ABSTRACT
THE ORIGIN OF FEDERAL STATUTES When the need for a new law is perceived, any member of either house of Congress may introduce a proposal, which at that stage is called a “bill.” Such bills are assigned to the appropriate committee in that house, where they are discussed and debated, often involving public hearings. The bill may undergo significant changes in this process, but will eventually either be rejected or voted on in a positive way in the committee, and then sent to the entire house for consideration, further debate, and often amendments. In the end, that house will vote on the bill as modified in the process, and if approved, the bill is sent to the other house of Congress where it goes through a similar process. Obviously, politics and the power of lobbyists play roles as do pressures from the constituents of the various members of Congress. But, if the second house approves the bill, often with differences from the version submitted by the first house, a “conference committee” made up of the members of both houses tries to reconcile the differences, after which final votes are taken on the revised bill. If passed, it goes to the President who will either sign it or veto it. If signed, or if the veto is overridden by Congress, it becomes a Public Law cited by the letters PL with an identifying number. This is also known as an Act, and becomes part of what is called the United States Code (U.S.C.), which is where all federal statutes are compiled after they have been finalized. The U.S.C. is divided into 50 volumes, called titles, each of which contains related laws. All of the federal laws pertaining to the FDA are in Title 21 of the U.S.C., which is divided into chapters and these in turn are divided into sections.
