Discuss a proposed rule on the Federal Register website
Description
Assignment:
Based on the information provided below, prepare an essay discussing a proposed rule on the Federal Register website (https://www.federalregister.gov).
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.
| Excellent | Good | Fair | Poor | ||
| Main Posting | 45 (45%) – 50 (50%)
Answers all parts of the discussion question(s) expectations with reflective critical analysis and synthesis of knowledge gained from the course readings for the module and current credible sources.
Supported by at least three current, credible sources.
Written clearly and concisely with no grammatical or spelling errors and fully adheres to current APA manual writing rules and style. |
40 (40%) – 44 (44%)
Responds to the discussion question(s) and is reflective with critical analysis and synthesis of knowledge gained from the course readings for the module.
At least 75% of post has exceptional depth and breadth.
Supported by at least three credible sources.
Written clearly and concisely with one or no grammatical or spelling errors and fully adheres to current APA manual writing rules and style. |
35 (35%) – 39 (39%)
Responds to some of the discussion question(s).
One or two criteria are not addressed or are superficially addressed.
Is somewhat lacking reflection and critical analysis and synthesis.
Somewhat represents knowledge gained from the course readings for the module.
Post is cited with two credible sources.
Written somewhat concisely; may contain more than two spelling or grammatical errors.
Contains some APA formatting errors. |
0 (0%) – 34 (34%)
Does not respond to the discussion question(s) adequately.
Lacks depth or superficially addresses criteria.
Lacks reflection and critical analysis and synthesis.
Does not represent knowledge gained from the course readings for the module.
Contains only one or no credible sources.
Not written clearly or concisely.
Contains more than two spelling or grammatical errors.
Does not adhere to current APA manual writing rules and style. |
|
| Main Post: Timeliness | 10 (10%) – 10 (10%)
Posts main post by day 3. |
0 (0%) – 0 (0%) | 0 (0%) – 0 (0%) | 0 (0%) – 0 (0%)
Does not post by day 3. |
|
| First Response | 17 (17%) – 18 (18%)
Response exhibits synthesis, critical thinking, and application to practice settings.
Responds fully to questions posed by faculty.
Provides clear, concise opinions and ideas that are supported by at least two scholarly sources.
Demonstrates synthesis and understanding of learning objectives.
Communication is professional and respectful to colleagues.
Responses to faculty questions are fully answered, if posed.
Response is effectively written in standard, edited English. |
15 (15%) – 16 (16%)
Response exhibits critical thinking and application to practice settings.
Communication is professional and respectful to colleagues.
Responses to faculty questions are answered, if posed.
Provides clear, concise opinions and ideas that are supported by two or more credible sources.
Response is effectively written in standard, edited English. |
13 (13%) – 14 (14%)
Response is on topic and may have some depth.
Responses posted in the discussion may lack effective professional communication.
Responses to faculty questions are somewhat answered, if posed.
Response may lack clear, concise opinions and ideas, and a few or no credible sources are cited. |
0 (0%) – 12 (12%)
Response may not be on topic and lacks depth.
Responses posted in the discussion lack effective professional communication.
Responses to faculty questions are missing.
No credible sources are cited. |
|
| Second Response | 16 (16%) – 17 (17%)
Response exhibits synthesis, critical thinking, and application to practice settings.
Responds fully to questions posed by faculty.
Provides clear, concise opinions and ideas that are supported by at least two scholarly sources.
Demonstrates synthesis and understanding of learning objectives.
Communication is professional and respectful to colleagues.
Responses to faculty questions are fully answered, if posed.
Response is effectively written in standard, edited English. |
14 (14%) – 15 (15%)
Response exhibits critical thinking and application to practice settings.
Communication is professional and respectful to colleagues.
Responses to faculty questions are answered, if posed.
Provides clear, concise opinions and ideas that are supported by two or more credible sources.
Response is effectively written in standard, edited English. |
12 (12%) – 13 (13%)
Response is on topic and may have some depth.
Responses posted in the discussion may lack effective professional communication.
Responses to faculty questions are somewhat answered, if posed.
Response may lack clear, concise opinions and ideas, and a few or no credible sources are cited. |
0 (0%) – 11 (11%)
Response may not be on topic and lacks depth.
Responses posted in the discussion lack effective professional communication.
Responses to faculty questions are missing.
No credible sources are cited. |
|
| Participation | 5 (5%) – 5 (5%)
Meets requirements for participation by posting on three different days. |
0 (0%) – 0 (0%) | 0 (0%) – 0 (0%) | 0 (0%) – 0 (0%)
Does not meet requirements for participation by posting on 3 different days. |
|
| Total Points: 100 | |||||