Research
How a drug rule gets made, and how a person gets heard
Anyone may ask the agency to write, change or scrap a rule, and anyone may comment on a proposal. The regulation is explicit that persuasiveness counts and volume does not.
Two doors, and both are open to individuals
Rules that decide what may be compounded, what a label must say and what a seller may claim are not handed down without a process. There are two ways into that process.
The first is a petition. Anyone may ask the agency to issue, amend or revoke a regulation or an order, or to take or refrain from taking some other administrative action.
The eligibility clause is unusually wide. The section applies to any petition submitted by a person, "including a person who is not a citizen of the United States".
The second is a comment on something already proposed. That is the more common route and the one with a deadline attached.
Both end up in the same place: a numbered public docket that holds every submission on the matter.
What a petition has to contain
The format is prescribed, which is helpful rather than obstructive because it tells you exactly what to write.
The petition states the statutory provision it is brought under and what it asks the Commissioner to do. Where it asks for a regulation to be issued, amended or revoked, it must give the exact wording of the existing regulation, if any, and of the proposal.
Then comes the substance. A full statement, in a well-organized format, of the factual and legal grounds relied on, including all relevant information and views.
And a requirement that has no equivalent in ordinary advocacy. The statement must include "as well as representative information known to the petitioner which is unfavorable to the petitioner's position".
A petitioner is obliged to put the evidence against itself on the record. That is worth knowing when reading someone else's petition, because a petition that presents no unfavorable information is either unusual or incomplete.
Petitions may be submitted electronically through the federal rulemaking portal, or on paper to the dockets office, with two copies where confidentiality is claimed.
What happens to it, and the deadline that is really a checkpoint
Once filed, the petition gets a unique docket number, and every later submission on the matter refers to that number and joins that file.
Other people can join in. "An interested person may submit comments to the Dockets Management Staff on a filed petition", and those comments "may support or oppose the petition in whole or in part".
There is a boundary on that. "A request for alternative or different administrative action must be submitted as a separate petition." You cannot convert someone else's petition into your own by commenting on it.
The agency then rules on the petition, taking into account available resources for the subject matter, the priority assigned to it, and any statutory time requirements.
The clock is stated. The Commissioner "shall furnish a response to each petitioner within 180 days of receipt of the petition".
But four outcomes satisfy that deadline, and only two are decisions. Approve. Deny. Dismiss as moot because law, facts or circumstances have changed. Or "Provide a tentative response, indicating why the agency has been unable to reach a decision".
A tentative response may indicate the likely ultimate answer and when a final one might come. So a hundred and eighty days guarantees a reply, not a result.
The proposal, and what the notice must tell you
The other route starts when the agency publishes a notice of proposed rulemaking, which every regulation must generally be the subject of.
The required contents of that notice are a checklist a reader can use.
The nature of the action. A summary in the first paragraph describing the substance "in easily understandable terms". Relevant dates, including the comment closing date and proposed effective dates.
The name, business address and phone number of an agency contact who can answer questions. An address for submitting written comments.
A preamble summarizing the proposal and the facts and policy underlying it, with references to all the information the Commissioner relies on, copies or a full list of which sit in the docket file.
Either the terms or substance of the proposed regulation, or a description of the subjects and issues. And the docket number.
The agency may also publish two or more alternative proposed regulations on the same subject specifically to get comment on the differences.
How long you get, and how to get longer
The default window is stated plainly. "The proposal will provide 60 days for comment", though the Commissioner may shorten or lengthen it for good cause.
There is a floor. "In no event is the time for comment to be less than 10 days."
Extensions can be requested by anyone, in writing, and the regulation even tells you what to put at the top: the request should be headed "REQUEST FOR EXTENSION OF COMMENT PERIOD".
The request has to make one of three arguments. That comments could not feasibly be submitted in the time allowed, that important new information will shortly be available, or that sound public policy otherwise supports more time.
An extension may in principle be limited to the people who asked for it, but the regulation says it will ordinarily apply to everyone.
An extension of thirty days or longer is published in the Federal Register and applies to all interested persons.
The sentence that should change how people comment
Organized comment campaigns rest on an assumption the regulation contradicts in two consecutive sentences.
"The quality and persuasiveness of the comments will be the basis for the Commissioner's decision."
And then: "The number or length of comments will not ordinarily be a significant factor in the decision", unless the number is material where the degree of public interest is a legitimate factor.
Alongside that sits a piece of practical advice the agency wrote into its own rules. "Persons submitting comments critical of a proposed regulation are encouraged to include their preferred alternative wording."
A comment that says what the rule should say instead is doing something a thousand identical form letters cannot.
The decision is also closed to anything outside the file. "The decision of the Commissioner on the matter will be based solely upon the administrative record."
The final rule, and the two ways comment gets skipped
After the comment period closes, the Commissioner reviews the entire administrative record and publishes a notice that either terminates the proceeding, issues a new proposal, or promulgates a final regulation.
A final regulation carries a preamble that must address each type of comment submitted and the conclusions on each, with "a thorough and comprehensible explanation of the reasons" for the decision on each issue.
Timing is constrained. The effective date of a final regulation "may not be less than 30 days after the date of publication" in the Federal Register.
Two exceptions to that. A regulation granting an exemption or relieving a restriction, and one where the Commissioner finds and states good cause for an earlier date.
Notice and comment itself can also be bypassed. The requirements do not apply where the Commissioner determines for good cause that they are "impracticable, unnecessary, or contrary to the public interest".
Where that happens the notice promulgating the regulation must state the reasons and provide an opportunity to comment on whether the rule should later be modified or revoked.
The agency may also add procedures rather than remove them, including meetings, hearings, a request for information before deciding whether to propose anything, a draft placed on public display, or a revised proposal.
Why this matters on a page about peptides
Several of the questions this site tracks are open because a rulemaking is unfinished rather than because the science is unsettled.
A substance sitting on a nomination list. A category awaiting a final rule. A policy operating as guidance rather than regulation. Each of those is a docket with a number, a comment history and a preamble that will eventually explain the outcome.
That means two things for a reader. The reasoning is public, in the preamble, and it is written to address the comments rather than to summarize a decision already made.
And participation is genuinely open, on a stated deadline, with a stated standard that rewards a specific, well-supported argument over a signature.
Two limits on this article. Only sections 10.30 and 10.40 were read, in full. No docket, petition or proposed rule was retrieved, so nothing here describes the status of any particular proceeding.
Key takeaways
- Anyone may petition the agency to issue, amend or revoke a rule, including a person who is not a United States citizen.
- A petition must include representative information known to the petitioner that is unfavorable to its own position.
- A response is due within a hundred and eighty days, but a tentative response satisfies that deadline.
- Others may comment on a filed petition, though a different request needs its own petition.
- A proposal provides sixty days for comment by default, and never fewer than ten.
- Quality and persuasiveness decide the outcome; the number of comments ordinarily does not.
- Critical comments are encouraged to include the preferred alternative wording.
- A final rule cannot take effect sooner than thirty days after publication, with two stated exceptions.
Frequently asked questions
Can an ordinary person ask the FDA to change a rule?
Yes. The petition section applies to any petition submitted by a person, including a person who is not a citizen of the United States. A petition can ask the Commissioner to issue, amend or revoke a regulation or an order, or to take or refrain from taking any other form of administrative action. It can be submitted electronically through the federal rulemaking portal or on paper to the dockets office.
What has to be in a petition?
The statutory basis and what is being asked for, with the exact wording of any existing and proposed regulation. Then a full statement, in a well-organized format, of the factual and legal grounds relied on, including all relevant information and views. It must also include representative information known to the petitioner which is unfavorable to the petitioner's position. That last requirement means a petition is expected to put the contrary evidence on the record itself.
How long does the agency take to answer a petition?
A response is due within a hundred and eighty days of receipt, but four outcomes satisfy that. Approval, denial, dismissal as moot where law, facts or circumstances have changed, or a tentative response explaining why no decision has been reached. A tentative response may indicate the likely ultimate answer and when a final one may come. The deadline guarantees a reply rather than a resolution.
How long is a comment period?
Sixty days by default, though the Commissioner may shorten or lengthen it for good cause, and in no event may it be less than ten days. Anyone may request an extension in writing, headed as a request for extension of the comment period. The request must argue that comments could not feasibly be submitted in time, that important new information is coming, or that sound public policy supports more time. Extensions of thirty days or more are published and apply to everyone.
Does the number of comments matter?
The regulation says it ordinarily does not. It states that the quality and persuasiveness of the comments will be the basis for the decision. It then states that 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. It also encourages people submitting critical comments to include their preferred alternative wording.
Can a rule take effect immediately?
Usually not. The effective date of a final regulation may not be less than thirty 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. Separately, notice and comment can be skipped where the Commissioner determines for good cause that it is impracticable, unnecessary or contrary to the public interest. In that case the reasons must be stated and a later opportunity to comment provided.
Where do I read the agency's reasoning?
In the preamble to the final regulation. It must address each type of comment submitted on the proposal and the Commissioner's conclusions on each, with a thorough and comprehensible explanation of the reasons for the decision on each issue. The decision itself is based solely on the administrative record, which is the docket file holding the proposal, the information relied on, and every comment.
Sources
Each document below is named as it names itself, with the date printed on that document rather than the day it was read.
- Title 21 Code of Federal Regulations section 10.30, Citizen petition, read in full for the format, the unfavorable information requirement, the docket and comment provisions and the response deadline — Electronic Code of Federal Regulations, Office of the Federal Register, July 2023
- Title 21 Code of Federal Regulations section 10.40, Promulgation of regulations for the efficient enforcement of the law, read in full for the notice contents, the comment period, the basis for decision and the effective date rule — Electronic Code of Federal Regulations, Office of the Federal Register, March 2001