Research · 10 min read
How a Federal Health Rule Gets Made, and How to Comment on One
A proposed rule is not a rule, and the gap between them is a defined procedure with a clock, a docket and a written answer to every kind of comment received. The regulation also says outright that persuasiveness beats volume.
Key takeaways
- A proposal has three possible outcomes: the proceeding is terminated, a new proposal issues, or a final regulation is promulgated.
- A notice of proposed rulemaking must carry a plain-language summary, the comment closing date, a named contact, a preamble with the facts and policy and the authority relied on, and the docket number.
- The default comment period is 60 days, adjustable for good cause, with an absolute floor of 10 days.
- Anyone may request an extension in writing; 30 days or more is published and applies to everyone.
- The decision rests on quality and persuasiveness, not the number or length of comments, and solely on the administrative record.
- Critical comments are encouraged to include preferred alternative wording.
- A final rule's preamble must summarize each type of comment and give the Commissioner's conclusions on each, with a thorough and comprehensible explanation.
- A final regulation's effective date is at least 30 days after publication, with two named exceptions.
- Notice and comment can be skipped for good cause, but the promulgating notice must state the reasons and open a comment opportunity on modification or revocation.
- Filing means only that no technical deficiencies were found, and every submission is a representation subject to the federal false statements statute.
Answer first: proposed is a stage, not a decision
The regulation sets out a sequence, and each step has a name.
With limited exceptions, each regulation must be the subject of a notice of proposed rulemaking published in the Federal Register.
After the time for comment expires, the Commissioner reviews the entire administrative record on the matter, including all comments. Then, in a published notice, the Commissioner does one of three things. Terminates the proceeding, issues a new proposal, or promulgates a final regulation.
So a proposal has three possible futures and only one of them is a rule. A headline about a proposed rule is a headline about the first stage of that sequence.
There is a floor on when a final rule can bite. The effective date may not be less than 30 days after publication. Two exceptions apply: a regulation that grants an exemption or relieves a restriction, and one where the Commissioner finds and states good cause for an earlier date.
What a proposal has to contain
The notice has a required structure, and knowing it makes one much faster to read.
The name of the agency, the nature of the action, and a summary in the first paragraph describing the substance of the document in easily understandable terms.
Relevant dates, such as the comment closing date and the proposed effective date. The name, business address and phone number of an agency contact person who can provide further information.
An address for submitting written comments.
Then the part where the reasoning lives. Supplementary information in the form of a preamble that summarizes the proposal and the facts and policy underlying it. It also includes references to all information the Commissioner relies on, and cites the authority under which the regulation is proposed.
The notice must give either the terms or substance of the proposed regulation, or a description of the subjects and issues involved. It also carries a reference to the existence or lack of need for an environmental impact statement.
And it carries the docket number, which identifies the docket file established for all relevant submissions on the matter.
That docket number is the single most useful thing on the page. It is the handle for everything anybody files.
The clock, and how to ask for more time
The comment window is set by default and adjustable in both directions.
The proposal will provide 60 days for comment, although the Commissioner may shorten or lengthen this period for good cause.
There is a hard floor. In no event is the time for comment to be less than 10 days.
After publication, any interested person may request an extension for an additional specified period, in writing, stating the grounds.
The regulation names what such a request has to discuss. The reason comments could not feasibly be submitted in the time permitted. That important new information will shortly be available. Or that sound public policy otherwise supports an extension.
The response can go several ways. The request may be granted, denied, or granted for a different period than asked for. An extension may be limited to specific persons who made and justified the request, though it will ordinarily apply to everyone.
Publication follows length. An extension of 30 days or longer is published in the Federal Register and applies to all interested persons. A shorter one is handled by a letter or memorandum filed with the docket office, or by a published notice.
Quality over volume, in the regulation's own words
One paragraph disposes of the most common misconception about public comment.
The quality and persuasiveness of the comments will be the basis for the Commissioner's decision.
It then addresses the count. The number or length of comments will not ordinarily be a significant factor in the decision, unless the number of comments is material where the degree of public interest is a legitimate factor for consideration.
The decision is also bounded. It will be based solely upon the administrative record.
And the regulation makes a suggestion that reads like practical advice. Persons submitting comments critical of a proposed regulation are encouraged to include their preferred alternative wording.
That is the difference between a comment that registers an objection and a comment that can be adopted. One says no; the other hands the agency a sentence.
What a final rule has to say back
The obligation on the agency at the end of the process is stronger than most readers assume.
A final regulation published in the Federal Register carries a preamble with the same identifying elements as a proposal. Agency, nature of the action, plain summary, relevant dates, contact person, and where comments may be submitted where they are permitted.
Then the part that answers you. The preamble's supplementary information must contain references to prior notices on the same matter and a summary of each type of comment submitted on the proposal, together with the Commissioner's conclusions on each.
And a standard is set for that discussion. The preamble is to contain a thorough and comprehensible explanation of the reasons for the Commissioner's decision on each issue.
So the preamble to a final rule is the closest thing to a written reply the public gets, and reading it is how you find out whether an argument landed.
When there is no comment period at all
Notice and comment do not apply universally, and the exceptions are stated.
The notice and public procedure requirements do not apply where the Commissioner determines for good cause that they are impracticable, unnecessary, or contrary to the public interest.
That determination is not silent. In those cases the notice promulgating the regulation must state the reasons for the determination and provide an opportunity for comment to determine whether the regulation should subsequently be modified or revoked.
A subsequent notice based on those comments may, but need not, provide additional opportunity for public comment.
Two other categories are carved out by name: food additive and color additive petitions, which follow a different procedure, and new animal drug regulations promulgated under a specific statutory section.
There is also a line about the source of the obligation. The notice and comment provisions apply only to the extent required by the Administrative Procedure Act, though the Commissioner may voluntarily follow them where they are not required.
Other doors the agency can open
Beyond the required notice, the regulation lists additional procedures the Commissioner may use before or after publication.
Conferences, meetings, discussions and correspondence. A hearing under one of several hearing parts.
A published notice requesting information and views before deciding whether to propose a regulation at all. That one is worth watching for, because it is the earliest point at which an outside view can matter.
A draft proposed regulation placed on public display at the docket office, with a notice stating that it is available and specifying the time for comment.
A revised proposal, which is then subject to all the same rules as an original one.
And a tentative final regulation placed on public display, with a copy mailed to each person who commented on the proposal where one was published.
What is in the record, and when it closes
The record is defined by a list, and knowing what is in it tells you what the decision can rest on.
The proposed rule as published, including all information the Commissioner identified or filed with the docket office on the proposal.
All comments received on the proposal, including all information submitted as part of those comments.
The notice promulgating the final regulation, including everything filed as part of its administrative record.
The transcripts, minutes of meetings, reports and notices resulting from the additional procedures — with one exclusion, the transcript of a closed portion of a public advisory committee meeting.
Closing is defined too. The record closes on the date the final regulation is published, unless another date is specified.
After that there are two named routes: a petition for reconsideration, or a petition for a stay of action. And a person who wants to rely on information not in the record must submit it with a new petition to modify the final regulation.
What a submission has to look like
A separate section governs the mechanics of filing anything with the docket office, and several rules in it are easy to trip over.
Information referred to or relied upon in a submission is to be included in full and may not be incorporated by reference, unless previously submitted in the same proceeding.
A copy of any cited article or source must be included, with four exceptions. A reported federal court case. A federal law or regulation. An agency document that is routinely publicly available. And a recognized medical or scientific textbook readily available to the agency.
Foreign-language material must come with a verified complete and accurate English translation, the translator's name, address and qualifications, and copies of the original publication.
Where relevant information sits inside a document that also holds irrelevant information, the irrelevant part is to be deleted and only the relevant part submitted.
Two deletions are mandatory. Names and other information identifying patients or research subjects, to preclude a clearly unwarranted invasion of personal privacy. And defamatory, scurrilous or intemperate matter.
Failing those requirements has a consequence. A deficient submission is not filed but returned with the applicable regulations indicating what was not complied with, and it can be corrected and filed again.
Two more things worth knowing before you file
Both are stated plainly in the same section.
Filing means less than it sounds like. The filing of a submission means only that the docket office has identified no technical deficiencies in it. Filing a petition does not mean or imply that it meets all applicable requirements, contains reasonable grounds, or that what it asks for is in accordance with law.
And a submission is a representation. All submissions are representations that, to the best of the knowledge, information and belief of the person making them, the statements made are true and accurate. They are subject to the federal false statements statute, under which a willfully false statement is a criminal offense.
Comments are public. Comments on documents published in the Federal Register are among the submissions placed on public display and available for public examination.
The regulation also describes the filing itself in paper terms — copies, mailing, postmark dates — while allowing a relevant Federal Register notice to specify otherwise. The notice you are commenting on is the authority on how to send it, and it is the thing to read for that.
What this page does not tell you
Three boundaries, stated where you can see them.
Everything above is drawn from the agency's own procedural regulations on rulemaking and on submissions to its docket office. No pending rulemaking is described and no company is named.
It does not name an electronic filing website or a specific online route for comments. The regulation's own text does not name one, no filing system was checked, and the notice you are responding to is the place that says how to submit.
And the separate procedure for asking the agency to act by petition is covered on its own page and is not repeated here.
Sources
- 21 CFR 10.40 — Promulgation of regulations for the efficient enforcement of the law, and 21 CFR 10.20 — Submission of documents to Dockets Management StaffSection 10.40(b) for each regulation being the subject of a notice of proposed rulemaking published in the Federal Register; 10.40(b)(1)(i) through (x) for the ten required contents of that notice, including the plain-language summary paragraph, relevant dates such as the comment closing date, the named contact with business address and phone number, an address for written comments, the preamble summarizing the proposal and the facts and policy underlying it with references to all information relied on and a citation of authority, either the terms or substance of the proposed regulation or a description of the subjects and issues, the environmental impact statement reference, and the docket number identifying the docket file established for all relevant submissions; 10.40(b)(2) for the 60-day default comment period, the Commissioner's ability to shorten or lengthen it for good cause, and the floor that in no event is the time for comment to be less than 10 days; 10.40(b)(3) for extension requests, and (b)(3)(i) for the three grounds a request must discuss and the Commissioner's options to grant, deny or grant a different period, and to limit an extension to specific persons though it will ordinarily apply to all; (b)(3)(ii) for extensions of 30 days or longer being published and applicable to all interested persons and shorter ones being handled by letter, memorandum or notice; 10.40(b)(5) for the encouragement to include preferred alternative wording. Section 10.40(c) for the post-comment review of the entire administrative record and the three outcomes — terminate the proceeding, issue a new proposal, or promulgate a final regulation; 10.40(c)(1) for quality and persuasiveness being the basis of the decision and number or length not ordinarily being a significant factor unless the number is material where public interest is a legitimate factor; 10.40(c)(2) for the decision being based solely upon the administrative record; 10.40(c)(3) for the final regulation's preamble contents including references to prior notices, a summary of each type of comment and the Commissioner's conclusions on each, and the requirement of a thorough and comprehensible explanation of the reasons for the decision on each issue; 10.40(c)(4) for the effective date being not less than 30 days after publication with the exemption/restriction-relief and good-cause exceptions. Section 10.40(d) for notice and comment applying only to the extent required by the Administrative Procedure Act and the Commissioner's discretion to follow them voluntarily. Section 10.40(e)(1) for the good cause exception where notice and public procedure are impracticable, unnecessary or contrary to the public interest, the requirement to state the reasons in the promulgating notice, and the opportunity for comment on subsequent modification or revocation; 10.40(e)(2) and (e)(3) for the food additive and color additive petition and new animal drug carve-outs. Section 10.40(f)(1) through (6) for the additional procedures, including conferences and meetings, hearings, a Federal Register notice requesting information and views before deciding whether to propose a regulation, a draft proposal placed on public display with a notice specifying the time for comment, a revised proposal, and a tentative final regulation placed on display with copies mailed to prior commenters. Section 10.40(g)(3) through (6) for the contents of the administrative record and the exclusion of the transcript of a closed portion of a public advisory committee meeting; 10.40(h) for the record closing on the date of publication of the final regulation unless another date is specified, the routes of a petition for reconsideration or for a stay of action, and the requirement to submit new information with a new petition to modify the final regulation. Section 10.20(a) for submissions being filed in copies except as otherwise specifically provided in a relevant Federal Register notice or another section, and for the Dockets Management Staff being the custodian; 10.20(c) for information relied on being included in full and not incorporated by reference unless previously submitted in the same proceeding; 10.20(c)(1)(i) through (iv) for the four exceptions to enclosing a cited source; 10.20(c)(2) for the verified English translation with the translator's name, address and qualifications and copies of the original publication; 10.20(c)(3) for deleting irrelevant information; 10.20(c)(4) for deleting names and other identifying information for patients or research subjects to preclude a clearly unwarranted invasion of personal privacy; 10.20(c)(5) for deleting defamatory, scurrilous or intemperate matter; 10.20(c)(6) for a deficient submission being returned with the applicable regulations indicating what was not complied with, and being correctable and re-filable; 10.20(d) for filing meaning only that no technical deficiencies were identified and not implying that a petition meets all requirements, contains reasonable grounds, or seeks action in accordance with law; 10.20(i) for every submission being a representation that its statements are true and accurate to the best of the submitter's knowledge, information and belief, and being subject to the False Reports to the Government Act under which a willfully false statement is a criminal offense; 10.20(j)(1)(ii) for comments on documents published in the Federal Register being on public display and available for public examination.
Frequently asked questions
Is a proposed rule in effect?
No. A proposal is one stage of a defined sequence. After the comment period closes, the Commissioner reviews the entire administrative record including all comments and, in a published notice, either terminates the proceeding, issues a new proposal, or promulgates a final regulation. Only the last of those produces a rule. A final regulation's effective date may not be less than 30 days after publication, except where it grants an exemption, relieves a restriction, or the Commissioner finds and states good cause for an earlier date.
How long is the comment period?
The proposal will provide 60 days for comment, though the Commissioner may shorten or lengthen that for good cause. In no event may the time for comment be less than 10 days. Any interested person may request an extension in writing, stating grounds such as the infeasibility of commenting in the time permitted, important new information becoming available shortly, or sound public policy. An extension of 30 days or longer is published and applies to everyone.
Does the number of comments matter?
Not usually, and the regulation says so. The quality and persuasiveness of the comments will be the basis for the decision. The number or length of comments will not ordinarily be a significant factor, unless the number is material where the degree of public interest is a legitimate factor for consideration. The decision is also based solely upon the administrative record.
What makes a comment useful?
The regulation offers one direct suggestion: persons submitting comments critical of a proposed regulation are encouraged to include their preferred alternative wording. Beyond that, the submission rules require that information relied on be included in full rather than incorporated by reference. They also require that a copy of any cited source be enclosed. The exceptions are a reported federal court case, a federal law or regulation, a routinely available agency document, and a recognized medical or scientific textbook readily available to the agency.
Does the agency have to respond to comments?
The preamble to a final regulation must contain references to prior notices on the same matter and a summary of each type of comment submitted, together with the Commissioner's conclusions on each. It is to contain a thorough and comprehensible explanation of the reasons for the decision on each issue. That preamble is where you find out what happened to an argument.
Can a rule be issued without any comment period?
In defined situations. The notice and public procedure requirements do not apply where the Commissioner determines for good cause that they are impracticable, unnecessary, or contrary to the public interest. In that case the notice promulgating the regulation must state the reasons. It must also provide an opportunity for comment on whether the regulation should later be modified or revoked. Food additive and color additive petitions and new animal drug regulations are separately carved out.
Are my comments public?
Yes. Comments on documents published in the Federal Register are among the submissions placed on public display and available for public examination. The submission rules also require deleting names and other information identifying patients or research subjects before filing, to preclude a clearly unwarranted invasion of personal privacy, and deleting defamatory, scurrilous or intemperate matter.
What happens after a final rule publishes?
The administrative record closes on the date of publication unless another date is specified. After that, an interested person may submit a petition for reconsideration or a petition for a stay of action. Someone who wants to rely on information or views not already in the record has to submit them with a new petition to modify the final regulation.