How to Find a Proposed Regulation:
1a. Make sure you submit a copy of your proposed regulation as an attachment to the Dropbox with this template. The Dropbox allows you to attach multiple documents in the same submission. (5 points)
1b. Identify the administrative agency (full name, not just the acronym) which controls the regulation. Briefly explain why this agency and your proposed regulation interests you. If this proposed regulation will affect you or the business in which you are working, please explain how. It is not required that the proposed regulation affect you professionally or personally. You can use any regulation for this assignment so long as you ...view middle of the document...
3. Write a comment which you would submit to the administrative agency regarding this proposed regulation. (For example, are you in favor of the proposed regulation or against it? Why?) If the deadline for comments has already passed, write the comment you would have submitted had there been time. Also, explain briefly what you wish to accomplish with your comment. (10 points)
In the case of this proposed regulation, I am fully supportive of the initiative. However, there are a few questions that I would like to ask to ensure that the proper steps are being taken to benefit the larger communities. First and foremost, there are some questions that are asked in the proposal that need to be addressed. There are vaccine candidates that should be excluded from this regulation that include the HA molecule because older strains of vaccinations that are currently available will be replaced by this version making people susceptible to the old strain in lieu of the new one. Additionally, with the mortality rate of hospitalized patients that contract influenza viruses rounding 50%, designating this virus as a Tier 1 HHS select agent, would allow for higher security requirements beyond what is already in place by the USDA and HPAI.
4. Provide the "deadline" (date) by which comments are (or were) due. If the due date has already passed, please provide when the deadline was. (NOTE: If you cannot find the answer to this question, you probably have not found a proposed regulation and you should look for a different one to complete your assignment.) (5 points)
The deadline for comments is September 14, 2015 at 11:59 PM ET.
5. a. If the proposal passes, identify and explain the five legal challenges you could use in an attempt to have the regulation declared invalid and overturned. These will be found in the activity at the end of the Week 2 Lecture. (Start a new paragraph for each of the five challenges). (2 points for identifying each of the 5 challenges and 1 point for explaining each of the 5 challenges for a total of 15 points)
Arbitrary and Capricious – “Generally applies to informal rule making and simply requires the agency to show evidence to support the proposed rule.” In this case, this instance arises when a decision is made without reasonable grounds or adequate consideration of the circumstances. Therefore if the CDC rushes to make the HA molecule a factor on the select agent list without substantial supporting evidence then this clause would come into play.
Unconstitutional – “Violates the...