Discuss a proposed rule on the Federal Register website

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Assignment: Based on the information provided below, prepare a 2 to 3-page essay discussing a proposed rule on the Federal Register website (https://www.federalregister.gov). Additional information can be found in Slide #74 of the Week 1 lecture material- US Therapeutic Product Development, Regulatory Evolution, and the Rulemaking Process. Background Information: New regulations or revisions to existing regulations are announced in the Federal Register. A Notice of Proposed Rulemaking describes the rule and provides background information. A comment period is established that defines how long the Agency will accept public comments. The Federal Register announcement marks the beginning of the comment period. Public comments can be submitted electronically through the regulations.gov website. Comments are logged, numbered, and placed in a file upon receipt by FDA. The comments become part of the public record and are available for anyone to read. During the comment period, FDA reviews public comments. Comment periods are generally at least 60 calendar days and can be as long as one year. Upon expiration of the comment period, FDA may promulgate interim or final rules, extend the comment period, or abandon its intention to promulgate a rule. Rules in the Federal Register are cited by volume and page number and are codified annually in the Code of Federal Regulations. Prompt: An important responsibility of Regulatory personnel is to understand the regulatory landscape pertinent to company operations, and to advise the company on how to remain compliant. For example, understanding the intricacies of procedures and expectations of global health authorities in clinical trial start-up will allow a company to efficiently ship a drug to clinical trials sites and study its safety and efficacy in human subjects. A strong Regulatory group will help the company to avoid delays associated with incomplete or inadequate Clinical Trial Authorization applications. A strong Regulatory group may help the company to remain in good standing with the FDA as well as the pubic by helping to report adverse events within defined timeframes and promoting the drug in an accurate and scientifically valid manner. In addition to understanding FDA’s current thinking on a given topic, Regulatory personnel should help to influence and shape the expectations and procedures set forth by regulatory authorities. One way to do this is to submit comments and feedback on proposed rules. Visit the Federal Register website and search for a proposed rule currently in the comment period. In your essay, summarize the proposed action, discuss its purpose, and indicate any important dates by when comments are due. Consider including and justifying an opinion as to whether the proposed rule you have chosen should be abandoned, amended, or enacted. There is no right or wrong answer to this question, so you will not be graded for your opinion. Evaluation will be based on your argument, the facts used to support your opinion, and proper citations and attribution of sources. Commenting on proposed rules is a useful development activity outside of this course. However, please do not submit public comments on behalf of your employer without your manager’s approval.

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