDA within one year of approval. According to data compiled by Public Citizen s Health Research Group [103], not one of the Phase IV study commitments for 107 new molecular entities approved between January 1995 and December 1999 had been completed as of December 1999. 

The Patent Statute. A patent represents a "contract" between an inventor and the public. The inventor offers full disclosure of his or her invention in sufficient detail to instruct the public about the invention and its use. In exchange for public disclosure and the societal benefits derived therefrom, a patent holder is granted exclusive rights to make, use, and sell the invention and the right to exclude all others from the same for a period of 20 years. Thus inventions that would otherwise remain preciously held secrets are made known for greater advancement of the public good. 

Federal confidentiality laws. Laws that protect clients from public disclosure. Lethality of a suicide plan. The likelihood that a plan will lead to a completed suicide. 

The national authority which is processing the information for EINECS could refuse the claim, in which case the firm must either allow for disclosure or use available remedies to appeal — or not use the material within the EEC in order to preserve confidential status elsewhere. Or the national authority could accept confidentiality, and could insist that it be told immediately upon public disclosure (or patent issuance disclosure) of the material s existence. 

CFR 171.1(c) describes in greater detail the data requirements for food additive petitions, including the five basic areas of information and scientific data noted above, as well as other administrative information and environmental assessment requirements. This document addresses chemistry-related issues only. As described in 21 CFR 171.1(h), certain data and information contained in food additive petitions are available for public disclosure, while other data are not. Questions in this regard should be directed to the Office of Premarket Approval. 

Note that the information developed for these regulations is to be protected from public disclosure but may be shared, at the secretary s discretion, with state and local government officials, including law enforcement officials and first responders possessing the necessary security clearances. Such shared information may not be... 

Public disclosure of information regarding disqualification Alternative or additional actions to disqualification Suspension or termination of a testing facility by a sponsor Reinstatement of a disqualified testing facility... 

Confidentiality of information. Under the Freedom of Information Act, ah information in government files is subject to public disclosure unless it falls within a specified exemption. Both... 

Public Disclosure of Information Regarding Disqualification 58.215 Alternatives or Additional Actions to Disqualification 58.217 Suspension or Termination of a Testing Facility by a Sponsor 58.219 Reinstatement of a Disqualified Testing Facility... 

A description of the general field of the invention and of previous public disclosures often called the prior art , it is common to identify the problem that the invention solves, and to indicate the disadvantages of the prior art solutions and advantages of the invention described in the patent specification. 

The procedure for obtaining a patent is typically started by filing a national patent application in a patent office of a country which is party to the Paris Convention (an international treaty agreeing certain reciprocal patent rights). This application can provide a so-called priority date for the invention disclosed in this priority application such that the patentability of the invention is assessed as of that date. This priority date can given to further patent applications filed in other Paris Convention territories provided that these further patent applications are filed within 12 months of the first priority application. A patent application must be filed before any public disclosure of the invention since, in most territories, public disclosures before the priority date can be used to attack the novelty and non-obviousness of an invention described in a patent application. 

In another example, in 2004 a judge ordered the USDA to identify the Hawaiian locations of four companies operating open air test sites for bio-pharmaceutical crops. The order had been earlier denied as it was considered to contain confidential business information protected from disclosure under federal law. Public disclosure could result in the destruction of the fields by anti-GM extremists. Vandalism such as this does little to protect the health of the public or the environment. Rather, it causes the dispersal of transgenic crops into the environment, thus creating the very harm feared by these adversaries (Jaffe, 2004a). 

What is the state of process Raman spectroscopy right now Is it still slowly building Is it a niche market and unlikely to expand Is it thriving and flourishing Since almost all industrial applications will use a commercial instrument, the instrument vendors are the only ones who can really answer these questions but are likely to be bound by confidentiality agreements with their customers. In the absence of publications or other public disclosures, it is useful to examine the factors that may be limiting or appearing to limit the use of Raman spectroscopy for process control. 

This chapter will focus on some, but not all, of the areas in which the U.S. Food and Drug Administration (FDA) and the European Union (EU) regulatory authorities have attempted to coordinate their efforts to provide uniform rules and standards for the pharmaceutical industry. Specifically, we will review the efforts to harmonize approaches relating to inspections (including public disclosure of confidential information) and product approval or authorization (including clinical trials). While space limitations do not provide sufficient opportunity to describe each regulatory authority s system or the harmonization attempts in detail, it is our hope to provide some background of where the efforts are now, where the efforts are intended to go, and what we believe will be the results of these efforts. In addition, the author is much more familiar with the U.S. system than the EU system because of his experience and daily exposure with FDA, this chapter will focus more on the U.S. structure. 

As we will learn shortly, not all public information is available for purposes of determining whether an invention is worthy of a patent. For example, some information may be considered in the examination of a patent application by one party but not another party, depending on who made the prior public disclosure. The types of public information that qualify for determining whether an invention is worthy of a... 

Availability for public disclosure of data and information in an apphcation or abbreviated application Addresses for applications and abbreviated apphcations Guidelines Scope... 

Each member of a panel shall publicly disclose all conflicts of interest that member may have with the work to be undertaken by the panel. No member of a panel may vote on any matter where the member or the immediate family of such member could gain financially from the advice given to the Secretary. The Secretary may grant a waiver of any conflict of interest requirement upon public disclosure of such conflict of interest if such waiver is necessary to afford the panel essential expertise, except that the Secretary may not grant a waiver for a member of a panel when the member s own scientific work is involved. 

See, for example, 21 C.F.R. 20.63(a), The names or other information which would identify patients or research subjects in any medical or similar report, test, study or other research project shall be deleted before the record is made available for public disclosure. ... 

In writing a patent application, the inventors generally give a broad overview of the field (with references) and describe their invention in relation to the public disclosures. To support patentability, the inventors will often provide surprising ... 

Prior Art. For the EPO this is anything made public by anyone, anywhere. In the US you can still file a patent up to one year after public disclosure by the inventor. All known prior art must be disclosed failure to do so will render the patent invalid. 

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