Research · 10 min read
How Anyone Can Formally Ask FDA to Act
There is a filing any person can make that obliges the agency to answer in writing, in a prescribed format, on a public docket. The strangest requirement in it is that you must include the evidence that cuts against you.
Key takeaways
- A citizen petition may be filed by any person, including someone who is not a U.S. citizen, asking FDA to issue, amend or revoke a regulation or order, or to take or refrain from any administrative action.
- The format is printed inside the regulation: action requested, statement of grounds, environmental impact, economic impact when requested, and a certification.
- Both the statement of grounds and the certification require the petitioner to include representative information unfavorable to their own position.
- FDA must respond within 180 days generally, 90 days for one generic-drug category, and states it intends to respond within 150 days for another.
- There are four permitted responses: approve with concurrent implementing action, deny, dismiss as moot, or give a tentative response.
- Anyone may comment on a filed petition and the comments join the docket, but a request for different relief must be a separate petition.
- The administrative record is exclusive and closes on the decision date; new evidence requires a new petition.
- Informal correspondence is not a petition and produces no final agency action subject to judicial review.
Answer first: it is called a citizen petition, and anyone may file one
The regulation opens as broadly as it could. The section applies to any petition submitted by a person — and it adds, in parentheses, including a person who is not a citizen of the United States.
What it asks for is specific. A petition requests the Commissioner of Food and Drugs to issue, amend or revoke a regulation or order, or to take or refrain from taking any other form of administrative action.
Once filed, it is stamped with the date of filing and assigned a unique docket number, and the petitioner is promptly notified of both. That docket number becomes the address for everything that follows.
And the agency has to answer. The Commissioner shall rule upon each petition filed, and shall furnish a response to each petitioner within 180 days of receipt, with narrower deadlines for two specific categories.
The five-part format, which is not optional
The regulation prints the form of the petition inside the regulation itself, which is unusual and makes it easy to check whether a document is really one.
It opens with a date and a sentence naming the statutory sections relied on, the statute, and what the Commissioner is being asked to do.
Section A, Action Requested. If the petition asks for a regulation to be issued, amended or revoked, it must give the exact wording of the existing regulation, if any, and the exact proposed wording. If it asks about an order, the same. If it asks for any other administrative action, the specific action or relief requested.
Section B, Statement of Grounds. A full statement, in a well-organized format, of the factual and legal grounds relied on.
Section C, Environmental Impact — either a claim for a categorical exclusion under the agency's environmental regulations, or an environmental assessment.
Section D, Economic Impact. This one is submitted only when the Commissioner requests it after reviewing the petition. It covers effects on costs and prices, productivity, competition, supplies of important materials or services, employment, and energy supply or demand.
Section E, Certification, which is where the interesting part lives.
You have to file the evidence against yourself
The certification reads, in the regulation's own words, that the undersigned certifies two things to the best of their knowledge and belief. That the petition includes all information and views on which it relies. And that it includes representative data and information known to the petitioner which are unfavorable to the petition.
The same duty appears a second time, one section earlier. The statement of grounds must include all relevant information and views the petitioner relies on, as well as representative information known to the petitioner which is unfavorable to the petitioner's position.
That is a genuinely unusual requirement for an advocacy document. A petition is a request for a specific outcome, filed by someone who wants it, and it must nevertheless carry the material that argues the other way.
It also gives a reader a test. When reading a filed petition, look for the unfavorable material. Its absence is not proof of anything by itself, but a petition that reads as entirely one-sided is worth reading against the certification it carries.
The four answers, and the one people misread
A response can take one of four forms, and the fourth is the one that causes confusion.
Approve the petition, in which case the Commissioner concurrently takes appropriate action implementing the approval — the regulation gives publication of a Federal Register notice as its example.
Deny the petition.
Dismiss the petition, where the Commissioner determines that changes in law, facts or circumstances since it was submitted have rendered it moot.
Or provide a tentative response, indicating why the agency has not been able to reach a decision — the regulation names other agency priorities or a need for additional information as examples. A tentative response may also indicate the likely ultimate answer and specify when a final response may be furnished.
A tentative response is a real, named outcome. It is not the agency failing to reply, and it is not a decision either. Reading one as a denial, or as silence, gets the state of play wrong in opposite directions.
The Commissioner may also grant or deny in whole or in part, and may grant other relief or take other action as the petition warrants. The decision is placed in the public docket file and may also appear as a Federal Register notice.
The clocks, and the word that changes between them
Three deadlines appear, and they are not phrased the same way.
The general rule: the Commissioner shall furnish a response to each petitioner within 180 days of receipt.
For a petition filed under one specific generic-drug provision of the statute: the Commissioner shall furnish a response within 90 days, and that response will either approve or disapprove the petition.
For a petition subject to another statutory provision: the Commissioner intends to furnish a response within 150 days.
Shall and intends are different commitments, and the regulation uses each deliberately. It is worth noticing which one governs a petition before treating a passing deadline as a failure.
The regulation also states what the Commissioner weighs in ruling. Available agency resources for the category of subject matter. The priority assigned to the petition, considering both the subject matter and the agency's overall work. And time requirements established by statute.
Anyone can comment, and the comments are part of the record
An interested person may submit comments on a filed petition, and those comments become part of the docket file. A comment must specify the docket number and may support or oppose the petition in whole or in part.
There is a limit on what a comment can do. A request for alternative or different administrative action has to be submitted as a separate petition rather than smuggled in as a comment.
That structure is what makes a docket readable years later. The request, the material for and against it, the comments, and the decision all sit in one numbered file.
The Dockets Management Staff also maintains a chronological list of petitions filed under this section, showing the docket number and the date each was filed.
The record is exclusive, and it closes
The administrative record consists of the petition and everything it relies on, together with all comments received and their supporting information. It also holds documents from any optional procedures the Commissioner used, and the Commissioner's decision with the material supporting it. Where reconsideration or a stay is sought, it holds the record specified for those as well.
The regulation then says something with real consequences. That record is the exclusive record for the Commissioner's decision, and it closes on the date of the decision unless another date is specified.
After that, an interested person may petition for reconsideration or for a stay of action, under separate sections.
But a person who wants to rely on information or views not in the record has only one route: submit them with a new petition to modify the decision. New evidence does not get added to a closed record.
That is why the timing of a comment matters as much as its content. Material filed after the record closes is not part of what the decision rests on.
What is not a petition
Two exclusions are stated outright, and the second one catches a lot of people.
The section does not apply to the referral of a matter to a United States attorney for court enforcement action, or to the related correspondence.
And it does not apply to requests, suggestions and recommendations made informally in routine correspondence received by FDA. Routine correspondence does not constitute a petition unless it purports to meet the requirements of the section.
The consequence is spelled out. Action on routine correspondence does not constitute final administrative action subject to judicial review.
So writing to the agency and receiving a reply produces no reviewable decision. The format above is what converts a request into something the agency must rule on and a court can later look at.
One more mechanical point worth knowing. A petitioner may supplement, amend or withdraw a petition without agency approval and without prejudice to resubmission, at any time until the Commissioner rules on it or it is referred for a hearing. After that, those steps need the Commissioner's approval, and a withdrawal may be approved with or without prejudice against resubmitting.
Why this matters for reading arguments in this category
Disputes about what may be compounded, about whether a drug belongs on a shortage list, and about what a label should say are frequently argued through this mechanism rather than in public statements.
That is useful to a reader for a simple reason. A press release is written to persuade you. A citizen petition is written to persuade the agency, in a prescribed format, on a public docket, under a certification that unfavorable material is included.
The comments filed against a petition are often the sharpest available statement of the other side's case, and they are in the same file.
Petitions are submitted electronically through the federal rulemaking portal at a general docket the regulation names, or by mail to the agency's Dockets Management Staff, with two copies where a petition is confidential.
The practical habit is to search the docket rather than the news. The decision, when it comes, is placed in that same public file.
Sources
- 21 CFR 10.30 — Citizen petitionParagraph (a) for the application to any petition submitted by a person, including a person who is not a citizen of the United States. Paragraph (b)(1) and (b)(2) for electronic submission through the federal rulemaking portal at the general docket the regulation names, and for non-electronic submission to the Dockets Management Staff with two copies for confidential petitions. Paragraph (b)(3) for the prescribed format in full: the opening statement naming the statutory sections and the action requested; section A on exact wording for a regulation or order and the specific relief for any other action; section B on the full statement of factual and legal grounds including representative information unfavorable to the petitioner's position; section C on environmental impact; section D on economic impact submitted only when the Commissioner requests it, with its six listed effects; and section E, the certification that the petition includes all information and views relied on and representative data and information known to the petitioner which are unfavorable to it. Paragraph (c) for filing, date stamping, the unique docket number and prompt notification. Paragraph (d) for comments by interested persons and the rule that a request for alternative or different action must be a separate petition. Paragraph (e)(1) for the three factors the Commissioner takes into consideration; (e)(2) for the 180-day response and the four permitted responses including the tentative response and its examples; (e)(3) for partial grants, other relief, dismissal for mootness, notification and placement in the public docket; (e)(4) for the 90-day response on a petition under section 505(j)(2)(C) of the act; and (e)(5) for the statement that the Commissioner intends to respond within 150 days for petitions subject to section 505(q). Paragraph (g) for supplementing, amending or withdrawing a petition before a ruling or referral, and the approval requirement afterward. Paragraph (h) for the optional review procedures. Paragraph (i) for the seven components of the administrative record. Paragraph (j) for the record being exclusive, its closing on the decision date, the availability of reconsideration and stay petitions, and the requirement that new information come in a new petition. Paragraph (k) for the two exclusions and the statement that action on routine correspondence is not final administrative action subject to judicial review. Paragraph (l) for the chronological list maintained by the Dockets Management Staff.
Frequently asked questions
Who can file a citizen petition?
Any person. The regulation says the section applies to any petition submitted by a person, and adds in parentheses that this includes a person who is not a citizen of the United States. There is no requirement to be a company, a clinician or an affected patient.
Does FDA have to answer?
Yes. The Commissioner shall rule upon each petition filed, and shall furnish a response to each petitioner within 180 days of receipt. Two categories have their own timing. For a petition under one generic-drug provision of the statute the deadline is 90 days, and the response will either approve or disapprove. For petitions subject to another statutory provision, the Commissioner intends to furnish a response within 150 days. The regulation uses shall in the first two and intends in the third.
What does a tentative response mean?
It is one of four permitted responses, alongside approval, denial and dismissal for mootness. It indicates why the agency has not been able to reach a decision, and the regulation gives other agency priorities or a need for additional information as examples. It may also indicate the likely ultimate response, and specify when a final one may be furnished. It is neither a denial nor silence.
Why would a petitioner include evidence against their own position?
Because the regulation requires it twice. The statement of grounds must include representative information known to the petitioner which is unfavorable to the petitioner's position. The certification at the end of the prescribed format says the same thing again, in its own words, about representative data and information unfavorable to the petition. That makes a filed petition a more useful document to read than an ordinary advocacy piece.
Can I comment on someone else's petition?
Yes. An interested person may submit comments on a filed petition, and they become part of the docket file. A comment must specify the docket number and may support or oppose the petition in whole or in part. What a comment cannot do is ask for different relief — a request for alternative or different administrative action must be submitted as a separate petition.
Can new evidence be added after a decision?
Not to the same record. The administrative record is the exclusive record for the Commissioner's decision, and it closes on the date of the decision unless another date is specified. A person wishing to rely on information or views not in the record must submit them with a new petition to modify the decision. Separate provisions allow a petition for reconsideration or for a stay of action.
Is writing a letter to FDA the same thing?
No, and the regulation is explicit. Requests, suggestions and recommendations made informally in routine correspondence are outside the section, and routine correspondence does not constitute a petition unless it purports to meet the section's requirements. Action on routine correspondence does not constitute final administrative action subject to judicial review. The prescribed format is what turns a request into something the agency must rule on.