Did anyone notice that seemingly innocuous link to the left top of on this page https://www.regulations.gov/commenton/CDC-2022-0024-0001 When you click on it… the rest of this post is what shows up …
- The comment process is not a vote – one well supported comment is often more influential than a thousand form letters
- this line could be the most important line in the entire text… “well supported comment” could very well me a comment with references to clinical studies to support the statement… the 211 page 2022 proposed dosing guidelines contained 20 pages of footnotes and references. And in looking at those 20 pages… one whole page had references with one of the author of each reference being one of the 5 who wrote/supervised the creation of this proposed guidelines.
- Historically, pt’s personal observation of health/pain issues are discounted as being anecdotal and of no clinical value, since they are considered as potentially biases and did not follow some sort of approved protocol and thus your submission may not be considered “well supported”
- There is about three weeks left to make comments. Right now there is abt 2600 comments have been accepted and posted. Just how many of comments from pts will have any influence on the final 2022 guidelines when they are published. We may never know, you can use the link above to go to the page to make a comment.
Write a Comment
https://www.regulations.gov/commenton/CDC-2022-0024-0001
Commenter’s Checklist
Tips for Submitting Effective Comments*
Overview
A comment can express simple support or dissent for a regulatory action. However, a constructive, information-rich comment that clearly communicates and supports its claims is more likely to have an impact on regulatory decision making.
These tips are meant to help the public submit comments that have an impact and help agency policy makers improve federal regulations.
Summary
- Read and understand the regulatory document you are commenting on
- Feel free to reach out to the agency with questions
- Be concise but support your claims
- Base your justification on sound reasoning, scientific evidence, and/or how you will be impacted
- Address trade-offs and opposing views in your comment
- There is no minimum or maximum length for an effective comment
- The comment process is not a vote – one well supported comment is often more influential than a thousand form letters
Detailed Recommendations
- Comment periods close at 11:59 eastern time on the date comments are due – begin work well before the deadline.
- Attempt to fully understand each issue; if you have questions or do not understand a part of the regulatory document, you may ask for help from the agency contact listed in the document. Note: Although the agency contact can answer your questions about the document’s meaning, official comments must be submitted through the comment form.
- Clearly identify the issues within the regulatory action on which you are commenting. If you are commenting on a particular word, phrase or sentence, provide the page number, column, and paragraph citation from the federal register document.
- If a rule raises many issues, do not feel obligated to comment on every one – select those issues that concern and affect you the most and/or you understand the best.
- Agencies often ask specific questions or raise issues in rulemaking proposals on subjects where they are actively looking for more information. While the agency will still accept comments on any part of the proposed regulation, please keep these questions and issues in mind while formulating your comment.
- Although agencies receive and appreciate all comments, constructive comments (either positive or negative) are the most likely to have an influence.
- If you disagree with a proposed action, suggest an alternative (including not regulating at all) and include an explanation and/or analysis of how the alternative might meet the same objective or be more effective.
- The comment process is not a vote. The government is attempting to formulate the best policy, so when crafting a comment it is important that you adequately explain the reasoning behind your position.
- Identify credentials and experience that may distinguish your comments from others. If you are commenting in an area in which you have relevant personal or professional experience (i.e., scientist, attorney, fisherman, businessman, etc.) say so.
- Agency reviewers look for sound science and reasoning in the comments they receive. When possible, support your comment with substantive data, facts, and/or expert opinions. You may also provide personal experience in your comment, as may be appropriate. By supporting your arguments well you are more likely to influence the agency decision making.
- Consider including examples of how the proposed rule would impact you negatively or positively.
- Comments on the economic effects of rules that include quantitative and qualitative data are especially helpful.
- Include the pros and cons and trade-offs of your position and explain them. Your position could consider other points of view, and respond to them with facts and sound reasoning.
- If you are uploading more than one attachment to the comment web form, it is recommend that you use the following file titles:
- Attachment1_<insert title of document>
- Attachment2_<insert title of document>
- Attachment3_<insert title of document>
This standardized file naming convention will help agency reviewers distinguish your submitted attachments and aid in the comment review process.
- Keep a copy of your comment in a separate file – this practice helps ensure that you will not lose your comment if you have a problem submitting it using the Regulations.gov web form.
Posted Comments
After submission, your comment will be processed by the agency and posted to Regulations.gov. At times, an agency may choose not to post a submitted comment. Reasons for not posting the comment can include:
- The comment is part of a mass submission campaign or is a duplicate.
- The comment is incomplete.
- The comment is not related to the regulation.
- The comment has been identified as spam.
- The comment contains Personally Identifiable Information (PII) data.
- The comment contains profanity or other inappropriate language.
- The submitter requested the comment not be posted.
Form Letters
Organizations often encourage their members to submit form letters designed to address issues common to their membership. Organizations including industry associations, labor unions, and conservation groups sometimes use form letters to voice their opposition or support of a proposed rulemaking. Many in the public mistakenly believe that their submitted form letter constitutes a “vote” regarding the issues concerning them. Although public support or opposition may help guide important public policies, agencies make determinations for a proposed action based on sound reasoning and scientific evidence rather than a majority of votes. A single, well-supported comment may carry more weight than a thousand form letters.
* Throughout this document, the term “Comment” is used in place of the more technically accurate term “Public Submission” in order to make the recommendations easier to read and understand.
Disclaimer: This document is intended to serve as a guide; it is not intended and should not be considered as legal advice. Please seek counsel from a lawyer if you have legal questions or concerns.
Filed under: General Problems
I’m having a hard time saying anything to this bunch of political hacks. The CDC and the FDA both took billions to promote “vaccines.” How many people know the definitions that were changed during covid? I’ve read so many articles that talk about how they “quietly changed….” and usually on a Friday afternoon/evening.
Nothing reputable about them. I’m with Senator Rand Paul. Get rid of the CDC.
I have given a “public submission” three times already, the first two anonymously and the last with my actual name and email.
Do you really think that these submissions are going to make a difference?
I don’t have statistics to back up my submissions, just personal experience along with the death of my best friend from kidney failure that I BELIEVE was caused by her being cut off from her pain meds.
I also mentioned all three times about how my QOL has drastically decreased, the REAL opioid crisis being caused by illicit fentanyl and heroin.
Every time I hear about another chronic pain patient committing suicide, my heart breaks just a little more…
I have been a “student of our various bureaucracies” for abt 40 yrs… and it is VERY, VERY SELDOM that proposed rule/law changes are influenced by public comment. The bureaucrats know that they have to play by the rule… you publish the proposed changes,,, you allow for public comment period… and they set up rules that the vast majority – or all – can’t provide “well documented arguments” .. most all they can provide is their own personal opinion, which doesn’t meet the clinical standard for a valid clinical study… they are considered anecdotal evidence and most likely biased because it is just one person’s experience and since in this case… all about subjective diseases – which there can’t be any really supported because there is no real tab tests to show the impact on the pt’s intensity of pain. So, in the end… they will not have any real valid clinical studies but their own – probably those that support the authors’ opinions and beliefs. In fact if one notices, there is 20 pages of foot notes and references and one WHOLE PAGE has references where one of the authors of this proposed guidelines was one of the authors in each of those whole page of references. IMO – how honest is it for a author of this proposed guidelines contain so many of the same author that is used to support the conclusion of this 2022 proposal. Both the 2016 guidelines and this 2022 proposed guidelines uses references to the MME system which has no double blind clinical studies or any science behind them as this article indicates https://www.acsh.org/news/2022/03/01/true-story-morphine-milligram-equivalents-mme-16154 It is reported that the MME system was first started to evolve back in the 1970’s when what medical science knew back them is like the “dark ages” in comparison to what medical science knows today – particularly involving how the body and many substance are metabolizes by the liver and many pts’ metabolism can greatly vary from pt to pt. But this MME system is not reference by the FDA in their professional prescribing information for any FDA approved medication and some disease will cause a higher intensity of pain and some pts will have multiple sources of pain… causing a overall body higher intensity of pain… and thus for these and many other individuals’ health variances would also guarantee that a “one size fits all dosing” … will never work. Maybe the CDC should at least have a double blind clinical trial to document that the MME system can be reproduced using current known medical system knowledge and systems. and rescind the 2016 guidelines and post pone implementing the new proposed 2022 guidelines. Healthcare practitioners are suppose to be “healers” and how can they expect to meet that goal using antiquate techniques and processes ?