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- QUESTION
Review the following videos prepared by the John Marshall Laws School law library. Pay particular attention to how to find the latest information from a particular agency and how to find information on a specific topic when you are not sure what agency might regulate that topic.
https://www.youtube.com/watch?v=PKW_19KxKcc&feature=youtu.be
https://www.youtube.com/watch?v=YGGEBeSlaLQ&feature=youtu.be
https://www.youtube.com/watch?v=GOheBZaWiec&feature=youtu.be
Once you have reviewed all three videos, let’s put those new (to some of you) skills to work. Search for a notice of proposed rulemaking (“NPRM”) by an agency in which you are interested. Review the NPRM and summarize the new rule in one page or less.
Answer the following questions:
1. How did you find the NPRM?
2. What agency is your NPRM from?
3. Is this a new rule or a modification of an existing rule?
4. What will the proposed rule do?
5. What are the next steps in the rulemaking process for this rule?
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| Subject |
Law and governance |
Pages |
3 |
Style |
APA |
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Answer
Researching Federal Agency Action
As a requirement by law, every agency has to publish all the proposed regulations in the Federal Register, which is the federal government’s official publication, used to notify the public of the numerous agency changes that directly or indirectly affect their wellbeing. This applies to all agencies, including the Food and Drug Administration (FAO), which I have a significant interest in because of their role in protecting public health through ensuring consumer safety, security, and efficacy. They achieve this through the development of proper regulations to help control food supply, biological products, veterinary drugs, cosmetics, medical devices, and radiation-emitting products. Therefore, while crosschecking their websites and the federal register, I found the notice of proposed rulemaking (NPRM), which would permit the importation of certain prescription drugs from Canada.
Although this will be the first step in importing prescription drugs from Canada, the proposed rule traces the policies under section 804 and previously described in the Administrative Safe Importation Action Plan. Nevertheless, it is an entirely new rule that significantly differs from the proposed regulation of implementing section 804 of the Federal Food, Drug, and Cosmetic Act since under this guidance, the drugs would be deemed multi-market approved products. Therefore, the proposed rule would empower the FDA to review and authorize the time-limited Section 804 Importation Programs (SIPs) that are critical in managing the importation of particular prescription drugs that meet the FDA quality standards and approved in the Canadian market. Besides, the rule will also limit the supply chain to help in monitoring quality and standard maintenance. After the review of the comments and with the closure of the 75 days, the agency can opt to provide additional notices of proposed rulemaking, which would lead to the final rule and preamble.
References
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Kim. P, Kupchyk. A. & London. A. (2019). Food and Drug Administration Issues Historic Proposed Rule and Draft Guidance on Drug Importation. Retrieved from: https://www.jdsupra.com/legalnews/food-and-drug-administration-issues-97887/
Appendix
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Appendix A:
Communication Plan for an Inpatient Unit to Evaluate the Impact of Transformational Leadership Style Compared to Other Leader Styles such as Bureaucratic and Laissez-Faire Leadership in Nurse Engagement, Retention, and Team Member Satisfaction Over the Course of One Year
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