Federal regulatory process

In the United States, the federal regulatory process starts when both Houses of Congress develop a law or statute. Generally, each House develops its own version. These are then sent to committee, where a compromise bill is agreed upon. This, in turn, goes to the President, who signs it (imless he chooses to use his power of veto). 

The Federal Drug Administration (FDA) describes the biopharmaceutical industries as self-regulated, retaining for itself the responsibility of assuring and checking on that self-regulatory process. Not surprisingly, then. 

The reason for adopting this broad definition of regulation is that any narrower concept (e.g. one limited to legislation and Federal agency rules) is not realistic and would impute more causality to a single government action than is in fact the case. In short, the regulatory process is complex, and should be viewed as such. 

Judges can use the obligation to explain as a powerful weapon against passivity and delay in the regulatory process. Since the early 1970s, federal courts have insisted that it is important for government officials not merely to justify positive decisions to act, but to explain why no action has been taken on a toxic hazard. In an... 

In 1979 the Select Committee on GRAS Substances issued an affirmative report (2) [see Safety Reviews above] and industry submitted proposed food grade specifications, but the regulatory process has not yet reached Federal Register publication. 

Just as important as providing various incentives for industrial innovation, is reducing the disincentives to the innovation process. It is no secret that, in general, industry views as one of the major disincentives to innovation, the vast and complex Federal regulatory regime that has evolved over the past decade or so. 1 hcpe it is no secret also, that the Administration is attuned to industry s views on this, and that regulatory reform has been one of its major efforts. 

A brief description of the federal legislative and regulatory processes may be helpful. Laws are a product of legislative activity. Legislation is usually proposed by senators and representatives to achieve a desired result, for example, improved employee safety or environmental protection. Proposed laws are often known by their Senate or House file numbers, for example, S.xxx or H.R.xxx. Copies of proposed laws can be obtained, even at this early stage in the process, by requesting them from local offices of House or Senate members. Sponsors of proposed legislation are open to comment from the public. Once a law is passed, it is known by its Public Law number, for example, P.L. 94-580, Resource Conservation and Recovery Act (RCRA). It is published in the United States Code and is referenced by volume and chapter number 42 USC 6901 et seq. is the citation for RCRA. 

Because there are always potential risks associated with any implantable device, before any new biotextile product can be distributed, sold and implanted clinically in a human patient in the United States, its properties and performance are required by law to be carefully reviewed and evaluated by the federal Food and Drug Administration. Its role is to ensure the safety and efficacy of all implantable devices before they are made available for surgical use in the United States. Other countries and jurisdictions have similar regulatory bodies that require all biotextile products to comply with their regulatory process (Chapter 7). 

Under the Federal Plant Pest Act the definition of a regulated article is the definition of the scope of the regulatory process. In the March 31,1993 notice a regulated article was defined as ... 

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