Administrative Regulation Essay

844 Words Dec 17th, 2013 4 Pages
Week 2 Homework-Administrative Regulations
K’Asha Nesbitt
November 9, 2013
1. State the administrative agency which controls the regulation. Explain why this agency and your proposed regulation interest you (briefly). Will this proposed regulation affect you or the business in which you are working? If so, how? The Department of Health and Human Services as well as the Food and Drug Administration controls the regulation. This particular regulation interests me because I am a Systemic Lupus Erythematous (SLE) patient and I have been suffering from this illness for over 10 years. There is a chance that somewhere in the near future I could develop Lupus Nephritis (LN) (renal disease stemming from SLE). Yes, this regulation could
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4. Provide the “deadline” by which the public comment was made. (If the date has passed, please provide when the deadline was). This deadline ended on June 22, 2010

5. What will you be legally entitled to do later in the promulgation process (if you should choose to do so)? If the proposal passes, identify and explain the five legal theories you could use in an attempt to have (any) administrative regulation declared invalid and overturned in court. Which of these challenges would be the best way to challenge the regulation you selected for this assignment if you wanted to have the regulation overturned and why? Within the promulgation process, as a constituent I have the legal right to challenge the validity of the rules of the court. If the regulation passes I could use five legal theories that can help the administrative regulation declared invalid and overturned in court. For example, I can use the Arbitrary and Capricious theory, which states that the agency and in this case, the FDA has to show evidence to support the proposed rule. I could also use the Substantial Evidence test. The FDA in this case would need to produce more convincing evidence that would support the regulation they are trying to pass.
Another way I could challenge the agency is by using the rule that a regulation can be set aside if the FDA did not comply with the Administrative Procedures Act requirements of notice, publication, and public

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